medical devices
The medical device's dual operating wire design enhances operability and flexibility, allowing precise control over bending directions for navigating complex anatomical structures.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-12-24
- Publication Date
- 2026-03-10
AI Technical Summary
Existing medical devices with manipulation wires lack sufficient operability for precise control and flexibility in bending the distal end.
A medical device design featuring two operating wires, arranged at opposite poles in the cross-section, allowing independent and simultaneous control of bending directions through a dual operation unit, enhancing flexibility and selectivity in navigating body cavities.
Improves the operability and flexibility of the medical device, enabling precise manipulation of the distal end to navigate complex anatomical structures with enhanced branching selectivity and stability.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to medical devices. [Background technology]
[0002] As a medical device capable of bending and manipulating the distal end, a type having a manipulation wire is known (for example, Patent Document 1).
[0003] In the medical device of Patent Document 1, multiple hollow tubes are arranged around a central lumen, and a manipulation wire is inserted into each of two hollow tubes facing each other via the central lumen. In the medical device of this document, the tip of the manipulation wire is fixed to the tip of the catheter. The medical device of this document is configured so that the rear end of the manipulation wire can be pulled and operated. This makes it possible to bend the tip of the catheter by selecting and pulling the manipulation wire. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2013-48711 Summary of the Invention [Problem to be solved by the invention]
[0005] However, the medical device of Patent Document 1 still has room for improvement in terms of operability.
[0006] The present invention has been made in view of the above problems, and aims to provide a medical device having a structure with improved operability. [Means for solving the problem]
[0007] The present invention includes a long medical device body, a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; an operating unit capable of pulling the first operating wire and the second operating wire individually and simultaneously; Equipped with the first operating wire and the second operating wire are arranged at opposite poles to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to a distal end portion of the medical device body; The medical device provides a medical device in which the tip of the second operation wire is fixed at a position on the proximal side of the tip of the first operation wire in the tip portion of the medical device body. [Effects of the Invention]
[0008] According to the present invention, it is possible to further improve the operability of medical devices. [Brief explanation of the drawings]
[0009] [Figure 1] Figures 1(a) and 1(b) are diagrams showing the tip of the medical device according to the first embodiment, where Figure 1(a) shows the state before a bending operation has been performed, and Figure 1(b) shows the state after a bending operation has been performed. [Figure 2] FIG. 2 is a longitudinal cross-sectional view of the medical device body in the first embodiment. [Figure 3] FIG. 3 is a cross-sectional view of the medical device body taken along line AA in FIG. 2. [Figure 4] FIG. 3 is a cross-sectional view of the medical device body taken along line BB in FIG. 2. [Figure 5] 1 is a side view showing an operation unit and its surrounding area of the medical device according to the first embodiment. FIG. [Figure 6] 1 is a plan view showing an operation unit and its surrounding area of the medical device according to the first embodiment. FIG. [Figure 7]Figure 7(a) is a side view of the tension release mechanism in the first embodiment, Figure 7(b) is a side view of the first rotating member in the first embodiment, Figure 7(c) shows the state in which the engagement recess and engagement protrusion in the first embodiment are engaged, and Figure 7(d) shows the state in which the engagement protrusion and engagement recess in the first embodiment are disengaged. [Figure 8] Each of Figures 8(a), 8(b), and 8(c) is a schematic diagram for explaining the bending operation of the distal end portion of the medical device body in the first embodiment. [Figure 9] 9(a) and 9(b) are schematic diagrams for explaining the bending operation of the distal end portion of the medical device body in the first embodiment. [Figure 10] FIG. 10 is a view showing the distal end of a medical device according to a second embodiment. [Figure 11] FIG. 10 is a longitudinal cross-sectional view of a medical device body according to a second embodiment. [Figure 12] 12 is a cross-sectional view of the medical device body taken along line AA in FIG. 11. [Figure 13] FIG. 10 is a plan view showing an operation unit and its surrounding area of a medical device according to a second embodiment. [Figure 14] FIG. 10 is a longitudinal cross-sectional view of a medical device body according to a third embodiment. [Figure 15] FIG. 15 is a cross-sectional view taken along line AA in FIG. [Figure 16] FIG. 10 is a plan view showing an operation unit and its surrounding area of a medical device according to a third embodiment. [Figure 17] Figures 17(a), 17(b) and 17(c) are each schematic diagrams for explaining the bending operation of the tip portion of the medical device main body in the third embodiment, where Figure 17(a) is a plan view, Figure 17(b) is a view viewed in the direction of arrow A shown in Figure 17(a), and Figure 17(c) is a view viewed in the direction of arrow B shown in Figure 17(a). [Figure 18] FIG. 11 is a schematic diagram for explaining the bending operation of the distal end portion of the medical device body in the third embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0010] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and the description thereof will be omitted where appropriate. The various components of the catheter according to this embodiment do not need to be independent entities, and it is acceptable for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be part of another component, or for part of one component to overlap with part of another component, etc.
[0011] Terms used in the description of this embodiment are defined as follows unless otherwise specified. The tip end is the end (distal end) of each part of the medical device 100 that is located at the insertion tip end of the medical device 100, and the base end is the end (proximal end) of each part of the medical device 100 that is located at the base end side of the medical device 100. The axis refers to the central axis along the longitudinal direction of the medical device body 10 . The longitudinal section of the medical device body 10 refers to a cross section obtained by cutting the medical device body 10 along the axis. The cross section of the medical device body 10 refers to a cross section obtained by cutting the medical device 100 along a plane perpendicular to the axis.
[0012] [First embodiment] First, the first embodiment will be described with reference to Fig. 1(a) to Fig. 8(c). In Fig. 1(a) and Fig. 1(b), the first operation wire 41 to the third operation wire 43 are indicated by dashed lines. Fig. 2 is a cross-sectional view taken along line AA in Fig. 3. In Fig. 5, the main body case 70a of the operation unit 70 is partially cut away to show the internal structure of the main body case 70a.
[0013] As shown in Figures 1(a), 2 and 3, the medical device 100 of this embodiment comprises a long medical device main body 10, a first operating wire 41 and a second operating wire 42 each extending along the longitudinal direction of the medical device main body 10, and an operating section 70 capable of pulling the first operating wire 41 and the second operating wire 42 individually and simultaneously. The first manipulation wire 41 and the second manipulation wire 42 are arranged at positions opposite to each other in the cross section of the medical device body 10. The tip of the first operating wire 41 is fixed to the tip portion 10a of the medical device main body 10, and the tip of the second operating wire 42 is fixed to a position on the base end side of the tip of the first operating wire 41 in the tip portion 10a of the medical device main body 10. Here, the position of opposite poles means that the first operating wire 41 and the second operating wire 42 are spaced apart from each other by 160 degrees or more in the circumferential direction of the medical device main body 10, and preferably, the first operating wire 41 and the second operating wire 42 are spaced apart from each other by 170 degrees or more in the circumferential direction of the medical device main body 10.
[0014] According to the present embodiment, by selectively pulling the first operation wire 41 out of the first operation wire 41 and the second operation wire 42, the distal end portion 10a of the medical device main body 10 can be selectively bent in one direction (hereinafter referred to as the first direction). Furthermore, by simultaneously pulling the first operation wire 41 and the second operation wire 42, as shown in FIG. 1(b), in the distal end portion 10a of the medical device main body 10, mainly a region distal to the tip of the second operation wire 42 (hereinafter referred to as the first region 12) can be bent in the first direction, while mainly a region proximal to the tip of the second operation wire 42 (hereinafter referred to as the second region 14) can be bent in the second direction. Furthermore, by selectively pulling the second operation wire 42 out of the first operation wire 41 and the second operation wire 42, the distal end portion 10a of the medical device main body 10 can be bent in the direction opposite to the first direction (the second direction). That is, the medical device main body 10 can be bent with a higher degree of freedom depending on the branching direction of a branching portion of a body cavity such as a blood vessel, thereby improving the branching selectivity of the medical device 100. Therefore, the operability of the medical device 100 can be improved.
[0015] In this embodiment, the medical device 100 is, for example, a catheter. More specifically, the medical device 100 is, for example, an intravascular catheter that is used by inserting the medical device main body 10 into a blood vessel. However, the medical device 100 may also be, for example, a guidewire that is used when inserting a catheter into a body cavity.
[0016] In this embodiment, as shown in FIGS. 1(a), 2 and 3, the medical device 100 further includes a third manipulation wire 43 extending along the longitudinal direction of the medical device body . The third operating wire 43 is positioned near the second operating wire 42 in the cross section of the medical device main body 10, and the tip of the third operating wire 43 is fixed at a position further distal than the tip of the second operating wire 42 in the tip portion 10a of the medical device main body 10. With this configuration, by pulling the third operating wire 43, the tip portion 10a of the medical device main body 10 can be bent in a direction substantially opposite to the direction in which it is bent by pulling the first operating wire 41. Here, being positioned in the vicinity of the second operating wire 42 means being positioned within 20 degrees from the position of the second operating wire 42 in the circumferential direction of the medical device main body 10, and preferably being positioned within 10 degrees from the position of the second operating wire 42. In the circumferential direction of the medical device body 10, the first operation wire 41, and the second and third operation wires 42 and 43 are arranged at positions opposite to each other. Furthermore, since the third operating wire 43 is positioned near the second operating wire 42 in the cross-section of the medical device main body 10, the first operating wire 41 and the third operating wire 43 are positioned at opposite poles to each other in the cross-section of the medical device main body 10. Here, the position of opposite poles means that the first operating wire 41 and the third operating wire 43 are spaced apart from each other by 160 degrees or more in the circumferential direction of the medical device main body 10, and preferably, the first operating wire 41 and the third operating wire 43 are spaced apart from each other by 170 degrees or more in the circumferential direction of the medical device main body 10.
[0017] 2 and 3, the first operation wire 41 and the second operation wire 42 are arranged at positions that are rotationally symmetrical by 180 degrees with respect to each other, with the axial center of the medical device main body 10 as the reference. Also, the second operation wire 42 and the third operation wire 43 are arranged at positions that are approximately equal to each other in the circumferential direction of the medical device main body 10, with the axial center of the medical device main body 10 as the reference. Therefore, the third operation wire 43 and the first operation wire 41 are arranged at positions that are rotationally symmetrical by 180 degrees with respect to each other, with the axial center of the medical device main body 10 as the reference. In this embodiment, the direction in which the tip portion 10a of the medical device main body 10 bends when the first operating wire 41 is pulled and the direction in which the tip portion 10a of the medical device main body 10 bends when the third operating wire 43 or the second operating wire 42 is pulled are opposite to each other. The first operation wire 41, the second operation wire 42, and the third operation wire 43 are each made of a thin wire such as metal or resin.
[0018] In this embodiment, the breaking strength of the second operation wire 42 is greater than the breaking strength of the first operation wire 41. This allows the second operating wire 42 to be pulled more strongly. More specifically, in the case of this embodiment, the first operation wire 41 and the second operation wire 42 are made of, for example, the same type of material. On the other hand, by setting the wire diameter of the second operation wire 42 to a dimension larger than the wire diameter of the first operation wire 41, the breaking strength of the second operation wire 42 can be made larger than the breaking strength of the first operation wire 41. However, for example, by using a material that has a breaking strength larger than the breaking strength of the material that makes up the first operation wire 41 as the material that makes up the second operation wire 42, the breaking strength of the second operation wire 42 can also be made larger than the breaking strength of the first operation wire 41. In addition, in the present embodiment, as an example, the third operating wire 43 and the first operating wire 41 are made of the same type of material, and the wire diameter of the third operating wire 43 is set to, for example, a dimension approximately equal to the wire diameter of the first operating wire 41. For example, the wire diameter of the third operation wire 43 and the wire diameter of the first operation wire 41 may be set to different dimensions. Also, the third operation wire 43 and the first operation wire 41 may be made of different types of materials.
[0019] The wire diameter of the first operating wire 41 and the wire diameter of the third operating wire 43 are not particularly limited, but are preferably 10 μm or more and 60 μm or less, and more preferably 20 μm or more and 50 μm or less. The wire diameter of the second operating wire 42 is not particularly limited, but is preferably 30 μm or more and 180 μm or less, and more preferably 60 μm or more and 150 μm or less. However, as described above, it is preferable that the wire diameter of the second operation wire 42 be larger than the wire diameter of the first operation wire 41.
[0020] In this embodiment, the medical device body 10 has a lumen 20 that opens at the tip of the medical device body 10 . As shown in Figures 2 and 3, the medical device body 10 has a two-layer structure, for example, including an inner layer 22 and an outer layer 23 arranged around the inner layer 22, and is configured by laminating the inner layer 22 and the outer layer 23 in this order from the axial side of the medical device body 10. The inner layer 22 is the innermost layer of the medical device body 10 and is formed, for example, in a cylindrical shape with a constant wall thickness regardless of the position in the axial direction. The inner layer 22 is open at both the distal and proximal ends of the medical device body 10. In this embodiment, the lumen 20 is defined by the inner circumferential surface of the inner layer 22. The inner layer 22 is made of, for example, a fluorine-based or olefin-based thermoplastic polymer resin. The fluorine-based thermoplastic polymer material is not particularly limited, but may be polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or perfluoroalkoxy fluororesin (PFA), and the olefin-based polymer material may be polyethylene. The outer layer 23 is the outermost layer of the medical device body 10. For example, the majority (majority) of the wall thickness of the medical device body 10 is accounted for by the wall thickness of the outer layer 23. The outer layer 23 is formed, for example, into a cylindrical shape whose wall thickness is approximately constant regardless of the position in the axial direction. However, the outer diameter of the tip of the distal end of the outer layer 23, for example, tapers slightly toward the distal end. A hydrophilic coating may be formed on the outer surface layer of the medical device body 10 as needed. The lumen 20 is formed continuously from the distal end to the proximal end of the medical device body 10, and opens at both the distal end and the proximal end of the medical device body 10.
[0021] As shown in FIGS. 2 to 4, the medical device body 10 further includes a first hollow tube 31, a second hollow tube 32, and a third hollow tube 33, each of which is embedded in the outer layer 23. A first operating wire 41 is inserted through the first hollow tube 31, a second operating wire 42 is inserted through the second hollow tube 32, and a third operating wire 43 is inserted through the third hollow tube 33. The first hollow tube 31, the second hollow tube 32, and the third hollow tube 33 are each a sub-lumen tube, and the inner lumens of these sub-lumen tubes are sub-lumens. That is, each operating wire (first operating wire 41, second operating wire 42, third operating wire 43) is inserted through a sub-lumen. The inner diameters of the first hollow tube 31 , the second hollow tube 32 and the third hollow tube 33 are smaller than the inner diameter of the lumen 20 .
[0022] In the present embodiment, the second operation wire 42 and the second hollow tube 32, and the third operation wire 43 and the third hollow tube 33 are arranged side by side in the radial direction of the medical device main body 10. The third operation wire 43 and the third hollow tube 33 are arranged radially outward of the medical device main body 10 (at a position farther from the axis of the medical device main body 10) than the second operation wire 42 and the second hollow tube 32. However, for example, the second operation wire 42 and the second hollow tube 32, and the third operation wire 43 and the third hollow tube 33 may be arranged side by side in the circumferential direction of the medical device main body 10. Furthermore, in the radial direction, the distance between the axis of the medical device main body 10 and the axis of the second operation wire 42 (or the axis of the second hollow tube 32) may be, for example, approximately equal to the distance between the axis of the medical device main body 10 and the axis of the third operation wire 43 (or the axis of the third hollow tube 33).
[0023] The materials for the first hollow tube 31, the second hollow tube 32 and the third hollow tube 33 may be, for example, resin materials such as polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or polyethylene.
[0024] As shown in FIGS. 1(a) and 2, a ring-shaped first marker 61 made of a radiopaque metal material is embedded in the distal end portion 10a of the medical device body 10. The first marker 61 is arranged coaxially with the lumen 20 and around the lumen 20 . The first marker 61 is arranged, for example, around the reinforcing layer 51.
[0025] Furthermore, in the medical device main body 10, a ring-shaped second marker 63 made of a radiopaque metal material is embedded in a portion closer to the base end than the portion where the first marker 61 is embedded. The second marker 63 is arranged coaxially with and around the lumen 20 . The second markers 63 are arranged, for example, around the reinforcing layer 51. The second marker 63 may have, for example, a through-hole (not shown) formed in the axial direction through a thick portion of the second marker 63. The second marker 63 may also have, for example, a portion in the circumferential direction of the second marker 63 that is discontinued, so that the second marker 63 has a substantially C-shape when viewed in the axial direction.
[0026] For example, the first marker 61 and the second marker 63 have the same inner diameter. For example, the outer diameter of the first marker 61 is larger than the outer diameter of the second marker 63.
[0027] The tip of the first operating wire 41 and the tip of the first hollow tube 31 are fixed to the base end of the first marker 61 by, for example, soldering (not shown), welding, or a mechanical joint that generates frictional resistance. The tip of the second operating wire 42 and the tip of the second hollow tube 32 are fixed to the base end of the second marker 63 by, for example, soldering (not shown), welding, or a mechanical joint that generates frictional resistance. The distal end of the third operating wire 43 and the distal end of the third hollow tube 33 are fixed to the proximal end of the first marker 61 by, for example, soldering (not shown), welding, or a mechanical joint that generates frictional resistance. Therefore, the tip of the first manipulation wire 41 and the tip of the third manipulation wire 43 are arranged at the same position (approximately the same position) in the axial direction of the medical device main body 10.
[0028] In this way, the medical device 100 comprises a first marker 61 fixed to the tip portion 10a of the medical device main body 10, and a second marker 63 fixed to a position on the proximal side of the first marker 61 at the tip portion 10a of the medical device main body 10, and the tip of the first operating wire 41 and the tip of the third operating wire 43 are fixed to the first marker 61, and the tip of the second operating wire 42 is fixed to the second marker 63. In the present invention, the number of markers provided on the medical device 100 may be, for example, two or more.
[0029] In the present embodiment, in the distal end portion 10a of the medical device main body 10, the region distal to the tip of the second marker 63 is the first region 12, and the region proximal to the tip of the second marker 63 is the second region 14. In the distal end portion 10a, the length of the first region 12 and the length of the second region 14 can be adjusted by setting the distance between the first marker 61 and the second marker 63 to a desired distance in the axial direction of the medical device main body 10.
[0030] In addition, the tip of the first operating wire 41 is fixed to the first marker 61, and thereby indirectly fixed to the tip 10a of the medical device main body 10, and the tip of the third operating wire 43 is fixed to the second marker 63, and thereby indirectly fixed to the tip 10a of the medical device main body 10.
[0031] As shown in Figures 1(a) and 2, the first operating wire 41 is routed through a portion of the medical device main body 10 radially outward of the arrangement area of the second marker 63, from a region closer to the base end than the second marker 63 to a region closer to the tip end than the second marker 63. More specifically, the first hollow tube 31 through which the first operating wire 41 is inserted is also routed from a region closer to the base end than the second marker 63 to a region closer to the tip end than the second marker 63 through a portion of the medical device main body 10 that is radially outer than the arrangement region of the second marker 63. However, in the present invention, the radial distance between the axial center of the medical device main body 10 and the axial center of the first operating wire 41 (or the axial center of the first hollow tube 31) may be, for example, approximately equal to the distance between the axial center of the medical device main body 10 and the axial center of the second operating wire 42 (or the axial center of the second hollow tube 32).
[0032] Similarly, the third operating wire 43 is routed through a portion of the medical device main body 10 radially outward of the arrangement area of the second marker 63, from a region closer to the base end than the second marker 63 to a region closer to the tip end than the second marker 63. More specifically, the third hollow tube 33 through which the third operating wire 43 is inserted is also routed from a region closer to the base end than the second marker 63 to a region closer to the tip end than the second marker 63 through a portion of the medical device main body 10 that is radially outer than the arrangement region of the second marker 63. However, in the present invention, the radial distance between the axis of the medical device main body 10 and the axis of the third operating wire 43 (or the axis of the third hollow tube 33) may be, for example, approximately equal to the distance between the axis of the medical device main body 10 and the axis of the second operating wire 42 (or the axis of the second hollow tube 32).
[0033] Here, in the case of this embodiment, the medical device main body 10 includes a reinforcing layer 51. The bending rigidity of the reinforcing layer 51 on the proximal side of the second marker 63 is greater than the bending rigidity of the reinforcing layer 51 on the distal side of the second marker 63. The bending rigidity of the medical device main body 10 on the proximal side of the second marker 63 is greater than the bending rigidity of the medical device main body 10 on the distal side of the second marker 63. 2 and 3, the reinforcing layer 51 includes, for example, a braided layer 53 embedded in the outer layer 23 and a wound wire 55 embedded in the outer layer 23. The braided layer 53 and the wound wire 55 each extend from the distal end side of the medical device main body 10 to the proximal end 10b. However, as shown in FIG. 2, the distal end of the braided layer 53 is disposed, for example, at a position substantially equivalent to the position of the distal end of the second marker 63 in the axial direction. On the other hand, the distal end of the wound wire 55 is disposed, for example, at a position substantially equivalent to the position of the distal end of the first marker 61 in the axial direction. As a result, in the medical device main body 10, the region on the proximal side of the second marker 63 is reinforced by the braid layer 53 and the winding wire 55, while the region on the distal side of the second marker 63 is reinforced by the winding wire 55. Therefore, the bending rigidity of the medical device main body 10 on the proximal side of the second marker 63 is greater than the bending rigidity of the medical device main body 10 on the distal side of the second marker 63. The braid layer 53 is formed by braiding a plurality of wires. The braid layer 53 is disposed around the inner layer 22, for example. The first hollow tube 31, the second hollow tube 32 and the third hollow tube 33 are arranged, for example, radially outward of the medical device body 10 (at positions farther from the axis of the medical device body 10) than the reinforcing layer 51. The material of the wires constituting the braid layer 53 is preferably a metal material such as stainless steel or tungsten, but may also be a resin material. The wound wire 55 is wound radially outward of the medical device body 10 relative to the reinforcing layer 51 , the first hollow tube 31 , the second hollow tube 32 and the third hollow tube 33 . The material of the wire constituting the winding wire 55 is preferably a metal material such as stainless steel or tungsten, but may also be a resin material. In the present invention, the tip of the braid layer 53 may be located, for example, at a position substantially equivalent to the position of the tip of the first marker 61 (the position of the tip of the wound wire 55). In this case, for example, it is preferable that the braid layer 53 is configured with fewer wires in the first region 12 than the number of wires in the second region 14, or that the opening width of the stitches of the braid layer 53 in the first region 12 is larger than the opening width of the stitches of the braid layer 53 in the second region 14. By doing so, it is possible to configure the bending rigidity of the medical device main body 10 on the proximal side of the second marker 63 to be larger than the bending rigidity of the medical device main body 10 on the distal side of the second marker 63. In the present invention, the reinforcing layer 51 may include, instead of the braid layer 53, a coil layer (not shown) formed by winding a wire multiple times.
[0034] As shown in FIGS. 5 and 6, in this embodiment, the medical device 100 has a hub 91 provided at the proximal end of the medical device body 10. Hub 91 has a connecting portion 93 for inserting an injector (syringe, not shown) from the base end of hub 91. A thread groove is formed on the outer periphery of connecting portion 93 so that the syringe can be detachably fixed. The hub 91 has two blades 92 on the outer periphery thereof, which are opposed to each other across the axis of the hub 91 . The proximal end of the medical device body 10 is inserted and fixed into the distal end of the hub 91. This allows the lumen 20 inside the medical device body 10 and the internal space of the hub 91 to communicate with each other. By rotating the wing portion 92 around the axis of the hub 91, torque operation for axially rotating the entire medical device body 10 is possible. A main body case 70a of the operation unit 70, which will be described below, is connected and fixed to the tip end of the hub 91.
[0035] As described above, the medical device 100 includes an operation unit 70 for bending the distal end portion 10a of the medical device main body 10. The operation unit 70 can be used to selectively pull one of the first operation wire 41 and the third operation wire 43, and can be used to pull the first operation wire 41 and the second operation wire 42 individually and simultaneously.
[0036] As shown in FIGS. 5 and 6, the operation unit 70 includes, for example, a main body case 70a and a first rotating member 71 that is rotatably supported by the main body case 70a. The first rotating member 71 is, for example, a pulley. In this specification, a member being rotatable is not limited to a member being rotatable by 360 degrees or more, but also includes a member being capable of swinging only within a predetermined angular range of less than 360 degrees. More specifically, a first dial operation unit 74 having a disk-like shape or the like is engaged with the first rotating member 71 coaxially with the first rotating member 71. Since the first dial operation unit 74 is rotatably supported on the main body case 70a, the first rotating member 71 is indirectly rotatably supported on the main body case 70a.
[0037] The proximal end 10b of the medical device main body 10 is guided through the inside of the main body case 70a to the proximal end side of the main body case 70a, and is inserted into and fixed to the distal end of the hub 91. The rotation axis of the first dial operation unit 74 extends in a direction perpendicular to the axial direction of the medical device main body 10 inside the main body case 70a.
[0038] As shown in FIG. 6, at least a portion of the first dial operating unit 74 is exposed to the outside of the main body case 70a, so that an operator operating the medical device 100 can operate the first dial operating unit 74 from outside the main body case 70a.
[0039] Furthermore, the operation unit 70 includes, for example, a first slider operation unit 81 that is fixed to the main body case 70a so as to be slidable in the axial direction. The main body case 70a has a slide hole (not shown) extending in the axial direction, and the first slider operating part 81 is guided by the slide hole so that it can slide in the axial direction relative to the main body case 70a. As shown in Figure 6, at least a portion of the first slider operating portion 81 is exposed to the outside of the main body case 70a through a slide hole, so that an operator operating the medical device 100 can slide the first slider operating portion 81 toward the base end or the tip end from outside the main body case 70a.
[0040] As shown in FIG. 5, the first operation wire 41, the second operation wire 42, and the third operation wire 43 are each led out from the medical device main body 10 within the main body case 70a. The base end of the first operation wire 41 is wound around the first rotating member 71 by, for example, one and a half turns, and the base end of the first operation wire 41 is fixed to the first rotating member 71. Furthermore, the base end of the third operation wire 43 is wound around the first rotating member 71 by, for example, one and a half turns, and the base end of the third operation wire 43 is fixed to the first rotating member 71. The winding direction of the first operation wire 41 and the winding direction of the third operation wire 43 with respect to the first rotary member 71 are opposite to each other. When the first dial operating unit 74 is rotated, the first rotating member 71 engaged with the first dial operating unit 74 rotates in one direction, and the first operating wire 41 of the first operating wire 41 and the third operating wire 43 is selectively pulled toward the base end. Furthermore, when the first rotating member 71 rotates in the opposite direction to the above-mentioned direction by rotating the first dial operating unit 74, the third operating wire 43 is selectively pulled toward the base end side out of the first operating wire 41 and the third operating wire 43.
[0041] The base end of the second operating wire 42 is fixed to the first slider operating portion 81, for example. When the first slider operation portion 81 is slid to move the first slider operation portion 81 toward the base end in the axial direction relative to the main body case 70a, the second operation wire 42 is pulled toward the base end.
[0042] Therefore, by operating either the first dial operation unit 74 or the first slider operation unit 81, it is possible to individually pull either the first operation wire 41 (or the third operation wire 43) or the second operation wire 42. Furthermore, by operating the first dial operation unit 74 and the first slider operation unit 81 in parallel, it is possible to simultaneously pull the first operation wire 41 (or the third operation wire 43) and the second operation wire 42. Here, pulling the first operation wire 41 and the second operation wire 42 simultaneously means that there is a timing at which both the first operation wire 41 and the second operation wire 42 are pulled, and it is not limited to the timing at which the pulling of both the first operation wire 41 and the second operation wire 42 begins being the same, nor is it limited to the timing at which the pulling of the first operation wire 41 and the second operation wire 42 ends being the same.
[0043] Furthermore, the operation section 70 is provided with a tension release mechanism 86 (see FIGS. 7(a) to 7(d)) that releases tension applied to the first operation wire 41 that is greater than or equal to a predetermined value. The tension release mechanism 86 includes, for example, an engaging recess 86a formed in the first rotating member 71 and an engaging protrusion 86b formed in the first dial operating portion 74. 7(b), an opening is formed in the center of the first rotating member 71, penetrating the first rotating member 71 in the thickness direction. In the first rotating member 71, the peripheral edge of the opening includes, for example, a plurality of concave and convex portions in which concave and convex portions are alternately arranged along the circumferential direction of the first rotating member 71, and the concave and convex portions form a plurality of engaging recesses 86a. As shown in FIG. 7A, in this embodiment, a pair of engaging protrusions 86b are formed on the first dial operation unit 74. Each of the pair of engaging protrusions 86b is formed with a shape that protrudes radially outward. The pair of engaging protrusions 86b are arranged at positions that are 180 degrees rotationally symmetrical with respect to each other, with the axial center of the first dial operation unit 74 as the reference. In addition, a pair of slits 86c are formed on the first dial operation unit 74 in the thickness direction. The pair of slits 86c are arranged at positions that are 180 degrees rotationally symmetrical with respect to each other, with the axial center of the first dial operation unit 74 as the reference. When viewed in the axial direction of the first dial operation unit 74, each slit 86c has, for example, an arc shape that protrudes radially outward. Due to the formation of each slit 86c, the first dial operation unit 74 is elastically deformable radially inward. As shown in FIG. 7(d), each of the engaging protrusions 86b engages with one of the plurality of engaging recesses 86a.
[0044] Next, the operation will be described.
[0045] First, when an operation is performed to selectively pull the first operating wire 41 toward the base end, tension is applied to the first operating wire 41, and as shown in Figure 8(a), the tip portion 10a of the medical device main body 10 is bent toward the first hollow tube 31 through which the first operating wire 41 is inserted (hereinafter referred to as the first direction) based on the axis of the medical device main body 10. Furthermore, when an operation is performed to selectively pull the third operation wire 43 toward the base end, tension is applied to the third operation wire 43, and as shown in Fig. 8(b), the distal end portion 10a of the medical device main body 10 is bent toward the third hollow tube 33 through which the third operation wire 43 is inserted (hereinafter, referred to as the second direction) with the axis of the medical device main body 10 as the reference. Here, for example, the first direction and the second direction are directions included in the same plane (hereinafter, referred to as the first imaginary plane) and are opposite to each other. 8(c), when an operation is performed to simultaneously pull both the first operation wire 41 and the second operation wire 42, the first region 12 mainly bends in the first direction, and the second region 14 mainly bends in the second direction. That is, when tension is applied to the second operation wire 42, the distal end portion 10a of the medical device main body 10 bends toward the second hollow tube 32 (the third hollow tube 33) through which the second operation wire 42 is inserted, with respect to the axis of the medical device main body 10, in a region on the proximal side of the first region 12. Therefore, a combined operation occurs in which the second region 14 mainly bends in the second direction due to the pulling of the second operation wire 42, and the first region 12 mainly bends in the first direction due to the pulling of the first operation wire 41. It is also possible to perform an operation of pulling the second operating wire 42 alone. In this case, the second region 14 is mainly bent in the second direction.
[0046] As described above, according to this embodiment, it is possible to selectively bend the distal end portion 10a of the medical device main body 10 in a first direction, to selectively bend the distal end portion 10a of the medical device main body 10 in a second direction, and to bend mainly the first region 12 in the first direction and mainly the second region 14 in the second direction. Therefore, the branch selectivity of the medical device 100 at each branching portion of a body cavity (blood vessel, etc.) is improved. More specifically, for example, when inserting the distal end portion 10a into each branch portion (branch portions 310 to 330 shown in FIGS. 9(a) and 9(b)) of a body cavity (blood vessel, etc.), as shown in FIG. 9(a), when the distal end of the distal end portion 10a approaches the second branch portion 320 branching from the first branch portion 310, the distal end portion 10a is bent in the second direction by pulling the third operation wire 43. This allows the distal end portion 10a to be inserted into the second branch portion 320. Subsequently, when the distal end of the distal end portion 10a approaches the third branch portion 330 branching from the second branch portion 320, the pulling on the third operation wire 43 is released, and the second operation wire 42 is pulled to bend the distal end portion 10a (mainly the second region 14) in the second direction, thereby achieving a backed-up state. More specifically, even if an attempt is made to perform a torque rotation operation to rotate the medical device main body 10 around its axis while the second operation wire 42 is being pulled toward the base end, the distal end portion 10a will attempt to maintain a state in which the second hollow tube 32 (second operation wire 42) side is on the innermost side of the curve (in-course) with respect to the axial center of the medical device main body 10, and therefore the rotation caused by the rotation operation will be difficult to transmit to the medical device main body 10. In other words, a backup state is achieved by suppressing the medical device main body 10 from rotating around its axis. Then, from this state, by pulling the first operating wire 41 while maintaining the second operating wire 42 in a pulled state, the tip portion 10a is bent into an approximately S-shape and inserted into the third branch portion 330, as shown in Figure 9(b). In this embodiment, the breaking strength of the second operation wire 42 is greater than the breaking strength of the first operation wire 41, as described above. This allows the first region 12 to bend primarily in the first direction while the second region 14 remains bent primarily in the second direction when the first operating wire 41 and the second operating wire 42 are pulled simultaneously. Furthermore, in the case of this embodiment, as described above, the medical device main body 10 includes the reinforcing layer 51. The bending rigidity of the reinforcing layer 51 on the proximal side of the second marker 63 is greater than the bending rigidity of the reinforcing layer 51 on the distal side of the second marker 63. The bending rigidity of the medical device main body 10 on the proximal side of the second marker 63 is greater than the bending rigidity of the medical device main body 10 on the distal side of the second marker 63. This makes it possible to more reliably bend mainly the first region 12 in the first direction while mainly maintaining the second region 14 bent in the second direction when the first operating wire 41 and the second operating wire 42 are pulled simultaneously.
[0047] In this embodiment, the maximum value of tension that can be applied to the second operation wire 42 by pulling by the operation unit 70 is greater than the maximum value of tension that can be applied to the first operation wire 41 by pulling by the operation unit 70. This makes it possible to sufficiently ensure the backup capability of the first operation wire 41 with respect to the second operation wire 42 and the third operation wire 43. Therefore, when the first operation wire 41 and the second operation wire 42 are pulled simultaneously, it is possible to more reliably bend mainly the first region 12 in the first direction while maintaining a state in which mainly the second region 14 is bent in the second direction.
[0048] More specifically, in the case of this embodiment, when an attempt is made to pull the first operation wire 41 with a tension equal to or greater than a certain level, the engagement between the engaging recess 86a and the engaging protrusion 86b is temporarily released, and the first dial operation unit 74 rotates freely relative to the first rotating member 71. In other words, the tension when the first dial operation unit 74 rotates freely relative to the first rotating member 71 is the maximum value of tension that can be applied to the first operation wire 41. More specifically, as described above, since the tip of the first operation wire 41 is fixed to the first marker 61, when the force pulling the first operation wire 41 toward the base end due to pulling by the operation unit 70 increases, the force trying to pull the first operation wire 41 back toward the tip end also increases. When the force trying to pull the first operation wire 41 back toward the tip end exceeds a certain level, the first rotating member 71 elastically deforms radially inward to release the force, and the engagement between the engaging recess 86a and the engaging protrusion 86b is temporarily released. This causes the first dial operation unit 74 to rotate freely relative to the first rotating member 71 (the rotation of the first dial operation unit 74 is no longer transmitted to the first rotating member 71). Then, when the force pulling the first operating wire 41 toward the base end and the force pulling the first operating wire 41 back toward the tip end are balanced, the engaging recess 86a and the engaging protrusion 86b engage with each other, and thus the engaged state between the first rotating member 71 and the first dial operating part 74 is maintained. Here, in the case of this embodiment, the medical device 100 is configured so that the maximum value of tension that can be applied to the first operation wire 41 (the tension when the first dial operation unit 74 rotates freely relative to the first rotating member 71) is smaller than the tension applied to the second operation wire 42 when the first slider operation unit 81 is slid to the proximal end side to its maximum. Therefore, it is possible to prevent the tension applied to the first operation wire 41 by pulling by the operation unit 70 from exceeding the maximum value of tension that can be applied to the second operation wire 42 by pulling by the operation unit 70. In this embodiment, the maximum tension that can be applied to the first operating wire 41 by pulling with the operating unit 70 can be appropriately set, for example, by the depth dimension (diametric dimension) of the engagement recess 86a, the depth dimension and length dimension (circumferential dimension) of the slit portion 86c, and the elastic force (spring force) of the first rotating member 71, etc. Furthermore, the maximum value of tension that can be applied to the second operation wire 42 by pulling with the operation portion 70 can be set appropriately according to, for example, the maximum stroke of the first slider operation portion 81 (the dimension of the slide hole in the axial direction).
[0049] Similarly, the maximum value of tension that can be applied to the second operation wire 42 by pulling it with the operation unit 70 is greater than the maximum value of tension that can be applied to the third operation wire 43 by pulling it with the operation unit 70. More specifically, the medical device 100 is configured so that the maximum tension that can be applied to the third operating wire 43 (the tension when the first dial operating unit 74 rotates freely relative to the first rotating member 71) is smaller than the tension applied to the second operating wire 42 when the first slider operating unit 81 is slid to the base end side to its maximum extent.
[0050] Second Embodiment Next, a second embodiment will be described with reference to Figures 10 to 13. Figure 11 is a cross-sectional view taken along line AA in Figure 12. The medical device 100 of this embodiment differs from the medical device 100 of the first embodiment described above in the points described below, but is otherwise configured in the same way as the medical device 100 of the first embodiment described above.
[0051] In this embodiment, the medical device 100 further includes a fourth manipulation wire 44 extending along the longitudinal direction of the medical device body 10. 11 and 12, the fourth operation wire 44 is disposed at a position near the first operation wire 41 in the cross section of the medical device main body 10, and the tip of the fourth operation wire 44 is fixed at a position closer to the proximal end than the tip of the third operation wire 43 in the tip portion 10a of the medical device main body 10. The breaking strength of the fourth operation wire 44 is greater than the breaking strength of the third operation wire 43. 10, by simultaneously pulling the third operation wire 43 and the fourth operation wire 44, it is possible to bend mainly the first region 12 in the second direction and mainly the second region 14 in the first direction. That is, an operation similar to a bending operation performed by simultaneously pulling the first operation wire 41 and the second operation wire 42 (however, an operation that is 180-degree rotationally symmetrical about the axis of the medical device main body 10) can also be achieved by simultaneously pulling the third operation wire 43 and the fourth operation wire 44. Therefore, a torque rotation operation that rotates the medical device main body 10 about the axis prior to the bending operation becomes unnecessary, or the amount of rotation in the torque rotation operation can be reduced. Therefore, the operability of the medical device 100 can be improved. In FIG. 11, the first to fourth operation wires 41 to 44 are indicated by dashed lines.
[0052] In the present embodiment, as shown in FIGS. 11 and 12, the third manipulation wire 43 and the fourth manipulation wire 44 are arranged at positions opposite to each other in the cross section of the medical device main body 10. Here, the position of opposite poles means that the third operating wire 43 and the fourth operating wire 44 are spaced apart from each other by more than 160 degrees in the circumferential direction of the medical device main body 10, and preferably, the third operating wire 43 and the fourth operating wire 44 are spaced apart from each other by more than 170 degrees in the circumferential direction of the medical device main body 10. More specifically, in the case of this embodiment, for example, the fourth operation wire 44 and the first operation wire 41 are arranged at approximately the same positions in the circumferential direction of the medical device body 10, with the axial center of the medical device body 10 as the reference. Therefore, the fourth operation wire 44 is arranged at positions that are 180 degrees rotationally symmetrical to the second operation wire 42 and the third operation wire 43, with the axial center of the medical device body 10 as the reference. In this embodiment, the direction in which the tip portion 10a of the medical device main body 10 bends when the fourth operating wire 44 is pulled and the direction in which the tip portion 10a of the medical device main body 10 bends when the third operating wire 43 (or the second operating wire 42) are pulled are opposite to each other.
[0053] As shown in Figures 10 and 11, in this embodiment, the medical device 100 has a fourth hollow tube 34 embedded in the outer layer 23, and a fourth operating wire 44 is inserted through the fourth hollow tube 34. The fourth hollow tube 34 is a sub-lumen tube, similar to the first hollow tube 31 to the third hollow tube 33, and the inner cavity of the sub-lumen tube is a sub-lumen. That is, the fourth operating wire 44 is inserted through the sub-lumen. The inner diameter of the fourth hollow tube 34 is smaller than the inner diameter of the lumen 20 . The fourth operation wire 44, like the first operation wire 41 to the third operation wire 43, is made of a thin wire such as metal or resin. The wire diameter of the fourth operation wire 44 is set, for example, to be approximately equal to the wire diameter of the second operation wire 42. Therefore, the wire diameter of the fourth operation wire 44 is larger than the wire diameter of the first operation wire 41 and the wire diameter of the third operation wire 43. The wire diameter of the fourth operating wire 44 is not particularly limited, but is preferably, for example, 30 μm or more and 180 μm or less, and more preferably 60 μm or more and 150 μm or less.
[0054] The tip of the fourth operation wire 44 and the tip of the fourth hollow tube 34 are fixed to the base end of the second marker 63. Therefore, the fixing positions of the tip of the second operation wire 42 and the tip of the fourth operation wire 44 are equivalent to each other in the longitudinal direction of the medical device main body 10. The fixing positions of the tip of the first operation wire 41 and the tip of the third operation wire 43 are closer to the tip side than the fixing positions of the tip of the second operation wire 42 and the tip of the fourth operation wire 44.
[0055] In this embodiment, in addition to the above-mentioned operations, the operation unit 70 can be operated to individually pull the fourth operation wire 44 toward the base end, and to simultaneously pull the third operation wire 43 and the fourth operation wire 44 toward the base end. Here, pulling the third operation wire 43 and the fourth operation wire 44 simultaneously means that there is a timing at which both the third operation wire 43 and the fourth operation wire 44 are pulled, and it is not limited to the timing at which the pulling of both the third operation wire 43 and the fourth operation wire 44 begins being the same, nor is it limited to the timing at which the pulling of the third operation wire 43 and the fourth operation wire 44 ends being the same.
[0056] More specifically, as shown in FIG. 13, the operation unit 70 further includes a second slider operation unit 84 that is fixed to the main body case 70a so as to be slidable in the axial direction. The second slider operation unit 84 is configured, for example, in the same manner as the first slider operation unit 81. Therefore, the main body case 70a is formed with a slide hole (not shown) that guides the second slider operation unit 84 along the axial direction. The first slider operation unit 81 and the second slider operation unit 84 are disposed at positions that are 180 degrees rotationally symmetrical to each other with respect to the axis of the medical device main body 10. As shown in FIG. 13, at least a portion of the second slider operating portion 84 is exposed to the outside of the main body case 70a, so that an operator operating the medical device 100 can slide the second slider operating portion 84 from outside the main body case 70a. The base end of the fourth operating wire 44 is fixed to the second slider operating portion 84, for example. When the second slider operating portion 84 is operated to slide toward the base end in the axial direction relative to the main body case 70a, the fourth operating wire 44 is pulled toward the base end. Therefore, by operating the first dial operation unit 74 and the second slider operation unit 84 in parallel, it is possible to perform an operation to pull the third operation wire 43 and the fourth operation wire 44 simultaneously.
[0057] Here, in this embodiment, the maximum tension that can be applied to the fourth operation wire 44 by pulling by the operation unit 70 is greater than the maximum tension that can be applied to the third operation wire 43 (first operation wire 41) by pulling by the operation unit 70. This makes it possible to more reliably bend mainly the first region 12 in the second direction and mainly the second region 14 in the first direction by simultaneously pulling the third operating wire 43 and the fourth operating wire 44. More specifically, the tension required to rotate the first dial operation unit 74 freely is configured to be smaller than the tension applied to the fourth operation wire 44 when the second slider operation unit 84 is slid to the proximal end side to its maximum. This makes it possible to prevent the tension applied to the third operation wire 43 by pulling by the operation unit 70 from exceeding the maximum value of tension that can be applied to the fourth operation wire 44 by pulling by the operation unit 70.
[0058] Third Embodiment Next, a third embodiment will be described with reference to FIGS. The medical device 100 of this embodiment differs from the medical device 100 of the first and second embodiments described above in the points described below, but is otherwise configured in the same way as the medical device 100 of the first and second embodiments described above.
[0059] As shown in FIGS. 14 and 15, in this embodiment, the medical device 100 further includes a fifth manipulation wire 45 extending along the longitudinal direction of the medical device main body 10. The fifth operating wire 45 is arranged in a region intermediate between the arrangement region of the first operating wire 41 and the fourth operating wire 44 and the arrangement region of the second operating wire 42 and the third operating wire 43 in the circumferential direction of the cross section of the medical device main body 10. The tip of the fifth operation wire 45 is fixed to a position on the tip side of the tip of the second operation wire 42 and the tip of the fourth operation wire 44 in the tip portion 10a of the medical device body 10. With this configuration, by pulling the fifth operating wire 45 toward the base end, the tip portion 10a of the medical device main body 10 can be bent in a direction different from the first direction and the second direction, thereby further improving the branching selectivity of the medical device 100 at each branching point of the body cavity (blood vessel, etc.). Furthermore, when inserting the distal end portion 10a into each branching portion of a body cavity (blood vessel, etc.), the torque rotation operation of rotating the medical device main body 10 around its axis prior to the bending operation becomes unnecessary, or the amount of rotation in the torque rotation operation can be reduced, thereby improving the operability of the medical device 100. Here, in this embodiment, it is preferable that the fifth operating wire 45 is arranged in a position that is at least approximately 45 degrees different in the circumferential direction from the arrangement area of the first operating wire 41 and the fourth operating wire 44 (or the arrangement area of the second operating wire 42 and the third operating wire 43), and it is more preferable that it is arranged in a position that is approximately 90 degrees different.
[0060] The fixed positions of the distal end of the fifth operation wire 45 and the distal end of the first operation wire 41 (and the third operation wire 43) are at the same positions in the longitudinal direction of the medical device main body 10. 15, as an example, the fifth operation wire 45, the first operation wire 41, and the third operation wire 43 are arranged at positions that differ by approximately 90 degrees from each other in the circumferential direction of the medical device main body 10. Similarly, as an example, the fifth operation wire 45, the third operation wire 43, and the fourth operation wire 44 are arranged at positions that differ by approximately 90 degrees from each other in the circumferential direction of the medical device main body 10.
[0061] As shown in FIG. 15, in this embodiment, the medical device 100 further includes a sixth manipulation wire 46 extending along the longitudinal direction of the medical device main body 10, for example. The fixed positions of the tip of the fifth operation wire 45 and the tip of the sixth operation wire 46 are equivalent to each other in the longitudinal direction of the medical device main body 10. Therefore, the fixed positions of the tip of the sixth operation wire 46 and the tip of the first operation wire 41 (and the third operation wire 43) are equivalent to each other in the longitudinal direction of the medical device main body 10. The sixth operation wire 46 and the fifth operation wire 45 are arranged at positions that are 180 degrees rotationally symmetrical to each other with respect to the axial center of the medical device main body 10. Therefore, the sixth operation wire 46 is arranged in a region intermediate between the arrangement region of the first operation wire 41 and the fourth operation wire 44 and the arrangement region of the second operation wire 42 and the third operation wire 43 in the circumferential direction of the cross section of the medical device main body 10. More specifically, the sixth operation wire 46, the first operation wire 41, and the third operation wire 43 are spaced apart from each other by approximately 90 degrees in the circumferential direction of the medical device main body 10, and the sixth operation wire 46, the third operation wire 43, and the fourth operation wire 44 are spaced apart from each other by approximately 90 degrees in the circumferential direction of the medical device main body 10. In this embodiment, the direction in which the tip portion 10a of the medical device main body 10 is bent by pulling the fifth operating wire 45 (hereinafter referred to as the third direction) and the direction in which the tip portion 10a of the medical device main body 10 is bent by pulling the sixth operating wire 46 (hereinafter referred to as the fourth direction) are opposite to each other.
[0062] 15 , in this embodiment, the medical device 100 includes a fifth hollow tube 35 and a sixth hollow tube 36 embedded in the outer layer 23. A fifth operation wire 45 is inserted through the fifth hollow tube 35, and a sixth operation wire 46 is inserted through the sixth hollow tube 36. The fifth hollow tube 35 and the sixth hollow tube 36 are sub-lumen tubes, similar to the first hollow tube 31 to the third hollow tube 33, and the inner cavity of the sub-lumen tube is a sub-lumen. The inner diameter of the fifth hollow tube 35 and the inner diameter of the sixth hollow tube 36 are smaller than the inner diameter of the lumen 20 . The fifth operation wire 45 and the sixth operation wire 46, like the first operation wire 41 to the third operation wire 43, are made of thin wires such as metal or resin. The breaking strength of the second operation wire 42 and the fourth operation wire 44 is greater than the breaking strength of the fifth operation wire 45 and the sixth operation wire 46. More specifically, in the case of this embodiment, the first operation wire 41 to the sixth operation wire 46 are made of the same type of material. However, the first operation wire 41 to the sixth operation wire 46 are made of, for example, different types of materials. On the other hand, by setting the wire diameters of the second operation wire 42 and the fourth operation wire 44 to dimensions larger than the wire diameters of the fifth operation wire 45 and the sixth operation wire 46, the breaking strength of the second operation wire 42 and the fourth operation wire 44 can be made larger than the breaking strength of the fifth operation wire 45 and the sixth operation wire 46. However, for example, by using a material that has a breaking strength larger than the breaking strength of the material that makes up the fifth operation wire 45 and the sixth operation wire 46, the breaking strength of the fourth operation wire 44 can also be made larger than the breaking strength of the fifth operation wire 45 and the sixth operation wire 46. The wire diameter of the fifth operating wire 45 and the wire diameter of the sixth operating wire 46 are not particularly limited, but are preferably 10 μm or more and 60 μm or less, and more preferably 20 μm or more and 50 μm or less.
[0063] 14, the distal end of the fifth hollow tube 35 and the distal end of the fifth operating wire 45 are fixed to the proximal end of the first marker 61. Similarly, the distal end of the sixth hollow tube 36 and the distal end of the sixth operating wire 46 are fixed to the proximal end of the first marker 61.
[0064] Thus, in this embodiment, the number of operating wires whose tip fixing positions are closer to the tip of the second operating wire 42 and the fourth operating wire 44 is greater than or equal to the number of operating wires whose tip fixing positions are equivalent to the second operating wire 42 and the fourth operating wire 44. Here, the term "equal position" means that the distance between the tips of the operation wires in the axial direction of the medical device main body 10 is smaller than the outer diameter of the medical device main body 10. Furthermore, when the tips of the operation wires are fixed to a common marker (the first marker 61 or the second marker 63) as in this embodiment, the dimension of the marker in the axial direction may be larger than the outer diameter of the medical device main body 10, but it is preferable that the dimension be smaller.
[0065] In this embodiment, in addition to the above-mentioned operations, the operation unit 70 can perform the following operations: an operation to selectively pull one of the fifth operation wire 45 and the sixth operation wire 46 toward the base end; an operation to pull the fifth operation wire 45 and the second operation wire 42 (or the fourth operation wire 44) individually and simultaneously; and an operation to pull the sixth operation wire 46 and the second operation wire 42 (or the fourth operation wire 44) individually and simultaneously. More specifically, as shown in FIG. 16, the operating unit 70 includes a second rotating member 76 that is rotatably supported on the main body case 70a, and a second dial operating unit 78 that is fixed to the second rotating member 76. The second rotating member 76 is configured, for example, in the same manner as the first rotating member 71. The second dial operating unit 78 is configured, for example, in the same manner as the first dial operating unit 74. In the example shown in Figure 16, the first dial operation unit 74 and the second dial operation unit 78 are arranged so that they overlap each other in a direction perpendicular to their plate surfaces, and the rotation axis of the first dial operation unit 74 and the rotation axis of the second dial operation unit 78 are arranged coaxially with each other. However, the rotation axis of the first dial operation unit 74 and the rotation axis of the second dial operation unit 78 do not have to be arranged coaxially with each other. For example, the first dial operation unit 74 and the second dial operation unit 78 may be arranged at different positions from each other in the axial direction of the medical device main body 10.
[0066] In this embodiment, the base end of the fifth operation wire 45 is wound around the second rotating member 76 by, for example, one and a half turns, and the base end of the fifth operation wire 45 is fixed to the second rotating member 76. Furthermore, the base end of the sixth operation wire 46 is wound around the second rotating member 76 by, for example, one and a half turns, and the base end of the sixth operation wire 46 is fixed to the second rotating member 76 . The winding direction of the fifth operation wire 45 and the winding direction of the sixth operation wire 46 with respect to the second rotating member 76 are opposite to each other.
[0067] When the second rotary member 76 engaged with the second dial operation unit 78 is rotated in one direction by a rotation operation on the second dial operation unit 78, the fifth operation wire 45 of the fifth operation wire 45 and the sixth operation wire 46 is selectively pulled toward the proximal end. Then, with the axis of the medical device main body 10 as a reference, the distal end portion 10a of the medical device main body 10 is bent toward the fifth hollow tube 35 through which the fifth operation wire 45 is inserted. Here, as described above, a plane including the direction (first direction) in which the distal end portion 10a is bent by pulling the first operation wire 41 and the direction (second direction) in which the distal end portion 10a is bent by pulling the second operation wire 42 is referred to as a first imaginary plane. The direction (referred to as a third direction) in which the distal end portion 10a is bent by pulling the fifth operation wire 45 is, for example, a direction included in a second imaginary plane that is perpendicular to the first imaginary plane. Furthermore, when the second rotary member 76 rotates in the opposite direction to the one direction by rotating the second dial operation unit 78, the sixth operation wire 46 of the fifth operation wire 45 and the sixth operation wire 46 is selectively pulled toward the base end. This causes the distal end portion 10a of the medical device main body 10 to bend toward the sixth hollow tube 36 through which the sixth operation wire 46 is inserted, with the axis of the medical device main body 10 as the reference. That is, the distal end portion 10a of the medical device main body 10 bends in the opposite direction to the third direction (fourth direction), with the axis of the medical device main body 10 as the reference. The fourth direction is also a direction included in the second imaginary plane. Furthermore, when an operation is performed to pull both the fifth operation wire 45 and the second operation wire 42 (or the fourth operation wire 44), as shown in Figures 17(a) to 17(c), the first region 12 is mainly bent in the third direction, while the second region 14 is mainly bent in the second direction (or the first direction). That is, in the first and second embodiments, the bending of the distal end portion 10a is a two-dimensional bending within the first imaginary plane, whereas in the present embodiment, the distal end portion 10a can be bent three-dimensionally (stereoscopically) by combining bending within the first imaginary plane and bending within the second imaginary plane. Furthermore, when an operation is performed to pull both the sixth operation wire 46 and the second operation wire 42 (or the fourth operation wire 44), the first region 12 is mainly bent in the fourth direction, while the second region 14 is mainly bent in the second direction (or the first direction). That is, in this case as well, the distal end portion 10a can be bent three-dimensionally (stereoscopically).
[0068] As described above, according to the present embodiment, the distal end portion 10a of the medical device main body 10 can be bent three-dimensionally (stereoscopically) by simultaneously pulling the fifth manipulation wire 45 and the second manipulation wire 42 (or the fourth manipulation wire 44), or by simultaneously pulling the sixth manipulation wire 46 and the second manipulation wire 42 (or the fourth manipulation wire 44). Therefore, for example, as shown in Fig. 18, the distal end portion 10a of the medical device main body 10 can be inserted along each branching portion (first branching portion 310 to third branching portion 330) of a body cavity (blood vessel, etc.) that branches three-dimensionally (stereoscopically).
[0069] Here, in this embodiment, the maximum tension that can be applied to the second operation wire 42 (or the fourth operation wire 44) by pulling by the operation unit 70 is greater than the maximum tension that can be applied to the fifth operation wire 45 by pulling by the operation unit 70. This provides sufficient backup, so that by simultaneously pulling the fifth operating wire 45 and the second operating wire 42 (or the fourth operating wire 44), it is possible to more reliably bend mainly the first region 12 in the third direction and mainly the second region 14 in the second direction (or the first direction).
[0070] Similarly, the maximum tension that can be applied to the second operation wire 42 (or the fourth operation wire 44) by pulling with the operation unit 70 is greater than the maximum tension that can be applied to the sixth operation wire 46 by pulling with the operation unit 70. Therefore, sufficient backup can be provided, and by simultaneously pulling the sixth operating wire 46 and the second operating wire 42 (or the fourth operating wire 44), it is possible to more reliably bend mainly the first region 12 in the fourth direction and mainly the second region 14 in the first direction (or the second direction).
[0071] More specifically, the operation section 70 includes, for example, a tension release mechanism (not shown) that releases tension of a predetermined value or more applied to the fifth operation wire 45 (or the sixth operation wire 46). The tension release mechanism may be configured similarly to tension release mechanism 86, for example. Therefore, the medical device 100 is configured so that the maximum tension that can be applied to the fifth operating wire 45 (or the sixth operating wire 46) (the tension when the second dial operating unit 78 rotates freely relative to the second rotating member 76) is smaller than the tension applied to the second operating wire 42 when the first slider operating unit 81 is slid to the base end side to its maximum.
[0072] Although the embodiments have been described above with reference to the drawings, these are merely examples of the present invention, and various other configurations can also be adopted. Furthermore, the above-described embodiments can be combined as appropriate without departing from the spirit of the present invention.
[0073] The present embodiment encompasses the following technical ideas. (1) A long medical device body, a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; an operating unit capable of pulling the first operating wire and the second operating wire individually and simultaneously; Equipped with the first operating wire and the second operating wire are arranged at opposite poles to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to a distal end portion of the medical device body; A medical device in which the tip of the second operating wire is fixed at a position on the proximal side of the tip of the first operating wire in the tip portion of the medical device body. (2) The medical device according to (1), wherein the breaking strength of the second operating wire is greater than the breaking strength of the first operating wire. (3) A medical device described in (1) or (2), wherein the maximum tension that can be applied to the second operating wire by pulling with the operating unit is greater than the maximum tension that can be applied to the first operating wire by pulling with the operating unit. (4) Further comprising a third operating wire extending along the longitudinal direction of the medical device body; the third operating wire is disposed at a position near the second operating wire in a cross section of the medical device body, A medical device described in any one of (1) to (3), wherein the tip of the third operating wire is fixed at a position more distal than the tip of the second operating wire in the distal portion of the medical device main body. (5) Further comprising a fourth operating wire extending along the longitudinal direction of the medical device body; the fourth operating wire is disposed at a position near the first operating wire in a cross section of the medical device body, a distal end of the fourth operation wire is fixed to a position on the proximal end side of the distal end of the third operation wire in the distal end portion of the medical device body, The medical device according to (4), wherein the breaking strength of the fourth operating wire is greater than the breaking strength of the third operating wire. (6) Further comprising a fifth operating wire extending along the longitudinal direction of the medical device body; the fifth operation wire is disposed in a region intermediate between an arrangement region of the first operation wire and the fourth operation wire and an arrangement region of the second operation wire and the third operation wire in the circumferential direction of the cross section of the medical device main body, The medical device described in (5) above, wherein the tip of the fifth operating wire is fixed at a position more distal than the tip of the second operating wire and the tip of the fourth operating wire in the distal portion of the medical device main body. (7) The fixed positions of the tip of the second operating wire and the tip of the fourth operating wire are at the same positions in the longitudinal direction of the medical device body, the number of operation wires whose tip fixing positions are located on the tip side of the second operation wire and the fourth operation wire is The medical device according to (6), wherein the number of operation wires is equal to or greater than the number of operation wires whose tips are fixed at positions equivalent to those of the second operation wire and the fourth operation wire. (8) a first marker fixed to the distal end portion of the medical device body; a second marker fixed at a position closer to the base end than the first marker at the distal end of the medical device body; Equipped with a tip of the first operating wire and a tip of the third operating wire are fixed to the first marker, The medical device according to any one of (4) to (7), wherein the tip of the second operating wire is fixed to the second marker. (9) The medical device body includes a reinforcing layer, The bending rigidity of the reinforcing layer on the proximal side of the second marker is greater than the bending rigidity of the reinforcing layer on the distal side of the second marker, A medical device as described in (8), wherein the bending rigidity of the medical device main body on the base side of the second marker is greater than the bending rigidity of the medical device main body on the tip side of the second marker. (10) The medical device is a catheter, The medical device according to any one of (1) to (9), wherein the medical device body has a lumen that opens at the tip of the medical device body. [Explanation of symbols]
[0074] 10 Medical device body 10a Tip 10b Base end 12 First area 14 Second area 20 lumens 22 Inner layer 23 Outer layer 31 1st hollow tube 32 2nd hollow tube 33 Third hollow tube 34 4th hollow tube 35 5th hollow tube 36 No. 6 hollow tube 41 First operating wire 42 Second operating wire 43 Third operating wire 44 4th operating wire 45 5th operating wire 46 No. 6 operating wire 51 Reinforcement layer 53 Braid Layer 55 turns of wire 61 First Marker 63 Second Marker 70 Operation section 70a Main body case 71 First rotating member 74 First dial operation section 76 Second rotating member 78 Second dial operation section 81 First slider operation unit 84 Second slider operation section 86 Tension release mechanism 86a Engagement recess 86b Engagement protrusion 86c Slit section 91 Hub 92 Wings 93 Connecting part 96 Gate 100 Medical Devices 310 First Branch 320 Second Branch 330 Third Branch
Claims
1. A long medical device body and a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; an operating unit capable of pulling the first operating wire and the second operating wire individually and simultaneously; Equipped with the first operating wire and the second operating wire are arranged at positions opposite to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to a distal end portion of the medical device body; a distal end of the second operation wire is fixed to a position on the proximal end side of the distal end of the first operation wire in the distal end portion of the medical device main body, A medical device in which the breaking strength of the second operating wire is greater than the breaking strength of the first operating wire.
2. A long medical device body, a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; an operating unit capable of pulling the first operating wire and the second operating wire individually and simultaneously; Equipped with the first operating wire and the second operating wire are arranged at positions opposite to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to a distal end portion of the medical device body; a distal end of the second operation wire is fixed to a position on the proximal end side of the distal end of the first operation wire in the distal end portion of the medical device main body, A medical device in which the maximum tension that can be applied to the second operating wire by pulling with the operating unit is greater than the maximum tension that can be applied to the first operating wire by pulling with the operating unit.
3. a third operating wire extending along the longitudinal direction of the medical device body; the third operating wire is disposed at a position near the second operating wire in a cross section of the medical device body, The medical device according to claim 1 or 2, wherein the tip of the third operating wire is fixed at a position on the tip portion of the medical device body that is more distal than the tip of the second operating wire.
4. A long medical device body, a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; a third operating wire and a fourth operating wire, each extending along the longitudinal direction of the medical device body; an operation unit that is capable of individually pulling the first operation wire, the second operation wire, the third operation wire, and the fourth operation wire, simultaneously pulling the first operation wire and the second operation wire, and simultaneously pulling the third operation wire and the fourth operation wire; Equipped with the first operating wire and the second operating wire are arranged at positions opposite to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to a distal end portion of the medical device body; a distal end of the second operation wire is fixed to a position on the proximal end side of the distal end of the first operation wire in the distal end portion of the medical device main body, the third operating wire is disposed at a position near the second operating wire in a cross section of the medical device body, a distal end of the third operation wire is fixed to a position on the distal end portion of the medical device main body that is more distal than a distal end of the second operation wire; the fourth operating wire is disposed at a position near the first operating wire in a cross section of the medical device body, a distal end of the fourth operation wire is fixed to a position on the proximal end side of the distal end of the third operation wire in the distal end portion of the medical device main body, A medical device in which the breaking strength of the fourth operating wire is greater than the breaking strength of the third operating wire.
5. a fifth operating wire extending along the longitudinal direction of the medical device body; the fifth operation wire is disposed in a region intermediate between an arrangement region of the first operation wire and the fourth operation wire and an arrangement region of the second operation wire and the third operation wire in a circumferential direction of the cross section of the medical device main body, The medical device according to claim 4 , wherein the tip of the fifth operating wire is fixed at a position on the distal end side of the tip of the second operating wire and the tip of the fourth operating wire in the distal portion of the medical device main body.
6. the distal end of the second operating wire and the distal end of the fourth operating wire are fixed at positions equivalent to each other in the longitudinal direction of the medical device main body; the number of operation wires whose tip fixing positions are located on the tip side of the second operation wire and the fourth operation wire is The medical device according to claim 5 , wherein the number of operation wires is equal to or greater than the number of operation wires whose distal ends are fixed at positions equivalent to those of the second operation wire and the fourth operation wire.
7. a first marker fixed to the distal end portion of the medical device body; a second marker fixed at a position closer to the proximal end than the first marker at the distal end of the medical device body; Equipped with a tip of the first operating wire and a tip of the third operating wire are fixed to the first marker, The medical device according to claim 3 , wherein the tip of the second operating wire is fixed to the second marker.
8. A long medical device body, a first operating wire and a second operating wire each extending along the longitudinal direction of the medical device body; a third operating wire extending along the longitudinal direction of the medical device body; an operation unit capable of individually pulling the first operation wire, the second operation wire, and the third operation wire, and simultaneously pulling the first operation wire and the second operation wire; a first marker fixed to a distal end of the medical device body; a second marker fixed at a position closer to the proximal end than the first marker at the distal end of the medical device body; Equipped with the first operating wire and the second operating wire are arranged at positions opposite to each other in a cross section of the medical device body, a distal end of the first operating wire is fixed to the distal end portion of the medical device body; a distal end of the second operation wire is fixed to a position on the proximal end side of the distal end of the first operation wire in the distal end portion of the medical device main body, the third operating wire is disposed at a position near the second operating wire in a cross section of the medical device body, a distal end of the third operation wire is fixed to a position on the distal end portion of the medical device main body that is more distal than a distal end of the second operation wire; a tip of the first operating wire and a tip of the third operating wire are fixed to the first marker, a tip of the second operating wire is fixed to the second marker, the medical device body includes a reinforcing layer; The bending rigidity of the reinforcing layer on the proximal side of the second marker is greater than the bending rigidity of the reinforcing layer on the distal side of the second marker, A medical device in which the bending rigidity of the medical device main body on the base end side of the second marker is greater than the bending rigidity of the medical device main body on the tip end side of the second marker.
9. the medical device is a catheter, The medical device according to claim 1 , wherein the medical device body has a lumen that opens at a tip of the medical device body.
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