JP3933880B2 - Biological tissue adhesive applicator - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a tissue adhesive applicator mainly applied as a multi-component preparation, and is particularly suitable for the affected part of a living body, which is suitable for, for example, resection stumps of the liver and lungs and hemostasis closure of digestive tract sutures. It is related with the biological tissue adhesive applicator for spraying and apply | coating to.
[0002]
[Prior art]
Fibrinogen is a coagulation factor that plays a very important role in the final stage of the so-called blood coagulation cascade. Fibrinogen is converted by thrombin from its soluble form to insoluble fibrin, which makes an important contribution to hemostasis and wound treatment, for example in the activation of the blood clotting system after injury. A tissue adhesive utilizing the principle of the final phase of blood coagulation has been developed and used in surgical operations as an adhesive for suturing a soft organ such as the liver or spleen, or as a suturing aid. At the same time, it is applied in a wide range of clinical settings. In recent years, a spray coating method in which a fibrinogen solution and a thrombin solution housed in two syringe bodies are simultaneously injected, and the injected two liquids are sprayed and mixed in a mist using an aseptic gas has begun to spread. . Suitable examples of such devices are described, for example, in WO / 947420.
[0003]
However, troubles using this device often occur in the so-called intermittent use where the application treatment is performed multiple times with time intervals. In other words, in a general method of use in which the spray body is left for several minutes when the application treatment is repeated several times, if the application is attempted again after the standing time, the clogging of the chemical solution will occur at the tip of the nozzle, and in some cases it cannot be removed. This is a phenomenon in which solid clogging occurs and subsequent coating treatment becomes impossible. This phenomenon is particularly common in spray coating methods, but it also occurs in other coating methods, and many of them remain. This is due to the contact of the two liquids in the exudation of the chemical liquid due to pressure and the increase in the viscosity of the chemical liquid by standing for a long time.
[0004]
When clogging occurs, some surgeons may take measures such as wiping off the tip of the applicator between intermittent uses, but this is not only a problem in terms of operation but also a problem in terms of hygiene.
In order to overcome this, various application tools having a structure have been devised, but in addition to the complexity of the structure, problems remain such as requiring special operations for preventing or releasing clogging. .
[0005]
[Problems to be solved by the invention]
An object of the present invention is to provide a biological tissue adhesive applicator that is not easily clogged during intermittent use, has a simple structure, and is easy to operate. is there.
[0006]
[Means for Solving the Problems]
That is, the present invention
(1) A plurality of chemical solution injection ports at the rear end, a sterile gas injection port near the center, and each chemical solution injection port at the tip, and a plurality of chemical solution discharge nozzles communicating with the chemical solution flow path, and each chemical solution discharge nozzle A cylindrical hood is provided on the outer end face of each of the sterile gas jets. A living body characterized in that the tip of the chemical solution discharge nozzle is located 0.5 to 2 mm inside from the tip of the cylindrical hood, and a sterile gas flow path is hermetically divided for each nozzle of the chemical solution. Tissue adhesive applicator.
(2) The living tissue adhesive applicator according to (1), wherein an inner diameter of the cylindrical hood is larger than an inner diameter of the sterile gas ejection port.
(3) The biological tissue adhesive applicator according to (1) or (2), wherein the inner shape of the cylindrical hood is a tapered shape whose inner diameter increases toward the outer side.
[0007]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in detail with reference to the drawings. 1 and 2 are both examples of a biological tissue adhesive applicator that is an embodiment of the present invention, FIG. 1 is a cross-sectional view of an embodiment of the present invention, (a) is a side view, and (b) is a side view. The cross section seen from the upper surface is shown. FIGS. 2A and 2B are diagrams showing states at the time of spraying and when spraying is stopped according to an embodiment of the present invention. FIG. 2A is a cross-sectional view at an initial stage when spraying is stopped, FIG. 2B is when spraying is stopped, and FIG. It is.
[0008]
A preferred example of the biological tissue adhesive applicator according to the present invention is provided with two chemical liquid injection ports at the rear end of the spray head (1) and a sterile gas injection port (8) near the center as shown in FIG. , A plurality of chemical solution discharge nozzles at the tip, aseptic gas jets 1 (12), 2 (13) and a nozzle hood 1 (for spraying a chemical solution arranged coaxially with each chemical solution discharge and in an outer ring shape) 16) and 2 (17).
[0009]
The inside of the spray head (1) is divided into chemical liquid flow passages 1 (4), 2 (5) and sterile gas flow passages 1 (10), 2 (11). For example, the chemical liquid injection ports 1 (2), 2 (3) ) And the chemical solution discharge nozzles 1 (6) and 2 (7) are connected by tubes, respectively, so that the chemical solution flow passages 1 (4) and 2 (5) can be separated from each other. The chemical product flow passages 1 (4) and 2 (5) separated from the aseptic gas flow passages 1 (10) and 2 (11) may be provided in advance on the molded product itself of (1).
[0010]
In addition, it is also a desirable example that a sterile filter (18) is installed in advance at the terminal of the sterile gas inlet (8). The sterile gas inlet (8) is connected in a gas flow manner to the sterile gas branch chamber (9), and is further connected to the connection between the sterile gas branch chamber (9) and the sterile gas flow passages 1 (10) and 2 (11). Is equipped with check valves 1 (14), 2 (15) capable of gas flow only in the direction from the aseptic gas branch chamber (9) to the respective aseptic gas flow passages, and is aseptic when spraying is stopped. The gas flow passages 1 (10) and 2 (11) are hermetically separated.
[0011]
The purpose of the nozzle hood is to form a film using the surface tension of the chemical solution inside the nozzle hood and outside the chemical solution discharge nozzle with a drop of the chemical solution exuded by the residual pressure when spraying is stopped. This film serves as a protective film for the chemical liquid discharge nozzle to prevent gelation and high viscosity of the chemical liquid inside the chemical liquid discharge nozzle due to drying and other factors, thereby preventing clogging of the chemical liquid discharge nozzle directly. Is. It is important that the tips of the chemical solution discharge nozzles 1 (6) and 2 (7) are located inside the nozzle hoods 1 (16) and 2 (17). Practically, it is preferably about 0.5 to 2.0 mm inside from the tip of the nozzle hood.
[0012]
The inner diameters of the nozzle hoods 1 (16) and 2 (17) are preferably larger than the inner diameter of the sterile gas outlet, and if the inner diameter of the sterile gas outlet is A and the inner diameter of the nozzle hood is B, B / A = Although it is preferably about 1.2 to 2.0, the size of the droplet formed by the residual pressure depends on the viscosity of each chemical solution, and the inner diameter value of the nozzle hood that can form a film by the surface tension is different, so these characteristics It is important to determine the dimensions considering the value. Needless to say, it is important to determine the dimensions of the nozzle hood in consideration of these characteristics.If the nozzle hood is too long, the spray angle is hindered by the nozzle hood and becomes smaller. Further, it is not preferable that the chemical liquid particles collide with the nozzle hood to be dropped into a large droplet and drop the adhesive strength.
[0013]
As will be described later with reference to a specific example, the film of the chemical solution formed in the nozzle hoods 1 (16) and 2 (17) is flushed by aseptic gas ejection, which is the initial stage of re-spraying. For this reason, it is preferable and important that the surface properties of the nozzle hoods 1 (16) and 2 (17) are uniform and have little surface roughness. Moreover, it is more preferable from a viewpoint of the flash | flush of a film | membrane to have a taper shape which an internal diameter expands toward an outer side.
The formation of the nozzle hood membrane is ensured by hermetically separating the sterile gas flow passages 1 (10) and 2 (11).
[0014]
When the viscosity of the chemical solution is high, a film is formed in the nozzle hood without moving the sterile gas flow passages 1 (10) and 2 (11) in an airtight manner, and the posture of the spray head (1) is moved. The film is difficult to break and there are few problems. However, depending on the usage environment, for example, when the room temperature is high and the viscosity of the chemical solution is lowered, the film may flow out depending on the posture of the spray head (1). In this case, since there is no protective film for the chemical solution discharge nozzle, gelation and high viscosity of the chemical solution without the chemical solution discharge nozzle cannot be prevented, resulting in clogging.
[0015]
When the aseptic gas flow passages 1 (10) and 2 (11) are hermetically separated, each gas flow passage is located outside the spray head (1) when a film is formed by the chemical solution after the spraying is stopped. In contrast, it is completely closed. In this state, the formed film is difficult to flow because the internal gas flow passage is in a closed system even if the viscosity is somewhat lowered. Therefore, even if the posture of the spray head (1) is changed, the formed film does not flow out, and the chemical discharge nozzle is protected by the protective film, and can reliably prevent clogging. It is.
[0016]
Finally, an example of the application operation of the two-component biological tissue adhesive using a fibrinogen solution and a thrombin solution will be described with reference to FIG.
First, the syringe filled with the fibrinogen solution and the tip of the syringe filled with the thrombin solution are connected to the chemical solution inlets 1 (2) and 2 (3) at the rear end of the spray head (1), respectively. Next, a sterile gas supply source is connected to the sterile gas inlet (8) via a sterile filter (18) to maintain an appropriate gas flow rate. Then, in general, the fibrinogen solution and the thrombin solution are ejected from the respective sterile gas ejection ports from the respective chemical solution ejection nozzles by pressing the pusher of the syringe by directing the tip of the spray head (1) to the affected area to stop hemostasis. It is sheared and mixed with aseptic gas, sprayed and applied to the affected area to stop hemostasis. At this time, since each nozzle hood has an appropriate size, spraying is not hindered.
[0017]
When the spraying is stopped, the fibrinogen solution having a high viscosity exudes due to the residual pressure in the chemical liquid flow passage 1 (4) to form droplets. When this droplet comes into contact with the inner wall of the nozzle hood 1 (16), a film (20) is instantaneously formed by the surface tension of the fibrinogen solution. Since the chemical discharge nozzle 1 (6) is located inside the film (20) formed at the tip of the nozzle hood 1 (16), it is possible to prevent the cause of clogging due to drying of the fibrinogen solution at the time of spray suspension, The nozzle hoods 1 (16) and 2 (17) can avoid direct contact between the thrombin solution and the fibrinogen solution, and can prevent clogging due to the curing reaction due to the two-component contact.
[0018]
In general, when a high-viscosity fibrinogen solution is used, clogging is very likely to occur.However, in the biological tissue adhesive applicator according to the present invention, the higher the viscosity, the easier the film is formed. Can be expected to prevent clogging without problems.
[0019]
On the other hand, since the thrombin solution has a low viscosity and the residual pressure in the chemical flow passage 2 (5) is small and the thrombin solution does not easily exude, a film is not easily formed on the nozzle hood 2 (17). However, since the thrombin solution is originally low in viscosity, clogging is unlikely to occur, and film formation is not always necessary. Accordingly, there is no problem even if the nozzle hood 2 (17) for the thrombin solution is omitted, and this is a preferred embodiment from the viewpoint of reducing raw materials. However, when there is a possibility that the type of chemical liquid cannot be restricted for each chemical liquid injection port, it is a preventatively preferable example that a nozzle hood is provided on either of them.
[0020]
When the membrane (20) is formed on the nozzle hood 1 (16), the inside of the spray head (1) becomes a closed system in terms of gas flow and the membrane (20) is difficult to flow out. Even if it is stopped, the chemical solution discharge nozzle 1 (6) is protected by the film (20). Even if no film is formed on the nozzle hood 2 (17) on the thrombin solution side, the sterile gas flow passages 1 (10) and 2 (11) are hermetically separated in the spray head (1), so the fibrinogen solution side The membrane (20) of the nozzle hood 1 (16) is maintained.
[0021]
After the stop time, the supply of sterile gas is first resumed to resume spraying. Aseptic gas is ejected from the aseptic gas outlets 1, 2 (12) and (13), and the membrane (20) at the tip of the nozzle hood 1 (16) is automatically flushed. Spraying can be resumed.
[0022]
【The invention's effect】
As described above, when this biological tissue adhesive application tool is used, the chemical solution that stays in the vicinity of the chemical solution discharge nozzle forms a film in the nozzle hood due to surface tension, so the chemical solution discharge nozzle while spraying is stopped Can prevent clogging factors such as coagulation due to contact with two liquids and high viscosity due to drying of chemicals, and the film is automatically released without requiring any special operation when resuming spraying, depending on the gas used for spraying. Therefore, spraying can be smoothly resumed without causing clogging, which is extremely useful.
[Brief description of the drawings]
1A and 1B are diagrams showing an example of a biological tissue adhesive applicator according to an embodiment of the present invention, in which FIG. 1A shows a side surface and FIG. 1B shows a cross section from the upper surface.
FIGS. 2A and 2B are diagrams showing an example of an internal structure at the time of spraying and when spraying is stopped with a biological tissue adhesive application tool according to an embodiment of the present invention, FIG. When spraying is stopped, (c) is a plan sectional view of an initial stage when spraying is resumed.
[Explanation of symbols]
1 Spray head 2 Chemical solution inlet 1
3 Chemical injection port 2
4 Chemical flow passage 1
5 Chemical flow passage 2
6 Chemical solution discharge nozzle 1
7 Chemical discharge nozzle 2
8 Aseptic gas inlet 9 Aseptic gas branch chamber 10 Aseptic gas flow passage 1
11 Aseptic gas flow path 2
12 Aseptic gas spout 1
13 Aseptic gas spout 2
14 Check valve 1
15 Check valve 2
16 Nozzle hood 1
17 Nozzle Hood 2
18 Sterile filter 19 Syringe 20 Membrane

Claims (3)

A plurality of chemical solution injection ports at the rear end, a sterile gas injection port near the center, and each chemical solution injection port at the tip, a plurality of chemical solution discharge nozzles communicating with the chemical solution flow path, and coaxial with each of the chemical solution discharge nozzles In an applicator for applying one or more chemical liquids provided with an aseptic gas spout arranged in an outer substantially annular shape, a cylindrical hood is provided on each outer end face of the aseptic gas spout, and the cylindrical shape The biological tissue adhesive is characterized in that the tip of the chemical solution discharge nozzle is positioned 0.5-2 mm inside from the tip of the hood of the hood, and a sterile gas flow path is hermetically divided for each nozzle of each chemical solution Application tool. The living tissue adhesive applicator according to claim 1, wherein an inner diameter of the cylindrical hood is larger than an inner diameter of the sterile gas ejection port. The biological tissue adhesive applicator according to claim 1 or 2, wherein an inner shape of the cylindrical hood is a tapered shape whose inner diameter increases toward the outer side.
It is a guide tube.

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