Mixing syringe assembly and method

Abstract

A mixing syringe assembly for mixing two constituent materials includes a barrel body and a barrel connector. The barrel body has a first part and a second part. The barrel connector connects the first part to the second part and includes a torsion seal having a plurality of flaps. The torsion seal operates to function in a closed configuration, where the torsion seal seals the first part from the second part, and an open configuration, where the plurality of flaps twist apart to provide an opening between the first part and the second part.

Description

Technical Field

[0001] Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 498,676, entitled "MIXING SYRINGE ASSEMBLIES AND METHODS OF MIXING CONSTITUENT MATERIALS", the entire disclosure of which is incorporated herein by reference.

[0002]

[0002] This disclosure generally relates to mixing syringe assemblies and methods, and more particularly to mixing syringe assemblies and related methods for delivering a radiation spacer material.

Background Art

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

[0004] <00000ffff16>

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

Summary of the Invention

[0005]

[0005] Embodiments of the present disclosure relate to various mixing syringe assemblies in which the separation of the constituent materials may be maintained until the mixed constituent materials are used.

[0006] In one embodiment, a mixing syringe assembly for mixing two constituent materials includes a barrel body having a first part and a second part, and a barrel connector connecting the first part to the second part. The barrel connector includes a torsion seal having a plurality of flaps, which operates to function in a closed configuration in which the torsion seal seals the first part from the second part, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first part and the second part.

[0006]

[0007] In another embodiment, the preloaded mixing syringe assembly includes a barrel body having a first part and a second part, a barrel connector connecting the first part to the second part, a first component material housed within the first part, and a second component material housed within the second part. The barrel connector has a torsion seal having a plurality of flaps, which operates to function from a closed configuration in which the torsion seal seals the first part from the second part, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first part and the second part. In the closed configuration, the torsion seal prevents the first component material from mixing with the second component material, and in the open configuration, the first component material is mixable with the second component material.

[0007]

[0008] In yet another embodiment, a method for assembling a mixing syringe assembly is disclosed. The method includes positioning a first component within a first portion of a barrel body, positioning a second component within a second portion of a barrel body, and connecting the first portion of the barrel body to the second portion of the barrel body by a barrel connector. The barrel connector includes a torsion seal having a plurality of flaps, the torsion seal operates to be operated from a closed configuration in which the torsion seal seals the first portion from the second portion, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first portion and the second portion.

[0008]

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

[0009]

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

[0010]

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

[0011] [Figure 1]

[0012] This figure schematically illustrates one embodiment of a syringe assembly for mixing constituent materials, according to one or more embodiments shown and described herein. [Figure 2]

[0013] This figure schematically shows a cross-section of the barrel connector of the syringe assembly shown in Figure 1, according to one or more embodiments shown and described herein. [Figure 3A]

[0014] This figure schematically illustrates a barrel connector having a triple flap seal according to one or more embodiments shown and described herein. [Figure 3B]

[0015] This figure schematically illustrates a barrel connector having an overlapping triple flap seal according to one or more embodiments shown and described herein. [Figure 3C]

[0016] This figure schematically illustrates a barrel connector having a torsion seal according to one or more embodiments shown and described herein. [Figure 3D]

[0017] This figure schematically shows a cross-section of the barrel connector in Figure 3C in a closed configuration, according to one or more embodiments shown and described herein. [Figure 3E]

[0018] This figure schematically shows the torsion seal of Figure 3C actuated to an open configuration according to one or more embodiments shown and described herein. [Figure 4]

[0019] This figure schematically illustrates a syringe assembly for mixing constituent materials according to one or more embodiments shown and described herein. [Figure 5]

[0020] This figure schematically shows a cross-section of a barrel connector according to one or more embodiments shown and described herein. [Figure 6]

[0021] This figure schematically illustrates a dual-barrel syringe assembly according to one or more embodiments shown and described herein. [Figure 7]

[0022] This figure schematically shows a barrel body having a dual barrel separated from the dual barrel assembly of Figure 6, according to one or more embodiments shown and described herein. [Figure 8]

[0023] This figure schematically illustrates a dual-barrel mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 9]

[0024] This flowchart shows a method for assembling a mixing syringe assembly according to one or more embodiments shown and described herein. [Modes for carrying out the invention]

[0012]

[0025] The present disclosure generally relates to a mixing syringe assembly for mixing at least two constituent materials. In particular, the present application relates to a mixing syringe assembly configured to deliver a radiation spacer. For example, the radiation spacer may be formed of one or more hydrogel materials, and the one or more hydrogel materials are delivered to a desired location, such as within or on a balloon, and cured at a predetermined location to block or substantially block radiation that may inadvertently be directed at healthy tissue instead of target / diseased tissue. During mixing of the hydrogel to form the radiation spacer, the plurality of materials may need to be combined immediately before and / or during delivery of the radiation spacer into a target location within the body. To maintain the quality of the materials, the powder component may need to be maintained in a dry or unconfigured state prior to application. However, during use, the powder component may need to be hydrated or mixed with a diluent. Using traditional methods, it can be difficult to determine the appropriate mixing volume, maintain sterility, and prevent unnecessary early mixing. However, embodiments of the present disclosure may provide pre-packaged, pre-measured, ready-to-use syringe assemblies that provide improved mixing, maintain sterility, and / or improve delivery, as described in more detail herein, for the constituent materials.

[0013]

[0026] Certain embodiments of the mixing syringe assembly include a barrel body having a first portion and a second portion, and a barrel connector connecting the first portion to the second portion. The barrel connector also acts as a sealing device to prevent interaction of the materials stored within the first and second portions until desired. For example, the barrel connector includes a seal that acts to be actuated from a closed configuration to an open configuration when desired to allow mixing of the materials. These and further embodiments and advantages will be described in more detail below.

[0014]

[0027] The directional terms used in this specification - for example, up, down, right, left, front, back, top, bottom - are made only with reference to the figures being depicted and are not intended to imply absolute orientation unless otherwise specified.

[0015]

[0028] Unless otherwise explicitly stated, it is never intended that any method described in this specification be construed as requiring that its steps be performed in a particular order, nor is it intended that any device require a particular orientation. Thus, where a method claim does not actually recite the order to be followed by its steps, or a claim for any device or assembly does not actually recite the order or orientation for the individual components, or steps are not limited to a particular order, or a particular order or orientation for the components of a device or assembly is not recited, it is never intended that the order or orientation be inferred in any way, unless otherwise specifically stated in the claim or description. This is valid for any conceivable non-express basis for interpretation, including logical matters regarding the sequence of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation; and the number or type of embodiments described in this specification.

[0016]

[0029] As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to "a" component includes aspects having two or more such components unless the context clearly dictates otherwise.

[0017]

[0030] Referring here to the drawings, Figure 1 shows an illustrative mixing syringe assembly 100. The mixing syringe assembly 100 may be used to combine two or more constituent materials, as will be described in more detail herein. In particular, the mixing syringe assembly 100 may be used to mix or combine two or more constituent components of a hydrogel for use as a radiation spacer. The mixing syringe assembly 100 generally includes a plunger 102, a barrel body 106, and a barrel connector 110, as shown. In some embodiments, the mixing syringe assembly 100 further includes one or more mixed masses 130. It should be noted that the mixing syringe assembly 100 may include more or fewer components without departing from the scope of this disclosure.

[0018]

[0031] The plunger 102 may be slidably disposed within the lumen 107 of the barrel body 106, and a fluid seal may be formed between the plunger 102 and the barrel body 106 by a seal 103 at the distal end of the plunger 102. For example, the seal 103 may be made of rubber or a similar conformable material to form a liquid-tight seal with the barrel body 106. The proximal end of the plunger 102 may have a pusher flange 108 for the user to engage in order to advance the plunger 102 along the barrel body 106.

[0019]

[0032] The barrel body 106 is generally hollow and may have a plunger receiving end 109 at its proximal end to receive a plunger 102, and a fluid delivery opening 113 (also called a discharge end) at its distal end, which may be coupled to a material delivery cannula (not shown; the material delivery cannula may include a manifold, delivery needle, or similar). In some embodiments, the fluid delivery opening 113 may be positioned axially with respect to the centerline of the barrel body 106 and / or the plunger 102. However, in other embodiments, the fluid delivery opening 113 may be offset from the centerline of the barrel body 106 and / or the plunger 102. Such an offset may be useful in preventing one or more mixed masses 130 from blocking the fluid delivery opening 113. The barrel body may be a barrel of any size, such as a 5 ml barrel, a 10 ml barrel, etc.

[0020]

[0033] In several embodiments, the barrel body 106 is divided into a first portion 106a and a second portion 106b. The first portion 106a and the second portion 106b are connected to each other by a barrel connector 110. As shown, the first portion 106a and the second portion 106b may have matching inner diameters. This may allow the same plunger 102 to pass through both the first portion 106a and the second portion 106b while maintaining a sealed state against the inner walls of both portions.

[0021]

[0034] The first part 106a provides a first component section 140, and the second part 106b provides a second component section 142, with separation between the first component section 140 and the second component section 142 provided by a barrel connector 110. The first component section 140 and the second component section 142 may occupy the same or substantially the same volume, as shown. However, in some embodiments, the initial volumes may differ from each other. Multiple embodiments provided herein may provide a modular assembly in which parts 106a, 106b having different volume capacities but the same inner diameter may be connected as desired based on the required volume for holding the component. As will be described in more detail, the first component 150a may be initially positioned within the first component section 140, and the second component 150b, which is different from the first component 150a, may be positioned within the second component section 142. As shown in the embodiments, the first component section 140 may be positioned in close proximity to the second component section 142. In other words, the first portion 106a may be positioned in close proximity to the second portion 106b, which includes the discharge end 113.

[0022]

[0035] The first component 150a may be a liquid for hydrating the second component 150b, which may be a powder or fine particles. For example, the first component may be saline solution, water, deionized water, or the like. As stated above, the second component may be a powder or fine particle material, but is not limited to albumin, polyethyleneimine (PEI), amine-containing polyethylene glycol (PEG), or protein, or N-hydroxysuccinimide (NHS) ester components such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and / or the like. In some embodiments, the molecular weight of the PEG component may range from about 2,000 to about 100,000. The powder or fine particle material may be biodegradable and / or bioabsorbable. As used herein, “biodegradable” and / or “bioabsorbable” refer to compounds that can be absorbed by the surrounding or local tissues of the person concerned, and / or that can be broken down and absorbed by the tissues of the person concerned.

[0023]

[0036] The powder or particulate material may consist of various amounts of various crosslinking substances designed to allow the hydrogel to persist in situ for a specific period before degradation. In several embodiments, the hydrogel components may be selected based on the degradation time corresponding to the expected length of radiotherapy. In several embodiments, the expected length of radiotherapy, and therefore the target time for hydrogel degradation, is up to 18 months, for example, 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 the time is only a rough guideline commonly used to target a suitable formulation of the hydrogel.

[0024]

[0037] The barrel connector 110 may take several different forms. However, generally, the various barrel connectors 110 described herein may be operated to selectively provide a flow path between the first component section 140 and the second component section 142, allowing the first component 150a from the first component section 140 to move into the second component section 142, thereby allowing mixing of the first component 150a and the second component 150b.

[0025]

[0038] Referring again to Figure 1, the barrel connector 110 includes a connector body 112 and an inner seal 116. The connector body may be of any suitable material (e.g., plastic) and may function to connect the first portion 106a to the second portion 106b. In several embodiments, the connector body 112 may be female-threaded, as shown, to couple to the first portion 106a and the second portion 106b. Thus, the first portion 106a and the second portion 106b may be male-threaded along predetermined portions adjacent to the connector body 112. The connector body 112 may be threaded to both the first portion 106a and the second portion 106b, allowing the first portion 106a and the second portion 106b to move axially toward each other. In some embodiments, the inner seal 116 may be sandwiched between the first and second portions or compressed between them when assembled together by the connector body 112. For example, in some embodiments, the inner seal 116 may not be coupled to the connector body 112, but rather may be held within the connector body 112 by a first portion 106a and a second portion 106b.

[0026]

[0039] One or more mixed masses 130 may initially be positioned within the first component section 140 or the second component section 142. It should be noted that in some embodiments, locating one or more mixed masses 130 within the second component section 142 may be advantageous in that it is not necessary to create a channel large enough to allow the one or more mixed masses 130 to pass through in order to move them from the first component section 140 to the second component section 142. One or more mixed masses 130 may be any suitable material that assists in mixing materials such as stainless steel, Delron, plastic polycarbonate, composites, aluminum, low carbon steel, chemically resistant PTFE, composites, titanium, vapor-resistant polyethylene, magnetic materials, etc. One or more mixed masses 130 may be any shape such as a sphere, cylinder, cube, ellipse, or any other regular or irregular shape. One or more mixed masses 130 may contain any number of masses, such as two or more, three or more, four or more, etc. One or more mixed masses 130 may be identical or different from one another. One or more mixed masses 130 may have various sizes, such as up to 7 mm in diameter, up to 6 mm in diameter, up to 5 mm in diameter, up to 4 mm in diameter, up to 3 mm in diameter, or 7 mm or less in diameter. In various embodiments, one or more mixed masses 130 may have a cut or etched design on their surface, which may enhance the mixing.

[0027]

[0040] Referring to Figure 2, the barrel connector 110 is shown schematically in a separated and cross-sectional view. In some embodiments, the connector body 112 may include a first threaded portion 114a that screw-engages with a first portion 106a of the barrel body 106 and a second threaded portion 114b that screw-engages with a second portion 106b of the barrel body 106. A seal holder 115 may be located between the threaded portion 114a and the second threaded portion 114b. For example, the seal holder 115 may include radially inwardly extending arms 115a, 115b that hold an inner seal 116 between them. As described above, in some embodiments, the inner seal 116 may not be directly coupled or held by the connector body 112, but may be held in place by the first portion 106a, the second portion 106b, or both. In some cases, the inner seal 116 may be initially attached to either the first portion 106a or the second portion 106b (for example, by adhesive, welding, or the like).

[0028]

[0041] Figures 3A–3E show various embodiments of an inner seal 116 that may be used in any barrel connector 110 described herein. As shown in Figures 3A–3E, the inner seal 116 may include a plurality of flaps 116a–116c. For example, the inner seal may include two or more flaps, such as three or more flaps. In the embodiment shown in Figure 3A, the inner seal 116 is a triple flap seal. That is, the inner seal 116 includes three flaps 116a–116c that are in contact edge to edge in a closed configuration, as shown. For example, the inner seal 116 may be similar to that of a HALO Haemostasis valve and / or a LUCOZADE sports bottle cap. When pressure is applied (for example, by the pressure brought about by axially advancing the plunger 102), the inner seal 116 may open to a radius such as that shown by circle 117.

[0029]

[0042] Referring here to Figure 3B, the inner seal 116 is also shown having a plurality of flaps 116a-116c. However, in this embodiment, adjacent flaps are shown overlapping each other. Overlapping each flap 116a-116c may help reduce any water vapor penetrating the inner seal 116 before the desired coupling. As in the above embodiment, when pressure is applied (for example by advancing the plunger 102), the flaps 116a-116b may open to a radius indicated by the circle 117, allowing the first constituent material 150a to pass through the inner seal 116.

[0030]

[0043] Referring here to Figures 3C-3E, the inner seal 116 is also shown as including a plurality of flaps 116a-116c. Three flaps are shown, but it should be noted that the inner seal may include any number of flaps. In this embodiment, the inner seal 116 is a torsion seal. The torsion seal seals the first part 106a (or first component section 140) from the second part 106b (or second component section 142) when in a closed configuration. In the closed configuration, the plurality of flaps 116a-116c twist together to provide a liquid-tight seal. Referring in particular to Figure 3E, when pressure is applied (for example by advancing the plunger 102), the flaps 116a-116c twist apart (e.g., unravel, branch) to provide an opening between the first and second parts. In several embodiments, the flaps 116a-116c may include engaging edges 118 or hooks so that when the flaps 116a-116c twist together, the engaging edges 118 catch on the flaps that twist around it, as shown. In several embodiments, the twist seal may twist outward from the discharge end 113. That is, the twisted portions of the flaps, in the closed configuration, face outward from the discharge end 113 in a proximal direction, as shown in Figure 3D. This may improve the seal against moisture movement when a liquid component is stored in the first portion 106a and a dry component is stored in the second portion 106b. When activated to the open configuration, as shown in Figure 3E, the flaps extend distally toward the discharge end 113.

[0031]

[0044] In each of the above embodiments, the flaps may be formed of a fluid-impermeable material (e.g., rubber or similar). The flaps may be formed to be displaced into a closed configuration. For example, the flaps may include a shape memory material, such as a shape memory polymer, to hold the flaps in a closed configuration. In some embodiments, the material stiffness selected for the flaps may have a stiffness value greater than the internal pressure applied to the flaps (without user input) to allow the flaps to maintain their position (closed), and then, when the user applies further force via the plunger, the flaps may bend and open. In some embodiments, the flaps may be plastically deformed so that each flap maintains its closed position. When the user applies force via the plunger, the flaps plastically deform to push the flaps into the open position. In some embodiments, such as the torsion seal embodiment, the flaps plastically deform to point in opposite directions (e.g., towards the discharge end). In some embodiments, such as the torsion seal embodiment, the multiple flaps may be displaced into an open configuration. However, the downward force generated by the torsion and overlap keeps each of the multiple flaps flat, maintaining the multiple flaps in a closed position, and eventually allows the user (by advancing the plunger) to generate enough force to undo the torsion and move the multiple flaps to an open position.

[0032]

[0045] Figure 4 shows a mixing syringe assembly 100 having another embodiment of the barrel connector 110', and Figure 5 shows the barrel connector 110' in more detail. The barrel connector 110' is substantially the same as the barrel connector 110 described above, and therefore the above description will not be repeated for the sake of brevity. In particular, the barrel connector 110' includes a barrel body 112 and an inner seal 116. However, in this embodiment, there are no threads. Instead, the barrel connector 110' may be press-fitted or overmolded onto the first part 106a and / or the second part 106b, thereby joining the first part 106a to the second part 106b.

[0033]

[0046] Referring here to Figure 6, in various embodiments, the mixing syringe assembly 100 may include one or more mixing syringe subassemblies, for example, to provide a dual-barrel syringe. For example, Figure 6 shows a dual mixing syringe assembly including a first mixing syringe subassembly 100a and a second mixing syringe subassembly 100b. Each subassembly 100a, 100b is substantially identical to the mixing syringe subassembly 100 described with respect to Figure 1 and / or Figure 4. In particular, each subassembly 100a may include a plunger 102, a barrel body 106 including a first part and a second part, and a barrel connector 110''. The barrel connector 110'' may be the same as barrel connector 110 or barrel connector 110', as will be further described below. In some embodiments, the subassemblies 100a, 100b further include one or more mixed masses 130. Therefore, the above description is applicable to this embodiment and will not be repeated.

[0034]

[0047] In some embodiments, each barrel body portion 106a or 106b is firmly coupled. For example, adjacent second portion 106b and / or adjacent first portion 106a of barrel body 106 may be integrally formed or joined to each other by brackets, welds, adhesives, or the like. Referring to Figure 7, the dual barrel assembly is shown without plungers. In the embodiments shown, the first portion 106a is firmly coupled to each other, and the second portion 106b is firmly coupled to each other. The first portion 106a is coupled to the second portion 106b by a barrel connector 110''. For example, and as similarly shown in Figure 8, the barrel connector 110'' is a coupled barrel connector including a connector body 112'' having two openings 114'' for coupling the first portion 106a to the corresponding second portion 106b. As in the embodiments described above, the first and second portions may be press-fitted or screwed into their respective openings 114''. In some embodiments, the connector body 112'' may be overmolded over various first and second parts. The barrel connector 110'' may include the seals described above. In embodiments having threaded connectors, it should be noted that the first parts 106a do not need to be firmly coupled to each other before screw-engaging with the connector body 112''. Similarly, the second parts 106b do not need to be firmly coupled to each other before screw-engaging with the connector body 112''. In some embodiments, the first or second parts 106a, 106b may be screw-engaged, while the other parts are intended to be press-fitted or overmolded into the barrel connector 110, 110'', or 110''.

[0035]

[0048] In some embodiments, the manifold 176 may connect the fluid delivery opening of the second portion 106b to a respective delivery needle or cannula (not shown) for fluid delivery. It should be noted that in various embodiments, it may be desirable to separate and maintain the mixed components from the first subassembly 100a and the second subassembly 100b until delivery at the target delivery location, such as within a person. Thus, a dual needle assembly and / or coaxial needle assembly, such as that described in International Patent Application No. PCT / US2021 / 023171, filed March 19, 2021, entitled "Multi-Component Sealant Delivery Systems Incorporating Quarter Turn Connectors," is incorporated by reference. For example, the first mixing syringe subassembly 100a may contain a first component material 150a and a second component material 150b, while the second mixing syringe subassembly 100b may hold different first component materials 150a and / or different second component materials 150b. For example, the second component material 150b of the first mixing syringe subassembly may hold PEG-8 having 20 kmw, while the second component material 150b of the second mixing syringe subassembly may hold PEG-8 having 15 kmw. The first component material 150a may similarly be the same or different, and may contain, but is not limited to, water, saline, deionized water, or similar. In some embodiments, the resulting mixtures or solutions in the first and second subassemblies 100a, 100b, respectively, may gel or solidify when in contact with each other. Therefore, it may be desirable to allow contact only at the moment of delivery, such as at the end of a dual-lumen cannula, as disclosed in International Patent Application No. PCT / US2021 / 023171, filed on March 19, 2021, entitled "Multi-Component Sealant Delivery Systems Incorporating Quarter Turn Connectors," which is incorporated by reference in its entirety.

[0036]

[0049] During use, in any embodiment of the above embodiments, the plunger 102 is initially positioned within the first section 106a. If desired, the user may apply a downward force to the plunger 102 to flush the diluent through the barrel connector 110 (e.g., the inner seal) into the second section 106b containing the powder. Once all the diluent has entered the second section 106b, the plunger 102 may be positioned approximately halfway down the entire length of the barrel body 106, such as at the barrel connector 110. At this stage, the user may hydrate the powder by shaking the assembly 100. Once the powder is sufficiently hydrated, the user may then continue to apply downward pressure to the plunger 102, thereby extending the plunger 102 through the barrel connector 110 to deliver the solution through the assembly 100, such as into the delivery needle (not shown). In some embodiments, the seal material is highly compressible or very thin to allow the plunger to pass through.

[0037]

[0050] Figure 9 shows an overall flowchart illustrating a method 200 for assembling a mixing syringe assembly 100. The method may be used to construct any mixing syringe assembly of the mixing syringe assemblies described herein. Method 200 may include more or fewer steps in any order without departing from the scope of the disclosure. In block 202, method 200 includes positioning a first component material 150a within a first portion 106a of the barrel body 106, as shown in Figure 1. In block 204, method 200 includes positioning a second component material 150b within a second portion 106b of the barrel body 106. In block 206, method 200 includes connecting the first portion 106a of the barrel body 106 to the second portion 106b of the barrel body 106 by a barrel connector 110, as described herein. In several embodiments, and as described above, connecting the first portion 106a of the barrel body 106 to the second portion 106b of the barrel body 106 by the barrel connector 110 includes screw-engaging each of the first portion 106a and the second portion 106b to the barrel connector 110. In some embodiments, connecting the first portion 106a of the barrel body 106 to the second portion 106b of the barrel body 106 by the barrel connector 110 includes press-fitting each of the first portion 106a and the second portion 106b to the barrel connector 110. In some embodiments, connecting the first portion 106a of the barrel body 106 to the second portion 106b of the barrel body 106 by the barrel connector 110 includes overmolding each of the first portion 106a and the second portion 106b by the barrel connector 110.

[0038]

[0051] In any embodiment of the embodiments described herein, the mixing syringe assembly 100 may be provided to the user as a preloaded mixing syringe assembly. That is, the mixing syringe assembly 100 may be preloaded with a first component material 150a positioned in a first part and a second component material 150b positioned in a second part. In embodiments in which the mixing syringe assembly is a dual-barrel syringe assembly, each part assembly 110a, 100b may be preloaded with the first component material 150a and the second component material 150b as described above. As in the above embodiments, in a closed configuration, the inner seal 116 (such as a torsion seal or other disclosed seal) prevents the first component material from mixing with the second component material, and in an open configuration, the inner seal 116 allows the first component material to mix with the second component material. That is, the first component material 150b can pass through the inner seal 116 to mix with the second component material 150b. Once mixed, the combined substances may be delivered via a needle or other means.

[0039]

[0052] Multiple embodiments may also be described with respect to the following numbered clauses:

[0053] 1. A mixing syringe assembly for mixing two constituent materials, comprising a barrel body having a first part and a second part, and a barrel connector connecting the first part to the second part, wherein the barrel connector comprises a torsion seal having a plurality of flaps, the torsion seal working to operate from a closed configuration in which the torsion seal seals the first part from the second part, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first part and the second part.

[0040]

[0054] 2. A mixing syringe assembly as described in Clause 1, wherein the first part and the second part have matching inner diameters.

[0055] 3. A mixing syringe assembly as described in Clause 1 or 2, wherein each of the plurality of flaps includes an engaging edge for catching around an adjacent flap.

[0041]

[0056] 4. A mixing syringe assembly as described in any one of clauses 1 to 3, wherein the barrel connector engages with the first and second parts in a screw-like manner.

[0042]

[0057] 5. A mixing syringe assembly as described in any one of Clauses 1 to 3, wherein the barrel connector is overmolded on the first and second parts.

[0043]

[0058] 6. A mixing syringe assembly as described in any one of Clauses 1 to 3, wherein a first part is press-fitted into a barrel connector and a second part is press-fitted into a barrel connector.

[0044]

[0059] 7. A mixing syringe assembly as described in any one of clauses 1 to 6, wherein the plurality of flaps comprises three or more flaps.

[0060] 8. A mixing syringe assembly according to any one of clauses 1 to 7, wherein the second part comprises a dispensing end, and the twisted portions of a plurality of flaps are directed outward from the dispensing end of the second part in a closed configuration.

[0045]

[0061] 9. A mixing syringe assembly as described in Clause 8, wherein the operation of the torsion seal, in an open configuration, causes a plurality of flaps to extend toward the dispensing end of the second portion.

[0046]

[0062] 10. A mixing syringe assembly as described in any one of clauses 1 to 9, wherein the plurality of flaps are shifted to a closed configuration.

[0063] 11. A preloaded mixing syringe assembly comprising a barrel body having a first part and a second part, a barrel connector connecting the first part to the second part, the barrel connector comprising a torsion seal having a plurality of flaps, the torsion seal working to operate from a closed configuration in which the torsion seal seals the first part from the second part, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first part and the second part, and a barrel connector comprising a first component material housed in the first part and a second component material housed in the second part, wherein in the closed configuration the torsion seal prevents the first component material from mixing with the second component material, and in the open configuration the first component material is mixable with the second component material.

[0047]

[0064] 12. A preloaded mixing syringe assembly as described in Clause 11, further comprising a plunger slidably positioned within a barrel body, wherein the plunger is sized to seal against the walls of both a first and a second portion.

[0048]

[0065] 13. A preloaded mixing syringe assembly as described in Clause 12, wherein advancing a plunger along a first portion activates a torsion seal from a closed configuration to an open configuration.

[0049]

[0066] 14. A preloaded mixing syringe assembly as described in any one of clauses 11 to 13, wherein the second part comprises a dispensing end, and the twisted portions of a plurality of flaps are directed outward from the dispensing end of the second part in a closed configuration.

[0050]

[0067] 15. A preloaded mixing syringe assembly as described in Clause 14, wherein the operation of the torsion seal, in an open configuration, causes a plurality of flaps to extend toward the dispensing end of a second portion.

[0051]

[0068] 16. A preloaded mixing syringe assembly as described in any one of clauses 11 to 15, wherein a plurality of flaps are shifted into a closed configuration.

[0052]

[0069] 17. A method for assembling a mixing syringe assembly, comprising positioning a first component within a first portion of a barrel body, positioning a second component within a second portion of a barrel body, and connecting the first portion of the barrel body to a second portion of the barrel body by a barrel connector comprising a torsion seal having a plurality of flaps, wherein the torsion seal operates to function from a closed configuration in which the torsion seal seals the first portion from the second portion, and from an open configuration in which the plurality of flaps twist apart to provide an opening between the first portion and the second portion.

[0053]

[0070] 18. A method according to Clause 17, wherein connecting a first portion of a barrel body to a second portion of a barrel body by a barrel connector includes screw-engaging each of the first and second portions to the barrel connector.

[0054]

[0071] 19. A method according to Clause 17, wherein connecting a first portion of a barrel body to a second portion of a barrel body by a barrel connector includes engaging the first portion and the second portion, respectively, with the barrel connector by press-fitting.

[0055]

[0072] 20. A method according to Clause 17, wherein connecting a first portion of a barrel body to a second portion of a barrel body by a barrel connector comprises overmolding the first portion and the second portion, respectively, by the barrel connector.

[0056]

[0073] It should be understood hereby that this disclosure relates to various mixing syringe assemblies and methods for mixing constituent materials using mixing syringe assemblies. Various embodiments provided herein may provide syringe assemblies that are ready for immediate use or readily assembled for easy mixing of components. Furthermore, some embodiments provided herein may help maintain sterility and / or constituent material integrity while improving ease of mixing and dispensing.

[0057]

[0074] While specific embodiments have been shown and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Furthermore, while various aspects of the claimed subject matter have been described herein, such aspects do not need to be used in combination. Therefore, the appended claims are intended to cover all such changes and modifications that fall within the scope of the claimed subject matter.

Claims

1. A mixing syringe assembly for mixing two constituent materials, A barrel body comprising a first part and a second part, A mixing syringe assembly comprising a barrel connector connecting the first portion to the second portion, the barrel connector comprising a torsion seal having a plurality of flaps, the torsion seal working to operate from a closed configuration in which the torsion seal seals the first portion from the second portion, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first portion and the second portion.

2. A mixing syringe assembly according to claim 1, wherein the first part and the second part have matching inner diameters.

3. A mixing syringe assembly according to claim 1, wherein each of the plurality of flaps includes an engaging edge for catching around an adjacent flap.

4. A mixing syringe assembly according to claim 1, wherein the barrel connector engages with the first portion and the second portion in a screw manner.

5. A mixing syringe assembly according to claim 1, wherein the barrel connector is overmolded on the first portion and the second portion.

6. A mixing syringe assembly according to claim 1, wherein the first part is press-fitted into the barrel connector and the second part is press-fitted into the barrel connector.

7. A mixing syringe assembly according to claim 1, wherein the plurality of flaps comprises three or more flaps.

8. A mixing syringe assembly according to claim 1, wherein the second portion comprises a dispensing end, and the twisted portions of the plurality of flaps are directed outward from the dispensing end of the second portion in the closed configuration.

9. A mixing syringe assembly according to claim 8, wherein the operation of the torsion seal, in the open configuration, causes the plurality of flaps to extend toward the dispensing end of the second portion.

10. A mixing syringe assembly according to claim 1, wherein the plurality of flaps are shifted to the closed configuration.

11. A preloaded mixing syringe assembly, A barrel body comprising a first part and a second part, A barrel connector connecting the first portion to the second portion, the barrel connector comprising a torsion seal having a plurality of flaps, the torsion seal operating to be operated from a closed configuration in which the torsion seal seals the first portion from the second portion, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first portion and the second portion, A first constituent material housed within the first portion, A preloaded mixing syringe assembly comprising a second component material housed within the second portion, wherein in the closed configuration, the torsion seal prevents the first component material from mixing with the second component material, and in the open configuration, the first component material is mixable with the second component material.

12. A preloaded mixing syringe assembly according to claim 11, further comprising a plunger slidably positioned within the barrel body, wherein the plunger is sized to seal against the walls of both the first and second portions.

13. A preloaded mixing syringe assembly according to claim 12, wherein advancing the plunger along the first portion causes the torsion seal to move from the closed configuration to the open configuration.

14. A preloaded mixing syringe assembly according to claim 11, wherein the second portion comprises a dispensing end, and the twisted portions of the plurality of flaps are directed outward from the dispensing end of the second portion in the closed configuration.

15. A preloaded mixing syringe assembly according to claim 14, wherein the operation of the torsion seal, in the open configuration, causes the plurality of flaps to extend toward the dispensing end of the second portion.

16. A preloaded mixing syringe assembly according to claim 11, wherein the plurality of flaps are shifted to the closed configuration.

17. A method for assembling a mixing syringe assembly, A step of positioning a first component material within a first portion of the barrel body, A step of positioning a second component material within a second portion of the barrel body, A barrel connector comprising a torsion seal having a plurality of flaps, the method comprising connecting a first portion of the barrel body to a second portion of the barrel body by the barrel connector, wherein the torsion seal operates to function from a closed configuration in which the torsion seal seals the first portion from the second portion, and an open configuration in which the plurality of flaps twist apart to provide an opening between the first portion and the second portion.

18. A method according to claim 17, wherein the step of connecting the first portion of the barrel body to the second portion of the barrel body by the barrel connector includes screw-engaging the first portion and the second portion, respectively, with the barrel connector.

19. A method according to claim 17, wherein the step of connecting the first portion of the barrel body to the second portion of the barrel body by the barrel connector includes engaging the first portion and the second portion, respectively, with the barrel connector by press-fitting.

20. A method according to claim 17, wherein the step of connecting the first portion of the barrel body to the second portion of the barrel body by the barrel connector includes overmolding the first portion and the second portion, respectively, by the barrel connector.

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