Mixing syringe assembly and method

Abstract

The mixing syringe assembly includes a barrel body and a sealing device. The barrel body includes tracks defining a first longitudinal path, a second longitudinal path, and a rotational path. The first and second longitudinal paths are rotated and offset from each other by the rotational path. The sealing device is positioned at a division position in the rotational path, and the sealing device divides the barrel body into a first component section and a second component section. The sealing device is rotatable in the rotational path, allowing the sealing device to enter the second longitudinal path and advance along the second longitudinal path. The sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section, which holds the second component.

Description

Technical Field

[0001] Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 498,656, filed on April 27, 2024, entitled "MIXING SYRINGE ASSEMBLIES AND METHODS OF MIXING CONSTITUENT MATERIALS", the entire disclosure of which is incorporated herein by reference.

[0002]

[0002] The present 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]

[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 tissues at risk.

[0004]

[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 start 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, the mixing syringe assembly includes a barrel body and a sealing device. The barrel body includes tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, the first and second longitudinal paths rotating and offset from each other by the rotational path. The sealing device is configured to be positioned at a division position in the rotational path, dividing the barrel body into a first component material section and a second component material section, and the sealing device is rotatable in the rotational path such that the rotation of the sealing device in the rotational path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component material from the first component material section to move into the second component material section holding the second component material.

[0006]

[0007] In another embodiment, the mixing syringe assembly includes a first mixing syringe subassembly and a second mixing syringe subassembly coupled to the first mixing syringe subassembly. Each mixing syringe subassembly includes a barrel body and a sealing device. The barrel body includes tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, the first and second longitudinal paths rotating and offset from each other by the rotational path. The sealing device is configured to be positioned at a division position within the rotation path, the sealing device divides the barrel body into a first component material section and a second component material section, the sealing device is rotatable within the rotation path such that the rotation of the sealing device within the rotation path allows the sealing device to enter a second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component material from the first component material section to move into the second component material section that holds the second component material.

[0007]

[0008] In yet another embodiment, a method for assembling a mixing syringe assembly includes inserting a first component into a barrel body, the barrel body comprising tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, the first and second longitudinal paths rotating and offset from each other by the rotational path, and inserting a sealing device into the barrel body, thereby positioning the sealing device within the rotational path and dividing the barrel body into a first component section and a second component section. The sealing device is rotatable within the rotational path such that rotation of the sealing device within the rotational path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path. The sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section holding the second component.

[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 illustrates a dual syringe assembly for mixing constituent materials according to one or more embodiments shown and described herein. [Figure 3]

[0014] Figure 3A schematically shows how a sealing device separates a barrel into a first component section and a second component section, according to one or more embodiments shown and described herein.

[0015] Figure 3B schematically illustrates, according to one or more embodiments shown and described herein, that a first component material moves from the first component material section to the second component material section through the sealing device of Figure 3A.

[0016] Figure 3C schematically shows the distal advancement of a plunger and sealing device within the barrel of Figure 3B according to one or more embodiments shown and described herein. [Figure 4]

[0017] This is a perspective view of a dual barrel according to one or more embodiments shown and described herein. [Figure 5]

[0018] This flowchart shows a method for assembling a mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 6]

[0019] This flowchart shows a method of using a mixing syringe assembly according to one or more embodiments shown and described herein. [Modes for carrying out the invention]

[0012]

[0020] This disclosure generally pertains to mixing syringe assemblies for mixing at least two constituent materials. In particular, this application pertains to mixing syringe assemblies configured for dispensing radiation spacers. For example, a radiation spacer may be formed of one or more hydrogel materials, which are dispensed to a desired location, such as within a balloon or on themselves, and cured in place to block or substantially block radiation that may be unintentionally directed to healthy tissue instead of target / disease tissue. During the mixing of hydrogels to form a radiation spacer, the multiple materials may need to be bound immediately before and / or at the time of dispensing the radiation spacer into the target location in the body. To maintain the quality of the materials, powder components may need to be kept dry or uncomposed before application. However, during use, powder components may need to be hydrated or mixed with a diluent. Determining the appropriate mixing volume, maintaining sterility, and preventing unnecessary premature mixing can be difficult using traditional methods. However, embodiments of the present disclosure may provide constituent materials in a pre-packaged, pre-measured, ready-to-use syringe assembly that provides improved mixing, maintains sterility, and / or improves dispensing, as described in more detail herein.

[0013]

[0021] A particular embodiment of the mixing syringe assembly includes a barrel body, a plunger, and a sealing device. The sealing device works to divide the barrel body into a first component section and a second component section, thereby maintaining the separation of the first component in the first component section and the second component in the second component section until the sealing device is actuated from a closed configuration to an open configuration. In embodiments of the present disclosure, the barrel or barrel body includes a track and a sealing device that separates the barrel body into a first component section and a second component section. The sealing device may maintain the fluid component from the powder component until the desired combination is achieved. When dispensing is desired, the sealing device is movable along the track to assist in dispensing the combined material. These and further embodiments and benefits will be described in more detail below.

[0014]

[0022] The directional terms used herein—for example, up, down, right, left, front, back, top, and bottom—are made solely in reference to the depicted figures and are not intended to suggest absolute orientation unless otherwise specified.

[0015]

[0023] Unless otherwise expressly stated, no method described herein is ever intended to be construed as requiring its steps to be performed in a particular order, nor is any device intended to require a particular orientation. Therefore, if a claim for a method does not actually describe the order followed by its steps, or if a claim for any device or assembly does not actually describe the order or orientation to its individual components, or if the steps are limited to a particular order, or if a particular order or orientation to the components of a device or assembly is not described, unless otherwise specifically stated in the claim or description, no order or orientation is ever intended to be presumed in any respect. This applies to any possible non-express basis for interpretation, including logical matters concerning the arrangement of steps, the flow of operations, the order of components, or the orientation of components; plain meaning derived from grammatical organization or punctuation; and the number or type of embodiments described herein.

[0016]

[0024] As used herein, the singular forms “a,” “an,” and “the” include multiple referents unless the context explicitly indicates otherwise. For example, a reference to a “a” component includes embodiments having two or more such components unless the context explicitly indicates otherwise.

[0017]

[0025] 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 sealing device 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]

[0026] 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 material 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]

[0027] The barrel body 106 is generally hollow and has a plunger receiving end 109 at its proximal end for receiving the plunger 102, and may have a fluid delivery opening 113 at its distal end that may be coupled to a material delivery cannula (not shown, the material delivery cannula may include a manifold, a delivery needle, or the like). In a plurality of embodiments, the fluid delivery opening 113 may be axially positioned along 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 when preventing one or more mixed masses 130 from blocking the fluid delivery opening 113.

[0020]

[0028] The sealing device 110 first separates the barrel body 106 into a first constituent material section 140 and a second constituent material section 142 when in the split position. The first constituent material section 140 and the second constituent material section 142 may initially occupy the same volume or substantially the same volume, as shown. However, in some embodiments, the initial volumes may be different from each other. As will be described in more detail, a first constituent material 150a may be initially positioned within the first constituent material section 140, and a second constituent material 150b different from the first constituent material 150a may be positioned within the second constituent material section 142. As shown in the embodiment shown, the first constituent material section 140 may be positioned adjacent to the second constituent material section 142.

[0021]

[0029] The first constituent material 150a may be a liquid for hydrating a second constituent material 150b which may be a powder or fine particles. For example, the first constituent material 150a may be physiological saline, water, deionized water, or the like. As described above, the second constituent material 150b may be, without limitation, albumin, polyethyleneimine (PEI), amine-containing polyethylene glycol (PEG) or protein, PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and / or the like, such as a powder or fine particle material such as an N-hydroxysuccinimide (NHS) ester component. 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 tissue of the subject person and / or that can be decomposed and absorbed by the tissue of the subject person.

[0022]

[0030] The powder or fine particle material may be composed of various amounts of various cross-linking substances designed to allow the hydrogel to persist at the current location for a specific period of time before decomposing. In a plurality of embodiments, the hydrogel component may be selected based on a decomposition time corresponding to the expected length of radiation therapy. In a plurality of embodiments, the expected length of radiation therapy, and thus the target time for hydrogel decomposition, may be 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 generally used to target the appropriate formulation of the hydrogel.

[0023]

[0031] The sealing device 110 may take several different forms. However, generally, the various sealing devices described herein may be moved or otherwise modified to selectively provide a flow path between the first component section 140 and the second component section 142, allowing the first component material 150a from the first component section 140 to move into the second component section 142, thereby allowing mixing of the first component material 150a and the second component material 150b.

[0024]

[0032] 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.

[0025]

[0033] Referring here to Figure 2, in various embodiments, the mixing syringe assembly 100 may include one or more mixing syringe subassemblies 100a, 100b, for example, to provide a dual-barrel syringe. For example, Figure 2 shows a dual mixing syringe assembly 100 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 assembly 100 described with respect to Figure 1. In particular, each subassembly 100a may include a plunger 102, a barrel body 106, and a sealing device 110. In some embodiments, the subassemblies 100a, 100b further include one or more mixing masses 130. Thus, the above description is applicable to this embodiment and is not repeated. In some embodiments, the barrel bodies 106 may be firmly coupled to one another. For example, adjacent barrel bodies 106 may be integrally formed or joined to each other by brackets, welding, adhesive, or the like. In some embodiments, the manifold 176 may have fluid delivery openings 113 coupled to their respective delivery needles or cannulas (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, dual needle assemblies and / or coaxial needle assemblies, such as those described in International Patent Application No. PCT / US2021 / 023171, filed March 19, 2021, entitled "Multi-Component Sealant Delivery Systems Incorporating Quarter Turn Connectors," which are incorporated by reference, may be desirable.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 100a may hold PEG-8 having 20 kmw, while the second component material 150b of the second mixing syringe subassembly 100b may hold PEG-8 having 15 kmw. The first component material 150a may similarly be the same or different from each other, and may include, 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, for example, at the end of a dual-lubricated 107 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.

[0026]

[0034] Figures 3A-3B show the use of the mixing syringe sub-assembly 100 of the dual barrel assembly 100. However, in the depiction, the barrel body 106 of the second sub-assembly 100b is empty to provide a better depiction of the internal structure of each barrel body 106. Such an internal structure would also be present in a single barrel design. Furthermore, the use / operation of the single barrel design on both sides would be the same. In particular, each barrel body 106 includes a track 160 defining a first longitudinal path 162, a second longitudinal path 164, and a rotation path 168. The first longitudinal path 162 and the second longitudinal path 164 may extend parallel to the axial direction of each barrel body 106 or plunger 102. However, the first longitudinal path 162 and the second longitudinal path 164 are rotated and offset from each other by the rotation path 168. For example, the first longitudinal path 162 and the second longitudinal path 164 may be rotated and offset from each other by an amount between 1 degree and 90 degrees, for example between approximately 5 degrees and 45 degrees, for example between approximately 5 degrees and 25 degrees, etc. The first longitudinal path 162 and the second longitudinal path 164 are connected to each other by a rotational path 168 to provide a continuous path along the barrel body 106. The rotational path 168 may extend perpendicular to the axial direction of the barrel body 106 or plunger 102. In some embodiments, the rotational path 168 does not need to be perpendicular to the axial direction of the barrel body 106 or plunger 102, but may be angled at a certain oblique angle with respect to the axial direction of the barrel body 106 or plunger 102. The first longitudinal path 162, the second longitudinal path 164, and the rotational path 168 may be channels recessed in the inner wall of each barrel body 106. In other embodiments, the first longitudinal path 162, the second longitudinal path 164, and the rotational path 168 may protrude from the inner wall of each barrel body 106.

[0027]

[0035] As best shown in Figure 4, each barrel body 106 may include multiple tracks 160. For example, each barrel body 106 may include two or more tracks 160, such as four tracks 160. The multiple tracks 160 may be equally or unequally spaced from one another. Each of the tracks 160 includes the first longitudinal path 162, the second longitudinal path 164, and the rotation path 168 described above. It should be noted that in some embodiments, the rotation path 168 may be oriented in opposing directions between one barrel body 106 and the other barrel body 106, which may result in opposite rotational directions for traversing the tracks 160.

[0028]

[0036] Referring again to Figures 3A-3C, in several embodiments, the sealing device 110 may include any number of sealing devices, such as check valves, one-way valves, film valves, or the like. In the embodiments shown in Figures 3A-3C, the sealing device 110 is shown as a film valve having a valve body 112 defining a flow path 114 through which the valve body 112 passes, and a burstable film 116 bonded to the valve body 112 (by welding, adhesive, or the like, etc.) and blocking the flow path 114. The burstable film 116 may be plastic, foil, or the like and may be configured to burst under pressure such as that supplied by a plunger 102 advancing toward the sealing device 110. In several embodiments, the sealing device 110 may engage with a track 160 and advance along the track 160, and may remain aligned with the track 160. For example, the sealing device 110 may include projections 118 that seat within each track 160 to allow the sealing device 110 to be guided by the tracks 160 along the length of the barrel body 106. Thus, the sealing device 110 may include a corresponding number of projections 118 and tracks 160. The projections 118 may be sized to fit into the tracks 160 so that they can travel along the longitudinal paths 162, 164 and the rotational path 168. The valve body 112 may include any number of conformable materials or similar to prevent leakage around the valve body 112, such as within the tracks 160.

[0029]

[0037] At the initial splitting position, the sealing device 110 may be inserted halfway down each barrel body 106 to the rotating path 168 in the track 160, thereby splitting the barrel body 106 into a first component section 140 and a second component section 142. For example, each section may have a volume of 5 ml, but other sizes are intended and possible. In some embodiments, the first component section 140 may hold the diluent described above (e.g., water, saline solution, etc.), and the second component section 142 may hold the powder described above (e.g., PEG, albumin, or similar).

[0030]

[0038] Referring to Figure 3B, the plunger 102 may be pushed down through the barrel body 106 until it contacts the sealing device 110 (e.g., valve body 112). While the plunger 102 is being pushed, the diluent is forced through the sealing device 110 into the second component section 142, as shown in Figure 3B. For example, the force or pressure generated by advancing the plunger 102 may actuate the sealing device 110 into an open configuration (e.g., the valve may open or the film may burst). The diluent can then be mixed with the powder in the second component section 142. The user may then shake the syringe assembly 100 to allow the powder (second component 150b) to dissolve in the diluent. The user pushes down the plunger(s) 102 to engage the plunger with the sealing device 110, such as the valve body 112. The plunger 102 may be engageable with the sealing device 110 such that rotation of the plunger rotates the sealing device within a rotation path. For example, the plunger 102 may frictionally engage with the sealing device 110 or mesh with the sealing device 110. Once engaged, the user may apply torque to the plunger 102. The torque will rotate the sealing device 110 through the rotation path 168, which will allow the projection 118 to enter the second longitudinal path 164. By traversing the rotation path 168, the sealing device 110 may then be pushed down to the distal end of the barrel body 106, as shown in Figure 3C. That is, once the sealing device 110 enters this second longitudinal path 164, the user then applies a torque-free downward force to push the plunger 102 and the sealing device 110 to the distal end of the barrel 106 (or more), ultimately delivering the gel through the distal end of the assembly 100.

[0031]

[0039] Although only movement through one side of the barrel body 106 is shown, it should be noted that the same process may occur on the other side for simultaneous mixing and dispensing.

[0040] Figure 5 shows an overall flowchart illustrating a method 200 for assembling the mixing syringe assembly 100 described above. Method 200 may include more or fewer steps than those shown below, and the steps may be performed in any order. Method 200 may include inserting the first component material 150a into the barrel body 106 in block 202. In block 204, Method 200 includes inserting the sealing device 110 into the barrel body 106, thereby engaging the barrel body 106 into the rotation path 168 and dividing the barrel body 106 into a first component material section 140 and a second component material section 142. Such a step may include inserting the sealing device 110 into the barrel body 106 by engaging the sealing device 110 into a first longitudinal path 162 and advancing the sealing device 110 along the first longitudinal path 162 to the rotation path 168. In block 206, method 200 may include inserting the second component 150b into the second component section 142. It should be noted that the user may first position the second component 150b before inserting the sealing device 110 and the first component 150a. Method 200 may further include positioning the plunger within the first component section 140. Thus, the mixing syringe assembly 100 may be ready for immediate use, having pre-measured components inside, which remain separated from each other by the sealing device.

[0032]

[0041] Figure 6 shows an overall flowchart illustrating method 300 using the mixing syringe assembly 100 (dual-barrel or single-barrel type). The method may be best understood in conjunction with Figures 3A-3C described above. Method 300 may include advancing the plunger 102 toward the sealing device 110 in block 302 to adjust the sealing device 110 to a non-sealing configuration (e.g., opening a valve, rupturing a film, etc.). In the non-sealing configuration, method 300 includes advancing the plunger 102 toward the sealing device 110 in block 304 to transfer the first component material 150a to the second component material section 142. After the first component material 150a has been delivered into the second component material section 142, method 300 includes engaging the plunger 102 with the sealing device 110 in block 306. Therefore, upon engagement with the sealing device 110, the first component 150a may be completely ejected into the second component section 142. In block 308, method 300 includes twisting the plunger 102, thereby rotating the sealing device 110 in the rotation path 168. For example, the plunger 102 may engage with or frictionally engage the sealing device 110 (such as the valve body 112), thereby causing the rotation of the plunger 102 to result in the rotation of the sealing device 110 along the rotation path 168. In block 310, method 300 further includes advancing the plunger 102 and the sealing device 110 along a second longitudinal path 164. Thus, the combined first component 150a and second component 150b may be ejected from the mixing syringe assembly 100. In some embodiments, before dispensing, the mixing syringe assembly 100 may be stirred to ensure complete mixing of the first component 150a and the second component 150b.

[0033]

[0042] In embodiments including a burstable film, tearing the film may be achieved by manual operation or assisted by a jig or cradle and a pressurizing actuator (e.g., a linear actuator mechanically engaged with the plunger 102 and / or barrel body 106).

[0034]

[0043] Multiple embodiments may be further described with respect to the following numbered clauses:

[0044] 1. A mixing syringe assembly comprising a barrel body having tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, wherein the first and second longitudinal paths rotate and offset each other by the rotational path, and a sealing device configured to be positioned at a division position in the rotational path, wherein the sealing device divides the barrel body into a first component section and a second component section, and the sealing device is rotatable in the rotational path such that rotation of the sealing device in the rotational path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section holding the second component.

[0035]

[0045] 2. A mixing syringe assembly as described in Clause 1, further comprising a plunger slidably positioned within a barrel body.

[0036]

[0046] 3. A mixing syringe assembly as described in Clause 2, wherein the plunger is engageable with a sealing device such that the rotation of the plunger causes the sealing device to rotate within a rotational path.

[0037]

[0047] 4. A mixing syringe assembly as described in any one of clauses 1 to 3, wherein the track is recessed within the wall of the barrel body.

[0048] 5. A mixing syringe assembly according to any one of clauses 1 to 4, wherein the sealing device comprises a projection extending into the track.

[0038]

[0049] 6. A mixing syringe assembly as described in any one of clauses 1 to 5, wherein the sealing device comprises a one-way valve.

[0050] 7. A mixing syringe assembly as described in any one of Clauses 1 to 6, wherein the sealing device comprises a burstable film.

[0039]

[0051] 8. A mixing syringe assembly for mixing multiple components, comprising a first mixing syringe subassembly and a second mixing syringe subassembly coupled to the first mixing syringe subassembly, each mixing syringe subassembly comprising a barrel body having a track defining a first longitudinal path, a second longitudinal path, and a rotation path, wherein the first and second longitudinal paths rotate away from each other and are offset by the rotation path, and a sealing device configured to be positioned at a division position in the rotation path, A mixing syringe assembly comprising a ring device which divides the barrel body into a first component material section and a second component material section, a sealing device which is rotatable in a rotation path such that the rotation of the sealing device in a rotation path allows the sealing device to enter a second longitudinal path and advance along the second longitudinal path, and the sealing device which works to adjust from a sealed configuration to an unsealed configuration such that the first component material from the first component material section moves into the second component material section which holds the second component material.

[0040]

[0052] 9. A mixing syringe assembly as described in Clause 8, wherein the barrel body of a first mixing syringe subassembly is coupled to the barrel body of a second mixing syringe subassembly.

[0041]

[0053] 10. A mixing syringe assembly according to Clause 8 or 9, wherein the first mixing syringe subassembly and the second mixing syringe subassembly further comprise a plunger slidably positioned within the barrel body.

[0042]

[0054] 11. A mixing syringe assembly as described in Clause 10, wherein each plunger is engageable with the respective sealing device such that the rotation of the plunger rotates the sealing device within the rotation path.

[0043]

[0055] 12. A mixing syringe assembly as described in any one of clauses 8 to 11, wherein the tracks are recessed into the walls of each barrel body.

[0044]

[0056] 13. A mixing syringe assembly according to any one of clauses 8 to 12, wherein each sealing device comprises a projection extending into its respective track.

[0045]

[0057] 14. A mixing syringe assembly as described in any one of clauses 8 to 13, wherein the sealing device comprises a one-way valve.

[0058] 15. A mixing syringe assembly according to any one of clauses 8 to 14, wherein the sealing device comprises a burstable film.

[0046]

[0059] 16. A method for assembling a mixing syringe assembly, comprising inserting a first component material into a barrel body, the barrel body comprising tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, wherein the first and second longitudinal paths are rotated and offset from each other by the rotational path; and inserting a sealing device into the barrel body, thereby engaging the barrel body within the rotational path and dividing the barrel body into a first component material section and a second component material section, wherein the sealing device is rotatable within the rotational path such that the rotation of the sealing device within the rotational path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path; and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component material from the first component material section to move into a second component material section holding the second component material.

[0047]

[0060] 17. A method according to Clause 16, wherein inserting a sealing device into a barrel body includes engaging the sealing device with a first longitudinal path and advancing the sealing device along the first longitudinal path to a rotational path.

[0048]

[0061] 18. A method relating to the method described in Clause 16 or 17, further comprising inserting a second component material into a second component material section.

[0062] 19. A method according to any one of the clauses 16 to 18, further comprising inserting a plunger into the barrel body.

[0049]

[0063] 20. A method of using a mixing syringe assembly as described in any one of Clauses 1 to 15, comprising: advancing a plunger toward a sealing device to adjust the sealing device to a non-sealing configuration; advancing the plunger further toward the sealing device to transfer a first component material into a second component material section; engaging the plunger with the sealing device; twisting the plunger to rotate the sealing device in a rotational path; and advancing the plunger and the sealing device along a second longitudinal path.

[0050]

[0064] 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.

[0051]

[0065] 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, A barrel body comprising a track defining a first longitudinal path, a second longitudinal path, and a rotational path, wherein the first longitudinal path and the second longitudinal path rotate away from each other and are offset by the rotational path, A mixing syringe assembly comprising a sealing device configured to be positioned at a division position in the rotation path, wherein the sealing device divides the barrel body into a first component section and a second component section, the sealing device is rotatable in the rotation path such that the rotation of the sealing device in the rotation path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section holding the second component.

2. A mixing syringe assembly according to claim 1, further comprising a plunger slidably positioned within the barrel body.

3. A mixing syringe assembly according to claim 2, wherein the plunger is engageable with the sealing device such that the rotation of the plunger causes the sealing device to rotate within the rotation path.

4. A mixing syringe assembly according to claim 1, wherein the track is recessed within the wall of the barrel body.

5. A mixing syringe assembly according to claim 1, wherein the sealing device comprises a projection extending into the track.

6. A mixing syringe assembly according to claim 1, wherein the sealing device comprises a one-way valve.

7. A mixing syringe assembly according to claim 1, wherein the sealing device comprises a burstable film.

8. A mixing syringe assembly for mixing multiple components, The device comprises a first mixing syringe assembly and a second mixing syringe assembly coupled to the first mixing syringe assembly, each mixing syringe assembly having: A barrel body comprising a track defining a first longitudinal path, a second longitudinal path, and a rotational path, wherein the first longitudinal path and the second longitudinal path rotate away from each other and are offset by the rotational path, A mixing syringe assembly comprising a sealing device configured to be positioned at a division position in the rotation path, wherein the sealing device divides the barrel body into a first component section and a second component section, the sealing device is rotatable in the rotation path such that the rotation of the sealing device in the rotation path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section holding the second component.

9. A mixing syringe assembly according to claim 8, wherein the barrel body of the first mixing syringe subassembly is coupled to the barrel body of the second mixing syringe subassembly.

10. A mixing syringe assembly according to claim 8, wherein the first mixing syringe subassembly and the second mixing syringe subassembly further comprises a plunger slidably positioned within the barrel body.

11. A mixing syringe assembly according to claim 10, wherein each of the plungers is engageable with the respective sealing device such that the rotation of the plunger causes the sealing device to rotate within the rotation path.

12. A mixing syringe assembly according to claim 8, wherein the track is recessed within the wall of each barrel body.

13. A mixing syringe assembly according to claim 8, wherein each sealing device comprises a projection extending into the respective track.

14. A mixing syringe assembly according to claim 8, wherein the sealing device comprises a one-way valve.

15. A mixing syringe assembly according to claim 8, wherein the sealing device comprises a burstable film.

16. A method for assembling a mixing syringe assembly, A step of inserting a first component material into a barrel body, wherein the barrel body is provided with tracks defining a first longitudinal path, a second longitudinal path, and a rotational path, and the first longitudinal path and the second longitudinal path rotate away from each other and are offset by the rotational path, A method comprising the steps of inserting a sealing device into the barrel body, thereby engaging the barrel body into the rotation path and dividing the barrel body into a first component section and a second component section, wherein the sealing device is rotatable in the rotation path such that rotation of the sealing device in the rotation path allows the sealing device to enter the second longitudinal path and advance along the second longitudinal path, and the sealing device works to adjust from a sealed configuration to an unsealed configuration, allowing the first component from the first component section to move into the second component section holding the second component.

17. A method according to claim 16, wherein the step of inserting the sealing device into the barrel body includes engaging the sealing device with the first longitudinal path and advancing the sealing device along the first longitudinal path to the rotational path.

18. A method according to claim 16, further comprising the step of inserting the second component material into the second component material section.

19. A method according to claim 16, further comprising the step of inserting a plunger into the barrel body.

20. A method using the mixing syringe assembly described in any one of claims 1 to 15, The steps include: advancing a plunger toward the sealing device in order to adjust the sealing device to the non-sealing configuration; The steps include: further advancing the plunger toward the sealing device in order to transfer the first component material into the second component material section; The steps of engaging the plunger with the sealing device, A twisting step of twisting the plunger, thereby rotating the sealing device within the rotation path, Steps include advancing the plunger and the sealing device along the second longitudinal path. Methods that include...

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