WO2010016124A1 - Catheter - Google Patents

Abstract

A catheter having an inner tube and an outer tube in which a guide wire inserted into the inner tube can be pulled out suitably from the middle position of the outer tube. A catheter kit (10) comprises an outer tube (16) inserted into a body from the distal end side thereof, and an inner tube (21) inserted into the lumen of the outer tube to move relatively. An inner through hole (41) is formed in the inner tube and an outer through hole (45) is formed in the outer tube. The outer tube has a distal end side outer region (51) and a proximal end side outer region (52) wherein the inner tube is biased for the outer through hole in the distal end side outer region to the opposite side holding the inner tube between. A thick portion (58) is formed at the proximal end portion of the distal end side outer region and its thick surface (58a) is facing the distal end side.

Description

catheter

The present invention relates to a catheter.

As a treatment method for expanding a stenosis site or an occlusion site in a living organ such as a blood vessel, a method of inserting a catheter into the living organ and placing a stent in the stenosis site or the occlusion site is known. Examples of the stent include a self-expandable stent having a self-expanding function and a balloon expandable stent that expands as the balloon is inflated. Both stents are attached to the catheter in a living organ. It is transported to a stenosis site or an occlusion site.

A catheter to which a stent is attached includes an inner tube and an outer tube in which the inner tube is inserted, and the stent is accommodated in a stent accommodating portion formed between the inner tube and the outer tube. . The catheter is configured such that a guide wire is inserted from the distal end thereof, and is inserted into the body so as to follow the guide wire previously inserted into the body. In addition, there are an over-the-wire type and a monorail type as the guide wire insertion type. In the over-the-wire type, the guide wire inserted from the distal end of the outer tube is led out from the proximal end of the outer tube. In the monorail type, the guide wire inserted from the distal end of the outer tube is It is the structure derived | led-out from the intermediate position of a tube.

The monorail type catheter has an inner port provided at an intermediate position of the inner tube and an outer port provided at an intermediate position of the outer tube as an outlet of the guide wire. Here, in the catheter, when the inner tube rotates relative to the outer tube about the axis, the inner port and the outer port may exist on the opposite sides across the axis. In this case, after the guide wire is led out from the inner port, it is difficult to lead out the guide wire from the outer port. On the other hand, for example, Patent Document 1 discloses a configuration in which a cylindrical member that passes through an inner port and an outer port is attached to a catheter, and the cylindrical member can be detached from the catheter. Accordingly, the guide wire can be easily led out from the intermediate position of the outer tube.
JP 2004-121343 A

However, in the configuration disclosed in Patent Document 1, it is necessary for the cylindrical member to be attached to the catheter, which is a necessary condition for inserting the guide wire through the catheter, and the catheter is inserted into the body. Workability may be reduced. Further, when the cylindrical member is not attached to the catheter, it is difficult to guide the guide wire from the outer port when the inner tube rotates relative to the outer tube as in the conventional case.

The present invention has been made in view of the above circumstances, and provides a catheter that includes an inner tube and an outer tube and that can suitably draw out a guide wire inserted into the inner tube from an intermediate position of the outer tube. It is the purpose.

Hereinafter, effective means for solving the above-mentioned problems will be described while showing the actions and effects as necessary.

The catheter of the present invention has an inner lumen extending from the distal end portion toward the proximal end side, and has an inner tube through which the guide wire is inserted and an outer lumen through which the inner tube is inserted. And an outer tube that encloses at least the distal end side of the inner tube from the outer peripheral surface side, and is provided so as to be relatively movable in at least the circumferential direction, and the inner tube defines the inner lumen. The inner tube is provided with an inner port for communicating the inner lumen with the outer lumen, and the outer tube has an outer port for opening the outer lumen to the outside on a peripheral wall portion defining the outer lumen. A guide wire inserted into the inner lumen from the distal end side of the inner tube, the inner port and the outer port The outer port is formed at a position closer to the proximal end side than the inner port, and the inner peripheral surface of the outer tube and the inner tube An insertion space into which the guide wire can be inserted is formed between the outer peripheral surface, and a structure for guiding the guide wire from the inner port to the outer port is formed in the insertion space. It is formed by a defining wall.

According to this configuration, when the guide wire is inserted into the inner lumen from the distal end portion of the inner tube, the guide wire is led out from the inner port so that it enters the outer lumen of the outer tube and passes through the outer lumen. To reach the outer port. That is, the catheter of this configuration is a multi-rail structure including an outer tube and an inner tube, and is a monorail type in which a guide wire is led out from an intermediate position of the catheter. In this case, when the guide wire passes through the insertion space after being led out from the inner port, it is guided by the guide structure from the inner port to the outer port, so the guide wire may pass through the outer port and enter the proximal end side. The guide wire can reach the outer port while preventing the wire from being wound around the inner tube. That is, the guide wire can be suitably led out from the intermediate position of the catheter without using an instrument or the like for communicating the inner port and the outer port.

The insertion space is formed between the inner port and the outer port in the longitudinal direction, and at least the insertion space sandwiches the inner tube with respect to the outer port on the inner peripheral surface of the outer tube. The inner tube is preferably arranged so that the inner tube is biased on the opposite side. In this case, the guide wire can easily reach the outer port while suppressing the guide wire from entering the opposite side of the outer port across the inner tube in the insertion space.

At least in the insertion space, the distance between the opposite side of the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube facing it is less than the diameter of the guide wire, and on the inner peripheral surface of the outer tube The inner tube may be arranged such that a distance between the outer port side and the outer peripheral surface of the inner tube facing the outer port is equal to or larger than the diameter of the guide wire. In this case, in the insertion space, the guide wire can enter the outer port side, and the guide wire can be prevented from entering the opposite side of the outer port with the inner tube interposed therebetween.

In the insertion space, the region from the position of the inner port to the position of the outer port is at least halfway between the opposite side of the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube facing it. When the distal end side of the guide wire enters, it is preferable that the distal end side of the guide wire is formed so as to be able to wrap around from the outer peripheral side of the inner tube to the region on the outer port side. In this case, even if an inner port exists on the opposite side of the outer port across the inner tube, the guide wire is led out from the inner port, so that the guide wire is connected to the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube. And the outer port can be reached by wrapping around from the outer peripheral side of the inner tube.

It is preferable that the insertion space is formed so that the cross section becomes smaller continuously or stepwise from the position of the inner port in the longitudinal direction toward the position of the outer port. In this case, the traveling direction of the guide wire can be gradually limited with respect to the direction toward the outer port. Therefore, it is possible to suitably guide the guide wire toward the outer port.

In the insertion space, the region on the outer port side of the inner tube is contracted so as to approach the outer shape of the cross section of the guide wire, and the region on the bias side has an outer shape of the cross section of the inner tube. It should be shrunk to get closer. In this case, in the insertion space, if the guide wire that advances toward the proximal end is made to enter the outer port side region, the subsequent guide wire naturally reaches the outer port without leaving the outer port side region. . Therefore, the guide wire can easily reach the outer port.

A partition portion is formed on the inner peripheral side of the outer tube to branch the outer lumen into the outer port side region and the biased side region at a midway position from the outer port position toward the distal end side. And good. In this case, if the guide wire that advances toward the proximal end is made to reach the partition portion in the outer port side region, the subsequent guide wire does not return to the region where the inner tube is biased. Therefore, the guide wire can reach the outer port more reliably.

The outer peripheral surface of the inner tube and the inner peripheral surface of the outer tube are formed in a curved shape that protrudes outward around the axis, and the inner tube is continuous from the inner port toward the proximal end side. Or it is good to form so that rigidity may become high in steps. In this case, since the distal end side of the inner tube is easily bent, even if the distance between the outer peripheral surface of the inner tube and the inner peripheral surface of the outer tube is smaller than the outer diameter of the guide wire on the biased side of the inner tube, It becomes possible to enter between the outer peripheral surface of the inner tube and the inner peripheral surface of the outer tube. In addition, since the restoring force of the inner tube is increased toward the proximal end side, the guide wire advances toward the proximal end side, so that the restoring force of the inner tube between the outer peripheral surface of the inner tube and the inner peripheral surface of the outer tube allows Extruded. Therefore, the guide wire can be advanced toward the outer port.

The outer tube is continuous at the distal end side with respect to the proximal end outer region and the proximal end outer region, and is extended in a predetermined direction outward with respect to the axis of the proximal end outer region, or A distal-side outer region whose amount of expansion in a predetermined direction is larger than that in the opposite direction, and the inner tube is disposed so as to pass through the proximal-side outer region. It is biased to the opposite side of the inner peripheral surface of the tube, and at the boundary portion between the base end side outer region and the tip end side outer region, the base end side outer region is expanded from the tip end side outer region. A stepped portion projecting outward toward the part is formed, and the outer port is preferably formed in the stepped portion. In this case, since the stepped portion is provided on the side opposite to the biased side of the inner tube, the guide wire traveling toward the proximal end side in the distal end side outer region easily reaches the stepped portion. Further, since the outer port is formed in the step portion, the guide wire can be easily led out from the outer port, and the guide wire can be led out along the longitudinal direction of the outer tube. That is, the guide wire can be smoothly led out from the outer port.

The inner tube includes a distal inner region including the inner port, and a proximal end formed so as to be continuous with the distal end side with respect to the distal inner region and to have higher rigidity than the distal inner region. It is preferable that the region where the step portion is formed in the outer tube is disposed around the proximal end inner region. In this case, even if the rigidity of the outer tube is locally changed at the stepped portion, the rigidity around the stepped portion in the entire catheter is locally changed by the proximal end inner region of the inner tube. Can be suppressed. Therefore, a decrease in kink resistance in the catheter can be suppressed.

The insertion space is formed between the inner port and the outer port in the longitudinal direction, and the region defining the insertion space on the inner peripheral surface of the outer tube is on the way toward the proximal end side A guide portion is formed so as to narrow the outer lumen at a position, and the guide portion faces the distal end side and guides the guide wire abutted from the distal end side toward the outer port. It is good that it is formed. In this case, in the insertion space, the guide wire traveling from the inner port toward the proximal end reaches the guide portion before passing through the inner port, and reaches the outer port by traveling toward the proximal end along the guide surface. To do. Therefore, the guide wire can be led out from the outer port simply by inserting it from the tip of the inner tube.

The guide surface is formed so as to surround the inner tube around the axis of the inner tube, and so that a gap does not occur between the inner peripheral edge and the outer surface of the inner tube. The gap is preferably formed so as to be less than the diameter of the guide wire. In this case, it is restricted that the guide wire passes through the guide surface and proceeds to the proximal end side. Therefore, the guide wire can be more reliably guided to the outer port by the guide surface.

The inner tube includes a distal inner region including the inner port, and a proximal end formed so as to be continuous with the distal end side with respect to the distal inner region and to have higher rigidity than the distal inner region. It is preferable that the region where the guide surface is formed in the outer tube is disposed around the base end side inner region. In this case, even if the rigidity of the outer tube is locally changed in the guide portion, the rigidity around the stepped portion in the entire catheter is locally changed by the proximal end inner region of the inner tube. Can be suppressed. Therefore, a decrease in kink resistance in the catheter can be suppressed.

The front view which shows the structure of the catheter kit in 1st Embodiment. The longitudinal cross-sectional view which expands and shows the intermediate position of a catheter kit. The diagonal sectional view which expands and shows the middle position of a catheter kit. The cross-sectional view of a catheter kit. The cross-sectional view of a catheter kit. Explanatory drawing for demonstrating the manufacturing process of an outer tube. The front view which shows the structure of the catheter kit in case a stent exists in an expanded state. The longitudinal cross-sectional view which expands and shows the intermediate position of another catheter kit.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Catheter kit as a catheter, 16 ... Outer tube, 21 ... Inner tube, 41 ... Inner through-hole as inner port, 45 ... Outer through-hole as outer port, 51 ... Front end side outer region, 52 ... Base end side outer Area 53: Stepped portion 55 55 Partitioning portion 55a Partitioning surface constituting guide surface 56 Main tube portion 57 Sub-wall portion 58 Thick portion 58a Thick surface constituting guide surface , 59 ... insertion space.

(First embodiment)
Hereinafter, a first embodiment of the present invention will be described with reference to the drawings. In the present embodiment, a catheter kit for expanding a stent in a living organ such as a blood vessel is embodied. FIG. 1 is a front view showing the configuration of the catheter kit 10.

As shown in FIG. 1, the catheter kit 10 includes a guiding catheter 11, an inner catheter 12, a stent 13 attached to the inner catheter 12, and a Y connector 14 attached to the guiding catheter 11. As a whole, for example, it has a length of about 1.5 m.

The guiding catheter 11 includes an outer tube 16 inserted into the body from a distal end (distal end), and an outer hub 17 attached to a proximal end (proximal end) of the outer tube 16. For example, it has a length of about 1.2 m. The outer tube 16 is formed in a tubular shape from a synthetic resin material, and has an outer lumen 16a extending from the distal end portion toward the proximal end portion. The outer lumen 16a forms an inner catheter lumen, and the inner catheter 12 is inserted through the outer lumen 16a.

The inner catheter 12 includes an inner tube 21 passed through the outer lumen 16a and an inner hub 22 attached to the proximal end portion of the inner tube 21, and has a length of about 1.4 m, for example. Yes. The inner tube 21 can be moved relative to the outer tube 16. For example, the inner tube 21 can move in the longitudinal direction with respect to the outer tube 16, rotate around an axis, and the like. The inner tube 21 is formed in a tubular shape and has an inner lumen 21a extending from the distal end portion toward the proximal end portion. The inner lumen 21a forms a guide wire lumen, and the guide wire G is inserted through the inner lumen 21a. The inner tube 21 is longer than the outer tube 16, and the base end portion of the inner tube 21 is exposed to the base end side of the guiding catheter 11. Therefore, the inner hub 22 is disposed on the proximal end side with respect to the outer hub 17.

The stent 13 is formed in a substantially cylindrical shape from a metal material such as a nickel titanium alloy. Further, the stent 13 has a contractible elasticity, and when an external force is applied, the stent 13 shifts from a normal state to a contracted state having a smaller outer diameter, and the external force is released to release the external force. It is configured to return from the contracted state to the normal state. At the front end of the inner tube 21, annular stoppers 25 and 26 projecting outward from the outer peripheral surface are arranged opposite to each other at a predetermined interval in the longitudinal direction, and a defined area defined by the pair of stoppers 25 and 26 The stent 13 is disposed on the surface. After the stent 13 is contracted in the specified region, the outer tube 16 is covered with the outer tube 16 in that state, and an external force is continuously applied by the outer tube 16 to maintain the contracted state. Thus, the state in which the stent 13 is mounted corresponds to an initial state in the catheter kit 10 and corresponds to a state in which the relative position between the inner tube 21 and the outer tube 16 is in the initial position. Further, the outer tube 16 is in a retracted position in which the outer tube 16 is retracted relatively to the proximal end side with respect to the inner tube 21, so that a treatment state in which the stent is exposed is obtained.

The stoppers 25 and 26 are made of a metal material having an X-ray contrast function. Further, a distal end member 27 formed to taper toward the distal end side is provided on the distal end side of the stoppers 25 and 26 in the inner tube 21.

The Y connector 14 is disposed between the inner hub 22 and the outer hub 17. The Y connector 14 includes a first tube portion 28 and a second tube portion 29 branched from a midway position of the first tube portion 28, and the inner tube 21 is inserted into the lumen of the first tube portion 28. Has been.

The catheter kit 10 is configured such that the guide wire G is led out from the intermediate position. The configuration will be described with reference to FIGS. 2 is an enlarged longitudinal sectional view showing an intermediate position of the catheter kit 10, FIG. 3 is an oblique sectional view showing the intermediate position of the catheter kit 10 in an enlarged manner, and FIG. 4 is a transverse sectional view of the catheter kit 10. is there. 4, (a) is a cross section taken along line AA, (b) is a cross section taken along line BB, (c) is a cross section taken along line CC, (d) is a cross section taken along line DD, and (e) is a cross section taken along line E- A cross section taken along line E, (f) shows a cross section taken along line FF, (g) shows a cross section taken along line GG, and (h) shows a cross section taken along line HH. Incidentally, the longitudinal section is a section parallel to the longitudinal direction of the catheter kit 10, the transverse section is a section orthogonal to the longitudinal direction, and the oblique section is a section intersecting obliquely with the longitudinal direction.

As shown in FIG. 2, the inner tube 21 is composed of a plurality of tubular shafts, and includes a proximal end side shaft 31 and a distal end side shaft 32 as the tubular shafts.

The base end side shaft 31 is formed in a circular cross section with a metal such as stainless steel or nickel titanium alloy, and has a length of, for example, a little over 1 m. The proximal end shaft 31 has a proximal end portion joined to the inner hub 22 and a distal end portion joined to the distal end side shaft 32. In addition, the base end side shaft 31 may be made of a synthetic resin, and a fluororesin such as PTFE may be coated on the outer periphery. When the coating is applied, the frictional force between the outer peripheral surface of the base end side shaft 31 and the inner peripheral surface of the outer tube 16 becomes a suitable magnitude, and the inner tube 21 is moved forward relative to the outer tube 16. Or retreating is easy.

The proximal shaft 31 has a tapered region 35 at the distal end thereof, and the tapered region 35 has a continuously decreasing rigidity from the proximal end toward the distal end. Specifically, the taper region 35 is formed in a tapered shape in which the inner diameter and the outer diameter are continuously reduced toward the distal end side, and a spiral cut 36 as a rigidity reduction structure is continuous in the length direction. Is formed. The pitch of the notches 36 is narrowed toward the tip side. This pitch means the distance between the notches 36 arranged in the length direction when viewed in the state of FIG.

Further, a core wire 37 is inserted into the proximal end side shaft 31. The core wire 37 has a tip portion formed in a taper shape, and the rigidity decreases toward the tip side. The distal end portion of the core wire 37 protrudes further toward the distal end side than the tapered region 35 through the distal end portion of the tapered region 35.

The distal shaft 32 is bonded to the distal end of the proximal shaft 31. The front end side shaft 32 is formed in a cylindrical shape from a synthetic resin material, and has a length of, for example, a little less than 0.25 m. The distal end portion of the core wire 37 and the distal end portion of the proximal end side shaft 31 enter the proximal end portion of the distal end side shaft 32, and the inserted portion serves as an adhesive portion of the shafts 31 and 32.

An inner through hole 41 that penetrates the outer lumen 16a and the inner lumen 21a is formed in the peripheral wall of the distal shaft 32. An inner shaft 33 is provided by welding one end of the inner through hole 41. The inner shaft 33 is inserted from the front end side opening of the front end side shaft 32 to the position of the inner through hole 41, and the end opposite to the side welded to the inner through hole 41 is the front end side shaft 32. It is welded to the opening on the tip side. The hole diameter of the inner shaft 33 is set larger than the outer diameter of the guide wire G, and the guide wire G can be inserted therethrough. The guide wire G is inserted into the inner shaft 33 from the distal end side of the distal end side shaft 32 and passes through the inner shaft 33 and enters the outer lumen 16a from the opening on the inner through hole 41 side. That is, the opening on the proximal end side of the inner shaft 33 has a function as an inner port serving as an outlet to the outer lumen 16a.

In the distal end side shaft 32, the distal end portion of the core wire 37 exists in the vicinity of the proximal end side of the inner through hole 41. Further, on the proximal end side with respect to the inner through hole 41, the rigidity is gradually increased from the distal end portion of the core wire 37 toward the tapered region 35 of the proximal end side shaft 31. Thus, the rigidity is not locally changed around the inner through hole 41, and the rigidity of the inner tube 21 is gradually increased toward the base end side. In this case, the proximal end side of the inner tube 21 with respect to the tapered region 35 is the proximal end inner region, and the distal end side including the tapered region 35 is the distal end side inner region.

The outer tube 16 has a distal outer region 51 provided on the distal end side from the intermediate position in the longitudinal direction, and a proximal outer region 52 provided on the proximal side of the distal outer region 51. Yes. The outer regions 51 and 52 are each formed in a tubular shape so as to be continuous at the boundary. In the distal end side outer region 51, the peripheral wall of the outer tube 16 is expanded outward (outer peripheral side) with reference to the axis of the proximal end side outer region 52, and the amount of expansion is larger than the opposite direction in a predetermined direction. It is getting bigger. A stepped portion 53 is formed in the distal outer region 51 on the side adjacent to the proximal outer region 52, and the stepped portion 53 is formed in the inner through hole 41 when the catheter kit 10 is in the initial state. It is provided in the position which exists in the base end side rather than.

The stepped portion 53 is extended outward from the proximal end side outer region 52 toward the distal end side. Thus, the outer peripheral surface of the stepped portion 53 is an inclined surface that is inclined so as to protrude outward from the proximal end side outer region 52 toward the distal end side. Note that the amount of expansion of the stepped portion 53 may increase stepwise toward the tip side.

In the stepped portion 53, an outer through hole 45 that penetrates the outer lumen 16a and the external space so as to communicate with each other is formed in a portion (a portion in a predetermined direction) that has a larger outward expansion amount than other portions. Yes. In this case, the outer through hole 45 is disposed at the proximal end portion of the distal end side outer region 51, as with the stepped portion 53, and is more proximal than the inner through hole 41 when the catheter kit 10 is in the initial state. Exists on the side. The outer through hole 45 is opened toward the base end side in the peripheral wall of the outer tube 16. The hole diameter of the outer through hole 45 is set to be larger than the outer diameter of the guide wire G, and the guide wire G can be inserted therethrough. The separation distance between the outer through hole 45 and the distal end portion of the outer tube 16 is, for example, 0.25 m.

The outer tube 16 includes a main tube portion 56 that communicates with the distal end side outer region 51 and the proximal end side outer region 52, and a sub tube portion 57 that is branched from the main tube portion 56 in the distal end side outer region 51. The lumen of the main tube portion 56 and the lumen of the sub tube portion 57 are formed by the outer lumen 16a. At the branch portion between the main tube portion 56 and the sub tube portion 57, a partition portion 55 that partitions the tube portions 56, 57 is provided, and the sub tube portion 57 is on the proximal end side along the main tube portion 56. It extends toward. The sub pipe portion 57 has an inner diameter larger than the outer diameter of the guide wire G, and the guide wire G can be inserted therethrough. Further, the sub pipe portion 57 has a base end portion formed by the stepped portion 53 and an opening on the base end side formed by the outer through hole 45. In this case, the guide wire G that has reached the sub pipe portion 57 passes through the sub pipe portion 57 and exits from the outer through hole 45 to the outside. That is, the opening on the proximal end side of the sub pipe portion 57 has a function as an outer port serving as an outlet from the outer tube 16.

In the outer tube 16, the inner tube 21 is inserted through the main tube portion 56. The inner tube 21 is disposed at the center of the transverse section in the proximal end side outer region 52, and as a result, in the distal end side outer region 51, the inner tube 21 is disposed biased on the opposite side of the expanded portion. That is, the inner tube 21 is biased to the opposite side of the inner tube 21 with respect to the outer through hole 45 on the inner peripheral surface of the outer tube 16 in the distal end side outer region 51. In this case, the axial line of the inner tube 21 and the outer tube 16 is on the same line in the proximal end side outer region 52, and the axial line of the inner tube 21 in the distal end side outer region 51 is the outer through hole 45 across the axis line of the outer tube 16. On the other side.

An insertion space 59 into which the guide wire G can be inserted is formed between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the main tube portion 56 in the distal end side outer region 51. In the insertion space 59, the space between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the main pipe portion 56 is on the bias side of the inner tube 21 (the opposite side of the outer through hole 45 sandwiching the inner tube 21). The distance is smaller than the outer diameter of the guide wire G, and the separation distance is larger than the outer diameter of the guide wire G on the outer through hole 45 side. Further, at the proximal end portion of the distal end side outer region 51, a part of the insertion space 59 faces the stepped portion 53 and a part thereof is opened to the outside through the outer through hole 45.

Further, a thick portion 58 where the thickness of the main tube portion 56 is increased is provided at the base end portion of the distal end side outer region 51 in the main tube portion 56. The thick portion 58 is disposed in the main tube portion 56 on the proximal side of the tapered region 35 of the proximal shaft 31 in the inner tube 21 when the catheter kit 10 is in the initial state. As shown in FIG. 3, in the thick portion 58, the thickness of the main pipe portion 56 is increased inward, and the inner peripheral surface of the thick portion 58 and the outer peripheral surface of the inner tube 21 are separated from each other. The distance of each portion is smaller than the outer diameter of the guide wire G. That is, the insertion space 59 is not formed between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the thick portion 58. Accordingly, the guide wire G is prevented from entering between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the thick portion 58 on the proximal end side with respect to the thick portion 58.

The thick portion 58 is formed so as to narrow the outer lumen 16a from the distal end side toward the proximal end side. In this case, the distal end side of the thick portion 58 exists on the biased side of the inner tube 21, and the cross-sectional area gradually increases so as to surround the outer peripheral surface of the inner tube 21 from there toward the proximal end side. Further, the thick part 58 is formed integrally with the partition part 55 between the sub pipe part 57 and the main pipe part 56. The thick portion 58 has a thick surface 58a as an end surface facing the distal end side, and the sub tube portion 57 side is inclined to the proximal end side with respect to the main tube portion 56 so as to surround the axis of the inner tube 21. It is a slanted surface. In addition, the partition part 55 has the partition surface 55a as an end surface which faces the front end side, and the partition surface 55a is an inclined surface which forms the same plane as the thick surface 58a.

In the proximal end side outer region 52, the inner peripheral surface of the main pipe portion 56 has the same size and shape as the inner peripheral surface of the proximal end portion of the thick portion 58, and the proximal end portion of the distal end side outer region 51 Similarly, the insertion space 59 is not formed between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the main tube portion 56. Specifically, the separation distance between the outer peripheral surface of the inner tube 21 and the inner peripheral surface of the main tube portion 56 is smaller than the outer diameter of the guide wire G in any part.

Next, the cross-sectional shapes of the main pipe portion 56 and the sub pipe portion 57 in the outer tube 16 will be described.

As shown in FIGS. 4A to 4C, in the distal outer region 51, the main pipe portion 56 crosses at a position from the distal end side to the tapered region 35 of the proximal shaft 31 with respect to the inner through hole 41. The inner tube 21 has a circular shape, and the distal end shaft 32 and the inner shaft 33 of the inner tube 21 have a circular cross section. The inner peripheral surface of the main tube portion 56 has a curvature that is greater than the outer peripheral surface of the inner tube 21. It is getting smaller. At these positions, since the inner tube 21 is biased with respect to the main pipe portion 56, the axis of the inner tube 21 is shifted to one side from the axis of the main pipe portion 56. Further, the inner peripheral surface of the main tube portion 56 and the outer peripheral surface of the inner tube 21 are curved so as to protrude outward around the axis, respectively, and the inner peripheral surface of the main tube portion 56 is the inner tube 21. Since the curve is gentler than the outer peripheral surface, the separation distance continuously increases from the biased side of the inner tube 21 toward the outer through hole 45 side. The insertion space 59 here has a size that allows the guide wire G to go around the outer peripheral side of the inner tube 21.

As shown in FIG. 4 (d), the main pipe portion 56 has an inner shape (shape on the inner peripheral side) on the biased side of the inner tube 21 at the position closer to the proximal end than the tapered region 35. The inner shape on the outer through hole 45 side is shrunk so as to approach the outer shape of the guide wire G. In other words, the main tube portion 56 is contracted in the radial direction at an intermediate position between the biased side of the inner tube 21 and the opposite side thereof.

As shown in FIG. 4 (e), at the position where the thick portion 58 exists on the biased side of the inner tube 21, the main pipe portion 56 is not only contracted on the biased side of the inner tube 21. The inner shape on the outer through hole 45 side is shrunk so as to approach the outer shape of the guide wire G. Further, the separation distance between the inner peripheral surface of the thick portion 58 and the outer peripheral surface of the inner tube 21 is smaller than the outer diameter of the guide wire G, and the proximal end of the inner tube 21 is more proximal than the thick portion 58. The approach of the guide wire G to the side is restricted.

As shown in FIG. 4 (f), the contraction range of the main pipe portion 56 is large at the position where the thick portion 58 exists on the side opposite to the biased side of the inner tube 21. That is, the inner shape of the inner tube 21 on the biased side of the inner tube 21 is closer to the outer shape of the inner tube 21, and the inner shape on the outer through hole 45 side is closer to the outer shape of the guide wire G. In this case, the insertion space 59 is continuously reduced from the distal end side toward the proximal end side. Further, the range in which the guide wire G is restricted from entering by the thick portion 58 is expanded to the outer through hole 45 side. Note that the insertion space 59 may be gradually reduced from the distal end side toward the proximal end side.

As shown in FIG. 4G, at the position where the partition portion 55 exists, the main tube portion 56 has an inner shape on the bias side of the inner tube 21 that is substantially the same as the outer shape of the inner tube 21. The inner shape on the outer through hole 45 side is substantially the same as the outer shape of the guide wire G. In this case, the insertion space 59 is not formed between the inner peripheral surface of the main tube portion 56 and the outer peripheral surface of the inner tube 21, and the range in which the guide wire G is restricted from entering is the entire main tube portion 56. It has been expanded. Further, the sub pipe portion 57 is branched from the main pipe portion 56 by the partition portion 55, and the sub pipe portion 57 communicates the insertion space 59 and the external space.

As shown in FIG. 4 (h), the main pipe portion 56 has an inner shape on the bias side of the inner tube 21 even at a position closer to the base end side than the sub pipe portion 57, that is, in the base end side outer region 52. The outer shape of the inner tube 21 is substantially the same, and the insertion space 59 is not formed. In this case, the axis of the main pipe portion 56 and the axis of the inner tube 21 are on the same line.

Next, the movement of the guide wire G when the guide wire G is led out from the catheter kit 10 will be described.

First, the case where the inner through hole 41 exists on the outer through hole 45 side will be described with reference to FIG.

The guide wire G (see FIG. 4A) inserted into the inner lumen 21a is led out from the inner through hole 41 to the outer through hole 45 side (see FIG. 4B), and the insertion space 59 passes through the inner tube 21. (See FIG. 4C). Then, it passes through the insertion space 59 that continuously decreases toward the base end side (see FIGS. 4D, 4E, and 4F) and reaches the partition portion 55. Then, it enters into the sub pipe part 57 along the partition surface 55a and the thick surface 58a (refer FIG.4 (g)). In this case, since the insertion space 59 is not formed between the partition surface 55a or the thick surface 58a and the inner tube 21, the guide wire G enters the proximal end side with respect to the partition surface 55a or the thick surface 58a. Is regulated. In this case, the guide wire G that advances toward the base end side is once again entered into the sub pipe portion 57, so that it is restricted by the partition portion 55 from entering the main pipe portion 56. 45 will be reached. And it is derived | led-out from the outer through-hole 45 through the sub pipe | tube part 57 (refer FIG.4 (h)).

Next, the case where the inner through hole 41 exists on the biased side of the inner tube 21 will be described with reference to FIG. FIG. 5 is a cross-sectional view of the catheter kit. In FIG. 5, (a) to (h) show cross sections corresponding to (a) to (h) of FIG.

The guide wire G (see FIG. 5A) inserted into the inner lumen 21a is led out from the inner through hole 41 to the bias side of the inner tube 21 (opposite side of the outer through hole 45) (FIG. 5B). )reference). In this case, on the bias side of the inner tube 21, the separation distance between the inner peripheral surface of the main tube portion 56 and the outer peripheral surface of the inner tube 21 is smaller than the outer diameter of the guide wire G. As a result, the inner tube 21 bends toward the outer through-hole 45 side, and the deviation of the inner tube 21 with respect to the main tube portion 56 is alleviated. Get in between.

Thereafter, the guide wire G is pushed out toward the base end side so that the separation distance between the inner peripheral surface of the main tube portion 56 and the outer peripheral surface of the inner tube 21 is larger. Specifically, since the rigidity of the inner tube 21 is gradually increased from the inner through hole 41 toward the proximal end side, the restoring force when bent toward the outer through hole 45 side is directed toward the proximal end side. Will be gradually increased. Accordingly, as the guide wire G advances from the inner through hole 41 to the proximal end side, the guide wire G is pushed out from the biased side of the inner tube 21 toward the larger separation distance by the restoration of the inner tube 21. That is, the guide wire G extends along the curved inner peripheral surface of the main tube portion 56 and the curved outer peripheral surface of the inner tube 21, and the outer through hole 45 side in the circumferential direction of the inner tube 21 and the opposite side thereof. (See FIG. 5C).

When the guide wire G enters the range in which the main tube portion 56 is contracted, the guide wire G is pushed out by the restoring force of the inner tube 21, and the guide wire G extends along the contracted range with the inner peripheral surface of the main tube portion 56. It progresses to the one where the separation distance between the outer peripheral surfaces of the inner tubes 21 is larger. Therefore, the inner tube 21 is pushed out from the intermediate direction between the outer through hole 45 side and the opposite side in the circumferential direction toward the outer through hole 45 (see FIG. 5D). And it pushes out to the sub pipe part 57 side rather than the inner tube 21 (refer FIG.5 (e)), and also the advancing direction is limited toward the sub pipe part 57 by the contraction range of the main pipe part 56 (FIG. 5). (Refer to (f)). As a result, the guide wire G reaches the sub pipe portion 57 so as to go around the outer peripheral side of the inner tube 21. Thereafter, similarly to the case where the inner through hole 41 is present on the sub pipe portion 57 side, the guide wire G passes through the sub pipe portion 57 (see FIG. 5G) and is led out from the outer through hole 45. (See FIG. 5 (h)).

Further, even when the inner through hole 41 exists at an intermediate position between the outer through hole 45 side and the opposite side, the guide wire G is led out from the outer through hole 45. Even in this case, in addition to being pushed out by the restoring force of the inner tube 21, the guide wire G led out from the inner through hole 41 advances to the outer through hole 45 side along the contraction range of the outer tube 16 ( This is because after entering the sub-pipe portion 57 (see FIG. 5 (g)), it is led out from the outer through hole 45 (see FIG. 5 (h)).

Next, a case where the guide wire G is not pushed out by the restoring force of the inner tube 21 or does not proceed to the outer through hole 45 side along the contraction range of the outer tube 16 will be described.

As shown in FIG. 3, the guide wire G reaches the thick portion 58 through the contraction range of the main pipe portion 56. Thereafter, the guide wire G advances to the proximal end side along the thick surface 58a, and reaches the partition portion 55 so as to wrap around the inner tube 21. Then, the sub pipe portion 57 is reached by proceeding along the partition surface 55 a, and is led out from the outer through hole 45 through the sub pipe portion 57. Further, in this case, in the main pipe portion 56, the guide wire G is in the sub-tube because the guide wire G entry restriction range is between the thick portion 58 and the partition portion 55 and the outer peripheral surface of the inner tube 21. It is guided to the sub pipe portion 57 without proceeding to the base end side from the portion 57.

Here, the kink resistance of the catheter kit 10 will be described.

The catheter kit 10 has a lower rigidity toward the distal end as a whole. For example, in the distal end side shaft 32 of the inner tube 21, there is a possibility that the rigidity of the proximal end portion of the inner shaft 33 and the distal end portion of the core wire 37 may locally change. Since the core wire 37 and the tip of the core wire 37 are arranged close to each other, the rigidity gradually decreases toward the tip. Therefore, a decrease in kink resistance of the catheter kit 10 can be suppressed.

Further, in the outer tube 16, the height of rigidity may be locally changed in the region where the stepped portion 53 and the thick portion 58 of the distal end side outer region 51 are formed. When the catheter kit 10 is in the initial state, the thick portion 58 is disposed so as to overlap with a portion (proximal inner region) closer to the proximal end than the tapered region 35 in the proximal shaft 31 of the inner tube 21. Therefore, the rigidity of the catheter kit 10 as a whole decreases toward the distal end side. This is because the rigidity of the inner region on the proximal end side in the inner tube 21 is sufficiently larger than the rigidity of the outer tube 16, and the rigidity of the outer tube 16 is locally changed by the step portion 53 and the thick portion 58. Even if it does, the change is because the rigidity of the catheter kit 10 whole does not change locally. Therefore, a decrease in kink resistance of the catheter kit 10 can be suppressed.

Furthermore, in the catheter kit 10, the inner catheter 12 and the guiding catheter 11 as a whole have a tracking ability to a bent blood vessel, a guide wire G, and the like, and a force transmission ability when inserted into the body (pushability). The thickness, outer diameter, etc. are set so that it can be increased.

Next, the manufacturing process of the outer tube 16 will be described with reference to FIG. FIG. 6 is an explanatory diagram for explaining a manufacturing process of the outer tube 16.

First, a combination process of combining the large diameter tube 61 and the small diameter tube 62 is performed. In the combination process, as shown in FIG. 6A, the small-diameter tube 62 is inserted into the large-diameter tube 61 in a state where the respective axes are parallel without overlapping. Here, the large-diameter tube 61 and the small-diameter tube 62 are each formed in a cylindrical shape, and the large-diameter tube 61 forms the distal end side outer region 51, and the small-diameter tube 62 forms the proximal end side outer region 52. . The large-diameter tube 61 has its end face oriented in a direction perpendicular to the axis of the large-diameter tube 61, and the small-diameter tube 62 has its end face oriented obliquely with respect to the axis of the small-diameter tube 62. ing. In a state where the small diameter tube 62 is inserted into the large diameter tube 61, the small diameter tube 62 is biased to one side in the circumferential direction, and the distal end side (pointed side) of the oblique end portion is the large diameter tube 61. It is in contact with the inner surface. In this case, the inner peripheral surface of the large diameter tube 61 and the outer peripheral surface of the small diameter tube 62 are separated from each other on the side opposite to the biased side of the small diameter tube 62.

Next, a steel material insertion step of inserting a steel material as a metal rod or welding jig into each tube 61, 62 is performed. In the steel material insertion step, as shown in FIG. 6B, the first steel material 65 is inserted into the lumens of the small diameter tube 62 and the large diameter tube 61, and the inner peripheral surface and the small diameter of the large diameter tube 61 are inserted. The second steel material 66 is inserted through a gap spaced from the outer peripheral surface of the tube 62. Here, each of the first steel member 65 and the second steel member 66 is formed in a columnar shape, and the first steel member 65 has an outer diameter that is the same as the inner diameter of the main pipe portion 56 in the proximal end outer region 52. The second steel member 66 has an outer diameter that is the same as the inner diameter of the sub pipe portion 57 in the distal end side outer region 51.

Next, a joining process for joining the large diameter tube 61 and the small diameter tube 62 by heat welding is performed. In the joining step, as shown in FIG. 4C, the contact surfaces of the large-diameter tube 61 and the small-diameter tube 62 are welded, and the tubes 61 and 62 are integrated, and the large-diameter tube 61 is attached to the second tube 61. The steel material 66 and the small diameter tube 62 are shrunk so as to be wound around. Thereafter, the first steel material 65 and the second steel material 66 are extracted from the tubes 61 and 62.

In the outer tube 16, the thick portion 58 and the partition portion 55 are respectively formed by the distal end portion of the small diameter tube 62, and the end face on the distal end side of the small diameter tube 62 becomes the thick surface 58a and the partition surface 55a. ing. Further, the sub pipe portion 57 is formed by contraction of the large-diameter tube 61, and thus has a large thickness as shown in FIG.

Then, the inner tube 21 is inserted through the main tube portion 56 of the outer tube 16 formed by performing the above steps.

At the time of shipment, the catheter kit 10 is attached with a plug member for closing the outer through hole 45 of the guiding catheter 11 when the catheter kit 10 is washed. Further, for the purpose of protecting the inner tube 21 and the outer tube 16, a protective member is inserted from the distal end portion of the inner tube 21. The protective member is a metal linear member or the like, and suppresses bending and deformation of the inner tube 21 and the outer tube 16.

Next, a method of using the stent 13 by the catheter kit 10 will be described with reference to FIG. FIG. 7 is a front view showing the configuration of the catheter kit 10 when the stent 13 is in an expanded state.

The catheter kit 10 is washed with washing water such as physiological saline before the catheter kit 10 is inserted into the body. Here, since the outer through hole 45 is blocked by the plug member, it is possible to prevent the washing water from leaking out from the outer through hole 45 when the inner lumen 21a and the outer lumen 16a are washed with the washing water. . Accordingly, the entire catheter kit 10 including the outer lumen 16a and the inner lumen 21a can be suitably washed.

Then, the catheter kit 10 with the plug member removed is inserted into the body along the guide wire G previously inserted into the body, and the portion of the catheter kit 10 where the stent 13 is mounted is treated. Place it at the target location. Thereafter, as shown in FIG. 7, the guiding catheter 11 is retracted to the proximal end side relative to the inner catheter 12, thereby exposing the stent 13 from the outer lumen 16a to the distal end side. In this case, the external force applied to the stent 13 by the guiding catheter 11 is released, and the stent 13 returns to the normal state from the contracted state by expanding to the outer peripheral side. And the inner catheter 12 is extracted from the stent 13, and the stent 13 is detained in the treatment object location. For example, when the stent 13 is placed in the blood vessel, the blood vessel is held in an expanded state, and blood flow is suitably secured.

According to the embodiment described above in detail, the following excellent effects can be obtained.

In the outer region 51 on the distal end side of the outer tube 16, the inner tube 21 is biased to the opposite side of the outer through hole 45 in the main pipe portion 56, and between the outer peripheral surface of the inner tube 21 and the outer peripheral surface of the outer tube 16. Is larger than the outer diameter of the guide wire G on the outer through-hole 45 side and smaller than the outer diameter of the guide wire G on the opposite side. For this reason, the guide wire G can be easily advanced to the outer through hole 45 side while restricting the guide wire G from entering the opposite side of the outer through hole 45. Further, the guide wire G is pushed toward the outer through hole 45 side by the restoring force of the inner tube 21 by proceeding to the proximal end side, so that the guide wire G can be further advanced to the outer through hole 45 side. Further, the cross-sectional area of the insertion space 59 decreases as it approaches the outer through hole 45 from the inner through hole 41. For this reason, the advancing direction of the guide wire G can be limited to the outer through hole 45 side. As a result, the guide wire G inserted into the inner tube 21 can be suitably pulled out from the intermediate position of the outer tube 16.

In the distal end side outer region 51, a stepped portion 53 is provided on the proximal end side of the insertion space 59, and the outer through hole 45 is formed in the stepped portion 53, so that the insertion space 59 is moved to the proximal end side. The guide wire G that advances toward the outside can be inserted into the outer through-hole 45 without changing the traveling direction thereof. In this case, since the guide wire G is led out along the longitudinal direction of the outer tube 16, the lead-out operation can be performed smoothly.

The outer tube 16 is provided with a partition surface 55 a and a thick surface 58 a as a guide surface. The partition surface 55 a and the thick surface 58 a are inclined with respect to the main tube portion 56 on the sub tube portion 57 side toward the base end side. Therefore, the guide wire G traveling toward the base end side can be guided to the outer through hole 45 so as to be along the partition surface 55a and the thick surface 58a. Further, since no insertion space 59 is formed between the partition surface 55a and the thick surface 58a and the outer peripheral surface of the inner tube 21, the guide wire G passes through the sub pipe portion 57 and enters the proximal end side outer region 52. It can suppress entering. As a result, the guide wire G inserted into the inner tube 21 can be suitably pulled out from the intermediate position of the outer tube 16.

(Second Embodiment)
In the present embodiment, the positional relationship between the outer tube 16 and the inner tube 21 is different from that of the first embodiment. Therefore, the different configuration will be described below. FIG. 8 is an enlarged longitudinal sectional view showing an intermediate position of the catheter kit 10. In FIG. 8, the same components as those in the first embodiment are denoted by the same reference numerals and description thereof is omitted.

In the distal end side outer region 51 of the outer tube 16, unlike the first embodiment, the amount of expansion in the circumferential direction at the expansion portion is uniform in any direction. That is, the main pipe portion 56 is formed in a circular cross section in both the distal end side outer region 51 and the proximal end side outer region 52, and the axes of the distal end side outer region 51 and the proximal end side outer region 52 are respectively It is the same. The step portion 53 is provided in any of the circumferential directions in the distal end side outer region 51, and the outer through hole 45 is provided in a part of the step portion 53. Further, the inner tube 21 is arranged in the main tube portion 56 of the outer tube 16 without being biased in any of the circumferential directions. Therefore, the axis of the main pipe portion 56 and the axis of the inner tube 21 are the same in both the distal end side outer region 51 and the proximal end side outer region 52.

The thick portion 58 is provided in the distal end side outer region 51 so as to extend from the vicinity of the proximal end side to the stepped portion 53 rather than the distal end portion of the core wire 37, and the thick surface 58 a facing the distal end side is formed from the core wire 37. It inclines so that it may extend from the front-end | tip part vicinity of 37 to the sub pipe | tube part 57. FIG. Even in this case, the thick portion 58 is formed integrally with the partition portion 55, and the partition surface 55a and the thick surface 58a continuously form the same plane. Further, the separation distance between the partition surface 55 a and the thick surface 58 a and the inner tube 21 is smaller than the outer diameter of the guide wire G. That is, the insertion space 59 is not formed between the partition surface 55 a and the thick surface 58 a and the inner tube 21.

According to such a configuration, when the guide wire G is inserted from the distal end of the inner tube 21, the guide wire G led out from the inner through hole 41 reaches the thick portion 58 and reaches the proximal end along the thick surface 58 a. When it reaches the partition part 55, it proceeds to the base end side along the partition surface 55a. In this way, the sub pipe portion 57 is guided.

According to the above configuration, the guide wire G reaches the thick portion 58 regardless of whether it travels on the opposite side of the outer through hole 45 with respect to the inner tube 21 or on the outer through hole 45 side. That is, as in the first embodiment, the guide wire G is guided to the outer through hole 45 by the thick surface 58a and the partition surface 55a regardless of the positional relationship between the inner through hole 41 and the outer through hole 45 in the circumferential direction. can do.

(Other embodiments)
The present invention is not limited to the contents described in the above embodiments, and may be implemented as follows, for example.

In the first embodiment, the thick surface 58a is inclined with respect to the longitudinal direction of the outer tube 16 in the distal end side outer region 51 of the outer tube 16, but the thick surface 58a is in the longitudinal direction. It may be a right angle. Even in this case, the guide wire G can be guided to the sub pipe portion 57 because the guide wire G is restricted from entering between the thick surface 58a and the outer peripheral surface of the inner tube 21. Similarly, the partition surface 55 a may be perpendicular to the longitudinal direction of the outer tube 16.

In the first embodiment, the thick portion 58 is provided in the outer region 51 on the distal end side of the outer tube 16, but the thick portion 58 may not be provided. Even in this case, if the insertion space 59 is contracted in the circumferential direction toward the outer through hole 45, the guide wire G can be suitably guided to the sub pipe portion 57.

In the first embodiment, the inner space of the outer tube 16 approaches the outer shape of the inner tube 21 from the inner through hole 41 toward the outer through hole 45, thereby reducing the cross-sectional area of the insertion space 59. However, the outer space of the inner tube 21 may approach the inner shape of the outer tube 16 so that the cross-sectional area of the insertion space 59 is reduced. Even in this case, the guide wire G can be guided to the outer through hole 45.

In the first embodiment, in the outer tube 16, the distal end outer region 51 has an expansion amount in a predetermined direction larger than an expansion amount in the opposite direction with respect to the axis of the proximal end outer region 52. However, it may be expanded only in a predetermined direction with reference to the axis of the base end side outer region 52. Further, only the inner peripheral surface of the distal outer region 51 may be expanded with the proximal outer region 52 as a reference. In this case, there is no step on the outer peripheral surface at the front end side outer region 51, the base end side outer region 52, and the boundary portion.

In each of the above embodiments, the outer through hole 45 is provided in the step portion 53, but the outer through hole 45 may be provided in a peripheral wall extending in the longitudinal direction in the outer tube 16. However, in this case, the guide wire G is led out from the outer through hole 45 in a direction crossing the longitudinal direction of the outer tube 16.

In the second embodiment, in the distal end side outer region 51, the thick portion 58 is provided so as to extend from the vicinity of the proximal end to the stepped portion 53 rather than the distal end portion of the core wire 37. The proximal end side shaft 31 may be provided closer to the proximal end side than the tapered region 35. In this case, since the thick portion 58 is disposed in a portion overlapping the proximal end inner region in the inner tube 21, even if the rigidity locally changes in the thick portion 58, the catheter kit 10. The fall of kink resistance of can be suppressed.

In each of the above embodiments, the outer tube 16 has a circular cross section as a whole, but the cross section may be rectangular or elliptical. Similarly, the inner tube 21 has a circular cross section as a whole, but the cross section may be rectangular or elliptical. Further, the outer tube 16 and the inner tube 21 may have different cross-sectional shapes on the inner peripheral surface and the outer peripheral surface. For example, the inner peripheral surface may be circular and the outer peripheral surface may be rectangular. However, in order to push out the guide wire G by the restoring force of the inner tube 21, it is preferable that the inner peripheral surface of the outer tube 16 and the outer peripheral surface of the inner tube 21 are both curved outwardly.

In each of the above embodiments, in the initial state of the catheter kit 10, the insertion space 59 is formed on the distal end side with respect to the outer through hole 45, but the insertion space 59 is interposed between the outer through hole 45 and the inner through hole 41. It may be formed only. Even in this case, the guide wire G can be suitably guided from the inner through hole 41 to the outer through hole 45.

In each of the above embodiments, the inner tube 21 is configured to move relatively in the longitudinal direction with respect to the outer tube 16, but may not move relatively in the longitudinal direction.

In each of the above embodiments, the catheter kit 10 has a double structure in which the inner tube 21 is inserted into the outer tube 16 so as to be relatively movable. However, another tube is inserted into the inner tube 21 so as to be relatively movable. Or the outer tube 16 may be inserted into another tube so as to be relatively movable, thereby forming a multiple structure of triple or more. Even in this case, the guide wire G can be suitably led out from the intermediate position of the outer tube by forming the guide structure between the outer peripheral surface of the outer tube and the inner peripheral surface of the inner tube.

In each of the above-described embodiments, the catheter kit 10 has a configuration for stent placement in which the stent 13 is attached to the distal end portion thereof, but may have a configuration for thrombus suction. In this case, for example, a suction part for sucking a thrombus is provided at the distal end of the inner catheter 12, and a thrombus is sucked by the suction part in a body organ such as a blood vessel. It is effective to apply a configuration in which the guide wire G is led out from the intermediate position of the catheter kit 10 even if the configuration is for thrombus suction.

Claims (13)

1. An inner tube having an inner lumen extending from the distal end portion toward the proximal end side, and a guide wire inserted through the inner lumen;
   An outer tube having an outer lumen through which the inner tube is inserted, encapsulating at least the distal end side of the inner tube from the outer peripheral surface side, and provided at least relatively movable in the circumferential direction;
   With
   The inner tube includes an inner port that communicates the inner lumen with the outer lumen in a peripheral wall portion that defines the inner lumen.
   The outer tube includes an outer port that opens the outer lumen to the outside on a peripheral wall portion that defines the outer lumen,
   The guide wire inserted into the inner lumen from the distal end side of the inner tube is configured to be able to be pulled out of the catheter kit through the inner port and the outer port.
   Further, the outer port is formed at a position closer to the base end side than the inner port, and an insertion space in which the guide wire can be inserted between the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube. Is formed,
   The catheter is characterized in that a structure for guiding the guide wire from the inner port to the outer port is formed in the insertion space by a wall portion that defines the insertion space.
2. The insertion space is formed between the inner port and the outer port in the longitudinal direction,
   At least in the insertion space, the inner tube is disposed so that the inner tube is biased to the opposite side of the inner tube with respect to the outer port on the inner peripheral surface of the outer tube. The catheter according to claim 1.
3. At least in the insertion space, the distance between the opposite side of the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube facing it is less than the diameter of the guide wire, and on the inner peripheral surface of the outer tube The catheter according to claim 2, wherein the inner tube is arranged so that a distance between the outer port side and an outer peripheral surface of the inner tube facing the outer port side is equal to or larger than a diameter of the guide wire. .
4. In the insertion space, the region from the position of the inner port to the position of the outer port is at least halfway between the opposite side of the inner peripheral surface of the outer tube and the outer peripheral surface of the inner tube facing it. 4. The guide wire according to claim 3, wherein when the distal end side of the guide wire enters, the distal end side of the guide wire is formed so as to be able to wrap around from the outer peripheral side of the inner tube to the outer port side region. The catheter described.
5. The said insertion space is formed so that a cross section may become small continuously or in steps toward the position of the outer port from the position of the inner port in the longitudinal direction. Catheter.
6. In the insertion space, the region on the outer port side of the inner tube is contracted so as to approach the outer shape of the cross section of the guide wire, and the region on the bias side has an outer shape of the cross section of the inner tube. The catheter according to claim 5, wherein the catheter is contracted to approach.
7. On the inner peripheral side of the outer tube, a partition portion is formed that branches the outer lumen into the outer port side region and the biased side region at a midway position from the outer port position toward the distal end side. The catheter according to claim 6.
8. The outer peripheral surface of the inner tube and the inner peripheral surface of the outer tube are formed in a curved shape that protrudes outward around the axis,
   Furthermore, the said inner tube is formed so that rigidity may become high continuously or in steps toward the base end side from the said inner port, The any one of Claim 2 thru | or 7 characterized by the above-mentioned. catheter.
9. The outer tube is continuous at the distal end side with respect to the proximal end outer region and the proximal end outer region, and is extended in a predetermined direction outward with respect to the axis of the proximal end outer region, or An outer region on the tip side where the amount of expansion in a predetermined direction is larger than that in the opposite direction,
   The inner tube is arranged so as to pass through the proximal end outer region, and is biased to the opposite side of the inner peripheral surface of the outer tube,
   At the boundary portion between the base end side outer region and the tip end side outer region, a stepped portion that protrudes outward from the base end side outer region toward the expanded portion of the tip end side outer region is formed. The catheter according to any one of claims 2 to 8, wherein the outer port is formed in the stepped portion.
10. The inner tube includes a distal inner region including the inner port, and a proximal end formed so as to be continuous with the distal end side with respect to the distal inner region and to have higher rigidity than the distal inner region. A side inner region, and
    10. The catheter according to claim 9, wherein the region where the step portion is formed in the outer tube is arranged around the proximal end inner region.
11. The insertion space is formed between the inner port and the outer port in the longitudinal direction,
    In the region defining the insertion space on the inner peripheral surface of the outer tube, a guide portion is formed so as to narrow the outer lumen at a midway position toward the base end side,
    11. The guide portion according to claim 1, wherein the guide portion is formed with a guide surface that faces the distal end side and guides the guide wire in contact with the distal end side toward the outer port. The catheter according to 1.
12. The guide surface is formed so as to surround the inner tube around the axis of the inner tube, and so that a gap does not occur between the inner peripheral edge and the outer surface of the inner tube. The catheter according to claim 11, wherein the gap is formed to be smaller than the diameter of the guide wire.
13. The inner tube includes a distal inner region including the inner port, and a proximal end formed so as to be continuous with the distal end side with respect to the distal inner region and to have higher rigidity than the distal inner region. A side inner region, and
    The catheter according to claim 11 or 12, wherein a region where the guide surface is formed in the outer tube is arranged around the proximal inner region.

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