Mixing syringe assembly and method

Abstract

The mixing syringe assembly includes a first barrel body portion, a second barrel body portion, and a sealing device. The first barrel body portion defines a first constituent material section. The second barrel body portion defines a second constituent material section. The first barrel body portion is slidably disposed within the second barrel body portion. The sealing device is coupled to the distal end of the first barrel body portion and selectively provides a fluid path between the first barrel body portion and the second barrel body portion. The sealing device includes a first portion that defines a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration.

Description

Technical Field

[0004] ,

[0005]

[0001] Cross - reference to related applications

[0001] This application claims priority to U.S. Patent Application No. 63 / 498,670, filed on April

[0005]

[0004] , 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 mixing and delivering materials to form radiation spacers.

Background Art

[0003]

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

[0004]

[0004] Conventional radiation spacers may include 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. Further, the components may need to remain separated until use; otherwise, the components may degrade over time due to limited stability.

Summary of the Invention

[0005]

[0005] Embodiments of the present disclosure relate to various mixing syringe 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 first barrel body portion, a second barrel body portion, and a sealing device. The first barrel body portion defines a first constituent material section. The second barrel body portion defines a second constituent material section. The first barrel body portion is slidably disposed within the second barrel body portion. The sealing device is coupled to the distal end of the first barrel body portion and selectively provides a fluid path between the first barrel body portion and the second barrel body portion. The sealing device includes a first portion that defines a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration.

[0006]

[0007] In another embodiment, the mixing syringe assembly includes a first barrel body portion, a second barrel body portion, a sealing device, a plunger, and a lock. The first barrel body portion defines a first constituent material section. The second barrel body portion defines a second constituent material section. The first barrel body portion is slidably disposed within the second barrel body portion. The sealing device is coupled to the distal end of the first barrel body portion and selectively provides a fluid path between the first and second barrel body portions. The sealing device includes a first portion that defines a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration. The plunger is axially movable within the first barrel body portion. The lock is configured to support the plunger in a locked position.

[0007]

[0008] In yet another embodiment, a method for assembling a mixing syringe assembly includes coupling a sealing device to the distal end of a first barrel body portion, the sealing device comprising a first portion defining a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration, and inserting the sealing device and the first barrel body portion into a second barrel body portion, thereby slidably disposed within the second barrel body 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 1A]

[0012] This figure schematically illustrates one embodiment of a mixing syringe assembly for mixing constituent materials, comprising a first barrel body portion, a second barrel body portion, and a sealing device, according to one or more embodiments shown and described herein. [Figure 1B]

[0013] This figure schematically illustrates the movement of the plunger in the first barrel body portion of Figure 1A according to one or more embodiments shown and described herein. [Figure 1C]

[0014] This diagram schematically illustrates the motion of the first barrel body portion and the plunger in Figure 1B within the second barrel body portion, according to one or more embodiments shown and described herein. [Figure 2A]

[0015] This is a more detailed diagram of the sealing device shown in Figure 1A, according to one or more embodiments shown and described herein. [Figure 2B]

[0016] This figure shows a sealing device on the end of the first barrel body portion, with the second barrel body portion of Figure 2A absent, according to one or more embodiments shown and described herein. [Figure 2C]

[0017] This is a cross-sectional view of a portion of a separated sealing device according to one or more embodiments shown and described herein. [Figure 3A]

[0018] This figure schematically shows a cross-sectional view of the sealing device of Figure 2C in a closed configuration according to one or more embodiments shown and described herein. [Figure 3B]

[0019] This figure schematically illustrates the operation of the sealing device in Figure 3A to an open configuration according to one or more embodiments shown and described herein. [Figure 4A]

[0020] This figure shows a dual-barrel mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 4B]

[0021] Figure 4A is a cross-sectional view of a dual-barrel mixing syringe assembly according to one or more embodiments shown and described herein. [Figure 4C]

[0022] Figure 4B shows the plunger of the dual-barrel mixing syringe assembly, actuated to a first position, according to one or more embodiments shown and described herein. [Figure 4D]

[0023] Figure 4C shows the plunger and first barrel body portion of the dual-barrel mixing syringe assembly of Figure 4C, actuated to the second position according to one or more embodiments shown and described herein. [Figure 5]

[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] This disclosure generally pertains to mixing syringe assemblies for mixing at least two constituent materials. More specifically, this application pertains to mixing syringe assemblies configured to deliver radiation spacers. For example, the radiation spacer may be formed of one or more hydrogel materials, which are delivered to a desired location, such as inside 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 delivery of the radiation spacer into the target location in the body. To maintain the quality of the materials, powder components may need to be kept dry or uncomposed before application. However, during use, powder components may need to be hydrated or mixed with a diluent. Determining the appropriate mixing volume, maintaining sterility, and preventing unnecessary premature mixing can be difficult using traditional methods. Embodiments of the present disclosure may provide constituent materials in a pre-packaged, pre-measured, ready-to-use syringe assembly that provides improved mixing, maintains sterility, and / or improves dispensing, as described in more detail herein.

[0013]

[0026] Certain embodiments of the mixing syringe assembly are directed to a nested barrel body design that includes a first barrel body portion, a second barrel body portion, and a sealing device. The first barrel body portion and the second barrel body portion may separate constituent material sections, which are maintained separated from each other by the sealing device until the sealing device is actuated from a closed configuration to an open configuration. That is, the sealing device prevents unwanted moisture movement between the first barrel body portion and the second barrel body portion. For example, the present disclosure includes two sealing mechanisms including a first portion that seals radially and a second portion that seals axially, thereby providing improved sealing between the constituent material sections of the first barrel body portion and the second barrel body portion. These and further benefits and embodiments will be described in more detail below.

[0014]

[0027] Directional terms used herein - for example, up, down, right, left, front, back, top, bottom - are made only with reference to the figures drawn and are not intended to imply absolute orientation unless otherwise specified.

[0015]

[0028] Unless otherwise expressly stated, no method described in this specification is ever intended to be construed as requiring that its steps be performed in a particular order, nor is any device intended to require a particular orientation. Accordingly, where a method claim does not actually recite the order to be followed by its steps, or where a claim for any device or assembly does not actually recite the order or orientation of its individual components, or where the steps are not limited to a particular order, or where no particular order or orientation of the components of a device or assembly is recited, no order or orientation is ever intended to be inferred in any respect, unless otherwise specifically stated in the claim or description. This applies to any possible non-express basis for interpretation, including logical matters regarding the arrangement of steps, operational flow, order of components, or orientation of components; plain meaning derived from grammatical organization or punctuation; and number or type of embodiments described in this specification.

[0016]

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

[0017]

[0030] Referring here to the drawings, Figures 1A–1C show an illustrative mixing syringe assembly 100. The mixing syringe assembly 100 may be used to bond 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 bond two or more components of a hydrogel for use as a radiation spacer. The mixing syringe assembly 100 generally includes a first barrel body portion 106a, a second barrel body portion 106b, and a sealing device 110. In some embodiments, the mixing syringe assembly 100 further includes a plunger 102, a plunger lock 143, and / or 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 first barrel body portion 106a may be a first component section 140 for holding the first component material or a hollow syringe barrel defining the internal volume. The first barrel body portion 106a may have a proximal end 108a and a distal end 108b. The proximal end 108a may be sized and shaped to receive the plunger 102 within the first component section 140. The first barrel body portion 106a may include a first fluid delivery opening 113a (shown in Figures 4A-4D) located at the distal end 108b of the first barrel body portion 106a. The proximal end 108a may have a first flange 109, that is, the first flange 109 may extend outward at the proximal end 108a, such as radially outward.

[0019]

[0032] The second barrel body portion 106b may also be a second component section 142 for holding a second component or a hollow syringe barrel that defines a volume internally. The second barrel body portion 106b may have a proximal end 111a and a distal end 111b. Similar to the first barrel body portion 106a, the second barrel body portion 106b may include a second fluid delivery opening 113b at the distal end 111b, 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 second fluid delivery opening 113b may be axially aligned with the centerline of the second barrel body portion 106b and / or the plunger 102. However, in other embodiments, the second fluid delivery opening 113b may be offset from the centerline of the second barrel body portion 106b and / or the plunger 102. Such an offset may be useful in preventing one or more mixed masses 130 from blocking the fluid outlet opening 113b.

[0020]

[0033] As shown, the first barrel body portion 106a is slidably disposed within the second barrel body portion 106b so as to fit into the second barrel body portion 106b. That is, the first barrel body portion 106a may have a smaller diameter than the second barrel body portion 106b. For example, the first barrel body portion 106a may be a 5 ml barrel body and the second barrel body portion 106b may be a 10 ml barrel body, but other sizes are intended and possible.

[0021]

[0034] The plunger 102 may be slidably disposed within the first constituent material section 140 of the first barrel body portion 106a, and a fluid seal 104 may be formed between the plunger 102 and the first barrel body portion 106a by a seal 104 at the distal end 108b of the plunger 102. For example, the seal 104 may be made of rubber or a similar material conformable material to form a liquid-tight seal with the first barrel body portion 106a. The proximal end 108a of the plunger 102 has a pusher flange 103 for the user to engage in order to advance the plunger 102 along the first barrel body portion 106a.

[0022]

[0035] In this embodiment, the sealing device 110 may be coupled to the distal end 108b of the first barrel body portion 106a, such as around the first fluid outlet opening 113a. For example, the sealing device 110 may screw-engage or press-fit to the distal end 108b of the first barrel body portion 106a around the first fluid outlet opening 113a. In some embodiments, any number of sealing materials, O-rings, or the like may be used to prevent leakage around the coupling of the sealing device 110 to the first barrel body portion 106a. Briefly referring to Figures 2A-2C, the sealing device 110 includes a first portion 114 that defines a fluid passage 120 which is selectively operable between a radially closed configuration and a radially open configuration, and a second portion 116 which is axially translatable between an axially closed configuration and an axially open configuration. In some embodiments, the sealing device 110 may further include a housing 112.

[0023]

[0036] In several embodiments, the housing 112 may be a collar that connects to the first portion 114. In some embodiments, it is intended that the housing 112 connects the first portion 114 to the distal end 108b of the first barrel body portion 106a. For example, the first portion 114 of the sealing device 110 may be positioned within the housing 112 and connected to the housing 112 via a meshing engagement, press-fit, screw connection, or similar. Similarly, the housing 112 may connect to the first barrel body portion 106a. For example, the housing 112 may screw-engage or press-fit to the distal end 108b of the first barrel body portion 106a around the first fluid outlet opening 113a. In several embodiments, any number of sealing materials, O-rings, or similar may be used to prevent leakage around the joint of the housing 112 to the first portion 114 of the sealing device 110 and to the distal end 108b of the first barrel body portion 106a. The joint may therefore provide a flow path from the first fluid outlet opening 113a to the fluid passage 120 of the first portion 114 of the sealing device 110. In some embodiments, the first portion of the sealing device 110 may receive the distal end 108b of the first barrel body portion 106a and be coupled to the distal end 108b by press-fit, screw engagement, or similar. In several embodiments, the sealing device 110 may include an O-ring 117 mounted on the housing 112 and in sliding contact with the second barrel body portion 106b. The O-ring 117 may prevent fluid leakage in the proximal direction around the sealing device 110.

[0024]

[0037] Figure 2C provides a longitudinal section of a portion of the sealing device 110, particularly the valve portion of the sealing device 110. The valve portion includes a first portion 114 and a second portion 116. The first portion 114 may be formed of a conformable or radially compressible material such as silicone or the like, and may be molded or otherwise formed to have a fluid passage 120. For example, the fluid passage 120 may be cut out of the body of the first portion 114. In the shown embodiment, the fluid passage 120 is shown in a radially open configuration. For example, fluid pressure, such as that brought about by the operation of the plunger 102, may force the fluid passage 120 into a radially open configuration.

[0025]

[0038] Referring again to Figure 2C, the first portion 114 has a mounting portion 122 for mounting toward or adjacent to the first fluid outlet opening 113a, for example, to receive fluid from the first fluid outlet opening. For example, in some embodiments, there may be a nozzle receiving recess 123 proximal to the fluid passage 120 for receiving the distal end 108b of the first barrel body portion 106a (such as a nozzle at the distal end 108b). In some embodiments, the mounting portion 122 may be sized to be received within the housing 112.

[0026]

[0039] In several embodiments, the first portion 114 includes a discharge portion 124 distal to the mounting portion 122. The discharge portion 124 may have an increased diameter relative to the mounting portion 122. The increased diameter may provide increased stability within the first barrel body portion 106a. A discharge outlet opening 125 may be formed at the end of the discharge portion 124 and in fluid communication with the fluid passage 120. As shown, the second portion 116 may be positioned within the first portion 114. For example, there may be a cavity 126 sized to hold the second portion 116 and allow its axial movement while in fluid communication with the fluid passage 120.

[0027]

[0040] In particular, the second portion 116 may be axially translationable between an axially closed configuration and an axially open configuration. That is, the second portion 116 may be a substrate, plate, disk, or similar, formed of a non-permeable membrane such as polyisoprene, but is not limited to this. The cavity 126 may be sized to allow the second portion 116 to axially translate within the cavity 126 under pressure. For example, referring to Figures 3A and 3B, the valve portions are shown in a closed configuration and an open configuration, respectively. As shown in Figure 3A, in the closed configuration, the fluid passage 120 is radially closed to a radially closed configuration. In several embodiments, the valve material (e.g., silicone or similar material) may be densely compressed or naturally displaced to close the fluid passage 120 to a radially closed configuration. For example, the fluid passage 120 may be provided by a linear cut, as opposed to a punch from which the material is removed. In a radially closed configuration, the fluid is substantially blocked from flowing through the fluid passage 120. Therefore, in an open configuration, the fluid may be pressured into the fluid passage 120 (for example, by the action of the plunger 102 moving distally within the first barrel body portion 106a) to open the fluid passage 120 radially or actuate it into a radially open configuration, thereby allowing fluid to flow through the fluid passage 120, as shown in Figure 3B.

[0028]

[0041] Referring again to Figure 3A, in the closed configuration, the second portion 116 may be positioned in an axially closed configuration. That is, the second portion 116 may be pressed against the fluid passage 120 (when in the radially closed configuration). In the axially closed configuration, the second portion 116 acts as a second barrier to prevent fluid leakage. The second portion 116 may be coupled to or attached to the first portion 114, similar to a suction cup engagement. In some embodiments, the second portion 116 may be displaced to the axially closed configuration via a spring or other displacement mechanism. In some embodiments, the second portion 116 is pulled to engage with the first portion 114, for example, by retracting the plunger 102 proximal. During delivery, the plunger 102 in the first barrel body portion 106a acts to configure the first portion 114 of the sealing device 110 to be radially open and the second portion 116 to be axially open. In other words, the plunger 102 may be actuated distally to push the fluid in the first barrel body portion 106a through the sealing device 110, thereby opening the fluid passage 120. The force of the fluid opening and / or impacting the second portion 116 causes the second portion 116 to move axially outward from the fluid passage 120, allowing the fluid to flow around the second portion 116 and out through the outlet opening 125 located distal to the second portion 116 (and into the second barrel body portion 106b). When no force is applied via the plunger 102, the first portion 114 may close, moving the fluid passage 120 to a radially closed configuration. Similarly, the second portion 116 may return to an axially closed configuration. For example, the second portion 116 may be shifted to an axially closed configuration, or any backflow may force the second portion 116 to a closed configuration to prevent backflow through the sealing device 110.

[0029]

[0042] In some embodiments, and as described above, the mixing syringe assembly 100 may include a plunger lock 143. Referring to Figure 1A, the plunger lock 143 may lock the plunger 102 in position relative to the first barrel body portion 106a, the second barrel body portion 106b, or both. In some embodiments, the lock 143 may include one or more struts extending between the first barrel body portion 106a and the pusher flange 103. In some embodiments, the lock 143 may be a collar that partially wraps around the plunger 102 and extends between the first barrel body portion 106a and the pusher flange 103 to lock the plunger 102 in place. In some embodiments, the plunger lock 143 may be used to hold the plunger 102 in a predetermined position that brings negative pressure to the sealing device 110 (to force tighter compression within the first section 114 and / or between the first section 114 and the second section 116) for additional safety and to prevent moisture transfer. During use, the plunger lock 143 may be removed before advancing the plunger 102.

[0030]

[0043] As described above, the first barrel body portion 106a defines the first component section 140. The first component section 140 may hold the first component. The first component may be a liquid for hydrating the second component, which may be a powder or fine particles. The second component may be held in the second component section 142 of the second barrel body portion 106b. For example, the first component may be saline, water, deionized water, or the like. As described above, the second component may be a powder or fine particle material such as albumin, polyethyleneimine (PEI), amine-containing polyethylene glycol (PEG), or protein, or an N-hydroxysuccinimide (NHS) ester component such as PEG-(SS)2, PEG-(SS)4, PEG-(SS)8, PEG-(SG)4, PEG-(SG)8, and / or the like. In some embodiments, the molecular weight of the PEG component may range from about 2,000 to about 100,000. The powder or particulate 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 in question, and / or that can be broken down and absorbed by the tissues of the person in question.

[0031]

[0044] 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.

[0032]

[0045] The sealing device 110 described above is operated to selectively provide a flow path between the first component section 140 and the second component section 142, allowing the first component to move from the first component section 140 into the second component section 142, thereby enabling mixing of the first component and the second component.

[0033]

[0046] Referring again to Figures 1A-1C, in some embodiments, one or more mixed masses 130 (e.g., balls, weights, etc.) may be positioned within the second constituent material section 142. One or more mixed masses 130 may be any suitable material that helps to mix 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 to one another 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 mixing. In some embodiments, the mixed masses 130 may not be present.

[0034]

[0047] Referring here to Figures 4A-4D, 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, Figures 4A-4D show 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 Figures 1A-1C. In particular, each subassembly 100a may include a plunger 102, a first barrel body portion 106a, a second barrel body portion 106b, and a sealing device 110. In some embodiments, the subassemblies 100a, 100b further include one or more mixed masses 130. Thus, the above description is applicable to these embodiments and will not be repeated. However, while each plunger 102 appears to be independently operable, it should be noted that in several embodiments the plungers 102 may be coupled to one another via a common pusher flange. In some embodiments the second barrel body portions 106b may be firmly coupled. For example, the second barrel body portions 106b may be integrally formed or joined to one another by brackets, welds, adhesives, or the like. Similarly, in some embodiments the first barrel body portions 106a may be coupled to one another, while allowing the first barrel body portions 106a to slide within each of the second barrel body portions 106b.

[0035]

[0048] In some embodiments, the manifold may have fluid delivery openings coupled to respective delivery needles or cannulas 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. Therefore, 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," which is 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, 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] Referring again to Figures 4A-4D, the operation is illustrated in its entirety. Figure 4A shows a perspective view of the dual syringe assembly. Figure 4B shows a cross-sectional view of Figure 4A, showing the first component 150a positioned within each first component section 140 and the second component 150b positioned within each second component section 142. Referring to Figure 1C, during operation, the plunger 102(or more) of the assembly may be advanced to build fluid pressure within the first component section 140 behind the sealing device 110. When the pressure exceeds the threshold of the first portion 114 of the sealing device 110, the fluid passage 120 is actuated radially to open (as shown in Figure 4C), and the second portion 116 is actuated axially to move away from the first portion 114. With both the first part 114 and the second part 116 actuated to the open configuration, the first component material 150a is allowed to pass from the first component material section 140 (e.g., of each part assembly) through the sealing device 110 to the second component material section 142 in the second barrel body section 106b. Once the first component material 150a enters the second component material section 142, the mixing syringe assembly 100 may then be agitated (e.g., shaken) to incorporate the first and second components. As described above, one or more mixing masses 130 may be used to assist the agitation while reducing the introduction of air bubbles. After mixing, the plunger 102 and the first barrel body section 106a may be advanced together with the sealing device 110 to discharge the combined components through the fluid discharge opening 113b (or the respective openings in the dual design). It should be noted that in various embodiments, the liquid component may be placed within the second component section 142, and the powder or particulate component may be initially placed within the first component section 140.

[0037]

[0050] In several embodiments including dual syringes, one mixing syringe subassembly 100a may contain albumin and / or fine particles as a second component material 150b, and the other mixing syringe subassembly 100a may contain PEG. Other combinations are conceivable and possible. After mixing with their respective liquid components, the liquid albumin and PEG solutions may be dispensed to form a gel at the desired location.

[0038]

[0051] It should be noted that in the above embodiments, the system may be provided as a fully assembled system. In some embodiments, different components may be provided individually and assembled before use.

[0039]

[0052] Referring here to Figure 5, a flowchart illustrating a method 200 for assembling a mixing syringe assembly 100 as described herein is shown in its entirety. It should be noted that method 200 may include more or fewer steps, performed in any order, without departing from the scope of the present disclosure. In several embodiments, method 200 includes, in block 202, coupling a sealing device 110 to the distal end 108b of the first barrel body portion 106a, as described above. For example, the sealing device 110 may be coupled to the first barrel body portion 106a using any suitable technique (e.g., press-fit, screw engagement, etc.). In some embodiments, the sealing device 110 includes a housing 112 that is coupled to the distal end 108b of the first barrel body portion 106a. Method 200 may further include inserting the sealing device 110 and the first barrel body portion 106a into the second barrel body portion 106b in block 204 such that the sealing device 110 and the first barrel body portion 106a are slidably disposed within the second barrel body portion 106b.

[0040]

[0053] In some embodiments, method 200 may further include inserting the plunger 102 into the first barrel body portion 106a in block 206. In some embodiments, method 200 may also include positioning the first component material 150a, as described above, within the first barrel body portion 106a in block 208. In some embodiments, the plunger 102 may be used to initially retract the first component material 150a into the first barrel body portion 106a before coupling the sealing device 110 to the first barrel body portion 106a. In some embodiments, after positioning the plunger 102, the plunger lock 143 may be attached to the plunger 102 to lock the plunger 102 in position relative to the first barrel body portion 106a.

[0041]

[0054] In some embodiments, method 200 may include placing the second component material 150b within the second barrel body portion 106b in block 208. In some embodiments, the second component material 150b may be placed before positioning the first barrel body portion 106a within the second barrel body portion 106b.

[0042]

[0055] In several embodiments, the mixing syringe assembly 100 may be provided in a pre-assembled form that is ready for use at any time, with appropriately measured materials already positioned within the assembly.

[0043]

[0056] Multiple embodiments may be further described with respect to the following numbered clauses:

[0057] 1. A mixing syringe assembly comprising a first barrel body portion defining a first constituent material section, and a second barrel body portion defining a second constituent material section, wherein the first barrel body portion comprises a second barrel body portion slidably disposed within the second barrel body portion, and a sealing device coupled to the distal end of the first barrel body portion, the sealing device selectively providing a fluid path between the first barrel body portion and the second barrel body portion, the sealing device comprising a first portion defining a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration.

[0044]

[0058] 2. A mixing syringe assembly as described in Clause 1, further comprising a plunger, wherein advancing the plunger within a first barrel body portion causes the first portion of the sealing device to be configured to be radially open and the second portion to be configured to be axially open.

[0045]

[0059] 3. A mixing syringe assembly according to Clause 1 or 2, wherein the first portion of the sealing device comprises radially compressible silicone.

[0046]

[0060] 4. A mixing syringe assembly according to any one of clauses 1 to 3, wherein the second part of the sealing device comprises a polyisoprene substrate.

[0047]

[0061] 5. A mixing syringe assembly according to any one of Clauses 1 to 4, wherein the sealing device comprises a housing coupled to the end of a first barrel body portion, and the first portion is positioned within the housing.

[0048]

[0062] 6. A mixing syringe assembly as described in Clause 5, wherein the sealing device further comprises an O-ring mounted on the housing and in sliding contact with a second barrel body portion.

[0049]

[0063] 7. A mixing syringe assembly comprising: a first barrel body portion defining a first constituent material section; a second barrel body portion defining a second constituent material section, wherein the first barrel body portion comprises a second barrel body portion slidably disposed within the second barrel body portion; a sealing device coupled to the distal end of the first barrel body portion, wherein the sealing device selectively provides a fluid path between the first barrel body portion and the second barrel body portion, and the sealing device comprises a first portion defining a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration; a plunger axially movable within the first barrel body portion; and a lock configured to support the plunger in a locked position.

[0050]

[0064] 8. A mixing syringe assembly as described in Clause 7, wherein advancing a plunger within a first barrel body portion causes the first portion of the sealing device to be configured to be radially open and the second portion to be configured to be axially open.

[0051]

[0065] 9. A mixing syringe assembly according to Clause 7 or 8, wherein the first portion of the sealing device comprises radially compressible silicone.

[0052]

[0066] 10. A mixing syringe assembly according to any one of clauses 7 to 9, wherein the second part of the sealing device comprises a polyisoprene substrate.

[0053]

[0067] 11. A mixing syringe assembly as described in any one of Clauses 7 to 10, wherein the sealing device comprises a housing coupled to the end of a first barrel body portion, and the first portion is positioned within the housing.

[0054]

[0068] 12. A mixing syringe assembly as described in Clause 11, wherein the sealing device further comprises an O-ring mounted on the housing and in sliding contact with a second barrel body portion.

[0055]

[0069] 13. A method for assembling a mixing syringe assembly, comprising: coupling a sealing device to the distal end of a first barrel body portion, the sealing device comprising a first portion defining a fluid passage selectively operable between a radially closed configuration and a radially open configuration, and a second portion axially translatable between an axially closed configuration and an axially open configuration; and inserting the sealing device and the first barrel body portion into a second barrel body portion, thereby slidably disposed within the second barrel body portion.

[0056]

[0070] 14. The method according to clause 13, further comprising inserting a plunger into a first barrel body portion, wherein the sliding of the plunger relative to the first barrel body portion causes the first portion of the sealing device to be configured to be radially open and the second portion to be configured to be axially open.

[0057]

[0071] 15. A method according to Clause 13 or 14, further comprising placing a first component material within a first barrel body portion.

[0072] 16. A method according to Clause 15, further comprising placing a second component material within a second barrel body portion, wherein the second component material is different from the first component material.

[0058]

[0073] 17. A method according to Article 16, wherein the first component is a liquid and the second component is a powder.

[0074] 18. A method according to any one of the clauses 13 to 17, comprising inserting a plunger into a first barrel body portion, wherein the sliding of the plunger relative to the first barrel body portion causes the first portion of the sealing device to be configured to be radially open and the second portion to be configured to be axially open. A method further comprising attaching a lock to a plunger in order to lock the plunger's position relative to a first barrel body portion.

[0059]

[0075] 19. A method according to any one of the clauses 13 to 18, wherein the first part of the sealing device comprises a radially compressible silicone.

[0076] 20. A method according to any one of the clauses 13 to 19, wherein the second part of the sealing device comprises a polyisoprene substrate.

[0060]

[0077] 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.

[0061]

[0078] 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 first barrel body portion defining a first constituent material section, A second barrel body portion defining a second constituent material section, wherein the first barrel body portion is slidably disposed within the second barrel body portion, A mixing syringe assembly comprising a sealing device coupled to the distal end of the first barrel body portion, wherein the sealing device selectively provides a fluid path between the first barrel body portion and the second barrel body portion, and the sealing device comprises a first portion that defines a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration.

2. A mixing syringe assembly according to claim 1, A mixing syringe assembly further comprising a plunger, wherein advancing the plunger within the first barrel body portion causes the first portion of the sealing device to be configured to be radially open, and the second portion to be configured to be axially open.

3. A mixing syringe assembly according to claim 1, The first portion of the sealing device is a mixing syringe assembly comprising radially compressible silicone.

4. A mixing syringe assembly according to claim 1, The second portion of the sealing device is a mixing syringe assembly comprising a polyisoprene substrate.

5. A mixing syringe assembly according to claim 1, The sealing device comprises a mixing syringe assembly having a housing coupled to the end of the first barrel body portion, the first portion being positioned within the housing.

6. A mixing syringe assembly according to claim 5, The sealing device is a mixing syringe assembly further comprising an O-ring mounted on the housing and in sliding contact with the second barrel body portion.

7. A mixing syringe assembly, A first barrel body portion defining a first constituent material section, A second barrel body portion defining a second constituent material section, wherein the first barrel body portion is slidably disposed within the second barrel body portion, A sealing device coupled to the distal end of the first barrel body portion, wherein the sealing device selectively provides a fluid path between the first barrel body portion and the second barrel body portion, and comprises a first portion defining a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration. A plunger that is movable in the axial direction within the first barrel body portion, A lock configured to support the plunger in the locked position A mixing syringe assembly equipped with [a specific feature].

8. A mixing syringe assembly according to claim 7, A mixing syringe assembly wherein advancing the plunger within the first barrel body portion causes the first portion of the sealing device to be configured to be radially open, and the second portion to be configured to be axially open.

9. A mixing syringe assembly according to claim 7, The first portion of the sealing device is a mixing syringe assembly comprising radially compressible silicone.

10. A mixing syringe assembly according to claim 7, The second portion of the sealing device is a mixing syringe assembly comprising a polyisoprene substrate.

11. A mixing syringe assembly according to claim 7, The sealing device comprises a mixing syringe assembly having a housing coupled to the end of the first barrel body portion, the first portion being positioned within the housing.

12. A mixing syringe assembly according to claim 11, The sealing device is a mixing syringe assembly further comprising an O-ring mounted on the housing and in sliding contact with the second barrel body portion.

13. A method for assembling a mixing syringe assembly, A step of coupling a sealing device to the distal end of a first barrel body portion, wherein the sealing device comprises a first portion that defines a fluid passage that is selectively operable between a radially closed configuration and a radially open configuration, and a second portion that is axially translatable between an axially closed configuration and an axially open configuration. A step of inserting the sealing device and the first barrel body portion into the second barrel body portion, thereby distributing the sealing device and the first barrel body portion slidably within the second barrel body portion, and Methods that include...

14. The method according to claim 13, A method further comprising the step of inserting a plunger into the first barrel body portion, wherein the sliding of the plunger relative to the first barrel body portion causes the first portion of the sealing device to be configured to be radially open and the second portion to be configured to be axially open.

15. The method according to claim 13, A method further comprising the step of placing a first component material inside the first barrel body portion.

16. The method according to claim 15, A method further comprising the step of placing a second component material within the second barrel body portion, wherein the second component material is different from the first component material.

17. The method according to claim 16, A method wherein the first constituent material is a liquid and the second constituent material is a powder.

18. The method according to claim 13, A step of inserting a plunger into the first barrel body portion, wherein the sliding of the plunger relative to the first barrel body portion causes the first portion of the sealing device to be configured to be radially open, and the second portion to be configured to be axially open, The steps include: attaching a lock to the plunger in order to lock the position of the plunger relative to the first barrel body portion; Methods that further include the above.

19. The method according to claim 13, A method wherein the first portion of the sealing device comprises radially compressible silicone.

20. The method according to claim 13, A method wherein the second portion of the sealing device comprises a polyisoprene substrate.

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