Aerosol patch applicator for hemostasis, nozzle assembly and method of applying surgical hemostatic agent to target site

Abstract

The present invention relates to a spray patch applicator for delivering ointment from a container, the applicator comprising: a delivery tube for connection to the container at a proximal end; and a nozzle assembly at the distal end of the delivery tube for delivering the paste in the form of a spray, preferably in the form of a spray of droplets.

Description

Technical Field

[0001] The present invention relates to an applicator for delivering a paste for hemostasis. Background Art

[0002] Surgical hemostatic agents are typically applied to a target site via the tip of a syringe. For some surgeries, such as minimally invasive surgeries, application can be performed via an extended delivery tube attached to the syringe such that when the syringe plunger is pushed, the hemostatic agent translates along the delivery tube and exits through an opening at the tip of the delivery tube.

[0003] Viscous fluids, such as surgical hemostatic agents and hemostatic pastes, can be applied to a target site with high spatial precision. This is due to the high viscosity and / or adhesiveness, which facilitate the extrusion of the hemostatic material substantially from the opening of the tip and its application by deposition onto the target site. Thus, the tip or opening of the tube acts as an extrusion die.

[0004] For bleeding, there is a risk that the extruded and deposited hemostatic agent is washed away by flowing blood. In such cases, it may be necessary to fix the hemostatic agent to the target site by applying additional compressive force, for example, by pressing a pad or wound dressing against the target site. This force may be applied for a period of time until the hemostatic agent is fixed, which will interrupt the surgical procedure. Additionally, during laparoscopy, it may be difficult or impossible to provide a pad or wound dressing at the target site.

[0005] Accordingly, there is a need for more efficient methods and devices for applying hemostatic agents to a target site and particularly to a target site including bleeding. Summary of the Invention

[0006] In view of the prior art described above, an object of the present invention is to provide a device that can preferably stop bleeding or surface bleeding (e.g., continuous seepage, problematic bleeding points, bleeding points that are difficult to access, and bleeding points that may re-bleed postoperatively) without having to apply manual pressure to the bleeding site.

[0007] This object can be achieved by an applicator according to Technical Solution 1.

[0008] Hemostatic pastes typically contain biocompatible polymers, such as gelatin, which provide a paste with high viscosity and excellent mechanical hemostatic action. Hemostatic pastes typically further contain active hemostatic agents, such as thrombin, which further aids in blood coagulation.

[0009] It has been found that the paste can be ejected by a mechanism small enough to fit through a trocar, and the paste in spray form is effective against bleeding.

[0010] Applying the hemostatic paste in the form of a spray onto the bleeding will cover a large area including the wound or bleeding site and the non-bleeding area surrounding it. By generating a spray of the paste, the paste will be dispersed into tiny droplets or microparticles, thereby providing a substantially uniform density of the paste over a larger area. The small paste droplets formed in the spray will immediately adhere together and adhere to the surrounding non-bleeding area when deposited on the bleeding and the surrounding non-bleeding area due to the high viscosity and sticky quality of the paste. The hemostatic agent in the paste will immediately start to coagulate the wound blood. The spray of the paste will form a layer over the bleeding, such as a plaster that will stop the bleeding. Hemostasis can be achieved by spraying the hemostatic paste. The microparticles can contain or consist of particles smaller than 1 mm or preferably smaller than 100 μm.

[0011] The spray of the paste will also have the following advantages: The user will not need to apply the paste on one area and then on an adjacent area as currently when applying a paste block on and around the bleeding. The user only needs to aim the nozzle assembly at the bleeding and spray the paste onto the bleeding.

[0012] The applicator of the present disclosure is easier to apply correctly, will stop bleeding faster, and will apply a layer of hemostatic agent that will not be washed away by the flowing blood.

[0013] In an embodiment, the applicator may include a pressure generating unit at the proximal end of the delivery tube to generate a jet pressure at the proximal end of the nozzle assembly, and the pressure generating unit is used to press the paste out of the container, make it enter and pass through the delivery tube.

[0014] The pressure generating unit will apply the pressure required to press the paste out of the container and make it enter the delivery tube. The pressure generating unit can be any device capable of pressurizing the paste, for example, a piston that pushes the paste; a screw that moves the paste forward when the screw rotates; or a high-pressure fluid that acts on the paste.

[0015] The delivery tube may include a valve for preventing the paste from flowing from the proximal end of the delivery tube through the delivery tube to the distal end of the delivery tube. The valve can be opened when the pressure acting on the paste in the delivery tube has accumulated through the pressure generating unit. A sudden increase in pressure through the nozzle will provide a good spray without producing any drooling effect (i.e., the paste will adhere to the outside of the applicator just outside the nozzle).

[0016] In an embodiment, the applicator may be configured such that the jetting pressure is at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, and possibly even at least 25 or 30 bar. The jetting pressure must be higher than the minimum pressure level for generating droplets or microparticles from the nozzle assembly. A jetting pressure of at least 2 bar can generate droplets from the nozzle assembly. At higher jetting pressures, even at higher flow rates, the droplets will leave the nozzle assembly, such that at a jetting pressure of at least 10 bar even at a relatively high flow rate, droplets will be provided from the nozzle so that even large-scale bleeding can be stopped quickly.

[0017] In an embodiment, the paste may have a viscosity of at least 100 Pa·s or between 100 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

[0018] In an embodiment, the applicator may be configured for delivering a spray of a paste having a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

[0019] The higher the viscosity, the stickier the paste will be. At the same time, a very sticky paste will require a higher pressure to be ejected from the nozzle assembly. Even if the viscosity can be between 1000 Pa·s and 2000 Pa·s, or between 2000 Pa·s and 3000 Pa·s, or between 3000 Pa·s and 4000 Pa·s, or between 4000 Pa·s and 5000 Pa·s, or between 5000 Pa·s and 6000 Pa·s or higher, but a viscosity above 500 Pa·s preferably achieves the required stickiness, and 1500 Pa·s seems to be an ideal balance between stickiness and ejection ability.

[0020] In order for the paste to be discharged from the applicator, the paste should be flowable when subjected to a force applicable to a syringe. Thus, the term "flowable paste" means a paste having a viscosity that promotes stable flow when the paste is subjected to a force. Examples of flowable pastes are pastes having a viscosity between 500 Pa·s and 8000 Pa·s or between 500 Pa·s and 3500 Pa·s when measured at 30 °C and a relative humidity between 65% and 75%. In an embodiment of the present invention, the paste is flowable.

[0021] The viscosity of the paste can be measured by a rheometer, and preferably by a rotational shear-based rheometer. The viscosity of the paste between 500 Pa·s and 8000 Pa·s or between 500 Pa·s and 3500 Pa·s is measured using a Discovery Hybrid Rheometer (DHR-1) from TA Instruments (New Castle, Delaware, USA) under controlled stress and the following measurement conditions: oscillatory measurement mode with time sweep, oscillatory strain of 1%, angular frequency of 1 rad / s, 20 mm plate as the upper geometric diameter, and gap size of 1.25 mm. The measurement is carried out at a temperature between 25 °C and 30 °C or between, and preferably at 25 °C and at a relative humidity between 65% and 75%.

[0022] In an embodiment, the nozzle assembly may include a paste inlet or a nozzle assembly inlet at the proximal end of the nozzle assembly and a spray outlet at the distal end of the nozzle assembly.

[0023] The paste will enter the nozzle assembly in the form of a paste at the paste inlet or the nozzle assembly inlet and leave the nozzle assembly in the form of a spray with a spray cone at the spray outlet.

[0024] In an embodiment, the nozzle assembly may include a nozzle head, which is preferably located in an extension of the distal end of the delivery tube, and the nozzle head has a spray orifice at or at the spray outlet.

[0025] The paste will leave the spray orifice or the nozzle in the form of a spray.

[0026] In an embodiment, the nozzle assembly may include a swirl unit for generating a rotational movement of the paste just before the paste enters the nozzle or the spray orifice. The swirl unit will cause the paste to rotate around the longitudinal center of the applicator, which will cause the paste to flow at an even higher speed, enabling the ejection of the paste at a lower pressure.

[0027] In an embodiment, the nozzle assembly may be configured to direct the paste to rotate around the longitudinal axis of the applicator or the nozzle assembly.

[0028] In an embodiment, the nozzle assembly may be configured to disrupt the axial flow of the paste during delivery. The axial flow that can be disrupted, which can represent a direction substantially along the longitudinal axis of the applicator, can represent a sudden change from the axial direction to the tangential direction. Such disruption will cause the spray of the paste to form at a lower pressure.

[0029] In an embodiment, the nozzle assembly may be configured to produce a complete conical spray pattern when delivering the paste in the form of a spray. Such a cone will provide a uniform distribution of the paste over a large area of the bleeding site.

[0030] In an embodiment, the nozzle head may include a nozzle head tube for radially surrounding the vortex unit. When assembled or attached to the delivery tube, the nozzle head tube will enable the spray orifice to be easily and correctly aligned, for example, centered on the longitudinal axis of the applicator.

[0031] In an embodiment, when viewed in the distal or proximal direction, the spray orifice of the nozzle head may be oval, preferably circular, or polygonal, such as pentagonal or hexagonal, that is, having an oval, preferably circular, or polygonal shape, such as pentagonal or hexagonal.

[0032] In an embodiment, the spray orifice may be centrally located in the distal end of the nozzle head.

[0033] In an embodiment, the spray orifice may include an inwardly opening paste inlet, where the paste inlet preferably converges in the distal direction, for example, its cross-section is conical, flared, or parabolic, bullet-shaped. The nozzle head surrounding the spray orifice has a specific thickness, and the paste inlet that converges in the distal direction will make the spray orifice have a length shorter than the thickness of the nozzle head. This shorter length of the spray orifice will increase the ability of the spray orifice to provide a spray of paste from the spray orifice.

[0034] In an embodiment, the spray orifice may include an outwardly opening spray outlet, where the spray outlet preferably diverges in the distal direction or the ejection direction, for example, its cross-section is conical, flared, or parabolic. The nozzle head surrounding the spray orifice has a specific thickness, and the spray outlet that diverges in the distal direction will make the spray orifice have a length shorter than the thickness of the nozzle head. This shorter length of the spray orifice will increase the ability of the spray orifice to provide a spray of paste from the spray orifice.

[0035] In an embodiment, where the spray orifice may form a double cone. The cross-section of the double cone may be conical, flared, or parabolic. The nozzle head surrounding the spray orifice has a specific thickness, and the paste inlet that converges in the distal direction and the spray outlet that diverges in the distal direction will make the spray orifice have a length shorter than the thickness of the nozzle head. This shorter length of the spray orifice will increase the ability of the spray orifice to provide a spray of paste from the spray orifice. Additionally, the paste inlet and the spray outlet may form a sharp edge at the junction of the paste inlet and the spray outlet. This sharp edge will provide a good spray even at low pressure and reduce the risk of drooling.

[0036] In an embodiment, the spray orifice may form a cylindrical passage, which is preferably away from the paste inlet and / or preferably close to the spray outlet.

[0037] Alternatively, the spray orifice may be cylindrical, such as a complete cylinder.

[0038] In an embodiment, the opening angle of the paste inlet and / or the spray outlet can be between 40 degrees and 140 degrees, preferably between 60 degrees and 120 degrees, more preferably between 80 degrees and 100 degrees, such as about 90 degrees or about 100 degrees or about 110 degrees.

[0039] This opening angle can be understood as the angle formed by two opposite sides or lines of the paste inlet and / or the spray outlet.

[0040] In an embodiment, the nozzle head can have an outer distal surface facing the distal direction and an inner proximal surface facing the proximal direction. This opening angle can be understood as the angle formed by the paste inlet and the distal surface of the nozzle head. This opening angle can be understood as the angle formed by the proximal surface of the nozzle head and the spray outlet.

[0041] In an embodiment, the distal end of the nozzle head can accommodate the spray orifice. The nozzle head can have a thickness less than 2 mm, preferably less than 1.5 mm, preferably between 0.1 mm and 1.5 mm, more preferably between 0.6 mm and 1.4 mm, such as 1.0 mm. The spray orifice can have a thickness less than 2 mm, preferably less than 1.5 mm, preferably between 0.1 mm and 1.5 mm, such as between 0.1 mm and 0.5 mm or between 0.1 mm and 0.3 mm.

[0042] When the spray orifice is short, the spray leaving the spray orifice will have a larger angle, such that the spray cone of the paste has a larger angle, and a large area of bleeding can be covered by the paste.

[0043] In an embodiment, the minimum diameter of the spray orifice can be less than 2 mm, preferably less than 1 mm, more preferably less than 0.6 mm, even more preferably between 0.25 mm and 0.55 mm, most preferably between 0.3 mm and 0.5 mm or between 0.2 mm and 0.5 mm or between 0.2 mm and 0.4 mm.

[0044] The length and diameter / width of the spray orifice can be selected based on the paste used and based on the viscosity of the paste. A paste with a lower viscosity can preferably use a spray orifice with a longer length and / or a smaller diameter / width to avoid leakage of the paste when no or little pressure is applied to the paste.

[0045] In an embodiment, the nozzle head can form part of the delivery tube. The nozzle head can be a continuation of the delivery tube.

[0046] In an embodiment, the nozzle head can be attached to the distal end of the delivery tube or can be an integral part of the distal end of the delivery tube.

[0047] In an embodiment, the cross-section of the nozzle head can be oval, preferably circular, polygonal, super-elliptical or rounded rectangular.

[0048] In an embodiment, the inner diameter of the nozzle head can be less than 10 mm, preferably less than 5 mm, most preferably less than 4 mm, preferably between 2 mm and 4 mm, and most preferably between 3 mm and 4 mm.

[0049] If the applicator is intended to be used in a trocar, the inner diameter of the nozzle head can preferably be less than 4 mm, preferably between 2 mm and 4 mm, and most preferably between 3 mm and 4 mm.

[0050] In an embodiment, the vortex unit can be adjacent to the nozzle head, preferably where the vortex unit can be adjacent to the proximal end of the nozzle head. In this way, the nozzle head and the vortex unit will have a tight connection.

[0051] In an embodiment, the vortex unit can be substantially cylindrical, optionally, can be entirely cylindrical. In an embodiment, the vortex unit can be symmetrically positioned about the central longitudinal axis of the applicator.

[0052] In an embodiment, the vortex unit can include one or more axial guides, such as two, three or more axial guides, which extend towards the paste inlet of the nozzle head, towards the nozzle head or in the distal direction.

[0053] In an embodiment, the axial guide can be formed as a second recess, such as a longitudinal recess, in the outer or peripheral surface of the vortex unit and / or on the inner surface of the nozzle head tube.

[0054] In an embodiment, the proximal surface of the vortex unit and / or the nozzle head can include one or more tangential guides or tangential channels towards the spray orifice in the center of the nozzle assembly and at the distal end of the nozzle assembly, such as two, three or more tangential guides.

[0055] Using two, three or more tangential guides or tangential channels means that the tangential guides or tangential channels can narrow as they approach the spray orifice, so that the flow rate of the paste increases. Then the paste can be ejected from the spray orifice under a lower pressure applied to the paste.

[0056] In an embodiment, the tangential guide can be formed as a first recess in the distal end of the vortex unit.

[0057] In an embodiment, the tangential guide can bend inwards towards the center of the vortex unit or the nozzle assembly.

[0058] In an embodiment, one or more tangential guides may extend non-radially. The non-radial extension of the tangential guide means that the tangential guide extends slightly offset from the position of the spray orifice inside the nozzle assembly, which will cause the paste to rotate before leaving the spray orifice and especially rotate around the spray orifice, so that the paste achieves a higher flow rate or velocity.

[0059] In an embodiment, the second groove forming the axial guide and / or the tangential guide may have a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, such as about 0.7 mm or 0.5 mm.

[0060] In an embodiment, the second groove forming the axial guide and / or the tangential guide may have a depth greater than 0.1 mm.

[0061] In an embodiment, the axial guide and / or the tangential guide may have a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, such as about 0.7 mm or 0.5 mm.

[0062] In an embodiment, the axial guide and / or the tangential guide may have a depth greater than 0.1 mm.

[0063] In an embodiment, the (one or more) axial guides may be connected to the corresponding tangential guides at the distal end of the vortex unit or the nozzle assembly.

[0064] In an embodiment, the vortex unit may include a pointed tip or a second protrusion at the distal end, and the tip or the second protrusion is preferably conical, flared or bullet-shaped. The tip may preferably be in the center of the nozzle assembly, preferably opposite to the paste inlet of the spray orifice. The tip will help the paste to move circularly before entering the spray orifice, so as to increase the flow rate or velocity (the flow rate and velocity may or may not be understood as interchangeable terms), and form a spray from the spray orifice at a lower pressure inside the applicator. The tip also guides the paste flow towards the paste inlet of the spray orifice, thereby reducing backflow. The tip provides a wide and uniform spray from the spray orifice.

[0065] In an embodiment, the tip may be at least partially located inside the spray orifice, or is configured to be at least partially located inside the spray orifice.

[0066] Such a configuration has been proven to be able to produce a paste spray with a wide cone shape.

[0067] In an embodiment, the tip of the vortex unit may only extend through a part of the spray orifice.

[0068] Such a configuration has been proven to be able to produce a paste spray with a wide cone shape.

[0069] In an embodiment, the tip has an included angle or a distal angle, where the included angle or the distal angle of the tip can be less than 80 degrees, preferably less than 70 degrees, more preferably less than 60 degrees, and most preferably about 50 degrees. In an embodiment, the included angle or the distal angle of the tip is the angle at the distal end of the tip.

[0070] In an embodiment, the included angle of the tip and the included angle of the paste inlet can have substantially the same angle.

[0071] In an embodiment, the included angle of the tip can be greater than the included angle of the paste inlet.

[0072] In an embodiment, the included angle of the tip can be less than the included angle of the paste inlet.

[0073] In an embodiment, the nozzle assembly can be provided at least partially or completely in metal, such as stainless steel, such as 316 stainless steel. The stainless steel nozzle assembly will be durable, can be easily sterilized, and can be used multiple times.

[0074] In an embodiment, the nozzle assembly can be provided at least partially, preferably completely, in plastic. Preferably, the nozzle assembly can be injection molded. This will be a cost-effective solution.

[0075] In an embodiment, the container can be a syringe.

[0076] In an embodiment, the delivery tube can have a length between 20 cm and 150 cm, more preferably between 25 cm and 80 cm, such as between 30 cm and 60 cm.

[0077] In an embodiment, the delivery tube can accommodate a volume of, for example, paste between 2 ml and 20 ml or between 3 ml and 18 ml or between 3 ml and 15 ml, preferably between 3 ml and 12 ml, such as 8 ml.

[0078] In an embodiment, the applicator can be an endoscopic and / or laparoscopic applicator.

[0079] In an embodiment, the applicator can be adapted to be inserted into a trocar, which can, for example, mean that the applicator has a length between 20 cm and 150 cm, more preferably between 25 cm and 80 cm, such as between 30 cm and 60 cm, and / or the applicator has an outer diameter and / or an inner diameter between 2 mm and 15 mm, more preferably between 3 mm and 8 mm, such as between 4 mm and 6 mm or between 3 mm and 5 mm.

[0080] In an embodiment, the applicator may comprise an inner diameter between 1 mm and 15 mm, more preferably between 2 mm and 8 mm, such as between 2 mm and 3 mm, between 2 mm and 4 mm, between 4 mm and 6 mm, or between 3 mm and 5 mm.

[0081] In an embodiment, the delivery tube may have a hardness higher than 0.5, 1.5 or 2 GPa·m, preferably higher than 10 or 20 GPa·m and more preferably higher than 50 or 60 GPa·m.

[0082] In an embodiment, the applicator may comprise a sheath that at least partially encloses the delivery tube. Preferably, the sheath encloses 90% or 95% or 97% of the proximal side of the delivery tube. Preferably, only the distal 5 cm or distal 4 cm of the delivery tube is not enclosed by the sheath. The sheath will enable the user to guide the applicator to the correct area. Since the sheath does not enclose the distal portion of the delivery tube, the distal portion of the delivery tube can be manipulated by an external robotic arm so that the spray from the spray orifice can be directed to the bleeding site. In an embodiment, the sheath may be shorter than the delivery tube so that the distal end of the applicator can be manipulated by a robotic arm for guiding the spray direction.

[0083] In an embodiment, the sheath may have a hardness higher than 0.5, 1.5 or 2 GPa·m, preferably higher than 10 or 20 GPa·m and more preferably higher than 50 or 60 GPa·m.

[0084] In an embodiment, the applicator may accommodate a volume of, for example, an ointment between 2 ml and 20 ml or between 3 ml and 20 ml or between 3 ml and 18 ml or between 3 ml and 15 ml, preferably between 4 ml and 12 ml, such as 8 ml or 10 ml. The amount of hemostatic agent in the applicator should be sufficient to stop bleeding from any incision at the surgical site. If the number of blood vessels at the surgical site is extremely small, a smaller amount of 1 ml to 3 ml or 2 ml to 4 ml, such as 2 ml, will be sufficient to stop bleeding from any incision at the surgical site. If the number of blood vessels at the surgical site is relatively large, a higher amount such as 5 ml to 10 ml or 8 ml to 12 ml, such as 10 ml, will be sufficient to stop bleeding from any incision at the surgical site. In some situations, a higher amount such as more than 10 ml may be preferred so that the applicator has sufficient hemostatic agent to stop bleeding multiple times without the need to refill the applicator with fresh hemostatic agent. The surgical procedure can then be performed at a higher speed.

[0085] In an embodiment, the container or syringe contains a volume of saline (or other inert solution) that is substantially the same as or slightly smaller than the volume of the paste in the applicator, such that when the container is emptied, the applicator is filled with saline and the applicator delivers all of the paste in the form of a spray onto the wound or bleeding site. No paste is wasted and no saline will enter the wound. Since saline is not toxic, there is no risk in using saline even if it enters the wound.

[0086] In an embodiment, the applicator has only a small volume for the paste and the applicator contains only a small amount / this small amount of paste, while the container or syringe contains a volume of paste between 2 ml and 20 ml, or between 3 ml and 20 ml, or between 3 ml and 18 ml, or between 3 ml and 15 ml, preferably between 4 ml and 12 ml, such as 8 ml or 10 ml, such that the container or syringe provides substantially all of the paste delivered to the wound through the applicator.

[0087] In an embodiment, the applicator may comprise a material selected from the group consisting of metal, plastic, polymer, glass, fiberglass, carbon fiber, polymer fiber, composites such as fiber-reinforced materials, and combinations thereof.

[0088] In an embodiment, the pressure generating unit can be a piston, a spring acting on a plate located at the distal end of the paste, a screw for at least partially rotating inside the delivery tube, or a gas pressurizing unit for providing enhanced pressure to a gas.

[0089] A spring, hydraulic fluid, pneumatic fluid can act on the piston or plate to apply pressure on the paste. A rotary mechanism where the rotational movement of a wheel is converted into a sliding movement of the piston. A ratchet mechanism used in a caulking gun can also be used to move the piston.

[0090] In an embodiment, the delivery tube and the nozzle assembly can be fluidly connected through a peripheral opening.

[0091] The paste will have to move tangentially to reach the nozzle or spray orifice. This will increase the flow rate of the paste and the spray of the paste will be formed at a lower pressure.

[0092] In an embodiment, the nozzle assembly may include a central wall at the proximal end that is substantially perpendicular to the longitudinal axis of the applicator or nozzle assembly, wherein the central wall has a peripheral opening connecting the delivery tube and the nozzle assembly.

[0093] The central wall will direct the paste away to the periphery of the applicator such that the paste will have to move tangentially to reach the nozzle or spray orifice. The spray from the spray orifice will be formed at a lower pressure inside the nozzle assembly.

[0094] In an embodiment, the nozzle assembly may include a central wall separating the delivery tube from the vortex unit, where the central wall has a peripheral opening connecting the delivery tube to the nozzle assembly.

[0095] In an embodiment, the central wall may have a proximally directed tip or a third protrusion for guiding the paste towards the peripheral opening, which will reduce friction and / or increase the flow rate or velocity of the paste through the applicator. The advantage is that the spray of the paste can be formed at a lower pressure. The pressure applied to the paste in the container will be transmitted to the paste located proximal to the spray orifice with a smaller pressure loss. The spray can be formed at a lower pressure applied to the paste in the container, which will be more comfortable in the case of manually applying pressure or will use less energy in the case of applying pressure by a machine. The pressure and stress acting on the delivery tube will be smaller.

[0096] In an embodiment, the vortex unit may be integrated into the nozzle assembly. Producing a single unit, for example by injection molding, will be faster and thus economically advantageous.

[0097] In an embodiment, the vortex unit can be a single unit or a separate unit. Producing a single unit, for example by injection molding, will be faster and thus economically advantageous.

[0098] In an embodiment, the applicator may have an outer thickness of less than 15 mm, or preferably less than 7 mm, more preferably less than 6 mm, even more preferably less than 5 mm, such as 5 mm or 4 mm or 3 mm, either completely or at least partially in at least one dimension or in two dimensions.

[0099] The present invention also relates to a nozzle assembly as described in the present application.

[0100] The present invention also relates to a method for applying a surgical hemostatic agent to a target site, the method comprising the steps of:

[0101] - providing an applicator connected to a container containing a paste as presented above and / or below,

[0102] - applying pressure to the paste in the container for feeding the paste into the applicator, and

[0103] - ejecting the paste onto the target site through a nozzle assembly.

[0104] In an embodiment, the pressure applied to the paste may form an ejection pressure on the nozzle assembly, the ejection pressure being at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, possibly even at least 25 or 30 bar.

[0105] In an embodiment, the paste may have a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s. Description of the Drawings

[0106] The present invention will be described in more detail hereinafter with reference to the following drawings:

[0107] Figure 1 Schematic diagram of an applicator connected to a container

[0108] Schematic diagrams of the first embodiment in FIGS. 2a to 2c

[0109] Schematic diagrams of the second embodiment in FIGS. 3a to 3c

[0110] Schematic diagrams of the third embodiment in FIGS. 4a to 4c

[0111] Schematic diagrams of the fourth embodiment in FIGS. 5a to 5c

[0112] Figure 6 Schematic diagram of the sixth embodiment

[0113] Figure 7 Schematic diagram of the seventh embodiment

[0114] Figure 8 Schematic diagram of a nozzle assembly ejecting droplets of paste onto a sheet of paper Detailed Description of the Embodiments

[0115] Figure 1 An applicator 102 is shown that includes a delivery tube 104 and a nozzle assembly 105, where the distal end 104a of the delivery tube 104 is connected to the nozzle assembly. The delivery tube 104 may be at least partially positioned within a rigid sheath 106 to enable a user to guide the applicator to the correct location, such as within a patient, during a surgical procedure. The diameter of the applicator may preferably be no greater than 5 mm for use inside a trocar.

[0116] The applicator is connected to a container 108, such as a syringe, at the proximal end of the delivery tube 104. The container 108 includes a pressure generating unit in the form of a piston 110 that applies pressure to the paste 112 inside the container to press the paste out of the container and into the delivery tube and further into the nozzle assembly to create a complete conical spray pattern when the paste is delivered from the nozzle assembly in a spray form.

[0117] The container 108 is positioned within an activator 114 having a trigger 116 and a rod 118, where actuating the trigger will move the rod a small distance towards the piston 110. By repeatedly pressing the trigger 116, force will be applied to the paste 112 through the piston, and the paste can be ejected from the nozzle assembly 105.

[0118] The activator can have many designs. The activator can be actuated electrically, for example, by a battery (not shown in the figure) inside the activator, such that actuating the trigger 116 will activate a motor (not shown in the figure), causing the rod 118 to move towards the piston 110 for ejecting the paste of the applicator 102.

[0119] Instead of pushing the piston into the container, the container can include a screw (not shown in the figure), which when rotated will press the paste into the delivery tube 104 for ejecting the paste from the applicator 102. The screw can be rotated by an off - center - positioned handle (not shown in the figure) or by being driven electrically (by a battery), thus rotating the motor actuated by the trigger 116.

[0120] Alternatively, a fluid - actuated second piston (not shown in the figure) can also be used to advance the piston 110, where a pressure source (not shown in the figure), such as a compressor, generates pressure that pushes the fluid - actuated second piston to act on the piston 110 for ejecting the paste from the applicator 102. The pressure source can be actuated by actuating the trigger 116, or when the trigger is actuated, pressurized fluid from the pressure source can be allowed to act on the fluid - actuated second piston.

[0121] Preferably, fluid is not allowed to act directly on the paste or enter the container 108 to avoid the risk of accidental fluid leakage into the applicator and being delivered to the surgical site in the patient's body.

[0122] Figures 2a through 2c show a first embodiment of an applicator 202 having a delivery tube 204 (only the distal end of the delivery tube is shown) and a nozzle assembly 205. The nozzle assembly includes a nozzle head 206 and an intermediate unit 207, where the nozzle 208 or spray orifice 208 is preferably located on the longitudinal central axis 209 of the nozzle head. The applicator 202 is preferably made of plastic.

[0123] The nozzle assembly 205 includes a central wall 210 at the distal end of the nozzle assembly 205. A vortex unit 211 in the form of a first protrusion 212 on the distal side of the central wall forms a tangential guide 213 or a first groove 213. The nozzle assembly 205 includes an axial guide 214 or a second groove 214 passing through the central wall 210. The second groove 214 is a peripheral opening as the second groove is located at the periphery of the central wall. The central wall 210 guides the paste away to the periphery of the applicator and through the second groove 214. The tangential guide 213 guides the paste on the distal side of the central wall from the periphery towards the longitudinal central axis 209, and guides the paste out in the form of a spray through the nozzle 208.

[0124] Figure 2a shows a perspective view and an exploded view of a first embodiment of the applicator 202. The applicator 202 has two opposite third grooves 215 for allowing easier grasping by forceps (not shown in the figure) with jaws of an external instrument. The third grooves 215 will allow the external instrument to move the applicator to the correct position at the surgical site.

[0125] Before a paste with a high viscosity moves towards the nozzle 208 and is ejected from the nozzle, a specific pressure will be required to be applied to the paste. Once the pressure is removed, the flow of the paste will stop. Using a paste with a high viscosity, a valve for preventing the flow of the paste will be unnecessary. If the applicator 202 does not include a valve for preventing the flow of the paste and the paste will flow through the nozzle 208 even at a lower pressure, the applicator 202 can be configured to be easily collapsible at the third grooves 215, such that the flow of the paste can be constricted by pressing the third grooves 215. By clamping the third grooves 215 with the jaws of an instrument, the flow of the paste can be reduced or even stopped.

[0126] Figure 2b shows an assembled view of a cross-section along Iib in Figure 2a of the first embodiment of the applicator 202. The cross-section is in a vertical plane in Figure 2a. The nozzle assembly 205 includes a first cavity 216 for receiving the paste from the delivery tube 204. The nozzle assembly 205 can have a second cavity 218 with an increased diameter at the distal end for receiving the delivery tube 204 at a well-defined position, and such that the first cavity and the delivery tube 204 have substantially the same inner diameter for allowing the paste to move with reduced friction. The delivery tube 204 and the nozzle assembly 205 are fixed to each other, for example, by glue or mechanically, such as by snap fit, or the delivery tube 204 and the nozzle assembly 205 can be welded together.

[0127] Figure 2b also shows the way the nozzle head 206 and the nozzle assembly 205 are assembled. The nozzle head 206 and the nozzle assembly 205 are fastened to each other, for example, by glue or welding or mechanically, such as by snap fit.

[0128] The central wall 210 may have a second protrusion or tip 220 at the middle of the central wall 210 on the distal side of the central wall 210. The second protrusion 220 may be conical or flared, or may have a parabolic cross-section (bullet-shaped - convex cross-section). The second protrusion 220 may at least partially protrude into the nozzle 208 for improving the spraying effect. The second protrusion 220 may protrude through half of the nozzle 208 for improving the spraying effect. The second protrusion 220 that at least partially protrudes into the nozzle will reduce the pressure required for spraying the paste from the nozzle. The second protrusion 220 may protrude up to the nozzle 208, or up to 1 mm from the nozzle, or up to 2 mm from the nozzle.

[0129] The nozzle head 206 may be just a plate with the nozzle 208, where the nozzle head is fastened to the nozzle assembly 205 at the distal end of the nozzle assembly. However, the nozzle head 206 with the tube structure 222 will help to position the nozzle 208 at the center of the nozzle assembly 205, which will be additionally advantageous when the nozzle and the second protrusion 220 will be aligned with each other.

[0130] The nozzle 208 may have a paste inlet 224 that converges in the distal direction, such as being conical, flared or bullet-shaped. The nozzle 208 may have a spray outlet 226 that diverges in the distal direction, such as being conical, flared or bullet-shaped. During spraying, the distal direction is in the spraying direction and / or in the direction of the paste. The nozzle head 206 may have an outer distal surface facing the distal direction and an inner proximal surface facing the proximal direction. In the case where the converging paste inlet meets the diverging spray outlet, in the case where the converging paste inlet meets the distal surface (if there is no diverging spray outlet), or in the case where the proximal surface meets the diverging spray outlet (if there is no converging paste inlet), the spray orifice will have a minimum spray orifice opening. The minimum spray orifice opening may have an orifice length less than 0.5 mm, preferably less than 0.3 mm, such as 0.2 mm or 0.1 mm. An orifice length less than 0.5 mm will provide a good-quality spray.

[0131] In an embodiment, the second protrusion 220 may protrude at least partially into the nozzle 208 to improve the spraying effect, or the second protrusion 220 may protrude at least partially into the smallest spray orifice opening to further improve the spraying effect. If the second protrusion protrudes at least partially into the nozzle or into the smallest spray orifice opening, a gap will be formed around the second protrusion 220, where the gap is the shortest distance between on the one hand the second protrusion 220 and on the other hand the nozzle 208, the paste inlet 224 or the smallest spray orifice opening. The gap may preferably be less than 0.5 mm, more preferably less than 0.3 mm, and even more preferably less than 0.1 mm, such as 0.06 mm or 0.08 mm. The smaller the gap, the wider the spray will be, and the spray will contain finer particles for providing a continuous and interconnected film on the wound that will stop bleeding more quickly.

[0132] Alternatively or in addition to the paste inlet 224 and / or the spray outlet 226, the nozzle 208 may also have a cylindrical portion 227 that neither converges nor diverges. The cylindrical portion may have a length of at least 0.1 mm, or at least 1 mm, or at least 2 mm, or at least 3 mm, and / or the cylindrical portion may have a length less than 10 mm, or less than 8 mm, or less than 6 mm.

[0133] The first protrusion 212 may be adjacent to the proximal surface of the nozzle head 206 to form a well-defined tangential guide 213 and axial guide 214 as shown in FIG. 2b.

[0134] FIG. 2c shows a cross-section along IIc in FIG. 2b. Even though FIG. 2b shows a cross-section, i.e., half of the applicator 202, the entire cross-section of the applicator is shown in FIG. 2c. FIG. 2c shows the vortex unit 211 with the first protrusion 212 that forms the tangential guide 213 and the axial guide 214. In the embodiment shown in FIG. 2c, the nozzle assembly 205 has three tangential guides 213.

[0135] As shown in FIG. 2c, the axial guide 214 has a direction substantially parallel to the longitudinal axis 209 of the applicator or the nozzle assembly, and the tangential guide 213 has a direction substantially perpendicular to the longitudinal axis and / or more or less parallel to the radial direction of the nozzle assembly. However, if the tangential guide 213 is not completely parallel to the radial direction of the nozzle assembly as shown in FIG. 2c, the moving paste will be subjected to a rotational movement in the vortex unit, which will enhance the ability of the paste to be ejected from the nozzle 208.

[0136] FIGS. 3a to 3c show a second embodiment of the applicator 302. Features of the second embodiment that have all the qualities and functionality of the corresponding features in the first embodiment are given the same reference numerals.

[0137] The applicator 302 has a delivery tube 204 and a nozzle assembly 305. The nozzle assembly includes a nozzle head 306 and an intermediate unit 307, where the nozzle 208 is preferably on the longitudinal central axis 209 of the nozzle head. The applicator 302 is preferably made of plastic.

[0138] The second embodiment of the applicator 302 may have any, any combination, or all of the features and advantages mentioned above with respect to the first embodiment. The difference between the second embodiment and the first embodiment is that the nozzle assembly 305 has a slightly flattened cross-section that is square or substantially rectangular, such that it has a smaller thickness in at least one dimension, which means that the third groove 315 can be more easily grasped by an external instrument having jaws, since the thickness on the third groove 315 is smaller in the second embodiment than in the first embodiment.

[0139] Figure 3a shows a perspective view and an exploded view of the second embodiment of the applicator 302. Due to the slightly flattened cross-section of the applicator, the thickness of the third groove 315 can be made thinner, such that the jaws of the grasping instrument can more easily grip the applicator 302 at the third groove 315 of the second embodiment compared to the third groove of the first embodiment.

[0140] Figure 3b shows an assembled view of the cross-section of the second embodiment of the applicator 302 along IIIb in Figure 3a. The cross-section is in a vertical plane in Figure 3a.

[0141] Figure 3c shows a cross-section along IIIc in Figure 3b. Even though Figure 3b shows a cross-section, i.e., half of the applicator 302, Figure 3c shows the entire cross-section of the applicator. Figure 3c shows a vortex unit 311 having a first protrusion 312 that forms a tangential guide 313 and an axial guide 314. In addition to the first embodiment, the nozzle assembly 305 of the second embodiment shown in Figure 3c has two tangential guides 313.

[0142] Figures 4a to 4c show a third embodiment of the applicator 402. Features of the third embodiment having all the qualities and functionality identical to the corresponding features in the first embodiment are given the same reference numerals.

[0143] The applicator 402 has a delivery tube 204 and a nozzle assembly 405. The nozzle assembly includes a nozzle head 406 and an intermediate unit 407, where the nozzle 208 is preferably on the longitudinal central axis 209 of the nozzle head. The applicator 402 is preferably made of plastic.

[0144] The third embodiment of the applicator 402 may have any, any combination, or all of the features and advantages mentioned above with respect to the first or second embodiment. The difference between the third embodiment and the first embodiment is that the vortex unit 411 is a single unit or a separate unit that is not part of the remainder of the nozzle assembly 405, the vortex unit has a third protrusion 430 on the proximal side of the vortex unit, and the first cavity 416 has a reduced inner diameter at least along a portion of the first cavity such that the thickness of the nozzle assembly 405 at two opposite third grooves 415 can be further reduced and the jaws of the clamping instrument can more easily grip the two opposite third grooves 415.

[0145] Figure 4a shows a perspective view and an exploded view of the third embodiment of the applicator 402. The third protrusion 430 will make it easier for a person or a robot assembling the applicator 402 to grip the vortex unit 411. The third protrusion 430 may also increase the flow rate of the paste at the transition from the first cavity 416 to the axial guide 214 by guiding the paste towards the axial guide 214 and reducing the back pressure. The third protrusion may be located on the proximal side of the central wall with or without the vortex unit.

[0146] Figure 4b shows an assembled view of a cross-section of the third embodiment of the applicator 402 along Ivb in Figure 4a, where the reduced inner diameter of the first cavity 416 is clearly visible. This cross-section is in a vertical plane in Figure 4a.

[0147] Figure 4c shows a cross-section along Ivc in Figure 4b. Even though Figure 4b shows a cross-section, that is, half of the applicator 402, the entire cross-section of the applicator is shown in Figure 4c. Figure 4c shows the vortex unit 411, which has the same design as the vortex unit 211 in Figure 2c when viewed from this direction.

[0148] Figures 5a to 5c show a fourth embodiment of the applicator 502. Features of the fourth embodiment that have all the qualities and functionality of the corresponding features in the first embodiment are given the same reference numerals.

[0149] The applicator 502 has a delivery tube 204 and a nozzle assembly 505. The nozzle assembly includes a nozzle head 506 and an intermediate unit 507, where the nozzle 208 is preferably on the longitudinal central axis 209 of the nozzle head. The applicator 502 is preferably made of plastic.

[0150] The fourth embodiment of applicator 502 may have any one, any combination, or all of the features and advantages mentioned above with respect to any of the first, second, and third embodiments. The difference between the fourth embodiment and the first embodiment is that the first protrusion 512 is an integral part of the nozzle head 506 or is molded together with the nozzle head, and the central wall 510, the second protrusion 220 or tip, and the third protrusion 530 on the proximal side of the central wall form a first single unit 532 or a separate unit. The first cavity 516 has a reduced inner diameter at least along a portion of the first cavity such that the thickness of the nozzle assembly 505 at two opposite third grooves 515 can be further reduced, and the jaws of the clamping instrument can more easily grip the two opposite third grooves 515.

[0151] Figure 5a shows a perspective view and an exploded view of the fourth embodiment of applicator 502. The third protrusion 530 will make it easier for a person or a robot assembling the applicator 502 to grip the first single unit 532. The third protrusion 530 can also increase the flow rate of the paste at the transition from the first cavity 516 to the axial guide 214 and through the central wall 510 by guiding the paste towards the periphery of the central wall and to the axial guide 214 and reducing the back pressure. The third protrusion can be located on the proximal side of the central wall with or without a vortex unit. The intermediate unit 507 includes a second central wall 534 that aligns the first single unit 532 through the third protrusion 530. There is a passage (not shown in the figure) through the second central wall 534 for guiding the paste through the second central wall 534.

[0152] Figure 5b shows an assembled view of a cross-section of the fourth embodiment of applicator 502 along Vb in Figure 5a, where the reduced inner diameter of the first cavity 516 is clearly visible. This cross-section is in a vertical plane in Figure 5a.

[0153] Figure 5c shows a cross-section along Vc in Figure 5b. Even though Figure 5b shows a cross-section, that is, half of the applicator 502, the entire cross-section of the applicator is shown in Figure 5c. Figure 5c shows: a vortex unit 511, which is part of the nozzle head 506; and a second protrusion 220, which is part of the first single unit 532.

[0154] The fourth embodiment may additionally have any one, any combination, or all of the features of any of the first, second, and third embodiments.

[0155] In a fifth embodiment of the applicator (not shown in the figure), the nozzle head is an integral part of the intermediate unit or is molded together with the intermediate unit. The vortex unit is a single unit that will be introduced into the first cavity from the proximal end of the intermediate unit. The vortex unit and possibly the second protrusion will be well-aligned with the nozzle and the spray orifice.

[0156] Figure 6 Showing the distal end of an example of a sixth embodiment of the applicator. In the sixth embodiment of the applicator, the vortex unit 611 may include a single second groove 614 and a single tangential guide 613 as shown in Figure 6 , such that the paste can be guided from the first cavity 616 through the central wall 610 and into and around the second protrusion 220. A nozzle head (not shown in the figures) is expected to have a tube structure (not shown in the figures) for aligning the nozzle head around the vortex unit by sliding the nozzle head downward on the outer surface 640 in the shown embodiment, such that the nozzle (not shown in the figures) can be correctly oriented and aligned with the second protrusion 220. A sixth embodiment without a tube structure may also be covered.

[0157] With a single second groove 614 and a single tangential guide 613, pressure can be applied to the paste by a pressure generating unit (not shown in the figures) to remove any blockage between the first cavity 616 and the nozzle (not shown in the figures) (including the first cavity and the nozzle). There are no alternative second grooves and / or single tangential guides through which the paste can pass, such that the blockage is not cleared.

[0158] In Figure 6 , the base width 642 of the second protrusion of the second protrusion is shown. The base width 642 of the second protrusion is the width of the second protrusion where the second protrusion is attached to the central wall 610. In one embodiment, the base width of the second protrusion may be less than 1 mm, preferably less than 0.8 mm, more preferably less than 0.6 mm, such as between 0.2 mm and 0.5 mm.

[0159] The sixth embodiment may have any one, any combination, or all of the features of any of the first, second, third, fourth, and fifth embodiments.

[0160] In the seventh embodiment, the second protrusion 220 may protrude into the nozzle 208 of the nozzle head 706, as shown in Figure 7 .

[0161] In a seventh embodiment, the second protrusion 220 may have a second protruding point 750 which preferably points in the distal direction, where the angle of the second protruding point is between 30° and 90°, preferably between 40° and 80°, more preferably between 50° and 70°, such as 60°. The second protrusion 220 protruding into the nozzle 208 and the paste inlet 224 may have opposing surfaces which may be at least partially parallel to provide a gap with a constant width between the opposing surfaces. The two opposing surfaces may form a gap in the form of a truncated cone which has a constant thickness depending on the distal-proximal position. Due to the truncated cone shape, the volume for the paste to move from the proximal end of the opposing surfaces to the distal end will decrease, such that the flow rate of the paste will increase when the paste approaches the second protruding point 750, which will increase the spraying quality, that is, the spray has smaller particles and a wider spray cone.

[0162] The two opposing surfaces may form a gap in the form of a truncated cone which has different thicknesses depending on the distal-proximal position. In Figure 7 the example shown, the opposing surfaces form a gap at the proximal end which decreases in the distal direction until reaching the waist gap 752, at which waist gap the gap has its narrowest passage. Distal to the waist gap, the width of the gap increases. The gap which continuously decreases until the waist gap 752 will significantly increase the flow rate of the paste to provide a well-quality spray.

[0163] The waist gap 752 may be positioned at the most distal end of the second protruding point 750 such that there is no second protruding point 750 distal to the waist gap. The paste leaving the gap will leave the gap at the highest flow rate, thereby providing a well-quality spray. The longitudinal axis 209 is also shown to show the central axis of the nozzle 208 and the second protruding point 750.

[0164] Figure 8 The applicator 800 in operation is shown in. The spray cone 802 leaves the nozzle assembly 804 at a spray angle between 20° and 40°. The spray is deposited on a plate 806 at about 90 mm from the nozzle assembly in the example of the present invention.

[0165] The first deposit 808 has been formed. Subsequently, the nozzle assembly is moved and / or rotated to form the second deposit 810. As can be seen from the example, the second deposit has the highest deposition rate at the center 812 of the second deposit, but still covers a relatively large peripheral area 814 around the center. Therefore, the applicator 800 will be able to stop severe bleeding and at the same time stop bleeding covering a large area in the example of the present invention.

[0166] Item

[0167] 1. An applicator for delivering a paste from a container, the applicator comprising:

[0168] - A delivery tube configured to be connected to the container or configured to be connected to the container at its proximal end, and

[0169] - A nozzle assembly at the distal end of the delivery tube, the nozzle assembly being configured to deliver the paste in the form of a spray, preferably in the form of a spray of droplets or particles.

[0170] 2. The applicator according to item 1, wherein the applicator comprises the container, and wherein the applicator comprises a pressure generating unit at the proximal end of the delivery tube to generate an ejection pressure at the proximal end of the nozzle assembly, the pressure generating unit being configured to press the paste out of the container, through the delivery tube.

[0171] 3. The applicator according to item 2, configured such that the ejection pressure is at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, possibly even at least 25 or 30 bar.

[0172] 4. The applicator according to any one of the preceding items, wherein the paste has a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s, and / or wherein the applicator is configured to deliver a spray of a paste having a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

[0173] 5. The applicator according to any one of the preceding items, wherein the nozzle assembly comprises a paste inlet or nozzle assembly inlet at the proximal end of the nozzle assembly and a spray outlet at the distal end of the nozzle assembly.

[0174] 6. The applicator according to any one of the preceding items, wherein the nozzle assembly comprises a nozzle head, preferably located in an extension of the distal end of the delivery tube, the nozzle head having a spray orifice at the spray outlet.

[0175] 7. The applicator according to any one of the preceding items, wherein the nozzle assembly comprises a vortex unit for generating a rotational movement of the paste.

[0176] 8. The applicator according to any one of the preceding items, wherein the nozzle assembly is configured to direct the paste to rotate about the longitudinal axis of the applicator or the nozzle assembly.

[0177] 9. The applicator according to any one of the preceding items, wherein the nozzle assembly is configured to disrupt the axial flow of the paste during delivery.

[0178] 10. The applicator according to any one of the preceding items, wherein the nozzle assembly is configured to produce a complete conical spray pattern when delivering the paste in the form of a spray.

[0179] 11. The applicator according to any one of the preceding items, wherein the nozzle head includes a nozzle head tube for radially surrounding the vortex unit.

[0180] 12. The applicator according to any one of items 6 to 11 of the preceding items, wherein the spray orifice of the nozzle head is oval, preferably circular, or polygonal, such as pentagonal or hexagonal.

[0181] 13. The applicator according to any one of items 6 to 12 of the preceding items, wherein the center of the spray orifice is located centrally in the distal end of the nozzle head.

[0182] 14. The applicator according to any one of items 6 to 13 of the preceding items, wherein the spray orifice includes a paste inlet opening inward, and the paste inlet preferably converges in the distal direction, for example, its cross-section is conical, flared or parabolic.

[0183] 15. The applicator according to any one of items 6 to 14 of the preceding items, wherein the spray orifice includes a spray outlet opening outward, and the spray outlet preferably diverges in the distal direction or the spraying direction, for example, its cross-section is conical, flared or parabolic.

[0184] 16. The applicator according to any one of items 6 to 15 of the preceding items, wherein the spray orifice forms a double conical, double flared or double parabolic shape, preferably having a waist.

[0185] 17. The applicator according to any one of items 6 to 16 of the preceding items, wherein the spray orifice forms a cylindrical passage, which is preferably away from the paste inlet and / or preferably close to the spray outlet.

[0186] 18. The applicator according to any one of items 6 to 17 of the preceding items, wherein the opening angle of the paste inlet and / or the spray outlet is between 40 degrees and 140 degrees, preferably between 60 degrees and 120 degrees, more preferably between 80 degrees and 100 degrees, such as about 90 degrees.

[0187] 19. The applicator according to any one of items 6 to 18 of the preceding items, wherein the distal end of the nozzle head accommodating the spray orifice has a thickness of less than 2 mm, preferably less than 1.5 mm, preferably between 0.1 mm and 1.5 mm, more preferably between 0.6 mm and 1.4 mm, such as 1.0 mm.

[0188] 20. The applicator according to any one of items 6 to 19 above, wherein the spray orifice has a length of less than 2 mm, preferably less than 1.5 mm, preferably between 0.1 mm and 1.5 mm, more preferably between 0.6 mm and 1.4 mm, such as 1.0 mm.

[0189] 21. The applicator according to any one of items 6 to 20 above, wherein the minimum diameter of the spray orifice is less than 2 mm, preferably less than 1 mm, more preferably less than 0.6 mm, even more preferably between 0.25 mm and 0.55 mm, and most preferably between 0.3 mm and 0.5 mm.

[0190] 22. The applicator according to any one of items 6 to 21 above, wherein the nozzle head forms part of the delivery tube.

[0191] 23. The applicator according to any one of items 6 to 22 above, wherein the nozzle head is attached to the distal end of the delivery tube or is an integral part of the distal end of the delivery tube.

[0192] 24. The applicator according to any one of items 6 to 23 above, wherein the cross-section of the nozzle head is oval, preferably circular, polygonal, super-elliptical or rounded rectangular.

[0193] 25. The applicator according to any one of items 6 to 24 above, wherein the inner diameter of the nozzle head is less than 10 mm, preferably less than 5 mm, most preferably less than 4 mm, preferably between 2 mm and 4 mm, and most preferably between 3 mm and 4 mm.

[0194] 26. The applicator according to any one of items 7 to 25 above, wherein the vortex unit abuts the nozzle head, preferably, wherein the vortex unit abuts the proximal end of the nozzle head.

[0195] 27. The applicator according to any one of items 7 to 26 above, wherein the vortex unit is substantially cylindrical.

[0196] 28. The applicator according to any one of items 7 to 27 above, wherein the vortex unit includes one or more axial guides, such as two, three or more axial guides, which extend towards the paste inlet.

[0197] 29. The applicator according to any one of items 7 to 28 above, wherein the axial guide is formed as a second groove, such as a longitudinal groove, in the outer surface of the vortex unit or on the distal surface of the nozzle head.

[0198] 30. The applicator according to any one of the preceding items 7 to 29, wherein the distal surface of the vortex unit and / or the nozzle head comprises one or more tangential guides or tangential channels, such as two, three or more tangential guides, for guiding the paste towards the spray outlet.

[0199] 31. The applicator according to any one of the preceding items 7 to 30, wherein the tangential guide is formed as a first groove in the distal end of the vortex unit.

[0200] 32. The applicator according to any one of the preceding items 7 to 31, wherein the tangential guide is curved, optionally curved inwards, optionally curved towards the center of the vortex unit.

[0201] 33. The applicator according to any one of the preceding items, wherein the one or more tangential guides extend non-radially.

[0202] 34. The applicator according to any one of the preceding items, wherein the second groove forming the axial guide and / or the first groove forming the tangential guide has a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, such as about 0.7 mm or 0.5 mm.

[0203] 35. The applicator according to any one of the preceding items, wherein the axial guide and / or the tangential guide has a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, such as about 0.7 mm or 0.5 mm.

[0204] 36. The applicator according to any one of the preceding items 7 to 35, wherein the (one or more) axial guides are connected to the corresponding (one or more) tangential guides at the distal end of the vortex unit and / or at the distal end of the (one or more) axial guides.

[0205] 37. The applicator according to any one of the preceding items 7 to 36, wherein the vortex unit comprises a tip or a second protrusion at the distal end, which tip or second protrusion is preferably conical, flared or bullet-shaped.

[0206] 38. The applicator according to item 37, wherein the tip is at least partially located inside the spray orifice, or is configured to be at least partially located inside the spray orifice.

[0207] 39. The applicator according to any one of the preceding items 37 to 38, wherein the tip of the vortex unit only extends through a part of the spray orifice.

[0208] 40. The applicator according to any one of items 37 to 39 above, wherein the opening angle of the tip is less than 80 degrees, preferably less than 70 degrees, more preferably less than 60 degrees, and most preferably about 50 degrees.

[0209] 41. The applicator according to any one of items 37 to 40 above, wherein the opening angle of the tip has a substantially same angle as the opening angle of the paste inlet.

[0210] 42. The applicator according to any one of items 37 to 41 above, wherein the opening angle of the tip is greater than the opening angle of the paste inlet.

[0211] 43. The applicator according to any one of items 37 to 42 above, wherein the opening angle of the tip is less than the opening angle of the paste inlet.

[0212] 44. The applicator according to any one of the above items, wherein the nozzle assembly is provided at least partially with a metal, such as stainless steel, such as 316 stainless steel.

[0213] 45. The applicator according to any one of the above items, wherein the nozzle assembly is provided at least partially, preferably completely, with a plastic, and preferably, the nozzle assembly is injection molded.

[0214] 46. The applicator according to any one of the above items, wherein the container is a syringe.

[0215] 47. The applicator according to any one of the above items, wherein the delivery tube has a length between 20 cm and 150 cm, more preferably between 25 cm and 80 cm, such as between 30 cm and 60 cm.

[0216] 48. The applicator according to any one of the above items, wherein the delivery tube accommodates a volume between 2 ml and 20 ml, preferably between 3 ml and 12 ml, such as 8 ml.

[0217] 49. The applicator according to any one of the above items, wherein the applicator is an endoscopic and / or laparoscopic applicator.

[0218] 50. The applicator according to any one of the above items, wherein the applicator is adapted to be inserted into a trocar.

[0219] 51. The applicator according to any one of the above items, wherein the applicator has an inner diameter between 1 mm and 15 mm, more preferably between 2 mm and 8 mm, such as between 2 mm and 3 mm, between 2 mm and 4 mm, between 4 mm and 6 mm, or between 3 mm and 5 mm.

[0220] 52. The applicator according to any one of the preceding items, wherein the delivery tube has a hardness higher than 0.5, 1.5 or 2 GPa·m, more preferably higher than 50 or 60 GPa·m.

[0221] 53. The applicator according to any one of the preceding items, wherein the applicator comprises a sheath that at least partially encloses the delivery tube.

[0222] 54. The applicator according to item 53, wherein the sheath has a hardness higher than 0.5, 1.5 or 2 GPa·m, more preferably higher than 50 or 60 GPa·m.

[0223] 55. The applicator according to any one of the preceding items, wherein the applicator is accommodated in a volume between 3 ml and 20 ml, preferably between 4 ml and 12 ml, such as 8 ml or 10 ml.

[0224] 56. The applicator according to any one of the preceding items, wherein the applicator comprises one of the materials selected from the group consisting of: metal, plastic, polymer, glass, glass fiber, carbon fiber, polymer fiber, composites such as fiber-reinforced materials, and combinations thereof.

[0225] 57. The applicator according to any one of items 2 to 56 of the preceding items, wherein the pressure generating unit is a piston, a spring acting on a plate positioned at the distal end of the paste, a screw for at least partially rotating inside the delivery tube, or a gas pressurizing unit for providing enhanced pressure to a gas.

[0226] 58. The applicator according to any one of the preceding items, wherein the delivery tube and the nozzle assembly are fluidly connected through a peripheral opening.

[0227] 59. The applicator according to any one of the preceding items, wherein the nozzle assembly comprises a central wall substantially perpendicular to the longitudinal axis of the applicator or the nozzle assembly at the proximal end, and the central wall has a peripheral opening connecting the delivery tube and the nozzle assembly.

[0228] 60. The applicator according to any one of the preceding items, wherein the nozzle assembly comprises a central wall separating the delivery tube from the vortex unit, and the central wall has a peripheral opening connecting the delivery tube and the nozzle assembly.

[0229] 61. The applicator according to item 59 or 60, wherein the central wall has a proximal-pointing tip or a third protrusion for guiding the paste towards the peripheral opening.

[0230] 62. The applicator according to any one of the preceding items, wherein the vortex unit is a single unit or an independent unit.

[0231] 63. The applicator according to any one of the preceding items, wherein the vortex unit is integrated into the nozzle assembly.

[0232] 64. The applicator according to any one of the preceding items, wherein the applicator has an external thickness of less than 7 mm, preferably less than 6 mm, more preferably less than 5 mm, such as 4 mm, at least in one dimension or in two dimensions, either completely or at least partially.

[0233] 65. A nozzle assembly according to any one of the preceding items.

[0234] 66. A method for applying a surgical hemostatic agent to a target site, the method comprising the steps of:

[0235] providing an applicator according to any one of items 1 to 65 above, the applicator being connected to a container containing a paste,

[0236] applying pressure to the paste in the container for feeding the paste into the applicator, and

[0237] spraying the paste onto the target site through a nozzle assembly.

[0238] 67. The method according to item 66, wherein the pressure applied to the paste forms a spraying pressure on the nozzle assembly, the spraying pressure being at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, possibly even at least 25 or 30 bar.

[0239] 68. The method according to item 66 or 67, wherein the paste has a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

Claims

1. An applicator for delivering a paste from a container, the applicator comprising: - a delivery tube for connection to the container at a proximal end, and - a nozzle assembly at a distal end of the delivery tube, the nozzle assembly for delivering the paste in the form of a spray, preferably in the form of a spray of droplets or particles.

2. The applicator according to claim 1, wherein the applicator comprises the container, and wherein the applicator comprises a pressure generating unit at the proximal end of the delivery tube to generate an ejection pressure at the proximal end of the nozzle assembly, the pressure generating unit for pressing the paste out of the container, through the delivery tube.

3. The applicator according to claim 2, configured such that the ejection pressure is at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, possibly even at least 25 or 30 bar.

4. The applicator according to any one of the preceding claims, wherein the paste has a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s, and / or wherein the applicator is configured to deliver a spray of a paste having a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

5. The applicator according to any one of the preceding claims, wherein the nozzle assembly comprises a nozzle head, preferably located in an extension of the distal end of the delivery tube, the nozzle head having a spray orifice at a spray outlet.

6. The applicator according to any one of the preceding claims, wherein the nozzle assembly comprises a vortex unit for generating a rotational movement of the paste.

7. The applicator according to claim 5 or 6, wherein the spray orifice comprises a paste inlet opening inwardly, wherein the paste inlet preferably converges in a distal direction, for example having a conical, flared or parabolic cross-section, and / or wherein the spray orifice comprises a spray outlet opening outwardly, wherein the spray outlet preferably diverges in a distal direction or ejection direction, for example having a conical, flared or parabolic cross-section.

8. The applicator according to any one of claims 6-7, wherein the vortex unit comprises one or more axial guides, such as two, three or more axial guides, extending towards the paste inlet.

9. The applicator according to any one of claims 6-8, wherein the distal surface of the vortex unit and / or the nozzle head comprises one or more tangential guides or tangential channels towards the spray outlet, such as two, three or more tangential guides.

10. The applicator according to claim 9, wherein the one or more tangential guides do not extend radially.

11. The applicator according to claim 9 or 10, wherein the tangential guide is curved.

12. The applicator according to any one of the preceding claims 6 - 10, wherein the vortex unit includes a tip or a second protrusion at the distal end, and the tip or the second protrusion is preferably conical, flared, or bullet-shaped.

13. The applicator according to claim 11, wherein the tip is at least partially located inside the spray orifice, or is configured to be at least partially located inside the spray orifice.

14. The applicator according to claim 12 or 13, wherein the tip of the vortex unit only extends through a part of the spray orifice.

15. The applicator according to any one of the preceding claims 12 - 14, wherein the included angle of the tip is less than 80 degrees, preferably less than 70 degrees, more preferably less than 60 degrees, and most preferably about 50 degrees.

16. The applicator according to any one of the preceding claims 12 - 15, wherein the included angle of the tip has substantially the same angle as the included angle of the paste inlet.

17. The applicator according to any one of the preceding claims 12 - 16, wherein the included angle of the tip is greater than the included angle of the paste inlet.

18. The applicator according to any one of the preceding claims 12 - 17, wherein the included angle of the tip is less than the included angle of the paste inlet.

19. The applicator according to any one of the preceding claims, wherein the applicator is adapted to be inserted into a trocar.

20. The applicator according to any one of the preceding claims, wherein the applicator includes a sheath that at least partially encloses the delivery tube.

21. The applicator according to claim 20, wherein the sheath has a hardness higher than 0.5, 1.5, or 2 GPa·m, and more preferably higher than 50 or 60 GPa·m.

22. The applicator according to claim 20 or 21, wherein the sheath is shorter than the delivery tube, such that the distal end of the applicator can be manipulated by a robotic arm for guiding the injection direction.

23. The applicator according to any one of the preceding claims, wherein the nozzle assembly includes a central wall substantially perpendicular to the longitudinal axis of the applicator or the nozzle assembly at the proximal end, and optionally, the central wall has a peripheral opening connecting the delivery tube and the nozzle assembly.

24. The applicator according to any one of the preceding claims, wherein the nozzle assembly includes a central wall separating the delivery tube and the vortex unit, and the central wall has a peripheral opening connecting the delivery tube and the nozzle assembly.

25. The applicator according to claim 23 or 24, wherein the central wall has a proximally-directed tip or a third protrusion for guiding the paste towards the peripheral opening.

26. A nozzle assembly according to any one of the preceding claims.

27. A method for applying a surgical hemostatic agent to a target site, the method comprising the steps of: providing an applicator according to any one of the preceding claims 1 to, the applicator being connected to a container containing a paste, applying pressure to the paste in the container for feeding the paste into the applicator, and spraying the paste onto the target site through a nozzle assembly.

28. The method according to claim 26, wherein the paste has a viscosity of at least 500 Pa·s or between 500 Pa·s and 8000 Pa·s, preferably between 500 Pa·s and 3500 Pa·s, such as 1500 Pa·s.

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