WO2018051952A1

WO2018051952A1 - Catheter

Info

Publication number: WO2018051952A1
Application number: PCT/JP2017/032703
Authority: WO
Inventors: 小杉　壮; 清水　良幸; 洋平高田; 岡田　裕之
Original assignee: 浜松ホトニクス株式会社
Priority date: 2016-09-15
Filing date: 2017-09-11
Publication date: 2018-03-22
Also published as: JP2018042810A; TW201813683A; JP6333909B2

Abstract

This catheter is provided with: a tube body having a first hole that extends in an axial direction; an optical fiber disposed in the first hole; a ring-shaped marker that is disposed around the outer periphery of a leading end of the tube body; a first fixing member that is fixed to the optical fiber in such a manner as to be situated at one side of the marker in the axial direction and that has an outer width greater than an inner width of the first hole in at least one direction perpendicular to the axial direction; and a second fixing member that is fixed to the optical fiber in such a manner as to be situated on the other side of the marker in the axial direction and that has an outer width greater than the inner width of the first hole in at least one direction perpendicular to the axial direction.

Description

catheter

The present disclosure relates to a catheter used in, for example, a laser thrombolysis treatment system.

In the catheter described in Patent Document 1, an optical fiber is disposed in a tubular body (capillary tube) so that laser light can be irradiated at the distal end of the catheter. The tube is also provided with a hole for sending a wire for guiding it into the blood vessel, a contrast medium for fluoroscopically seeing the state of the thrombus in the blood vessel, etc., to the tip of the catheter. ing. Furthermore, a ring-shaped marker that absorbs X-rays is fitted at the tip of the tube.

Japanese Patent No. 4409499

In the above-described catheter, the marker needs to be securely fixed at a predetermined position in the axial direction of the tubular body in order to accurately grasp the tip position of the catheter. Further, it is important that the optical fiber is securely fixed so that the tip of the optical fiber substantially coincides with the tip of the tube, for example, in order to realize appropriate laser light irradiation.

This disclosure is intended to provide a catheter in which a ring-shaped marker is securely fixed to the outer periphery of a tubular body and an optical fiber is securely fixed in a hole of the tubular body.

A catheter according to an embodiment of the present disclosure includes a tube having a first hole extending in the axial direction, an optical fiber disposed in the first hole, and a ring-shaped marker disposed on an outer periphery of a distal end portion of the tube. And a first fixing member fixed to the optical fiber so as to be positioned on one side of the marker in the axial direction, and having an outer width larger than the inner width of the first hole in at least one direction perpendicular to the axial direction; A second fixing member fixed to the optical fiber so as to be positioned on the other side of the marker in the axial direction and having an outer width larger than the inner width of the first hole in at least one direction perpendicular to the axial direction. .

In this catheter, the first fixing member and the second fixing member fixed to the optical fiber cooperate with the marker disposed on the outer periphery of the distal end portion of the tube body, and both the marker and the optical fiber are attached to the tube body. Thus, movement in the axial direction is suppressed. Therefore, the marker is securely fixed to the outer periphery of the tubular body, and the optical fiber is securely fixed to the tubular body (in the first hole of the tubular body). Specifically, the first fixing member and the second fixing member act on both sides of the marker so as to expand the first hole in at least one direction perpendicular to the axial direction, so that the outer periphery of the tubular body is also increased. Acts to spread. Thereby, it is suppressed that the outer periphery of a tubular body becomes smaller than the inner periphery of a marker in the both sides of a marker. Therefore, it is suppressed that a marker moves to an axial direction with respect to a tubular body. On the other hand, since the marker prevents the outer periphery of the tube body from expanding beyond the inner periphery, the first fixing member and the second fixing member that act to expand the outer periphery of the tube body as described above. Is prevented from moving in the axial direction beyond the position of the marker. Therefore, it is possible to prevent the optical fiber in which the first fixing member and the second fixing member are fixed from moving in the axial direction with respect to the tubular body. Therefore, in this catheter, the ring-shaped marker is securely fixed to the outer periphery of the tube, and the optical fiber is securely fixed in the first hole of the tube.

In the catheter according to an embodiment of the present disclosure, the first fixing member and the second fixing member may have an outer width larger than the inner width of the first hole in all directions perpendicular to the axial direction. According to this, the action of the first fixing member and the second fixing member expanding the first hole works equally in all directions perpendicular to the axial direction of the first hole. Therefore, it can suppress more effectively that both a marker and an optical fiber move to an axial direction with respect to a tubular body.

In the catheter according to an embodiment of the present disclosure, the first fixing member and the second fixing member may each have a spheroid shape whose longitudinal direction is the axial direction. According to this, since the shape of the outer periphery of the tubular body expanded by the first fixing member and the second fixing member changes gently, the distal end portion of the tubular body can be smoothly inserted into a blood vessel or the like. Further, when the catheter is manufactured by inserting the optical fiber to which the first fixing member and the second fixing member are fixed into the first hole of the tube body, the smooth shape of the first fixing member and the second fixing member Since the shape of the inner wall of the first hole also changes smoothly along the line, at least one of the first fixing member and the second fixing member is prevented from being caught by the inner wall of the first hole and damaging the inner wall of the first hole. be able to.

In the catheter according to one embodiment of the present disclosure, the first fixing member and the second fixing member may each be formed of resin. According to this, it can suppress that the identification of the marker by X-rays is inhibited by the 1st fixing member and the 2nd fixing member. In addition, the first fixing member and the second fixing member can be easily and reliably fixed to the optical fiber.

In the catheter according to an embodiment of the present disclosure, the tube body may further include a second hole extending in the axial direction. According to this, the wire for guiding the tube, the contrast agent, and the like can be delivered to the distal end of the catheter using the second hole different from the first hole in which the optical fiber is disposed.

In the catheter according to one embodiment of the present disclosure, the optical fiber may be used for irradiating laser light. According to this, a catheter can be used for the thrombolysis apparatus which melt | dissolves the thrombus with a laser beam.

According to the present disclosure, it is possible to provide a catheter in which the ring-shaped marker is securely fixed to the outer periphery of the tubular body and the optical fiber is securely fixed in the hole of the tubular body.

FIG. 1 is an overall view of a catheter according to an embodiment. 2 is a longitudinal sectional view of the distal end portion of the catheter of FIG. FIG. 3 is a cross-sectional view taken along line III-III in FIG. FIG. 4 is a diagram showing an example of a manufacturing procedure of the catheter of FIG.

Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings. In addition, in each figure, the same code | symbol is attached | subjected to the same or an equivalent part, and the overlapping description is abbreviate | omitted.

As shown in FIG. 1, the catheter 1 is configured around a tube body 4 in which an optical fiber 7 is disposed, and an optical fiber 7 disposed in the tube body 4 is provided at a proximal portion 3 thereof. Is provided to the outside of the tubular body 4. The optical fiber 7 led out of the tube 4 at the branch part 3a is connected to the laser incident connector 11 at its end.

The catheter 1 constitutes a laser thrombolysis apparatus that dissolves a thrombus in a blood vessel with laser light. The laser light for dissolving the thrombus is a laser light source (not shown) connected to a laser incident connector 11. ) To the thrombus located immediately before the distal end portion 2 of the catheter 1 (which is also the distal end portion 4a of the tube 4 as shown in FIG. 2) via the optical fiber 7. That is, the optical fiber 7 is used for irradiating laser light.

2 and 3, the tube body 4 of the catheter 1 has a first hole 5 and a second hole 6 extending in the axial direction A thereof. The optical fiber 7 is disposed in the first hole 5. The optical fiber 7 is arranged so that the tip position thereof substantially coincides with the tip position of the tube body 4. In one example, the tip position of the optical fiber 7 is adjusted so that the tip of the optical fiber 7 is retracted from 0 mm to 0.1 mm from the tip of the tube 4. The second hole 6 passes a guide wire for guiding the tube body 4 to a desired place in the body through the blood vessel, and a contrast agent for X-raying the thrombus condition in the blood vessel is provided at the tip of the tube body 4. It is used for sending to e.g. The distal end of the tube body 4 may be cut perpendicular to the axial direction A, or may be cut obliquely with respect to the axial direction A. The tip position of the optical fiber 7 is adjusted so that the tip of the optical fiber 7 does not jump out of the tip of the tube body 4 even when it is cut obliquely. The first hole 5 and the second hole 6 are provided with a hydrophilic coating (not shown) made of a hydrophilic polymer, and the optical fiber 7 is fixed to the inner wall of the first hole 5 with an adhesive. I can't do it.

Generally, the hole provided in the catheter tube so as to extend in the axial direction is also referred to as “lumen”. The relatively small hole in which the optical fiber is placed is also called a “fiber lumen” or “sub-lumen”. The largest hole used for delivery of a guide wire or a contrast medium is also called “main lumen”.

The optical fiber 7 is made of quartz or the like. In one example, the fiber diameter of the optical fiber 7 is 0.14 mm. The tube body 4 is formed of a flexible resin (for example, a polyamide-based resin) or the like. In one example, the outer diameter of the tube body 4 is 0.85 mm, the inner diameter of the main lumen (ie, the second hole 6) is 0.36 mm, and the inner diameter of the sub-lumen (ie, the first hole 5) is 0. 2 mm.

A ring-shaped marker 8 for grasping the distal end position of the catheter 1 (the distal end position of the tubular body 4) by X-ray fluoroscopy at a predetermined position (for example, a position of about 1 mm from the distal end) in the distal end portion 4a of the tubular body 4. Is provided. The ring-shaped marker 8 is attached to the outer periphery of the distal end portion 4 a of the tube body 4 so that the thickness of the ring-shaped marker 8 bites into the tube body 4. The marker 8 is made of a metal (for example, platinum) that hardly transmits X-rays. In one example, the inner diameter of the marker 8 is 0.76 mm, and the outer diameter of the marker 8 is 0.83 mm.

The first fixing member 9 and the second fixing member 10 are fixed to the optical fiber 7. More specifically, the first fixing member 9 is fixed to the optical fiber 7 so as to be positioned on one side of the marker 8 (the tip end side of the tube body 4) in the axial direction A. The second fixing member 10 is fixed to the optical fiber 7 so as to be positioned on the other side of the marker 8 in the axial direction A (the side opposite to the distal end side of the tube body 4). The first fixing member 9 and the second fixing member 10 each have a spheroid shape with the axial direction A as the longitudinal direction. A spheroid is a solid obtained by rotating an ellipse about its major axis or minor axis as a rotation axis. “A spheroid whose longitudinal direction is the axial direction A” is an ellipse whose major axis is Is a solid obtained by being rotated about the axis of rotation, and its long axis is along the axial direction A. In addition, the first fixing member 9 and the second fixing member 10 each have an outer width larger than the inner width of the first hole 5 in all directions perpendicular to the axial direction A. Here, the first fixing member 9, the second fixing member 10, and the first hole 5 are all circular when viewed from the axial direction A, and the first fixing member 9 and the second fixing member 10 Each outer diameter is larger than the inner diameter of the first hole 5. In one example, the outer diameters of the first fixing member 9 and the second fixing member 10 are each 0.3 mm. The first fixing member 9 and the second fixing member 10 are each formed of a resin obtained by curing an adhesive.

The inner width of the first hole 5 is the inner width of the first hole 5 in a state where the first fixing member 9 and the second fixing member 10 are not disposed in the first hole 5. The outer widths of the first fixing member 9 and the second fixing member 10 are the first fixing member 9 and the second fixing member 9 in a state where the first fixing member 9 and the second fixing member 10 are not disposed in the first hole 5. This is the outer width of the fixing member 10.

The catheter 1 configured as described above is manufactured as follows as an example. First, as shown in FIG. 4A, the marker 8 is attached to a predetermined position (a position about 1 mm from the distal end) in the distal end portion 4 a of the tubular body 4. Next, the optical fiber 7 is inserted into the first hole (fiber lumen) 5 from the branch portion 3 a in the proximal portion 3 of the catheter 1, and sent out until protruding from the distal end of the tube body 4. Then, as shown in FIG. 4 (b), of the protruding portion, the place that will eventually be located on one side of the marker (the tip side of the tube 4) and the other of the marker 8 The first fixing member 9 and the second fixing member 10 are fixedly formed at two locations, which are located on the side (the side opposite to the distal end side of the tube body 4). Thereafter, the optical fiber 7 is pulled back together with the first fixing member 9 and the second fixing member 10 through the first hole (fiber lumen) 5 to the position shown in FIG.

This procedure is an example, and other procedures may be adopted. For example, the marker 8 may be attached last instead of first.

As described above, in the catheter 1, the first fixing member 9 and the second fixing member 10 fixed to the optical fiber 7 cooperate with the marker 8 disposed on the outer periphery of the distal end portion 4 a of the tube body 4. The movement of both the marker 8 and the optical fiber 7 in the axial direction A with respect to the tube body 4 is suppressed. Therefore, the marker 8 is securely fixed to the outer periphery of the tube 4 and the optical fiber 7 is securely fixed in the tube 4 (in the first hole 5 of the tube 4). Specifically, the first fixing member 9 and the second fixing member 10 act on both sides of the marker 8 so as to push and expand the first hole 5 in all directions perpendicular to the axial direction A. The outer periphery of 4 also acts to expand. Thereby, it is suppressed that the outer periphery of the tubular body 4 becomes smaller than the inner periphery of the marker 8 on both sides of the marker 8. Therefore, the marker 8 is suppressed from moving in the axial direction A with respect to the tubular body 4. On the other hand, since the marker 8 suppresses the outer periphery of the tube body 4 from expanding beyond the inner periphery thereof, the first fixing member 9 and the first fixing member 9 acting to push and expand the outer periphery of the tube body 4 as described above. The two fixing members 10 are prevented from moving in the axial direction A beyond the position of the marker 8. Therefore, the optical fiber 7 to which the first fixing member 9 and the second fixing member 10 are fixed is prevented from moving in the axial direction A with respect to the tube body 4. Therefore, in the catheter 1, the ring-shaped marker 8 is securely fixed to the outer periphery of the tube body 4, and the optical fiber 7 is securely fixed in the first hole 5 of the tube body 4.

As a method for fixing the optical fiber 7 in the first hole 5 of the tubular body 4, in addition to the above method in which the first fixing member 9 and the second fixing member 10 are provided, the inner wall of the first hole 5 and the light It is also conceivable to insert resin beads between the fibers 7 to improve the frictional force between the inner wall of the first hole 5 and the optical fiber 7. Such a method was also tried as a comparative example, but the effect of fixing the optical fiber 7 in the comparative example in the first hole 5 of the tube 4 was not sufficient. The effect of fixing the optical fiber 7 in the first hole 5 of the tube body 4 with only the second fixing member 10 is not sufficient. In addition, the method of fixing the optical fiber 7 in the first hole 5 of the tube body 4 with only the first fixing member 9 is not effective. On the other hand, in the present embodiment, the optical fiber 7 can be reliably fixed in the first hole 5 of the tubular body 4.

This embodiment is particularly effective when the optical fiber 7 cannot be fixed to the inner wall of the first hole 5 with an adhesive because of the hydrophilic coating.

In the example of the present embodiment, the height of the bulge in the outer peripheral portion of the tubular body 4 at the location where the first fixing member 9 and the second fixing member 10 are provided is about 0.04 mm to 0.07 mm, If it is such an excitement, the operation of the catheter will not be hindered.

The first fixing member 9 and the second fixing member 10 in the present embodiment have outer widths larger than the inner width of the first hole 5 in all directions perpendicular to the axial direction A, respectively. Thus, the action of the first fixing member 9 and the second fixing member 10 expanding the first hole 5 works equally in all directions perpendicular to the axial direction A of the first hole 5, so that the marker 8 and the optical fiber 7 is effectively suppressed from moving in the axial direction with respect to the tubular body 4.

The first fixing member and the second fixing member in the present embodiment each have a spheroid shape with the axial direction A as the longitudinal direction. Thereby, since the shape of the outer periphery of the tube body 4 expanded by the first fixing member 9 and the second fixing member 10 is gradually changed, the distal end portion 4a of the tube body 4 is smoothly inserted into a blood vessel or the like. be able to. Further, like the manufacturing method as an example, the catheter 1 is manufactured by inserting the optical fiber 7 to which the first fixing member 9 and the second fixing member 10 are fixed into the first hole 5 of the tube body 4. In this case, since the shape of the inner wall of the first hole 5 also changes smoothly along the smooth shape of the first fixing member 9 and the second fixing member 10, at least one of the first fixing member 9 and the second fixing member 10. It is possible to prevent the inner wall of the first hole 5 from being damaged by being caught on the inner wall of the first hole 5.

The first fixing member 9 and the second fixing member 10 in the present embodiment are each formed of a resin (for example, a resin obtained by curing an adhesive). Thereby, it can suppress that the identification of the marker 8 by an X-ray is inhibited by the 1st fixing member 9 and the 2nd fixing member 10, and also the 1st fixing member 9 and the 2nd fixing member with respect to the optical fiber 7 10 can be fixed easily and reliably.

The tubular body 4 of the present embodiment also has a second hole 6 extending in the axial direction A in addition to the first hole 5. Thereby, using the second hole 6, a wire for guiding the tube 4, a contrast agent, and the like can be delivered to the distal end of the catheter 1.

Since the first fixing member 9, the second fixing member 10, and the first hole 5 of the present embodiment are all circular when viewed from the axial direction A, the first fixing member 9 and the second fixing member When the member 10 is inserted into the first hole 5, there is also an effect that it is not necessary to care about the directions of the first fixing member 9 and the second fixing member 10. This effect is obtained if at least one of the first fixing member 9 and the second fixing member 10 or the first hole 5 has a circular shape when viewed from the axial direction A.

Although one embodiment of the catheter of the present disclosure has been described above, the catheter of the present disclosure is not limited to the above-described embodiment.

For example, in the above-described embodiment, each of the first fixing member 9 and the second fixing member 10 has a spheroid shape with the axial direction A as the longitudinal direction, but has other shapes. Also good. In the above-described embodiment, the first fixing member and the second fixing member each need only have an outer width larger than the inner width of the first hole in at least one direction perpendicular to the axial direction. Or a spheroid having an axial direction A as a short direction, and when viewed from the axial direction A, a shape other than a circle such as an ellipse may be used. It may be presented.

In the above-described embodiment, the shape of the first hole 5 viewed from the axial direction A is circular. However, the first hole is fixed in at least one direction whose inner width is perpendicular to the axial direction. Any shape other than a circle may be used as long as it is smaller than the outer width of the second fixing member in at least one direction perpendicular to the axial direction.

In the above-described embodiment, the first fixing member 9 and the second fixing member 10 are formed of a resin obtained by curing an adhesive, but may be formed of other materials. Good. The first fixing member and the second fixing member are sufficient if they can be fixed to the optical fiber 7 and have sufficient hardness to produce the above-described effects, and any material can be used.

In the above-described embodiment, the tubular body 4 has two holes, the first hole 5 and the second hole 6, but the number of holes is not limited to two. In the catheter of the present disclosure, the number of holes is not limited, and it is sufficient to have at least one hole in which the optical fiber is disposed. Therefore, the catheter has only the first hole 5 and does not have the second hole 6. Alternatively, one or more additional holes may be provided in addition to the first hole 5 and the second hole 6.

In the above-described embodiment, the optical fiber 7 is used for irradiating laser light, but the application is not limited. The optical fiber may be used for, for example, illumination of an endoscope or imaging.

DESCRIPTION OF SYMBOLS 1 ... Catheter, 4 ... Tube, 4a ... Tip part, 5 ... 1st hole, 6 ... 2nd hole, 7 ... Optical fiber, 8 ... Marker, 9 ... 1st fixing member, 10 ... 2nd fixing member, A ... Axial direction.

Claims

A tube having a first hole extending in the axial direction;
An optical fiber disposed in the first hole;
A ring-shaped marker disposed on the outer periphery of the tip of the tubular body;
A first fixing fixed to the optical fiber so as to be positioned on one side of the marker in the axial direction and having an outer width larger than the inner width of the first hole in at least one direction perpendicular to the axial direction. Members,
A second fixing fixed to the optical fiber so as to be positioned on the other side of the marker in the axial direction and having an outer width larger than the inner width of the first hole in at least one direction perpendicular to the axial direction. A catheter comprising: a member;
The catheter according to claim 1, wherein each of the first fixing member and the second fixing member has an outer width larger than an inner width of the first hole in all directions perpendicular to the axial direction.
The catheter according to claim 1 or 2, wherein each of the first fixing member and the second fixing member has a spheroid shape whose longitudinal direction is the axial direction.
The catheter according to any one of claims 1 to 3, wherein each of the first fixing member and the second fixing member is formed of a resin.
The catheter according to any one of claims 1 to 4, wherein the tubular body further has a second hole extending in the axial direction.
The catheter according to any one of claims 1 to 5, wherein the optical fiber is used for irradiating a laser beam.