WO2014122759A1

WO2014122759A1 - Balloon catheter priming method

Info

Publication number: WO2014122759A1
Application number: PCT/JP2013/052924
Authority: WO
Inventors: 重義長尾; 達也川瀬
Original assignee: テルモ・クリニカルサプライ株式会社
Priority date: 2013-02-07
Filing date: 2013-02-07
Publication date: 2014-08-14

Abstract

This balloon catheter priming method is for a balloon catheter which is provided with a balloon which by means of an injected liquid can be inflated to a shape going beyond that obtainable by plastic deformation, and with a balloon lumen (12) communicating with the inside of the balloon, and which does not have an air discharge mechanism. This priming method involves a pressure reduction step for reducing the pressure inside of the balloon lumen (12), a balloon inflating step for injecting a priming liquid into the pressure-reduced balloon lumen (12) until the inflating part (41) of the balloon (4) goes beyond the shape obtainable by plastic deformation to reach a state of inflation resulting from elastic deformation, and an air discharge step for holding the balloon catheter (1) such that the balloon (4) is down and moving the air inside of the balloon (4) and the balloon lumen (12) upwards for discharge from the balloon catheter.

Description

Priming method for balloon catheter

The present invention relates to a priming method for a balloon catheter that is inserted into a small body cavity such as a blood vessel or a bile duct.

The balloon catheter is used for angiography, injection of a chemical solution such as a chemotherapeutic agent, embolization, percutaneous coronary artery dilatation (PTCA), percutaneous arterial dilatation (PTA) and the like.
As a balloon catheter, there is JP-A-2005-103120 proposed by the applicant of the present application.
The balloon catheter is used after priming the inside of the balloon and inside the balloon lumen with a contrast medium-containing liquid (internal air is replaced with liquid) before use.
The balloon catheter 1 of Patent Document 1 includes a double-tube catheter main body 3 including an inner tube 9 and an outer tube 21. A balloon 7 is attached to the distal end portion of the catheter body, and an infusate passage 23 formed between the inner tube and the outer tube is communicated with the balloon 7 through the distal end opening 22 of the outer tube. A purge hole 24 is formed in the outer tube, and the purge hole cover 33 closes it. When purging the internal air, the purge hole cover is elastically displaced outward in the radial direction of the catheter and exhausted, but the reverse flow is blocked.

JP-A-2005-103120

Since the balloon catheter of Patent Document 1 includes the purge hole as described above, priming can be performed reliably and easily.
However, recently, insertion into thinner and curved blood vessels has been required. For this reason, the balloon catheter is required to have a small diameter, and it has been difficult to provide the purge hole as described above in such a thin catheter. In some balloon catheter applications, an inflated balloon is required to press a body cavity wall (blood vessel wall) with a certain amount of force. In such a type of balloon catheter, the purge hole may not be provided.

Accordingly, an object of the present invention is to have a pre-formed bulge portion, the bulge portion having a balloon that can be inflated by the liquid to be injected, and an air discharge mechanism communicating with the inside of the balloon. A balloon catheter priming method capable of reliably priming the inside of a balloon and a balloon lumen is provided.

What achieves the above object is as follows.
A balloon having a bulging portion formed by plastic deformation, the bulging portion being inflatable beyond a form formed by plastic deformation by an injected liquid, and a balloon communicating with the inside of the balloon; A balloon catheter priming method that includes a lumen and does not have an air discharge mechanism communicating with the balloon lumen, the priming method comprising: a decompression step of decompressing the inside of the balloon lumen; and the bulging of the balloon A balloon inflating step of injecting the priming liquid into the balloon lumen that has been decompressed until the portion exceeds the formation form formed by plastic deformation and is inflated by elastic deformation, and the balloon into which the priming liquid has been injected Hold the catheter so that the balloon is at the bottom, and within the balloon and balloon By migrating the air in the lumen above, priming method of a balloon catheter to perform an air discharge step of discharging from said balloon catheter.

Moreover, what achieves the said objective is as follows.
The balloon has a bulging portion formed in advance, and the bulging portion includes a balloon that is inflatable by the liquid to be injected, and a balloon lumen that communicates with the inside of the balloon, and communicates with the balloon lumen. A priming method for a balloon catheter that does not have an air discharge mechanism, the priming method including a decompression step for decompressing the inside of the balloon lumen, and a balloon material that exceeds a formation form in which the bulging portion of the balloon is formed in advance. A balloon inflating step of injecting the priming liquid into the balloon lumen that has been decompressed until it reaches an inflated state exceeding 70% of its breaking elongation, and the balloon catheter into which the priming liquid has been injected comprises the balloon In the balloon and the lumen of the balloon The air is shifted upward, the priming method of a balloon catheter to perform an air discharge step of discharging from said balloon catheter.

FIG. 1 is a partially omitted external view of an example of a balloon catheter to which the balloon catheter priming method of the present invention is applied. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the balloon catheter shown in FIG. 1 when the balloon is inflated. FIG. 3 is an enlarged longitudinal sectional view of a rear end portion of the balloon catheter shown in FIG. FIG. 4 is an explanatory diagram for explaining a balloon catheter priming method according to the first embodiment of the present invention. FIG. 5 is an explanatory diagram for explaining a balloon catheter priming method according to the first embodiment of the present invention. FIG. 6 is an explanatory diagram for explaining a balloon catheter priming method according to the first embodiment of the present invention. FIG. 7 is an explanatory diagram for explaining a balloon catheter priming method according to the first embodiment of the present invention. FIG. 8 is an explanatory diagram for explaining a balloon catheter priming method according to the first embodiment of the present invention. FIG. 9 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention. FIG. 10 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention. FIG. 11 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention. FIG. 12 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention. FIG. 13 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention. FIG. 14 is an explanatory diagram for explaining a balloon catheter priming method according to a second embodiment of the present invention.

The balloon catheter priming method of the present invention will be described with reference to the drawings.
The balloon catheter priming method of the present invention includes a bulging portion 41 formed by plastic deformation, and the bulging portion 41 is inflatable beyond the form formed by plastic deformation by an injected liquid. This is a balloon catheter priming method that includes a balloon 4 and a balloon lumen 12 that communicates with the inside of the balloon and that does not have an air discharge mechanism that communicates with the balloon lumen 12.
Then, the priming method of the present invention exceeds the depressurization step of depressurizing the inside of the balloon 4 and the balloon lumen 12 and the form in which the bulging portion 41 of the balloon 4 is formed by plastic deformation, until it is in an expanded state by elastic deformation. The balloon inflation step of injecting the priming liquid into the decompressed balloon lumen 12 and the balloon catheter 1 into which the priming liquid has been injected are held so that the balloon 4 faces downward, and inside the balloon 4 and the balloon lumen 12 The air is discharged upward from the balloon catheter and the air is discharged from the balloon catheter.
In addition, the balloon catheter priming method of the present invention has a bulging portion 41 formed in advance, and the bulging portion 41 is inflatable by the injected liquid, and a balloon communicating with the inside of the balloon. The balloon catheter priming method includes a lumen 12 and does not have an air discharge mechanism communicating with the balloon lumen 12.
In the priming method of the present invention, the depressurizing step of depressurizing the inside of the balloon 4 and the balloon lumen 12, and the bulging portion 41 of the balloon 4 is in an inflated state exceeding 70% of the breaking elongation of the balloon material. Until the balloon 4 is inflated, and the balloon catheter 1 into which the priming liquid has been injected is held so that the balloon 4 faces downward. The inside air is moved upward, and the air discharging step of discharging from the balloon catheter 1 is performed.

Examples of balloon catheters to which the balloon catheter priming method of the present invention can be applied include those having a structure as shown in FIGS.
This balloon catheter 1 is provided coaxially with the inner tube 3 having a main lumen 11 (guide wire lumen), and has a distal end at a position retracted by a predetermined length from the distal end of the inner tube 3. The outer tube 2 that forms the balloon lumen 12 between the outer tube 3 and the distal end 42 is fixed to the inner tube 3, the rear end 44 is fixed to the outer tube 2, and the inside communicates with the balloon lumen 12. Possible balloon 4.
The illustrated balloon catheter 1 has a double tube structure (coaxial structure) having an inner tube and an outer tube, and a balloon lumen is formed between the outer tube and the inner tube. However, the priming method of the present invention is not limited to such a type of balloon catheter, and can also be applied to a type having a main lumen and a balloon lumen in one catheter shaft.

The balloon catheter 1 of this embodiment is formed by an outer tube 2, an inner tube 3, a balloon 4 and a branch hub 5.
The inner tube 3 is a tube body having a main lumen 11 having an open end. The main lumen 11 is used for insertion of a guide wire, injection of a chemical solution, and the like. In the balloon catheter 1 of this embodiment, the main lumen 11 of the inner tube 3 communicates with the first opening 54 provided in the branch hub 5. The inner tube 3 is inserted into the outer tube 2, and the tip of the inner tube 3 protrudes from the outer tube 2. A second lumen (balloon inflation lumen) 12 is formed between the outer surface of the inner tube 3 and the inner surface of the outer tube 2 and has a sufficient volume.

In the inner tube 3, a contrast marker 32 is fixed at the distal end (slightly rearward from the distal end 31, near the distal end 42 of the balloon 4). The contrast marker is made of a radiopaque material (for example, gold, platinum, tungsten, or an alloy thereof, silver-palladium alloy, platinum-iridium alloy, or the like). The inner tube 3 is provided with a rigidity imparting body 35.
The outer tube 2 is a tube body that is inserted in the inner tube 3 and located at a portion (a predetermined length rear end side) whose tip is retracted by a predetermined length from the tip of the inner tube 3. The balloon lumen 12 communicates with the inside of a bulging portion 41 of the balloon 4 to be described later, and the rear end of the balloon lumen 12 is provided on the branch hub 5 and is a fluid for inflating the balloon (for example, for balloon inflation). It communicates with the second opening 55 of the branch pipe 53 for injecting a liquid, specifically an angiographic agent.

The material for forming the outer tube 2 and the inner tube 3 is preferably a material having a certain degree of hardness and a certain degree of flexibility. For example, polyolefins such as polyethylene and polypropylene, polyamides such as polyamide and polyethylene terephthalate, PTFE, Fluorine polymers such as ETFE, PEEK (polyetheretherketone), polyimide, olefin elastomer (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomer, styrene elastomer (eg, styrene-butadiene-styrene copolymer, styrene) -Isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane elastomer, fluororesin elastomer Which synthetic resin elastomers, urethane rubber, silicone rubber, synthetic rubbers such as butadiene rubber, a rubber such as natural rubber, such as latex rubber is used.

The balloon 4 of the balloon catheter to which the priming method of the present invention is applied includes a bulging portion 41 formed by plastic deformation, and the bulging portion 41 has a forming form formed by plastic deformation by a liquid to be injected. It can be expanded beyond. The balloon 4 includes a front end side cylindrical portion 42 extending in the front end direction from the front end of the bulging portion 41 and a rear end side cylindrical portion 43 extending in the rear end direction from the rear end of the bulging portion 41. Further, the balloon 4 includes a rear end side tapered portion that is located on the rear end side of the bulging portion 41 (in other words, constituted by the rear end portion of the bulging portion 41). The rear end side tapered portion is a thickness changing portion that gradually becomes thicker toward the rear end side tubular portion 43. Further, the balloon 4 includes a distal end side tapered portion that is located on the distal end side of the bulging portion 41 (in other words, constituted by the distal end portion of the bulging portion 41). The tip side taper portion is a thickness changing portion that gradually becomes thicker toward the tip side tubular portion 42. And the front end side part of the front end side taper part and the rear end side part of the rear end side taper part are substantially unexpandable.

Further, in the balloon 4 of this embodiment, the bulging portion 41 has a shape-formed form formed by plastic deformation, and can be expanded by elastic deformation. Moreover, the front end side cylindrical part 42 is smaller in diameter and thicker than the bulging part 41, and is substantially unexpandable. The rear end side tubular portion 43 is formed on the rear end side of the bulging portion 41, is smaller in diameter and thicker than the bulging portion 41, and is substantially unexpandable. The bulging portion 41 can be expanded (expanded) by elastic deformation by applying an internal pressure, and is restored to the shape before elastic deformation by releasing the internal pressure load. That is, the bulging part 41 of the balloon 4 is inflated by the injected liquid and can be brought into close contact with the inner wall of the blood vessel. Specifically, the bulging portion 41 can be restored to a molded form by the injection of a balloon inflation liquid and further expanded (expanded). For this reason, it adheres firmly to the inner wall of the blood vessel and does not damage the inner wall. In particular, in this embodiment, the bulging portion 41 is formed by stretching under a temperature condition not lower than the glass transition point and lower than the softening point. And until it is plastically deformed (molded form), it expands without resistance, and the subsequent expansion expands (extends) by elastic deformation according to the pressure of the inflating balloon inflating liquid. Restores the form before expansion by elastic deformation.
Note that the balloon catheter to which the priming method of the present invention is applied is limited to a balloon having a shaped form formed by plastic deformation as described above and capable of being expanded by elastic deformation. Is not to be done. As long as the balloon 4 has a pre-formed bulging portion, the balloon 4 may be elastically deformed from the beginning of the expansion, and further, the elastic deformation may be continued until breakage.

As the material for forming the balloon 4, a thermoplastic synthetic resin having elasticity is used. Specifically, for example, polyurethane and urethane elastomer, olefin elastomer (for example, polyethylene elastomer, polypropylene elastomer), polyester such as polyethylene terephthalate, soft polyvinyl chloride, polyamide and amide elastomer (for example, polyamide elastomer), fluorine Synthetic resin elastomers such as resin elastomers and ethylene-vinyl acetate copolymers are preferred. In particular, polyurethane-based thermoplastic elastomers (for example, aromatic polyurethane-based thermoplastic elastomers, aliphatic polyurethane-based thermoplastic elastomers, etc. are preferred. Examples of polyurethane-based thermoplastic elastomers include aromatic and aliphatic thermoplastic elastomer polyurethanes. It is done.

Furthermore, the material for forming the balloon 4 preferably has a glass transition point of 0 ° C. or lower, particularly preferably −10 ° C. or lower. The softening point (Vicat softening point) is preferably 70 ° C. or higher, and particularly preferably from 80 ° C. to 130 ° C. The balloon 4 has higher flexibility and flexibility than the outer tube 4. In particular, the balloon 4 is preferably more flexible and flexible than the inner tube 3 and the outer tube 4.

The balloon catheter includes an inclined annular fixing portion 6 that joins the rear end portion 44 of the balloon 4 and the tip portion of the outer tube 2. The distal end portion of the outer tube 2 includes an inclined distal end surface 21 that is inclined with respect to the central axis of the outer tube 2, and the balloon 4 is inclined at the rear end portion 44 with respect to the central axis of the tubular portion 43. A rear end face 45 is provided. And the front-end | tip part of the outer tube | pipe 2 and the rear-end part 44 of the balloon 4 have a part which overlaps with the axial direction of a balloon catheter. Further, a belt-shaped inclined annular fixing portion 6 provided at an overlapping portion of the distal end portion of the outer tube 2 and the rear end portion 44 of the balloon 4 and inclined with respect to the central axis of the outer tube 2 and formed airtight. I have. The outer tube 2 and the balloon 4 are fixed by the inclined annular fixing portion 6. Since the cylindrical portion 43 and the rear end portion 44 of the balloon 4 are more flexible and flexible than the distal end portion of the outer tube 2, the inclined annular fixing portion 6 is formed from the rear end side to the distal end side. Flexibility toward the side increases. Therefore, a sharp property change point in the vicinity of the distal end portion of the outer tube 2 is not formed, and the occurrence of kinks is prevented and good deformability is provided.

As shown in FIG. 3, the branch hub 5 has a first opening 54 communicating with the main lumen 11, and communicates with the inner tube hub 52 fixed to the rear end portion of the inner tube 3 and the balloon lumen 12. And an outer tube hub 51 fixed to the rear end of the outer tube 2. The outer tube hub 51 and the inner tube hub 52 are fixed to each other. Yes. The outer tube hub 51 and the inner tube hub 52 are fixed by inserting and joining the inner tube 3 from the front end of the outer tube hub 51 attached to the rear end portion of the outer tube 2. Further, the branch hub 5 is provided with a bending prevention tube 56 that encloses the rear end portion of the outer tube 2 and the front end portion of the branch hub 5. The branch pipe 53 is formed by a branch portion 53a extending from the side wall of the outer tube hub 51, a branch hub 53b, and a connection tube 53c that connects the branch portion 53a and the branch hub 53b. As a material for forming the branch pipe, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used. As the connection tube, a flexible or soft synthetic resin tube is used.

The balloon catheter to which the priming method of the present invention is applied is not limited to the structure described above, and a guide wire is provided in the middle portion of the balloon catheter (the rear end side from the inclined annular fixing portion 6). It may have a guide wire insertion port communicating with the lumen.
The balloon catheter of the present invention is preferably applied to a catheter for drug administration with a vascular occlusion function, but is not limited thereto, and can be applied to a PTCA catheter, a balloon inflatable stent delivery system, and the like. it can.

In the priming method of the present invention, the decompression step of decompressing the inside of the balloon lumen 12 and the decompressed balloon lumen 12 until the bulging portion 41 of the balloon 4 is in an inflated state exceeding the formation form formed by plastic deformation. A balloon inflating step for injecting a priming liquid into the balloon, and holding the balloon catheter 1 into which the priming liquid has been injected so that the balloon 4 faces downward, and the air inside the balloon 4 and the balloon lumen 12 is moved upward. Thus, an air discharging process for discharging from the balloon catheter is performed.

Therefore, the priming method of the first embodiment will be described with reference to FIGS.
As shown in FIG. 4, the balloon lumen internal pressure reducing step is first performed at the base end of the balloon lumen (the second opening 55 formed in the branch pipe 53, in other words, the base end of the branch hub 53 b). A suction means attaching step is performed in which 70 is attached and the syringe 80 is attached to the three-way cock 70.
This suction means attaching step is preferably performed by attaching the tip of the syringe 80 with the three-way cock 70 attached to the branch pipe 53. This step may be performed by attaching the three-way cock 70 to the branch pipe 53 and then attaching the syringe 80 to the port of the three-way cock 70.

Subsequently, a suction process is performed in which the inside of the balloon lumen 12 is sucked using a syringe, and the inside of the balloon lumen 12 and the balloon 4 is in a negative pressure state. This is done by pulling the plunger 81 of the syringe 80 in the direction of the arrow in FIG. By this suction step, the bulging portion 41 of the balloon 4 is in close contact with the outer surface of the inner tube 2. Then, after the suction process, the three-way cock is operated to perform a three-way cock closing operation process for closing the balloon lumen 12. By this step, the balloon lumen 12 is closed and kept in a negative pressure state.
Subsequently, a balloon inflation process is performed. The balloon inflating step is performed by injecting the priming liquid into the decompressed balloon lumen 12 until the bulging portion 41 of the balloon 4 exceeds the form formed by plastic deformation and becomes inflated by elastic deformation. .
Specifically, in the balloon inflation step, first, the suction syringe 80 connected to the three-way cock is removed, and the priming liquid filling syringe 90 in which the priming liquid-filled syringe 90 filled with the priming liquid is attached to the three-way cock 70 A syringe mounting process is performed.

Subsequently, the cap 73 of the three-way stopcock 70 is removed after the mounting step of the priming liquid-filled syringe 90 and before the three-way stopcock communication operation (operation of the three-way stopcock for communicating the syringe 90 and the balloon lumen 12), and the syringe 90 is removed. It is preferable to perform a three-way cock priming step that operates to replace the air in the three-way cock 70 with a priming liquid. As shown in FIG. 5, the cock 72 of the three-way stopcock 70 is operated to bring the syringe 90 and the port 74 from which the cap has been removed into communication with each other, and then the plunger 91 is slightly pushed to remove the priming liquid. By injecting into the three-way cock, the air in the three-way cock is discharged from the port 74.
Then, as shown in FIG. 6, the cock 72 of the three-way cock 70 is operated (turned), and the inside of the priming liquid filling syringe 90 is communicated with the balloon lumen 12 in a negative pressure state, so that the priming liquid A negative pressure-based priming liquid injection step is performed in which the priming liquid in the filling syringe 90 flows into the balloon lumen. This step is automatically performed by operating (turning) the cock 72 of the three-way cock 70 to cause the priming liquid-filled syringe 90 and the balloon lumen 12 to communicate with each other.

Then, after the negative pressure-based priming liquid injection step, a forced priming liquid injection step is performed in which the plunger of the priming liquid-filled syringe 90 is pushed in the direction of the arrow to forcibly inject the priming liquid into the balloon lumen 12. In the forced priming liquid injection step, the amount of priming liquid exceeding the formation form in which the bulging portion 41 of the balloon 4 is formed by plastic deformation is injected. Specifically, it is preferable to inject the priming liquid until the bulging portion of the balloon 4 exceeds 70% of the rupture elongation of the balloon material. By doing so, there is no air bubble remaining on the inner surface of the balloon, and the inside of the balloon can be reliably primed.
Then, the balloon inflating step exceeds the form in which the balloon bulging portion 41 is formed by plastic deformation, the amount by which the bulging portion elastically deforms, and the amount by which the bulging portion does not undergo plastic deformation or the amount by which plastic deformation slightly occurs. It is preferable to inject the priming liquid.
Specifically, in the balloon inflating step, the priming liquid amount A1 until the bulging portion of the balloon is formed by plastic deformation, the amount at which the elastic deformation of the bulging portion is completed and the plastic deformation starts. The priming liquid injection amount X is preferably set so that X = A + 0.1 to 1.2 × (BA) with respect to the priming liquid amount B1. In particular, the priming liquid injection amount X is preferably X = A + 0.2 to 1.0 × (BA).
In addition, the forced priming liquid injection step in the balloon inflating step is preferably performed in an amount in which the bulging portion 41 of the balloon 4 exceeds the form of 70% with respect to the breaking elongation of the balloon material.
In other words, in the balloon inflation process, the amount of priming liquid A2 until the balloon bulge is formed in advance, and the amount of priming liquid that exceeds the allowable deformation area when the balloon bulge is inflated. It is preferable that the priming liquid injection amount X is set such that X = A + 0.1 to 1.0 × (BA) with respect to B2. In particular, it is preferable that the priming liquid injection amount X is X = A + 0.2 to 0.8 × (BA).

Subsequently, an air discharge process for discharging air in the balloon lumen is performed. As shown in FIG. 7, in the air discharging step, the cock 72 of the three-way cock 70 is operated so that the balloon lumen 12 is in a closed state, and the balloon 4 in which the three-way cock 70 is inflated and inflated is in the lower direction. The balloon catheter 1 is held in the air and the air in the balloon 4 and the balloon lumen 12 is moved upward. Then, the cock 72 of the three-way cock 70 is operated so that the balloon lumen 12 and the syringe 90 communicate with each other, and then the syringe 90 is operated (pulling the plunger 90 slightly), together with some priming liquid. This is done by sucking air into the syringe. The air discharging step may be performed by discharging from the port 74 of the three-way cock 70.
And after completion | finish of an air discharge process, the syringe 90 is operated, the priming liquid is attracted | sucked, and the balloon contraction process which deflates a balloon is performed. The balloon contraction step is performed by pulling the plunger 91 of the syringe 90 in the direction of the arrow in FIG. 8 and sucking the priming liquid in the balloon lumen 12 to the extent that the bulging portion 41 of the balloon 4 is contracted. Is called. Then, the priming operation is completed by operating the cock 72 of the three-way cock 70 to close the balloon lumen 12.

Next, a priming method according to the second embodiment will be described with reference to FIGS.
Also in the priming method of this embodiment, the decompression step of decompressing the inside of the balloon lumen 12, and the priming liquid is injected into the decompressed balloon lumen 12 in an amount exceeding the form in which the bulging portion 41 of the balloon 4 is formed in advance. The balloon inflating step with the priming liquid for inflating the balloon and the balloon catheter 1 into which the priming liquid has been injected are held so that the balloon 4 faces downward, and the air in the balloon 4 and the balloon lumen 12 is moved upward. The air discharge process which transfers and discharges from a balloon catheter is performed.

As shown in FIG. 9, the balloon lumen internal decompression step is performed by first attaching a three-way stopcock 70 to the base end of the balloon lumen (second opening 55 formed in the branch pipe 53), and attaching the three-way stopcock 70 to the three-way stopcock 70. A suction means mounting step is performed in which the suction syringe 80 and the priming liquid-filled syringe 90 are mounted.
This suction means attaching step is preferably carried out by attaching the suction syringe 80 and the priming liquid-filled syringe 90 attached to the three-way cock 70 to the branch tube 53 of the balloon catheter 1. This step may be performed by attaching the three-way stopcock 70 to the branch pipe 53 and then attaching the suction syringe 80 and the priming liquid-filled syringe 90 to the port of the three-way stopcock 70.

Subsequently, a suction process is performed in which the inside of the balloon lumen 12 is sucked using the suction syringe 80 to place the inside of the balloon lumen 12 and the balloon 4 in a negative pressure state. This is done by pulling the plunger 81 of the syringe 80 in the direction of the arrow in FIG. By this suction step, the bulging portion 41 of the balloon 4 is in close contact with the outer surface of the inner tube 2. Then, after the suction process, the three-way cock is operated to perform a three-way cock closing operation process for closing the balloon lumen 12. By this step, the balloon lumen 12 is closed and kept in a negative pressure state.
Subsequently, a balloon inflation process is performed. The balloon inflating step is performed by injecting the priming liquid into the decompressed balloon lumen 12 until the bulging portion 41 of the balloon 4 exceeds the form formed by plastic deformation and becomes inflated by elastic deformation. .

Specifically, in the balloon inflating step, first, before the three-way stopcock communication operation (the three-way stopcock operation for connecting the priming liquid-filled syringe 90 and the balloon lumen 12), as shown in FIG. The three-way cock priming step is performed in which the air in the three-way cock 70 is replaced with the priming liquid by communicating the priming liquid-filled syringe 90 and the suction syringe 80 in a negative pressure state. In this step, the cock 72 of the three-way cock 70 is positioned as shown in FIG. 10, and it is confirmed that the priming liquid in the priming liquid-filled syringe 90 has flowed into the port 74 of the three-way cock 70. ,finish.
Subsequently, as shown in FIG. 11, the cock 72 of the three-way cock 70 is operated (turned), and the inside of the priming liquid-filled syringe 90 is communicated with the balloon lumen 12 in a negative pressure state for priming. A negative pressure-based priming liquid injection step is performed in which the priming liquid in the liquid-filled syringe flows into the balloon lumen. This step is automatically performed by operating (turning) the cock 72 of the three-way cock 70 to cause the priming liquid-filled syringe 90 and the balloon lumen 12 to communicate with each other.

Then, after the negative pressure priming liquid injection step, as shown in FIG. 11, the plunger of the priming liquid filling syringe 90 is pushed in the direction of the arrow, and the priming liquid is forcibly injected into the balloon lumen 12. A liquid injection process is performed. In the forced priming liquid injection step, the priming liquid is injected in an amount exceeding the form in which the bulging portion 41 of the balloon 4 is formed in advance. By doing so, there is no air bubble remaining on the inner surface of the balloon, and the inside of the balloon can be reliably primed.
The forced priming liquid injection step in the balloon inflating step is such that the amount of the bulging portion 41 of the balloon 4 exceeds 70% of the breaking elongation of the balloon material, and the bulging portion 41 has an allowable deformation region. It is preferable to carry out by injecting an amount of priming liquid that does not exceed. Furthermore, in the balloon inflating step, the priming liquid amount A until the balloon bulge is formed in advance, and the priming liquid amount B exceeding the allowable deformation region when the balloon bulge is inflated. The priming liquid injection amount X is preferably such that X = A + 0.1 to 3.0 × (BA). In particular, the priming liquid injection amount X is preferably set so that X = A + 1.0 to 2.0 × (BA).

Subsequently, an air discharge process for discharging air in the balloon lumen is performed. In the air discharge process, as shown in FIG. 12, the cock 72 of the three-way stopcock 70 is operated to bring the balloon lumen 12 into a closed state. And as shown in FIG. 12, the balloon catheter 1 is hold | maintained so that the balloon 4 which the three-way cock 70 expanded and it expanded may become the downward direction, and the air in the balloon 4 and the balloon lumen 12 is moved upwards. Thereafter, as shown in FIG. 13, the cock 72 of the three-way cock 70 is operated, the balloon lumen 12 is communicated with the suction syringe 80, air is collected by the syringe 80, and discharged from the catheter. Note that the air discharging step may be recovered not to the suction syringe 80 but to the priming liquid-filled syringe 90. Further, the suction syringe 80 may be detached from the port 74 of the three-way cock 70 and air may be discharged from the port 74.

Then, after the air discharge process is completed, a balloon contraction process is performed in which the syringe is operated to suck the priming liquid and contract the balloon. In the balloon contraction step, the plunger 91 of the priming liquid-filled syringe 90 is pulled in the direction of the arrow in FIG. 14, and the priming liquid in the balloon lumen 12 is sucked to such an extent that the bulging portion 41 of the balloon 4 is contracted. Is done. The balloon contraction step may be performed by pulling the plunger 81 of the suction syringe 80 and sucking the priming liquid in the balloon lumen 12 to the extent that the bulging portion 41 of the balloon 4 is contracted. Good. Then, the priming operation is completed by operating the cock 72 of the three-way cock 70 to close the balloon lumen 12.

As the priming liquid used in the priming method of the present invention, it is preferable to use an X-ray contrast substance-containing liquid. As the X-ray contrast medium-containing liquid, a mixture of an angiographic contrast medium and physiological saline is preferably used. The mixing ratio of the two varies depending on the viscosity of the angiographic agent used, but the angiographic agent: saline is preferably 1: 1 to 3. The priming liquid preferably has a viscosity of 0.7 to 3.0 mPa · s.

The balloon catheter priming method of the present invention is as follows.
(1) a balloon having a bulging portion formed by plastic deformation, and the bulging portion is inflatable beyond a form formed by plastic deformation by an injected liquid; A balloon catheter priming method that includes a balloon lumen that communicates with the balloon lumen and does not have an air discharge mechanism that communicates with the balloon lumen, the priming method comprising: a decompression step of decompressing the inside of the balloon lumen; A balloon inflating step of injecting the priming liquid into the balloon lumen that has been decompressed until the bulging portion exceeds the formation form formed by plastic deformation and becomes inflated by elastic deformation, and the priming liquid is injected Holding the balloon catheter so that the balloon faces downward, and in the balloon and A balloon catheter priming method in which air in a balloon lumen is moved upward and is discharged from the balloon catheter.
The balloon catheter priming method of the present invention includes a pre-formed bulging portion, and the bulging portion includes a balloon that can be inflated by a liquid to be injected, and communicates with the inside of the balloon. For balloon catheters without In particular, the balloon catheter priming method of the present invention performs a balloon inflation process using a priming liquid that inflates the balloon by injecting a priming liquid into the balloon lumen in an amount exceeding the form in which the balloon bulge is formed. .
Thereby, the air on the inner surface of the balloon can be surely peeled and replaced with the priming liquid even though the purge hole is not provided. For this reason, when using a balloon catheter, there is no occurrence of poor visibility due to X-ray contrast due to bubbles remaining in the balloon and insufficient expansion of the balloon.

The priming method for the balloon catheter of the present invention is as follows.
(2) A balloon having a bulge portion formed in advance, the bulge portion being inflatable by an injected liquid, and a balloon lumen communicating with the inside of the balloon, and the balloon A priming method for a balloon catheter that does not have an air discharge mechanism communicating with a lumen. The priming method includes a decompression step for decompressing the inside of the balloon lumen, and a form in which the bulging portion of the balloon is formed in advance. A balloon inflating step of injecting a priming liquid into the balloon lumen that has been decompressed until the inflated state exceeds 70% of the breaking elongation of the exceeding balloon material, and a balloon catheter into which the priming liquid has been injected Holding the balloon so that the balloon is in the lower position. A balloon catheter priming method in which air inside the men is moved upward and an air discharging step of discharging from the balloon catheter is performed.
Even in the above-described method for priming a balloon catheter according to the present invention, the air on the inner surface of the balloon can be surely peeled and replaced with the priming liquid even though the purge hole is not provided. For this reason, when using a balloon catheter, there is no occurrence of poor visibility due to X-ray contrast due to bubbles remaining in the balloon and insufficient expansion of the balloon.

And the following may be sufficient as the embodiment of this invention.
(3) The decompression step includes a suction means attaching step in which a three-way stopcock is attached to a proximal end of the balloon lumen, and a syringe is attached to the three-way stopcock, and the inside of the balloon lumen using the syringe The above-mentioned (1) is a suction step for sucking and setting the inside of the balloon lumen to a negative pressure state, and a three-way stopcock closing step for operating the three-way stopcock after the suction step to close the balloon lumen. ) Or the balloon catheter priming method according to (2).
(4) The balloon inflating step includes a priming liquid-filled syringe mounting step of mounting a priming liquid-filled syringe filled with a priming liquid in a three-way cock, and the inside of the priming liquid-filled syringe by operating the three-way cock. A priming liquid injection step for allowing a priming liquid in the priming liquid-filled syringe to flow into the balloon lumen; and a negative pressure using priming After the liquid injection step, the priming liquid filling syringe is operated to perform a forced priming liquid injection step in which the bulging portion of the balloon injects an amount of priming liquid that exceeds the formation form. The balloon category according to any one of (1) to (3) above -The priming method.
(5) The balloon inflating step is a three-way operation in which the syringe is operated to replace the air in the three-way stopcock with the priming liquid after the priming liquid-filled syringe mounting step and before the three-way stopcock communication operation. The balloon catheter priming method according to (4), wherein the stopcock priming step is performed.
(6) In the air discharge step, the three-way stopcock moves the air in the balloon and the balloon lumen upward by holding the balloon catheter so that the three-way stopcock is upward and the inflated balloon is downward. The balloon catheter priming method according to any one of (3) to (5), wherein the balloon catheter is discharged from the port.
(7) The decompression step includes a suction means mounting step in which a three-way stopcock is attached to a proximal end of the balloon lumen, and a suction syringe and a priming liquid-filled syringe are attached to the three-way stopcock; A suction step for sucking the inside of the balloon lumen using the suction syringe and making the inside of the balloon lumen in a negative pressure state, and a three-way stopcock for operating the three-way stopcock and closing the balloon lumen after the suction step The balloon catheter priming method according to (1) or (2), wherein the occluding operation step is performed.
(8) In the balloon inflation step, the three-way stopcock is operated, and the inside of the priming liquid-filled syringe is communicated with the balloon lumen in a negative pressure state for priming in the priming liquid-filled syringe. After the negative pressure priming liquid injection step for flowing liquid into the balloon lumen and the negative pressure priming liquid injection step, the priming liquid-filled syringe is operated, and the bulging portion of the balloon is formed. The balloon catheter priming method according to the above (7), wherein the forced priming liquid injection step of injecting an amount of priming liquid exceeding the form is performed.
(9) The balloon inflation step communicates the priming liquid-filled syringe and the suction syringe in a negative pressure state by the three-way stopcock closing operation step or by further operating the three-way stopcock. The balloon catheter priming method according to the above (7) or (8), wherein a three-way stopcock priming step of replacing the air in the three-way stopcock with the priming liquid is performed.
(10) The air discharging step holds the balloon catheter so that the three-way cock is upward and the inflated balloon is downward, and moves the air in the balloon and the balloon lumen upward, and the syringe The balloon catheter priming method according to any one of the above (7) to (9), wherein the operation is performed by sucking the air in the balloon lumen together with the priming liquid.
(11) In the priming method, after the air discharging step, the syringe is operated to suck the priming liquid and deflate the balloon to perform the balloon deflating step (3) to (10). ) For priming a balloon catheter.
(12) In the priming method, after the air discharging step, the syringe is operated, the priming liquid is sucked, and the balloon contracting step of contracting the balloon is performed. 11) The balloon catheter priming method according to any one of 11).
(13) The balloon inflating step may exceed the form in which the bulging portion of the balloon is formed by plastic deformation, the amount by which the bulging portion elastically deforms, and the amount by which the bulging portion does not cause plastic deformation or The priming method for a balloon catheter according to any one of the above (1) to (12), wherein an amount of priming liquid that is slightly plastically deformed is injected.
(14) In the balloon inflating step, the priming liquid amount A1 until the bulging portion of the balloon is formed by plastic deformation, the elastic deformation of the bulging portion is completed, and plastic deformation starts. The above priming liquid injection amount X is performed so that the priming liquid injection amount X is X = A + 0.1 to 1.2 × (BA) with respect to the amount of priming liquid amount B1. A balloon catheter priming method according to any one of the above.
(15) In the balloon inflating step, the amount of priming liquid A1 until the bulging portion of the balloon is formed by plastic deformation, the elastic deformation of the bulging portion is completed, and plastic deformation starts. The above priming liquid injection amount X is performed so that the priming liquid injection amount X is X = A + 0.2 to 1.0 × (BA) with respect to the amount of priming liquid amount B1. A balloon catheter priming method according to any one of the above.
(16) In the balloon inflating step, the priming liquid amount A2 until the bulging portion of the balloon is formed in advance, and the priming liquid exceeding the allowable deformation region when the bulging portion of the balloon is inflated. Any of (1) to (13) above, wherein the priming liquid injection amount X is X = A + 0.1 to 1.0 × (BA) with respect to the amount B2. Priming method for balloon catheter.
(17) The balloon inflating step includes a priming liquid amount A2 until the bulging portion of the balloon is formed in advance, and a priming liquid in which the bulging portion of the balloon expands and exceeds an allowable deformation region. Any of (1) to (13) above, wherein the priming liquid injection amount X is X = A + 0.2 to 0.8 × (BA) with respect to the amount B2. Priming method for balloon catheter.
(18) The balloon catheter priming method according to any one of (1) to (17), wherein an X-ray contrast medium-containing liquid is used as the priming liquid.

Claims

A balloon having a bulging portion formed by plastic deformation, the bulging portion being inflatable beyond a form formed by plastic deformation by an injected liquid, and a balloon communicating with the inside of the balloon; A balloon catheter priming method having a lumen and not having an air discharge mechanism communicating with the balloon lumen,
The priming method includes a decompression step for decompressing the inside of the balloon lumen, and the decompressed balloon lumen until the bulging portion of the balloon is in an inflated state due to elastic deformation beyond a form formed by plastic deformation. A balloon expansion step for injecting a priming liquid into the interior;
An air discharge step is performed in which the balloon catheter into which the priming liquid has been injected is held so that the balloon is positioned downward, and the air in the balloon and the balloon lumen is moved upward to discharge from the balloon catheter. A balloon catheter priming method.
The balloon has a bulging portion formed in advance, and the bulging portion includes a balloon that is inflatable by the liquid to be injected, and a balloon lumen that communicates with the inside of the balloon, and communicates with the balloon lumen. A balloon catheter priming method that does not have an air discharge mechanism,
The priming method is a decompression step for decompressing the inside of the balloon lumen, and an expanded state in which the bulging portion of the balloon exceeds a pre-formed form and exceeds 70% of the rupture elongation of the balloon material. Until the balloon inflation step of injecting a priming liquid into the decompressed balloon lumen;
An air discharge step is performed in which the balloon catheter into which the priming liquid has been injected is held so that the balloon is positioned downward, and the air in the balloon and the balloon lumen is moved upward to discharge from the balloon catheter. A balloon catheter priming method.
The decompression step includes a suction means mounting step in which a three-way stopcock is attached to the proximal end of the balloon lumen, and a syringe is attached to the three-way stopcock, and the inside of the balloon lumen is aspirated using the syringe, The suction process for making the inside of the balloon lumen a negative pressure state, and the three-way cock closing operation step for operating the three-way cock after the suction process and closing the balloon lumen are performed. The balloon catheter priming method described.
The balloon inflating step includes a priming liquid-filled syringe mounting step for mounting a priming liquid-filled syringe filled with a priming liquid in a three-way cock, and a negative pressure inside the priming liquid-filled syringe by operating the three-way cock. A negative pressure-based priming liquid injection step for allowing the priming liquid in the priming liquid-filled syringe to flow into the balloon lumen in communication with the balloon lumen in a state; and the negative pressure-based priming liquid injection The forced priming liquid injection step of operating the priming liquid-filled syringe after the step and injecting an amount of the priming liquid in which the bulging portion of the balloon exceeds the formation form. Or a balloon catheter plastic according to any one of claims 1 to 3. Timing method.
The balloon inflation step is a three-way stopcock priming step in which the syringe is operated to replace the air in the three-way stopcock with the priming liquid after the priming liquid-filled syringe mounting step and before the three-way stopcock communication operation The method for priming a balloon catheter according to claim 4.
The air discharging step holds the balloon catheter so that the three-way stopcock is above and the inflated balloon is below, and moves the air in the balloon and the balloon lumen upward, from the port of the three-way stopcock 6. The balloon catheter priming method according to claim 3, wherein the balloon catheter is discharged.
The decompression step includes a suction means mounting step in which a three-way stopcock is attached to a proximal end of the balloon lumen, and a suction syringe and a priming liquid-filled syringe are attached to the three-way stopcock; A suction step for sucking the inside of the balloon lumen using a syringe and setting the inside of the balloon lumen to a negative pressure state, and a three-way stopcock closing step for operating the three-way stopcock and closing the balloon lumen after the suction step The method for priming a balloon catheter according to claim 1 or 2.
In the balloon inflation step, the three-way cock is operated to communicate the inside of the priming liquid-filled syringe with the balloon lumen in a negative pressure state, and the priming liquid in the priming liquid-filled syringe is After the negative pressure-based priming liquid injection step for flowing into the balloon lumen and the negative pressure-based priming liquid injection step, the priming liquid-filled syringe is operated, and the bulging portion of the balloon exceeds the formation form The method for priming a balloon catheter according to claim 7, wherein a forced priming liquid injection step of injecting an amount of the priming liquid is performed.
In the balloon inflation step, the priming liquid-filled syringe and the suction syringe in a negative pressure state are communicated by the three-way stopcock closing operation step or by further operating the three-way stopcock, The priming method for a balloon catheter according to claim 7 or 8, wherein a three-way cock priming step of replacing air in the three-way cock with the priming liquid is performed.
The air discharging step holds the balloon catheter so that the three-way cock is upward and the inflated balloon is downward, moves air in the balloon and the balloon lumen upward, and operates the syringe. The balloon catheter priming method according to claim 7, wherein the balloon lumen is evacuated together with a priming liquid.
The said priming method performs the balloon contraction process of operating the said syringe after the said air discharge | emission process, aspirating the said priming liquid, and contracting the said balloon. Priming method for balloon catheter.
The said priming method performs the balloon contraction process of operating the said syringe after the said air discharge | emission process, aspirating the said priming liquid, and contracting the said balloon. The balloon catheter priming method described.
The balloon inflating step exceeds the form in which the bulging portion of the balloon is formed by plastic deformation, the amount by which the bulging portion elastically deforms, and the amount by which the bulging portion does not cause plastic deformation or slightly plastic deformation The priming method for a balloon catheter according to any one of claims 1 to 12, wherein an amount of priming liquid to be injected is injected.
In the balloon inflating step, a priming liquid amount A1 until the bulging portion of the balloon is formed by plastic deformation, and an amount of priming at which the elastic deformation of the bulging portion is completed and plastic deformation starts. The priming liquid injection amount X is performed so that the priming liquid injection amount X is X = A + 0.1 to 1.2 × (BA) with respect to the liquid amount B1. A balloon catheter priming method.
In the balloon inflating step, a priming liquid amount A1 until the bulging portion of the balloon is formed by plastic deformation, and an amount of priming at which the elastic deformation of the bulging portion is completed and plastic deformation starts. 14. The priming liquid injection amount X is performed so that the priming liquid injection amount X is X = A + 0.2 to 1.0 × (BA) with respect to the liquid amount B1. A balloon catheter priming method.
In the balloon inflating step, a priming liquid amount A2 until the bulging portion of the balloon is formed in advance, and a priming liquid amount B2 in which the bulging portion of the balloon inflates and exceeds an allowable deformation region. 14. The balloon catheter priming method according to claim 1, wherein the priming liquid injection amount X is X = A + 0.1 to 1.0 × (BA). .
In the balloon inflating step, a priming liquid amount A2 until the bulging portion of the balloon is formed in advance, and a priming liquid amount B2 in which the bulging portion of the balloon inflates and exceeds an allowable deformation region. 14. The balloon catheter priming method according to claim 1, wherein the priming liquid injection amount X is X = A + 0.2 to 0.8 × (BA). .
The priming method for a balloon catheter according to any one of claims 1 to 17, wherein an X-ray contrast medium-containing liquid is used as the priming liquid.