JP2021115325A - catheter - Google Patents

Abstract

To provide a catheter capable of increasing a cross sectional area of a main lumen relative to a prior catheter of parallel tube structure.SOLUTION: A catheter 100 comprises: a main lumen 11; and a sub-lumen 15. The catheter 100 comprises: an internal reinforcement material 13 having a processed part 13a which is arranged on a periphery of or in the vicinity of the periphery of the main lumen 11, is formed of a metal or plastic pipe, and has been subjected to processing for removing at least a part thereof for securing pipe bending property, and a sub-lumen formation part in which the sub-lumen is formed and which is provided in a portion other than the processed part; and a sub-lumen 15 formed in the sub-lumen formation part.SELECTED DRAWING: Figure 2

Description

The present invention relates to a catheter.

Some catheters, such as those used for balloon catheters, have multiple lumens inside the catheter. Catheter having a plurality of lumens includes a catheter having a concentric double tube structure and a catheter having a parallel tube structure in which lumens are arranged in parallel (see Patent Document 1).

In the case of a catheter having such a parallel tube structure, there is a problem that the cross-sectional area of the main lumen becomes small because it has a region through which the sub-lumen passes. In particular, in recent years, in percutaneous coronary intervention used for ischemic heart disease such as angina and myocardial infarction, and balloon dilatation in catheter treatment for peripheral arterial disease, complicated blood vessels such as heart and peripheral artery are used. Since the guiding catheter cannot be inserted into the lesion because it needs to be passed through the system, a balloon, stent, IVUS, or OCT should be inserted using a microcatheter or half-pipe catheter that is thinner than the guiding catheter. Is being done. However, since the microcatheter and the half-pipe catheter have a short diameter, there is a problem that the main lumen becomes narrower.

Japanese Unexamined Patent Publication No. 2019-50861

Therefore, the present invention has been made to solve such a problem, and in a catheter having a parallel tube structure, the cross-sectional area of the main lumen can be increased as compared with a catheter having a conventional parallel tube structure. The purpose is to provide a catheter.

The present invention has taken the following measures to achieve the above object.

The catheter of the present invention
In a catheter with a main lumen and a sublumen
A processed portion which is arranged on or near the outer circumference of the main lumen, is made of a metal or plastic pipe, and is processed to remove at least a part in order to secure the curvature of the pipe, and the above-mentioned An internal reinforcing material having a sub-lumen forming portion that is a portion other than the processed portion and on which the sub-lumen is formed,
The sub-lumen formed in the sub-lumen forming portion and
It is characterized by having.

In the catheter according to the present invention, a wide area of the main lumen is secured by directly providing the sub-lumen to the internal reinforcing material arranged on the outer periphery or the vicinity of the outer peripheral side of the main lumen in order to reinforce the main lumen. Generally, the internal reinforcing material is made of a coil or a braid, but in the case of an internal reinforcing material of a coil or a braid, if a slit or a notch is made to install a sublumen, it will be unraveled or separated. Therefore, it is not possible to make slits or cuts in the coil or braid. However, in the present invention, the shape can be maintained even if slits or notches are made by producing the internal reinforcing material by using a base material made of metal or plastic which has been processed into a pipe in advance. Therefore, it is possible to form sublumens in the slits and notches.

Further, in the catheter according to the present invention, the processed portion of the internal reinforcing material may be characterized in that it is cut-processed.

The internal reinforcing material is notched in order to ensure curvature. The form is not particularly limited as long as the curvature can be ensured.

Further, in the catheter according to the present invention, the internal reinforcing material may be characterized in that the processed portion is formed in a slit shape.

By forming the processed portion in a slit shape, the slit-shaped portion can be curved so as to open, or can be curved so as to close. Therefore, a highly flexible catheter can be obtained.

Further, in the catheter according to the present invention, the internal reinforcing material may be characterized in that the processed portion is formed in a net shape or a mesh shape.

By adopting such a configuration, the portion formed in a net shape or a mesh shape is deformed, so that it becomes easy to bend, and a highly flexible catheter can be obtained.

Further, in the catheter according to the present invention,
The sub-lumen may be characterized in that it is joined to a slit for a sub-lumen in which a portion other than the processed portion is cut into a slit shape.

In forming the sub-lumen, a portion other than the processed portion of the internal reinforcing material is cut in the longitudinal direction to form a slit for the sub-lumen, and the sub-lumen is attached to the slit for the sub-lumen. By adopting such a configuration, a main lumen having a larger cross section can be provided as compared with the case where the sub-lumen is provided on the outer peripheral side of the internal reinforcing material as in the conventional case.

Further, in the catheter according to the present invention,
The sub-lumen may be characterized in that it is formed of a through hole that penetrates a portion other than the processed portion in the longitudinal direction.

By adopting such a configuration, the step of reattaching the sub-lumen can be omitted, and the sub-lumen can be easily formed. Further, since the joint between the sublumen and the internal reinforcing material is prevented from being cut, a more stable catheter can be obtained.

Further, the catheter according to the present invention may be characterized in that a balloon is provided at the distal end or in the vicinity of the distal end.

It is a balloon catheter having a balloon at the distal end or near the distal end. By using a balloon catheter, the sublumen can be used as a lumen for an expansion fluid.

Further, in the catheter according to the present invention,
The catheter is a half-pipe catheter having a pipe-shaped portion and a half-pipe-shaped portion.
The pipe-shaped portion includes the internal reinforcing material having the processed portion, the sub-lumen forming portion, and the sub-lumen formed in the sub-lumen forming portion.
The half-pipe shaped portion is characterized in that the sub-lumen forming portion and the sub-lumen extend from the pipe-shaped portion.

The present invention uses a half-pipe catheter as the catheter. When a half-pipe catheter is used, the pipe-shaped portion is provided with an internal reinforcing material having a processed portion, a sub-lumen forming portion, and a sub-lumen formed in the sub-lumen forming portion to provide a main lumen. In addition to securing the area of, the half-pipe shape portion is provided so that only the sub-lumen extends from the pipe shape portion.

According to the catheter according to the present invention, it is possible to provide a catheter capable of increasing the cross-sectional area of the main lumen as compared with a conventional catheter having a parallel tube structure.

FIG. 1 is a diagram showing an outline of the configuration of the catheter 100 according to the first embodiment. FIG. 2 is a cross-sectional view taken along the line AA of FIG. FIG. 3 is a perspective view showing the internal reinforcing material 13 of the catheter 100 according to the first embodiment. FIG. 4 is a side view showing another embodiment of the internal reinforcing material 13 of the catheter 100 according to the first embodiment. FIG. 5 is a schematic view showing another embodiment of the processed portion of the internal reinforcing material 13 of the catheter 100 according to the first embodiment. FIG. 6 is a perspective view showing a state in which the sub-lumen 15 is attached to the internal reinforcing member 13 of the catheter 100 according to the first embodiment. FIG. 7 is a cross-sectional view taken along the line BB of FIG. FIG. 8 is a cross-sectional view showing another embodiment of the sub-lumen 15 of the internal reinforcing material 13 of the catheter 100 according to the first embodiment. FIG. 9 is a diagram showing an outline of the configuration of the catheter 100 according to the second embodiment. FIG. 10 is a diagram illustrating a method of using the catheter 100 according to the second embodiment.

Next, an embodiment of the catheter 100 according to the present invention will be described in detail with reference to the drawings. The embodiments and drawings described below exemplify a part of the embodiments of the present invention, are not used for the purpose of limiting to these configurations, and do not deviate from the gist of the present invention. It can be changed as appropriate within the range. In the present embodiment, a half-pipe catheter will be described as an example of the catheter 100, but in the case of a normal catheter, the description will be omitted because the configuration is the same as that of the pipe-shaped portion 10 in the embodiment.

(First Embodiment)
The catheter 100 according to the first embodiment is shown in FIG. As shown in FIG. 1, the catheter 100 according to the first embodiment has a cylindrical pipe-shaped portion 10 in order from the distal end side, a half-pipe-shaped portion 30 having a shape in which a part of the pipe shape is cut off, and a wire. A portion 50 and a grip portion 70 are provided.

As shown in FIG. 2, the pipe-shaped portion 10 includes a main lumen 11 formed of a large cavity formed substantially in the center in a cross-sectional view, an internal reinforcing member 13 provided on or near the outer circumference of the main lumen 11, and the inside thereof. A sublumen 15 provided as a part of the reinforcing material 13 is provided. In the pipe shape portion 10, the main lumen 11, the internal reinforcing member 13, and the sub-lumen 15 are formed over the entire length.

The main lumen 11 is provided at a position substantially centered or slightly eccentric with respect to the cross section of the catheter 100, and is a portion that occupies the largest area in the cross section of the catheter 100. Preferably, it is formed so as to occupy an area of 80% or more, more preferably 90% or more of the cross-sectional area. The main lumen 11 is a therapeutic insertion device (not shown) such as a balloon, a stent, an IVUS or OCT sensor used for passing a guide wire used for inserting the catheter 100 to the treatment area or for treating a stenosis or the like. .) Is used to pass through.

An internal reinforcing member 13 is provided on the outer periphery of the main lumen 11. The internal reinforcing member 13 is provided to prevent the main lumen 11 from being crushed when the catheter 100 is curved or being divided when the catheter 100 is pulled out. As shown in FIG. 3, the internal reinforcing material 13 is formed by using a metal or plastic pipe as a base material and processing the pipe by cutting, laser processing, etching, or the like. As the material of the pipe, in the case of metal, stainless steel, Ni-Ti (nickel titanium) alloy, Ni-Ti-Co (nickel titanium cobalt) alloy and the like are used. In the case of plastic, for example, polyamide, polyethylene, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane, polypropylene and the like can be mentioned. The internal reinforcing material 13 has a processed portion 13a that has been processed to partially remove the internal reinforcing material 13 in order to ensure the curvature of the internal reinforcing material 13. The processed portion 13a is formed by processing a pipe by cutting, cutting, laser processing, etching, or the like. The processed portion 13a is formed in a range of at least 60% or more of the outer circumference of the pipe. More preferably, it is 80% or more. As the processing form, as shown in FIG. 3, it may be formed in a slit shape, or as shown in FIG. 4, it may be formed in a net shape or a mesh shape. In short, the processed portion 13a may have any form or a complicated form as long as the curvature of the internal reinforcing member 13 can be guaranteed. As shown in FIG. 5A, it is not necessary to cut out in a straight line, and it may be cut out so as to have a complicated curve. It may be formed by including notches in the form. As shown in FIG. 3, the portion other than the processed portion 13a has a non-processed portion 13b formed continuously in the longitudinal direction, and the sub-lumen 15 is attached or formed to a part of this portion. Become.

The sublumen 15 is used, for example, for injecting a drug solution or inserting other therapeutic instruments. The sublumen 15 is arranged at least in the sub-lumen forming portion of the internal reinforcing member 13 other than the processed portion 13a. For example, as shown in FIG. 6, a non-processed portion is cut as a sub-lumen forming portion along the longitudinal direction in a portion (non-processed portion) 13b other than the processed portion 13a to form a sub-lumen slit 13c, and this sub is formed. By joining the sub-lumen 15 to the lumen slit 13c, the sub-lumen 15 can be manufactured as a part of the internal reinforcing material 13. Generally, since the internal reinforcing material 13 uses a coil or a braid, when the slit 15c for the sublumen is processed, the internal reinforcing material 13 may be unraveled or loosened. However, the internal reinforcing material 13 according to the present invention uses a pipe as a base material. Since it is used, it can be processed without any problem because the shape is maintained even if the slit 13c for the sub-lumen is formed. At this time, the inner peripheral surface 15a of the sub-lumen 15 may be formed so as to be located inside the main lumen 11 as shown in FIG. 2, but it protrudes too much from the inner peripheral surface 11a of the main lumen 11. And, when inserting a guide wire, a therapeutic insertion instrument, etc., it may be an obstacle, so even if it is provided so as to be the same as the inner peripheral surface 11a of the main lumen 11 or located outside the inner peripheral surface 11a. good.

The outer peripheral side of the internal reinforcing material 13 thus produced is coated with the protective resin 18, and the pipe-shaped portion 10 of the catheter 100 is produced. Examples of the resin used here include polyamide, polyethylene, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane and polypropylene. The inner peripheral surface of the internal reinforcing material 13 may be coated with a protective resin.

As shown in FIG. 1 or 7, the half-pipe shape portion 30 is formed in an arc shape having a circular cross section lacking a part. The half-pipe shape portion 30 is a portion used as a guide when inserting a therapeutic insertion device such as a balloon, a stent, an IVUS or OCT sensor used for treating a stenosis or the like into the main lumen 11 described above. By sliding and inserting the therapeutic insertion device into the half-pipe shaped portion 30, the therapeutic inserting device can be easily inserted into the main lumen 11 of the pipe-shaped portion 10. As shown in α of FIG. 3, the internal reinforcing member 13 arranged in the half pipe shape portion 30 does not have the processed portion 13a and is formed in an arc shape according to the cross section of the half pipe shape portion 30. That is, a portion other than the processed portion 13a is extended from the pipe shape portion 10 to form the pipe shape portion 10. The sublumen 15 is continuously formed from the pipe-shaped portion 10. The half-pipe shape portion 30 may be formed only by the sub-lumen 15 without providing the internal reinforcing member 13.

The wire portion 50 transmits the push force of the operation on the hand side to the pipe shape portion 10 and the half pipe shape portion 30, and a separately manufactured wire may be attached, or the internal reinforcing member 13 may be wire-shaped. May be processed into. A sublumen is formed inside the wire.

The grip portion 70 is not particularly limited, and may be manufactured so that the pipe shape portion 10, the half pipe shape portion 30, and the wire portion 50 can be operated while gripping.

In the catheter 100 produced as described above, since the sub-lumen 15 is provided at a position closer to the main lumen 11 as compared with the conventional case, the cross section of the main lumen 11 can be provided larger. Further, since the sub-lumen 15 and the internal reinforcing member 13 are integrally formed, the catheter 100 can be made more easy to handle because it can have directivity with respect to bending.

In the first embodiment, the sub-lumen 15 is attached to the internal reinforcing material 13 by post-processing, but as shown in FIG. 8, the portion of the internal reinforcing material 13 other than the processed portion 13a is lengthened in advance. A pipe provided with a through hole penetrating in the direction may be used. That is, the sublumen forming portion is formed on the pipe itself. By manufacturing in this way, it is not necessary to post-process the sublumen 15, and the catheter 100 can be manufactured more easily.

(Second Embodiment)
The catheter 100 according to the second embodiment is shown in FIG. The catheter 100 according to the second embodiment is a balloon catheter in which a balloon 90 is provided at the distal end or in the vicinity of the distal end. Since the pipe shape portion 10, the half pipe shape portion 30, and the wire portion 50 are the same as those in the first embodiment, the description thereof will be omitted.

The second embodiment is different in that the balloon 90 is provided at the distal end of the catheter 100 and the hub 95 is provided on the hand side.

The catheter 100 according to the second embodiment is provided with a balloon 90 on the distal end side, and an opening hole 17 communicating with the sublumen 15 is provided in the balloon 90. Further, on the hand side, instead of the grip portion 70, a hub 95 for connecting to a pressurizer (not shown) for inserting an expansion fluid into the sublumen 15 is provided.

The catheter 100 produced as described above can be used as a normal balloon catheter, and when a therapeutic insertion device such as a guide wire or a balloon, a stent, an IVUS or OCT sensor is inserted as a microcatheter. It can be effectively used as a backup. That is, as shown in FIG. 10, when the therapeutic insertion instrument 96 is inserted into the stenosis or the like, the guiding catheter 97 comes off from the coronary artery and no force is transmitted to the device, so that the treatment insertion instrument 96 is inserted into the stenosis. You may not be able to pass through. In such a case, the tip of the catheter 100 can be fixed at a position closer to the lesion by inserting the catheter 100 according to the embodiment and inflating the balloon 90 at a predetermined position. Then, by inserting the therapeutic insertion instrument 96 in a state of being fixed at the tip, the force is transmitted to the therapeutic insertion instrument 96, and the lesion can be easily reached. As described above, according to the catheter 100 according to the second embodiment, it can also be used as the catheter 100 having a backup function.

As shown in the above-described embodiment, it can be industrially used as a catheter for treating a lesion.

10 ... Pipe shape part, 11 ... Main lumen, 13 ... Internal reinforcing material, 13a ... Processed part, 13b ... Non-processed part, 13c ... Sublumen slit, 15 ... Sublumen, 15a ... Inner peripheral surface, 17 ... Opening hole , 18 ... protective resin, 30 ... half pipe shape part, 50 ... wire part, 70 ... grip part, 90 ... balloon, 95 ... hub, 96 ... therapeutic insertion device, 97 ... guiding catheter, 100 ... catheter

In the case of a catheter having such a parallel tube structure, there is a problem that the cross-sectional area of the main lumen becomes small because it has a region through which the sub-lumen passes. In particular, in recent years, in percutaneous coronary intervention used for ischemic heart disease such as angina and myocardial infarction, and balloon dilatation in catheter treatment for peripheral arterial disease, complicated blood vessels such as the heart and peripheral arteries Since the guiding catheter cannot be inserted to the lesion because it needs to be passed through the system, a balloon, stent, IVUS, or OCT should be inserted using a microcatheter or half-pipe catheter that is thinner than the guiding catheter. Is being done. However, since the microcatheter and the half-pipe catheter have a short diameter, there is a problem that the main lumen becomes narrower.

Claims (8)

In a catheter with a main lumen and a sublumen
A processed portion which is arranged on or near the outer circumference of the main lumen, is made of a metal or plastic pipe, and is processed to remove at least a part in order to secure the curvature of the pipe, and the above-mentioned An internal reinforcing material having a sub-lumen forming portion other than the processed portion on which the sub-lumen is formed, and
The sub-lumen formed in the sub-lumen forming portion and
A catheter characterized by having. The catheter according to claim 1, wherein the processed portion of the internal reinforcing material is notched. The catheter according to claim 1 or 2, wherein the internal reinforcing material has the processed portion formed in a slit shape. The catheter according to claim 1 or 2, wherein the internal reinforcing material has the processed portion formed in a net shape or a mesh shape. The catheter according to any one of claims 1 to 4, wherein the sublumen is joined to a slit for sublumen in which a portion other than the processed portion is cut into a slit shape. The catheter according to any one of claims 1 to 5, wherein the sublumen is formed of a through hole penetrating a portion other than the processed portion in the longitudinal direction. The catheter according to any one of claims 1 to 6, wherein a balloon is provided at the distal end or in the vicinity of the distal end. The catheter is a half-pipe catheter having a pipe-shaped portion and a half-pipe-shaped portion.
The pipe-shaped portion includes the internal reinforcing material having the processed portion, the sub-lumen forming portion, and the sub-lumen formed in the sub-lumen forming portion.
The catheter according to any one of claims 1 to 7, wherein the sub-lumen forming portion and the sub-lumen extend from the pipe-shaped portion in the half-pipe shaped portion.

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