JP2010051696A - Method of manufacturing nozzle - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of manufacturing a nozzle, wherein this method has an advantage in reducing the diameter of a nozzle, secures the mixing of first and second liquids and controls any pressure loss arising within the nozzle when it jets the mixed liquids. <P>SOLUTION: The method is for manufacturing a nozzle including a first tube 44a, a second tube 45a, and a third tube 47a with which the ends of the first and second tubes 44a and 45a are connected. The method includes a process of forming a contract part 48, while a first and a second bar-like insertion parts of a tool are kept inserted into the ends of the first and the second tubes 44a and 45a respectively, by heating and fusing these ends together, and a process to remove the tool from the contract part 48 and connect this contract part 48 with the base end of the third tube 14. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a method for manufacturing a nozzle.

  Conventionally, a method of mixing two or more kinds of liquids and spraying them onto an affected area to form an adhesion preventing material, a biological tissue adhesive or the like has been known, and an applicator for that purpose has been developed.

  Such an applicator has a configuration in which components that coagulate when mixed, for example, a solution containing thrombin and a solution containing fibrinogen are separated from each other, sent to the vicinity of the affected area, and applied while mixing in the affected area. is there.

  As a conventional applicator, each of two syringes containing different types of liquid is installed in a state where the flow paths are arranged side by side, and the liquid is ejected while spreading from the tips of both flow paths, that is, the respective discharge ports. Some liquids are configured to mix these liquids (see, for example, Patent Document 1).

  In the nozzle of the applicator described in Patent Document 1, two flow paths (tubes) are arranged side by side, and accordingly, two discharge ports are also arranged side by side. Further, as described above, the liquid is ejected from each discharge port while spreading. Due to the ejection of the liquid and the arrangement of the two discharge ports, the ejected liquid has a portion where the two kinds of liquid are mixed and a portion where the liquid remains without being mixed. (For example, refer to FIG. 2A in Patent Document 1). For this reason, there has been a problem that the affected part is applied with a non-uniformly mixed liquid, that is, a liquid in which two kinds of liquids are mixed and a liquid that is not mixed (or insufficiently mixed).

  Moreover, in the nozzle of the applicator described in Patent Document 1, since the two discharge ports are arranged side by side, the size (outer diameter) of the nozzle becomes relatively large. For this reason, for example, when a liquid is applied to an affected part in a body cavity using this applicator, the nozzle may not be inserted into the body cavity depending on the size of the body cavity.

  Moreover, in the general applicator represented by the applicator described in Patent Document 1, in order to make the liquid ejected from each discharge port into a mist, the flow path from the syringe to the discharge port Make the inner diameter as small as possible. However, when the inner diameter is reduced over the entire length of the flow path in this way, excessive pressure loss occurs in the flow path when the liquid passes through the flow path. For this reason, the liquid cannot be applied smoothly (rapidly) to the affected area.

JP 2002-282368 A

  An object of the present invention is advantageous in reducing the diameter of a nozzle, and can reliably suppress a pressure loss in the nozzle when a plurality of types of fluids are reliably mixed and the mixed fluid is ejected. It is providing the nozzle manufacturing method which manufactures a nozzle.

Such an object is achieved by the present inventions (1) to (14) below.
(1) A first end, a second tube arranged in parallel with the first tube, a proximal end portion connected to the first tube and the distal end portion of the second tube, and a distal end portion And a third tube having a portion from which a fluid is ejected.
A long jig body and a rod-like shape that protrudes from the end of the jig body, has an outer diameter smaller than the inner diameter of the first tube, and can be inserted into the first tube. An insertion portion and an end portion of the jig main body are formed so as to protrude in parallel with the first insertion portion, have a rod shape whose outer diameter is smaller than the inner diameter of the second tube, and are inserted into the second tube. A nozzle manufacturing jig provided with a possible second insertion portion, and inserting the first insertion portion of the nozzle manufacturing jig into the distal end portion of the first tube, and the second A jig mounting step in which the insertion portion is inserted into the distal end portion of the second tube;
In the inserted state, the distal end portion of the first tube and the distal end portion of the second tube are heated so that the inner diameter of the lumen of the distal end portion of the first tube is outside the first insertion portion. The distal ends of the second tube are integrated with each other while maintaining the inner diameter of the lumen of the distal end portion of the second tube to be equal to the outer diameter of the second insertion portion. An integrated part forming step for forming an integrated part,
A jig removing step of removing the first insertion part and the second insertion part from the integrated part in the inserted state;
A method of manufacturing a nozzle, comprising: a tube connecting step of connecting a base end portion of the third tube and the integrated portion.

  (2) In the integral part forming step, the tip part of the first tube and the tip part of the second tube in the inserted state are collectively covered with a heat-shrinkable tube having heat shrinkability, and the state The method for producing a nozzle according to (1), wherein the heat shrinkable tube is heated together.

(3) The heat shrinkable tube has a length shorter than the length of the first insertion portion and the second insertion portion,
In the integral part forming step, the heat-shrinkable tube is a nozzle manufacturing method according to the above (2), in which the heat-shrinkable tube is disposed in the middle of the first insertion part and the second insertion part in the longitudinal direction.

  (4) The method for manufacturing a nozzle according to (2) or (3), further including a tube removing step for removing the heat shrinkable tube between the integral part forming step and the jig removing step.

  (5) The method for manufacturing a nozzle according to any one of (2) to (4), wherein the heat shrinkable tube, the first tube, and the second tube are made of different resin materials. .

  (6) The nozzle manufacturing method according to (5), wherein the heat-shrinkable tube is made of a silicone-based resin, and each of the first tube and the second tube is made of a urethane-based resin. .

  (7) The method for manufacturing a nozzle according to any one of (1) to (6), wherein the integral part has a circular cross-sectional shape.

  (8) The manufacturing method of the nozzle according to (7), wherein the outer diameter of the integrated portion is smaller than the sum of the outer diameter of the first tube and the outer diameter of the second tube before the heating.

  (9) The nozzle according to any one of (1) to (8), wherein the first insertion portion and the second insertion portion are different from each other in at least one of an outer diameter and a length. Production method.

  (10) The nozzle manufacturing method according to any one of (1) to (9), wherein each of the first insertion portion and the second insertion portion has a rounded tip.

  (11) In the tube connecting step, when the integral portion is inserted into the proximal end portion of the third tube, an outer peripheral portion of the integral portion and an inner peripheral portion of the proximal end portion of the third tube The method for producing a nozzle according to any one of the above (1) to (10), wherein an adhesive is applied between the integrated portion and the proximal end portion of the third tube via the adhesive.

(12) The nozzle is provided at a tip portion of the third tube, and includes a spout forming member having a cylindrical shape that forms a fluid spout from which the fluid that has passed through the third tube spouts. ,
The method for manufacturing a nozzle according to any one of (1) to (11), further including a spout mounting step in which the spout forming member is inserted into the third tube.

  (13) In the jet nozzle mounting step, when the jet nozzle forming member is inserted into the third tube, the tip of the jet nozzle forming member is in a protruding state protruding from the tip surface of the third tube. The manufacturing method of the nozzle as described in said (12).

  (14) Using the outer peripheral surface of the protruding tip portion as an adhesive margin for bonding the tip surface of the third tube via an adhesive, the jet port forming member is bonded to the tube. The manufacturing method of the nozzle as described in (13).

  According to the present invention, plural kinds of fluids can be reliably mixed in the third tube, and the mixed fluid can be ejected from the nozzle.

  Further, in the first tube, a portion where the inner diameter is narrowed becomes an integral part of the first tube. Similarly, in the second tube, the portion where the inner diameter is reduced is an integral part of the second tube. With such a configuration, when the mixed fluid is ejected from the nozzle, pressure loss occurs in the nozzle mainly in the integrated portion, and thus pressure loss as a whole nozzle can be suppressed.

  In addition, since the nozzle can be configured to have one portion where the mixed fluid is ejected, the thickness of the entire nozzle can be suppressed, that is, it is advantageous for reducing the nozzle diameter. As a result, the nozzle can be easily and reliably inserted into the body cavity.

Hereinafter, the nozzle manufacturing method of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
FIG. 1 is a schematic partial longitudinal sectional view showing an example of a usage state of an applicator having a nozzle manufactured by a nozzle manufacturing method, and FIG. 2 and FIG. 3 are enlarged partial vertical cross sections of the applicator shown in FIG. 4, FIG. 4 and FIG. 5 are longitudinal sectional views (views showing the use state) of the tip side portion of the nozzle in the applicator of FIG. 1, respectively, and FIG. FIG. 7 is a perspective view of a nozzle manufacturing jig used in the nozzle manufacturing method, and FIGS. 8 to 19 are longitudinal sectional views for sequentially explaining each manufacturing process in the nozzle manufacturing method. In the following, for convenience of explanation, the right side in FIGS. 1 to 4 and 7 to 19 is referred to as “base end (rear end)”, and the left side is referred to as “tip”.

  As shown in FIG. 1, the applicator 1 is inserted into the abdominal cavity 500, for example, during laparoscopic surgery, and two types of liquids (first liquid (first fluid) L1, While mixing the second liquid (second fluid) L2), the mixture (mixed liquid) is applied to the organ, the abdominal wall 501 and the like. The applicator 1 is inserted into the abdominal cavity 500 through the trocar tube 40 previously placed on the abdominal wall 501. Specifically, by inserting the nozzle 4 of the applicator 1 into the trocar tube 40 and projecting the nozzle head 42 of the nozzle 4 from the trocar tube 40, the applicator 1 (nozzle head 42) is placed in the abdominal cavity 500. Can be inserted into.

Before describing the applicator 1, the trocar tube 40 will be described.
As shown in FIG. 1, the trocar tube 40 has a tubular main body portion (tubular body) 401 and a hub 402 provided at the base end portion of the main body portion 401.

  The main body 401 has an opening at the distal end and the proximal end. The tip opening 403 of the main body 401 is inclined with respect to the axis of the main body 401. As a result, the distal end portion of the trocar tube 40 has an easy shape for inserting the trocar tube 40 into the abdominal cavity 500 from the distal end side. Therefore, the operation of inserting the trocar tube 40 into the abdominal cavity 500 can be easily performed.

  The hub 402 is a portion whose inner diameter and outer diameter are larger than those of the main body 401 and communicates with the main body 401.

  A gas supply port 404 protrudes from the outer periphery of the hub 402. The gas supply port 404 is connected to a gas cylinder (gas supply means) 300a through a tube 302a. The gas (sterile gas) G1 supplied from the gas cylinder 300a sequentially passes through the tube 302a, the gas supply port 404, the hub 402, and the main body 401, and is supplied into the abdominal cavity 500 (see FIG. 1). By supplying the gas G1, the abdominal pressure (internal pressure) in the abdominal cavity 500 is increased by, for example, about 8 to 12 mmHg from the atmospheric pressure, and the abdominal cavity 500 is expanded. As a result, the abdominal cavity 500 is large enough to perform laparoscopic surgery. The gas cylinder 300a has the same configuration as a gas cylinder 300b described later, and the description thereof is omitted here.

  Further, a duckbill valve (valve element) 406 is installed at the base end opening 405 of the hub 402 so as to cover the base end opening 405. The duckbill valve 406 is closed (closed) when the applicator 1 is not inserted into the trocar tube 40 and opens when the applicator 1 is inserted. The duckbill valve 406 can prevent the gas G1 from flowing out of the proximal end opening 405 even when the applicator 1 is inserted. Therefore, the gas G1 is efficiently and reliably supplied into the abdominal cavity 500. The The constituent material of the duckbill valve 406 is not particularly limited. For example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, polyamide And elastic materials such as various thermoplastic elastomers such as olefins and styrenes, or mixtures thereof.

  Moreover, the main-body part 401 and the hub 402 may be integrally formed, each may be comprised by a different body, and these separate bodies may be connected and fixed. Examples of the constituent material of the main body 401 and the hub 402 include polyvinyl chloride, polyethylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, and acrylonitrile-butadiene-styrene copolymer. And various resins such as polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12). Resins such as polypropylene, cyclic polyolefin, and polyester are preferred because they are easy to mold and have low water vapor permeability.

  As described above, the applicator 1 applies two liquids (first liquid L1 and second liquid L2) having different liquid compositions while mixing them (see FIGS. 1 to 3). The applicator 1 is used by loading a first syringe (liquid supply means) 2 for storing the first liquid L1 and a second syringe (liquid supply means) 3 for storing the second liquid L2. It is done. Since the 1st syringe 2 and the 2nd syringe 3 are the substantially the same structures, the 1st syringe 2 is demonstrated typically.

  The first syringe 2 includes an outer cylinder (syringe outer cylinder) 21, a gasket 24 that can slide in the outer cylinder 21, and a push that moves the gasket 24 along the longitudinal direction (axial direction) of the outer cylinder 21. A child (plunger rod) 26 is provided. The gasket 24 is connected to the tip of the pusher 26.

  The outer cylinder 21 is composed of a bottomed cylindrical member, and a reduced diameter part (mouth part) 22 that is reduced in diameter relative to the body part of the outer cylinder 21 is integrally formed at the center of the bottom part on the front end side. ing.

A flange 23 is integrally formed on the outer periphery of the rear end of the outer cylinder 21.
A scale indicating the amount of liquid is attached to the outer peripheral surface of the outer cylinder 21.

  The constituent material of the outer cylinder 21 is not particularly limited. For example, various resins as described in the description of the trocar tube 40 can be used. In addition, it is preferable that the constituent material of the outer cylinder 21 is substantially transparent in order to ensure internal visibility.

  In such an outer cylinder 21, a gasket 24 made of an elastic material is accommodated (inserted). By sliding while the outer peripheral surface of the gasket 24 is in close contact with the inner peripheral surface of the outer cylinder 21, the first liquid L1 is directed toward the mouth portion 22 while the liquid tightness is reliably maintained in the outer cylinder 21. Can be extruded. The constituent material of the gasket 24 is not particularly limited, and for example, an elastic material as described in the description of the duckbill valve 406 of the trocar tube 40 can be used.

  The gasket 24 is moved by operating the pusher 26 to move. The pusher 26 is a long member, and a disc-shaped flange 29 is formed on the base end side thereof. Further, as the constituent material of the pusher 26, the same material as that of the outer cylinder 21 described above can be used.

  Before the first syringe 2 is loaded into the applicator 1, the space surrounded by the outer cylinder 21 and the gasket 24 (liquid storage space) is filled with the first liquid L1. The second syringe 3 is filled with the second liquid L <b> 2 in a space (liquid storage space) surrounded by the outer cylinder 21 and the gasket 24.

  The first liquid L1 filled in the first syringe 2 and the second liquid L2 filled in the second syringe 3 have different compositions (components).

  The 1st liquid L1 and the 2nd liquid L2 are suitably selected according to the use of the applicator 1, a purpose of use, a case, etc. For example, when used for administration of a biological tissue adhesive, one of the first liquid L1 and the second liquid L2 is a liquid containing thrombin (solution or the like), and the other is a liquid containing fibrinogen (solution or the like). ).

  In addition, when used for administration of the anti-adhesion material, one of the first liquid L1 and the second liquid L2 is a liquid (solution or the like) containing carboxymethyldextrin modified with a succinimidyl group, and the other is phosphorus It can be set as the liquid (solution etc.) containing disodium oxyhydrogen.

  The first liquid L1 and the second liquid L2 in such a combination are altered, that is, gelled (solidified) when they are mixed. By being gelled, for example, a mixture of the first liquid L1 and the second liquid L2 (hereinafter sometimes referred to as “mixture (mixed liquid)”) is applied to a living tissue (target site). You can stay with confidence. In addition, since the mixture remains reliably at the target site, the function as a biological tissue adhesive or an adhesion preventing material can be reliably exhibited at the target site.

  Needless to say, the types and combinations of the first liquid L1 and the second liquid L2 are not limited to those described above. In the present embodiment, the viscosity (viscosity) of the first liquid L1 is lower than the viscosity (viscosity) of the second liquid L2.

  The 1st syringe 2 and the 2nd syringe 3 of such a structure are connected to the nozzle 4 mentioned later, and the 1st liquid flow path 44 of the nozzle 4 is made into the 1st liquid flow path 44 by pressing each pusher 26. The liquid L1 can be supplied (sent) easily and reliably to the second liquid flow path 45. Moreover, the pressing operation of each pusher 26 is manually performed by an operator (user) of the applicator 1. Therefore, the operator can apply the mixture at his / her arbitrary timing.

  Moreover, the applicator 1 ejects the 1st liquid L1 and the 2nd liquid L2 with gas G2 (refer FIGS. 1-3). The mixture is atomized by the gas G2, and the mixture can be uniformly applied to a target site (target site such as an affected area). The gas G2 is supplied from the gas cylinder 300b. The gas cylinder 300b is connected to the nozzle through the tube 302b.

  The gas cylinder 300b is filled with a high-pressure (compressed) sterile gas G2 (hereinafter simply referred to as “gas G2”) in its internal space, and supplies the gas G2 flowing at high speed to the applicator 1 (nozzle 4). You can (send). An openable / closable valve (cock) (not shown) for controlling supply / stop of supply of the gas G to the applicator 1 is installed in the middle of the gas cylinder 300b or the tube 302b. When applying the mixture, the valve is opened.

  As shown in FIGS. 1 to 3, the applicator 1 includes an applicator main body 7, a long nozzle 4 installed on the distal end side of the applicator main body 7, and a sheath (outer tube) 11 through which the nozzle 4 is inserted. And.

  As shown in FIG. 1, the applicator main body 7 includes a syringe holding portion 71 that holds the outer cylinder 21 of the first syringe 2 and the outer cylinder 21 of the second syringe 3, and a pusher for the first syringe 2. 26 flanges 29 and a flange connecting portion 72 that connects the flange 29 of the pusher 26 of the second syringe 3.

  The syringe holding part 71 fixes the 1st syringe 2 (outer cylinder 21) and the 2nd syringe 3 (outer cylinder 21) side by side (in parallel). The syringe holding part 71 is located on the proximal end side of the fitting part 711 into which the mouth part 22 of each outer cylinder 21 is fitted (inserted) and the fitting part 711, and the flange 23 of each outer cylinder 21. The insertion portion 712 into which the edge portion is inserted, and the connection portion 713 that connects the fitting portion 711 and the insertion portion 712 are included.

  When the mouth portion 22 of each outer cylinder 21 is fitted to the fitting portion 711, the mouth portion 22 of the first syringe 2 is connected to the first liquid flow path 44 of the nozzle 4 and the mouth of the second syringe 3. The unit 22 is connected to a second liquid channel (liquid channel (liquid transfer channel)) 45. As a result, the first liquid L1 can be supplied to the first liquid channel 44, and the second liquid L2 can be supplied to the second liquid channel 45 (see FIG. 4).

  Further, a connecting portion 715 is formed on the outer peripheral portion of the fitting portion 711 so as to protrude from the end of the tube 302b through which the gas G2 from the gas cylinder 300b passes. When the tube 302 b is connected to the connection portion 715, the tube 302 b is connected to the gas flow path 46 of the nozzle 4. Thereby, gas G2 can be supplied to the gas flow path 46 (refer FIG. 4).

  A groove 714 into which the edge of the flange 23 of each outer cylinder 21 is inserted is formed in the insertion portion 712.

  In the syringe holding part 71, the mouth part 22 of each outer cylinder 21 is fitted to the fitting part 711, and the flange 23 of the outer cylinder 21 is inserted into the insertion part 712 (groove 714). It can be held securely.

  The flange connecting portion 72 is a plate-like member that connects the flange 29 of the pusher 26 of the first syringe 2 and the flange 29 of the pusher 26 of the second syringe 3. A groove 721 into which the edge of the flange 29 of each pusher 26 is inserted is formed in the flange connecting portion 72. By pressing the flange connecting portion 72 toward the distal end, the pushers 26 can be moved together toward the distal end. Thus, the flange connection part 72 functions as an operation part that is pressed by the user when the applicator 1 is used, that is, when the mixture is applied to a target site such as an affected part.

  As a constituent material of the syringe holding part 71 and the flange connection part 72, for example, various resins as described in the description of the trocar tube 40 can be used.

  A nozzle 4 is installed on the distal end side of the applicator main body 7. The nozzle 4 ejects the first liquid L1 and the second liquid L2 (mixture) together with the gas G2.

  As shown in FIGS. 2 to 4, the nozzle 4 can be divided into an elongated nozzle body 43 and a nozzle head 42 located on the tip side of the nozzle body 43.

  As shown in FIG. 4, the nozzle 4 (nozzle body 43) includes a first liquid flow path (first liquid transfer path) 44 through which the first liquid L1 from the first syringe 2 passes, and a second liquid L1. A second liquid channel (second liquid transfer channel) 45 through which the second liquid L2 from the syringe 3 passes, and a first liquid channel 44 and a second liquid L2 that have passed through each channel. Has a merging part (merging space) 47 and a gas flow path 46 through which the gas G2 from the gas cylinder 300b passes.

  The first liquid channel 44 is configured (formed (defined)) by a first tube (first channel forming member) 44a. The first tube 44 a extends to a position where the base end portion is connected to the mouth portion 22 of the first syringe 2.

  The second liquid channel 45 is configured (formed (defined)) by a second tube (second channel forming member) 45a. The second tube 45 a extends to a position where the base end portion is connected to the mouth portion 22 of the second syringe 3.

  The first tube 44a and the second tube 45a are made of the same (same type) material, and examples of the material include polyvinyl chloride, polyamide, polyurethane, polypropylene, polytetrafluoroethylene, silicone rubber, polyethylene, Examples thereof include materials having flexibility such as nylon and ethylene-vinyl acetate copolymer. As a result, as shown in FIGS. 11 to 13, in the process of manufacturing the nozzle 4, the distal ends of the first tube 44 a and the second tube 45 a can be reliably fused and integrated. it can. Hereinafter, this integrated part is referred to as a “shrinkage part (integral part) 48”.

  As shown in FIG. 4, the inner diameter of the first tube 44a and the inner diameter of the second tube 45a are different from each other, that is, the inner diameter of the first tube 44a is larger than the inner diameter of the second tube 45a. Furthermore, the size relationship is significant in the contraction portion 48. Specifically, the inner diameter of the portion other than the contraction portion 48 of the first tube 44a is 30 to 70% of the inner diameter of the portion other than the contraction portion 48 of the second tube 45a. The inner diameter at the contraction portion 48 is 10 to 50% of the inner diameter at the contraction portion 48 of the second tube 45a.

  As described above, since the viscosity (viscosity) of the first liquid L1 is lower than the viscosity (viscosity) of the second liquid L2, the first liquid L1 passes through the first tube 44a. The flow resistance against the first liquid L1 when the second liquid L2 passes through the second tube 45a and the flow resistance against the second liquid L2 when the second liquid L2 passes through the second tube 45a. is there. When the flow path resistance in each liquid is the same, when the flange connecting portion 72 that connects the pusher 26 of the first syringe 2 and the pusher 26 of the second syringe 3 is pressed, for example, Such a problem that the pusher 26 becomes harder to move than the other pusher 26 is prevented, and the pressing operation can be performed stably.

  As shown in FIG. 4, the contraction portion 48, which is a portion where the first tube 44 a and the second tube 45 a are integrated, is a base of the third tube (merging portion forming member) 47 a that forms the merging portion 47. Connected to the end. The third tube 47a communicates with the first tube 44a and the second tube 45a, passes through the first tube 44a (flowed down), and passes through the second tube 45a. The second liquid L2 that has flowed (flowed down) can flow in. As a result, the first liquid L1 and the second liquid L2 merge in the third tube 47a (merging portion 47), and thus can be mixed uniformly (see FIG. 4). Thereby, a mixture can be apply | coated to an affected part in a suitable state (a state with uniform mixing).

  Further, the wall of the third tube 47a is constituted by a gas permeable membrane 471. Thereby, the gas G2 in the gas flow path 46 flows into (permeates through) the gas permeable membrane 471 and flows into the third tube 47a. This inflowing gas G2 is ejected from the ejection port 491 together with the mixture (see FIG. 4). As a result, the mixture becomes mist and is applied to the affected area.

  Further, as shown in FIG. 5, when the ejection of the mixture stops, the gas G2 that has flowed in through the gas permeable membrane 471 surely pushes out (blows away) the mixture in the third tube 47a. Thereby, it is prevented that a mixture remains in the jet nozzle 491. Therefore, clogging is prevented from occurring at the ejection port 491 (nozzle 4).

  A large number of pores (not shown) are formed in the gas permeable membrane 471 through which such gas G2 permeates. Each pore penetrates the gas permeable membrane 471 in the thickness direction. The average pore diameter of these pores is not particularly limited, but is preferably 2 μm or less, for example. Examples of the air-permeable membrane 471 having such pores include “Pore-Flon tube (TB-0201)” manufactured by Sumitomo Electric Fine Polymer Co., Ltd. This is a gas permeable membrane 471 having an average pore diameter of about 1 μm.

  In addition, by setting the pore diameter to 0.01 to 0.45 μm, the gas G2 can surely permeate, and the gas permeable membrane 471 has a bacteria impermeability. Since the gas permeable membrane 471 is impermeable to bacteria, even if the gas G2 in the cylinder 300b is not in a sterile state, the fungi in the gas G2 are removed by the gas permeable membrane 471, and the fungi are third. It is reliably prevented from flowing into the tube 47a. Thereby, the aseptic mixture can be applied to the affected area.

  Moreover, the film thickness (wall pressure) of the ventilation film 471 is not particularly limited, and is preferably 0.1 to 1 mm, and more preferably 0.3 to 0.8 mm, for example.

Moreover, it is preferable that the surface area (area of an outer peripheral surface) of the ventilation film 471 is 20-200 mm < ² >, and it is more preferable that it is 40-100 mm < ² >.

  The gas permeable membrane 471 is impermeable (water repellency) to the first liquid L1 and the second liquid L2, that is, has hydrophobicity. This reliably prevents the mixed liquid in the third tube 47a from flowing back into (flowing into) the cover tube 46a (gas flow path 46) via the gas permeable membrane 471. Such a gas permeable membrane 471 is made of a hydrophobic material, or the surface thereof is subjected to a hydrophobic treatment. Examples of the hydrophobic material (component material) include polytetrafluoroethylene (PTFE), a copolymer of tetrafluoroethylene and hexafluoropropylene (FEP), and a copolymer of tetrafluoroethylene and perfluoroalkyl vinyl ether ( PFA), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), copolymer of ethylene and tetrafluoroethylene (ETFE), copolymer of ethylene and chlorotrifluoroethylene (ECTFE), polypropylene (PP) Etc. As the gas permeable membrane 471, a material obtained by making these materials porous by a stretching method, a microphase separation method, an electron beam etching method, a sintering method, an argon plasma particle, or the like is preferably used. The method for the hydrophobizing treatment is not particularly limited, and examples thereof include a method of coating the surface of the gas permeable membrane 471 with the hydrophobic material (for example, a fluorine resin material).

  As shown in FIG. 4, an ejection port forming member (nozzle tip) 49 is installed (inserted) at the tip of the third tube 47a. The jet outlet forming member 49 is formed of a cylindrical body (cylinder), and a tip opening portion of the jet outlet forming member 49 forms a liquid jet outlet 491 from which the mixed liquid is jetted.

  Further, as shown in FIG. 16, the jet port forming member 49 has a bullet-shaped outer shape. That is, the ejection port forming member 49 is configured by a tapered portion 492 having a tapered shape provided at the distal end portion thereof, and an outer diameter constant portion 493 provided at the proximal end of the tapered portion 492.

  The taper portion 492 is a portion where the outer diameter gradually decreases toward the tip, that is, the outer peripheral surface 492a is rounded. The tapered portion 492 protrudes from the tip (tip surface) 472 of the third tube 47a in a state of being fixed (attached) to the third tube 47a. Since the taper portion 492 protrudes in this way, as shown in FIG. 19, when fixing the ejection port forming member 49 to the third tube 47 a, the outer peripheral surface 492 a of the taper portion 492 is attached to the adhesive 10. It can be used as a bonding allowance for bonding to the tip 472 of the third tube 47a and the tip (tip surface) 461 of the cover tube 46a. Since the outer peripheral surface 492a of the tapered portion 492 is rounded, the outer peripheral surface 492a of the tapered portion 492 contacts the organ, the abdominal wall 501 and the like when the nozzle head 42 of the nozzle 4 is inserted into the abdominal cavity 500. Even in this case, these living tissues can be reliably prevented from being damaged at the outer peripheral surface 492a. In addition, the taper portion 492 has an inner diameter that gradually decreases in the distal direction. Thereby, the mixture is reliably atomized when ejected from the ejection port 491.

  The constant outer diameter portion 493 located on the proximal end side of the tapered portion 492 is a portion whose outer diameter is constant along the longitudinal direction. In addition, the outer diameter of the constant outer diameter portion 493 is substantially equal to the inner diameter of the third tube 47a. As a result, the fixed outer diameter portion 493 can be fitted (inserted) into the third tube 47a. Therefore, the synergistic effect of the fixing method by the fitting and the fixing method by the adhesion described above causes the third to occur. The ejection port forming member 49 can be more securely fixed to the tube 47a.

  Further, the base end surface 494 of the jet port forming member 49 is chamfered (see FIG. 16). Thereby, insertion operation at the time of inserting the spout formation member 49 into the 3rd tube 47a from the base end side can be performed easily (refer FIG. 16, FIG. 17).

  The ejection port forming member 49 is preferably made of a hard material (hard material) different from the third tube 47a. Although it does not specifically limit as this material, For example, metal materials, such as a resin material and stainless steel which were mentioned by description about the main-body part 401 and the hub 402 of the trocar tube 40, can be used. When the jet port forming member 49 is made of such a resin material, as a fixing method when the jet port forming member 49 is fixed to the third tube 47a, in addition to the above-described adhesion method, fusion bonding is performed. It is possible to use a method by (thermal fusion, high frequency fusion, ultrasonic fusion, etc.). Further, when a metal material such as stainless steel is used as the constituent material of the ejection port forming member 49, it is possible to assist the position confirmation of the tip portion of the nozzle 4 under X-ray fluoroscopy.

  As shown in FIG. 4, the gas flow path 46 through which the gas G2 passes is the outer periphery of the first tube 44a and the second tube 45a constituting the first liquid flow path 44 and the second liquid flow path 45, respectively. That is, it is constituted by a cover tube (gas flow path forming member) 46a through which the first tube 44a and the second tube 45a are inserted. The cover tube 46a has a tip inner peripheral portion fitted to a tip outer peripheral portion of the third tube 47a. Further, the tip 461 of the cover tube 46 a and the tip 472 of the third tube 47 a are at the same position in the longitudinal direction of the nozzle 4. Further, the cover tube 46 a extends to a position where the base end portion is connected to the tube 302 b via the connection portion 715 of the applicator main body 7.

  The constituent material of the cover tube 46a is not particularly limited. For example, a material having flexibility similar to that of the first tube 44a and the second tube 45a can be used.

  The nozzle body 43 configured as described above has a curved portion 431 that is curved or bent at the distal end portion (the distal end side) and has flexibility (flexibility) (see FIGS. 1 and 2). ). In the present embodiment, the bending portion 431 is bent or bent so that the tip thereof faces obliquely downward. Due to the curved portion 431, the axis 426 of the nozzle head 42 is inclined with respect to the axis 433 of the nozzle body 43 (strictly, the axis of the portion 432 on the proximal end side of the curved portion 431 of the nozzle body 43) ( (See FIG. 2).

  The inclination angle θ of the axis 426 of the nozzle head 42 with respect to the axis 433 of the nozzle body 43 is about 30 to 90 ° when the bending portion 431 is bent or bent without being restricted by the sheath 11 described later. Is preferable, and is preferably about 45 to 70 °.

  As shown in FIG. 4, the nozzle head 42 located on the tip side of the nozzle body 43 has a first taper portion 427 whose outer shape is cylindrical and whose outer diameter gradually increases in the tip direction, and an outer diameter. A constant outer diameter constant portion 428 along the longitudinal direction (axis 426) and a second taper portion 429 whose outer diameter gradually decreases in the distal direction are arranged in this order from the base end side.

  By forming the first taper portion 427, when the nozzle 4 changes from the state shown in FIG. 2 to the state shown in FIG. 3, the edge 114 inside the distal end opening 113 of the sheath 11 is the first taper portion. It can move smoothly along 427. Thereby, the nozzle head 42 can be reliably introduced into the sheath 11. Note that the edge 114 is preferably rounded. Thereby, the edge part 114 can move more smoothly along the 1st taper part 427. FIG.

  The second taper portion 429 is located on the tip side of the first taper portion 427. By forming the second taper portion 429, for example, when the applicator 1 is inserted into the trocar tube 40 in the state shown in FIG. 3, the second taper portion 429 smoothly passes through the duckbill valve 406 of the trocar tube 40. can do. Thereby, insertion operation to the trocar tube 40 of the applicator 1 can be performed easily. Further, the outer diameter of the proximal end of the second tapered portion 429 is larger than the inner diameter of the sheath 11. As a result, the nozzle head 42 can be prevented from entering the sheath 11, that is, the tip of the nozzle head 42 can be prevented from moving closer to the proximal end than the tip of the sheath 11.

  A constant outer diameter portion 428 is located between the first tapered portion 427 and the second tapered portion 429. The outer diameter of the constant outer diameter portion 428 is the same as the outer diameter (maximum outer diameter) of the tip of the first taper portion 427 and is equal to or slightly larger than the inner diameter of the sheath 11. As a result, as shown in FIG. 3, when the axis 426 of the nozzle head 42 and the axis 433 of the nozzle main body 43 coincide with each other, the constant outer diameter portion 428 (including the tip of the first taper portion 427) It enters and fits into the tip opening 113. Therefore, it is possible to maintain a state where the axis 426 of the nozzle head 42 and the axis 433 of the nozzle main body 43 coincide. In addition, the mixture can be applied to the target site in the abdominal cavity 500 in this maintained state. In the applicator 1, the constant outer diameter portion 428 and the tip (part) of the first taper portion 427 can be referred to as a “fitting portion” that fits with the tip opening 113 of the sheath 11.

  As shown in FIG. 2 (the same applies to FIGS. 1 and 3), the applicator 1 has a sheath 11 having a function as a shape regulating member that regulates the shape of the curved portion 431 of the nozzle body 43. The sheath 11 is composed of a long tubular body whose distal end and proximal end are opened, and a nozzle 4 (nozzle body 43) is inserted (inserted) into the sheath 11. In the present embodiment, the sheath 11 is inserted from the distal end portion (the constant outer diameter portion 428 of the nozzle head 42) to the vicinity of the proximal end portion of the nozzle main body 43 relative to the curved portion 431. The sheath 11 is movable with respect to the nozzle body 43 along the longitudinal direction (axial direction) of the nozzle body 43.

  The sheath 11 is made of a hard material so that the shape of the bending portion 431 can be regulated (corrected) when part or all of the bending portion 431 is covered, and has a necessary and sufficient rigidity. Furthermore, it is desirable that it has low slidability.

  Examples of the constituent material of the sheath 11 include polyolefin resins such as polyethylene and polypropylene, fluorine resins such as polytetrafluoroethylene, hard resins such as polycarbonate, polyethylene terephthalate, and polyamide, stainless steel, aluminum, copper, and copper alloys. Various ceramic materials such as various metal materials, various glasses, alumina, silica and the like can be mentioned.

  As described above, the sheath 11 can be moved along the longitudinal direction of the nozzle body 43. By this moving operation, the bending portion 431 is inserted into the sheath 11, the protrusion length of the bending portion 431 from the distal end of the sheath 11 is adjusted, and the shape of the bending portion 431 can be corrected (changed) ( (See FIGS. 2 and 3). Thereby, the inclination angle θ (direction of the nozzle head 42) of the axis 426 of the nozzle head 42 with respect to the axis 433 of the nozzle body 43 can be adjusted. In other words, as shown in FIG. 3, the sheath 11 is straightened by the curved portion 431 being corrected (restricted) by the sheath 11, and the direction of the axis 426 of the nozzle head 42 and the direction of the axis 433 of the nozzle body 43. 2 and the first position (inclination angle θ = 0 °), and as shown in FIG. 2, the bending portion 431 is bent or bent without being restricted by the sheath 11, and the axis 433 of the nozzle body 43 is The nozzle head 42 can move between a second position inclined with respect to the axis 426 of the nozzle head 42 (the inclination angle θ is the maximum inclination angle). Thereby, the inclination angle θ can be freely adjusted within the range from 0 ° to the maximum inclination angle by moving the sheath 11 to a predetermined position between the first position and the second position. .

  In this way, by moving the sheath 11 and appropriately adjusting the inclination angle θ, the inclination angle θ of the nozzle head 42 is changed, and the mixture is transferred from the nozzle head 42 to a plurality of locations in the abdominal cavity 500 (for example, organs and abdominal walls). 501). Therefore, the applicator 1 can apply the mixture easily and reliably over a wide range within the abdominal cavity 500. In the applicator 1, by appropriately setting the degree of bending (inclination angle θ) of the bending portion 431 in a natural state where no external force is applied (for example, “U” shape), the applicator 1 can be applied to the living body. The mixture can also be applied to the back surface (back side) of the abdominal wall 501 facing the organ located in the insertion direction.

  The sheath 11 is formed with a plate-like flange (projection) 115 projecting from the outer peripheral portion of the base end thereof. The sheath 11 can be moved by gripping the flange 115 and moving it along the longitudinal direction of the sheath 11. Thus, the flange 115 functions as an operation unit when the sheath 11 is moved.

  As described above, the applicator 1 is used while being inserted into the trocar tube 40. When the applicator 1 is pressed in the distal direction in this state, the flange 115 of the sheath 11 comes into contact with the proximal end opening 405 (base end) of the hub 402. As a result, the limit of movement of the sheath 11 in the distal direction relative to the trocar tube 40 can be restricted, and accordingly, the proximal end portion of the sheath 11 can be inadvertently introduced into the trocar tube 40, that is, the sheath 11. It is possible to prevent the proximal end portion from moving toward the distal end side with respect to the proximal end opening 405 of the trocar tube 40. Thereby, the base end part (part) of the sheath 11 protrudes reliably from the base end opening 405 of the trocar tube 40, and the protruding part can be gripped. Therefore, the sheath 11 can be moved. Thus, the flange 115 also functions as a restricting means for restricting the movement limit of the sheath 11 in the distal direction relative to the trocar tube 40.

  The operation for adjusting the tilt angle θ and the operation for ejecting (jetting) the first liquid L1 and the second liquid L2 can be performed in any order.

  That is, the operation for adjusting the tilt angle θ and the operation for ejecting the first liquid L1 and the second liquid L2 may be performed simultaneously, and the first liquid L1 and the second liquid L2 are ejected. The operation may be started first, and then the operation for adjusting the tilt angle θ may be performed. In these cases, after starting the ejection of the first liquid L1 and the second liquid L2, the range of application can be expanded by adjusting the inclination angle θ. Alternatively, the operation of adjusting the inclination angle θ may be performed first, and then the operation of ejecting the first liquid L1 and the second liquid L2 may be performed.

  As shown in FIGS. 2 and 3, a gap 15 is formed between the sheath 11 and the nozzle 4. The gap 15 is formed along the longitudinal direction of the sheath 11 (nozzle 4), that is, from the distal end opening 113 to the proximal end opening 116 of the sheath 11.

  The sheath 11 has two side holes 117 penetrating the wall portion on the proximal end side with respect to the distal end opening portion 113. These side holes 117 are arranged opposite to each other through the axis of the sheath 11 at the same position in the longitudinal direction of the sheath 11. Each side hole 117 communicates with the gap 15 and functions as an inflow port (an intake port for taking in the gas G3) through which the gas G3 in the abdominal cavity 500 flows into the gap 15 (see FIGS. 2 and 3). Note that the number of side holes 117 formed is not limited to two, and may be one or three or more, for example.

  Such a gap 15 functions as an exhaust path for discharging the gas (gas) G3 in the abdominal cavity 500 to the outside of the body. This will be described below.

  As shown in FIG. 1, the gas G1 is ejected from the trocar tube 40 into the abdominal cavity 500, and the gas G2 is ejected together with the mixture from the applicator 1 (nozzle head 42). As described above, the gas G1 increases the abdominal pressure in the abdominal cavity 500, and the abdominal cavity 500 expands. In addition, the pneumoperitoneum pressure in the abdominal cavity 500 is also increased by the gas G2, which causes the abdominal cavity 500 to further expand. However, the gas G3 (including gases G1 and G2) in the abdominal cavity 500 flows into the gap 15 through the side holes 117 (see FIGS. 2 and 3). Then, the gas G3 flows down in the gap 15 and is discharged from the proximal end opening 116 (see FIGS. 2 and 3). This can suppress (or prevent) an excessive increase in the pneumoperitoneum pressure in the abdominal cavity 500 and prevent the abdominal cavity 500 from further expanding.

  Further, as described above, the applicator 1 is configured so that the mixture can be easily and reliably applied over a wide range within the abdominal cavity 500. Since the mixture is applied over a wide range within the abdominal cavity 500, the ejection amount of the mixture increases, and the ejection amount of the gas G2 also increases accordingly. When a large amount of gas G2 is ejected, the pneumoperitoneum pressure in the abdominal cavity 500 is likely to increase, but the increase can be suppressed by the exhaust action of the gap. Thus, the applicator 1 is also effective when applying the mixture over a wide range within the abdominal cavity 500.

  In the middle of the gap 15, a ring-shaped spacer (elastic body) 16 is installed along the outer peripheral direction of the nozzle 4 (see FIGS. 2 and 3). The outer peripheral surface of the spacer 16 is fixed to the inner peripheral surface 118 of the sheath 11, and the inner peripheral surface is in contact with the outer peripheral surface 435 of the nozzle body 43. The inner peripheral surface of the spacer 16 slides on the outer peripheral surface 435 of the nozzle main body 43 when the sheath 11 moves, and a frictional resistance is generated between the outer peripheral surface 435 of the nozzle main body 43 and the inner peripheral surface of the spacer 16.

  The spacer 16 having such a configuration functions as positioning means for positioning the sheath 11 in the longitudinal direction of the nozzle 4 at the stop position when the sheath 11 is moved and stopped. Thereby, the inclination angle θ of the nozzle head 42 can be maintained, and the mixture can be ejected in this state.

  The spacer 16 is installed in a compressed state between the inner peripheral surface 118 of the sheath 11 and the outer peripheral surface 435 of the nozzle body 43. Thereby, the spacer 16 becomes difficult to deform in the radial direction, and also exhibits a function of regulating (maintaining) the gap distance (gap length) of the gap 15. As a result, the inner peripheral surface 118 of the sheath 11 and the outer peripheral surface 435 of the nozzle body 43 are in contact with each other, so that it is possible to reliably prevent the gap 15 (exhaust passage) from being blocked. It is possible to exhaust more reliably.

  As shown in FIG. 2, the spacer 16 is disposed on the tip side of each side hole 117. At this position, the spacer 16 seals the gap 15 in the middle. In the state shown in FIG. 3, the tip opening 113 of the sheath 11 is blocked by the nozzle head 42, but the gas G <b> 3 enters the gap 15 from each side hole 117. Can be exhausted.

  The constituent material of the spacer 16 is not particularly limited, and for example, various elastic materials as mentioned in the description of the duckbill valve 406 can be used.

  The nozzle 4 of the applicator 1 configured as described above is manufactured by the manufacturing method (manufacturing method of the nozzle) of the present invention. Hereinafter, this manufacturing method will be described, but before that, a nozzle manufacturing jig (hereinafter simply referred to as “jig”) 20 used in the manufacturing method will be described.

  The jig 20 shown in FIG. 7 is used when the nozzle 4 is manufactured. The jig 20 includes a long jig body 201, a first insertion portion (first mandrel) 203 formed on the base end surface 202 (base end portion) of the jig body 201, and a second insertion. Part (second mandrel) 204.

  The jig body 201 has a cylindrical shape and functions as a gripping part that is gripped when the jig 20 is used.

  The first insertion portion 203 has a rod shape and is a portion that is inserted into the first tube 44a (see FIG. 9). The outer diameter of the first insertion portion 203 is smaller than the inner diameter of the first tube 44a before the contraction portion 48 is formed on the first tube 44a, and the contraction portion 48 is present on the first tube 44a. It is equivalent to the inner diameter of the first tube 44a at the contracted portion 48 when formed. Further, the end face 205 of the first insertion portion 203 is rounded (see FIG. 8). Thereby, the insertion operation at the time of inserting the 1st insertion part 203 in the 1st tube 44a can be performed easily.

  The second insertion portion 204 has a rod shape and is arranged in parallel with the first insertion portion 203. This 2nd insertion part 204 is a site | part inserted in the 2nd tube 45a (refer FIG. 9). The outer diameter of the second insertion portion 204 is smaller than the inner diameter of the second tube 45a before the contraction portion 48 is formed on the second tube 45a, and the contraction portion 48 is formed on the second tube 45a. This is equivalent to the inner diameter of the second tube 45a at the contracted portion 48 when it is formed. Further, the end face 206 of the second insertion portion 204 is rounded (see FIG. 8). Thereby, the insertion operation at the time of inserting the 2nd insertion part 204 in the 2nd tube 45a can be performed easily.

  The length of the second insertion portion 204 is shorter than the length of the first insertion portion 203. In the jig 20, the outer diameters of the first insertion portion 203 and the second insertion portion 204 are compared with each other, and the thinner tube is securely inserted into the thinner insertion portion, and the thicker insertion portion is inserted. In addition to being able to securely insert the thicker tube, even if the lengths of the first insertion portion 203 and the second insertion portion 204 are compared, the narrower insertion portion This tube can be securely inserted, and the thicker tube can be reliably inserted into the remaining (other) insertion portion. In this way, erroneous insertion can be reliably prevented. In addition, the first insertion portion 203 is lengthened so that the thinner tube, which is relatively difficult to insert, can be inserted first, and the second insertion portion 204 is inserted so that the thicker tube, which is easy to insert, can be inserted later. By shortening, both tubes can be inserted smoothly.

  The sum of the outer diameter of the first insertion portion 203, the outer diameter of the second insertion portion 204, and the gap distance (gap length) h in the gap 209 is set to be smaller than the inner diameter of the merge portion 47. Thereby, it is reliably prevented that the two flow paths formed in the integrated contraction part 48 are closed when the contraction part 48 is fitted to the merge part.

  In addition, although it does not specifically limit as a constituent material of the jig | tool 20, For example, metal materials, such as stainless steel, can be used. Further, the jig 20 may be one in which the jig main body 201, the first insertion portion 203, and the second insertion portion 204 are integrally formed, or the jig main body 201 and the first insertion portion. The part 203 and the second insertion part 204 may be configured separately and connected (joined) to each other.

Next, a manufacturing method for manufacturing the nozzle 4 will be described with reference to FIGS.
This manufacturing method includes a jig mounting process, a contracted part forming process (integral part forming process), a heat shrink tube removing process, a jig removing process, a tube connecting process, a spout mounting process, and a cover tube mounting. A process and an adhesive application process.

[1] Jig Mounting Process As shown in FIG. 8, a jig 20 is prepared. In addition, a first tube 44a and a second tube 45a are prepared.

  Also, the first tube 44a and the second tube 45a are arranged so as to correspond to the respective insertion portions with the jig 20 facing the first insertion portion 203 and the second insertion portion 204 toward the proximal end side. .

  Then, from the state shown in FIG. 8, the first insertion portion 203 is inserted into the distal end portion of the first tube 44a, and the second insertion portion 204 is inserted into the distal end portion of the second tube 45a. Thereby, as shown in FIG. 9, the first insertion portion 203 is inserted into the first tube 44a, and the second insertion portion 204 is inserted into the second tube 45a. In this inserted state, the distal end 441 of the first tube 44a and the distal end 451 of the second tube 45a are separated from the base end surface 202 of the jig body 201 of the jig 20, respectively. The tips 441 and 451 are at the same position in the tube longitudinal direction.

[2] Shrinkage forming step Next, the tip of the first tube 44a and the tip of the second tube 45a in the inserted state shown in FIG. Thereby, as shown in FIG. 10, the front-end | tip part of each tube can be collectively covered with the heat contraction tube 60. FIG.

  The heat shrinkable tube 60 used here is a tube made of a material having heat shrinkability. Such a material is not particularly limited, and examples thereof include silicone resins and polyethylene. Moreover, it is preferable that the material (resin material) which comprises the heat contraction tube 60 differs from the material (resin material) which comprises the 1st tube 44a and the 2nd tube 45a. For example, when the first tube 44a and the second tube 45a are each made of a urethane resin, the heat-shrinkable tube 60 can be made of a silicone resin having a higher melting point than the urethane resin. As described later, when heated by the heater 70 (see FIG. 11), the first tube 44a and the second tube 45a are melted before the heat shrinkable tube 60 is melted. The tips of the tubes 45a are fused together. Moreover, since the heat-shrinkable tube 60 shrinks due to heat, the distal ends of the first tube 44a and the second tube 45a are fastened together. Thereby, fusion | melting of the front-end | tip parts of the 1st tube 44a and the 2nd tube 45a is performed reliably. Further, since the heat shrinkable tube 60 does not melt, even if the distal ends of the first tube 44a and the second tube 45a are tightened, they are prevented from being integrated with each tube. Thereby, the heat shrinkable tube 60 can be easily removed (peeled) from the first tube 44a and the second tube 45a in the subsequent steps (see FIG. 12).

  Then, as shown in FIG. 11, the portion covered with the heat shrinkable tube 60 is heated by the heater 70 together with the heat shrinkable tube 60. As a result, the heat-shrinkable tube 60 is contracted (diametered), and the contracted and deformed portions of the first tube 44a and the second tube 45a are tightened and contracted by the contracted heat-shrinkable tube 60. The parts are fused together. Thereby, the shrinkage | contraction part 48 with which the front-end | tip parts of the 1st tube 44a and the 2nd tube 45a were united can be formed. The degree of contraction (outer diameter) of the contraction section 48 is smaller than the sum of the outer diameter of the first tube 44a and the outer diameter of the second tube 45a before heating.

  Further, when heated by the heater 70, the tip of the first tube 44 a is in contact with the outer peripheral surface 207 of the first insertion portion 203 of the jig 20 until the entire inner peripheral surface 442 thereof is in close contact with the first tube 44 a, that is, the first tube 44 a. The lumen of the distal end portion of the tube 44a is contracted and deformed while maintaining the inner diameter thereof to be equal to the outer diameter of the first insertion portion 203. Similarly, the distal end portion of the second tube 45a is also in contact with the outer peripheral surface 208 of the second insertion portion 204, ie, the lumen of the distal end portion of the second tube 45a. Is contracted and deformed while maintaining the inner diameter to be equal to the outer diameter of the second insertion portion 204. Thereby, the contraction part 48 which each front-end | tip part of the 1st tube 44a and the 2nd tube 45a contracted without excess and deficiency can respectively be formed.

  The contracted portion 48 thus formed has a circular cross-sectional shape (see FIG. 6). The outer diameter of the contraction portion 48 is equal to or slightly smaller than the inner diameter of the third tube 47a. Thus, when the contraction part 48 has a circular cross-sectional shape, when the third tube 47a is inserted into the contraction part 48 in the subsequent steps (see FIG. 16), the insertion operation can be easily performed. Moreover, the contraction part 48 and the 3rd tube 47a fit reliably.

  As shown in FIG. 10, the inner diameter of the heat-shrinkable tube 60 before being heated is larger than the sum of the inner diameter of the first tube 44a and the inner diameter of the second tube 45a. Accordingly, the first tube 44a and the second tube 45a can be easily and collectively inserted into the heat shrinkable tube 60.

  In the state shown in FIG. 10, the tip 601 of the heat-shrinkable tube 60 is located on the tip side of the tip 441 of the first tube 44a and the tip 451 of the second tube 45a. Thereby, when the heat-shrinkable tube 60 contracts, each of the tips 441 and 451 can be reliably contracted and deformed by the contraction force (see FIG. 11).

  In addition, the base end 602 of the heat shrinkable tube 60 is located in the middle of the first insertion portion 203 and the second insertion portion 204 in the longitudinal direction, that is, the length of the heat shrinkable tube 60 is determined by the jig 20. This is shorter than the length of the first insertion portion 203 and the second insertion portion 204. Thereby, the heat-shrinkable tube 60 can be located in the middle of the longitudinal direction of the 1st insertion part 203 (same also about the 2nd insertion part 204). When the heat-shrinkable tube 60 contracts in this state, the contraction force can reliably contract and deform a portion necessary for forming the contracting portion 48 of the first tube 44a (second tube). The same applies to 45a).

[3] Heat Shrinkable Tube Removal Step Next, as shown in FIG. 12, the contracted heat shrinkable tube 60 is removed from the contracted portion 48, that is, the contracted portion 48 is removed from the contracted heat shrinkable tube 60. As described above, even if the heat-shrinkable tube 60 is heated, the heat-shrinkable tube 60 is prevented from being integrated with the first tube 44a and the second tube 45a. It can be done easily.

[4] Jig Removal Step Next, as shown in FIG. 13, the first insertion portion 203 and the second insertion portion 204 of the jig 20 are removed from the contracted portion 48 in the inserted state.

[5] Tube Connection Step Next, as shown in FIG. 14, the proximal end side of the third tube 47 a and the distal end side of the contracting portion 48 are opposed to each other. And as shown in FIG. 15, a part or all of the shrinkage | contraction part 48 is inserted in the base end part of the 3rd tube 47a. As a result, the contraction portion 48 is securely fitted to the proximal end portion of the third tube 47a, so that the first tube 44a, the second tube 45a, and the third tube 47a are reliably connected.

  Further, the outer diameter of the third tube 47a is the outer diameter of the first tube 44a before heating, that is, the outer diameter of the portion other than the contraction portion 48 of the first tube 44a, and the second tube before heating. It is substantially the same as the sum of the outer diameter of 45a, that is, the outer diameter of the portion of the second tube 45a other than the contracting portion 48 (see, for example, FIG. 4). Thereby, it is possible to suppress the occurrence of a dead space in the cover tube 46a, and thus it is possible to prevent the cover tube 46a from becoming thick, that is, to contribute to a reduction in the diameter of the nozzle 4.

  Moreover, as shown in FIG. 14, when inserting the shrinkage | contraction part 48 in the base end part of the 3rd tube 47a, the adhesive agent 80 is used for a part of outer peripheral surface (outer peripheral part) 481 of the shrinkage | contraction part 48, for example, an adhesive agent Application is performed using an applicator 90. Then, the contraction section 48 is inserted while rotating the third tube 47a about its axis. As a result, the adhesive 80 is applied between the inner peripheral surface (inner peripheral portion) 473 of the proximal end portion of the third tube 47 a and the outer peripheral surface 481 of the contraction portion 48. The proximal end portion of the third tube 47a and the contracted portion 48 are bonded to each other through the adhesive 80, so that the first tube 44a, the second tube 45a, and the third tube 47a are more reliably connected. To do. In the configuration shown in FIG. 14, the adhesive 80 is applied to the outer peripheral surface 481 of the contraction portion 48, but is not limited thereto, and is applied to the inner peripheral surface 473 of the base end portion of the third tube 47 a. May be. Moreover, the adhesive 80 can use the same thing (same kind) as the adhesive 10 mentioned later.

[6] Jetting Port Mounting Step Next, as shown in FIG. 16, the base end side of the jetting port forming member 49 and the tip end side of the third tube 47a are opposed to each other. Then, as shown in FIG. 17, the ejection port forming member 49 is inserted in the middle of the distal end portion of the third tube 47 a, that is, to the boundary portion between the tapered portion 492 and the constant outer diameter portion 493. As a result, the outer diameter constant portion 493 of the jet port forming member 49 that is substantially equal to the inner diameter of the third tube 47a is fitted, so that the jet port forming member 49 is attached to the third tube 47a. be able to.

  At this time, the tapered portion 492 (tip portion) of the ejection port forming member 49 is in a protruding state protruding from the tip 472 of the third tube 47a. The protruding outer peripheral surface 492a of the tapered portion 492 adheres the spout forming member 49 to the tip 472 of the third tube 47a and the tip 461 of the cover tube 46a via the adhesive 10 in the adhesive application step described later. It is used as a bonding allowance for

[7] Cover Tube Mounting Step Next, as shown in FIG. 18, the member obtained in the jet port mounting step is inserted into the cover tube 46a. Thereby, the cover tube 46a is attached.

  The tip 461 of the cover tube 46a and the tip 472 of the third tube 47a are at the same position in the tube longitudinal direction.

[8] Adhesive Application Step Next, as shown in FIG. 19, using the adhesive applicator 90, the outer peripheral surface 492 a of the tapered portion 492 serving as the bonding allowance of the spout formation member 49 and the third tube 47 a. The adhesive 10 is applied (applied) to the tip 472 and the tip 461 of the cover tube 46a. When the adhesive 10 is cured, the jet forming member 49 is securely fixed to the third tube 47a and the cover tube 46a via the adhesive 10. Thereby, the nozzle 4 is obtained.

  Further, when the adhesive 10 is cured, its thickness gradually decreases outward (in the vertical direction in FIG. 19). Thereby, the protrusion part from the front-end | tip 472 of the 3rd tube 47a of the taper part 492 can be relieve | moderated. Thereby, for example, when the nozzle head 42 of the nozzle 4 is inserted into the abdominal cavity 500, even if the periphery of the tip of the nozzle 4 comes into contact with the living tissue, the living tissue is reliably prevented from being damaged at that portion. .

  Further, the maximum thickness of the cured adhesive 10 is smaller than the protruding amount of the tapered portion 492 of the jet forming member 49. As a result, since only the leading edge of the tapered portion 492 protrudes, even if the merged liquid (mixed liquid) drips from the tip of the nozzle, the merged liquid does not stay at the leading edge of the tapered portion 492, and clogging occurs. Hard to happen.

  The adhesive 80 is not particularly limited. For example, an ultraviolet curable, visible light curable, or electron beam curable adhesive such as silicone, epoxy, acrylic, cyanoacrylate, polyurethane, or the like is used. Of these, cyanoacrylates are particularly preferred.

  Further, the length of the bonding margin, that is, the protruding amount of the tapered portion 492 protruding from the tip 472 of the third tube 47a (tip 461 of the cover tube 46a) is 10 to 70% of the outer diameter of the jet forming member 49. It is preferred that it is 30 to 50%. Thereby, it is possible to sufficiently secure an application area necessary for applying the adhesive 10 to the jet forming member 49. Accordingly, the jet forming member 49 is connected to the third tube 47a via the adhesive 10. It can be securely fixed against. In addition, it is possible to prevent or suppress damage to the protruding jet forming member 49 when it comes into contact with the living body.

  Further, since the outer peripheral surface 492a of the tapered portion 492 is rounded (has a tapered shape) as described above, for example, it is bonded to the adhesive 10 as compared with a case where it is linear in a side view. The area increases, thus increasing the adhesive strength.

  Further, the outer peripheral surface 492a of the tapered portion 492 may be subjected to a surface treatment that imparts affinity with the adhesive 10. The surface treatment is not particularly limited, and examples thereof include a roughening treatment. When the outer peripheral surface 492a of the taper part 492 is roughened, the adhesive strength of the adhesive 10 with respect to the outer peripheral surface 492a is increased as compared with the case where the outer peripheral surface 492a is smooth.

  By the manufacturing method as described above, the nozzle 4 (applicator 1) has the joining portion 47 constituted by the third tube 47a. Thereby, the 1st liquid L1 and the 2nd liquid L2 can be mixed reliably in the junction part 47, and this mixture can be ejected from the nozzle 4. FIG.

  In addition, since the mixture has one jet outlet, the overall thickness of the nozzle 4 can be suppressed, that is, it is advantageous for reducing the diameter of the nozzle 4. Thereby, the nozzle 4 can be easily and reliably inserted into the body cavity.

  Further, since the adhesive 10 is not interposed between the ejection port forming member 49 and the third tube 47a, it is possible to prevent the nozzle 4 from becoming thicker, which is advantageous for reducing the diameter of the nozzle 4. .

  Further, in the first liquid channel 44 through which the first liquid L1 passes, the portion where the channel diameter is narrowed is the contraction part 48 of the first tube 44a. Similarly, also in the second liquid channel 45 through which the second liquid L2 passes, the portion where the channel diameter is narrowed is the contraction part 48 of the second tube 45a. Further, in the merge portion 47 through which the first liquid L1 and the second liquid L2 pass, the portion where the flow path diameter is narrowed is in the jet forming member 49. With such a configuration, when the mixture is ejected from the nozzle 4, pressure loss occurs in the nozzle 4 mainly in the contraction portion 48 and the ejection port forming member 49. Pressure loss can be suppressed.

  As mentioned above, although the manufacturing method of the nozzle of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each process which comprises the manufacturing method of a nozzle is arbitrary which performs the same operation. It can be replaced with that of the process. Moreover, arbitrary processes may be added.

  The applicator can be used by being inserted into the abdominal cavity, but is not limited thereto, and can be used by being inserted into a body cavity such as a thoracic cavity or a uterus.

  In addition, the applicator is used for a procedure for inflating the abdominal cavity by supplying gas into the abdominal cavity from the trocar tube. However, the applicator is not limited thereto. It can also be used for procedures, so-called suspension methods.

  In addition, when a plurality of trocar tubes are placed (punctured) in the abdominal wall under the laparoscope, gas is supplied from, for example, one trocar tube among these trocar tubes, and gas is supplied from the other trocar tubes. Supply may be stopped.

  In the nozzle manufacturing jig, the lengths of the first insertion portion and the second insertion portion are different, but the lengths of the first insertion portion and the second insertion portion are the same. Good.

  Moreover, what passes through the first tube and the second tube of the nozzle is not limited to being a liquid. For example, what passes through one tube is a liquid and passes through the other tube. The thing to do may be a gas.

It is a general | schematic fragmentary longitudinal cross-section which shows an example of the use condition of the applicator which has the nozzle manufactured by the manufacturing method of a nozzle. It is an expanded partial longitudinal cross-sectional view of the applicator shown in FIG. It is an expanded partial longitudinal cross-sectional view of the applicator shown in FIG. It is a longitudinal cross-sectional view (figure which shows a use condition) of the part at the front end side of the nozzle in the applicator of FIG. It is a longitudinal cross-sectional view (figure which shows a use condition) of the part at the front end side of the nozzle in the applicator of FIG. It is the sectional view on the AA line in FIG. It is a perspective view of the jig for nozzle manufacture used with the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle. It is a longitudinal cross-sectional view for demonstrating in order each manufacturing process in the manufacturing method of a nozzle.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Applicator 2 1st syringe (liquid supply means)
21 outer cylinder 22 reduced diameter part (mouth)
23 Flange 24 Gasket 26 Pusher (plunger rod)
29 Flange 3 Second syringe (liquid supply means)
DESCRIPTION OF SYMBOLS 4 Nozzle 42 Nozzle head 426 Axis 427 1st taper part 428 Outer diameter constant part 429 2nd taper part 43 Nozzle main body 431 Bending part 432 A part of a base end side from a bending part 433 Axis line 435 Outer peripheral surface 44 1st liquid flow path ( First liquid transfer path)
44a First tube (first flow path forming member)
441 Tip 442 Inner peripheral surface 45 Second liquid flow path (second liquid transfer path)
45a Second tube (second flow path forming member)
451 tip 452 inner peripheral surface 46 gas flow path 46a cover tube (gas flow path forming member)
461 Tip 47 Merging section (merging space)
47a Third tube (merging portion forming member)
471 Ventilation membrane 472 Tip 473 Inner peripheral surface (inner peripheral part)
48 Shrinkage (integral part)
481 Outer peripheral surface (outer peripheral part)
49 Jetting Port Formation Member 491 Jetting Port 492 Tapered Portion 492a Outer Peripheral Surface 493 Outer Diameter Constant Portion 494 Base End Surface 7 Applicator Main Body 71 Syringe Holding Portion 711 Fitting Portion 712 Inserting Portion 713 Connection Portion 714 Groove 715 Connection Portion 72 Flange Connection Portion 721 Groove 10 Adhesive 11 Sheath (outer tube)
113 Tip opening 114 Edge 115 Flange (projection)
116 Base end opening 117 Side hole 118 Inner peripheral surface 15 Gap 16 Spacer (elastic body)
20 Nozzle manufacturing jig
201 Jig body 202 Base end face 203 First insertion portion (first mandrel)
204 Second insert (second mandrel)
205, 206 End surface 207, 208 Outer peripheral surface 209 Gap 300a, 300b Gas cylinder (gas supply means)
302a, 302b Tube 40 Trocar tube 401 Main body (tubular body)
402 Hub 403 Tip opening 404 Gas supply port 405 Base opening 406 Duckbill valve (valve)
500 abdominal cavity 501 abdominal wall 60 heat shrinkable tube 601 distal end 602 proximal end 70 heater 80 adhesive 90 adhesive applicator G1, G2 gas (sterile gas)
G3 gas (gas)
L1 first liquid (second fluid)
L2 second liquid (second fluid)
h Gap distance (gap length)
θ Inclination angle

Claims (14)

A base end portion is connected to a first tube, a second tube arranged in parallel with the first tube, a distal end portion of the first tube and the second tube, and a fluid is supplied to the distal end portion. A method of manufacturing a nozzle comprising a third tube having a portion to be ejected,
A long jig body and a rod-like shape that protrudes from the end of the jig body, has an outer diameter smaller than the inner diameter of the first tube, and can be inserted into the first tube. An insertion portion and an end portion of the jig main body are formed so as to protrude in parallel with the first insertion portion, have a rod shape whose outer diameter is smaller than the inner diameter of the second tube, and are inserted into the second tube. A nozzle manufacturing jig provided with a possible second insertion portion, and inserting the first insertion portion of the nozzle manufacturing jig into the distal end portion of the first tube, and the second A jig mounting step in which the insertion portion is inserted into the distal end portion of the second tube;
In the inserted state, the distal end portion of the first tube and the distal end portion of the second tube are heated so that the inner diameter of the lumen of the distal end portion of the first tube is outside the first insertion portion. The distal ends of the second tube are integrated with each other while maintaining the inner diameter of the lumen of the distal end portion of the second tube to be equal to the outer diameter of the second insertion portion. An integrated part forming step for forming an integrated part,
A jig removing step of removing the first insertion portion and the second insertion portion from the integrated portion in the inserted state;
A method of manufacturing a nozzle, comprising: a tube connecting step of connecting a base end portion of the third tube and the integrated portion.   In the integral portion forming step, the distal end portion of the first tube and the distal end portion of the second tube in the inserted state are collectively covered with a heat shrinkable tube having heat shrinkability, and the heat The method for producing a nozzle according to claim 1, wherein the entire shrinkable tube is heated. The heat shrinkable tube has a length shorter than the length of the first insertion portion and the second insertion portion,
3. The method of manufacturing a nozzle according to claim 2, wherein, in the integral part forming step, the heat-shrinkable tube is disposed in the middle of the first insertion part and the second insertion part in the longitudinal direction.   The method for manufacturing a nozzle according to claim 2, further comprising a tube removing step for removing the heat shrinkable tube between the integral part forming step and the jig removing step.   The nozzle manufacturing method according to claim 2, wherein the heat shrinkable tube, the first tube, and the second tube are made of different resin materials.   The method for manufacturing a nozzle according to claim 5, wherein the heat-shrinkable tube is made of a silicone-based resin, and each of the first tube and the second tube is made of a urethane-based resin.   The nozzle manufacturing method according to claim 1, wherein the integral part has a circular cross-sectional shape.   The nozzle manufacturing method according to claim 7, wherein an outer diameter of the integrated portion is smaller than a sum of an outer diameter of the first tube and an outer diameter of the second tube before the heating.   The nozzle manufacturing method according to claim 1, wherein the first insertion portion and the second insertion portion are different from each other in at least one of an outer diameter and a length.   The nozzle manufacturing method according to any one of claims 1 to 9, wherein each of the first insertion portion and the second insertion portion has a rounded tip.   In the tube connecting step, when the integrated portion is inserted into the proximal end portion of the third tube, an adhesive is bonded between the outer peripheral portion of the integral portion and the inner peripheral portion of the proximal end portion of the third tube. The method for manufacturing a nozzle according to any one of claims 1 to 10, wherein an agent is applied, and the integrated portion and the base end portion of the third tube are bonded via the adhesive. The nozzle is provided at a distal end portion of the third tube, and includes a jet forming member having a cylindrical shape that forms a fluid jet from which the fluid that has passed through the third tube is jetted,
The manufacturing method of the nozzle in any one of Claim 1 thru | or 11 which has a spout mounting process which inserts and mounts | wears with the said spout formation member in the said 3rd tube.   13. In the jet nozzle mounting step, when the jet nozzle forming member is inserted into the third tube, the tip of the jet nozzle forming member is in a protruding state protruding from the tip surface of the third tube. The manufacturing method of the nozzle as described in 2 ..   14. The jet port forming member is bonded to the tube by using an outer peripheral surface of the protruding distal end portion as an adhesive margin for bonding the distal end surface of the third tube via an adhesive. The manufacturing method of the nozzle of description.

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