WO2024263922A2

WO2024263922A2 - Multilumen connector

Info

Publication number: WO2024263922A2
Application number: PCT/US2024/035031
Authority: WO
Inventors: Carly Sue FILGUEIRA; Varun Mitra RACHAKONDA; Nilesh MATHURIA
Original assignee: Methodist Hospital
Current assignee: Methodist Hospital
Priority date: 2023-06-23
Filing date: 2024-06-21
Publication date: 2024-12-26
Anticipated expiration: 2025-12-23
Also published as: WO2024263922A3

Abstract

A device for combining fluids may include at least a first arm and a second arm. The first arm includes a first free end defining a first inlet and a first downstream end. The second arm includes a second free end defining a second inlet and a second downstream end. A trunk is connected to the first and second downstream ends of the first and second arms to define a first outlet adjacent a second outlet. The first arm, the second arm, and the trunk define a first fluid pathway extending from the first inlet to the first outlet and a second fluid pathway extending from the second inlet to the second outlet. The first and second fluid pathways are defined using a plurality of angled surfaces sufficiently angled to produce at least partial non-laminar flow in the first fluid and second fluid as they exit the outlets.

Description

Attorney Docket No.10063-077WO1 MULTILUMEN CONNECTOR FIELD [0001] The present application is directed to connectors for multi-lumen devices and in particular multi-lumen systems for defining multiple pathways to improve homogeneity and/or mixing of combined fluids. BACKGROUND [0002] Industrial and medical procedures can benefit from a mixing of two or more liquids into a composition to facilitate various processes and procedures. Also, the mixture itself may be a desirable product. [0003] One example is the use biocompatible plasmonic gold nanoparticles (nano-shells) for targeted photothermal ablation with near-infrared (NIR) light to create transmural lesions eliminating refractory ventricular tachycardia. The nano-shells are embedded in a composite of two liquids that together can form a matrix – such as a gel – to aid in the targeted application of energy. For example, the gel and nano-shell composition may be delivered into targeted cardiac tissue for ablation. Use of the gel reduces the incidence of migration to other tissue structures. The gel reduces nanoparticle washout and increases extended release within the target area. [0004] Available catheters can deliver multiple fluids, but no devices can accurately deliver viscous fluids for formation of polymerized or crosslinked product in situ. Old methods include dual lumen syringes that allow for simultaneously aspirating of a pair of fluids from respective containers and/or dispensing the fluids through a common outlet tip. The outlets are identically sized and parallel to each other. [0005] Accordingly, there remains a need for devices, systems, and methods providing for mixing of two or more liquids supplied by two or more lumens. SUMMARY [0006] Implementations of the present invention include a device for combining at least a first fluid and a second fluid (and optionally three or more fluids) by inducing non-laminar flow in at least one of those fluids. [0007] Another implementation includes inducing non-laminar flow via one or more angled surfaces. Attorney Docket No.10063-077WO1 [0008] Another implementation, which can be combined with either of the above implementations, includes dispensing the fluids in an adjacent relationship so as to promote mixing. [0009] For example, the device may include at least a first arm and a second arm, and a trunk. The first arm includes a first free end defining a first inlet and a first downstream end. The second arm includes a second free end defining a second inlet and a second downstream end. The trunk is connected to the first and second downstream ends of the first and second arms and defines a first outlet adjacent to a second outlet. The first arm, the second arm and the trunk define a first fluid pathway extending from the first inlet to the first outlet and a second fluid pathway extending from the second inlet to the second outlet. The first and second fluid pathways are defined using a plurality of angled surfaces sufficiently angled to produce at least partial non-laminar flow in the first fluid and second fluid as they exit the adjacent first and second outlets. [0010] In some implementations, the device includes a first and second arms. The first arm includes a first inlet and the second arm includes a second inlet. A trunk of the device is connected to a first and second downstream ends of the first and second arms. A first and second corresponding outlets are defined adjacent to each other on the trunk to facilitate mixing. The first arm, second arm and trunk define a first fluid pathway extending from the first inlet to the first outlet. A second fluid pathway is also defined extending from the second inlet to the second outlet. Defining the first and second fluid pathways are a plurality of angled surfaces. These angled surfaces are sufficiently structured (e.g., angled) to produce at least a partial non-laminar flow. Thus, as the first and second fluids exit the first and second outlets they are better mixed. The device can also combine additional fluid pathways by selective use of angled surfaces and adjacent outlets. Angled surfaces can include various angled means such as baffles, curved shapes, roughened surfaces, zig-zag pathways, bottlenecks, chambers, bumps and various combinations thereof. [0011] In other implementations the device is a connector in a larger system defining multiple fluid pathways. For example the connector can be connected to supply lines of the fluids and then dispense those fluids via adjacent outlets to a plurality of needles, one for each fluid, which then dispense those fluids onto a workpiece in an adjacent relationship with non-laminar flow characteristics to improve mixing. [0012] Various aspects of the implementations described above can be combined based on desired connector and fluid delivery system characteristics. Attorney Docket No.10063-077WO1 [0013] Implementations of the present invention include a method for combining at least a first fluid and a second fluid. [0014] For example, the method may include providing a device including at least a first arm and a second arm, the first arm including a first free end defining a first inlet and a first downstream end, and the second arm including a second free end defining a second inlet and a second downstream end. The device may further include a trunk connected to the first and second downstream ends of the first and second arms and defining a first outlet adjacent a second outlet. The method may further include inserting a first syringe tip within the first inlet of the first arm. The method may further include inserting a second syringe tip within the second inlet of the second arm. The method may further include causing the first fluid to flow along a first fluid pathway defined by the first arm, the second arm, and the trunk, the first fluid pathway extending from the first inlet to the first outlet. The method may further include causing the second fluid to flow along a second fluid pathway defined by the first arm, the second arm, and the trunk, the second fluid pathway extending from the second inlet to the second outlet. The method may further include combining the first fluid and the second fluid at the first and second outlets. The first and second fluid pathways may be defined using a plurality of angled surfaces sufficiently angled to produce at least partial non-laminar flow in the first fluid and the second fluid as they exit the adjacent first and second outlets. DESCRIPTION OF DRAWINGS [0015] FIG.1 is a cross-sectional view of a dual-lumen connector using a switchback to induce non-laminar flow and to promote mixing of two fluids; [0016] FIG.2 is a schematic of the connector of FIG.1 showing the fluids in the dual fluid pathways; [0017] FIG.3 is a perspective view of the schematic of FIG.2; [0018] FIG.4 is a cross-sectional view of a dual-lumen connector including a zigzag flow path; [0019] FIG.5 is a schematic of the connector of FIG.4 showing the fluids in the dual fluid pathways; [0020] FIG.6 is a perspective view of the schematic of FIG.5; [0021] FIG.7 is a sectional view of a dual-lumen connector including a plurality of parallel pathways extending between chambers; [0022] FIG.8 is a schematic of the connector of FIG.7 showing the fluids in the fluid pathways; [0023] FIG.9 is a perspective view of the schematic of FIG.8; Attorney Docket No.10063-077WO1 [0024] FIG.10 is a sectional view of a dual lumen connector including a plurality of triangular parallel pathways extending between chambers; [0025] FIG.11 is a schematic of the connector of FIG.10 showing the fluids in the fluid pathways; [0026] FIG.12 is a perspective view of the schematic of FIG.11; [0027] FIG.13 is a sectional view of a dual lumen connector including a pair of abutting frustoconical chambers; [0028] FIG.14 is a schematic of the connector of FIG.13 showing the fluids in the fluid pathways; [0029] FIG.15 is a perspective view of the schematic of FIG.14; [0030] FIG.16 is a sectional view of a dual-lumen connector including a pair of barrels including spherical baffles; [0031] FIG.17 is a schematic of the connector of FIG.16 showing the fluids in the fluid pathways; [0032] FIG.18 is a perspective view of the schematic of FIG.17; [0033] FIG.19 is a plan view of a syringe system of another implementation of the present invention including the connector of FIGS.1-3. DETAILED DESCRIPTION [0034] The following description of certain examples of the inventive concepts should not be used to limit the scope of the claims. Other examples, features, aspects, implementations, and advantages will become apparent to those skilled in the art from the following description. As will be realized, the device and/or methods are capable of other different and obvious aspects, all without departing from the spirit of the inventive concepts. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. [0035] For purposes of this description, certain aspects, advantages, and novel features of the aspects of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed aspects, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved. Attorney Docket No.10063-077WO1 [0036] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect or example of the present disclosure are to be understood to be applicable to any other aspect or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The present disclosure is not restricted to the details of any foregoing aspects. The present disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. [0037] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. [0038] As used in the specification and the appended claims, the singular forms “a,” "an" and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. [0039] "Optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. [0040] Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as "comprising" and "comprises," means "including but not limited to," and is not intended to exclude, for example, other additives, components, integers or steps. Attorney Docket No.10063-077WO1 "Exemplary" means "an example of" and is not intended to convey an indication of a preferred or ideal aspect. "Such as" is not used in a restrictive sense, but for explanatory purposes. [0041] Disclosed implementations include a device, such as a connector, and associated systems and methods, are for combining a first and second fluids in a relatively homogeneous and/or well-mixed composition. Implementations however are not limited to two fluids and/or mixing and can include other features, such as inducing non-laminar flow in three or more fluids for example. [0042] The term “fluid” herein is to be construed broadly as including all forms of substance that can flow including things referred to herein as substances, materials, compounds, gels, liquids, components, etc. and mixtures thereof. Anything described herein using the latter terms can also apply to fluids generally. For example, many of the materials investigated for injectable therapy that have shown preservation or improvements in cardiac function (such as fibrin glue, collagen, alginate, chitosan, Matrigel, and hyaluronic acid) are not translatable to catheter delivery as they are not injectable as they do not remain liquid. However, implementations of the invention would overcome this limitation as the gel would be formed in situ, and the two primary components (each in their liquid form) (for example, component 1 including fibrinogen, Factor XIII, and fibronectin along with component 2 including thrombin to make fibrin glue) would be loaded separately into two different syringes and simultaneously, and continuously, pushed through the syringe system whereby they would merge at the injection site and polymerize immediately prior to delivery in the tissue. The needle could be retractable such that the system could be moved to a different location for delivery at multiple spots. Although many of the implementations are illustrated used in medical applications, other applications are also possible such as industrial chemical applications. [0043] In some implementations, the device includes a first and second arms. The first arm includes a first inlet and the second arm includes a second inlet. A trunk of the device is connected to a first and second downstream ends of the first and second arms. A first and second corresponding outlets are defined adjacent to each other on the trunk to facilitate mixing. The first arm, second arm and trunk define a first fluid pathway extending from the first inlet to the first outlet. A second fluid pathway is also defined extending from the second inlet to the second outlet. Defining the first and second fluid pathways are a plurality of angled surfaces. These angled surfaces are sufficiently structured (e.g., angled) to produce at least a partial non-laminar flow. Thus, as the first and second fluids exit the first and second outlets they are better mixed. The device can also combine additional fluid pathways by selective use of angled surfaces and adjacent outlets. Angled surfaces can include various angled means such as baffles, curved Attorney Docket No.10063-077WO1 shapes, roughened surfaces, zig-zag pathways, bottlenecks, chambers, bumps and various combinations thereof. [0044] FIG.19 illustrates a syringe system 10 that includes a multi-pathway connector 12 that attaches to a pair of syringe bodies 14 having contents urged by a holder 16 that drives multiple plungers 18 through the syringe bodies. The plungers 18 urge the contents of the syringe bodies 14 through the connector 12, which induces non-laminar flow, and out of the ends of a pair of needles 20. These needles may be proximate an operational site, such as an area on a heart for forming a lesion. The contents for example may be a calcium chloride solution in a first pathway 30 and gold nano-shells in a sodium alginate solution in a second pathway 32. These two liquids experience non-laminar flow as they exit the fluid pathways 30, 32 to form a gel with gold nano- shells in suspension. Then the gel can be used with laser light to induce the lesion which leads to scar tissue and addresses electrical signal propagation that is associated with tachycardia. [0045] The holder 16, as shown in FIG.19, includes a body 22 defining a pair of parallel openings 24 and a pair of finger grips 26. The parallel openings (which could be 2, 3, 4 or more openings depending on the number of syringes and number of fluids and their respective pathways) are sized to receive the bodies of the syringes 14 in a snug or press fit arrangement. The finger grips 26 are sized and placed to receive a pair of fingers for manual urging. [0046] The holder 16 also includes a plunger cap 28 that cooperates with the body 22 to drive the multiple plungers 18 through the syringe bodies 14. The plunger cap 28 includes a plate- shaped body that has defined therein multiple slots to receive the individual plungers 18 therein to couple the operation of those plungers. Also, the plunger cap 28 provides a surface on which the thumb or fingers of the user applies pressure while pulling with other fingers on the finger grips 26 of the holder 16 to depress the plungers 18 in a coordinated manner. The coordinated urging of the plungers 18 simultaneously urges the fluids held in the syringe bodies 14 out of their tips and through the connector 12. [0047] Thus, in one implementation, the invention includes a multi-lumen holder that has a body of elongate cavities or lumens with two or more channels for simultaneous ejection of the contents of two or more separate syringes using one plunger. In the same procedure the operator can release the contents of one or more compartments with the same force using only one hand. The device allows for mixing of the components of the separate syringes at the outflow point allowing for improved yield of component mixing. [0048] The device may be constructed out of a plastic, metal, or silicone-based material or a combination of these materials or others. Its operation is such that with one or more continuous motion of injections, it allows for the mixing of multiple components of different viscosities Attorney Docket No.10063-077WO1 and/or compositions. An elongated slidable plunger allows the operator to easily eject the components from each channel or syringe with the same force such that the individual components overlap and interact in a way that they initiate mixing. [0049] This mixing may result in the initiation of a chemical reaction to generate a new substance with different physical and chemical properties than their parent substances, such as a polymer via polymerization, a solid precipitate, semi-solid material, or generation of a gas. The device may contain angled or twisted fluid outlets of different diameters such that upon injection from the operator, mixing results in a high yield of the daughter substance. This mixing may occur within or upon expulsion from a joining piece in the form of a connector. [0050] It should be noted that although embodiments of the present invention are shown defining fluid pathways through various devices such as syringes and syringe holders, there are other ways of defining fluid pathways to induce non-laminar flow where the fluids are deployed in an adjacent relationship with mixing. For example, pathways could be defined through machined blocks or molded plastic and urged by the application of a pressurized fluid supply or by electrical solenoids. In any case, the multiple fluid pathways include angled surfaces that facilitate non-laminar flow and adjacent dispensing (close enough that the fluids can mix) to facilitate mixing and a more homogeneous combined composition. Different embodiments of the invention are particularly useful for more viscous fluids which are more resistive to non-laminar flow. [0051] Implementations of the present invention include use of various configurations of connectors 12 that facilitate creation of non-laminar flow in the fluid pathways such as pathways 30, 32. FIGS.1-3, for example, disclose a connector 12 that includes portions of the first and second fluid pathways 30, 32 for inducing non-laminar flow. (Even the portions of the overall fluid pathways defined herein can be themselves fluid pathways.) The connector 12 includes a first arm 34, a second arm 36 and a trunk 38. [0052] Each of the first and second arms includes a first and second free ends, 44 and 46 respectively, that are opposite first and second downstream ends, 48 and 50, respectively. Each of the arms has a cylindrical shape adjacent the free ends 44, 46 that, moving downstream, forms a first bend 52 or a second bend 54 that extends at about a right-angle inward toward a central axis of the connector 12. Each of the bends has a rounded outer radius and a tighter inner radius corresponding with the right angle formed thereby. The downstream ends 48, 50 of the arms 34, 36 terminate at an upstream end 56 of the trunk 38. [0053] The first and second arms define first and second inlets, 40 and 42, respectively having cylindrical shapes with tapered ends that are configured to fit on the cylindrical types of fluid Attorney Docket No.10063-077WO1 supplies such as the syringe bodies 14. Also, the free ends of the arms 40, 42 have rounded flanges to facilitate connections to fluid supply structures such as the syringe tips, luer locks or the like. It should be noted however that not all implementations of this invention are limited to such cylindrical connections. Different shapes and styles of such connectors can be employed to establish some amount of fluid communication between the supply and the fluid pathways of the connector. [0054] The trunk, in the illustrated implementation, has a generally cylindrical shape that starts at the connections to the arms 34, 36 and terminates in the downstream trunk free end 58. The trunk defines a distal connector opening 60 that has a generally cylindrical shape that includes internal threads. The connector opening 60 is configured to receive a mating (male) shape of a connector (including for example threads) from an additional structure, such as the needles 20, that define further downstream aspects of the fluid pathways. Notably any connection disclosed herein of male to female or vice versa can be reversed to accomplish the same connection. And connections can be made with other fasteners such as clips, elastic bands, adhesives, etc. Also, non-cylindrical shapes are available such as square or oval shapes. [0055] The trunk 38 also includes an extender 62 extending at its free end 58 and protruding further from the ferrule portion of the trunk body that defines the connector opening 60. The extender 62 has a small diameter cylindrical shape that extends centrally along the axis of the connector within the ferrule shape formed by the connector opening 60 at the downstream free end of the trunk 38. The extender 62 defines a first outlet 64 of the first fluid pathway 30 and a second outlet 66 of the second fluid pathway 32. As will be discussed in more detail below, as a fluid passes through the fluid pathways, including through the connector 12 from the arms 34, 36 to the trunk 38 and its extender 62 free end, the fluid pathways induce non-laminar flow due to the pathways being defined by various angled surfaces. [0056] Generally, the term “angled surfaces” as used herein refers to any surface texture or gross change in direction, or varying degrees or combinations thereof, that causes a perturbation in the fluid flow. Implementations of the present invention use different configurations of fluid pathways (which can number two or more) defined within various structure, such as tubing or the connector(s), syringes, etc. to create sufficiently angled surfaces to create at least partial non- laminar flow within the different fluids to promote mixing of those fluids together at a worksite. [0057] Referring again to FIGS.1-3, in this implementation, the connector 12 defines the pathways 30, 32 in a largely symmetric manner extending between the first and second inlets 40, 42 through to the first and second outlets 64, 66 and with various angled surfaces therein. Each Attorney Docket No.10063-077WO1 of the pathways 30, 32 includes three primary portions, a switchback 68, a chamber 70 and a helix 72. [0058] The switchback 68 portion starts from the respective first or second inlet 40, 42 in the first and second arms 34, 36. Generally the switchback 68 includes two spiral sections 76 with tight turns connected by an intervening linear section 74 connecting two sharp turns, one sharp turn at the downstream end of an upstream one of the spiral sections and another sharp turn at the upstream end of a downstream one of the spiral sections. FIG.1 shows how the length of the linear section 74 falls within the plane of the section while the upstream and downstream spiral sections pass through the plane as they wind back and forth across the plane. In addition, as shown in FIG.3, the spiral sections in each pathway reverse their spiraling direction after being connected by the linear section 74. Advantageously, the tight turns and direction reversal of the switchback 68 drive up the Dean and/or Reynolds numbers of the fluid being urged therethrough to promote non-laminar flow. Generally, the cross-section of the switchback is circular, and the diameter (and area) is smaller than the diameter of the chamber and the helical sections thus accelerating fluid velocity. [0059] The Dean number (De) is a dimensionless group in fluid mechanics, which occurs in the study of flow in curved pipes and channels. If a fluid is moving along a straight pipe that after some point becomes curved, the centripetal forces at the bend will cause the fluid particles to change their main direction of motion. There will be an adverse pressure gradient generated from the curvature with an increase in pressure, therefore a decrease in velocity close to the convex wall, and the contrary will occur towards the outer side of the pipe. This gives rise to a secondary motion superposed on the primary flow, with the fluid in the center of the pipe being swept towards the outer side of the bend and the fluid near the pipe wall will return towards the inside of the bend. This secondary motion is expected to appear as a pair of counter-rotating cells, which are called Dean vortices. [0060] The flow is completely unidirectional for low Dean numbers (De < 40~60). As the Dean number increases between 40~60 to 64~75, some wavy perturbations can be observed in the cross-section, which evidences some secondary flow. At higher Dean numbers than that (De > 64~75) the pair of Dean vortices becomes stable, indicating a primary dynamic instability. A secondary instability appears for De > 75~200, where the vortices present undulations, twisting, and eventually merging and pair splitting. Fully turbulent flow forms for De > 400. Laminar flow can be maintained for larger Reynolds numbers (even by a factor of two for the highest curvature ratios studied) than for straight pipes, even though curvature is known to cause instability. Attorney Docket No.10063-077WO1 Regardless, in some implementations, the De can exceed 40, 60, 64 or even 75 or 80 to exceed laminar characteristics. [0061] Regardless, after exiting the switchback, the fluid in the pathway (30 or 32) empties into chamber 70. Generally, in this implementation, the switchback 68 is defined at a longitudinal position adjacent to one of the arms 34, 36 (at its bend) of the connectors 12 and extends into the trunk 38. Chamber 70 is defined closer to the central axis of the trunk 38 than the arms 34, 36. The chamber 70 has a rounded frustoconical shape with the larger diameter adjacent the end of the switchback 68 and then tapering in the downstream direction to communicate with the helix 72 portion of the pathway. Generally, the effect of the tapering in the downstream direction effects the flow velocity which is directly proportional to the Reynolds number. [0062] The helices 72 intertwine extending in downstream direction around the axis of the trunk 38 and within the extender 62 which extends along the connector axis in the direction of the trunk’s free end 58. Eventually the helices 72 empty at the first or second outlets 64, 66. As shown in FIG.1, the helix 72 has a flattened oval shape with the inner edge being more relatively curved than the outer edge. The diameter and area of the helix in cross section is generally larger than that of the switchback portion – by 2X, 3X or even 4X or more – thus for the same pressure the speed of fluid travel will be higher in the switchback 68. The outlets 64, 66 are positioned adjacent to each other at the downstream end of the extender 62 which has a comparatively small diameter compared to the diameter of the two helices 72. The implementation of FIGS.1-3 combining the switchback, chamber and helix portions of the pathways kick off and ramp up non-laminar flow characteristics in a progressive way as the compositions in the pathway progress downstream. Generally, the theory is that with non- laminar flow, we expect better mixing and cross-linking at the outflow channels. Each departure from straight, smooth pathway is an implementation of an angled surface or surfaces that induce non-laminar flow including Dean flow and turbulent flow, for example. [0063] Referring again to FIG.19, the outlets 64, 66 may, in some implementations, be coupled in fluid communication with respective needles 20. The exit openings of these needles are similarly adjacent to each other as the outlets 64, 66. Adjacent placement of the needle tips along with the non-laminar flow induced in the compositions (including liquids, gels and semisolids) facilitates mixing of the two compositions as described herein. The term “adjacent” as used herein means in close enough proximity in 3D space to ensure some amount of mixing by two or more compositions when at least one of those compositions experienced non-laminar flow within its pathway due to the angled surfaces. Such proximity does not require a common plane or shape or size of the exit holes per se although such characteristics can affect whether and to what Attorney Docket No.10063-077WO1 degree there is mixing of the two compositions. Generally, the smaller the distance between adjacent openings and the larger the size of those openings and the amount of non-laminar flow will facilitate more and better mixing. However, optimized mixing is not required to be within the scope of the present invention. In addition, adjacent outlets are not necessarily outlets that exit from the device for immediate mixing. (Of course, certain implementations that further improve the degree of mixing can be additional implementations.) For example, the adjacent outlets 64, 66 are merely precursors to flow into the needles 20 for later downstream mixing – including in aspects where the exits of those structures are also adjacent. [0064] There are other implementations that can use angled surfaces to induce non-laminar flow in two, three or more compositions exiting in adjacent relationships to promote mixing. For example, FIGS.4-6 show another implementation of the connector wherein each of the pathways 30, 32 includes three primary portions, a zigzag 78, a chamber 70 and a helix 72 portion. Chamber 70 and the helix 72 portions are largely the same (except where fluid flow is affected by other differences) as those for FIGS.1-3. For example, the zigzag 78 downstream end empties into the middle of chamber 70 rather than at one end like the switchback 68 implementation. [0065] The zigzag 78 includes a plurality of linear sections with sharp (acute angle) reversals forming corners in the pathway portion as it extends towards chamber 70. Generally, the angles may range from about 45 degrees to 135 degrees. As shown in FIG.4, in the illustrated implementation, the zigzag portion falls within the same plane. The zigzag concept could also be combined with aspects of the switchback, spiral and chamber to induce even greater nonlaminar flow. For example, a spiral or helix could have sharp corners that reverse the direction of the flow and form corners. Also, the corners could be formed by more gentle angles such as obtuse angles. The illustrated implementation includes four corners and five linear portions, but the number of corners and/or straight portions can be varied. Also, again, although the illustrated implementation is symmetrical different structures of angled surfaces might be used for each of multiple pathways through the syringe system 10 or the connector 12. [0066] The implementation also includes a partial bubble-like shape (bubble 80) at the first and second inlets 40, 42 that smooths the transition for the fluid ingress into the pathways 30, 32. [0067] FIGS.10-12 show another implementation wherein the fluid pathways 30, 32 include four primary portions including a first spherical chamber 82, parallel pathways 84, a second spherical chamber 86 and then the helix 72 portions. The spherical chambers 82, 86 are larger diameter (relative to the remaining pathway) spherical chambers that are positioned on either Attorney Docket No.10063-077WO1 side of the parallel pathways 84. For example, the first spherical chamber 82 forms inlet 40 or 42 of the pathway 30 or 32. [0068] The parallel pathways 84 include a plurality of radially spaced channels extending around a line connecting the two closest points of the first and second spherical chambers 82, 86. The parallel pathways can be any of several cross-sectional shapes including circular, oval, irregular, square, etc. but the illustrated implementation is triangular to improve their collective area for fluid flow in a radial arrangement. An upstream end of the parallel pathways 84 is in communication with the first chamber 82 and a downstream end is in communication with the second chamber 86. The second spherical chamber receives the fluids from the parallel pathways 84 and as an enlarged spherical container induces further non-laminar flow before the fluid exits into the helix 72 which has a similar impact on fluid flow as described in prior implementations. [0069] FIGS.7-9 illustrate another implementation wherein the parallel pathways 84 have a circular cross-section forming cylindrical parallel pathways. [0070] FIGS.13-15 illustrate another implementation where the fluid pathways 30, 32 include two of chamber 70 with the smaller diameter frustoconical ends in fluid communication. The rapid tightening in cross section and then rapid expansion help to promote non-laminar flow. The chambers then lead to a similar helix 72 portion of the pathways as described above. [0071] FIGS.16-18 illustrate another implementation wherein each of the fluid pathways 30, 32 defined in connector 12 include a barrel 88 and the helix 72 portions. The helix 72 is like those above. The barrel 88 has an elongate cylindrical shape that includes a plurality of baffles 90 spaced along an internal surface of the barrel. In one implantation the baffles 90 have semi- spherical shapes and are spaced circumferentially and longitudinally along the interior surface of the barrel 99. Other implementations of a baffle structure are also possible including, for example, plates, cones, cubes, cilia, and other structures arranged in a pathway causing the fluids to have to undergo a circuitous pathway and 180-degree direction changes to induce nonlaminar flow. Baffles could also be employed in any one of the other depicted implementations of FIGS. 1-15. [0072] Some implementations of the invention address the technical problem of improving output yield through the mixing of multiple components in a way that each parent component can be reduced in volume to generate improved yield of a daughter substance. The outlet diameters, angling and paths take into consideration the flow and viscosity properties of the separate parent components to facilitate mixing or reacting. These improvements allow for a decreased amount of parent/initiator substances needed as well as ease of use for the operator so Attorney Docket No.10063-077WO1 that changes in applied pressure do not significantly alter substance mixing and yield. These improvements provide a more consistent output yield than would otherwise be generated. [0073] To improve delivery of a gelatinous material into a biological environment, such as vessels or tissues, the liquid can be formulated in a way that it maintains flowability prior to delivery as well as gel-like behavior in the target. For example, this can be achieved by use of a two-component system which polymerizes upon mixing and contact with each other to transition from solution-to-gel at the target site. One primary fluid component can be 3% (w/v) calcium chloride dissolved in MilliQ water.500 µl of the 3% calcium chloride is loaded into a 1 mL BD slip tip syringe without the needle head. The other primary fluid component can be a working solution of 1% (w/v) sodium alginate (50-100 m*Pas) dissolved in MilliQ water. To create this component, 0.5 g of sodium alginate (50-100 m*Pas) is weighed out and placed in a centrifuge tube containing 50 mL of MilliQ water, which is then dissolved through use of a micro homogenizer (Omni International, Kennesaw, GA, USA). [0074] The sodium alginate component can be combined with nanoparticles, cells, or therapeutics such as antibiotics, anesthetics, and/or analgesics by concentrating the nanoparticles/cells via centrifugation, confirming their concentration through use of ICP- OES/cell counter, and then resuspending the concentrated pellet with the 1% sodium alginate. 500 µl of 1% sodium alginate (either with or without a loading material, such as particles, cells, or drug) is separately loaded into another 1 mL BD slip tip syringe without the needle head. Both syringes are then attached to the dual-lumen adaptor (used herein interchangeably for the term “connector”) which is then connected to an 18G needle, and the entire apparatus is placed on a syringe-infusion pump (KD Scientific, Inc., Holliston, MA, USA) set a flow rate of 500 µl/min. The needle tip is centrally positioned into the specimen of interest. Various viscosities of sodium alginate (100-200 and >200 m*Pas), various percent weight of the components, and various volumes to evaluate effects on gel stiffness, dispersion, degradability, and release can be adapted by employment of different implementations. [0075] In other implementations, a kit including the syringe system 10 would contain both individual liquid components and the dual lumen adaptor (connector). The two individual components each provided in lyophilized form which could be easily resuspended by the operator or surgical assistant. The adaptor (external to the body) would have greater applicability for gel delivery into a vessel or superficial tissue. In the case of vessel delivery, it would be connected (through use of a luer-lock) onto the end of a catheter. In the case of superficial tissue, it would be connected to a needle head. Attorney Docket No.10063-077WO1 [0076] In the case that cell delivery is required, or another component needs to be encapsulated into the gel for therapeutic means and is unable to withstand lyophilization, this component would be a separate product (sold as an add-on). In this way, the add-on could be kept sterile and maintained at its required temperature prior to administration. Further, a fiberoptic diffuser could be sold as an add-on as well to the adaptor for photoexcitation. [0077] In view of the many possible aspects to which the principles of the disclosed disclosure can be applied, it should be recognized that the illustrated aspects are only preferred examples of the disclosure and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims. We, therefore, claim as our disclosure all that comes within the scope and spirit of these claims. For example, in other implementations rather than having reversing direction spiral sections 76 connected by linear section 74, the entire portion of the pathway between the first inlet 40 or 42 to the chamber 70 may be a spiral. The spiral for example may be a spiral that tightens downstream or opens downstream. Or the spiral may have increasing or decreasing amplitude in the downstream direction. Or various pitches and amplitudes and varying diameters depending upon the amount and nature of non-laminar flow desired. [0078] For example, various outflow points (inlets 40, 42 or outlets 64, 66 or the junctions between portions of the flow paths for example) may comprise multiple holes of diameters improved by taking into consideration the viscosity of each fluid component and are angled such that the individual fluid components have maximum surface of interaction with each other prior to delivery. Also incorporated is the force at which the operator deploys the fluid such that there is not too much resistance with administration and uniform delivery of the multiple fluid components. The device 10 may be fabricated such that it allows for integration with a luer-lock device that is present on another system component, such as a catheter, needle, or syringe or it may lack this adaptation for direct injection onto a surface or target organ. [0079] With each implementation, final gel yield is quantified so that the dual lumen adaptor results in improved mixing and cross-linking of the two components upon elution and reduced excess residual primary ingredients. This can reduce the unreacted primary ingredients, thus reducing undesirable consequences in a biological system especially in large quantity. List of Elements: 10 syringe system 12 connector Attorney Docket No.10063-077WO1 syringe bodies holder plungers needles body parallel openings finger grips plunger cap first pathway second pathway first arm second arm trunk first inlet of first arm second inlet of second arm first free end of first arm second free end of second arm first downstream end second downstream end first bend second bend upstream end of trunk free end of trunk connector opening of trunk extender first outlet second outlet switchback chamber helix Attorney Docket No.10063-077WO1 linear section spiral section zigzag bubble first spherical chamber parallel pathways second spherical chamber barrel baffles

Claims

Attorney Docket No.10063-077WO1 CLAIMS What is claimed is: 1. A device for combining at least a first fluid and a second fluid, the device comprising: at least a first arm and a second arm, the first arm including a first free end defining a first inlet and a first downstream end, and the second arm including a second free end defining a second inlet and a second downstream end; and a trunk connected to the first and second downstream ends of the first and second arms and defining a first outlet adjacent a second outlet; wherein the first arm, the second arm and the trunk define a first fluid pathway extending from the first inlet to the first outlet and a second fluid pathway extending from the second inlet to the second outlet; wherein the first and second fluid pathways are defined using a plurality of angled surfaces sufficiently angled to produce at least partial non-laminar flow in the first fluid and second fluid as they exit the adjacent first and second outlets. 2. The device of claim 1, wherein the first and second arms are configured to receive a first and second syringe tip within the first and second inlets, respectively. 3. The device of claim 2, wherein the trunk further includes a free trunk end configured to engage a needle so as to establish fluid communication between the needle and the adjacent first and second outlets. 4. The device of any one of claims 1-3, wherein each of the first and second fluid pathways includes an arm portion and a trunk portion. 5. The device of any one of claims 1-4, wherein the arm portion defines an arm helical pathway. 6. The device of any one of claims 1-5, wherein the trunk portion defines a trunk helical pathway. 7. The device of any one of claims 1-6, wherein the arm and trunk helical pathways have opposite helical orientations. 8. The device of any one of claims 1-4, wherein the arm portion defines a zig-zag pathway. 9. The device of claim 8, wherein the trunk portion defines a chamber. 10. The device of any one of claims 8 or 9, wherein the trunk portion further defines a trunk helical pathway in communication with the chamber. 11. The device of any one of claims 1-4, wherein the arm portion includes an array of pathway portions. Attorney Docket No.10063-077WO1 12. The device of claim 11, wherein the pathway portions are in parallel with each other. 13. The device of claim 12, wherein each of the parallel portions are relatively straight channels. 14. The device of claim 13, wherein the arm portion includes an arm chamber in communication with a first end of the straight channels and with one of the first or second inlet. 15. The device of any one of claims 13 or 14, wherein the trunk portion defines a trunk chamber in communication with a second end of the straight channels. 16. The device of claim 15, wherein the trunk portion further defines a trunk helical pathway in communication with the trunk chamber and with one of the first or second outlet. 17. The device of any one of claims 1-4, wherein the arm pathway defines a bottleneck. 18. The device of claim 17, wherein the bottleneck includes a pair of frustoconical chambers connected at their narrow diameters. 19. The device of any one of claims 1-4, wherein the arm pathway is defined with a plurality of bumps. 20. The device of claim 19, wherein the plurality of bumps includes a plurality of hemispherical protrusions extending into an elongate chamber of the arm pathway. 21. The device of any one of claims 1-20, wherein the plurality of angled surfaces define a roughened lining of the first and second fluid pathways. 22. The device of any one of claims 1-20, wherein the plurality of angled surfaces define one of a helical, zig-zag, bottleneck or bumpy portions of the first and second fluid pathways. 23. The device of any one of claims 1-20, wherein the non-laminar flow is at least partially turbulent flow. 24. The device of any one of claims 1-20, wherein the non-laminar flow includes a Dean number of De > 64~75. 25. A method for combining at least a first fluid and a second fluid, the method comprising: providing a device comprising: at least a first arm and a second arm, the first arm including a first free end defining a first inlet and a first downstream end, and the second arm including a second free end defining a second inlet and a second downstream end; and a trunk connected to the first and second downstream ends of the first and second arms and defining a first outlet adjacent a second outlet; inserting a first syringe tip within the first inlet of the first arm; inserting a second syringe tip within the second inlet of the second arm; Attorney Docket No.10063-077WO1 causing the first fluid to flow along a first fluid pathway defined by the first arm, the second arm, and the trunk, the first fluid pathway extending from the first inlet to the first outlet; causing the second fluid to flow along a second fluid pathway defined by the first arm, the second arm, and the trunk, the second fluid pathway extending from the second inlet to the second outlet; and combining the first fluid and the second fluid at the first and second outlets, wherein the first and second fluid pathways are defined using a plurality of angled surfaces sufficiently angled to produce at least partial non-laminar flow in the first fluid and the second fluid as they exit the adjacent first and second outlets. 26. The method of claim 25, further comprising: engaging a needle with a free trunk end of the trunk to establish fluid communication between the needle and the adjacent first and second outlets. 27. The method of any one of claims 25-26, wherein the plurality of angled surfaces define one of a helical, zig-zag, bottleneck or bumpy portions of the first and second fluid pathways. 28. The method of any one of claims 25-27, wherein the non-laminar flow is at least partially turbulent flow. 29. The method of any one of claims 25-28, wherein the non-laminar flow includes a Dean number of De > 64~75.