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

[0005]

[0001] The present invention relates to an indwelling device with a cylindrical treatment tool.

Background Art

[0002] Conventionally, cylindrical treatment tools such as stent grafts used for treating tumors and the like that occur in blood vessel walls are known, and various proposals have also been made regarding indwelling devices for transporting and indwelling the cylindrical treatment tool at the affected area (see, for example, Patent Documents 1 to 3). Generally, the indwelling device transports the cylindrical treatment tool to the affected area in a state where the cylindrical treatment tool is radially contracted, and expands the cylindrical treatment tool radially at the affected area to indwell the cylindrical treatment tool at the affected area.

[0003] One of the conventional indwelling devices can indwell a so-called tip-latero-opening type cylindrical treatment tool. This type of indwelling device has, for example, a tip chip that can accommodate an arm-shaped portion provided at the opening end of the main body portion of the cylindrical treatment tool (see, for example, Patent Document 1). The above-described indwelling device transports the cylindrical treatment tool to the affected area while accommodating the arm-shaped portion in the tip chip, expands the main body portion at the affected area, and then releases the arm-shaped portion from the tip chip to bring the cylindrical treatment tool into contact with the blood vessel wall.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0005] The aforementioned implantation device has two shafts as a mechanism for releasing the arm-like portion housed in the tip: one shaft connected to the tip that houses the arm-like portion, and another shaft that holds the arm-like portion so that it can move relative to the tip. As a result, the aforementioned implantation device has a complex structure and a large number of parts. Furthermore, the two shafts in the aforementioned implantation device have a double structure in which the other shaft is inserted through the hollow part of one shaft. Therefore, the sheath that houses the cylindrical treatment instrument also becomes large in diameter in the aforementioned implantation device.

[0006] Therefore, the present invention has been made in view of these problems, and aims to provide an indwelling device with a tubular therapeutic instrument that can reduce the diameter of the sheath that houses the tubular therapeutic instrument and simplify the structure of the device. [Means for solving the problem]

[0007] One aspect of the present invention is a tubular therapeutic device implantation device for implanting a radially expandable tubular therapeutic device in a biological lumen. The tubular therapeutic device implantation device comprises a tubular therapeutic device having an engaging portion, a sheath capable of housing the tubular therapeutic device, and a long axial member configured to move back and forth along the axial direction of the sheath inside the sheath. The axial member has a holder portion formed projecting radially outward from a base provided on the axial member, and an engaged portion into which the engaging portion of the tubular therapeutic device engages. The implantation device further comprises a linear member that restricts the radial expansion of the engaging portion engaged with the engaged portion. The linear member is The engagement part is wrapped around It includes a first linear member and a second linear member disposed in the axial direction of the shaft-shaped member and engaging with the first linear member. The holder portion is The holder portion has a hole formed that penetrates it in the circumferential direction, and by inserting it through the hole... The second linear member is held in place, thereby restricting its radial displacement. base teeth, hole A position radially inward from the position Inserted into the hole Includes a notch for receiving a second linear member 。 [Effects of the Invention]

[0008] According to the present invention, it is possible to reduce the diameter of the sheath that houses the tubular therapeutic instrument and to simplify the structure of the device. [Brief explanation of the drawing]

[0009] [Figure 1] (a) is an exploded view of the implantation device of this embodiment, (b) is a diagram showing the assembled state of the implantation device of this embodiment, and (c) is a diagram showing the vicinity of one side of the opening in the stent graft of this embodiment. [Figure 2] (a) is a perspective view showing an example of the configuration near the tip of the small-diameter section of the shaft, and (b) is a diagram showing the state with the stent graft attached to the small-diameter section of the shaft. [Figure 3] Figures (a) to (f) show the procedure for implanting a stent graft using an implantation device. [Figure 4] This figure shows a first modified example of restricting the bare portion by winding a linear member. [Figure 5] This is a perspective view showing the second modified example with a stent graft attached to the small-diameter section of the shaft. [Figure 6] This diagram illustrates the arrangement of the first and second linear members in the second modified example. [Figure 7] This is a perspective view showing an example of the configuration near the tip of the small-diameter section of the shaft in the second modified example. [Figure 8] Figure 7 is an enlarged view of the wire holder section. [Modes for carrying out the invention]

[0010] The following describes examples of the configurations of the implantation device and cylindrical therapeutic instrument according to the present invention, with reference to the drawings.

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

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

[0013] First, the configuration of the stent graft 10 of the present embodiment will be described. The stent graft 10 is an example of a tubular treatment tool, and is indwelt in a lesion site such as a stenosis site or an occlusion site in a biological lumen, and is applied to expand these lesion sites. The stent graft 10 is indwelt at a predetermined position of a blood vessel, which is an example of a biological lumen (for example, a lesion site where an aneurysm has occurred in a blood vessel), using an indwelling device.

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

[0015] The overall shape of the stent graft 10 may be a linear shape, or may be a curved shape corresponding to the shape of the patient's blood vessel. That is, the stent graft 10 may be curved in advance assuming the indwelling location before indwelling, or may be curved along the shape of the blood vessel after indwelling.

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

[0017] The skeletal portion 12 is formed, for example, by winding a thin metal wire (wire material) in a spiral shape. For example, the skeletal portion 12 is formed by winding a thin metal wire in a spiral shape while folding it back in a zigzag pattern so that peaks and valleys are alternately formed. The skeletal portion 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 that make up the metal wires of the skeletal part 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 for the skeletal part 12, the expanded shape can be stored in the skeletal part 12 by shaping it into an expanded state and then subjecting it to a predetermined heat treatment. The skeletal part 12 may also be formed from a material other than metal (for example, ceramic or resin).

[0019] The coating portion 13 is a tubular, flexible membrane that forms the aforementioned flow path and is attached to the skeletal portion 12 so as to close the gaps in the skeletal 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] One open end 11a of the main body 11 is provided with a bare portion 15 made of a metal skeleton, which is an example of an engaging 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 is responsible for creating friction with the inner wall of the blood vessel when the stent graft 10 is placed, thereby suppressing displacement (migration) of the stent graft 10.

[0021] Furthermore, the bearing portion 15 is provided with fixing pins (also called barbs) 16 that protrude radially outward. The fixing pins 16 function to assist in fixing the bearing portion 15 to the blood vessel by catching on the inner wall of the blood vessel.

[0022] Next, an example of the configuration of the storage device in this embodiment will be described. As shown in Figures 1(a) and 1(b), the implantation device 1 comprises a tubular sheath 20 and a tubular shaft 30 positioned inside the sheath 20.

[0023] The sheath 20 is capable of housing the retracted stent graft 10 inside. The sheath 20 has a sheath body portion 21 and a hub 22 provided at the other end of the sheath body portion 21. The hub 22 has a nut (not shown) for fixing the sheath 20 to the shaft 30, and an operating member (not shown) for operating the linear member 36 described later.

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

[0025] The shaft 30 is a axial member that is longer than the sheath 20 and is configured to move back and forth along the axial direction Ax. The shaft 30 has a shaft body portion 31 and a shaft small diameter portion 32 formed on one side of the shaft body portion 31. Examples of materials for the shaft 30 include various materials having appropriate hardness and flexibility, such as resin (plastics and elastomers, etc.) and metal.

[0026] The shaft's small-diameter portion 32 is coaxial with the shaft's main body portion 31 and has a smaller diameter than the shaft's main body portion 31. In the implantation device 1, the stent graft 10 is housed in the space formed between the outer circumference of the shaft's small-diameter portion 32 and the inner circumference of the sheath's main body portion 21. In addition, holes (not shown) for inserting the guide wire 40, which will be described later, are formed along the axial direction Ax in the shaft's main body portion 31 and the shaft's small-diameter portion 32. Furthermore, a tip 35 is attached to one end of the small-diameter section 32 of the shaft, which closes the opening at one end of the sheath 20.

[0027] Figure 2(a) is a perspective view showing an example of the configuration near the tip of the small-diameter shaft portion 32. Figure 2(b) shows the state in which the stent graft 10 is attached to the small-diameter shaft portion 32. Note that the tip 35 is not shown in Figures 2(a) and (b).

[0028] The small-diameter portion 32 of the shaft 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 such that its base end rises radially from the shaft's small diameter portion 32, and its tip bends and protrudes to one side of the shaft's small diameter portion 32. Multiple hook pieces 33 are provided at intervals in the circumferential direction of the shaft's small diameter portion 32. As shown in Figure 2(b), the end of the bearing portion 15 can be hooked onto and engaged with each hook piece 33.

[0030] The linear member holder 34 is a flat, plate-shaped piece that rises radially from the small-diameter portion 32 of the shaft and extends along the axial direction Ax. The linear member holder 34 has a holding hole 34a through which the linear member 36 is inserted in the circumferential direction. The linear member 36 is made of a material having a predetermined strength and rigidity, and can be made of suture thread such as nylon fiber or fluorofiber, metal fine wire made of nickel-titanium alloy or stainless steel, or a string-like member made of resin. In the example shown in Figure 2, two linear member holders 34 are arranged in the small-diameter section 32 of the shaft at a 180-degree interval. The number of linear member holders 34 in the small-diameter section 32 of the shaft is not limited to the example above; it may be one or three or more.

[0031] As shown in Figure 2(b), when attaching the stent graft 10 to the small-diameter section 32 of the shaft, the bare portion 15 of the stent graft 10 is hooked onto and engaged with the hook piece 33 of the small-diameter section 32 of the shaft. A linear member 36 is then wound around the outside of the bare portion 15 that is engaged with the hook piece 33 in the circumferential direction. The winding of the linear member 36 restricts and limits the radial outward expansion of the bare portion 15, and fixes one end of the stent graft 10 to the small-diameter section 32 of the shaft.

[0032] The linear member 36 described above is wound around multiple bearing portions 15 in the circumferential direction, passing through the holding holes 34a of the linear member holder 34. A radially outward force acts on the linear member 36 as it winds around the bearing portions 15 due to the reaction force from the bearing portions 15. However, by passing the linear member 36 through the holding holes 34a of the linear member holder 34, the linear member 36 is held by the linear member holder 34. This restricts the radially outward displacement of the linear member 36, making it easy to maintain the winding state of the linear member 36 on the bearing portions 15. Thus, the linear member holder 34 functions as a restricting member that works in cooperation with the linear member 36 to restrict the radial expansion of the bare portion 15 engaged with the hook piece 33.

[0033] Furthermore, the other end 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 bearing portion 15 becomes expandable in the radial direction.

[0034] Here, referring to Figures 3(a) to 3(f), the procedure for implanting a stent graft 10 in a blood vessel 50 using an implantation device will be explained. The example in Figure 3 shows the implantation of a stent graft 10 in a lesion site where an aneurysm 51 has formed in a curved blood vessel 50. Note that 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, the guidewire 40 is positioned within the blood vessel 50 so as to pass through the lesion site where the aneurysm 51 has formed. Then, the guidewire 40 is inserted into the implantation device 1, which contains the contracted stent graft 10, from one end of the implantation device 1. Subsequently, as shown in Figures 3(a) to (c), the implantation device 1 is advanced within the blood vessel from one end to the other along the guidewire 40 so that one end of the implantation device 1 passes through the lesion site where the aneurysm 51 has formed.

[0036] Next, as shown in Figures 3(d) to 3(e), in the implantation device 1, while maintaining the position of the shaft 30 that restrains the bare portion 15 of the stent graft 10, the sheath 20 is moved to the other side to be pulled out. As a result, the stent graft 10 is released from the sheath 20 of the implantation device 1. The main body 11 of the stent graft 10 self-expands radially outward as it is released to the outside from the sheath 20. As a result, the expanded main body 11 adheres closely to the inner wall surface of the blood vessel 50.

[0037] Figure 3(e) shows the stent graft 10 in its entirety, released from the sheath 20. In the state shown in Figure 3(e), the stent graft 10 is fixed to the blood vessel so as to cover the lesion site where the aneurysm 51 has formed from the inside of the blood vessel 50. In the stages shown in Figures 3(a) to 3(e) above, the linear member 36 is wound around the outside of the bearing portion 15, and the radial expansion of the bearing portion 15 is restricted in all cases.

[0038] Subsequently, the winding of the linear member 36 is released in the implantation device 1, thereby releasing the restriction on the radial expansion of the bare portion 15. As a result, the bare portion 15 expands radially outward due to its own expansion force and comes into contact with the inner wall of the blood vessel 50 (see Figure 3(f)). This causes friction between the bare portion 15 and the fixing pin 16 against the inner wall of the blood vessel 50, suppressing displacement of the stent graft 10 from the implantation position.

[0039] Subsequently, as shown in Figure 3(f), the sheath 20 and guidewire 40 are withdrawn to the other side, and the implantation device 1 is removed from the blood vessel. With these steps, the implantation of the stent graft 10 is completed.

[0040] The effects of the implantation device 1 of this embodiment will be described below. In the implantation device 1 of this embodiment, the small-diameter portion 32 of the shaft 30 has a hook piece 33 that engages with the bare portion 15 of the stent graft 10, and a linear member holder 34. The linear member holder 34 cooperates with the linear member 36 to restrict the radial expansion of the bare portion 15 that is engaged with the hook piece 33. Furthermore, the linear member holder 34 releases the restriction on the radial expansion of the bare portion 15 when the winding of the linear member 36 around the bare portion 15 is released. According to this embodiment, the switching from a state in which the radial expansion of the bearing portion 15 is restricted to a state in which the restriction is released can be performed by operating the linear member 36. In other words, in this embodiment, it is not necessary to provide, for example, a mechanism having a double-structured shaft inside the sheath 20 in order to release the restriction on the radial expansion of the bearing portion 15. As a result, the structure of the storage device 1 is simplified, and it is possible to improve assembly workability by reducing the number of parts and suppress manufacturing costs.

[0041] Furthermore, according to this embodiment, since it is not necessary to provide a mechanism with a double-layered shaft inside the sheath 20 as described above, the outer diameter of the sheath 20 can be made smaller compared to an indwelling device with a double-layered shaft. Therefore, in the procedure for implanting the stent graft 10, the sheath 20 of the indwelling device 1 can be introduced into the blood vessel more smoothly, thereby reducing the invasiveness to the patient's body.

[0042] Furthermore, as described above, indwelling devices with a double-layered shaft are difficult to bend and introduce into curved blood vessels. In contrast, the indwelling device 1 of this embodiment does not have a double-layered shaft as described above, making it easier to bend and thus easier to introduce into curved blood vessels.

[0043] Furthermore, in a stent graft device having a double-structured shaft as described above, for example, when a stent graft 10 is placed in a curved blood vessel, the bending of the entire shaft along the curvature of the blood vessel may cause one shaft and the other shaft to come into uneven contact in a part of the circumferential direction, which can hinder the smooth sliding of the two. In contrast, this embodiment does not have a double-structured shaft, and the radial expansion of the bare portion 15 is possible by unwinding the linear member 36. Therefore, in this embodiment, even when a stent graft 10 is placed in a curved blood vessel, the radial expansion of the bare portion 15 can be performed smoothly, just as when a stent graft 10 is placed in a straight blood vessel, thereby improving the reliability of the operation of the stent graft device 1.

[0044] Next, as a modification of the above embodiment, a configuration will be described in which two linear members are used to restrict the bearing portion 15 so that it can be converted from a reduced diameter state to an expanded diameter state. Figure 4 shows a first modified example of restricting the bearing portion 15 by winding a linear member. In the first modified example, the radial expansion of the bearing portion 15 is restricted by a first linear member 36a wound around the outer circumferential surface of the bearing portion 15 and a second linear member 36b that engages with the first linear member 36a.

[0045] The first linear member 36a is wound around the outer circumferential surface of the bearing portion 15 in a manner that it cannot maintain its wound state on its own, and is held in a way that prevents it from falling off by engaging with the second linear member 36b. In other words, the second linear member 36b holds the first linear member 36a in a way that prevents it from falling off the bearing portion 15 and the small-diameter shaft portion 32.

[0046] Specifically, the first linear member 36a is wound around the outer surface of the bearing portion 15 in the circumferential direction, bending with each rotation and wound in the opposite direction. The bent portions of the first linear member 36a are formed in the axial direction Ax. On the other hand, the second linear member 36b is positioned along the axial direction Ax, weaving through each bent portion of the first linear member 36a. In other words, the second linear member 36b is inserted through each bent portion of the first linear member 36a. Furthermore, the other end 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] In the example shown in Figure 4, the first linear member 36a and the second linear member 36b are engaged by winding the first linear member 36a around the second linear member 36b, which is positioned along the axial direction Ax, while hooking the bent portion onto it. At this time, the diameter of the bearing portion 15 can be reduced by applying tension by appropriately pulling both ends of the first linear member 36a.

[0048] Furthermore, the first linear member 36a is held in a wound state by its 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 small-diameter portion 32 of the shaft. This releases the restriction on the radial expansion of the bearing portion 15.

[0049] Here, the first linear member 36a and the second linear member 36b can be the same as those used for the linear member 36 described above. It is preferable that the first linear member 36a and the second linear member 36b are made of different materials to improve slipperiness and facilitate the removal of the second linear member 36b. Furthermore, it is preferable that the second linear member 36b is made of a material having predetermined strength and rigidity, while the first linear member 36a is made of a material with lower rigidity than the second linear member 36b. For example, the first linear member 36a can be made of suture thread such as nylon fiber or fluorofiber, or a resin string-like member, while the second linear member 36b can be made of a nickel-titanium alloy or a stainless steel metal wire. The first linear member 36a may also be formed in the shape of a wide tape. Note that the winding configuration of the first linear member 36a in the modified example shown in Figure 4 is just one example, and other winding configurations may be applied.

[0050] Next, a second modified example of the above embodiment will be described. In the description of the second modified example, elements similar to those in the above embodiment and the first modified example will be denoted by the same reference numerals, and any redundant explanations will be omitted.

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

[0052] Figure 5 is a perspective view showing the stent graft 10 attached to the small-diameter shaft portion 32 in the second modified example. Figure 6 is a diagram illustrating the arrangement of the first and second linear members 36a and 36b in the second modified example. Figure 7 is a perspective view showing an example of the configuration near the tip of the small-diameter shaft portion 32 in the second modified example. Figure 8 is an enlarged view of the wire holder portion 60 shown in Figure 7.

[0053] As shown in Figure 7, in the second modified example, the small-diameter shaft portion 32 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 retaining piece 62 that holds the second linear member 36b. The wire holder portion 60 shown in Figure 7 has two retaining pieces 62 spaced 180 degrees apart.

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

[0055] Furthermore, the base portion 61 of the wire holder portion 60 has a notch (receiving portion) 61a formed therein to receive the second linear member 36b passing through the hole 62a of the retaining piece 62. As shown in Figure 8, the notch 61a is cut radially inward from the circumferential surface of the base portion 61 and is formed continuously on both sides of the circumferential surface of the base portion 61, straddling the retaining piece 62. The notch 61a extends from one side of the base portion 61 to the other in a direction intersecting the circumferential direction. The notch 61a shown in Figures 7 and 8 has a shape in which the small diameter portion 32a of the shaft is exposed at the bottom surface. However, the notch 61a may have a bottom formed by the base portion 61, and the small diameter portion 32a of the shaft may not be exposed at the bottom surface.

[0056] In the example shown in Figure 8, the notch 61a is formed spirally on the circumferential surface of the base 61, straddling the retaining piece 62. This allows the second linear member 36b, which extends in the axial direction Ax, to be supported in the space of the notch 61a, which is located radially inward from the hole 62a of the retaining piece 62, when the second linear member 36b is passed through the hole 62a of the retaining piece 62.

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

[0058] Furthermore, as shown in Figure 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 arranging it along the shaft 30, the second linear member 36b can more easily follow the movement of the shaft 30 at bends in blood vessels, and the bending of the second linear member 36b away from the shaft 30 can be suppressed. By suppressing the bending of the second linear member 36b, the operation of withdrawing the second linear member 36b when releasing the stent graft 10 is also made easier. Note that the first linear member 36a may also be inserted through the wire guide rings 38.

[0059] When attaching the stent graft 10 to the small-diameter section 32 of the shaft, the bare portion 15 of the stent graft 10 is hooked onto and engaged with the hook piece 33 of the small-diameter section 32 of the shaft. Then, the first linear member 36a is wound around the outside of the bare portion 15 and the second linear member 36b that are engaged with the hook piece 33 in the circumferential direction, thereby reducing the diameter of the bare portion 15 and restricting its radial expansion. In the second modified example, the first linear member 36a is wound in the axial direction Ax at a position between the hook piece 33 and the wire holder portion 60. One end of the first linear member 36a extends to the other side of the shaft 30, passing inside the stent graft 10.

[0060] Furthermore, the first linear member 36a is tied to the second linear member 36b via the outside of the second linear member 36b, bundling the bare portion 15 together. The knot of the first linear member 36a is held in place by engaging with the second linear member 36b, preventing it from coming loose. This allows the framework of the bare portion 15 to remain closed. When the stent graft 10 is 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. This releases the knot of the first linear member 36a, and the restriction on the radial expansion of the bare portion 15 by the first linear member 36a is released.

[0061] In the second modified example, the knot of the first linear member 36a is lifted radially outward by passing through the second linear member 36b, which extends radially after passing through the wire holder portion 60, making it less likely to fall into the skeleton side (radially inward). As a result, when the stent graft 10 is released, the first linear member 36a is more likely to separate from the outside of the bare portion 15, and the phenomenon of the first linear member 36a wrapping around the bare portion 15 is suppressed.

[0062] Furthermore, in the second modified example, the knot of the first linear member 36a is fixed on one side of the wire holder portion 60 by the second linear member 36b, which has passed through the wire holder portion 60. Therefore, the first linear member 36a is prevented from shifting and falling towards the other side of the wire holder portion 60 or the stent graft 10.

[0063] Furthermore, the wire holder portion 60 can receive the second linear member 36b passing through the hole 62a of the retaining piece 62 in the space of the notch portion 61a. As a result, the amount by which the second linear member 36b protrudes radially outward from the surface of the wire holder portion 60 can be suppressed, making it easier to bundle the bare portion 15 compactly in the radial direction.

[0064] Furthermore, in the stent graft 10, a guide ring 17 is provided at one end of the coating portion 13 through which the first linear member 36a is inserted. By positioning the first linear member 36a through the guide ring 17, the movement of the first linear member 36a can be restricted when the stent graft 10 is released. This suppresses the occurrence of the first linear member 36a getting caught in the valleys of the skeleton when the first linear member 36a is recovered.

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

[0066] In the above embodiment, an example was described in which the linear member 36 is held in the holding hole 34a of the linear member holder 34, thereby restricting the radially outward displacement of the linear member 36. However, the means for restricting the radially outward displacement of the linear member 36 are not limited to the configuration of the above embodiment. For example, the linear member 36 that wraps around the bare portion 15 may be fixed with a biocompatible, soluble adhesive, and the constraint on the bare portion 15 by the linear member 36 may be released as the adhesive exposed outside the sheath 20 dissolves. Here, the adhesive can be, for example, a medical adhesive. Furthermore, the adhesive may be one that starts to dissolve at a temperature of about body temperature, or one that starts to dissolve upon contact with components of bodily fluids such as water or blood.

[0067] For example, in the above embodiment, a stent graft 10, which is placed inside a blood vessel, was given as an example of a tubular therapeutic device. However, the tubular therapeutic device may be placed in a biological lumen other than a blood vessel (for example, the digestive tract). Furthermore, the tubular therapeutic device may be a so-called bare stent, in which the skeletal portion 12 is not covered by the membrane portion 13.

[0068] Furthermore, the embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of the present invention is indicated by the claims rather than by the foregoing description, and all modifications within the meaning and scope equivalent to the claims are intended to be included. [Explanation of symbols]

[0069] 1...Indwelling device, 10...Stent graft (tubular treatment device), 11...Main body, 12...Skeleton, 13...Sheath, 15...Bare part (engaging part), 20...Sheath, 30...Shaft, 31...Shaft main body, 32...Shaft small diameter part, 33...Hook piece (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 part (receiving part), 62...Holding piece, 62a...Hole (holding part)

Claims

1. A tubular therapeutic device with an implantation device for implanting a radially expandable tubular therapeutic device into a biological lumen, The cylindrical therapeutic device having an engaging portion, A sheath capable of housing the aforementioned tubular treatment instrument, The sheath comprises a long, axial member configured to move back and forth along the axial direction of the sheath inside the sheath, The aforementioned axial member is A holder portion is formed that protrudes radially outward from the base provided on the axial member, The cylindrical therapeutic device has an engaged portion that engages with the engaging portion, The retaining device further includes a linear member that restricts the 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 disposed in the axial direction of the shaft-shaped member and engaging with the first linear member. The holder portion has a hole formed through the holder portion in the circumferential direction, and by inserting the second linear member through the hole, it holds the second linear member and restricts the radial displacement of the second linear member. The base portion includes a notch located radially inward from the position of the hole, which receives the second linear member inserted into the hole. Indwelling device with tubular treatment device.

2. The aforementioned notch is cut radially inward from the base and is formed to extend in a direction intersecting the circumferential direction. An indwelling device with a tubular therapeutic device according to claim 1.

3. The hole is an elongated hole that extends in the axial direction, The second linear member is positioned within the elongated hole at an angle to the direction in which the elongated hole penetrates. The indwelling device with a cylindrical therapeutic device according to claim 2.

4. The notches are formed continuously on both sides of the holder portion, straddling the hole, on the circumferential surface of the base portion. The indwelling device with a tubular therapeutic device according to claim 3.

5. The first linear member is detachable from the engaging portion and the axial member. The second linear member holds the first linear member in a manner that prevents it from falling out of the engagement portion. The radial expansion of the engagement portion is restricted when the first linear member and the second linear member are engaged, and the restriction is released when the engagement between the first linear member and the second linear member is released. An indwelling device with a cylindrical therapeutic device according to any one of claims 1 to 4.

6. The first linear member is wound around the outer circumference of the engaging portion in the circumferential direction, and bends and folds back in the opposite direction with each rotation. Multiple bent portions of the first linear member are formed in the axial direction, The second linear member is inserted through the bent portion of the first linear member to hold the first linear member. An indwelling device with a cylindrical therapeutic device according to any one of claims 1 to 4.

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