Catheter handle and catheter equipped with same

JPWO2023112412A5Active Publication Date: 2025-04-16KANEKA CORP
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Patent Information

Application Number
JP2023567547
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-09-14
Filing Date
2022-09-14
Publication Date
2025-04-16
Estimated Expiration
2042-09-14

AI Technical Summary

Technical Problem

Existing catheter handles lack a novel structure that efficiently controls the bending of catheter tubes for precise manipulation during medical procedures, limiting the flexibility and precision of catheter operations.

Method used

A catheter handle with a handle body, shaft, slider, rotary knob, and linear member, where the slider and rotary knob engage in a spiral fashion to convert rotational movement into axial displacement, allowing for independent control of the catheter's distal end through a combination of materials and engagement mechanisms, enabling precise bending of the catheter tube.

Benefits of technology

The catheter handle provides enhanced control over the catheter's distal end, allowing for precise bending and manipulation, improving the flexibility and precision of catheter operations during medical procedures.

✦ Generated by Eureka AI based on patent content.
Patent Text Reader

Abstract

A catheter handle (1) equipped with: a handle body (2); a shaft (3) that is disposed in a lumen of the handle body (2) and fixed to the handle body (2); a slider (4) that is disposed on the outside of the shaft (3), has a spirally extending first engaging part (11) on the outer surface, and is provided so as to be displaceable in the axial direction along the shaft (3); a rotary knob (5) that is provided so as to be capable of rotating relative to the handle body (2) and has a second engaging part (12), which engages with the first engaging part (11), on the inner surface; a linear member (7) having a first portion (7A), a second portion (7B), and a middle portion (7C) between the first and second portions, the first portion (7A) and the second portion (7B) being disposed in a lumen of a tube (22), and the middle portion (7C) being disposed in the lumen of the handle body (2); and a reversing guide (8) that is in contact with the middle portion (7C) of the linear member (7). The linear member (7) is fixed to the slider (4) on the first-portion (7A) side from the portion in contact with the reversing guide (8).
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Description

Catheter handle and catheter equipped with same

[0001] The present invention relates to a handle used for a catheter and a catheter equipped with the handle.

[0002] A catheter typically comprises a tube for insertion into a body cavity such as a blood vessel, digestive tract, or urinary tract, and a handle provided proximal to the tube. Some catheters are known that allow the distal end of the tube to be bent by manipulating the handle at the proximal end. Such catheters have a wire disposed within the lumen of the tube, the distal end of the wire fixed to the distal end of the tube, and the proximal end of the wire connected to the handle, so that the distal end of the tube can be bent by manipulating the handle. For example, in a catheter having two wires disposed within the lumen of the tube, the distal end of the tube can be bent to one side by pulling one of the two wires proximally, and the distal end of the tube can be bent to the other side by pulling the other wire.

[0003] As such a catheter handle, for example, Patent Document 1 discloses a catheter handle having two control wires whose distal ends are connected to a distal region of a catheter, the catheter handle including a housing, a sliding assembly disposed within the housing and configured to linearly translate within the housing, and a control knob rotatably provided relative to the housing, wherein the proximal ends of the two control wires are disposed within the housing, and the sliding assembly is configured to operate each of the two control wires separately by linearly translating the sliding assembly; rotating the control knob in a first rotational direction causes the sliding assembly to be displaced distally and apply tension to one of the two control wires, thereby deflecting the catheter in a first deflection direction; and rotating the control knob in a second rotational direction causes the sliding assembly to be displaced proximally and apply tension to the other of the two control wires, thereby deflecting the catheter in a second deflection direction. Patent Document 2 discloses a catheter handle for deflecting a distal portion of a catheter, the catheter handle comprising a first rotating member having a first diameter and to which a first wire is coupled, and a second rotating member having a second diameter smaller than the first diameter and to which a second wire is coupled, the second rotating member being coupled to the first rotating member such that the center point of the second rotating member is offset from the center point of the first rotating member, and the first and second rotating members being configured such that rotation of the first rotating member via the first wire rotates the second rotating member and the second wire, thereby deflecting the distal portion of the catheter.

[0004] Special table 2015-523892 publication Special table 2018-515215 publication

[0005] As described above, various catheter handles have been proposed in the past, and an object of the present invention is to provide a catheter handle with a novel structure and a catheter equipped with the same.

[0006] The present invention includes the following catheter handles and catheters: [1] A handle for manipulating a catheter tube, comprising: a handle body having an axially extending lumen; a shaft disposed in the lumen of the handle body, extending axially, and fixed to the handle body; a slider disposed on the outside of the shaft, having a first engagement portion extending spirally on its outer surface, and disposed axially displaceable along the shaft; a rotation knob disposed axially relative to the handle body and having a second engagement portion on its inner surface that engages with the first engagement portion of the slider; a linear member having a first end and a second end, and having a first portion including the first end, a second portion including the second end, and an intermediate portion between the first and second portions, the first and second portions being disposed in the lumen of the tube, and the intermediate portion being disposed in the lumen of the handle body; and an inversion guide disposed in the lumen of the handle body, with at least a portion of the intermediate portion of the linear member abutting, wherein the linear member is fixed to the slider at a portion of the linear member closer to the first end than the portion of the linear member abutting the inversion guide. [2] A catheter handle according to [1], wherein the intermediate section of the linear member is made of a material different from that of the first and second sections. [3] A catheter handle according to [1] or [2], wherein the intermediate section is made of rope. [4] A catheter handle according to any one of [1] to [3], wherein one of the first and second engagement sections is a convex section and the other is a groove. [5] A catheter handle according to any one of [1] to [4], wherein a third engagement section is provided on the outer surface of the slider, and a fourth engagement section that engages with the third engagement section is provided on the inner surface of the handle body, and at least one of the third engagement section and the fourth engagement section is formed to extend in the axial direction. [6] A catheter handle according to any one of [1] to [5], wherein a fifth engagement section is provided on the inner surface of the slider, and a sixth engagement section that engages with the fifth engagement section is provided on the outer surface of the shaft, and at least one of the fifth engagement section and the sixth engagement section is formed to extend in the axial direction. [7] A catheter comprising the catheter handle according to any one of [1] to [6], and a tube provided distally of the catheter handle.

[0007] According to the catheter handle and catheter of the present invention, the tube provided on the distal side of the catheter handle can be operated by rotating the rotation knob.

[0008] Fig. 1 shows an overall view of a catheter equipped with a catheter handle. Fig. 2 shows a plan view of the internal structure of the catheter handle provided in the catheter shown in Fig. 1. Fig. 3 shows a plan view of the internal structure of the catheter handle shown in Fig. 2, with the slider partially cut away along the axial direction. Fig. 4 shows a plan view of the internal structure of the catheter handle shown in Fig. 2, with the slider and shaft removed. Fig. 5 shows a VV cross-sectional view of the catheter handle shown in Fig. 2.

[0009] The catheter handle of the present invention and a catheter equipped with said handle will be specifically described below based on the following embodiments, but the present invention is not limited to the following embodiments and can of course be implemented with appropriate modifications within the scope of the spirit described above and below, all of which are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to helping understand the features of the present invention.

[0010] An overall description of a catheter equipped with a catheter handle will be given with reference to Figure 1. A catheter 21 according to an embodiment of the present invention has a catheter handle 1 (hereinafter sometimes referred to as "handle 1") and a tube 22 provided distal to the handle 1. The catheter 21 is used for treatment or examination, for example, by inserting the tube 22 into a patient's blood vessels or a body cavity such as the digestive tract.

[0011] In the present invention, the proximal side of the catheter refers to the direction toward the user's hand relative to the extending direction of the catheter, and the distal side refers to the opposite side of the proximal side, i.e., the direction toward the treatment target side.

[0012] The tube 22 has a flexible tubular structure and can be made of synthetic resins such as polyolefin resins (e.g., polyethylene and polypropylene), polyamide resins (e.g., nylon), polyester resins (e.g., PET), aromatic polyether ketone resins (e.g., PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, and fluororesins (e.g., PTFE, PFA, and ETFE), or metals such as stainless steel, carbon steel, and nickel-titanium alloys. Metal materials can also be used as metal wires embedded in the synthetic resin tube. The axial length of the tube 22 (near-to-far direction) is several to several tens of times longer than the length of the handle 1 in that direction, e.g., approximately 500 mm to 1200 mm. The outer diameter of the tube 22 may be, for example, approximately 0.6 mm to 5 mm.

[0013] The tube 22 has an internal lumen, and may be either a single-lumen structure with one internal lumen or a multi-lumen structure with multiple internal lumen. The tube 22 may also have a coaxial structure with multiple coaxial lumens. A wire for manipulating the tube 22 is disposed in the internal lumen of the tube 22. The wire is disposed, for example, to control the bending of the distal end of the tube 22. In this case, the distal end of the wire is preferably fixed to the distal end of the tube 22, for example, the distal one-third of the tube 22. The internal lumen of the tube 22 may house a conducting wire, an optical fiber, an endoscope, etc., and may also be provided with a lumen for inserting a guidewire or another treatment tool, or a lumen for passing a drug, a contrast agent, or any fluid.

[0014] The handle 1 is provided on the proximal side of the tube 22, and when assembled into a catheter, the proximal end of a wire disposed in the lumen of the tube 22 is connected to the handle 1.

[0015] The catheter handle will be described in detail with reference to Figures 2 to 5. Figure 2 shows a plan view of the internal structure of the catheter handle provided in the catheter shown in Figure 1. Figure 3 shows a plan view of the internal structure of the catheter handle shown in Figure 2, with the slider partially cut away along the axial direction. Figure 4 shows a plan view of the internal structure of the catheter handle shown in Figure 2, with the slider and shaft removed. Figure 5 shows a VV cross-sectional view of the catheter handle shown in Figure 2. Figure 2 shows a plan view of the catheter handle in which the handle body and rotation knob, which form the housing of the catheter handle, have been cut away along the axial direction to reveal the internal structure. In Figure 5, the cut-away portion of the handle body in Figure 2 is indicated by a dotted line.

[0016] A handle 1 according to an embodiment of the present invention includes a handle body 2 having a lumen extending in an axial direction x, a shaft 3 disposed in the lumen of the handle body 2, extending in the axial direction x, and fixed to the handle body 2, a slider 4 disposed in the lumen of the handle body 2 and outside the shaft 3, having a first engagement portion 11 extending spirally on its outer surface, and disposed displaceable in the axial direction x along the shaft 3, and a rotation knob 5 disposed rotatably about the axial direction x relative to the handle body 2 and having a second engagement portion 12 on its inner surface that engages with the first engagement portion 11 of the slider 4. In the handle 1, the axial direction x corresponds to the direction in which the rotation axis of the rotation knob 5 extends, and a proximal side and a distal side are defined as one side and the other side relative to the axial direction x. Furthermore, a radial direction is defined as a direction perpendicular to the axial direction x.

[0017] The handle body 2 has an inner cavity extending in the axial direction x (see FIG. 4 ). The inner cavity of the handle body 2 preferably has a cylindrical portion centered in the axial direction x, and the rotation knob 5 is preferably disposed in the cylindrical portion of the inner cavity. The rotation knob 5 is provided to the handle body 2 so as to be rotatable about the axial direction x. The rotation knob 5 is preferably disposed in at least a portion of the inner cavity of the handle body 2, and preferably only a portion of the rotation knob 5 in the axial direction x is disposed in the inner cavity of the handle body 2.

[0018] The rotation knob 5 preferably has a cavity extending in the axial direction x, and together with the cavity of the handle main body 2, forms the internal space of the handle 1. The cavity of the rotation knob 5 preferably has a cylindrical portion centered in the axial direction x. The cavity of the rotation knob 5 communicates with the cavity of the handle main body 2 in the axial direction x, and the cavity of the rotation knob 5 and the cavity of the handle main body 2 preferably integrally form the internal space of the handle 1, and the shaft 3 and slider 4 are preferably disposed in this internal space.

[0019] The handle body 2 is preferably formed open on at least one of the distal side and the proximal side, and the rotation knob 5 is inserted from the distal side or the distal side of the open handle body 2, and the rotation knob 5 is disposed in the lumen of the handle body 2. On the other hand, the rotation knob 5 is preferably formed open on the proximal side or the distal side, which is inserted into the handle body 2 and located in the lumen of the handle body 2. As a result, the lumen of the handle body 2 and the lumen of the rotation knob 5 integrally form the internal space of the handle 1. In the handle 1 shown in the drawings, the distal side of the handle body 2 is formed open, and the proximal side of the rotation knob 5 is formed open, and the rotation knob 5 is inserted into the lumen of the handle body 2 from the distal side of the handle body 2. In the handle 1, the handle body 2 and the rotation knob 5 are exposed to the outside, and the handle 1 can be operated, for example, by holding the handle body 2 with one hand and holding the rotation knob 5 with the other hand and rotating it relative to the handle body 2.

[0020] The shaft 3 is disposed in the lumen of the handle body 2 so as to extend in the axial direction x (see FIG. 3 ). The shaft 3 is fixed to the handle body 2 so as not to rotate or move relative to the handle body 2. The shaft 3 may be formed integrally with the handle body 2. The shaft 3 is preferably disposed at a position that serves as the rotation axis of the rotation knob 5. The shaft 3 is preferably disposed from the lumen of the handle body 2 to the lumen of the rotation knob 5, and may be disposed so as to extend distally and / or proximally beyond the handle body 2 and the rotation knob 5.

[0021] A tube 22 is preferably connected to the distal side of the shaft 3. The connection between the shaft 3 and the tube 22 may be located within the interior space of the handle 1, may be located distal to the interior space of the handle 1, or may be located outside the handle 1. The shaft 3 and the tube 22 may also be formed integrally.

[0022] The shaft 3 may be solid or hollow. Preferably, the shaft 3 is hollow and its lumen is connected to the lumen of the tube 22. This allows a treatment tool to be delivered to a treatment target area or a drug or contrast agent to be injected from the proximal side of the catheter 21 through the lumen of the shaft 3 and the lumen of the tube 22. Examples of treatment tools include electrode catheters, ablation catheters, mapping catheters, balloon catheters, microcatheters, forceps, laser probes, fiberscopes, high-frequency treatment tools, and electrohydraulic impact fragmentation probes. To allow for the insertion of such treatment tools, the shaft 3 preferably has a proximal opening outside the handle 1. The shaft 3 may have a branched portion, and a switch cock may be provided at the branched portion of the shaft 3. This allows, for example, separate insertion ports for treatment tools and injection ports for drugs or the like to be provided.

[0023] A slider 4 is disposed on the outside of the shaft 3. The slider 4 is disposed in the internal space of the handle 1, extending from the inner cavity of the handle body 2 to the inner cavity of the rotation knob 5 (see FIGS. 2 and 3). The slider 4 is disposed radially outward of the shaft 3, and therefore preferably has a through-hole extending in the axial direction x and penetrating the slider 4 in the axial direction x, with the shaft 3 being inserted through this through-hole.

[0024] The slider 4 is provided so as to be displaceable in the axial direction x along the shaft 3, i.e., so as to be movable in the axial direction x within the internal space of the handle 1. Therefore, the length of the slider 4 in the axial direction x is preferably shorter than the length of the shaft 3 in the internal space of the handle 1 in the axial direction x, and is also preferably shorter than the length of the internal space of the handle 1 in the axial direction x.

[0025] The slider 4 is configured to be displaced in the axial direction x by rotating the rotary knob 5 about the axial direction x. To this end, a first engagement portion 11 extending spirally is formed on the outer surface of the slider 4, and a second engagement portion 12 that engages with the first engagement portion 11 is formed on the inner surface of the rotary knob 5.

[0026] The first engagement portion 11 is formed on the outer surface of the slider 4, i.e., on the radially outer surface of the slider 4, so as to extend in a spiral shape. In particular, the first engagement portion 11 is formed on the outer surface of the slider 4 so as to extend in a spiral shape with the axial direction x of the handle 1 as its axis, and is preferably formed on the outer surface of the slider 4 which is formed in a cylindrical shape. The first engagement portion 11 may be formed continuously or intermittently. The first engagement portion 11 may be formed in a clockwise spiral shape or a counterclockwise spiral shape from the proximal side to the distal side.

[0027] The second engagement portion 12 is formed on the inner surface of the rotation knob 5, i.e., on the radially inward surface of the rotation knob 5, so as to be able to engage with the first engagement portion 11 (see FIGS. 3 and 4). The second engagement portion 12 is formed so as to extend spirally on the inner surface of the rotation knob 5, more specifically, so as to extend spirally with the axial direction x of the handle 1 as its axis. The second engagement portion 12 is preferably formed on the inner surface of the rotation knob 5, which is formed in a cylindrical shape. The second engagement portion 12 may be formed continuously or discontinuously.

[0028] As described above, the first engagement portion 11 is formed on the outer surface of the slider 4, and the second engagement portion 12 is formed on the inner surface of the rotary knob 5. By rotating the rotary knob 5 about the axial direction x, the slider 4 can be moved in the axial direction x in the internal space of the handle 1. In other words, the spirally formed first engagement portion 11 and second engagement portion 12 can convert the rotational movement of the rotary knob 5 about the axial direction x into a translational movement of the slider 4 in the axial direction x.

[0029] The first engagement portion 11 and the second engagement portion 12 may be formed to extend continuously or intermittently in a spiral shape for one or more revolutions, or for less than one revolution. At least one of the first engagement portion 11 and the second engagement portion 12 is preferably formed to extend continuously or intermittently in a spiral shape for one or more revolutions, more preferably for two or more revolutions, and even more preferably for three or more revolutions. Meanwhile, the other of the first engagement portion 11 and the second engagement portion 12 may be formed to extend continuously or intermittently in a spiral shape for less than one revolution, for example, for only half a revolution. In the handle 1 shown in the drawings, the first engagement portion 11 provided on the slider 4 is formed to extend spirally for one or more revolutions, and the second engagement portion 12 provided on the rotary knob 5 is formed to extend spirally for less than one revolution.

[0030] The first engagement portion 11 and the second engagement portion 12 can be formed by a combination of a convex portion and a groove. That is, it is preferable that one of the first engagement portion 11 and the second engagement portion 12 is a convex portion and the other is a groove. When the first engagement portion 11 or the second engagement portion 12 is formed as a groove, it is preferable that the groove is formed so as to extend continuously in a spiral shape. The groove may be a bottomed groove or a through groove, but in order to ensure the strength of the slider 4 or the rotary knob 5, the groove is preferably a bottomed groove. On the other hand, when the first engagement portion 11 or the second engagement portion 12 is formed as a convex portion, the convex portion may be formed so as to extend continuously in a spiral shape or in an intermittent spiral shape. In the drawings, the first engagement portion 11 provided on the slider 4 is formed as a convex portion (convex streak), and the second engagement portion 12 provided on the rotary knob 5 is formed as a groove.

[0031] A linear member 7 is provided in the internal space of the handle 1, bending proximally and extending distally at both ends (see FIG. 3 ). Both ends of the distally extending linear member 7 are disposed within the lumen of the tube 22. More specifically, the linear member 7 has a first end as one end and a second end as the other end, with the portion including the first end defined as a first portion 7A, the portion including the second end defined as a second portion 7B, and the portion between the first portion 7A and the second portion 7B defined as an intermediate portion 7C. The first and second ends are defined as the ends of the linear member 7 when it is extended straight. The linear member 7 is then bent at the intermediate portion 7C, with at least a portion of the intermediate portion 7C including the bent portion disposed within the lumen of the handle body 2, and at least a portion of the first portion 7A and the second portion 7B disposed within the lumen of the tube 22.

[0032] The first portion 7A and the second portion 7B of the linear member 7 serve as wires for controlling the tube 22. The distal end of the first portion 7A, i.e., the portion thereof including the first end and the portion thereof adjacent thereto, and the distal end of the second portion 7B, i.e., the portion thereof including the second end and the portion thereof adjacent thereto, are preferably fixed to the distal end of the tube 22. In this case, by operating the handle 1 and pulling the first portion 7A proximally, the distal end of the tube 22 can be bent in one direction, and by pulling the second portion 7B proximally, the distal end of the tube 22 can be bent in the other direction. The distal end of the first portion 7A can be defined, for example, as a portion within 100 mm proximally of the first end of the first portion 7A, and the distal end of the second portion 7B can be defined, for example, as a portion within 100 mm proximally of the second end of the second portion 7B. The distal end of the tube 22 can be defined, for example, as a portion within 100 mm proximally of the distal end of the tube 22.

[0033] It is preferable that the linear member 7 extends from the inner cavity of the shaft 3 or the tube 22 to the outside in the internal space of the handle 1, and that the intermediate portion 7C of the linear member 7 extends from the inner cavity of the rotating knob 5 to the inner cavity of the handle body 2.

[0034] The linear member 7 is preferably disposed in the inner cavity of the slider 4, i.e., in a through hole extending in the axial direction x. For example, it is preferable that a gap extending in the axial direction x (a gap penetrating the slider 4 in the axial direction x) is formed between the inner surface of the through hole of the slider 4 and the shaft 3, and the linear member 7 is disposed in this gap.

[0035] A reversing guide 8 for guiding bending of the intermediate portion 7C of the linear member 7 is provided in the inner cavity of the handle body 2, and at least a portion of the intermediate portion 7C of the linear member 7 abuts against the reversing guide 8. The reversing guide 8 is fixed to the handle body 2 and is provided so as not to rotate or move relative to the handle body 2. The reversing guide 8 may be formed integrally with the handle body 2.

[0036] The reversal guide 8 is preferably provided at a position overlapping with the slider 4 in the axial direction x, or at a position closer to the slider 4 than the slider 4. More preferably, the reversal guide 8 is provided closer to the slider 4 than the slider 4 when the slider 4 is positioned at the most proximal side.

[0037] The reversal guide 8 is provided with a guide passage that causes the linear member 7 to make a U-turn distally, and the linear member 7 abuts against the guide passage. The guide passage is preferably formed in a U-shape or an arc shape (e.g., semicircular) that is convex toward the proximal side in a plan view along the axial direction x. The guide passage is preferably formed as a tubular passage, and the intermediate portion 7C of the linear member 7 is preferably inserted into the lumen of the tubular passage.

[0038] The linear member 7 is movable in the axial direction x in the internal space of the handle 1, with a portion of the linear member 7 closer to the first end (first portion 7A) than the reversing guide 8 and a portion of the linear member 7 closer to the second end (second portion 7B) than the reversing guide 8 working together. The portion of the linear member 7 closer to the first end than the reversing guide 8 is connected to the portion of the linear member 7 closer to the second end than the reversing guide 8 via the portion where the portion of the linear member 7 closer to the first end than the reversing guide 8 abuts against the reversing guide 8. Therefore, when the portion of the linear member 7 closer to the first end than the reversing guide 8 moves proximally, the portion of the linear member 7 closer to the second end than the reversing guide 8 moves distally, and when the portion of the linear member 7 closer to the first end than the reversing guide 8 moves distally, the portion of the linear member 7 closer to the second end than the reversing guide 8 moves proximally.

[0039] The first portion 7A and the second portion 7B may be entirely or partially disposed in the tube 22. The middle portion 7C may be entirely or partially disposed in the interior space of the handle 1. In FIG. 3 , the middle portion 7C is connected to the first portion 7A and the second portion 7B in the interior space of the handle 1 by a connecting portion 10. As shown, the first portion 7A and the second portion 7B preferably extend from the tube 22 to the interior space of the handle 1, specifically, into the lumen of the rotation knob 5. It is preferable that portions of the first portion 7A and the second portion 7B are located in the lumen of the rotation knob 5 regardless of displacement of the linear member 7 in the axial direction x. The first portion 7A and the second portion 7B may also extend into the lumen of the handle body 2. It is preferable that the middle portion 7C includes all of the portion of the linear member 7 that abuts against the reversal guide 8 due to displacement of the linear member 7 in the axial direction x. In other words, it is preferable that the middle portion 7C of the linear member 7 abuts against the reversal guide 8. Furthermore, it is preferable that a portion of the intermediate portion 7C is located within the cavity of the rotary knob 5 regardless of the displacement of the linear member 7 in the axial direction x.

[0040] The linear member 7 is fixed to the slider 4 at a portion of the linear member 7 closer to the first end than the portion where the linear member 7 abuts the reversing guide 8. In FIG. 3 , the linear member 7 is fixed to the slider 4 by a fixture 9 provided on the slider 4. As a result, when the rotation knob 5 is rotated about the axial direction x, the slider 4 is displaced in the axial direction x, and accordingly, the portion of the linear member 7 closer to the first end than the reversing guide 8 can be displaced in the axial direction x, and the portion of the linear member 7 closer to the second end than the reversing guide 8 can be displaced in the opposite axial direction x. Specifically, when the slider 4 is displaced proximally, the portion of the linear member 7 closer to the first end than the reversing guide 8 is displaced proximally, and the portion of the linear member 7 closer to the second end than the reversing guide 8 is displaced distally. When the slider 4 is displaced distally, the portion of the linear member 7 closer to the first end than the reversing guide 8 is displaced distally, and the portion of the linear member 7 closer to the second end than the reversing guide 8 is displaced proximally. This allows the first portion 7A and the second portion 7B of the linear member 7 disposed in the lumen of the tube 22 to be pulled proximally or pushed distally, thereby controlling, for example, the bending of the distal end portion of the tube 22. For example, by rotating the rotating knob 5 clockwise as viewed from the proximal side, the distal end portion of the tube 22 can be bent in one direction, and by rotating the rotating knob 5 counterclockwise as viewed from the proximal side, the distal end portion of the tube 22 can be bent in the other direction.

[0041] The linear member 7 is preferably fixed to the inner surface of the slider 4. In Fig. 3, a fixture 9 for the linear member 7 is provided on the inner surface of the slider 4, and the linear member 7 is fixed to this fixture 9, but the linear member 7 may be fixed directly to the inner surface of the slider 4 with an adhesive or the like. When the linear member 7 is fixed directly to the inner surface of the slider 4, the fixture 9 may not be necessary. Methods for fixing the linear member 7 to the fixture 9 or the inner surface of the slider 4 include bonding with an adhesive, welding, fitting, caulking, screwing, etc.

[0042] The portion where the linear member 7 is fixed to the slider 4 is preferably located proximal to the point where the linear member 7 extends outward from the lumen of the shaft 3 or the tube 22 when the slider 4 is located at its most distal side. In other words, the linear member 7 preferably extends outward from the lumen of the shaft 3 or the tube 22 at a position distal to the portion where the linear member 7 is fixed to the slider 4 when the slider 4 is located at its most distal side.

[0043] When the slider 4 is positioned most proximal, a portion of the linear member 7 on the first end side of the contact portion with the reversing guide 8 is fixed to the slider 4. By fixing the linear member 7 to the slider 4 in this manner, the linear member 7 is fixed to the slider 4 on the first end side of the contact portion with the reversing guide 8, regardless of displacement of the slider 4 in the axial direction x. On the other hand, it is preferable that the linear member 7 is not fixed to the slider 4 on the second end side of the contact portion with the reversing guide 8, and more specifically, it is preferable that the linear member 7 is not fixed to the slider 4 on the second end side of the contact portion with the reversing guide 8 when the slider 4 is positioned most proximal.

[0044] The linear member 7 may be made of a metal wire such as stainless steel, carbon steel, or nickel-titanium alloy, or a resin wire (i.e., fiber material) made of a synthetic resin such as polyamide resin (e.g., nylon), polyolefin resin (e.g., polyethylene or polypropylene), polyester resin (e.g., PET), aromatic polyether ketone resin (e.g., PEEK), polyimide resin, aromatic polyamide resin (e.g., aramid), or fluororesin (e.g., PTFE, PFA, FEP, or ETFE). These metal wires or resin wires may have a monofilament structure or a multifilament structure. The linear member 7 may be covered by a cylindrical body made of a coiled metal or synthetic resin. The diameter of the linear member 7 may be, for example, approximately 100 μm to 1500 μm.

[0045] The first portion 7A, the second portion 7B, and the intermediate portion 7C of the linear member 7 may be made of the same material or different materials. It is preferable that the intermediate portion 7C be made of a different material from the first portion 7A and the second portion 7B. The intermediate portion 7C is preferably made of a flexible material so that it can be bent with a relatively small bending radius by the inversion guide 8. On the other hand, the first portion 7A and the second portion 7B are disposed within the lumen of the tube 22 and are required to transmit the movement of the linear member 7 in the axial direction x at the handle 1 to the distal end of the tube 22 via the first portion 7A and the second portion 7B. Therefore, the first portion 7A and the second portion 7B are preferably made of a relatively rigid material, and are not required to be more flexible than the intermediate portion 7C. Therefore, it is preferable that the intermediate portion 7C has lower bending rigidity than the first portion 7A and the second portion 7B. It is also preferable that the first portion 7A and the second portion 7B have higher axial rigidity than the intermediate portion 7C. For example, it is preferable that the middle portion 7C is made of a resin wire material, and the first portion 7A and the second portion 7B are made of a metal wire material.

[0046] If the intermediate portion 7C is made of a material different from that of the first portion 7A and the second portion 7B, the joining of the intermediate portion 7C to the first portion 7A and the joining of the intermediate portion 7C to the second portion 7B at the connecting portion 10 can be performed by adhesive bonding, welding, crimping, etc.

[0047] The middle portion 7C is preferably made of a rope. This ensures the strength of the middle portion 7C while facilitating smooth bending of the middle portion 7C by the reversing guide 8. The rope may be a fiber rope made of a fibrous material or a wire rope made of a metal material, but a fiber rope is preferred. This allows the middle portion 7C to bend smoothly. The fiber rope is preferably made of a high-strength fiber material to prevent breakage, and is preferably made of so-called super fibers. Examples of super fibers include aramid fibers, ultra-high molecular weight polyethylene fibers, polyarylate fibers, ultra-high strength polyvinyl alcohol fibers, polyparaphenylene benzobisoxazole (PBO) fibers, and polyphenylene sulfide (PPS) fibers. The super fibers preferably have a tensile strength of 1 GPa or more, preferably 2 GPa or more, and an elastic modulus of 25 GPa or more, preferably 50 GPa or more.

[0048] In order to prevent the slider 4 from rotating together with the rotary knob 5 when the rotary knob 5 is rotated about the axial direction x, the handle 1 preferably has a third engagement portion 13 on the outer surface of the slider 4, a fourth engagement portion 14 that engages with the third engagement portion 13 on the inner surface of the handle body 2, and at least one of the third engagement portion 13 and the fourth engagement portion 14 extending in the axial direction x. This allows the slider 4 to be displaced along the axial direction x without rotating about the axial direction x.

[0049] The third engagement portion 13 and the fourth engagement portion 14 can be formed by a combination of a convex portion and a groove. That is, it is preferable that one of the third engagement portion 13 and the fourth engagement portion 14 is a convex portion and the other is a groove. In the handle 1 shown in the drawings, the third engagement portion 13 provided on the outer surface of the slider 4 is formed as a convex portion, and the fourth engagement portion 14 provided on the inner surface of the handle body 2 is formed as a groove.

[0050] The third engagement portion 13 or the fourth engagement portion 14 formed as a groove is preferably formed to extend in the axial direction x, and more preferably formed to extend continuously in the axial direction x. The groove may be a bottomed groove or a through groove, but the groove is preferably a bottomed groove in order to ensure the strength of the slider 4 or the handle body 2. On the other hand, the third engagement portion 13 or the fourth engagement portion 14 formed as a convex portion may or may not be formed to extend in the axial direction x.

[0051] As shown in the drawings, when the third engagement portion 13 is formed as a convex portion and the fourth engagement portion 14 is formed as a groove, the convex portion formed as the third engagement portion 13 on the outer surface of the slider 4 is preferably located closer to the proximal side of the slider 4 than the first engagement portion 11. At least a portion of the groove formed as the fourth engagement portion 14 on the inner surface of the handle body 2 is preferably located closer to the distal side of the reversal guide 8.

[0052] Although not shown in the drawings, when a groove is formed as the third engagement portion 13 on the outer surface of the slider 4, the groove may be formed on the slider 4 at a position overlapping with the first engagement portion 11 in the axial direction x, or may be formed on the proximal side of the first engagement portion 11. In this case, it is preferable that at least a portion of the convex portion formed as the fourth engagement portion 14 on the inner surface of the handle body 2 is positioned distal to the reversal guide 8.

[0053] 5 , in order to prevent the slider 4 from rotating together with the rotary knob 5 when the rotary knob 5 is rotated around the axial direction x, a fifth engagement portion 15 may be provided on the inner surface of the slider 4, and a sixth engagement portion 16 that engages with the fifth engagement portion 15 may be provided on the outer surface of the shaft 3, with at least one of the fifth engagement portion 15 and the sixth engagement portion 16 extending in the axial direction x. Even when the fifth engagement portion 15 and the sixth engagement portion 16 are provided in this manner, the slider 4 can be displaced along the axial direction x without rotating around the axial direction x.

[0054] The fifth engagement portion 15 and the sixth engagement portion 16 can be formed by a combination of a convex portion and a groove. That is, it is preferable that one of the fifth engagement portion 15 and the sixth engagement portion 16 is a convex portion and the other is a groove. In Fig. 5, the fifth engagement portion 15 provided on the inner surface of the slider 4 is formed as a groove, and the sixth engagement portion 16 provided on the outer surface of the shaft 3 is formed as a convex portion.

[0055] The fifth engagement portion 15 or the sixth engagement portion 16 formed as a groove is preferably formed to extend in the axial direction x, and more preferably formed to extend continuously in the axial direction x. The groove may be a bottomed groove or a through groove, but the groove is preferably a bottomed groove in order to ensure the strength of the slider 4 or the shaft 3. On the other hand, the fifth engagement portion 15 or the sixth engagement portion 16 formed as a convex portion may or may not be formed to extend in the axial direction x.

[0056] 5 , when the fifth engagement portion 15 is formed as a groove and the sixth engagement portion 16 is formed as a protrusion, the groove formed as the fifth engagement portion 15 on the inner surface of the slider 4 may be formed at a position on the slider 4 that overlaps with the first engagement portion 11 in the axial direction x, or may be formed on the proximal or distal side of the first engagement portion 11. It is preferable that at least a portion of the protrusion formed as the sixth engagement portion 16 on the outer surface of the shaft 3 is disposed distal to the reversal guide 8.

[0057] Although not shown in the drawings, when a convex portion is formed as the fifth engagement portion 15 on the inner surface of the slider 4, the convex portion may be arranged at a position on the slider 4 that overlaps with the first engagement portion 11 in the axial direction x, or may be arranged on the proximal or distal side of the first engagement portion 11. In this case, it is preferable that at least a part of the groove formed as the sixth engagement portion 16 on the outer surface of the shaft 3 is arranged distal to the reversal guide 8.

[0058] If the handle 1 is provided with the third engagement portion 13 and the fourth engagement portion 14, the fifth engagement portion 15 and the sixth engagement portion 16 may not be provided. Conversely, if the handle 1 is provided with the fifth engagement portion 15 and the sixth engagement portion 16, the third engagement portion 13 and the fourth engagement portion 14 may not be provided. In either case, when the rotary knob 5 is rotated about the axial direction x, the slider 4 can be displaced along the axial direction x without rotating about the axial direction x. Of course, the handle 1 may be provided with the third engagement portion 13 and the fourth engagement portion 14, and further with the fifth engagement portion 15 and the sixth engagement portion 16.

[0059] Although the catheter handle of the present invention has been described above, the catheter handle of the present invention is not limited to one that controls the bending of the distal end of the tube, as long as it displaces the first and second sections of the linear member distally or proximally within the lumen of the tube. For example, the catheter handle may be one that allows the first and / or second sections of the linear member to be inserted and removed from the distal end of the tube by operating the catheter handle. Alternatively, a treatment tool such as a knife or snare may be attached to the distal end of the first or second section of the linear member, and the treatment tool attached to the distal end of the first or second section may be inserted and removed from the distal end of the tube by operating the catheter handle.

[0060] This application claims the benefit of priority based on Japanese Patent Application No. 2021-201977, filed on December 13, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-201977, filed on December 13, 2021, are incorporated herein by reference.

[0061] 1: Catheter handle 2: Handle body 3: Shaft 4: Slider 5: Rotating knob 7: Linear member, 7A: First part, 7B: Second part, 7C: Intermediate part 8: Reversal guide 9: Fixing device 10: Connecting part 11: First engaging part 12: Second engaging part 13: Third engaging part 14: Fourth engaging part 15: Fifth engaging part 16: Sixth engaging part 21: Catheter 22: Tube

Claims

1. A handle for manipulating a tube of a catheter, a handle body having an axially extending bore; a shaft disposed in a lumen of the handle body, extending in the axial direction, and fixed to the handle body; a slider disposed on the outside of the shaft, the slider having a first engagement portion extending in a spiral shape on an outer surface thereof, and the slider being provided so as to be displaceable in the axial direction along the shaft; a rotation knob provided to be rotatable about the axial direction with respect to the handle body, the rotation knob having a second engagement portion on an inner surface thereof that engages with the first engagement portion of the slider; a linear member having a first end and a second end, a first portion including the first end, a second portion including the second end, and an intermediate portion between the first portion and the second portion, the first portion and the second portion being disposed in an inner cavity of the tube, and the intermediate portion being disposed in an inner cavity of the handle body; a reversal guide disposed in an inner cavity of the handle body and in contact with at least a portion of the intermediate portion of the linear member; the linear member is fixed to the slider at a portion closer to the first end than a portion of the linear member that abuts against the reversing guide, A catheter handle in which the first and second portions of the linear member are made of metal wire, and the intermediate portion is made of a resin wire.

2. 2. The catheter handle of claim 1, wherein the intermediate section is constructed from rope.

3. The catheter handle according to claim 1 , wherein one of the first engagement portion and the second engagement portion is a convex portion and the other is a groove.

4. 2. A catheter handle as described in claim 1, wherein a third engagement portion is provided on an outer surface of the slider, a fourth engagement portion that engages with the third engagement portion is provided on an inner surface of the handle body, and at least one of the third engagement portion and the fourth engagement portion is formed to extend in the axial direction.

5. 2. The catheter handle according to claim 1, wherein a fifth engagement portion is provided on an inner surface of the slider, a sixth engagement portion that engages with the fifth engagement portion is provided on an outer surface of the shaft, and at least one of the fifth engagement portion and the sixth engagement portion is formed to extend in the axial direction.

6. A catheter handle according to any one of claims 1 to 5; and a tube disposed distal to the catheter handle.