Sprayable patch applicator for stopping bleeding, nozzle assembly, and method for applying a surgical hemostatic agent to a target site

Abstract

The present invention relates to a sprayable patch applicator for delivering a paste from a container, the patch applicator comprising a delivery tube for connecting to the container at a proximal end and a nozzle assembly at the distal end of the delivery tube for delivering the paste as a spray, preferably as a spray of droplets.

Description

[Technical Field]

[0001] The present invention relates to an applicator for delivering a paste to stop bleeding. [Background technology]

[0002] Surgical hemostatic agents are typically applied to a target site via a syringe tip. In some procedures, such as minimally invasive surgical procedures, application may occur via an extended delivery tube attached to the syringe, such that when the syringe plunger is depressed, the hemostatic agent translates along the delivery tube and is expelled from an opening in the delivery tube tip.

[0003] Viscous fluids, such as surgical hemostat and hemostatic paste, can be applied to a target site with high spatial precision. This is due to the high viscosity and / or tackiness of the hemostatic material, which facilitates application by essentially extruding it from the opening at the tip and depositing it at the target site. Thus, the tip or opening of the tube functions as an extrusion die. Summary of the Invention [Problem to be solved by the invention]

[0004] In the event of bleeding, there is a risk that the extruded and deposited hemostatic agent will be washed away by the flowing blood. In such cases, it may be necessary to secure the hemostatic agent at 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 effect is achieved, which interrupts the surgical procedure. In addition, it may be difficult or impossible to provide a pad or wound dressing at the target site during laparoscopy.

[0005] Therefore, more efficient methods and devices for applying hemostatic agents to target sites, particularly target sites involving bleeding, are desirable.

[0006] In view of the above-mentioned prior art, it is an object of the present invention to provide a device that can stop bleeding or superficial bleeding, such as continuous oozing, problematic bleeding, difficult to access bleeding, and bleeding that may re-bleed after surgery, preferably without the need to apply manual pressure to the bleeding site. [Means for solving the problem]

[0007] The object can be achieved by an applicator according to claim 1.

[0008] Hemostatic pastes typically contain a biocompatible polymer, such as gelatin, which provides the paste with a high viscosity with excellent mechanical hemostatic properties. Hemostatic pastes also typically contain an active hemostatic agent, such as thrombin, to further aid in the clotting of blood.

[0009] The paste can be sprayed with a mechanism small enough to fit through a trocar, and the paste in spray form has been found to be effective against bleeding.

[0010] Applying hemostatic paste as a spray to bleeding results in coverage of a large area, including both the wound or bleeding site and the surrounding non-bleeding areas. By creating a paste spray, the paste breaks down into small droplets or microparticles, providing a paste of substantially uniform density over a larger area. When the small droplets of paste formed into the spray are deposited on the bleeding and surrounding non-bleeding areas, they quickly stick together and adhere to the surrounding non-bleeding areas due to the paste's high viscosity and adhesive qualities. The hemostatic agent in the paste immediately initiates clotting of the blood in the wound. The paste spray forms a layer on the bleeding, similar to a plaster that stops bleeding. Bleeding can be stopped by spraying the hemostatic paste. The microparticles may include or contain particles less than 1 mm, or preferably less than 100 μm.

[0011] Spraying the paste also has the advantage that the user does not have to apply the paste to one area and then to an adjacent area, as is currently done when applying a blob of paste over and around the bleeding. The user simply needs to point the nozzle assembly at the bleeding and spray the paste onto the bleeding.

[0012] The applicator of the present disclosure is easier to apply precisely, stops bleeding more quickly, and applies a hemostatic layer that is not washed away by flowing blood.

[0013] In one embodiment, the applicator may include a pressure generating unit at the proximal end of the delivery tube that forces the paste from the container into and through the delivery tube, generating a spray pressure at the proximal end of the nozzle assembly.

[0014] The pressure generating unit applies the pressure necessary to force the paste out of the container and into the delivery tube. The pressure generating unit can be anything that can pressurize the paste, such as a piston that pushes the paste, a screw that moves the paste forward as it rotates, or a high pressure fluid that acts on the paste.

[0015] The delivery tube may include a valve for blocking the paste flowing through the delivery tube from the proximal end to the distal end of the delivery tube. The valve can be opened when pressure on the paste in the delivery tube is increased by the pressure generating unit. The sudden increase in pressure through the nozzle provides a good spray without the dripping effect of paste adhering to the outside of the applicator just outside the nozzle.

[0016] In one embodiment, the applicator can be configured to provide a spray pressure of at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, and possibly at least 25 or 30 bar. The spray pressure must exceed the minimum pressure level required to generate droplets or microparticles from the nozzle assembly. A spray pressure of at least 2 bar can generate droplets from the nozzle assembly. While higher spray pressures result in droplets exiting the nozzle assembly even at higher flow rates, a spray pressure of at least 10 bar can provide droplets from the nozzle even at relatively high flow rates, thereby enabling even heavy bleeding to be stopped quickly.

[0017] In one 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, for example 1500 Pa·s.

[0018] In one embodiment, the applicator can be configured to deliver a spray from a paste with 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, for example 1500 Pa·s.

[0019] The higher the viscosity, the more viscous the paste. At the same time, very viscous pastes require higher pressures to spray from the nozzle assembly. A viscosity above 500 Pa·s is preferred to achieve the required viscosity, and 1500 Pa·s appears to be the ideal balance between viscosity and sprayability, even though 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 even higher.

[0020] For a paste to be expelled from an applicator, the paste should be flowable when subjected to a force applicable to a syringe. Thus, the term "flowable paste" refers to a paste having a viscosity that promotes a steady flow when the paste is subjected to a force. An example of a flowable paste is a paste 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 one embodiment of the present disclosure, a paste is "flowable."

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

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

[0023] The paste enters the nozzle assembly as a paste at a paste inlet or nozzle assembly inlet and exits the nozzle assembly at a spray outlet as a spray with a spray cone.

[0024] In one embodiment, the nozzle assembly may comprise a nozzle head, preferably located in an extension of the distal end of the delivery tube, the nozzle head having a spray orifice at or at the spray outlet.

[0025] The paste exits the spray orifice or nozzle as a spray.

[0026] In one embodiment, the nozzle assembly can include a swirl unit for generating a rotational motion of the paste just before it enters the nozzle or spray orifice, causing the paste to rotate about the longitudinal center of the applicator, which causes the paste to flow at a much higher velocity, and as a result, spraying of the paste can be achieved at a lower pressure.

[0027] In one embodiment, the nozzle assembly can be configured to guide the paste in a rotational motion about a longitudinal axis of the applicator or nozzle assembly.

[0028] In one embodiment, the nozzle assembly can be configured to disrupt the axial flow of the paste during delivery. Disrupting the axial flow of the paste, which can mean substantially along the longitudinal axis of the applicator, can mean a sudden change in direction from axial to tangential. Such disruption causes the paste spray to form at a lower pressure.

[0029] In one embodiment, the nozzle assembly can be configured to produce a full cone spray pattern when delivering the paste as a spray, such a cone providing an even distribution of the paste over a large area of ​​the bleeding site.

[0030] In one embodiment, the nozzle head can include a nozzle head tube for radially surrounding the swivel unit, which when assembled or attached to the delivery tube allows for easy and precise alignment of the spray orifice, e.g., centered on the longitudinal axis of the applicator.

[0031] In one embodiment, the spray orifice of the nozzle head may be elliptical, preferably circular, or polygonal, e.g., pentagonal or hexagonal, when viewed distally or proximally, i.e., elliptical, preferably circular, or polygonal, e.g., pentagonal or hexagonal, in shape.

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

[0033] In one embodiment, the spray orifice can include an inwardly opening paste inlet, which preferably converges distally, e.g., is conical, trumpet-shaped, parabolic, or bullet-shaped in cross section. The nozzle head surrounding the spray orifice has a constant thickness, and the distally converging paste inlet causes the spray orifice to have a length that is shorter than the thickness of the nozzle head. A shorter spray orifice length enhances the ability of the spray orifice to provide a spray of paste from the spray orifice.

[0034] In one embodiment, the spray orifice can have an outwardly opening spray outlet, which preferably flares in a distal or spray direction, e.g., conically, trumpet-shaped, or parabolically shaped cross section. The nozzle head surrounding the spray orifice has a constant thickness, and the distally flaring spray outlet causes the spray orifice to have a length that is shorter than the thickness of the nozzle head. A shorter spray orifice length enhances the ability of the spray orifice to provide a spray of paste from the spray orifice.

[0035] In one embodiment, the spray orifice can form a double cone. The double cone can be conical, trumpet-shaped, or parabolic in cross section. The nozzle head surrounding the spray orifice has a constant thickness, and the distally converging paste inlet and distally diverging spray outlet allow the spray orifice to have a length shorter than the thickness of the nozzle head. The shorter length of the spray orifice enhances the ability of the spray orifice to provide a spray of paste from the spray orifice. Additionally, the paste inlet and spray outlet may form a sharp edge where the paste inlet and spray outlet meet. The sharp edge provides a good spray even at low pressures and reduces the risk of dripping.

[0036] In one embodiment, the spray orifice may form a cylindrical passage, preferably distal to the paste inlet and / or preferably proximal to the spray outlet.

[0037] Alternatively, the spray orifice can be cylindrical, such as perfectly cylindrical.

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

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

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

[0041] In one embodiment, the distal end of the nozzle head can accommodate a spray orifice. The nozzle head can have 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, for example, 1.0 mm. The spray orifice can have a thickness of less than 2 mm, preferably less than 1.5 mm, preferably between 0.1 mm and 1.5 mm, for example, 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 exiting the spray orifice has a large angle, so the spray cone of the paste has a large angle and a large area of ​​bleeding can be covered with paste.

[0043] In one embodiment, the minimum diameter of the spray orifice may 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, and 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 the viscosity of the paste. A paste with a lower viscosity preferably uses a spray orifice with a longer length and / or a smaller diameter / width to avoid leakage of the paste when no or small pressure is applied to the paste.

[0045] In one embodiment, the nozzle head may form part of the delivery tube. The nozzle head may be an extension of the delivery tube.

[0046] In one 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.

[0047] In one embodiment, the cross section of the nozzle head may be elliptical, preferably circular, polygonal, super-elliptical, or rectangular with rounded corners.

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

[0049] Where the applicator is intended for use with a trocar, the inner diameter of the nozzle head may preferably be less than 4 mm, preferably between 2 mm and 4 mm, most preferably between 3 mm and 4 mm.

[0050] In one embodiment, the swivel unit can abut against the nozzle head, preferably against the proximal end of the nozzle head, so that the nozzle head and the swivel unit have a tight connection.

[0051] In one embodiment, the swivel unit may optionally be substantially cylindrical in its entirety, hi one embodiment, the swivel unit may be symmetrically disposed about a central longitudinal axis of the applicator.

[0052] In one embodiment, the swivel unit may comprise one or more axial guides, such as two, three or more axial guides, extending towards, toward or distal to the paste inlet of the nozzle head.

[0053] In one embodiment, the axial guide may be formed as a second recess, such as a longitudinal recess, in the outer or circumferential surface of the swivel unit and / or in the inner surface of the nozzle head tube.

[0054] In one embodiment, the proximal face of the swivel unit and / or nozzle head may include one or more tangential guides or tangential channels, such as two, three or more tangential guides, toward the spray orifices at the center and distal end of the nozzle assembly.

[0055] The use of two, three or more tangential guides or channels means that the tangential guides or channels may narrow as they approach the spray orifice, resulting in an increased paste flow rate. The spraying of the paste from the spray orifice may then occur at a lower pressure applied to the paste.

[0056] In one embodiment, the tangential guide may be formed as a first recess in the distal end of the pivot unit.

[0057] In one embodiment, the tangential guides may curve inward toward the center of the swivel unit or nozzle assembly.

[0058] In one embodiment, one or more tangential guides may extend non-radially, meaning that the tangential guide extends a short distance from the location of the spray orifice inside the nozzle assembly, causing the paste to rotate, particularly spin, around the spray orifice before exiting the spray orifice, resulting in a higher flow or flow velocity of the paste.

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

[0060] In one embodiment, the second recess forming the axial and / or tangential guide may have a depth of more than 0.1 mm.

[0061] In one embodiment, the axial and / or tangential guides may have a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, for example about 0.7 mm or 0.5 mm.

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

[0063] In one embodiment, the axial guide may be connected to a corresponding tangential guide at the distal end of the swivel unit or nozzle assembly.

[0064] In one embodiment, the swirl unit can have a pointed tip or second protrusion, preferably conical, trumpet-shaped, or bullet-shaped, at its distal end. The pointed tip can be located in the center of the nozzle assembly, preferably facing the paste inlet of the spray orifice. The pointed tip contributes to the circular motion of the paste before it enters the spray orifice, resulting in increased flow or flow rate (flow and flow rate may or may not be understood as interchangeable terms) and a spray formed from the spray orifice at a lower pressure within the applicator. The pointed tip also directs the paste flow toward the paste inlet of the spray orifice, reducing backflow. The pointed tip provides a wide, uniform spray from the spray orifice.

[0065] In one embodiment, the sharp tip is disposed at least partially inside the spray orifice or can be configured to be disposed at least partially inside the spray orifice.

[0066] Such an arrangement has been found to result in a spray of paste having a wide cone.

[0067] In one embodiment, the pointed tip of the swirl unit may extend only partially through the spray orifice.

[0068] Such an arrangement has been found to result in a spray of paste having a wide cone.

[0069] In one embodiment, the pointed tip has an opening or distal angle, and the opening or distal angle of the pointed 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 one embodiment, the opening or distal angle of the pointed tip is the angle at the distal end of the pointed tip.

[0070] In one embodiment, the sharp tip and the paste inlet opening angle may have substantially the same angle.

[0071] In one embodiment, the opening angle of the pointed tip may be larger than the paste inlet.

[0072] In one embodiment, the opening angle of the pointed tip may be smaller than the paste inlet.

[0073] In one embodiment, the nozzle assembly can be at least partially or completely provided from a metal, such as stainless steel, such as stainless steel 316. Stainless steel nozzle assemblies are durable, can be easily sterilized, and can be used multiple times.

[0074] In one embodiment, the nozzle assembly may be at least partially, preferably completely, provided from plastic, and preferably the nozzle assembly may be injection molded, which provides a cost effective solution.

[0075] In one embodiment, the container may be a syringe.

[0076] In one embodiment, the delivery tube may have a length of between 20cm and 150cm, more preferably between 25cm and 80cm, for example between 30cm and 60cm.

[0077] In one embodiment, the delivery tube may contain a volume of 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 of paste.

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

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

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

[0081] In one embodiment, the delivery tube may have a stiffness greater than 0.5 Gpa·m, 1.5 Gpa·m or 2 Gpa·m, preferably greater than 10 Gpa·m or 20 Gpa·m, more preferably greater than 50 Gpa·m or 60 Gpa·m.

[0082] In one embodiment, the applicator may include a sheath that at least partially surrounds the delivery tube. Preferably, the sheath surrounds the proximal 90%, 95%, or 97% of the delivery tube. Preferably, only the distal 5 cm or 4 cm of the delivery tube is unsurrounded by the sheath. The sheath allows the user to aim the applicator at the right area. Because the sheath does not surround the distal portion of the delivery tube, the distal portion of the delivery tube can be manipulated by an external robotic arm, thereby directing the spray from the spray orifice toward the bleeding. In one embodiment, the sheath may be shorter than the delivery tube so that the distal end of the applicator can be manipulated by the robotic arm to direct the spray direction.

[0083] In one embodiment, the sheath may have a stiffness of greater than 0.5, 1.5 or 2 Gpa·m, preferably greater than 10 or 20 Gpa·m, more preferably greater than 50 or 60 Gpa·m.

[0084] In one embodiment, the applicator may contain 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, e.g., 8 ml or 10 ml. The hemostatic volume of the applicator should be sufficient to stop bleeding from any incisions at the surgical site. If the number of blood vessels at the surgical site is small, a small volume of 1 ml to 3 ml or 2 ml to 4 ml, such as 2 ml, may be sufficient to stop bleeding from any incisions at the surgical site. If the number of blood vessels at the surgical site is relatively large, a larger volume, such as 5 ml to 10 ml or 8 ml to 12 ml, e.g., 10 ml, may be sufficient to stop bleeding from any incisions at the surgical site. In some cases, a larger volume, such as more than 10 ml, may be preferred so that the applicator contains enough hemostatic agent to stop bleeding several times without the need to refill the applicator with new hemostatic agent. The surgical procedure can then be performed at a higher pace.

[0085] In one embodiment, the container or syringe contains a volume of saline (or another inert solution) substantially equal to or slightly less than the volume of paste in the applicator, so that when the container is emptied, the applicator fills with saline, and the applicator delivers all of the paste as a spray to the wound or bleeding site. No paste is wasted, and no saline gets into the wound. Because saline is not toxic, there are no risks associated with using saline if it gets into the wound.

[0086] In one embodiment, the applicator has only a small volume for the paste, and the applicator contains only this small amount of paste, and the container or syringe contains a volume of paste of 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, for example 8 ml or 10 ml, such that the container or syringe provides essentially all of the paste delivered to the wound through the applicator.

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

[0088] In one 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 partial rotation within the delivery tube, or a gas pressurization unit for providing increased pressure to the gas.

[0089] A spring, hydraulic fluid, or pneumatic fluid can act on a piston or plate to apply pressure to the paste. A rotary mechanism converts the rotational motion of a wheel into the sliding motion of a piston. A ratchet mechanism, like those used in caulking guns, can also be used to move the piston.

[0090] In one embodiment, the delivery tube and nozzle assembly may be fluidly connected by a peripheral opening.

[0091] The paste must travel tangentially to reach the nozzle or spray orifice, which increases the paste flow rate and creates a spray of paste at a lower pressure.

[0092] In one embodiment, the nozzle assembly can include a central wall at its proximal end that is substantially perpendicular to the longitudinal axis of the applicator or nozzle assembly, the central wall having a peripheral opening that connects the delivery tube and the nozzle assembly.

[0093] The central wall guides the paste around the periphery of the applicator so that it must travel tangentially to reach the nozzle or spray orifice. The spray from the spray orifice is formed at a lower pressure within the nozzle assembly.

[0094] In one embodiment, the nozzle assembly may include a central wall dividing the delivery tube and the swivel unit, the central wall having a peripheral opening connecting the delivery tube and the nozzle assembly.

[0095] In one embodiment, the central wall can have a proximally directed tip or third protrusion to direct the paste toward the peripheral opening, which reduces friction and / or increases the flow or flow rate of the paste through the applicator. An advantage is that the paste spray can be formed at a lower pressure. The pressure applied to the paste in the container is transferred to the paste located proximal to the spray orifice with less pressure loss. The spray can be formed at a lower pressure applied to the paste in the container, which is more comfortable if the pressure is applied by hand and uses less energy if the pressure is applied by machine. There is less pressure and stress on the delivery tube.

[0096] In one embodiment, the swirl unit can be integrated into the nozzle assembly, for example, it is faster and therefore more economical to manufacture a single unit by injection molding.

[0097] In one embodiment, the swivel unit can be a single unit or a stand-alone unit. For example, it is faster and therefore more economical to manufacture a single unit by injection molding.

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

[0099] The present disclosure also relates to the nozzle assemblies described in this application.

[0100] The present disclosure also relates to a method for applying a surgical hemostatic agent to a target site, comprising: - providing an applicator as described above and / or below, connected to a container containing the paste; - applying pressure to the paste in the container to feed the paste into the applicator; - spraying the paste through a nozzle assembly onto the target site; Includes.

[0101] In one embodiment, the pressure applied to the paste may create a spray pressure on the nozzle assembly that is at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, and in some cases at least 25 or 30 bar.

[0102] In one 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, for example 1500 Pa·s.

[0103] The invention will now be described in more detail with reference to the accompanying drawings. [Brief explanation of the drawings]

[0104] [Figure 1] FIG. 1 is a schematic diagram of an applicator connected to a container. [Figure 2a] FIG. 1 is a schematic diagram of a first embodiment. [Figure 2b] FIG. 1 is a schematic diagram of a first embodiment. [Figure 2c] FIG. 1 is a schematic diagram of a first embodiment. [Figure 3a] FIG. 10 is a schematic diagram of a second embodiment. [Figure 3b] FIG. 10 is a schematic diagram of a second embodiment. [Figure 3c] FIG. 10 is a schematic diagram of a second embodiment. [Figure 4a] FIG. 10 is a schematic diagram of a third embodiment. [Figure 4b] FIG. 10 is a schematic diagram of a third embodiment. [Figure 4c] FIG. 10 is a schematic diagram of a third embodiment. [Figure 5a] FIG. 10 is a schematic diagram of a fourth embodiment. [Figure 5b] FIG. 10 is a schematic diagram of a fourth embodiment. [Figure 5c] FIG. 10 is a schematic diagram of a fourth embodiment. [Figure 6] FIG. 10 is a schematic diagram of a sixth embodiment. [Figure 7] FIG. 10 is a schematic diagram of a seventh embodiment. [Figure 8] FIG. 1 is a schematic diagram of a nozzle assembly that sprays droplets of paste onto a sheet of paper. DETAILED DESCRIPTION OF THE INVENTION

[0105] 1 shows an applicator 102 comprising a delivery tube 104 and a nozzle assembly 105, with a distal end 104a of the delivery tube 104 connected to the nozzle assembly. The delivery tube 104 may be at least partially disposed in a rigid sheath 106 to allow a user to orient the applicator, for example, to the correct position on a patient during surgery. The applicator may preferably be 5 mm or less in diameter for use inside a trocar.

[0106] The applicator is connected to a container 108, e.g., 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 for applying pressure to paste 112 in the container, forcing the paste from the container into the delivery tube and into the nozzle assembly to generate a full cone spray pattern when the paste is delivered as a spray from the nozzle assembly.

[0107] The container 108 is placed in an actuator 114 with a trigger 116 and rod 118, and when the trigger is actuated, the rod moves a small distance towards the piston 110. By repeatedly pressing the trigger 116, a force is applied through the piston to the paste 112, causing the paste to spray from the nozzle assembly 105.

[0108] The actuator can have many designs. The actuator can be electrically powered, for example, by a battery (not shown) internal to the actuator, such that actuation of the trigger 116 activates a motor (not shown) that moves the rod 118 toward the piston 110 to spray the paste of the applicator 102.

[0109] Instead of a piston being pressed into the container, the container may include a screw (not shown) that, when rotated, forces the paste into the delivery tube 104 for spraying from the applicator 102. The screw may be rotated by an off-center handle (not shown) or by an electrically (battery) powered rotary motor actuated by the trigger 116.

[0110] Alternatively, a fluid-actuated second piston (not shown) can be used to push piston 110, and a pressure source (not shown), e.g., a compressor, generates pressure to push the fluid-actuated second piston, acting on piston 110 to spray paste from applicator 102. The pressure source can be actuated by actuating trigger 116, or pressurized fluid from the pressure source can be caused to act on the fluid-actuated second piston when the trigger is actuated.

[0111] It is preferable not to apply the fluid directly to the paste or to place the fluid in the container 108 to avoid the risk of the fluid accidentally leaking into the applicator and being delivered to the surgical site inside the patient.

[0112] 2a-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 comprises a nozzle head 206 with a nozzle 208 or spray orifice 208 preferably located on a central longitudinal axis 209 of the nozzle head, and an intermediate unit 207. The applicator 202 is preferably made of plastic.

[0113] The nozzle assembly 205 includes a central wall 210 at its distal end. A pivot unit 211 in the form of a first protrusion 212 on the distal side of the central wall forms a tangential guide 213 or first recess 213. The nozzle assembly 205 includes an axial guide 214 or second recess 214 that passes through the central wall 210. The second recess 214 is a peripheral opening disposed around the periphery of the central wall. The central wall 210 directs paste through the second recess 214 to the periphery of the applicator. The tangential guide 213 directs paste on the distal side of the central wall from the periphery towards the longitudinal central axis 209 and out through the nozzle 208 as a spray.

[0114] 2a shows a perspective exploded view of a first embodiment of an applicator 202. The applicator 202 has two opposing third recesses 215 to allow for easier grasping by tweezers with the jaws of an external instrument (not shown). The third recesses 215 allow the external instrument to move the applicator into the correct position at the surgical site.

[0115] A high viscosity paste requires a certain pressure to be applied to the paste before it moves toward the nozzle 208 and is sprayed from the nozzle. As soon as the pressure is removed, the paste flow stops. When a high viscosity paste is used, a valve to stop the paste flow is not necessary. If the applicator 202 does not include a valve to stop the paste flow and the paste flows through the nozzle 208 even at lower pressures, the applicator 202 can be configured to easily collapse at the third recess 215 so that the paste flow can be constricted by pressing the third recess 215. The paste flow can be reduced or even stopped by clamping the third recess 215 with the jaws of the instrument.

[0116] FIG. 2b shows a cross section of the first embodiment of the applicator 202 along IIb in FIG. 2a in an assembled view. The cross section is in a vertical plane in FIG. 2a. The nozzle assembly 205 includes a first cavity 216 for receiving paste from the delivery tube 204. The nozzle assembly 205 may have a second cavity 218 at its distal end with an enlarged diameter for receiving the delivery tube 204 in a well-defined position, such that the first cavity and the delivery tube 204 have substantially the same inner diameter to enable reduced-friction paste transfer. The delivery tube 204 and the nozzle assembly 205 may be secured to each other by, for example, an adhesive or by mechanical means, such as a snap fit, or the delivery tube 204 and the nozzle assembly 205 may be welded to each other.

[0117] Figure 2b also shows how the nozzle head 206 and nozzle assembly 205 are assembled. The nozzle head 206 and nozzle assembly 205 are fastened together, for example, by adhesive or welding or by mechanical means, for example by a snap fit.

[0118] The central wall 210 may have a second protrusion 220 or pointed tip 220 in the center of the central wall 210 distal to the central wall 210. The second protrusion 220 may be conical or trumpet-shaped and may have a parabolic cross-section (bullet-shaped - convex cross-section). The second protrusion 220 may protrude at least partially into the nozzle 208 to improve spray efficiency. The second protrusion 220 may protrude partway into the nozzle 208 to improve spray efficiency. The second protrusion 220 protruding at least partially into the nozzle reduces the pressure required to provide a spray of paste from the nozzle. The second protrusion 220 may protrude into the nozzle 208, or up to 1 mm from the nozzle, or up to 2 mm from the nozzle.

[0119] The nozzle head 206 can be simply a plate with the nozzle 208, which is fastened to the nozzle assembly 205 at the distal end of the nozzle assembly. However, the nozzle head 206 having the tubular structure 222 helps to center the nozzle 208 in the nozzle assembly 205, which is particularly beneficial when the nozzle and the second protrusion 220 are aligned with each other.

[0120] The nozzle 208 can have a distally converging paste inlet 224, e.g., cone-, trumpet-, or bullet-shaped. The nozzle 208 can have a distally diverging spray outlet 226, e.g., cone-, trumpet-, or bullet-shaped. The distal direction is the direction of spray and / or the direction of the paste being sprayed. The nozzle head 206 can have an outer distal surface facing the distal direction and an inner proximal surface facing the proximal direction. The spray orifice has a minimum spray orifice opening when the converging paste inlet intersects with the diverging spray outlet, when the converging paste inlet intersects with the distal surface in the absence of a diverging spray outlet, or when the proximal surface intersects with the diverging spray outlet in the absence of a converging paste inlet. The minimum spray orifice opening may have an orifice length of less than 0.5 mm, preferably less than 0.3 mm, e.g., 0.2 mm or 0.1 mm. An orifice length of less than 0.5 mm provides a good quality spray.

[0121] In one embodiment, the second protrusion 220 may protrude at least partially into the nozzle 208 to improve spray effectiveness, or the second protrusion 220 may protrude at least partially into the smallest spray orifice opening to further improve spray effectiveness. When the second protrusion protrudes at least partially into the nozzle or smallest spray orifice opening, a clearance is formed surrounding the second protrusion 220. This clearance is the shortest distance between the second protrusion 220 on the one hand and the nozzle 208, paste inlet 224, or smallest spray orifice opening on the other hand. The clearance is preferably 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 clearance, the wider the spray and the finer the particles contained in the spray to more quickly provide a continuous, interconnected film on the wound that stops bleeding.

[0122] Alternatively, or in addition to the paste inlet 224 and / or the spray outlet 226, the nozzle 208 may have a non-converging or non-diverging cylindrical portion 227. 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 of less than 10 mm, or less than 8 mm, or less than 6 mm.

[0123] The first protrusion 212 may be clamped against the proximal face of the nozzle head 206 to form well-defined tangential and axial guides 213, 214, as shown in Figure 2b.

[0124] Figure 2c shows a cross section along IIc of Figure 2b. Figure 2b shows a cross section, i.e., half, of applicator 202, while the full cross section of the applicator is shown in Figure 2c. Figure 2c shows swivel unit 211 with first protrusion 212 forming tangential guide 213 and axial guide 214. In the embodiment shown in Figure 2c, nozzle assembly 205 has three tangential guides 213.

[0125] As shown in Figure 2c, the axial guide 214 has an orientation substantially parallel to the longitudinal axis 209 of the applicator or nozzle assembly, and the tangential guide 213 has an orientation substantially perpendicular to the longitudinal axis and / or approximately parallel to the radial direction of the nozzle assembly. However, if the tangential guide 213 is not perfectly parallel to the radial direction of the nozzle assembly, as shown in Figure 2c, the moving paste will be subjected to the rotational motion of the swirl unit, which will enhance the sprayability of the paste from the nozzle 208.

[0126] Figures 3a-3c show a second embodiment of an applicator 302. Features of the second embodiment that have all the qualities and functions as corresponding features in the first embodiment are numbered the same.

[0127] Applicator 302 has a delivery tube 204 and a nozzle assembly 305. The nozzle assembly preferably comprises a nozzle head 306 with a nozzle 208 on a central longitudinal axis 209 of the nozzle head, and an intermediate unit 307. Applicator 302 is preferably made of plastic.

[0128] The second embodiment of the applicator 302 can have any, any combination, or all of the features and advantages as described 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 somewhat flatter cross-section with a square or substantially rectangular shape, resulting in a smaller thickness in at least one dimension, which means that the thickness above the third recess 315 is smaller in the second embodiment than in the first embodiment, making the third recess 315 more amenable to gripping by an external instrument with jaws.

[0129] 3a shows a perspective exploded view of a second embodiment of the applicator 302. The slightly flattened cross section of the applicator allows the thickness of the third recess 315 to be further reduced, so that the jaws of a grasping tool can more easily clamp the applicator 302 in the third recess 315 of the second embodiment than in the first embodiment.

[0130] Figure 3b shows in an assembled view a cross section along IIIb of Figure 3a of a second embodiment of an applicator 302. The cross section is in a vertical plane in Figure 3a.

[0131] Figure 3c shows a cross section along IIIc in Figure 3b. Figure 3b shows a cross section, i.e., half, of applicator 302, while the full cross section of the applicator is shown in Figure 3c. Figure 3c shows swivel unit 311 with first protrusion 312 forming tangential guide 313 and axial guide 314. Apart from the first embodiment, nozzle assembly 305 of a second embodiment shown in Figure 3c has two tangential guides 313.

[0132] Figures 4a-4c show a third embodiment of an applicator 402. Features of the third embodiment that have all the qualities and functions as corresponding features in the first embodiment are numbered the same.

[0133] Applicator 402 has delivery tube 204 and nozzle assembly 405. The nozzle assembly preferably comprises a nozzle head 406 with a nozzle 208 on a central longitudinal axis 209 of the nozzle head, and an intermediate unit 407. Applicator 402 is preferably made of plastic.

[0134] The third embodiment of the applicator 402 can have any, any combination, or all of the features and advantages as described above with respect to the first or second embodiments. The third embodiment differs from the first embodiment in that the swivel unit 411 is a single or stand-alone unit that is not part of the remainder of the nozzle assembly 405, the swivel unit has a third protrusion 430 proximal to the swivel unit, and the first cavity 416 has a reduced inner diameter along at least a portion of the first cavity, such that the thickness of the nozzle assembly 405 at the two opposing third recesses 415 can be further reduced and the jaws of a clamping instrument can more easily clamp the two opposing third recesses 415.

[0135] 4a shows a third embodiment of the applicator 402 in a perspective exploded view. The third protrusion 430 makes it easier for a human or robot assembling the applicator 402 to hold it on the swivel unit 411. The third protrusion 430 may also increase paste flow at the transition from the first cavity 416 to the axial guide 214 by guiding the paste toward the axial guide 214 and reducing backpressure. The third protrusion may be located proximal to the central wall, with or without the swivel unit.

[0136] Figure 4b shows an assembled cross section along line IVb of Figure 4a of a third embodiment of applicator 402, clearly showing the reduction in the inner diameter of first cavity 416. The cross section is in a vertical plane in Figure 4a.

[0137] Figure 4c shows a cross section along line IVc of Figure 4b. Figure 4b shows a cross section, i.e., half, of applicator 402, while the full cross section of the applicator is shown in Figure 4c. Figure 4c shows a swivel unit 411, which, when viewed from this direction, has the same design as swivel unit 211 of Figure 2c.

[0138] Figures 5a-5c show a fourth embodiment of an applicator 502. Features of the fourth embodiment that have all the qualities and functions as corresponding features in the first embodiment are numbered the same.

[0139] Applicator 502 has delivery tube 204 and nozzle assembly 505. The nozzle assembly preferably comprises a nozzle head 506 with a nozzle 208 on a central longitudinal axis 209 of the nozzle head, and an intermediate unit 507. Applicator 502 is preferably made of plastic.

[0140] The fourth embodiment of the applicator 502 can have any, any combination, or all of the features and advantages as described above with respect to any of the first, second, and third embodiments. The fourth embodiment differs from the first embodiment in that the first protrusion 512 is an integral part of or injection molded with the nozzle head 506, the central wall 510, the second protrusion 220 or pointed tip, and the third protrusion 530 proximal to the central wall form a first single unit 532 or stand-alone unit, and the first cavity 516 has a reduced inner diameter along at least a portion of the first cavity, such that the thickness of the nozzle assembly 505 at the two opposing third recesses 515 can be further reduced and the jaws of a clamping instrument can more easily clamp the two opposing third recesses 515.

[0141] FIG. 5a shows a fourth embodiment of the applicator 502 in a perspective exploded view. The third protrusion 530 facilitates the human or robot assembling the applicator 502 to hold the first single unit 532. The third protrusion 530 may also guide the paste toward the periphery of the central wall and into the axial guide 214, reducing backpressure and thereby increasing paste flow at the transition from the first cavity 516 to the axial guide 214 and through the central wall 510. The third protrusion may be positioned proximal to the central wall, with or without a pivot unit. The intermediate unit 507 includes a second central wall 534 that aligns the first single unit 532 through the third protrusion 530. A channel (not shown) passes through the second central wall 534 to guide the paste through the second central wall 534.

[0142] Figure 5b shows an assembled cross section along Vb in Figure 5a of the fourth embodiment of the applicator 502, clearly showing the reduced inner diameter of the first cavity 516. The cross section is in the vertical plane in Figure 5a.

[0143] Figure 5c shows a cross section along Vc in Figure 5b. Figure 5b shows a cross section, i.e., half, of applicator 502, while the full cross section of the applicator is shown in Figure 5c. Figure 5c shows swivel unit 511, which is part of nozzle head 506, and second protrusion 220, which is part of first single unit 532.

[0144] The fourth embodiment may otherwise have any, any feature, any combination, or all of the features of any of the first, second, and third embodiments.

[0145] In a fifth embodiment of the applicator (not shown), the nozzle head is an integral part of the intermediate unit or is injection molded with the intermediate unit. The swivel unit is a single unit that is introduced into the first cavity from the proximal end of the intermediate unit. The swivel unit and optionally the second protrusion are well aligned with the nozzle and spray orifice.

[0146] FIG. 6 shows the distal end of an example of a sixth embodiment of the applicator. In the sixth embodiment of the applicator, the swivel unit 611 may include a single second recess 614 and a single tangential guide 613, as shown in FIG. 6, so that paste can be guided from the first cavity 616, through the central wall 610, and into and around the second protrusion 220. In the illustrated embodiment, the nozzle head (not shown) is assumed to have a tube structure (not shown) for aligning the nozzle head around the swivel unit by sliding the nozzle head downwardly over the outer surface 640, so that the nozzle (not shown) can be precisely oriented and aligned with respect to the second protrusion 220. A sixth embodiment without a tube structure is also conceivable.

[0147] The single second recess 614 and the single tangential guide 613 allow the blockage between and including the first cavity 616 and the nozzle (not shown) to be removed by applying pressure to the paste by a pressure generating unit (not shown). There is no alternative second recess and / or single tangential guide through which the paste can pass, and as a result the blockage is not removed.

[0148] 6 shows a second protrusion base width 642 of the second protrusion. The second protrusion base width 642 is the width of the second protrusion when it is attached to the central wall 610. In one embodiment, the second protrusion base width can be less than 1 mm, preferably less than 0.8 mm, and more preferably less than 0.6 mm, for example, between 0.2 mm and 0.5 mm.

[0149] The sixth embodiment may have any, any combination, or all features of any of the first, second, third, fourth, and fifth embodiments.

[0150] In the seventh embodiment, the second protrusion 220 may protrude into the nozzle 208 of the nozzle head 706 as shown in FIG.

[0151] In the seventh embodiment, the second protrusion 220 may have a second protrusion point 750, preferably pointing distally, with a second protrusion point angle of between 30° and 90°, preferably between 40° and 80°, more preferably between 50° and 70°, e.g., 60°. The second protrusion 220 protruding into the nozzle 208 and the paste inlet 224 may have opposing surfaces that may be at least partially parallel to provide a clearance between the opposing surfaces with a constant width. The two opposing surfaces may form a clearance in the form of a truncated cone with a constant thickness depending on the distal-proximal position. Due to the truncated cone shape, the volume of paste moving from the proximal end to the distal end of the opposing surfaces decreases. As a result, the paste flow rate increases as it approaches the second protrusion point 750, which improves spray quality, i.e., a spray with smaller particles and a wider spray cone.

[0152] The two opposing surfaces may form a clearance in the form of a truncated cone with varying thickness depending on the distal-proximal position. In the example shown in Figure 7, the opposing surfaces form a clearance at the proximal end that decreases distally until a waist clearance 752 is reached, where the clearance has its narrowest passage. Distal to the waist clearance, the width of the clearance increases. The reduction in clearance to waist clearance 752 significantly increases the paste flow rate to provide a quality spray.

[0153] The waist clearance 752 may be located at the distal-most end of the second protruding point 750 such that there are no second protruding points 750 distal to the waist clearance. Paste exiting the clearance does so at the highest flow rate to provide a quality spray. The longitudinal axis 209 is also shown to indicate the central axis of the nozzle 208 and the second protruding point 750.

[0154] Applicator 800 in operation is shown in Figure 8. A spray cone 802 emerges from a nozzle assembly 804 at a spray angle of approximately between 20 and 40 degrees. The spray is deposited on a plate 806, which in this example is approximately 90 mm away from the nozzle assembly.

[0155] A first deposit 808 is formed. The nozzle assembly is then moved and / or rotated to form a second deposit 810. As can be seen from this 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. Thus, the applicator 800 of this example is capable of stopping heavy bleeding while simultaneously stopping bleeding that covers a larger area.

[0156] Additional notes 1. An applicator for delivering a paste from a container, comprising: a delivery tube for or configured to connect to a container at a proximal end; a nozzle assembly at the distal end of the delivery tube for delivering the topical paste as a spray, preferably as a spray of droplets or fine particles; An applicator comprising:

[0157] 2. An applicator as described in appended claim 1, wherein the applicator includes a container and a pressure generating unit at the proximal end of the delivery tube that extrudes paste from the container into and through the delivery tube to generate spray pressure at the proximal end of the nozzle assembly.

[0158] 3. An applicator according to claim 2, configured so that the spray 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 in some cases at least 25 bar or 30 bar.

[0159] 4. An applicator according to any one of the preceding clauses, 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, for example 1500 Pa·s, and / or the applicator is configured to deliver a spray from a paste with 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, for example 1500 Pa·s.

[0160] 5. An applicator described in any one of the above clauses, wherein the nozzle assembly includes a paste inlet or nozzle assembly inlet at the proximal end of the nozzle assembly and a spray outlet at the distal end.

[0161] 6. An applicator described in any one of the above appended claims, wherein the nozzle assembly includes a nozzle head preferably disposed in an extension of the distal end of the delivery tube, the nozzle head having a spray orifice at the spray outlet.

[0162] 7. An applicator according to any one of the preceding clauses, wherein the nozzle assembly comprises a swivel unit for optionally generating rotational movement of the paste.

[0163] 8. An applicator according to any one of the preceding clauses, wherein the nozzle assembly is configured to guide the paste in a rotational motion about a longitudinal axis of the applicator or nozzle assembly.

[0164] 9. An applicator according to any one of the preceding clauses, wherein the nozzle assembly is configured to disrupt the axial flow of the paste during delivery.

[0165] 10. An applicator according to any one of the preceding clauses, wherein the nozzle assembly is configured to produce a full cone spray pattern when delivering the paste as a spray.

[0166] 11. An applicator according to any one of the preceding clauses, wherein the nozzle head comprises a nozzle head tube for radially surrounding the swivel unit.

[0167] 12. An applicator according to any one of the above clauses 6 to 11, wherein the spray orifice of the nozzle head is elliptical, preferably circular, or polygonal, for example pentagonal or hexagonal.

[0168] 13. An applicator according to any one of clauses 6 to 12, wherein the spray orifice is located at the center of the distal end of the nozzle head.

[0169] 14. An applicator described in any one of clauses 6 to 13 above, wherein the spray orifice has a paste inlet that opens inward, and the paste inlet preferably converges in a distal direction, for example being conical, trumpet-shaped, or parabolic in cross section.

[0170] 15. An applicator described in any one of clauses 6 to 14 above, wherein the spray orifice has a spray outlet that opens outward, and the spray outlet preferably widens in the distal or spray direction, for example in a conical, trumpet-shaped, or parabolic cross-section.

[0171] 16. An applicator according to any one of clauses 6 to 15, wherein the spray orifice forms a double cone, double trumpet, or double parabola, preferably with a waist.

[0172] 17. An applicator according to any one of clauses 6 to 16 above, wherein the spray orifice forms a cylindrical passage, preferably distal to the paste inlet and / or preferably proximal to the spray outlet.

[0173] 18. An applicator described in any one of the above appended claims 6 to 17, wherein the opening angle of the paste inlet and / or spray outlet is between 40 and 140 degrees, preferably between 60 and 120 degrees, more preferably between 80 and 100 degrees, for example about 90 degrees.

[0174] 19. An applicator described in any one of the above appended claims 6 to 18, wherein the distal end of the nozzle head containing 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, for example 1.0 mm.

[0175] 20. An applicator according to any one of clauses 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, for example 1.0 mm.

[0176] 21. An applicator described in any one of the above clauses 6 to 20, 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.

[0177] 22. An applicator according to any one of clauses 6 to 21, wherein the nozzle head forms part of the delivery tube.

[0178] 23. An applicator according to any one of clauses 6 to 22, 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.

[0179] 24. An applicator according to any one of the above appended claims 6 to 23, wherein the cross section of the nozzle head is elliptical, preferably circular, polygonal, hyperelliptical, or rounded rectangular.

[0180] 25. An applicator described in any one of the above appended claims 6 to 24, 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, most preferably between 3 mm and 4 mm.

[0181] 26. An applicator according to any one of the above clauses 7 to 25, wherein the swivel unit abuts against the nozzle head, preferably the swivel unit abuts against the proximal end of the nozzle head.

[0182] 27. An applicator according to any one of clauses 7 to 26, wherein the swivel unit is substantially cylindrical.

[0183] 28. An applicator according to any one of claims 7 to 27, wherein the swivel unit comprises one or more axial guides, such as two, three or more axial guides, extending towards the paste inlet.

[0184] 29. An applicator according to any one of claims 7 to 28, wherein the axial guide is formed as a second recess, such as a longitudinal recess, on the outer surface of the swivel unit or the distal surface of the nozzle head.

[0185] 30. An applicator described in any one of the above appended claims 7 to 29, wherein the distal surface of the swivel unit and / or nozzle head is provided with one or more tangential guides or tangential channels, such as two, three or more tangential guides, for guiding the paste towards the spray outlet.

[0186] 31. An applicator according to any one of clauses 7 to 30, wherein the tangential guide is formed as a first recess in the distal end of the swivel unit.

[0187] 32. An applicator according to any one of clauses 7 to 31 above, wherein the tangential guide is optionally curved inward, optionally towards the centre of the swivel unit.

[0188] 33. An applicator according to any one of the preceding clauses, wherein one or more tangential guides extend in a non-radial direction.

[0189] 34. An applicator described in any one of the above appended claims, wherein the second recess forming the axial guide and / or the first recess forming the tangential guide have a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, for example about 0.7 mm or 0.5 mm.

[0190] 35. An applicator described in any one of the above appended claims, wherein the axial guide and / or tangential guide have a depth of less than 2 mm, preferably less than 1 mm, more preferably less than 0.75 mm, for example about 0.7 mm or 0.5 mm.

[0191] 36. An applicator according to any one of clauses 7 to 35 above, wherein the axial guide is connected to a corresponding tangential guide at the distal end of the swivel unit and / or the distal end of the axial guide.

[0192] 37. An applicator according to any one of clauses 7 to 36, wherein the swivel unit has a pointed tip or second protrusion, preferably conical, trumpet-shaped or bullet-shaped, at its distal end.

[0193] 38. The applicator of claim 37, wherein the pointed tip is positioned at least partially inside the spray orifice or is configured to be positioned at least partially inside the spray orifice.

[0194] 39. An applicator according to any one of the preceding paragraphs 37 to 38, wherein the pointed tip of the swivel unit extends through only a portion of the spray orifice.

[0195] 40. An applicator described in any one of the above appended claims 37 to 39, wherein the opening angle of the pointed tip is less than 80 degrees, preferably less than 70 degrees, more preferably less than 60 degrees, and most preferably about 50 degrees.

[0196] 41. An applicator according to any one of the above appended claims 37 to 40, wherein the opening angle of the pointed tip and the paste inlet have substantially the same angle.

[0197] 42. An applicator according to any one of the above appended claims 37 to 41, wherein the opening angle of the pointed tip is larger than that of the paste inlet.

[0198] 43. An applicator according to any one of the above appended claims 37 to 42, wherein the opening angle of the pointed tip is smaller than that of the paste inlet.

[0199] 44. An applicator according to any one of the preceding clauses, wherein the nozzle assembly is at least partially provided from a metal, such as stainless steel, such as 316 stainless steel.

[0200] 45. An applicator according to any one of the preceding clauses, wherein the nozzle assembly is at least partially, preferably entirely, provided from plastic, and preferably the nozzle assembly is injection molded.

[0201] 46. ​​An applicator according to any one of the above clauses, wherein the container is a syringe.

[0202] 47. An applicator according to any one of the preceding clauses, wherein the delivery tube has a length of between 20 cm and 150 cm, more preferably between 25 cm and 80 cm, for example between 30 cm and 60 cm.

[0203] 48. An applicator according to any one of the preceding clauses, wherein the delivery tube comprises a volume of between 2 cm and 20 ml, preferably between 3 cm and 12 ml, for example 8 ml.

[0204] 49. The applicator of any one of the preceding clauses, wherein the applicator is an endoscopic and / or laparoscopic applicator.

[0205] 50. An applicator according to any one of the preceding clauses, wherein the applicator is adapted to be inserted into a trocar.

[0206] 51. An applicator described in any one of the above appended clauses, wherein the applicator has an inner diameter of between 1 mm and 15 mm, more preferably between 2 mm and 8 mm, for example 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.

[0207] 52. An applicator according to any one of the preceding clauses, wherein the delivery tube has a stiffness greater than 0.5 GPa·m, 1.5 GPa·m or 2 GPa·m, more preferably greater than 50 GPa·m or 60 GPa·m.

[0208] 53. The applicator of any one of the above clauses, wherein the applicator comprises a sheath at least partially surrounding the delivery tube.

[0209] 54. An applicator according to clause 53, wherein the sheath has a stiffness greater than 0.5 GPa·m, 1.5 GPa·m or 2 GPa·m, more preferably greater than 50 GPa·m or 60 GPa·m.

[0210] 55. An applicator according to any one of the preceding clauses, wherein the applicator contains a volume of between 3 and 20 ml, preferably between 4 and 12 ml, for example 8 ml or 10 ml.

[0211] 56. An applicator described in any one of the above appended claims, wherein the applicator comprises a material selected from the group consisting of metal, plastic, polymer, glass, glass fiber, carbon fiber, polymer fiber, composite materials such as fiber-reinforced materials, and combinations thereof.

[0212] 57. An applicator described in any one of the above appended claims 2 to 56, 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 partial rotation within the delivery tube, or a gas pressurization unit for providing increased pressure to the gas.

[0213] 58. The applicator of any one of the above clauses, wherein the delivery tube and nozzle assembly are fluidly connected by a peripheral opening.

[0214] 59. An applicator described in any one of the above appended claims, wherein the nozzle assembly has a central wall at its proximal end that is substantially perpendicular to the longitudinal axis of the applicator or nozzle assembly, the central wall having a peripheral opening connecting the delivery tube and the nozzle assembly.

[0215] 60. An applicator described in any one of the above appended claims, wherein the nozzle assembly includes a central wall dividing the delivery tube and the swivel unit, the central wall having peripheral openings connecting the delivery tube and the nozzle assembly.

[0216] 61. The applicator of claim 59 or 60, wherein the central wall has a proximally directed tip or third protrusion for directing paste toward the peripheral opening.

[0217] 62. An applicator according to any one of the preceding clauses, wherein the swivel unit is a single unit or a stand-alone unit.

[0218] 63. An applicator according to any one of the preceding clauses, wherein the swivel unit is integrated into the nozzle assembly.

[0219] 64. An applicator described in any one of the above appended clauses, wherein the applicator has, completely or at least partially, an outer thickness in at least one or two dimensions of less than 7 mm, preferably less than 6 mm, more preferably less than 5 mm, for example 4 mm.

[0220] 65. A nozzle assembly according to any one of the preceding clauses.

[0221] 66. A method for applying a surgical hemostatic agent to a target site, comprising: - providing an applicator according to any one of clauses 1 to 65 connected to a container containing a paste; - applying pressure to the paste in the container to feed the paste into the applicator; - spraying the paste through a nozzle assembly onto the target site; A method comprising:

[0222] 67. The method described in appended paragraph 66, wherein the pressure applied to the paste creates a spray pressure on the nozzle assembly that is at least 2 bar, preferably at least 5 bar, more preferably at least 10 bar, even more preferably at least 20 bar, and in some cases at least 25 bar or 30 bar.

[0223] 68. The method according to claim 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, for example 1500 Pa·s. [Explanation of symbols]

[0224] 102,202,302,402,502 Applicator, 104,204 Delivery tube, 104a Distal end of delivery tube, 105,205,305,405,505,804 Nozzle assembly, 106 Rigid sheath, 108 Container, 110 Piston, 112 Paste, 114 Actuator, 116 Trigger, 118 Rod, 206,306,406,506,706 Nozzle head, 207,307,407,507 Intermediate unit, 208 Spray orifice, 209 Longitudinal central axis, 210,510,610 Central wall, 211,311,411,511,611 Swivel unit, 212,312,512 First protrusion, 213, 313, 613 Tangential guide, 214, 314 Axial guide, 215, 315, 415, 515 Third recess, 216, 416, 516, 616 First cavity, 217 Second cavity, 220 Second protrusion, 222 Tubular structure, 224 Paste inlet, 226 Spray outlet, 227 Cylindrical portion, 430, 530 Third protrusion, 532 First single unit, 534 Second central wall, 614 Second recess, 640 Outer surface, 642 Second protrusion base width, 750 Second protrusion point, 752 Waist clearance, 800 Applicator in operation, 802 Spray cone, 806 Plate, 808 First deposit, 810 Second deposit, 812 Center of the second deposit, 814 surrounding area

Claims

1. 1. An applicator for delivering a paste from a container, comprising: a delivery tube for connecting at its proximal end to said container; a nozzle assembly at the distal end of said delivery tube for delivering said paste as a spray, preferably as a spray of droplets or fine particles; An applicator comprising:

2. the applicator comprises the container; 2. The applicator of claim 1, further comprising a pressure generating unit at a proximal end of the delivery tube, the pressure generating unit forcing the paste from the container into and through the delivery tube to generate a spray pressure at the proximal end of the nozzle assembly.

3. 3. The applicator of claim 2, configured such that the spray 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 at least 25 bar or 30 bar.

4. 4. An applicator according to any one of claims 1 to 3, 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, for example 1500 Pa.s, and / or the applicator is configured to deliver a spray from a paste with 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, for example 1500 Pa.s.

5. 5. An applicator according to any one of claims 1 to 4, wherein the nozzle assembly comprises a nozzle head, preferably arranged in an extension of the distal end of the delivery tube, the nozzle head having a spray orifice at a spray outlet.

6. 6. An applicator according to any one of claims 1 to 5, wherein the nozzle assembly comprises a swivel unit for generating a rotational movement of the paste.

7. 7. An applicator according to claim 5 or 6, wherein the spray orifice comprises an inwardly opening paste inlet, the paste inlet preferably converging in a distal direction, e.g. conically, trumpet-shaped or parabolically in cross section, and / or the spray orifice comprises an outwardly opening spray outlet, the spray outlet preferably diverging in the distal or spray direction, e.g. conically, trumpet-shaped or parabolically in cross section.

8. 8. Applicator according to claim 6 or 7, wherein the swivel unit comprises one or more axial guides, such as two, three or more axial guides, extending towards the paste inlet.

9. 9. An applicator according to any one of claims 6 to 8, wherein the distal surface of the swivel 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 paste towards a spray outlet.

10. The applicator of claim 9 , wherein one or more of the tangential guides extend in a non-radial direction.

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

12. 11. An applicator according to any one of claims 6 to 10, wherein the swivel unit comprises at its distal end a pointed tip or second protrusion, preferably conical, trumpet-shaped or bullet-shaped.

13. 11. The applicator of claim 10, wherein the pointed tip is disposed at least partially inside the spray orifice or configured to be disposed at least partially inside the spray orifice.

14. 14. An applicator according to claim 12 or 13, wherein the pointed tip of the swivel unit extends through only a portion of the spray orifice.

15. 15. An applicator according to any one of claims 12 to 14, wherein the pointed tip has an opening angle of less than 80 degrees, preferably less than 70 degrees, more preferably less than 60 degrees, and most preferably about 50 degrees.

16. 16. An applicator according to any one of claims 12 to 15, wherein the opening angle of the pointed tip and the paste inlet have substantially the same angle.

17. 17. An applicator according to any one of claims 12 to 16, wherein the opening angle of the pointed tip is greater than the paste inlet.

18. 18. An applicator according to any one of claims 12 to 17, wherein the opening angle of the pointed tip is smaller than the paste inlet.

19. 19. The applicator of any one of claims 1 to 18, wherein the applicator is adapted to be inserted into a trocar.

20. 20. The applicator of any one of claims 1 to 19, wherein the applicator comprises a sheath at least partially surrounding the delivery tube.

21. 21. The applicator of claim 20, wherein the sheath has a stiffness greater than 0.5 GPa.m, 1.5 GPa.m or 2 GPa.m, more preferably greater than 50 GPa.m or 60 GPa.m.

22. 22. The applicator of claim 20 or 21, wherein the sheath is shorter than the delivery tube so that the distal end of the applicator can be manipulated by a robotic arm to direct the spray direction.

23. 23. An applicator according to any one of claims 1 to 22, wherein the nozzle assembly comprises at a proximal end a central wall substantially perpendicular to a longitudinal axis of the applicator or the nozzle assembly, optionally the central wall having a peripheral opening connecting the delivery tube and the nozzle assembly.

24. 24. The applicator of any one of claims 1 to 23, wherein the nozzle assembly comprises a central wall dividing the delivery tube and the swivel unit, the central wall having a peripheral opening connecting the delivery tube and the nozzle assembly.

25. 25. An applicator according to claim 23 or 24, wherein the central wall has a proximally directed tip or third projection for directing the paste towards the peripheral opening.

26. 26. A nozzle assembly according to any one of claims 1 to 25.

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

28. 28. The method of claim 27, 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, for example 1500 Pa.s.

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