Multi-chambered syringe

Abstract

Systems and methods for a multi-chamber syringe are described. In some embodiments, the multi-chamber syringe includes a housing having an inner cavity and a first plunger and a second plunger at least partially disposed within the inner cavity. The first and second plungers are slidably displaced relative to the housing and are associated with a first chamber and a second chamber, respectively. A separator is at least partially disposed between the first and second plungers to form the first and second chambers. The separator is slidably displaced relative to the plungers and the housing to selectively place the first and second chambers, comprising a first material and a second material, in fluid communication. When the separator is displaced, the first and second materials are mixed in the combined volume of the first and second chambers. Displacement of the first plunger, the second plunger, and the separator can dispense the mixed material from the combined volume.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 046,200, filed June 30, 2020, under priority of 35 U.S.SC §119(e), the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The disclosed embodiments relate to multi-chamber syringes. Background Technology

[0004] A standard syringe may consist of a hollow plastic cartridge and a plunger. Depressing the plunger dispenses material from the syringe, which is contained within the cartridge's cavity. Retracting the plunger draws the material back into the cartridge. In the medical field, syringes are frequently used to dispense a known amount of material at a target point. For example, syringes can be used to inject an accurate volume of therapeutic agent into a patient, or to deliver a hemostatic matrix to a bleeding point. Summary of the Invention

[0005] In some embodiments, a multi-chamber syringe includes a housing with an inner cavity, a first plunger and a second plunger, and a separator. The first and second plungers are at least partially disposed within the inner cavity of the housing and are slidably displaced relative to the housing. The separator is at least partially disposed within the inner cavity of the housing between the first and second plungers and is slidably displaced relative to the first and second plungers.

[0006] In some embodiments, a method includes: displacing a separator to fluidly communicate a first chamber comprising a first material with a second chamber comprising a second material; mixing the first material and the second material in a combined volume of the first and second chambers; and displacing a first plunger associated with the first chamber, a second plunger associated with the second chamber, and the separator to dispense the mixed first and second materials from the combined volume.

[0007] In some embodiments, a multi-chamber syringe includes a housing with an inner cavity, a separator, and a first plunger and a second plunger. The separator is at least partially disposed within the inner cavity of the housing and is configured to selectively separate a first chamber from a second chamber within the inner cavity. The first plunger is at least partially disposed within the first chamber and is slidably displaced relative to the housing. The second plunger is at least partially disposed within the second chamber and is slidably displaced relative to the housing. The first plunger, separator, and second plunger are configured to form a combined plunger to displace material in the combined volume of the first and second chambers.

[0008] It should be understood that the foregoing concepts and other concepts discussed below can be arranged in any suitable combination, as this disclosure is not limited to that aspect. Furthermore, other advantages and novel features of this disclosure will become apparent when considered in conjunction with the accompanying drawings, based on the following detailed description of various non-limiting embodiments. Attached Figure Description

[0009] The accompanying drawings are not intended to be drawn to scale. In the drawings, identical or nearly identical parts illustrated in various figures can be represented by similar numbers. For clarity, not every part may be labeled in each figure. In the accompanying drawings:

[0010] Figure 1A This is an isometric view of one embodiment of a multi-chamber syringe;

[0011] Figure 1B Before the separator was moved Figure 1A A front view of the barrel of a multi-chamber syringe;

[0012] Figure 1C After the separator has been moved Figure 1A A front view of the barrel of a multi-chamber syringe;

[0013] Figure 2A This is a front view of one embodiment of a multi-chamber syringe when a first material is drawn into the first chamber by displacing the first plunger;

[0014] Figure 2B After the separator is moved to allow the first and second materials to mix. Figure 2A Front view of a multi-chamber syringe;

[0015] Figure 2C In the case where the first and second plungers are moved together to dispense the mixed first and second materials from the syringe. Figure 2A Front view of a multi-chamber syringe;

[0016] Figure 3 This is a perspective view of one embodiment of a multi-chamber syringe;

[0017] Figure 4 This is an exploded perspective view of one embodiment of a multi-chamber syringe;

[0018] Figure 5 This is a front cross-sectional view of one embodiment of a multi-chamber injector;

[0019] Figures 6A to 6I One implementation of a method for operating a multi-chamber syringe is described;

[0020] Figures 7A to 7CThese are top cross-sectional views of different embodiments of the protrusions configured to facilitate mixing within a multi-chamber syringe; and

[0021] Figures 8A to 8E An embodiment of a multi-chamber injector with a combined plunger is described. Detailed Implementation

[0022] As described above, syringes can be used to deliver materials to a specific location. In some cases, multiple materials can be mixed before delivery. For example, many hemostatic agents comprise dry and liquid components, and the hemostatic agent can benefit from one or more mixing steps before use. Of course, syringes for delivering mixtures of multiple materials can be used in fields other than medicine. For example, syringes can be used in the construction, manufacturing, and / or hobby industries, such as when applying two-component epoxy resins. Therefore, it should be understood that the present invention is not limited to any particular application.

[0023] Mixing multiple materials prior to syringe delivery can be associated with several challenges. First, the mixing process may involve a complex sequence of steps that can be physically demanding, require user skill, and / or be difficult to execute. For example, some mixing procedures may require manually passing the material back and forth between two (or more) syringes many times to ensure adequate mixing and distribution. Additionally, the mixing process can be associated with long mixing times, which can delay the use of the mixed material. Delays due to mixing can be particularly problematic during surgery, such as when rapid application of hemostatic agents may be expected. Furthermore, if mixing is not performed at the appropriate ratio or for the appropriate amount of time, the mixing process can lead to blockage of the syringe or its lumen. Adverse outcomes can also be caused by other variables associated with the mixing process, including but not limited to the specific conditions of the mixing environment (e.g., temperature, humidity, light), material properties (the material properties of the mixed material and / or the container in which the mixed material is mixed), and other variables.

[0024] In view of the above, the inventors have recognized and understood the benefits of constructing a multi-chamber syringe that enables the mixing of multiple materials within the syringe itself. A multi-chamber syringe can be a readily available option that reduces both the number of mixing steps and the mixing time compared to conventional mixing processes. Furthermore, multi-chamber syringes are easier and more convenient to use than conventional syringes. In addition, multi-chamber syringes can reduce the amount of waste generated during the mixing process because a single container can be used compared to using multiple conventional chambers and potentially other mixing devices.

[0025] In some embodiments, a multi-chamber syringe may include a syringe with multiple chambers, each of which may be configured to contain a different material. The chambers may be separated by one or more movable separators. Displacement of the separator located between two chambers allows for mixing of the materials disposed within those chambers. Furthermore, the process of slidably displacing the separator can generate turbulence in the material disposed in the chamber adjacent to the separator, which can promote more thorough mixing of the materials. In this way, a multi-chamber syringe with movable separators separating the multiple chambers can be associated with faster, simpler, and more consistent mixing of two or more materials in a solution compared to conventional mixing procedures involving conventional syringes.

[0026] In one embodiment, operating a multi-chamber syringe may include displacing a first plunger to aspirate a first material into a first chamber. Aspirating the material into the chamber may include translating the plunger in a proximal direction along the longitudinal axis of the syringe. Where it is not desirable to be bound by theory, displacing the plunger relative to the chambers of the syringe may increase the volume of the chambers, thereby generating a negative gauge pressure. This negative pressure may then draw material in through an opening in the chamber, such as the nozzle of the syringe. After the first material has been aspirated into the chambers, a separator disposed between the first and second chambers may be displaced to place the first and second chambers in fluid communication with each other and to release the second material disposed in the second chamber. In some embodiments, the separator may be displaced in the same direction as the first plunger. The first and second materials may then be mixed together in the combined region of the first and second chambers of the syringe. As further described below, mixing may be facilitated by generating turbulence within the material adjacent to the separator when it is displaced. In some cases, the first plunger associated with the first chamber, the second plunger associated with the second chamber, and the separator may then be displaced distally together with each other, or in other suitable directions, to dispense the mixed material from the nozzle of the syringe. In some implementations, the separator may be coupled to the first plunger and / or the second plunger before dispensing the mixed material.

[0027] In some embodiments, a multi-chamber syringe may include multiple chambers. It should be understood that a multi-chamber syringe may include two, three, four, five, or any suitable number of chambers, as this disclosure is not limited in this respect. Furthermore, it should be understood that the chambers of a multi-chamber syringe may have any suitable shape. The chambers of a multi-chamber syringe may be cylindrical, annular, prismatic, or any other suitable shape, as this disclosure is not limited in this respect. Relatedly, the cross-section of a chamber of a multi-chamber syringe, taken perpendicular to the longitudinal axis of the syringe, may be circular, elliptical, oval, annular, triangular, rectangular, or any other suitable shape, as this disclosure is not limited to any particular chamber shape.

[0028] In some embodiments, a multi-chamber syringe may include a first chamber and a second chamber arranged in a nested configuration, wherein the first chamber is disposed within the second chamber. For example, the first chamber may be generally cylindrical and disposed within the second chamber, and the second chamber may be generally annular. Thus, the first chamber may be an inner chamber, and the second chamber may be an outer chamber. The first and second chambers may be separated by a movable separator, which may be annular or tubular. Two or more of the group consisting of the first chamber, the separator, the second chamber, and the syringe barrel may be concentric and / or coaxial. For example, in some embodiments, the separator may be coaxial with the syringe barrel. In some embodiments, the separator may be coaxial with the first plunger, and the first plunger may be at least partially disposed within the separator. In some embodiments, the first plunger may be coaxial with the second plunger. Of course, a multi-chamber syringe with nested chambers may include more than two chambers, as this disclosure is not limited thereto. Additionally, a multi-chamber syringe may include nested chambers that may not be circular, annular, or otherwise radially symmetrical. For example, a first chamber comprising a rectangular cross-section with rounded corners may be disposed within a second chamber comprising an oval cross-section. It should be understood that a multi-chamber syringe with nested chambers can include chambers of any suitable shape, as this disclosure is not limited thereto.

[0029] In some embodiments, a multi-chamber syringe may include chambers arranged adjacent to each other such that the chambers do not nest. In embodiments with two chambers, the first chamber may be positioned adjacent to the second chamber. It should be understood that a multi-chamber syringe may include any suitable number of chambers having any suitable shape and arranged adjacent to each other, as this disclosure is not limited in this respect. In some embodiments, a multi-chamber syringe may include chambers arranged in a combination of nested and lateral arrangements. For example, the first chamber may be positioned adjacent to the second chamber, and both the first and second chambers may be disposed within a third chamber. A first planar separator may separate the first and second chambers, while a second annular separator may separate the first and second chambers from the third chamber.

[0030] In view of the foregoing, it should be understood that a multi-chamber syringe may include any suitable number, shape and arrangement of chambers, as this disclosure is not limited in this respect.

[0031] In some embodiments, a multi-chamber syringe may include one or more separators disposed between the chambers of the syringe. The separators are movable relative to the syringe barrel. Removing a separator disposed between two chambers allows the materials disposed within those two chambers to mix, since the two chambers are no longer physically separated. In some embodiments, the act of displacing the separators between the chambers of a multi-chamber syringe can be associated with improved mixing of the materials disposed within those chambers. Without being bound by theory, displacing the separators can apply shear forces to one or more materials in contact with the separators. The shear forces applied to the fluid material can be associated with turbulence and / or turbulent mixing. Increased turbulence can be associated with increased mixing quality and / or reduced mixing time. Without being bound by theory, the amount of turbulence generated can be associated with the velocity at which the separators are removed, fluid viscosity, fluid density, the clearance distance between the chamber walls and the separators, and / or other variables related to the separators and / or the materials in contact with the separators. In some embodiments, the separators may include surface features configured to facilitate turbulent mixing, as described in more detail below. It should be understood that, as used herein, the term "fluid" can refer to any substance in any state exhibiting flow characteristics. Non-limiting examples include liquids, gases, suspensions, gels, and / or flowable solids (e.g., powders), each of which can be used with any of the embodiments described herein.

[0032] In some embodiments, a multi-chamber syringe may include one or more plungers configured to dispense material out of the chamber and / or aspirate material into the chamber. Each chamber of the syringe may be associated with a separate plunger. However, in some embodiments, a single plunger may be associated with multiple chambers, or multiple plungers may be associated with a single chamber, as this disclosure is not limited in terms of the relative number of chambers and plungers.

[0033] In some embodiments, the plungers and / or separators may be selectively engaged to lock together and form a plunger assembly. For example, after slidably displacing the separator separating the first and second chambers to allow the first and second materials to mix, the separator may engage with and in some cases lock to the first and / or second plungers to form a combined plunger. Pressing down the combined plunger may dispense the mixed material from the combined volume of the first and second chambers. It should be understood that the combined plunger may include a combination of plungers and separators, a combination of two plungers, a combination of separators and two plungers, or any other suitable combination of any suitable number of plungers and / or separators, as this disclosure is not limited in this respect. In some embodiments, the separators and one or more plungers may be configured to lock together using: protrusions and grooves, friction fits, magnetic coupling, spring-loaded protrusions configured to be received in recesses, and / or any other suitable mechanism configured to allow the plungers and separators to engage. It should be understood that any part of the engagement may be provided on the separator or the plunger. For example, in some embodiments, the separator may include a protrusion, and the plunger may include a groove configured to receive the protrusion. In some embodiments, the plunger may include a protrusion, and the separator may include a groove configured to receive the protrusion. Therefore, this disclosure is not limited in terms of the type or specific arrangement of the connection between the separator and the plunger.

[0034] In some embodiments, a multi-chamber syringe may include one or more gaskets configured to provide a seal and prevent unwanted fluid communication between different areas of the syringe. One or more gaskets may be disposed between the first plunger and the separator, between the separator and the second plunger, between the second plunger and the barrel, between the separator and the inner wall of one or more chambers, or between any other suitable component of the multi-chamber syringe, as this disclosure is not limited thereto. For example, an O-ring may be provided between the separator and the plunger. However, it should be understood that the gaskets may include any suitable material having any suitable shape configured to provide a seal, as this disclosure is not limited in this respect. In some embodiments, different surfaces of the components of the multi-chamber syringe may include coatings and / or strips of material configured to promote a seal between the different chambers. For example, the plunger head may include an elastic material, such as rubber, configured to provide a watertight seal when positioned adjacent to another surface. Additionally or alternatively, the surface may include an elastic coating configured to promote a seal when the plunger and / or separator contacts the surface. For example, the distal inner surface of one or more portions of the barrel may include an elastic material configured to achieve a seal when the separator contacts a seal.

[0035] In some embodiments, the material may be disposed in one or more chambers of a multi-chamber syringe. The material may include any suitable material in any suitable form, as this disclosure is not limited in this respect. The material may be solid, liquid, gas, gel, suspension, or may be in any other suitable form. A single chamber may include multiple materials, such as a mixture of two liquid materials, or a solid material suspended in a liquid material. Therefore, mixing materials from different chambers of a multi-chamber syringe (e.g., when the separator is removed) may include mixing solid, liquid, gas, or any other form of material. The resulting mixed material may similarly be solid, liquid, gas, suspension, gel, flowable matrix, or any suitable form of material.

[0036] In some embodiments, the first and / or second materials may include therapeutic compounds, carriers such as sodium chloride solution, and / or any other suitable materials. Therapeutic compounds may include, but are not limited to, thrombin, hemostatic agents, combinations of thrombin and hemostatic agents, and / or any other suitable agents. For example, the first material in the first chamber may include a sodium chloride solution, or a mixture of sodium chloride solution and thrombin, and the second material in the second chamber may include a hemostatic agent such as collagen. Hemostatic agents may be in powder, tablet, and / or fibrous form. In some embodiments, the material may at least partially comprise dextran. However, it should be understood that any suitable material may be contained in any chamber of a multi-chamber syringe, as this disclosure is not limited in this respect.

[0037] Therapeutic compounds used for the purposes of this application may correspond to any suitable material, including but not limited to any drug, pharmaceutical, medical preparation, contrast agent, and / or biological material such as proteins, antisense molecules, and gene therapy viral vectors, as this disclosure is not limited thereto. When a therapeutic compound is presented at a particular location in an “effective amount,” it means that the concentration of the therapeutic compound is greater than or equal to trace amounts and sufficient to achieve the desired purpose, such as allowing the detection of a subject for diagnostic purposes, treating a subject’s disease or condition, and / or enhancing treatment of the subject’s disease or condition. In some embodiments, an effective amount of a particular therapeutic compound is defined as sufficient to reduce or alleviate the amount of one or more conditions associated with a particular condition.

[0038] In some embodiments, a multi-chamber injector may include one or more protrusions and / or surface features configured to facilitate mixing. As described above, slidably displacing the separator can be associated with generating turbulence within the fluid material adjacent to the separator. Protrusions and / or surface features on the movable separator (or any other component of the multi-chamber injector) may be configured to increase the amount of turbulence generated. Protrusions and / or surface features may include fins, recesses, indentations, ribs, or any other suitable protrusions and / or surface features, as this disclosure is not limited in this respect. Protrusions and / or surface features may be disposed on any suitable component and / or surface of the multi-chamber injector, including but not limited to separators, plungers, barrels, nozzles, and / or barrel tips. For example, the distal portion of the separator may include one or more mixing fins configured to induce turbulent mixing as the separator displaces relative to material disposed in a chamber adjacent to the separator. It should be understood that protrusions and / or surface features may facilitate mixing without generating turbulence, as this disclosure is not limited in this respect.

[0039] In some embodiments, a multi-chamber syringe may include one or more functional coatings on any suitable surface of the syringe to provide various desired functionalities. For example, the coating may be disposed on the inner surface of the barrel, the outer surface of the separator, and / or any other suitable surface of the syringe. In some embodiments, the coating may include a hydrophobic coating. A hydrophobic coating can help improve the mixing of one or more materials disposed within the syringe when the separator between the two chambers containing different materials is removed. Without being bound by theory, a hydrophobic coating can prevent materials disposed within the chambers from adhering to the surface of the chambers, thereby enabling a more homogeneous mixture. Of course, other coatings besides hydrophobic coatings, or as an alternative, may be included in a multi-chamber syringe. Therefore, it should be understood that any suitable coating may be included on any suitable surface of any suitable portion of a multi-chamber syringe, as this disclosure is not limited thereto.

[0040] Turning to the accompanying drawings, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments can be used individually and / or in any desired combination, as this disclosure is not limited to the specific embodiments described herein.

[0041] Figure 1AThis is an isometric view of one embodiment of a multi-chamber syringe 100. The syringe 100 includes a housing and a first plunger 110 disposed at least partially within the cavity of the housing. In the embodiment shown in the figures, the housing is the barrel 102 of the syringe 100. The first plunger 110 is slidably displaceable relative to the barrel 102. The proximal portion of the barrel 102 includes a barrel flange 104. In some embodiments, the barrel flange may assist a user in grasping and / or controlling the syringe. For example, the barrel flange may be configured to receive one or more fingers of a user's hand or be grasped by one or more fingers of a user's hand when the user operates the syringe. In the embodiment shown in the figures, the distal portion of the barrel 102 includes a nozzle 106 or other suitable outlet. In some embodiments, displacing one or more plungers relative to the syringe housing may dispense material disposed within the housing out of the nozzle. In the embodiment shown in the figures, the proximal portion of the first plunger 110 includes a first plunger flange 112. In some embodiments, the plunger flange may assist a user in grasping the plunger or controlling the position of the plunger within the syringe. For example, the plunger flange may be configured to receive the user's thumb when the user operates the syringe. In an embodiment of the figures, the distal portion of the first plunger 110 includes a first plunger head 114. The plunger head may include one or more resilient portions, gaskets, O-rings, or any other suitable structure configured to achieve a seal between the plunger head and the body, and the plunger head may be disposed in the body to form a sliding seal therewith.

[0042] Additionally, the multi-chamber syringe 100 includes a separator 130 at least partially disposed within the cavity of the barrel 102. The separator 130 is slidably displaced relative to both the barrel 120 and the first plunger 110 in a distal direction along the longitudinal axis of the syringe 100. However, embodiments in which the separator can move in different directions are also contemplated. The proximal portion of the separator 130 may include a separator flange 132. In some embodiments, the separator flange may assist a user in grasping the separator and / or controlling the position of the separator within the syringe.

[0043] Figure 1B and Figure 1C (Respectively) before and after the displacement of the separator 130. Figure 1A A schematic diagram of a multi-chamber syringe 100. When the separator 130 is in its initial sealed configuration, as... Figure 1BAs shown, the distal portion 134 of the separator 130 can contact the distal inner surface of the barrel 102 or other suitable inner surface to form a seal. As noted above, the separator can be moved in the proximal direction along the longitudinal axis of the syringe to move the separator to an unsealed configuration. In this way, the separator 130 is configured to selectively separate different chambers of the cavity. That is, the separator 130 partially defines a first chamber and a second chamber within the cavity of the barrel 102. The first chamber 140 is at least partially defined by the inner surface of the separator 130, the distal surface of the barrel 102, and the distal surface of the first plunger 110, such as the surface of the first plunger head 114. Accordingly, the second chamber 150 is at least partially defined by the outer surface of the separator 130, the distal surface of the barrel 102, the inner surface of the barrel 102, and the distal surface of the second plunger (not shown for clarity). A first material 142 is disposed in the first chamber 140, and a second material 152 is disposed in the second chamber 150. Figure 1C As shown, when the separator 130 retracts in the proximal direction relative to the inner cavity of the cylinder, the distal portion 134 of the separator 130 breaks contact with the distal inner surface of the cylinder 102, thereby disrupting the seal. Therefore, the first chamber 140 and the second chamber 150 are in fluid communication with each other to form a combined volume, thereby allowing the first material 142 and the second material 152 to mix into a mixture 162 in the combined volume 160 as the separator shifts toward the fully displaced configuration.

[0044] Figures 2A to 2C One embodiment involving a mixing sequence of a multi-chamber syringe 100 is depicted. The syringe 100 includes a barrel 102, which includes a nozzle 106 or other outlet. The nozzle 106 of the barrel 102 is coupled to a vial 108. Figure 2A As can be seen, the first plunger 110 of the retracted syringe 100 draws first material 142 from the vial 108 through the nozzle 106 and draws the first material 142 into the first chamber 140 within the barrel 102 of the syringe 100. Second material 152 is disposed in the second chamber 150. The first plunger 110 includes a first plunger flange 112 configured to be grasped by the user when drawing the first material 142 from the vial 108. Figure 2B As can be seen, the separator 130 of the syringe 100 can be displaced relative to the barrel 102. When the separator 130 is displaced, the first material 142 mixes with the second material 152 to form a mixture 162 in the combination region 160. When the separator 130 is displaced, the first plunger 110 displaces together with the separator 130 such that the first plunger head 114 does not move relative to the separator 130. In other embodiments, displacing the separator may include displacing the separator relative to the syringe housing, one or more plungers of the syringe, or any other part of the syringe. Figure 2CAs can be seen, the first syringe 110 is displaced relative to the separator 130. Finally, the first plunger 110 reaches its fully deployed position relative to the separator 130. At this point, the first plunger head 114 is aligned with the second plunger head 124 of the second plunger (not shown) associated with the second chamber 150. The first plunger 110, the separator 130, and the second plunger form a combined plunger. Displacement of the combined plunger causes the mixed material 162 to be dispensed out of the combined volume 160 through the nozzle 106.

[0045] Figures 3 to 5 Various views of one embodiment of a multi-chamber syringe 100 are depicted. The syringe 100 includes a barrel 102 having an internal volume. The distal portion of the barrel 102 includes a nozzle 106 or other outlet in fluid communication with the internal volume of the barrel, and the proximal portion of the barrel 102 may include a barrel flange 104. A first plunger 110 is at least partially disposed within the cavity of the barrel 102 and is slidably displaced relative to the barrel 102. Additionally, a second plunger 120 is at least partially disposed within the cavity of the barrel 102 and is slidably displaced relative to the barrel 102. In the depicted embodiment, the second plunger is configured to at least partially surround the first plunger. A separator 130 is at least partially disposed between the first plunger 110 and the second plunger 120. As shown in the figures, in some embodiments, the separator may be a tube disposed between the first and second plungers and coaxially positioned with respect to both plungers. Furthermore, the separator can form a first chamber and a second chamber within the cylinder via a seal formed between the distal portion of the separator and the distal inner surface of the cylinder that contacts the distal portion of the separator. In some embodiments, the distal inner surface of the cylinder may include a coating 103, such as an elastic coating, to aid in the sealing of the separator.

[0046] The first plunger 110 and the second plunger 120 can be disposed in regions of the internal volume of the cylinder 102 corresponding respectively to the first chamber 140 and the second chamber 150, such that movement of the plungers can change the volume contained in the first and second chambers. In either case, the separator can be slidably displaced relative to the first plunger 110, the second plunger 120, and the cylinder to selectively bring the first and second chambers into fluid communication with each other or to isolate the first and second chambers. Figure 5As best shown, the first chamber 140 is in fluid communication with the nozzle 106 or other outlet of the syringe 100. Therefore, movement of the first plunger 110 relative to the proximal end of the separator when the first plunger 110 is in its initial sealed configuration can draw the first material 142 into the first chamber. However, embodiments where the first material is already contained in the first chamber are also contemplated. Additionally, in the initial configuration, the second plunger 120 can be located away from the distal inner surface of the barrel to define an initial volume of the second chamber 150, which can contain the second material 152 disposed therein. The second volume can be isolated from the syringe nozzle until the separator is displaced into an unsealed configuration. The operation of these components is described below.

[0047] In some embodiments, the first plunger, the separator, and the second plunger may be configured to be individually displaced relative to each other along the longitudinal axis of the syringe in a first operating mode and to be uniformly displaced together with each other in a second operating mode, as further detailed below. For example, in one embodiment, the separator may be selectively engaged with one or more plungers of a multi-chamber syringe to allow the plungers and separator of the syringe to move uniformly during dispensing of material from the syringe. In the embodiment shown in the figures, the separator 130 includes a locking structure, such as one or more protrusions 138, configured to engage a groove 128 of the second plunger 120 or another suitable structure as the separator moves proximally toward an unsealed configuration relative to the second plunger. Specifically, displacing the separator 130 in the proximal direction causes the protrusions 138 to translate proximally toward the groove 128 of the second plunger 120. After translating a predetermined distance, the protrusions 138 engage the groove 128, thereby connecting the separator 130 to the outer plunger 120. One or more leaf springs 129 are configured to lock the protrusion 138 into the groove 128. Therefore, in some embodiments, the separator may be configured to engage with the plunger to connect the separator and one or more plungers, such that the separator and plunger can move in a distal direction coherently with each other along the longitudinal axis of the syringe during dispensing of material from the syringe. Of course, while specific locking features for connecting the separator and plungers have been shown, this disclosure is not limited to the depicted protrusion and groove. Therefore, as previously noted, any suitable locking device can be used. Additionally, embodiments in which the separator and one or more plungers are not locked together when in an unsealed configuration are also contemplated.

[0048] In some cases, it is desirable to prevent unintentional movement of the separator from a sealed configuration to an unsealed configuration. Therefore, in some embodiments, the separator 130 may include a separator flange 132 disposed in a recess of the cylinder 102 near the cylinder flange 104. Rotation of the separator 130 about a longitudinal axis releases the separator flange 132 from the recess of the cylinder 102, thereby freeing the separator to translate along the longitudinal axis. However, any suitable locking mechanism, including a latch, pawl, pin, or other means, may also be used to prevent unintentional displacement of the separator.

[0049] To provide the desired seal, the multi-chamber syringe 100 may include a plurality of gaskets. As shown in the figures, a first plunger 110 includes a circumferential recess on a distal portion of the first plunger. This recess is configured to receive a first plunger gasket 116 disposed between the first plunger 110 and the separator 130. A second plunger 120 includes a first circumferential recess on an outer surface of the second plunger, configured to receive a second plunger gasket 126 disposed between the second plunger 120 and the barrel 102. Additionally, the second plunger 120 includes a second circumferential recess on an inner surface of the second plunger, configured to receive a separator gasket 136 disposed between the second plunger 120 and the separator 130. These gaskets allow the plunger and separator to move relative to each other while maintaining the desired seal with each other. As described above, the gaskets may be any suitable material, size, or shape configured to provide a seal, as this disclosure is not limited to the specific types of gaskets or seals used in the disclosed embodiments.

[0050] Figures 6A to 6I Depicting the use and about Figures 3 to 5 One implementation of a method for a multi-chamber syringe, similar to the described multi-chamber syringe. Figure 6A In this multi-chamber syringe 100, a valve 109 in fluid communication with a nozzle 106 of the syringe barrel 102 is connected to a vial 108. As described above, the barrel 102 includes an inner cavity in which a first plunger 110, a second plunger 120, and a separator 130 are disposed. A first chamber 140 is disposed within the inner cavity of the separator and associated with the first plunger, and a second chamber 150 is disposed between the separator and its inner surface and associated with the second plunger. In an initial state, a first portion 142a of a first material is disposed within the first chamber. A second material 152 is disposed within the second chamber. A second portion 142b of the first material is disposed within the vial 108. In some embodiments, the vial may contain thrombin and the first chamber may initially contain a sodium chloride solution. In some embodiments, the second chamber may contain dextran, starch-based materials, and / or collagen-based materials. It should be understood that any suitable material may be disposed in any chamber of the syringe and / or vial.

[0051] exist Figure 6B In this process, the first plunger 110 is displaced distally relative to the cylinder 102. The cylinder 102 includes a cylinder flange 104 configured to assist the user in displacing the first plunger 110. As the first plunger is displaced, a first portion 142a of the first material is dispensed from the first chamber 140 through the nozzle 106, through the open valve 109, and into the vial 108. The first portion 142a of the first material is mixed with a second portion 142b of the first material to obtain the first material 142. Figure 6C In this process, vial 108 may be shaken to further promote mixing. In some embodiments, a sodium chloride solution may be injected into a vial containing thrombin (or any other suitable therapeutic fluid), and shaking the vial may include rotating the vial to reformulate the thrombin (or other fluid).

[0052] exist Figure 6D In the process, the first plunger 110 is retracted to draw the first material 142 out of the vial 108 and into the first chamber 140. Figure 6E In this case, vial 108 is disconnected from syringe 100. Figure 6F In this process, valve 109 is closed to prevent material from leaving the nozzle 106 of syringe 100. In some embodiments, the material aspirated into the syringe may include a mixture of sodium chloride solution and thrombin, but other materials and / or combinations thereof are also contemplated, and this disclosure is not limited in this respect. It should be understood that in some embodiments of the method of operating a multi-chamber syringe, [the following may not be included] Figures 6A to 6E The steps described herein. That is, in some embodiments, the method can be derived from a position... Figure 6F The syringe, as depicted in the image, begins to contain two or more chambers that hold two or more materials ready to be mixed.

[0053] exist Figure 6G In this configuration, the separator flange 132 formed in the proximal portion of the separator 130 can rotate out of the recess 105 of the barrel flange 104. After the separator flange 132 is released from the recess 105, the separator 130 unlocks from the barrel 102 of the syringe 100 and is free to translate axially. Although in Figure 6G The embodiments shown depict a configuration of protrusions and grooves; however, it should be understood that this disclosure is not limited to this type of connection. More precisely, any suitable releasable connection can be used between the separator and the syringe body, including but not limited to protrusions and grooves, friction fits, magnetic connections, spring-loaded protrusions configured to be received in recesses, and / or other suitable mechanisms configured to selectively allow or prevent movement of the separator. Figure 6HIn this configuration, the separator 130 is slidably displaced in the proximal direction until the protrusion 138 of the separator 130 engages with the groove 128 of the second plunger 120, thereby connecting the separator 130 and the second plunger 120 so that the separator and the second plunger can move synchronously with each other during distal displacement of the combined plunger assembly. With the distal portion of the separator 130 not contacting the distal inner surface of the cylinder 102, the first chamber 140 and the second chamber 150 are no longer separated, thereby allowing the first material 142 and the second material 152 to mix in the combined volume 160 to produce a mixed material 162.

[0054] exist Figure 6I In the depicted embodiment, valve 109 is opened, and the first plunger 110 is displaced in the distal direction. The separator 130 includes a radially inwardly extending lip 135 for engaging with the distal surface of the first plunger. Therefore, distal movement of the first plunger correspondingly displaces the separator in the distal direction. Since the protrusion 138 of the separator 130 engages with the groove 128 of the second plunger 120, the second plunger 120 also displaces in the distal direction when the separator is displaced. In this way, the first plunger 110, separator 130, and second plunger 120 form a combined plunger configured to displace the mixture 162 from the combined volume 160. With the combined plunger displaced, the mixture 162 is dispensed out of the combined volume 160 via nozzle 106 and out of the opened valve 109, thereby delivering the mixture 162 to the target location. In some embodiments, the distal portions of the plunger and the separator can be shaped to form surfaces that substantially match the size and shape of the distal inner surface of the barrel. Of course, while a specific configuration for forming a combined plunger from the separator and two plungers has been described, it should be understood that any suitable configuration capable of dispensing material from a syringe in the same manner as a combined plunger can be used.

[0055] Figures 7A to 7CVarious embodiments of a multi-chamber syringe configured to promote mixing are illustrated. In the embodiments shown in the figures, protrusions 170 and 172 are disposed on the inner and / or outer surfaces of a separator 130 (shown in a top cross-sectional view). The separator 130 is disposed within the cavity of the syringe barrel 102. As described above, protrusions and / or surface features such as fins, recesses, indentations, or ribs can be configured to promote turbulent mixing within the multi-chamber syringe. Protrusions and / or surface features can be disposed on any suitable component and / or surface of the multi-chamber syringe, including but not limited to separators, plungers, barrels, and / or barrel nozzles. In the embodiments shown in the figures, the separator 130 includes both a protrusion 170 projecting into a first chamber 140 adjacent to the separator 130 and a protrusion 172 projecting into a second chamber 150 adjacent to the separator 130. Protrusions 170 and 172 promote turbulence, thereby enhancing mixing between materials, in the event of displacement of the separator 130 relative to the material disposed in the first chamber 140 and the second chamber 150.

[0056] Figures 8A to 8E An embodiment of a multi-chamber injector 100 with a combined plunger 180 is depicted. The combined plunger 180 may be configured to control material disposed in multiple chambers of the multi-chamber injector. The combined plunger 180 may include one or more features configured to receive a separator 130. In this way, when both the combined plunger 180 and the separator 130 are in the same relative position (e.g., fully retracted or fully deployed), the combined plunger 180 and the separator 130 may form a nested structure and / or an interlocking structure.

[0057] Figure 8A A cross-sectional side view of a multi-chamber syringe 100 in which the separator 130 is deployed and the combined plunger 180 is retracted is shown. The combined plunger 180 may include a connecting portion 182 connecting an inner portion 184 and an outer portion 186 of the combined plunger 180. The inner portion 184 of the combined plunger 180 may be associated with an inner chamber of the multi-chamber syringe 100. The outer portion 186 of the combined plunger 180 may be associated with an outer chamber of the multi-chamber syringe 100. Of course, it should be understood that the combined plunger 180 may include any portion suited to its shape and / or arrangement, which may depend at least in part on the corresponding shape and / or arrangement of the multi-chamber syringe.

[0058] exist Figure 8B When the separator 130 is displaced relative to the cylinder 102, the separator 130 retracts into the recess in the combined plunger 180, thereby forming an interlocking structure. Figure 8C An interlocking structure formed by the combined plunger 180 and the separator 130 in the deployment position is shown. The interlocking structure allows for rapid depressurization and / or dispensing of material from the syringe 100. Figures 8D to 8EDescribing as Figure 8A The cross-sectional bottom view of the multi-chamber syringe indicated in the figure. These views help to illustrate the structural features that allow the combined plunger 180 to be positioned on the inner and outer sides of the separator 130.

[0059] While this teaching has been described in conjunction with various embodiments and examples, it is not intended to limit this teaching to these embodiments or examples. Rather, as will be understood by those skilled in the art, this teaching encompasses various alternatives, modifications, and equivalents. Therefore, the foregoing description and figures are by way of example only.

Claims

1. A multi-chamber syringe, comprising: A housing, the housing including an inner cavity; A first plunger is disposed at least partially within the cavity of the housing, wherein the first plunger is slidably displaced relative to the housing; A second plunger, at least partially disposed within the cavity of the housing, wherein the second plunger is slidably displaceable relative to the housing; and A separator, at least partially disposed within the cavity of the housing between the first plunger and the second plunger, wherein the separator forms a first chamber and a second chamber, the first chamber being defined at least by a first surface of the separator and a distal surface of the first plunger, and the second chamber being defined at least by a second surface of the separator and a distal surface of the second plunger, wherein the separator is slidably displaced relative to the first plunger and the second plunger to facilitate mixing of the volumes of the first chamber and the second chamber, and wherein the first plunger, the second plunger, and the separator are each configured to be displaced individually in a first operating mode and move uniformly in a second operating mode.

2. The multi-chamber syringe according to claim 1, wherein, The separator can selectively engage with the first plunger and / or the second plunger.

3. The multi-chamber syringe according to claim 1, further comprising a first material disposed in the first chamber.

4. The multi-chamber syringe according to claim 3, wherein, The first material includes a sodium chloride solution.

5. The multi-chamber syringe according to claim 1, further comprising a second material disposed in the second chamber.

6. The multi-chamber syringe according to claim 5, wherein, The second material includes one or more selected from the group consisting of dextran, starch-based materials and collagen-based materials.

7. The multi-chamber syringe according to claim 1, wherein, The housing is annular, and the separator is annular.

8. The multi-chamber syringe according to claim 7, wherein, The separator is coaxial with the housing.

9. The multi-chamber syringe according to claim 1, wherein, The first plunger is cylindrical.

10. The multi-chamber syringe according to claim 9, wherein, The separator is annular, and wherein the separator is coaxial with the first plunger.

11. The multi-chamber syringe according to claim 9, wherein, The second plunger is annular.

12. The multi-chamber syringe according to claim 11, wherein, The second plunger is coaxial with the first plunger.

13. The multi-chamber syringe of claim 1, further comprising one or more gaskets located between two or more of the group consisting of the first plunger, the separator, the second plunger, and the housing.

14. The multi-chamber syringe according to claim 1, wherein, The separator is configured to lock with the first plunger and / or the second plunger when shifted to an unsealed configuration.

15. The multi-chamber syringe of claim 1, further comprising one or more protrusions formed on the separator, wherein, The protrusion is designed to facilitate mixing.

16. A method of operating a multi-chamber syringe according to claim 1, the method comprising: The first plunger associated with the first chamber is displaced individually relative to the second plunger associated with the second chamber; The separator is individually displaced relative to the first plunger and the second plunger to arrange the first chamber, which includes the first material, in fluid communication with the second chamber, which includes the second material; The first material and the second material are mixed in the combined volume of the first chamber and the second chamber; as well as The first plunger, the second plunger, and the separator are moved in unison to dispense the mixed first and second materials from the combined volume.

17. The method according to claim 16, wherein, Displace the first plunger of the multi-chamber syringe to draw the first material into the first chamber.

18. The method according to claim 17, wherein, Displace the first plunger to draw in the first material includes displacing the first plunger in a first direction, wherein displacing the separator to release the second material includes displacing the separator in a second direction, and wherein the first direction is parallel to the second direction.

19. The method according to claim 18, wherein, Displacing the first plunger, the second plunger, and the separator to dispense the mixed first and second materials includes displacing the first plunger, the second plunger, and the separator in a third-direction upward, wherein the third-direction is opposite to the first direction.

20. The method of claim 16, further comprising coupling the separator to the first plunger and / or the second plunger before displacing the first plunger, the second plunger, and the separator.

21. The method according to claim 20, wherein, Connecting the separator to the first plunger and / or the second plunger includes inserting a protrusion associated with the separator into a groove associated with the first plunger and / or the second plunger.

22. The method according to claim 16, wherein, The separator is annular, and the first plunger is at least partially disposed within the separator.

23. The method according to claim 16, wherein, The second plunger is annular, and the separator is at least partially disposed within the second plunger.

24. The method according to claim 23, wherein, The separator is annular, and the first plunger is at least partially disposed within the separator.

25. The method of claim 16, further comprising unlocking the partition before displacing the partition to position the first chamber in fluid communication with the second chamber.

26. The method of claim 16, wherein, The first material includes a sodium chloride solution.

27. The method of claim 16, wherein the second material comprises one or more selected from the group consisting of dextran, starch-based materials, and collagen-based materials.

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