JP2003126268A - Biological tissue adhesive applicator - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an applicator providing a strong adhesion for a biological tissue adhesive and reducing wasteful application to parts other than an affected region by sufficiently mixing sprays of an equal or different quantities of two or more biological tissue adhesives using a turning flow. SOLUTION: The biological tissue adhesive applicator is intended to spray a liquid medicine composed of a plurality of components, and has a means to generate the turning flow of a sterile gas, including all liquid medicine spray nozzles.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device for applying a tissue adhesive, which is mainly applied as a multi-component preparation, and particularly to a hemostasis closure of a resected stump of the liver or lung or a sutured part of the digestive tract. The present invention relates to a biological tissue adhesive application tool suitable for spraying and applying to a diseased part of a living body.

[0002]

BACKGROUND OF THE INVENTION Fibrinogen is a coagulation factor which 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 healing, for example in the activation of the blood coagulation system after injury. Tissue adhesives utilizing the principle of this final phase of blood coagulation have been developed and used in surgery as adhesives for suture replacement of soft organs such as the liver or spleen, or as suture auxiliary agents. At the same time, it is applied in a wide range of clinical settings.
In general, the method of dropping the fibrinogen solution and the thrombin solution separately stored in a syringe separately, or at the same time, was applied dropwise to the application site, but since the closing effect is insufficient, as a method of easily obtaining a higher closing effect, 1
A spray method using a fluid nozzle has been devised and put into practical use, but it has not yet reached a sufficient closing effect.
It was inferior in practical use due to problems such as clogging.

As a method for improving this, in recent years, a fibrinogen solution and a thrombin solution stored in two syringes are simultaneously injected, and the injected two solutions are atomized and mixed by using a sterile gas. The spray coating method is becoming popular. Suitable examples of such devices are disclosed, for example, in WO / 947420. However, in such a mixed spray in which a plurality of two-fluid parallel nozzles are arranged in parallel, mixing efficiency is poor except for the coating areas overlapping each other due to the respective spray angles and positional relationships, and a large amount of chemical liquid is wasted. In cases where strong adhesion and closure effects are required, such as treatment of air leaks in the lungs, there still existed problems to be overcome before the tissue adhesive exerts a sufficient effect.

On the other hand, it has been experimentally confirmed that it is effective to increase the fibrinogen concentration by changing the mixing ratio of the fibrinogen solution and the thrombin solution as a method for enhancing the effect of the tissue adhesive. A device applied to these tissue adhesives, that is, a device for simultaneously injecting a fibrinogen solution and a thrombin solution in different volumes is disclosed in JP-A-61-293443 and WO97-3363.
It is disclosed in Japanese Patent No. 3 and Japanese Patent Laid-Open No. 2000-262525. However, as an application tool, an ordinary one having two chemical spray nozzles for applying the same volume of the two-component chemical solution is used, and the discharge balance becomes uneven, so that a sufficient mixed state cannot be obtained. was there. That is, when the volumes of the two component chemical liquids are significantly different, the discharge speeds of the individual chemical liquids are greatly different, so that the two liquids are simultaneously discharged.
It is difficult to form a mist of the liquid, resulting in an insufficiently mixed state beyond the above coating method, and in particular, the curing time of the adhesive may be extended.

As a means for solving this problem, as shown in JP 2001-57979 A, aseptic gas is ejected from the chemical solution by making the discharge rates of two or more chemical solutions of different volumes more uniform. Nozzles for atomizing and mixing sufficiently are shown by. However,
Basically, it has a structure in which a plurality of two-fluid parallel nozzles are arranged. Therefore, the poor mixing efficiency of the mist of each component, which is fundamentally possessed by this type of nozzle, that is, the parts other than the overlapping parts of spray application of each chemical spray nozzle There was a problem that the mixing efficiency was poor, in other words, the chemical liquid was wastedly applied to a portion other than the application portion.

[0006]

SUMMARY OF THE INVENTION The present invention is intended to solve the above-mentioned conventional problems, and utilizes a swirling flow to spray two or more liquid chemicals of equal or different volumes. By providing sufficient mixing, a high-strength tissue adhesive can be applied, and in addition, a tool that can reduce wasteful application bottoms other than the application part is provided.

[0007]

Means for Solving the Problems That is, according to the present invention, (1) a coating tool for spraying a chemical liquid of a plurality of components is provided with a means for generating a swirl flow of a sterile gas including a chemical liquid spray nozzle. Characteristic biological tissue adhesive application tool,
(2) The means for generating a swirl flow is composed of a plurality of sterile gas flow passages provided on the circumference including the chemical liquid spray nozzle, and the sterile gas flow passage up to immediately before the sterile gas ejection port has an axis in the spray direction. On the other hand, the living tissue adhesive application tool according to (1), which has a substantially spiral shape inclined in the same direction,
(3) The application tool is provided with a plurality of drug solution inlets at the rear end, a sterile gas inlet near the center, and a plurality of drug solution spray nozzles communicating with the drug solution inlets through the drug solution flow passages at the tip. The biological tissue adhesive application tool according to (1) or (2),
(4) The living body according to (3), wherein each chemical liquid spray nozzle is a two-fluid parallel type nozzle including a chemical liquid discharge port and a sterile gas jet port arranged substantially coaxially with the chemical liquid discharge port and substantially annularly outside thereof. Tissue adhesive application tool, (5) The biological tissue adhesive application tool according to (3), wherein each chemical solution spray nozzle is a one-fluid nozzle having fine holes.

[0008]

DETAILED DESCRIPTION OF THE INVENTION The present invention will be described in detail below with reference to the drawings. 1 is an external view of an embodiment of the present invention, FIG. 2 is an enlarged view of an embodiment of a nozzle, (a) is an exploded view and (b) is a view after assembly. 3 is a sectional view of the spray head (1) during spraying, and FIG. 4 is an enlarged sectional view of the nozzle (2) during spraying. (A) is an example of a spray state according to the present invention, and (b) shows a conventional spray state. 5A to 5D are views showing a part of the embodiment of the swirl flow generating device of the present invention,
FIG. 6 shows an embodiment of the structure of a chemical spray nozzle applicable to the present invention. (A) is a two-fluid parallel nozzle for spraying using sterile gas, (b) uses sterile gas. FIG. 3 shows an example of a one-fluid nozzle that sprays only by pressurizing a chemical liquid without performing.

FIG. 1 shows an embodiment of the present invention, in which a syringe (6) separately filled with a fibrinogen solution and a thrombin solution as described above is provided in a holder 1 (7) and a holder 2
It is sprayed from the nozzle (2) at the same time by setting it in (8) and pressing the holder 2 (8). The nozzle (2) is composed of a chemical liquid spray nozzle (9) for atomizing the chemical liquid, and a swirl flow generation device that creates a swirl flow for enclosing and mixing the mist generated by the chemical liquid spray nozzle (9).

More specifically, as shown in FIG. 3, the chemical spray nozzle (9) has a chemical discharge port (10) and a chemical discharge port (1).
0) Aseptic gas jets (1
1) is a spray having two parallel two-fluid nozzles, and the relationship between each drug solution and the aseptic gas flow passage is completely independent as shown in FIG. It passes through the inside of the spray head (1) from the inlet (4) and is jetted to the outside from each sterile gas jet (11). The aseptic gas jet (11) does not have to be a perfect ring, and there is no problem if it is separated by a rib or the like for fixing the chemical liquid outlet (10) almost coaxially, but the sterile gas jet (11) If the total area of the ribs in the same ring is larger than the total area of the openings of (11), it is not preferable because the particles of the spray may become coarse, which is not preferable.
It is preferable that the total of the opening areas is larger. More preferably, the total area of aseptic gas jets: total rib area = 2: 1 or more. Further, it is preferable that the ribs are regularly arranged at equal intervals.

On the other hand, each chemical liquid is injected from each chemical liquid injection port (3), passes through the chemical liquid flow passage (13), and is discharged to the outside from the chemical liquid discharge port (10). The swirl flow generator of the present embodiment shown in FIG. 2 is an assembly of a plurality of swirl flow generation nozzles (12) arranged at approximately equal intervals on a substantially annular line including all the chemical liquid spray nozzles (9), and spraying is performed. It consists of a collection of sterile gas flow passages (14) of substantially spiral shape, with the axis being substantially symmetrical with respect to the spray axis. The sterile gas ejected from the swirl flow generation nozzle (12) generates a so-called swirl flow, which is a cylindrical rotating flow advancing while having a rotational direction component with respect to the spray axis direction. The mist produced by the spray nozzles (9) will be well mixed with each other and applied.

More specifically, as shown in FIG. 2 (a), a substantially spiral groove is arranged on the outer periphery of a cylindrical part forming the nozzle (2), and as shown in FIG. 2 (b). The sterile gas flow passage (14) having a substantially spiral shape is formed by fitting with the spray head (1). It is desirable that the shape and size of the aseptic gas flow passage (14) have an appropriate size and shape in consideration of the type of aseptic gas, gas pressure and flow rate during use, and the like. Various sizes and shapes are conceivable as shown in the front view examples in FIGS.
Similarly, it is desirable that the angle of the spiral shape be a shape that produces an optimum swirl flow depending on the type of sterile gas, the gas pressure and flow rate during use, the type of sprayed chemical liquid, and the discharge amount.

Since the spray in this field is disposable and requires a simple structure from the viewpoint of cost, it is considered that the structure shown in FIG. 2 or 5 is preferable. There is no problem as long as a swirl flow including the spray nozzle can be generated. For example, a structure in which the sterile gas jet itself rotates or a structure in which a swirl flow is generated by a fan or the like may be used.

However, since the present invention is for medical use, it is required that the raw materials of the parts to be used are those whose safety has been confirmed for medical use. Although it is not particularly limited, considering that it is disposable,
A medical grade resin such as ABS, polypropylene, or polyethylene is preferable, and an appropriate resin may be selected in consideration of processing, moldability, and assemblability.

The effect of the swirl flow generating nozzle (12) will be described below. The so-called swirl flow, which is generally called swirl flow, is known to induce the substances contained in it in the direction of the central axis of the swirl, and if multiple gases or mist are injected into this swirl flow, they swirl with each other. It will be mixed while gathering in the central axis direction of the flow. The state of spraying by this swirling flow is shown in FIG. Since the swirl flow generated by the swirl flow generation nozzle (12) includes the chemical liquid spray nozzle (9), wasteful diffusion of the mist is prevented, and since the swirl is swirled, the mist is mixed toward the central axis of the swirl flow. It effectively works to concentrate and concentrate, and as a result, it is possible to eliminate wasteful spraying / application of the chemical liquid to a portion other than the application site, and the nozzle (2) of the present invention mixes it very efficiently and holds down the application area small. Because it is possible, it is efficient.

On the other hand, the conventional spray is shown in FIG.
As shown in (b), the mist diffuses as it moves away from the chemical spray nozzle (9), and the mixing ratio of the chemicals is extremely low except for the area near the center where the fog of the chemicals overlaps. Since it does not happen, the adhesive closing effect cannot be obtained and it is completely wasted. Further, in the swirl flow generating device of the present embodiment, the hood (15) that covers all the swirl flow generation nozzles (12) in a substantially annular shape is provided. This improves the mixing efficiency of the mist by adjusting the turbulence and spread of the swirling flow. It is desirable to install the swirling flow when the application area is desired to be further reduced. It is important to make the protruding size of the hood (15) an optimum size depending on the intended application area, but if it is extremely long, it is not preferable from the viewpoint of application efficiency such as adhesion of the chemical solution to the inner surface of the hood (15). It is necessary to consider the positional relationship with the chemical liquid spray nozzle (9) because there is a concern that a situation will occur. Consider appropriate dimensions according to the type of chemical liquid spray nozzle described below. Is desirable.

Since the swirl flow generator can mix the fog more efficiently than before, it is necessary to atomize the chemical liquid as shown in FIG.
Even if the two-fluid parallel nozzle shown in (a) is not used,
There is no problem even with a chemical spray nozzle using a general pressure type one-fluid nozzle that sprays a chemical liquid pressurized from fine holes (16) as shown in FIG.
Any other atomizing device principle such as a fluid orthogonal nozzle may be used. However, if a simpler and more reliable high-strength adhesive closing effect is desired, a chemical spray nozzle of the type shown in FIG. 6 (a) is selected, which produces fine mist with fine mist particles in a relatively low pressure region. It is preferable. Further, in the case of performing non-equal amounts of chemical liquid spray, a chemical liquid spray specialized in non-equal amounts in which not only the number of chemical liquid discharge ports of three or four but also the opening area of the chemical liquid discharge ports is appropriately distributed. The use of a nozzle is effective and more preferable because it can obtain a stronger adhesive closing effect.

[0018]

As described above, when the present biological tissue adhesive application tool is used, the swirling flow of aseptic gas including all the drug solution spray nozzles can enhance the mixing efficiency of each drug solution, and it is possible to improve the mixing efficiency of each drug solution. Since it is possible to reduce unnecessary application to
It is extremely useful as a tissue adhesive application tool that achieves a high adhesive closing effect.

[Brief description of drawings]

FIG. 1 is a diagram showing an example of an external appearance of a biological tissue adhesive application tool according to an embodiment of the present invention.

FIG. 2 is an enlarged view of a nozzle of a biological tissue adhesive application tool according to an embodiment of the present invention, (a) is an exploded view, and (b) is a transmission view after assembly.

FIG. 3 is a plan cross-sectional view showing an example of the internal structure of the biological tissue adhesive application tool according to an embodiment of the present invention during spraying.

FIG. 4 is an enlarged cross-sectional view of a nozzle of a biological tissue adhesive application tool according to an embodiment of the present invention when spraying, (a) is an example of a spray state according to the present invention, and (b) is a conventional spray. It shows an example of.

FIG. 5 is a diagram showing an example of a swirling flow generating device of a biological tissue adhesive application tool according to an embodiment of the present invention.

FIG. 6 shows an example of the structure of a chemical spray nozzle of a biological tissue adhesive application tool according to an embodiment of the present invention,
(A) is a diagram showing an example of a two-fluid parallel type nozzle that sprays using a sterile gas, and (b) is a diagram showing an example of a one-fluid nozzle that sprays only by pressurizing a chemical solution without using a sterile gas. is there.

[Explanation of symbols]

1 spray head 2 nozzles 3 Chemical injection port 4 Aseptic gas inlet 5 aseptic filter 6 syringes 7 holder 1 8 holder 2 9 Chemical spray nozzle 10 Chemical outlet 11 Aseptic gas jet 12 Swirl flow generation nozzle 13 Chemical flow passage 14 Aseptic gas flow passage 15 Hood 16 fine holes

   ─────────────────────────────────────────────────── ─── Continued front page    F-term (reference) 4C060 MM24 MM26                 4C167 AA67 BB02 BB21 BB70 CC06                       CC20 CC21 CC23 CC24                 4F033 QA01 QB03X QB17 QD02                       QD09 QD18 QD25 QE19 QF17X

Claims (5)

[Claims] 1. An application tool for spraying a drug solution of a plurality of components, wherein a means for generating a swirl flow of a sterile gas including a drug solution spray nozzle is provided and a biological tissue adhesive application tool. 2. The means for generating a swirl flow comprises a plurality of aseptic gas flow passages provided on the circumference including a chemical liquid spray nozzle, and the sterile gas flow passage immediately before the aseptic gas ejection port has a spray direction. The biological tissue adhesive application tool according to claim 1, wherein the biological tissue adhesive application tool has a substantially spiral shape inclined in the same direction with respect to the axis. 3. The application tool has a plurality of chemical solution inlets at its rear end,
3. The biological tissue adhesive application tool according to claim 1, wherein a sterile gas injection port is provided near the center, and further a plurality of drug solution spray nozzles communicating with the drug solution injection port via the drug solution flow passage are provided at the tip. 4. The two-fluid parallel type nozzle, wherein each chemical liquid spray nozzle is composed of a chemical liquid discharge port and a sterile gas jet port arranged substantially coaxially with the chemical liquid discharge port and substantially annularly outside thereof. A biological tissue adhesive application tool. 5. The biological tissue adhesive application tool according to claim 3, wherein each chemical solution spray nozzle is a one-fluid nozzle having fine holes.