Syringe systems and related methods

Abstract

In one embodiment, the syringe system includes a double-barrel syringe, a two-chamber mixing cartridge, and multiple mixing blocks. The double-barrel syringe includes a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge is configured to fit into the double-barrel syringe and includes a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber. Multiple mixing blocks are positioned inside the first and second powder chambers.

Description

Technical Field

[0001] Cross - reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 501,534, filed May 11, 2023, under the name "MIXING SYRINGE SYSTEMS AND DEVICES, AND METHODS OF MIXING CONSTITUENT MATERIALS", and U.S. Provisional Application No. 63 / 501,546, filed May 11, 2023, under the name "MIXING SYRINGE ASSEMBLIES AND METHODS OF MIXING CONSTITUENT MATERIALS", which are hereby incorporated herein by reference in their entirety.

[0002]

[0001] The present disclosure relates generally to syringe systems and methods, particularly syringe systems and methods for mixing constituent materials of a radiation spacer.

Background Art

[0003]

[0002] Prostate cancer is the most common non - skin cancer diagnosed in men. Radiation therapy is an excellent treatment option for prostate cancer. However, radiation exposure can cause unintended side effects to adjacent non - target tissues. Radiation spacers, such as radiation protection spacers, can be implanted to avoid incidental radiation and minimize damage to surrounding tissues by creating a space between the target tissue and the at - risk non - target tissue.

[0004]

[0003] Conventional radiation spacers may include a gelling material that is delivered as a liquid and can harden. However, the components of the gel may start to gel when they come into contact with each other, which can make delivery difficult. Also, the components may need to remain separated until use, or else they may have limited stability and degrade over time.

Summary of the Invention

[0005]

[0004] Embodiments of the present disclosure relate to various syringe systems that can maintain the separation of component materials until the mixed component materials are used.

[0005] In one embodiment, the syringe system includes a double-barrel syringe, a two-chamber mixing cartridge, and a plurality of mixing masses. The double-barrel syringe includes a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge is configured to fit into the double-barrel syringe and includes a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber. The plurality of mixing masses are positioned inside the first and second powder chambers.

[0006]

[0006] In another embodiment, the syringe system includes a double-barrel syringe, a two-chamber mixing cartridge, and a collar. The double-barrel syringe includes a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge includes a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber. The collar is configured to receive and fluidly couple (1) the first port and the first cartridge port and (2) the second port and the second cartridge port, and the collar is rotatable relative to the first and second ports and the first and second cartridge ports, and couples the two-chamber mixing cartridge to the double-barrel syringe.

[0007]

[0007] In yet another embodiment, the method for mixing component materials includes coupling a double-barrel syringe with a two-chamber mixing cartridge. The double-barrel syringe includes a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge includes a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber, with multiple mixing masses positioned inside the first and second powder chambers. The method further includes advancing a plunger inside at least one of the first or second diluent chambers so that the first or second diluent enters the first or second powder chamber, respectively, and stirring a plurality of mixed masses inside a two-chamber mixing cartridge so that the first or second powder dissolves in the first or second diluent, respectively.

[0008]

[0008] In yet another embodiment, the method of mixing the constituent materials includes coupling a double-barrel syringe to a two-chamber mixing cartridge with a collar. The double-barrel syringe includes a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge includes a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber. The collar fluidly couples (1) the first port and the first cartridge port with (2) the second port and the first cartridge port, and the collar is rotatable relative to the first and second ports and the first and second cartridge ports, coupling the two-chamber mixing cartridge to the double-barrel syringe. The method further includes advancing a plunger inside at least one of the first or second diluent chambers so that the first or second diluent enters the first or second powder chamber through the collar, respectively, and stirring the two-chamber mixing cartridge so that the first or second powder dissolves in the first or second diluent, respectively.

[0009]

[0009] Further features and advantages of the embodiments described herein are described in the following detailed description, some of which 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, the claims, and the accompanying drawings.

[0010]

[0010] It should be understood that both the above-mentioned general description and the following detailed description are intended to describe various embodiments and to provide an overview or framework for understanding the nature and features of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various embodiments and are incorporated herein and constitute part of this specification. The drawings illustrate the various embodiments described herein and, together with the description, help to illustrate the principles and operation of the claimed subject matter.

[0011]

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

[0012] [Figure 1]

[0012] This is a schematic cross-sectional view showing an exemplary syringe system including a two-chamber mixing cartridge and an applicator according to one or more embodiments shown and described herein. [Figure 2]

[0013] Figure 1 shows an exemplary distal end view of a quarter-turn connector of a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 3]

[0014] Figure 1 shows an exemplary proximal end view of the corresponding quarter-turn connector of the two-chamber mixing cartridge according to one or more embodiments shown and described herein. [Figure 4]

[0015] This is a proximal end view of an applicator according to one or more embodiments shown and described herein. [Figure 5A]

[0016] This figure shows the connection of the two-chamber mixing cartridge of Figure 1 to a double-barrel syringe in an open quarter-turn configuration, according to one or more embodiments shown and described herein. [Figure 5B]

[0017] This figure shows the connection of a two-chamber mixing cartridge in a closed quarter-turn configuration to the double-barrel syringe of Figure 5A, according to one or more embodiments shown and described herein. [Figure 5C]

[0018] Figure 5B is a cross-sectional view of a two-chamber mixing cartridge and a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 5D]

[0019] This figure shows how a plunger is advanced inside the double-barrel syringe shown in Figure 5C to deliver a diluent to a two-chamber mixing cartridge, according to one or more embodiments shown and described herein. [Figure 5E]

[0020] This figure shows how the plunger in Figure 5D is pulled out to draw back the mixture obtained into each chamber of the double-barrel syringe, according to one or more embodiments shown and described herein. [Figure 6A]

[0021] This figure shows a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 6B]

[0022] This figure shows a double-barrel syringe with the cap removed, according to one or more embodiments shown and described herein. [Figure 6C]

[0023] This figure shows the first and second ports of the double-barrel syringe shown in Figure 6A, according to one or more embodiments described herein. [Figure 7A]

[0024] This figure shows a two-chamber mixing cartridge according to one or more embodiments shown and described herein. [Figure 7B]

[0025] This figure shows the first and second cartridge ports of the two-chamber mixing cartridge of Figure 7A, according to one or more embodiments shown and described herein. [Figure 8A]

[0026] A diagram showing a collar for coupling a double-barrel syringe to a two-chamber mixing cartridge according to one or more embodiments shown and described herein. [Figure 8B]

[0027] A cross-sectional view of the collar of FIG. 8A according to one or more embodiments shown and described herein. [Figure 9A]

[0028] A diagram showing the collar of FIG. 8A coupled to a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 9B]

[0029] A cross-sectional view of a collar engaged with the double-barrel syringe of FIG. 9A with respect to a two-chamber mixing cartridge according to one or more embodiments shown and described herein. [Figure 9C]

[0030] A cross-sectional view of the collar of FIG. 9B rotated to couple a double-barrel syringe to a two-chamber mixing cartridge according to one or more embodiments shown and described herein. [Figure 10A]

[0031] A diagram showing a double-barrel syringe adjacent to an applicator according to one or more embodiments shown and described herein. [Figure 10B]

[0032] A cross-sectional view of the applicator of FIG. 10A engaged with a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 10C]

[0033] A diagram showing an applicator rotated with respect to FIG. 10B and coupled to a double-barrel syringe according to one or more embodiments shown and described herein. [Figure 10D]

[0034] A schematic diagram showing the delivery of a radiation spacer from the applicator of FIG. 10C according to one or more aspects shown and described herein.

Mode for Carrying Out the Invention

[0013]

[0035] This disclosure covers syringe systems for mixing multiple component materials as a whole. This application also covers syringe systems configured for delivering radiation spacers. For example, a radiation spacer may be formed from one or more hydrogel materials and delivered to a desired location, for example, inside a balloon or alone, and harden in situ to block or substantially block radiation that may be unintentionally directed towards healthy tissue rather than target or diseased tissue. When mixing hydrogels to form a radiation spacer, multiple materials may need to be combined immediately before and / or at the time of delivery of the radiation spacer into a target site in the body. To maintain material quality, 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. When using traditional methods, determining the appropriate mixing ratio, maintaining sterility, and preventing undesirable premature mixing can be difficult. Embodiments of the present disclosure allow for the supply of component materials in pre-packaged, pre-measured, and ready-to-use syringe assemblies, enabling improved mixing with reduced bubbles, maintenance of sterility, and / or improved delivery, as further described herein.

[0014]

[0036] In certain embodiments, a syringe system for mixing component materials includes a double-barrel syringe comprising a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The system further comprises a two-chamber mixing cartridge configured to be mounted on the double-barrel syringe, comprising a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber. In some embodiments, multiple mixing masses may be positioned inside the first and second powder chambers to facilitate mixing of the component materials. In some embodiments, a collar may be included to receive and fluidly couple (1) a first port and a first cartridge port and (2) a second port and a first cartridge port, the collar being rotatable relative to the first and second ports and the first and second cartridge ports, and coupling a two-chamber mixing cartridge to a double-barrel syringe. Such a collar can enable coupling that prevents rapid and efficient leakage of components.

[0015]

[0037] The systems, devices, and methods described herein are described together with quarter-turn coupling mechanisms used to join components together for mixing. The term “quarter-turn” as used herein should be understood to refer to a rotation completed in approximately one-quarter of a full rotation; that is, a quarter-turn is approximately 90° clockwise or counterclockwise. Components described herein are referred to as “quarter-turn” components because they allow for approximately 90° rotation of the components relative to one another. However, the use of quarter-turn connectors is merely one illustrative example, and it should be understood that other types of connectors (such as turn / rotation connectors, snap connectors, press-fit connectors, etc.) are intended and included within the scope of this disclosure. In particular, quarter-turn connectors can be further described in International Patent Application PCT / US2021 / 023171, filed on 19 March 2021, entitled “Multi-Component Sealant Delivery Systems Incorporating Quarter Turn Connectors,” which is incorporated herein by reference in its entirety.

[0016]

[0038] The solutions realized by the devices, systems, and methods described herein have several distinct advantages over conventional devices, systems, and methods. First, in embodiments including a mixing mass, the mixing mass is contained in a two-chamber mixing cartridge rather than a double-barrel syringe, thereby preventing the mixing mass from interfering with the development of the hydrogel and reducing bubbles that would otherwise be generated during the mixing process. Second, by venting excess air into the two-chamber mixing cartridge, accidental loss of the hydrogel solution is prevented. If the hydrogel solution is accidentally vented into the two-chamber mixing cartridge, the user can easily draw the fluid back into the double-barrel syringe. Third, in embodiments including a collar as described herein, the assembly process may be improved.

[0017]

[0039] The directional terms used herein, such as up, down, right, left, front, back, apex, and bottom, are derived solely from reference to the depicted figures and are not intended to suggest absolute orientation unless otherwise specified.

[0018]

[0040] Unless expressly otherwise provided, no method described herein is ever intended to be construed as requiring its steps to be performed in a specific order or requiring any apparatus to have a specific orientation. Therefore, if a claim for a method does not actually specify the order in which its steps are followed, or if a claim for a device or assembly does not actually specify the order or orientation of its individual components, or if the claim or description does not specifically state that the steps are limited to a specific order, or if no specific order or orientation of the components of a device or assembly is specified, no order or orientation is ever intended to be presumed in any respect. This applies to all possible implicit grounds for interpretation, including logical issues relating to the configuration of the steps, the flow of operations, the order of components, or the orientation of components, plain meaning derived from grammatical structure or punctuation, and the number or type of embodiments described in the specification.

[0019]

[0041] As used herein, the singular forms “a,” “an,” and “the” include multiple referents unless the context explicitly indicates otherwise. Thus, for example, a reference to a “a” component includes embodiments having two or more such components unless the context explicitly indicates otherwise.

[0020]

[0042] Moving on to the figures, Figure 1 shows an exemplary syringe system 100 for mixing component materials according to various embodiments. According to aspects of this disclosure, the syringe system 100 may be used for mixing and / or delivering radiation spacers as described above.

[0021]

[0043] Syringe system 100 generally includes a double-barrel syringe 110 and a two-chamber mixing cartridge 120. In some embodiments, syringe system 100 may further include, for example, an applicator 130 for delivering radiation spacers. Various components of syringe system 100 may be adapted via a coupling system so that the double-barrel syringe 110 can be coupled to the two-chamber mixing cartridge 120 for mixing components of a multi-component material, and can be detached from the two-chamber mixing cartridge 120 and coupled to the applicator 130 for further mixing and delivery of components. When coupled to the two-chamber mixing cartridge 120, as shown in Figures 5A–5E, the combination of the two-chamber mixing cartridge 120 and the double-barrel syringe 110 may be referred to herein as a mixing device 200. When coupled to the applicator 130, the combination of the applicator 130 and the double-barrel syringe 110 may be referred to herein as the delivery device 250, an embodiment thereof is shown in Figures 10A–10C.

[0022]

[0044] In the embodiment, the double-barrel syringe 110 may include a barrel body 112. The barrel body 112 may define a first diluent chamber 112A, a second diluent chamber 112B, a first port 112A-1 fluidly coupled to the first diluent chamber 112A, and a second port 112B-1 fluidly coupled to the second diluent chamber 112B. The double-barrel syringe 110 may further include plungers 114A, 114B corresponding to the first diluent chamber 112A and the second diluent chamber 112B, respectively. In particular, the barrel body 112 may define two separate hollow cavities defining the first diluent chamber 112A and the second diluent chamber 112B. The double-barrel syringe 110 may have a proximal end 113A providing openings into the interiors of the first diluent chamber 112A and the second diluent chamber 112B, respectively, for receiving plungers 114A and 114B. At the distal end 113B, opposite the proximal end 113A, the first port 112A-1 and the second port 112B-1 are located. The first port 112A-1 and the second port 112B-1 may be used to deliver material to or from a two-chamber mixing cartridge 120 or to an applicator 130, as will be described in more detail in the specification. As shown, the first port 112A-1 and the second port 112B-1 may be offset toward each other, for example, from the centerlines of the respective diluent chambers 112A and 112B, as shown. This may be useful when providing a smaller assembly. However, in some embodiments, the first port 112A-1 and the second port 112B-1 may be aligned with the centerlines of the diluent chambers 112A and 112B, respectively.

[0023]

[0045] Referring briefly to Figure 5C, a first diluent 101A and a second diluent 101B may be present inside each diluent chamber 112A and 112B. The diluent may be any liquid component in which the powdered components can be dissolved or suspended. For example, in some embodiments, the first diluent 101A, the second diluent 101B, or both may be saline solution, water, deionized water, etc. Diluents 101A and 101B may be the same or different from each other. Also, diluents 101A and 101B may be provided in the same amount or in different amounts.

[0024]

[0046] Referring again to Figure 1, the plungers 114A and 114B may be slidably disposed in the first diluent chamber 112A and the second diluent chamber 112B of the barrel body 112, respectively, and a fluid seal may be formed between the barrel body 112 and the distal ends of each plunger 114A and 114B via seals 114A-1 and 114B-1. For example, the seals 114A-1 and 114B-1 may be made of rubber or a similar material, a suitable material, for forming a fluid-tight seal with the barrel body 112. Push flanges 114A-2 and 114B-2 may be provided at the proximal ends of each plunger 114A and 114B for the user to engage in advancing the plungers 114A and 114B along the barrel body 112. In some embodiments, the plunger connector 115 encapsulates both the push flanges 114A-2 and 114B-2, allowing the movement of the plungers 114A and 114B to be synchronized with each other. This ensures that mixing and / or delivery can be performed simultaneously.

[0025]

[0047] Referring to Figure 2, the barrel body 112 of the double-barrel syringe 110 further includes a connector integrated with the distal end 113B of the double-barrel syringe 110 around the first port 112A-1 and the second port 112B-1. In the embodiments described herein, the barrel body 112 of the double-barrel syringe 110 includes a quarter-turn connector 300 integrated with the distal end 113B of the double-barrel syringe 110. More specifically, as shown in Figure 1, the various components of the quarter-turn connector 300 are integrated with the barrel body 112 such that the quarter-turn connector 300 and the barrel body 112 form a single monolithic piece. However, this is merely illustrative, and it should be understood that the various components of the quarter-turn connector 300 may be separate pieces permanently or semi-permanently joined to the barrel body 112 of the double-barrel syringe 110. Furthermore, as described herein, the quarter-turn connector 300 is merely illustrative, and other connectors may be used instead of the quarter-turn connector 300 without departing from the scope of this disclosure.

[0026]

[0048] The quarter-turn connector 300 is generally located at the distal end 113B of the barrel body 112 such that the various components of the quarter-turn connector 300 are positioned adjacent to the first output port 112A-1 and the second output port 112B-1. As described herein, the various components of the system 100 may be coupled to one another via quarter-turn coupling structures. For example, the quarter-turn connector 300 is generally shaped and sized to removably interlock with the corresponding quarter-turn connector 400 of the two-chamber mixing cartridge 120 and / or the corresponding quarter-turn connector 450 of the applicator 130. As will be described in more detail herein, when the applicator 130 or two-chamber mixing cartridge 120 is coupled to the double-barrel syringe 110 via quarter-turn connectors 300, 400, 450, its various ports are aligned and sealed with the first port 112A-1 and the second port 112B-1 of the double-barrel syringe 110.

[0027]

[0049] Continuing to refer to Figures 1 and 2, the quarter-turn connector 300 of the double-barrel syringe 110 may include a circular projection 302 extending distally (e.g., in the -x direction of the coordinate axis) from the distal end 113B of the double-barrel syringe 110, and a pair of coupling members (e.g., a first coupling member 306A and a second coupling member 306B) positioned radially outward from the circular projection 302, thereby defining a path between them. In the illustrated embodiment, the first port 112A-1 and the second port 112B-1 are located within the circular projection 302. That is, the openings to the first chamber 112A and the second chamber 112B are located within the circular projection 302. In some embodiments, as shown in Figure 2, sealing devices 105 (such as O-rings or similar) may be positioned around the first and second ports 112A-1 and 112B-1 respectively, to help provide a fluid-tight seal when engaged with the applicator 130 or the two-chamber mixing cartridge 120.

[0028]

[0050] The circular projection 302 is generally shaped and sized to correspond to recesses formed in the applicator 130 and the two-chamber mixing cartridge 120, as will be described in more detail herein. The circular projection 302 may generally be located in or around the central area of ​​the distal end 113B of the barrel body 112. In some embodiments, the circular projection 302 may be concentric with the barrel body 112 such that the central axis C1 of the barrel body 112 extends through the center of the circular projection 302. The distance the circular projection 302 extends away from the distal end 113B of the barrel body 112 is generally a distance corresponding to the depth of the recesses formed in the applicator 130 and the two-chamber mixing cartridge 120, and the circular projection 302 can be fully inserted into the recesses, but is not limited thereto.

[0029]

[0051] Referring again to Figures 1 and 2, the first coupling member 306A and the second coupling member 306B each extend from the distal end 113B of the barrel body 112 of the double-barrel syringe 110 and are generally shaped and sized to hold the two-chamber mixing cartridge 120 or applicator 130 when coupled to the double-barrel syringe 110. The first coupling member 306A and the second coupling member 306B each may be a bayonet-type coupling member, an L-shaped beam coupling member, or similar. For example, as particularly shown in Figure 1, the first connecting member 306A extends distally from the distal end 113B of the barrel body 112 at a specific distance, turns about 90 degrees, and extends inward toward the central axis C1 of the barrel body 112, thereby providing a first extension piece 306A-1 extending substantially parallel to the central axis C1 of the barrel body 112 (for example, along the x-axis of the coordinate axes in Figures 1 and 2), and a second extension piece 306A-2 extending substantially perpendicular to the central axis C1 of the barrel body 112 (for example, along the z-axis of the coordinate axes in Figures 1 and 2), thereby defining a pocket 307A between the distal end 113B of the barrel body 112 and the second extension piece 306A-2. Similarly, the second connecting member 306B extends distally from the distal end 113B of the barrel body 112 at a specific distance, turns about 90 degrees, and extends inward toward the central axis C1 of the barrel body 112, thereby providing a first extension piece 306B-1 extending substantially parallel to the central axis C1 of the barrel body 112 (for example, along the x-axis of the coordinate axes in Figures 1 and 2), and a second extension piece 306B-2 extending substantially perpendicular to the central axis C1 of the barrel body 112 (for example, along the z-axis of the coordinate axes in Figures 1 and 2), thereby defining a pocket 307B between the distal end 113B of the barrel body 112 and the second extension piece 306B-2.

[0030]

[0052] As shown in Figures 1 and 2, the first coupling member 306A and the second coupling member 306B are positioned radially outward from the circular projection 302 and facing each other. However, this is merely illustrative, and other locations and spacings are intended and included within the scope of this disclosure. Furthermore, this embodiment includes a pair of coupling members (e.g., the first coupling member 306A and the second coupling member 306B), but this is also merely illustrative; other quantities of coupling members are also intended and included within the scope of this disclosure.

[0031]

[0053] Next, moving to Figures 1 and 3, the two-chamber mixing cartridge 120 generally includes a cartridge body 121 having a proximal end 122A and a distal end 122B spaced apart from the proximal end 122A. The cartridge body 121 also defines a pair of powder chambers, including a first powder chamber 121A and a second powder chamber 121B. The two-chamber mixing cartridge 120 further defines a first cartridge port 121A-1 fluidly coupled to the first powder chamber 121A, and a second cartridge port 121B-1 fluidly coupled to the second powder chamber 121B. In some embodiments, the first powder chamber 121A and the second powder chamber 121B are arranged substantially parallel to each other in the longitudinal direction. Initially, the first powder chamber 121A and the second powder chamber 121B each hold the first powder component 101C and the second powder component 101D, respectively, as shown in Figure 5C. In some embodiments, the first powder chamber 121A and the second powder chamber 121B may hold different powder component materials and / or different amounts. The powder material may be a powder precursor of a desired hydrogel, such as being used as a radiation spacer. The powder material may include, but is not limited to, albumin, polyethyleneimine (PEI), polyethylene glycol (PEG) or protein-containing amines, 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. Powdered or particulate materials may be biodegradable and / or bioabsorbable. As used herein, “biodegradable” and / or “bioabsorbable” means a compound that can be absorbed into the surrounding or local tissues of the subject and / or can be broken down and absorbed by the tissues of the subject.

[0032]

[0054] Powdered or particulate materials can be composed of varying amounts of different crosslinking agents and designed to persist in situ for a predetermined time before the hydrogel degrades. In some embodiments, the hydrogel components may be selected based on the degradation time corresponding to the expected duration of radiotherapy. In some embodiments, the expected duration of radiotherapy, i.e., the target time for hydrogel degradation, may be up to 18 months, for example, ranging from about 0 months to about 18 months, including about 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, and 18 months. It should be understood that this time is merely a rough guideline commonly used to target an appropriate hydrogel formulation.

[0033]

[0055] In some embodiments, one or more mixed lumps 124 are also located inside the first powder chamber 121A and / or the second powder chamber 121B (two mixed lumps in each of the first and second powder chambers 121A are shown for illustrative purposes only). One or more mixed lumps 124 may be any suitable material that helps to mix materials such as stainless steel, acetal resin (such as Delrin® acetal resin), plastic polycarbonate, composites, aluminum, low carbon steel, chemical-resistant PTFE, composites, titanium, moisture-resistant polyethylene, magnetic materials, etc. One or more mixed lumps 124 may be any shape, such as spherical, cylindrical, cubic, ellipsoidal, or any other regular or irregular shape. One or more mixed lumps 124 may contain any number of lumps, such as two or more, three or more, four or more, etc. One or more mixed lumps 124 may be identical to or different from one another. One or more mixing lumps 124 may have varying sizes, such as up to 6 mm in diameter, up to 5 mm in diameter, up to 4 mm in diameter, up to 3 mm in diameter, and up to 7 mm in diameter, up to a maximum of 7 mm in diameter. In various embodiments, one or more mixing lumps 124 may have cut or engraved designs, patterns, protrusions and / or the like on their surface, which can enhance mixing.

[0034]

[0056] The first cartridge port 121A-1 of the first powder chamber 121A and the second cartridge port 121B-1 of the second powder chamber 121B may be located within the proximal end 122A of the cartridge body 121 of the two-chamber mixing cartridge 120. The first cartridge port 121A-1 and the second cartridge port 121B-1 are generally output / input ports aligned with other ports of other components as described herein, so that each component initially present in the powder chambers 121A, 121B can be dispensed from their respective powder chambers 121A, 121B, and / or (for example, the liquid initially present in the diluent chambers 112A, 112B) can be received by their respective powder chambers 121A, 121B. In some embodiments, the first cartridge port 121A-1 may be positioned concentrically with the first powder chamber 121A, and the second cartridge port 121B-1 may be positioned concentrically with the second powder chamber 121B. However, in other embodiments, for example, in the embodiment shown in Figure 1, the first cartridge port 121A-1 may be positioned radially inward of the central area of ​​the first powder chamber 121A, and the second cartridge port 121B-1 may be positioned radially inward of the central area of ​​the second powder chamber 121B, so that the first cartridge port 121A-1 and the second cartridge port 121B-1 are closer to the central axis C2 of the cartridge body 121 of the two-chamber mixing cartridge 120, facilitating alignment with other components of the syringe system 100 described herein.

[0035]

[0057] Continuing to refer to Figures 1 and 3, the corresponding quarter-turn connector 400 of the two-chamber mixing cartridge 120 includes a circular recess 402 sized to receive a circular projection 302 on the distal end 113B of the double-barrel syringe 110. In some embodiments, the quarter-turn connector 400 of the two-chamber mixing cartridge 120 may include a protruding edge 404 extending radially outward from the circular recess 402. In some embodiments, the protruding edge 404 may have a constant thickness in the longitudinal direction (e.g., the y-direction of the indicated coordinate axes). However, in some embodiments, a portion of the protruding edge 404 may have a sloping shape or gradually increasing thickness. In some embodiments, extending distally from the protruding edge 404 may be a stop projection 408, which may be configured to engage with a first coupling member 306A or a second coupling member 306B. In some embodiments, the thickness of the protruding edge 404 may increase toward the stop projection 408 and decrease toward the stop projection 408. This increase in the retaining protrusion 408 allows for increased sealing pressure when the two-chamber mixing cartridge 120 is mounted on the double-barrel syringe 110.

[0036]

[0058] The circular recess 402 is generally defined by a wall 403 extending proximal (for example, in the +x direction of the coordinate axes in Figure 1) from the proximal end 122A of the cartridge body 121 of the two-chamber mixing cartridge 120. The wall 403 extends around the central axis C2 of the cartridge body 121 of the two-chamber mixing cartridge 120 to form the circular recess 402. The wall 403 may be shaped and sized such that the circular recess 402 it forms corresponds to the shape and size of the circular projection 302 of the double-barrel syringe 110. In some embodiments, the wall 403 may be an extension of the side wall of the cartridge body 121 of the two-chamber mixing cartridge 120.

[0037]

[0059] The first and second cartridge ports 121A-1, 121B-1 may extend within the circular recess 402 through the proximal end 122A of the cartridge body 121 of the two-chamber mixing cartridge 120. That is, the circular recess 402 contains a plurality of cartridge ports 121A-1, 121B-1. In some embodiments, the circular recess 402 may include one or more feature parts (e.g., additional recesses, retaining pieces, channels, etc.) adapted to hold at least one seal (e.g., a sealing element or similar) around the plurality of cartridge ports 121A-1, 122A-2. For example, a seal 126 may be held within the circular recess 402 around the first cartridge port 121A-1 and the second cartridge port 121B-1. Any seal 126 may be any seal capable of forming a seal when the two-chamber mixing cartridge 120 is connected to the double-barrel syringe 110 as described herein, in which case the first cartridge port 121A-1 is joined and sealed to the first output port 112A-1 (e.g., forming a fluid coupling between the first cartridge port 121A-1 and the first output port 112A-1), and the second cartridge port 121B-1 is joined and sealed to the second output port 112B-1 (e.g., forming a fluid coupling between the second cartridge port 121B-1 and the second output port 112B-1). For example, seal 126 may be an O-ring, a stadium-shaped seal, an elliptical seal and / or similar. While a single seal is shown for each port in this specification, the disclosure is not limited thereto. For example, a single seal such as a number 8-shaped gasket or similar may be used to individually seal the ports as described herein. However, it should be understood that the ports (for example, the first cartridge port 121A-1 and the second cartridge port 121B-1) maintain a state of sealing from each other to avoid cross-contamination of the components in their respective powder chambers 121A and 121B. It should also be understood that the term “seal” is not limiting and may include any type of sealing element, sealing device or similar.

[0038]

[0060] The projection 404 is formed by a wall 403 that defines a circular recess 402 overall. That is, the projection 404 extends radially outward from the wall 403 overall. The projection 404 is shaped and sized such that when the corresponding quarter-turn connector 400 is rotated relative to the quarter-turn connector 300 as described herein, it is received and held by a pair of coupling members 306A, 306B. That is, the projection 404 has a first thickness in one or more first portions (for example, defined along the x-axis of the coordinate axes in Figure 1) and gradually increases to a second thickness in one or more second portions (for example, defined along the x-axis of the coordinate axes in Figure 1), allowing the pair of coupling members 306A, 306B to compress and hold the projection 404 within its pockets 307A, 307B. In some embodiments, the projection 404 may extend around the entire perimeter of the wall 403. In other embodiments, the projection 404 may extend only around a portion of the perimeter of the wall 403. In such embodiments, multiple projections may be used.

[0039]

[0061] As described above, in some embodiments, the corresponding quarter-turn connector 400 further includes a pair of retaining projections 408 (only one is shown in Figure 3). Each of the pair of retaining projections 408 extends distally from the projection 404 (for example, in the -x direction of the coordinate axes in Figure 3, toward the distal end 122B of the cartridge body 121). Each of the retaining projections 408 is aligned with the corresponding quarter-turn connector 400 such that the pair of retaining projections 408 contact the coupling members 306A, 306B during the quarter-turn movement, thereby preventing further rotational movement of the corresponding quarter-turn connector 400 beyond a quarter turn relative to the quarter-turn connector 300. Any number of retaining projections may be used, but it should be understood that the number of retaining projections may approximately correspond to the number of coupling members (or may be less than the number of coupling members). For example, if the quarter-turn connector 300 includes two coupling members 306A and 306B, the corresponding quarter-turn connector 400 may include one or two retaining projections 408. In some embodiments, the pair of retaining projections 408 may extend radially outward from the wall 403 and may not be connected to the protruding edge 404.

[0040]

[0062] Next, moving to Figures 1 and 4, in the embodiment, the applicator 130 has a proximal end 131A extending in the proximal direction (the +x direction of the coordinate axes in Figure 1) and a distal end 131B extending in the distal direction (for example, the -x direction of the coordinate axes in Figure 1). The applicator 130 generally includes a hub 131 and an elongated hollow probe 148 extending distally from the hub 131 (for example, the -x direction of the coordinate axes in Figure 1). The hub 131 may be fixedly attached to the proximal end 131A of the elongated hollow probe 148 by overmolding, adhesive, and / or press-fitting, etc. The hub 131 includes a plurality of input ports of the applicator 130 (for example, a first input port 132A-1 and a second input port 132B-1). The hub 131 is configured for a removable connection to the double-barrel syringe 110 via a corresponding quarter-turn connector 450, and when connected, the first input port 132A-1 of the applicator 130 is aligned and sealed with the first port 112A-1 of the double-barrel syringe 110, and the second input port 132B-1 of the applicator 130 is aligned and sealed with the second port 112B-1 of the double-barrel syringe 110, as will be described in further detail herein.

[0041]

[0063] The elongated, hollow probe needle 148 of the applicator 130 is configured to facilitate fluid communication with multiple ports 112A-1, 112B-1 of the double-barrel syringe 110, as schematically shown in Figures 10A-10C, to receive two compositions 102A, 102B (obtained by mixing the constituent materials) from the double-barrel syringe 110 and guide the two compositions 102A, 102B to its distal end 131B for mixing and delivery.

[0042]

[0064] Continuing to refer to Figures 1 and 4, in this embodiment, the elongated hollow probe needle 148 may consist, for example, of an outer elongated cannula 150 and an inner elongated cannula 152. As shown in Figure 10B, a first material delivery lumen 150-1 may be provided between the outer elongated cannula 150 and the inner elongated cannula 152, and a second material delivery lumen 152-1 may be provided within the inner elongated cannula 152. Thus, the outer elongated cannula 150 and the inner elongated cannula 152 may define two separate flow paths so that the material flowing through them remains separated until it is mixed toward the distal end 131B of the applicator 130.

[0043]

[0065] Referring particularly to Figure 1, the hub 131 may further include a plurality of passages to fluidly connect the first input port 132A-1 to the first material delivery lumen 150-1 and the second input port 132B-1 to the second material delivery lumen 152-1. For example, in some embodiments, the first input port 132A-1 may be connected to the first material delivery lumen 150-1 by a first channel 142A extending through the hub 131 from the first input port 132A-1 to the first material delivery lumen 150-1. In another example, the second input port 132B-1 may be connected to the second material delivery lumen 152-1 by a second channel 142B extending through the hub 131 from the second input port 132B-1 to the second material delivery lumen 152-1. The positioning of the first channel 142A and the second channel 142B may be determined by the location of the first input port 132A-1 and the second input port 132B-1. For example, the first input port 132A-1 and the second input port 132B-1 are spaced apart so as to align with the ports 112A-1 and 112B-1 of the double-barrel syringe 110. In this way, the first input port 132A-1 and the second input port 132B-1 are spaced radially outward at approximately the same distance from the central axis C3 of the applicator 130.

[0044]

[0066] Referring to Figures 1 and 4, the corresponding quarter-turn connector 450 of the applicator 130 includes a circular recess 452 sized to receive a circular projection 302 on the distal end 113B of the double-barrel syringe 110, and an applicator projection 454 extending radially outward from the circular recess 452.

[0045]

[0067] The circular recess 452 is generally a recess defined by a wall 453 extending proximal (e.g., in the +x direction of the coordinate axes in Figure 1) from the proximal end 131A of the applicator 130 (e.g., extending proximal from the hub 131 of the applicator 130). The wall 453 extends around the central axis C3 of the applicator 130 to form the circular recess 452. The wall 453 may be shaped and sized such that the circular recess 452 it forms corresponds to the shape and size of the circular projection 302 of the double-barrel syringe 110. In some embodiments, the wall 453 may be an extension of the side wall of the hub 131 of the applicator 130.

[0046]

[0068] Multiple input ports 132A-1, 132B-1 extend through the proximal end 131A of the applicator 130 within a circular recess 452. That is, the circular recess 452 contains the multiple input ports 132A-1, 132B-1. In some embodiments, the circular recess 452 may include one or more feature portions (e.g., additional recesses, retaining pieces, channels, etc.) adapted to hold at least one seal around the multiple input ports 132A-1, 132B-1. For example, a seal 136 may be held within the circular recess around the first input port 132A-1 and the second input port 132B-1. Any seal 136 may be any seal capable of forming a seal with the double-barrel syringe 110 when the applicator 130 is coupled as described herein, in which case the first input port 132A-1 is joined and sealed with the first port 112A-1 (e.g., forming a fluid coupling between the first input port 132A-1 and the first port 112A-1), and the second input port 132B-1 is joined and sealed with the second port 112B-1 (e.g., forming a fluid coupling between the second input port 132B-1 and the second port 112B-1). For example, the seal may be an O-ring, a stadium-shaped seal, an elliptical seal and / or similar. While a single seal is shown for each port in this specification, the disclosure is not limited thereto. For example, a single seal such as a number 8-shaped gasket may be used to individually seal the ports as described herein. However, it should be understood that the ports (e.g., the first input port 132A-1 and the second input port 132B-1) maintain a state of sealing from each other to avoid premature combination of components before they reach the distal chamber.

[0047]

[0069] Continuing to refer to Figures 1 and 4, the applicator projection 454 is generally formed by a wall 453 defining a circular recess 452. That is, the applicator projection 454 generally extends radially outward from the wall 453. The applicator projection 454 is shaped and sized such that, as described herein, when the corresponding quarter-turn connector 450 is rotated relative to the quarter-turn connector 300, it is received and held by a pair of coupling members 306A, 306B. In embodiments, the applicator projection 454 has a first thickness in one or more first portions (for example, defined along the x-axis of the coordinate axes in Figure 1) and gradually increases to a second thickness in one or more second portions (for example, defined along the x-axis of the coordinate axes in Figure 1), allowing the pair of coupling members 306A, 306B to compress and hold the applicator projection 454 within its pockets 307A, 307B. In some embodiments, the applicator projection 454 may extend around the entire perimeter of the wall 453. In other embodiments, the applicator projection 454 may extend around only a portion of the perimeter of the wall 453. In such embodiments, multiple applicator projections may be used.

[0048]

[0070] In some embodiments, the corresponding quarter-turn connector 450 further includes a pair of stop projections 458 (only one is shown in Figure 4). Each of the pair of stop projections 458 extends distally from the applicator projection 454 (for example, toward the distal end 131B of the applicator 130 in the -x direction of the coordinate axes in Figure 4B). Each of the pair of stop projections 458 is aligned with the corresponding quarter-turn connector 450 such that the pair of stop projections 458 contact the coupling members 306A, 306B during the quarter-turn movement, thereby preventing further rotational movement of the corresponding quarter-turn connector 450 beyond a quarter turn relative to the quarter-turn connector 300. Any number of stop projections may be used, but it should be understood that the number of stop projections is approximately equivalent to (or less than) the number of coupling members. For example, if the quarter-turn connector 300 includes two coupling members 306A and 306B, the corresponding quarter-turn connector 450 may include one or two retaining projections 458. In some embodiments, the pair of retaining projections 458 may extend radially outward from the wall 453 and may not be connected to the applicator protrusion 454.

[0049]

[0071] In the embodiment, the features of the quarter-turn connectors 300, 400, and 450 may advantageously provide a structure that allows the user to quickly connect and then disconnect components (e.g., a double-barrel syringe 110, a two-chamber mixing cartridge 120, and an applicator 130), which allows the user to easily confirm that the components are precisely sealed and aligned with each other, ensuring that the precise materials held inside are mixed and then delivered to the desired site on the subject.

[0050]

[0072] As stated above, the various quarter-turn connectors described herein are merely illustrative, and it should be understood that other connectors are also intended and included within the scope of this disclosure.

[0051]

[0073] Next, moving to Figures 5A-5E, an exemplary method for mixing component materials using the double-barrel syringe 110 and the two-chamber mixing cartridge 120 described above is shown. For example, as shown in Figures 5A-5B, the double-barrel syringe 110 and the two-chamber mixing cartridge 120 are coupled together, for example, via quarter-turn connectors 300, 400 to form a mixing device 200. In particular, Figure 5A shows that the double-barrel syringe 110 is engaged with the two-chamber mixing cartridge 120, but is misaligned by a quarter turn, so the two-chamber mixing cartridge 120 is not held in place by the double-barrel syringe 110. That is, the coupling members 306A, 306B are not engaged with the protruding edge 404. Figure 5B shows that the two-chamber mixing cartridge 120 is aligned after a quarter turn. In this configuration, as best shown in the cross-sectional view of Figure 5C, the protruding edge 404 engages with the coupling members 306A, 306B and their respective pockets 307A, 307B, so that the two-chamber mixing cartridge 120 is not pulled longitudinally away from the double-barrel syringe 110. When joined in this manner, the various ports are aligned and sealed with each other, allowing communication between them. In particular, the first port 112A-1 is aligned with the first cartridge port 121A-1, and the second port 112B-1 is aligned with the second cartridge port 121B-1. In some embodiments, the double-barrel syringe may be coupled to the two-chamber mixing cartridge via a collar, as will be described in more detail below. Thus, in such embodiments, the method may include coupling the double-barrel syringe 110 to the two-chamber mixing cartridge 120 via a collar, as will be described in more detail below.

[0052]

[0074] In the illustrated embodiment, the first diluent 101A is located in the first diluent chamber 112A, the second diluent 101B is located in the second diluent chamber 112B, the first powder component 101C is located in the first powder chamber 121A, and the second powder component 101D is located in the second powder chamber 121B. For example, the first powder component 101C may contain albumin, and the second powder component 101D may contain PEG. Other combinations are also conceivable and possible.

[0053]

[0075] If desired, the user may compress the plungers 114A and 114B, as shown in Figure 5D, so that the first diluent 101A enters the first powder chamber 121A from the first diluent chamber 112A, and the second diluent 101B enters the second powder chamber 121B from the second diluent chamber 112B. In this way, the first and second diluents 101A and 101B maintain isolation from each other. In some embodiments, the mixing device 200 is then agitated (up and down, left and right, and / or in a vortex, etc.) so that the mixture mass 124 (if present) vortexes or moves in other ways within the first powder chamber 121A and the second powder chamber 121B so that the powder components 101C, 101D and the respective liquid components 101A, 101B are completely mixed, and the first composition 102A can be obtained in the first powder chamber 121A and the second composition 102B in the second powder chamber 121B. In some embodiments, the plungers 114A, 114B can be repeatedly pulled and pushed down to further mix the respective compositions 102A, 102B. Once mixing is complete, the plungers 114A and 114B may be withdrawn, as shown in Figure 5E, to keep the respective compositions 102A and 102B isolated from each other while drawing them back into the respective first and second diluent chambers 112A and 112B. In some embodiments, the gas may be discharged and returned into the two-chamber mixing cartridge 120. If, when the gas is discharged, some of the first composition 102A and / or the second composition 102B flows back into the first powder chamber 121A or the second powder chamber 121B, such compositions may be withdrawn again using the plungers 114A and 114B. After the two-chamber mixing cartridge 120 is removed, the applicator 130 may be assembled with the double-barrel syringe in substantially the same manner as the two-chamber mixing cartridge 120.

[0054]

[0076] Referring here to Figures 6A-9B, alternative embodiments of the double-barrel syringe 110' and the two-chamber mixing cartridge 120' are schematically shown. These embodiments are substantially similar to those described above, and unless otherwise stated or evident, the descriptions of similar components above also apply to these embodiments. Therefore, such descriptions will not be repeated in detail.

[0055]

[0077] Referring particularly to Figures 6A-6C, as described above, the double-barrel syringe 110' may generally include a barrel body 112' defining a first diluent chamber 112A', a second diluent chamber 112B', a first port 112A-1' fluidly coupled to the first diluent chamber 112A', and a second port 112B-1' fluidly coupled to the second diluent chamber 112B'. Furthermore, the double-barrel syringe 110' may include a quarter-turn connector 300' substantially similar to the quarter-turn connector 300 described above. In particular, the quarter-turn connector 300' includes a first coupling member 306A' and a second coupling member 306B' which are substantially identical in features to the coupling members 306A and 306B described above. However, in this embodiment, the quarter-turn connector 300' does not include a circular projection between the first coupling member 306A' and the second coupling member 306B'. Instead, the first port 112A-1' and the second port 112B-1' protrude and extend distally adjacent to each other. In such an embodiment, the first port 112A-1' may be defined by the first port cylindrical portion 314A', and the second port 112B-1' may include the second port cylindrical portion 314B'. The first port cylindrical portion 314A' and the second port cylindrical portion 314B' may include a neck region 316' with a reduced diameter, within which an O-ring or similar sealing device 317' as described above may be positioned. The sealing device 317' can help provide a fluid-tight seal when engaged with the collar 600 or applicator, which will be described in more detail below.

[0056]

[0078] In some embodiments, as shown in Figure 6A, the cap 500 may engage with the distal end 113B of the double-barrel syringe 110'. For example, the cap 500 may extend over the first port cylindrical portion 314A' and the second port cylindrical portion 314B' to seal these portions, thereby preventing material leakage from the respective ports 112A-1' and 112B-1'. In some embodiments, the cap 500 may cover the first and second coupling members 306A' and 306B'. As shown in Figure 6B, the cap 500 may be sized to receive the port cylindrical portions 314A' and 314B' and engage with the corresponding sealing device 317', and may include a recess 502 formed therein to provide a fluid-tight seal. This ensures the integrity of the fluid held in the first diluent chamber 112A' and the second diluent chamber 112B'.

[0057]

[0079] Referring to Figure 6C, in some embodiments, in addition to or instead of the cap 500, each port 112A-1', 112B-1' may be sealed via a membrane 315' (e.g., foil, plastic or similar). The membrane 315' can be bonded or welded, for example, to the first port cylindrical portion 314A' and the second port cylindrical portion 314B' to seal the respective first and second ports 112A-1', 112B-1'. Although two membranes are shown, it is conceivable that a single membrane may cover both the first port 112A-1' and the second port 112B-1'. Before use, the membrane 315' may be peeled off or ruptured under pressure by advancing the plungers 114A, 114B inside the first and second diluent chambers 112A', 112B'. In some embodiments, instead of the membrane 315', individual caps may extend over the first and second ports 112A-1', 112B-1'. Although the membrane 315' is shown only for this embodiment, it should be noted that the aforementioned ports 112A-1', 112B-1' may also be covered with a membrane before mixing the constituent materials.

[0058]

[0080] Referring next to Figures 7A-7B, an embodiment of the two-chamber mixing cartridge 120' is schematically shown. The two-chamber mixing cartridge 120' is similar to the two-chamber mixing cartridge 120 described above. Therefore, unless otherwise stated or made clear, the above description applies to this embodiment. For example, the two-chamber mixing cartridge 120' includes a first powder chamber 121A', a second powder chamber 121B', a first cartridge port 121A-1' fluidly coupled to the first powder chamber 121A', and a second cartridge port 121B-1' fluidly coupled to the second powder chamber 121B'. It should be noted that in the illustrated embodiment, a void is shown between the first powder chamber 121A' and the second powder chamber 121B'. However, the void is not required.

[0059]

[0081] Another difference in the illustrated embodiment is that the two-chamber mixing cartridge 120' does not include a circular recess or protruding edge. Instead, the two-chamber mixing cartridge 120' includes a quarter-turn connector 400' which is substantially identical to that of the double-barrel syringe 110'. In particular, the two-chamber mixing cartridge 120' has a first coupling member 406A' and a second coupling member 406B'. Furthermore, the first cartridge port 121A-1' and the second cartridge port 121B-1' protrude and extend adjacent to each other. In such embodiments, the first cartridge port 121A-1' may be defined by the first cartridge port cylindrical portion 424A', and the second cartridge port 121B-1' may be defined by the second cartridge port cylindrical portion 424B'. The first cartridge port cylindrical portion 424A' and the second cartridge port cylindrical portion 424B' may include a neck region 426' with a reduced diameter, in which an O-ring or similar sealing device 427' as described above may be positioned. As will be described later, the sealing device 427' can help provide a fluid-tight seal when engaged with the collar 600, which will be described in more detail below.

[0060]

[0082] The first and second coupling members 406A' and 406B' may be positioned opposite each other, straddling the first cartridge port cylindrical portion 424A' and the second cartridge port cylindrical portion 424B'. Similar to coupling members 306A and 306B, the first coupling member 406A' and the second coupling member 406B' each extend from the proximal end 122A of the two-chamber mixing cartridge 120' and are generally shaped and sized to hold the collar 600, which will be described in more detail below. The first coupling member 406A' and the second coupling member 406B' may each be a bayonet-type coupling member, an L-shaped beam coupling member, or similar. For example, as particularly shown in Figure 7B, the first coupling member 406A' extends proximal at a specific distance from the proximal end 122A of the two-chamber mixing cartridge 120', turns about 90 degrees, and extends inward toward the two-chamber mixing cartridge 120', thereby obtaining a first extension piece 406A-1' extending substantially parallel to the central axis C4 of the two-chamber mixing cartridge 120' and a second extension piece 406A-2' extending substantially perpendicular to the central axis C4, thereby defining a pocket 407A' between the proximal end 122A and the second extension piece 406A-2'. Similarly, the second connecting member 406B' extends distally from the proximal end 122A at a specific distance, turns about 90 degrees, and extends inward toward the central axis C4, thereby obtaining a first extension piece 406B-1' extending substantially parallel to the central axis C4 and a second extension piece 406B-2' extending substantially perpendicular to the central axis C4, thereby defining a pocket 407B' between the proximal end 122A and the second extension piece 406B-2'.

[0061]

[0083] This embodiment includes a pair of connecting members (for example, a first connecting member 406A' and a second connecting member 406B'), but this is merely illustrative. That is, other quantities of connecting members are also intended and included within the scope of this disclosure.

[0062]

[0084] In some embodiments, as shown, the cap 700 may be substantially identical to the cap 500, but may engage with the proximal end 122A of the two-chamber mixing cartridge 120'. For example, the cap 700 may extend over the first cartridge port 121A-1' and the second cartridge port 121B-1' to seal these ports. In some embodiments, the cap 700 may cover the first and second coupling members 406A', 406B'. Similar to the cap 500, the cap 700 may include recesses formed therein, set to a size that receive the first cartridge port cylindrical portion 424A' and the second cartridge port cylindrical portion 424B' and engage with the corresponding sealing device 427', thereby providing a fluid-tight seal. This ensures the integrity of the powder held in the first powder chamber 121A and the second powder chamber 121B.

[0063]

[0085] Referring to Figure 7B, in some embodiments, in addition to or instead of the cap 700, each cartridge port 121A-1', 121B-1' may be sealed via a membrane 425' (e.g., foil, plastic or similar). The membrane 425' can be bonded or welded, for example, to the first cartridge port cylindrical portion 424A' and the second cartridge port cylindrical portion 424B' to seal the respective first and second cartridge ports 121A-1', 121B-1'. Although two membranes are shown, it is conceivable that a single membrane may cover both the first cartridge port 121A-1' and the second cartridge port 121B-1'. Before use, the membrane 425' may be peeled off or ruptured under pressure by advancing the plungers 114A, 114B when coupled to the double-barrel syringe 110'. In some embodiments, instead of the membrane 425', individual caps may extend over the first and second cartridge ports 121A-1', 121B-1'. Although the membrane 425' is shown only in reference to this embodiment, it should be noted that the cartridge ports 121A-1, 121B-1 described above may be covered with the membrane 425' before the constituent materials are mixed.

[0064]

[0086] Referring here to Figures 8A and 8B, the collar 600 is shown. The collar 600 receives and rotates to fluidly couple the first port 112A-1' to the first cartridge port 121A-1' and the second port 112B-1' to the second cartridge port 121B-1'. In particular, the collar may include an internal body 610 and an external housing 620. A portion of the collar 600, for example, the external housing 620 or a portion thereof, may be rotatable relative to the internal body 610.

[0065]

[0087] The internal body 610 may be formed of any suitable material, such as plastic, rubber, metal, glass, or ceramic, and may define a first communication path 612A and a second communication path 612B. The first communication path 612A may include a first receiving port 612A-1 at a first end and a second receiving port 612A-2 at the opposite end. The first receiving port 612A-1 and the second receiving port 612A-2 may be sized to accommodate a first port cylindrical portion 314A' and a first cartridge port cylindrical portion 424A' to provide a fluid path between them, as shown in Figures 9B and 9C. In the embodiment, sealing devices 317' and 427' seal against the inner wall 613 of the internal body 610, thereby preventing leakage of the constituent materials. Similarly, the second communication path 612B may include a first receiving port 612B-1 at the first end and a second receiving port 612B-2 at the opposite end. The first receiving port 612B-1 and the second receiving port 612B-2 may be sized to accommodate a second port cylindrical portion 314B' and a second cartridge port cylindrical portion 424B' to provide a fluid path between them, as shown in Figures 9B and 9C. In the embodiment, sealing devices 317' and 427' can seal against the inner wall 613 of the internal body 610, thereby preventing leakage of the constituent material.

[0066]

[0088] The external housing 620 may be formed from any suitable material, such as plastic, rubber, metal, glass, or ceramic. The external housing 620 may surround the internal body 610 and rotate relative to it. For example, bearings 602 such as ball bearings or ring bearings, or sealing devices such as O-rings may be provided between the external housing 620 and the internal body 610. Although two bearings are shown, any number of bearings 602 may be included. Similar to the quarter-turn connectors 400 and 450, the external housing 620 includes a first quarter-turn connector 650A at the first end and a second quarter-turn connector 650B at the second end. The first quarter-turn connector 650A and the second quarter-turn connector 650B may include a plurality of tabs 652 similar to the protruding edges described above.

[0067]

[0089] The tab 652 may generally be formed by the wall 622 of the external housing 620 that houses the internal body 610. That is, the tab 652 may extend radially outward overall from the wall 622. Each tab 652 is shaped and sized to be received and held by a pair of coupling members 306A', 306B' of a quarter-turn connector 300', or by coupling members 406A', 406B' of a quarter-turn connector 400' that is rotated relative to the quarter-turn connector 300', as described herein. Similar to the protruding edges described above, in embodiments the tab 652 may have an inclined shape. For example, each tab 652 may have a first thickness (e.g., defined along the y-axis of the coordinate axes in Figures 8A and 8B) in one or more first portions thereof, and this first thickness gradually increases to a second thickness in one or more second portions thereof, allowing for compression holding of the tab 652 by the pair of coupling members in their respective pockets. For example, the multiple tabs may include a first cartridge engagement tab 652B-1 that engages with a first cartridge coupling member 406A', and a second cartridge engagement tab 652B-2 that engages with a second cartridge coupling member 406B'. Similarly, the multiple tabs may include a first barrel engagement tab 652A-1 configured to engage with a first coupling member 306A', and a second barrel engagement tab 652A-2 configured to engage with a second coupling member 306B'. In some embodiments, a stopper projection 656 similar to the stopper projection described above may extend from the tab 652. Each stopper projection 656 may be configured to engage with a corresponding coupling member. In some embodiments, the thickness of the tab 652 may increase toward the stopper projection 656 and decrease toward the stopper projection 656. Such an increase toward the stopper projection 656 can increase the sealing pressure as described in the embodiments above.

[0068]

[0090] Figures 9A-9C show how the collar 600 connects the double-barrel syringe 110' to the two-chamber mixing cartridge 120'. In this embodiment, the first and second ports 112A-1', 112B-1', (e.g., the first and second port cylindrical portions 314A', 314B') are located within the respective first receiving ports 612A-1, 612B-1, and the first and second cartridge port cylindrical portions 424A', 424B' are located within the respective second receiving ports 612A-2, 612B-2. The seals 317', 427' engage with the inner wall 613 to provide a fluid-tight seal with it. The external housing 620 may be rotated relative to the internal housing 610 and its respective ports, for example by a quarter turn, to lock each tab 652 under the respective coupling members of the double-barrel syringe 110' and the two-chamber mixing cartridge 120'.

[0069]

[0091] Once installed, plungers 114A and 114B are advanced, allowing the diluent to be moved through the collar 600 from the diluent chambers 112A' and 112B' to the respective powder chambers 121A' and 121B'. Similar to the embodiments described above, the mixing device 200 is then agitated so that the mixture 124 (if present) and constituent materials swirl or otherwise rotate within the first powder chamber 121A' and the second powder chamber 121B', so that the powder components and their respective liquid components are completely mixed, and as described above, the first composition 102A can be obtained in the first powder chamber 121A' and the second composition 102B in the second powder chamber 121B'. In some embodiments, the plungers 114A and 114B can be repeatedly pulled and pushed down to further mix the respective compositions 102A and 102B. Once mixing is complete, the plungers 114A and 114B may be withdrawn, keeping the respective compositions 102A and 102B isolated from each other, while drawing them back into their respective first and second diluent chambers 112A' and 112B'. In some embodiments, the gas may be discharged and returned through the collar into the two-chamber mixing cartridge 120. Once fully combined and returned to their respective first and second diluent chambers 112A' and 112B', the collar 600 can be twisted (for example, by a quarter turn in the opposite direction) and removed together with the two-chamber mixing cartridge 120'.

[0070]

[0092] Figures 10A–10D show an applicator 130' similar to the applicator 130 described above. Therefore, the above description is applicable unless otherwise stated. In particular, in this embodiment, the hub 131' includes an inner portion 131A' defining a plurality of input ports 132A-1', 132B-1', and an outer portion 131B' rotatable relative to the inner portion 131A'. The outer portion 131B' may be fixedly attached to the outer elongated cannula 150, and the inner portion 131A' may be fixedly attached to the inner elongated cannula 152 by, for example, overmolding, adhesive, press-fit or similar. A bearing 140 (e.g., ball bearing, ring bearing, etc.) or a sealing device such as an O-ring can support the rotation of the outer portion 131B' relative to the inner portion 131A'. Therefore, during rotation, the outer elongated cannula 150 can rotate relative to the inner elongated cannula 152. Although a single bearing is shown, any number of bearings can be intended and used.

[0071]

[0093] The quarter-turn connector 450' may be substantially the same as the quarter-turn connector 450 described above. However, in this embodiment, the inner portion 131A' includes two circular recesses 131A-1', 131A-2' for receiving the first port cylindrical portion 314A' and the second port cylindrical portion 314B' and sealing them, for example, via a seal 315'. The applicator protrusion 454 and the retaining projection 456 are mounted on the outer portion 131B'.

[0072]

[0094] Therefore, when assembled, as shown in Figure 10B, the inner portion 131A' receives the first port cylindrical portion 314A' in the first circular recess 131A-1' and the second port cylindrical portion 314B' in the second circular recess 131A-2'. The outer housing 131B' is then rotated, as described above and shown in Figure 10C, so that the applicator protrusions 454 can engage with the first and second coupling members 306A, 306B respectively. Thus, the respective mixed compositions 102A, 102B remain separated but flow out of the double-barrel syringe 110' (via pressure from the plungers 114A, 114B) and through the hub 131, the first material delivery lumen 150-1, and the second material delivery lumen 152-2, and combine at the desired delivery site, as shown in Figure 10C.

[0073]

[0095] Embodiments of this disclosure may be further described with respect to the following numbered clauses.

[0096] 1. A syringe system comprising: a double-barrel syringe including a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber; a two-chamber mixing cartridge configured to be attached to the double-barrel syringe, including a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber; and a plurality of mixing masses positioned inside the first and second powder chambers.

[0074]

[0097] 2. The syringe system described in the preceding paragraph, wherein the double-barrel syringe and the two-chamber mixing cartridge are connected to each other via a quarter-turn coupling structure.

[0098] 3. Any syringe system according to the preceding paragraph, further comprising a collar configured to receive and fluidly connect (1) a first port and a first cartridge port, and (2) a second port and the first cartridge port.

[0075]

[0099] 4. Any syringe system according to the preceding paragraph, further comprising an applicator configured to be attached to the first and second ports of a double-barrel syringe.

[0076]

[0100] 5. A syringe system comprising: a double-barrel syringe having a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber; a two-chamber mixing cartridge having a first powder chamber, a second powder chamber, a first cartridge port fluidically coupled to the first powder chamber, and a second cartridge port fluidically coupled to the second powder chamber; and a collar configured to receive and fluidly couple (1) the first port and the first cartridge port, and (2) the second port and the first cartridge port, wherein the collar is rotatable relative to the first and second ports and the first and second cartridge ports, and the two-chamber mixing cartridge is coupled to the double-barrel syringe.

[0077]

[0101] 6. Any syringe system according to the preceding paragraph, wherein the double-barrel syringe includes a first coupling member and a second coupling member, and the collar includes a first tab configured to engage with the first coupling member and a second tab configured to engage with the second coupling member.

[0078]

[0102] 7. Any syringe system according to the preceding paragraph, wherein the two-chamber mixing cartridge includes a first cartridge coupling member and a second cartridge coupling member, and the collar includes a first tab configured to engage with the first cartridge coupling member and a second tab configured to engage with the second cartridge coupling member.

[0079]

[0103] 8. Any syringe system according to the preceding paragraph, wherein the collar includes an internal body and an external housing, and the external housing rotates relative to the internal body.

[0104] 9. Any syringe system according to the preceding paragraph, wherein the collar includes a plurality of angled engagement tabs for engaging with the corresponding coupling member of a double-barrel syringe and / or a two-chamber mixing cartridge.

[0080]

[0105] 10. Any syringe system according to the preceding paragraph, further comprising a plurality of mixed masses positioned inside a first powder chamber and a second powder chamber.

[0106] 11. Any syringe system according to the preceding paragraph, further comprising an applicator configured to be attached to the first and second ports of a double-barrel syringe.

[0081]

[0107] 12. A method for mixing component materials, comprising combining a double-barrel syringe with a two-chamber mixing cartridge, the double-barrel syringe comprising a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidly coupled to the first diluent chamber, and a second port fluidly coupled to the second diluent chamber, the two-chamber mixing cartridge comprising a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidly coupled to the first powder chamber, and a second powder A method comprising: coupling a second cartridge port fluidly coupled to a powder chamber, wherein a plurality of mixed masses are positioned inside a first powder chamber and a second powder chamber; advancing a plunger inside at least one of the first or second diluent chambers so that a first diluent or a second diluent enters the first or second powder chamber, respectively; and agitating the plurality of mixed masses inside a two-chamber mixing cartridge so that the first or second powder is dissolved in the first or second diluent, respectively.

[0082]

[0108] 13. Any method of the preceding paragraph relating to a double-barrel syringe, wherein the method comprises coupling a collar to both the double-barrel syringe and the two-chamber mixing cartridge such that (1) the first port is fluidly coupled to the first cartridge port and (2) the second port is fluidly coupled to the second cartridge port.

[0083]

[0109] 14. Any method of the preceding paragraph, wherein the attachment of the collar to both a double-barrel syringe and a two-chamber mixing cartridge includes rotating a portion of the collar relative to the double-barrel syringe.

[0084]

[0110] 15. Any method of the preceding paragraph, wherein coupling a collar to both a double-barrel syringe and a two-chamber mixing cartridge includes rotating a portion of the collar relative to the two-chamber mixing cartridge.

[0085]

[0111] 16. Any method of the preceding paragraph, wherein attaching the collar to both the double-barrel syringe and the two-chamber mixing cartridge includes rotating a portion of the collar relative to both the double-barrel syringe and the two-chamber mixing cartridge.

[0086]

[0112] 17. A method for mixing constituent materials, comprising coupling a double-barrel syringe to a two-chamber mixing cartridge with a collar, wherein the double-barrel syringe includes a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidly coupled to the first diluent chamber, and a second port fluidly coupled to the second diluent chamber; the two-chamber mixing cartridge includes a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidly coupled to the first powder chamber, and a second cartridge port fluidly coupled to the second powder chamber; the collar comprises (1) the first port and the first A method comprising: coupling a two-chamber mixing cartridge to a double-barrel syringe, wherein (2) the cartridge port of (1) a second port and the first cartridge port are fluidly coupled, the collar being rotatable relative to the first and second ports and the first and second cartridge ports; advancing a plunger inside at least one of the first or second diluent chambers so that the first or second diluent enters the first or second powder chamber through the collar, respectively; and agitating the two-chamber mixing cartridge so that the first or second powder dissolves in the first or second diluent, respectively.

[0087]

[0113] 18. Any method of the preceding paragraph, wherein the attachment of the collar to both a double-barrel syringe and a two-chamber mixing cartridge includes rotating a portion of the collar relative to the double-barrel syringe.

[0088]

[0114] 19. Any method of the preceding paragraph, wherein coupling a collar to both a double-barrel syringe and a two-chamber mixing cartridge includes rotating a portion of the collar relative to the two-chamber mixing cartridge.

[0089]

[0115] 20. Any method of the preceding paragraph, wherein attaching a collar to both a double-barrel syringe and a two-chamber mixing cartridge includes rotating a portion of the collar relative to both the double-barrel syringe and the two-chamber mixing cartridge.

[0090]

[0116] It should be understood here that this disclosure relates to various mixing syringe assemblies and methods for mixing component materials in mixing syringe assemblies. The various embodiments described herein can provide ready-to-use or easily assembled syringe assemblies for easy mixing of components. Furthermore, the embodiments described herein can improve ease of mixing and delivery while helping to maintain sterility and / or integrity of component materials.

[0091]

[0117] While specific embodiments are 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 are described herein, such aspects do not need to be used in combination. Therefore, the appended claims are intended to encompass all changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A double-barrel syringe comprising a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber, A two-chamber mixing cartridge configured to be attached to the double-barrel syringe, comprising a first powder chamber, a second powder chamber, a first cartridge port fluidly coupled to the first powder chamber, and a second cartridge port fluidly coupled to the second powder chamber, A syringe system comprising: a first powder chamber and a plurality of mixed lumps positioned inside the second powder chamber.

2. A syringe system according to claim 1, A syringe system in which the double-barrel syringe and the two-chamber mixing cartridge are connected to each other via a quarter-turn coupling structure.

3. A syringe system according to claim 1, A syringe system further comprising (1) the first port and the first cartridge port, and (2) a collar configured to receive and fluidly couple the second port and the first cartridge port.

4. A syringe system according to claim 1, A syringe system further comprising applicators configured to be attached to the first port and the second port of the double-barrel syringe.

5. A double-barrel syringe comprising a first diluent chamber, a second diluent chamber, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber, A two-chamber mixing cartridge comprising a first powder chamber, a second powder chamber, a first cartridge port fluidly coupled to the first powder chamber, and a second cartridge port fluidly coupled to the second powder chamber, A syringe system comprising: (1) the first port and the first cartridge port; and (2) a collar configured to receive and fluidly couple the second port and the first cartridge port, wherein the collar is rotatable relative to the first and second ports and the first and second cartridge ports, and the two-chamber mixing cartridge is coupled to the double-barrel syringe.

6. A syringe system according to claim 5, The double-barrel syringe includes a first coupling member and a second coupling member, Syringe system, wherein the collar includes a first tab configured to engage with the first coupling member and a second tab configured to engage with the second coupling member.

7. A syringe system according to claim 5, The two-chamber mixing cartridge includes a first cartridge coupling member and a second cartridge coupling member. Syringe system, wherein the collar includes a first tab configured to engage with the first cartridge coupling member and a second tab configured to engage with the second cartridge coupling member.

8. A syringe system according to claim 5, A syringe system comprising an internal body and an external housing, wherein the external housing rotates relative to the internal body.

9. A syringe system according to claim 5, The syringe system comprises a collar including a plurality of angled engagement tabs for engaging with the corresponding coupling member of the double-barrel syringe and / or the two-chamber mixing cartridge.

10. A syringe system according to claim 5, A syringe system further comprising a plurality of mixed masses positioned inside the first powder chamber and the second powder chamber.

11. A syringe system according to claim 5, A syringe system further comprising applicators configured to be attached to the first port and the second port of the double-barrel syringe.

12. A method for mixing component materials, The step of connecting a double-barrel syringe to a two-chamber mixing cartridge, The double-barrel syringe includes a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge includes a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidly coupled to the first powder chamber, and a second cartridge port fluidly coupled to the second powder chamber, wherein a plurality of mixed masses are positioned inside the first powder chamber and the second powder chamber, comprising the steps of coupling, Steps include advancing a plunger inside at least one of the first diluent chamber or the second diluent chamber so that the first diluent or the second diluent enters the first powder chamber or the second powder chamber, respectively; The steps include stirring the plurality of mixed lumps inside the two-chamber mixing cartridge so that the first powder or the second powder is dissolved in the first diluent or the second diluent, Methods that include...

13. A method according to claim 12, The step of coupling the double-barrel syringe to the two-chamber mixing cartridge is a method comprising the step of coupling a collar to both the double-barrel syringe and the two-chamber mixing cartridge such that (1) the first port is fluidly coupled to the first cartridge port and (2) the second port is fluidly coupled to the second cartridge port.

14. The method according to claim 13, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to the double-barrel syringe.

15. The method according to claim 13, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to the two-chamber mixing cartridge.

16. The method according to claim 13, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to both the double-barrel syringe and the two-chamber mixing cartridge.

17. A method for mixing constituent materials, The step involves color-coupling a double-barrel syringe to a two-chamber mixing cartridge, The double-barrel syringe includes a first diluent chamber for holding a first diluent, a second diluent chamber for holding a second diluent, a first port fluidically coupled to the first diluent chamber, and a second port fluidically coupled to the second diluent chamber. The two-chamber mixing cartridge includes a first powder chamber for holding a first powder, a second powder chamber for holding a second powder, a first cartridge port fluidly coupled to the first powder chamber, and a second cartridge port fluidly coupled to the second powder chamber. The collar fluidly connects (1) the first port and the first cartridge port and (2) the second port and the first cartridge port, the collar is rotatable relative to the first and second ports and the first and second cartridge ports, and the two-chamber mixing cartridge is connected to the double-barrel syringe. Steps include advancing a plunger inside at least one of the first diluent chamber or the second diluent chamber so that the first diluent or the second diluent enters the first powder chamber or the second powder chamber through the collar, The steps include stirring the two-chamber mixing cartridge so that the first powder or the second powder is dissolved in the first diluent or the second diluent, Methods that include...

18. The method according to claim 17, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to the double-barrel syringe.

19. The method according to claim 17, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to the two-chamber mixing cartridge.

20. The method according to claim 17, A method comprising the step of connecting the collar to both the double-barrel syringe and the two-chamber mixing cartridge, the step of rotating a portion of the collar relative to both the double-barrel syringe and the two-chamber mixing cartridge.

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