Medical indwelling device transport device and medical indwelling device transport device with indwelling device

Abstract

To provide a medical indwelling instrument delivery device capable of optimally adjusting an angle of a tip of a sheath, and a medical indwelling instrument delivery device with an indwelling instrument.SOLUTION: A medical indwelling instrument delivery device includes: a long inner sheath 4 around which a stent graft 2 is disposed when the stent graft 2 is delivered; an outer sheath 5 sliding to a proximal side in an axial direction with respect to the inner sheath 4 while covering a radially outer side of the inner sheath 4, so as to expose the stent graft 2; an inner operating line 70 disposed in the axial direction of the inner sheath 4 with a tip 70a thereof connected to a distal end 4b of the inner sheath 4, and bending the inner sheath 4 by being pulled to a proximal side; and outer operating lines 71 and 72 disposed in the axial direction of the outer sheath 5 with tip ends 71a and 72a thereof connected to a distal end 5a of the outer sheath 5, and bending the outer sheath 5 by being pulled to the proximal side.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a medical indwelling device delivery device and a medical indwelling device delivery device with an indwelling device. [Background technology]

[0002] 2. Description of the Related Art Stents, stent grafts, and the like are examples of indwelling devices that are placed in the body for medical purposes. In a medical device delivery device (stent graft delivery device) for placing a device in the aortic arch having a curved shape, the inner sheath cannula or introducer may be given (shaped) in advance to have a shape that conforms to the aortic arch. In this way, attempts have been made to improve the fitting of the stent graft by shaping the inner sheath cannula or introducer.

[0003] For example, the following Patent Document 1 discloses a medical indwelling device transport device (referred to as a stent delivery device in the document) that includes a sheath (referred to as a catheter portion in the document) that has a curved distal end and is equipped with an inner sheath and an outer sheath. This sheath places a stent graft in a body tube along the curve of a guide wire. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2012-139471 A Summary of the Invention [Problem to be solved by the invention]

[0005] The sheath in the medical indwelling device delivery device described in Patent Document 1 is only given a certain curved shape. Since there are various curved shapes in the human body tract, it was difficult to adjust the sheath to an appropriate shape when placing the indwelling device.

[0006] This problem will be described with reference to Fig. 15. Fig. 15 is a diagram showing a state in which a stent graft 2 is deployed using a conventional inner sheath 400 and an outer sheath 500. Fig. 15(a) is an image diagram of the stent graft 2 with the outer sheath 500 disposed on the greater curvature side before deployment, and Fig. 15(b) is an image diagram of the stent graft 2 during deployment.

[0007] For example, if the radius of curvature of the tip of the outer sheath 500 is larger than the radius of curvature of the aortic arch 50, which is the target site for placement of the stent graft 2, the outer sheath 500 will be disposed along the aortic arch 50, outside the axis 50b. When the outer sheath 500 is pulled proximally from this state to deploy the stent graft 2, contact with the inner wall on the greater curvature side occurs more than contact with the inner wall on the lesser curvature side, which may cause a bird's beak to form on the lesser curvature side. There has been a demand for a device that can prevent the formation of this bird's beak.

[0008] In particular, when placing the straight stent graft 2 in the aortic arch 50, the stent graft 2 may separate from the inner wall on the lesser curvature side even if the distal end of the outer sheath 500 is bent. This is because when the outer sheath 500 is pulled proximally (toward the end) and the stent graft 2 is exposed from the outer sheath 500, a force acts from the stent graft 2 to restore it to a straight shape, moving the inner sheath 400 to the greater curvature side. Thus, in the conventional medical indwelling device delivery device, there is room for improvement in terms of angle adjustment of the sheath tip end.

[0009] The present invention has been made in consideration of the above-mentioned problems, and provides a medical indwelling device delivery device that can suitably adjust the angle of the tip of the sheath, and a medical indwelling device delivery device with an indwelling device. [Means for solving the problem]

[0010] The medical indwelling device transportation device of the present invention is a medical indwelling device transportation device for delivering an indwelling device into a body, and is characterized in comprising: a long inner sheath around which the indwelling device is disposed when the indwelling device is transported; an outer sheath covering the radial outside of the inner sheath and configured to be slidable in the axial direction relative to the inner sheath, covering the outer periphery of the indwelling device when the indwelling device is transported and exposing the indwelling device by sliding proximally in the axial direction relative to the inner sheath; an inner operating wire having a tip connected to a distal end of the inner sheath, disposed in the axial direction of the inner sheath, and bent the inner sheath when pulled proximally; and an outer operating wire having a tip connected to the distal end of the outer sheath, disposed in the axial direction of the outer sheath, and bent the outer sheath when pulled proximally.

[0011] The medical indwelling device delivery device with an indwelling device of the present invention is characterized by comprising the medical indwelling device delivery device and the indwelling device attached to the inner sheath. Effect of the Invention

[0012] According to the medical indwelling device delivery device and the medical indwelling device delivery device with an indwelling device of the present invention, the angle of the tip of the sheath can be adjusted to a suitable angle. [Brief description of the drawings]

[0013] [Figure 1] FIG. 2 is a schematic diagram showing a state in which a stent graft is placed in the aortic arch by a delivery device (a delivery device with a stent graft). [Diagram 2] 1 is a schematic diagram showing a state in which a portion of a stent graft other than the proximal end portion is exposed from an outer sheath. [Diagram 3] FIG. 13 is a schematic diagram illustrating the positional relationship between a pusher and an inner sheath when deploying a stent graft. [Figure 4] FIG. 2(a) is a diagram showing the inner sheath in a straight state, and FIG. 2(b) is a diagram showing the inner sheath in a bent state (natural state). [Diagram 5] FIG. 1 shows the state of a stent graft being deployed using an inner sheath and an outer sheath. (a) is an image of the stent graft before deployment, with the outer sheath disposed along the axis of the aortic arch, and (b) is an image of the stent graft during deployment. [Figure 6] FIG. 13 is a diagram showing the relationship between the pulling length and the pulling force when moving the outer sheath. [Figure 7] 13 is a diagram showing the relationship between the ratio of the length of a space to the length of a tubular portion and the maximum tensile load of an operating wire. FIG. [Figure 8] 1 is a schematic diagram showing an operating mechanism including a bobbin for an inner operating line and a bobbin for an outer operating line. FIG. [Figure 9] FIG. 13 is a schematic diagram showing an operation mechanism including a folded bobbin according to a first modified example. [Figure 10] 10A is a schematic diagram showing an operation mechanism including a gear-shaped bobbin for an inner operating line and a bobbin for an outer operating line according to a second modified example, and FIG. 10B is an enlarged view of the XB portion shown in FIG. [Figure 11] FIG. 13 is a schematic diagram of the operating mechanism according to the second modified example, seen from the bottom, showing a state in which the bobbin for the inner operating wire and the bobbin for the outer operating wire are engaged with each other. [Figure 12] FIG. 13 is a schematic diagram of the operating mechanism according to the second modified example, seen from the bottom, illustrating a state in which the bobbin for the inner operating wire and the bobbin for the outer operating wire are separated from each other. [Figure 13] FIG. 13 is a schematic diagram showing an operation mechanism including a cable guide according to a third modified example. [Figure 14] FIG. 13 is a schematic diagram showing an operating mechanism including an inner sheath operating handle and an outer sheath operating handle according to a fourth modified example. [Figure 15] FIG. 1 shows the state of a stent graft being deployed using a conventional inner sheath and outer sheath. (a) is an image of the stent graft before deployment with the outer sheath disposed on the greater curvature side, and (b) is an image of the stent graft during deployment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the embodiment described below is merely an example for facilitating understanding of the present invention, and is not intended to limit the present invention. In other words, the shapes, dimensions, arrangements, and the like of the members described below may be changed or improved without departing from the spirit of the present invention, and the present invention naturally includes equivalents thereof. In addition, in all drawings, similar components are given similar symbols and duplicated explanations are omitted as appropriate. In the following, the side closer to the user (practitioner) is referred to as the proximal side (base end side, terminal side), and the side farther from the user (practitioner) is referred to as the distal side (tip side, central side).

[0015] <Summary> First, an overview of a medical indwelling device delivery device (delivery device 1) and a medical indwelling device with an indwelling device (delivery device with stent graft 1S) according to this embodiment will be described mainly with reference to FIGS. Fig. 1 is a schematic diagram showing a state in which a stent graft 2 is placed in an aortic arch 50 by a delivery device 1 (a delivery device 1S with a stent graft). Fig. 2 is a schematic diagram showing a state in which the stent graft 2 is exposed from an outer sheath 5 except for a proximal end portion 2c. Note that in Fig. 1, the inner sheath 4 shown in Fig. 2 is shown in a simplified form.

[0016] The medical indwelling device delivery device (delivery device 1) according to this embodiment is for delivering an indwelling device (stent graft 2) into the body. The delivery device 1 is characterized by comprising a long inner sheath 4 around which the stent graft 2 is disposed when the stent graft 2 is delivered, an outer sheath 5 which covers the radial outside of the inner sheath 4 and is configured to be slidable in the axial direction relative to the inner sheath 4, covering the outer periphery of the stent graft 2 when the stent graft 2 is delivered and exposing the stent graft 2 by sliding proximally in the axial direction relative to the inner sheath 4, an inner operating wire 70 which has a tip end 70a connected to the distal end 4b of the inner sheath 4, is disposed in the axial direction of the inner sheath 4, and is pulled proximally to bend the inner sheath 4, and outer operating wires 71, 72 which have tip ends 71a, 72a connected to the distal end 5a of the outer sheath 5, are disposed in the axial direction of the outer sheath 5, and are pulled proximally to bend the outer sheath 5.

[0017] The term "insertion device" includes, in addition to the stent graft 2, a stent (bare stent) having only the stent portion 2a without the graft portion 2b, an artificial valve, or other indwelling device to be placed in a biological lumen. Furthermore, in this specification, the term "bend" refers not only to a "curve" that is a gentle bend, but also to a sharp bend.

[0018] Furthermore, the bending direction of the inner operating wire 70 and the outer operating wires 71, 72 is not particularly limited. In other words, bending refers to deforming the inner sheath 4 or the outer sheath 5 by applying a bending moment from their natural state. Therefore, particularly when the inner sheath 4 or the outer sheath 5 is pre-shaped in a bent state, bending also includes returning it to a straight state.

[0019] As described above, by configuring both the inner sheath 4 and the outer sheath 5 to be bendable, it is possible to adjust to an angle that could not be adjusted by the inner sheath 4 or the outer sheath 5 alone. For this reason, the delivery device 1 is preferably used when supplying the stent graft 2 to a highly curved blood vessel such as the aortic arch 50 having a large degree of curvature.

[0020] Furthermore, with the above configuration, the delivery device 1 can easily bring the stent graft 2 into close contact with the inner wall of the blood vessel, thereby contributing to the reduction of bird's beaks (end leaks) and preventing blood from passing through unintended areas. Furthermore, by having the inner operating wire 70 handle the bending of the inner sheath 4 and the outer operating wires 71, 72 handle the bending of the outer sheath 5, the load on each operating wire in response to the bending of the entire sheath 3 can be reduced compared to when only one of the operating wires is used.

[0021] A device comprising the above-mentioned medical indwelling device delivery device (delivery device 1) and the indwelling device (stent graft 2) attached to the inner sheath 4 is called a medical indwelling device delivery device with indwelling device (delivery device with stent graft 1S). According to the above configuration, the medical indwelling device delivery device with indwelling device (stent graft-equipped delivery device 1S) can also enjoy the above effects.

[0022] <Configuration of each part of the conveying device> The configuration of each part of the conveying device 1 will be described with reference to FIGS. 1 and 2 as well as FIGS. Fig. 3 is a schematic diagram for explaining the positional relationship between the pusher 11 and the inner sheath 4 when the stent graft 2 is deployed. Fig. 4(a) is a diagram showing the inner sheath 4 in a straight state, and Fig. 4(b) is a diagram showing the inner sheath 4 in a bent state (natural state). Fig. 5 shows a state in which the stent graft 2 is deployed using the inner sheath 4 and the outer sheath 5. Fig. 5(a) is an image diagram of the stent graft 2 before deployment in which the outer sheath 5 is disposed along the axis 50b of the aortic arch 50, and Fig. 5(b) is an image diagram of the stent graft 2 during deployment. Fig. 6 is a diagram showing the relationship between the traction length and the traction force when the outer sheath 5 is movable, and Fig. 7 is a diagram showing the relationship between the ratio of the length of the space 41c to the length of the tubular portion 41b and the maximum tensile load of the inner operating wire 70.

[0023] The delivery device 1 in this embodiment has a stent graft 2 as an indwelling device, and as shown in Figure 1, the delivery device 1 is configured to place (supply) the stent graft 2 in an aortic arch 50 or the like (a lesion such as an aortic aneurysm 55) inside the body, and is equipped with a sheath 3 that houses the stent graft 2. More specifically, the delivery device 1 of this embodiment inserts the sheath 3 through the descending aorta 51 to the aortic arch 50, and places the stent graft 2 so that the stent graft 2 presses approximately uniformly against the inner wall 50a of the aortic arch 50, where the aortic aneurysm 55 is located.

[0024] The stent graft 2 according to this embodiment is composed of a graft portion 2b which is a resin film and a stent portion 2a which is a metal wire attached to the graft portion 2b by sewing, and is about 150 mm in this embodiment. The length of the stent graft 2 may be from 110 mm to 200 mm.

[0025] The sheath 3 comprises an inner sheath 4 to which the stent graft 2 is attached around the outer periphery of the distal end 4b, a pusher 11 (see Figure 3) that limits the movement of the stent graft 2 toward the base end, and an outer sheath 5 that covers the inner sheath 4, the stent graft 2 and the pusher 11.

[0026] A thermoplastic polymer material can be used as the main material of the inner sheath 4 and the outer sheath 5. Examples of the thermoplastic polymer material include polyimide (PI), polyamide-imide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), nylon elastomer such as polyether block amide (PEBA), polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), and polypropylene (PP).

[0027] The outer sheath 5 covers and protects the stent graft 2 when the sheath 3 is inserted into the body. Furthermore, the outer sheath 5 is attached to be axially slidable relative to the inner sheath 4 and the pusher 11 so that the outer sheath 5 can be pulled proximally to expose the stent graft 2 when the stent graft 2 is placed inside the body. The outer sheath 5 according to the present embodiment is initially formed in a bent state by shaping, and will be described as an example of a configuration in which it can be straightened or further bent by pulling the outer operating wires 71, 72.

[0028] At least a pair of outer operating wires 71, 72 are provided inside the outer sheath 5 on an imaginary plane passing through the axis of the outer sheath 5. One inner operating wire 70, which will be described later, is provided inside the inner sheath 4 on an imaginary plane.

[0029] Regarding the above-mentioned "on a virtual plane," it is not limited to being arranged so that even the center line is completely aligned on the virtual plane, but it is sufficient that a portion of the inner operating wire 70 is on the virtual plane, taking into account manufacturing errors, etc. Regarding "one piece," when the inner operating wire 70 is composed of multiple twisted wires, the whole is counted as one piece. According to the above configuration, the amount of deformation of the outer sheath 5 caused by the outer operating wire and the amount of deformation of the inner sheath 4 caused by the inner operating wire 70 are added together, so that the amount of deformation of the entire sheath 3 can be maximized. When the inner operating wire 70 is assembled to the inner sheath 4 and the outer operating wires 71, 72 are assembled to the outer sheath 5, the operating direction of the outer sheath 5 and the inner sheath 4 can be determined.

[0030] 2, a fixing ring 5b is attached to the distal end 5a of the outer sheath 5. A tip end 71a of an outer operating wire 71 and a tip end 72a of an outer operating wire 72 are attached to the fixing ring 5b.

[0031] Since the fixing ring 5b is located radially outward of the fixing tip 41f provided at the distal end 4b of the inner sheath 4, the outer operating wires 71, 72 are more likely to apply a bending moment than the inner operating wire 70. For this reason, when bending the entire sheath 3, the outer operating wires 71, 72 are pulled.

[0032] For example, when orienting the sheath 3 when selecting a branched blood vessel, a guide wire (not shown) passed through the inner sheath 4 is used, but the movable mechanism of the outer sheath 5 using the outer operating wires 71, 72 can also be used when selecting a blood vessel. Therefore, the movable mechanism of the outer sheath 5 can improve blood vessel traversability.

[0033] Moreover, the outer sheath 5 according to this embodiment is formed into a bent shape. When the outer sheath 5 is formed into a bent shape, the movement (change in shape in the bending direction) is larger than that of the inner sheath 4, which is subjected to a smaller bending moment and has a smaller amount of bending, and therefore the shape can be intuitively understood under X-ray fluoroscopy.

[0034] As shown in Figure 4(b), in the initial state, the inner sheath 4 is formed into a bent state by shaping. While the inner sheath 4 is contained within the outer sheath 5, the inner sheath 4 is forcibly straightened as shown in Figure 4(a), so that the inner operating wire 70 provided inside the inner sheath 4 is not loosened and is in a state of tension.

[0035] The distal end 4b of the inner sheath 4 and the distal end 5a of the outer sheath 5 are each shaped in a predetermined bending direction so as to be bent in a natural state. The bending direction of the distal end 4b of the inner sheath 4 and the distal end 5a of the outer sheath 5 is the same.

[0036] According to the above configuration, since the inner sheath 4 and the outer sheath 5 are shaped, it is easier to maintain the bent state during deployment of the stent graft 2 (when it is exposed from the outer sheath 5), making it easier to release the stent graft 2 coaxially with the axis of the aortic arch 50.

[0037] Furthermore, since the inner sheath 4 and the outer sheath 5 are shaped, it is possible to reduce the range of motion of the inner operating wire 70 and the outer operating wires 71, 72 that pull them. As a result, it is possible to reduce the load applied to the inner operating wire 70 and the outer operating wires 71, 72 during pulling.

[0038] Therefore, the maximum tensile load of the inner operating wire 70 and the outer operating wires 71, 72 can be kept low, allowing them to be made thinner in diameter, and the inner sheath 4 and the outer sheath 5 that contain them to be made thinner. As a result, it is possible to ensure the arrangement space of the stent graft 2 and reduce the resistance during release and deployment, making it possible to load a larger stent graft 2.

[0039] The inner sheath 4 is configured to pass a guide wire (not shown), and the stent graft 2 is fixed to the outer periphery of the inner sheath 4. The diameter of the inner sheath 4 (the maximum diameter of a guide wire lumen portion 40 and an operating wire lumen portion 41 described later) is approximately 6 mm.

[0040] 1, a tip tip 12 is joined to the distal end 4b (more distal than a fixed tip 41f described later) of the inner sheath 4. The tip tip 12 protects the tip of the sheath 3 so as not to damage the blood vessel when the sheath 3 travels through the blood vessel. The tip tip 12 is not shown in FIGS. 4, 5, and 15.

[0041] As shown in FIG. 4, the inner sheath 4 is formed with a guidewire lumen portion 40 through which a guidewire (not shown) is passed, and an operating line lumen portion 41 through which the inner operating line 70 is passed. The operating line lumen section 41 has a low rigidity region (space 41c) having a lower rigidity than the guidewire lumen section 40, and is provided in parallel to the guidewire lumen section 40. The operating line lumen section 41 and the guidewire lumen section 40 according to this embodiment each have an inner diameter of 1.00 mm and an outer diameter of 1.25 mm.

[0042] A trigger wire lumen (not shown) through which a trigger wire (not shown) is passed may be further formed in the inner sheath 4. This trigger wire is attached to a knot of a wire (not shown) that fixes the stent graft 2 to the inner sheath 4, and when the stent graft 2 is detached from the inner sheath 4, the trigger wire is pulled and the knot is untied.

[0043] In addition, the space 41c, which is a portion without any object (tubular portions 41a and 41b), is given as an example of the "low rigidity region." In other words, the "low rigidity region" according to this embodiment includes the space 41c, and this space 41c belongs to the operating line lumen portion 41. However, the present invention is not limited to such a configuration. For example, the low rigidity region may be an area that corresponds to the object but has low rigidity because it is made of a material having a lower Young's modulus than the guidewire lumen portion 40. In other words, the inner operating wire 70 may be configured not to be exposed from the middle part of the inner sheath 4 (the operating wire lumen portion 41).

[0044] Furthermore, the term "lumen portion" is a concept that includes not only the inner cavity but also the portion that defines the inner cavity (the inner wall of the hole or the tubular body). The guidewire lumen portion 40 and the operating line lumen portion 41 are connected to each other by, specifically, heat fusion, adhesion, or the like.

[0045] According to the above configuration, by pulling the inner operating wire 70, the inner sheath 4 can be easily bent toward the operating wire lumen portion 41 having a low rigidity region (space 41c) lower in rigidity than the guidewire lumen portion 40.

[0046] The inner operating wire 70 is fixed to the distal end 41d (fixed tip 41f) of the operating wire lumen portion 41, which is shifted in a direction perpendicular to the axial direction of the guidewire lumen portion 40 at the distal end of the guidewire lumen portion 40. With this configuration, a bending moment can be applied to the guidewire lumen portion 40 when the inner operating wire 70 is pulled. Therefore, the inner sheath 4 can be bent with a simple configuration.

[0047] In this embodiment, a resin lumen portion 41 for an operating line having tubular portions 41a and 41b is joined to the side surface of the guidewire lumen portion 40. Note that the connection to the guidewire lumen portion 40 may be made stronger by using a metal material for the tubular portion 41b or by forming multiple lumens inside the wall thickness of one tube.

[0048] The operating line lumen portion 41 further includes high-rigidity regions (tubular portions 41a, 41b) having higher rigidity than the low-rigidity region (space 41c). The operating line lumen portion 41 has the high-rigidity regions (tubular portions 41a, 41b) and the low-rigidity regions (space 41c) alternately in the longitudinal direction.

[0049] According to the above configuration, the portion defining the operating wire lumen portion 41 through which the inner operating wire 70 passes has high rigidity regions (tubular portions 41a, 41b) and low rigidity regions (space 41c) alternately in the longitudinal direction, so that each portion in the longitudinal direction of the inner sheath 4 can be bent when the inner operating wire 70 is pulled. As a result, according to this configuration, the inner sheath 4 can be bent over a long range in the longitudinal direction, and the amount of bending can be increased.

[0050] More specifically, the operating line lumen portion 41 according to this embodiment is formed by a plurality of tubular portions 41a, 41b provided intermittently in the longitudinal direction. The high rigidity regions are the tubular portions 41a, 41b, and the low rigidity region is the space 41c between the adjacent tubular portions 41a, 41b. The "tubular portions 41a, 41b" include tubes and rings, and may be anything that defines a hole through which the inner operating wire 70 passes.

[0051] According to the above configuration, the low rigidity region is formed by the space 41c, so that when the inner sheath 4 is bent, interference between adjacent tubular portions 41a, 41b sandwiched between the space 41c is avoided, and the inner sheath 4 can be bent smoothly. In other words, the space 41c can suppress an increase in internal stress occurring as a restoring force in the operating line lumen portion 41 when the inner sheath 4 is bent.

[0052] The low-rigidity region (space 41c) is provided in a partial region on the distal end side of the retention device (stent graft 2) attached to the inner sheath 4. Specifically, the space 41c is formed at a position overlapping the distal end side of the stent graft 2 as shown in FIG.

[0053] According to the above configuration, a low rigidity region (space 41c) is provided in a portion of the tip side of the retention device (stent graft 2), making it easier to bend only that portion of the tip side of the stent graft 2, and allowing the stent graft 2 to be retained so as to follow the curved portion inside the body. Note that, in order to allow at least the distal end of the stent graft 2 to be bent, the space 41c may be provided so as to overlap a partial region of the distal end of the stent graft 2, but is not limited to such a configuration. For example, the space 41c may be provided over the entire longitudinal direction of the stent graft 2.

[0054] As shown in FIG. 3, it is preferable that a proximal end 41e of the low-rigidity region (space 41c) is disposed distal to a bending start position 4a of the shaped inner sheath 4. According to the above configuration, since the proximal end 41e of the low rigidity region (space 41c) is located proximal to the bending start position 4a of the formed shape, the shape formed in the operating wire lumen portion 41 having the space 41c can be further easily bent by pulling with the inner operating wire 70.

[0055] The distal end 41d of the operating line lumen portion 41 in this embodiment is provided with a fixing portion (fixed tip 41f) for fixing the tip portion 70a of the inner operating line 70, and the inner operating line 70 is welded to the fixed tip 41f. 4 shows a configuration in which the tip 70a of the inner operating wire 70 is connected (welded) to the fixed tip 41f in a state where it abuts against the fixed tip 41f, but the present invention is not limited to such a configuration. The tip 70a of the inner operating wire 70 may be welded in a state where it is aligned along the outer circumferential surface of the fixed tip 41f.

[0056] According to the above configuration, since the inner operating wire 70 is welded to the fixed tip 41f, the joining strength can be increased compared to a case in which the inner operating wire 70 is connected to the fixed tip 41f by, for example, crimping. This makes it possible to prevent the inner operating wire 70 from breaking off from the operating wire lumen portion 41 and coming off the inner sheath 4. It should be noted that if the inner operating wire 70 is joined to the fixed tip 41f by laser welding, arc welding, resistance welding or other welding, the joining strength is high and this is preferable, but the present invention is not limited to this configuration. For example, the inner operating wire 70 may be connected to the fixed chip 41f by soldering, heat fusion, adhesion with an adhesive, mechanical fastening (caulking), or the like.

[0057] A bending start position 4 a of the shaped shape of the inner sheath 4 is disposed distal to the connection portion 11 a of the pusher 11 . The pusher 11 according to this embodiment is formed in a cylindrical shape, has an inner diameter slightly larger than the outer diameter of the inner sheath 4 so as to cover the outer periphery of the inner sheath 4, and is assembled to the outer periphery of the inner sheath 4.

[0058] According to the above configuration, the bending start position 4a of the shaped configuration is located distal to the connection portion 11a of the pusher 11, so that the inner sheath 4 can be bent together with the stent graft 2, whose proximal movement is restricted by the pusher 11.

[0059] Furthermore, when the stent graft 2 is attached to the inner sheath 4, the proximal end 2c of the stent graft 2 is positioned proximal to the proximal end 41e of the low rigidity region (space 41c) and distal to the connection portion 11a of the pusher 11. The proximal end 41e of the low rigidity region (space 41c) means, when multiple spaces 41c are provided in the operating line lumen portion 41 as shown in Figure 4 for this embodiment, the proximal end 41e of the space 41c that is located most proximal among the multiple spaces 41c.

[0060] According to the above configuration, the proximal end 2c of the retention device (stent graft 2) is located proximal to the proximal end 41e of the low rigidity region (space 41c), thereby stabilizing the position of the proximal end 2c of the stent graft 2 in a position that is less likely to be deformed by traction by the inner operating wire 70. Furthermore, since the proximal end 2c of the stent graft 2 is located distal to the connection portion 11a of the pusher 11, the pusher 11 can restrict the movement of the stent graft 2 in the proximal direction.

[0061] Even if the inner sheath 4 is shaped in a bent state, when it is covered with the outer sheath 5, the biasing force (reaction force) from the inner wall of the outer sheath 5 restricts deformation in the bending direction. Then, as shown in Figure 5(b), when the outer sheath 5 is pulled proximally and the inner sheath 4 is exposed, the biasing force from the outer sheath 5 is eliminated, and the inner sheath 4 is bent to its shaped state (natural state). In this regard, since the inner sheath 4 and the outer sheath 5 according to this embodiment are shaped in the same direction, the difference between the radius of curvature at the distal end 5a of the outer sheath 5 and the radius of curvature at the distal end 4b of the inner sheath 4 is kept low. This makes it possible to prevent the distal end 4b of the inner sheath 4 exposed from the outer sheath 5 from moving outward in the bending direction. Therefore, the user can deploy the stent graft 2 with the inner sheath 4 aligned along the axis 50b, making it easier to determine the deployment position of the stent graft 2 before deployment.

[0062] In order to make it easier to determine the deployment position of the stent graft 2 before such deployment, it is preferable that the inner sheath 4 and the outer sheath 5 are shaped and bent in the same direction, but this configuration is not limited to this. For example, both the inner sheath 4 and the outer sheath 5 may be unshaped. Even in such a case, if the distal end portions 4b, 5a of the inner sheath 4 and the outer sheath 5 are inclined to a nearly straight line before the stent graft 2 is deployed, the user can predict from the linear inclination of the distal end portion 5a of the outer sheath 5 that the distal end portion 4b of the inner sheath 4 exposed when the outer sheath 5 is pulled proximally will have approximately the same inclination.

[0063] After the sheath 3 is inserted into the body, the position of the sheath 3 can be confirmed under X-ray fluoroscopy. The position of the sheath 3 in the aortic arch 50 can be determined by a method of aligning the position using an unillustrated radiography wire as a landmark, or by a method of naturally fitting the sheath 3 into the aortic arch 50 by using a pre-shaped structure (shaping).

[0064] In the state shown in Figure 2, i.e., in the state where the outer sheath 5 covers the proximal end 2c of the stent graft 2, there is no exit for the blood flow entering the stent graft 2, so the blood flow needs to be slowed or stopped. On the other hand, in this state, the position of the distal end 2d side of the stent graft 2 can be changed by changing the degree of bending of the inner sheath 4 with the inner operating wire 70. At the same time, the position of the proximal end 2c side of the stent graft 2 can be changed by changing the degree of bending of the outer sheath 5 with the outer operating wires 71, 72. That is, in this state, the positions of both ends of the stent graft 2 can be adjusted.

[0065] 3, that is, after the stent graft 2 is fully deployed, the blood flow can be secured because an outlet for the blood flow entering the stent graft 2 is formed between the proximal end 2c of the stent graft 2 and the pusher 11 and the outer sheath 5. In this state, the amount of bending of the distal end 2d of the stent graft 2 can be adjusted and the positioning can be performed by pulling or relaxing the inner operating wire 70.

[0066] Furthermore, the movable mechanism of the outer sheath 5 allows each portion of the stent graft 2 in the longitudinal direction to be deployed at a suitable position along the axis 50b. Specifically, as the outer sheath 5 moves proximally from a position where it completely covers the stent graft 2 to a position where it covers only the proximal end 2c of the stent graft 2 as shown in Figure 2, each longitudinal portion of the stent graft 2 can be deployed in a suitable position by pulling or relaxing the outer operating wires 71, 72.

[0067] As shown in Figure 6, a tensile test was conducted using five samples of the outer sheaths 5. When the tensile length of the outer operating wires 71, 72 was about 20 mm, a load of about 15 N was applied to the outer sheath 5. When the stent graft 2 is placed inside the outer sheath 5, an additional load of about 4 N to about 5 N is applied. When the tensile length of the inner operating wire 70 was about 5 mm, a load of about 10 N to about 20 N was applied.

[0068] 4(a), the axial length of the space 41c is A, the axial length of the tubular portion 41b is B, and the length from the proximal end 41e of the plurality of spaces 41c (the distal end of the tubular portion 41a) to the distal end 41d of the operating line lumen portion 41 is C. Note that C is equal to the bending length when the inner operating line 70 is pulled.

[0069] When the target value of the curvature radius of the inner sheath 4 after the inner operating wire 70 is pulled is set to 30 mm to 40 mm (a value that follows the shape of the aortic arch 50), the bending length C may be 65 mm.

[0070] The traction force of the inner operating wire 70 according to this embodiment is not less than 8 N and not more than 20 N when the pulled length is 5 mm. More specifically, it is preferable that the ratio of the longitudinal length of each space 41c to the longitudinal length of each tubular portion 41b (value A / B) shown in FIG. 7 is in the range of 1 or more and 3 or less, and the traction force is in the above range. By pulling the inner operating wire 70 with a force of 8 N or more and 20 N or less, the placement position of the stent graft 2 can be finely adjusted. According to Figure 7, it can be seen that when the longitudinal length of each space 41c is at least one time the longitudinal length of each tubular portion 41b (when the value of A / B is 1 or more), the inner sheath 4 can be bent with less force.

[0071] If the ratio of the length of the space 41c to the length of the tubular portion 41b is too small, the vertical load applied from the inner operating wire 70 to the operating wire lumen portion 41 when the inner sheath 4 is bent will become large, and the joint between the guidewire lumen portion 40 and the operating wire lumen portion 41 will peel off.

[0072] Within the above numerical range, the inner sheath 4 can be easily bent, and as shown in FIG. 7, the tensile load applied by the inner operating wire 70 when bending the inner sheath 4 can be reduced. In addition, as shown in Figure 7, it was suggested that the larger the A / B ratio (the shorter the distance ratio of the resin part), the more likely it is that bending can be achieved with a smaller traction force.

[0073] [About the operation mechanism] Next, the operating mechanism 15 for bending the inner sheath 4 and the outer sheath 5 will be described with reference to Fig. 8. Fig. 8 is a schematic diagram showing the operating mechanism 15 including a bobbin 30 for an inner operating line and a bobbin 31 for an outer operating line.

[0074] The delivery device 1 further includes an operation section (operation handle 20) that is operated by a user when the outer sheath 5 is pulled proximally relative to the inner sheath 4 to deploy the retention device (stent graft 2). The operating handle 20 is attached to the outer sheath 5 and is attached to the inner sheath 4 so as to be slidable in the axial direction. The operating handle 20 is provided with an inner operating wire bobbin 30 around which the inner operating wire 70 can be wound and pulled out, and an outer operating wire bobbin 31 around which the outer operating wire 71 can be wound and pulled out.

[0075] In other words, the operating handle 20 is used both when moving the outer sheath 5 to the proximal side and when bending the inner sheath 4 and the outer sheath 5. An inner operating wire 70 and an outer operating wire 71 are passed through the inside of the operating handle 20 and wound around a bobbin 30 for the inner operating wire and a bobbin 31 for the outer operating wire.

[0076] According to the above configuration, since the bobbin 30 for the inner operating line is provided on the operating handle 20, the inner operating line 70 can be wound around the bobbin 30 for the inner operating line simultaneously with, or continuously with, the operation of pulling the outer sheath 5 proximally relative to the inner sheath 4 to deploy the stent graft 2. Furthermore, since the outer operating line bobbin 31 is provided on the operating handle 20, the pulling force of the outer sheath 5 can be maintained when the outer sheath 5 is pulled proximally relative to the inner sheath 4.

[0077] When the user retracts the outer sheath 5 proximally to release the stent graft 2, the portion of the inner operating wire 70 that has been wound in advance around the inner operating wire bobbin 30 is pulled out and caused to follow. The inner operating wire 70 pulled out from the inner operating wire bobbin 30 is disposed between the outer sheath 5 and the pusher 11.

[0078] In addition, in the operating handle 20 according to the present embodiment, a configuration is described in which only one pair is provided: the outer operating wire 71 and the outer operating wire bobbin 31. However, the operating handle 20 according to the present invention is not limited to such a configuration, and may further include an outer operating wire 72 provided on the radially opposite side of the outer operating wire 71, and an outer operating wire bobbin 31 that can be wound around and pulled out from the outer operating wire 72.

[0079] <First Modification> 8, that is, in the case where the inner operating wire 70 is pulled out from the inner operating wire bobbin 30 to the distal side, it is necessary to prevent a force pulling the inner operating wire 70 from being generated from the inner operating wire bobbin 30 when the operating handle 20 is moved to the proximal side to deploy the stent graft 2, thereby preventing a change in the angle of the inner sheath 4. For this reason, it was necessary to wind the inner operating wire 70 around the inner operating wire bobbin 30 in the initial state, so that the inner operating wire 70 can be pulled out from the inner operating wire bobbin 30. Next, an operation mechanism 16 according to a first modified example will be described with reference to Fig. 9. Fig. 9 is a schematic diagram showing an operation mechanism 16 including a folded bobbin 32 according to a first modified example.

[0080] The transport device 1 further includes a folded portion (folded bobbin 32) that slidably supports the inner operating wire . The folded bobbin 32 is disposed proximal to the inner operating line bobbin 30 . The inner operating wire 70 is pulled out proximally from the inner operating wire bobbin 30 and folded back by the fold-back bobbin 32, and the tip portion 70a of the inner operating wire 70 is fixed to the distal end portion 41d of the inner sheath 4 (operating wire lumen portion 41) as shown in Figure 4(a).

[0081] The folded bobbin 32 as the folded portion according to this embodiment is formed in a cylindrical shape and is rotatably attached to a base 33 fixed to the outer periphery of the pusher 11. The folded portion according to the present invention is not limited to the cylindrical folded bobbin 32, and may have a polygonal cross section. Furthermore, the part of the folded portion that comes into contact with the inner operating wire 70 may be knurled to provide an anti-slip treatment.

[0082] According to the above configuration, since a folded portion (folded bobbin 32) is provided, the inner operating wire 70 can be extended proximally from the inner operating wire bobbin 30, so that the operating handle 20 can be moved smoothly when moved proximally to deploy the stent graft 2.

[0083] According to the configuration of this embodiment, the inner operating wire 70 is folded back from the proximal side by the folded-back bobbin 32 and connected to the inner operating wire bobbin 30, so that even when the operating handle 20 is moved to the proximal side, no force pulling the inner operating wire 70 is generated from the inner operating wire bobbin 30. Therefore, it is no longer necessary to wind the inner operating wire 70 around the inner operating wire bobbin 30 in the initial state, making it easier to assemble the device.

[0084] When the operating handle 20 is moved proximally, the inner operating wire 70 becomes loose between the folded-back bobbin 32 and the inner operating wire bobbin 30. Therefore, after the stent graft 2 is deployed and released, the user can rotate the inner operating wire bobbin 30 to wind up the inner operating wire 70.

[0085] <Second Modification> Next, an operation mechanism 17 according to a second modified example will be described with reference to FIGS. Figure 10(a) is a schematic diagram showing an operating mechanism 17 having a gear-shaped inner operating line bobbin 34 and an outer operating line bobbin 35 in a second modified example, and Figure 10(b) is an enlarged view of the XB portion shown in Figure 10(a). FIG. 11 is a schematic diagram of the operating mechanism 17 according to the second modified example, seen from the bottom, showing a state in which the inner operating line bobbin 34 and the outer operating line bobbin 35 are engaged with each other. FIG. 12 is a schematic diagram of the operating mechanism 17 according to the second modified example, seen from the bottom, illustrating a state in which the inner operating line bobbin 34 and the outer operating line bobbin 35 are separated from each other.

[0086] The transport device 1 includes a slack adjustment mechanism 8 that winds and pulls out the inner operating wire 70 onto the inner operating wire bobbin 30 according to the moving position of the operating section (operating handle 20) toward the proximal side. The slack adjustment mechanism 8 is constituted by the rack portion 11b and the inside operating line bobbin 34, and will be described in detail later. According to the above configuration, the slack adjustment mechanism 8 can prevent the inner operating wire 70 from slackening when the operating handle 20 is moved proximally.

[0087] The delivery device 1 further includes a pressing member (pusher 11) that restricts the indwelling device (stent graft 2) from moving in the proximal direction. The inner operating line bobbin 34 is formed in a gear shape having teeth 34a on its outer periphery. At least a portion of the pusher 11 is disposed between the inner sheath 4 and the operating portion (operating handle 20) in the radial direction. The pusher 11 has a rack portion 11b extending in the near and far directions. The rack portion 11b and the inner operating line bobbin 34 are engaged with each other, thereby functioning as the slack adjustment mechanism 8.

[0088] According to the above configuration, when the operating handle 20 is moved proximally to deploy the stent graft 2, the inner operating line bobbin 34 (its teeth 34a) is rotated to engage with the rack portion 11b, thereby automatically winding the inner operating line 70 around the inner operating line bobbin 34. The slack adjustment mechanism 8 is not limited to one constituted by the inner operating wire bobbin 34 and the rack portion 11b, and may be any configuration that allows the inner operating wire 70 to be wound around or pulled out from the inner operating wire bobbin 34. For example, it may be one constituted by a drum and a leaf spring, such as a spring, that utilizes the elastic restoring force of the spring to pull or release the inner operating wire 70.

[0089] 11, the pressing member (pusher 11) may be formed with a through hole 11c that connects the outer space of the inner sheath 4 with the inner space of the operating portion (operating handle 20) in the radial direction. The inner operating wire 70 is passed through the through hole 11c. Specifically, the through hole 11c is formed on the side of the pusher 11 facing the inner operating wire 70, and is formed long along the extension direction of the pusher 11.

[0090] 10, if the rack portion 11b of the pusher 11 and the teeth 34a of the inner operating line bobbin 34 are engaged with each other, when the operating handle 20 is moved proximally together with the outer sheath 5, the rack portion 11b rotates the inner operating line bobbin 34 counterclockwise in FIG. 10. For this reason, it is possible to automatically wind the inner operating line 70 around the inner operating line bobbin 34.

[0091] On the other hand, in such a configuration in which the rack portion 11b and the teeth 34a of the bobbin 34 for the inner operating line do not mesh with each other, when the operating handle 20 is moved proximally, the inner operating line 70 becomes loose between the bobbin 34 for the inner operating line and the folded-back bobbin 32, causing a problem in that the inner sheath 4 and the pusher 11 are hindered from being positioned. Therefore, by forming a through hole 11c in the pusher 11 described above as shown in Figure 11, the through hole 11c allows the inner operating wire 70, which is brought out of the inner sheath 4 and attached to the operating handle 20, to loosen, and the inner operating wire 70 can be prevented from being obstructed by the inner sheath 4 and the pusher 11.

[0092] The inner operating line bobbin 34 and the outer operating line bobbin 35 are each formed in a gear shape with teeth 34a, 35a on the outer periphery. An inner operating line bobbin 34 and an outer operating line bobbin 35 are arranged so as to be able to mesh with each other. According to the above configuration, by simply operating either the inner operating line bobbin 34 or the outer operating line bobbin 35, both operating lines (the inner operating line 70 and the outer operating line 71) can be pulled and loosened.

[0093] In this embodiment, as shown in FIG. 11, the inside operating line bobbin 34 is provided with an operating lever 34b that protrudes to the outside from the operating handle 20 via a connecting member 34c.

[0094] As shown in FIG. 12, the inner operating line bobbin 34 and the outer operating line bobbin 35 are arranged to be movable from an engaged position to a disengaged position. 11 and 12, the outer operating line bobbin 35 is connected to an operating lever 34b provided outside the operating handle 20 via a rod-shaped connecting member 34c. In particular, the connecting member 34c is fixed to the inner operating line bobbin 34 and the operating lever 34b, and is configured to be able to transmit rotational torque.

[0095] When the user pulls the operating lever 34b in a direction away from the operating handle 20, the bobbin 34 for the inner operating line can be moved from the engaged position shown by the dotted line in Figure 12 to the disengaged position shown by the solid line, thereby disengaging it from the bobbin 35 for the outer operating line. According to the above configuration, by disengaging the inner operating line bobbin 34 and the outer operating line bobbin 35, the inner operating line bobbin 34 and the outer operating line bobbin 35 can be operated individually.

[0096] In this embodiment, before the stent graft 2 is deployed, the bobbin 34 for the inner operating line is in a position where it is not engaged with the rack portion 11b, and is engaged with the bobbin 35 for the outer operating line (see Figure 11).

[0097] Therefore, before the stent graft 2 is deployed, the position of the stent graft 2 provided inside the outer sheath 5 can be adjusted by moving the distal end portion 5a of the outer sheath 5. When the operating lever 34b is rotated counterclockwise in Fig. 10 (the winding direction of the inner operating line bobbin 34), the outer operating line 71 of the outer sheath 5 is wound around the outer operating line bobbin 35, and the inner operating line 70 of the inner sheath 4 is wound around the inner operating line bobbin 34. This generates tension in both the inner operating line 70 and the outer operating line 71, allowing the stent graft 2 to be moved smoothly.

[0098] 10 (the direction in which the inner operating line bobbin 34 is pulled out), the outer operating line 71 of the outer sheath 5 is pulled out from the outer operating line bobbin 35, and the inner operating line 70 of the inner sheath 4 is pulled out from the inner operating line bobbin 34. This reduces the tension of both the inner operating line 70 and the outer operating line 71, allowing the stent graft 2 to be returned to its original position.

[0099] When the stent graft 2 is deployed, that is, when the outer sheath 5 is pulled relative to the inner sheath 4, as shown in Fig. 12, the operating lever 34b is pulled out from the operating handle 20 to release the meshing between the inner operating line bobbin 34 and the outer operating line bobbin 35. At this time, as shown in Fig. 10, the teeth 34a of the inner operating line bobbin 34 mesh with the rack portion 11b. In this manner, as described above, by moving the operating handle 20 equipped with the bobbin 34 for the inner operating line proximally, the rack portion 11b rotates the bobbin 34 for the inner operating line counterclockwise (winding direction), making it possible to automatically wind the inner operating line 70 around the bobbin 34 for the inner operating line.

[0100] 12, the user can adjust the degree of bending of the distal end portion 4b of the inner sheath 4 by rotating the operation lever 34b clockwise or counterclockwise. This operation is performed after the stent graft 2 is deployed, including after the stent graft 2 is released. The stent graft 2 is released by pulling a trigger wire (not shown) to untie the knot of the stent graft 2 to the inner sheath 4.

[0101] After releasing the stent graft 2, the user moves the operating handle 20 distally relative to the pusher 11, and returns the outer sheath 5 connected to the operating handle 20 to a position where it abuts against the distal tip 12, thereby storing the inner sheath 4. At this time, the operating lever 34b may be operated to bring the teeth 34a of the inner operating line bobbin 34 into engagement with the rack portion 11b of the pusher 11. In this way, as the operating handle 20 moves distally, the inner operating line bobbin 34 rotates clockwise (in the pulling-out direction) in FIG. 10, and the inner operating line 70 can be pulled out from the inner operating line bobbin 34 without tension being generated in the inner operating line 70.

[0102] <Third Modification> Next, an operation mechanism 18 according to a third modified example will be described with reference mainly to Fig. 13. Fig. 13 is a schematic diagram showing an operation mechanism 18 including a cable guide 36 according to the third modified example.

[0103] As shown in FIG. 13, the delivery device 1 further includes an operating wire guiding portion (cable guide 36) that covers the radially outer side of a portion of the proximal side of the inner operating wire 70 and extends over a long length. The cable guide 36 is disposed outside the outer sheath 5 and the inner sheath 4. The cable guide 36 according to the present embodiment is located proximal to the outer sheath 5 and radially outward from the inner sheath 4, and is provided on the pusher 11.

[0104] The cable guide 36 according to this embodiment connects the inner operating line bobbin 30 and the folded-back bobbin 32, forms a path through which the inner operating line 70 passes, and restricts the inner operating line 70 from bending radially outward. In this embodiment, the cable guide 36 is formed of a plurality of cylindrical rings 36a arranged in a row to form the path. The rings 36a are attached to the side surface of the pusher 11. According to the above configuration, the cable guide 36 is provided, so that the inner operating wire 70 can be restricted from bending radially outward.

[0105] Furthermore, the operating wire guiding portion according to the present invention only needs to be able to restrict bending of the inner operating wire 70 radially outward, and may be formed in a tubular shape or may be a lumen provided in the pusher 11. In particular, when formed in a tubular shape, it is preferable that the operating wire guiding portion is axially expandable and contractible, such as a bellows, since it can deform following the movement of the operating handle 20 in the approach and retract directions and does not impede the movement of the operating handle 20.

[0106] <Fourth Modification> Next, an operation mechanism 19 according to a fourth modified example will be described with reference to Fig. 14. Fig. 14 is a schematic diagram showing an operation mechanism 19 including an inner sheath operation handle 21 and an outer sheath operation handle 22 according to the fourth modified example.

[0107] As shown in FIG. 14, the delivery device 1 further includes an outer sheath operating part (outer sheath operating handle 22) that is operated by the user when pulling the outer sheath 5 proximally relative to the inner sheath 4 to deploy the retention device (stent graft 2), and an inner sheath operating part (inner sheath operating handle 21) that is provided separately from the outer sheath operating handle 22 and is directly or indirectly attached to the inner sheath. The inner sheath operating handle 21 is provided with an inner operating wire bobbin 30 around which the inner operating wire 70 can be wound and pulled out.

[0108] The inner sheath manipulating handle 21 according to this embodiment is indirectly attached to the inner sheath 4 via the pusher 11, but is not limited to this configuration and may be directly attached to the inner sheath 4.

[0109] According to the above configuration, since the inner sheath operating handle 21 and the outer sheath operating handle 22 are provided separately, there is no effect on the pulling of the inner operating wire 70 by the inner sheath operating handle 21 when the outer sheath operating handle 22 is pulled proximally.

[0110] It is not necessary for the various components according to the present invention to exist independently of one another. It is acceptable for multiple components to be formed as one member, for one component to be formed from multiple members, for one component to be a part of another component, or for part of one component to overlap with part of another component.

[0111] The above embodiment encompasses the following technical ideas. (1) A medical indwelling device delivery device for delivering an indwelling device into a body, comprising: a long inner sheath around which the indwelling device is disposed when the indwelling device is delivered; an outer sheath that covers the radial outside of the inner sheath and is configured to be slidable in the axial direction relative to the inner sheath, covering the outer periphery of the retention device when the retention device is transported and exposing the retention device by sliding toward the proximal side in the axial direction relative to the inner sheath; an inner operating wire having a tip portion connected to a distal end portion of the inner sheath, disposed in an axial direction of the inner sheath, and bent by being pulled proximally; an outer operating wire having a tip portion connected to a distal end portion of the outer sheath, disposed in an axial direction of the outer sheath, and bent by being pulled proximally; A medical indwelling device delivery device comprising: (2) At least a pair of the outer operating wires is provided in the outer sheath on a virtual plane passing through an axis of the outer sheath, The medical indwelling device delivery device according to (1), wherein the inner operating wire is disposed as a single wire on the imaginary plane within the inner sheath. (3) The medical retention device delivery device according to (1) or (2), wherein the distal end of the inner sheath and the distal end of the outer sheath are each shaped in a predetermined bending direction so as to be bent in a natural state, and the bending direction of the distal end of the inner sheath and the distal end of the outer sheath are the same. (4) The device further includes an operation unit that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device, the operating portion is attached to the outer sheath and is attached to be slidable in the axial direction relative to the inner sheath, The medical indwelling device delivery device according to any one of (1) to (3), wherein the operation section is provided with an inner operating wire bobbin that can be wound around and pulled out from the inner operating wire. (5) A folded portion that slidably supports the inner operating wire is further provided, The folded portion is disposed proximal to the inner operating line bobbin, The medical retention device delivery device according to (4), wherein the inner operating wire is pulled out from the inner operating wire bobbin to the proximal side and folded back at the folded back portion, and the tip end of the inner operating wire is fixed to the distal end of the inner sheath. (6) The medical indwelling device delivery device according to (4) or (5), further comprising a slack adjustment mechanism that winds and pulls out the inner operating wire around the inner operating wire bobbin depending on the proximal movement position of the operating part. (7) The device further includes a pressing member for restricting the indwelling device from moving in the proximal direction, The inner operating line bobbin is formed in a gear shape having teeth on an outer periphery, The pressing member has a rack portion extending in the near and far direction, The medical indwelling device delivery device according to (6), wherein the rack portion and the inner operating line bobbin are engaged with each other, thereby functioning as the slack adjustment mechanism. (8) The device further includes a pressing member for restricting the indwelling device from moving in the proximal direction, At least a portion of the pressing member is disposed between the inner sheath and the operating portion in the radial direction, a through hole is formed in the pressing member to radially communicate a space outside the inner sheath with a space inside the operation portion, The medical indwelling device delivery device according to any one of (4) to (7), wherein the inner operating wire is passed through the through hole. (9) The device further includes an operation unit that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device, the operating portion is attached to the outer sheath and is attached to be slidable in the axial direction relative to the inner sheath, The medical indwelling device delivery device according to any one of (1) to (8), wherein the operating section is provided with an outer operating wire bobbin that can be wound around and pulled out from the outer operating wire. (10) Each of the inner operating line bobbin and the outer operating line bobbin is formed in a gear shape having teeth on an outer periphery, The medical indwelling device delivery device according to (9) which cites (4), wherein the inner operating wire bobbin and the outer operating wire bobbin are arranged so as to be meshable with each other. (11) The medical indwelling device delivery device according to (10), wherein the inner operating line bobbin and the outer operating line bobbin are arranged to be movable from an engaged position to a disengaged position. (12) Further comprising an operating wire guide portion extending long and covering a radially outer side of a part of a proximal side of the inner operating wire, The medical indwelling device delivery device according to any one of (1) to (11), wherein the operating wire guide portion is disposed outside the outer sheath and the inner sheath. (13) an outer sheath operation section that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device; An inner sheath operating part provided separately from the outer sheath operating part and directly or indirectly attached to the inner sheath, The medical indwelling device delivery device according to any one of (1) to (3), wherein the inner sheath operation section is provided with an inner operating wire bobbin that can be wound around and pulled out from the inner operating wire. (14) The indwelling device is a stent graft, and the medical indwelling device delivery device is for placing the stent graft in the aortic arch, The medical indwelling device delivery device according to any one of (1) to (13), wherein the traction force of the inner operating wire is 8 N or more and 20 N or less when the tensile length is 5 mm. (15) A medical indwelling device delivery device according to any one of (1) to (14), the indwelling device attached to the inner sheath. [Explanation of symbols]

[0112] 1S Stent graft delivery device (medical device delivery device with indwelling device) 1. Transport device (medical indwelling device transport device) 2. Stent graft (insertion device) 2a Stent section 2b Graft section 2c Proximal end 2d Distal end 3 Sheath 4 Inner sheath 4a Bending start position 4b Distal end 5 Outer sheath 5a Distal end 5b Fixing ring 8. Slack adjustment mechanism 11 Pusher (holding member) 11a Connection 11b Rack section 11c through hole 12 Tip 15, 16, 17, 18, 19 Operating mechanism 20 Operation handle (operation part) 21 Inner sheath operating handle (inner sheath operating part) 22 Outer sheath operating handle (outer sheath operating part) 30 Inner operating line bobbin 31 Outer operating line bobbin 32 Turned bobbin (turned part) 33 Base 34 Inner operating line bobbin 34a Teeth 34b Operating lever 34c Connecting member 35 Outer operating line bobbin 35a Teeth 36 Cable guide (operating line guide part) 36a Ring 40 Guidewire lumen portion (rigid portion) 41 Lumen section for operating line 41a, 41b Tubular part (high rigidity area) 41c Space (low rigidity area) 41d Distal end 41e Proximal end 41f Fixed Chip 50 Aortic arch (body canal) 50a inner wall 50b axis 51 Descending aorta (body duct) 55 Aortic aneurysm 70 Inner operating line 70a Tip 71, 72 Outer operating line 71a, 72a tip 400 Inner sheath 500 outer sheath

Claims

1. A medical indwelling device delivery device for delivering an indwelling device into a body, comprising: a long inner sheath around which the indwelling device is disposed when the indwelling device is delivered; an outer sheath that covers the radial outside of the inner sheath and is configured to be slidable in the axial direction relative to the inner sheath, covering the outer periphery of the retention device when the retention device is transported and exposing the retention device by sliding toward the proximal side in the axial direction relative to the inner sheath; an inner operating wire having a tip portion connected to a distal end portion of the inner sheath, disposed in an axial direction of the inner sheath, and bent by being pulled proximally; an outer operating wire having a tip portion connected to a distal end portion of the outer sheath, disposed in an axial direction of the outer sheath, and bent by being pulled proximally; A medical indwelling device delivery device comprising:

2. At least a pair of the outer operating wires is provided in the outer sheath on a virtual plane passing through an axis of the outer sheath, The medical indwelling device delivery device according to claim 1, wherein the inner operating wire is disposed on the imaginary plane within the inner sheath.

3. 3. The medical indwelling device delivery device according to claim 1, wherein the distal end of the inner sheath and the distal end of the outer sheath are each shaped in a predetermined bending direction so as to be bent in a natural state, and the bending direction of the distal end of the inner sheath and the distal end of the outer sheath are the same.

4. The device further includes an operation unit that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device, the operating portion is attached to the outer sheath and is attached to be slidable in the axial direction relative to the inner sheath, 4. The medical indwelling device delivery device according to claim 1, wherein the operation section is provided with an inner operating wire bobbin that can be wound around and pulled out from the inner operating wire.

5. A folded portion that slidably supports the inner operating wire is further provided, The folded portion is disposed proximal to the inner operating line bobbin, 5. The medical indwelling device delivery device according to claim 4, wherein the inner operating wire is pulled out from the inner operating wire bobbin to the proximal side and folded back at the folded back portion, and the tip portion of the inner operating wire is fixed to the distal end portion of the inner sheath.

6. 6. The medical indwelling device delivery device according to claim 4, further comprising a slack adjustment mechanism for winding and unwinding the inner operating wire onto the inner operating wire bobbin in accordance with a proximal moving position of the operating part.

7. The device further includes a pressing member for restricting the indwelling device from moving in the proximal direction, The inner operating line bobbin is formed in a gear shape having teeth on an outer periphery, The pressing member has a rack portion extending in the near and far direction, The medical indwelling device delivery device according to claim 6, wherein the rack portion and the inner operating line bobbin are engaged with each other, thereby functioning as the slack adjustment mechanism.

8. The device further includes a pressing member for restricting the indwelling device from moving in the proximal direction, At least a portion of the pressing member is disposed between the inner sheath and the operating portion in the radial direction, a through hole is formed in the pressing member to radially communicate a space outside the inner sheath with a space inside the operation portion, The medical indwelling device delivery device according to any one of claims 4 to 7, wherein the inner operating wire is passed through the through hole.

9. The device further includes an operation unit that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device, the operating portion is attached to the outer sheath and is attached to be slidable in the axial direction relative to the inner sheath, The medical indwelling device delivery device according to any one of claims 1 to 8, wherein the operating section is provided with an outer operating wire bobbin that can be wound around and pulled out from the outer operating wire.

10. Each of the inner operating line bobbin and the outer operating line bobbin is formed in a gear shape having teeth on an outer periphery, The medical indwelling device delivery device according to claim 9, which depends on claim 4, wherein the inner operating line bobbin and the outer operating line bobbin are disposed so as to be engageable with each other.

11. The medical indwelling device delivery device according to claim 10, wherein the inner operating line bobbin and the outer operating line bobbin are arranged to be movable from an engaged position to a disengaged position.

12. Further comprising an operating wire guide portion extending long and covering a radially outer side of a part of a proximal side of the inner operating wire, The medical indwelling device delivery device according to any one of claims 1 to 11, wherein the operating wire guide portion is disposed outside the outer sheath and the inner sheath.

13. an outer sheath operation section that is operated by a user when the outer sheath is pulled proximally relative to the inner sheath to deploy the indwelling device; An inner sheath operating part provided separately from the outer sheath operating part and directly or indirectly attached to the inner sheath, 4. The medical indwelling device delivery device according to claim 1, wherein the inner sheath operation section is provided with an inner operating wire bobbin that can be wound around and pulled out from the inner operating wire.

14. The indwelling device is a stent graft, and the medical indwelling device delivery device is for placing the stent graft in the aortic arch, 14. The medical indwelling device delivery device according to claim 1, wherein the traction force of the inner operating wire is 8 N or more and 20 N or less when the tensile length is 5 mm.

15. The medical indwelling device delivery device according to any one of claims 1 to 14, the indwelling device attached to the inner sheath.

Images