Handheld gas spray system for mixing and dispensing multi-component compositions

Abstract

A handheld gas atomizing system for mixing and dispensing multi-component compositions.

Description

Technical Field

[0001]

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 068,666, filed Aug. 21, 2020, which is hereby incorporated by reference in its entirety.

Background Art

[0002]

[0002] Dispensing devices, such as multi-component dispensing devices, are used to mix and dispense multi-component fluids. The multi-component fluid can be a sealant that needs to remain separated prior to dispensing. For example, several fluid components can be mixed together to form a biological sealant or adhesive. Sealants and adhesives are manufactured by mixing the respective fluid components together, which react with each other after mixing to cure or solidify. Often, two fluid components react quickly and cure to form a sealant or adhesive, such as a tissue adhesive. Due to the rapid reactivity after component contact, the mixing of the fluid components is only performed when the multi-component fluid is ready to be dispensed and applied.

[0003]

[0003] Gas systems, or systems using a propellant gas, are intended for the atomization and application of fibrin sealants. In order to properly form the sealant or adhesive, each fluid component should be well mixed prior to applying the multi-component fluid. For example, partially mixed fluid components can result in a sealant that does not fully polymerize upon application. If the multi-component fluid cures prior to dispensing, the dispensing device can become clogged and flow is impeded, usually requiring replacement of a part of the dispensing device. Further, discharging the cured components or blockages can pose a risk to the patient, and an adhesive that coagulates prematurely may not properly seal the wound. Unfortunately, existing methods for dispensing multi-component biological sealants are often inadequate.

Summary of the Invention

[0004]

[0004] The present disclosure provides a gas spray device for mixing and dispensing a two-component composition (e.g., a sealant). The gas system can be intended for atomization and application of fibrin sealant using a propellant gas. Such a system can produce a very fine mist of fibrin sealant. However, such systems typically require a hospital to maintain the supply of a large compressed gas cylinder and often require the setting of both a tubing set and a pressure or flow rate adjustment system, which increases the overall setup time. Further, the equipment and setup time detract from ease of use. The present disclosure aims to house a pressurized gas source within the disposable device itself, eliminating the need for an external gas source, external regulator, and any tubing set connections, thereby improving ease of use without sacrificing performance.

[0005]

[0005] The handheld gas spray system disclosed herein is expected to provide convenience comparable to that of a non-gas-assisted spray device for fibrin sealant. Further, the handheld gas spray system is expected to provide spray performance (i.e., very fine atomization) comparable to that of more traditional gas-assisted application devices. In particular, the handheld gas spray system does not rely on the use of an external gas supply source and does not require maintenance of an external gas regulator. Further, the handheld gas spray system disclosed herein does not require connection of tubing between such a regulator and the application device. Collectively, these advantages are expected to provide users with a more convenient alternative to conventional gas-assisted applicators with a less cumbersome setup.

[0006]

[0006] Another advantage of the present disclosure is to provide a dispensing device (e.g., a spray applicator) that prevents cross-contamination of fluid components.

[0007]

[0007] A further advantage of the present disclosure is to provide a dispensing device (e.g., a spray applicator) that can spray a two-component sealant such as fibrin sealant.

[0008] Additional features and advantages of the disclosed handheld, gas-assisted, multi-component dispensing applicators, systems, and methods will be described in, and will be apparent from, the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those of ordinary skill in the art in view of the drawings and description. Also, any particular embodiment need not have all of the advantages listed herein. Further, note that the language used herein has been selected primarily for readability and for the purpose of explanation, and is not intended to limit the scope of the subject matter of the present invention.

Brief Description of the Drawings

[0009]

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Best Mode for Carrying Out the Invention

[0010]

[0054] The handheld gas spraying system for mixing and dispensing the multi-component compositions described herein provides an improved dispensing device (e.g., a spray applicator) that prevents clogging and avoids cross-contamination of the components to the intended mixing point, and is particularly useful for applying a high-viscosity multi-component tissue adhesive to a surgical site. For example, one way to prevent or avoid clogging can be to ensure that the gas is the first fluid entering the spray tip and the last fluid exiting the spray tip. Clogging and cross-contamination, such as with a polymerization adhesive or a sealant (e.g., a fibrin sealant), are problematic because they can cause injury to the patient if discharged and may not properly seal the wound or tissue. Further, clogging and cross-contamination can increase the costs associated with the dispensing applicator because the clogged device may be inoperable or may require a new dispensing tip. The multi-component dispensing applicator (e.g., a spray applicator) described herein improves multi-component fluid dispensing by preventing, resisting, alleviating, or reducing clogging and cross-contamination.

[0011]

[0055] The handheld gas spray system described herein is a sterile device and may be a disposable device. A small gas cartridge (e.g., a CO2 cartridge) is housed within the handle of the device. The gas cartridge can be filled to a specified fill weight to ensure that a two-phase system of vapor and liquid in equilibrium exists when operating the handheld gas spray system within the expected operating temperature range. By filling the cartridge in this way, the system can suitably reduce the possibility of excessive mass flow through the flow restrictor due to the presence of saturated liquid when operating the system at high temperatures. When the device trigger is actuated by the user, CO2 flows to the end of the device facing the patient. At the same time, a two-component sealant is carried from a syringe installed in the device to the spray tip. The pressurized gas and the two-component sealant mix inside the spray tip, resulting in an atomized spray. In one example, when the actuation of the device trigger stops, the flow of the two-component sealant may first stop, followed by the flow of the gas. Clogging can be prevented or avoided or reduced or mitigated by providing a flow of gas during the period before the flow of the sealant and after the flow of the two-component sealant has stopped.

[0012]

[0056] Pistol grip spray device Referring to the drawings, FIGS. 1A, 1B, 1C, 1D and 1E show exemplary embodiments of a handheld gas spray system 100A. The handheld gas spray system 100A is a direct grip type or pistol grip type spray device. The handheld gas spray system 100A, which may also be referred to herein as a spray delivery device or a spray applicator, includes a ratchet trigger 110a provided in front of a pistol grip handle 120a. When pulled by a user, the trigger 110a actuates a gas valve (described in more detail below) and pushes a syringe 130 to deliver a two-component sealant through a fluid feed subassembly 140 to the distal end of the handheld gas spray system 100a. Different from the direct grip design shown in FIGS. 2A and 2B (described in more detail below), it may be necessary to pull the trigger 110a of the system 100A several times to deliver all the contents of the syringe 130 to the surgical site. However, one advantage of the handheld gas spray system 100a shown in FIGS. 1A, 1B, 1C, 1D and 1E is that the ratchet trigger 110a can provide precise control by the user in that it gradually increases and distributes the syringe contents with a relatively low gripping force.

[0013]

[0057] FIG. 1B is an exploded view of the handheld gas spray system 100A. As described above, the gas spray system 100A includes a trigger 110a, a housing 115 that can form a handle 120a, a syringe 130, and a fluid feed subassembly 140. The housing 115 can include a right-hand side casing cover 102 and a left-hand side casing cover 104 (when viewing the system 100a from the spray tip). When the casing covers 102 and 104 are joined to form the housing 115, the lower part of the housing 115 forms a handle 120a adapted to accommodate a gas cartridge 106 that is further held in place by a cartridge actuator knob 108.

[0014]

[0058] In the illustrated example, the casing covers 102 and 104 can be joined by screws 103, but other connectors or connection types such as snap fits, press-fit connections, or other plastic welding techniques (e.g., ultrasonic welding, etc.) may be possible. The casing covers 102 and 104 can be adapted to provide points for the rigid assembly of the liquid feed subassembly 140 and the gas valve subassembly (described in more detail below) within the system 100A. The cartridge actuator knob 108 may be housed within the lower portion of the housing 115 (e.g., the lower portions of the covers 102 and 104) and enables the rotation / translation of the gas cartridge 106 (e.g., a CO2 cartridge) housed within the housing 115. Further, the cartridge actuator knob 108 and the housing 115 are also adapted to prevent the complete removal of the gas cartridge 106 from the system 100A.

[0015]

[0059] The gas spray system 100A can also include a cam lever 112, a gas lever 114, a ratchet arm 116, and a pawl 118, which operate in conjunction with a pawl torsion spring 122 and a trigger torsion spring 124. The various components described above may be mechanically coupled via dowel pins 126a - g, generally referred to hereinafter as dowel pins 126. The gas spray system 100a can also include a pressure relief valve 132 that communicates with a connector 134 and a tube 136 that is in fluid communication with a gas source or gas cartridge 106. In one example, the connector 134 is a male luer lock for a barb connector.

[0016]

[0060] Furthermore, the gas spray system 100A can include a slider rack 142 that is mechanically coupled to the trigger to push down the syringe plunger, and a spacer 144 for physically restraining the syringe with a smaller bore size in the vertical direction. The slider rack 142 is further shown in FIGS. 14A and 14B, which show a ratchet mechanism (e.g., notches or teeth) at the bottom of the slider rack 142 that is adapted to assist in pushing down the syringe plunger.

[0017]

[0061] Figure 1C shows additional details of the trigger assembly, which is disposed inside the device handle 120a and is provided as a series of interconnected components configured to connect the trigger 110a to both the gas valve assembly 150 (as shown in FIGS. 1D and 1E) and the syringe 130 (e.g., a sealant syringe). As described above, the trigger assembly includes the trigger 110a, the cam lever 112, the ratchet arm 116, and the pawl 118, which operate in conjunction with the pawl torsion spring 122 and the trigger torsion spring 124. As described above, the various components of the trigger assembly may be mechanically connected via dowel pins 126. A small displacement of the trigger 110a rotates the cam lever 112 to fully actuate the gas valve assembly 150 to the open state. Under further displacement, the ratchet arm 116 and the pawl 118, which can form a ratchet / pawl sub-assembly, move along a track and engage a rack (not shown). Further displacement also moves the rack along a track formed within the casing covers 102 and 104. For example, the track may be formed inside the casing covers 102 and 104. As the trigger 110a moves towards the pistol grip handle 120a, the gas remains on while the rack gradually compresses the syringe 130 and a portion of the sealant contained within the syringe 130 is delivered in a spray pattern. As described above, to reduce or prevent clogging, the gas may remain on for a period of time after compression of the syringe 130 has stopped. For example, the gas can remain on by continuing to hold the trigger 110a in the actuated position for a period sufficient to remove residual sealant from the spray tip.

[0018]

[0062] Direct Grip Spray Device Another exemplary embodiment of the handheld gas spray system 100B is shown in FIGS. 2A, 2B, and 2C. The handheld gas spray system 100B includes a handle 120b at the rear of the device, which slides when compressed by the user and pushes the loaded syringe 130 to deliver the two-component sealant through the fluid delivery subassembly 140. When the handle 120b slides when compressed, the user's grip simultaneously actuates the trigger 110b to open the gas valve, allowing gas to flow to the distal end of the device to atomize the sealant. The user may continuously hold the system 100B, which may also be referred to herein as a spray delivery device or a spray applicator, until the entire contents of the syringe 130 are discharged, or may pause the application and deliver it in several short bursts.

[0019]

[0063] Similar to the system 100A, the housing 115 of the system 100b can include a right-hand side casing cover 102 and a left-hand side casing cover 104. The casing covers 102 and 104 can be adapted to provide points for the rigid assemblies of the liquid delivery subassembly 140 and the gas valve subassembly (described in more detail below) within the system 100B. Similarly, the system 100B can include a cartridge activator knob 108. The cartridge activator knob 108 may be housed within the lower portion of the housing 115 (e.g., the lower portions of the covers 102 and 104) and allows for the rotation / translation of a gas cartridge 106 (e.g., a CO2 cartridge) housed within the housing 115. Further, the cartridge activator knob 108 and the housing 115 are also adapted to prevent the complete removal of the gas cartridge 106 from the system 100b. The handle 120b at the rear of the system 100b is adapted to slide along tracks formed inside the casing covers 102 and 104. The system 100b can also include a mechanical stop to prevent the removal of the handle 120b from the device.

[0020]

[0064] Figure 2B shows system 100b in which trigger 110b and handle 120b extend away from each other. Trigger 110b is rotatably fitted in a bore provided by casing covers 102 and 104 and is characterized by two coaxially opposed round bosses on the left and right sides of trigger 110b that allow rotation about a fixed axis. Specifically, as shown in Figure 2C, trigger 110b is provided to be gripped by a user's finger. Further, trigger 110b is characterized by a cam 152 that presses down on a valve stem of gas valve assembly 150 (not shown here, but see valve stem 204 in Figures 3A, 3B, and 3C), thereby opening the gas valve and activating the gas flow. Handle 120b at the rear of the device moves simultaneously and delivers a sealant to the spray tip so as to be mixed with the gas. The pivot position of trigger 110b can be adjusted to ensure that the force required to activate the gas valve does not exceed the force required to dispense the sealant from the loaded syringe, enabling the gas to be activated before and after the delivery of the sealant spray to help remove residual sealant from the device spray tip.

[0021]

[0065] Figures 2D, 2E, and 2F show alternative embodiments of exemplary handheld gas spray system 100B. In the illustrated examples of Figures 2D, 2E, and 2F, handle 120b is connected to housing 115 via joint 220. Joint 220 allows handle 120b to rotate about joint 220 (instead of sliding as described for the embodiments of Figures 2A and 2B).

[0022]

[0066] Gas valve assembly Figures 3A, 3B, and 3C show gas valve assembly 150. In the illustrated example, gas valve assembly 150 includes valve body 202 (a cross-sectional view of valve body 202 is shown in Figure 14C), valve stem 204, valve barb 206, and piercing needle 208. Flow restrictor 210 is disposed between valve body 202 and valve barb 206. Also, piercing needle 208 is connected to valve body 202 by ball 212 and spring 214.

[0023]

[0067] The gas valve assembly 150 is adapted to controllably enable gas to flow from a gas cartridge 106 (e.g., a small compressed gas cartridge) to the fluid delivery sub-assembly 140 of the device or system 100A, 100B. In one example, a piercing needle 208, which may also be referred to as a perforating needle, may be threaded into the valve body 202. Alternatively, other attachment means (e.g., mechanical press fit, etc.) may be used to secure the piercing needle 208 to the valve body 202. The piercing needle 208 is adapted to capture the spring 214 and the ball 212 when threaded into the valve body 202 or installed by other means. The ball 212 and the spring 214 together form a poppet 216. In one example, the lower portion of the valve body 202 is sized to threadedly engage a threaded gas cartridge 106 (e.g., a threaded CO2 cartridge). To prevent gas leakage during and after piercing of the gas cartridge 106 by the piercing needle 208, a cartridge seal O-ring (not shown) may be included. Although an O-ring is provided as an example of a seal structure, it should be understood that any suitable elastomeric seal of a size such that the needle 208 forms a proper seal prior to piercing the pressurized gas cartridge 106 at this location and ensures the securing of the leak prevention seal can be placed.

[0024]

[0068] Furthermore, the valve stem 204 is installed within the upper bore of the valve body 202. The valve stem 204 can include a ground where two stem O-rings (not shown) are installed, ensuring that the valve stem 204 is slidably connected to the valve body 202 without leakage. For example, the two stem O-rings provide a slidable and leak-free connection between the valve stem 204 and the valve body 202. The ground dimensions, O-ring sizes, and bore sizes may be conventional for this type of joint interface and should be apparent to those skilled in the art. It should be understood that less than two or more than three seal O-rings can be utilized to ensure a leak prevention interface between the valve stem and the valve body. The valve stem 204 is pushed down to move the valve from its normal closed state to its open state.

[0025]

[0069] The barb 206 can be installed in a side port of the valve body 202 via a captured O-ring seal or other O-ring type seal to send gas to a gas tube (see gas tube 302 in FIGS. 4A, 4B, and 4C). For example, the valve body 202 can be characterized by a countersink (or other appropriately designed recess) on a surface that aligns with the barb mounting hole of the valve body 202 to ensure a proper seal. Additionally, a flow restrictor 210 can be installed inside the barb 206 to control the downstream gas flow and ensure a safe and functionally useful flow rate. Importantly, the orifice of the flow restrictor 210 is sized such that, considering the vapor pressure of a compressed fluid cartridge, e.g., a CO2 cartridge, the choked flow always results in a mass flow rate that matches a value previously demonstrated to be safe for use at a specified distance from the patient's tissue.

[0026]

[0070] Figures 4A, 4B, and 4C show the gas tube connection from between the gas cartridge 106 and the gas valve assembly 150 to the fluid delivery subassembly 140. Figure 4A shows the gas tube connection of the system 100A, and Figures 4B and 4C show the gas tube connections of the alternative system 100B. As shown in Figures 4A and 4B, the gas tube 302 is connected to the valve barb 206 at the first end and communicates with another barb 304 at the second end of the gas tube 302. The valve 204 may be luer-connected to the relief valve 308. The relief valve 308 is provided to ensure that excess pressure is safely discharged to the environment. For example, when the downstream portion of the device or systems 100A, 100B is blocked when the gas flow is turned on, the relief valve 308 discharges the excess pressure to the environment.

[0027]

[0071] In some examples, the relief valve 308 can be designed or specified by characterizing the normal operating pressure of the systems 100A, 100B. For example, the minimum cracking pressure of such a relief valve 308 can be above the normal operating pressure of the portion of the fluid path where the relief valve 308 is installed. Additionally or alternatively, the maximum (cracking) pressure of the relief valve 308 can be characterized or selected based on established safety limits (e.g., clinically determined maximum safe operating pressure). For example, to determine the maximum pressure threshold, pressure in the range exceeding the normal operating pressure of the compressed gas cartridge 106 can be supplied to the gas valve assembly 150, and then the impact pressure occurring at a given distance from the device spray tip can be observed or measured. More generally, the relief valve 308 can be sized to ensure release of system pressure when the pressure in the upstream system results in excessive pressure being applied to tissue a predetermined distance from the spray tip. In one example, the cracking pressure can be specified in the range of differential pressure of about 70 - 110 kilopascals (kPa).

[0028]

[0072] Further, the relief valve 308 may be connected to the gas filter 310 via a luer slip connection. In some examples, the gas filter 310 may be intended to ensure that the gas is sterile and essentially free of particulate matter prior to delivery to the patient. The gas filter 310 can include a suitable membrane material selected based on the sealant and the desired composition of the gas. For example, when the compressed gas is carbon dioxide and the sealant composition is aqueous, the gas filter 310 can be implemented to include a hydrophobic membrane material (e.g., PTFE) to ensure that wetting does not prevent or limit or reduce the passage of the gas stream.

[0029]

[0073] Fluid delivery subassembly The fluid delivery subassembly 140 facilitates the transport of two surgical sealant components from the syringe 130 and the gas flow from the device handle 120 to the distal tip. These three fluid flows are not in fluid communication until they reach the subassembly of the spray tip 414. This is important for the functionality of systems 100A, 100B because polymerization of the two-component sealant begins rapidly after the two components of the two-component sealant meet. It is desirable to deliver a spray of the sealant that is well mixed but not polymerized to the target tissue site.

[0030]

[0074] The fluid delivery subassembly 140 can have various configurations, three of which are shown in FIGS. 5A, 5B, and 5C. FIG. 5A shows a first configuration of a fluid delivery subassembly 140a adapted for laparotomy. In one example, the fluid delivery subassembly 140a can have a working length of about 6 cm and can generally include a rigid structure. As shown in FIG. 5A, the fluid delivery subassembly 140a includes sealant tubes 410a, b that are led down the length of the outer cannula 420 to a threaded plug 412. At the distal end 422 of the outer cannula 420, the outer cannula 420 is coupled to the threaded plug 412 and can provide an airtight or leak-proof seal. The threaded plug 412 may be coupled (e.g., threaded) to the subassembly of the spray tip 414. At the proximal end 424 of the outer cannula 420, the outer cannula 420 is coupled to the Y-connector distal component 430 and can provide an airtight or leak-proof seal between the outer cannula 420 and the Y-connector distal component 430 (additional views of the Y-connector distal component 430 are shown in FIGS. 14E and 14F).

[0031]

[0075] The Y connector proximal component 432 may be ultrasonically welded to the Y connector distal component 430 (a cross-sectional view of the Y connector proximal component 432 is shown in FIG. 14D). In one example, sealant tubes 410a and 410b, generally referred to hereinafter as sealant tube 410, are coupled into two bosses 434a, b disposed in the Y connector proximal component 432. The other end of the sealant tube 410 is coupled to a corresponding receiving structure (described in more detail hereinafter) within the threaded plug 412. A gas connection port 440 may be provided on the underside of the Y connector distal component 430 to enable connection to the gas filter 310 described in FIGS. 4A and 4B. The gas filter 310 can be connected to the gas connection port 440 via a luer lock connection. The fluid delivery subassembly 140a may also include check valves 450a and 450b, which can be installed in corresponding female luer lock connections 436a, b of the Y connector proximal component 432 to prevent backflow into the syringe 130 under pressure. Note that the female luer connections 436a, b of the Y connector proximal component 432 can be arranged with a predetermined axial offset corresponding to the outlet spacing of the syringe 130 being used.

[0032]

[0076] FIG. 5B shows a second configuration of the fluid delivery subassembly 140b adapted for laparoscopic surgery. For example, laparoscopic surgical procedures may require a longer cannula 420, as shown in FIGS. 5B and 5C. On the other hand, a shorter cannula 420 can be used for procedures closer to the surface of the skin, as shown in FIG. 5A. In one example, the fluid delivery subassembly 140b can have a working length of about 40 cm and can generally include a rigid structure. As shown in FIG. 5B, the fluid delivery subassembly 140b includes each of the components described above in subassembly 140a. However, the sealant tubes 410a, b and the outer cannula 420 are longer so that the fluid delivery subassembly 140b has a longer working length.

[0033]

[0077] Figure 5C shows a third configuration of the fluid delivery sub-assembly 140c adapted for laparoscopic surgery. In one example, the fluid delivery sub-assembly 140c can have a working length of about 40 cm and generally can include a rigid structure having a flexible portion that allows the device to be bent at its distal end to enable positioning during laparoscopic surgery. As shown in Figure 5C, the fluid delivery sub-assembly 140c includes each of the components described above in sub-assemblies 140a and 140b. However, the sealant tubes 410a, b and the outer cannula 420 are longer, similar to the fluid delivery sub-assembly 140b, such that the fluid delivery sub-assembly 140c has a longer working length. Further, the fluid delivery sub-assembly 140c includes an additional flexible tube 460 and a flexible collar 470 disposed between the outer cannula 420 and the screw plug 412. For example, as in Figure 5A, instead of the distal end 422 of the outer cannula 420 being coupled to the screw plug, the distal end 422 of the outer cannula 420 may be connected or coupled to the flexible tube 460, and the flexible tube 460 may be connected or coupled to the collar 470. For example, the proximal end 464 of the flexible tube 460 may be connected to the distal end 422 of the outer cannula 420, and the distal end 462 of the flexible tube 460 may be connected to the proximal end 474 of the collar 470. Further, the distal end 472 of the collar 470 may be connected to the screw plug 412. The collar 470 is coupled to the threaded plug 412 and can provide a gas-tight or leak-proof seal. Similar to sub-assemblies 140a and 140b, the threaded plug 412 may be coupled to the sub-assembly of the spray tip 414.

[0034]

[0078] The entire malleable portion (e.g., malleable tube 460 and collar 470) may be about 4.5 cm in length, and thus the outer cannula 420 is shorter than the sealant tubes 410a, b as compared to the fluid delivery subassembly 140b. Referring back to FIG. 5B, the sealant tubes 410a, b, hereinafter sealant tube 410, may be approximately the same length as the combined length of the Y-connector distal component 430 and the outer cannula 420. However, the sealant tube 410 of FIG. 5C may be approximately the same length as the combined length of the Y-connector distal component 430, the outer cannula 420, the malleable tube 460, and the collar 470.

[0035]

[0079] In each of FIGS. 5A, 5B, and 5C, the first and second sealant tubes 410 provide fluid communication between a fluid container such as syringe 130 and a spray tip subassembly 414 ultimately. The fluid moves while remaining separated, exits the syringe 130, passes through the check valve 450, then enters the Y-connector proximal component 432 and passes through the sealant tube 410. The fluid remains completely separated as it moves through the system to the threaded plug 412. The fluid then moves to a detachable spray tip subassembly 414 that can be removably coupled to the threaded plug 412. Systems 100A, 100B are shown with an interface for receiving two fluid sources, but it should be understood that systems 100A, 100B can be configured to receive three or more fluid sources (e.g., sealants). For example, systems 100A, 100B may be configured to mix and dispense adhesives or sealants such as biologic sealants composed of fluids of three or more components. It should also be understood that systems 100A, 100B can include additional interfaces (e.g., syringe interfaces) for additional fluid containers. For example, systems 100A, 100B shown herein show a dual syringe 120 having two separate sealant tubes 410, but three or more fluid containers and / or sealant tubes 410 may be used. For example, some multi-component fluids can include three or more fluids that are mixed to form a sealant or adhesive. Further, it should be understood that systems 100A, 100B can be configured to receive a single fluid source (e.g., a one-component sealant). For example, systems 100A, 100B may be configured to dispense a one-component adhesive. It should be understood that systems 100A, 100B can include a single interface for a single fluid container. For example, systems 100A, 100B shown herein show a dual syringe 120 having two separate sealant tubes 410, but a single fluid container and / or sealant tube 410 may be used.

[0036]

[0080] Outer cannula, malleable tube, collar, and sealant tube Figures 6A and 6B show the end and side shapes of the outer cannula 420. The outer cannula 420 can have an inner diameter (D I ) 502, an outer diameter (D O ) 504, and a length (L OC ) 506. The inner diameter (D I ) 502 can be about 5 mm, and the outer diameter (D O ) 504 can be about 5.30 mm. The length (L OC ) 506 can vary depending on the configuration of the fluid delivery subassembly 140. For example, the length (L OC ) 506 can be about 63 mm, 401 mm, and 342 mm for subassemblies 140a, 140b, and 140c, respectively. In one example, the outer cannula 420 can be made of a rigid material such as 304 stainless steel.

[0037]

[0081] Figures 7A and 7B show the end and cross-sectional shapes of the flexible tube 460. The flexible tube 460 can have an inner diameter (D I ) 512, an outer diameter (D O ) 514, a length (L MT ) 516, and a wall thickness (T W ) 518. The inner diameter (D I ) 512 can be about 4 mm, and the outer diameter (D O ) 514 can be about 5 mm. The length (L MT ) 516 can be about 65 mm. The wall thickness (T W ) 518 of the flexible tube 460 can be about 0.5 mm. Further, the flexible tube 460 can include an aperture or channel 530 that extends along the length of the flexible tube 460 and is sized and shaped to receive the wire 532. The channel 530 can have a diameter of about 0.75 mm. The spacing (S C ) 534 between the longitudinal axis 542 of the channel 530 and the longitudinal axis 544 of the tube 460 can be about 1.7 mm.

[0038]

[0082] Wire 532 can be a reinforcing wire to add additional strength and support to the malleable tube 460. Further, wire 532 may be adapted to provide malleability to tube 460 while maintaining the shape of the malleable tube 460. Wire 532 may be a malleable wire and may be made of stainless steel. The malleable tube 460 may be made of a malleable plastic or rubber material. In one example, the malleable tube 460 is made of a thermoplastic polyurethane elastomer.

[0039]

[0083] Figures 8A and 8B show the end and side shapes of the collar 470. The collar 470 can have an inner diameter (D I ) 552, an outer diameter (D O ) 554, and a length (L MC ) 556. The inner diameter (D I ) 552 may be about 5 mm, and the outer diameter (D O ) 554 may be about 5.30 mm. The length (L MC ) 556 may be about 15 mm. In one example, the collar 470 may be made of a rigid material such as 304 stainless steel. In another example, the collar 470 may be made of a rigid or semi-rigid plastic material. Alternatively, the collar 470 may be made of a plastic or elastomeric material similar to the malleable tube 460. Alternatively, the collar 470 may be integrated as part of the threaded plug 412.

[0040]

[0084] Figures 9A and 9B show the end and side shapes of the sealant tube 410. The sealant tube 410 can have an inner diameter (D I ) 562, an outer diameter (D O ) 564, and a length (L ST ) 566. The inner diameter (D I ) 562 may be about 1 mm, and the outer diameter (D O ) 564 may be about 1.78 mm. The length (L ST ) 566 can vary depending on the configuration of the fluid feed subassembly 140. For example, the length (L ST)566 may be about 93 mm, 432 mm, and 432 mm for sub-assemblies 140a, 140b, and 140c, respectively. In one example, the sealant tube 410 may be made of an elastomeric polymer such as ethylene vinyl acetate (“EVA”).

[0041]

[0085] Threaded plug Figures 13A - 13G show exemplary embodiments of the threaded plug 412. As described above, the fluid delivery sub-assembly 140a includes sealant tubes 410a, b that are led down the length of the outer cannula 420 to the threaded plug 412. In one example, the outer cannula 420 (or the malleable collar 470) can be coupled to the threaded plug 412 to provide an airtight or leak - proof seal. The threaded plug 412 may be coupled to the spray tip sub-assembly 414. For example, the threaded plug 412 can include a male thread 902 adapted to engage a corresponding thread (e.g., the thread portion 636 of the tip body 610).

[0042]

[0086] The threaded plug 412 facilitates a removable connection to the outer cannula 420 or the malleable collar 470 of the spray tip sub-assembly 414, depending on the configuration of the fluid delivery sub-assembly 140. By design, the threaded plug 412 features a taper (e.g., the tapered surface 904) for sealing against the inner surface of the spray tip body 610 to prevent leakage of the pressurized fluid mixture. Further, the threaded plug 412 can include two sealant passages 906a, b (hereinafter generally referred to as sealant passage 906) adapted to receive the corresponding sealant tubes 410a, b at the proximal end 924 of the threaded plug 412. For example, as shown in Figure 13F, the sealant passages 906a, b can include sealant tube receiving portions 907a, b sized and shaped such that the corresponding sealant tubes 410 can be press - fit into the threaded plug 412 and / or coupled within the receiving portion 907 of the threaded plug 412 to form a fluid - tight seal.

[0043]

[0087] The threaded plug 412 also includes one or more gas passages 908a, b (hereinafter generally referred to as gas passage 908) adapted to permit passage of gas from the outer cannula 420 to the spray tip sub-assembly 414. The gas passages 908a, b and the sealant passages 906a, b extend from the proximal end 924 to the distal end 922 of the threaded plug. At the distal end 922 of the plug 412, the gas passage 908 can be configured to open into the spray tip sub-assembly 414 ahead of the sealant passage 906, thereby allowing the gas to properly spread through the spray tip before the sealant enters the spray tip, which can assist in properly mixing and atomizing the two-component sealant. For example, as shown in FIG. 13A, the plug 412 can include two recesses 930a, b that permit the gas to communicate with the spray tip sub-assembly 414 before the sealant communicates with and enters the spray tip. In one example, each of the sealant passage 906 and the gas passage 908 can have a diameter of about 0.8 mm.

[0044]

[0088] The threaded plug can also include a flange 940 configured to function as a stopper and abut against the outer cannula 420 when the threaded plug 412 is connected to the cannula 420 (or a similarly malleable collar depending on the configuration).

[0045]

[0089] When the sealant moves down the sealant tubes 410a, b and gas flows through the outer cannula 420, the fluids remain completely separated as they move through the system and remain separated when the sealant moves through the sealant passage 906 and when the gas moves through the gas passage 908 of the threaded plug 412. Specifically, the sealant tubes 410 and the plug 412 ensure that the fluid remains isolated as it moves between the syringe 130 and the spray tip subassembly 414. The fluid (e.g., sealant component and gas) then moves to a detachable spray tip subassembly 414 that can be connected to the threaded plug 412, where the fluids begin to mix.

[0046]

[0090] Spray tip subassembly Figures 10A and 10B show the spray tip subassembly 414. At the distal end of the device, two sealant components and the gas flow are mixed within the spray tip subassembly 414, which includes a spray tip body 610 and an insert 670. The threaded plug 412 facilitates a removable connection to the outer cannula 420 or the malleable collar 470 of the spray tip subassembly 414, depending on the configuration of the fluid delivery subassembly 140. By design, the threaded plug 412 features a taper for sealing against the inner surface of the spray tip body 610 to prevent leakage of the pressurized fluid mixture. The fluid mixture is mixed by the tip insert 670. In one example, the tip insert 670 is non-removably assembled into the spray tip body 610 by press fitting. A geometry of a vortex chamber or a spin chamber (described in more detail below) is provided as part of the tip insert 670 to impart rotation to the fluid mixture as it exits the spray tip subassembly 414.

[0047]

[0091] The distal end body 610 can be a hollow body that forms a cavity 612. The size and shape of the cavity 612, along with the size and shape of the insert 670, can be selected to optimize the mixing volume and mixing characteristics of the spray tip subassembly 414. The cavity 640 can have a cavity diameter (D C ) 614 and a cavity depth (C D ) 616 (see FIGS. 11A and 11B). Further, the tip insert 670 has a volume (V I ), the cavity 612 has a volume (V C ), and the difference between the cavity volume (V C ) and the insert volume (V I ) forms the mixing volume (V M ) of the spray tip subassembly 414. By adjusting the size, shape, and geometry of the components of the spray tip subassembly 414, the size of the mixing volume (V M ) and the geometry of the created mixing chamber are adjusted. As further shown in FIG. 10B, the size and shape of the cavity 612, along with the size and shape of the insert 670, can be selected to adjust the mixing characteristics of the spray tip subassembly 414. For example, the geometric shapes of the distal end body 610 and the insert 670 can be selected to provide an optimal fluid path distance (FP 距離 ) 618 before the fluid impinges on the first contact surface 620 of the insert 670 and initiates turbulent flow and mixing. By adjusting the geometric shapes of the distal end body 610 and the insert 670 along with the fluid path distance (FP 距離 ) 618, the turbulent flow generated in the spray tip subassembly 414 can be increased or decreased.

[0048]

[0092] Distal end body Figures 11A, 11B, and 11C show various views of the distal end body 610. The distal end body 610 may be generally cylindrical and hollow, thereby forming a cavity 612 having a wall thickness of about 0.4 mm. As shown in Figure 11B, the cavity 612 may be generally cylindrical. In some cases, the cavity 612 may be tapered such that an initial cavity diameter (D C ) 614a near the proximal end 624 of the distal end body 610 is larger than a final cavity diameter (D C ) 614b near the distal end 622 of the distal end body 610. The cavity diameter (D C ) 614a may start at about 4 mm and gradually decrease until it reaches a cavity diameter (D C ) 614b of about 3.7 mm as the cavity extends towards the distal end 622 of the distal end body 610. In the illustrated example, the last portion 626 of the cavity 612 may have a constant cavity diameter (D C ) 614b. The last portion 626 may have a depth (C DLS ) 628 of about 4 mm.

[0049]

[0093] As described above, systems 100A, 100B can include one threaded spray tip subassembly 414 and one or more replacement spray tip subassemblies 414 that can be exchanged for the original threaded spray tip subassembly 414 if the original spray tip becomes clogged during use. To assist in removing and reattaching each spray tip subassembly 414, the distal end body 610 can include a gripping portion 630. The gripping portion 630 can include ridges, protrusions, grooves, textured surfaces, or other surface finishes or surface geometries that aid in gripping the distal end body 610. In the example shown in Figure 11A, the gripping portion 630 can have a gripping length (L G ) 632 that may be about 14 mm. The distal end 622 of the distal end body 610 also has a notch width (W N)It can include a small notch 656 that protrudes only 658. The notch 656 may be present in the last 2 mm of the tip body 610 and may have a notch width (W N )658. The notch 656 can further assist the user in removing the spray tip sub-assembly 414.

[0050]

[0094] As described above, the tip body 610 may be substantially cylindrical with an outer diameter (D O )634. In one example, the outer diameter (D O )634 is about 5.3 mm. Further, the threaded portion 636 can have a height (H T )638, and the height (H T )638 of the threaded portion 636 is about 4 mm.

[0051]

[0095] As shown in FIGS. 11B and 11C, the tip body 610 also has an orifice or outlet 640 related to an initial outlet diameter (D IO )642 for the initial outlet portion 641, a transition outlet diameter (D TO )644 for the transition outlet portion 643, and a final outlet diameter (D FO )646 for the final outlet portion 645. Similarly, each of the initial outlet portion 641, the transition outlet portion 643, and the final outlet portion 645 can have respective heights (H IP )650, (H TP )652, and (H FP )654. The height (H IP )650 of the initial outlet portion 641 may be about 0.23 mm. The height (H TP )652 of the transition outlet portion 643 may be about 0.6 mm. Further, the height (H FP )654 of the final outlet portion 645 may be about 0.2 mm. The transition outlet diameter (D TO) can deterministically govern, together with the geometric shape of the vortex chamber described below, the width and uniformity of the resulting spray pattern. The geometric shape of the outlet portion (e.g., height and diameter) can be configured to create a preferred spray shape or based on the materials used in systems 100A, 100B.

[0052]

[0096] Tip insert The tip insert 670 acts as a static mixing element within the spray tip subassembly 414. The tip insert 670 is shown in more detail in FIGS. 12A and 12B, which show that the insert 670 has a generally cylindrical body or barrel 700 with a plurality of mixing protrusions 702 (e.g., mixing protrusions 702a - 702d are visible in FIG. 12A). The mixing protrusions in the illustrated example have a triangular shape with a baseline length (L 基線 ) 704 and an interior angle (β) 706. The baseline length (L 基線 ) 704 may be about 2.9 mm in length, and the interior angle (β) 706 may be about 60 degrees. The mixing protrusions 702 may be evenly spaced around the tip insert 670. In the illustrated example, the mixing protrusions 702 are spaced apart by a spacing (S ME ) 703 (e.g., spacings 703a, 703b, and 703c). The spacing (S ME ) 703 may be about 0.5 mm.

[0053]

[0097] In one example, the plurality of mixing protrusions 702 may be arranged around the cylindrical body 700. In the illustrated example, the tip insert 670 includes three pairs of alternatingly intersecting protrusions 720 such that a first set of protrusions (protrusions 702a and the other protrusion 702a on the opposite side, not visible in FIG. 12A) form a "T" near the proximal end 734, and the next set of protrusions 702 (e.g., protrusions 702b and 702c) can be arranged at different circumferential positions around the tip insert 670. In one example, the second set of mixing protrusions 702 may be arranged 90 degrees from the first set. In one example, the mixing protrusions 720 may be arranged at different circumferential positions (e.g., 30 degrees, 45 degrees, etc.).

[0054]

[0098] The cylindrical body 700 has a diameter (D B ) 710 and a height (H B ) 712. The body mixing section diameter (D BM ) 714, which is the diameter of the tip insert 670 including the mixing protrusion 702, may be about 3.6 mm.

[0055]

[0099] In one example, one or more of the mixing protrusions 702 can include a retention mechanism 720 that can be a protrusion, barb, or notch that creates a tight friction fit between the tip insert 670 and the tip body 610. In one example, the retention mechanism 720 ensures that the insert 670 does not come off the tip body 610 over the storage life of the device or during use, and also ensures that the tip insert 670 can withstand the pressure built up by the fluid in the vortex chamber (described in more detail below). The retention mechanism 720 allows the insert 670 to have an overall width (R C ) 795 of about 3.8 mm, which is about 0.1 mm larger than the diameter (D etention ) 614b (refer back to FIG. 11B). The friction fit of the retention mechanism 720 is further shown in FIG. 10B, which shows that a portion of the tip insert 670 is oversized with respect to the corresponding cavity 612 of the tip body 610.

[0056]

[0100] In the illustrated example, the retention mechanism 720 is a rectangular structure having a retention height (H R ) 722 and a retention width (W R ) 724. In one embodiment, the retention height (H R ) 722 may be about 1.0 mm and the retention width (W R ) 724 may be about 1.2 mm. In the illustrated example, the retention mechanism 720 is spaced from the proximal end 734 of the tip insert 670 by an interval (S RF which can be about 7.8 mm.) It is spaced apart by 750. Further, the holding mechanism 720 can include an inclined profile that helps with alignment during installation via a friction fit with the tip insert 670 when the tip insert 670 is press-fitted into the tip body 610. As shown in FIGS. 12A and 12B, the holding mechanism 720 can have an inclined portion 754 and a flat portion 756, and the flat portion has an engagement surface having a height (H ES ) having 752.

[0057]

[0101] The tip insert 670 can have a proximal end 734 and a distal end 732 closest to the orifice or outlet 640 of the tip body 610. The mixing tip insert 670 can have a blunt or flat fluid contact surface at the proximal end 734, which can be the first surface of the tip insert 670 that the multi-component sealant encounters. Further, the tip insert 670 can include a vortex chamber portion 740 near the distal end 732 of the tip insert 670. The vortex chamber portion can have a diameter (D SC ) of about 3.7 mm and a height (H SC ) of about 1.5 mm. The geometry of the vortex chamber (e.g., height and diameter) can be configured based on creating a preferred spray pattern or the materials used in systems 100A, 100B.

[0058]

[0102] As described above, the mixing tip insert 670 can have a blunt or flat fluid contact surface at the proximal end 734. For example, the contact surface can be the first surface where both fluids come into contact and flow around it, thereby initially generating turbulent flow in the spray tip subassembly 414 and starting the mixing of the fluids. Other mixing shapes may be used. For example, it should be understood that the tip insert 670 can include shapes such as spiral, triangular, or rectangular shapes. Further, other lattice or matrix-type mixing structures may be used. Further, for example, when used with a sealant that requires restrictions on mixing before application, the mixing structure may be completely omitted.

[0059]

[0103] When gas and two-component sealant are pushed through an applicator or device (e.g., systems 100A, 100B), the various components of the sealant and gas enter the spray tip subassembly 414 and mixing begins within cavity 612 by interaction with tip insert 670. As more fluid (e.g., gas and sealant) enters the spray tip subassembly 414, the mixed fluid is pushed out of cavity 612 through outlet orifice 630 of tip body 610. Before exiting through outlet orifice 630, the fluid moves through a vortex chamber 800 shown in more detail in FIG. 12C.

[0060]

[0104] In one example, the components of spray tip 414, spray tip insert 470, and threaded plug 412 may be constructed of a radiation shielding resin to enable visualization under x-ray imaging (e.g., 20% by weight loading of barium sulfate).

[0061]

[0105] Vortex chamber Referring back to FIG. 12A (which can also be seen in FIG. 10A), tip insert 670 includes channels 780 (e.g., channels 780a and 780b visible in FIG. 12A) formed within vortex chamber portion 740. Channels 780 direct the mixed fluid, as shown in FIG. 12C, towards the distal end 732 of the tip insert and into corresponding horizontal channels 802 of vortex chamber 800. Horizontal channels 802 function as feeder channels that direct the mixed fluid tangentially into vortex chamber 800, which may also be referred to as a spin chamber.

[0062]

[0106] Channel 802 or passageway may narrow as channel 802 approaches vortex chamber 800. For example, each channel 802 may narrow at a constant dimension or at an angle (α) 806 of about 15 degrees. When channel 802 reaches the vortex chamber, channel 802 has a channel width (W) of about 0.4 mm C)808 and can have a channel depth of about 0.5 mm. The channel 802 can have a trapezoidal cross-section whose cross-sectional area gradually decreases as the channel 802 approaches the vortex chamber 800 of the tip body 610. The reduced cross-sectional area increases the velocity of the fluid entering the vortex chamber 800. When the pressurized fluid mixture enters the vortex chamber 800, the increased velocity and angle / tangential direction of approach caused by the channel 802 preferably forms a vortex and improves mixing and nozzle performance at the spray orifice 630.

[0063]

[0107] The number of channels 780 and 802 can depend on the preferred spray pattern or spray material used for the spray tip subassembly 414. For example, the number of channels 780 and 802 can be determined based on the viscosity of the fluid entering the vortex chamber 800 and the preferred volume flow rate. In the illustrated example shown in FIG. 12C, the vortex chamber 800 is supplied by four channels 802. For example, when used with a high-viscosity fluid such as fibrinogen from a fibrin sealant product, four feeder channels 802 can be more effective compared to other channel configurations.

[0064]

[0108] The vortex chamber 800 and the corresponding channel 802 may include rounded corners to assist with formability. For example, the edge 812 where the channel 802 intersects the vortex chamber 800 may be rounded with a radius of about 0.05 mm.

[0065]

[0109] Vortex chamber (D SC )820 may have a diameter of about 1.6 mm. Further, the diameter (D SC ) of the vortex chamber 820, the geometric shapes of the channels 780 and 802, and other features of the spray tip subassembly 414 can control the velocity of the fluid exiting the spray tip. As described above, the insert 670 has a retaining mechanism 720 such as a crush rib to ensure that the insert 670 does not come off the tip body 610 during storage or use.

[0066]

[0110] Mixing As described above, syringe 130 may be a multi-chamber syringe that includes a plurality of chambers or containers (e.g., first and second fluid containers such as syringes). Syringe 130 may contain a reactive fluid. For example, syringe 130 may include a first fluid and a second fluid. The fluids can react to produce a sealant or adhesive such as a biological tissue sealant. Due to the reactivity of the fluids, the fluids are separately contained in different chambers or containers within syringe 130, and the separation of the fluids is maintained through various system components up to a desired mixing point within the removable spray tip subassembly 414. Particularly, multi-component fluids with high reactivity tend to form coagulates immediately after the fluid paths converge and mix within the applicator. For example, in the case of a reactive solution such as a biological tissue sealant, the residence time until coagulate formation is short and can often be only a few seconds. Therefore, it is effective to maintain the separation of the fluids up to the desired mixing point to prevent early coagulation. Additionally, it is effective to provide a removable or detachable spray tip subassembly 414 that can be replaced if clogging occurs during or between uses.

[0067]

[0111] The geometric shape of insert 670, more specifically the diameter of insert 670, as well as the geometric shape of mixing protrusion 702, can control the cross-sectional area through which the fluid flow passes as the fluid flow moves through spray tip subassembly 414. The geometric shape can also control the velocity of the fluid and the injection pressure required to pass through spray tip subassembly 414. Mixing protrusion 702 can generate turbulence in the fluid path, mix different fluid flows, and enable the generation of a combined fluid flow before entering vortex chamber 800. In one example, the number of mixing protrusions 702, as well as other geometric considerations of tip body 610 and tip insert 670, can be determined based on the physical properties of the fluid (e.g., viscosity, density, etc.) and the level of mixing required before entering vortex chamber 800.

[0068]

[0112] The systems 100A, 100B disclosed herein are preferably configured to produce a well - mixed reactive sealant formulation that exits the spray tip sub - assembly 414 in a uniform spray pattern to quickly cover a target surgical site.

[0069]

[0113] Component - Connection It should be understood that many of the components described herein may be component parts that can be assembled together. For example, each component of the systems 100A, 100B may be removably attached to the other such that each component can be disassembled and reassembled. Further, the components may be joined to each other via chemical fasteners. Examples of chemical fasteners include, for example, adhesives, chemical bonds, welded joints, or molding processes suitable for fixing the components. For example, each of the components shown in FIGS. 5A, 5B, and 5C may be attached, linked, or connected to each other via a screw fit, snap fit, adhesive, or any other suitable fastener such that each component is connected to maintain fluid communication from the syringe 130 to the detachable spray tip sub - assembly 414. In other examples, the component parts may alternatively be formed as a single part.

[0070]

[0114] Assembly In the case of a rigid device configuration, more specifically when assembling the fluid delivery sub - assembly 140, the sealant tube 410 is cut to length and joined to the threaded plug 412. For example, the sealant tube 410 can be joined to the threaded plug 412 by applying a small amount of adhesive, such as cyanoacrylate, to the outer surface of the sealant tube 410 and inserting the sealant tube 410 into the tube receiving portion 907 (which may also be referred to as a tube coupling pocket) of the threaded plug 412.

[0071]

[0115] After preparing the adhesive, a small amount of adhesive can be applied to the outer surface of the threaded plug 412 before inserting the proximal end of the threaded plug 412 into the distal end of the outer cannula 420 until the flange of the threaded plug 412 is flush with the end of the outer cannula 420. Again, after preparing the adhesive, a small amount of adhesive can be applied to the outer surface of the proximal end of the outer cannula 420 (opposite the threaded plug), and the Y-connector distal component 430 can be inserted into the cannula 420.

[0072]

[0116] When inserting the Y-connector distal component 430, the component should be aligned such that the seal passage of the threaded plug 412 is in the same plane as the horizontal surface of the Y-connector distal component 430. After preparing the adhesive, the adhesive can be applied to the outer surface of the free seal tube end, and then the free seal tube end can be inserted into the boss 434 of the Y-connector proximal component 432. Then, the check valve 450 can be attached to the female Luer of the Y-connector proximal component 432. Next, the gas filter 310 can be attached to the female Luer at the bottom of the Y-connector distal component 430.

[0073]

[0117] A similar assembly process is performed for the malleable device configuration. However, instead of inserting the threaded plug 412 into the outer cannula 420, the threaded plug 412 is inserted into the malleable collar 470 instead. Then, a small amount of adhesive is applied to the outer surface of one end of the malleable tube 460, and then the malleable tube 460 is inserted into the malleable collar 470. When assembling, the stainless steel wire can be downward.

[0074]

[0118] Next, apply the adhesive to the outer surface of the free end of the malleable tube 460, and then insert the free end of the malleable tube 460 into the outer cannula 420. The insertion depth can be governed by the exposed length of the malleable tube 460. When correctly positioned, the gap between the malleable collar 470 and the outer cannula 420 can be, for example, 45 mm. Next, apply the adhesive to the outer surface of the proximal end of the outer cannula 420, and then insert the proximal end of the outer cannula 420 into the Y-connector distal component 430. The remaining assembly steps follow the same pattern as described above for the assembly of the rigid device.

[0075]

[0119] In the case of the spray tip assembly, the assembly is initiated by orienting the geometry of the vortex chamber 800 downward and firmly inserting the spray tip insert 470 into the spray tip body 410. The distal face of the insert 470 should be flush with the tip body 410. Next, thread the spray tip 414 onto the threaded plug 412 until the proximal end is flush with the flange of the plug 412.

[0076]

[0120] When assembling the applicator device or system 100A, 100B, the right-hand casing may be placed on a flat surface. Next, use a small amount of adhesive to install the gas cartridge onto the gas activator knob. The gas activator knob is threaded clockwise to partially screw the gas cartridge into the valve assembly. In one example, the gas activator knob is threaded three turns to ensure that the cartridge engages fully with the valve without being punctured.

[0077]

[0121] Next, connect the gas tube to the valve barb outlet and install the luer barb on the free end of the gas tube. Then connect the luer barb to the relief valve by a luer lock connection. Insert the male luer slip connector of the relief valve into the gas filter on the fluid delivery subassembly. The gas activator knob is positioned within the corresponding groove of the casing, and the gas tube and relief valve are routed to create the corresponding features of the casing.

[0078]

[0122] Next, install the fluid feed subassembly in the corresponding groove of the casing. Assemble the connection, i.e., then one or more of the pin, trigger, and / or torsion spring can be installed (depending on the embodiment of the system to be assembled). Then, align the opposite side of the casing with the other casing and attach it with screws.

[0079]

[0123] Aspects of the subject matter described herein may be useful alone or in combination with one or more other aspects described herein.

[0080]

[0124] To the extent that any of these aspects are mutually exclusive, it should be understood that such mutual exclusivity never limits the combination of such an aspect with any other aspect, whether or not such an aspect is explicitly described. Any of these aspects may be claimed as a system, method, apparatus, device, medium, etc., but are not limited thereto.

[0081]

[0125] Many features and advantages of the present disclosure are apparent from the described description, and thus the appended claims are intended to cover all such features and advantages of the present disclosure. Further, since many modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to exactly the same configuration and operation as illustrated and described. Accordingly, the described embodiments should be construed as illustrative rather than limiting, and the present disclosure should not be limited to the details given herein, but should be defined by the full scope of the following claims and their equivalents, whether presently or in the future foreseeable or unforeseeable.

Claims

1. An applicator for mixing and dispensing a multi-component fluid, comprising: A fluid feed sub-assembly in fluid communication with a syringe containing at least two different sealant components; A housing; A gas cartridge disposed inside the housing; A gas valve assembly disposed inside the housing, in fluid communication with the gas cartridge and the fluid feed sub-assembly, and configured to control the flow of gas from the gas cartridge to the fluid feed sub-assembly; A trigger configured to operate the gas valve assembly; A detachable spray tip in fluid communication with the fluid feed sub-assembly and configured to dispense the multi-component fluid from the applicator; and wherein the detachable spray tip comprises: A body including an open end, a closed end, and an internal cavity extending between the open end and the closed end, the closed end having an inward-facing surface and an outlet orifice; A spray tip insert received within the body, the spray tip insert including a plurality of mixing protrusions disposed at different longitudinal positions between the proximal end and the distal end of the spray tip insert and radially spaced apart from each other and protruding outwardly, the spray tip insert and the body forming a mixing chamber within the internal cavity, the spray tip insert being configured to act as a static mixing element; An applicator.

2. The detachable spray tip of claim 1, further comprising: A vortex chamber formed from the inward-facing surfaces of the spray tip insert and the body, the spray tip insert being configured to mix the multi-component fluid within the mixing chamber before entering the vortex chamber and exiting through the outlet orifice. The applicator of claim 1.

3. The gas valve assembly includes a valve body having a lower part shaped to engage with the gas cartridge The applicator according to claim 1.

4. The gas valve assembly includes a flow restrictor orifice sized to control or reduce the gas flow from the gas cartridge to the fluid feed sub-assembly, and the flow restrictor orifice is disposed in a side port of the valve body. The applicator according to claim 3.

5. The valve body has an internal cavity extending at least between the lower part of the valve body and the side port of the valve body for transporting gas flowing from the gas cartridge to the flow restrictor orifice. The applicator according to claim 4.

6. The gas valve assembly includes a valve barb shaped to connect to the valve body and extending away from the valve body at the side port, and the flow restrictor orifice is disposed inside the valve barb. The applicator according to claim 4.

7. The gas cartridge is a threaded gas cartridge, and the valve body is shaped to threadedly engage with the threaded gas cartridge. The applicator according to claim 3.

8. The gas valve assembly includes a valve stem installed in a bore of the valve body, and the valve stem is configured to shift the gas valve assembly from a closed state to an open state by depressing the valve stem. The applicator according to claim 1.

9. Further includes a relief valve disposed inside the housing, and the relief valve is disposed along a fluid path of gas flowing from the gas valve assembly to the fluid feed sub-assembly. The applicator according to claim 1, wherein the relief valve is configured to release at least a portion of the gas from the fluid path based on the pressure of the gas exceeding a threshold pressure. **Claim 10**: The applicator according to claim 9, further comprising a gas pipe disposed inside the housing, the gas pipe extending between the gas valve assembly and the relief valve for transporting the gas flowing from the gas valve assembly to the relief valve.

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