JP2020081501A - Medical tube, catheter and production method of medical tube - Google Patents

Abstract

To improve flexibility, torque transmission and visual quality in a medical tube for use in catheters.SOLUTION: A medical tube 100 includes a reinforcing layer 20 comprising a coil body, and an outer layer 10 for covering the outside of the reinforcing layer. A fixing part for partially fixing the reinforcing layer and the outer layer is provided in the inside of the outer layer, and is capable of obtaining flexibility by the coil body (reinforcing layer) and the improvement effect of torque transmission. The reinforcing layer and the outer layer are fixed partially, and therefore wrinkles are hard to be generated on the surface of the outer layer, and thereby the visual quality can be improved.SELECTED DRAWING: Figure 2

Description

The present invention relates to medical tubes used for catheters and the like.

For example, it is used as a tubular member of a catheter or an endoscope, and is inserted into a body lumen such as vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory gland and reproductive system. The medical tube used is known (for example, patent documents 1-4). For example, Patent Document 1 discloses that in a catheter including an inner layer and an outer layer, a reinforcing layer is formed on the outer peripheral surface of the inner layer. For example, Patent Document 2 discloses that a catheter in which a coil member is spirally wound around a tube body is provided with an elastic member that covers the outer peripheral surface of the tube body and is in close contact with the end of the coil member.

JP2012-139345A JP, 2013-255577, A JP, 2014-233534, A JP, 2014-18821, A

However, in the technique described in Patent Document 1, since the inner layer having the reinforcing layer and the outer layer are not fixed, the flexibility and torque transmission are excellent, while wrinkles easily occur on the surface of the outer layer, and the appearance There was room for improvement in quality. Further, in the technique described in Patent Document 2, there is a problem that flexibility and torque transmissibility are impaired because all of the wires forming the coil member (reinforcing layer) are fixed by the elastic member. This point is the same for the techniques described in Patent Documents 3 and 4.

The present invention has been made to solve at least a part of the problems described above, and an object thereof is to improve flexibility, torque transmissibility, and appearance quality in a medical tube used for a catheter or the like. To do.

The present invention has been made to solve at least a part of the problems described above, and can be realized as the following modes.

(1) According to one aspect of the present invention, a medical tube is provided. This medical tube includes a reinforcing layer formed of a coil body formed by winding a wire, and an outer layer that covers the outer side of the reinforcing layer, and the inner layer of the outer layer includes the reinforcing layer and the outer layer. A fixing portion for partially fixing is provided.

According to this configuration, the medical tube includes a reinforcing layer formed of a coil body, and an outer layer that covers the outer side of the reinforcing layer, and a fixing portion that partially fixes the reinforcing layer and the outer layer is provided inside the outer layer. It is provided. That is, in the medical tube of this configuration, the reinforcing layer and the outer layer are not fixed but partially fixed, so that the coil body (reinforcing layer) can provide flexibility and an effect of improving torque transmissibility. You can Further, in the medical tube of this configuration, since the reinforcing layer and the outer layer are partially fixed, wrinkles are formed on the surface of the outer layer as compared with the configuration in which the reinforcing layer and the outer layer are all separated from each other. It is hard to generate and the appearance quality can be improved.

(2) In the medical tube of the above aspect, a void may be provided between the reinforcing layer and a portion of the outer layer where the fixing portion is not provided. According to this configuration, since a gap is provided between the portion where the fixing portion is not provided and the reinforcing layer inside the outer layer, wrinkles are less likely to occur on the surface of the outer layer, and the appearance quality is improved. Can be further improved.

(3) In the medical tube of the above aspect, the fixing portion may be a convex portion in which a part of an inner surface of the outer layer projects toward the reinforcing layer, and the convex portion may be fixed to the reinforcing layer. Good. According to this configuration, since the convex portion formed on a part of the inner surface of the outer layer is fixed to the reinforcing layer, the number of parts of the medical tube is reduced as compared with the case where a separate fixing member is provided. be able to. As a result, the manufacturing process and manufacturing cost of the medical tube can be reduced.

(4) In the medical tube of the above aspect, a recess may be provided at a position corresponding to the protrusion on the outer surface of the outer layer. According to this configuration, since the outer surface of the outer layer is provided with the recess, the resin adhesion can be improved when the outer surface of the outer layer is coated with the hydrophilic or hydrophobic resin. Further, since the concave portion on the outer surface of the outer layer is provided at a position corresponding to the convex portion on the inner surface, the concave portion and the convex portion are separated from each other by thermal processing from the outer surface of the outer layer in the production of the medical tube. Since they can be formed at the same time, the manufacturing process and manufacturing cost of the medical tube can be reduced.

(5) In the medical tube of the above aspect, the recess is formed in a groove shape, and further includes an element wire that is provided along the recess and at least a portion of which is embedded in the recess. May be. According to this configuration, since the wire is provided along the groove-shaped recess and at least a part of the wire is embedded in the recess, it is possible to improve the slidability of the medical tube in the living body lumen. You can

(6) In the medical tube of the above aspect, a part of the strand of wire may protrude from the outer surface of the outer layer. According to this configuration, since the part of the wire embedded in the recess protrudes from the outer surface of the outer layer, the slidability of the medical tube in the living body lumen can be further improved, and the medical tube is Even when they are stacked in the cavity, the stacked state can be canceled by the rotating operation.

(7) In the medical tube of the above aspect, the fixing portion may be spirally extended in the axial direction of the medical tube on the inner surface of the outer layer. According to this configuration, the fixing portion that partially fixes the reinforcing layer and the outer layer is helically extended in the axial direction of the medical tube on the inner surface of the outer layer, and thus the coil body (reinforcing layer). Therefore, the flexibility and the torque transmissibility can be further improved. Further, when the concave portion is provided on the outer surface of the outer layer at a position corresponding to the fixing portion (convex portion), the medical tube in the living body lumen is formed by the concave portion that extends spirally on the outer surface of the outer layer. The slidability of can be further improved.

(8) The medical tube of the above aspect may further include an outer layer reinforcing body that is covered with the outer layer and reinforces the outer layer. According to this configuration, since the outer layer reinforcement body that is covered with the outer layer and reinforces the outer layer is provided, the elongation resistance and the compression resistance of the medical tube can be improved. For example, the medical tube of this configuration is used for other devices (for example, a catheter inserted in the lumen of the medical tube) and other components (for example, a core shaft provided for the lumen of the medical tube). As a result of being used in combination with the medical tube, it is possible to suppress damage to the medical tube when a force of compressing and/or extending in the axial direction is applied to the medical tube.

(9) According to one aspect of the present invention, a catheter is provided. This catheter comprises the medical tube of the above-mentioned form. With this configuration, it is possible to provide a catheter that is excellent in flexibility, torque transmissibility, and appearance quality.

(10) According to one aspect of the present invention, a method for manufacturing a medical tube is provided. This manufacturing method comprises winding a wire to form a coil-shaped reinforcing layer, forming an outer layer covering the outer side of the reinforcing layer, and forming a recess in a part of the outer surface of the outer layer. A step of forming a part of the inner surface of the outer layer at a position corresponding to the concave part as a convex part protruding toward the reinforcing layer, and joining the convex part and the reinforcing layer to each other, And a step of forming a fixing portion that partially fixes the outer layer. According to this configuration, in manufacturing a medical tube excellent in flexibility, torque transmissibility, and appearance quality, it is possible to reduce man-hours and manufacturing cost of the medical tube.

The present invention can be realized in various modes, for example, in the form of a medical tube, a catheter including a medical tube, a medical tube or a method of manufacturing a catheter.

It is explanatory drawing which shows the whole structure of the catheter of 1st Embodiment. It is a fragmentary sectional view of the tip side of the catheter. It is a fragmentary sectional view by the side of the tip of the catheter of a 2nd embodiment. It is a perspective view showing a schematic structure of a reinforcement layer. It is an enlarged view of the front end side of the catheter in the third embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 3rd embodiment. It is an enlarged view of the tip side of the catheter in a 4th embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 4th embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 5th embodiment. It is an enlarged view of the tip side of the catheter in a 6th embodiment. It is an enlarged view of the tip side of the catheter in a 7th embodiment. It is an enlarged view of the tip side of the catheter in an 8th embodiment. It is an enlarged view of the tip side of the catheter in a 9th embodiment. It is a fragmentary sectional view by the side of the tip of the catheter in a 10th embodiment. It is a fragmentary sectional view at the tip side of a catheter in an 11th embodiment. It is an enlarged view of the tip side of the catheter in a 12th embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 13th embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 14th embodiment. It is a fragmentary sectional view at the tip side of a catheter in a 15th embodiment.

<First Embodiment>
FIG. 1 is an explanatory diagram showing the overall configuration of the catheter 1 of the first embodiment. The upper part of FIG. 1 shows the entire catheter 1, and the lower part of FIG. 1 shows an enlarged view of the distal end side A of the catheter 1. The catheter 1 is inserted into a living body lumen such as a vascular system, a lymphatic system, a biliary system, a urinary system, an airway system, a digestive system, a secretory gland and a reproductive organ, and diagnoses or treats the living body lumen. Used for. The catheter 1 includes a medical tube 100 and a connector 90 connected to the proximal end side of the medical tube 100.

In FIG. 1, an axis passing through the center of the catheter 1 is represented by an axis O (dashed line). In the following examples, both the axis passing through the center of the medical tube 100 and the axis passing through the center of the connector 90 coincide with the axis O. However, the axes passing through the centers of the medical tube 100 and the connector 90 may be different from the axis O, respectively. Further, FIG. 1 shows XYZ axes which are orthogonal to each other. The X-axis corresponds to the axial direction of the catheter 1, the Y-axis corresponds to the height direction of the catheter 1, and the Z-axis corresponds to the width direction of the catheter 1. The left side (−X axis direction) of FIG. 1 is called the “tip side” of the catheter 1 and each component, and the right side (+X axis direction) of FIG. 1 is called the “proximal side” of the catheter 1 and each component. Further, regarding the catheter 1 and each of the constituent members, the end located on the distal end side is referred to as a “distal end” or simply “distal end”, and the end located on the proximal end side is referred to as a “proximal end” or simply “proximal end”. Call. The distal end side corresponds to the “distal side” inserted into the living body, and the proximal end side corresponds to the “proximal side” operated by an operator such as a doctor. These points are common to FIG. 1 and subsequent figures.

FIG. 2 is a partial sectional view of the distal end side of the catheter 1. FIG. 2 shows a cross section of the distal end side of the catheter 1 shown in the lower part of FIG. 1, that is, a part 1 pa (broken line frame) on the distal end side of the medical tube 100. Note that the XYZ axes shown in each of the figures after FIG. 2 correspond to the XYZ axes in FIG. The medical tube 100 includes an outer layer 10 and a reinforcing layer 20.

The reinforcing layer 20 is a substantially cylindrical coil body formed by spirally winding the wire 21. In the example of FIG. 2, the reinforcing layer 20 is a single-strand coil formed by winding a single strand of wire. The strand 21 can be formed of, for example, an arbitrary metal material such as a stainless alloy such as SUS304 or a superelastic alloy such as a NiTi alloy, or an arbitrary resin material such as reinforced plastic (PEEK). The average diameter of the coil (the average diameter of the outer diameter and the inner diameter) of the reinforcing layer 20, the wire diameter of the wire 21, the cross-sectional shape, and the like can be arbitrarily determined. The lumen 1L formed inside the reinforcing layer 20 functions as a guide wire lumen for inserting a guide wire into the medical tube 100 (catheter 1), and also inserts another medical device into the medical tube 100. It also functions as a lumen for the device.

The outer layer 10 is a long tubular member that covers the outer side of the reinforcing layer 20 in the entire region from the distal end portion to the proximal end portion of the reinforcing layer 20. The outer layer 10 can be formed of any resin material such as polyamide, polyamide elastomer, polyester, polyurethane, polyurethane elastomer, or the like. As shown in the lower part of FIG. 1, the outer layer 10 of the present embodiment extends as a spiral groove over the entire region in the axis O direction (X-axis direction) from the tip portion 10d to the base portion 10p. A recess 12 is formed. As shown in FIG. 2, the recess 12 is a part of the outer surface of the outer layer 10 that is recessed toward the reinforcing layer 20. Further, the outer layer 10 is formed with a convex portion 13 in which a part of the inner side surface of the outer layer 10 projects toward the reinforcing layer 20 at a position corresponding to the concave portion 12 in the axis O direction (X axis direction). A portion of the outer layer 10 where the concave portion 12 and the convex portion 13 are not formed is a flat flat portion 11.

Here, a fixing portion JP that partially fixes the outer layer 10 and the reinforcing layer 20 is provided inside the outer layer 10. Further, a gap SP is provided between the reinforcing layer 20 and a portion of the inner side of the outer layer 10 where the fixing portion JP is not provided. The size of the void SP (length in the Y-axis direction) can be arbitrarily determined. The sizes of the voids SP may be the same or different at different positions in the axis O direction (X-axis direction). Hereinafter, the portion provided with the fixed portion JP is also referred to as “fixed portion R1”, and the portion not provided with the fixed portion JP is also referred to as “non-fixed portion R2”. In the example of FIG. 2, the convex portion 13 provided on the inner side of the outer layer 10 is fixed to a part of the wire 21 that forms the reinforcing layer 20 to form the fixing portion JP. Therefore, in the example of FIG. 2, the portion provided with the convex portion 13 corresponds to the fixed portion R1, and the portion provided with the flat portion 11 corresponds to the non-fixed portion R2.

In addition, in the cross section shown in FIG. 2, the interval between the adjacent convex portions 13 (fixing portions JP), in other words, the spiral cycle of the convex portions 13 is arbitrarily determined according to the performance required for the medical tube 100. Can be changed. For example, if the interval between the adjacent convex portions 13 is narrowed, the fixing range of the outer layer 10 and the reinforcing layer 20 by the fixing portion JP is expanded, so that the rigidity of the medical tube 100 can be increased. On the other hand, if the interval between the adjacent convex portions 13 is widened, the fixing range of the outer layer 10 and the reinforcing layer 20 by the fixing portion JP is narrowed, so that the flexibility of the medical tube 100 can be increased. The interval between the adjacent convex portions 13 may not be constant. For example, it may be continuously changed by gradually narrowing the interval between the adjacent convex portions 13 from the proximal end side of the medical treatment tube 100 toward the distal end side.

Similarly, the length of the convex portion 13 (fixed portion JP) in the direction of the axis O (X axis direction) can also be arbitrarily changed according to the performance required for the medical tube 100. For example, if the length of the convex portion 13 in the direction of the axis O is increased, the fixing range of the outer layer 10 and the reinforcing layer 20 by the fixing portion JP is expanded, so that the rigidity of the medical tube 100 can be increased. On the other hand, if the length of the convex portion 13 in the direction of the axis O is shortened, the fixing range of the outer layer 10 and the reinforcing layer 20 by the fixing portion JP is narrowed, so that the flexibility of the medical tube 100 can be increased. The lengths of the protrusions 13 in the direction of the axis O may not be the same. For example, the length of the convex portion 13 in the direction of the axis O may be gradually changed from the base end side of the medical treatment tube 100 toward the distal end side, and may be continuously changed.

Furthermore, regarding the range in the axis O direction (X axis direction) in which the convex portion 13 (fixed part JP) is provided and the range in the circumferential direction (YZ axis direction) of the outer layer 10, the medical tube 100 is similarly provided. It can be arbitrarily changed according to the required performance. For example, the convex portion 13 may be provided on a part of the outer layer 10 in the direction of the axis O (for example, a part on the tip side of the outer layer 10, a part on the base end side, both end parts, etc.). For example, the protrusion 13 may be provided on a part of the outer layer 10 in the circumferential direction.

Such a medical tube 100 can be manufactured by the following steps a1 to a5, for example.
(A1) The coil-shaped reinforcing layer 20 is formed by winding the wire 21.
(A2) The outer layer 10 having an inner diameter larger than the outer diameter of the reinforcing layer 20 is formed. At this point, the concave portion 12 and the convex portion 13 are not formed in the outer layer 10, and the entire region from the tip portion 10d to the base end portion 10p is the flat portion 11. The inner diameter of the outer layer 10 is equal to the outer diameter of the reinforcing layer 20+the size of the void SP×2.
(A3) The reinforcing layer 20 is inserted inside the outer layer 10.
(A4) By forming the recess 12 in a part of the outer surface of the outer layer 10, a part of the inner surface at a position corresponding to the recess 12 is formed as a protrusion 13 that protrudes toward the reinforcing layer 20. Specifically, for example, a wire-shaped heating element is spirally wound around the outer surface of the outer layer 10 and heated to deform a part of the outer layer 10 to form the concave portion 12 and the convex portion 13. In addition, for example, by heating the outer layer 10 with the reinforcing layer 20 inserted in a heating chamber and winding the wire around the outer surface of the outer layer 10 in a state where the outer layer 10 is flexible, The concave portion 12 and the convex portion 13 may be formed by partially deforming.
(A5) The convex portion 13 and a part of the wire 21 forming the reinforcing layer 20 are joined to each other to form a fixing portion JP for partially fixing the outer layer 10 and the reinforcing layer 20. Specifically, for example, when the wire-shaped heating element is used in the procedure a4, the projection 13 and a part of the wire 21 can be welded by heat treatment when forming the recess 12 and the projection 13. It should be noted that, for example, by applying a bonding agent such as an epoxy adhesive to the convex portion 13, the convex portion 13 and a part of the strand 21 may be bonded.

Returning to FIG. 1, the description will be continued. The connector 90 includes a shaft portion 91 and a blade portion 92. The shaft portion 91 is a substantially cylindrical member whose diameter is reduced from the base end side to the tip end side. The proximal end portion 10p of the medical tube 100 is connected to the distal end side of the shaft portion 91, and the lumen of the shaft portion 91 communicates with the lumen 1L of the medical tube 100. The blade portion 92 is connected to the base end side of the shaft portion 91. The blade portion 92 is a member in which two blades extending in the ±Y axis direction are formed in a substantially cylindrical main body. The inner cavity of the main body of the blade portion 92 communicates with the inner cavity of the shaft portion 91 and the inner cavity 1L of the medical tube 100. The operator inserts a guide wire or other medical device through an opening provided at the base end of the blade 92. The connector 90 can be formed of a resin material such as polyurethane, polypropylene, hard polyvinyl chloride, or the like.

As described above, according to the catheter 1 of the first embodiment, the medical tube 100 includes the reinforcing layer 20 including the coil body and the outer layer 10 that covers the outer side of the reinforcing layer 20, and the inner layer of the outer layer 10 is A fixing portion JP for partially fixing the reinforcing layer 20 and the outer layer 10 is provided (FIG. 2). That is, in the medical tube 100 according to the first embodiment, since the reinforcing layer 20 and the outer layer 10 are not all fixed but partially fixed at the fixed portion R1, the flexibility of the reinforcing layer 20 made of a coil body is improved. As a result, the effect of improving torque transmissibility can be obtained. Further, in the medical tube 100 according to the first embodiment, the reinforcing layer 20 and the outer layer 10 are partially fixed at the fixing portion R1, so that the reinforcing layer 20 and the outer layer 10 are all separated from each other. Compared with the above, wrinkles are less likely to occur on the surface of the outer layer 10, and the appearance quality can be improved. As a result, it is possible to provide the catheter 1 and the medical tube 100 which are excellent in flexibility, torque transmissibility, and appearance quality. Moreover, according to the catheter 1 of the first embodiment, the medical tube 100 is provided between the reinforcing layer 20 and a portion of the inner side of the outer layer 10 where the fixing portion JP is not provided (non-fixing portion R2). A space SP is provided. Therefore, wrinkles are less likely to occur on the surface of the outer layer 10, and the appearance quality can be further improved.

Further, according to the catheter 1 of the first embodiment, in the medical tube 100, the fixing portion JP (that is, the convex portion 13) that partially fixes the reinforcing layer 20 and the outer layer 10 on the inner surface of the outer layer 10, Since the medical tube 100 is spirally extended in the direction of the axis O, the flexibility and torque transmissibility of the reinforcing layer 20 made of a coil body can be further improved. Further, since the concave portion 12 is formed on the outer surface of the outer layer 10 at a position corresponding to the fixed portion JP (that is, the convex portion 13 ), the spiral portion 12 also has a recess 12 formed on the outer surface of the outer layer 10. The slidability of the medical tube 100 inside the living body lumen can be further improved.

Furthermore, according to the catheter 1 of the first embodiment, in the medical tube 100, the convex portion 13 formed on a part of the inner surface of the outer layer 10 is fixed to the reinforcing layer 20, so that a separate member for fixing is used. The number of parts of the medical tube 100 can be reduced as compared with the case where the medical tube 100 is provided. As a result, the number of manufacturing steps and manufacturing cost of the medical tube 100 can be reduced.

Furthermore, according to the catheter 1 of the first embodiment, since the medical tube 100 has the recess 12 on the outer surface of the outer layer 10, the outer surface of the outer layer 10 is coated with a hydrophilic or hydrophobic resin. In this case, the adhesion of the coating resin can be improved. Further, since the concave portion 12 on the outer side surface of the outer layer 10 is provided at a position corresponding to the convex portion 13 on the inner side surface, as described above in the procedure a4 of manufacturing the medical tube 100, the outer portion of the outer layer 10 is not covered. The concave portion 12 and the convex portion 13 can be simultaneously formed by heat processing or the like from the side surface, and the number of manufacturing steps and the manufacturing cost of the medical tube 100 can be reduced.

<Second Embodiment>
FIG. 3 is a partial cross-sectional view of the distal end side of the catheter 1A of the second embodiment. FIG. 4 is a perspective view showing a schematic configuration of the reinforcing layer 20A. In the catheter 1A of the second embodiment, the medical tube 100A includes an outer layer 10A and a reinforcing layer 20A that have different configurations from those of the first embodiment. As shown in FIG. 4, the reinforcing layer 20A of the second embodiment is a multi-strand coil formed by winding a plurality of (eight in the illustrated example) strands into multiple strands, and is illustrated by a broken line. It has a substantially cylindrical shape having a cavity. The reinforcing layer 20A is obtained by, for example, closely twisting eight strands of wire 21(1) to (8) on a core metal so that they are in contact with each other, and then removing residual stress using a known heat treatment method. It can be formed by removing the core metal. The material of the strand 21 may be the same as or different from the strand 21 of the first embodiment. Further, the number of the strands of wire constituting the reinforcing layer 20A may be plural and is not limited to eight.

As shown in FIG. 3, the outer layer 10A of the second embodiment includes a flat portion 11, a concave portion 12, and a convex portion 13A as in the first embodiment. On the other hand, in the outer layer 10A of the second embodiment, the convex portion 13A that functions as the joining portion JPA is provided at a position where only the specific strand 21 is fixed among the multiple strands 21 that configure the reinforcing layer 20A. ing. Specifically, in the example of FIG. 3, the convex portion 13A (joint portion JPA) is provided at a position for fixing the first and second strands 21, and the third to eighth strands 21 are Not fixed. As described above, the reinforcing layer 20A is formed by spirally winding a plurality of element wires 21, and similarly, the convex portion 13A of the outer layer 10A is also formed in a spiral shape extending in the direction of the axis O. Therefore, by adjusting the period of each spiral in the reinforcing layer 20A and the outer layer 10A, it is possible to obtain a configuration in which the convex portion 13A (joint portion JPA) fixes only the specific strand 21. The number and the number of the strands 21 fixed by the convex portion 13A may be arbitrarily determined. For example, if the rigidity of the medical tube 100A is desired to be increased, the number of the wires 21 fixed by the convex portion 13A may be increased, and if the flexibility of the medical tube 100A is desired to be increased, the convex portion 13A may be fixed. It suffices to reduce the number of strands 21 to be formed.

Thus, the reinforcing layer 20A is not limited to the single-strand coil, and may be a multi-strand coil. In addition, the reinforcing layer 20A may be configured as a single-strand coil that is formed by winding a stranded wire obtained by twisting a plurality of strands into a single stranded wire. The reinforcing layer 20A may be configured as a multi-strand coil that is formed by using a plurality of twisted wires obtained by twisting a plurality of strands and winding each twisted wire in multiple turns. When the reinforcing layer 20A is a multi-strand coil, a wire and a stranded wire may be used in combination. Furthermore, the reinforcing layer 20A may be coated with a hydrophobic resin material, a hydrophilic resin material, or a mixture thereof. Also in the catheter 1A and the medical treatment tube 100A of the second embodiment, the same effect as that of the first embodiment can be obtained.

<Third Embodiment>
FIG. 5 is an enlarged view of the distal end side of the catheter 1B according to the third embodiment. FIG. 6 is a partial cross-sectional view of the distal end side of the catheter 1B according to the third embodiment. FIG. 6 illustrates a cross section of a portion 1pa on the distal end side of the catheter 1B (medical tube 100B) illustrated in FIG. In the catheter 1B of the third embodiment, the medical tube 100B further includes an element wire 31 arranged along the recess 12 on the outer surface of the outer layer 10.

As shown in FIG. 6, at least a part (in the illustrated example, about half located on the reinforcing layer 20 side) of the strand 31 is embedded in the recess 12, and the other part is an outer surface of the flat portion 11 of the outer layer 10. It is arranged so as to project from the outside to the outside. In the illustrated cross section, the length L1 between the end point of the outermost strand 31 and the flat portion 11, in other words, the protruding length L1 of the strand 31 may be arbitrarily determined. The strands 31 can be formed of any metal material or any resin material. When the strands 31 are made of a metal material, for example, the same material as the strands 21 described in the first embodiment can be used. The wires 31 and 21 may be made of the same material or different materials. When the strands 31 are made of a resin material, for example, PEEK or the like can be used.

The medical tube 100B of the third embodiment can be manufactured by performing the following procedure a6 after the procedures a1 to a5 described in the first embodiment.
(A6) After applying an arbitrary bonding agent such as an epoxy adhesive to the recess 12 formed on the outer surface of the outer layer 10, the wire strand 31 is arranged. As a result, the wire 31 is fixed to the recess 12.

When PEEK is used as the strand 31, the medical tube 100B may be manufactured by performing the following steps b4 and b5 instead of the steps a4 and a5 described in the first embodiment.
(B4) A process of shrinking by heating is performed in advance on the PEEK formed into a wire shape.
(B5) The processed PEEK is spirally wound around the outer surface of the outer layer 10 and heated in a heating chamber. The shrinkage of PEEK due to heating forms a recess 12 on a part of the outer surface of the outer layer 10 and also forms a projection 13 on a part of the inner surface corresponding to the recess 12. In addition, the space between the recess 12 and the PEEK, and the space between the projection 13 and the wire 21 forming the reinforcing layer 20 are welded by heating.

Also in the catheter 1B and the medical treatment tube 100B of the third embodiment, the same effect as that of the first embodiment can be obtained. Further, in the catheter 1B of the third embodiment, the medical tube 100B is provided along the groove-shaped recess 12 and includes the strands 31 that are at least partially embedded in the recess 12. The slidability of the medical tube 100B in the cavity can be improved. In addition, since a part of the wire 31 projects to the outside from the outer surface of the flat portion 11 of the outer layer 10, the slidability can be further improved, and the medical tube 100B is stacked in the body lumen. Also in, the stuck state can be canceled by the rotating operation. Furthermore, in the medical treatment tube 100B of the third embodiment, according to the above-described manufacturing method that performs steps b4 and b5, the number of manufacturing steps and the manufacturing cost when manufacturing the medical treatment tube 100B can be further reduced.

<Fourth Embodiment>
FIG. 7 is an enlarged view of the distal end side of the catheter 1C according to the fourth embodiment. FIG. 8 is a partial cross-sectional view of the distal end side of the catheter 1C according to the fourth embodiment. FIG. 8 shows a cross section of a portion 1pa on the distal end side of the catheter 1C (medical tube 100C) shown in FIG. In the catheter 1C of the fourth embodiment, in the medical tube 100C, the recess 12 is not formed on the outer surface of the outer layer 10C, and the outer surface of the outer layer 10C is flat over the entire area from the distal end portion 10d to the proximal end portion 10p. It is shaped. On the other hand, similarly to the first embodiment, the convex portion 13 that functions as the joint portion JP is formed on the inner side surface of the outer layer 10C, and the outer layer 10C and the reinforcing layer 20 are fixed at the convex portion 13. As described above, the recess 12 may not be provided on the outer surface of the outer layer 10C. Also in such a catheter 1C and medical tube 100C of the fourth embodiment, the same effects as those of the first embodiment can be obtained.

<Fifth Embodiment>
FIG. 9 is a partial cross-sectional view of the distal end side of the catheter 1D according to the fifth embodiment. In the catheter 1D of the fifth embodiment, the medical tube 100D is provided with the fixing member 40 while the recess 12 and the projection 13 described in the first embodiment are not formed. The fixing member 40 is arranged between the inner side surface of the outer layer 10D and the adjacent strand 21 of the reinforcing layer 20, and functions as the joint portion JPD. In the example of FIG. 9, the fixing member 40 has a substantially triangular shape in which the base is located on the inner surface of the outer layer 10D and the apex is located between the strands 21 of the reinforcing layer 20 (in other words, the direction of the axis O). It is a long member having a cross section. The fixing member 40 is arranged on the inner surface of the outer layer 10D in a spiral shape extending in the direction of the axis O, similarly to the convex portion 13 of the first embodiment. The fixing member 40 can be formed of any metal material or any resin material. The cross-sectional shape and size of the fixing member 40 are merely examples, and may be arbitrarily determined.

In the example of FIG. 9, the fixing member 40 and the outer layer 10D and the fixing member 40 and the reinforcing layer 20 are fixed by an arbitrary bonding agent such as an epoxy adhesive. That is, in the present embodiment, the fixing member 40 functions as the fixing portion JPD that fixes the outer layer 10D and the reinforcing layer 20. Note that the fixing member 40 and the outer layer 10D and the fixing member 40 and the reinforcing layer 20 do not have to be fixed. Even if the fixing member 40 is not fixed, the fixing member 40 can function as the fixing portion JPD by being caught between the inner surface of the outer layer 10D and the strand 21 of the reinforcing layer 20 and functioning as a wedge. .. When not fixed, the fixing member 40 is preferably made of a material having a high friction coefficient such as an elastic body. As described above, the joint portion JPD may be realized by not providing the convex portion 13 on the outer layer 10D and by using another member (fixing member 40) arranged inside the outer layer 10D. Also in the catheter 1D and the medical treatment tube 100D of the fifth embodiment, the same effect as that of the first embodiment can be obtained.

<Sixth Embodiment>
FIG. 10 is an enlarged view of the distal end side of the catheter 1E according to the sixth embodiment. In the catheter 1E of the sixth embodiment, the outer layer 10E of the medical tube 100E includes an annular concave portion 12E and a convex portion 13. The recess 12E is an annular recess formed on the outer surface of the outer layer 10E so as to surround the outer layer 10E in the circumferential direction (YZ-axis direction). A plurality of them are arranged over. Similarly to the recesses 12E, a plurality of the protrusions 13 (not shown) are arranged on the inner surface of the outer layer 10E at positions corresponding to the recesses 12E. As described above, the concave portions 12E and the convex portions 13 are not limited to the spiral arrangement, and various modes can be adopted. Also in the catheter 1E and the medical treatment tube 100E of the sixth embodiment, the same effect as that of the first embodiment can be obtained.

<Seventh Embodiment>
FIG. 11 is an enlarged view of the distal end side of the catheter 1F according to the seventh embodiment. In the catheter 1F of the seventh embodiment, the outer layer 10F of the medical tube 100F includes an inclined annular concave portion 12F and convex portion 13. The recess 12F is an annular recess that is formed on the outer surface of the outer layer 10F so as to surround the outer layer 10F in the circumferential direction (YZ direction) and is inclined in the axis O direction (+X axis direction). The plurality of outer layers 10F are arranged from the front end portion 10d to the base end portion 10p. Similarly to the concave portion 12F, a plurality of convex portions 13 (not shown) are arranged at positions corresponding to the concave portions 12F on the inner side surface of the outer layer 10F. Also in the catheter 1F and the medical treatment tube 100F of the seventh embodiment, the same effect as that of the first embodiment can be obtained.

<Eighth Embodiment>
FIG. 12 is an enlarged view of the distal end side of the catheter 1G according to the eighth embodiment. In the catheter 1G of the eighth embodiment, the outer layer 10G of the medical tube 100G includes a substantially elliptical concave portion 12G and a convex portion 13. The recesses 12G are substantially elliptical recesses formed on the outer surface of the outer layer 10G, and in the illustrated example, a plurality of recesses 12G are arranged from the tip 10d to the base 10p of the outer layer 10G. The size of the recess 12G can be arbitrarily determined. In the illustrated example, the recesses 12G are provided separately from each other, but the recesses 12G may be in contact with each other or may intersect with each other. Similarly to the concave portion 12G, a plurality of convex portions 13 (not shown) are arranged at positions corresponding to the concave portions 12G on the inner side surface of the outer layer 10G. Also in the catheter 1G and the medical treatment tube 100G of the eighth embodiment, the same effect as that of the first embodiment can be obtained.

<Ninth Embodiment>
FIG. 13 is an enlarged view of the distal end side of the catheter 1H according to the ninth embodiment. In FIG. 13, an enlarged view of the distal end side of the catheter 1H is shown in the upper stage, and each configuration of the A1-A1 cross section and the A2-A2 cross section of the catheter 1H is shown in the broken line frame shown in the lower stage. In the catheter 1H of the ninth embodiment, the outer layer 10H of the medical tube 100H includes a substantially circular recess 12H and a protrusion 13H. The recess 12H is a substantially circular recess formed on the outer surface of the outer layer 10H, and in the illustrated example, a plurality of recesses 12H are arranged from the tip 10d to the base 10p of the outer layer 10H. The size of the recess 12H can be arbitrarily determined. Further, the recess 12H is not limited to a substantially circular shape, and various shapes (for example, a substantially polygonal shape, a wavy shape, etc.) can be adopted. As shown in the lower part of FIG. 13, a plurality of convex portions 13H are also arranged at positions corresponding to the concave portions 12H on the inner side surface of the outer layer 10H, similarly to the concave portions 12H. In addition, the convex portion 13H has a vertical direction (+Y axis direction and -Y axis direction) shown in the A1-A1 cross section and a horizontal direction (+Z axis) shown in the A2-A2 cross section in the circumferential direction (YZ axis direction) of the outer layer 10H. Direction and the −Z axis direction). Thus, the convex portion 13H may be provided in a part of the outer layer 10H in the circumferential direction. Also in the catheter 1H and the medical treatment tube 100H of the ninth embodiment, the same effect as that of the first embodiment can be obtained.

<Tenth Embodiment>
FIG. 14 is a partial cross-sectional view of the distal end side of the catheter 1J according to the tenth embodiment. In the catheter 1J of the tenth embodiment, a medical tube 100J includes a flat strand 31J having a substantially elliptical cross section instead of the strand 31 described in the third embodiment. In the cross section shown in the drawing, the strand 31J is arranged so that the whole is embedded in the recess 12 with the major axis oriented in the axis O direction (X axis direction) and the minor axis oriented in the Y axis direction, It does not have a portion protruding outward from the outer surface of the flat portion 11 of the outer layer 10. That is, the protruding length L1 of the strand 31 is zero or less than zero. Similar to the strand 31, the strand 31J can be formed of an arbitrary metal material or an arbitrary resin material. The cross-sectional shape of the strand of wire 31J is not limited to a substantially elliptical shape, but may be a different shape such as a substantially circular shape. Also in the catheter 1J and the medical treatment tube 100J of the tenth embodiment, the same effects as those of the first and third embodiments can be obtained.

<Eleventh Embodiment>
FIG. 15 is a partial cross-sectional view of the distal end side of the catheter 1K according to the eleventh embodiment. In the catheter 1K of the eleventh embodiment, the medical tube 100K further includes an inner layer 50 in addition to the configuration described in the first embodiment. The inner layer 50 is a long tubular member provided inside the reinforcing layer 20 in the entire region from the distal end portion to the proximal end portion of the reinforcing layer 20. In other words, the eleventh embodiment has a configuration in which the reinforcing layer 20 covers the outside of the inner layer 50 and the outer layer 10 covers the outside of the reinforcing layer 20. Therefore, the inner cavity 1L formed inside the inner layer 50 functions as a guide wire lumen and a device lumen. The inner layer 50 can be formed of any resin material, such as PTFE (polytetrafluoroethylene).

The medical tube 100K of the eleventh embodiment can be manufactured by performing the following procedures c1 and c2 instead of the procedure a1 described in the first embodiment.
(C1) The inner layer 50 is formed.
(C2) The reinforcing layer 20 is formed by winding the wire 21 around the outer surface of the inner layer 50.

Also in the catheter 1K and the medical treatment tube 100K of the eleventh embodiment as described above, the same effect as that of the first embodiment can be obtained. Further, in the catheter 1K of the eleventh embodiment, the medical tube 100K further has the inner layer 50 provided inside the reinforcing layer 20, so that the guide wire and other devices inserted into the catheter 1K are prevented from slipping. It is possible to provide a catheter 1K that can be improved and is more convenient.

<Twelfth Embodiment>
FIG. 16 is an enlarged view of the distal end side of the catheter 1M according to the twelfth embodiment. In the catheter 1M of the twelfth embodiment, in the outer layer 10M of the medical tube 100M, the concave portion 12M and the convex portion 13 are formed only on the distal end side, and the proximal end side has a flat configuration without the concave portion 12 and the convex portion 13. is there. As described above, the concave portion 12M and the convex portion 13 are not arranged over the entire region in the axis O direction (X-axis direction) from the tip portion 10d to the base end portion 10p of the outer layer 10M, but are arranged in a part. Good. In FIG. 16, the concave portion 12M and the convex portion 13 are illustrated as being provided in a part on the distal end side, but the concave portion 12M and the convex portion 13 may be provided in a substantially central portion in the direction of the axis O or on the proximal end side. It may be provided. Also in the catheter 1M and the medical tube 100M of the twelfth embodiment, the same effect as that of the first embodiment can be obtained.

<Thirteenth Embodiment>
FIG. 17 is a partial cross-sectional view of the distal end side of the catheter 1N according to the thirteenth embodiment. In the catheter 1N of the thirteenth embodiment, the medical tube 100N further includes an inner reinforcing body 60 in addition to the configuration described in the first embodiment. The inner reinforcing body 60 is a braided body in which the wires 61 and the wires 62 are woven in a mesh shape, and is covered (embedded) in the outer layer 10N. The wire 61 and the wire 62 can be formed of any metal material, like the wire 21. The material of the wires 61 and 62 may be the same as or different from that of the wires 21. In FIG. 17, a braided body formed by using two strands of wire as the inner reinforcement body 60 is illustrated, but a coiled body formed by using one or a plurality of strands of wire as the inner reinforcement body 60. May be adopted.

Also in the catheter 1N and the medical treatment tube 100N of the thirteenth embodiment, the same effect as that of the first embodiment can be obtained. According to the catheter 1N of the thirteenth embodiment, the medical tube 100N is covered with the outer layer 10N and includes the inner reinforcing body 60 that reinforces the outer layer 10N. Therefore, the elongation resistance and the compression resistance of the medical tube 100N are improved. And can be improved. For example, the medical tube 100N of the thirteenth embodiment is different from other devices (for example, other catheters inserted in the lumen 1L of the medical tube 100N) and other components (for example, medical tube 100N). As a result of being used in combination with the core shaft provided in the cavity 1L), medical treatment is performed when a force for compressing and/or expanding in the axis O direction (X-axis direction) is applied to the medical tube 100N. It is possible to suppress breakage of the working tube 100N.

<Fourteenth Embodiment>
FIG. 18 is a partial cross-sectional view of the distal end side of the catheter 1P according to the fourteenth embodiment. In the catheter 1P of the fourteenth embodiment, in the medical tube 100P, the inner surface of the flat portion 11 of the outer layer 10P and the outer surface of the reinforcing layer 20 are in contact with each other in the non-fixed portion R2 between the outer layer 10P and the reinforcing layer 20. Have a configuration. That is, in the present embodiment, the void SP between the outer layer 10P and the reinforcing layer 20 is not provided in the non-fixed portion R2. The medical tube 100P of the fourteenth embodiment is an outer layer that covers the outside of the reinforcing layer 20 by extruding the outer layer 10P with respect to the reinforcing layer 20, instead of the steps a2 and a3 described in the first embodiment. 10P may be formed. The catheter 1P and the medical treatment tube 100P of the fourteenth embodiment can also achieve the same effects as those of the first embodiment. Further, if the outer layer 10P is formed by extrusion molding, the outer layer 10P that covers the outside of the reinforcing layer 20 can be easily manufactured.

<Fifteenth Embodiment>
FIG. 19 is a partial cross-sectional view of the distal end side of the catheter 1Q according to the fifteenth embodiment. In FIG. 19, an enlarged view of the distal end side of the catheter 1Q is shown in the upper stage, and the configuration of the BB cross section of the catheter 1Q is shown in the broken line frame shown in the lower stage. In the catheter 1Q of the fifteenth embodiment, the outer layer 10Q of the medical tube 100Q includes a substantially linear concave portion 12Q and a convex portion 13Q. The recessed portion 12Q is a substantially linear recessed portion formed on the outer surface of the outer layer 10Q, and in the illustrated example, the recessed portion 12Q is arranged at one place from the tip portion 10d to the base end portion 10p of the outer layer 10Q. The recess 12Q is not limited to a substantially linear shape, but various shapes (for example, a substantially wavy shape, a sawtooth shape, etc.) can be adopted. As shown in the lower part of FIG. 19, as with the concave portion 12Q, the convex portion 13Q is also arranged at one position on the inner side surface of the outer layer 10Q at a position corresponding to the concave portion 12Q. Further, the convex portion 13Q is locally provided in the circumferential direction (YZ axis direction) of the outer layer 10Q in the right direction (−Z axis direction) shown in the BB cross section. Thus, the convex portion 13Q may be provided in a part of the outer layer 10Q in the circumferential direction. Also in the catheter 1Q and the medical treatment tube 100Q of the ninth embodiment, the same effect as that of the first embodiment can be obtained.

<Modification of this embodiment>
The present invention is not limited to the above-described embodiment, and can be implemented in various modes without departing from the scope of the invention, and the following modifications are possible, for example.

[Modification 1]
In the said 1st-15th embodiment, the structure of the catheters 1 and 1A-1Q was illustrated. However, the configuration of the catheter can be modified in various ways. For example, in each of the above-described embodiments, the catheter having the medical tube and the connector is illustrated, but the catheter may further include other constituent elements (for example, a balloon member, a mesh member made of a mesh-like element wire, a medical tube). Core shaft, etc., which is inserted into Further, the medical tube may be configured as a single unit without the connector described in the above embodiment.

[Modification 2]
In the said 1st-15th embodiment, the structure of medical tube 100, 100A-100Q was illustrated. However, the configuration of the medical tube can be modified in various ways. For example, the outer surface (outer surface of the outer layer and/or inner surface of the inner layer) of the medical tube may be coated with a resin such as PTFE (polytetrafluoroethylene). For example, the medical tube may have another configuration not described above, for example, a tip fixing member that is arranged at the tip portion and integrally holds the outer layer and the reinforcing layer (or the outer layer, the reinforcing layer, and the inner layer). ..

[Modification 3]
In the said 1st-15th embodiment, the structure of the outer layers 10 and 10A-10Q was illustrated. However, various modifications can be made to the configuration of the outer layer. For example, the position of the concave portion provided on the outer side surface of the outer layer and the position of the convex portion provided on the inner side surface of the outer layer do not correspond to each other and may be different positions. For example, the cross-sectional shape of the concave portion (FIG. 2) and the cross-sectional shape of the convex portion (FIG. 2) do not correspond to each other and may be different shapes. For example, the cross-sectional shape of the concave portion and the convex portion may be an arbitrary shape such as a substantially rectangular shape or a substantially V shape other than the substantially semicircular shape exemplified in the above embodiment.

[Modification 4]
The configurations of the catheters 1, 1A to 1Q (medical tubes 100, 100A to 100Q) according to the first to fifteenth embodiments, and the configurations of Modifications 1 to 3 may be appropriately combined. For example, in the configuration including the reinforcing layer described in the second embodiment, the element wire embedded in the recess described in the third and tenth embodiments may be included, and the fourth, sixth, seventh, eighth, ninth and twelfth. The concave and convex configurations described in the embodiment may be adopted, the fixing member described in the fifth embodiment may be provided, the inner layer described in the eleventh embodiment may be provided, and the thirteenth embodiment. The inner reinforcing member described in 1 may be provided.

Although the present aspect has been described above based on the embodiment and the modified examples, the embodiment of the aspect described above is for facilitating the understanding of the present aspect and does not limit the present aspect. The present embodiment can be modified and improved without departing from the spirit and scope of the claims, and the present embodiment includes the equivalents thereof. If the technical features are not described as essential in this specification, they can be deleted as appropriate.

1, 1A to 1Q... Catheter 10, 10A to 10Q... Outer layer 11... Flat portion 12, 12E, F, G, H, Q... Recessed portion 13, 13A, H, Q... Convex portion 20, 20A... Reinforcing layer 21... Element Wire 31, 31J... Element wire 40... Fixing member 50... Inner layer 60... Inner reinforcement 61... Element wire 62... Element wire 90... Connector 91... Shaft part 92... Blade part 100, 100A-100Q... Medical tube

Claims (10)

A medical tube,
A reinforcing layer formed of a coil body formed by winding a wire,
An outer layer covering the outside of the reinforcing layer,
A medical tube in which a fixing portion that partially fixes the reinforcing layer and the outer layer is provided inside the outer layer. The medical tube according to claim 1,
A medical tube, wherein a gap is provided between the reinforcing layer and a portion of the inner side of the outer layer where the fixing portion is not provided. The medical tube according to claim 1 or 2, wherein
The said fixed part is a medical tube in which a part of inner surface of the said outer layer is a convex part which protruded toward the said reinforcement layer, and the said convex part is being fixed to the said reinforcement layer. The medical tube according to claim 3,
A medical tube in which a concave portion is provided at a position corresponding to the convex portion on an outer surface of the outer layer. The medical tube according to claim 4,
The recess is formed in a groove shape,
Furthermore, the medical tube provided with the strand which was provided along the said recessed part, and was arrange|positioned in the state which at least one part was embedded in the said recessed part. The medical tube according to claim 5,
The medical tube in which a part of the strand of wire projects from the outer surface of the outer layer. The medical tube according to any one of claims 1 to 6,
The medical tube, wherein the fixing portion spirally extends in the axial direction of the medical tube on the inner surface of the outer layer. The medical tube according to any one of claims 1 to 7, further comprising:
A medical tube comprising an outer layer reinforcement body which is covered with the outer layer and reinforces the outer layer. A catheter,
A catheter comprising the medical tube according to any one of claims 1 to 8. A method of manufacturing a medical tube,
Winding the wire to form a coil-shaped reinforcing layer,
A step of forming an outer layer covering the outside of the reinforcing layer,
By forming a recess in a portion of the outer surface of the outer layer, a step of forming a portion of the inner surface of the outer layer at a position corresponding to the recess as a protrusion protruding toward the reinforcing layer,
A step of joining the convex portion and the reinforcing layer to form a fixing portion for partially fixing the reinforcing layer and the outer layer;
A method of manufacturing a medical tube, comprising:

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