Spray applicator for two-component surgical sealant and methods of use thereof

Abstract

An applicator includes a housing having a barrel, a plunger, and a needle. The barrel extends between a proximal end and a distal end, the plunger is movably received within the barrel, and the needle is coupleable to the barrel and configured to extend distally therefrom. The housing is configured to removably receive a vial in association with a distal end of the needle. The applicator further includes a nozzle assembly coupleable to the housing, the nozzle assembly, including a fluid flow path communicating with barrel. The applicator has a first state and a second state, whereby, in the first state, the needle is spaced from the barrel and the vial and whereby, in the second state, a proximal end of the needle penetrates the barrel and the distal end of the needle penetrates the vial.

Description

SYKCMF 3.4-054SPRAY APPLICATOR FOR TWO-COMPONENT SURGICAL SEALANTAND METHODS OF USE THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority to U.S. Provisional Application 63 / 735,546, filed December 18, 2024, the disclosure of which is hereby incorporated by reference in its entirety herein. BACKGROUND OF THE INVENTION

[0002] A number of medically useful compositions comprise two or more ingredients that for optimal results should not be mixed together until shortly prior to use. In some instances, a chemical reaction between two ingredients at the time of mixing may begin immediately and thus transition the ingredients into a gel or solid state. Therefore, it is desirable to have an applicator that can easily deliver multiplecomponent formulations for use in the body which are capable of keeping the individual components separated during storage and mixing them prior to application.

[0003] Use of a dual-ingredient composition can be accomplished with a conventional syringe by first loading one ingredient into the syringe, then adding the second ingredient, shaking the syringe or otherwise agitating the contents to achieve mixing, and subsequently dispensing the resulting mixture as prescribed. This procedure, however, may present shortcomings, including contamination and loss of sterility. For example, using a conventional syringe of the kind that is filled through a fill needle connected to the outlet orifice of the syringe, it is necessary to replace the needle after the first ingredient has been drawn into the syringe in order to avoid contamination of the supply of the second ingredient. Even then it may be difficult to complete the procedure without rendering the outlet portion of the syringe non-sterile, e.g. , by extended contact with air. Another technique that may be employed utilizes a syringe of generally conventional construction in which one ingredient has initially been loaded into the syringe, usually followed by a sterilization procedure. Again, however, it is often rather difficult to load the syringe with the second ingredient without undermining the sterile characteristics of the syringe. Moreover, in both of these procedures the user’s manipulative steps are complex enough that some difficulty may be experienced.

[0004] There exist medical sealant / adhesive products which are based on hydrogel formulations which comprise multiple components housed in separated containers. However, such products may have shortcomings such as needing assembly at the time of use and also may utilize static mixing systems that allow the hydrogel formulation to gel within the mixing nozzle, precluding a start-and-stop application technique. Even if a device is designed to expel its components shortly after mixing, other potential issues may occur during implementation. That is, minor errors in use or failure to follow very specific instructions may cause an impact on the outcome of the solution and thus the surgical procedure for which the device is being used. For example, when using previous designs in which the different substances are kept separate in vials and mixed within the applicator, a user may incorrectly install the vials onto the applicator, a user may fail to properly mix components per the instructions, or the user may be tasked with determining when the solutions have properly mixed and may incorrectly determine the same.

[0005] Thus, there exists a need to improve the design of a multi-component spray applicator and simplify its use to reduce or altogether prevent errors during implementation.SYKCMF 3.4-054BRIEF SUMMARY OF THE INVENTION

[0006] A spray applicator is described herein for spraying a solution, particularly a sealant, onto a surgical site during a medical operation. The spray applicator includes certain modular aspects which may be coupled to and decoupled from one another. For instance, the applicator includes a housing with a double syringe and a dual -plunger which may be provided to a user pre-assembled with a buffer solutions disposed in each of the two barrels of the double syringe. Separate from but attachable to the pre-assembled housing are a vial cartridge and a nozzle assembly. The vial cartridge may include two vials with solutions therein and may be coupled to the housing to prepare the applicator for use. Specifically, the applicator may include a pair of double-sided needles coupled to the vial cartridge, each of which may penetrate a barrel and a vial to transfer fluids to and from. Thus, the vials may be attached to the housing, the dual plunger may be depressed to inject the buffer soludons held in the barrels into the vials, then the dual plunger may be retracted again to withdraw the mixed solutions into the corresponding barrels.

[0007] After the applicator is prepared with separate solutions in the two syringes, the vial cartridge may be detached from the housing by unlatching the vial cartridge and pulling it apart from the housing. Next, a spray / dispensing nozzle may be attached to the housing using the same mechanical latch feature. A pair of single-sided needles extending proximally from the nozzle assembly may then be inserted into corresponding barrels, and the single-sided needles may then lead into a Y-adaptor and elongate tubes which translate fluid through the nozzle assembly when the plungers are depressed by the user. When the fluids reach a distal portion of the nozzle assembly, they reach a mixing chamber where they combine with each other and begin to chemically react.

[0008] The applicator may also include an air pump which is electrically connected to a disposable battery. When the nozzle assembly is attached to the housing, a conductive element on the nozzle assembly may close the circuit between the battery and the air pump so that the air pump is automatically turned on. The air pump then consistently pumps air through an airflow passage defined within an outer tube of the nozzle which is adjacent, but separate from, elongate tubes which carry the syringe soludons through the nozzle. The pumped air meets the fluids at a distal portion of the nozzle generally where the solutions are mixed and carries the solutions quickly to an exit orifice of the nozzle to be sprayed onto a surgical site. The pressure applied by the air pump helps to expel the solution mixture from the nozzle before the solutions are given too much time to potentially react with one another such as solidification and possible clogging within the nozzle.

[0009] The modular applicator may take the form of three different states. The first state, referred to as the shipping state, includes the vial cartridge partially coupled to the housing such that the double-sided needles are floating in the housing and held in the housing by detents on the needles and spaced from the associated syringe. The vials may then be fully attached to the housing. Contact between the vials and the needles during attachment may cause the needles to puncture the vials and also move proximally to puncture the barrel entryway. Once the vials are securely attached and the needles open a line of fluid communication between the syringe barrels and the vial chambers, the applicator is then in a second stateSYKCMF 3.4-054 referred to as the preparation state. The plungers may be depressed and / or retracted in the preparation state to transfer fluids between the vial chambers and the barrel chambers.

[0010] After the barrel solutions have been prepared, the vials may be unlatched and detached from the housing and a nozzle assembly may then be coupled and secured to the housing. Once the nozzle assembly is latched to the housing, the air pump is activated and the applicator is in a third state, referred to as the delivery state, in which the dual plunger can be depressed to spray the solution and the applicator is ready for use.

[0011] According to a first aspect of the disclosure, an applicator may include a housing and a nozzle assembly coupleable to the housing. The housing may include a first barrel extending between a proximal end and a distal end, a first plunger moveably received within the first barrel, a first needle coupleable to the first barrel and configured to extend distally therefrom, a second barrel extending between a proximal end and a distal end, a second plunger moveably received within the second barrel, and a second needle coupleable to the first barrel and configured to extend distally therefrom. The housing may be configured to removably receive a first vial in association with a distal end of the first needle and to removably receive a second vial in association with a distal end of the second needle. The nozzle assembly may include a first fluid flow path configured to communicate with the first barrel and a second fluid flow path configured to communicate with the second barrel. The applicator may have a first state and a second state, both when the first and second vials are received within the housing. In the first state, the first needle may be spaced from the first barrel and the first vial, and the second needle may be spaced from the second barrel and the second vial. In the second state, a proximal end of the first needle may penetrate the first barrel, the distal end of the first needle may penetrate the first vial, a proximal end of the second needle may penetrate the second barrel, and the distal end of the second needle may penetrate the second vial.

[0012] Further in the first aspect of the disclosure, the first state may be a shipping state in which the applicator is configured to be transported to a user, and the second state may be a preparation state in which the applicator is configured to be prepared for use. The first needle may include a first detent configured to adjustably fix the applicator in the first state. The first detent may be included on a first support structure coupled to and surrounding the first needle. The first support structure may include a first wing and a second wing opposite the first wing, each of the first and second wings extending radially outward relative to the first needle. The first wing may include a first elongate portion extending generally parallel to the first needle configured to be elastically deformable, and the second wing may include a second elongate portion extending generally parallel to the first needle configured to be elastically deformable. The first wing may include a first protrusion extending radially outward relative to the first needle, and the first protrusion may be adapted to removably engage a first recess defined by an interior surface of a vial cartridge to hold the first and second vials. The second wing may include a second protrusion extending radially outward relative to the first needle, and the second protrusion may be to removably engage a second recess defined by the vial cartridge.

[0013] Further in the first aspect of the disclosure, when the applicator is in the first state, the first protrusion may be removably disposed within the first interior recess and the second protrusion may beSYKCMF 3.4-054 removably disposed within the second interior recess. When the applicator is in the second state, the first protrusion may be displaced and spaced from the first interior recess and the second protrusion may be displaced and spaced from the second interior recess. The second needle may include a second detent configured to adjustably fix the applicator in the first state. The first detent may be a first protrusion extending radially outward relative to the first needle and the second detent may be a second protrusion extending radially outward relative to the second needle, and the first protrusion and second protrusion may be movably fixed to a vial cartridge in the first state.

[0014] Further in the first aspect of the disclosure, the applicator may further include the first and second vials removably coupled to the housing. The first vial and the second vial may be contained within a vial cartridge to form a vial assembly, and the vial assembly may be coupled to the housing in the first state and the second state. The applicator may have a third state in which the nozzle assembly is coupled to the housing. The third state may be a delivery state in which the applicator is configured to dispense a fluid. When the applicator is in the third state, a third needle disposed within the nozzle assembly may be coupled to the first barrel and the first fluid flow path and a fourth needle disposed within the nozzle assembly may be coupled to the second barrel and the second fluid flow path. When the applicator is in the third state, the third needle may fluidly communicate the first barrel with the first fluid flow path and the fourth needle may fluidly communicate the second barrel with the second fluid flow path such that a first fluid is configured to be transmitted from the first barrel to the nozzle assembly and a second fluid is configured to be transmitted from the second barrel to the nozzle assembly when a pressure is applied to the first and second plungers.

[0015] Further in the first aspect of the disclosure, the first barrel may include a first elastomeric cap and the first needle may be configured to pierce the elastomeric cap when the applicator is in the second state. When the applicator is in the second state, the first needle may fluidly communicate the first barrel with the first vial such that retraction of the first plunger is configured to translate a first fluid from the first vial toward the first barrel. The first elastomeric cap may be configured to prevent a first fluid from passing therethrough after the first needle has penetrated the first elastomeric cap and is decoupled from the elastomeric cap.

[0016] According to a second aspect of the disclosure, an applicator may include a housing and a nozzle assembly coupleable to the housing. The housing may include a first barrel extending between a proximal end and a distal end, a first plunger moveably received within the first barrel, and a first needle coupleable to the first barrel and configured to extend distally therefrom. The housing may be configured to removably receive a first vial in association with a distal end of the first needle. The nozzle assembly may include a first fluid flow path configured to communicate with the first barrel. The applicator may have a first state and a second state, both when the first vial is received within the housing. In the first state, the first needle may be spaced from the first barrel and the first vial. In the second state, a proximal end of the first needle may penetrate the first barrel, and the distal end of the first needle may penetrate the first vial.

[0017] Further in the second aspect of the disclosure, the housing may further include a second barrel extending between a proximal end and a distal end, a second plunger moveably received within the secondSYKCMF 3.4-054 barrel, and a second needle coupleable to the first barrel and configured to extend distally therefrom. The housing may be configured to removably receive a second vial in association with a distal end of the second needle. The nozzle may further include a second fluid flow path configured to communicate with the second barrel. The second vial may be received within the housing in both he first state and the second state. In the first state, the second needle may be spaced from the second barrel and the second vial. In the second state, a proximal end of the second needle may penetrate the second barrel, and the distal end of the second needle may penetrate the second vial.

[0018] According to a third aspect of the disclosure, a method for using an applicator may include providing the applicator in a first state in which a first vial and a second vial are removably coupled to a housing of the applicator, the housing including a first barrel and a second barrel, a first needle adjacent the first barrel and a second needle adjacent the second barrel, wherein in the first state, the first needle is spaced from the first vial and the second needle is spaced from the second vial; transitioning the applicator from the first state to a second state in which the first needle penetrates the first barrel and the first vial and the second needle penetrates the second barrel and the second vial; retracting a plunger moveably coupled to the first and second barrels to translate a first fluid from the first vial to the first barrel and a second fluid from the second vial to the second barrel; decoupling the first and second vials from the housing; coupling a nozzle assembly to the housing such that the first barrel is in fluid communication with a first fluid flow path of the nozzle assembly and the second barrel is in fluid communication with a second fluid flow path of the nozzle assembly; and pressing the plunger to translate the first fluid from the first barrel through the first fluid flow path and the second fluid from the second barrel through the second fluid flow path.

[0019] Further in the third aspect of the disclosure, transitioning the applicator from the first state to the second state may include applying an external force to one of the housing or the first and second vials toward the other of the housing and the first and second vials. The first state may be a shipping state in which the applicator is configured to be shipped, and the second state may be a preparation state in which the applicator is configured to be prepared for use. In the first state, a proximal end of the first needle may be spaced from the first barrel and a distal end of the first needle may be spaced from the first vial, and a proximal end of the second needle may be spaced from the second barrel and a distal end of the second needle may be spaced from the second vial.

[0020] Further in the third aspect of the disclosure, the step of pressing the plunger may include translating the first fluid from the first barrel into a mixing chamber of the nozzle assembly and translating the second fluid from the second barrel into the mixing chamber, and the method may further include mixing the first fluid and the second fluid in the mixing chamber. The step of pressing the plunger may include expelling the first fluid and second fluids from the applicator via an exit port of the nozzle assembly after mixing the first and second fluids in the mixing chamber. An air flow may pass through the nozzle assembly and interact with a mixture formed by mixing the first and second fluids to push the mixture toward the exit port and out of the nozzle assembly.

[0021] Further in the third aspect of the disclosure, the method of using the applicator may include, before the step of decoupling the first and second vials from the housing, pressing the plunger to translate a firstSYKCMF 3.4-054 buffer solution from the first barrel to the first vial and a second buffer solution from the second barrel to the second vial. The step of coupling the nozzle assembly to the housing may include activating an air pump by closing an electrical circuit with a conductive element disposed on the nozzle assembly. The step of coupling the nozzle assembly to the housing may include orienting the nozzle assembly so that a first alignment indicator on the nozzle assembly aligns with a second corresponding alignment indicator on the housing. The method may further include coupling a cartridge including the first vial and the second vial to the housing to provide the applicator in the first state. The step of coupling the cartridge to the housing may include orienting the cartridge so that a first mating feature on a side of the cartridge aligns with a second corresponding mating feature on a corresponding side of the housing.

[0022] According to a fourth aspect of the disclosure, an applicator may include a housing and a nozzle assembly coupleable to the housing. The housing may include a first barrel extending between a proximal end and a distal end, a first plunger moveably received within the first barrel, and a first needle coupleable to the first barrel and configured to extend distally therefrom, an air pump configured to expel fluid from the applicator, and a power source configured to supply power to the air pump. The nozzle assembly may include a first fluid flow path configured to communicate with a distal end of the first barrel and an electrically conductive element which is configured to close an electrical circuit between the air pump and the power source to activate the air pump when the nozzle assembly is coupled to the housing.

[0023] Further in the fourth aspect of the disclosure, the electrically conductive element may include a first terminal configured to contact a first end of the power source when the nozzle assembly is coupled to the housing. The first terminal may be a positive terminal. A second end of the power source opposite the first end may be coupled to a first terminal of the air pump by a wire. The first terminal of the air pump may be a negative terminal. The electrically conductive element may include a first terminal configured to contact a spring wire extending from a first terminal of the air pump when the nozzle assembly is coupled to the housing. The power source may be a disposable battery. Airflow from the air pump may be configured to contact the fluid in a mixing chamber of the nozzle assembly to expel the fluid from the applicator.

[0024] According to a fifth aspect of the disclosure, a nozzle assembly for an applicator may include a first elongate tube, a second elongate tube, a separator, a mixing baffle, a cap, and an outer tube. The first elongate tube may define a first fluid flow path configured to communicate with a first barrel of a syringe to receive a first fluid disposed in the first barrel. The second elongate tube may define a second fluid flow path configured to communicate with a second barrel of the syringe to receive a second fluid disposed in the second barrel. The separator may be disposed between and extending distally beyond the first elongate tube and the second elongate tube. The mixing baffle may be coupled to and extending distally from the separator. The cap may peripherally surround the mixer and define an orifice for expelling the first and second fluids from the nozzle assembly. The outer tube may peripherally surround the first and second elongate tubes, and the outer tube may define an air passage extending adjacent to and separately from the first and second fluid flow paths. The mixer and the cap may define a first channel in fluid communication with the first fluid flow path and a second channel in fluid communication with the second fluid flow path,SYKCMF 3.4-054 and the first channel may be separated from the second channel by a proximal portion of the mixer. The mixer and the cap may define a mixing chamber distal to and in fluid communication with the first and second channels. The air passage may be in fluid communication with the first channel and the second channel and the air passage may be adapted to permit air pumped by an air pump to pass therethrough.

[0025] Further in the fifth aspect of the disclosure, the mixing baffle may define at least one curved wall configured to guide at least one of the first and second fluids therealong. The mixing baffle may include at least one protrusion extending a radially outward direction configured to be received by the cap to properly align the cap relative to the mixing baffle. The nozzle assembly may further include a Y-adaptor disposed between and connecting the first elongate tube to the first barrel and the second elongate tube to the second barrel. The nozzle assembly may further include a first mating feature on a first side of a proximal surface of the nozzle assembly having a first size and shape, and a second mating feature on a second side of the proximal surface of the nozzle assembly having a second size and shape different from the first size and shape. The nozzle assembly may further include an alignment graphic on an exterior surface of the nozzle assembly for identifying the first mating feature. The distal interior surface of the cap may have a curved surface.

[0026] According to a sixth aspect of the disclosure, a kit may include an applicator housing, a first vial and a nozzle assembly. The applicator housing may include a first barrel extending between a proximal end and a distal end, a first plunger moveably received within the first barrel, and a first needle coupled to the housing and spaced from the first barrel. The first vial may include a first fluid disposed therein, and the first vial may be configured to be penetrated by a distal end of the first needle. The nozzle assembly may be configured to be coupled to the applicator housing. The nozzle assembly may include a first fluid flow path configured to communicate with the first barrel.

[0027] Further in the sixth aspect of the disclosure, the first needle may include a detent configured to adjustably fix the first needle relative to the first vial while the first needle is spaced from the first vial and the first barrel. The applicator may further include a second barrel extending between a proximal end and a distal end, a second plunger removably received within the first barrel, and a second needle coupled to the housing and spaced from the second barrel. The kit may further include, a second vial including a second fluid disposed therein, and the second vial may be configured to be penetrated by a distal end of the second needle. The nozzle assembly may further include a second fluid flow path configured to communicate with the second barrel.

[0028] According to a seventh aspect of the disclosure, a kit may include an applicator housing, and a nozzle assembly configured to be coupled to the applicator housing. The applicator housing may include a first barrel extending between a proximal end and a distal end, a first plunger moveably received within the first barrel, and a first needle coupled to the housing and spaced from the first barrel. The nozzle assembly may include a first fluid flow path configured to communicate with the first barrel.

[0029] Further in the seventh aspect of the disclosure, the kit may further include a first vial adapted to be removably coupled to the applicator housing in association with a distal end of the first needle. The applicator housing and the nozzle assembly may be provided in a first package and the cartridge containingSYKCMF 3.4-054 the first vial may be provided in a second package. The applicator housing may further include a second barrel extending between a proximal end and a distal end, a second plunger moveably received within the second barrel, and a second needle coupled to the housing and spaced from the second barrel. The kit may further include a first vial adapted to be removably coupled to the applicator housing in association with a distal end of the first needle and a second vial adapted to be removably coupled to the applicator housing in association with a distal end of the second needle. The first vial and the second vial may be included in a cartridge.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIGS. 1 A-1B are perspective views of an applicator in preparation and delivery states, respectively, according to an embodiment of the disclosure.

[0031] FIG. 2 is a transparent view of a housing of the applicator of FIGS. 1A-1B.

[0032] FIG. 3 is an exploded view of a barrel assembly of the housing of FIG. 2.

[0033] FIG. 4 is a top schematic view of the applicator in FIG. 1 A.

[0034] FIG. 5 is a partial schematic view of the housing of the applicator of FIG. 1 A in a shipping state.

[0035] FIG. 6 is a perspective view of a needle assembly included in the housing as shown in FIG. 5.

[0036] FIG. 7 is a schematic view of the needle assembly of FIG. 6 in the housing as shown in FIG. 5 when the applicator is in the shipping state.

[0037] FIG. 8 A is a partial cross-sectional view of the housing as shown in FIG. 5 illustrating a first needle assembly in the shipping state and a second needle assembly in the preparation state.

[0038] FIG. 8B is a partial schematic view of the housing as shown in FIG. 5 in the preparation state.

[0039] FIG. 9 is a perspective view of a vial cartridge of the applicator of FIG. 1 A.

[0040] FIG. 10 is a partial cross-sectional view of the vial cartridge of FIG. 9 and the housing of FIG. 2.

[0041] FIG. 11 is a perspective view of a nozzle assembly of the applicator of FIG. IB.

[0042] FIG. 12 is a proximal perspective view of the nozzle assembly of FIG. 11.

[0043] FIG. 13 is a schematic top view of the nozzle assembly of FIG. 11.

[0044] FIG. 14 is a partial top cross-sectional view of the nozzle assembly of FIG. 11.

[0045] FIG. 15 is a partial perspective cross-sectional view of the nozzle assembly of FIG. 11.

[0046] FIG. 16 is a partial transparent view of the nozzle assembly of FIG. 11.

[0047] FIG. 17 is a partial schematic view of the nozzle assembly of FIG. 11.

[0048] FIG. 18 is a partial transparent view of the nozzle assembly of FIG. 11.

[0049] FIG. 19 is a transparent view of a cap of the nozzle assembly of FIG. 11.

[0050] FIG. 20 is an alternative perspective view of the nozzle assembly of FIG. 11.

[0051] FIG. 21 is a front (e.g., proximal facing) view of a face of the housing of FIG. 2.

[0052] FIG. 22 is a rear (e.g. , distal facing) view of the nozzle assembly of FIG. 11.

[0053] FIG. 23 is an exploded perspective view of the applicator of FIG. IB illustrating a housing separated from the nozzle assembly.SYKCMF 3.4-054

[0054] FIG. 24 is a partial close-up side view of an interface between the nozzle assembly and housing of the applicator of FIG. IB.

[0055] FIG. 25 is a partial cross-sectional view of the housing of FIG. 2.

[0056] FIG. 26 is a rear (e.g., distal facing) view of a face of a housing according to another embodiment of the disclosure.

[0057] FIG. 27 is a perspective exploded view of a housing of the applicator according to another embodiment of the disclosure.

[0058] FIGS. 28A-28B are perspective cross-sectional views of the housing of FIG. 27 illustrating uncoupled and coupled configurations, respectively.

[0059] FIGS. 29A-29B are close-up front views of the cross-section illustrated in FIGS. 28A-28B, respectively, illustrating the uncoupled and coupled configurations, respectively.DETAILED DESCRIPTIONIntroduction to Spray Applicator And Components Thereof

[0060] The present invention is related to a device for dispensing a multi-part component and method of using the device. Various components are present in the invention, including for example, a housing, a vial cartridge, a nozzle assembly and other components as will be explained below. Certain aspects of the invention relate to an applicator which can house a multiple component formulation in separate material receptacles and which can then be easily reconstituted at time of use with little or no assembly by the user. The invention may also provide an applicator system in which the manipulation by a user is minimized, the number of device components is minimized, and / or the preparation of the device is made more intuitive for the user.

[0061] In certain embodiments, a device of the invention can be used for, but is not limited to, applying hydrogel formulation to dura mater, abdominal tissue in hernia repair, tissues near the spine, lung tissue, intestinal tissue, vascular tissues or any of the internal tissues. In certain embodiments, a device of the invention can be configured to apply a spray or a stream of liquid formulation onto a surface to be treated. In certain embodiments, a device of the invention can be configured to deliver the formulation through a trocar in a scope (e.g., an endoscope or laparoscope).

[0062] One aspect of the invention relates to an applicator system, and methods of use thereof, that can be used to separately house liquids, viscous liquids and solids (e.g., components of a polymerizable hydrogel). The applicator may be further designed to facilitate the dissolulion of the solids inside the applicator, and may also be designed to facilitate the application of the mixture to a surface. In certain embodiments, such an applicator may be used for delivering a formulation to the dura, cornea, or lung. In addition, the applicators may be useful for a variety of other appli cal ions, including for example, preparation and application of a vascular sealant, liquid embolic or arterial access closures.

[0063] While the invention will often be described herein as facilitating the formation and effective delivery to a padent of a polymerizable hydrogel formulation, this characterization is not intended in any way to limit the scope of the invention to such an application. Rather, the applicator(s) and the methods of the invention may be used in any application requiring mixing two or more components (e.g., solids andSYKCMF 3.4-054 liquids, or different liquids) prior to use. It is understood that these applicators may be useful for a variety of applications including, for example, Irealing / sealing / adhering dura mater, cardiovascular tissue, ducts, bladders, lung tissue, liver, other parenchymal organs, as well as adhering soft tissue mesh to the body.

[0064] In certain embodiments, the applicators of the invention can be used to prepare and apply a hydrogel formulation. In other embodiments, the hydrogel formulation is delivered in liquid form and quickly polymerizes into a hydrogel. In still other embodiments, the hydrogel formulation comprises a cross linker (such as PEI or any others known in the art); an activated polymer (such as activated PEG); and a buffer solution or solutions.

[0065] As used herein, the term “reconstitution” means the mixing of more than one component into a formulation or formulation part which is at least meta-stable for some amount of time. It also may include dissolution (i.e., the process in which one substance is dissolved in another.). In certain embodiments, the individual components may not be stable in the “reconstituted” state or may suffer from other difficulties such as tolerance to sterilization procedures which makes it necessary for the components to be separate during the bulk of the storage lime of the device but allow for it to be “reconstituted” into a formulation or formulation part prior to application.

[0066] As used herein, the term “user” refers to the individual dispensing the material or sealant from the device and / or the individual preparing the applicator for such dispensing. As used herein, the term “proximal” will refer to a location closest to the user dispensing the sealant from the device, e.g. , the doctor or other medical professional. As used herein, the term “distal” shall refer to a location closest to the delivery site, e.g., furthest away from the user dispensing the sealant from the device.

[0067] FIGS. 1 A and IB illustrate an embodiment of the invention. The applicator 100a is shown in FIG. 1 A in a first state which will be referred to as the preparation state and shown in FIG. IB in a second state, which will be referred to as the delivery state. For clarity, the applicator will be referred to throughout this disclosure with reference numeral 100a when a housing 110 of the applicator is in association with a vial cartridge 105 and the applicator will be referred to throughout this disclosure with reference numeral 100b when the housing 110 is in association with a nozzle assembly 150.

[0068] The applicator 100a includes the housing 110 with the vial cartridge 105 removably coupled to the housing 110. The housing 110 includes a handle 112 and the applicator 100a extends generally from a proximal end 102 to a distal end 104. As noted above, the proximal and distal directions will be referenced throughout this disclosure referring to a location relative to the intended user of the device. That is, the proximal end 102 will be closer to a user (e.g. , the user’s hand) gripping the handle 112 when the applicator 100b is held as intended, and the distal end 104 will be farther away from the user gripping the handle 112.

[0069] The applicator 100b is shown in FIG. IB in a second state, which will be referred to as the delivery state, in which the applicator 100b includes the housing 110 with a nozzle assembly 150 removably coupled to the housing 110. That is, as will be described below in greater detail, the applicator 100b is in the delivery state when the nozzle assembly 150 is coupled to a distal end of the housing (e.g., after the vial cartridge 105 has been decoupled from the housing 110).SYKCMF 3.4-054

[0070] The housing 110 is shown in FIG. 2 in further detail, the housing 110 having a pistol shape and including several components of the applicator therein. The housing 110 can include a power source 186, an air pump 180 and an air flow tube 182 configured to convey the air pumped by the air pump 180, which will be discussed below in further detail. The housing 110 includes a plurality of elongate tubular or cylindrical chambers or barrels 115a, 115b. First barrel 115a and second barrel 115b are disposed in a side-by-side manner, each barrel preferably being substantially parallel to the other, with their respective axes running from the proximal end 102 of the device to the distal end 104 of the device.

[0071] Within each barrel 115a, 115b is disposed a plunger 120a, 120b, respectively, which extends substantially the length of the barrel 115a, 115b and exits the barrel 115a, 115b at a proximal end 102 of the device. Each plunger 120a, 120b is housed within the respective barrel 115a, 115b in such a fashion that it is movable in an axial direction in the proximal and distal directions. Each plunger 120a, 120b includes a piston 122a, 122b, respectively, at a distal end of the plunger. At least a portion of the piston 122a, 122b is slidably positioned with the corresponding barrel 115a, 115b. Each plunger 120a, 120b also includes a piston rod 124a, 124b, respectively attached to and extending proximally from the corresponding piston 122a, 122b. The piston rods 124a, 124b are coupled to one another at their proximal ends by a pusher 125, which is monolithically formed with each of the piston rods 124a, 124b.

[0072] The pusher 125 is maintained outside the barrels 115a, 115b, and allows the user to push or pull the plungers 120a, 120b as necessary, thus moving the plungers 120a, 120b axially either proximally or distally with respect to the barrels 115a, 115b. Moving the plungers 120a, 120b proximally withdraws the plungers out of the barrels 115a, 115b, while moving the plungers 120a, 120b distally pushes the plungers into the barrels 115a, 115b. The unitary formation of the pusher 125 with piston rods 124a, 124b allows for simultaneous pushing and pulling of each plunger 120a, 120b in the housing 110 to preserve the intended mix ratio of the fluids contained in the barrels 115a, 115b. It is also contemplated that each piston rod 124a, 124b is connected to its own corresponding pusher, and the pushers may then be coupled to each other rather than a single pusher formed monolithically with the piston rods.

[0073] In some embodiments, the pusher 125 may be curved or have ergonomic features to conform to a user’s fingers, aiding in the comfort and ease of use. Each plunger 120a, 120b should form an air-tight seal with the corresponding barrel 115a, 115b, thus pulling fluid within the barrel 115a, 115b when withdrawn axially out (proximally) and forcing fluid out of the barrel 115a, 115b when pushed axially in (distally). The air-tight seal may be achieved, for example, by using a deformable rubber or plastic piston 122a, 122b which is snugly fit within the interior of the corresponding barrel 115a, 115b. The plungers 120a, 120b may be partially withdrawn from the barrels 115a, 115b by pulling the pusher 125 axially in the proximal direction.

[0074] Optionally, the plungers 120a, 120b may be completely withdrawn from the barrels 115a, 115b by pulling the pusher 125 so that the plungers 120a, 120b are completely removed. In some embodiments, the plungers 120a, 120b may be fixed within the barrels 115a, 115b, such that they cannot be completely removed therefrom. For example, there may securement features, such as tabs or locks, on the housing or barrels 115a, 115b which restrict complete removal of the plungers 120a, 120b from the barrels 115a, 115b.SYKCMF 3.4-054Such securement features prevent a user from inadvertently pulling the plungers 120a, 120b completely out of the barrels 115a, 115b, which aids in preventing accidental opening of the barrels 115a, 115b and spilling its contents.

[0075] As shown in FIG. 3, the barrels 115a, 115b are held in place by a barrel support structure 121 included in the housing 110. Further, each barrel 115a, 115b includes a barrel nose 116a, 116b, respectively, extending distally from the corresponding barrel 115a, 115b. Each barrel nose 116a, 116b is sized and shaped to receive a barrel tip holder 117a, 117b, respectively, which each defines an orifice sized and shaped to snugly receive an elastomeric tip 118a, 118b, respectively. Finally, a barrel cover 119a, 119b is sized and shaped to couple to the barrel tip holder 117a, 117b, respectively, thereby covering and maintaining the position of the corresponding elastomeric dp 118a, 118b relative to the corresponding barrel 115a, 115b.

[0076] As shown in FIG. 3 and with reference to first barrel 115a, each of the barrel nose 116a, barrel tip holder 117a and barrel cover 119a defines an aperture all aligned along a single axis, e.g.. the barrel longitudinal axis. Each barrel 115a, 115b is adapted to receive a needle along the barrel longitudinal axis through the corresponding barrel nose 116a, 116b as will be discussed below in further detail. The elastomeric tips 118a, 118b are configured to be pierced by a needle to allow passage therethrough. Furthermore, the elastomeric tips 118a, 118b have a “healing” property such that after a needle that has pierced the elastomeric tip 118a, 118b has been removed therefrom, the elastomeric tip 118a, 118b is capable of substantially resuming the shape it exhibited prior to having been pierced by the needle. This property allows the elastomeric tip 118a, 118b to prevent fluid from passing therethrough (e.g. , entering or escaping the chamber of the barrel 115a, 115b) after a needle has been removed or decoupled from the elastomeric tip 118a, 118b.

[0077] With reference to FIG. 4, the housing 110 accommodates a first needle 130a and a second needle 130b which are coupled to and extend from the vial cartridge 105. The first needle 130a is associated with the first barrel 115a and the second needle 130b is associated with the second barrel 115b. Each needle 130a, 130b is an elongate and cannulated tube having sharp opposing ends that taper to a point configured for piercing a surface. That is, the proximal end of each of needles 130a, 130b forms a sharp point configured for piercing the corresponding elastomeric cap 118a, 118b and to protrude into the corresponding barrel 115a, 115b, and the distal end of each of needles 130a, 130b forms a sharp point configured for piercing a cover of a vial 107a, 107b, respectively. The double-sided needles help to ease installation and removal for the vial cartridge 105 and nozzle assembly 150. Each of the needles 130a, 130b may be fitted within the housing 110 with a support structure such that the needles 130a, 130b are stably floating within the respective cannulas defined by the housing 110. More specifically, each needle 130a, 130b includes a detent configured to engage with an interior surface of the housing 110 to adjustably affix the needle in place relative to the housing.

[0078] FIG. 6 illustrates the first needle 130a which will be described alone for ease of description, but it should be understood that the second needle 130b has the same structure in the illustrated embodiment. The needle 130a includes a support structure 132a extending radially outward from the cannulated tubeSYKCMF 3.4-054131a. The support structure 132a includes a first support bar 133a extending generally parallel to the cannulated tube 131a and projecting in a radially outward direction relative to the cannulated tube 131a. The support structure 132a further includes a second support bar 134a opposite the first support bar 133a relative to the cannulated tube 131a. That is, the second support bar 134a extends generally parallel to the cannulated tube 131a and projects in a radially outward direction relative to the cannulated tube 131a in a direction opposite that of the first support bar 133a. The support bars 133a, 134a are sized to contact an interior surface of the housing 110 and fit snugly therewithin to hold the needle 130a, and more particularly the cannulated tube 131a, steady relative to the housing 110 while also permitting axial displacement of the needle 130a relative to the housing in the proximal -distal direction.

[0079] Further in FIG. 6, the support structure 132a in this embodiment includes a first wing 136a protruding in a radially outward direction relative to the cannulated tube 131a and a second wing 137a opposite the first wing 136. That is, the second wing 137a in this embodiment protrudes in a radially outward direction opposite that of the first wing 136a relative to the cannulated tube 131a. The first and second wings 136a, 137a are coupled to the support structure 132a at shoulders 138a, 139a, respectively, and each wing 136a, 137a includes an elongate portion 141a, 142a, respectively, extending generally parallel to and spaced from the cannulated tube 131a. The elongate portions 140a, 141a of the wings 136a, 137a are configured to be elastically deformable with respect to the corresponding shoulders 138a, 139a at which they are connected to the support structure 132a. The wings 136a, 137a in this embodiment each include a protrusion 142a, 143a, respectively, at an end of the corresponding elongate portion 140a, 141a opposite the shoulder 138a, 139a, and each protrusion 142a, 143a is adapted to engage with a recess or opening defined by the vial cartridge 105 (e.g., 193a, 194a as shown in FIGS. 7 and 9) to removably fix the needle 130a with respect to the vial cartridge 105. That is, the first protrusion 142a is adapted to engage with and sit within a first interior recess (e.g., 193a) defined by the vial cartridge 105 and the second protrusion 143a is adapted to engage with and sit within a second interior recess (e.g. , 194a) defined by the vial cartridge 105 opposite the first recess.

[0080] The first and second support bars 133a, 134a extend in directions which are approximately ninety degrees offset from each of the first and second wings 136a, 137a. The support bars 133a, 134a hold the needle 130a stably within the housing 110 while permitting axial displacement, while the protrusions 142a, 143a moveably fix the axial position of the needle 130a with respect to the vial cartridge 105. The various possible states and positions of the needles 130a, 130b being movably fixed relative to the housing 110 and the vial cartridge 105 are described below in further detail.Spray Applicator and Vial Cartridge

[0081] As shown in FIG. 1 A, the housing 110 of the applicator 100a is adapted to receive and couple to a vial cartridge 105. The vial cartridge 105 includes the first and second vials 107a, 107b coupled thereto which are associated and aligned with the first and second needles 130a, 130b, respectively. The applicator 100a may be designed to assume at least one of two different fixed states when the vial cartridge 105 is coupled to the housing 110, specifically relating to the relative positioning of the needles 130a, 130b and the vial cartridge 105, which will be described herein with reference to FIGS. 7 and 8A-8B.SYKCMF 3.4-054

[0082] The first of the different states will be referred to as the shipping state, which is illustrated in FIGS. 5 and 7. In the shipping state, the vial cartridge 105 may optionally be preliminarily coupled to the housing 110 via what will be described herein as a partial coupling. The partial coupling may be formed with a feature in the packaging design that would keep the vial cartridge 105 partially decoupled from the housing 110 so that the needles 130a, 130b do not pierce the corresponding barrels 115a, 115b. Such a feature may include a stopper (e.g. , a protrusion, a ring, or the like) which is disposed between the housing 110 and the vial cartridge 105 to create friction therebetween that can be overcome over a threshold force, or alternatively a wrap surrounding both the housing 110 and vial cartridge 105 which temporarily holds the components partially coupled to one another. That is, the vial cartridge 105 and the housing 110 may be movably fixed with respect to one another, but a gap may exist between a proximal surface of the vial cartridge 105 and a distal surface of the housing 110.

[0083] In the shipping state, the needles 130a, 130b are movably fixed within the vial cartridge 105 via the flexible wings (e.g., 136a, 137a) as described above having protrusions (e.g., 142a, 143a) disposed within respective recesses or openings defined by an interior surface of the vial cartridge. For example, as shown in FIG. 7, the protrusion 143a is positioned within the vial cartridge opening 193a and the protrusion 142a is positioned within the vial cartridge opening 194a, thereby removably holding the needle 130a in place relative to the vial 107a. Further in the shipping state, the needles 130a, 130b are positioned such that they are spaced from the corresponding vials 107a, 107b, as shown in FIG. 7, and the needles 130a, 130b are also spaced from the corresponding barrels 115a, 115b. That is, by way of example, when the applicator 100a is in the shipping state, a gap exists between a proximal end of the cannulated tube 131a and the elastomeric tip 118a, and another gap exists between a distal end of the cannulated tube 131a and the vial 107a, such that there is no fluid communication between the barrel 115a and the vial 107a. It is also contemplated that the vials 107a, 107b need not be partially coupled to the housing 110 at all and the applicator 100a may still be in the shipping state. That is, the shipping state may alternatively include the needles 130a, 130b floating within the vial cartridge 105 as shown in FIG. 7 with the vials 107a, 107b completely detached from the housing 110.

[0084] The second of the different states which the applicator 100a may assume with the vial cartridge 105 coupled to the housing 110 will be referred to as the preparation state, which is illustrated in FIG. 8B. In the preparation state, the vial cartridge 105 is fully coupled to the housing 110 such that a proximal surface of the vial cartridge 105 contacts a distal surface of the housing 110 and therefore no gap exists therebetween. An example of one way in which the applicator 100a may be transitioned from the shipping state to the preparation state is by application of a compressive force on the proximal and distal ends 102, 104 of the applicator 100a when the vial cartridge 105 is partially coupled to the housing 110, or by application of a force on a proximal end 102 of the housing 110 toward the vial cartridge 105 or application of a force on a distal end 104 of the vial cartridge 105 toward the housing 110. The force may be applied by a user of the device.

[0085] When the applicator 100a is transitioned from the shipping state to the preparation state via the external force, the barrels 115a, 115b and the vials 107a, 107b are moved axially closer to one another,SYKCMF 3.4-054 thereby decreasing the distance between the vials 107a, 107b and the barrels 115a, 115b. The distance between the vials 107a, 107b and the barrels 115a, 115b may be smaller than the lengths of the cannulated tubes 131a, 131b of the needles 130a, 130b, thus resulting in the needles 130a, 130b piercing both the corresponding caps of the vials 107a, 107b and the corresponding elastomeric tips 118a, 118b. For example, when the applicator 100a is transitioned into the preparation state, the vial 107a is brought closer to the barrel 115a such that the cap of the vial 105a contacts a distal end of the cannulated tube 131a and the elastomeric tip 118a contacts the proximal end of the cannulated tube 131a, and further pressure is applied so that the cannulated tube 131a pierces and enters the chambers defined by the barrel 115a and the vial 105a, thus forming a fluid connection, i.e., fluid communication, between the vial 107a and the barrel 115a.

[0086] The pressure applied to the needle during the transition axially translates the needle such that the wings (e.g., 136a, 137a) are displaced from disposal within the recesses (e.g., 193a, 194a) defined by the interior surface of the vial cartridge 105 described above. More specifically in the illustrated example, when a force is applied on the vial cartridge 105 toward the housing 110, the vials 107a and needles 130a may simultaneously move toward the barrel 115a until the cannulated tube 131a pierces the barrel 115a and the support bars 133a, 134a and / or shoulders 138a, 139a abut a distal-facing surface of the elastomeric cap 118a. Abutment of the support structure 132a against the elastomeric cap 118a may then prevent further rel alive movement between the needle 130a and the barrel 115a. Thus, continued application of force on the vial cartridge 105 toward the housing 110 may then result in proximal movement of the vial cartridge 105 (e.g., toward the housing) relative to the needle 130a and the barrel 115a. The protrusions 142a, 143a are displaced from corresponding proximal recesses 194a, 193a, and the vial 107a is moved closer to the needle 130a until the vial cap is pierced and penetrated by the distal end of the cannulated tube 131a, thereby forming the fluid connection between the vial 107a and the corresponding barrel 115a. After the vial cap is pierced and the vial cartridge 105 is moved proximally toward the needle 130a, the protrusions 142a, 143a of the needle 130a may then be positioned within distal recesses 196a, 195a, respectively, as shown in FIG. 7 to removably hold the vial cartridge 105 stationary relative to the needle 130a in the preparation state. Although not shown, the needle 130b corresponding portion of the vial cartridge 105 may include the same structure as described above.

[0087] In other examples, the housing 110 may define first and second pairs of opposing interior recesses for accommodating the wings of each needle assembly in the shipping and preparation states, such that the needles are removably fixed to the housing 110 rather than the vial cartridge 105. Similar to the illustrated embodiment, the second pair of recesses in such an example may be axially spaced from the first pair of recesses , such that when the needle assemblies are impacted and moved proximally to pierce the barrel noses, they are then secured in place by positioning the protrusions (e.g., 142a, 143a) of the wings (e.g., 136a, 137a) within the second pair of interior recesses.

[0088] Once the fluid coin muni cal ion between the vial 107a and barrel 115a is formed, a user may control passage of the fluids between the vial 107a and barrel 115a through the needle 130a via depression and retraction of the pusher 125 as described above. For purposes of comparison, FIG. 8 A illustrates the firstSYKCMF 3.4-054 needle 130a in the shipping state while the second needle 130b is in the preparation state, however it should be noted that in practice, the vials 107a, 107b will be displaced simultaneously with the vial cartridge 105, and therefore both needles 130a, 130b will transition from the shipping state to the preparation state at approximately the same time.

[0089] As noted above, in some examples, the vial cartridge 105 may be provided to the user already pari i ally coupled to the housing 110 such that the applicator 100a is in the shipping state. In other examples, the vial cartridge 105 may be provided to the user separately from the housing 110, in which case the user may be tasked with coupling the vial cartridge 105 to the housing 110. To assist with properly orienting the vial cartridge 105 rclali ve to the housing 110, the vial cartridge 105 may include a first cartridge nose 108a aligned with the first vial 107a having an alignment indicator or marking I l la and a second cartridge nose 108b aligned with the second vial 107b having an alignment indicator or marking 11 lb as shown in FIG. 9. The markings I lla, 111b may respectively correspond to similar markings on the housing 110 so as to indicate which vial should be coupled to which barrel.

[0090] In some examples, the vial cartridge 105 may be affixed to the housing 110 in the preparation state by a mechanical latch connection. As shown in FIG. 10, the vial cartridge 105 may include a fastener 112 forming a U-shape extending proximally from the vial cartridge 105, and the housing 110 may include a ramped catch 113 extending inwardly from an interior surface of the housing 110. The fastener 112 and catch 113 are positioned relative to one another such that when the vial cartridge 105 and the housing 110 are brought towards one another as illustrated, the fastener 112 is configured to contact a distally-facing ramped surface of the catch such that a sufficient force applied on the vial cartridge 105 toward the housing 115 will cause the fastener 112 to elastically deform enough to pass the fastener 112 to a side of the catch 113 opposite the ramped surface. Once the fastener 112 is passed beyond the ramped surface of the catch 113, the fastener 112 returns to its original configuration so that a distally facing surface of the fastener 112 abuts a proximal-facing surface of the catch 113, and the catch 113 prevents the hook and thus the vial cartridge 105 from moving distally relative to the housing 105. The fastener 112 may then be unlatched from the catch 113 by application of a compressive force on the vial cartridge 105 pressing the fastener 112 inwardly to elastically flex the fastener 112 sufficiently to pass distally over the catch 113The illustrated example includes a second set of a fastener and catch on a second side opposing the fastener 112 and catch 113 described above, however any number is contemplated to form the connection. Thus, a user may decouple the vial cartridge 105 from the housing 110 by applying the compressive force noted above to the vial cartridge 105 and pulling the vial cartridge 105 away from the housing 110. As the needles 130a, 130b are coupled to the vial cartridge 105, decoupling the vial cartridge 105 from the housing 110 includes detaching the vial cartridge 105 and separating both the vial cartridge 105 and the needles 130a, 130b from the housing 110.

[0091] The applicator 100a and the vial cartridge 105 may be supplied as a pre-assembled applicator and two separate glass vials. The two glass vials may contain either an activated polyethylene glycol (PEG) ester powder or a polyethyleneimine (PEI) dissolved in sterile water. The crosslinking components may be reconstituted prior to use by their respective reconstitution buffers which are housed within theSYKCMF 3.4-054 applicator (e.g. , the barrels 115a, 115b). Examples of solutions which may be provided in the device are disclosed in U.S. Pat. Nos. 8,846,022; 9,878,066; 10,688,216; 8,410,189; and 11,027,043, the disclosures of which are hereby incorporated by reference in their entirety. The resulting soludons mix within the applicator, as described below in greater detail, and quickly crosslink to form a hydrogel sealant soon after exiting the applicator 100b. The delivered solution immediately crosslinks to form a hydrogel sealant which may be absorbed over time, e.g., approximately 20 to 100 days, which may be sufficient time to allow for healing of the surgical site.

[0092] Although not shown in FIG. 9, it is contemplated that the vial cartridge 105 may include a cover plate extending perpendicular to the first cartridge nose 108a and second cartridge nose 108b to conceal the interior of the vial cartridge 105. That is, the first and second cartridge noses 108a, 108b are shown protruding from a middle portion of the vial cartridge 105 in FIG. 9, and the cover plate may be disposed perpendicular to the middle portion where the cartridge noses 108a, 108b couple to the middle portion, the cover plate circumventing the cartridge noses 108a, 108b and shielding the interior components of the vial cartridge 105 (e.g. , the components disposed within the middle portion) from the user or exterior elements. Spray Applicator and Nozzle Assembly

[0093] As shown by the applicator 100b in FIG. IB, the housing 110 is also adapted to receive and couple to the nozzle assembly 150. The nozzle assembly 150 may be secured to the housing 110 via the same mechanical latch feature as described above. When the nozzle assembly 150 is coupled to the housing 110 as in FIG. IB, the applicator 100b is in a delivery state. The nozzle assembly 150 includes a nozzle assembly body 151, a first nozzle connector 152a and a second nozzle connector 152b. The nozzle connectors 152a, 152b are generally cylindrical and hollow protrusions extending proximally from the body 151 and are approximately equal in size and symmetrical with respect to a center axis extending along the length of the nozzle assembly 150. Each nozzle connector 152a, 152b defines a passage therethrough adapted to receive ends of a single-sided needle (e.g., first needle 171a and second needle 171b) as shown in FIGS. 12-13. Although not illustrated in FIGS. 11-12, it is contemplated that each of the nozzle connectors 152a, 152b may define an aperture or a window in a side thereof (e.g., the cylindrical surface circumferentially surrounding the respective needle 171a, 171b) to allow for increased visibility of the needles 171a, 171b for purposes of inspection during production. The windows may also be utilized for added visibility for the user.

[0094] When the nozzle assembly 150 is coupled to the housing and the applicator 100b is in the delivery state, the first and second needles 171a, 171b are positioned to couple to distal ends of the barrels 115a, 115b. For example, a proximal end of the first needle 171a may penetrate the nose of the first barrel 115a such that the chamber defined by the barrel 115a is in fluid communication with the first needle 171a. The needles 171a, 171b are in fluid communication with a Y-adaptor 158, which has a first end 158a and a second end 158b, which allows fluid to pass from the barrels 115a, 115b through the needles 171a, 171b and into the Y-adaptor 158. It should be noted that the proximal ends of the needles 171a, 171b penetrate the elastomeric caps 118a, 118b, respectively, and are disposed within the chambers of the barrels 115a, 115b, respectively, when the applicator 100b is in the delivery state.SYKCMF 3.4-054

[0095] The nozzle assembly 150 further includes an air flow connector 153 which is a generally cylindrical and hollow protrusion extending proximally from the body 151 having a size smaller than the nozzle connectors 152a, 152b. The air flow connector 153 defines a passage therethrough which extends toward and into the body 151. A nose 154 extends distally from a center of the body 151 , the nose 154 also having a generally cylindrical hollow shape. As such, the nose 154 may extend parallel to or, in some examples, be concentric with the longitudinal axis of the nozzle assembly 154 while the nozzle connectors 152a, 152b and the air flow connector 153 are offset and parallel to the longitudinal axis. Received within the hollow shape of the of nose 154 is an elongate outer tube 155 extending parallel to (and may in some examples be collinear with) the longitudinal axis of the nozzle assembly 150. An air filter may optionally be included within the air flow connector 153 to filter the air passing from the air pump to the distal dp of the nozzle.

[0096] As shown in FIG. 13, a first elongate tube 156a and a second elongate tube 156b (e.g. , hypodermic tubes) extend from a distal end of the Y-adaptor 158 and within outer tube 155. That is, the first and second elongate tubes 156a, 156b are circumferentially surrounded by the outer tube 155. The first and second elongate tubes 156a, 156b are cannulated and each define a fluid flow path therewithin. In other words, the first elongate tube 156a defines a first fluid flow path and the second elongate tube 156b defines a second fluid flow path. The elongate tubes 156a, 156b are each in fluid communication with the Y-adaptor 158, and thus, when the nozzle assembly 150 is coupled to the housing 150 in the delivery state, the elongate tubes 156, 156b are also in fluid communication with the needles 171a, 171b, respectively, and the chambers of the barrels 115a, 115b, respectively. Accordingly, fluid can be translated, for example, from the first barrel 115a through the first needle 171a, through the first end 158a of the Y-adaptor 158 and additionally through the first elongate tube 156a.

[0097] Located at the distal portion of the nozzle assembly 150 is a separator 160, a mixing baffle 162 and a cap 164 peripherally surrounding the separator 160 and the mixing baffle 162. The separator 160 is disposed between and extends distally from the first and second elongate tubes 156a, 156b, as shown in FIGS. 14-17. The cap 164 is hollow and defines an internal space which receives fluid after the fluid escapes distally from the elongate tubes 156a, 156b. The separator 160 is generally rectangular in shape but fits snugly within the cap 164 so as to separate a portion of the cap into two separate channels. The separator 160 may have a proximal portion wedged between the elongate tubes 156a, 156b and a distal portion extending distally beyond distal ends of the elongate tubes 156a, 156b.

[0098] The separator 160 compartmentalizes a portion of the internal space of the cap 164 such that the separator 160 defines two separate channels within the cap 164: a first fluid channel 161a adjacent to and in communication with the fluid flow channel of the first elongate tube 156a, and a second fluid channel 161b adjacent to and in communication with the fluid flow channel of the second elongate tube 156b. Accordingly, when fluid is translated distally, for example, through the first elongate tube 156a and escapes the channel of the first elongate tube 156a, the fluid then enters the first fluid channel 161a which is defined between an interior surface of the cap 164 and a first side of the separator 160. Furthermore, when fluid is translated distally through the second elongate tube 156b and escapes the channel of the second elongate tube 156b, the fluid then enters a second fluid channel 161b defined between an interior surface of the capSYKCMF 3.4-054164 and a second side of the separator 160 opposite the first side. Thus, the separator 160 maintains separation between fluid from the first elongate tube 156a and fluid from the second elongate tube 156b when the fluid enters the cap space. The separator 160 prevents the fluid streams from reacting prematurely. That is, if the fluid streams react before being sufficiently proximate the exit port 170, they may begin to gel too early and cause clogging within the cap 164.

[0099] The mixing baffle 162 extends distally from the separator 160, as shown in FIGS. 14-17. A proximal portion of the mixing baffle 162 includes an inner wall section 163 continuing from the separator 160, the inner wall 163 maintaining further separation between the fluid channels. Meanwhile, outer walls165 of the mixing baffle 162 extend distally further than the inner wall 163 as shown in FIG. 18 and define a mixing chamber 166 between the outer walls 165 at a location distal to a terminal edge of the inner wall 163. Thus, fluids from the first and second fluid flow channels 161a, 161b may freely flow through the mixing baffle 162 into the mixing chamber 166 to mix with each other. Interior surfaces of the outer walls 165 of the mixing baffle 162 may be formed to create a smooth fluid path from the tubes 156a, 156b into the mixing chamber 166 to prevent the pre-mixing of the two constituted solutions before reaching the mixing baffle 162. Such a design may reduce the chance of clogging in the distal tip of the nozzle assembly. For example, the interior surfaces may be curved, as illustrated, or alternatively form various planar surfaces angled with respect to one another. A distal end of the mixing baffle 162 is open-ended and in communication with an exit port 170, which is an orifice defined by a distal surface of the cap 164 through which fluids are able to pass through to exit the nozzle assembly 150. Thus, the mixing baffle 162 directs the fluid streams into each other to interact and mix adjacent the exit port 170.

[0100] The mixing baffle 162 includes a pair of alignment protrusions 167a and 167b which protrude radially outward from the mixing baffle 162 and extend longitudinally along opposing outer surfaces of the mixing baffle 162. The alignment protrusions 167a, 167b are positioned to align with respective opposing longitudinal recesses defined by the cap 164 such that the protrusions 167a, 167b extend through the recesses and prevent relative axial and rotational movement between the mixing baffle 162 and the cap 164. The illustrated example includes two opposing protrusions, but any number of alignment protrusions and corresponding cap recesses are contemplated.

[0101] Given the outer tube 155 of the nozzle assembly 150 is hollow and surrounds the elongate tubes 156a, 156b, there exists space within the outer tube 155 that is outside of both elongate tubes 156a, 156b. As shown in FIG. 17, such space defines an air flow passage 168 adapted to contain and convey air pumped by the air pump 180 through the nozzle assembly 150 which contacts the fluids and pushes them toward and out the exit port 170. The air flow passage 168 extends parallel to and separately from the fluid flow passages defined by the elongate tubes 156a, 156b for a substantial length of the nozzle assembly 150. The air flow passage 168 is in fluid communication with the fluid flow channels approximately upon reaching the space defined within the cap 164. That is, air travelling distally through the air flow passage 168 exits the air flow passage 168 andSYKCMF 3.4-054 enters each of the fluid channels 161a, 161b. Air pumped by the air pump 180 will therefore interact with any fluid travelling through the fluid channels 161a, 161b and accelerate movement of the fluids through the cap 164 and mixing baffle 162 generally toward the exit port 170.

[0102] In some examples, the nozzle assembly 150 is provided to the user separately from the housing 110, in which case the user may be tasked with coupling the nozzle assembly 150 to the housing 110. To assist the user with properly orienting the nozzle assembly 150 relative to the housing 110, the first nozzle connector 152a has an alignment indicator or marking 159a and the second nozzle connector 152b has an alignment indicator or marking 159b as shown in FIG. 20. The markings 159a, 159b may respectively correspond to similar markings on the housing 110 so as to indicate which elongate tube 156a, 156b should correspond to and be in communication with which barrel 115a, 115b.

[0103] In addition to the alignment markings 159a, 159b, the nozzle assembly 150 includes a first male mating feature 172a located on an outer edge of the proximal face. The nozzle assembly 150 further includes a second male mating feature 172b located on an outer edge of the proximal face opposite the first male mating feature 172a. The second male mating feature 172b is sized and / or shaped differently than the first male mating feature 172a. Meanwhile, the housing 110 defines a first female mating feature 173a located on an outer edge of the distal face and a second female mating feature 173b located on an outer edge of the distal face opposite the first female mating feature 173a. Again, the first female mating feature 173a is sized and / or shaped differently than the second female mating feature 173b.

[0104] The first male mating feature 172a of the nozzle assembly is positioned to align with and mate with the first female mating feature 173a of the housing 150 when the nozzle assembly 150 is coupled to the housing as shown in FIG. 23. Furthermore, the second male mating feature of the nozzle assembly 150 is positioned to align and mate with the second female mating feature 173b of the housing 150 when the nozzle assembly 150 is coupled to the housing 110. However, the mating features are sized and shaped such that the first male mating feature 172a is not adapted to mate with the second female mating feature 173b and the second male mating feature 172b is not adapted to mate with the first female mating feature 172a. Accordingly, if the user attempts to couple the nozzle assembly 150 to the housing 110 with improper alignment (e.g., the first nozzle connector 152a is aligned with the second barrel 115b instead of the first barrel 115a and the nozzle assembly 150 is “upside down”), the differing sizes and / or shapes of the mating features will prevent the nozzle assembly 150 from properly attaching to the housing 110. This will prevent a user from inadvertently attaching the nozzle assembly 150 with the wrong orientation, which in turn prevents clogging of the nozzle assembly in the locations of its needles 158a, 158b.SYKCMF 3.4-054

[0105] The male mating features 172a, 172b may be protrusions, lips or any suitable piece able to be inserted into a space defined by the female mating features 173a, 173b. The female mating features 173a, 173b may span differing distances (e.g., in a vertical direction as shown in FIG. 21). In the illustrated example, the second female mating feature 173b spans a distance greater than the first female mating feature 173a, and the male mating features 172a, 172b are sized such that the second male mating feature 172b is able to fit within the space defined by the second female mating feature 173b but is too large to be inserted into or fit within the space defined by the first female mating feature 173a. It is contemplated, however, that the mating features are not limited to the illustrated example and the sizes and shapes thereof can vary in any way and still accomplish the same objective. It is also noted that alignment marking 159a corresponds the side of the nozzle assembly 150 having the first male mating feature 172a and the alignment marking 159b corresponds to the size of the nozzle assembly 150 having the second male mating feature 172b. Of course, any suitable structure or structures can be employed to serve the function of the mating structures described above.

[0106] Furthermore, a fastener 169 extends from the body 151 of the nozzle assembly 150 and is positioned to correspond and align with the ramped catch 113 (see FIG. 21) formed on the housing 110 to affix the nozzle assembly 150 relative to the housing 110. Similar to the fastener 112 of the vial cartridge 105 described above, the fastener 169 may be coupled to the catch 113 via relative axial movement and / or pressure of the nozzle assembly 150 toward the housing 110. It is also contemplated that the nozzle assembly 150 may be decoupled from the housing by applying a downward pressure on a top of the body 155 of the nozzle assembly 150 to unlock the fastener 169 from the catch 113 and then pulling the nozzle assembly 150 apart from the housing 110 in the axial direction.

[0107] The connection between the nozzle assembly 150 and the housing 110 will be discussed herein in more detail with reference to FIGS. 21-23. FIG. 21 illustrates a distally facing face of the housing 110 and FIG. 22 illustrates a proximally facing face of the nozzle assembly 150 which are brought together to contact one another when the nozzle assembly 150 is coupled to the housing 110. That is, the barrel cover 119a is positioned to be inserted into the first nozzle connector 152a and the second barrel cover 119b is positioned to be inserted into the second nozzle connector 152b when the nozzle assembly 150 is coupled to the housing 110. The air flow tube 182 is sized and position to be inserted into the air flow connector 153 to form a communicative passage for conveying air flow pumped by the air pump 180 through the housing 110 and the nozzle assembly 150.

[0108] The housing includes the power source 186 (e.g., a disposable battery, an external battery, or the like) disposed therewithin and a housing terminal 188 generally proximate to the powerSYKCMF 3.4-054 source 186. In the illustrated example, the power source 186 is a disposable battery held securely in place by a battery cover 187, but other sources of power are contemplated as well. Both the power source 186 and the housing terminal 188 are exposed on and protruding from a distal face of the housing 110 as shown in FIG. 21.

[0109] The nozzle assembly 150 includes an electrically conductive element 190 which is exposed on a proximal face of the nozzle assembly 150. The electrically conductive element 190 is generally rectangular and includes a first nozzle terminal 191 and a second nozzle terminal 192 spaced from the first nozzle terminal 191. The electrically conductive element 190 is sized and positioned to align with and form an electrical interface with the power source 186 and the housing terminal 188 as shown in FIG. 24. The first nozzle terminal 191 is approximately centered on the proximal face of the nozzle assembly 150 and is positioned to align with the power source 186 which is approximately centered on the distal face of the housing 110. The second nozzle terminal 192 is offset from a center axis of the nozzle assembly 150 and is positioned to align with the housing terminal 188 which is offset from a center axis of the housing 110. In other words, the first nozzle terminal 191 and the second nozzle terminal 192 mirror the power source 186 and the housing terminal 188, respectively, so that the first nozzle terminal 191 contacts the power source 186 and the second nozzle terminal 192 contacts the housing terminal 186 when the nozzle assembly 150 is attached and secured to the housing 110. The electrically conductive element may be formed of any material, such as a metal, which is conducive to conducting electricity provided by the power source 186.

[0110] The housing 110 includes electrically conductive wiring to operatively couple the power source 186 to the air pump 180, as shown in FIG. 25. The air pump 180 includes a first terminal 183a and a second terminal 183b located on an end surface of the air pump 180. A first wire 184 has a first end 184a which couples to (e.g., contacts) the first air pump terminal 183a and extends through the housing 110 to contact an end of the power source 186. In some examples, the first end 184a may be formed in a coil extending along and pressed between the air pump 180 and the interior of the housing to increase the contact points and stability of connection of the first terminal 183a and the first end 184a of the first wire 184. The coil may be oriented such that it extends longitudinally perpendicular to a longitudinal direction of the air pump 180, or alternatively parallel to the longitudinal direction of the air pump 180. A second wire 185 couples to (e.g., contacts) the second air pump terminal 183b and extends through the housing 110 to contact the housing terminal 188 at its second end 185b. Similarly, the second wire 185 may also be formed in a coil extending along and pressed between the second air pump terminal 183b and the interior of the housing. In some examples, the housing terminal 188 may be the second end 185b of theSYKCMF 3.4-054 second wire 185 itself, and in other examples, the housing terminal 188 may be a separate electrically conductive piece which is contacted by the second end 185b of the second wire 185.

[0111] The wires 184, 185 may be formed of a material having shape-memory properties such that the wire has a resting configuration and is able to be elastically deformed from its resting configuration by an external force and still return to its resting configuration after the external force is removed. As such, the second end 184b of the first wire 184 which contacts the power source 186 may be formed in a helical spring shape extending along an axis as shown in FIG. 25. A proximal end of the power source 186 may then contact the helical spring-shaped end 184b of the first wire 184 when positioned within the housing 110, deforming the helical spring-shaped wire end 184b from its resting configuration and thereby causing the helical spring to be biased toward the power source 186 and ensure contact is maintained therebetween. Similarly, in an example in which a second end 185b of the second wire 185 which forms the housing terminal 188, the second end 185b of the second wire 185 may be formed in the helical spring shape for maintaining contact for the second nozzle terminal 192 of the electrically conductive element 190.

[0112] The components shown in the housing 110 in FIG. 25 form an open circuit. That is, the air pump 180 contacts the first wire 184 where the first end 184a of the first wire 184 meets the first air pump terminal 183a, and the first wire 184 then extends from the first end 184a to the second end 184b. The air pump also contacts the second wire 185 where the first end 185a of the second wire 185 meets the second air pump terminal 183b, and the second wire 185 then extends from the first end 185a to the second end 185b. The power source 186 may be inserted into the housing 110 so that the proximal end of the power source 186 contacts the second end 185b of the second wire 185 and the distal end of the power source 186 is exposed at the distal face of the housing 110. So long as the nozzle assembly 150 is separated from or detached from the housing 110, the electrical circuit remains open. However, when the nozzle assembly 150 is attached and secured to the housing 110, the electrically conductive element 190 completes and closes the electrical circuit via contact between the distal end of the power source 186 and the first nozzle terminal 191 and contact between the housing terminal 110 (e.g., the second end 185b of the second wire 185) and the second nozzle terminal 192.

[0113] The first air pump terminal 183a and the housing terminal 188 may be positive terminals and the second air pump terminal 183b and the second end 184b of the first wire 184 may be negative terminals, or vice versa. Completion and closure of the electrical circuit results in activation of the air pump 180, and air is continuously pumped through the housing 110 and nozzle assembly 150 for as long as the nozzle assembly 150 is attached to the housing 110 and / or the power source 186 has remaining power to supply. By the attachment of the nozzle assembly 150 closing the electrical circuit, the need for a power button is eliminated, which both removes a stepSYKCMF 3.4-054 in the process of use for the user’s convenience and also reduces / eliminates the chance for inadvertent error in forgetting to activate the air pump before use.

[0114] As can be seen in FIGS. 14-18, the design of the distal portion of the nozzle assembly (e.g., the separator 160, the mixing baffle 162, and the cover 164) is optimized for fluid flow at the nozzle tip to allow for pauses and stops in the application without solution or fluids dribbling out of the applicator and to reduce or prevent clogs. The cover 164 may have a concave shape to minimize the axial length of the exit port 170 and thus limit the opportunity for clogging in the exit port 170, though any suitable shape will suffice.

[0115] The illustrated embodiment is described above, but it is noted that other embodiments and modifications to the illustrated embodiment are also contemplated. For example, the device may include any number of vials, e.g., one vial or three or more vials, and the device may be modified to have a corresponding number of barrels. For instance, the device may have only one vial and one barrel, or three vials and three barrels, in which case the device may also have three needles, and the Y-adaptor of the nozzle assembly may have three branches fluidly communicating the barrels with nozzle assembly. In other examples, the vials may be configured to be coupled directly to the housing (e.g., the distal ends of the needles) without the need for a vial cartridge containing the vials therein. In other examples, shielding ribs may be included on the outside of the nozzle assembly to limit tip occlusions for situations in which the tip is pushed up against a tissues or structure at the surgical site. The shielding ribs would allow for better flow of air and / or material even if the tip is pushed up against the tissue or structure.

[0116] In further examples, the housing can have any of several form factors. For example, the applicator can be shaped like a gun with a pistol style grip, a pen, or any number of other forms. In further examples, the detent holding the needle assemblies in place in the shipping state may include a protrusion defined by an interior surface of the housing which is sized and positioned to engage with a recess defined by the needle assembly, as may be described as the inverse of the illustrated embodiment. In other examples, the applicator may employ compressed air or gas to create air pressure and air flow through the device to convey the fluids out the distal end of the nozzle.

[0117] It is further contemplated that the conductive element 190 may be disposed on the housing 110 (e.g., the terminal 188) rather than the nozzle assembly 150. In such an arrangement, when the user inserts the nozzle assembly 150 into housing 110, a mechanical feature of the nozzle assembly 150 may deflect the housing terminal 188 so that it contacts the battery terminal 186, thus closing the electrical circuit between the air pump and the battery assembly. In other words, the device still operates in substantially the same manner, but the conductive element 190 is affixed on the housing rather than the nozzle assembly.SYKCMF 3.4-054

[0118] In further examples, FIG. 26 illustrates a distally facing face of another housing 210 in a manner similar to the example shown and described with respect to FIG. 22, wherein like numerals correspond to like features. A power source 286 (e.g., a disposable battery) is secured in place by a cover 287 for use and operation of the device. The cover 287 may define an aperture 287a therethrough and may be deformable such that it can be deformed or adjusted to reveal the socket defined by the device for receiving the power source 286. The cover 287 may then be adjusted to cover the power source 286 and hold it in place after insertion of the power source 286 into the device. The cover 287 may be biased in a closed position (i.e., covering the power source 286) and the cover 287 may be deformable to an open position. As such, a user may deform the cover 287 from the closed position to the open position to reveal the battery socket, and the cover 287 may be returned to the closed position by the user or return to the closed position after being released by the user. Alternatively, the cover 287 may have a hinged connection about which the cover 287 deforms to reveal the socket. The cover 287 may be formed of any material which as capable of deforming and returning to its original shape or position, such as a plastic, polymer or a shape memory material.

[0119] Furthermore, a wire 284 may be disposed between the cover 287 and the power source 286, the wire 284 passing transverse to the socket defined by the housing 210 for receipt of the power source 286. After the power source 286 is disposed in the socket and the cover 287 is arranged in the closed position to secure the power source 286 within the socket, but before the housing 210 is coupled to the nozzle assembly 150, a space may exist between the wire 284 and the power source 286 separating the two components, thereby maintaining an open circuit between the air pump 180 and the power source 286. The nozzle assembly 150 may include a protrusion (not shown) which corresponds in size and position to extend through the aperture 287a of the cover 287 when the nozzle assembly 150 is coupled to the housing 210. After the nozzle assembly 150 is coupled to the housing 110, the protrusion on the nozzle assembly 150 may extend through the aperture 287a and press against the wire 284 in the proximal direction such that contact between the wire 284 and the power source 286 is formed and maintained so long as the nozzle assembly 150 remains coupled to the housing 210, thereby closing the circuit between the power source 286 and the air pump 180 and activating the device.

[0120] In further examples, a housing 310 according to another embodiment of the disclosure is illustrated in FIGS. 27, 28A-28B, and 29A-29B. The housing 310 may be formed by the coupling of a first housing part 310a and a second housing part 310b. The first housing part 310a includes several male coupling members 312a (e.g., latches) spaced from one another and protruding from an edge of the first housing part 310a in an interior direction (e.g., toward the second housing part 310b when the housing parts are coupled). Each of the male coupling members 312a is generallySYKCMF 3.4-054 rectangular and defines an aperture 314a therethrough in the middle thereof such that the aperture 314a is bounded on all sides. A first side 316a of each male coupling member 312a overlaps with the first housing part 310a and is fastened or secured to the first housing part 310a (e.g., may be monolithically coupled to the first housing part 310a). A second side 318a opposing the first side 316a protrudes from the first housing part 310a and is adapted to overlap with a surface of the second housing part 310b when the first and second housing parts 310a, 310b are coupled to one another. Thus, the second side 318a of each male coupling member 312a forms a generally U- shape extending from the first housing part 310a as shown in FIG. 27.

[0121] The second housing part 310b includes several female coupling members 312b, each of which corresponds in size and positioning to a respective male coupling member 312a on the first housing part 310a. Each female coupling member 312b includes a recess 313b formed in a surface of the second housing part 310b, and includes a ramp 315b protruding from the recessed surface 313b, as shown in FIG. 27. The recessed surface 313b surrounds the ramp 315b on three sides, and the recessed surface 313b therefore defines space to receive the second side 318a (e.g., Ilshaped portion) of the corresponding male coupling member 312a. The ramp 315b is inclined in a direction away from the first housing part 310a. Each of the male coupling members 312a are formed of a material (e.g., plastic, polymer, or the like) which is elastically deformable, such that each male coupling member 312a is configured to deform when engaged with the corresponding ramp 315b. That is, as the first housing part 310a is initially pressed to the second housing part 310b for coupling together, each male coupling member 312a contacts an initial (e.g., relatively lower inclined) portion of the ramp 315b. As the first housing part 310a and the second housing part 310b are pressed further toward one another, the second side 318a of the male coupling member 312a travels along the ramp 315b and elastically deforms until the aperture 314a of the male coupling member 312a aligns fully (e.g., vertically) with the ramp 315b and the male coupling member 312a aligns with the recessed surface 313b of the female coupling member 312b, causing the male coupling member 312a to return to its undeformed configuration and fully surround the ramp 315b as shown in FIGS. 28B and 29B. In the closed configuration of the housing 310 (i.e., when the various male coupling members 312a are fully coupled to corresponding female coupling members 312b), the rear surface 317b of the ramp 315b abuts the aperture-facing surface 320a on the second side 318a of the male coupling member 312a as shown in FIG. 29B, thereby locking the male and female coupling members 312a, 312b and securing the first housing part 310a to the second housing part 310b.

[0122] Method of Using Spray Applicator and Its Components

[0123] An example method and process of using the applicator 100a, 100b is described herein. As described above, the applicator may be in any one of a shipping state, a preparation state, andSYKCMF 3.4-054 a delivery state, which will be referenced herein while describing the method. In the present example, the applicator 100a is provided to the user in the shipping state, wherein the needles 130a, 130b are spaced from both the vials 107a, 107b, respectively, and the needles 130a, 130b are also spaced from the barrels covers 119a, 119b, respectively. Also in the shipping state, the pusher 125 may be in a retracted position, the first vial 107a may be filled with a first fluid (e.g., PEI), the second vial 107b may be filled with a second fluid (e.g., PEG), and the barrels 115a, 115b may be filled with buffer solutions.

[0124] The user may then apply an axially compressive force to the proximal end 102 and the distal end 104 of the applicator, e.g., pressing the housing 110 toward the vial cartridge 105 and / or pressing the vial cartridge 105 toward the housing 110, to transition the applicator 100a from the shipping state to the preparation state. While in the preparation state, when the chambers of the vials 107a, 107b are in fluid communication with the chambers of the barrels 115a, 115b, respectively, the user may depress the pusher 125 to deposit the buffer solution of the first barrel 115a into the first vial 107a and the buffer solution of the second barrel 115b into the second vial 107b. The solutions of each vial 107a, 107b may then be mixed optionally by shaking or other additional agitation to prepare the solutions. It is noted that the barrels 115a, 115b may be provided with different buffer solutions, e.g., a first buffer solution intended to mix with a solution in the first vial 107a and a second buffer solution intended to mix with a solution in the second vial 107b. It may be important to orient the vial cartridge 105 properly with respect to the housing 110, thus demonstrating the importance of the alignment features described above on the nozzle assembly 105 and the housing 110, so that the vials 107a, 107b receive the appropriate buffer solutions.

[0125] After the solutions are prepared in the vials 107a, 107b, the user may retract the pusher 125 (e.g., pull the pusher 125 in the proximal direction) to translate and withdraw the solution of the first vial 107a into the first barrel 115a and the solution of the second vial 107b into the second barrel 115b. When the barrels 115a, 115b are filled to a desirable level, the vial cartridge 105 may be decoupled and detached from the housing 110 by pressing on a body of the vial cartridge 105 to deform or displace the vial cartridge fastener 112 and pulling the vial cartridge 105 apart from (e.g., proximally relative to) the housing 110. Detachment of the vial cartridge 105 thereby removes the double-sided needles 130a, 130b as well. Because the double-sided needles 130a, 130b are removed from the housing 110, the “healing” property of the elastomeric tips 118a, 118b is helpful to prevent fluids from leaking out of the barrels 115a, 115b between the time after the needles 130a, 130b and prior to the installation of the nozzle assembly 150.

[0126] Next, the nozzle assembly 150 may be coupled to and secured to the housing 110 by aligning the proximal face of the nozzle assembly 150 with the distal face of the housing 110. TheSYKCMF 3.4-054 user may refer to the alignment markings 159a, 159b to determine the proper orientation of the nozzle assembly 150 relative to the housing. After determining the proper orientation of the markings 159a, 159b, the user may apply an axially compressive pressure or force upon the housing 110 and nozzle assembly 150 so that the fastener 169 of the nozzle assembly 150 is secured to the catch 113 and the single-sided needles 171a, 171b penetrate the barrels 115a, 115b, respectively, by piercing the corresponding elastomeric tips 118a, 118b. As the nozzle assembly 150 is attached, the electrical circuit is closed, thereby activating the air pump 180, and the applicator 100b enters the delivery state. As noted above, the air pump 180 may be automatically activated when operatively coupled to the power source, eliminating the need for an additional actuation step required by the user and therefore improving ease and efficiency and ensuring proper use.

[0127] With air being consistently pumped through the housing 110 and the nozzle assembly 150 and flowing out the exit port 170, the applicator 100b may then be positioned proximate a surgical site and the fluids contained within the barrels 115a, 115b may be dispensed via actuation of the pusher 125. Actuation may occur by depressing the pusher 125 distally relative to the housing 150 so that the plungers 120a, 120b translate distally and increase distal pressure on the fluids contained within the barrels 115a, 115b to push the fluids through the needles 171a, 171b, through the Y-adaptor 158, through the elongate tubes 156a, 156b, through the fluid channels 161a, 161b, into the mixing chamber 166 and out the exit port 170. The addition of air flow pressurizing and carrying the fluids toward the exit port 170 mitigates potential clogging within the nozzle assembly 150 so that the fluids are dispensed in a desirable state (e.g., before the fluids are given excessive time to chemically react within the mixing chamber 166 to solidify or become excessively gel-like before exiting the nozzle assembly 170). Once application has begun by applying pressure to the pusher 125 and at least partially depressing the pusher 125, it may be stopped at any time by manually decreasing the pressure on the pusher 125 and plungers 120a, 120b, and pressure may be resumed again thereafter.

[0128] In some examples, applicator 100b may be disposable and intended for one-time use. In other examples, the applicator 100b may be sterilized, the nozzle assembly 150 may be detached from the housing 110, and the process described above may be repeated with a new vial cartridge while using the same housing 110 and nozzle assembly 150.

[0129] Kit for Spray Applicator and Components Thereof

[0130] The applicator 100a, 100b and associated components described throughout the disclosure may be provided to the user in a kit. In some examples, the applicator 100a may be packaged and provided with the vial cartridge 105 partially coupled to the housing 110 (e.g., in the shipping state) as described above, and the nozzle assembly 150 may be provided separately in the same orSYKCMF 3.4-054 a different package. In other examples, the housing 110, the vial cartridge 105 and the nozzle assembly 150 may be provided all separately from one another in either the same or different packages, and of course shipped separately and / or stored separately from one another before being used together. In any of the examples described above, the power source 160 may be provided within the housing 110 or separately from the housing 110. For instance, a pair of batteries may be provided within the housing 110 and maintained in position by the battery cover 187, or alternatively, a pair of disposable batteries may be provided in a package either alongside or attached to a package containing the housing 110.

[0131] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made, and are encouraged to be made, to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

SYKCMF 3.4-054CLAIMS1. An applicator comprising: a housing including: a first barrel extending between a proximal end and a distal end; a first plunger moveably received within the first barrel; a first needle coupleable to the first barrel and configured to extend distally therefrom; a second barrel extending between a proximal end and a distal end; a second plunger moveably received within the second barrel; a second needle coupleable to the first barrel and configured to extend distally therefrom; the housing being configured to removably receive a first vial in association with a distal end of the first needle and to removably receive a second vial in association with a distal end of the second needle; a nozzle assembly coupleable to the housing, the nozzle assembly including: a first fluid flow path configured to communicate with the first barrel; a second fluid flow path configured to communicate with the second barrel; the applicator having a first state and a second state, both when the first and second vials are received within the housing; whereby, in the first state, the first needle is spaced from the first barrel and the first vial, and the second needle is spaced from the second barrel and the second vial; and whereby, in the second state, a proximal end of the first needle penetrates the first barrel, the distal end of the first needle penetrates the first vial, a proximal end of the second needle penetrates the second barrel, and the distal end of the second needle penetrates the second vial.

2. The applicator of claim 1 , wherein the first state is a shipping state in which the applicator is configured to be transported to a user, and the second state is a preparation state in which the applicator is configured to be prepared for use.

3. The applicator of claim 1, wherein the first needle includes a first detent configured to adjustably fix the applicator in the first state.

4. The applicator of claim 3, wherein the first detent is included on a first support structure coupled to and surrounding the first needle.

5. The applicator of claim 4, wherein the first support structure includes a first wing and a second wing opposite the first wing, each of the first and second wings extending radially outward relative to the first needle.SYKCMF 3.4-0546. The applicator of claim 5 , wherein the first wing includes a first elongate portion extending generally parallel to the first needle configured to be elastically deformable, and wherein the second wing includes a second elongate portion extending generally parallel to the first needle configured to be elastically deformable.

7. The applicator of claim 6, wherein the first wing includes a first protrusion extending radially outward relative to the first needle, the first protrusion adapted to removably engage a first recess defined by an interior surface of a vial cartridge holding the first and second vials.

8. The applicator of claim 7, wherein the second wing includes a second protrusion extending radially outward relative to the first needle, the second protrusion adapted to removably engage a second recess defined by the vial cartridge.

9. The applicator of claim 7, wherein when the applicator is in the first state, the first protrusion is removably disposed within the first interior recess and the second protrusion is removably disposed within the second interior recess.

10. The applicator of claim 7, wherein when the applicator is in the second state, the first protrusion is displaced and spaced from the first interior recess and the second protrusion is displaced and spaced from the second interior recess.

11. The applicator of claim 3, wherein the second needle includes a second detent configured to adjustably fix the applicator in the first state.

12. The applicator of claim 11, wherein the first detent is a first protrusion extending radially outward relative to the first needle and the second detent is a second protrusion extending radially outward relali ve to the second needle, and wherein the first protrusion and second protrusion are movably fixed to a vial cartridge in the first state.

13. The applicator of claim 1 , further comprising the first and second vials removably coupled to the housing.

14. The applicator of claim 13, wherein the first vial and the second vial are contained within a vial cartridge to form a vial assembly, and wherein the vial assembly is coupled to the housing in the first state and the second state.SYKCMF 3.4-05415. The applicator of claim 1, wherein the applicator has a third state in which the nozzle assembly is coupled to the housing.

16. The applicator of claim 15, wherein the third state is a delivery state in which the applicator is configured to dispense a fluid.

17. The applicator of claim Al 5, wherein when the applicator is in the third state, a third needle disposed within the nozzle assembly is coupled to the first barrel and the first fluid flow path and a fourth needle disposed within the nozzle assembly is coupled to the second barrel and the second fluid flow path.

18. The applicator of claim 17, wherein when the applicator is in the third state, the third needle fluidly communicates the first barrel with the first fluid flow path and the fourth needle fluidly communicates the second barrel with the second fluid flow path such that a first fluid is configured to be transmitted from the first barrel to the nozzle assembly and a second fluid is configured to be transmitted from the second barrel to the nozzle assembly when a pressure is applied to the first and second plungers.

19. The applicator of claim 1, wherein the first barrel includes a first elastomeric cap and wherein the first needle is configured to pierce the elastomeric cap when the applicator is in the second state.

20. The applicator of claim 19, wherein when the applicator is in the second state, the first needle fluidly communicates the first barrel with the first vial such that retraction of the first plunger is configured to translate a first fluid from the first vial toward the first barrel.

21. The applicator of claim 19, wherein the first elastomeric cap is configured to prevent a first fluid from passing therethrough after the first needle has penetrated the first elastomeric cap and decoupled from the elastomeric cap.

22. An applicator comprising: a housing including: a first barrel extending between a proximal end and a distal end; a first plunger moveably received within the first barrel; a first needle couplable to the first barrel and configured to extend distally therefrom; the housing being configured to removably receive a first vial in association with a distal end of the first needle; a nozzle assembly coupleable to the housing, the nozzle assembly including: a first fluid flow path configured to communicate with the first barrel;SYKCMF 3.4-054 the applicator having a first state and a second state, both when the first vial is received within the housing; whereby, in the first state, the first needle is spaced from the first barrel and the first vial; and whereby, in the second state, a proximal end of the first needle penetrates the first barrel, and the distal end of the first needle penetrates the first vial.

23. The applicator of claim 22, wherein the housing further includes: a second barrel extending between a proximal end and a distal end; a second plunger moveably received within the second barrel; a second needle coupleable to the first barrel and configured to extend distally therefrom; the housing being configured to removably receive a second vial in association with a distal end of the second needle; the nozzle further includes: a second fluid flow path configured to communicate with the second barrel; wherein the second vial is received within the housing in both the first state and the second state; whereby, in the first state, the second needle is spaced from the second barrel and the second vial; and whereby, in the second state, a proximal end of the second needle penetrates the second barrel, and the distal end of the second needle penetrates the second vial.

24. A method for using an applicator, comprising: providing the applicator in a first state in which a first vial and a second vial are removably coupled to a housing of the applicator, the housing including a first barrel and a second barrel, a first needle adjacent the first barrel and a second needle adjacent the second barrel, wherein in the first state, the first needle is spaced from the first vial and the second needle is spaced from the second vial; transitioning the applicator from the first state to a second state in which the first needle penetrates the first barrel and the first vial and the second needle penetrates the second barrel and the second vial; retracting a plunger moveably coupled to the first and second barrels to translate a first fluid from the first vial to the first barrel and a second fluid from the second vial to the second barrel; decoupling the first and second vials from the housing; coupling a nozzle assembly to the housing such that the first barrel is in fluid communication with a first fluid flow path of the nozzle assembly and the second barrel is in fluid communication with a second fluid flow path of the nozzle assembly; and pressing the plunger to translate the first fluid from the first barrel through the first fluid flow path and the second fluid from the second barrel through the second fluid flow path.SYKCMF 3.4-05425. The method of claim 24, wherein transitioning the applicator from the first state to the second state includes applying an external force to one of the housing or the first and second vials toward the other of the housing and the first and second vials.

26. The method of claim 24, wherein the first state is a shipping state in which the applicator is configured to be shipped, and the second state is a preparation state in which the applicator is configured to be prepared for use.

27. The method of claim 24, wherein in the first state, a proximal end of the first needle is spaced from the first barrel and a distal end of the first needle is spaced from the first vial, and a proximal end of the second needle is spaced from the second barrel and a distal end of the second needle is spaced from the second vial.

28. The method of claim 24, wherein the step of pressing the plunger includes translating the first fluid from the first barrel into a mixing chamber of the nozzle assembly and translating the second fluid from the second barrel into the mixing chamber, and the method further comprises mixing the first fluid and the second fluid in the mixing chamber.

29. The method of claim 28, wherein the step of pressing the plunger includes expelling the first fluid and second fluids from the applicator via an exit port of the nozzle assembly after mixing the first and second fluids in the mixing chamber.

30. The method of claim 29, wherein an air flow passes through the nozzle assembly and interacts with a mixture formed by mixing the first and second fluids to push the mixture toward the exit port and out of the nozzle assembly.

31. The method of claim 24, further comprising, before the step of decoupling the first and second vials from the housing, pressing the plunger to translate a first buffer solution from the first barrel to the first vial and a second buffer solution from the second barrel to the second vial.

32. The method of claim 24, wherein the step of coupling the nozzle assembly to the housing includes activating an air pump by closing an electrical circuit with a conductive element disposed on the nozzle assembly.

33. The method of claim 24, wherein the step of coupling the nozzle assembly to the housing includes orienting the nozzle assembly so that a first alignment indicator on the nozzle assembly aligns with a second corresponding alignment indicator on the housing.SYKCMF 3.4-05434. The method of claim 24, further comprising coupling a cartridge including the first vial and the second vial to the housing to provide the applicator in the first state.

35. The method of claim 34, wherein the step of coupling the cartridge to the housing includes orienting the cartridge so that a first mating feature on a side of the cartridge aligns with a second corresponding inaling feature on a corresponding side of the housing.

36. An applicator comprising: a housing including: a first barrel extending between a proximal end and a distal end; a first plunger moveably received within the first barrel; a first needle coupleable to the first barrel and configured to extend distally therefrom; an air pump configured to expel a fluid from the applicator; a power source configured to supply power to the air pump; a nozzle assembly coupleable to the housing, the nozzle assembly including: a first fluid flow path configured to communicate with a distal end of the first barrel; an electrically conductive element which is configured to close an electrical circuit between the air pump and the power source to acli vale the air pump when the nozzle assembly is coupled to the housing.

37. The applicator of claim 36, wherein the electrically conductive element includes a first terminal configured to contact a first end of the power source when the nozzle assembly is coupled to the housing.

38. The applicator of claim 37, wherein the first terminal is a positive terminal.

39. The applicator of claim 37, wherein a second end of the power source opposite the first end is coupled to a first terminal of the air pump by a wire.

40. The applicator of claim 39, wherein the first terminal of the air pump is a negative terminal.

41. The applicator of claim 36, wherein the electrically conductive element includes a first terminal configured to contact a spring wire extending from a first terminal of the air pump when the nozzle assembly is coupled to the housing.

42. The applicator of claim 36, wherein the power source is a disposable battery.SYKCMF 3.4-05443. The applicator of claim 36, wherein airflow from the air pump is configured to contact the fluid in a mixing chamber of the nozzle assembly to expel the fluid from the applicator.

44. A nozzle assembly for an applicator comprising: a first elongate tube defining a first fluid flow path configured to communicate with a first barrel of a syringe to receive a first fluid disposed in the first barrel; a second elongate tube defining a second fluid flow path configured to communicate with a second barrel of the syringe to receive a second fluid disposed in the second barrel; a separator disposed between and extending distally beyond the first elongate tube and the second elongate tube; a mixing baffle coupled to and extending distally from the separator; a cap peripherally surrounding the mixer and defining an orifice for expelling the first and second fluids from the nozzle assembly; and an outer tube peripherally surrounding the first and second elongate tubes, the outer tube defining an air passage extending adjacent to and separately from the first and second fluid flow paths, wherein the mixer and the cap define a first channel in fluid communication with the first fluid flow path and a second channel in fluid communication with the second fluid flow path, the first channel separated from the second channel by a proximal portion of the mixer; wherein the mixer and the cap define a mixing chamber distal to and in fluid communication with the first and second channels, and wherein the air passage is in fluid communication with the first channel and the second channel and the air passage is adapted to permit air pumped by an air pump to pass therethrough.

45. The nozzle assembly of claim 44, wherein the mixing baffle defines at least one curved wall configured to guide at least one of the first and second fluids therealong.

46. The nozzle assembly of claim 44, wherein the mixing baffle includes at least one protrusion extending a radially outward direction configured to be received by the cap to properly align the cap relali ve to the mixing baffle.

47. The nozzle assembly of claim 44, further comprising Y-adaptor disposed between and connecting the first elongate tube to the first barrel and the second elongate tube to the second barrel.

48. The nozzle assembly of claim 44, further comprising a first mating feature on a first side of a proximal surface of the nozzle assembly having a first size and shape, and a second mating feature on a second side of the proximal surface of the nozzle assembly having a second size and shape different from the first size and shape.SYKCMF 3.4-05449. The nozzle assembly of claim 48, further comprising an alignment graphic on an exterior surface of the nozzle assembly for identifying the first mating feature.

50. The nozzle assembly of claim 44, wherein a distal interior surface of the cap has a curved surface.

51. A kit comprising : an applicator housing including: a first barrel extending between a proximal end and a distal end; a first plunger moveably received within the first barrel; a first needle coupled to the housing and spaced from the first barrel; a first vial including a first fluid disposed therein, the first vial configured to be penetrated by a distal end of the first needle; and a nozzle assembly configured to be coupled to the applicator housing, the nozzle assembly including: a first fluid flow path configured to communicate with the first barrel.

52. The kit of claim 51 , wherein the first needle includes a detent configured to adjustably fix the first needle relative to the first vial while the first needle is spaced from the first vial and the first barrel.

53. The kit of claim 51 , wherein the applicator further includes: a second barrel extending between a proximal end and a distal end; a second plunger removably received within the first barrel; a second needle coupled to the housing and spaced from the second barrel; and wherein the kit further comprises: a second vial including a second fluid disposed therein, the second vial configured to be penetrated by a distal end of the second needle; and wherein the nozzle assembly further includes: a second fluid flow path configured to communicate with the second barrel.

54. A kit comprising: an applicator housing including: a first barrel extending between a proximal end and a distal end; a first plunger moveably received within the first barrel; a first needle coupled to the housing and spaced from the first barrel; a nozzle assembly configured to be coupled to the applicator housing, the nozzle assembly including: a first fluid flow path configured to communicate with the first barrel.SYKCMF 3.4-05455. The kit of claim 54, further comprising a first vial adapted to be removably coupled to the applicator housing in association with a distal end of the first needle.

56. The kit of claim 55, wherein the applicator housing and the nozzle are provided in a first package and the cartridge containing the first vial is provided in a second package.

57. The kit of claim 54, wherein the applicator housing further includes: a second barrel extending between a proximal end and a distal end; a second plunger moveably received within the second barrel; a second needle coupled to the housing and spaced from the second barrel.

58. The kit of claim 57, further comprising a first vial adapted to be removably coupled to the applicator housing in association with a distal end of the first needle and a second vial adapted to be removably coupled to the applicator housing in association with a distal end of the second needle.

59. The kit of claim 58, wherein the first vial and the second vial are included in a cartridge.

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