One-handed operation applicator for a double check valve

Abstract

To provide delivery devices, delivery systems and related methods for precise administration of hemostatic compositions, which include a trigger mechanism, a pusher, a valve and a cannula.SOLUTION: A pusher 9 is configured to engage with a trigger mechanism and retain a first syringe 10 at least by coupling with a plunger of the first syringe 10. A valve is fluidly coupled to the first syringe. The valve is further configured to engage with a second syringe in fluid communication with both the valve and the first syringe 10. A cannula extends distally from the valve and is fluidly coupled to the valve. Activation of the trigger mechanism causes the pusher 9 and the plunger of the first syringe 10 to translate in a distal direction so that a composition out of the first syringe 10 is expelled through the valve, through the cannula, and from a distal end of the cannula.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001]

[0001] In medical applications, it is important to prevent excessive bleeding. Currently, there are numerous procedures and related materials for preventing excessive bleeding and thus reducing the transfusion rate during surgery and other minor complications. One such example involves introducing barrier materials, such as metals, polymers, and natural materials, to the bleeding site. However, these products may not fit well with the underlying tissue. Other materials, such as nylon, cellophane, polytetrafluoroethylene, polyethylene, siloxane, elastomers, and polylactic acid copolymer films, are more flexible but non-biodegradable and thus remain in the body with unpredictable and potentially undesirable results. Additionally, the placement and fixation of implants at the bleeding site are often difficult.

[0002]

[0002] Alternative materials for preventing excessive bleeding may include non-solid anti-adhesion materials such as hemostatic matrix materials. The use of these materials requires sufficient fluidity to penetrate and conform to the area being treated while at the same time having sufficient viscosity to remain at the bleeding site until the tissue heals. Viscous materials often require high compressive forces for delivery. For example, it is often difficult to manually extrude a viscous material through a syringe. Furthermore, delivering non-solid anti-adhesion materials to bleeding sites on the body surface or within the body requires a high degree of user control. The material should be delivered in a controlled manner to target the therapeutically effective site, such as the bleeding site. For at least these reasons, any desired delivery device should be easy to use and control.

[0003]

[0003] A typical procedure for delivering a hemostatic material may include loading the hemostatic material into a delivery tube. Specifically, a surgeon can load the delivery tube by filling the delivery tube with a syringe. This can be a time-consuming process. Typically, in such a process, the delivery tube is placed by the surgeon at a location on the patient's body. Next, the surgeon inserts a stylet concentric with the delivery tube into the rear end of the delivery tube. By inserting the stylet into the rear end of the delivery tube, the hemostatic material is discharged from the front end of the delivery tube at the said location on the patient's body. This procedure requires the use of both hands, one hand to hold and position the delivery tube and the other hand to push the stylet. It is preferable to perform the procedure with one hand. Further, since the stylet cannot translate the delivery tube from beginning to end, a portion of the hemostatic material remains in the delivery tube, thus wasting the hemostatic material. It is preferable not to waste the hemostatic material unnecessarily.

[0004]

[0004] For the reasons described above, it is desirable to provide an improved delivery device, delivery system and related method for accurately administering a hemostatic material composition.

Summary of the Invention

[0005]

[0005] New delivery devices, delivery systems and delivery methods are described herein to improve treatment, particularly to prevent excessive bleeding. The present disclosure seeks to implement new devices, systems and methods for delivering a composition to a patient with a high degree of user control with respect to both the delivery location and the delivery rate, which can further reduce clogging of the delivery device, improve the preparation time associated with preparing to use the delivery device, and reduce wasteful material associated with incomplete delivery.

[0006] In a first aspect of the present disclosure, which may be combined with any other aspect enumerated herein without any limitation to the scope of the present invention unless otherwise specified, the delivery device includes a trigger mechanism, a pusher, a valve, and a cannula. The pusher is configured to engage with the trigger mechanism and couple with at least a plunger of a first syringe to hold the first syringe. The valve is fluidly coupled to the first syringe. The cannula extends distally from the valve and is fluidly coupled to the valve. Upon actuation of the trigger mechanism, the pusher and the plunger of the first syringe translate distally such that the composition within the first syringe is discharged from the distal end of the cannula through the cannula, through the valve, and out of the first syringe. The valve is further configured to engage with a second syringe such that the second syringe is in fluid communication with both the valve and the first syringe.

[0007] In a second aspect of the present disclosure, which may be combined with any other aspect enumerated herein without any limitation to the scope of the present invention unless otherwise specified, prior to actuation of the trigger mechanism, the composition is discharged from the second syringe through the valve into the first syringe such that the first syringe is filled with the composition by the second syringe.

[0008] In a third aspect of the present disclosure, which may be combined with any other aspect enumerated herein without any limitation to the scope of the present invention unless otherwise specified, the engagement between the valve and the second syringe is a luer lock engagement.

[0009] In a fourth aspect of the present disclosure, which may be combined with any other aspect enumerated herein without any limitation to the scope of the present invention unless otherwise specified, the valve is a two-way check valve.

[0010] In a fifth aspect of the present disclosure, which may be combined with any other aspect enumerated herein without any limitation to the scope of the present invention unless otherwise specified, the valve is a user-switchable stopcock valve.

[0011] In a sixth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the pusher comprises a plurality of teeth, the trigger mechanism comprises a ratchet, and the ratchet is configured to engage the plurality of teeth of the pusher.

[0012] In a seventh aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the composition is a viscous hemostatic material.

[0013] In an eighth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the device further comprises a window indicator that indicates the amount of composition remaining in the first syringe.

[0014] In a ninth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the cannula comprises an inner cannula configured to deliver the composition and an outer cannula concentrically disposed around the inner cannula.

[0015] In a tenth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the outer cannula is stainless steel.

[0016] In an eleventh aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the delivery system comprises a delivery device. The delivery device comprises a trigger mechanism, a pusher, a valve, and a cannula. The pusher is configured to engage with the trigger mechanism and hold the first syringe, at least by coupling with the plunger of the first syringe. The valve is fluidly coupled to the first syringe. The cannula extends distally from the valve and is fluidly coupled to the valve. The delivery system further comprises a second syringe fluidly coupled to the valve, the second syringe further containing a composition. By pushing the plunger of the second syringe, the composition is discharged from the second syringe through the valve into the first syringe. Actuation of the trigger mechanism causes the pusher and the plunger of the first syringe to translate distally such that the composition in the first syringe is discharged from the first syringe through the valve, through the cannula, and out of the distal end of the cannula.

[0017] In a twelfth aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the valve is a two-way check valve such that the composition can flow only in a first direction, from the second syringe through the valve into the first syringe, and in a second direction, from the first syringe through the valve into the cannula.

[0018] In a thirteenth aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the engagement between the valve and the second syringe is a luer lock engagement.

[0019] In a fourteenth aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the composition is a viscous hemostatic agent.

[0020] In a fifteenth aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the cannula comprises an inner cannula configured to deliver a composition and an outer cannula disposed concentrically around the inner cannula.

[0021] In a sixteenth aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, a method of delivering a composition includes attaching a supply syringe containing the composition to a valve of a delivery device. The method includes pushing a plunger of the supply syringe such that, in response to pushing the plunger, the composition is discharged from the supply syringe through the valve into a delivery syringe. The method includes actuating a trigger mechanism of the delivery device such that, in response to actuating the trigger mechanism, a plunger of the delivery syringe is pushed and the composition is discharged from the delivery syringe through the valve into the cannula. The method includes further pushing the plunger of the supply syringe such that, in response to pushing the plunger, additional composition is discharged from the supply syringe through the valve into the delivery syringe. The method includes further actuating the trigger mechanism of the delivery device such that, in response to actuating the trigger mechanism, the plunger of the delivery syringe is pushed and additional composition is discharged from the delivery syringe through the valve into the cannula.

[0022]

[0022] In a seventeenth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the method includes removing the supply syringe from the valve of the delivery device. The method includes attaching a cleaning syringe containing a cleaning fluid different from the composition to the valve of the delivery device. The method includes pushing the plunger of the cleaning syringe so that the cleaning fluid is discharged from the cleaning syringe through the valve into the delivery syringe in response to pushing of the plunger. The method includes actuating the trigger mechanism of the delivery device so that the plunger of the delivery syringe is pushed and the cleaning fluid is discharged from the delivery syringe through the valve into the cannula, such that the cleaning fluid pushes the composition out of the cannula, in response to actuation of the trigger mechanism.

[0023]

[0023] In an eighteenth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the cleaning fluid is saline, or another liquid medium, or a gas.

[0024]

[0024] In a nineteenth aspect of the present disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the composition is prepared for administration in the supply syringe before first attaching the supply syringe to the valve of the delivery device.

[0025] In a 20th aspect of the disclosure, which may be combined with any of the other aspects recited herein unless otherwise specified, the kit includes a prefilled sodium chloride solution syringe, a thrombin vial, a prefilled gelatin matrix syringe, and a delivery device. The delivery device includes a trigger mechanism, a pusher, a valve, and a cannula. The pusher is configured to engage the trigger mechanism and is further configured to hold the delivery syringe by coupling at least to the plunger of the delivery syringe. The valve is fluidly coupled to the delivery syringe. The cannula extends distally from the valve and is fluidly coupled to the valve. The prefilled gelatin matrix syringe is fluidly coupled to the valve. By pushing the plunger of the prefilled gelatin matrix syringe, the composition is discharged from the prefilled gelatin matrix syringe through the valve and into the delivery syringe. Actuation of the trigger mechanism causes the pusher and the plunger of the delivery syringe to translate distally such that the composition within the delivery syringe is discharged from the delivery syringe through the valve, through the cannula, and out of the distal end of the cannula.

[0026] Additional features and advantages of the disclosed devices, systems, and methods will be described in, and will be apparent from, the following detailed description and the drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings and description. Further, any particular embodiment need not have all of the advantages enumerated herein. It should also be noted that the terminology used herein has been chosen primarily for readability and explanatory purposes and is not intended to limit the scope of the subject matter of the invention.

[0027] It is understood that the drawings depict only typical embodiments of the invention and should not be considered as limiting the scope of the disclosure, and with reference to the accompanying drawings, the disclosure will be described and explained in more specific detail. The drawings are listed below.

Brief Description of the Drawings

[0028]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

Figure 6

Figure 7A

Figure 7B

[0029]

[0035] As briefly described above, the present disclosure is directed to devices, systems, and methods for suppressing bleeding by locally applying a material to a wound site in various embodiments. The material is typically a hemostatic matrix material such as a flowable hemostatic material. In certain embodiments, the delivery devices, systems, and methods are configured to deliver a viscous hemostatic matrix, such as FLOSEAL® VH S / D (FLOSEAL® HEMOSTATIC MATRIX VH S / D, FLOSEAL® HEMOSTATIC MATRIX, and also known as FLOSEAL®) (Baxter Healthcare Corporation), a bovine-derived gelatin matrix combined with a human-derived thrombin solution. However, it should be understood that the delivery devices, systems, and methods disclosed herein may deliver other materials such as any viscous material, liquid material, solid material, or gaseous material.

[0030]

[0036] Before applying the hemostatic material, the bleeding tissue is generally blotted or gently aspirated to remove excess blood so that the hemostatic material can be applied directly and immediately to the bleeding site. Clogging of the tip of the syringe and / or applicator can be reduced by minimizing contact of the tip of the syringe or applicator with the wet surface. Similarly, clogging can be prevented by certain configurations of the delivery devices or delivery systems described herein. After applying the hemostatic material, it is common to apply gentle approximation to the treatment site using a non-adherent substrate such as a moistened gauze. If bleeding persists after the initial application, the user may apply additional hemostatic material. If the non-adherent substrate adheres to the wound site, gentle perfusion with non-heparinized saline can help remove the substrate while minimizing disruption of the thrombus. Once bleeding has stopped, the hemostatic material not incorporated into the thrombus is carefully removed by gentle perfusion and suctioned from the treatment site.

[0031]

[0037] Delivery of the compositions of the present disclosure is particularly suitable for suppressing (performing hemostasis) bleeding on abraded or damaged tissue surfaces, which may be on any organ surface, such as the liver, spleen, heart, kidney, intestine, blood vessels, other vascular organs, etc. For example, a hemostatic material may be applied to the bleeding area using the delivery device or delivery system described herein. Exemplary methods of applying the material include dispensing the material directly from the delivery device or using the tip of an applicator. Since it is often difficult to access sites within a patient's body cavity, an endoscopic applicator may be used to deliver the hemostatic material to the bleeding site.

[0032]

[0038] As described above, typical endoscopic applicators cannot be easily used with one hand. For example, a typical applicator includes a hollow tube loaded with a hemostatic material and a stylet manually inserted into the hollow tube to dispense the hemostatic material. This configuration has room for improvement for several reasons. First, to load the endoscopic applicator, the user needs to manually load the hollow tube by filling it (with a source syringe), which is often a time-consuming process. Second, the source syringe needs to be separated from the hollow tube so that the stylet can be inserted into the hollow tube for delivery. Third, positioning the endoscopic applicator requires the user to hold the stylet with one hand while awkwardly holding the hollow tube with the other hand and positioning the distal end at the delivery site. Fourth, delivery of the material through the endoscopic applicator requires the user to push the stylet into the hollow tube with one hand while keeping the other hand still to ensure accurate delivery. This becomes increasingly difficult in the case of viscous materials that require high compressive force for extrusion. Fifth, it is difficult for the user to measure the delivery volume or delivery rate of the hemostatic material. Finally, although not completely, even if the device is discharged to its maximum capacity, a hold-up volume of the hemostatic material remains unused on the surfaces of the hollow tube and the stylet, effectively becoming waste material.

[0033]

[0039] Compared with the typical applicator systems described above, the delivery devices, delivery systems, and related methods disclosed herein advantageously provide advanced user control regarding accurate dosing, delivery location, and delivery rate, reduced clogging, improved preparation time, and reduced waste material.

[0034] Delivery Devices and Delivery Systems

[0040] Referring now to FIG. 1, an exploded perspective view of a delivery device 5 is shown. In one embodiment, the delivery device 5 comprises a two-piece molded housing including a left housing 7 and a right housing 8. The left housing 7 and the right housing 8 are each configured to couple to one another. In various embodiments, the coupling can be achieved by friction fitting, mechanical press fitting, ultrasonic welding, or any other mechanical engagement. In one embodiment, the left housing 7 and the right housing 8 are composed of injection molded polycarbonate, glass filled polyamide polymer, or other related materials. Alternatively, the assembly of the left housing 7 and the right housing 8, also referred to herein as the “overall housing,” may be injection molded as a one-piece material, such as polypropylene, PVC, non-DEHP PVC, polyethylene, polystyrene, polypropylene blend, or other similar materials, and / or formed by other means, such as 3D printing or other similar plastic manufacturing methods. In one embodiment, the overall housing is configured to be handheld such that a user can hold the delivery device 5 with one hand.

[0035]

[0041] The delivery device 5 comprises a pusher 9 which can be composed of injection-molded polycarbonate, glass-filled polyamide polymer or other related materials. The delivery device 5 further comprises a reservoir syringe 10 having a plunger, and the plunger is assembled and configured to engage and seal with the inner cylindrical surface of the barrel of the reservoir syringe 10. In this way, the plunger can translate along the length of the barrel of the reservoir syringe 10. The plunger and barrel of the reservoir syringe 10 can each be composed of any suitable plastic material, such as polypropylene, PVC, non-DEHP PVC, polyethylene, polystyrene, polypropylene mixture or other similar materials. Preferably, the plunger and barrel of the reservoir syringe 10 are each composed of polypropylene, but it should be understood that any known material or combination of materials can be employed for this function. In one embodiment, the reservoir syringe 10 contains a composition such as a viscous hemostatic agent.

[0036]

[0042] The pusher 9 is configured to actuate the barrel of the reservoir syringe 10. Specifically, the pusher 9 is configured to hold the reservoir syringe 10 by at least coupling with the plunger of the reservoir syringe 10. In one embodiment, the pusher 9 comprises a slot configured to receive the flanged end of the plunger of the reservoir syringe 10. When the pusher 9 translates, the barrel of the reservoir syringe 10 translates as well. Thus, the reservoir syringe 10 is actuated by the translation of the pusher 9.

[0037]

[0043] Delivery device 5 includes a trigger mechanism 15 that, when actuated, translates pusher 9. In one embodiment, trigger mechanism 15 includes an engagement claw 16, an engagement rack 17, an engagement spring 18, an engagement pin 19, a trigger 20, a trigger spring 21, and a trigger pin 22. It should be understood that engagement claw 16, engagement rack 17, and trigger 20 may each be constructed of injection molded polycarbonate, glass filled polyamide polymer, or other related materials. Similarly, the springs and pins may each be constructed of a metal such as 302 stainless steel or other related metals.

[0038]

[0044] Referring now to FIGS. 2-4, exploded side views of delivery device 5 in various trigger configurations are shown. More specifically, FIGS. 2-4 show how pusher 9 engages trigger mechanism 15 and its sub-components. In this way, a rotational force, such as that applied to trigger 20 of trigger mechanism 15 by a user, for example, is converted into a linear force that translates pusher 9 for syringe actuation.

[0039]

[0045] More specifically, the bottom of the pusher 9 may be provided with other types of raised portions such as pusher teeth 28 or teeth of a linear gear, which contact the engagement claws 16. The engagement claws 16 are retained by an engagement spring 18 (not shown) and may be pivotable about an engagement pin 19 such that the engagement claws 16 are biased in a specific direction toward the pusher 9 and the pusher teeth 28. Generally, the engagement claws 16, the engagement rack 17, the engagement spring 18, and the engagement pin 19 are coupled to each other and are sometimes generally referred to as a mechanical dog that engages with the pusher teeth 28 of the pusher 9. Since the engagement claws 16 are biased in a specific direction, e.g., an inclined direction, toward the pusher 9, the pusher 9 translates in a specific direction, e.g., a distal direction toward the cannula 23, together with the engagement rack 17 and the engagement claws 16, and the pusher 9 does not translate when these components translate in the opposite direction. For example, when the engagement rack 17 and the engagement claws 16 translate in the proximal direction away from the cannula 23, the pusher 9 does not translate; rather, the pusher 9 remains in its current position. In this way, the delivery device 5 exhibits a ratchet effect, as will be described in more detail below.

[0040]

[0046] The engagement rack 17 further engages with the upper portion of the trigger 20. For example, the upper portions of the engagement rack 17 and the trigger 20 may each be provided with teeth or ridges such as teeth of a linear or curved gear so that a force can be converted from the trigger 20 to the engagement rack 17. The trigger 20 is pivotable about a trigger pin 22 and is biased in an open configuration by a trigger spring 21 (not shown).

[0041]

[0047] Further, the delivery device 5 includes a slot 29 having a linear end 30 and a curved end 31. In one embodiment, the slot 29 is located in one of the left housing 7 or the right housing 8. In different embodiments, the slot 29 is located in both the left housing 7 and the right housing 8. The engaging rack 17 and its related components are in contact with the slot 29 such that the slot 29 restricts the movement of the engaging rack 17 in a direction defined by the slot 29, including a linear direction and a curved direction. Since the slot 29 includes both a linear end 30 and a curved end 31, the slot 29 provides engagement and disengagement of the engaging claw 16 from the pusher tooth 28.

[0042]

[0048] For example, FIG. 2 shows a first trigger configuration in which the trigger 20 extends from the handle of the delivery device 5 at approximately 50°. The upper portions of the engaging rack 17 and the trigger 20 each include teeth that engage with each other. Since the trigger 20 is located in an open position such as 50° from the handle, the teeth of the trigger 20 push the engaging rack 17 in the proximal direction along the slot 29. Specifically, the engaging rack 17 is located at the curved end 31 of the slot 29. Since a part of the engaging rack 17 is at the curved end 31, the engaging rack 17 pivots slightly from the direction defined by the linear end 30 of the slot 29. In this way, by pivoting the engaging rack 17, the engaging claw 16 is disengaged from the pusher tooth 28. The disengagement is useful, for example, so that the user can manually translate the pusher 9 in the proximal direction to load the reservoir syringe 10 into the delivery device 5, or so that the user can fill or refill the reservoir syringe 10, as will be described in more detail below.

[0043]

[0049] Although the engaging claw 16 is disengaged when the trigger 20 is at 50° from the handle of the delivery device 5, it should be understood that alternative disengagement configurations of the trigger 20 are contemplated and the engaging claw 16 may be disengaged in any other rotational orientation of the trigger 20. Further, the specific configuration and geometry of the engaging claw 16, the engaging rack 17, and the slot 29 including the linear end 30 and the curved end 31 may affect the range of disengagement.

[0044]

[0050] Figure 3 shows a second configuration in which the trigger 20 extends from the handle of the delivery device 5 at approximately 40°. For example, in this second configuration, the user holds the trigger 20 in a partially squeezed state. Just to confirm, the engaging rack 17 and the upper part of the trigger 20 each have teeth that engage with each other. Since the trigger 20 is partially squeezed, the teeth of the trigger 20 rotate and push the engaging rack 17 distally along the slot 29. The engaging rack 17 is no longer located at the curved end 31 of the slot 29 and thus does not pivot away from the direction defined by the straight end 30 of the slot 29. By not pivoting, the engaging rack 17 directly engages the engaging claw 16 and the pusher teeth 28. This engagement is useful, for example, because the user can deliver material from the reservoir syringe 10 by squeezing the trigger 20.

[0045]

[0051] More specifically, when the user squeezes the trigger 20, the trigger 20 rotates about the trigger pin 22 into a closed configuration. When the trigger 20 is squeezed, the rotational movement of the trigger 20 is converted into a linear movement in the engaging rack 17 by the engagement of the teeth of the gears of these components. Thus, the engaging rack 17 and its associated components translate linearly. For example, these components translate along the slot 29 towards the straight end 30.

[0046]

[0052] The linear movement of the engaging rack 17 and the engaging claw 16 is further converted into a linear movement of the pusher 9 by the engagement between the engaging claw 16 and the pusher teeth 28, as described above. In other words, when the engaging rack 17 and the engaging claw 16 translate towards the straight end 30 of the slot 29, the pusher 9 translates towards the distal end of the delivery device 5. In this way, the trigger mechanism 15 effectively converts the rotational movement from the trigger 20 into a linear movement of the pusher 9. Also, as described above, since the pusher 9 holds the reservoir syringe 10, the translation of the pusher 9 actuates the reservoir syringe 10.

[0047]

[0053] When the user releases the trigger 20, the trigger spring 21 biases and rotates the trigger 20 toward the open position about the trigger pin 22. When the trigger 20 is released, the rotational movement of the trigger 20 is converted into linear movement in the engagement rack 17 by the engagement of the teeth of the gears of these components. The engagement rack 17 and its associated components each translate linearly along the slot toward the curved end 31.

[0048]

[0054] However, when the engagement rack 17 and the engagement claw 16 translate along the slot 29 toward the curved end 31, the pusher 9 does not translate. For example, as described above, the engagement between the engagement claw 16 and the pusher teeth 28 may generally be referred to as a mechanical dog. Since the engagement claw 16 is biased in a specific inclined direction toward the pusher 9, the pusher 9 only translates in a specific direction, for example, the distal direction toward the cannula 23, along with the engagement rack 17 and the engagement claw 16, and the pusher 9 does not translate when these components translate in the opposite direction. With this configuration, the user can repeatedly squeeze and release the trigger 20. The entire trigger mechanism 15 has a ratchet effect for engaging the pusher 9, repeatedly translates the pusher 9 in the distal direction, and repeatedly actuates the reservoir syringe 10.

[0049]

[0055] When the delivery device 5 completely delivers the material in the reservoir syringe 10, the pusher 9 will translate to its most distal point. In this configuration, it is advantageous for the user to be able to disengage the engagement rack 17 and the engagement claw 16, such as for loading a new reservoir syringe 10.

[0050]

[0056] Figure 4 shows a third trigger configuration where the trigger 20 extends from the handle of the delivery device 5 at approximately 50°. Similar to FIG. 2, since the trigger 20 is in an open position such as 50°, the engagement rack 17 is located at the curved end 31 of the slot 29 and thus pivots slightly from the direction defined by the straight end 30 of the slot 29. In this way, the engagement rack 17 disengages the engagement claw 16 from the pusher tooth 28. As will be described in more detail below, the disengagement is useful, for example, so that the user can manually slide the pusher 9 proximally to load a new reservoir syringe 10 into the delivery device 5 or so that the user can fill or refill the reservoir syringe 10. It should be understood that the trigger 20 may have an alternative disengagement configuration.

[0051]

[0057] In addition, the disengagement of the engagement rack 17 and the engagement claw 16 is beneficial for other reasons in addition to the loading, replacement, and / or filling and refilling of the reservoir syringe 10. Specifically, it is advantageous for the disengagement of the engagement rack 17 and the engagement claw 16 to cause a pressure release between successive squeezes of the trigger 20. As the user repeatedly squeezes the trigger 20, the pusher 9 translates distally and the pressure within the reservoir syringe 10 increases. Most of this pressure is removed as the material exits the delivery device 5 through the cannula 23. However, due to the viscosity of the particular material within the reservoir syringe 10, a pressure differential remains within the reservoir syringe 10, which can cause an undesirable leak from the reservoir syringe 10. To relieve this pressure differential, the delivery device is configured to release the pressure. For example, the user can squeeze the trigger 20, such as from 50° to 40°, to expel material from the reservoir syringe. When the user releases the trigger 20, the trigger 20 returns biased to the open configuration of 50°. In this open configuration, the engagement rack 17 and the engagement claw 16 are disengaged from the pusher tooth 28. Thus, the pusher 9 can freely translate slightly distally to relieve any pressure differential remaining within the reservoir syringe 10.

[0052]

[0058] Furthermore, the pusher 9 may engage with the trigger mechanism 15 by any other associated mechanical means and components such as additional gears, claws, and springs, and it should be understood that these other mechanical components may be used to translate movement from the trigger mechanism 15 to the pusher 9. Thus, regardless of the specific configuration, when the trigger mechanism 15 is actuated, the trigger mechanism 15 translates movement to the pusher 9.

[0053]

[0059] Referring again to FIG. 1, the delivery device further includes a window housing 13 with a transparent window 14 such that a user can view the reservoir syringe 10. The transparent window 14 may further comprise a gradation or physical markings that can be associated with the volume of the composition remaining within the reservoir syringe 10 and / or the volume of the composition dispensed from the reservoir syringe 10.

[0054]

[0060] The delivery device 5 further comprises a valve 11 configured to be in fluid communication with the reservoir syringe 10. In one embodiment, the valve 11 is further configured to be in fluid communication with a second syringe, as described in more detail herein.

[0055]

[0061] Delivery device 5 comprises a cannula 23 configured to deliver the composition to a delivery site. The cannula 23 is configured to engage the valve 11 at a connection point 24 such that the cannula 23 is in fluid communication with the valve 11. In one embodiment, the connection point 24 is a luer lock fitting. In an alternative embodiment, the engagement between the valve 11 and the connection point 24 of the cannula 23 may be a screw engagement, an interference fit engagement, a Velcro (registered trademark) type engagement, a snap engagement, a magnetic engagement, or any other type of mechanical engagement for attaching the cannula 23 to the valve 11. In a preferred embodiment, the cannula 23 is a single lumen cannula. The cannula 23 may be formed in any of a variety of lengths, such as between 10 and 46 cm, to support a plurality of different surgical applications, including pediatric and spinal surgeries. In one embodiment, the cannula 23 is cuttable so that the user can customize the length of the cannula 23 to a particular surgical application. The cannula 23 extends distally and includes a tip 27 at its distal end. In various embodiments, the tip 27 may be a rigid extension tip, a cuttable extension tip, a flexible tip, or a malleable tip such as a polyurethane tip having a stainless steel wire for manipulation by the user.

[0056]

[0062] In an alternative embodiment, the cannula 23 may comprise a plurality of lumens such as an inner cannula 25, an outer cannula 26, and a tip 27. The inner cannula 25 may be configured to deliver the composition to the delivery site. The inner cannula 25 preferably can have an inner diameter of 1 to 5 mm, whereby the residual amount of the composition remaining inside the inner cannula 25 after delivery can be optimized. Also, the diameter of the inner cannula 25 may be optimized for a particular material delivered from the reservoir syringe 10. For example, the diameter of the inner cannula 25 may be determined with respect to the viscosity of the material, for example, to avoid clogging of the inner cannula 25. Similarly, for example, the outer cannula 26 may be configured to be concentrically disposed around the inner cannula 25 to protect the inner cannula 25. In one example, the outer cannula 26 is composed of stainless steel. The outer cannula 26 preferably may have a length of 41 cm to support all surgical specialties including endoscopic applications. The outer cannula 26 further imparts enhanced rigidity to the entire cannula 23, which is beneficial during surgical manipulation and operation.

[0057]

[0063] As described above, the reservoir syringe 10 may contain a composition. In response to the engagement of the trigger mechanism 15, the pusher 9 and the plunger of the reservoir syringe 10 translate distally toward the tip 27 of the cannula 23. In this way, the composition within the reservoir syringe 10 passes from the reservoir syringe 10 through the valve 11 and through the cannula 23 (or alternatively through the inner cannula 25 of the cannula 23) and is discharged from the tip 27 at the distal end of the cannula 23.

[0058]

[0064] Figures 5A-5B show perspective views of the delivery device 5. As shown, the delivery device 5 includes a valve 11, a trigger 20, and a cannula 23. Since the delivery device 5 is self - contained, it should be understood that it may include all other aspects described in more detail above, such as the remaining components of the trigger mechanism 15 and the reservoir syringe 10. The delivery device 5 is preferably sized and ergonomically designed for one - handed use by a user.

[0059]

[0065] The valve 11 is further configured to engage a second syringe, such as a supply syringe. For example, FIG. 6 shows a side elevation view of a delivery system 100 including a supply syringe 110. First, it should be understood that portions of the left housing 7 and the right housing 8 have been removed for purposes of illustration to view the reservoir syringe 10 and the pusher 9.

[0060]

[0066] As shown in FIG. 6, the valve 11 engages the supply syringe 110 such that the supply syringe 110 is in fluid communication with the valve 11. In one embodiment, the engagement between the supply syringe 110 and the valve 11 is a luer - lock engagement. The supply syringe 110 may first fill the reservoir syringe 10 with a composition and / or refill the reservoir syringe 10 with additional composition. For example, prior to engagement of the trigger 20, the user pushes the plunger of the supply syringe 110 to expel the composition from the supply syringe 110. The composition moves through the valve 11 and into the reservoir syringe 10. Thus, the reservoir syringe 10 is supplied with composition by the supply syringe 110. As a result, upon engagement of the trigger 20 and the trigger mechanism 15 as a whole, the composition within the reservoir syringe 10 is expelled from the reservoir syringe 10, through the valve 11, through the cannula 23, and out of the distal end of the cannula 23, as described above.

[0061]

[0067] The valve 11 may be characterized as a two-way check valve. In other words, the valve 11 allows two separate fluid flow paths, namely a first flow path and a second flow path. FIG. 7A shows the first flow path defined from the supply syringe 110 through the valve 11 into the reservoir syringe 10. The composition can flow only in the direction defined by the first flow path between the supply syringe 110 and the reservoir syringe 10. The one-way flow ensures that the composition does not inadvertently flow from the reservoir syringe 10 through the valve 11 into the supply syringe 110. FIG. 7B shows the second flow path defined from the reservoir syringe 10 through the valve 11 into the cannula 23. It is advantageous that the two-way check valve can eliminate the need for the user to manually switch the direction of flow, such as by a switch valve. However, in an alternative embodiment, the valve 11 may be a user-switchable stopcock valve, whereby the user can manually select the direction in which the composition can flow and the direction in which the composition cannot flow. In one embodiment, the valve 11 is configured such that the reservoir syringe 10 and the supply syringe 110 are oriented perpendicular to each other. In other embodiments, the valve 11 is configured such that the reservoir syringe 10 and the supply syringe 110 are oriented parallel to each other or at any other angle relative to each other.

[0062]

[0068] In summary, the valve 11 is configured to engage with the reservoir syringe 10 such that the reservoir syringe 10 is in fluid communication with the valve 11. The cannula 23 is configured to engage with the valve 11 such that the cannula 23 is in fluid communication with the valve 11 and extends in the distal direction. The valve 11 is configured to engage with the supply syringe 110 such that the supply syringe 110 is in fluid communication with the valve 11. The supply syringe 110 initially contains the composition. In response to pushing the plunger of the supply syringe 110, the composition is discharged from the supply syringe 110 through the valve 11 into the reservoir syringe 10. In response to the engagement of the trigger 20, the pusher 9 and the plunger of the reservoir syringe 10 translate distally such that the composition in the reservoir syringe 10 flows from the reservoir syringe 10 through the valve 11, through the cannula 23, and is discharged from the distal end of the cannula 23.

[0063]

[0069] In one embodiment, the trigger mechanism 15 of the delivery system 100 may be configured to deliver a specific amount of the composition each time the trigger 20 is pulled. For example, by knowing the distance the pusher 9 moves each time the trigger 20 is pulled and the cross-sectional area of the reservoir syringe 10, the volume delivered by the delivery system 100 each time the trigger 20 is pulled can be easily calculated. In a specific example, when the trigger 20 is squeezed halfway, 0.5 mL of the composition is delivered, and when the trigger 20 is fully squeezed, 1.0 mL of the composition is delivered.

[0064]

[0070] As disclosed, the delivery system 100 of the present specification provides advanced user control with respect to both the delivery position and the delivery speed. The delivery system 100 provides one-handed delivery of a composition such as a hemostatic material. More specifically, both the accuracy and control of the delivery of the hemostatic material are improved by the one-handed placement of the delivery device 5 and the associated actuation of the delivery device 5 via the trigger mechanism 15. When using the delivery device 5, the user can place both the delivery device 5 and the cannula 23 with one hand, and thus can free the other hand for other purposes. The user can better control to ensure proper placement while supplying the hemostatic material on the one hand. In addition to placement, the delivery of the hemostatic material is controlled from both the perspectives of quantity and speed. The hemostatic material is delivered only when the trigger 20 is pulled, that is, when the trigger 20 is pulled, only a specific amount of the hemostatic material is delivered. Similarly, the hemostatic material cannot be inadvertently delivered, such as by accidentally hitting the stylet. Rather, the user must pull the trigger 20 to deliver the hemostatic material from the cannula 23. Consistent trigger actuation can result in consistent delivery of the hemostatic material, thus preventing situations of accidental delivery and over-delivery such as product loss and rupture. These situations can be particularly problematic for the patient by causing embolism events, flushing away previously delivered hemostatic materials, or causing other undesirable side effects. Similarly, by biasing the trigger 20 to open such that the engagement rack 17 and the engagement claw 16 disengage from the pusher teeth 28, the pusher 9 is free to translate rearward to relieve any pressure differential remaining within the reservoir syringe 10 and avoid undesirable leakage.

[0065]

[0071] In an alternative embodiment, the delivery system 100 and the delivery device 5 may implement additional components to replace the manually repeated trigger actuation disclosed above. For example, the delivery device 5 may comprise electromechanical components such as an electromechanical motor, an associated gear assembly, and a battery or an external power source so that it can engage the trigger mechanism 15 to deliver the material without requiring physical engagement of the trigger 20.

[0066]

[0072] In addition, the delivery of the hemostatic material via the delivery device 5 and the delivery system 100 results in mechanical optimization of the device itself. For example, the trigger 20 and the trigger mechanism 15 can generate greater force compared to conventional delivery techniques such as manual delivery by pushing a stylet through a delivery tube. If greater delivery force is available, the dimensions of the delivery device 5, such as the diameter of the cannula 23 and the size of the reservoir syringe 10, can be reduced. Specifically, for example, the cannula 23 may be more slender. Reducing certain dimensions of the delivery device 5, such as the diameter of the cannula 23, is always desirable when the delivery device 5 is used in an endoscopic setting. For example, a part of the delivery device 5, such as the cannula 23, can pass through the patient's endoscopic port.

[0067]

[0073] Furthermore, the delivery device 5 and the delivery system 100 result in mechanical optimization by "decreasing" the diameter of the syringe. For example, in one embodiment, the supply syringe 110 may be a 25 mL syringe. Just to confirm, the user may mount the supply syringe 110 and deliver the composition through the valve 11 to supply the composition to the reservoir syringe 10. The reservoir syringe 10 may be a 5 mL syringe. Since the size of the reservoir syringe 10, including the cross-sectional area of the syringe, is smaller than the size of the supply syringe 110, less force is required to generate sufficient pressure to discharge the composition from the reservoir syringe 10. Similarly, by applying an equivalent force to the plunger of the supply syringe 110, a high pressure is generated in the supply syringe 110 due to the smaller cross-sectional area of the reservoir syringe 10. The higher pressure is advantageous for dispensing the viscous composition into the slender cannula. Thus, the decrease in the diameter of the syringe can result in optimization of the force required to dispense the viscous composition, size optimization by reducing the overall size of the supply syringe 110 for a more compact delivery device 5, and the like.

[0068] Method of administering the hemostatic matrix

[0074] As described above, the delivery device 5 and the delivery system 100 may be implemented when administering or delivering a composition. Specifically, the user may attach the supply syringe 110 to the valve 11 of the delivery device 5. The supply syringe 110 contains a composition to be administered, such as a viscous hemostatic matrix. Before attaching to the valve 11, the user may prepare the composition for administration within the supply syringe 110.

[0069]

[0075] For example, when administering a hemostatic matrix such as FLOSEAL® , first, it must be prepared for administration of FLOSEAL® . FLOSEAL® VH S / D may be prepared according to the manufacturer's instructions (Baxter Healthcare Corporation, 2014). In particular, the thrombin solution may be prepared by attaching a prefilled sodium chloride solution syringe to the luer connector of a vial adapter containing the thrombin solution. Pierce the rubber stopper of the thrombin vial and transfer all the contents of the sodium chloride syringe to the thrombin vial. Then, vent the thrombin vial and stir until the thrombin is completely dissolved. Next, fill an empty 10 mL supply syringe 110 with the thrombin solution up to the indicated mark, such as 8 mL, and then connect the gelatin matrix syringe to the supply syringe 110 containing the thrombin solution to prepare FLOSEAL® VH S / D. Then, pass the thrombin solution through the gelatin matrix syringe and reciprocate the mixture between the two syringes at least 20 times. The resulting hemostatic matrix within the supply syringe 110 is typically ready for administration between 30 seconds and 20 minutes after preparation.

[0070]

[0076] Once the hemostatic matrix is prepared, the user attaches the supply syringe 110 containing the hemostatic matrix to the valve 11 of the delivery device 5. In a preferred embodiment, the reservoir syringe 10 is initially empty and the plunger of the reservoir syringe 10 is initially compressed. Next, the user pushes the plunger of the supply syringe 110 such that, in response to pushing the plunger, the hemostatic matrix is discharged from the supply syringe 110 through the valve 11 into the reservoir syringe 10. In one embodiment, the user discharges only a portion of the supply syringe 110 into the reservoir syringe 10. For example, the supply syringe 110 may have a much larger volume capacity than the reservoir syringe 10.

[0071]

[0077] Next, the user repeatedly engages the trigger mechanism 15 of the delivery device 5, specifically the trigger 20, such that, in response to the engagement of the trigger mechanism 15, the plunger of the reservoir syringe 10 is pushed. For example, the pusher 9 translates in the distal direction to push the plunger of the reservoir syringe 10. The hemostatic matrix is discharged from the reservoir syringe 10 through the valve 11 into the cannula 23.

[0072]

[0078] Next, the user further pushes the plunger of the supply syringe 110 such that additional hemostatic matrix is discharged from the supply syringe 110 through the valve 11 into the reservoir syringe 10. For example, the user can reload the reservoir syringe 10 with additional hemostatic matrix. During reloading, the components of the trigger mechanism 15 can be reset and, once the reservoir syringe 10 is filled with additional hemostatic matrix, other components such as the pusher 9 and the plunger of the reservoir syringe 10 can translate in the proximal direction.

[0073]

[0079] Next, in response to the engagement of the trigger mechanism 15, the user repeatedly engages the trigger mechanism 15 of the delivery device 5, specifically the trigger 20, such that the plunger of the reservoir syringe 10 is pushed in and additional hemostatic matrix is discharged from the reservoir syringe 10 through the valve 11 into the cannula 23. By repeating this process, the hemostatic matrix is discharged from the tip 27 of the cannula 23.

[0074]

[0080] When the user has exhausted the hemostatic matrix in the supply syringe 110, the user can remove the empty supply syringe 110 from the valve 11 and attach a new supply syringe 110 to the valve 11 to continue the process. This advantageously allows both the preparation time associated with preparing the delivery device 5 and the reload time associated with reloading additional hemostatic matrix into the delivery device 5 to be improved.

[0075]

[0081] In related embodiments, the delivery device 5 may include a liquid propellant for discharging material from the tip 27 of the cannula 23. For example, in this embodiment, the reservoir syringe 10 is initially empty and the plunger of the reservoir syringe 10 is initially compressed. As described above, the user pushes the plunger of the supply syringe 110 such that the hemostatic matrix is discharged from the supply syringe 110 through the valve 11 into the reservoir syringe 10 in response to pushing in the plunger. Next, the user repeatedly engages the trigger mechanism 15 of the delivery device 5, specifically the trigger 20, such that the plunger of the reservoir syringe 10 is pushed in. The hemostatic matrix is discharged from the reservoir syringe 10 through the valve 11 into the cannula 23.

[0076]

[0082] At this point, the user can attach a second supply syringe, such as a liquid filling syringe, to the valve 11. The user pushes the plunger of the second supply syringe so that, in response to pushing the plunger, the liquid is discharged from the second supply syringe through the valve 11 into the reservoir syringe 10. For example, the user can load the reservoir syringe 10 with liquid after delivering the hemostatic material to the cannula 23. During the loading of the liquid, the components of the trigger mechanism 15 can be reset, and when the reservoir syringe 10 is filled with liquid, other components such as the pusher 9 and the plunger of the reservoir syringe 10 can translate in the proximal direction. Next, the user further repeatedly engages the trigger mechanism 15 of the delivery device 5, specifically the trigger 20, so that, in response to the engagement of the trigger mechanism 15, the plunger of the reservoir syringe 10 is pushed and the liquid is discharged from the reservoir syringe 10 through the valve 11 into the cannula 23. In this way, the liquid acts as a pressurized propellant and the hemostatic material is discharged from the tip 27 of the cannula 23.

[0077]

[0083] In different related embodiments, all components of the delivery device 5 are made of stainless steel and can be configured for repeated use. For example, the delivery device 5 may be used as described above and then sterilized by an autoclave or other commercially available sterilizer. Once sterilized, the delivery device 5 can be effectively reused at a later date to deliver the hemostatic matrix to different patients.

[0078] Washing method

[0084] It is further advantageous that the delivery device 5 and the delivery system 100 can reduce waste material associated with incomplete delivery. For example, the method described above may further include a washing operation. Specifically, when the user finishes discharging the hemostatic matrix from the tip 27 of the cannula 23, an unused hold-up volume of the hemostatic matrix remains in the cannula 23. In this situation, the user can remove the supply syringe 110 from the valve 11 of the delivery device 5. Next, the user attaches a washing syringe to the valve 11 of the delivery device 5.

[0079]

[0085] The flushing syringe contains a flushing fluid different from the hemostatic matrix. For example, the flushing fluid may be liquid physiological saline, or other liquid media, or a gas. When the flushing syringe is attached to the valve 11, the user pushes the plunger of the flushing syringe so that the flushing fluid is discharged from the flushing syringe through the valve 11 into the reservoir syringe 10. Then, the user can engage the trigger mechanism 15 so that the plunger of the reservoir syringe 10 is pushed and the flushing fluid is discharged from the reservoir syringe 10 through the valve 11 into the cannula 23. In this way, the flushing fluid and the associated pressure generated by the flushing fluid discharge any remaining hemostatic matrix from the cannula 23.

[0080]

[0086] The flushing operation results in an optimal supply of the hemostatic matrix and minimizes the waste of the hemostatic matrix remaining in the cannula 23. The flushing operation further eliminates clogging by minimizing the amount of hemostatic material remaining in the cannula 23.

[0081] Delivery device kit

[0087] The kit according to the present disclosure may include a hemostatic material and a delivery device 5. The hemostatic material is sterilized by aseptic processing or, preferably, by terminal sterilization using gamma irradiation, ethylene oxide, electron beam irradiation, etc. The hemostatic material is packaged in a sterile package such as a pouch, tube, tray, box, etc. in its sterile form. Instructions for use defining the method of placing the material on the tissue when blood is present at the wound or surgical site may also be provided as part of the kit. An exemplary kit includes hemostatic materials such as a dried bovine-derived gelatin matrix (granules) and a human-derived thrombin solution in individual syringes, a tip of an applicator, the delivery device described herein configured to be used with the syringe, and instructions for use defining the method of suppressing bleeding by placing a sterile material at a target site of tissue that can be any other site of a wound or bleeding tissue using a delivery device or delivery system as disclosed herein.

[0082]

[0088] In one embodiment, the kit includes a prefilled sodium chloride solution syringe, a thrombin vial, a prefilled gelatin matrix syringe, and a delivery device. The prefilled sodium chloride solution syringe, the thrombin vial, and the prefilled gelatin matrix syringe can be used to prepare the hemostatic matrix described above. The delivery device 5 may be configured to engage with the prefilled gelatin matrix supply syringe 110 as described in more detail above.

[0083]

[0089] As used herein, including in the claims, the term "and / or" is an inclusive or exclusive conjunction. Thus, the term "and / or" means that two or more items within a group are present, or that one selection from a group of alternatives can be made.

[0084]

[0090] Many features and advantages of the present disclosure are apparent from the described description, and accordingly, the appended claims are intended to cover all such features and advantages of the present disclosure. Further, since those skilled in the art will readily conceive of numerous modifications and changes, the present disclosure is not limited to the exact construction and operation illustrated and described. Accordingly, the described embodiments are to be understood as illustrative and not restrictive, and the present disclosure should not be limited to the details given herein, but rather should be defined by the following claims and their full scope of equivalents, whether foreseeable or unforeseeable at present or in the future.

Claims

**Claim 1**: A pusher configured to hold the first syringe by coupling with at least the plunger of the first syringe, a trigger actuated by a user, and a trigger mechanism comprising an engaging claw configured to engage and disengage with the pusher, a valve fluidly coupled to the first syringe, a cannula extending distally from the valve and fluidly coupled to the valve, a delivery device comprising: upon actuation of the trigger, the engaging claw engages the pusher to translate the pusher and the plunger of the first syringe in a distal direction, whereby the composition in the first syringe is discharged from the distal end of the cannula through the cannula through the valve from the first syringe, the valve is further configured to engage a second syringe, whereby the second syringe is in fluid communication with both the valve and the first syringe, the trigger mechanism further comprises an engaging rack coupled to the engaging claw and configured to contact a slot of the delivery device, whereby the slot restricts movement of the engaging rack in a direction defined by the slot, the slot having a linear end and a curved end, the engaging rack engaging the trigger, and upon actuation of the trigger, the engaging rack translates from the curved end of the slot to the linear end of the slot to engage the engaging claw with the pusher and translate the pusher in a distal direction. Delivery device. **Claim 2** The delivery device according to claim 1, wherein when the trigger is not actuated, the trigger is biased to an open configuration at a predetermined angle. **Claim 3** The delivery device according to claim 2, wherein when the trigger is in the open configuration, the engaging claw is disengaged from the pusher. **Claim 4** The delivery device according to claim 1, wherein the pusher includes a plurality of teeth, and the engaging claw is configured to engage with the plurality of teeth of the pusher when the trigger is actuated, so as to translate the pusher in the distal direction.

5. The delivery device according to claim 1, wherein the engaging rack includes a plurality of teeth configured to engage with a plurality of teeth of the trigger.

6. When the trigger is not actuated, the trigger is biased to an open configuration, pushing the engaging rack into the curved end of the slot and disengaging the engaging claw from the pusher, according to claim 1. Delivery device described.

7. The delivery device according to claim 1, wherein the engaging claw is configured to translate the pusher only in the distal direction.

8. The delivery device according to claim 1, wherein the engagement between the valve and the second syringe is a luer lock engagement.

9. The delivery device according to claim 1, wherein the valve is a two-way check valve.

10. A delivery system comprising a delivery device and a second syringe, wherein the delivery device A pusher configured to hold the first syringe by coupling with at least the plunger of the first syringe, A trigger mechanism including a trigger actuated by a user and an engaging claw configured to engage and disengage with the pusher, A valve fluidly coupled to the first syringe, A cannula extending distally from the valve and fluidly coupled to the valve, The second syringe is fluidly coupled to the valve and contains a composition, By pushing the plunger of the second syringe, the composition is discharged from the second syringe through the valve into the first syringe. Upon activation of the trigger, the engaging claw engages with the pusher, translating the pusher and the plunger of the first syringe distally, whereby the composition within the first syringe is discharged from the distal end of the cannula through the cannula, through the valve, and from the first syringe. The trigger mechanism further comprises an engaging rack coupled to the engaging claw and configured to contact a slot of the delivery device, whereby the slot restricts movement of the engaging rack in a direction defined by the slot. The slot comprises a linear end portion and a curved end portion. The engaging rack engages with the trigger, and upon activation of the trigger, the engaging rack translates from the curved end portion of the slot to the linear end portion of the slot, engaging the engaging claw with the pusher and translating the pusher distally. Delivery system. **Claim 11** The delivery system according to claim 10, wherein when the trigger is not actuated, the trigger is biased to an open configuration at a predetermined angle. **Claim 12** The delivery system according to claim 11, wherein when the trigger is in the open configuration, the engaging claw is disengaged from the pusher. **Claim 13** The delivery system according to claim 10, wherein the pusher includes a plurality of teeth, and the engaging claw is configured to engage the plurality of teeth of the pusher upon actuation of the trigger to translate the pusher distally. **Claim 14** The delivery system according to claim 10, wherein the engaging rack comprises a plurality of teeth configured to engage a plurality of teeth of the trigger. **Claim 15** The delivery system according to claim 10, wherein when the trigger is not actuated, the trigger is biased to an open configuration, pushing the engaging rack into the curved end portion of the slot and disengaging the engaging claw from the pusher. **Claim 16** The delivery system according to claim 10, wherein the engaging claw is configured to translate the pusher only in the distal direction.

17. The delivery system according to claim 10, wherein the engagement between the valve and the second syringe is a luer lock engagement.

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