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 smoothly bending a sheath along body tubes with different shapes, and a medical indwelling instrument delivery device with an indwelling instrument.SOLUTION: A delivery device includes: an inner sheath 4 to which a stent graft is attached; an outer sheath covering a radially outer side of the inner sheath 4 and configured to be slidable in an axial direction with respect to the inner sheath 4; and an operating line 7 including a tip 7a connected to a distal end 41d of the inner sheath 4 and bending the inner sheath 4 by being pulled to a proximal side. The inner sheath 4 is shaped to be bent in a natural state. The operating line 7 is disposed inward in the bending direction of the inner sheath 4. The operating line 7 is connected to the inner sheath 4 such that when the inner sheath 4 is linearly deformed, it is in a tensioned state and when the inner sheath 4 is in the natural state, it retains the stretched state.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, so when placing the indwelling device, it is difficult to adjust the sheath to an appropriate shape when there are various curved shapes in the human body tract. Furthermore, the sheath in the same document only follows the guide sheath, so there is room for improvement in operability when adjusting the sheath shape.

[0006] The present invention has been made in consideration of the above-mentioned problems, and provides a medical indwelling device delivery device that is capable of smoothly bending a sheath along body tubes of different shapes, and a medical indwelling device delivery device with an indwelling device. [Means for solving the problem]

[0007] The medical indwelling device delivery device of the present invention is a medical indwelling device delivery device for delivering an indwelling device into a body, comprising: a long inner sheath to which the indwelling device is attached when the indwelling device is delivered; an outer sheath covering the radial outside of the inner sheath and configured to be axially slidable relative to the inner sheath, covering the outer periphery of the indwelling device when the indwelling device is delivered and exposing the indwelling device when the indwelling device is indwelled; and an operating wire having a tip end connected to a distal end of the inner sheath and disposed in the axial direction of the inner sheath, and bending the inner sheath when pulled proximally, wherein the inner sheath is shaped to be bent in a natural state, and the operating wire is disposed on the inside of the inner sheath in the bending direction, and is connected to the inner sheath so as to be in a tensioned state when the inner sheath is linearly deformed and to maintain an extended state when the inner sheath is in the natural state.

[0008] 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

[0009] According to the medical indwelling device delivery device and the medical indwelling device delivery device with an indwelling device of the present invention, when the inner sheath is further bent from its natural state by pulling the operating wire, the operating gap is eliminated and the inner sheath can be smoothly bent along the body canal. [Brief description of the drawings]

[0010] [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] 1A is a schematic diagram showing the inner sheath in a straight state, FIG. 1B is a schematic diagram showing the inner sheath in a bent state which is a natural state, and FIG. 1C is a schematic diagram showing the inner sheath in a state in which the operating wire is pulled. [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] 13 is a diagram showing the maximum tensile load of the operating wire required to bend the tip portion by 180 degrees for inner sheaths having different space lengths and tubular portion lengths. FIG. [Figure 6] 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 7] FIG. 2 is a schematic diagram showing an inner sheath covered with a cover film. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] 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).

[0012] <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. 1 and 2. FIG. 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). Figure 2(a) is a schematic diagram showing the inner sheath 4 in a straight state, Figure 2(b) is a schematic diagram showing the inner sheath 4 in a bent state, which is its natural state, and Figure 2(c) is a schematic diagram showing the inner sheath 4 in a state in which the operating wire 7 is pulled. In FIG. 1, the inner sheath 4 shown in FIG. 2 is shown in a simplified form.

[0013] 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 comprises a long inner sheath 4 to which the stent graft 2 is attached 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 axially slidable relative to the inner sheath 4, covers the outer periphery of the stent graft 2 when the stent graft 2 is delivered and exposes the stent graft 2 when the stent graft 2 is placed, and an operating wire 7 whose tip end 7a is connected to the distal end 41d of the inner sheath 4, is arranged in the axial direction of the inner sheath 4, and is pulled proximally to bend the inner sheath 4. The inner sheath 4 is shaped as shown in FIG. 2(b) so as to be bent in its natural state. As shown in Fig. 2, the operating wire 7 is disposed on the inside in the bending direction of the inner sheath 4 (the inner peripheral side of the inner sheath 4 in the bent state). The operating wire 7 is in a state in which tension is generated when the inner sheath 4 is linearly deformed (in the state shown in Fig. 2(a)). The operating wire 7 is connected to the inner sheath 4 so that the extended state (a state in which tension is applied or the operating wire 7 is straight even when no tension is applied) is maintained when the inner sheath 4 is in its natural state (in the state shown in Fig. 2(b)).

[0014] The delivery device 1 having the above configuration can bend the inner sheath 4 together with the stent graft 2 by pulling the operating wire 7, even in a state in which the stent graft 2 is deployed and placed (the outer sheath 5 is retracted relatively to the inner sheath 4). In other words, the stent graft 2 can be kept in a bent state until just before it is completely deployed.

[0015] In addition, after the inner sheath 4 is linearly deformed as shown in Fig. 2(a) by the force from the outer sheath 5, when this force is released, the inner sheath 4 returns to its natural shape as shown in Fig. 2(b). Even when the inner sheath 4 has returned to its natural shape, the operating wire 7 is attached to the inner sheath 4 so as not to become loose. In other words, the operating wire 7 is attached to the inner sheath 4 so as to be in an extended state when the inner sheath 4 is in the shaped bent state.

[0016] 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. Moreover, the "inner side of the bending direction" of the inner sheath 4 is not limited to being completely in the same direction as the bending direction, but may be any direction as long as it includes an inner component. Furthermore, in this specification, the term "bend" refers not only to a "curve" that is a gentle bend, but also to a sharp bend.

[0017] According to the above configuration, since the inner sheath 4 is naturally bent due to shaping, the operating wire 7 may be pulled by an amount corresponding to the difference in curvature of the body lumen (aortic arch 50) which varies among individuals, thereby additionally bending the inner sheath 4. Therefore, it is easy to control the degree of bending of the inner sheath 4 to match the shape of the aortic arch 50. In particular, since the operating wire 7 is in an extended state when the inner sheath 4 is in its natural bent state, when the operating wire 7 is pulled to further bend the inner sheath 4 from its natural bent state, an operating gap is eliminated and the inner sheath 4 can be bent smoothly.

[0018] When the inner sheath 4 is in a bent state (the state shown in FIG. 2(b)) compared with when the inner sheath 4 is in a straight state (the state shown in FIG. 2(a)), the length of the operating wire lumen portion 41 supporting the operating wire 7 on the inner side in the bending direction becomes shorter. For example, if the operating wire 7 is assembled with the inner sheath 4 straightened and no tension is applied to the operating wire 7 in this state, slack will occur in the operating wire 7 when the inner sheath 4 is bent (the state shown in Figure 2(b)). In other words, when the outer sheath 5 is pulled to expose the tip 4b of the inner sheath 4 and the stent graft 2, slack will occur in the operating wire 7 when the inner sheath 4 returns to its bent state (natural state).

[0019] If the operating wire 7 is pulled from this state, a time lag occurs between the start of the pulling operation and the start of further bending of the inner sheath 4, corresponding to the time required to remove the slack. According to the above-mentioned configuration, such a deviation (operation gap) does not occur, and the inner sheath 4 can be bent smoothly.

[0020] A device comprising the above 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.

[0021] <Configuration of each part of the conveying device> The configuration of each part of the delivery device 1 will be described with reference to Figs. 1 and 2 as well as Figs. 3 to 6. Fig. 3 is a schematic diagram illustrating 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 illustrating the inner sheath 4 in a straight state, and Fig. 4(b) is a diagram illustrating the inner sheath 4 in a bent state (natural state). Fig. 5 is a diagram illustrating the maximum tensile load of the operating wire 7 required to bend the tip portion 4b by 180 degrees for inner sheaths 4 having different lengths of the space 41c and the tubular portion 41b. Fig. 6 is a diagram illustrating 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 operating wire 7.

[0022] As shown in FIG. 1, a delivery device 1 according to this embodiment supplies a stent graft 2 to a lesion such as an aortic aneurysm 55 inside the body, and includes a sheath 3 for housing the stent graft 2 therein. 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.

[0023] 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.

[0024] As shown in Figure 3, the sheath 3 comprises an inner sheath 4 to which the stent graft 2 is attached around the outer periphery of its tip portion 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.

[0025] 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).

[0026] The outer sheath 5 covers and protects the stent graft 2 when the sheath 3 is inserted into the body. The outer sheath 5 is attached to the inner sheath 4 and the pusher 11 so as 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 in the body.

[0027] 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. As shown in Figure 2(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 2(a), so that the operating wire 7 provided inside the inner sheath 4 does not slacken and is in a state of tension.

[0028] 1, a distal tip 12 is joined to the distal end of the inner sheath 4 (more distal than a fixed tip 41f, described later). The distal tip 12 protects the distal end of the sheath 3 so as not to damage the blood vessel when the sheath 3 travels through the blood vessel. Note that the distal tip 12 is not shown in FIG. 2.

[0029] When the outer sheath 5 is pulled proximally and the tip of the inner sheath 4 is exposed, the tip of the inner sheath 4 returns to the natural state (bent state) to which it has been shaped because the biasing force of the outer sheath 5 is no longer applied. When the operating wire 7 is pulled to bend it to fit the shape of the aortic arch 50, since the inner sheath 4 is in this natural state, the pulling operation can be performed from a state in which there is no slack in the operating wire 7, and the control sensitivity by the operating wire 7 can be improved.

[0030] 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 operating line 7 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. 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.

[0031] 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 operating wire 7 may be configured not to be exposed from the middle part of the inner sheath 4 (the operating wire lumen portion 41).

[0032] 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). Moreover, 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.

[0033] According to the above configuration, by pulling the operating wire 7, 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 .

[0034] The operating wire 7 is fixed to a 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 operating wire 7 is pulled. Therefore, the inner sheath 4 can be bent with a simple configuration.

[0035] 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.

[0036] 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.

[0037] According to the above configuration, the portion defining the operating wire lumen portion 41 through which the operating wire 7 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 operating wire 7 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.

[0038] 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 operating wire 7 passes.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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 operating wire 7.

[0043] The distal end 41d of the operating wire lumen portion 41 in this embodiment is provided with a fixing portion (fixed tip 41f) for fixing the distal end of the operating wire 7, and the operating wire 7 is welded to the fixed tip 41f. 2 shows a configuration in which the tip 7a of the operating wire 7 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 7a of the operating wire 7 may be welded in a state where it is aligned along the outer circumferential surface of the fixed tip 41f.

[0044] According to the above configuration, since the operating wire 7 is welded to the fixed tip 41f, the joint strength can be increased compared to a case where the operating wire 7 is connected to the fixed tip 41f by crimping, for example. Therefore, it is possible to prevent the operating wire 7 from breaking off from the operating wire lumen portion 41 and coming off from the inner sheath 4. It should be noted that if the operating wire 7 is joined to the fixed tip 41f by laser welding, arc welding, resistance welding or other welding, the joining strength is high and it is preferable, but the present invention is not limited to such a configuration. For example, the operating wire 7 may be connected to the fixed chip 41f by soldering, heat fusion, adhesion with an adhesive, mechanical fastening (caulking), or the like.

[0045] The delivery device 1S with the stent graft further includes a pusher 11 that is connected to the inner sheath 4 and restricts the movement of the retention device (stent graft 2) in the proximal direction. In other words, the pusher 11 that restricts the movement of the retention device (stent graft 2) in the proximal direction is connected to the inner sheath 4. A bending start position 4a of the shaped inner sheath 4 is disposed distal to the connection part 11a 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.

[0046] 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.

[0047] 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 3 for this embodiment, the proximal end 41e of the space 41c that is located most proximal among the multiple spaces 41c.

[0048] 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 operating wire 7. 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.

[0049] 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 operating line 7 is pulled.

[0050] As shown in Figure 5, the maximum tensile load of the operating wire 7 required to bend it 180 degrees was investigated by changing various lengths. In Figure 5, the horizontal axis is the length of B, and the vertical axis is the tensile load when the operating wire is pulled. The legend where A is 5 mm is indicated by a circle mark, the legend where A is 10 mm is indicated by a square mark, and the legend where A is 15 mm is indicated by a triangle mark. In addition, the length of C in this verification ranged from 95 mm to 110 mm. In all cases, no kinks were observed when the cable was bent to 90 degrees.

[0051] It was found that the longer the length of A, the smaller the maximum tensile load could be kept. In addition, in this test, under the conditions enclosed by the dashed ovals in FIG. 5, that is, under the conditions where A is 5 mm and 10 mm and B is 10 mm or less, the inner sheath 4 could be bent up to 180 degrees without kinking. 5, it is clear that the length of B has little effect on the tensile load, and also has little effect on achieving the desired curvature of the inner sheath 4. In other words, when B is 5 mm compared with 10 mm, the tensile load is small when it is 5 mm, and therefore the operability by the operating wire 7 is good. Furthermore, when the target value of the curvature radius of the inner sheath 4 after the operating wire 7 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.

[0052] As shown in FIG. 6, the longitudinal length of each space 41c is preferably 1 to 3 times the longitudinal length of each tubular portion 41b. According to Figure 6, 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.

[0053] 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 operating wire 7 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.

[0054] Within the above numerical range, the inner sheath 4 can be easily bent, and as shown in FIG. 6, the tensile load applied by the operating wire 7 when bending the inner sheath 4 can be reduced. In addition, as shown in Figure 6, 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.

[0055] <Modification> Next, a modified example will be described with reference to Fig. 7. Fig. 7 is a schematic diagram showing the inner sheath 4 covered with a cover film . The medical indwelling device delivery device (delivery device 1) is provided with a heat-shrinkable cover film . The cover film 42 covers the tip portion 7a of the operating wire 7 and is pressed against the tip portion 7a. The above-mentioned "heat shrinkability" refers to the material property of the resin material, and the heat-compressible cover film 42 also includes a film that has exhausted and lost its heat shrinkage force after being pressed against the tip portion 7a. According to the above configuration, the tip portion 7a of the operating wire 7 can be firmly connected to the inner sheath 4 by pressure bonding with the cover film 42.

[0056] Furthermore, the cover film 42 brings the guidewire lumen portion 40 and the operating wire lumen portion 41 together with a substantially cylindrical cover layer, making it possible to level the area in contact with the inner surface of the outer sheath 5. Therefore, when the outer sheath 5 is retracted to deploy the stent graft 2, it is possible to suppress interference with the retraction movement of the outer sheath 5 due to localized frictional force being applied to the outer sheath 5.

[0057] 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.

[0058] 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 to which the indwelling device is attached during delivery of the indwelling device; an outer sheath that covers the radial outside of the inner sheath, is configured to be axially slidable relative to the inner sheath, covers the outer periphery of the retention device when the retention device is transported, and exposes the retention device when the retention device is retained; an operating wire having a tip end connected to a distal end portion of the inner sheath, disposed in an axial direction of the inner sheath, and pulled proximally to bend the inner sheath, The inner sheath is shaped to be bent in a natural state, the operating wire is disposed on the inside of the inner sheath in the bending direction, and is connected to the inner sheath so as to be in a tensioned state when the inner sheath is linearly deformed, and to be maintained in an extended state when the inner sheath is in its natural state. (2) The inner sheath is formed with a guidewire lumen portion through which a guidewire is passed and an operating line lumen portion through which the operating line is passed, The medical indwelling device delivery device according to (1), wherein the operating wire lumen portion has a low rigidity region having a rigidity lower than that of the guidewire lumen portion and is provided in parallel with the guidewire lumen portion. (3) The medical indwelling device delivery device according to (2), wherein the proximal end of the low rigidity region is disposed distal to a bending start position of the shaped configuration of the inner sheath. (4) The operating line lumen portion further includes a high-rigidity region having a higher rigidity than the low-rigidity region, and the high-rigidity region and the low-rigidity region are alternately arranged in a longitudinal direction. The medical indwelling portion transport device according to (2) or (3), wherein the length in the longitudinal direction of one of the low rigidity regions is from 1 to 3 times the length in the longitudinal direction of one of the high rigidity regions. (5) A fixing portion for fixing the distal end portion of the operating line lumen portion is provided at the distal end portion of the operating line, The medical indwelling device delivery device according to any one of (2) to (4), wherein the operating wire is welded to the fixing portion. (6) Equipped with a heat-shrinkable cover film, A fixing portion for fixing the distal end portion of the operating line lumen portion is provided at the distal end portion of the operating line, The medical indwelling device delivery device according to any one of (2) to (5), wherein the cover film covers the tip end of the operating wire and is pressure-bonded to the tip end. (7) A pusher that restricts the movement of the retention tool in a proximal direction is connected to the inner sheath, The medical indwelling device delivery device according to any one of (1) to (6), wherein a bending start position of the shaped inner sheath is disposed distal to a connection portion of the pusher. (8) A medical indwelling device delivery device according to any one of (1) to (7), the indwelling device attached to the inner sheath. (9) a pusher connected to the inner sheath for restricting the movement of the retention device in a proximal direction; The inner sheath is formed with a guidewire lumen portion through which a guidewire is passed and an operating line lumen portion through which the operating line is passed, the operating wire lumen portion has a low-rigidity region having a lower rigidity than the guidewire lumen portion, and is provided in parallel with the guidewire lumen portion, The medical retention device delivery device with retention device according to (8), wherein when the retention device is attached to the inner sheath, a proximal end of the retention device is disposed proximal to the proximal end of the low rigidity region and distal to the connection portion of the pusher. [Explanation of symbols]

[0059] 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 3 Sheath 4 Inner sheath 4a Bending start position 4b Tip 5 Outer sheath 7 Operating Line 7a Tip 11 Pusher 11a Connection 12 Tip 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 42 Cover Film 50 Aortic arch (body canal) 50a inner wall 51 Descending aorta (body duct) 55 Aortic aneurysm

Claims

1. A medical indwelling device delivery device for delivering an indwelling device into a body, comprising: a long inner sheath to which the indwelling device is attached during delivery of the indwelling device; an outer sheath that covers the radial outside of the inner sheath, is configured to be axially slidable relative to the inner sheath, covers the outer periphery of the retention device when the retention device is transported, and exposes the retention device when the retention device is retained; An operating wire disposed in the axial direction of the inner sheath, a distal end of the operating wire is connected to a distal end of the inner sheath; The operating wire is pulled proximally to bend the inner sheath, The inner sheath is shaped to be bent in a natural state, the operating wire is disposed on the inner side of the inner sheath in a bending direction, and is connected to the inner sheath so as to be in a tensioned state when the inner sheath is linearly deformed, and to be maintained in an extended state when the inner sheath is in the natural state, The inner sheath is formed with a guide wire lumen portion through which a guide wire is passed and an operating line lumen portion through which the operating line is passed, the operating wire lumen portion has a low-rigidity region having a lower rigidity than the guidewire lumen portion, and is provided in parallel with the guidewire lumen portion, A medical indwelling device delivery device, wherein the proximal end of the low rigidity region is disposed distal to a bending start position of the shaped configuration of the inner sheath.

2. A medical indwelling device delivery device for delivering an indwelling device into a body, comprising: a long inner sheath to which the indwelling device is attached during delivery of the indwelling device; an outer sheath that covers the radial outside of the inner sheath, is configured to be axially slidable relative to the inner sheath, covers the outer periphery of the retention device when the retention device is transported, and exposes the retention device when the retention device is retained; An operating wire disposed in the axial direction of the inner sheath, a distal end of the operating wire is connected to a distal end of the inner sheath; The operating wire is pulled proximally to bend the inner sheath, The inner sheath is shaped to be bent in a natural state, the operating wire is disposed on the inner side of the inner sheath in a bending direction, and is connected to the inner sheath so as to be in a tensioned state when the inner sheath is linearly deformed, and to be maintained in an extended state when the inner sheath is in the natural state, The inner sheath is formed with a guide wire lumen portion through which a guide wire is passed and an operating line lumen portion through which the operating line is passed, the operating wire lumen portion has a low-rigidity region having a lower rigidity than the guidewire lumen portion, and is provided in parallel with the guidewire lumen portion, The operating line lumen portion further includes a high-rigidity region having a higher rigidity than the low-rigidity region, and the high-rigidity region and the low-rigidity region are alternately arranged in a longitudinal direction. A medical indwelling device delivery device, wherein the length in the longitudinal direction of one of the low rigidity regions is from 1 to 3 times the length in the longitudinal direction of one of the high rigidity regions.

3. A fixing portion for fixing the distal end portion of the operating line lumen portion is provided at the distal end portion of the operating line, 3. The medical indwelling device delivery device according to claim 1, wherein the operating wire is welded to the fixing portion.

4. Equipped with a heat-shrinkable cover film, A fixing portion for fixing the distal end portion of the operating line lumen portion is provided at the distal end portion of the operating line, 4. The medical indwelling device delivery device according to claim 1, wherein the cover film covers the distal end of the operating wire and is pressure-bonded to the distal end.

5. A pusher that restricts the movement of the retention tool in a proximal direction is connected to the inner sheath, The medical indwelling device delivery device according to claim 1 , wherein a bending start position of the shaped inner sheath is disposed distal to a connection portion of the pusher.

6. A medical retention device transport device for delivering a retention device into the body, comprising: a long inner sheath to which the retention device is attached when the retention device is transported; an outer sheath covering the radially outside of the inner sheath and configured to be axially slidable relative to the inner sheath, covering the outer periphery of the retention device when the retention device is transported and exposing the retention device when the retention device is retained; and an operating wire arranged in the axial direction of the inner sheath, a distal end of the operating wire connected to a distal end of the inner sheath, the operating wire being shaped so that the inner sheath is bent when pulled proximally and the inner sheath is bent in its natural state, the operating wire being arranged on the inside in the bending direction of the inner sheath and connected to the inner sheath so that a tension is generated when the inner sheath is linearly deformed and a stretched state is maintained when the inner sheath is in its natural state; The indwelling device is attached to the inner sheath. The medical indwelling device delivery device further includes a pusher connected to the inner sheath and restricting the movement of the indwelling device in a proximal direction, The inner sheath is formed with a guide wire lumen portion through which a guide wire is passed and an operating line lumen portion through which the operating line is passed, the operating wire lumen portion has a low-rigidity region having a lower rigidity than the guidewire lumen portion, and is provided in parallel with the guidewire lumen portion, a proximal end portion of the retention device attached to the inner sheath, the proximal end portion being disposed proximal to the proximal end of the low rigidity region and distal to the connection portion of the pusher.

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