Indwelling device with tubular treatment device

Abstract

To provide an indwelling device with a tubular treatment device which can reduce the diameter of a sheath that stores the tubular treatment device and simplify the device structure.SOLUTION: A shaft-shaped member of an indwelling device includes: a holder portion 60 which is formed so as to protrude outward in the radial direction from a base portion; and an engaged portion 33 with which an engaging portion 15 of a tubular treatment device 10 engages. The indwelling device 10 further includes a linear member which regulates expansion in the radial direction of the engaging portion 15 that engages with the engaged portion 33. The linear member includes a first linear member 36a and a second linear member 36b that engages with the first linear member 36a. The holder portion 60 holds the second linear member 36b and regulates the displacement in the radial direction of the second linear member. The holder portion 60 includes a notch which receives the second linear member 36b at a position on the inner side in the radial direction relative to a position where the second linear member 36b is held.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates to an indwelling device with a tubular therapeutic device. [Background technology]

[0002] Conventionally, tubular therapeutic devices such as stent grafts used for treating aneurysms occurring in blood vessel walls have been known, and various proposals have been made regarding placement devices for carrying and placing the tubular therapeutic device at an affected area (see, for example, Patent Documents 1 to 3). In general, the placement device carries the tubular therapeutic device to the affected area in a radially contracted state, and places the tubular therapeutic device at the affected area by radially expanding the tubular therapeutic device at the affected area.

[0003] One of the conventional placement devices is capable of placing a so-called distal end rear-opening type tubular treatment tool. This type of placement device has, for example, a distal tip that can accommodate an arm-like portion provided at the open end of the main body of the tubular treatment tool (see, for example, Patent Document 1). The placement device described above carries the tubular treatment tool to the affected area while keeping the arm-like portion accommodated in the distal tip, expands the main body at the affected area, and then releases the arm-like portion from the distal tip to bring the tubular treatment tool into contact with the blood vessel wall. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 5408866 [Patent Document 2] Patent No. 4928449 [Patent Document 3] Patent No. 6261619 Summary of the Invention [Problem to be solved by the invention]

[0005] The above-mentioned placement device has two shafts as a mechanism for releasing the arm-like portion housed in the tip tip: one shaft connected to the tip tip housing the arm-like portion, and another shaft holding the arm-like portion so that it can move relative to the tip tip. Therefore, the above-mentioned placement device has a complex structure and a large number of parts. In addition, the two shafts in the above-mentioned placement device have a double structure in which one shaft is inserted into the hollow part of the other shaft. Therefore, in the above-mentioned placement device, the sheath in which the tubular treatment tool is housed also becomes large in diameter.

[0006] Therefore, the present invention has been made in consideration of such problems, and has an object to provide a placement device with a tubular medical device that can reduce the diameter of the sheath that houses the tubular medical device and simplify the device structure. [Means for solving the problem]

[0007] One aspect of the present invention is a placement device with a tubular therapeutic device for placing a tubular therapeutic device expandable in a biological lumen. The placement device with a tubular therapeutic device includes a tubular therapeutic device having an engagement portion, a sheath capable of accommodating the tubular therapeutic device, and a long shaft-shaped member configured to be movable forward and backward along the axial direction of the sheath inside the sheath. The shaft-shaped member has a holder portion formed by protruding radially outward from a base portion provided on the shaft-shaped member, and an engaged portion with which the engaging portion of the tubular therapeutic device engages. The placement device further includes a linear member that restricts radial expansion of the engaging portion engaged with the engaged portion. The linear member includes a first linear member and a second linear member disposed in the axial direction of the shaft-shaped member and engaged with the first linear member. The holder portion holds the second linear member and restricts radial displacement of the second linear member. The holder portion includes a cutout portion for receiving the second linear member at a position radially inward from a position where the second linear member is held. Another aspect of the present invention is a placement device with a tubular therapeutic device for placing a radially expandable tubular therapeutic device in a biological lumen, the placement device comprising: a tubular therapeutic device having an engagement portion; a sheath capable of accommodating the tubular therapeutic device; and a long axial member configured to be able to advance and retreat inside the sheath along the axial direction of the sheath, the axial member having an engaged portion with which the engaging portion of the tubular therapeutic device engages, and a linear member that restricts radial expansion of the engaging portion engaged with the engaged portion, the linear member having a first linear member wound around the engaging portion, and a second linear member that holds the first linear member so that it cannot fall off from the engaging portion, the first linear member being detachable from the engaging portion and the axial member, the radial expansion of the engaging portion is restricted by engagement between the first linear member and the second linear member, and the restriction is released by disengaging the first linear member from the second linear member. Effect of the Invention

[0008] According to the present invention, it is possible to reduce the diameter of the sheath that houses the tubular treatment tool and to simplify the device structure. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1(a) is an exploded view of the placement device of this embodiment, FIG. 1(b) is a view showing the assembled state of the placement device of this embodiment, and FIG. 1(c) is a view showing the vicinity of an opening on one side of the stent graft of this embodiment. [Diagram 2] FIG. 2(a) is a perspective view showing a configuration example of the vicinity of the tip of a small diameter shaft portion, and FIG. 2(b) is a view showing a state in which a stent graft is attached to the small diameter shaft portion. [Diagram 3] 1(a) to 1(f) are diagrams showing the procedure for placing a stent graft using a placement device. [Figure 4] 13A and 13B are diagrams showing a first modified example of the regulation of the bare portion by winding a linear member. [Diagram 5] FIG. 11 is a perspective view showing a state in which a stent graft is attached to a shaft small diameter portion in a second modified example. [Figure 6] 13 is a diagram illustrating the arrangement of first and second linear members in a second modified example. FIG. [Figure 7] 13 is a perspective view showing a configuration example of the vicinity of a tip end of a small diameter portion of a shaft in a second modified example. FIG. [Figure 8] 8 is an enlarged view of the wire holder shown in FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, configuration examples of the placement device and the tubular treatment device according to the embodiments of the present invention will be described with reference to the drawings.

[0011] Fig. 1(a) is an exploded view of the placement device 1 of this embodiment, and Fig. 1(b) is a view showing the assembled state of the placement device 1 of this embodiment. Fig. 1(c) is a view showing the vicinity of an opening on one side of a stent graft 10 of this embodiment.

[0012] The shapes, dimensions, etc. of each part in the drawings are shown diagrammatically and do not represent the actual shapes, dimensions, etc. In the drawings, the axial direction Ax of the placement device and the tubular treatment tool is indicated by an arrow as necessary. In addition, the direction approximately perpendicular to the axial direction Ax is defined as the radial direction. In addition, one side of the placement device and the tubular treatment tool is indicated by the symbol F, and the other side is indicated by the symbol B in the drawings as necessary.

[0013] First, the configuration of the stent graft 10 of this embodiment will be described. The stent graft 10 is an example of a tubular medical device, and is placed at a lesion such as a stenosed or blocked area in a biological lumen to expand the lesion. The stent graft 10 is placed at a predetermined position in a blood vessel, which is an example of a biological lumen (for example, a lesion where a blood vessel has a cyst), using a placement device.

[0014] The stent graft 10 has a so-called self-expanding configuration in which the shape of the expanded state is memorized. The stent graft 10 is housed in a tubular sheath 20 of the placement device 1 and introduced into the blood vessel in a state in which it is contracted radially inward. After being transported to a predetermined position in the blood vessel, the stent graft 10 is released from the sheath 20 and expands radially outward. The expanded stent graft 10 is placed in the blood vessel in a state in which it is in close contact with the inner wall of the blood vessel, as shown in FIG. 3(f) described below.

[0015] The overall shape of the stent graft 10 may be linear, or may be curved to correspond to the shape of the patient's blood vessel. That is, the stent graft 10 may be curved in advance in accordance with the placement site before placement, or may be curved to match the shape of the blood vessel after placement.

[0016] The stent graft 10 includes a main body portion 11 formed in a tubular shape with one side and the other side communicating with each other in the axial direction Ax. As shown in Fig. 1(c), the main body portion 11 includes a skeleton portion 12 and a coating portion 13 fixed to the skeleton portion 12. The internal space of the main body portion 11 forms a flow path through which the patient's blood can pass when the stent graft 10 is placed in a blood vessel.

[0017] The skeleton 12 is formed, for example, by winding a thin metal wire (wire material) in a spiral shape. For example, the thin metal wire is wound in a spiral shape while being folded back in a zigzag pattern so that peaks and valleys are alternately formed, thereby forming the skeleton 12. The skeleton 12 is configured to be deformable so as to self-expand from a contracted state in which it is contracted radially inward to an expanded state in which it is expanded radially outward.

[0018] Examples of materials constituting the metal wires of the skeleton 12 include known metals or metal alloys such as Ni-Ti alloy (nitinol), cobalt-chromium alloy, titanium alloy, and stainless steel. When Ni-Ti alloy is used as the material of the skeleton 12, the skeleton 12 can memorize the shape of the expanded state by performing a predetermined heat treatment after adjusting the shape of the skeleton 12 to the expanded state. The skeleton 12 may be formed of a material other than metal (e.g., ceramic, resin, etc.).

[0019] The coating portion 13 is a tubular flexible membrane that forms the above-mentioned flow path, and is attached to the skeleton portion 12 so as to close the gaps in the skeleton portion 12. Examples of materials that form the coating portion 13 include fluororesins such as PTFE (polytetrafluoroethylene) and polyester resins such as polyethylene terephthalate.

[0020] A bare portion 15 made of a metal skeleton is provided at one open end 11a of the main body 11 as an example of an engagement portion. The bare portion 15 protrudes from the open end 11a of the main body 11 toward one side in the axial direction Ax. The bare portion 15 generates friction with the inner wall of the blood vessel when the stent graft 10 is placed, and serves to suppress displacement (migration) of the stent graft 10.

[0021] Additionally, a fixing pin (also called a barb) 16 that protrudes radially outward is provided on bare portion 15. Fixing pin 16 serves to assist in fixing bare portion 15 to the blood vessel by catching on the inner wall of the blood vessel.

[0022] Next, a configuration example of the placement device in this embodiment will be described. As shown in FIGS. 1( a ) and 1 ( b ), the placement device 1 includes a tubular sheath 20 and a tubular shaft 30 disposed inside the sheath 20 .

[0023] The sheath 20 is capable of housing the stent graft 10 in a contracted state therein. The sheath 20 has a sheath main body 21 and a hub 22 provided at the other end of the sheath main body 21. The hub 22 has a nut (not shown) for fixing the sheath 20 to the shaft 30, an operating member (not shown) for operating the linear member 36 described below, and the like.

[0024] The sheath main body 21 is a tube made of a flexible material. Examples of the material for the sheath main body 21 include biocompatible synthetic resins (elastomers) selected from fluororesins, polyamide resins, polyethylene resins, polyvinyl chloride resins, and the like, resin compounds in which these resins are mixed with other materials, multilayer structures made of these synthetic resins, and composites of these synthetic resins and metal wires.

[0025] The shaft 30 is an axial member longer than the sheath 20, and configured to be movable forward and backward along the axial direction Ax. The shaft 30 has a shaft main body 31 and a shaft small diameter section 32 formed on one side of the shaft main body 31. Examples of materials for the shaft 30 include various materials having appropriate hardness and flexibility, such as resins (plastics, elastomers, etc.) and metals.

[0026] The small diameter shaft portion 32 is coaxial with the shaft main body 31 and has a smaller diameter than the shaft main body 31. In the placement device 1, the stent graft 10 is housed in a space formed between the outer periphery of the small diameter shaft portion 32 and the inner periphery of the sheath main body 21. Furthermore, a hole (not shown) for inserting a guide wire 40 (described later) is formed in the axial direction Ax in the shaft main body 31 and the small diameter shaft portion 32 of the shaft 30. Further, a distal tip 35 that closes an opening at one end of the sheath 20 is attached to one end of the shaft small diameter portion 32 .

[0027] Fig. 2(a) is a perspective view showing a configuration example near the tip of the shaft small diameter section 32. Fig. 2(b) is a view showing the state in which the stent graft 10 is attached to the shaft small diameter section 32. Note that the tip tip 35 is omitted from Figs. 2(a) and (b).

[0028] The shaft small diameter portion 32 has, in order from one end, a hook piece 33 and a linear member holder 34.

[0029] The hook piece 33 is an example of an engaged portion, and is formed in a shape in which the base end side rises radially from the small diameter shaft portion 32 and the tip portion is bent and protrudes to one side of the small diameter shaft portion 32. A plurality of hook pieces 33 are provided at intervals in the circumferential direction of the small diameter shaft portion 32. As shown in Fig. 2(b), each hook piece 33 can be engaged by hooking an end of the bare portion 15.

[0030] The linear member holder 34 is a small flat piece rising radially from the shaft small diameter portion 32 and extending along the axial direction Ax. A holding hole 34a is formed in the linear member holder 34, through which the linear member 36 is inserted in the circumferential direction. The linear member 36 is formed from a material having a predetermined strength and rigidity, and examples of the material that can be used include suture thread such as nylon fiber or fluorine fiber, thin metal wire made of nickel-titanium alloy or stainless steel, and string-like members made of resin. 2, two linear member holders 34 are arranged at an interval of 180 degrees on the shaft small diameter section 32. Note that the number of linear member holders 34 on the shaft small diameter section 32 is not limited to the above example, and may be one, or three or more.

[0031] 2(b), when attaching the stent graft 10 to the shaft small diameter section 32, the bare portion 15 of the stent graft 10 is hooked and engaged with the hook 33 of the shaft small diameter section 32. Then, a linear member 36 is wound circumferentially from the outside of the bare portion 15 engaged with the hook 33. By winding the linear member 36, the radially outward expansion of the bare portion 15 is restrained and restricted by the linear member 36, and one end of the stent graft 10 is fixed to the shaft small diameter section 32.

[0032] The linear member 36 passes through the retaining hole 34a of the linear member holder 34 and is wound in the circumferential direction across the bare parts 15. A radially outward force due to a reaction force from the bare parts 15 acts on the linear member 36 wound around the bare parts 15, but by passing the linear member 36 through the retaining hole 34a of the linear member holder 34, the linear member 36 is held by the linear member holder 34. This restricts radially outward displacement of the linear member 36, making it easy to maintain the wound state of the linear member 36 around the bare parts 15. In this way, the linear member holder 34 functions as a restricting portion that cooperates with the linear member 36 to restrict the radial expansion of the bare portion 15 engaged with the hook 33 .

[0033] Moreover, the other side of the linear member 36 passes through the sheath 20 and is connected to an operating member of the hub 22 provided at the other end of the sheath 20. By operating the operating member of the hub 22, the linear member 36 can be pulled out to the other side. When the linear member 36 is pulled out to the other side, the winding of the linear member 36 is released, and the bare portion 15 becomes capable of expanding in the radial direction.

[0034] Here, a procedure for placing the stent graft 10 in the blood vessel 50 using the placement device will be described with reference to Figures 3(a) to (f). The example in Figure 3 shows a case where the stent graft 10 is placed in a lesion site where a varicose vein 51 is formed in a curved blood vessel 50. The left side of each figure in Figure 3 corresponds to one side, and the right side of each figure in Figure 3 corresponds to the other side.

[0035] First, a guidewire 40 is placed in a blood vessel 50 so as to pass through a lesion site where a lump 51 has formed. Then, the guidewire 40 is inserted into the placement device 1, which houses the stent graft 10 in a contracted state, from one end of the placement device 1. Thereafter, as shown in Figs. 3(a) to (c), the placement device 1 is advanced in the blood vessel from the other side to the one side along the guidewire 40 so that the one end of the placement device 1 passes through a lesion site where a lump 51 has formed.

[0036] Next, as shown in Figures 3(d) to 3(e), in the placement device 1, while maintaining the position of the shaft 30 that is restraining the bare portion 15 of the stent graft 10, the sheath 20 is moved so as to be pulled out towards the other side. Then, the stent graft 10 is released from the sheath 20 of the placement device 1. The main body portion 11 of the stent graft 10 self-expands radially outward by being released to the outside from the sheath 20. As a result, the expanded main body portion 11 comes into close contact with the inner wall surface of the blood vessel 50.

[0037] Fig. 3(e) shows a state in which the entire stent graft 10 has been released from the sheath 20. In the state shown in Fig. 3(e), the stent graft 10 is fixed to the blood vessel 50 so as to cover the lesion site where aneurysm 51 has formed from the inside of the blood vessel 50. In the stage of Figs. 3(a) to 3(e), the linear member 36 is wound around the outside of the bare portion 15, so that any radial expansion of the bare portion 15 is restricted.

[0038] Thereafter, the winding of the linear member 36 is released in the placement device 1, and the restriction on the radial expansion of the bare portion 15 is released. Then, the bare portion 15 expands radially outward due to its own expansion force and contacts the inner wall of the blood vessel 50 (see FIG. 3(f)). This causes friction between the bare portion 15 and the fixing pins 16 and the inner wall of the blood vessel 50, suppressing displacement of the stent graft 10 from the placement position.

[0039] 3(f), the sheath 20 and the guide wire 40 are pulled out to the other side, and the placement device 1 is removed from the blood vessel. Through the above procedure, placement of the stent graft 10 is completed.

[0040] The effects of the placement device 1 of this embodiment will be described below. In the placement device 1 of this embodiment, the shaft small diameter section 32 of the shaft 30 has a hook 33 with which the bare portion 15 of the stent graft 10 engages, and a linear member holder 34. The linear member holder 34 cooperates with the linear member 36 to restrict radial expansion of the bare portion 15 engaged with the hook 33. In addition, the linear member holder 34 releases the restriction on radial expansion of the bare portion 15 when the linear member 36 is released from winding around the bare portion 15. According to this embodiment, switching from a state in which radial expansion of the bare portion 15 is restricted to a state in which the restriction is released can be performed by operating the linear member 36. That is, in this embodiment, it is not necessary to provide, for example, a mechanism having a double-structure shaft in the sheath 20 in order to release the restriction on radial expansion of the bare portion 15. Therefore, the device structure of the placement device 1 is simplified, and the number of parts is reduced, which improves assembly workability and reduces manufacturing costs.

[0041] Furthermore, according to this embodiment, since it is not necessary to provide a mechanism having a double-structure shaft inside the sheath 20 as described above, the outer diameter of the sheath 20 can be made thinner than that of a placement device having a double-structure shaft. Therefore, in the procedure of placing the stent graft 10, the sheath 20 of the placement device 1 can be introduced more smoothly into the blood vessel, and the invasiveness to the patient's body can be reduced.

[0042] In addition, a placement device having a double-structure shaft as described above is difficult to introduce into a curved blood vessel because the double-structure portion is difficult to bend. In contrast, the placement device 1 of the present embodiment does not have a double-structure shaft as described above, and is therefore easier to bend, making it easier to introduce into a curved blood vessel.

[0043] In addition, in the placement device having the double-structure shaft as described above, for example, when the stent graft 10 is placed in a curved blood vessel, one shaft and the other shaft may come into contact with each other in a biased manner in a part of the circumferential direction due to bending of the entire shaft along the curvature of the blood vessel, and smooth sliding between the two shafts may be hindered. In contrast, this embodiment does not have a double-structure shaft, and the bare portion 15 can be expanded in the radial direction by releasing the winding of the linear member 36. Therefore, in this embodiment, even when the stent graft 10 is placed in a curved blood vessel, the bare portion 15 can be expanded in the radial direction smoothly in the same way as when the stent graft 10 is placed in a blood vessel without curvature, and the reliability of the operation of the placement device 1 can be improved.

[0044] Next, as a modification of the above embodiment, a configuration in which two linear members are used to regulate the bare portion 15 so as to be convertible from a reduced diameter state to an increased diameter state will be described. 4 is a diagram showing a first modified example of restricting bare portion 15 by winding a linear member. In the first modified example, a first linear member 36a is wound around the outer circumferential surface of bare portion 15, and a second linear member 36b is engaged with first linear member 36a to restrict radial expansion of bare portion 15.

[0045] The first linear member 36a is wound around the outer circumferential surface of the bare portion 15 in a manner that it cannot maintain a wound state by itself, and is held in place by engaging with the second linear member 36b. In other words, the second linear member 36b holds the first linear member 36a in place so that it cannot fall off from the bare portion 15 and the shaft small diameter portion 32.

[0046] Specifically, the first linear member 36a is wound around the outer circumferential surface of the bare portion 15 in the circumferential direction, and is bent and wound in the opposite direction for each rotation. The bent portions of the first linear member 36a are aligned in the axial direction Ax. Meanwhile, the second linear member 36b is arranged along the axial direction Ax, weaving through the bent portions of the first linear member 36a. That is, the second linear member 36b is inserted through each of the bent portions of the first linear member 36a. The other side of the second linear member 36b passes through the sheath 20 and is connected to an operating member of the hub 22 provided at the other end of the sheath 20, and the second linear member 36b can be pulled out along the axial direction.

[0047] 4, the first linear member 36a is wound around the second linear member 36b arranged along the axial direction Ax while hooking the bent portion, thereby engaging the first linear member 36a and the second linear member 36b. At this time, the bare portion 15 can be reduced in diameter by appropriately pulling both ends of the first linear member 36a to apply tension.

[0048] Furthermore, the first linear member 36a is held in a wound state by engagement with the second linear member 36b. Therefore, when the engagement between the first linear member 36a and the second linear member 36b is released by pulling out the second linear member 36b, the first linear member 36a naturally falls off the shaft small diameter portion 32. This allows the restriction on radial expansion of the bare portion 15 to be released.

[0049] Here, the first linear member 36a and the second linear member 36b can be the same as the linear member 36 described above. In order to improve the slipperiness and make it easier to pull out the second linear member 36b, it is preferable that the first linear member 36a and the second linear member 36b are made of different materials. It is also preferable that the second linear member 36b is made of a material having a predetermined strength and rigidity, and the first linear member 36a is made of a material having a lower rigidity than the second linear member 36b. For example, the first linear member 36a can be made of a suture thread such as nylon fiber or fluorine fiber, a string-like member made of resin, or the like, and the second linear member 36b can be made of a thin metal wire made of nickel-titanium alloy or stainless steel, or the like. The first linear member 36a may be formed in a wide tape shape. The winding manner of the first linear member 36a in the modified example shown in FIG. 4 is just one example, and other winding manners may also be applied.

[0050] Next, a second modified example of the above embodiment will be described. In the description of the second modified example, the same elements as those in the above embodiment and the first modified example will be given the same reference numerals, and duplicated descriptions will be omitted.

[0051] The second modified example is configured to use two linear members to restrict bare portion 15 so that it can be converted from a reduced diameter state to an expanded diameter state, similar to the first modified example described with reference to Fig. 4. In the second modified example as well, the radial expansion of bare portion 15 is restricted by a first linear member 36a wound around the outer circumferential surface of bare portion 15 and a second linear member 36b engaged with the first linear member 36a. Although not particularly limited, in the second modified example, the first and second linear members 36a, 36b may have the same configuration as in the first modified example.

[0052] Fig. 5 is a perspective view showing a state in which the stent graft 10 is attached to the shaft small diameter section 32 in the second modified example. Fig. 6 is a diagram explaining the arrangement of the first and second linear members 36a, 36b in the second modified example. Fig. 7 is a perspective view showing a configuration example of the vicinity of the tip end of the shaft small diameter section 32 in the second modified example. Fig. 8 is an enlarged view of the wire holder part 60 shown in Fig. 7.

[0053] As shown in Fig. 7, the small diameter shaft portion 32 in the second modified example has, in order from one end, a hook piece 33 and a wire holder portion 60 which is an example of a restricting portion. The wire holder portion 60 has a cylindrical base portion 61 attached to the small diameter shaft portion 32 and a holding piece 62 which holds the second linear member 36b. The wire holder portion 60 shown in Fig. 7 has two holding pieces 62 spaced 180 degrees apart.

[0054] The holding piece 62 of the wire holder part 60 is a small flat piece that protrudes radially from the base part 61 and extends along the axial direction Ax. The holding piece 62 is provided with a hole 62a through which the second linear member 36b is inserted in the circumferential direction.

[0055] Further, the base 61 of the wire holder part 60 is formed with a notch part (receiving part) 61a for receiving the second linear member 36b passing through the hole 62a of the holding piece 62. As shown in FIG. 8, the notch part 61a is cut out radially inward from the circumferential surface of the base 61, and is continuously formed on both sides of the circumferential surface of the base 61 across the holding piece 62. The notch part 61a extends in a direction intersecting with the circumferential direction from one side of the base 61 to the other side. The notch part 61a shown in FIG. 7 and FIG. 8 is shaped so that the small diameter part 32a of the shaft is exposed at the bottom surface. However, the notch part 61a may have a bottom formed by the base 61, and may be shaped so that the small diameter part 32a of the shaft is not exposed at the bottom surface.

[0056] 8, the cutout portion 61a is formed in a spiral shape across the holding piece 62 on the circumferential surface of the base 61. With this, when the second linear member 36b is passed through the hole 62a of the holding piece 62, the second linear member 36b extending in the axial direction Ax can be received in the space of the cutout portion 61a located radially inward of the hole 62a.

[0057] In the second modified example, the second linear member 36b is disposed in the axial direction Ax along the shaft 30. One side of the second linear member 36b is engaged with the distal tip 35 or the like, and the other side passes through the inside of the stent graft 10 and is connected to the operating member of the hub 22. The second linear member 36b can be pulled out to the other side along the axial direction by operation of the operating member. 5 and 6, the second linear member 36b passes through the hole 62a of the holding piece 62 of the wire holder part 60 in the shaft small diameter portion 32. Therefore, the path of the second linear member 36b in the shaft small diameter portion 32 is defined with the hole 62a of the holding piece 62 as a passing point.

[0058] As shown in FIG. 6, the shaft 30 is provided with wire guide rings 38, through which the second linear member 36b is inserted, at predetermined intervals in the axial direction. By inserting the second linear member 36b through the wire guide rings 38 and disposing the second linear member 36b along the shaft 30, the second linear member 36b can easily follow the movement of the shaft 30 at a bent portion of the blood vessel, and the second linear member 36b can be prevented from deviating from the shaft 30 and bending. By preventing the bending of the second linear member 36b, the operation of pulling out the second linear member 36b when releasing the stent graft 10 can be facilitated. The first linear member 36a may also be inserted through the wire guide ring 38.

[0059] When the stent graft 10 is attached to the shaft small diameter portion 32, the bare portion 15 of the stent graft 10 is hooked and engaged with the hook 33 of the shaft small diameter portion 32. Then, the first linear member 36a is wound in the circumferential direction from the outside of the bare portion 15 and the second linear member 36b engaged with the hook 33, so that the bare portion 15 is reduced in diameter and its radial expansion is restricted. The first linear member 36a in the second modification is wound at a position between the hook 33 and the wire holder portion 60 in the axial direction Ax. One end of the first linear member 36a passes through the inside of the stent graft 10 and extends to the other side of the shaft 30.

[0060] The first linear member 36a is knotted so as to bundle the bare portion 15 via the outside of the second linear member 36b. The knot of the first linear member 36a is held in an inseparable state by engaging with the second linear member 36b. This allows the framework of the bare portion 15 to be held in a closed state. When the stent graft 10 is to be released, the engagement between the first linear member 36a and the second linear member 36b is released by pulling out the second linear member 36b. Then, the knot of the first linear member 36a is untied, and the restriction of the radial expansion of the bare portion 15 by the first linear member 36a is released.

[0061] The knot of the first linear member 36a in the second modified example is lifted radially outward by passing through the wire holder part 60 and via the second linear member 36b that protrudes radially, and is less likely to fall toward the framework side (radially inward). This makes it easier for the first linear member 36a to separate to the outside of the bare part 15 when the stent graft 10 is released, and the first linear member 36a is prevented from wrapping around the bare part 15.

[0062] Furthermore, the knot of the first linear member 36a in the second modified example is fixed on one side of the wire holder part 60 by the second linear member 36b that passes through the wire holder part 60. This prevents the first linear member 36a from shifting and dropping toward the wire holder part 60 or the stent graft 10 on the other side.

[0063] Furthermore, the wire holder part 60 can receive the second linear member 36b passing through the hole 62a of the holding piece 62 in the space of the notch part 61a. Therefore, the amount by which the second linear member 36b protrudes radially outward from the surface of the wire holder part 60 can be restricted, making it easy to bundle the bare parts 15 compactly in the radial direction.

[0064] Furthermore, in the stent graft 10, a guide ring 17 through which the first linear member 36a is inserted is provided at one end of the coating portion 13. By disposing the first linear member 36a through the guide ring 17, it is possible to restrict the movement of the first linear member 36a when releasing the stent graft 10. This makes it possible to prevent the first linear member 36a from getting caught in a valley of the framework when the first linear member 36a is retrieved.

[0065] The present invention is not limited to the above-described embodiment, and various improvements and design changes may be made without departing from the spirit of the present invention.

[0066] In the above embodiment, the linear member 36 is held by the holding hole 34a of the linear member holder 34, and the radially outward displacement of the linear member 36 is restricted. However, the means for restricting the radially outward displacement of the linear member 36 is not limited to the configuration of the above embodiment. For example, the linear member 36 wound around the bare portion 15 may be fixed with a soluble adhesive having biocompatibility, and the constraint of the bare portion 15 by the linear member 36 may be released as the adhesive exposed to the outside of the sheath 20 dissolves. Here, for example, a medical adhesive or the like may be used as the above adhesive. In addition, the above adhesive may be one that starts to dissolve at a temperature of about body temperature, or one that starts to dissolve when it comes into contact with moisture or a component of a body fluid such as blood.

[0067] For example, in the above embodiment, the stent graft 10 that is placed in a blood vessel for use is exemplified as the tubular therapeutic device. However, the tubular therapeutic device may be placed in a body lumen other than a blood vessel (e.g., the digestive tract, etc.). In addition, the tubular therapeutic device may be a so-called bare stent in which the framework portion 12 is not covered with the coating portion 13.

[0068] In addition, the embodiments disclosed herein should be considered to be illustrative and not restrictive in all respects. The scope of the present invention is defined by the claims, not the above description, and is intended to include all modifications within the meaning and scope of the claims. [Explanation of symbols]

[0069] 1... placement device, 10... stent graft (cylindrical treatment device), 11... main body, 12... skeleton, 13... coating, 15... bare part (engagement part), 20... sheath, 30... shaft, 31... shaft main body, 32... shaft small diameter part, 33... hook (engaged part), 34... linear member holder (regulating part), 34a... holding hole (holding part), 36, 36a, 36b... linear member, 40... guide wire, 50... blood vessel (biological lumen), 51... aneurysm, 60... wire holder part (regulating part), 61... base, 61a... notch (receiving part), 62... holding piece, 62a... hole (holding part)

Claims

1. A placement device with a tubular therapeutic device for placing a tubular therapeutic device expandable in a radial direction in a living body lumen, comprising: The cylindrical treatment tool having an engagement portion; A sheath capable of accommodating the tubular treatment device; a long shaft-shaped member configured to be movable along an axial direction of the sheath inside the sheath, The shaft member is a holder portion formed to protrude radially outward from a base portion provided on the shaft member; and an engaged portion with which the engaging portion of the cylindrical treatment tool engages, The placement device further includes a linear member that restricts radial expansion of the engaging portion engaged with the engaged portion, the linear member includes a first linear member and a second linear member disposed in an axial direction of the shaft member and engaged with the first linear member; the holder portion holds the second linear member and restricts radial displacement of the second linear member; The holder portion includes a notch portion for receiving the second linear member at a position radially inward from a position at which the second linear member is held. A placement device with a tubular treatment device.

2. The cutout portion is cut out radially inward from the base portion and is formed so as to extend in a direction intersecting the circumferential direction. The placement device with a tubular therapeutic device according to claim 1.

3. The notch is formed continuously on both sides of the circumferential surface of the base across the holder. The placement device with a tubular therapeutic device according to claim 2.

4. The cutout portion is formed in a spiral shape on the circumferential surface of the base portion and across the holder portion. The indwelling device with a tubular therapeutic device according to claim 3.

5. the first linear member is wound around the engagement portion and is removable from the engagement portion and the shaft member; the second linear member holds the first linear member so as not to fall off the engagement portion, The first linear member and the second linear member are engaged with each other to restrict radial expansion of the engagement portion, and the restriction is released by releasing the engagement between the first linear member and the second linear member. The placement device with a tubular therapeutic device according to any one of claims 1 to 4.

6. The first linear member is wound around the outer periphery of the engagement portion in a circumferential direction, and is bent and folded back in the opposite direction for each rotation, The first linear member has a plurality of bent portions formed in a line in an axial direction, The second linear members are inserted through the bent portions of the first linear members to hold the first linear members. The placement device with a tubular therapeutic device according to any one of claims 1 to 4.

7. A placement device with a tubular therapeutic device for placing a tubular therapeutic device expandable in a radial direction in a living body lumen, comprising: The cylindrical treatment tool having an engagement portion; A sheath capable of accommodating the tubular treatment device; a long shaft-shaped member configured to be movable along an axial direction of the sheath inside the sheath, The shaft member is an engaged portion with which the engaging portion of the cylindrical treatment tool engages; a linear member that restricts radial expansion of the engaging portion engaged with the engaged portion, the linear member includes a first linear member wound around the engaging portion and a second linear member that holds the first linear member so as not to fall off from the engaging portion, the first linear member is capable of being dislodged from the engagement portion and the shaft member, The first linear member and the second linear member are engaged with each other to restrict radial expansion of the engagement portion, and the restriction is released by releasing the engagement between the first linear member and the second linear member. A placement device with a tubular treatment device.

8. The first linear member is wound around the outer periphery of the engagement portion in a circumferential direction, and is bent and folded back in the opposite direction for each rotation, The first linear member has a plurality of bent portions formed in a line in an axial direction, The second linear members are inserted through the bent portions of the first linear members to hold the first linear members. The placement device with a tubular therapeutic device according to claim 7.

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