nozzle

JP7917570B2Active Publication Date: 2026-09-08ASAHI KASEI MEDICAL CO LTD +1
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Patent Information

Application Number
JP2024123444
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2024-07-30
Publication Date
2026-09-08
Estimated Expiration
2044-07-30

AI Technical Summary

Benefits of technology

【0013】 〔4〕或いは、当該ノズル(1)の側面視において、互いに対向する第1胴部(11)の側面(11s)及び第2胴部(21)の側面(21s)が略平行であり、第2吐出口(22)の端面(22t)が、好ましくは下記式(4)、より好ましくは下記式(5)、更に好ましくは下記式(6)で表される関係を満たすようにしてもよい。すなわち; H<0.90×D …(4) H<0.85×D …(5) H<0.80×D …(6) ここで、Hは、第2吐出口(22)の端面(22t)の最先端(22f)における側面(22s)の高さを示し、Dは、第1胴部(11)の側面(11s)と、第2胴部(22)の側面(21s)との間の距離を示す。このように構成すれば、第1胴部(11)と第2胴部(21)との間に十分なクリアランスが確保され、ガス(G)の流路が形成される。これにより、第1薬液(S1)及び第2薬液(S2)の十分な霧化と均一な混合噴霧をより確実且つ効果的に実現しつつ、端面(22t)の高さ(H)を距離(D)に対して小さく抑え得るので、金型及びノズル(1)の製造を更に容易ならしめることができる。

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Abstract

To provide a nozzle capable of suppressing splashing and dripping of two chemical liquids and achieving uniform mixing and spraying by sufficient atomization of the two chemical liquids and application to an appropriate range.SOLUTION: A nozzle that atomizes and sprays a first liquid medicine and a second liquid medicine for forming a biological tissue adhesive by a pressure of a gas includes a first nozzle having a first barrel portion that has a cylindrical shape and through which the first liquid medicine flows and a first discharge port for the first liquid medicine provided at a distal end portion of the first barrel portion, a second nozzle having a second barrel portion that has a cylindrical shape and through which the second liquid medicine flows and a second discharge port that protrudes from a distal end portion of the second barrel portion toward a distal end portion of the first barrel portion and through which the second liquid medicine is discharged, and a gas flow path having a gas discharge port through which a gas is discharged at least toward a space between the distal end portion of the first barrel portion and the second discharge port. The end surface of the second discharge port is inclined such that a virtual straight line connecting the foremost end and the rearmost end of the end surface approaches the second body portion from the front end side toward the rear end side.SELECTED DRAWING: Figure 3
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Description

[Technical Field]

[0001] This disclosure relates to a nozzle, and more particularly to a nozzle that can be used in a device for applying a bioadhesive, which is produced by mixing and spraying two chemical solutions, to a living organism. [Background technology]

[0002] For the purpose of hemostasis and suturing of wounds such as human incised tissue, bioadhesives consisting of a mixture of two chemical solutions, such as a fibrinogen-containing solution and a thrombin-containing solution, are widely used, and dedicated application devices for this purpose are also widely available. As an example of such an application device, a spray-type device is known that dispenses the two chemical solutions separately from the tip of a nozzle, and then sprays a gas onto the dispensing site, atomizing and mixing the two chemical solutions using the pressure.

[0003] As a nozzle for this purpose, for example, Patent Document 1 discloses a triple-tube structure nozzle having a cylindrical first nozzle that serves as a passage for the first chemical solution, an outer gas passage provided concentrically on the outer circumference of the first nozzle, and an inner gas passage provided concentrically on the inner circumference of the first nozzle, and a cylindrical second nozzle provided parallel to and spaced apart from the triple-tube structure nozzle that serves as a passage for the second chemical solution. In this nozzle, the opening end at the tip of the second nozzle, which serves as the discharge port for the second chemical solution, is configured to face the cylindrical body at the tip of the first nozzle, which serves as the discharge port for the first chemical solution, at a right angle. Furthermore, the two chemical solutions are atomized by gas supplied through the outer gas passage being injected toward the tips of the first and second nozzles, and the two chemical solutions are mixed and sprayed forward along the extending axis of the first nozzle by the gas injected from the outer and inner gas passages. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] Patent No. 3483250 [Overview of the project] [Problems that the invention aims to solve]

[0005] The conventional nozzle described above is suitable for use in endoscopic surgeries such as thoracoscopic surgery because it achieves the spraying of two drug solutions to an optimal application area by uniform mixing of the two drug solutions, while preventing the adhesion of hardened adhesive material to the nozzle tip due to the early mixing and hardening of the two drug solutions. However, after the applicant conducted extensive research on nozzles with such a configuration, it was found that in some cases, the atomization (micronization) of the drug solution was not sufficient, resulting in liquid splashing (e.g., droplet formation or splashing of the drug solution) or dripping from the nozzle tip, preventing the two drug solutions from mixing sufficiently or failing to achieve an adequate application area. It was also found that this phenomenon is more likely to occur when using drug solutions with relatively high viscosity.

[0006] Therefore, this disclosure has been made in view of these circumstances, and aims to provide a nozzle that can suppress splashing and dripping of the two chemical solutions when atomizing and spraying them, thereby enabling uniform mixing and spraying of the two chemical solutions and application to an appropriate area. [Means for solving the problem]

[0007] [1] One embodiment of a nozzle according to the present disclosure comprises a first nozzle (10) having a cylindrical first body (11) through which a first chemical solution (S1) flows, and a first discharge port (12) provided at the tip of the first body (11) from which the first chemical solution (S1) is discharged; a second nozzle (20) having a cylindrical second body (21) through which a second chemical solution (S2) flows, and a second discharge port (22) projecting from the tip of the second body (21) toward the tip of the first body (11) from which the second chemical solution (S2) is discharged; and a gas flow path (30) having a gas outlet (32) through which gas (G) flows and which discharges gas (G) toward at least the area between the tip of the first body (11) and the second discharge port (22). Furthermore, in a side view of the nozzle (1), the end face (22t) of the second discharge port (22) is inclined such that a virtual straight line (4) connecting the leading edge (22f) and the rearmost edge (22b) of the end face (22t) approaches the second body (21) from the leading edge to the rear end of the nozzle (1).

[0008] In this document, "side view" refers to a view along the y-axis, which is perpendicular to both the extension axis of the first body (11) or the extension axis of the second body (21), or the x-axis along the discharge direction of the first chemical solution (S1), and the extension axis of the second discharge port (22) or the z-axis along the discharge direction of the second chemical solution (S2).

[0009] In the nozzle (1) configured in this way, the first chemical solution (S1) supplied to the tip side of the nozzle (1) through the first nozzle (10) is discharged forward along the extending axis of the nozzle (1) from the first discharge port (12) according to an appropriate supply pressure. In addition, the second chemical solution (S2) supplied to the tip side of the nozzle (1) through the second nozzle (20) is discharged toward the first body (11) of the first nozzle (10) from the second discharge port (22) according to an appropriate supply pressure. At this time, the gas (G) supplied through the gas passage (30) provided on the outer circumference of the first body (11) is discharged (injected) toward the area between the tip of the first body (11) and the second discharge port (22) according to an appropriate supply pressure. As a result, the first chemical solution (S1) and the second chemical solution (S2) are atomized and mixed by the pressure of the gas (G) to form a bio-tissue adhesive (S), which is then sprayed forward along the extending axis of the nozzle (1). At this time, since the end face (22t) of the second discharge port (22) has the inclination described above, splashing and dripping of liquid at the tip side of the second discharge port (22) is effectively suppressed.

[0010] [2] More specifically, in the above configuration, the end face (22t) of the second discharge port (22) may be flat. This makes it relatively easy to manufacture a mold for forming the nozzle and to mold it, thereby contributing to improved production efficiency and economics of the nozzle.

[0011] [3] In addition, in the above configuration, in a side view of the nozzle (1), the side surfaces (11s) of the first body portion (11) and the side surfaces (21s) of the second body portion (21) that face each other may be substantially parallel, and the end face (22t) of the second discharge port (22) may preferably satisfy the relationship represented by the following formula (1), more preferably the following formula (2), and even more preferably the following formula (3). That is; 2°<θ <tan -1 (0.90 × D / L) …(1) 3°<θ <tan -1 (0.85 × D / L) …(2) 8°<θ <tan -1 (0.80 × D / L) …(3)

[0012] Here, θ represents the interior angle between the side surface (21s) of the second body (21) and the virtual straight line (4), D represents the distance between the side surface (11s) of the first body (11) and the side surface (21s) of the second body (21), and L represents the distance between the intersection point (IP) of the side surface (21s) of the second body (21) and the virtual straight line (4) and the outermost point (22f) of the end face (22t) of the second discharge port (22). In this document, "approximately" means within ±5% of the center value. Therefore, "approximately parallel" here is a concept that includes a slope of up to ±5% from parallel. With this configuration, atomization and uniform mixed spraying of the first chemical solution (S1) and the second chemical solution (S2) can be achieved more reliably and effectively, and a side wall height of the second discharge port (22) that is preferable for processing can be secured.

[0013] [4] Alternatively, in a side view of the nozzle (1), the side surfaces (11s) of the first body (11) and the side surfaces (21s) of the second body (21) that face each other may be substantially parallel, and the end face (22t) of the second discharge port (22) may satisfy the relationship preferably represented by the following formula (4), more preferably by the following formula (5), and even more preferably by the following formula (6). That is; H < 0.90 × D …(4) H < 0.85 × D …(5) H < 0.80 × D …(6) Here, H indicates the height of the side surface (22s) at the leading edge (22f) of the end face (22t) of the second discharge port (22), and D indicates the distance between the side surface (11s) of the first body (11) and the side surface (21s) of the second body (22). With this configuration, sufficient clearance is ensured between the first body (11) and the second body (21), and a gas (G) flow path is formed. This makes it possible to more reliably and effectively achieve sufficient atomization and uniform mixed spraying of the first chemical (S1) and the second chemical (S2), while keeping the height (H) of the end face (22t) small relative to the distance (D), thereby further facilitating the manufacture of the mold and nozzle (1). [Brief explanation of the drawing]

[0014] [Figure 1]It is a perspective view schematically showing the appearance of an example of a nozzle according to the present embodiment. [Figure 2] It is a side view schematically showing a part of the nozzle shown in FIG. 1. [Figure 3] It is a schematic cross-sectional view (lateral cross-sectional view) corresponding to the side view of FIG. 2, and corresponds to a cross-sectional view along the line III-III in FIG. 4(B). [Figure 4] (A) is an enlarged view showing a part of the side view of FIG. 2, and (B) is a plan view (bottom view) seen along the line B-B in (A). [Figure 5] It is an enlarged view showing another part of the side view of FIG. 2, showing the periphery of the end face of the second discharge port at the tip of the nozzle. [Figure 6] (A) is a side view conceptually showing the gas flow that occurs in a conventional nozzle in which the end face of the second discharge port is not provided with an inclination, and (B) is a side view conceptually showing the gas flow that occurs in the nozzle according to the present disclosure in which the end face of the second discharge port is provided with an inclination. [Figure 7A] It is a photograph showing an example of the spraying state by a conventional product in spray test 1. [Figure 7B] It is a photograph showing an example of the spraying state by the product of the invention in spray test 1. [Figure 8A] It is a photograph showing an example of the state of chemical liquid traces sprayed onto a nonwoven fabric by a conventional product in spray test 2. [Figure 8B] It is a photograph showing an example of the state of chemical liquid traces sprayed onto a nonwoven fabric by the product of the invention in spray test 2. [Figure 9A] It is a photograph showing an example of the state of a chemical liquid sprayed onto a test stand by a conventional product in spray test 3. [Figure 9B] It is a photograph showing an example of the state of the chemical liquid when the OHP sheet on the test stand is erected within 3 seconds after the completion of spraying by the conventional product in spray test 3. [Figure 10A] It is a photograph showing an example of the state of a chemical liquid sprayed onto a test stand by the product of the invention in spray test 3. [Figure 10B]This photograph shows an example of the state of the chemical solution when the OHP sheet on the test stand is raised within 3 seconds after the spraying by the invention in spray test 3 is complete. [Figure 11A] This photograph shows an example of the state of the chemical solution sprayed onto the test bench using the conventional product in spray test 4. [Figure 11B] This photograph shows an example of the state of the chemical solution when the OHP sheet on the test stand is raised within 3 seconds after spraying with the conventional product in spray test 4. [Figure 12A] This photograph shows an example of the state of the chemical solution sprayed onto the test bench by the invention during spray test 4. [Figure 12B] This photograph shows an example of the state of the chemical solution when the OHP sheet on the test stand is raised within 3 seconds after the spraying by the invention in spray test 4 is complete. [Modes for carrying out the invention]

[0015] This embodiment will be described below with reference to the attached drawings. To facilitate understanding of the description, the same reference numerals are used for identical components in each drawing whenever possible, and redundant descriptions are omitted. The following embodiments are illustrative examples for illustrating the present disclosure and are not intended to limit the present disclosure to these embodiments only. Furthermore, the present disclosure can be modified in various ways without departing from its essence. Moreover, those skilled in the art can adopt embodiments in which each of the elements described below is replaced with equivalent components, and such embodiments are also included within the scope of the present disclosure.

[0016] Figure 1 is a schematic perspective view showing the external appearance of an example of a nozzle according to this embodiment, Figure 2 is a schematic side view showing a part of the nozzle shown in Figure 1, and Figure 3 is a schematic cross-sectional view (side section view) corresponding to the side view in Figure 2. Furthermore, Figure 4(A) is an enlarged view showing a part of the side view in Figure 2, and Figure 4(B) is a plan view (bottom view) viewed along line BB in Figure 4(A). Note that Figure 3 corresponds to a cross-sectional view along line III-III in Figure 4(B).

[0017] The nozzle 1 according to this embodiment is for atomizing and spraying a first drug solution S1 and a second drug solution S2 for forming a biological tissue adhesive S by the pressure of a gas G. Examples of the first drug solution S1 and the second drug solution S2 include a fibrinogen-containing solution and a thrombin-containing solution, respectively, and correspond to the relatively viscous drug solutions mentioned above. These can preferably be prepared from plasma separated from autologous blood collected from a patient.

[0018] This nozzle 1 comprises a first nozzle 10 through which a first chemical solution S1 flows, and a second nozzle 20 through which a second chemical solution S2 flows. Of these, the first nozzle 10 has a cylindrical body portion 11 (an example of the "first body portion"), and the internal space of the body portion 11 defines a flow path R1 for the first chemical solution S1. The tip end of the body portion 11 of the first nozzle 10 is open, and a first discharge port 12 is formed through which the first chemical solution S1 supplied through the flow path R1 is discharged forward from the open end along the extending axis (x-axis in the figure) of the first nozzle 10.

[0019] Furthermore, the second nozzle 20 has a body portion 21 (an example of the "second body portion") which is composed of a cylindrical inner body portion 21a and a generally cylindrical outer body portion 21b that covers the outer circumference of the tip side of the inner body portion 21a. In this second nozzle 20, the flow path R2 of the second chemical solution S2 is defined by the internal spaces of the mutually communicating body portions 21a and 21b. In particular, as shown in Figure 2, the tip side of the body portion 21b of the second nozzle 20 is sealed, and the flow path R2 is a path that is bent at a right angle inside the outer body portion 21b as shown in the figure. With this structure, a second discharge port 22 is provided protruding from the side surface 21s at the tip of the outer body portion 21b of the body portion 21, through which the second chemical solution S2 supplied through the flow path R2 is discharged toward the tip of the body portion 11 of the first nozzle 10.

[0020] Furthermore, a gas flow path 30 is defined on the outer circumference of the first nozzle 10, generally in a concentric pattern, through which gas G flows. The leading end of this gas flow path 30 is open, and a gas outlet 32 ​​is formed through which the gas G supplied through the gas flow path 30 is ejected (discharged) forward from the open end along the extending axis of the first nozzle 10.

[0021] Here, Figure 5 is an enlarged view showing another part of the side view of Figure 2, showing the tip of the nozzle 1 and the area around the end face 22t of the second discharge port 22. As shown in Figure 5, in a side view, the end face 22t of the second discharge port 22 of the second nozzle 20 has an inclination such that a virtual straight line 4 connecting its leading edge 22f and rearmost edge 22b approaches the body portion 21 (side surface 21s) from the leading edge to the rear end of the nozzle 1 (to the right in the plane of the paper along the x-axis shown). In this embodiment, the end face 22t of the second discharge port 22 is formed to be planar.

[0022] Furthermore, as shown in Figure 5, it is preferable that, in a side view of the nozzle 1, the side surfaces 11s of the body portion 11 and the side surface 21s of the body portion 21 that face each other are substantially parallel, and that the end surface 22t of the second discharge port 22 is formed to satisfy the relationship represented by the following formula (1). 2°<θ <tan -1 (0.90 × D / L) …(1)

[0023] Here, θ represents the interior angle between the side surface 21s of the body 21 and the virtual straight line 4. Also, D represents the distance between the side surface 11s of the body 11 and the side surface 21s of the body 21. Furthermore, L represents the distance between the intersection point IP of the side surface 21s of the body 21 and the virtual straight line 4 and the outermost tip 22f of the end face 22t of the second discharge port 22. More specifically, L is the distance in the x-axis direction (horizontal direction in the figure).

[0024] Furthermore, it is more preferable that the nozzle 1 is formed to satisfy the relationship shown in formula (2) below, and even more preferable that it is formed to satisfy the relationship shown in formula (3) below. 3°<θ <tan -1 (0.85 × D / L) …(2) 8°<θ <tan -1 (0.80 × D / L) …(3)

[0025] Furthermore, as shown in Figure 5, it is also preferable that, in a side view of the nozzle 1, the end face 22t of the second discharge port 22 is formed such that it satisfies the relationship expressed by the following formula (4). H < 0.90 × D …(4) Here, H represents the height of the side surface 22s at the very tip 22f of the end face 22t of the second discharge port 22, and D represents the distance between the side surface 11s of the body 11 and the side surface 21s of the body 21. Furthermore, it is more preferable that the nozzle 1 is formed to satisfy the relationship represented by the following formula (5), and even more preferable that it is formed to satisfy the relationship represented by the following formula (6). H < 0.85 × D …(5) H < 0.80 × D …(6)

[0026] In addition, chamfered portions 23, 23 with flat outer surfaces are formed on both sides of the center of the outer body portion 21b, which constitutes a part of the body portion 21 of the second nozzle 20, and are located in front of the second discharge port 22 (base portion).

[0027] In the nozzle 1 configured in this way, the first chemical solution S1 is supplied to the tip side of the nozzle 1 through the first nozzle 10 by an appropriate supply means, and is discharged from the first discharge port 12 forward along the extending axis of the nozzle 1 (forward along the x-axis in the figure) according to the supply pressure. Also, the second chemical solution S2 is supplied to the tip side of the nozzle 1 through the second nozzle 20 by an appropriate supply means, and is discharged from the second discharge port 22 toward the body 11 of the first nozzle 10 (downward along the z-axis in the figure) according to the supply pressure. At this time, gas G is supplied to the tip side of the nozzle 1 through a gas passage 30 provided on the outer circumference of the body 11 by an appropriate supply means, and is discharged (injected) toward the space between the tip of the body 11 and the second discharge port 22 according to the supply pressure. As a result, the first chemical solution S1 and the second chemical solution S2 are atomized and mixed by the pressure of gas G to form a bio-tissue adhesive S, which is sprayed forward along the extending axis of the nozzle 1 (forward along the x-axis in the figure).

[0028] In this case, it was confirmed that with nozzle 1, the inclination of the end face 22t of the second discharge port 22 as described above effectively suppresses liquid splashing and dripping at the tip of the second discharge port 22. Further investigation and study are underway to confirm the details of this mechanism, and it is presumed that one of the reasons for this is the occurrence of the following physical phenomena. Figure 6(A) is a conceptual side view showing the flow of gas G in a conventional nozzle 1' in which the end face 22t' of the second discharge port 22 is not inclined, and Figure 6(B) is a conceptual side view showing the flow of gas G in nozzle 1 according to this disclosure in which the end face 22t of the second discharge port 22 is inclined.

[0029] In general, injection molding is often used to form a nozzle for spraying drug solutions suitable for endoscopic surgery. In this case, electrical discharge machining is generally useful for producing a mold to form a complex shape having a second discharge port 22 as in this embodiment. However, the machining electrode used in this process tends to oscillate slightly due to the discharge from the electrode itself. As a result, rounded edges (R-shaped) are easily formed at the corners of the contour that defines the space formed in the mold. As shown in Figures 6(A) and (B), the corners of the outer casing of the second discharge port 22 and other parts (the leading edge 22f and the trailing edge 22b), which are the inverse of the original shape, are also less likely to be sharp edges and more likely to be rounded edges.

[0030] As a result, as shown in Figure 6(A), in a conventional nozzle 1' where the end face 22t' of the second discharge port 22 is not sloped, a so-called "Coanda effect" occurs in the flow of gas G, causing a gas diversion Ga to flow upward along the R shape of the leading edge 22f of the second discharge port 22 located downstream. As a result, the second liquid S2 of the two liquids, especially the second liquid discharged from the second discharge port 22', is pulled upward as if caught in the gas diversion Ga, and is easily pulled upward as shown, resulting in insufficient atomization and leading to splashing and dripping.

[0031] In contrast, as shown in Figure 6(B), in the nozzle 1 according to this disclosure, the end face 22t of the second discharge port 22 is provided with a slope such that the height H of the second discharge port 22 gradually decreases from the leading edge 22f to the rearmost edge 22b. Therefore, even if an R shape is formed on the leading edge 22f side, the angle of that part becomes relatively steep, or in other words, it approaches a pseudo-edge shape. As a result, the "Coanda effect" caused by the R shape of the leading edge 22f is reduced, and the degree of gas diversion Gb flowing upward along the R shape is also weakened. This weakens the degree to which the second chemical solution S2 discharged from the second discharge port 22 is pulled upward so as to be caught in the gas diversion Gb, so that it can be sufficiently atomized and the occurrence of splashing and dripping can be suppressed. Furthermore, due to the chamfered portion 23 having the flat outer surface described above, the gas flow converges from the rear end side to the leading edge side of the chamfered portion 23, further reducing the Coanda effect.

[0032] In this way, the nozzle 1 according to this disclosure makes it possible to suppress splashing and dripping of the first drug solution S1 and the second drug solution S2 when atomizing and spraying them, enabling sufficient mixing and spraying of the two drug solutions and application to an appropriate area. Therefore, uneven coating of the bio-adhesive S formed from the two drug solutions is less likely to occur, and wasteful consumption of the drug solutions can be prevented. This is even more effective for the autologous blood-derived fibrinogen-containing solution and thrombin-containing solution, which are valuable drug solutions with limited production quantities as envisioned in this invention.

[0033] Furthermore, since the end face 22t of the second discharge port 22 of nozzle 1 is flat, the mold manufacturing and molding of nozzle 1 can be made relatively easy, thereby improving the production efficiency and economic viability of nozzle 1.

[0034] Furthermore, in the nozzle 1, the shape parameter of the end face 22t is such that the angle θ of the interior angle formed by the side surface 21s of the body portion 21 and the virtual straight line 4 is preferably greater than 2°, more preferably greater than 3°, and even more preferably greater than 8°, as shown in the above formulas (1) to (3). Also, preferably the angle is such that tan(θ) is less than 0.90 × D / L, more preferably less than 0.85 × D / L, and even more preferably less than 0.80 × D / L. This ensures sufficient atomization and uniform mixed spraying of the first chemical solution S1 and the second chemical solution S2 more reliably and effectively, and also ensures a side wall height of the second discharge port 22 that is preferable for processing.

[0035] Furthermore, in nozzle 1, as a shape parameter of the end face 22t, from another viewpoint, the height H of the side surface 22s of the leading edge 22f of the second discharge port 22 is preferably less than 0.90 × D, more preferably less than 0.85 × D, and even more preferably less than 0.80 × D. This allows for more reliable and effective atomization and uniform mixed spraying of the first chemical solution S1 and the second chemical solution S2, while keeping the height H of the end face 22t small relative to the distance D, thereby ensuring sufficient clearance between the body portions 11 and 21 and forming a gas flow path for the gas G. As a result, the ease of manufacturing and productivity of the mold and nozzle 1 can be further improved.

[0036] [Spray test of two chemical solutions] <Spray Test 1: Confirmation of Spray Condition> (Conventional product) First, a prototype nozzle 1' with a conventional configuration, as shown in Figure 6(A), was fabricated, in which the end face 22t' of the second discharge port 22 was not sloped. This nozzle 1' was then attached to a conventional sprayer. Tap water was prepared as both the first chemical solution S1 and the second chemical solution S2, and predetermined amounts (1 mL each) were placed in syringes and set in the sprayer. Then, a regulator connected to a compressed air source was connected to the sprayer via an air supply tube, and the supply pressure was set to approximately 0.08 MPa. While spraying from the gas outlet 32, the plunger of the chemical solution supply unit was pressed, causing the first chemical solution S1 and the second chemical solution S2 to be discharged from the first discharge port 12 and the second discharge port 22, respectively. An example of the spray state at this time is shown in Figure 7A. As a result, as shown in Figure 7A, it was confirmed that liquid splashing (scattering) of the chemical solution occurred, as shown in the dashed box Ea, regardless of the magnitude of the plunger pressing speed (chemical solution supply pressure).

[0037] (Invention) Next, a prototype nozzle 1 according to this disclosure, which has a slope on the end face 22t (angle θ = 2.9°), was fabricated in place of the conventional nozzle 1', and a spray test of the chemical solution was conducted using the same procedure as described above (for the conventional product). An example of the spray state at this time is shown in Figure 7B. As a result, as shown in Figure 7B, regardless of the magnitude of the plunger pressing speed (chemical solution supply pressure), no splashing (scattering) of the chemical solution occurred, and it was confirmed that the chemical solution was sufficiently atomized, as shown in the dashed frame Eb. From these results, the superiority of the nozzle 1 according to this disclosure over the conventional nozzle 1' can be understood.

[0038] <Spray Test: 2:2 Chemical Solution Mixing Performance> (Conventional product) First, a fibrinogen-containing solution and a thrombin-containing solution prepared from human plasma were prepared as the first drug solution S1 and the second drug solution S2, respectively (frozen and thawed at the time of the test). The first drug solution S1 was colored red with food coloring and the second drug solution S2 was colored blue. The entire volume of these drugs (1 mL each) was mixed and sprayed onto a nonwoven fabric with a spray diameter of 1 cm to 10 cm, with the tip of nozzle 1 pointed towards the center of the circle and the distance to the nonwoven fabric fixed at 2.5 cm. A spray test was then conducted in the same manner as in spray test 1 (conventional product). An example of the state of the drug solution residue sprayed onto the nonwoven fabric is shown in Figure 8A. As a result, as shown in Figure 8A, the state of the drug solution residue confirmed that the conventional nozzle 1' did not atomize the drug solution sufficiently, causing droplets to scatter. Furthermore, although Figure 8A is a monochrome display and difficult to discern, it was found that in actual color photographs, not only the second chemical solution S2 (blue) but also the first chemical solution S1 (red) were droplet-formed to a similar degree. From this, it was confirmed that the atomization of both the first chemical solution S1 and the second chemical solution S2 can be hindered due to the "Coanda effect" explained in Figure 6(A).

[0039] (Invention) Next, a spray test was conducted using the same procedure as described above (for the conventional product), except that the nozzle 1 according to this disclosure was used instead of the conventional nozzle 1'. An example of the state of the chemical residue sprayed onto the nonwoven fabric is shown in Figure 8B. As shown in Figure 8B, the state of the chemical residue also confirms that with the nozzle 1 according to this disclosure, there was no droplet scattering, the chemical was sufficiently atomized, and the spray was good. Furthermore, although Figure 8B is a monochrome display and difficult to discern, similar to Figure 8A, an actual color photograph revealed that the chemical residue as a whole appeared purple as a result of sufficiently and uniformly mixing the atomized fine particles of the first chemical solution S1 (red) and the atomized fine particles of the second chemical solution S2 (blue). These results demonstrate the superiority of the nozzle 1 according to this disclosure over the conventional nozzle 1' (especially its two-chemical solution mixing performance).

[0040] <Spray Test 3: Coverage Area and Solidification Performance (Wide-Area Spray)> (Conventional product) First, instead of a non-woven fabric, a 38 cm 2 area-marked grid paper overlaid with an OHP sheet was used as a test stand. A spray test was carried out in the same manner as Spray Test 2 (conventional product), except that the entire amount of the chemical liquid was sprayed (double-coated) while moving the nozzle 1' so as to completely cover the inside of the 38 cm 2 area of the test stand. An example of the state of the chemical liquid sprayed onto the test stand at this time is shown in Fig. 9A. Further, an example of the state of the chemical liquid when the OHP sheet on the test stand is erected within 3 seconds after completion of spraying is shown in Fig. 9B. As a result, as shown in Fig. 9A, with the conventional nozzle 1', although it covers the entire 38 cm 2 area as a whole, it was found that droplet formation of the chemical liquid was observed. Further, as shown in Fig. 9B, it was confirmed that significant dripping occurred in a part of the test stand with the conventional nozzle 1'.

[0041] (Inventive product) Next, a spray test was carried out according to the same procedure as the above (conventional product), except that the nozzle 1 according to the present disclosure was used instead of the conventional nozzle 1'. As the nozzle 1, prototypes were produced with an angle θ of the end face 22t of 2.9° and θ of 8.6°. An example of the state of the chemical liquid sprayed onto the test stand at this time is shown in Fig. 10A. Further, an example of the state of the chemical liquid when the OHP sheet on the test stand is erected within 3 seconds after completion of spraying is shown in Fig. 10B. As a result, as shown in Fig. 10A, with the nozzle 1 according to the present disclosure, even when spraying over a wide area (38 cm 2 ), no droplet formation of the chemical liquid was observed, and it was found that the 38 cm 2 area was uniformly covered with a sufficient amount. Further, with the nozzle 1 according to the present disclosure, as shown in Fig. 10B, it was confirmed that no dripping occurred over the entire test stand. From these results, the superiority of the nozzle 1 according to the present disclosure over the conventional nozzle 1' (particularly in terms of coverage area and coagulation performance during wide-area spraying) can be understood. It was confirmed that all of the plurality of test specimens in this Spray Test 3 (inventive product) exhibited equivalent excellent effects.

[0042] <Spray Test 4: Coverage Area and Coagulation Performance (Concentrated Spraying)> (Conventional product) 38cm 2 Instead of graph paper with markings indicating the area of ​​a fraction, use 7cm 2 The spray test was conducted using the same procedure as in spray test 3 (conventional product), except that graph paper marked with area indicators was used. An example of the state of the chemical solution sprayed onto the test stand is shown in Figure 11A. An example of the state of the chemical solution when the OHP sheet on the test stand was raised within 3 seconds after spraying was completed is shown in Figure 11B. As a result, as shown in Figure 11A, with the conventional nozzle 1', the total volume was 7 cm 2 Although the area was covered, it was found that droplet formation of the chemical solution was still observed. Furthermore, as shown in Figure 11B, it was confirmed that significant dripping occurred in a portion of the test stand with the conventional nozzle 1' configuration.

[0043] (Invention) Next, a spray test was conducted using the same procedure as described above (for the conventional product), except that the nozzle 1 according to this disclosure was used instead of the conventional nozzle 1'. An example of the state of the chemical solution sprayed onto the test stand is shown in Figure 12A. An example of the state of the chemical solution when the OHP sheet on the test stand was raised within 3 seconds after the completion of spraying is shown in Figure 12B. As a result, as shown in Figure 12A, with the nozzle 1 according to this disclosure, a concentrated narrow area (7 cm) was sprayed. 2 Even when sprayed onto ) the liquid did not form droplets, and 7cm 2 It was found that the area was uniformly covered with a sufficient amount. Furthermore, as shown in Figure 12B, it was confirmed that no dripping occurred across the entire test stand with nozzle 1 according to this disclosure. These results demonstrate the superiority of nozzle 1 according to this disclosure over the conventional nozzle 1' (particularly in terms of coverage area and solidification performance during concentrated spraying). In addition, it was confirmed that all of the test specimens in this spray test 4 (invented product) exhibited similarly excellent effects.

[0044] The embodiments described above, with reference to specific examples and test results, are intended to facilitate understanding of this disclosure and are not intended to limit its interpretation. In other words, this disclosure is not limited to these specific examples, and designs modified by those skilled in the art are also included within the technical scope of this disclosure, as long as they retain the features of this disclosure. Furthermore, the elements, arrangements, materials, conditions, shapes, dimensions, scales, etc., of each of the aforementioned specific examples are not limited to those exemplified unless otherwise specified, and can be modified as appropriate. Moreover, the elements of each of the aforementioned specific examples can be combined in different ways as appropriate, as long as no technical inconsistencies arise. For example, the chamfered portion 23 does not need to be provided, but it may be advantageous to provide the chamfered portion 23 from the viewpoint of reducing the Coanda effect. [Explanation of Symbols]

[0045] 1…Nozzle, 1'…Nozzle (conventional product), 4…Imaginary straight line, 10…First nozzle, 11…Body (first body), 11s…Side view, 12…First discharge port, 20…Second nozzle, 21…Body (second body), 21a…Inner body, 21b…Outer body, 21s…Side view, 22…Second discharge port, 22'…Second discharge port (conventional product), 22b…Rear end, 22f…Front end, 22s…Side view, 22t…End face, 22t'…End face (conventional product), 23…Chamfered part, 30…Gas flow path, 32…Gas outlet, D…Distance, Ea, Eb…Dashed line frame, G…Gas, Ga…Gas diversion (conventional product), Gb…Gas diversion, IP…Intersection, R1, R2…Flow path, S…Adhesive for biological tissue, S1…First chemical solution, S2…Second chemical solution, θ…Angle

Claims

1. A nozzle for atomizing and spraying a first and second chemical solution for forming an adhesive for biological tissues using gas pressure, A first body portion that is cylindrical and through which the first liquid chemical flows, and a first nozzle provided at the tip of the first body portion and having a first discharge port from which the first liquid chemical is discharged, A second body portion that is cylindrical and through which the second liquid chemical flows, and a second nozzle that protrudes from the tip of the second body portion toward the tip of the first body portion and has a second discharge port through which the second liquid chemical is discharged, A gas flow path through which the gas flows and which has a gas outlet from which the gas is discharged toward at least the tip of the first body and the second discharge port, Equipped with, In a side view of the nozzle, the end face of the second discharge port is inclined such that a virtual straight line connecting the leading edge and the rearmost edge of the end face approaches the second body of the nozzle from the leading edge to the rear end. nozzle.

2. The nozzle according to claim 1, wherein the end face of the second discharge port is planar.

3. In a side view of the nozzle, The sides of the first fuselage and the sides of the second fuselage, which face each other, are substantially parallel. The end face of the second discharge port is as shown in formula (1): 2°<θ<tan -1 (0.90×D / L) …(1)、 θ: The angle of the interior between the side surface of the second body and the imaginary straight line. D: The distance between the side surface of the first torso and the side surface of the second torso, L: The distance between the side surface of the second body and the intersection of the imaginary straight line and the leading edge of the end face of the second discharge port. The nozzle according to claim 1, satisfying the relationship represented by the expression.

4. In a side view of the nozzle, The sides of the first fuselage and the sides of the second fuselage, which face each other, are substantially parallel. The end face of the second discharge port is as shown in formula (4); H<0.90×D…(4), H: Height of the side surface at the very tip of the end face of the second discharge port, D: The distance between the side surface of the first torso and the side surface of the second torso, The nozzle according to claim 1, satisfying the relationship represented by the expression.

Citation Information

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