JP7187331B2 - Catheter manufacturing method - Google Patents

Description

The present invention relates to a method of manufacturing a catheter having a lead in the lumen of the shaft and to a catheter having a lead in the lumen of the shaft.

Catheters having electrodes connected to leads are sometimes used in examinations and treatments. Specifically, when examining arrhythmia such as atrial fibrillation, a catheter having electrodes is inserted into the heart chamber to measure the intracardiac potential to identify the abnormal site of the heart that causes the arrhythmia. During treatment of arrhythmia, a high-frequency current is passed from the electrodes of the catheter to the myocardium causing the arrhythmia, and the source of the arrhythmia is cauterized to be electrically isolated from the heart (ablation surgery). In addition, if atrial fibrillation occurs spontaneously during these examinations or treatments, or if atrial fibrillation occurs to identify an abnormal part of the heart, electrical stimulation is applied to the heart from the electrodes of the catheter. Give defibrillation. In addition to the electrodes, a catheter may be used in which sensors such as a temperature sensor and a pressure sensor are connected to conducting wires.

For example, Patent Literatures 1 to 4 disclose catheters having electrodes and sensors and conducting wires in the lumen of the shaft.

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

A plurality of conducting wires are generally arranged in the lumen of the shaft of a catheter having electrodes, corresponding to the electrodes. To manufacture such a catheter, the wires are threaded one by one through the lumen of the shaft. When another conducting wire is inserted into the lumen of the shaft in which the conducting wire is arranged, the other conducting wire is caught in the conducting wire arranged in the lumen of the shaft and cannot be advanced forward, resulting in multiple conducting wires. It is difficult to insert the catheter into the lumen of the shaft, and there is a problem that the production efficiency of the catheter is low.

In addition, it is preferable to reduce the outer diameter of the shaft in order to increase the insertability into a lumen such as a blood vessel and improve minimally invasive treatment. Reducing the outer diameter of the shaft also reduces the bore of the shaft. Such shafts are more difficult to sequentially thread multiple conductors through the lumen of the shaft. Therefore, it is necessary to provide a certain amount of room in the bore of the shaft, and there is also the problem that it is difficult to reduce the diameter of the shaft.

The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a method for manufacturing a catheter that makes it difficult for the wires to get tangled when the wires are inserted into the lumen of the shaft, and that facilitates the step of inserting the wires, and To provide a catheter in which conducting wires are less likely to get entangled.

A first method for manufacturing a catheter that can solve the above problems is provided with a distal side, a proximal side, and a lumen, and a first hole and a second hole that communicate the lumen with the outside. inserting a first conductor wire through the first hole and into the lumen of the shaft to expose the first conductor wire from the proximal end of the shaft; and inserting the second lead wire through the second hole through the lumen of the shaft to expose the second lead wire from the proximal end of the shaft. The step of inserting the second conductor wire is performed after the step of moving the first conductor wire to the inside of the curve of the shaft.

In the method of manufacturing the catheter of the present invention, it is preferable to finish the step of pulling the first lead wire inside the curve of the shaft after exposing the second lead wire from the proximal end of the shaft.

A second method for manufacturing a catheter that can solve the above problems is provided with a distal side, a proximal side, and a lumen, and a first hole and a second hole that communicate between the lumen and the outside. inserting a first conductor wire through the first hole and into the lumen of the shaft to expose the first conductor wire from the proximal end of the shaft; and inserting the second lead wire through the second hole and into the lumen of the shaft to expose the second lead wire from the proximal end of the shaft. It is.

In the manufacturing method of the catheter of the present invention, it is preferable to finish the step of pulling the first lead wire after the second lead wire is exposed from the proximal end of the shaft.

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

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

In the manufacturing method of the catheter of the present invention, the shaft has a plurality of holes, and the conducting wires are sequentially inserted through the lumen of the shaft from the most proximal hole to expose the conducting wires from the proximal end of the shaft. is preferred.

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

In the method of manufacturing the catheter of the present invention, the electrodes or sensors are preferably ring-shaped.

The method for manufacturing a catheter of the present invention comprises the steps of placing a lead wire pulling member in the lumen of the shaft and fixing the first lead wire to the lead wire pulling member prior to the step of inserting the first lead wire. is preferred.

In the method for manufacturing a catheter of the present invention, in the step of fixing the first conductor, the first conductor is inserted through the first hole into the lumen of the shaft, the first conductor is exposed from the distal end of the shaft, Preferably, the exposed first wire is secured to the wire pull member.

In the manufacturing method of the catheter of the present invention, in the step of arranging the lead wire pulling member, the other end of the lead wire pulling member opposite to the one end portion where the first lead wire is fixed is moved from the distal end of the shaft to the shaft. is preferably inserted into the lumen of the

In the method for manufacturing a catheter of the present invention, in the step of inserting the first conductor, when the portion of the conductor wire pulling member for fixing the first conductor passes through the portion where the first hole exists, the first conductor It is preferred to bend distally the portion exposed from the first hole of the .

In the manufacturing method of the catheter of the present invention, a tubular bending jig for bending the shaft is provided. A shaft fixture is preferably inserted between the inner surface.

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

In the manufacturing method of the catheter of the present invention, the distal end portion has a wire fixed to the distal end portion 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 that can solve the above problems includes 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, and a shaft inserted through the hole. a conducting wire arranged in the lumen and an electrode connected to the conducting wire, wherein the conducting wire connected to the electrode is located on the side including the hole in a cross section perpendicular to the axial direction of the shaft, It is characterized in that 70% or more of all the conductors connected to the electrodes are arranged.

According to the method for manufacturing a catheter of the present invention, even if the lumen of the shaft is small, the conducting wire inserted through the lumen of the shaft is less likely to get tangled, and the catheter can be manufactured efficiently. Further, according to the catheter of the present invention, even if the catheter is bent, the conductor wires arranged in the lumen of the shaft are less likely to get entangled.

The top view of the shaft bending process in embodiment of this invention is shown. The top view of the insertion process of the 1st conductor in embodiment of this invention is represented. The top view of the process which draws the 1st conducting wire in embodiment of this invention to the inner side of the curve of a shaft is shown. 4 shows a cross-sectional view along the axial direction of the shaft in the process shown in FIG. 3; FIG. The top view of the insertion process of the 2nd conductor in embodiment of this invention is represented. The top view of the process which draws the 2nd conducting wire in embodiment of this invention to the inner side of the curve of a shaft is shown. FIG. 4A shows a cross-sectional view of a step of arranging a wire pulling member according to an embodiment of the present invention; FIG. 4C is a cross-sectional view along the axial direction of the shaft in the step of inserting the first conductive wire in the embodiment of the present invention; FIG. 4 shows an enlarged plan view (partial cross-sectional view) of the proximal side of the bending jig for the shaft according to the embodiment of the present invention; FIG. 2 shows a schematic diagram of a cross-sectional view along the axial direction of the distal end of a catheter in an embodiment of the present invention; Fig. 3 shows a cross-sectional view perpendicular to the axial direction of the distal end of a catheter in an embodiment of the invention; FIG. 10 is a plan view of a shaft bending jig in 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 can be modified appropriately within the scope of the above and later descriptions. It is of course possible to carry out in addition, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member numbers, etc. may be omitted. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various members in the drawings may differ from the actual dimensions, since priority is given to helping to understand the features of the present invention.

1 to 8 are views of each step of a method for manufacturing a catheter according to an embodiment of the present invention, FIG. 9 is an enlarged plan view of the proximal side of a shaft bending jig, and FIG. 10 is a catheter. 11 is a cross-sectional view of the distal end along the axial direction, FIG. 11 is a cross-sectional view of the distal end perpendicular to the axial direction of the catheter, and FIG. 12 is a shaft curvature 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 has a distal side and a proximal side and is disposed in a shaft 10 having a lumen extending from the distal side to the proximal side and the lumen of the shaft 10. It has a wire 30 and an electrode 40 placed on the surface of the shaft 10 and connected to the wire 30 . The catheter 1 shown in FIG. 10 has the electrode 40 connected to the lead wire 30, but the lead wire 30 may be connected to a sensor (not shown). Details of the catheter 1 of the present invention will be described later.

The first manufacturing method of the catheter 1 of the present invention is provided with a distal side, a proximal side, and a lumen, and a shaft 10 having a first hole 21 and a second hole 22 communicating between the lumen and the outside. and inserting the first conducting wire 31 from the first hole 21 into the lumen of the shaft 10 to expose the first conducting wire 31 from the proximal end 10b of the shaft 10; Later, a step of moving the first conducting wire 31 to the inside of the curve of the shaft 10, and inserting the second conducting wire 32 from the second hole 22 into the lumen of the shaft 10 to insert the second conducting wire 32 into the shaft 10. and the step of exposing from the proximal end 10 b , and the step of inserting the second lead wire 32 is performed after the step of pulling the first lead wire 31 to the inside of the curve of the shaft 10 .

In the present invention, the proximal side refers to the user's hand side with respect to the extending direction of the shaft 10, and the distal side refers to the side opposite to the proximal side, that is, the treatment target side. Moreover, the extending direction of the shaft 10 is called an axial direction. The radial direction refers to the radial direction of the shaft 10, the radially inward refers to the direction toward the axial center of the shaft 10, and the radially outward refers to the direction opposite to the inner side. 1 to 3, 5, 6, 10 and 12, the right side of the drawing is the proximal side of the catheter 1, and the left side of the drawing is the distal side. 7 and 8, the lower side of the drawing is the distal side, and the upper side of the drawing is the proximal side.

As shown in FIG. 1, first, a step 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 communicating between the lumen and the outside. I do. This process is sometimes called a bending process.

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

Materials constituting the shaft 10 include, for example, polyolefin-based resins such as polyethylene and polypropylene, polyamide-based resins such as nylon, polyester-based resins such as PET, aromatic polyetherketone-based resins such as PEEK, polyether-polyamide-based resins, Polyurethane-based resins, polyimide-based resins, fluorine-based resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride-based resins can be used. 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, the intermediate layer of the resin tube that constitutes the shaft 10 may be a structure using a metal braid of stainless steel, carbon steel, nickel-titanium alloy, or the like. The material constituting the shaft 10 is preferably fluororesin, more preferably PTFE. Since the shaft 10 is configured in this way, the outer surface of the shaft 10 has good slidability and has appropriate rigidity, so that the catheter 1 can be easily inserted into a blood vessel.

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

The outer diameter of shaft 10 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1 mm or more. By setting the lower limit value of the outer diameter of the shaft 10 in this way, it is possible to impart appropriate rigidity to the shaft 10 and improve the pushability of the catheter 1 . Also, the outer diameter of the shaft 10 is preferably 3 mm or less, more preferably 2.8 mm or less, and even more preferably 2.5 mm or less. By setting the upper limit of the outer diameter of the shaft 10 in this manner, the catheter 1 can be made thinner, and the insertability into lumens in the body such as blood vessels can be improved, thereby improving minimally invasive treatment. becomes possible.

The thickness of the shaft 10 is preferably 50 μm or more, more preferably 100 μm or more, and even more preferably 150 μm or more. By setting the lower limit value of the thickness of the shaft 10 in this way, it is possible to increase the rigidity of the shaft 10 and to provide the catheter 1 with good insertability. Moreover, the thickness of the shaft 10 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit of the thickness of the shaft 10 in this manner, the lumen of the shaft 10 can be widened, and the lead 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 indicates 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 on the same plane. Bending the shaft 10 three-dimensionally refers to 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 not on the same plane.

In the bending step, a portion of the shaft 10 in the axial direction may be bent, but it is preferable to bend the entire shaft 10 . By curving the shaft 10 as a whole in the axial direction, the first conducting wire 31 is moved to the inside of the curve of the shaft 10 in the entirety of the shaft 10 in the step of moving the first conducting wire 31 to the inside of the curve of the shaft 10 . The step of inserting the second lead wire 32 into the lumen of the shaft 10 in which the first lead wire 31 is inserted is further facilitated.

The shaft 10 may be curved at one location, or may be curved at multiple locations. When bending the shaft 10 at a plurality of locations, it is preferable that the bending directions of the bending portions are substantially the same. By bending the shaft 10 at a plurality of locations in this way, in the step of moving the first conducting wire 31 to the inside of the curve of the shaft 10, which is performed after the bending step, the first lead wire 31 is bent to the inside of the curve of the shaft 10 at each curved portion. The second conducting wire 31 can be easily moved, and the second conducting wire 32 can be easily inserted into the shaft 10 after the first conducting wire 31 has been inserted.

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

As shown in FIGS. 3 and 4, after the step of inserting the first conductor wire 31, the step of moving the first conductor wire 31 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 curve. There is a mode in which the bending portion of the shaft 10 is arranged above both ends of the shaft 10 in the bending step, the insertion step is performed after bending the shaft 10 , and the first conducting wire 31 is brought together by the weight of the first conducting wire 31 . mentioned.

As shown in FIGS. 5 and 6, the step of inserting the second lead wire 32 through the second hole 22 and into the lumen of the shaft 10 to expose the second lead wire 32 from the proximal end 10b of the shaft 10 is performed. conduct. This step is sometimes referred to as the step of inserting the second conductor 32 . The step of inserting the second conductor wire 32 is performed after the step of moving the first conductor wire 31 to the inside of the curve of the shaft 10 .

A conductor 30 including a first conductor 31 and a second conductor 32 electrically connects an external device (not shown) such as a power supply device of the catheter 1 and electrodes 40 and sensors, which will be described later. By connecting the lead wire 30 to the external equipment of the catheter 1, the external equipment of the catheter 1 and the electrodes 40 and sensors are electrically connected. In addition, although not shown, the catheter 1 has a connector on the proximal side, and the lead wire 30 is connected to the connector. may be connected to the electrode 40 or the sensor. In addition, when the catheter 1 has a connector, it is preferable to have a step of connecting the first conductor 31 and the second conductor 32 to the connector after the step of inserting the second conductor 32. It is more preferable to have the connecting step after the step of moving the shaft 10 to the inside of the curve and the step of moving the second conductor wire 32 to the inside of the curve of the shaft 10 .

Wire 30 preferably has a core and a sheath. The material forming the core of the conductor wire 30 may be any conductive material, and examples thereof include metal materials such as iron, copper, silver, stainless steel, tungsten, nickel, titanium, and alloys thereof. Among others, the material forming the core of the conducting wire 30 is preferably stainless steel. Since stainless steel has straightness and rigidity, the material forming the core of the conducting wire 30 is made of stainless steel. Disconnection of 30 becomes difficult to occur.

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

The coating of the conductive wire 30 may be made of any insulating material. For example, polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyetherketone resins such as PEEK, Synthetic resins such as polyether polyamide resins, polyurethane resins, polyimide resins, fluorine resins such as PTFE, PFA and ETFE, and polyvinyl chloride resins. The material forming the covering of the conductor wire 30 is preferably a fluororesin, and more preferably PFA. Since the coating of the conductor 30 is configured in this way, the insulation of the conductor 30 can be improved, and the slidability with other objects such as other conductors 30 in the lumen of the shaft 10 can be improved. Thus, damage to the coating due to contact between the coating of the conductor 30 and other objects can be prevented.

After exposing the second wire 32 from the proximal end 10b of the shaft 10, the step of drawing the first wire 31 inside the curve of the shaft 10 is preferably completed. That is, by applying an external force to the first conductor wire 31 or the like, the first conductor wire 31 is moved to the inside of the curve of the shaft 10, and in this state, the second conductor wire 32 is inserted, and the second conductor wire 32 is inserted. It is preferable to release the external force applied to the first conductor wire 31 after the insertion step is completed. By performing the step of moving the first conductor wire 31 to the inside of the curve of the shaft 10 in this way, it is possible to secure a wide space inside the shaft 10 in the step of inserting the second conductor wire 32, and the inner space of the shaft 10 can be secured. When inserting the second conductor 32 into the cavity, the second conductor 32 is less likely to get entangled with the first conductor 31, and the step of inserting the second conductor 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 to the inside of the curve of the shaft 10. FIG. By performing such a process, after inserting the second conducting wire 32 into the lumen of the shaft 10 , other objects such as the conducting wire 30 other than the first conducting wire 31 and the second conducting wire 32 are inserted into the shaft 10 . It is possible to secure a wide space in the shaft 10 when inserting it into the lumen, and it is difficult for other objects to get entangled in the first conducting wire 31 and the second conducting wire 32 during the process of inserting other objects. It is possible to facilitate the insertion process.

When the second conducting wire 32 is brought to the inside of the curve of the shaft 10 , it is preferable to bring not only the second conducting wire 32 but also the first conducting wire 31 to the inside of the curve of the shaft 10 . In other words, it is preferable to perform the step of bringing the first conducting wire 31 and the second conducting wire 32 to the inside of the curve of the shaft 10 after the step of inserting the second conducting wire 32 . By performing such a step, the first conductor 31 and the second conductor 32 can be densely packed in the lumen of the shaft 10, and the conductors 30 other than the first conductor 31 and the second conductor 32 and , members other than the lead wire 30 to be placed in the lumen of the shaft 10 can be easily inserted. It is also possible to prevent the first conducting wire 31 and the second conducting wire 32 from getting entangled with other objects. The first conducting wire 31 and the second conducting wire 32 may be brought to the inside of the curve of the shaft 10 at the same time, or may be brought to the inside of the curve of the shaft 10 sequentially.

The second manufacturing method of the catheter 1 of the present invention is provided with a distal side, a proximal side, and a lumen, and a shaft 10 having a first hole 21 and a second hole 22 communicating between the lumen and the outside. and inserting the first conducting wire 31 from the first hole 21 into the lumen of the shaft 10 to expose the first conducting wire 31 from the proximal end 10b of the shaft 10; Later, the step of pulling the first lead wire 31 and inserting the second lead wire 32 from the second hole 22 into the lumen of the shaft 10 exposes the second lead wire 32 from the proximal end 10b of the shaft 10. and a step of causing. In addition, in the description of the second manufacturing method of the present invention, the description of the parts overlapping with the description of the first manufacturing method is omitted.

In the second manufacturing method of the catheter 1 of the present invention, the first lead wire 31 is pulled after the bending step. By pulling the first conducting wire 31, the first conducting wire 31 tends to move toward the inside of the curve of the shaft 10.例文帳に追加As a result, a large space inside the shaft 10 can be secured, 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 placed in the inner space of the shaft 10 . When the first conductor 31 is inserted into the shaft 10, the first conductor 31 is less likely to be entangled with other objects, and the insertion into the lumen of the shaft 10 is facilitated.

Preferably, in the step of pulling the first lead wire 31, the proximal side of the first lead wire 31 is pulled. Specifically, in the step of inserting the first lead wire 31 , it is preferable to pull the portion of the first lead wire 31 exposed from the proximal end 10 b of the shaft 10 . By performing the pulling step of the first conducting wire 31 in this manner, the inserting step and the pulling step of the first conducting wire 31 can be performed with the electrode 40 and the sensor connected in advance to the distal side of the first conducting wire 31. , and the catheter 1 can be manufactured efficiently. The pulling of the conducting wire 30 includes, for example, a mode in which weights of a predetermined weight are attached to both ends of the conducting wire 30 and the conducting wire 30 is moved to the inside of the curve of the shaft 10 .

After exposing the second wire 32 from the proximal end 10b of the shaft 10, the step of pulling the first wire 31 is preferably completed. That is, it is preferable that the first conductor wire 31 is continuously pulled while the second conductor wire 32 is being inserted. By performing the step of pulling the first conductor wire 31 in this manner, the second conductor wire 32 can be inserted while the first conductor wire 31 is kept on the inside of the curve of the shaft 10 . can be easily inserted into the lumen of the shaft 10. Also, in the step of inserting the second conductor 32, the first conductor 31 and the second conductor 32 can be prevented from becoming entangled.

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 performing such a process, when inserting another object such as the conductor 30 different from the first conductor 31 and the second conductor 32 into the lumen of the shaft 10, the space inside the shaft 10 can be increased. becomes possible. Therefore, the step of inserting other objects is facilitated, and other objects are less likely to get entangled with the first conductor 31 and the second conductor 32 .

When performing the step of pulling the second wire 32, it is preferable to pull not only the second wire 32 but also the first wire 31. By performing such a process, the first conductor 31 and the second conductor 32 can be densely packed in the lumen of the shaft 10, and the other conductors 30, etc. of the first conductor 31 and the second conductor 32 can be arranged. A wide space for inserting other objects can be secured, and the other objects are less likely to get entangled with the first conducting wire 31 and the second conducting wire 32, thereby facilitating the process of inserting other objects.

Preferred aspects of the first and second manufacturing methods of the catheter 1 of the present invention are described below.

As shown in FIG. 4 , in the step of inserting the second conducting wire 32 , the first conducting wire 31 is preferably arranged inside the curve of the shaft 10 with respect to the central axis L<b>1 of the lumen of the shaft 10 . In addition, in FIG. 4 , the lower side of the drawing is the inner side of the curve 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 . Therefore, when the second conducting wire 32 is inserted into the lumen of the shaft 10, the second conducting wire 32 may contact and become entangled with the first conducting wire 31, and the first conducting wire 31 may become entangled with the second conducting wire 32. It is possible to prevent obstruction to the insertion and facilitate the insertion process of the second conductor 32 .

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 at the bent portion of the shaft 10 relative to the central axis L1 of the lumen of the shaft 10. It is more preferable that the first conducting wire 31 is arranged inside the curve of the shaft 10 relative 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 becomes possible to secure a large space inside the shaft 10 over a wide range inside the shaft 10 , and when the second conducting wire 32 is inserted, the first conducting wire 31 becomes less of a hindrance.

First hole 21 is preferably proximal to second hole 22 . A first hole 21 and a second hole 22 are thus provided in the shaft 10 , and a first lead wire 31 is inserted through the first hole 21 into the lumen of the shaft 10 and then through the second hole 22 . By inserting the second conducting wire 32 into the lumen of the shaft 10, the first conducting wire 31 and the second conducting wire 32 are less likely to get entangled, and the step of inserting the second conducting wire 32 becomes easier, thereby manufacturing the catheter 1. Efficiency can be increased.

The shaft 10 may have a hole 20 that is different than the first hole 21 and the second hole 22 . That is, the shaft 10 may have a first hole 21 , a second hole 22 , and a hole 20 other than the first hole 21 and the second hole 22 . The additional hole 20 may be one or plural. Since the shaft 10 has a plurality of holes 20 , different conductors 30 can be inserted through each of the holes 20 . By connecting electrodes 40 or sensors to the conductors 30 , a plurality of electrodes 40 and sensors can be connected. It can be a catheter 1 having.

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. Among others, the shape of the hole 20 is preferably circular or elliptical. Since the hole 20 is configured in this way, when the conducting wire 30 is inserted from the hole 20 into the inner cavity of the shaft 10, the external force is prevented from concentrating on one point on the edge of the hole 20, and the hole 20 is torn. damage of the shaft 10 can be prevented.

The longitudinal length of the hole 20 including the first hole 21 and the second hole 22 can be set as appropriate. For example, it can be set according to the longitudinal length of the electrode 40, the sensor, etc. For example, the length of the hole 20 in the longitudinal direction is shorter than the length of the electrode 40, the sensor, etc. in the longitudinal direction. is preferred. The length of the hole 20 in the longitudinal direction is preferably 100 μm or more, more preferably 125 μm or more, and even more preferably 150 μm or more. By setting the lower limit of the length of the hole 20 in the long axis direction in this manner, it becomes easier to insert the conductor 30 into the hole 20 . Moreover, the length of the hole 20 in the major axis direction is preferably 300 μm or less, more preferably 250 μm or less, and even more preferably 200 μm or less. By setting the upper limit of the length of the hole 20 in the longitudinal direction in this way, the gap between the hole 20 and the lead wire 30 can be reduced, and the gap between the hole 20 and the lead wire 30 can be reduced when the catheter 1 is used. This makes it difficult for liquid such as blood to enter the lumen of the shaft 10 . When the shape of the hole 20 is circular or polygonal, the outer diameter of the hole 20 is preferably within the same range as the length of the hole 20 in the direction perpendicular to the long axis direction.

The shaft 10 has a plurality of holes 20 through which the wires 30 can be sequentially passed through the lumen of the shaft 10 from the most proximal hole 20 to expose the wires 30 from the proximal end 10b of the shaft 10. preferable. That is, the lead 30 is passed through the lumen of the shaft 10 from the most proximal hole 20, then through the hole 20 adjacent to the most proximal hole 20, and finally through the hole 20 at the distal most position. A wire 30 is preferably passed through 20 . By inserting the conductors 30 into the lumen of the shaft 10 in this manner, the conductors 30 are less likely to get tangled during the process of inserting the conductors 30, and the process of inserting the conductors 30 is facilitated.

As shown in FIG. 1, it is preferable to arrange the first hole 21 and the second hole 22 so as to be inside the bending of the shaft 10 in the bending process. By arranging the shaft 10 in this way, the first conducting wire 31 inserted into the lumen of the shaft 10 from the first hole 21 is easily arranged inside the curve of the shaft 10, and the second conducting wire 32 is inserted. becomes easier to do. In addition, the second conductor 32 can be easily arranged inside the curve of the shaft 10, and the step of inserting other objects such as the conductor 30 other than the first conductor 31 and the second conductor 32 can be easily performed.

The first hole 21 and the second hole 22 may be arranged on one side of 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 arranged 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 arranging the first hole 21 and the second hole 22 on one side of the cross section perpendicular to the axial direction of the shaft 10, the first conducting wire 31 inserted through the first hole 21 and the second conducting wire 31 are connected. The second conducting wire 32 inserted through the hole 22 is more likely to be arranged inside the bend of the shaft 10, and the first conducting wire 31 and the second conducting wire 32 are less likely to get entangled.

A first lead 31 has an electrode 40 or sensor at the distal end of the first lead 31 and a second lead 32 has an electrode 40 or sensor at the distal end of the second lead 32 is preferred. A temperature sensor, a pressure sensor, etc. are mentioned as a sensor. By having the electrodes 40 on the first conducting wire 31 and the second conducting wire 32, the catheter 1 having the electrodes 40 on the distal side of the shaft 10 can be provided, which can be used for cauterization of lesions, measurement of intracardiac potential, and ablation. Treatment and examination for fibrillation, etc. 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, the blood vessel, etc. and the catheter 1, and the temperature, blood pressure, body temperature, etc. around the lesion accompanying cauterization of the lesion can be detected. Measurement can be performed using the catheter 1, treatment and examination are facilitated, and the procedure time can be shortened.

The shape of the electrode 40 or the sensor may be a plate shape such as a rectangle or square, or may be a ring shape. When the electrode 40 or the sensor is flat, at least one of the rear surface (inner surface) and front surface (outer surface) of the flat plate may be curved so as to easily follow the curved surface of the shaft 10 . Among others, the electrode 40 or sensor is preferably ring-shaped. Since the electrode 40 or the sensor is ring-shaped, 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 the target site such as the inner wall of the heart. Become.

Examples of materials that constitute the electrodes 40 or sensors include metallic materials such as copper, gold, platinum, aluminum, iron, or alloys thereof. Among them, the material constituting the electrode 40 or the sensor is preferably platinum or its alloy. By configuring the electrodes 40 or sensors in this way, the electrodes 40 or sensors can be made more imaging to X-rays, and the position of the electrodes 40 or sensors can be confirmed by using X-rays when the catheter 1 is in use. can do.

As a method of connecting the lead wire 30 to the electrode 40 or the sensor, for example, welding, brazing such as soldering, caulking, or the like can be used. The preferred method of connecting the wire 30 to the electrode 40 or sensor is welding, among others. By connecting the lead wire 30 to the electrode 40 or sensor by welding, the connection between the lead wire 30 and the electrode 40 or sensor can be easily made strong. Also, although not shown, the conductor 30 and the electrode 40 or the sensor may be connected with a conductive member interposed between the conductor 30 and the electrode 40 or the sensor.

It is preferable that the connecting portion between the lead 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 the moisture contained in the air or the like. Resins used for this coating include, for example, polyurethane-based resins and epoxy-based resins.

If the electrode 40 or sensor is ring-shaped, it is preferred that the conductor 30 is connected to the inside of the ring. Since the electrode 40 or the sensor is configured in this manner, the connection portion between the electrode 40 or the sensor and the conductor wire 30 is not exposed to the outside, and the connection portion may come into contact with another object, and the conductor wire 30 may be damaged by the electrode 40. Alternatively, it is possible to prevent detachment from the sensor.

When the distal end of the first conductor 31 has an electrode 40 or a sensor, the electrode 40 or the sensor of the first conductor 31 is attached to the outer surface of the shaft 10 after the step of inserting the first conductor 31 . It is preferable to have a step of arranging the In this step, it is preferable to arrange the connecting portion between the electrode 40 or the sensor and the first lead wire 31 so as to overlap at least a portion of the first hole 21 . In this way, by arranging the connecting portion with the first conducting wire 31 so as to overlap at least a part of the first hole 21 , a gap is less likely to occur between the electrode 40 or the sensor and the shaft 10 . It is possible to prevent 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 when the catheter 1 is used. It also has a ring-shaped electrode 40 or sensor at the distal end of the first lead 31 that wraps around the shaft 10 and a similar ring-shaped electrode 40 or sensor at the distal end of the second lead 32 . , placing the electrode 40 or sensor of the first lead 31 on the outer surface of the shaft 10 prior to placing the electrode 40 or sensor of the second lead 32 on the outer surface of the shaft 10 is preferred. By arranging the electrodes 40 or sensors in this manner, the respective electrodes 40 or sensors can be arranged smoothly.

Similarly, when the electrode 40 or the sensor is provided at the distal end of the second conducting wire 32, after the second conducting wire 32 is inserted, the electrode 40 or the sensor possessed by the second conducting wire 32 is removed. The electrode 40 or sensor of the second conductor 32 is preferably placed on the outer surface of the shaft 10 such that the connection with the second conductor 32 overlaps at least a portion of the second hole 22 .

As shown in FIG. 7, prior to the step of inserting the first lead wire 31, a step of placing the lead wire pulling member 110 in the lumen of the shaft 10, and a step of fixing the first lead wire 31 to the lead wire pulling member 110. , is preferred. By using the lead wire pulling member 110 in manufacturing the catheter 1, it becomes easier to insert the first lead wire 31 into the lumen of the shaft 10, and the time required for the step of inserting the first lead wire 31 can be shortened. As a result, the manufacturing efficiency of the catheter 1 can be enhanced. The step of arranging the lead wire pulling member 110 in the lumen of the shaft 10 may be referred to as the lead wire pulling member 110 placement step, and the step of fixing the first lead wire 31 to the lead wire pulling member 110 may be referred to as the first lead wire pulling member 110 placement step. 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 lumen of the shaft 10 . Conductive wire pulling member 110 is preferably a linear object. Examples of the material forming the wire pulling member 110 include metal materials such as iron, copper, silver, stainless steel, tungsten, nickel, titanium, and alloys thereof. Among others, it is preferable that the material constituting the wire pulling member 110 is stainless steel. Since the lead wire pulling member 110 is configured in this manner, the lead wire pulling member 110 has straightness, so that it can easily pass through the lumen of the shaft 10 , and the lead wire 30 can be easily inserted into the lumen of the shaft 10 . can.

The wire pulling member 110 preferably has a portion for fixing the wire 30 at one end. As a portion for fixing the conductor wire 30, a part of the conductor wire pulling member 110 may be formed in a ring shape or a C shape, and the conductor wire 30 may be hooked on this portion, or may be provided with a portion for holding the conductor wire 30. etc. Among them, one end of the wire pulling member 110 is ring-shaped, and it is preferable that the wire 30 is hooked on the ring-shaped portion to be fixed. By configuring the lead wire pulling member 110 in this manner, the lead wire 30 can be easily fixed, and the lead wire 30 can be easily inserted into the lumen of the shaft 10 .

The outer diameter of the lead wire pulling member 110 including the portion where the lead wire 30 is fixed can be appropriately selected according to the inner diameter of the shaft 10 through which the lead wire 30 is inserted. The outer diameter of the other end of the lead wire pulling member 110 is set to a size that can impart appropriate rigidity to the lead wire pulling member 110 and a size that allows the lead wire pulling member 110 to easily pass through the lumen of the shaft 10. is preferred.

As shown in FIG. 7 , in the step of fixing the first lead wire 31 , the first lead wire 31 is inserted through the first hole 21 into the lumen of the shaft 10 , and the first lead wire 31 is attached to the distal end of the shaft 10 . Preferably, the first wire 31 exposed from 10 a is secured to the wire puller 110 . By performing the step of fixing the first conductor 31 in this manner, the first conductor 31 can be easily and reliably fixed to the conductor wire pulling member 110, and the step of inserting the first conductor 31 can be easily performed. becomes.

In the step of arranging the lead wire pulling member 110, the other end of the lead wire pulling member 110 opposite to the one end where the first lead wire 31 is fixed is moved from the distal end 10a of the shaft 10 to the inner cavity of the shaft 10. It is preferable to insert the By performing the step of arranging the conductor wire pulling member 110 in this way, the first conductor wire 31 can be easily fixed to the conductor wire pulling member 110, and the first conductor wire 31 fixed to the conductor wire pulling member 110 can be inserted into the lumen of the shaft 10. Easier to insert.

As shown in FIG. 8, in the step of inserting the first conductor wire 31, when the portion of the conductor wire pulling member 110 for fixing the first conductor wire 31 passes through the portion of the shaft 10 where the first hole 21 exists, , the portion of the first conductor 31 exposed through the first hole 21 is preferably bent distally. By performing the step of inserting the first conductor wire 31 in this way, when the conductor wire pulling member 110 to which the first conductor wire 31 is fixed passes through the portion where the first hole 21 is present, the first conductor wire 31 is It becomes difficult to damage the shaft 10 in the vicinity of the first hole 21, and it is possible to prevent the occurrence of defective products in the manufacture of the catheter 1, such as the shaft 10 being torn in the vicinity of the first hole 21.

After the step of inserting the first wire 31 is completed, removing the first wire 31 from the wire pulling member 110; 2, the step of fixing the conductor 32 is preferably performed. By performing such a step, the step of inserting the second conductive wire 32 is facilitated.

In the step of fixing the second lead wire 32, the second lead wire 32 is inserted through the second hole 22 into the lumen of the shaft 10, the second lead wire 32 is exposed from the distal end 10a of the shaft 10, and exposed. Preferably, the second wire 32 is secured to the wire pull member 110 . By performing the fixing process of the second conductor wire 32 in this way, the second conductor wire 32 can be easily and reliably fixed to the conductor wire pulling member 110, and the insertion step of the second conductor wire 32 can be easily performed. be able to.

In the manufacturing method of the catheter 1 , it is preferable to have a bending jig 120 for bending the shaft 10 . As shown in FIGS. 1 to 3, 5, and 6, the bending jig 120 preferably has a cylindrical shape, so that the shaft 10 can be It is easy to bend, and the bending state of the shaft 10 can be easily maintained. Moreover, the bending jig 120 may hold the shaft 10 continuously, or may hold the shaft 10 partially. For example, as shown in FIG. 12, the bending jig 120 may have two members that hold a portion of the shaft 10 on the distal side and a portion on the proximal side. The cross section of the bending jig 120 in the longitudinal direction can be circular, notched circular, L-shaped, or the like. The bending jig 120 only needs to be able to hold the shaft 10 in a curved shape, so it may be an adhesive surface member or the like.

As shown in FIG. 9, in the bending step, the shaft 10 is inserted into the lumen 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 using such a jig, it is preferable to perform the bending step before other steps such as the step of inserting the first conductor 31 . By performing such a step, the shaft 10 moves in the step of inserting the lead wire 30 into the lumen of the shaft 10, which is the step of inserting the first lead wire 31 and the second lead wire 32 after the bending step. This makes it easier to insert the conductor 30 and prevents the conductor 30 from getting entangled.

The shaft fixture 130 is inserted between the bending jig 120 and the shaft 10 inserted through the lumen of 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, a solid columnar shape, and the like. Above all, it is preferable that the shaft fixture 130 is flat. Since the shaft fixture 130 is configured in this way, when the shaft fixture 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. While doing so, the shaft 10 can be made less likely to be damaged.

The material forming the bending jig 120 is preferably a transparent or translucent synthetic resin. By configuring the bending jig 120 in this way, it is possible to visually confirm the shaft 10 inserted through the lumen of the bending jig 120, and to confirm the state of the shaft 10 in the bending process.

The bending jig 120 has a lead wire fixing portion 140 that grips the first lead wire 31. In the process of inserting the second lead wire 32, the first lead wire exposed from the proximal end 10b of the shaft 10 is removed. 31 is preferably fixed to the wire fixing portion 140 . By performing such a step, the first conductor wire 31 and the second conductor wire 32 are less likely to get entangled, and the second conductor wire 32 can be easily inserted into the lumen of the shaft 10 .

The conductor wire fixing portion 140 has, for example, an adhesive tape, the first conductor wire 31 is attached to the adhesive tape, and a holding portion is provided, and the first conductor wire 31 is held by the holding portion. , fixing the first conductor 31 by directly tying the first conductor 31 to the conductor fixing portion 140, or the like. Among them, it is preferable that the conductor wire fixing portion 140 has an adhesive tape, and the first conductor wire 31 is fixed to the conductor wire fixing portion 140 by attaching the first conductor wire 31 to the adhesive tape. By configuring the conductor wire fixing portion 140 in this way, the first conductor wire 31 can be fixed easily and quickly.

An inner tube 150 may be inserted into the proximal end 10b of the shaft 10, as shown in FIG. In the inner tube 150, the conducting wire 30 inserted through the shaft 10 is passed through the lumen of the inner tube 150, so that the conducting wire 30 comes into contact with the proximal end 10b of the shaft 10 and the conducting wire 30 and the proximal end of the shaft 10 are damaged. can prevent you from doing it.

Inner tube 150 is preferably fixed to shaft 10 . By fixing the inner tube 150 to the shaft 10, the inner tube 150 is prevented from coming off the shaft 10 during the process of inserting the conductor 30, and the process of inserting the conductor 30 is facilitated. The fixing between the inner tube 150 and the shaft 10 can be performed by, 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 moved in one direction. Bending to the side is preferred. 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 manner, it becomes easy to bring the distal end of the catheter 1 into contact with a target site such as the heart chamber, and treatment and examination using the electrodes 40 and sensors can be easily performed. . In addition, the fact that the distal end portion of the wire 50 is fixed to the distal end portion of the shaft 10 means that the distal end portion of the wire 50 is directly fixed to the distal end portion of the shaft 10. It also includes the fact that the distal end of 50 is indirectly fixed via another object such as a distal tip, which will be described later.

As for the wire 50, the distal end of the wire 50 may be 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. By fixing the wire 50 to the shaft 10 in this way, the distal side of the shaft 10 can be greatly bent.

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

The diameter of the wire 50 can be appropriately selected according to the inner diameter of the shaft 10, the outer diameter of the conducting wires 30 to be arranged, the number of wires, and the like. In particular, it is preferable that the wire 50 has sufficient strength and that the inner lumen of the shaft 10 can be sufficiently wide.

Although not shown, shaft 10 may have a distal tip at its distal end. The distal tip can be a hemispherical electrode 40 or sensor, a lid-like member that closes the opening at the distal end of shaft 10 . Since the shaft 10 has a distal tip, water such as blood enters the lumen of the shaft 10 when the catheter 1 is used, and the water enters the connecting portion between the electrode 40 or the sensor and the lead wire 30 and the plurality of lead wires 30 . It is possible to prevent the deterioration of the insulation between the conductors 30 due to the contact and the occurrence of a drift phenomenon in which the baseline potential of the electrocardiogram becomes unstable when measuring the intracardiac potential. In addition, the distal tip serves as a guide for the distal end of the catheter 1, so that the insertability of the catheter 1 can be improved.

If the catheter 1 has a wire 50 , the distal tip can be a fixed portion of the wire 50 in the lumen of the shaft 10 . Having the fixed end of the wire 50 at the distal tip allows the manipulation of the wire 50 to effectively bend the distal end of the catheter 1 .

If the catheter 1 has a wire 50 and the shaft 10 has a distal tip at its distal end, fixing the distal end of the wire 50 to the distal end of the shaft 10 will Preferably, the wire is a metal wire, the tip is made of metal, and the wire 50 and the tip are fixed by soldering. This fixation of the distal end of the wire 50 and the distal end of the shaft 10 provides a strong fixation between the wire 50 and the shaft 10 for distal bending of the shaft 10 . Even if the wire 50 is moved in the axial direction, the wire 50 can be made difficult to come 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. It should be noted that the tip can also serve as the electrode 40 or the sensor by forming the tip from a conductive material such as the material that forms the electrode 40 or the sensor and connecting the tip to the lead wire 30 .

The opening at the distal end of the shaft 10 may be closed by heat-sealing the distal end portion of the shaft 10 without providing the tip at the distal end of the shaft 10 .

Further, even when using the catheter 1 having a plurality of conducting wires 30 in the lumen of the shaft 10, when the catheter 1 is bent, the conducting wires 30 become entangled with other conducting wires 30 and wires 50 for bending, and the electrodes 40 and sensors are damaged. There are also problems such as being unusable and disconnection of the conducting wire 30 . The catheter 1 of the present invention that can solve this problem will be described below.

The catheter 1 of the present invention includes a shaft 10 having a distal side, a proximal side, and a lumen, a hole 20 through which the outside of the shaft 10 and the lumen of the shaft 10 are communicated, and the hole 20 to which the shaft 10 is inserted. and an electrode 40 connected to the lead wire 30 arranged in the lumen of the shaft 10, and the electrode 40 is located on the side including the hole 20 in the cross section orthogonal to the axial direction of the shaft 70% or more of all the conductors 30 connected to the electrodes 40 are arranged. Note that 70% or more of the total number of conductors 30 connected to the electrodes 40 refers to 70% or more of the total number of conductors 30 connected to the electrodes 40 .

As shown in FIG. 10, the catheter 1 includes a shaft 10 having a distal side, a proximal side, and a lumen; and has a lead 30 disposed in the lumen of the shaft 10 and an electrode 40 connected to the lead 30 .

Hole 20 preferably has at least a first hole 21 and a second hole 22 . That is, the catheter 1 preferably has multiple holes 20 . Since the hole 20 of the catheter 1 has at least the first hole 21 and the second hole 22, the catheter 1 can be provided with a plurality of electrodes 40 and sensors, and the catheter 1 can be made multipolar and multifunctional. It can be performed.

Conductor 30 preferably has at least a first conductor 31 and a second conductor 32 . That is, it is preferable that the catheter 1 has a plurality of conducting wires 30 . The lead 30 having at least a first lead 31 and a second lead 32 allows the catheter 1 to have multiple electrodes 40, multiple sensors, or both electrodes 40 and sensors.

The catheter 1 may have at least one electrode 40 connected to the lead wire 30 , but preferably has a plurality of electrodes 40 connected to the lead wire 30 . The catheter 1 also has an electrode 40 connected to the first lead 31 and an electrode 40 connected to the second lead 32, different from the electrode 40 connected to the first lead 31. It is preferable to have By configuring the catheter 1 in this manner, the catheter 1 can be made multipolar, and treatment and examination such as cauterization at multiple locations and measurement of intracardiac potential can be performed at once, thereby shortening the procedure time. can do.

As shown in FIG. 11, in a cross section perpendicular to the axial direction of the shaft 10, the conductor 30 connected to the electrode 40 is located on the side including the hole 20, and the entire conductor 30 connected to the electrode 40 70% or more of the The side of the shaft 10 on which the hole 20 is included is the portion of the section divided by the straight line L2 passing through the axial center of the shaft 10 in the cross section perpendicular to the axial direction of the shaft 10 where the hole 20 of the shaft 10 is present. point to the side In addition, in the catheter 1 shown in FIG. 11 , the lower side of the drawing is the side including the hole 20 .

In a cross section perpendicular to the axial direction of the shaft 10, 70% or more of all the conductors 30 connected to the electrodes 40 are arranged on the side including the hole 20. preferably 75% or more, more preferably 80% or more, even more preferably 85% or more, and particularly 90% or more. preferable. By configuring the catheter 1 in this manner, the lead wire 30 is less likely to get entangled with other objects when the catheter 1 is in use, which effectively prevents the electrodes 40 and sensors from becoming unusable and the lead wire 30 from breaking. can be prevented.

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 bent to one side, A cross section orthogonal to the axial direction of the shaft 10 preferably includes a hole 20 on the one side. By configuring the catheter 1 in this way, when the distal side of the catheter 1 is bent, an external force is less likely to be applied to the lead wire 30 inserted through the hole 20, and the lead wire 30 is less likely to break.

Although not shown, the catheter 1 may have a handle on the proximal side. Preferably, the handle is connected to the proximal end of shaft 10 and the proximal end of wire 50 is secured to the handle. By configuring the catheter 1 in this manner, the wire 50 can be easily moved in the axial direction, and the catheter 1 can be easily operated.

Preferably, the conductor 30 has an electrode 40 connected to its distal end and an electrical connector connected to its proximal end. Examples of electrical connectors include connectors, boards, and the like. Since the lead wire 30 is 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 lead wire 30 to the external device of the catheter 1 .

Although not shown, the catheter 1 preferably has an elastic member whose distal end is 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 an elastic member, it is possible to finely adjust the bending degree of the distal side of the shaft 10 by moving the wire 50 in the axial direction.

For example, the elastic member may be composed of a leaf spring, a coil spring, or the like. Among them, it is preferable that the elastic member is a leaf spring. A leaf spring is a spring using a plate material, and has a rectangular cross-sectional shape perpendicular to the axial direction of the leaf spring. Since the long side of the cross-sectional shape of the leaf spring is bent, when the wire 50 is moved in the axial direction, the long side of the leaf spring is bent toward the wire 50 side. Therefore, by using the leaf spring as the elastic member, the bending direction of the distal side of the shaft 10 can be determined.

Materials constituting the elastic member include, for example, stainless steel, carbon steel, copper alloys, and titanium alloys. Among others, it is preferable that the material constituting the elastic member is stainless steel. By configuring the elastic member in this way, it becomes easier to adjust the bending degree of the distal side of the shaft 10 .

The distal end of the elastic member may be fixed to the distal end of shaft 10 , but preferably the distal end of the elastic member is fixed to the distal end of the lumen of shaft 10 . This fixation of the distal end of the elastic member to the shaft 10 facilitates adjustment of the distal bending of the shaft 10 .

The method of fixing the distal end portion of the elastic member and the distal end portion of the shaft 10 is not particularly limited. The fixation between the distal end of the elastic member and the distal end of the shaft 10 is such that the shaft 10 has a metal tip at the distal end, the elastic member is metal, and the elastic member and the tip are fixed together. are preferably fixed by soldering. By fixing the distal end of the elastic member and the distal end of the shaft 10 in this manner, the elastic member can be firmly fixed to the shaft 10, and the distal side of the shaft 10 can be bent. It is possible to prevent the elastic member from coming off from the shaft 10 even if the elastic member is attached. 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, an inner cylinder is arranged in the lumen of the shaft 10, and the wire 50 and the elastic member are arranged in the lumen of the inner cylinder, Conductive wire 30 is preferably disposed in the lumen of shaft 10 and outside the inner cylinder. By configuring the catheter 1 in this way, it is possible to prevent the lead wire 30 from coming into contact with the wire 50 or the elastic member and from being damaged.

Examples of the inner cylindrical member include a tube having a cylindrical shape and a coil obtained by spirally winding a wire rod. Moreover, the synthetic resin, the metal, etc. which were mentioned as the material which comprises the shaft 10 can be used for the material which comprises an inner cylinder member. Among others, the inner cylindrical member is preferably made of metal, and more preferably a coil formed by spirally winding a stainless steel wire rod. By configuring the inner cylindrical member in this way, it is possible to increase the rigidity of the shaft 10 while also imparting appropriate flexibility to it, so that it can be easily inserted into a blood vessel, and the distal side of the shaft 10 can be easily inserted. It is possible to make the catheter 1 easy to adjust the degree of bending.

As described above, the first manufacturing method of the catheter of the present invention has a distal side, a proximal side, and a lumen, and has a first hole and a second hole communicating between the lumen and the outside. bending the shaft; inserting a first conductor wire through the first hole and into the lumen of the shaft to expose the first conductor wire from the proximal end of the shaft; urging the lead to the inside of the curvature of the shaft; and inserting the second lead through the second hole and into the lumen of the shaft to expose the second lead from the proximal end of the shaft; The step of inserting the second conductor wire is characterized in that it is performed after the step of bringing the first conductor wire closer to the inside of the curve of the shaft. A second manufacturing method of the catheter of the present invention is a step of curving a shaft having a distal side, a proximal side, and a lumen, and having a first hole and a second hole communicating between the lumen and the outside. and inserting the first lead wire through the first hole and into the lumen of the shaft to expose the first lead wire from the proximal end of the shaft; and pulling the first lead wire after the bending step. and inserting the second conductor through the second hole and into the lumen of the shaft to expose the second conductor from the proximal end of the shaft. By performing the first manufacturing method and the second manufacturing method of the catheter of the present invention in this way, even if the shaft has a small lumen, the conducting wire inserted through the shaft lumen is less likely to get tangled, and the catheter can be effectively used. The catheter can be manufactured in

In addition, the catheter of the present invention includes 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, and a catheter inserted through the hole and arranged in the lumen of the shaft. and an electrode connected to the conductive wire, and the conductive wire connected to the electrode is connected to the electrode on the side including the hole in a cross section orthogonal to the axial direction of the shaft 70% or more of all of the conducting wires are arranged. Since the catheter of the present invention is configured in this way, even if the catheter is bent, the conductor wires arranged in the lumen of the shaft are less likely to get entangled.

1: catheter 10: shaft 10a: distal end of shaft 10b: proximal end of shaft 20: hole 21: first hole 22: second hole 30: lead 31: first lead 32: second lead 40: Electrode 50: Wire 110: Lead wire pulling member 120: Bending jig 130: Shaft fixture 140: Lead wire fixing part 150: Inner tube L1: Central axis of lumen of shaft L2: Straight line passing through the axial center of shaft

Claims (17)

curving a shaft comprising a distal side, a proximal side and a lumen, the shaft having first and second holes communicating between the lumen and the exterior;
passing a first wire through the first hole and into the lumen of the shaft to expose the first wire from the proximal end of the shaft;
a step of, after the bending step, moving the first conductor to the inside of the curve of the shaft;
passing a second lead wire through the second hole and through the lumen of the shaft to expose the second lead wire from the proximal end of the shaft;
A method for manufacturing a catheter, wherein the step of inserting the second lead wire is performed after the step of moving the first lead wire to the inside of the curve of the shaft. 2. The method of manufacturing a catheter according to claim 1, wherein after exposing the second conductor from the proximal end of the shaft, the step of bringing the first conductor inside the curve of the shaft is terminated. curving a shaft comprising a distal side, a proximal side and a lumen, the shaft having first and second holes communicating between the lumen and the exterior;
passing a first wire through the first hole and into the lumen of the shaft to expose the first wire from the proximal end of the shaft;
a step of pulling the first conductor after the bending step;
a step of inserting a second conducting wire through the second hole and into the lumen of the shaft to expose the second conducting wire from the proximal end of the shaft. . 4. The method of manufacturing a catheter according to claim 3, wherein the step of pulling the first lead wire is terminated after the second lead wire is exposed from the proximal end of the shaft. 5. The first conducting wire according to any one of claims 1 to 4, wherein in the step of inserting the second conducting wire, the first conducting wire is arranged inside the curve of the shaft with respect to the central axis of the lumen of the shaft. method of manufacturing a catheter. The method for manufacturing a catheter according to any one of claims 1 to 5, wherein the first hole is closer to the proximal side than the second hole. the shaft has a plurality of holes,
The method for manufacturing a catheter according to any one of claims 1 to 6, wherein the conducting wire is sequentially passed through the lumen of the shaft from the most proximal hole, and the conducting wire is exposed from the proximal end of the shaft. The method for manufacturing a catheter according to any one of claims 1 to 7, wherein in the bending step, the first hole and the second hole are arranged inside the curve of the shaft. said first lead having an electrode or sensor at a distal end of said first lead;
The method of manufacturing a catheter according to any one of claims 1 to 8, wherein the second conductor has an electrode or sensor at the distal end of the second conductor. 10. The method of manufacturing a catheter of claim 9, wherein the electrodes or sensors are ring-shaped. 10. Claims 1 to 10, comprising the steps of placing a lead wire pulling member in a lumen of the shaft and fixing the first lead wire to the lead wire pulling member before the step of inserting the first lead wire. A method for manufacturing a catheter according to any one of Claims 1 to 3. In the step of fixing the first conductor, the first conductor is inserted through the first hole into the lumen of the shaft, and the first conductor is exposed from the distal end of the shaft. 12. The method of manufacturing a catheter of claim 11, wherein the first lead wire is secured to the lead pull member. In the step of arranging the lead wire pulling member, the other end of the lead wire pulling member opposite to the one end that is the portion for fixing the first lead wire is inserted from the distal end of the shaft into the lumen of the shaft. 13. A method for manufacturing the catheter according to claim 11 or 12, wherein the catheter is inserted. In the step of inserting the first conductor wire, when the portion of the conductor wire pulling member for fixing the first conductor wire passes through the portion where the first hole exists, the first 14. The method of manufacturing a catheter according to claim 13, wherein the portion exposed from the hole of the is bent distally. It has a tubular bending jig for bending the shaft,
15. The bending step according to any one of claims 1 to 14, wherein the shaft is inserted through a 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. A method for manufacturing the catheter according to item 1. The bending jig has a conductor fixing portion that grips the first conductor,
16. The method of manufacturing a catheter according to claim 15, wherein in the step of inserting the second lead wire, the first lead wire exposed from the proximal end of the shaft is fixed to the lead 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 any one of claims 1 to 16, wherein the distal side of the shaft is bent to one side by moving the wire in the axial direction.

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