JP2020110437A - Catheter production method and catheter - Google Patents

Abstract

To provide a method of producing a catheter which prevents a conductor wire from being intertangled when a plurality of conductor wires are inserted into a lumen of a shaft and facilitates a conductor wire insertion step, and a catheter which prevents a conductor wire from being intertangled.SOLUTION: A method of producing a catheter comprises the steps of: bending a shaft 10 having a distal side, a proximal side, and a lumen, and having a first hole 21 and a second hole 22 through which the lumen and the outside are in communication; inserting a first conductor wire 31 into a lumen of the shaft 10 from the first hole 21 to expose the first conductor wire 31 from a proximal end 10b of the shaft 10; after the bending step, bringing the first conductor wire 31 close to an inner side of bending of the shaft 10; and inserting a second conductor wire 32 into a lumen of the shaft 10 from the second hole 22 to expose the second conductor wire 32 from the proximal end 10b of the shaft 10. The step of inserting the second conductor wire 32 is performed later than the step of bringing the first conductor wire 31 close to the inner side of bending of the shaft 10.SELECTED DRAWING: Figure 5

Description

The present invention relates to a method of manufacturing a catheter having a conductive wire in a lumen of a shaft, and a catheter having a conductive wire in a lumen of a shaft.

In examinations and treatments, a catheter having an electrode connected to a conducting wire may be used. Specifically, at the time of examination of arrhythmia such as atrial fibrillation, a catheter having an electrode is inserted into a heart chamber, and an intracardiac potential is measured to identify an abnormal part of the heart causing the arrhythmia. During treatment of arrhythmia, a high-frequency current is passed from the electrode of the catheter to the myocardium causing the arrhythmia, and the source of the arrhythmia is cauterized to electrically separate it from the heart (ablation operation). Also, if atrial fibrillation spontaneously occurs during these examinations or treatments, or if atrial fibrillation occurs to identify abnormal parts of the heart, electrical stimulation is applied to the heart from the electrodes of the catheter. Give and defibrillate. In addition to the electrodes, a catheter in which a sensor such as a temperature sensor or a pressure sensor is connected to the conductive wire may be used.

For example, Patent Documents 1 to 4 disclose catheters that have electrodes and sensors and that have lead wires in the lumen of a shaft.

JP2012-176163A JP, 2012-34852, A JP, 2017-140426, A JP 2012-192005 A

In general, a plurality of conducting wires are arranged in the lumen of the shaft of a catheter having electrodes, depending on the electrodes. In order to manufacture such a catheter, the wires are inserted one by one into the lumen of the shaft. When inserting another conductor into the inner lumen of the shaft where the conductor is arranged, the other conductor cannot be advanced due to being caught by the conductor arranged in the inner lumen of the shaft. It is difficult to insert the catheter into the lumen of the shaft, and the production efficiency of the catheter is poor.

In addition, it is preferable to reduce the outer diameter of the shaft in order to enhance the ability to be inserted into the lumen of a living body such as a blood vessel and improve the minimally invasive treatment. Reducing the outer diameter of the shaft also reduces the inner lumen of the shaft. In such a shaft, it is more difficult to sequentially insert a plurality of conducting wires into the lumen of the shaft. Therefore, there is a problem that it is difficult to reduce the diameter of the shaft because it is necessary to allow a certain amount of allowance in the inner cavity of the shaft.

The present invention has been made in view of the above circumstances, and an object thereof is a method for manufacturing a catheter in which the conductor wire is less likely to be entangled when a plurality of conductor wires are inserted into the lumen of the shaft, and the conductor wire insertion step is easy to perform, and An object of the present invention is to provide a catheter in which the conducting wire is not easily entangled.

A first catheter manufacturing method capable of solving the above-mentioned problems is provided with a distal side, a proximal side, and an inner cavity, and includes a first hole and a second hole through which the inner cavity communicates with the outside. Bending the shaft having, a step of inserting the first conductive wire from the first hole into the lumen of the shaft to expose the first conductive wire from the proximal end of the shaft, and a step of bending after the first step. Moving the lead wire inside the bend of the shaft and inserting the second lead wire through the second hole into the lumen of the shaft to expose the second lead wire from the proximal end of the shaft. The step of inserting the second conductive wire is performed after the step of moving the first conductive wire to the inside of the curve of the shaft.

In the method for manufacturing a catheter of the present invention, it is preferable that after the second conductive wire is exposed from the proximal end of the shaft, the step of bringing the first conductive wire closer to the inside of the curve of the shaft is completed.

A second catheter manufacturing method capable of solving the above-mentioned problems is provided with a distal side, a proximal side, and a lumen, and a first hole and a second hole through which the lumen communicates with the outside. Bending the shaft having, a step of inserting the first conductive wire from the first hole into the lumen of the shaft to expose the first conductive wire from the proximal end of the shaft, and a step of bending after the first step. And pulling the second lead wire through the second hole into the lumen of the shaft to expose the second lead wire from the proximal end of the shaft. It is a thing.

In the method for manufacturing a catheter of the present invention, it is preferable that the step of pulling the first conductive wire be completed after exposing the second conductive wire from the proximal end of the shaft.

In the catheter manufacturing method of the present invention, it is preferable that, in the step of inserting the second conductive wire, the first conductive wire is arranged inside the curve of the shaft with respect to the central axis of the lumen of the shaft.

In the catheter manufacturing method of the present invention, it is preferable that the first hole is closer to the proximal side than the second hole.

In the method for manufacturing a catheter of the present invention, the shaft has a plurality of holes, and the lead wire is sequentially inserted into the lumen of the shaft through the hole on the most proximal side to expose the lead wire from the proximal end of the shaft. Is preferred.

In the method of manufacturing a catheter of the present invention, it is preferable that the first hole and the second hole are arranged inside the curve of the shaft in the bending step.

In the method for manufacturing a catheter of the present invention, the first conductive wire has an electrode or a sensor at a distal end portion of the first conductive wire, and the second conductive wire has an electrode or a sensor at a distal end portion of the second conductive wire. It is preferable to have a sensor.

In the catheter manufacturing method of the present invention, it is preferable that the electrode or the sensor has a ring shape.

The method for manufacturing a catheter of the present invention includes a step of disposing a conductive wire pulling member in the inner cavity of the shaft and a step of fixing the first conductive wire to the conductive wire pulling member before the step of inserting the first conductive wire. It is preferable.

In the method for manufacturing a catheter of the present invention, in the step of fixing the first conductive wire, the first conductive wire is inserted through the first hole into the lumen of the shaft, and the first conductive wire is exposed from the distal end of the shaft, It is preferable to fix the exposed first conductive wire to the conductive wire pulling member.

According to the method for manufacturing a catheter of the present invention, in the conducting wire traction member arranging step, the other end portion of the conducting wire pulling member opposite to the one end portion, which is a portion for fixing the first conducting wire, is provided from the shaft distal end to the shaft. It is preferable to insert it in the inner lumen.

In the catheter manufacturing method of the present invention, in the step of inserting the first conducting wire, when the portion of the conducting wire pulling member that fixes the first conducting wire passes through the portion where the first hole exists, the first conducting wire is provided. It is preferable to fold the part exposed from the first hole of the distal end side.

The catheter manufacturing method of the present invention has a tubular bending jig that bends the shaft, and in the bending step, the shaft is inserted into the inner cavity of the bending jig, and the outer surface of the shaft and the bending jig It is preferable to insert a shaft fixing tool between the inner surface and the inner surface.

In the method for manufacturing a catheter of the present invention, the bending jig has a lead wire fixing portion that holds the first lead wire, and in the step of inserting the second lead wire, the bending jig is exposed from the proximal end of the shaft. It is preferable to fix the first conductor to the conductor fixing portion.

In the method for manufacturing a catheter of the present invention, the distal end has a wire fixed to the distal end of the shaft, and the distal side of the shaft can be bent to one side by moving the wire in the axial direction. preferable.

A catheter capable of solving the above-mentioned problems is a shaft having a distal side, a proximal side, and an inner lumen, a hole through which the outside of the shaft communicates with the inner lumen of the shaft, and a hole inserted into the hole to The conductor wire having the conductor wire arranged in the lumen and the electrode connected to the conductor wire, and the conductor wire connected to the electrode on the side including the hole in the cross section orthogonal to the axial direction of the shaft, It is characterized in that 70% or more of the entire conductors connected to the electrodes are arranged.

According to the method for manufacturing a catheter of the present invention, even if the inner lumen of the shaft is small, the conductive wire inserted into the inner lumen of the shaft is unlikely to be entangled, and the catheter can be efficiently manufactured. Further, according to the catheter of the present invention, even if the catheter is bent, the conducting wire arranged in the lumen of the shaft is less likely to be entangled.

FIG. 6 shows a plan view of a shaft bending step in the embodiment of the present invention. The top view of the insertion process of the 1st conducting wire in embodiment of this invention is represented. FIG. 6A is a plan view of a step of bringing the first conductive wire toward the inside of the curvature of the shaft in the embodiment of the present invention. FIG. 4 is a sectional view taken along the axial direction of the shaft in the step shown in FIG. 3. The top view of the insertion process of the 2nd conducting wire in embodiment of this invention is represented. FIG. 5A is a plan view of a step of bringing the second conductive wire toward the inside of the curvature of the shaft in the embodiment of the present invention. FIG. 6 is a cross-sectional view showing a step of disposing a wire pulling member in the embodiment of the present invention. FIG. 5 is a cross-sectional view taken along the axial direction of the shaft in the step of inserting the first conductor wire according to the embodiment of the present invention. FIG. 3 is an enlarged plan view (partial cross-sectional view) on the proximal side of the bending jig for the shaft in the embodiment of the present invention. FIG. 3 is a schematic view of a cross-sectional view taken along the axial direction of the distal end portion of the catheter according to the embodiment of the present invention. FIG. 4 is a cross-sectional view of the distal end portion of the catheter according to the embodiment of the present invention, the cross-section being perpendicular to the axial direction. FIG. 6 is a plan view of a bending jig for a shaft according to another embodiment of the present invention.

Hereinafter, the present invention will be described in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and may be appropriately changed within a range compatible with the gist of the preceding and the following. In addition, it is of course possible to carry out, and all of them are included in the technical scope of the present invention. Note that, in each drawing, hatching, member reference numerals, and the like may be omitted for convenience, but in such a case, the specification and other drawings are referred to. Further, the dimensions of various members in the drawings may be different from the actual dimensions because priority is given to contributing to the understanding of the features of the present invention.

1 to 8 are views of respective steps of the method for manufacturing a catheter according to the embodiment of the present invention, FIG. 9 is an enlarged plan view of a proximal side of a bending jig of a shaft, and FIG. FIG. 12 is a sectional view of the distal end taken along the axial direction, FIG. 11 is a sectional view of the distal end perpendicular to the axial direction of the catheter, and FIG. 12 is a curve of the shaft in another embodiment of the present invention. It is a top view of a jig.

A catheter 1 having an electrode 40 of the present invention includes a shaft 10 having a distal side and a proximal side, having a lumen extending from the distal side to the proximal side, and disposed in the lumen of the shaft 10. It has a conductive wire 30 and an electrode 40 arranged on the surface of the shaft 10 and connected to the conductive wire 30. In the catheter 1 shown in FIG. 10, the electrode 40 is connected to the conducting wire 30, but a sensor (not shown) may be connected to the conducting wire 30. Details of the catheter 1 of the present invention will be described later.

A first method of manufacturing a catheter 1 of the present invention includes a shaft 10 that includes a distal side, a proximal side, and a lumen, and has a first hole 21 and a second hole 22 that allow the lumen and the outside to communicate with each other. The bending step, the step of inserting the first conducting wire 31 from the first hole 21 into the inner cavity of the shaft 10 to expose the first conducting wire 31 from the proximal end 10b of the shaft 10, and the bending step. After that, a step of bringing the first conductive wire 31 closer to the inside of the curve of the shaft 10 and inserting the second conductive wire 32 through the second hole 22 into the inner cavity of the shaft 10 to move the second conductive wire 32 to the shaft 10. And the step of exposing the second conductor 32 from the proximal end 10b, and the step of inserting the second conductor 32 is performed after the step of bringing the first conductor 31 into the inside of the curve of the shaft 10.

In the present invention, the proximal side refers to the hand side of the user with respect to the extending direction of the shaft 10, and the distal side refers to the opposite side of the proximal side, that is, the treatment target side. Moreover, the extending direction of the shaft 10 is referred to as an axial direction. The radial direction refers to the radial direction of the shaft 10, the inner side in the radial direction refers to the direction toward the axial center of the shaft 10, and the outer side refers to the direction toward the opposite side to the inner side in the radial direction. 1 to 3, FIG. 5, FIG. 6, FIG. 10 and FIG. 12, the right side of the figure is the proximal side of the catheter 1, and the left side of the figure is the distal side. 7 and 8, the lower side of the figure is the distal side, and the upper side of the figure is the proximal side.

As shown in FIG. 1, first, a step of bending a shaft 10 that includes a distal side, a proximal side, and a lumen, and has a first hole 21 and a second hole 22 that communicate the lumen and the outside. I do. This process may be called a bending process.

The shaft 10 may have a single-lumen structure having one lumen or a multi-lumen structure having a plurality of lumens. When the shaft 10 has a single-lumen structure, there is no partition wall or the like for partitioning the lumen inside the shaft 10, so that the space inside the shaft 10 can be increased, and the first lead wire to the lumen of the shaft 10 can be obtained. The step of inserting the conductor wire 30 and the like including the first conductor wire 31 and the second conductor wire 32 is facilitated.

The material forming the shaft 10 is, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, or a polyether polyamide resin, Examples thereof include polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA and ETFE, and synthetic resins such as polyvinyl chloride resins. The shaft 10 may have a single-layer structure or a multi-layer structure. When the shaft 10 has a multi-layer structure, for example, a structure using a metal braid of stainless steel, carbon steel, nickel titanium alloy, or the like can be used as the intermediate layer of the resin tube forming the shaft 10. The material forming the shaft 10 is preferably a fluorine-based resin, and more preferably PTFE. With the shaft 10 configured in this manner, the outer surface has good slip properties, and since the shaft 10 has appropriate rigidity, the catheter 1 can be easily inserted into a blood vessel.

As the axial length of the shaft 10, a length suitable for treatment can be selected. For example, the axial length of the shaft 10 can be 500 mm or more and 2000 mm or less.

The outer diameter of the shaft 10 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and further preferably 1 mm or more. By setting the lower limit value of the outer diameter of the shaft 10 in this manner, the shaft 10 can be provided with appropriate rigidity and the pushability of the catheter 1 can be enhanced. The outer diameter of the shaft 10 is preferably 3 mm or less, more preferably 2.8 mm or less, and further preferably 2.5 mm or less. By setting the upper limit value of the outer diameter of the shaft 10 in this manner, the catheter 1 can be made thin, and the ability to insert into the lumen of a living body such as a blood vessel can be improved and the minimally invasive treatment can be improved. Is possible.

The thickness of the shaft 10 is preferably 50 μm or more, more preferably 100 μm or more, and further preferably 150 μm or more. By setting the lower limit value of the thickness of the shaft 10 in this way, the rigidity of the shaft 10 can be increased and the catheter 1 with good insertability can be obtained. Further, the thickness of the shaft 10 is preferably 350 μm or less, more preferably 300 μm or less, and further preferably 250 μm or less. By setting the upper limit value of the thickness of the shaft 10 in this way, the lumen of the shaft 10 can be widened, and the conductor wire 30 and the like can be easily inserted into the lumen of the shaft 10.

The shaft 10 may be curved two-dimensionally or three-dimensionally. Curving the shaft 10 in a plane means a state in which the distal end 10a and the proximal end 10b of the shaft 10 and the curved portion of the shaft 10 are substantially in the same plane. The three-dimensionally bending of the shaft 10 refers to a state in which the distal end 10a and the proximal end 10b of the shaft 10 and the bending portion of the shaft 10 are not on the same plane.

In the bending step, a part of the shaft 10 in the axial direction may be bent, but it is preferable to bend the entire shaft 10. By bending the entire shaft 10 in the axial direction, in the process of bringing the first conducting wire 31 closer to the inside of the curvature of the shaft 10, the first conducting wire 31 shifts toward the inside of the curvature of the shaft 10 in the entire shaft 10. This facilitates the process of inserting the second conductive wire 32 into the inner cavity of the shaft 10 in which the first conductive wire 31 is inserted.

The shaft 10 may be curved at one place, but may be curved at a plurality of places. When bending a plurality of portions of the shaft 10, it is preferable that the bending directions of the bending portions are substantially the same. By bending a plurality of portions of the shaft 10 in this way, in the step of bringing the first conducting wire 31 closer to the inside of the bending of the shaft 10 after the bending step, the first conducting wire 31 is placed inside the bending of the shaft 10 at each bending portion. The conductive wire 31 is easily shifted, and the second conductive wire 32 can be easily inserted into the shaft 10 after the insertion of the first conductive wire 31.

As shown in FIG. 2, the step of inserting the first conducting wire 31 from the first hole 21 into the inner cavity of the shaft 10 to expose the first conducting wire 31 from the proximal end 10 b of the shaft 10 is performed. This step may be referred to as a step of inserting the first conducting wire 31. One of the bending step and the inserting step can be performed first, or can be performed simultaneously. When a jig such as the bending jig 120 described later is used, it is preferable to perform the bending step first.

As shown in FIGS. 3 and 4, after the step of inserting the first conductive wire 31, a step of bringing the first conductive wire 31 closer to the inside of the curve of the shaft 10 is performed. In order to bring the first conducting wire 31 to the inside of the curve of the shaft 10, for example, by pulling the first conducting wire 31, an external force is applied to the first conducting wire 31 to bring the first conducting wire 31 to the inside of the bending. Aspect, in the bending step, the bending portion of the shaft 10 is arranged above both ends of the shaft 10 to bend the shaft 10 and then the insertion step is performed, and the first conductive wire 31 is brought closer by the weight of the first conductive wire 31. Can be mentioned.

As shown in FIGS. 5 and 6, a step of inserting the second conductive wire 32 through the second hole 22 into the inner cavity of the shaft 10 to expose the second conductive wire 32 from the proximal end 10 b of the shaft 10. To do. This step may be referred to as a step of inserting the second conducting wire 32. The step of inserting the second conductive wire 32 is performed after the step of moving the first conductive wire 31 to the inside of the curve of the shaft 10.

The conductive wire 30 including the first conductive wire 31 and the second conductive wire 32 electrically connects an external device (not shown) such as a power supply device of the catheter 1 to an electrode 40 or a sensor described later. By connecting the conducting wire 30 to the external device of the catheter 1, the external device of the catheter 1 and the electrode 40 or the sensor are electrically connected. Although not shown, the catheter 1 has a connector on the proximal side, and the conductor 30 is connected to the connector. By connecting the connector to the external device of the catheter 1, the external device is connected. The electrode 40 and the sensor may be connected to each other. In addition, when the catheter 1 has a connector, it is preferable to have a step of connecting the first conductor wire 31 and the second conductor wire 32 to the connector after the step of inserting the second conductor wire 32, and to connect the second conductor wire 32. It is more preferable to have the connecting step after the step of bringing the shaft 10 inside the curve and the step of bringing the second conducting wire 32 inside the curve of the shaft 10.

The conductive wire 30 preferably has a core and a coating. The material forming the core of the conductive wire 30 may be a conductive material, and examples thereof include metal materials such as iron, copper, silver, stainless steel, tungsten, nickel, titanium, and alloys thereof. Above all, the material forming the core of the conductive wire 30 is preferably stainless steel. Since stainless steel has straightness and rigidity, the material forming the core of the conductive wire 30 is stainless, so that it becomes easy to insert the conductive wire 30 into the inner cavity of the shaft 10 in the step of inserting the conductive wire 30. The disconnection of 30 is less likely to occur.

It is preferable that the conductive wire 30 has a coating on portions other than both end portions connected to other objects such as the electrode 40 and the sensor. Specifically, for example, by partially removing the coating on one end of the conductive wire 30 and welding this portion to the electrode 40 or the sensor, the one end of the conductive wire 30 is connected to the electrode 40 or the sensor, and the catheter 1 By partially removing the coating on the other end of the conductive wire 30 connected to the external device or the connector, the conductive wire 30 can be configured to have a coating on the part other than both ends.

The conductive wire 30 may be coated with an insulating material, for example, a polyolefin resin such as polyethylene or polypropylene, a polyamide resin such as nylon, a polyester resin such as PET, an aromatic polyetherketone resin such as PEEK, or the like. Examples thereof include polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. Above all, the material forming the coating of the conductive wire 30 is preferably a fluorine-based resin, and more preferably PFA. Since the coating of the conductive wire 30 is configured in this manner, the insulating property of the conductive wire 30 can be enhanced, and the slidability of the conductive wire 30 with other objects such as the other conductive wire 30 can be improved in the inner cavity of the shaft 10. However, it is possible to prevent damage to the coating of the conductive wire 30 due to contact between the coating of the conductive wire 30 and another object.

After exposing the second conductive wire 32 from the proximal end 10b of the shaft 10, it is preferable to finish the step of bringing the first conductive wire 31 closer to the inside of the curve of the shaft 10. That is, by applying an external force to the first conductive wire 31, the first conductive wire 31 is brought closer to the inside of the curve of the shaft 10, and in this state, the second conductive wire 32 is inserted, and the second conductive wire 32 is inserted. It is preferable to release the external force applied to the first conductive wire 31 after the insertion step is completed. By thus performing the step of bringing the first conductive wire 31 closer to the inside of the curve of the shaft 10, it is possible to secure a large internal space of the shaft 10 in the insertion step of the second conductive wire 32, and the inner space of the shaft 10 can be secured. When the second conducting wire 32 is inserted into the cavity, the second conducting wire 32 is unlikely to be entangled with the first conducting wire 31, and the step of inserting the second conducting wire 32 is facilitated.

After the step of inserting the second conductive wire 32, it is preferable to perform the step of bringing the second conductive wire 32 closer to the inside of the curve of the shaft 10. By performing such a step, after inserting the second conductive wire 32 into the inner cavity of the shaft 10, another object such as the conductive wire 30 different from the first conductive wire 31 and the second conductive wire 32 is attached to the shaft 10. A large space within the shaft 10 can be ensured when it is inserted into the inner cavity, and it is difficult for other objects to get entangled with the first conductive wire 31 and the second conductive wire 32 during the insertion process of other objects, and The insertion step can be facilitated.

When the second conducting wire 32 is brought closer to the inside of the curve of the shaft 10, it is preferable that not only the second conducting wire 32 but also the first conducting wire 31 be brought closer to the inside of the curvature of the shaft 10. That is, it is preferable to perform the step of bringing the first conductive wire 31 and the second conductive wire 32 closer to the inside of the curve of the shaft 10 after the step of inserting the second conductive wire 32. By performing such a step, the first conductor wire 31 and the second conductor wire 32 can be densely packed in the inner cavity of the shaft 10, and the other conductor wires 30 of the first conductor wire 31 and the second conductor wire 32 and Thus, it becomes easy to insert a member other than the conducting wire 30 to be arranged in the inner cavity of the shaft 10. Further, it becomes possible to prevent the first conducting wire 31 and the second conducting wire 32 from easily becoming entangled with other objects. The first conducting wire 31 and the second conducting wire 32 may be moved to the inside of the curve of the shaft 10 at the same time, or may be sequentially moved to the inside of the curve of the shaft 10.

The second manufacturing method of the catheter 1 of the present invention includes the distal side, the proximal side, and the inner cavity, and the shaft 10 having the first hole 21 and the second hole 22 that allow the inner cavity and the outside to communicate with each other. The bending step, the step of inserting the first conducting wire 31 from the first hole 21 into the inner cavity of the shaft 10 to expose the first conducting wire 31 from the proximal end 10b of the shaft 10, and the bending step. Thereafter, the step of pulling the first conductive wire 31 and inserting the second conductive wire 32 through the second hole 22 into the inner cavity of the shaft 10 to expose the second conductive wire 32 from the proximal end 10b of the shaft 10. And a step of performing the step. In the description of the second manufacturing method of the present invention, the description of the same parts as those of the first manufacturing method will be omitted.

In the second method of manufacturing the catheter 1 of the present invention, the first conducting wire 31 is pulled after the bending step. By pulling the first conductive wire 31, the first conductive wire 31 is likely to move closer to the inside of the curve of the shaft 10. As a result, a large space inside the shaft 10 can be ensured, and other objects such as the second conducting wire 32 and the conducting wire 30 different from the first conducting wire 31 and the second conducting wire 32 can be secured inside the shaft 10. It is possible to prevent the first conductive wire 31 and other objects from becoming entangled with each other when the shaft 10 is inserted, and thus it is easy to insert the shaft 10 into the inner cavity.

In the step of pulling the first conductive wire 31, it is preferable to pull the proximal side of the first conductive wire 31. Specifically, in the step of inserting the first conducting wire 31, it is preferable to pull the portion of the first conducting wire 31 exposed from the proximal end 10b of the shaft 10. By performing the pulling process of the first conductive wire 31 in this manner, the inserting process and the pulling process of the first conductive wire 31 are performed with the electrode 40 and the sensor connected in advance to the distal side of the first conductive wire 31. Therefore, the catheter 1 can be manufactured efficiently. The pulling of the conductive wire 30 may be performed, for example, by attaching a weight of a predetermined weight to both ends of the conductive wire 30 and bringing the conductive wire 30 closer to the inside of the curve of the shaft 10.

It is preferable to finish the pulling process of the first conductive wire 31 after exposing the second conductive wire 32 from the proximal end 10b of the shaft 10. That is, it is preferable that the first conductive wire 31 be continuously pulled while the second conductive wire 32 is inserted. By thus performing the pulling process of the first conducting wire 31, the second conducting wire 32 can be inserted while keeping the first conducting wire 31 inside the curve of the shaft 10, so that the second conducting wire 32 is inserted. Can be easily inserted into the inner cavity of the shaft 10. Further, in the step of inserting the second conducting wire 32, it is possible to prevent the first conducting wire 31 and the second conducting wire 32 from being entangled with each other.

It is preferable to perform the step of pulling the second conductive wire 32 after the step of inserting the second conductive wire 32. By carrying out such a step, when inserting another object such as the conductor 30 different from the first conductor 31 and the second conductor 32 into the inner cavity of the shaft 10, a large space is provided inside the shaft 10. It becomes possible. Therefore, the step of inserting another object is facilitated, and the other object is less likely to be entangled with the first conductive wire 31 and the second conductive wire 32.

When performing the pulling process of the second conducting wire 32, it is preferable to pull not only the second conducting wire 32 but also the first conducting wire 31. By performing such a step, the first conducting wire 31 and the second conducting wire 32 can be densely packed in the inner cavity of the shaft 10, and the other conducting wires 30 of the first conducting wire 31 and the second conducting wire 32, etc. It is possible to secure a wide space for inserting the other object, the other object is less likely to be entangled with the first conductor wire 31 and the second conductor wire 32, and the insertion step of the other object is facilitated.

Preferred embodiments of the first manufacturing method and the second manufacturing method of the catheter 1 of the present invention will be described below.

As shown in FIG. 4, in the step of inserting the second conducting wire 32, it is preferable that the first conducting wire 31 is arranged inside the curve of the shaft 10 with respect to the central axis L1 of the lumen of the shaft 10. In addition, in FIG. 4, the lower side of the figure is the inside of the curve of the shaft 10. By arranging the first conducting wire 31 in this way, it is possible to secure a wide space inside the shaft 10. Therefore, when the second conducting wire 32 is inserted into the inner cavity of the shaft 10, the second conducting wire 32 comes into contact with the first conducting wire 31 and is entangled, and the first conducting wire 31 is separated from the second conducting wire 32. It is possible to prevent the insertion of the second conductor 32 from being hindered and facilitate the step of inserting the second conductive wire 32.

In the insertion step of the second conductive wire 32, it is preferable that the first conductive wire 31 is arranged inside the curve of the shaft 10 with respect to the central axis L1 of the inner cavity of the shaft 10 at the bent portion of the shaft 10. More preferably, the first conducting wire 31 is arranged inside the curve of the shaft 10 with respect to the central axis L1 of the lumen of the shaft 10 over the entire length of the shaft 10. By arranging the first conducting wire 31 in this way, it is possible to secure a large space inside the shaft 10 over a wide area inside the shaft 10, and the first conducting wire 31 can be inserted when the second conducting wire 32 is inserted. Is less likely to interfere.

The first hole 21 is preferably closer to the proximal side than the second hole 22. The shaft 10 is provided with the first hole 21 and the second hole 22 in this manner, and after the first conductor 31 is inserted from the first hole 21 into the inner cavity of the shaft 10, the second hole 22 is inserted. By inserting the second conducting wire 32 into the inner cavity of the shaft 10, the first conducting wire 31 and the second conducting wire 32 are unlikely to be entangled with each other, and the step of inserting the second conducting wire 32 is facilitated to manufacture the catheter 1. The efficiency can be increased.

The shaft 10 may have a hole 20 that is different from the first hole 21 and the second hole 22. That is, the shaft 10 may have the first hole 21, the second hole 22, and the hole 20 different from the first hole 21 and the second hole 22. The other hole 20 may be one or plural. Since the shaft 10 has the plurality of holes 20, different conductors 30 can be inserted from the respective holes 20, and by connecting the electrodes 40 or the sensors to the conductors 30, the plurality of electrodes 40 or the sensors can be formed. The catheter 1 may be included.

The shape of the hole 20 including the first hole 21 and the second hole 22 may be circular, elliptical, polygonal, or the like. The shape of the hole 20 may be linear like a slit. Above all, the shape of the hole 20 is preferably circular or elliptical. By configuring the hole 20 in this way, when inserting the conducting wire 30 from the hole 20 into the inner cavity of the shaft 10, it is possible to prevent the external force from concentrating on one point of the edge of the hole 20, and the hole 20 is torn or the like. It is possible to prevent the shaft 10 from being damaged.

The length of the hole 20 including the first hole 21 and the second hole 22 in the long axis direction can be set as appropriate. For example, the length can be set according to the length of the electrode 40, the sensor, etc. in the long axis direction, and for example, the length of the hole 20 in the long axis direction is shorter than the length of the electrode 40, the sensor, etc. in the long axis direction. It is preferable. The length of the hole 20 in the major axis direction is preferably 100 μm or more, more preferably 125 μm or more, and further preferably 150 μm or more. By setting the lower limit value of the length of the hole 20 in the major axis direction in this way, the conductor wire 30 can be easily inserted into the hole 20. The length of the hole 20 in the long axis direction is preferably 300 μm or less, more preferably 250 μm or less, and further preferably 200 μm or less. By setting the upper limit value of the length of the hole 20 in the major axis direction in this way, the gap between the hole 20 and the conductive wire 30 can be reduced, and the gap between the hole 20 and the conductive wire 30 can be reduced when the catheter 1 is used. Therefore, it is possible to make it difficult for liquid such as blood to enter the inner cavity of the shaft 10. When the shape of the hole 20 is circular or polygonal, the outer diameter of the hole 20 is preferably in the same range as the length of the hole 20 in the direction perpendicular to the major axis direction.

The shaft 10 has a plurality of holes 20, and the lead wire 30 can be sequentially inserted from the most proximal hole 20 into the inner cavity of the shaft 10 to expose the lead wire 30 from the proximal end 10 b of the shaft 10. preferable. That is, the lead wire 30 is inserted from the most proximal hole 20 into the lumen of the shaft 10, then the lead wire 30 is inserted into the hole 20 adjacent to the most proximal hole 20, and finally the most distal hole. It is preferable to insert the conductor wire 30 into the wire 20. By thus inserting the conductive wire 30 into the inner cavity of the shaft 10, the conductive wire 30 is less likely to be entangled in the insertion process of each conductive wire 30, and the insertion process is facilitated.

As shown in FIG. 1, in the bending step, the first hole 21 and the second hole 22 are preferably arranged so as to be inside the bending of the shaft 10. By arranging the shaft 10 in this way, the first conductive wire 31 inserted through the first hole 21 into the inner cavity of the shaft 10 can be easily arranged inside the curve of the shaft 10, and the insertion process of the second conductive wire 32 can be performed. Is easier to do. Further, the second conducting wire 32 is also easily arranged inside the curve of the shaft 10, and the step of inserting another object such as the conducting wire 30 other than the first conducting wire 31 and the second conducting wire 32 is also facilitated.

The first hole 21 and the second hole 22 may be arranged on one side in a cross section perpendicular to the axial direction of the shaft 10 in the circumferential direction of the shaft 10. The holes 20 may be located at different positions in the circumferential direction of the shaft 10, or may be arranged at the same position in the circumferential direction of the shaft 10. By disposing the first hole 21 and the second hole 22 on one side in the cross section perpendicular to the axial direction of the shaft 10, the first conductor wire 31 inserted into the first hole 21 and the second conductor wire 31 The second conducting wire 32 inserted into the hole 22 is easily arranged inside the bend of the shaft 10, and the first conducting wire 31 and the second conducting wire 32 are less likely to be entangled.

The first conductor 31 has an electrode 40 or sensor at the distal end of the first conductor 31, and the second conductor 32 has an electrode 40 or sensor at the distal end of the second conductor 32. It is preferable. Examples of the sensor include a temperature sensor and a pressure sensor. Since the first conducting wire 31 and the second conducting wire 32 have the electrodes 40, the catheter 1 having the electrodes 40 on the distal side of the shaft 10 can be obtained, and cauterization of lesions, measurement of intracardiac potential, and removal of the cardiac potential. Treatment and examinations such as fibrillation can be performed. Since the first conducting wire 31 and the second conducting wire 32 have sensors, the contact force between the inner wall of the heart, blood vessels, etc. and the catheter 1 and the temperature, blood pressure, body temperature, etc. near the lesion due to cauterization of the lesion are measured. Measurement can be performed by the catheter 1, treatment and inspection are facilitated, and man-hours can be shortened.

The shape of the electrode 40 or the sensor may be a flat plate shape such as a rectangle or a square, or may be a ring shape. When the electrode 40 or the sensor has a flat plate shape, at least one of the back surface (inner surface) and the front surface (outer surface) of the flat plate may be a curved surface so as to easily follow the curved surface of the surface of the shaft 10. Above all, the electrode 40 or the sensor is preferably ring-shaped. Since the electrode 40 or the sensor has a ring shape, the area of the electrode 40 or the sensor on the circumference of the shaft 10 can be increased, and the electrode 40 or the sensor can be easily brought into contact with a target site such as the inner wall of the heart. Become.

Examples of the material forming the electrode 40 or the sensor include metal materials such as copper, gold, platinum, aluminum, iron, and alloys thereof. Above all, the material forming the electrode 40 or the sensor is preferably platinum or its alloy. By configuring the electrode 40 or the sensor in this way, the contrast of the electrode 40 or the sensor with respect to the X-ray can be enhanced, and the position of the electrode 40 or the sensor can be confirmed by using the X-ray when the catheter 1 is used. can do.

As a method of connecting the conductive wire 30 to the electrode 40 or the sensor, for example, welding, brazing of solder or the like, connection by caulking, or the like can be used. Among them, the method of connecting the conductive wire 30 to the electrode 40 or the sensor is preferably welding. Since the conductive wire 30 is connected to the electrode 40 or the sensor by welding, the connection between the conductive wire 30 and the electrode 40 or the sensor can be easily strengthened. Although not shown, the conductive wire 30 and the electrode 40 or the sensor may be connected to each other with a conductive member interposed between the conductive wire 30 and the electrode 40 or the sensor.

It is preferable that the connecting portion between the conductive wire 30 and the electrode 40 or the sensor is coated with a resin or the like in order to prevent oxidative deterioration due to moisture contained in the atmosphere or the like. Examples of resins used for this coating include polyurethane resins and epoxy resins.

When the electrode 40 or the sensor has a ring shape, it is preferable that the conductor wire 30 is connected to the inside of the ring. Since the electrode 40 or the sensor is configured in this manner, the connecting portion between the electrode 40 or the sensor and the conductive wire 30 is not exposed to the outside, and the connecting portion contacts another object so that the conductive wire 30 is not exposed to the electrode 40. Alternatively, it can be prevented from coming off the sensor.

When the electrode 40 or the sensor is provided at the distal end portion of the first conductive wire 31, the electrode 40 or the sensor included in the first conductive wire 31 is attached to the outer surface of the shaft 10 after the step of inserting the first conductive wire 31. It is preferable to have a step of disposing. In this step, it is preferable that the connection portion between the electrode 40 or the sensor and the first conductive wire 31 is arranged so as to overlap at least a part of the first hole 21. By arranging the connection portion with the first conductive wire 31 so as to overlap at least a part of the first hole 21 in this manner, a gap is unlikely to be formed between the electrode 40 or the sensor and the shaft 10, and the catheter 1 It is possible to prevent a liquid such as blood from entering the inside of the shaft 10 through the first hole 21 and hindering the operation of the catheter 1 during use. Further, a ring-shaped electrode 40 or sensor surrounding the shaft 10 is provided at the distal end of the first conductive wire 31, and a similar ring-shaped electrode 40 or sensor is provided at the distal end of the second conductive wire 32. Locating the electrode 40 or sensor of the first conductor 31 on the outer surface of the shaft 10 prior to locating the electrode 40 or sensor of the second conductor 32 on the outer surface of the shaft 10. Is preferred. By arranging the electrodes 40 or sensors in this way, the respective electrodes 40 or sensors can be smoothly arranged.

Similarly, when the electrode 40 or the sensor is provided at the distal end portion of the second conductive wire 32, the electrode 40 or the sensor included in the second conductive wire 32 is also provided after the step of inserting the second conductive wire 32. It is preferable to arrange the electrode 40 or the sensor included in the second conductive wire 32 on the outer surface of the shaft 10 so that the connection portion with the second conductive wire 32 overlaps at least a part of the second hole 22.

As shown in FIG. 7, prior to the step of inserting the first conductive wire 31, the step of disposing the conductive wire traction member 110 in the inner cavity of the shaft 10 and the step of fixing the first conductive wire 31 to the conductive wire traction member 110. It is preferable to have In the manufacture of the catheter 1, by using the conductive wire pulling member 110, it becomes easier to insert the first conductive wire 31 into the inner cavity of the shaft 10, and it is possible to shorten the time required for the insertion process of the first conductive wire 31. Therefore, the manufacturing efficiency of the catheter 1 can be improved. The step of disposing the conductive wire pulling member 110 in the inner cavity of the shaft 10 may be referred to as a conductive wire pulling member 110 disposing step, and the step of fixing the first conductive wire 31 to the conductive wire pulling member 110 may be referred to as the first step. It may be referred to as a step of fixing the conducting wire 31.

The lead wire pulling member 110 is a member for inserting the lead wire 30 into the inner cavity of the shaft 10. The lead wire pulling member 110 is preferably a linear object. Examples of the material forming the lead wire pulling member 110 include metal materials such as iron, copper, silver, stainless steel, tungsten, nickel, titanium, and alloys thereof. Above all, the material forming the conductive wire pulling member 110 is preferably stainless steel. Since the conductor pulling member 110 is configured in this manner, the conductor pulling member 110 has straightness, so that the conductor pulling member 110 can easily pass through the lumen of the shaft 10, and the conductor 30 can be easily inserted into the lumen of the shaft 10. it can.

The conductor pulling member 110 preferably has a portion for fixing the conductor 30 at one end. As a portion for fixing the conductor wire 30, a part of the conductor wire pulling member 110 is formed into a ring shape or a C-shape, and the conductor wire 30 is hooked to this portion or a portion having the conductor wire 30 is sandwiched. Etc. Above all, one end of the conductor pulling member 110 has a ring shape, and it is preferable that the conductor 30 is hooked and fixed to this ring-shaped portion. With the conductor pulling member 110 thus configured, the conductor 30 can be easily fixed, and the conductor 30 can be easily inserted into the inner cavity of the shaft 10.

The outer diameter of the conductive wire pulling member 110 including the portion for fixing the conductive wire 30 can be appropriately selected according to the inner diameter of the shaft 10 through which the conductive wire 30 is inserted. The outer diameter of the other end of the wire pulling member 110 is set to a size that allows the wire pulling member 110 to have appropriate rigidity and a size that allows the wire pulling member 110 to easily pass through the inner cavity of the shaft 10. It is preferable.

As shown in FIG. 7, in the step of fixing the first conductive wire 31, the first conductive wire 31 is inserted through the first hole 21 into the inner cavity of the shaft 10, and the first conductive wire 31 is attached to the distal end of the shaft 10. It is preferable that the first conductive wire 31 exposed from 10a is fixed to the conductive wire pulling member 110. By performing the fixing process of the first conductive wire 31 in this manner, the first conductive wire 31 can be easily and reliably fixed to the conductive wire pulling member 110, and the insertion process of the first conductive wire 31 can be easily performed. Becomes

In the step of arranging the conductive wire pulling member 110, the other end of the conductive wire pulling member 110 opposite to the one end, which is a portion for fixing the first conductive wire 31, is provided from the distal end 10a of the shaft 10 to the inner cavity of the shaft 10. It is preferable to insert into. By performing the conductor wire pulling member 110 arranging step in this way, it is easy to fix the first conductor wire 31 to the wire conductor pulling member 110, and the first conductor wire 31 fixed to the wire conductor pulling member 110 is introduced into the inner cavity of the shaft 10. Easy to insert

As shown in FIG. 8, in the step of inserting the first conductive wire 31, when the portion of the conductive wire pulling member 110 that fixes the first conductive wire 31 passes through the portion of the shaft 10 where the first hole 21 exists. It is preferable to bend the portion of the first conductive wire 31 exposed from the first hole 21 to the distal side. By performing the step of inserting the first conductive wire 31 in this manner, when the conductive wire pulling member 110 having the first conductive wire 31 fixed passes through the portion where the first hole 21 is present, the first conductive wire 31 moves to the first conductive wire 31. It is possible to prevent the shaft 10 near the first hole 21 from being damaged, and prevent the production of defective products in the manufacture of the catheter 1 such as tearing around the first hole 21 of the shaft 10.

After the step of inserting the first conductive wire 31 is completed, the step of removing the first conductive wire 31 from the conductive wire pulling member 110, the step of disposing the conductive wire pulling member 110 in the inner cavity of the shaft 10, and the step of removing the conductive wire pulling member 110 It is preferable to perform the step of fixing the second conducting wire 32. By performing such a step, the step of inserting the second conductive wire 32 can be easily performed.

In the step of fixing the second conductive wire 32, the second conductive wire 32 is inserted through the second hole 22 into the inner cavity of the shaft 10 to expose the second conductive wire 32 from the distal end 10a of the shaft 10 and expose it. It is preferable to fix the second conductive wire 32 that is attached to the conductive wire pulling member 110. By performing the fixing process of the second conductive wire 32 in this way, it becomes easy and secure to fix the second conductive wire 32 to the conductive wire pulling member 110, and the inserting process of the second conductive wire 32 is easily performed. be able to.

The method for manufacturing the catheter 1 preferably has a bending jig 120 that bends the shaft 10. As shown in FIGS. 1 to 3, 5 and 6, the bending jig 120 preferably has a tubular shape. The shaft 10 can be easily bent, and the bent state of the shaft 10 can be easily maintained. The bending jig 120 may hold the shaft 10 continuously, or may partially hold the shaft 10. For example, as shown in FIG. 12, the bending jig 120 may be configured to include two members that hold a part of the shaft 10 on the distal side and a part of the shaft 10 on the proximal side. The cross section of the bending jig 120 in the long axis direction may be circular, notched circular, L-shaped or the like. The bending jig 120 may be an adhesive surface member or the like as long as it can hold the shaft 10 in a curved shape.

As shown in FIG. 9, in the bending step, the shaft 10 is inserted into the inner cavity of the bending jig 120, and the shaft fixture 130 is inserted between the outer surface of the shaft 10 and the inner surface of the bending jig 120. Is preferred. When such a jig is used, it is preferable to perform the bending step before other steps such as the step of inserting the first conductive wire 31. By performing such a step, the shaft 10 moves in the step of inserting the conductive wire 30 into the inner cavity of the shaft 10 after the bending step, which is the step of inserting the first conductive wire 31 and the second conductive wire 32. This facilitates the step of inserting the conductive wire 30 and prevents the conductive wire 30 from being entangled.

The shaft fixture 130 is inserted between the shaft 10 inserted into the inner cavity of the bending jig 120 and the bending jig 120 to prevent the shaft 10 from moving. Examples of the shape of the shaft fixture 130 include a flat plate shape, a cylindrical shape, and a solid columnar shape. Above all, the shaft fixture 130 is preferably flat. Since the shaft fixing tool 130 is configured in this way, when the shaft fixing tool 130 is inserted between the outer surface of the shaft 10 and the inner surface of the bending jig 120, the movement of the shaft 10 is sufficiently prevented. At the same time, it is possible to prevent the shaft 10 from being damaged.

The material forming the bending jig 120 is preferably a transparent or translucent synthetic resin. With the bending jig 120 configured in this way, the shaft 10 inserted into the inner cavity of the bending jig 120 can be visually recognized, and the state of the shaft 10 in the bending step can be confirmed.

The bending jig 120 has a conductive wire fixing portion 140 that holds the first conductive wire 31, and in the insertion process of the second conductive wire 32, the first conductive wire exposed from the proximal end 10b of the shaft 10. It is preferable to fix 31 to the lead wire fixing portion 140. By performing such a step, the first conducting wire 31 and the second conducting wire 32 are less likely to be entangled, and the second conducting wire 32 can be easily inserted into the inner cavity of the shaft 10.

The conductor wire fixing portion 140 has, for example, an adhesive tape, has the first conductor wire 31 attached to the adhesive tape, has a holding portion, and holds the first conductor wire 31 with the holding portion. The first conductive wire 31 may be fixed by directly connecting the first conductive wire 31 to the conductive wire fixing portion 140. Above all, it is preferable that the conductive wire fixing portion 140 has an adhesive tape, and the first conductive wire 31 is fixed to the conductive wire fixing portion 140 by attaching the first conductive wire 31 to the adhesive tape. With the conductor fixing portion 140 configured in this way, the first conductor 31 can be fixed easily and quickly.

As shown in FIG. 9, the inner tube 150 may be inserted into the proximal end 10b of the shaft 10. In the inner tube 150, the conductor wire 30 inserted into the shaft 10 is passed through the inner cavity of the inner tube 150 so that the conductor wire 30 comes into contact with the proximal end 10 b of the shaft 10 and the conductor wire 30 and the proximal end portion of the shaft 10 are damaged. Can be prevented.

The inner tube 150 is preferably fixed to the shaft 10. Since the inner tube 150 is fixed to the shaft 10, the inner tube 150 is prevented from coming off the shaft 10 during the step of inserting the conductive wire 30, and the step of inserting the conductive wire 30 is facilitated. The inner tube 150 and the shaft 10 can be fixed with, for example, an adhesive tape.

As shown in FIG. 10, the catheter 1 has a wire 50 whose distal end is fixed to the distal end of the shaft 10, and by moving the wire 50 in the axial direction, the distal side of the shaft 10 is It is preferable to bend to the side. By arranging a plurality of wires 50, the shaft 10 can be bent in a plurality of directions. By configuring the catheter 1 in this way, it becomes easy to bring the distal end portion of the catheter 1 into contact with a target site such as the inside of the heart chamber, and it becomes easier to perform treatment or inspection using the electrode 40 or the sensor. .. Note that the distal end of the wire 50 is fixed to the distal end of the shaft 10 means that the distal end of the wire 50 is directly fixed to the distal end of the shaft 10. It also includes that the distal end portion of 50 is indirectly fixed via another object such as a tip to be described later.

The wire 50 need only have the distal end of the wire 50 fixed to the distal end of the shaft 10, but the distal end of the wire 50 should be fixed to the distal end of the lumen of the shaft 10. Is preferred. Since the wire 50 is thus fixed to the shaft 10, the distal side of the shaft 10 can be largely bent.

The material forming the wire 50 can be, for example, synthetic resin or metal. The wire 50 may have a structure in which a metal material and a synthetic resin material are combined, and for example, a metal wire material and a synthetic resin wire material braided or a metal wire material coated with a resin can be used. The method of fixing the distal end of the wire 50 and the distal end of the shaft 10 is not particularly limited, and it is preferable that the wire 50 is firmly fixed so as not to come off during operation.

The diameter of the wire 50 can be appropriately selected depending on the inner diameter of the shaft 10, the outer diameter of the conductive wire 30 to be arranged, the number of wires, and the like. In particular, it is preferable to set it in consideration of the strength of the wire 50 being sufficient and the lumen of the shaft 10 being sufficiently wide.

Although not shown, the shaft 10 may have a tip at its distal end. The tip may be a hemispherical electrode 40 or sensor, a lid-like member that closes the opening at the distal end of the shaft 10. Since the shaft 10 has the distal end tip, water such as blood enters the inner cavity of the shaft 10 when the catheter 1 is used, and the water is applied to the connecting portion between the electrode 40 or the sensor and the conductive wire 30 and the plurality of conductive wires 30. It is possible to prevent the insulating property between the conductive wires 30 from being deteriorated due to the contact, and a drift phenomenon in which the baseline potential of the electrocardiogram becomes unstable when the intracardiac potential is measured. Further, the distal tip serves as a guide for the distal end of the catheter 1, and the insertability of the catheter 1 can be improved.

When the catheter 1 has the wire 50, the distal tip can be a fixed part of the wire 50 in the lumen of the shaft 10. The presence of the fixed end of the wire 50 in the tip allows the distal end of the catheter 1 to be effectively bent by manipulating the wire 50.

When the catheter 1 has the wire 50 and the shaft 10 has a tip at the distal end, the fixation of the distal end of the wire 50 and the distal end of the shaft 10 is performed by the wire 50. It is preferable that the tip is made of metal and the wire 50 and the tip are fixed by soldering. Since the distal end portion of the wire 50 and the distal end portion of the shaft 10 are fixed in this way, the wire 50 and the shaft 10 are firmly fixed, and the distal end of the shaft 10 is bent. Even if the wire 50 is moved in the axial direction, it is possible to prevent the wire 50 from coming off from the shaft 10.

The material forming the distal tip is not particularly limited, but for example, the material forming the shaft 10 described above, the material forming the electrode 40 or the sensor described above, or the like can be used. Note that the tip chip can also serve as the electrode 40 or the sensor by forming the tip chip with a conductive material such as the material forming the electrode 40 or the sensor and connecting the tip chip to the conductive wire 30.

The tip of the shaft 10 may not be provided at the distal end thereof, and the distal end of the shaft 10 may be heat-sealed to close the opening at the distal end of the shaft 10.

Further, even when the catheter 1 having a plurality of conducting wires 30 in the lumen of the shaft 10 is used, when the catheter 1 is bent, the conducting wire 30 is entangled with other conducting wires 30 and the bending wire 50, and the electrode 40 and the sensor are There are also problems such as being unusable and breaking the conductive wire 30. The catheter 1 of the present invention which can solve this problem will be described below.

The catheter 1 of the present invention has a shaft 10 having a distal side, a proximal side, and a lumen, a hole 20 through which the outside of the shaft 10 communicates with the lumen of the shaft 10, and the shaft 20 inserted through the hole 20. Of the electrode 40 on the side including the hole 20 in the cross section orthogonal to the axial direction of the shaft 10 and having the conductor 30 arranged in the inner cavity of the electrode 40 and the electrode 40 connected to the conductor 30. It is characterized in that 70% or more of the entire conductive wires 30 connected to the electrodes 40 are arranged. Note that 70% or more of the total number of the conductive wires 30 connected to the electrode 40 means 70% or more of the total number of the conductive wires 30 connected to the electrode 40.

As shown in FIG. 10, the catheter 1 has a shaft 10 having a distal side, a proximal side, and a lumen, a hole 20 through which the outside of the shaft 10 communicates with the lumen of the shaft 10, and the catheter 20 inserted through the hole 20. And has a conductor wire 30 arranged in the inner cavity of the shaft 10 and an electrode 40 connected to the conductor wire 30.

The hole 20 preferably has at least a first hole 21 and a second hole 22. That is, the catheter 1 preferably has a plurality of holes 20. Since the hole 20 of the catheter 1 has at least the first hole 21 and the second hole 22, it is possible to provide the catheter 1 with a plurality of electrodes 40 and sensors, and to make the catheter 1 multipolar and multifunctional. It can be performed.

The conductive wire 30 preferably has at least a first conductive wire 31 and a second conductive wire 32. That is, it is preferable that the catheter 1 has a plurality of conducting wires 30. Since the conductive wire 30 has at least the first conductive wire 31 and the second conductive wire 32, the catheter 1 having the plurality of electrodes 40, the plurality of sensors, or both the electrodes 40 and the sensors can be obtained.

The catheter 1 may have at least one electrode 40 connected to the conducting wire 30, but preferably has a plurality of electrodes 40 connected to the conducting wire 30. Further, the catheter 1 has an electrode 40 connected to the first conducting wire 31, and an electrode 40 different from the electrode 40 connected to the first conducting wire 31 and connected to the second conducting wire 32. It is preferable to have By configuring the catheter 1 in this way, the catheter 1 can be multipolarized, and it becomes possible to perform treatments and tests such as cauterization at multiple points and measurement of intracardiac potential at one time, and shorten the procedure time. can do.

As shown in FIG. 11, in the cross section orthogonal to the axial direction of the shaft 10, the conducting wire 30 connected to the electrode 40 is provided on the side including the hole 20 and the entire conducting wire 30 connected to the electrode 40. 70% or more of the The side where the hole 20 of the shaft 10 is included means that the hole 20 of the shaft 10 is present in a portion sectioned by a straight line L2 passing through the axial center of the shaft 10 in a cross section orthogonal to the axial direction of the shaft 10. Points to the side. In the catheter 1 shown in FIG. 11, the lower side of the figure is the side including the hole 20.

In the cross section orthogonal to the axial direction of the shaft 10, the conductor wire 30 connected to the electrode 40 is arranged at 70% or more of the whole conductor wire 30 connected to the electrode 40 on the side including the hole 20. However, it is preferable that 75% or more is arranged, 80% or more is more preferable, 85% or more is further preferable, and 90% or more is particularly preferable. preferable. By configuring the catheter 1 in this way, it is possible to more effectively prevent the conductive wire 30 from being entangled with other objects when the catheter 1 is used, making it impossible to use the electrode 40 and the sensor, and breaking the conductive wire 30. It becomes possible to prevent it.

The catheter 1 has a wire 50 whose distal end is fixed to the distal end of the shaft 10. By moving the wire 50 in the axial direction, the distal side of the shaft 10 is bent to one side, It is preferable that the hole 20 is included on one side in a cross section orthogonal to the axial direction of the shaft 10. By configuring the catheter 1 in this manner, when the distal side of the catheter 1 is bent, an external force is less likely to be applied to the conductor wire 30 inserted into the hole 20, and the conductor wire 30 is less likely to break.

Although not shown, the catheter 1 may have a handle on the proximal side. The handle is connected to the proximal end of shaft 10 and the proximal end of wire 50 is preferably secured to the handle. With the catheter 1 thus configured, the wire 50 can be easily moved in the axial direction, and the catheter 1 can be easily operated.

The conductor 30 preferably has an electrode 40 connected to its distal end and an electrical connector connected to its proximal end. Examples of the electrical connector include a connector and a board. With the conductor 30 configured in this manner, the electrode 40 of the catheter 1 and the external device can be easily electrically connected by connecting the electrical connector to the external device (not shown) of the catheter 1. be able to. Alternatively, the electrode 40 and the external device may be connected by directly connecting the proximal end of the conductive wire 30 to the external device of the catheter 1.

Although not shown, the catheter 1 preferably has an elastic member having a distal end fixed to the distal end of the shaft 10. The elastic member extends along the axial direction of the shaft 10. Since the catheter 1 has the elastic member, it is possible to finely adjust the degree of bending on the distal side of the shaft 10 by moving the wire 50 in the axial direction.

Examples of the elastic member include a leaf spring and a coil spring. Above all, the elastic member is preferably a leaf spring. The leaf spring is a spring that uses a leaf material, and has a rectangular cross-sectional shape perpendicular to the axial direction of the leaf spring. Since the long side portion of the leaf spring bends in the sectional shape, when the wire 50 is moved in the axial direction, the long side portion of the leaf spring bends toward the wire 50 side. Therefore, since the elastic member is a leaf spring, the bending direction of the shaft 10 on the distal side can be determined.

Examples of the material forming the elastic member include stainless steel, carbon steel, copper alloys and titanium alloys. Among them, the material forming the elastic member is preferably stainless steel. By configuring the elastic member in this way, it becomes easier to adjust the degree of bending of the shaft 10 on the distal side.

The distal end of the elastic member may be fixed to the distal end of the shaft 10, but the distal end of the elastic member is preferably fixed to the distal end of the lumen of the shaft 10. By fixing the distal end of the elastic member to the shaft 10 in this manner, it becomes easy to adjust the bending of the shaft 10 on the distal side.

The method of fixing the distal end of the elastic member and the distal end of the shaft 10 is not particularly limited, and examples thereof include brazing of solder or the like, welding, bonding with an adhesive, connection by caulking, and the like. For fixing the distal end of the elastic member and the distal end of the shaft 10, the shaft 10 has a metal tip at the distal end, the elastic member is made of metal, and the elastic member and the tip are fixed. And are preferably fixed by soldering. Since the distal end portion of the elastic member and the distal end portion of the shaft 10 are thus fixed, the elastic member can be firmly fixed to the shaft 10, and the distal side of the shaft 10 can be bent. Even so, it is possible to make the elastic member hard to come off from the shaft 10. Further, the step of fixing the elastic member and the shaft 10 may be performed simultaneously with the step of fixing the wire 50 and the shaft 10.

When the catheter 1 has the wire 50 and the elastic member, although not shown, the inner cylinder is arranged in the inner cavity of the shaft 10, and the wire 50 and the elastic member are arranged in the inner cavity of the inner cylinder. It is preferable that the lead wire 30 is arranged outside the inner cylinder of the shaft 10. By configuring the catheter 1 in this manner, it is possible to prevent the conductive wire 30 from coming into contact with the wire 50 or the elastic member and damaging the conductive wire 30.

Examples of the inner cylinder member include a tube having a cylindrical shape, a coil formed by spirally winding a wire rod, and the like. Further, as the material forming the inner cylinder member, the synthetic resin, the metal or the like mentioned as the material forming the shaft 10 can be used. Among them, the inner cylinder member is preferably made of metal, and more preferably a coil formed by spirally winding a stainless steel wire rod. Since the inner cylinder member is configured in this way, the rigidity of the shaft 10 can be increased and appropriate flexibility can be imparted to the shaft, so that the shaft 10 can be easily inserted into a blood vessel, and further the distal side of the shaft 10 can be provided. The catheter 1 can be easily adjusted in the degree of bending.

As described above, the first method for manufacturing a catheter of the present invention includes the distal side, the proximal side, and the inner cavity, and has the first hole and the second hole that allow the inner cavity and the outside to communicate with each other. Bending the shaft, inserting a first wire into the lumen of the shaft through the first hole to expose the first wire from the proximal end of the shaft, and after the bending step, Moving the lead wire inside the curvature of the shaft, inserting the second lead wire through the second hole into the lumen of the shaft, exposing the second lead wire from the proximal end of the shaft, The step of inserting the second conductive wire is performed after the step of moving the first conductive wire to the inside of the curve of the shaft. A second method of manufacturing a catheter of the present invention comprises a step of bending a shaft having a distal side, a proximal side and an inner cavity, and having a first hole and a second hole through which the inner cavity communicates with the outside. And a step of inserting a first conductive wire through the first hole into the lumen of the shaft to expose the first conductive wire from the proximal end of the shaft, and a step of pulling the first conductive wire after the bending step. And a step of inserting a second conductive wire through the second hole into the lumen of the shaft to expose the second conductive wire from the proximal end of the shaft. By carrying out the first manufacturing method and the second manufacturing method of the catheter of the present invention in this way, even if the inner lumen of the shaft is small, the conductor wire inserted into the inner lumen of the shaft is unlikely to be entangled, which is efficient. A catheter can be manufactured.

Further, the catheter of the present invention has a shaft having a distal side, a proximal side, and an inner cavity, a hole through which the outside of the shaft communicates with the inner lumen of the shaft, and the hole is inserted into the inner cavity of the shaft. The conductor connected to the conductor, and the electrode connected to the conductor, and the conductor connected to the electrode is connected to the electrode on the side including the hole in the cross section orthogonal to the axial direction of the shaft. It is characterized in that 70% or more of all the conducting wires are arranged. By configuring the catheter of the present invention in this way, even if the catheter is bent, the conducting wire arranged in the inner cavity of the shaft is unlikely to be entangled.

1: Catheter 10: Shaft 10a: Distal end of shaft 10b: Proximal end of shaft 20: Hole 21: First hole 22: Second hole 30: Conductive wire 31: First conductive wire 32: Second conductive wire 40: Electrode 50: Wire 110: Conducting wire pulling member 120: Bending jig 130: Shaft fixing tool 140: Conducting wire fixing part 150: Inner tube L1: Central axis of lumen of shaft L2: Straight line passing through axial center of shaft

Claims (18)

Bending a shaft having a distal side, a proximal side, and a lumen, the shaft having a first hole and a second hole communicating the lumen with the outside;
Inserting a first conductive wire into the lumen of the shaft through the first hole to expose the first conductive wire from the proximal end of the shaft;
After the bending step, a step of bringing the first conductive wire inside the bending of the shaft,
Inserting a second conductive wire through the second hole into the lumen of the shaft to expose the second conductive wire from the proximal end of the shaft;
The method for manufacturing a catheter, wherein the step of inserting the second conductive wire is performed after the step of bringing the first conductive wire closer to the inside of the curve of the shaft. The method for manufacturing a catheter according to claim 1, wherein the step of bringing the first conductive wire toward the inner side of the curvature of the shaft is completed after exposing the second conductive wire from the proximal end of the shaft. Bending a shaft having a distal side, a proximal side, and a lumen, the shaft having a first hole and a second hole communicating the lumen with the outside;
Inserting a first conductive wire into the lumen of the shaft through the first hole to expose the first conductive wire from the proximal end of the shaft;
A step of pulling the first conductive wire after the bending step,
Inserting the second conducting wire into the lumen of the shaft through the second hole to expose the second conducting wire from the proximal end of the shaft. .. The method for manufacturing a catheter according to claim 3, wherein the pulling step of the first conductive wire is completed after exposing the second conductive wire from the proximal end of the shaft. The insertion process of the said 2nd conducting wire WHEREIN: The said 1st conducting wire is arrange|positioned inside the curve of the said shaft rather than the central axis of the internal cavity of the said shaft. Manufacturing method of catheter. The said 1st hole is a manufacturing method of the catheter as described in any one of Claims 1-5 which exists in the proximal side rather than the said 2nd hole. The shaft has a plurality of holes,
The method for manufacturing a catheter according to claim 1, wherein a conductive wire is sequentially inserted from the hole on the most proximal side into the lumen of the shaft to expose the conductive wire from the proximal end of the shaft. The catheter manufacturing method according to claim 1, wherein, in the bending step, the first hole and the second hole are arranged so as to be inside a curve of the shaft. The first conductor has an electrode or sensor at the distal end of the first conductor,
The method for manufacturing a catheter according to claim 1, wherein the second conductive wire has an electrode or a sensor at a distal end portion of the second conductive wire. The method for manufacturing a catheter according to claim 9, wherein the electrode or the sensor has a ring shape. Prior to the step of inserting the first conductive wire, there is a step of disposing a conductive wire traction member in the inner cavity of the shaft, and a step of fixing the first conductive wire to the conductive wire traction member. A method for manufacturing the catheter according to any one of 1. In the step of fixing the first conductive wire, the first conductive wire is inserted into the inner cavity of the shaft through the first hole, and the first conductive wire is exposed from the distal end of the shaft and is exposed. The method for manufacturing a catheter according to claim 11, wherein the first conducting wire that is present is fixed to the conducting wire pulling member. In the conducting wire traction member arranging step, the other end portion of the conducting wire traction member opposite to the one end portion which is a portion for fixing the first conducting wire is provided from the distal end of the shaft to the inner cavity of the shaft. The method for manufacturing a catheter according to claim 11 or 12, wherein the catheter is inserted. In the step of inserting the first conductive wire, when the portion of the conductive wire pulling member that fixes the first conductive wire passes through the portion where the first hole exists, the first conductive wire is The method for manufacturing a catheter according to claim 13, wherein a portion exposed from the hole is bent distally. It has a tubular bending jig that bends the shaft,
15. In the bending step, the shaft is inserted through the inner cavity of the bending jig, and a shaft fixture is inserted between an outer surface of the shaft and an inner surface of the bending jig. The method for manufacturing a catheter according to one item. The bending jig has a conductor fixing portion that holds the first conductor,
The catheter manufacturing method according to claim 15, wherein, in the step of inserting the second conductive wire, the first conductive wire exposed from the proximal end of the shaft is fixed to the conductive wire fixing portion. A distal end having a wire secured to the distal end of the shaft,
The method for manufacturing a catheter according to claim 1, wherein the distal side of the shaft is bent to one side by moving the wire in the axial direction. A shaft having a distal side, a proximal side and a lumen,
A hole through which the outside of the shaft communicates with the lumen of the shaft,
A lead wire that is inserted into the hole and is arranged in the inner cavity of the shaft;
An electrode connected to the conductor,
On the side including the hole in the cross section orthogonal to the axial direction of the shaft, the conductor wire connected to the electrode is arranged in 70% or more of the whole conductor wire connected to the electrode. A catheter characterized by the following.

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