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

Abstract

To provide a handheld gas spray system for mixing and dispensing multi-component compositions.SOLUTION: The handheld gas spray system includes a ratcheting trigger that is provided in front of a pistol-grip handle. When pulled by a user, the trigger activates a gas valve and pushes a syringe to deliver two-component sealant through a fluid conveyance subassembly to a distal end of the handheld gas spray system.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 63 / 068,666, filed August 21, 2020, which is incorporated herein by reference in its entirety. [Background technology]

[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 be kept separate before dispensing. For example, several fluid components can be mixed together to form a biological sealant or adhesive. Sealants and adhesives are made by mixing the fluid components together, which react with each other and cure or solidify after mixing. In many cases, the two fluid components react quickly and harden into a sealant or adhesive, such as a tissue adhesive. Due to the rapid reactivity of the components after contact, mixing of the fluid components is only performed when the multi-component fluid is ready to be dispensed and applied.

[0003] Gas systems, or systems using propellant gases, are intended for atomization and application of fibrin sealants. To properly form the sealant or adhesive, each fluid component should be thoroughly mixed before applying the multi-component fluid. For example, partially mixed fluid components may result in a sealant that does not sufficiently polymerize upon application. If the multi-component fluid hardens before dispensing, the dispensing device may clog, impeding flow and typically necessitating partial replacement of the dispensing device. Furthermore, expelling the hardened components or obstruction can pose a risk to the patient, and prematurely solidified adhesives may not properly seal the wound. Unfortunately, existing methods for dispensing multi-component biological sealants are often inadequate. Summary of the Invention

[0004] The present disclosure provides a gas atomizing device for mixing and dispensing two-component compositions (e.g., sealants). The gas system can be intended for atomizing and applying fibrin sealants using a propellant gas. Such systems can generate a very fine mist of fibrin sealant. However, such systems typically require the hospital to maintain a supply of large compressed gas cylinders and often require the setup of both a tubing set and a pressure or flow regulation system, which increases overall setup time. Furthermore, the setup and setup time detract from ease of use. The present disclosure aims to house the 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 compromising performance.

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

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

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

[0008]

[0008] Additional features and advantages of the disclosed handheld, gas-assisted, multi-component dispensing applicators, systems, and methods will be described in and 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 skilled in the art in view of the drawings and description. Also, any particular embodiment need not possess all of the advantages enumerated herein. Furthermore, it should be noted that the language used herein has been chosen primarily for purposes of readability and explanation, and not to limit the scope of the inventive subject matter. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1 is a perspective view of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 1B] FIG. 1B is an exploded perspective view of the exemplary handheld gas atomizing system of FIG. 1A. [Figure 1C] FIG. 1 is an exploded perspective view of a trigger assembly according to the present disclosure; [Figure 1D] 1 is an elevated side view of a portion of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 1E] FIG. 1 is a perspective view of a portion of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 2A] FIG. 1 is a perspective view of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 2B] FIG. 2B is an elevated side view of the handheld gas nebulizer system of FIG. 2A. [Figure 2C] 1 is an elevated side view of a portion of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 2D] FIG. 10 is a perspective view of an alternative embodiment of an exemplary handheld gas atomizing system according to the present disclosure. [Figure 2E] FIG. 2E is an exploded perspective view of the exemplary handheld gas atomizing system of FIG. 2D. [Figure 2F] FIG. 2E is an elevated side view of a portion of the exemplary handheld gas atomizing system of FIG. 2D. [Figure 3A]FIG. 2 is an exploded side view of an exemplary gas valve assembly of the present disclosure. [Figure 3B] FIG. 3B is an elevated front view of the gas valve assembly of FIG. 3A. [Figure 3C] FIG. 3C is an elevational cross-sectional view taken along line 3C-3C of FIG. 3B. [Figure 4A] FIG. 2 is an elevated side view illustrating exemplary gas tubing connections within an exemplary handheld gas atomizing system according to the present disclosure. [Figure 4B] FIG. 2 is an elevated side view illustrating exemplary gas tubing connections within an exemplary handheld gas atomizing system according to the present disclosure. [Figure 4C] FIG. 2 is an elevated side view illustrating exemplary gas tubing connections within an exemplary handheld gas atomizing system according to the present disclosure. [Figure 5A] FIG. 2 is an exploded perspective view of an exemplary fluid delivery subassembly according to the present disclosure. [Figure 5B] FIG. 2 is an exploded perspective view of an exemplary fluid delivery subassembly according to the present disclosure. [Figure 5C] FIG. 2 is an exploded perspective view of an exemplary fluid delivery subassembly according to the present disclosure. [Figure 6A] FIG. 1 is an elevated front view of an exemplary outer cannula according to the present disclosure. [Figure 6B] FIG. 1 is an elevated side view of an exemplary outer cannula according to the present disclosure. [Figure 7A] FIG. 1 is an elevated front view of an exemplary malleable tube according to the present disclosure. [Figure 7B] FIG. 1 is an elevated side view of an exemplary malleable tube according to the present disclosure. [Figure 8A] FIG. 1 is an elevated front view of an exemplary malleable collar according to the present disclosure. [Figure 8B] FIG. 1 is an elevated side view of an exemplary malleable collar according to the present disclosure. [Figure 9A] FIG. 1 is an elevated front view of an exemplary sealant tube according to the present disclosure. [Figure 9B] FIG. 1 is an elevated side view of an exemplary sealant tube according to the present disclosure. [Figure 10A] FIG. 1 is a perspective cross-sectional view of an exemplary spray tip subassembly according to the present disclosure. [Figure 10B] FIG. 1 is a cross-sectional elevation view of an exemplary spray tip subassembly according to the present disclosure. [Figure 11A] FIG. 1 is an elevated side view of an exemplary spray tip body according to the present disclosure. [Figure 11B] FIG. 1 is an elevational cross-sectional view of an exemplary spray tip body according to the present disclosure. [Figure 11C] FIG. 11C is a partial view of detail 11C of the elevational cross-section of FIG. 11B. [Figure 12A] FIG. 1 is an elevated side view of an exemplary spray tip insert according to the present disclosure. [Figure 12B] FIG. 1 is an elevational cross-sectional view of an exemplary spray tip insert according to the present disclosure. [Figure 12C] FIG. 12C is an elevational cross-sectional view taken along line 12C-12C of FIG. 12A. [Figure 12D] FIG. 12D is an elevational cross-sectional view taken along line 12D-12D of FIG. 12B. [Figure 13A] FIG. 1 is a perspective view of an exemplary threaded plug according to the present disclosure. [Figure 13B] FIG. 1 is an elevated side view of an exemplary threaded plug according to the present disclosure. [Figure 13C] FIG. 1 is an elevated rear view of an exemplary threaded plug according to the present disclosure. [Figure 13D] FIG. 1 is an elevated front view of an exemplary threaded plug according to the present disclosure. [Figure 13E] FIG. 1 is a cross-sectional elevation view of an exemplary threaded plug according to the present disclosure. [Figure 13F] FIG. 13F is an elevational cross-sectional view taken along line 13F-13F of FIG. 13D. [Figure 13G] FIG. 13G is an elevational cross-sectional view taken along line 13G-13G of FIG. 13E. [Figure 14A] 10A-10C illustrate additional views of exemplary components of the handheld gas atomizing system described herein. [Figure 14B] 10A-10C illustrate additional views of exemplary components of the handheld gas atomizing system described herein. [Figure 14C] 10A-10C illustrate additional views of other exemplary components of the handheld gas atomizing system described herein. [Figure 14D] 10 shows another additional view of another exemplary component of a handheld gas atomizing system as described herein. [Figure 14E] 10A-10C illustrate additional views of yet other exemplary components of the handheld gas atomizing system described herein. [Figure 14F] 10 shows another additional view of yet another exemplary component of a handheld gas atomizing system as described herein. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0054] The handheld gas spray system for mixing and dispensing multi-component compositions described herein provides an improved dispensing device (e.g., spray applicator) that prevents clogging and avoids cross-contamination of components until the intended mixing point, making it particularly useful for applying high-viscosity multi-component tissue adhesives to surgical sites. For example, one way in which clogging can be prevented or avoided is by ensuring that the gas is the first fluid to enter the spray tip and the last fluid to exit the spray tip. Clogging and cross-contamination of polymerized adhesives or sealants (e.g., fibrin sealants) are problematic because they can cause injury to the patient if expelled and may not properly seal the wound or tissue. Furthermore, clogging and cross-contamination can increase the costs associated with the dispensing applicator, as a clogged device may be inoperable or require a new dispensing tip. The multi-component dispensing applicator (e.g., spray applicator) described herein improves multi-component fluid dispensing by preventing, resisting, mitigating, or reducing clogging and cross-contamination.

[0011]

[0055] The handheld gas spraying 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 may be filled with a specified fill weight to ensure the presence of an equilibrium vapor and liquid two-phase system when the handheld gas spraying system is operated within its expected operating temperature range. By filling the cartridge in this manner, the system can advantageously reduce the possibility of excessive mass flow through the flow restrictor due to the presence of saturated liquid when the system is operated at elevated temperatures. Upon activation of the device trigger by the user, CO2 flows into the patient-facing end of the device. Simultaneously, two-component sealant is delivered to the spray tip from a syringe installed in the device. The pressurized gas and two-component sealant mix inside the spray tip, resulting in an atomized spray. In one example, when activation of the device trigger is stopped, the flow of the two-component sealant may stop first, followed by the flow of gas. By providing a gas flow for a period before the sealant flow and after the two-component sealant flow has stopped, clogging can be prevented, avoided, reduced, or mitigated.

[0012]

[0056] Pistol Grip Spraying Device Referring to the drawings, FIGS. 1A, 1B, 1C, 1D, and 1E illustrate an exemplary embodiment of a handheld gas spray system 100A. The handheld gas spray system 100A is a direct-grip or pistol-grip spray device. The handheld gas spray system 100A, which may also be referred to herein as a spray delivery device or spray applicator, includes a ratchet trigger 110a located 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), pushing a syringe 130 to deliver two-component sealant through a fluid delivery subassembly 140 to the distal end of the handheld gas spray system 100a. Unlike 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 multiple times to deliver the entire contents of the syringe 130 to the surgical site. However, one advantage of the handheld gas spray system 100a shown in Figures 1A, 1B, 1C, 1D and 1E is that the ratchet trigger 110a may provide precise control to the user in that it dispenses the syringe contents in incremental increments with a relatively low gripping force.

[0013]

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

[0014]

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

[0015]

[0059] Gas spray system 100A may 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, hereinafter generally referred to as dowel pin 126. Gas spray system 100a may also include a pressure relief valve 132 in communication with a connector 134 and a tube 136 in fluid communication with the gas source or gas cartridge 106. In one example, connector 134 is a male luer lock to barb connector.

[0016]

[0060] Additionally, gas spray system 100A can include a slider rack 142 mechanically coupled to the trigger to depress the syringe plunger, and a spacer 144 to physically restrain syringes of smaller bore sizes in the vertical direction. Slider rack 142 is further shown in Figures 14A and 14B, which show a ratchet mechanism (e.g., notches or teeth) on the bottom of slider rack 142 adapted to assist in depressing the syringe plunger.

[0017]

[0061] FIG. 1C shows additional details of the trigger assembly, which is a series of linked components positioned inside the device handle 120a and connecting 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 linked via the dowel pin 126. A small displacement of the trigger 110a rotates the cam lever 112, fully actuating the gas valve assembly 150 to the open state. Under further displacement, the ratchet arm 116 and the pawl 118, which may form a ratchet / pawl subassembly, move along a track and engage a rack (not shown). The further displacement also moves the rack along a track formed in the casing covers 102 and 104. For example, the track may be formed on the inside of the casing covers 102 and 104. As the trigger 110a moves toward the pistol grip handle 120a, the gas remains on while the rack gradually compresses the syringe 130, delivering a portion of the sealant contained within the syringe 130 in spray form. As described above, to reduce or prevent clogging, the gas may remain on for a period of time after compression of the syringe 130 stops. For example, the gas can remain on by continuing to hold the trigger 110a in the actuated position for a period of time sufficient to remove residual sealant from the spray tip.

[0018]

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

[0019]

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

[0020]

[0064] FIG. 2B shows the system 100b with the trigger 110b and handle 120b extended away from each other. The trigger 110b features two coaxially opposed round bosses on the left and right sides of the trigger 110b that rotatably mate with bores provided by the casing covers 102 and 104, allowing rotation about a fixed axis. Specifically, as shown in FIG. 2C, the trigger 110b is adapted to be grasped by a user's fingers. Additionally, the trigger 110b features a cam 152 that depresses the valve stem of the gas valve assembly 150 (not shown here, but see valve stem 204 in FIGS. 3A, 3B, and 3C), thereby opening the gas valve and activating gas flow. The handle 120b at the rear of the device moves simultaneously, delivering sealant to the spray tip to be mixed with the gas. The pivot position of trigger 110b can be adjusted to ensure that the force required to actuate the gas valve does not exceed the force required to dispense sealant from a loaded syringe, allowing the gas to be actuated before and after delivery of the sealant spray to help remove residual sealant from the device spray tip.

[0021]

[0065] Figures 2D, 2E, and 2F show an alternative embodiment of exemplary handheld gas spray system 100B. In the illustrated example 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 embodiment of Figures 2A and 2B).

[0022]

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

[0023]

[0067] The gas valve assembly 150 is adapted to controllably allow gas to flow from the gas cartridge 106 (e.g., a miniature compressed gas cartridge) to the fluid delivery subassembly 140 of the device or system 100A, 100B. In one example, a puncture needle 208, which may also be referred to as a piercing needle, may be threaded into the valve body 202. Alternatively, the puncture needle 208 may be secured to the valve body 202 using other attachment means (e.g., a mechanical press fit, etc.). The puncture needle 208 is adapted to capture a spring 214 and a ball 212 when threaded or otherwise installed into the valve body 202. The ball 212 and spring 214 together form a poppet 216. In one example, the lower portion of the valve body 202 is sized for threaded engagement with a threaded gas cartridge 106 (e.g., a threaded CO2 cartridge). A cartridge seal O-ring (not shown) may be included to prevent gas leakage during and after puncturing of the gas cartridge 106 by the puncture needle 208. While an O-ring is provided as an example of a sealing structure, it should be understood that any suitable elastomeric seal sized to form an adequate seal and ensure a leak-proof seal before the needle 208 punctures the pressurized gas cartridge 106 may be placed in this location.

[0024]

[0068] Additionally, a valve stem 204 is installed within the upper bore of the valve body 202. The valve stem 204 may include a gland in which two stem O-rings (not shown) are installed to ensure a leak-proof, slidable connection of the valve stem 204 to the valve body 202. For example, two stem O-rings provide a slidable, leak-proof connection between the valve stem 204 and the valve body 202. The gland dimensions, O-ring sizes, and bore sizes may be conventional for this type of articulation interface and should be apparent to those skilled in the art. It should be understood that fewer than two or more than two sealing O-rings may be utilized to ensure a leak-proof interface between the valve stem and the valve body. The valve stem 204 is depressed to move the valve from a normally closed state to an open state.

[0025]

[0069] The barb 206 can be mounted to a side port of the valve body 202 via a captured O-ring seal or other O-ring-type seal to deliver gas to the gas line (see gas line 302 in FIGS. 4A, 4B, and 4C). For example, the valve body 202 can feature a surface counterbore (or other appropriately designed recess) that mates with the barb mounting hole in the valve body 202 to ensure a proper seal. Additionally, a flow restrictor 210 can be mounted inside the barb 206 to control downstream gas flow and ensure a safe and functionally useful flow rate. Importantly, the orifice of the flow restrictor 210 is sized to account for the vapor pressure of the compressed fluid cartridge, e.g., a CO2 cartridge, to ensure that the choked flow always results in a mass flow rate consistent with values ​​previously demonstrated to be safe for use at specified distances from patient tissue.

[0026]

[0070] 4A, 4B, and 4C illustrate the gas tubing connections between the gas cartridge 106 and the gas valve assembly 150 to the fluid delivery subassembly 140. FIG. 4A illustrates the gas tubing connections for system 100A, while FIGS. 4B and 4C illustrate the gas tubing connections for alternative system 100B. As shown in FIGS. 4A and 4B, a gas tubing 302 is connected at a first end to a valve barb 206 and leads to another barb 304 at a second end of the gas tubing 302. The barb 204 may be luer-connected to a relief valve 308. The relief valve 308 is provided to ensure that excess pressure is safely vented to the environment. For example, if a downstream portion of the device or system 100A, 100B becomes blocked when gas flow is turned on, the relief valve 308 vents 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 system 100A, 100B. For example, the minimum cracking pressure of such a relief valve 308 can be equal to or greater than the normal operating pressure of the portion of the fluid pathway in which 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., a clinically determined maximum safe operating pressure). For example, to determine the maximum pressure threshold, a pressure range exceeding the normal operating pressure of the compressed gas cartridge 106 can be supplied to the gas valve assembly 150, and the resulting impact pressure at a given distance from the device spray tip can then be observed or measured. More generally, the relief valve 308 can be sized to ensure a release of system pressure if 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 a differential pressure range of approximately 70 to 110 kilopascals (kPa).

[0028]

[0072] Additionally, the relief valve 308 may be connected to a 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 before delivery to the patient. The gas filter 310 may include an appropriate membrane material selected based on the desired composition of the sealant and gas. For example, if the compressed gas is carbon dioxide and the sealant composition is aqueous, the gas filter 310 may be implemented to include a hydrophobic membrane material (e.g., PTFE) to ensure that wetting prevents, restricts, or reduces gas flow.

[0029]

[0073] Fluid Feed Subassembly The fluid delivery subassembly 140 facilitates the transport of the two surgical sealant components from the syringe 130 and the gas flow from the device handle 120 to the distal tip. These three fluid streams are not in fluid communication until they reach the spray tip 414 subassembly. This is important to the functionality of the 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 well-mixed, but unpolymerized, sealant to the target tissue site.

[0030]

[0074] The fluid delivery subassembly 140 can have a variety of configurations, three of which are shown in Figures 5A, 5B, and 5C. Figure 5A shows a first configuration of the fluid delivery subassembly 140a, which is adapted for open surgery. In one example, the fluid delivery subassembly 140a can have a working length of approximately 6 cm and can comprise a generally rigid structure. As shown in Figure 5A, the fluid delivery subassembly 140a includes sealant tubes 410a, b that run down the length of an outer cannula 420 to a threaded plug 412. At the distal end 422 of the outer cannula 420, the outer cannula 420 can be coupled to the threaded plug 412 to provide an airtight or leak-proof seal. The threaded plug 412 can be coupled (e.g., threadedly coupled) to a spray tip 414 subassembly. At the proximal end 424 of the outer cannula 420, the outer cannula 420 is coupled to a Y-connector distal component 430, which 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 Figures 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, hereinafter generally referred to as sealant tube 410, are coupled into two bosses 434a, b disposed on 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 below) in a threaded plug 412. A gas connection port 440 may be provided on the underside of the Y-connector distal component 430, allowing connection to the gas filter 310 shown in FIGS. 4A and 4B . The gas filter 310 can be connected to the gas connection port 440 via a Luer lock connection. Fluid delivery subassembly 140a can also include check valves 450a and 450b, which can be installed at corresponding female luer lock connections 436a,b of Y-connector proximal component 432 to prevent backflow under pressure into syringe 130. Note that female luer connections 436a,b of Y-connector proximal component 432 can be positioned at a predetermined axial offset corresponding to the outlet spacing of the syringe 130 being used.

[0032]

[0076] FIG. 5B illustrates a second configuration of 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, procedures closer to the skin's surface may use a shorter cannula 420, as shown in FIG. 5A. In one example, fluid delivery subassembly 140b may have a working length of approximately 40 cm and may include a generally rigid structure. As shown in FIG. 5B, fluid delivery subassembly 140b includes each of the components described above in subassembly 140a. However, sealant tubes 410a, b and outer cannula 420 are longer, such that fluid delivery subassembly 140b has a longer working length.

[0033]

[0077] FIG. 5C illustrates a third configuration of fluid delivery subassembly 140c adapted for laparoscopic surgery. In one example, fluid delivery subassembly 140c can have a working length of approximately 40 cm and generally include a rigid structure with a malleable portion that allows the device to bend at its distal end to facilitate positioning during laparoscopic surgery. As shown in FIG. 5C, fluid delivery subassembly 140c includes each of the components described above in subassemblies 140a and 140b. However, sealant tubes 410a, b and outer cannula 420 are longer, similar to fluid delivery subassembly 140b, so that fluid delivery subassembly 140c has a longer working length. Additionally, fluid delivery subassembly 140c includes an additional malleable tube 460 and a malleable collar 470 disposed between outer cannula 420 and threaded plug 412. For example, instead of the distal end 422 of the outer cannula 420 being coupled to a threaded plug as in FIG. 5A , the distal end 422 of the outer cannula 420 may be coupled or connected to a malleable tube 460, which in turn may be coupled or connected to a collar 470. For example, the proximal end 464 of the malleable tube 460 may be connected to the distal end 422 of the outer cannula 420, and the distal end 462 of the malleable tube 460 may be connected to the proximal end 474 of the collar 470. Furthermore, the distal end 472 of the collar 470 may be connected to the threaded plug 412. The collar 470 may be coupled to the threaded plug 412 to provide an airtight or leak-proof seal. Similar to subassemblies 140a and 140b, the threaded plug 412 may be coupled to a subassembly of the spray tip 414.

[0034]

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

[0035]

[0079] In each of FIGS. 5A, 5B, and 5C, first and second sealant tubes 410 provide fluid communication between a fluid container, such as a syringe 130, and ultimately a spray tip 414 subassembly. The fluids remain separated as they travel through the system to a threaded plug 412 after passing through a check valve 450, into a Y-connector proximal component 432, and through the sealant tube 410. The fluids remain completely separated as they travel through the system to a threaded plug 412. The fluids then travel to a detachable spray tip subassembly 414, which can be removably coupled to the threaded plug 412. While systems 100A, 100B are shown with interfaces for accepting two fluid sources, it should be understood that systems 100A, 100B can be configured to accept more than two fluid sources (e.g., sealants). For example, systems 100A, 100B can be configured to mix and dispense adhesives or sealants, such as biosealants, comprised of three or more component fluids. It should also be understood that systems 100A, 100B can include additional interfaces (e.g., syringe interfaces) for additional fluid containers. For example, while systems 100A, 100B illustrated herein show dual syringes 120 with two separate sealant tubes 410, three or more fluid containers and / or sealant tubes 410 may be used. For example, some multi-component fluids may include three or more fluids that are mixed to form a sealant or adhesive. Furthermore, it should be understood that systems 100A, 100B can be configured to accept 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 also be understood that systems 100A, 100B can include a single interface for a single fluid container. For example, while systems 100A, 100B illustrated herein show dual syringes 120 with two separate sealant tubes 410, a single fluid container and / or sealant tube 410 may be used.

[0036]

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

[0037]

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

[0038]

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

[0039]

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

[0040]

[0084] 9A and 9B show the end and side profiles of sealant tube 410. Sealant tube 410 has an inner diameter (D I )562, outer diameter (D O ) 564, and length (L ST ) 566. I )562 is about 1mm, outer diameter (D O ) 564 may be about 1.78 mm. ST ) 566 may vary depending on the configuration of the fluid delivery subassembly 140. For example, the length (L ST) 566 may be approximately 93 mm, 432 mm, and 432 mm for subassemblies 140a, 140b, and 140c, respectively. In one example, sealant tube 410 may be made from a resilient polymer such as ethylene vinyl acetate ("EVA").

[0041]

[0085] Threaded Plug 13A-13G show an exemplary embodiment of the threaded plug 412. As described above, the fluid delivery subassembly 140a includes sealant tubing 410a,b that is routed 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 subassembly 414. For example, the threaded plug 412 can include external threads 902 adapted to engage with corresponding threads (e.g., the threaded portion 636 of the tip body 610).

[0042]

[0086] The threaded plug 412 facilitates removable connection of the spray tip subassembly 414 to the outer cannula 420 or the malleable collar 470, depending on the configuration of the fluid delivery subassembly 140. By design, the threaded plug 412 features a taper (e.g., tapered surface 904) for sealing against the inner surface of the spray tip body 610, preventing leakage of the pressurized fluid mixture. Additionally, the threaded plug 412 may include two sealant passages 906 a, b (hereinafter generally referred to as sealant passages 906) adapted to receive corresponding sealant tubes 410 a, b at a proximal end 924 of the threaded plug 412. For example, as shown in FIG. 13F, the sealant passages 906a, b can include sealant tube receiving portions 907a, b sized and shaped such that a corresponding sealant tube 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 passages 908) adapted to allow the passage of gas from the outer cannula 420 to the spray tip subassembly 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 subassembly 414 before the sealant passage 906, thereby allowing the gas to properly propagate through the spray tip before the sealant enters the spray tip, which can help properly mix and atomize the two-component sealant. For example, as shown in FIG. 13A , the plug 412 can include two recesses 930a, b that allow the gas to communicate with the spray tip subassembly 414 before the sealant communicates with and enters the spray tip. In one example, the sealant passage 906 and the gas passage 908 may each have a diameter of about 0.8 mm.

[0044]

[0088] The threaded plug may also include a flange 940 configured to abut the outer cannula 420 and act as a stop when the threaded plug 412 is coupled to the cannula 420 (or similarly to a malleable collar, depending on the configuration).

[0045]

[0089] As the sealant travels down sealant tubes 410a,b and the gas flows through outer cannula 420, the fluids remain completely separated as they travel through the system, with the sealant traveling through sealant passage 906 and the gas traveling through gas passage 908 in threaded plug 412. Specifically, sealant tube 410 and plug 412 ensure that the fluids remain separated as they travel between syringe 130 and spray tip subassembly 414. The fluids (e.g., sealant components and gas) then travel to detachable spray tip subassembly 414, which may be coupled to threaded plug 412, where the fluids begin to mix.

[0046]

[0090] Spray Tip Sub-Assembly 10A and 10B show the spray tip subassembly 414. At the distal end of the device, the two sealant components and the gas stream are mixed within the spray tip subassembly 414, which includes the spray tip body 610 and the insert 670. A threaded plug 412 facilitates removable connection of the spray tip subassembly 414 to the outer cannula 420 or the malleable collar 470, depending on the configuration of the fluid delivery subassembly 140. By design, the threaded plug 412 features a taper to seal against the inner surface of the spray tip body 610, preventing leakage of the pressurized fluid mixture. The fluid mixture is mixed by the tip insert 670. In one example, the tip insert 670 is permanently assembled to the spray tip body 610 by a press fit. A vortex chamber or spin chamber geometry (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] Tip body 610 may be hollow, forming cavity 612. The size and shape of cavity 612, along with the size and shape of insert 670, may be selected to optimize the mixing volume and mixing characteristics of spray tip subassembly 414. Cavity 640 may have a cavity diameter (D C ) 614 and cavity depth (C D ) 616 (see FIGS. 11A and 11B). Additionally, the tip insert 670 can have a volume (V I ), and cavity 612 has a volume (V C ) and the cavity volume (V C ) and insert volume (V I ) is the mixing volume (V M By adjusting the size, shape, and geometry of the components of the spray tip subassembly 414, the mixing volume (V M ) and the geometry of the mixing chamber created. As further shown in FIG. 10B, the size and shape of cavity 612, along with the size and shape of insert 670, can be selected to adjust the mixing characteristics of spray tip subassembly 414. For example, the geometry of tip body 610 and insert 670 can be adjusted to provide an optimal fluid path distance (FP ) before the fluid impacts first contact surface 620 of insert 670 and begins turbulence and mixing. 距離 The geometry of the tip body 610 and insert 670 together can be selected to provide a fluid path distance (FP) 618. 距離 ) 618 can be adjusted to increase or decrease the turbulence generated in the spray tip subassembly 414.

[0048]

[0092] Tip body 11A, 11B, and 11C show various views of the tip body 610. The tip 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 FIG. 11B, the cavity 612 may be generally cylindrical. In some cases, the cavity 612 may have an initial cavity diameter (D C ) 614a is the final cavity diameter (D C ) 614b. C ) 614a may start at about 4 mm and decrease to a cavity diameter (D ) of about 3.7 mm as the cavity extends toward the distal end 622 of the tip body 610. C In the illustrated example, the end portion 626 of the cavity 612 may gradually decrease until it reaches a constant cavity diameter (D C ) 614b. The rearmost portion 626 may have a depth (C DLS ) 628.

[0049]

[0093] As described above, systems 100A, 100B may include one threaded spray tip subassembly 414 and one or more replacement spray tip subassemblies 414 that can replace the original threaded spray tip subassembly 414 if the original spray tip becomes clogged during use. To aid in the removal and reinstallation of each spray tip subassembly 414, tip body 610 may include a gripping portion 630. Grip portion 630 may include ridges, protrusions, grooves, a textured surface, or other surface finish or shape that aids in gripping tip body 610. In the example shown in FIG. 11A , gripping portion 630 has a gripping length (L ) that may be approximately 14 mm. G The distal end 622 of the tip body 610 can also have a notch width (W NThe tip body 610 may include a small notch 656 that protrudes a notch width (W ) 658 over the last 2 mm of the tip body 610. The notch 656 may be present in the last 2 mm of the tip body 610 and may have a notch width (W ) of about 0.1 mm. N ) 658. The notch 656 can further assist the user in removing the spray tip subassembly 414.

[0050]

[0094] As mentioned above, the tip body 610 has an outer diameter (D O ) 634. In one example, the outer diameter (D O ) 634 is about 5.3 mm. T ) 638, and the height (H T )638 is approximately 4mm.

[0051]

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

[0052]

[0096] Tip Insert Tip insert 670 acts as a static mixing element within spray tip subassembly 414. Tip insert 670 is shown in more detail in Figures 12A and 12B, which show that 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 Figure 12A). The mixing protrusions in the illustrated example have a base length (L 基線 ) 704 and an interior angle (β) 706. 基線 ) 704 may be approximately 2.9 mm long and the included angle (β) 706 may be approximately 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 at intervals (S ME ) 703 (e.g., intervals 703a, 703b, and 703c). ME ) 703 may be about 0.5 mm.

[0053]

[0097] In one example, multiple mixing protrusions 702 may be arranged around the cylindrical body 700. In the illustrated example, the tip insert 670 includes three pairs of protrusions 720 that are staggered such that a first set of protrusions (protrusion 702a and the other opposite protrusion 702a, 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) may be arranged at different circumferential positions around the tip insert 670. In one example, the second set of mixing protrusions 702 may be arranged at a 90-degree angle 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 height (H B ) 712. The diameter of the tip insert 670 including the mixing projections 702 is the main mixing diameter (D BM ) 714 may be approximately 3.6 mm.

[0055]

[0099] In one example, one or more of the mixing protrusions 702 may include a retention feature 720, which may 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 feature 720 may be a crush rib that ensures that the insert 670 does not become dislodged from the tip body 610 over the shelf life of the device or during use, and 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 feature 720 allows the insert 670 to fit within the diameter (D C ) 614b (see back to FIG. 11B) is about 0.1 mm larger than the overall width (R etention ) 795. The friction fit of the retention feature 720 is further illustrated in FIG. 10B, which shows that a portion of the tip insert 670 is oversized relative to the corresponding cavity 612 in the tip body 610.

[0056]

[0100] In the illustrated example, the holding mechanism 720 has a holding height (H R )722 and 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 In the illustrated example, the retention feature 720 is spaced from the proximal end 734 of the tip insert 670 at a spacing (S ) that may be approximately 7.8 mm. RF) 750. Additionally, retention feature 720 can include an angled profile that aids in alignment during installation via a friction fit with tip insert 670 when tip insert 670 is press-fit into tip body 610. As shown in FIGS. 12A and 12B, retention feature 720 can have an angled portion 754 and a flat portion 756, where the flat portion has a height (H ES ) 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. Additionally, the tip insert 670 can include a swirl chamber portion 740 near the distal end 732 of the tip insert 670. The swirl chamber portion can have a diameter (D SC ) 742 and a height (H) of approximately 1.5 mm SC ) 744. The geometry (e.g., height and diameter) of the swirl chamber can be configured to create a preferred spray shape or based on the materials used in the 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 that both fluids contact and flow around, which can initially create turbulence in the spray tip subassembly 414 and initiate mixing of the fluids. It should be understood that other mixing shapes can be used, for example, the tip insert 670 can include a spiral, triangular, or rectangular shape, etc. Additionally, other lattice or matrix type mixing structures can be used. Furthermore, the mixing structure can be omitted entirely, for example, when used with sealants that require limited mixing prior to application.

[0059]

[0103] As the gas and two-component sealant are forced 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 begin to mix within the cavity 612 due to interaction with the tip insert 670. As more fluid (e.g., gas and sealant) enters the spray tip subassembly 414, the mixed fluid is forced out of the cavity 612 and through the exit orifice 630 of the tip body 610. Before exiting through the exit orifice 630, the fluid travels through a vortex chamber 800, which is shown in more detail in FIG. 12C.

[0060]

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

[0061]

[0105] vortex chamber 12A (also visible 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 toward distal end 732 of tip insert 670 and into corresponding horizontal channels 802 of vortex chamber 800, as shown in FIG. 12C . 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] The channels 802 or passages may narrow as the channels 802 approach the vortex chamber 800. For example, each channel 802 may narrow at an angle (α) 806, which may be a constant dimension or about 15 degrees. When the channels 802 reach the vortex chamber, the channels 802 narrow to a channel width (W) of about 0.4 mm. C) 808 and a channel depth of about 0.5 mm. The channel 802 may have a trapezoidal cross-section that gradually decreases in cross-sectional area as the channel 802 approaches the swirl chamber 800 of the tip body 610. The decreased cross-sectional area increases the velocity of the fluid entering the swirl chamber 800. As the pressurized fluid mixture enters the swirl chamber 800, the increased velocity and angular / tangential approach caused by the channel 802 favorably forms a vortex, improving mixing at the spray orifice 630 and nozzle performance.

[0063]

[0107] The number of channels 780 and 802 may depend on the preferred spray shape or spray material used in spray tip subassembly 414. For example, the number of channels 780 and 802 may be determined based on the viscosity and preferred volumetric flow rate of the fluid entering vortex chamber 800. In the illustrated example shown in FIG. 12C, vortex chamber 800 is fed 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 may be more effective compared to other channel configurations.

[0064]

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

[0065]

[0109] Vortex chamber (D SC The diameter of the vortex chamber 820 (D ) may be about 1.6 mm. SC ), the geometry of channels 780 and 802, and other features of spray tip subassembly 414 can control the velocity of fluid exiting the spray tip. As mentioned above, insert 670 has a retention feature 720, such as a crush rib, that ensures that insert 670 does not become dislodged from tip body 610 during storage or use.

[0066]

[0110] mixture As described above, the syringe 130 may be a multi-chamber syringe including multiple chambers or containers (e.g., first and second fluid containers, such as syringes). The syringe 130 may contain reactive fluids. For example, the syringe 130 may contain 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 contained separately in different chambers or containers within the syringe 130, and the separation of the fluids is maintained through various system components until the desired mixing point within the removable spray tip subassembly 414. Reactive multi-component fluids, in particular, tend to form a clot shortly after the fluid paths converge and mix within the applicator. For example, for reactive solutions such as biological tissue sealants, the residence time before clot formation is short, often only a few seconds. Therefore, maintaining the separation of the fluids until the desired mixing point to prevent premature coagulation is effective. Additionally, it may be advantageous to provide a removable or detachable spray tip subassembly 414 that can be replaced if it becomes clogged during or between uses.

[0067]

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

[0068]

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

[0069]

[0113] Components - Connections 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 systems 100A, 100B may be removably attached to the other so that the components can be disassembled and reassembled. Additionally, components may be coupled to one another via chemical fasteners. Chemical fasteners include, for example, adhesives, chemical bonds, welded bonds, or molding processes suitable for securing the components. For example, each of the components shown in FIGS. 5A, 5B, and 5C may be attached, coupled, or connected to one another via threaded fits, snap fits, adhesives, or any other suitable fasteners such that the components are connected and maintain fluid communication from the syringe 130 to the detachable spray tip subassembly 414. In other examples, the component parts may instead be molded as a single piece.

[0070]

[0114] Assembly For rigid device configurations, and more particularly when assembling the fluid delivery subassembly 140, the sealant tube 410 is cut to length and coupled to the threaded plug 412. For example, the sealant tube 410 can be coupled to the threaded plug 412 by applying a small amount of adhesive, such as cyanoacrylate, to the exterior 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-bonding 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 threaded plug 412 before inserting the proximal end of threaded plug 412 into the distal end of outer cannula 420 until the flange of threaded plug 412 is flush with the end of 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 outer cannula 420 (opposite the threaded plug) and Y-connector distal component 430 can be inserted into cannula 420.

[0072]

[0116] When inserting the Y connector distal component 430, the components should be aligned so that the sealant passage of the threaded plug 412 is in-plane with the horizontal surface of the Y connector distal component 430. After preparing the adhesive, the adhesive is applied to the exterior surface of the free sealant tubing end, which can then be inserted into the boss 434 of the Y connector proximal component 432. The check valve 450 can then be attached to the female luer of the Y connector proximal component 432. The gas filter 310 can then 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 threaded plug 412 into outer cannula 420, threaded plug 412 is instead inserted into malleable collar 470. A small amount of adhesive is then applied to the exterior surface of one end of malleable tube 460, and malleable tube 460 is then inserted into malleable collar 470. When assembled, the stainless steel wire may face downwards.

[0074]

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

[0075]

[0119] For the spray tip assembly, assembly begins by firmly inserting the spray tip insert 470 into the spray tip body 410 with the swirl chamber 800 geometry facing downwards. The distal face of the insert 470 should be perfectly flush with the tip body 410. The spray tip 414 is then threaded 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. The gas cartridge is then installed onto the gas activator knob using a small amount of adhesive. The gas activator knob is screwed clockwise to partially thread the gas cartridge onto the valve assembly. In one example, the gas activator knob is screwed in three turns to ensure the cartridge fully engages the valve but does not puncture it.

[0077]

[0121] The gas tube is then connected to the valve barb outlet, and a Luer barb is installed at the free end of the gas tube. The Luer barb is then connected to the relief valve via a Luer lock connection. The male Luer slip connector of the relief valve is inserted into the gas filter on the fluid delivery subassembly. The gas activator knob is placed into a corresponding groove in the casing, and the gas tube and relief valve are routed to match the corresponding features of the casing.

[0078]

[0122] The fluid delivery subassembly is then installed into the corresponding groove in the casing. The connection is assembled, i.e., one or more of the pin, trigger, and / or torsion spring can then be installed (depending on the embodiment of the system being assembled). The opposite side of the casing is then aligned and screwed to the other casing.

[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 any of these aspects are mutually exclusive, it is understood that such mutual exclusivity in no way limits the combination of such aspect with any other aspect, whether or not such aspect is explicitly recited. Any of these aspects may be claimed as, but are not limited to, a system, method, apparatus, device, medium, etc.

[0081]

[0125] The many features and advantages of the present disclosure are apparent from the written description, and thus, the appended claims are intended to cover all such features and advantages of the present disclosure. Moreover, since numerous modifications and changes will readily occur to those skilled in the art, the present disclosure is not limited to the exact construction and operation as shown and described. Therefore, the described embodiments should be construed as illustrative rather than restrictive, 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 foreseeable or unforeseeable now or in the future.

Claims

[Claim 1] The invention described in the specification.

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