JP7494525B2 - Medical equipment - Google Patents

Description

The present invention relates to a medical device, and more particularly to a medical device in which a sheath is inserted into the body.

Medical devices include those that insert a sheath into a lumen inside the body to administer a drug, those that place a stent or stent graft, and those that use electrodes to cauterize a lesion.
Since lumens within the body are curved, medical devices that are equipped with a mechanism (steering) that can be operated to bend the distal portion of the sheath so that it fits the wall of the lumen are in general use.

For example, Patent Document 1 discloses a medical device (referred to as a catheter in the document) that bends the distal portion of a sheath (referred to as a catheter shaft in the document) by operating a handle to pull an operating wire (referred to as a pull wire in the document) fixed to the distal portion of the sheath.

International Publication No. 2014/182855

However, in the medical device described in Patent Document 1, the amount of operation of the handle is equal to the amount of pulling of the operating wire, so it is not easy to fine-tune the amount of bending of the sheath, and there is room for improvement in positioning the tip of the sheath so that it follows the lumen wall inside the body.

The present invention was made in consideration of the above-mentioned problems, and provides a medical device in which the tip of a sheath can be positioned so as to follow the lumen wall inside the body.

The medical device of the present invention comprises a base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that houses the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
a rotation limiting member for limiting rotation of the worm;
Equipped with
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line ,
The worm has a non-circular portion formed in a non-circular shape at a part thereof,
the rotation limiting member limits rotation of the worm by abutting against a surface of the non-rotating portion,
The worm is provided with a through hole extending in an axial direction,
a wall surface defining the through hole is the non-circular portion having a non-circular cross section;
The rotation limiting member is disposed so as to pass through the through hole and limits the rotation of the worm by abutting against the wall surface of the through hole .

The medical device of the present invention allows the tip of the sheath to be positioned along the lumen wall.

FIG. 2 is a schematic explanatory diagram showing the initial state of the delivery device according to the first embodiment (a state in which the stent graft is entirely contained within the outer sheath). FIG. 13 is a schematic explanatory diagram showing the delivery device in a pre-deployment state (a state in which the distal end of the stent graft is exposed from the outer sheath due to operation of the pre-deployment mechanism). 11 is a schematic explanatory diagram of a conveying device showing a state in which an outer worm is rotated about an axis to bend a tip portion of a sheath. FIG. 13 is a schematic explanatory diagram of a delivery device illustrating the operation of screwing the claws of the swing arm into the outer worm to deploy the stent graft. FIG. FIG. 2 is a schematic illustration of the delivery device showing the stent graft fully deployed. FIG. 13 is a schematic explanatory diagram of the delivery device showing a state in which the outer sheath has been returned to its initial position. FIG. 13 is a schematic explanatory diagram of the transport device showing a state in which the preliminary deployment mechanism has been returned to its initial position. FIG. 8 is a cross-sectional view taken along line VIII-VIII of FIG. 7. FIG. 8 is an explanatory diagram showing an enlarged view of part IX in FIG. 7 . FIG. 8 is a view taken in the direction of the arrow X in FIG. 7 . Figure 1 shows the transition of changes in sheath deflection when the outer sheath is pulled to deploy the stent graft, (a) showing the state when the outer sheath is pulled from a state in which the distal end of the sheath is bent 30 degrees without pre-deployment of the stent graft, and (b) showing the state when the outer sheath is pulled from a state in which the distal end of the sheath is bent 30 degrees after pre-deployment of the stent graft. 8A and 8B are drawings corresponding to the view taken in the X direction of FIG. 7, in which FIG. 8A shows an inner worm and a pipe guide according to a first modified example, and FIG. 8B shows an inner worm and a pipe guide according to a second modified example. 8A and 8B are drawings corresponding to the view taken in the X direction of FIG. 7, in which FIG. 8A shows an inner worm and a pipe guide according to a third modified example, and FIG. 8B shows an inner worm and a pipe guide according to a fourth modified example. FIG. 11 is a schematic perspective view showing a conveying device according to a second embodiment. FIG. FIG. 2 is a perspective view of the interior of the delivery device with the movable handle body and base removed. FIG. FIG. 4 is a schematic cross-sectional view for explaining the layout of an operating line. FIG. 4 is an explanatory diagram showing an initial state of the conveying device. 11 is an explanatory diagram showing a state of the conveying device when the sheath is bent. FIG. 13 is an explanatory diagram showing a state of the conveying device when the tension of the operating line is reduced. FIG. FIG. 13 is an explanatory diagram showing the state of the delivery device when the stent graft is deployed.

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.

First Embodiment
＜Overview＞
First, an overview of a medical device (transportation device 1) according to this embodiment will be described with reference mainly to Figs. 1 to 3.
Fig. 1 is a schematic explanatory diagram showing the initial state of the delivery device 1 according to the first embodiment (a state in which the stent graft 2 is entirely housed within the outer sheath 3Y). Fig. 2 is a schematic explanatory diagram showing the pre-deployment state of the delivery device 1 (a state in which the distal end of the stent graft 2 is exposed from the outer sheath 3Y by the operation of the pre-deployment mechanism PD). Fig. 3 is a schematic explanatory diagram of the delivery device 1 showing a state in which the outer worm 13 is rotated around the axis to bend the tip portion 3bb of the sheath 3.

In addition, in the drawings such as FIG. 1 and FIG. 2, an inner worm 12, an inner sheath 3X, and a pipe guide 6X, which will be described later, are shown overlapping each other.
10, a through hole 12c is formed in the center of the inner worm 12, and the inner sheath 3X and the pipe guide 6X pass through this through hole 12c. With this configuration, the inner worm 12, the inner sheath 3X, and the pipe guide 6X are configured to operate independently in the axial direction.

The medical device (transport device 1) of this embodiment comprises a base (distal portion 8Z of the device main body portion 8), a long, flexible sheath 3 connected to the distal end of the distal portion 8Z of the device main body portion 8, an operating wire 4 slidably inserted through the sheath 3 and having a distal side connected to the distal portion of the sheath 3, a worm (inner worm 12) with which the proximal side of the operating wire 4 is engaged and which has an outer circumferential thread 12b formed around an axis, and a cylindrical movable handle portion (outer worm 13) that houses the worm (inner worm 12) inside and has a screw portion (inner circumferential thread 13a) on its inner surface that screws into the outer circumferential thread 12b of the worm (inner worm 12).
A feature of this device is that when the movable handle portion (outer worm 13) is rotated around the axis, the worm (inner worm 12) moves in the axial direction, thereby adjusting the traction force of the operating wire 4.

The term "medical device" includes not only the delivery device 1 that delivers the stent graft 2 according to this embodiment, but also a catheter (not shown) capable of administering a drug.
The "threaded portion" is not limited to a portion formed in a threaded shape as long as it can be threadedly engaged with the outer peripheral thread 12b, and may be a protrusion disposed between the threads of the outer peripheral thread 12b.

In the above configuration, the movable handle portion (outer worm 13) is rotated to move the worm (inner worm 12) that screws into the screw portion (inner peripheral thread 13a) of the outer worm 13 in the axial direction. At this time, the operating wire 4, the proximal side of which is engaged with the worm (inner worm 12), is pulled or relaxed, thereby bending the tip portion 3bb of the sheath 3 or returning it to its original state from the bent state, thereby making it possible to finely adjust the position of the tip portion 3bb of the sheath 3 so that it fits along the lumen wall.
It should be noted that "bending" includes curvature, which is a gentle bend, as well as a sharp bend.

In addition, by screwing the worm (inner worm 12) and the outer worm 13 together, a self-locking function can be provided by friction, especially when the lead angle of the screwing is small. Therefore, when the tip 3bb of the sheath 3 is bent, a stopper is not required to maintain that state.

<About the action and function of the transport device>
First, the operation and function of the conveying device 1 will be described with reference to Figures 4 to 7 in addition to Figures 1 to 3. The details of the configuration of each part will be described later.
Fig. 4 is a schematic explanatory diagram of the delivery device 1 for explaining the operation when the claw portion 14a of the swing arm 14 is screwed into the outer worm 13 to deploy the stent graft 2. Fig. 5 is a schematic explanatory diagram of the delivery device 1 showing a state in which the stent graft 2 is completely deployed. Fig. 6 is a schematic explanatory diagram of the delivery device 1 showing a state in which the outer sheath 3Y has been returned to its initial position, and Fig. 7 is a schematic explanatory diagram of the delivery device 1 showing a state in which the preliminary deployment mechanism PD has been returned to its initial position.

As shown in Figure 1, the practitioner inserts the distal end of the sheath 3 with the stent graft 2 completely contained within the tip portion 3bb (between the inner sheath 3X and the outer sheath 3Y), for example, from the thigh of a subject (not shown). The practitioner inserts this sheath 3, for example, to a position near the aortic aneurysm, which is proximal to the position where the stent graft 2 is to be placed.

[Preliminary deployment operation]
Next, as shown in FIG. 2, the practitioner operates the preliminary deployment mechanism PD to expose the distal end of the stent graft 2 from the tip portion 3bb (distal portion 3Ya) of the sheath 3 (outer sheath 3Y).
Specifically, the practitioner moves the movable block 10a constituting the preliminary deployment mechanism PD in the distal direction so as to approach the proximal end of the proximal section 8X of the device main body 8. In this way, the inner sheath 3X and the push unit 11 move in the distal direction via the Y-shaped connector 22 connected to the movable block 10a.
Then, the stent graft 2, which is pushed distally by the push unit 11, moves in the distal direction relative to the outer sheath 3Y and becomes exposed from the distal portion 3Ya of the outer sheath 3Y.

When exposing the tip portion of the stent graft 2 from the outer sheath 3Y, if the outer sheath 3Y is pulled, the position of the load applied from the operating wire 4 to the outer sheath 3Y may shift, causing the tip portion 3bb of the sheath 3 to bend even more.
As described above, when pre-deploying a portion of the stent graft 2, by pushing in the push unit 11 without pulling the outer sheath 3Y, it is possible to suppress vibration of the distal portion 3Ya of the outer sheath 3Y and preferably expose the tip portion of the stent graft 2.
For example, with the tip portion 3bb of the sheath 3 bent by the operating wire 4, the tip portion of the stent graft 2 can be exposed from the outer sheath 3Y without moving the outer sheath 3Y containing the operating wire 4.

[Towing operation]
Furthermore, as shown in FIG. 3, the practitioner bends the distal end portion 3bb of the sheath 3 so that the sheath 3 is positioned along the site where the sheath 3 is to be inserted (for example, the aortic arch).
Specifically, the practitioner operates the traction mechanism PM to pull the operating wire 4, the distal portion of which is fixed to the distal portion 3Ya of the outer sheath 3Y, thereby bending the sheath 3 including the outer sheath 3Y.

In more detail, the practitioner pinches the proximal handle portion 13X or the distal handle portion 13Z and rotates the outer worm 13 in the circumferential direction around its axis without moving the outer worm 13 in the near or far direction. This causes the inner worm 12, which is threaded into the inner peripheral thread 13a of the outer worm 13, to move in the near or far direction. In this embodiment, when the outer worm 13 is rotated counterclockwise as viewed from the proximal side, the inner worm 12 moves to the distal side. On the other hand, when the outer worm 13 is rotated clockwise as viewed from the proximal side, the inner worm 12 moves to the proximal side.

Details will be described later, but because the inner worm 12 is restricted in its circumferential rotation by the pipe guide 6X etc., it is pushed by the inner peripheral thread 13a of the rotating outer worm 13 and moves in the near and far directions. As the inner worm 12 moves in this way, it pulls the operating wire 4, the proximal end 4a of which is fixed to the inner worm 12, by moving proximally, and loosens the pulling operating wire 4 by moving from the proximal side to the distal side.

When the operating wire 4 is pulled, the outer sheath 3Y to which the distal end of the operating wire 4 is fixed (or fixed via a ring, not shown) is pulled, and the distal portion 3Ya is bent. Conversely, when the operating wire 4 is loosened, the tensile force of the outer sheath 3Y is weakened, and the amount of bending of the distal portion 3Ya is reduced.
In addition, the movement of the outer worm 13 in the approach and far directions may be restricted by a locking mechanism (not shown).

[Deployment Operation]
Next, the practitioner performs an operation to deploy the stent graft 2 from the outer worm 13. First, the practitioner releases a locking mechanism that restricts the movement of the outer worm 13 in the near and far directions (not shown). After that, the practitioner moves the slide piece 15 proximally so that the claw portion 14a of the swing arm 14 screws into the outer peripheral thread 13b of the outer worm 13 (see FIG. 4), and presses and bends the swing arm 14 with the slide piece 15.

Then, the practitioner grasps the proximal handle portion 13X or the distal handle portion 13Z and rotates the outer worm 13 in the circumferential direction (counterclockwise when viewed from the proximal side) about its axis.
Then, because the outer peripheral screw 13b is screwed into the claw portion 14a, the outer worm 13 moves proximally in accordance with the amount of counterclockwise rotation of the outer worm 13.
As the outer worm 13 moves proximally, the outer sheath 3Y connected to the outer worm 13 moves proximally, gradually exposing the stent graft 2, whose proximal movement is restricted by the pusher 6, from the distal side to the proximal side.

In addition, when the outer worm 13 rotates counterclockwise, the inner worm 12 moves distally relative to the outer worm 13 because the inner circumferential thread 13a of the outer worm 13 is screwed into the outer circumferential thread 12b of the inner worm 12.
As a result, the proximal end of the operating wire 4 fixed to the inner worm 12 approaches the distal end of the operating wire 4 fixed to the distal portion 3Ya of the outer sheath 3Y.

Therefore, the traction force of the operating wire 4 on the outer sheath 3Y weakens as the practitioner rotates the outer worm 13 counterclockwise, in other words, as the practitioner moves the outer sheath 3Y proximally via the outer worm 13.
In other words, the outer sheath 3Y can be moved proximally to expose the stent graft 2 while reducing the amount of bending of the tip portion 3bb.

The bending angle of the stent graft 2 housed in the bent sheath 3 decreases toward the proximal side. When deploying the bent stent graft 2 from the bent sheath 3, it is advisable to move the outer sheath 3Y toward the proximal side in accordance with the bending angle of the stent graft 2 while weakening the traction force of the operating wire 4 pulling the outer sheath 3Y. In this way, the stent graft 2 can be placed in the desired position in the desired shape.

The practitioner further rotates the outer worm 13 counterclockwise to move the outer worm 13 to a position where the claw portion 14a is disengaged from the outer peripheral thread 13b of the outer worm 13. Here, the position where the claw portion 14a is disengaged from the outer peripheral thread 13b of the outer worm 13 is a position where the claw portion 14a of the swing arm 14 faces a part of the outer worm 13 that is farther away than the outer peripheral thread 13b. In other words, this position is a position where the claw portion 14a comes off the distal end of the outer peripheral thread 13b.

When the screwing is released as described above, the outer worm 13 can be freely moved proximally. The practitioner then moves the outer worm 13 into the storage section 8Xa in the proximal section 8X of the device main body 8, exposing the stent graft 2 to a position where the entire stent graft 2 can be deployed. The practitioner then pulls the trigger wire (not shown) to untie the suture (not shown), and elastically restores the stent graft 2 in the radial direction as shown in FIG. 5, placing the stent graft 2 in the desired position.

[Removal operation]
Next, in order to smoothly remove the sheath 3 from the body, the practitioner moves the outer worm 13 distally, as shown in FIG. 6, and moves the outer sheath 3Y connected to the outer worm 13 distally.
7, the surgeon moves the movable block 10a constituting the preliminary deployment mechanism PD away from the proximal section 8X to the proximal side. When the movable block 10a moves to the proximal side in this manner, the inner sheath 3X indirectly connected to the movable block 10a also moves to the proximal side, and the inner sheath 3X is housed in the outer sheath 3Y. Then, the distal tip 5 fixed to the inner sheath 3X comes into close contact with the outer sheath 3Y.
With the distal tip 5 thus in close contact with the outer sheath 3Y, the practitioner can smoothly remove the sheath 3 from inside the body to outside.

[others]
In the above description, the distal end of the stent graft 2 is pre-deployed from the outer sheath 3Y at the stage of aligning the placement site before bending the distal end 3bb of the sheath 3. This configuration makes it possible to avoid the phenomenon in which the distal end 3bb is further bent due to the load applied from the stent graft 2 to the distal end 3bb of the sheath 3 during pre-deployment.
However, the present invention is not limited to such a technique, and if the effect of the above-mentioned phenomenon on the shifting of the placement position of the stent graft 2 is small, the stent graft 2 may be pre-deployed with the tip 3bb of the sheath 3 bent.

<Details of the configuration of each part of the conveying device>
Next, the details of the configuration of each part of the conveying device 1 will be described mainly with reference to FIGS. 8 to 10 in addition to FIGS. 1 to 7.
8 is a cross-sectional view taken along line VIII-VIII in FIG. 7, FIG. 9 is an explanatory view showing an enlarged view of part IX in FIG. 7, and FIG. 10 is a view seen in the direction of the arrow X in FIG.

The medical device (delivery device 1) includes a self-expanding indwelling device (stent graft 2) housed in a sheath 3 in a contracted state.
The "retention device" may be anything that is held by the sheath 3 and retained within the subject's body, and includes, in addition to the stent graft 2, a bare stent that does not have a resin film cover (not shown), an artificial valve, or other retention devices that are retained within a biological lumen.

The sheath 3 is composed of an inner sheath 3X and an outer sheath 3Y that covers the radially outer side of a portion of the tip side of the inner sheath 3X.
A thermoplastic polymer material can be used as the material of the sheath 3. Examples of the thermoplastic polymer material include polyimide (PI), polyamideimide (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).

[Inner sheath]
As shown in FIG. 8, the inner sheath 3X according to this embodiment is composed of two members: a cylindrical inner sheath 3Xa through which a trigger wire (not shown) is passed, and a cylindrical inner sheath 3Xb through which a guide wire (not shown) is passed.
The trigger wire (not shown) is a wire for releasing a suture (not shown) that is restraining the bare stent portion when completely deploying the bare stent portion at the tip of the stent graft 2. The guide wire (not shown) is passed through the blood vessel in advance when the sheath 3 is inserted into the blood vessel, and guides the tip 3bb of the sheath 3 to the lesion.

The stent graft 2 according to this embodiment has a specified maximum deployment force of 40 N, an outer diameter of 34 mm, and a length of 130 mm.
As shown in FIG. 10, a base end side of the inner sheath 3X is housed in a stainless steel pipe guide 6X (described later), and at least a portion of a tip end side of the inner sheath 3X is housed in a through hole 6c formed in an axial center portion of a pusher 6 (described later), as shown in FIG.

As described above, the inner sheath 3X is composed of the inner sheaths 3Xa and 3Xb. However, in order to simplify the illustration and make it easier to understand, in figures other than FIG. 8, they are shown as an integrated unit called the inner sheath 3X.
It should be noted that the inner sheath 3X according to the present invention is not limited to such a configuration, and may be a single sheath in which a lumen for passing a guide wire and a lumen for passing a trigger wire are formed.

A tip tip 5 is joined to the tip of the inner sheath 3X. The tip tip 5 protects the tip of the outer sheath 3Y so that the sheath 3 (outer sheath 3Y) does not damage the blood vessel when it travels through the blood vessel.

[Outer sheath]
8, the outer sheath 3Y according to this embodiment is not uniform in thickness in the circumferential direction and is the outermost tube in the sheath 3. A lumen 3Yb is formed in the thick-walled portion of the outer sheath 3Y along the axial direction. The operating wire 4 is housed in the lumen 3Yb.
When the practitioner pulls the operating wire 4, a load corresponding to the amount of pulling is applied to the tip portion 3bb of the sheath 3, and the tip portion 3bb is bent by an amount corresponding to the load.
As shown in FIG. 9, a connector 3c is attached to the proximal end of the outer sheath 3Y and engages with the tip of the outer worm 13 (between the distal piece 13e and the engagement piece 13g).

The connector 3c engages with the outer worm 13 described below, which is movable in the near and far directions, allowing the outer sheath 3Y to slide proximally when the stent graft 2 is deployed and to slide distally when it is removed.
The connector 3c is configured to include a cylindrical portion 3ca to which the proximal end of the outer sheath 3Y is attached, and a flange portion 3cb with a through hole provided at the proximal end of the cylindrical portion 3ca. The radially outer end of the flange portion 3cb is inserted between a distal piece 13e provided at the distal end of the outer worm 13 described later and an engagement piece 13g provided with a space on the proximal side from the distal piece 13e. In this way, the connector 3c (outer sheath 3Y) and the outer worm 13 are engaged, and the engagement portion between the outer sheath 3Y and the outer worm 13 is connected so as to be freely rotatable in the circumferential direction.

As shown in FIG. 9, a protector 9 that prevents kinking (bending) of the sheath 3 (outer sheath 3Y) is fitted to the distal portion 8Z of the device main body 8, which will be described later. The distal end of the protector 9 is formed in a cylindrical shape, and the proximal end has a flange that expands in the radial direction. The protector 9 is fitted to the distal portion 8Z such that the flange of the protector 9 is embedded in the distal portion 8Z of the device main body 8.

The operating wire 4 bends the sheath 3 by pulling the tip portion 3bb of the sheath 3 at an eccentric position.
The distal end of the operating wire 4 is directly or indirectly fixed to the distal portion (tip portion 3bb, distal portion 3Ya) of the sheath 3 (outer sheath 3Y).

The distal end of the operating wire 4 in this embodiment is fixed to a stainless steel ring (not shown) provided at the tip of the outer sheath 3Y, and the proximal end is extended from inside the outer sheath 3Y through a side hole and is fixed to the inner worm 12 (see Figure 9).

More specifically, the distal side of the operating wire 4 is inside the outer sheath 3Y, and as shown in FIG. 9, it is pulled out from the circumferential surface of the outer sheath 3Y near the outer worm 13 and distal to the connector 3c, and extends to the inner worm 12. The operating wire 4 may be inserted through the flange portion 3cb of the connector 3c as shown in FIG. 9.

The operating wire 4 is disposed so as not to interfere with the distal piece 13 e and the engagement piece 13 g provided on the rotating outer worm 13 .
Specifically, the distal piece 13e and the engagement piece 13g are located radially outward from the position where the operating wire 4 is arranged, and are formed in a position where they are clamped and engaged with the flange portion 3cb of the connector 3c.

[Pre-deployment mechanism]
As shown in Figures 1 and 2, the preliminary deployment mechanism PD is mainly composed of an operating section 10, an inner sheath 3X to which the stent graft 2 is attached, a pipe guide 6X covering the outer periphery of the inner sheath 3X, and a pusher 6 connected to the pipe guide 6X.
As will be described later, the combination of the pipe guide 6X and the pusher 6 is also referred to as a push unit 11.

(Pipe guide)
As shown in FIG. 10, the medical device (transportation device 1) further includes a rotation limiting member (pipe guide 6X) that limits the rotation of the worm (inner worm 12).
The pipe guide 6X houses the base end side of the inner sheath 3X inside the device main body 8 described below, and has a function of guiding the forward and backward movement of the inner worm 12. The pipe guide 6X limits the rotation of the inner worm 12 by abutting against the surface of a non-rotating portion (inner circumferential surface 12a) of the inner worm 12 described below.

More specifically, the pipe guide 6X is arranged to pass through a through hole 12c of the inner worm 12 described later, and limits the rotation of the inner worm 12 by abutting against the wall surface (inner surface 12a) of the through hole 12c.
More specifically, when the outer worm 13 rotates, the pipe guide 6X restricts the rotation of the inner worm 12 that screws into the outer worm 13, thereby guiding the inner worm 12 to move only in the near and far directions.

In this embodiment, an outer peripheral surface 6Xa of the pipe guide 6X and an inner peripheral surface 12a of the inner worm 12 are formed to have a regular hexagonal cross section as shown in FIG.
In other words, the inner surface 12a, which faces the outer peripheral surface 6Xa of the pipe guide 6X and defines the through hole 12c of the inner worm 12 described later through which the pipe guide 6X passes, also has a shape similar to a regular hexagon in cross section so as to correspond to the outer peripheral surface 6Xa of the pipe guide 6X.
The maximum diameter of the outer circumferential surface of the pipe guide 6X is larger than the minimum diameter of the inner circumferential surface 12a of the inner worm 12. The inner wall surface of the pipe guide 6X is formed into a circular cross section.

According to the above configuration, the rotation limiting member (pipe guide 6X) abuts against the surface of the non-rotating portion (inner peripheral surface 12a) of the worm (inner worm 12), thereby limiting the rotation of the inner worm 12. Then, the inner worm 12 can be moved in the axial direction by rotating the movable handle portion (outer worm 13) having a female thread (inner peripheral thread 13a) that meshes with the inner worm 12.

The pipe guide 6X is disposed along the axis of the sheath 3 and is located so as not to touch the operating wire 4 which is located at a position offset from the axis. The pipe guide 6X enters the inside of the outer worm 13 from a through hole 13d (see FIG. 1) formed in a proximal piece 13c of the outer worm 13 described later, passes through a through hole 12c (see FIG. 10) of the inner worm 12, and passes through a through hole 13f (see FIG. 9) in a distal piece 13e of the outer worm 13, penetrating the outer worm 13.
The proximal side of the pipe guide 6X is fixed to the movable block 10a via a connector portion 22c at the distal end of a Y-shaped connector 22, which will be described later.

Although details will be described later, it is sufficient that at least a portion of the pipe guide 6X abuts when the inner worm 12 attempts to rotate so that the pipe guide 6X can restrict the rotation of the inner worm 12.
Furthermore, the means for restricting the rotation of the inner worm 12 is not limited to the pipe guide 6X through which the inner worm 12 passes, but may be a means that abuts against the outer surface of the inner worm 12 to restrict its movement.
Furthermore, it may be a rod-shaped object that is passed through a lumen formed in a part of the inner worm 12 (a part other than the center of the inner worm 12).

The preliminary deployment mechanism PD is constructed in a location different from the location where the operating wire 4 is arranged, and keeps the amount of fluctuation in the distance between the distal end and proximal end 4a of the operating wire 4 smaller than the amount of movement of the stent graft 2 when pushing out the stent graft 2.
In this embodiment, the "part where the operating wire 4 is disposed" is the outer sheath 3Y. More specifically, the operating wire 4 is disposed in the lumen 3Yb of the outer sheath 3Y as shown in Fig. 8, and is fixed to the distal portion 3Ya of the outer sheath 3Y via a ring (not shown) as described above.
As described above, the preliminary deployment mechanism PD according to this embodiment is made up of the operation section 10, which is different from the outer sheath 3Y, the inner sheath 3X, the pipe guide 6X, and the pusher 6.

According to the above configuration, the preliminary deployment mechanism PD can push out the stent graft 2 without directly operating the operating wire 4 via the outer sheath 3Y, while minimizing the amount of variation in the distance between the distal end and proximal end 4a of the operating wire 4.

[Operation section and push unit]
More specifically, the preliminary deployment mechanism PD comprises an operating unit 10 that can be operated relative to the sheath 3 on the distal side in the longitudinal direction of the sheath 3 by operation of the practitioner, and a push unit 11 that is connected to the operating unit 10 and is connected to the proximal end of the retention device (stent graft 2).

The operation unit 10 in this embodiment is provided with a movable block 10 a that allows sliding distally relative to the device body 8 .
More specifically, the operation unit 10 includes a movable block 10a and a plurality of slide cylinders 10b protruding distally from the distal surface of the movable block 10a.
In this specification, the term "operating portion" includes not only a portion that is directly operated by the practitioner, but also a portion of a portion that is subordinate to the directly operated portion.

The movable block 10a is attached to the proximal portion 8X of the device main body 8, and has a pipe guide 6X, a Y-shaped connector 22 and a flush port 21 fixed thereto.
A Y-shaped connector 22 is connected to the proximal side of the movable block 10a, and a connector portion 22c provided at the distal end of the Y-shaped connector 22 is connected to a pipe guide 6X of the push unit 11 described later.

The Y-shaped connector 22 is an entrance and exit for each of the two inner sheaths 3Xa and 3Xb.
A portion of the Y-shaped connector 22 that extends linearly from the connector portion 22c is connected to an inner sheath 3Xb for passing a guide wire (not shown). A hemostatic valve (not shown) is attached to the proximal end of the portion.

The branched portion of the Y-shaped connector 22 is connected to an inner sheath 3Xb for passing a trigger wire (not shown) used to maintain the stent graft 2 in a folded state. The end of the trigger wire (not shown) is attached to this portion. The trigger wire is a wire for final deployment of the stent graft 2, and a tip (not shown) is fixed to its proximal end.

A plurality of accommodation holes 8a for accommodating the slide cylinder 10b are formed in the proximal surface of the block at the proximal end of the proximal portion 8X of the device main body 8, which will be described later. The plurality of accommodation holes 8a are formed at positions corresponding to (facing) the slide cylinder 10b, and extend in the near and far directions.
A guide rod 8b that slidably supports a slide cylinder 10b from the hollow space side and guides its movement is disposed in the center of the accommodation hole 8a so as to extend in the near and far directions.

According to the above configuration, the push unit 11 connected to the operating unit 10 can be moved distally by sliding the operating unit 10 relative to the device body 8 using the movable block 10a, thereby pre-deploying the stent graft 2.

The flush port 21 is connected between the pipe guide 6X and the inner sheath 3X. The flush port 21 passes between the pipe guide 6X and the inner sheath 3X and serves as a fluid supply port for flushing (degassing) from the tip of the pusher 6 to the stent graft 2.

The push unit 11 is configured to be able to apply a load in the distal direction to the stent graft 2 by the operation of the operating section 10 .
The push unit 11 in this embodiment is composed of a long pipe guide 6X and a pusher 6 formed on an axial extension of the pipe guide 6X and arranged so that its rear end abuts against the tip end of the pipe guide 6X.

(Pusher)
The medical instrument (delivery device 1 ) is provided with a limiting member (pusher 6 ) capable of limiting the proximal movement of the stent graft 2 relative to the sheath 3 .
When deploying the stent graft 2 housed in the distal end 3bb of the sheath 3, the practitioner slides the outer sheath 3Y proximally (retraction side), causing the outer sheath 3Y to apply a frictional force to the stent graft 2. The pusher 6 is a cylindrical rod that comes into contact with the base end of the stent graft 2 at this time to limit the retraction of the stent graft 2.
That is, in this specification, "pushing" refers to the application of a passively generated force, in other words, an expression including a reaction force against the load received from the stent graft 2. The pusher 6 abuts against the stent graft 2 from the proximal side at a predetermined position, thereby restricting its movement.
The proximal end of the pusher 6 is butt-joined to a stainless steel pipe guide 6X. The proximal ends of the pipe guide 6X and the inner sheath 3X are fixed to a connector portion 22c at the distal end of the Y-shaped connector 22, and are connected to the movable block 10a via the connector portion 22c.

According to the above configuration, the practitioner can move the operation unit 10 so as to abut against the proximal portion 8X, and can operate the push unit 11 indirectly connected to the movable block 10a in the distal direction. Then, the practitioner can pre-deploy the stent graft 2 by moving the push unit 11 in the distal direction without moving the device main body 8 and the outer sheath 3Y.
For example, the pushing force for moving the operation unit 10 to operate the preliminary deployment mechanism is preferably set to approximately 50 N or more.

The push unit 11 (each of the pipe guide 6X and the pusher 6) has a through hole extending in the longitudinal direction. The inner sheath 3X is disposed through this through hole.
According to the above configuration, the push unit 11 and the guide wire (not shown) that is passed through the inner sheath 3Xa can be arranged coaxially in the longitudinal direction. Then, the stent graft 2 can be placed by the push unit 11 at the end where the inner sheath 3Xa is guided by the guide wire.

[Device body]
As shown in FIG. 1 , the transport device 1 includes a device main body 8 that houses at least a portion of the movable handle portion (outer worm 13 ) and supports a portion of the circumferential surface of the sheath 3 .
The device main body 8 is composed of a proximal portion 8X having a storage section 8Xa capable of storing an outer worm 13, an intermediate portion 8Y having a swing arm 14 and a slide piece 15, and a distal portion 8Z having a protector 9 that holds the sheath 3.

The middle portion 8Y of the device body 8 includes a protrusion (claw portion 14a of the swing arm 14) that protrudes into the thread groove between the threads of the outer peripheral screw 13b of the outer worm 13 and is capable of slidingly contacting the thread groove.
The proximal end 4a of the operating wire 4 is directly or indirectly held by the device main body 8. In the present embodiment, the proximal end 4a of the operating wire 4 is fixed to the inner worm 12 and indirectly held by the device main body 8 via the inner worm 12 and the outer worm 13.
Although it has been described that the proximal end 4a of the operating wire 4 is held directly or indirectly by the device main body 8, it does not need to be held therein at all times, and it is sufficient that it be held therein when the preliminary deployment mechanism PD is operating, as in this embodiment.

[Deployment mechanism, traction mechanism, and traction force change unit]
The delivery device 1 comprises a deployment mechanism DM that operates to fully deploy the stent graft 2, a traction mechanism PM that can pull the operating wire 4, and a traction force change unit PS that changes the traction force in accordance with the deployment operation of the stent graft 2.

The deployment mechanism DM is mainly configured to include an outer worm 13 and an outer sheath 3Y connected to the outer worm 13.
The traction mechanism PM in this embodiment is specifically composed of an inner worm 12, an outer worm 13 that is screwed into the inner worm 12 and moves the inner worm 12 in the longitudinal direction by rotating around the axial direction, and an operating wire 4 connected to the inner worm 12 and the outer sheath 3Y.
The push unit 11 is disposed inside the device body 8 in the longitudinal direction of the sheath 3 through the traction mechanism PM.

According to the above configuration, the push unit 11 passes through the traction mechanism PM in the longitudinal direction of the sheath 3 and is disposed along the axis of the sheath 3, making it easier for the push unit 11 to apply a load to the retention device (stent graft 2) supported by the sheath 3.

The traction force change unit PS changes the traction force of the outer sheath 3Y when the relative position between the restricting member (pusher 6) and the outer sheath 3Y is changed so that the sheath 3 (outer sheath 3Y) is positioned relatively proximally.
The traction force changing unit PS (the inner worm 12, the outer worm 13, and the swing arm 14) changes the traction force of the operating wire 4 by making the amount of movement of the worm (the inner worm 12) in the direction pulling the distal side of the operating wire 4 smaller than the amount of movement of the sheath 3 in the retraction direction by the movable handle unit (the outer worm 13) relative to the pusher 6. The configuration of the traction force changing unit PS will be described in detail later.

According to the above configuration, the amount of movement of the engagement portion (inner worm 12) in the direction of pulling the distal side of the operating wire 4 is made smaller than the amount of movement of the sheath 3 (outer sheath 3Y) in the retraction direction by the movable handle portion (outer worm 13) relative to the restricting member (pusher 6), thereby weakening the traction force of the operating wire 4 when pulling the sheath 3 to expand the retention device (stent graft 2).

(Inner Warm)
10, the inner worm 12 has an inner circumferential surface 12a partially formed in a non-circular shape (a hexagonal shape having a non-circular cross section). A through hole 12c extending in the axial direction is provided in the central portion of the inner worm 12. The wall surface (inner circumferential surface 12a) defining the through hole 12c is a non-circular portion formed with a non-circular cross section so as to move in the approach and distance directions along the outer surface of the pipe guide 6X.
The inner worm 12 has an outer surface formed with a thread that is adapted to be screwed into an inner peripheral thread 13 a of the outer worm 13 .

The inner worm 12 is housed inside the outer worm 13, and a proximal end 4a of the operating wire 4 is fixed to a part of the inner worm 12.
More specifically, the proximal side of the operating wire 4 is disposed inside the outer surface of the inner worm 12 in the radial direction of the worm (inner worm 12).
In this embodiment, the proximal end of the operating wire 4 is embedded in the inner worm 12 .

According to the above configuration, the proximal side of the operating wire 4 is disposed inside the outer surface of the inner worm 12, so that the engagement between the outer surface of the inner worm 12 and the inner peripheral thread 13a of the movable handle portion (outer worm 13) can be prevented from interfering with the traction of the operating wire 4.

(Outer Warm)
The outer worm 13 is used as a deployment mechanism DM to pull the outer sheath 3Y proximally, and is also used as a traction mechanism PM to move the inner worm 12 in the axial direction.

The movable handle portion (outer worm 13) is directly or indirectly connected to the sheath 3 (outer sheath 3Y) in the axial direction of the sheath 3.
Specifically, the outer worm 13 according to this embodiment is indirectly connected to the sheath 3 by a connector 3c having a flange portion 3cb disposed between a distal piece 13e and an engagement piece 13g.

The outer worm 13 is not limited to being indirectly connected to the sheath 3 via the connector 3c. For example, a hole (not shown) through which the sheath 3 can pass may be formed in a portion of the tip side of the outer worm 13, and the sheath 3 may be passed through the hole in a radially contracted state, so that the elastic restoring force of the sheath 3 directly engages the wall surface of the hole.

The outer worm 13 includes a proximal handle portion 13X and a distal handle portion 13Z, which are located at positions sandwiching the outer peripheral thread 13b in the axial direction and which are touched when the practitioner operates the outer worm 13. The proximal handle portion 13X and the distal handle portion 13Z are formed to protrude radially outward beyond other portions.
The practitioner can touch the proximal handle portion 13X and the distal handle portion 13Z through an opening formed in the middle portion 8Y of the device main body 8, which connects the outside and the inside, and perform rotational operations on the outer worm 13 and movement in the near and far directions.

According to the above configuration, the sheath 3 connected to the outer worm 13 can be moved proximally by pulling the movable handle portion (outer worm 13) proximally in the axial direction. Then, the retention device (stent graft 2), whose movement proximally is restricted by the restricting member (pusher 6), can be expanded from the sheath 3.

An inner circumferential thread 13a that screws into the inner worm 12 is formed on the inner surface of the outer worm 13, and an outer circumferential portion of the outer worm 13 is provided with an outer thread (outer circumferential thread 13b) that screws into the swing arm 14 described later.
The inner thread (inner peripheral thread 13a) and the outer peripheral thread 13b, which are screw-engagement portions provided on the outer worm 13, are twisted in opposite directions.

The outer worm 13 has an inner worm 12 built in, and when the tip 3bb of the sheath 3 is bent, the axial movement is locked by a locking member (not shown), making it possible to rotate (freely rotate) in the circumferential direction in the same position without moving in the approach or retreat direction.
When the outer worm 13 is rotated idly, the inner worm 12 that is screwed into the inner peripheral thread 13a of the outer worm 13 moves in the front-rear direction.

In this embodiment, the claw portion 14a of the swing arm 14 is exemplified as the "protrusion" that protrudes into the thread groove of the outer peripheral thread 13b.
Since the "protrusion" is the claw portion 14a of the swing arm 14, it is possible to adjust the state in which the claw portion 14a is screwed into the outer peripheral thread 13b and the state in which it is not screwed by switching the swing position. Therefore, by releasing the screwing, the outer worm 13 can be rapidly moved forward when the stent graft 2 is exposed from the outer sheath 3Y.
However, the “protrusion” according to the present invention is not limited to the one having the swing arm 14, but may be a protruding piece (not shown) formed on the outer worm 13 without being deformed.

According to the above configuration, with the protrusion (claw portion 14a of the swing arm 14) disposed within the thread groove of the external thread (peripheral thread 13b), the outer worm 13 can be moved in the axial direction of the sheath 3 by rotating the movable handle portion (outer worm 13) relative to the device body portion 8. This movement causes the sheath 3 connected to the outer worm 13 to move in the axial direction.

The inner worm 12, to which the proximal side of the operating wire 4 is connected, is engaged with the inner thread (inner circumferential thread 13a) of the outer worm 13, which is a reverse thread to the outer thread (outer circumferential thread 13b), and therefore moves in the opposite direction to the axial movement of the movable handle part (outer worm 13).
That is, when the sheath 3 is moved proximally to expand the indwelling device (stent graft 2), when the outer worm 13 is moved proximally, the inner worm 12 moves distally relative to the outer worm 13. This weakens the traction force of the operating wire 4 connected to the inner worm 12. In this way, the inner worm 12, the outer worm 13, and the swing arm 14 function as a traction force changing unit PS.

The slide piece 15 functions to screw the claw portion 14a of the swing arm 14 shown in Fig. 4 into and release the screwing from the outer worm 13. The slide piece 15 is formed in a tapered cross section so as to protrude toward the outer worm 13 side as it moves toward the distal side.
By sliding the slide piece 15 proximally, the oscillating arm 14 formed on the outer worm 13 side of the slide piece 15 deforms toward the outer worm 13 side, and the claw portion 14a engages with the outer peripheral thread 13b of the outer worm 13.

In this state, the practitioner can grasp the proximal handle portion 13X or the distal handle portion 13Z (described later) and rotate the outer worm 13 (counterclockwise) to slowly retract the outer worm 13 proximally. At the same time that the outer worm 13 rotates and retracts, the outer sheath 3Y engaged with the outer worm 13 by the distal piece 13e and the engagement piece 13g is pulled by the outer worm 13 and similarly retracts.
In other words, with the claw portion 14a of the swing arm 14 screwed into the outer peripheral screw 13b, the outer worm 13 moves proximally while rotating relative to the device main body 8, thereby moving the sheath 3 in the retracting direction.

At that time, the inner worm 12 that is screwed into the inner peripheral thread 13a of the outer worm 13 advances relatively to the outer sheath 3Y (outer worm 13). Due to this advancement of the inner worm 12, the operating wire 4 gradually loosens in accordance with the movement of the outer sheath 3Y toward the proximal side.
Then, as the tension applied to the distal portion 3Ya of the outer sheath 3Y decreases, the curvature of the bent tip portion 3bb of the sheath 3 gradually decreases.
In other words, the inner worm 12, outer worm 13 and oscillating arm 14, which serve as the traction force changing unit PS, make the amount of movement of the worm (inner worm 12) in the direction pulling the distal side of the operating wire 4 smaller than the amount of movement of the sheath 3 in the retraction direction by the movable handle unit (outer worm 13) relative to the pusher 6.

Furthermore, by changing the ratio between the pitch of the threads of the inner screw 13a and the inner worm 12 and the pitch of the threads of the outer screw 13b, the amount of slack in the operating wire 4 relative to the amount of proximal movement of the outer sheath 3Y can be adjusted.
In other words, by making the pitch of the threads of the inner screw 13a and the inner worm 12 larger than the pitch of the threads of the outer screw 13b, the amount of slack in the operating wire 4 when the outer sheath 3Y moves proximally can be increased.

Moreover, it is more preferable to provide a stopper (not shown) that locks the position of the outer worm 13 and the device main body 8 so that the outer worm 13 does not move in the far-near direction when the inner worm 12 moves in the far-near direction to bend the sheath 3.

In this embodiment, the operating wire 4 is pulled out from (a side hole provided in) the side surface of the proximal end of the outer sheath 3Y and extends toward the inner worm 12.
However, this configuration is not limited to this, and as long as the connector 3c is provided with a through hole (not shown) for passing the operating wire 4 therethrough, or the like, so long as the connector 3c is configured so as not to interfere with the positioning, the operating wire 4 may be pulled out from the proximal end face of the outer sheath 3Y and arranged to extend linearly to the inner worm 12.

With this configuration, the operating wire 4 can be pulled linearly along the axis thereof, thereby improving the bending response of the distal portion 3Ya of the outer sheath 3Y.
In particular, it is preferable that the operating wire 4 is arranged so as not to come into contact with the outer worm 13 such as the distal piece 13e and the engagement piece 13g, since this does not impede the rotation of the outer worm 13.

<Sheath behavior>
Next, mainly with reference to FIG. 11, the behavior of the sheath 3 when the stent graft 2 is deployed will be described.
Figure 11 is a diagram showing the transition of change in the deflection of the sheath 3 when the outer sheath 3Y is pulled to deploy the stent graft 2, with Figure 11(a) being a diagram when the outer sheath 3Y is pulled from a state in which the distal end 3bb of the sheath 3 is bent by 30 degrees without pre-deploying the stent graft 2. Figure 11(b) is a diagram when the outer sheath 3Y is pulled from a state in which the distal end 3bb of the sheath 3 is bent by 30 degrees after the stent graft 2 has been pre-deployed.

If the pre-deployment mechanism PD is not operated and the stent graft 2 is not pre-deployed, and the outer worm 13 is operated to deploy the stent graft 2, the tip 3bb of the sheath 3 will swing significantly, as shown in Figure 11 (a).
Specifically, when the tip 3bb of the sheath 3 (outer sheath 3Y) is bent 30 degrees by pulling the operating wire 4 (state (1)), and the outer worm 13 is operated to pull the outer sheath 3Y proximally, the amount of bending of the sheath 3 (inner sheath 3X) gradually increases until the stent graft 2 begins to be exposed from the sheath 3 (state (2)).

This is because a frictional force (reaction force) having a component in a direction that further bends the outer sheath 3Y is applied from the distal end of the stent graft 2, the movement of which is restricted by the pusher 6, to the outer sheath 3Y.
As the amount of the stent graft 2 exposed from the sheath 3 increases, the frictional force that the outer sheath 3Y receives from the stent graft 2 gradually decreases, and accordingly the amount of bending of the sheath 3 decreases until it is completely exposed (the stent state (3)).

When the pre-deployment mechanism PD is operated to pre-deploy the stent graft 2 (the distal end of the stent graft 2 is exposed from the outer sheath 3Y), and the outer worm 13 is then operated to deploy the stent graft 2, vibration of the tip 3bb of the sheath 3 is suppressed, as shown in Figure 11 (b).
Specifically, after the stent graft 2 is pre-deployed, the tip 3bb of the sheath 3 (outer sheath 3Y) is bent 30 degrees by pulling the operating wire 4 (state (1)), and then the outer worm 13 is operated to pull the outer sheath 3Y proximally, so that the stent graft 2 begins to be further exposed from the sheath 3 (state (2)).
At this time, since the distal end of the stent graft 2 is exposed from the outer sheath 3Y during pre-deployment, no frictional force is applied to the outer sheath 3Y from the distal end of the stent graft 2, and therefore the outer sheath 3Y does not bend further.

As the amount of the stent graft 2 exposed from the sheath 3 increases, the frictional force that the outer sheath 3Y receives from the stent graft 2 gradually decreases, and accordingly the amount of bending of the sheath 3 decreases until it is completely exposed (stent state (3)).
In this manner, by operating the pre-deployment mechanism PD before bending the stent graft 2, the vibration of the sheath 3 can be effectively suppressed.

Furthermore, even after the outer sheath 3Y has been bent, it is advisable to operate the preliminary deployment mechanism PD before operating the outer worm 13 to pull and deploy the outer sheath 3Y.
The state in which the outer sheath 3Y is bent is a state in which the inner worm 12 is moved proximally relative to the outer worm 13 and the distal portion 3Ya of the outer sheath 3Y is pulled by the operating wire 4. In this state, if the outer sheath 3Y is pulled proximally without operating the preliminary deployment mechanism PD, the connection portion between the outer sheath 3Y and the operating wire 4 will move over the distal end portion of the stent graft 2 and approach the proximal side.
In this way, when the connection portion between the outer sheath 3Y and the operating wire 4 passes over the distal end of the stent graft 2, a large frictional force is applied from the stent graft 2 to the outer sheath 3Y, causing large vibrations of the sheath 3 (inner sheath 3X).

On the other hand, if the preliminary deployment mechanism PD is operated after bending the outer sheath 3Y and before pulling the outer sheath 3Y proximally, the stent graft 2 can be protruded distally from the outer sheath 3Y before the connection portion between the outer sheath 3Y and the operating wire 4 approaches the proximal side.
This makes it possible to avoid application of a load to the outer sheath 3Y from the distal end of the stent graft 2, and to pull the outer sheath 3Y proximally relative to the stent graft 2, thereby minimizing the vibration of the sheath 3.

<Modification>
The pipe guide 6X that abuts against the inner peripheral surface 12a of the inner worm 12 and restricts the rotation of the inner worm 12 according to the above embodiment has been described as having an outer peripheral surface 6Xa with a regular hexagonal cross section. This configuration is preferable in terms of ease of processing, but the present invention is not limited to this configuration.

Next, a modified combination of an inner worm and a pipe guide capable of restricting rotation of the inner worm will be described with reference to Figs. 12 and 13 .
Figure 12 is a drawing corresponding to the view seen from the X direction arrow in Figure 7, where Figure 12(a) is a drawing showing an inner worm 12S and a pipe guide 6S relating to a first modified example, and Figure 12(b) is a drawing showing an inner worm 12T and a pipe guide 6T relating to a second modified example.
Figure 13 is a drawing corresponding to the view seen from the X direction arrow in Figure 7, where Figure 13(a) is a drawing showing an inner worm 12U and a pipe guide 6U relating to a third modified example, and Figure 13(b) is a drawing showing an inner worm 12V and a pipe guide 6V relating to a fourth modified example.

As shown in FIG. 12(a), the pipe guide 6S, which serves as a member for limiting the rotation of the inner worm 12S in the first modified example, has two ridges 6Sd on the outer circumferential surface 6Sa that protrude radially outward from the periphery and extend in the axial direction. The two ridges 6Sd in this example are formed at positions offset by 180 degrees from the axis of the pipe guide 6S.

The inner worm 12S has an inner peripheral surface 12Sa having a U-shaped groove 12Sd as a non-circumferential portion. The U-shaped groove 12Sd is formed at a position to accommodate a part of the two protrusions 6Sd, that is, at a position shifted by 180 degrees from the axis of the inner worm 12S.
The pipe guide 6S restricts the rotation of the inner worm 12S by abutting the opposing protrusions 6Sd against the surfaces of two U-shaped grooves 12Sd in the inner peripheral surface 12Sa.

In particular, the length of the protrusion 6Sd protruding from the axis is longer than the shortest length of the inner circumferential surface 12Sa from the axis, and shorter than the length to the bottom of the U-groove 12Sd. The radius of curvature of the U-groove 12Sd is larger than the radius of curvature of the protrusion 6Sd.

In the above description, two protrusions 6Sd and two U-grooves 12Sd for accommodating the protrusions 6Sd are provided. This configuration is preferable because it reduces the gap between the pipe guide 6S and the inner worm 12S while not restricting the relative axial movement of the inner worm 12S with respect to the pipe guide 6S, but the present invention is not limited to this configuration.
In other words, the number of protrusions 6Sd and the number of inner worms 12S may be more than one, or conversely, only one of each may be provided.

As shown in FIG. 12(b), the pipe guide 6T, which serves as a member for limiting the rotation of the inner worm 12T in the second modified example, has a single flat surface 6Td extending in the axial direction on its outer circumferential surface 6Ta. The single flat surface 6Td in this example has a shape formed by cutting a part of the cylindrical shape of the pipe guide 6T along a surface parallel to the axis.

The inner worm 12T has an inner circumferential surface 12Ta having a flat portion 12Td as a non-circumferential portion.
The flat surface portion 12Td of the inner circumferential surface 12Ta is formed at a position facing the one flat surface portion 6Td.
The pipe guide 6T limits the rotation of the inner worm 12T by abutting the flat portion 6Td against the flat portion 12Td of the inner circumferential surface 12Ta.

In particular, the shortest length from the axis of the pipe guide 6T to the circumferential edge of the flat portion 6Td is longer than the shortest length from the axis of the inner worm 12T (pipe guide 6T) to the flat portion 12Td.

As shown in FIG. 13(a), the pipe guide 6U, which serves as a member for limiting the rotation of the inner worm 12U in the third modified example, has a V-shaped groove 6Ud extending in the axial direction on the outer circumferential surface 6Ua.

The inner worm 12U has an inner circumferential surface 12Ua having a sharp protrusion 12Ud as a non-circumferential portion.
The sharp-pointed protrusion 12Ud is disposed at a position facing the V-groove 6Ud, and the tip of the sharp-pointed protrusion 12Ud is received in the V-groove 6Ud.
The pipe guide 6U limits the rotation of the inner worm 12U by the inclined surface forming the V-groove 6Ud coming into contact with the sharp protrusion 12Ud of the inner circumferential surface 12Ua.

As shown in FIG. 13(b), the pipe guide 6V, which serves as a member for limiting the rotation of the inner worm 12V in the fourth modified example, has one groove 6Vd extending in the axial direction on the outer circumferential surface 6Va.

The inner worm 12V has an inner circumferential surface 12Va having a protruding portion 12Vd as a non-rotating portion.
The convex portion 12Vd is disposed at a position facing the concave groove 6Vd, and the tip portion of the convex portion 12Vd is received in the concave groove 6Vd.
The pipe guide 6V restricts the rotation of the inner worm 12V by abutting the side surface forming the concave groove 6Vd against the convex portion 12Vd of the inner peripheral surface 12Va.

The U-groove 12Sd, the flat portion 12Td, the sharp protrusion 12Ud, and the convex portion 12Vd may be formed in a portion of the axial direction of the inner worms 12S, 12T, 12U, and 12V.
In addition, the protrusion 6Sd, the flat portion 12Td, the sharp protrusion 12Ud, and the convex portion 12Vd are shown in Figures 12 and 13 as being integral with the pipe guide or the inner worm, but they may also be keys (that fit into key grooves) formed separately from these.

<<Second embodiment>>
＜Overview＞
Next, the configuration of a conveying device 1X according to a second embodiment will be described with reference mainly to FIGS.
FIG. 14 is a schematic perspective view showing a conveying apparatus 1X according to the second embodiment, and FIG. 15 is a vertical cross-sectional view of the conveying apparatus 1X.
FIG. 16 is a perspective view showing the inside of the transport device 1X with the movable handle body 33 and base 35 removed, and FIG. 17 is a front view showing the worm 32. As shown in FIG.
FIG. 18 is a schematic cross-sectional view for explaining the layout of the operating wire 4. As shown in FIG.

The medical device (transportation device 1X) of the second embodiment comprises a base 35, a long, flexible sheath 3 connected to the distal end (protector 35a) of the base 35, an operating wire 4 slidably inserted through the sheath 3 and having a distal side connected to the distal part of the sheath 3, a worm 32 (see Figures 15 to 18) with which the proximal side of the operating wire 4 is engaged and which has an outer circumferential thread 32b formed around the axis, and a cylindrical movable handle portion (movable handle main body 33) that houses the worm 32 inside and has a screw portion (inner circumferential thread 33a) on its inner surface that screws into the outer circumferential thread 32b of the worm 32.
When the movable handle portion (movable handle body 33) is rotated about the axis, the worm 32 moves in the axial direction, thereby adjusting the traction force of the operating wire 4.

According to the above configuration, the movable handle part (movable handle body 33) is rotated, and the worm 32 that is screwed into the screw part (internal thread 33a) of the movable handle part (movable handle body 33) is moved in the axial direction. At this time, the operating wire 4, the proximal side of which is engaged with the worm 32, is pulled or loosened, so that the tip 3bb of the sheath 3 can be bent or returned to its original state from the bent state.

<Configuration>
Next, the configuration of each part of the transport device 1X according to the second embodiment will be described in detail. Although not shown, the transport device 1X is equipped with a preliminary deployment mechanism PD, similar to the transport device 1 according to the first embodiment. In other words, the transport device 1X is equipped with the movable block 10a and the Y-shaped connector 22 according to the first embodiment, etc., on the proximal side of the end plate 36f. The presence or absence of the preliminary deployment mechanism PD is optional.

(Guide tube)
The conveying device 1X according to this embodiment further includes a guide tube 36 extending in the axial direction so as to insert a worm 32 (described later) therethrough and guide the axial movement of the worm 32.
The pusher 6 is passed through the guide tube 36, and a sheath support joint 34, which will be described later, is attached to the guide tube 36 on the tip side rather than the central portion.

An outer peripheral surface 36e of the guide tube 36 is formed with a non-circular cross section, and the guide tube 36 functions as a rotation limiting member by abutting against the surface of the non-rotating portion (the inner peripheral portion 32a of the worm 32).
A "non-circular cross section" is a cross-sectional shape that is not circular, and includes straight lines and arcs with different central angles.

The guide tube 36 according to this embodiment is formed by two-way machining (machining both ends in the radial direction to form two parallel planes) from a cylindrical material. As a result, the outer circumferential surface 36e of the guide tube 36 (excluding the slit 36c portion) has a non-circular cross section formed by two parallel sides and an arc.

The inner peripheral portion 32a of the worm 32, which will be described later, also has a non-circular cross section formed by two parallel sides and an arc, and has a shape similar (including approximately similar) to the cross section of the outer peripheral surface 36e of the guide tube 36 excluding the slit 36c.

According to the above-described configuration, the guide tube 36 allows the worm 32 to move smoothly in the axial direction.
In particular, since the outer peripheral surface 36e of the guide tube 36 is formed with a non-circular cross-section, the rotation of the worm 32, which similarly has a non-circular cross-section and is configured to be able to abut against the guide tube 36, can be restricted, thereby effectively guiding the axial movement of the worm 32.

Further, the guide tube 36 is formed with a guide tube side insertion portion (slit 36c) through which the operating wire 4 passes from the inside to the outside.
Four slits 36c are formed at 90° intervals with the central axis as a central angle, and extend in the axial direction through the thickness direction of the guide tube 36. Note that, on the proximal side of the guide tube 36, the plate side separated by the slits 36c is also referred to as an extension piece 36b extending in the axial direction.
According to the above configuration, it is possible to prevent the guide tube 36 from interfering with the routing of the operating wire 4 to the worm 32 .

In particular, the slit 36c extending in the axial direction is preferable in that it allows the operating wire 4 to move over a wide range.
Specifically, when the sheath support joint 34 is moved axially relative to the guide tube 36 and the outer sheath 3Y is pulled, even if the portion where the operating wire 4 comes out of the outer sheath 3Y moves relatively in the axial direction, the slit 36c prevents the guide tube 36 from interfering with the pulling of the operating wire 4.

The "guide tube side insertion portion" may be anything that allows the operating wire 4 to pass through the guide tube 36 so that the guide tube 36 does not interfere with the pulling of the operating wire 4. In other words, the "guide tube side insertion portion" is not limited to the slit 36c, but may be a hole or groove that penetrates the inside and outside of the guide tube 36.

(Warm)
The worm 32 pulls the operating wire 4 in accordance with the amount of rotation of the movable handle body 33, thereby bending the tip portion 3bb of the sheath 3.
As described above, the inner peripheral portion 32a of the worm 32 has a shape similar to the cross section of the outer peripheral surface 36e of the guide tube 36 excluding the slits 36c, and is formed slightly larger than the outer peripheral surface 36e of the guide tube 36.

The proximal side of the operating wire 4 according to the second embodiment is disposed inside the outer surface of the worm 32 in the radial direction of the worm 32 .
17 and 18, two insertion holes 32d that run parallel to the axial direction are formed in a thick-walled portion that is on the inside of the outer surface of the worm 32. Each of the two insertion holes 32d is located opposite one of the two insertion holes 34d of the sheath support joint 34.
The operating wire 4 is passed through one of the insertion holes 34d from the distal side to the proximal side, folded back on the proximal side of the worm 32, and passed through the other insertion hole 34d from the proximal side to the distal side.

In particular, the operating wire 4 is passed through one of the four slits 36c provided in the two-way portion of the guide tube 36, and is attached by passing through a sheath support joint 34 and a worm 32, which will be described later. With this configuration, it becomes possible to pass the operating wire 4 through an insertion hole 32d in a thick portion of the worm 32 that faces the two-way portion of the guide tube 36, among the worm 32 attached around the guide tube 36.
Therefore, the effect of a decrease in strength of the worm 32 caused by providing the insertion hole 32d can be suppressed.

18, an operating line fastener 39 is attached to a portion of the operating line 4 by crimping or the like. The operating line fastener 39 is for attaching a portion of the operating line 4 to the worm 32 and linking the operation of the worm 32 with the pulling operation of the operating line 4. The operating line fastener 39 is fixed to the proximal end of the worm 32 by adhesion or the like.
In addition, in FIG. 18, the folded portion on the proximal side of the operating line 4 is shown as intersecting the pusher 6 and the inner sheath 3X, but in reality, it is arranged in a detour so as not to intersect with the pusher 6 and the inner sheath 3X.

(Movable handle body)
When the practitioner rotates the movable handle body 33 around its axis, the worm 32 that screws into the inner thread 33a of the movable handle body 33 moves in the axial direction, thereby bending the tip portion 3bb of the sheath 3 via the operating wire 4.
Furthermore, when the movable handle body 33 is moved in the axial direction by the practitioner, it moves the outer sheath 3Y in the axial direction via a sheath support joint 34, which will be described later. In this manner, the movable handle body 33 is operated when exposing the stent graft 2 or when returning the outer sheath 3Y to its original position after the stent graft 2 is placed.

The movable handle body 33 is formed in a generally cylindrical shape, and as described above, an inner peripheral thread 33a is formed on the inner peripheral surface, which screws into the outer peripheral thread 32b of the worm 32. In addition, as shown in FIG. 15, a support groove 33c is formed in the circumferential direction on the distal side of the inner peripheral thread 33a in the movable handle body 33.

The support groove 33c accommodates a part of a ring portion 34a of the sheath support joint 34 described later, and is connected to the ring portion 34a so as to be slidable in the circumferential direction.
Furthermore, since the inner surface of the support groove 33c is positioned so as to overlap with the ring portion 34a of the sheath support joint 34 in the axial direction, it is possible to move the sheath support joint 34 in the axial direction when the practitioner operates the movable handle main body 33 in the axial direction.

The medical device (transportation device 1X) further includes a movement limiting portion (handle lock screw 37) that limits the axial movement of the movable handle portion (movable handle main body 33).
The movement limiting portion according to this embodiment is a handle lock screw 37 that can be engaged with the guide tube 36 .
The handle lock screw 37 is configured to be able to pass through a through hole 33 b formed in the thickness direction of the movable handle body 33 and engage with a peripheral groove 36 d formed in the circumferential direction on the outer surface of the guide tube 36 .

According to the above configuration, by limiting the axial movement of the movable handle portion (movable handle main body 33), the movement of the worm 32 screwed into the movable handle main body 33 (pulling of the operating wire 4 connected to the worm 32) can be precisely controlled.
More specifically, the position of the worm 32 that screws into the movable handle body 33 is aligned with the axial position of the movable handle body 33 .

As described above, by limiting the axial position of the movable handle body 33, when the movable handle body 33 is rotated, the axial movement of the worm 32 can be adjusted solely by the screwing position (degree of screwing) of the movable handle body 33.
In other words, even if the surgeon unintentionally applies axial force to the movable handle body 33 when rotating the movable handle body 33, the movement of the movable handle body 33 can be limited by the handle lock screw 37, and the movement of the worm 32 can be precisely controlled.

In addition, at least a portion of the slit 36c may be narrower than the tip of the handle lock screw 37, or the slit 36c may not be provided so as not to overlap with the circumferential groove 36d, or the slit 36c may be buried by another member.
With this configuration, the engagement between the handle lock screw 37 and the circumferential groove 36d can be made more reliable, thereby restricting the axial movement of the movable handle body 33.

(Sheath support joint)
The medical device (transportation device 1X) further includes a sheath support joint 34 that supports the outer peripheral surface of the sheath 3 (outer sheath 3Y). The sheath support joint 34 is connected to the guide tube 36 so as to be axially slidable. The sheath 3 is indirectly connected to the movable handle main body 33 via the sheath support joint 34.

Specifically, the sheath support joint 34 includes a ring portion 34a, spoke portions 34b arranged in a cross shape inside the ring portion 34a, and a shaft portion 34c arranged in the center of the spoke portions 34b.
The spoke portions 34 b of the sheath support joint 34 pass through slits 36 c of the guide tube 36 and communicate with the inside and outside of the guide tube 36 .
In other words, the four extension pieces 36 b of the guide tube 36 are passed through the spaces between the four spoke portions 34 b of the sheath support joint 34 .
In this manner, the sheath support joint 34 is supported relative to the guide tube 36 so as to be axially slidable along the slit 36c.

According to the above configuration, for example, when the sheath support joint 34 is moved proximally to retract the sheath 3 (outer sheath 3Y) (to expose the stent graft 2), it is possible to prevent the guide tube 36 from becoming an obstacle.
Furthermore, for example, when the sheath 3 is pulled out from inside the body to outside, the sheath support joint 34 is moved distally to advance the sheath 3 (outer sheath 3Y) (when the sheath 3 is brought into close contact with the distal tip 5 shown in FIG. 1), and this prevents the guide tube 36 from becoming an obstacle.

As shown in FIG. 15, the sheath supporting joint 34 is rotatably supported by the movable handle portion (movable handle main body 33).
More specifically, on the inner surface of the movable handle body 33, distal to the inner circumferential thread 33a, a support groove 33c that is recessed from the surrounding area and supports the sheath support joint 34 is formed all around the circumference.
The radial size of the bottom surface of the support groove 33c is slightly larger than the outer diameter of the sheath support joint 34 (ring portion 34a).

With the above configuration, when the movable handle part (movable handle body 33) is rotated, the sheath support joint 34 does not rotate accordingly, and the sheath 3 supported by the sheath support joint 34 can be prevented from rotating.

The sheath support joint 34 is axially engaged with the movable handle portion (movable handle body 33).
More specifically, the radial size around the support groove 33c is slightly smaller than the outer diameter dimension of the sheath support joint 34 (ring portion 34a), and the width of the support groove 33c is slightly larger than the width of the ring portion 34a of the sheath support joint 34.
With this configuration, the sheath support joint 34 is engaged in the support groove 33c formed in the movable handle body 33 at the ring portion 34a in the axial direction.

According to the above configuration, the surgeon can axially move the movable handle body 33 to move the sheath support joint 34 that engages with the movable handle body 33, and thus the sheath 3 supported thereby.

The shaft portion 34c is formed in a cylindrical shape and extends further proximally than the ring portion 34a and the spoke portions 34b. A central hole 34f is formed at the center of the shaft portion 34c, penetrating in the axial direction and allowing the inner sheath 3X and the pusher 6 to pass through. A support hole 34e is formed on the distal side of the central hole 34f, and is larger than the proximal side, to support the proximal end of the outer sheath 3Y.
Specifically, the proximal end of the outer sheath 3Y is inserted into the support hole 34e in a reduced diameter state, and an elastic restoring force is generated, so that the proximal end of the outer sheath 3Y is attached to the support hole 34e. An adhesive may be used to connect the outer sheath 3Y and the sheath support joint 34.

In addition, by forming the shaft portion 34c, the area of the sheath support joint 34 that slides against the inner surface of the guide tube 36 can be increased, preventing the sheath support joint 34 from rattling relative to the guide tube 36s.

The sheath support joint 34 is formed with a joint-side insertion portion (insertion hole 34d) through which the operating wire 4 passes in the axial direction.
More specifically, as shown in Figures 16 and 22, the insertion hole 34d, which serves as the joint side insertion portion, is formed by penetrating in the thickness direction of the two spoke portions 34b located at positions 180 degrees apart around the axis of the sheath support joint 34.

According to the above configuration, the sheath support joint 34 is prevented from interfering with the handling of the operating wire 4 around the worm 32, and the sheath 3 can be smoothly bent when the worm 32 is moved axially relative to the sheath 3 to pull the operating wire 4.
The "joint-side insertion portion" is not limited to one that penetrates the spoke portions 34b in the thickness direction as long as it allows the operating wire 4 to be inserted through the sheath support joint 34. For example, the "joint-side insertion portion" may be a space between the four spoke portions 34b, or may be a groove that is formed in a part of the sheath support joint 34 and extends in the axial direction.

(Base 35)
The base 35 is the part that the practitioner holds, is formed in a cylindrical shape, has its inner surface fixed to the distal end of the guide tube 36, and has an outer diameter that tapers from the proximal side to the distal side.
The base 35 has a protector 35 a , which is hat-shaped in side view, at its distal end for supporting and protecting the proximal side of the sheath 3 .

<How to use>
Next, a method of using the conveying device 1X will be described with reference mainly to FIGS.
FIG. 19 is an explanatory diagram showing the initial state of the conveying device 1X, and FIG. 20 is an explanatory diagram showing the state of the conveying device when the sheath 3 is bent.
FIG. 21 is an explanatory diagram showing the state of the delivery device 1X when the tension on the operating wire 4 is reduced, and FIG. 22 is an explanatory diagram showing the state of the delivery device 1X when the stent graft 2 is deployed.
In order to show the internal mechanism of the transport device 1X, the movable handle body 33 and the base 35 are shown transparently by two-dot chain lines in FIGS.

First, with the delivery device 1X in the initial state shown in FIG. 10, saline or the like is passed through the lumen of the pusher 6 from the proximal side to degas it and remove any air bubbles within the sheath 3 and the stent graft 2.

Next, the practitioner passes the sheath 3 into the body and bends the sheath 3 so as to fit along the lumen.
At this time, as shown in Fig. 20, with the tip of the handle lock screw 37 inserted into the circumferential groove 36d, the practitioner rotates the movable handle body 33 of the transport device 1X in one direction about the axis to move the worm 32 screwed into the movable handle body 33 to the proximal side. The movable handle body 33 rotates with its axial movement restricted relative to the guide tube 36 by the handle lock screw 37.
As a result, the operating wire 4 connected to the worm 32 is pulled, causing the tip portion 3bb of the sheath 3 to bend, so that the tip portion 3bb can be positioned so as to follow the bent lumen.

Next, the practitioner operates the pre-deployment mechanism PD described in the first embodiment to first deploy the distal end portion (not shown) of the stent graft 2 .
Thereafter, as shown in FIG. 21, the movable handle body 33 is rotated in the opposite direction about its axis to move the worm 32 to its original position (distal position), thereby reducing the tension on the operating wire 4.

Finally, the practitioner pulls out the handle lock screw 37 from the circumferential groove 36d, and then moves the movable handle body 33 proximally to a position where it abuts against the end plate 36f. In this way, the sheath support joint 34 engaged with the movable handle body 33 can be moved proximally, and the outer sheath 3Y supported by the sheath support joint 34 can be retracted, and the stent graft 2 can be exposed from the outer sheath 3Y.
By pulling a trigger wire (not shown), the stent graft 2 can be fully deployed and placed in the body.

The various components of the conveying device 1, 1X of the present invention do not need to exist independently. It is acceptable for multiple components to be formed as a single member, for one component to be formed from multiple members, for one component to be part of another component, or for part of one component to overlap with part of another component, etc.

The above embodiment encompasses the following technical ideas.
(1)
A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that accommodates the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
A medical device characterized in that when the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line.
(2)
The worm further includes a rotation limiting member that limits rotation of the worm.
The worm has a non-circular portion formed in a non-circular shape at a part thereof,
The medical device according to claim 1, wherein the rotation limiting member limits the rotation of the worm by abutting against a surface of the non-rotating portion.
(3)
The worm is provided with a through hole extending in an axial direction,
a wall surface defining the through hole is the non-circular portion having a non-circular cross section;
The medical device according to claim 2, wherein the rotation limiting member is disposed so as to pass through the through hole and limits the rotation of the worm by abutting against the wall surface of the through hole.
(4)
A medical device described in any one of (1) to (3), wherein the proximal side of the operating wire is arranged radially inward of the outer surface of the worm.
(5)
The medical device according to any one of (1) to (4), wherein the movable handle portion is directly or indirectly connected to the sheath in the axial direction of the sheath.
(6)
The medical device according to any one of (1) to (5), further comprising a guide tube extending in the axial direction through which the worm is inserted to guide the axial movement of the worm.
(7)
The medical device described in (6) citing (2), in which the outer peripheral surface of the guide tube is formed with a non-circular cross section, and the guide tube functions as the rotation limiting member by abutting against the surface of the non-circular portion.
(8)
a self-expanding indwelling device housed in a contracted state inside the sheath;
a limiting member capable of limiting proximal movement of the indwelling device relative to the sheath;
a traction force change unit that changes a traction force of the sheath when a relative position between the limiting member and the sheath is changed so that the sheath is relatively positioned on the proximal side,
The medical device described in any one of (1) to (7), wherein the traction force changing unit changes the traction force of the operating wire by making the amount of movement of the worm in the direction of pulling the distal side of the operating wire smaller than the amount of movement of the sheath in the retraction direction by the movable handle unit relative to the limiting member.
(9)
a device body that houses at least a portion of the movable handle;
The movable handle portion further includes an external thread provided on an outer periphery thereof,
The device body includes a protrusion that protrudes into the thread groove so as to be capable of sliding in the thread groove between the threads of the outer screw,
The inner thread and the outer thread, which are the screw-engagement portion provided on the movable handle portion, have shapes twisted in opposite directions,
The medical device described in (8) above, wherein the movable handle portion moves proximally while rotating relative to the device main body portion to move the sheath in a retracting direction.
(10)
The medical device according to (6) or (7), wherein the guide tube has a guide tube side insertion portion through which the operating wire passes from the inside to the outside.
(11)
A movement limiting portion that limits the axial movement of the movable handle portion,
The medical device according to (6), (7) or (10), wherein the movement limiting portion is configured to be capable of engaging with the guide tube by inserting the movable handle portion therethrough.
(12)
Further comprising a sheath support joint for supporting an outer circumferential surface of the sheath,
The medical device according to claim 6, 7, 10 or 11, wherein the sheath support joint is connected to the guide tube so as to be axially slidable therewith.
(13)
The medical device according to claim 12, wherein the sheath support joint is rotatably supported on the movable handle portion.
(14)
The medical device according to (12) or (13), wherein the sheath support joint is axially engaged with the movable handle portion.
(15)
The medical device according to any one of (12) to (14), wherein the sheath support joint is formed with a joint-side insertion portion through which the operating wire passes in the axial direction.

DM Deployment mechanism PD Pre-deployment mechanism PM Traction mechanism PS Traction force change unit 1, 1X Transport device (medical equipment)
2. Stent graft (insertion device)
3 Sheath 3X, 3Xa, 3Xb Inner sheath 3Y Outer sheath 3Ya Distal portion 3Yb Lumen 3bb Tip portion (distal portion)
3c Connector 3ca Cylindrical portion 3cb Flange portion 4 Operating wire 4a Proximal end portion 5 Tip tip 6 Pusher (restriction member)
6c Through hole 6S Pipe guide (rotation limiting member, guide tube)
6Sa: Outer circumferential surface 6Sd: Ridge 6T: Pipe guide (rotation limiting member, guide tube)
6Ta: Outer circumferential surface 6Td: Plane portion 6U: Pipe guide (rotation limiting member, guide tube)
6Ua Outer circumferential surface 6Ud V-groove 6V Pipe guide (rotation limiting member, guide tube)
6Va Outer circumferential surface 6Vd Groove 6X Pipe guide (rotation limiting member, guide tube)
6Xa Outer Circumferential Surface 8 Device Body 8X Proximal Part 8Xa Storage Part 8Y Middle Part 8Z Distal Part (Base)
8a: accommodation hole 8b: guide rod 9: protector 10: operation unit 10a: movable block 10b: slide cylinder 11: push unit 12: inner worm (worm, traction force change unit)
12a Inner circumferential surface (non-circumferential portion)
12b Outer circumferential screw 12c Through hole 12S Inner worm 12Sa Inner circumferential surface (non-rotating portion)
12Sd U-groove 12T Inner worm 12Ta Inner peripheral surface (non-circumferential portion)
12Td: Flat portion 12U: Inner worm 12Ua: Inner peripheral surface (non-rotating portion)
12Ud Sharp protrusion 12V Inner worm 12Va Inner surface (non-rotating portion)
12 Vd convex portion 13 outer worm (movable handle portion, traction force change portion)
13X Proximal handle portion 13Z Distal handle portion 13a Inner peripheral thread 13b Outer peripheral thread 13c Proximal piece 13d Through hole 13e Distal piece 13f Through hole 13g Engagement piece 14 Swing arm (traction force change portion)
14a: Claw portion 15: Slide piece 21: Flush port 22: Y-shaped connector 22c: Connector portion 32: Worm 32a: Inner peripheral portion (non-circumferential portion)
32b Outer circumferential screw 32d Insertion hole 33 Movable handle body (movable handle portion)
33a: Inner peripheral thread 33b: Through hole 33c: Support groove 34: Sheath support joint (movable handle portion)
34a Ring portion 34b Spoke portion 34c Shaft portion 34d Insertion hole 34e Support hole 34f Center hole 35 Base portion 35a Protector (distal end portion)
36 Guide tube (rotation limiting member)
36a: Tip portion 36b: Extension piece 36c: Slit (guide tube side insertion portion)
36d Circumferential groove 36e Outer circumferential surface 36f End plate 37 Handle lock screw (movement limiting portion)
39 Operating line fixing device

Claims (13)

A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that houses the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
a rotation limiting member for limiting rotation of the worm;
Equipped with
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line ,
The worm has a non-circular portion formed in a non-circular shape at a part thereof,
the rotation limiting member limits rotation of the worm by abutting against a surface of the non-rotating portion,
The worm is provided with a through hole extending in an axial direction,
a wall surface defining the through hole is the non-circular portion having a non-circular cross section;
The rotation limiting member is disposed so as to pass through the through hole, and limits the rotation of the worm by abutting against the wall surface of the through hole . A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that accommodates the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line,
A medical device in which the proximal side of the operating wire is arranged radially inward from the outer surface of the worm. A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that accommodates the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line,
The movable handle portion is a medical device that is directly or indirectly connected to the sheath in the axial direction of the sheath. A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that accommodates the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line,
The medical device further includes a guide tube extending in the axial direction through which the worm is inserted to guide the axial movement of the worm. The worm further includes a rotation limiting member that limits rotation of the worm.
The worm has a non-circular portion formed in a non-circular shape at a part thereof,
the rotation limiting member limits rotation of the worm by abutting against a surface of the non-rotating portion,
The medical device according to claim 4 , wherein the outer peripheral surface of the guide tube is formed with a non-circular cross section, and the guide tube functions as the rotation limiting member by abutting against a surface of the non-circular portion. A base and
a long, flexible sheath connected to a distal end of the base;
an operating wire that is slidably inserted through the sheath and has a distal side connected to a distal portion of the sheath;
A worm having an outer circumferential thread formed around an axis and engaged with a proximal side of the operating wire;
a cylindrical movable handle portion that accommodates the worm therein and has a threaded portion on an inner peripheral surface thereof that threadably engages with the outer peripheral thread of the worm;
When the movable handle portion is rotated around the axis, the worm moves in the axial direction, thereby adjusting the traction force of the operating line,
a self-expanding indwelling device housed in a contracted state inside the sheath;
a limiting member capable of limiting proximal movement of the indwelling device relative to the sheath;
a traction force change unit that changes a traction force of the sheath when a relative position between the limiting member and the sheath is changed so that the sheath is relatively positioned on the proximal side,
The traction force changing unit changes the traction force of the operating wire by making the amount of movement of the worm in the direction pulling the distal side of the operating wire smaller than the amount of movement of the sheath in the retraction direction by the movable handle unit relative to the limiting member. a device body that houses at least a portion of the movable handle;
The movable handle portion further includes an external thread provided on an outer periphery thereof,
The device body includes a protrusion that protrudes into the thread groove so as to be capable of sliding in the thread groove between the threads of the outer screw,
The inner thread and the outer thread, which are the screw-engagement portion provided on the movable handle portion, have shapes twisted in opposite directions,
The medical device according to claim 6 , wherein the movable handle portion moves proximally while rotating relative to the device body portion to move the sheath in a retracting direction. The medical device according to claim 4 or 5 , wherein the guide tube has a guide tube-side insertion portion through which the operating wire passes from the inside to the outside. A movement limiting portion that limits the axial movement of the movable handle portion,
The medical device according to claim 4 , 5 or 8 , wherein the movement limiting portion is configured to be able to engage with the guide tube by inserting the movable handle portion therethrough. Further comprising a sheath support joint for supporting an outer circumferential surface of the sheath,
10. The medical device according to claim 4 , 5 , 8 or 9 , wherein the sheath support joint is connected to the guide tube so as to be axially slidable therewith. The medical instrument of claim 10 , wherein the sheath support joint is pivotally supported on the movable handle portion. The medical device of claim 10 or 11 , wherein the sheath support joint is axially engaged with the movable handle portion. The medical device according to claim 10 , wherein the sheath support joint is formed with a joint-side insertion portion through which the operating wire passes in the axial direction.

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