JP7532803B2 - Medical device transport device - Google Patents

Description

The present invention relates to a medical indwelling device delivery device.

2. Description of the Related Art Stents, stent grafts and the like are examples of indwelling devices that are placed in the body for medical purposes.
Stents are used by being placed in narrowed, blocked, or adherent areas (hereinafter sometimes referred to as "narrowed areas, etc.") that occur in biological lumens. Stents are generally formed as small, expandable, mesh-like metal tubes.

A stent graft is a tubular device made by integrating an artificial blood vessel (graft) with a metal mesh-like stent. Stent grafts are used by being placed inside stenotic areas, as well as inside aortic aneurysms in the abdomen or chest. Stent grafts allow blood to flow inside the graft, and blood pressure is not applied to the aortic aneurysm outside the graft, preventing the aortic aneurysm from rupturing.

Stents and stent grafts are attached to the distal part of a long, flexible tubular body called a catheter shaft or sheath and introduced into a biological lumen.

For example, Patent Document 1 describes a medical indwelling device delivery device (referred to as a stent graft placement device in the document) that delivers a stent graft into a blood vessel.
The medical retention device delivery device described in Patent Document 1 comprises a pusher (referred to as a dilator in the document) to which a stent graft is attached at its narrow diameter portion, a sheath that is attached to the outer periphery of the stent graft, and an operating wire (referred to as a wire in the document) that adjusts the insertion angle and placement position of the stent graft.

JP 2013-52282 A

However, in the medical indwelling device delivery device described in Patent Document 1, when a stent graft is deployed from a sheath with a bent tip, the sheath may sway so that the degree of bending of the sheath increases.

For example, as shown diagrammatically in Figure 17 , when the tip 300b of the sheath 300 is bent by pulling the operating line 400X, and the sheath 300 is then pulled proximally, the degree of bending of the sheath 300 can increase due to the frictional force applied by the stent graft 200.
For this reason, there is room for improvement in placing the stent graft 200, which is released along the sheath 300, at a desired position.

The present invention was made in consideration of the above-mentioned problems, and provides a medical indwelling device delivery device that can place an indwelling device at a desired position.

The medical indwelling device delivery device of the present invention comprises a long, flexible tubular body that holds a self-expanding medical indwelling device to be retained in the body, an operating wire that is slidably inserted into the tubular body and that can be pulled by a practitioner to bend a distal portion of the tubular body, a preliminary deployment mechanism that pushes out the indwelling device to cause the distal end of the indwelling device to protrude from the distal portion of the tubular body, a deployment mechanism that deploys the indwelling device when it is detached from the tubular body and retained in the body of a subject, and a device main body that supports a portion of the circumferential surface of the tubular body. a distal end of the operating wire is directly or indirectly fixed to the distal portion of the tubular body, and a proximal end of the operating wire is directly or indirectly held by the device main body, and the preliminary deployment mechanism includes an operating section operable with respect to the tubular body on the distal side in the longitudinal direction of the tubular body by the operation of the practitioner, a push unit connected to the operating section and connected to the proximal end of the indwelling device, and a push unit provided between the operating section and the device main body, and assists the movement of the operating section toward the distal side relative to the device main body by a biasing force due to elastic restoration. and a lock mechanism that switches, by operation by the practitioner, from a locked state in which the operation unit and the operation main body are locked to an unlocked state in which the lock between the operation unit and the operation main body is released. The operation unit is provided with a slide portion that allows the operation unit to slide distally relative to the device main body, and the pushing-out operation of the retention device using the preliminary deployment mechanism is performed by moving the operation unit distally relative to the tubular main body through the operation of the operator on the operation unit, thereby pushing out the retention device using the preliminary deployment mechanism. The retention device is moved in a distal direction relative to the tubular body, and as a result of this movement, the push unit presses the retention device distally, causing the retention device to move in the distal direction relative to the tubular body and the distal end of the retention device to become exposed from the tubular body. During the pushing-out operation, the locking mechanism is switched from the locked state to the unlocked state by the operator's operation, causing the elastic member to elastically restore, and the distal movement of the operating part relative to the device main body is assisted by the elastic member .

The medical indwelling device delivery device of the present invention makes it possible to place the indwelling device in the desired position.

FIG. 2 is a schematic explanatory diagram showing the initial state of the delivery device according to the present 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 . Fig. 1 shows the transition of change 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 by 30 degrees without pre-deploying 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 by 30 degrees after pre-deployment of the stent graft. 1A and 1B are diagrams showing an operating unit according to a first modified example, in which (a) is a schematic explanatory diagram showing an initial state in which a compression spring is compressed, and (b) is a schematic explanatory diagram showing a preliminary deployment state in which the compression spring is expanded. FIG. 11 is a schematic diagram showing an operation unit according to a second modified example. FIG. 13 is a schematic diagram showing an operation unit according to a third modified example. 13A and 13B are schematic diagrams showing an operating section for a fourth modified example, where FIG. 13A is a schematic explanatory diagram showing an initial state, and FIG. 13B is a schematic explanatory diagram showing the state when the stent graft is pre-deployed. 13A and 13B are schematic diagrams showing an operating section for a fifth modified example, where FIG. 13A is a schematic explanatory diagram showing an initial state, and FIG. 13B is a schematic explanatory diagram showing a state in which the stent graft is pre-deployed. FIG. 13 is an explanatory diagram showing a schematic diagram of the behavior of a stent graft when deployed from a conventional delivery device.

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.

＜Overview＞
First, an overview of a medical indwelling device delivery device (delivery device 1) according to this embodiment will be described mainly with reference to Figs. 1 and 2.
Fig. 1 is a schematic explanatory diagram showing the initial state of the delivery device 1 according to this embodiment (a state in which the stent graft 2 is entirely housed within the outer sheath 3Y), and Fig. 2 is a schematic explanatory diagram showing the delivery device 1 in a pre-deployment state (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).

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.
In reality, a through hole 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. 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 transport device 1 of this embodiment comprises a long, flexible tubular body (sheath 3) that holds a self-expanding medical retention device (stent graft 2) to be retained within the body, an operating wire 4 that is slidably inserted through the sheath 3 and can bend a distal portion (tip portion 3bb of the sheath 3, distal portion 3Ya of the outer sheath 3Y) of the sheath 3 (outer sheath 3Y) when pulled by a practitioner, a preliminary deployment mechanism PD that pushes out the stent graft 2 to cause a part of the stent graft 2 to protrude from the tip portion 3bb of the sheath 3, and a deployment mechanism DM that deploys the stent graft 2 when the stent graft 2 is detached from the sheath 3 and retained within the subject's body.
The preliminary deployment mechanism PD is characterized by keeping the amount of movement of the operating wire 4 smaller than the amount of movement of the stent graft 2 when the stent graft 2 is pushed out.

The above-mentioned "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, and other retention devices that are retained within a biological lumen.
The above "bend" includes not only a sharp bend but also a gentle bend.

In addition, the above ``amount of movement of the stent graft 2'' means the relative amount of movement of the stent graft 2 with respect to the sheath 3, and the ``amount of movement of the operating wire 4'' means the relative amount of movement of the operating wire 4 with respect to the sheath 3.
The pre-deployment mechanism PD pushes out the stent graft 2 and does not act on the sheath 3 connected to the operating wire 4. In other words, the pre-deployment mechanism PD operates the stent graft 2 without directly operating the operating wire 4.
Strictly speaking, the "amount of movement of the operating wire 4" is the amount of movement caused by the friction that the outer sheath 3Y receives from the stent graft 2 and the device pushing out the stent graft 2 (the pusher 6 described later), and is very small compared to the "amount of movement of the stent graft 2."
In other words, "directly operating the operating wire 4" does not include the preliminary deployment mechanism PD operating other parts of the operating wire 4, causing the operating wire 4 to operate due to frictional forces between the other parts.

With the above configuration, the preliminary deployment mechanism PD can suppress the amount of movement of the operating wire 4 to a small amount, thereby pushing out the retention device (stent graft 2) and causing a part of it to protrude from the distal portion (tip portion 3bb) of the tubular body (sheath 3).

With this configuration, it is possible to suppress large swings of the sheath 3 caused by large fluctuations in the amount of pulling of the operating wire 4 in the initial stage of the stent graft 2 protruding from the sheath 3. This makes it easier to place the stent graft 2 at a desired position when detaching the stent graft 2 by the deployment mechanism DM.
The delivery device 1 equipped with the indwelling device (stent graft 2) is also referred to as a medical indwelling device-equipped delivery device D1.

<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 3 to 7 in addition to Figures 1 and 2. The details of the configuration of each part will be described later.
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 3bb of the sheath 3. Fig. 4 is a schematic explanatory diagram of the delivery device 1 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 fully deployed. Fig. 6 is a schematic explanatory diagram of the delivery device 1 showing a state in which the outer sheath 3Y is returned to the initial state position, and Fig. 7 is a schematic explanatory diagram of the delivery device 1 showing a state in which the preliminary deployment mechanism PD is returned to the initial state position.

Note that in Figures 4(c), 5, and 6(a), the reinforcing layer 31e is shown as if it has no thickness, but in reality, it has a thickness equivalent to the mesh that forms the reinforcing layer 31e. Also, in Figure 7 and Figure 8 described later, the mesh of the reinforcing layer 31e is omitted and shown in a simplified manner.

As shown in Figure 1, the practitioner inserts the distal end of the sheath 3, for example, from the thigh of the subject, with the stent graft 2 completely contained within the distal end 3bb (between the inner sheath 3X and the outer sheath 3Y). The practitioner inserts the sheath 3, for example, to a position near the aortic aneurysm, 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 circumferential 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 circumferential rotation of the inner worm 12 is restricted 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. In detail, as shown in Fig. 4, the practitioner first releases a lock mechanism that restricts the movement of the outer worm 13 in the near and far directions. After that, the practitioner moves the slide piece 15 to the proximal side so that the claw portion 14a of the swing arm 14 screws into the outer peripheral thread 13b of the outer worm 13, 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 thread 13b is screwed into the claw portion 14a, the counterclockwise rotation of the outer worm 13 moves the outer worm 13 to the proximal side.
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 inner worm 12 (outer surface).
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 released from the outer peripheral thread 13b of the outer worm 13. Here, the position where the claw portion 14a is released 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 portion 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 from the distal end of the outer peripheral thread 13b.
When the practitioner releases the screwing as described above, it becomes possible for the practitioner to freely move the outer worm 13 proximally, and the practitioner moves the outer worm 13 into the storage section 8Xa in the proximal section 8X of the device main body 8 to expose the stent graft 2 to a position where the entire stent graft 2 can be deployed. Then, the practitioner 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, thereby placing the stent graft 2 at 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 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 the bare stent portion at the tip of the stent graft 2 is fully deployed. The guide wire (not shown) is passed through the blood vessel in advance when the sheath 3 is inserted into the blood vessel, and serves to guide the tip 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, the 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 the tip end side of the inner sheath 3X is housed in a through hole 6c formed in the axial center portion of the pusher 6, 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 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.

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 arranged 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]
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)
The pipe guide 6X houses the base end side of the inner sheath 3X inside the device body 8 described below, and has the function of guiding the inner worm 12 forward and backward.
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 so that it moves only in the near and far directions.

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 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 pre-deployment handle (movable block 10a) via a connector portion 22c at the distal end of a Y-shaped connector 22 described later.

In this embodiment, as shown in FIG. 10, the outer shape of the pipe guide 6X is formed to have a hexagonal cross section, and the inner wall surface of the pipe guide 6X is formed to have a circular cross section. The inner wall surface of the through hole of the inner worm 12 (described later) that faces the outer peripheral surface of the pipe guide 6X and through which the pipe guide 6X passes also has a shape similar to the hexagonal cross section so as to correspond to the outer diameter of the pipe guide 6X.

The pipe guide 6X is formed in this manner, and thus has the function of guiding the inner worm 12 by restricting the rotation range of the inner worm 12.
Note that it is sufficient that at least a portion of the pipe guide 6X comes into contact with the inner worm 12 when the inner worm 12 rotates so that the pipe guide 6X can restrict the rotation of the inner worm 12. In other words, as long as the shape is not circular, it is not limited to a hexagonal shape and may be a polygonal shape, and further, a configuration in which a protrusion formed on one side engages with an edge surface or a protrusion of a recess formed on the other side may be used.

In addition, the device that limits 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 device that abuts against the outer surface of the inner worm 12 to limit its movement.

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 the retention device (stent graft 2) is pushed out.
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.

With the above configuration, the preliminary deployment mechanism PD can push out the retention device (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 tubular body (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 slide portion (movable block 10 a ) that allows it to slide 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 also called a slide portion or a pre-deployment handle, and 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 operating unit 10 can be slid relative to the device body 8 by the slide portion (movable block 10a), thereby moving the push unit 11 connected to the operating unit 10 distally to pre-deploy 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 operation 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)
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 (pre-deployment handle) 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 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 guide wire guides the inner sheath 3Xa.

[Device body]
The transport device 1 includes a device main body 8 that supports a portion of the circumferential surface of the tubular body (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 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 and traction mechanism]
The delivery device 1 is equipped with a deployment mechanism DM that operates to fully deploy the stent graft 2 , and a traction mechanism PM that can traction the operating wire 4 .
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 tubular body (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 tubular body (sheath 3) and is disposed along the axis of the sheath 3, making it easier to apply a load from the push unit 11 to the retention device (stent graft 2) supported by the sheath 3.

(Inner Warm)
The inner worm 12 has a hollow portion (through hole) extending in the axial direction at its central portion, and has an inner wall surface formed in a non-circular shape (hexagonal in cross section) to define the hollow portion and move in the near and far directions along the outer surface of the pipe guide 6X. A thread is formed on the outer surface of the inner worm 12 to screw into the inner peripheral thread 13a of the outer worm 13.
The inner worm 12 is housed inside the outer worm 13, and the operating wire 4 is fixed to a part of the inner worm 12.

(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 operate the inner worm 12 to move in the axial direction.

The outer worm 13 has a proximal handle portion 13X and a distal handle portion 13Z that the practitioner touches when operating the outer worm 13, located at positions that sandwich the outer peripheral thread 13b in the axial direction. The proximal handle portion 13X and the distal handle portion 13Z are formed to protrude radially outward from other portions. The practitioner can touch the proximal handle portion 13X and the distal handle portion 13Z from an opening formed in the middle portion 8Y of the device main body portion 8 that communicates between the outside and the inside, and can rotate the outer worm 13 or move it in the near and far directions.

An inner peripheral thread 13a that screws into the inner worm 12 is formed on the inner surface of the outer worm 13, and an outer peripheral thread 13b that screws into a swing arm 14 (described later) is formed on the outer surface of the outer worm 13.
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), so that the inner worm 12 rotates circumferentially (freewheels) in the same position without moving toward or away from the axis.
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.

The slide piece 15 functions to screw the claw portion 14a of the swing arm 14 shown in FIG.
The slide piece 15 is formed with a tapered cross section so as to protrude toward the outer worm 13 as it moves toward the distal side.
By sliding the slide piece 15 proximally, the swing arm 14 formed on the outer worm 13 side of the slide piece 15 deforms toward the outer worm 13 and 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 it proximally. At the same time that the outer worm 13 rotates and retracts, the outer sheath 3Y, which is 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.

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.
In other words, 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.

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, the present invention is not limited to this configuration, and as long as the connector 3c is provided with a through hole for passing the operating wire 4 therethrough, for example, so long as the connector 3c does not interfere with the positioning, the operating wire 4 may be drawn out from the proximal end face of the outer sheath 3Y and disposed so as to extend linearly to the inner worm 12. With this configuration, the operating wire 4 can be pulled linearly along the axis of the operating wire 4, thereby improving the bending responsiveness 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.

<First Modification>
The operating unit 10 in the above embodiment has been described as comprising a movable block 10a and a plurality of sliding tubes 10b, and pre-deploying the stent graft 2 by operating the operating unit 10 to accommodate the sliding tubes 10b in the accommodation holes 8a provided in the proximal portion 8X of the device main body 8; however, the present invention is not limited to such a configuration.

Next, an operation unit 10A according to a first modified example will be described with reference to FIG.
12A and 12B are diagrams showing an operating unit 10A according to a first modified example, in which FIG. 12A is a schematic explanatory diagram showing an initial state in which the compression spring 16 is compressed, and FIG. 12B is a schematic explanatory diagram showing a preliminary deployment state in which the compression spring 16 is expanded.

In this modified example, the transport device 1 further includes an elastic member (compression spring 16) provided between the operation unit 10A (movable block 10Aa) and the device main body 18A (proximal end portion 18Aa).
The bias of the compression spring 16 assists the forward movement (distal movement) of the operation unit 10A (movable block 10Aa) relative to the device main body 18A (proximal end portion 18Aa).
More specifically, the device body 18A includes a proximal end 18Aa and a support 18Ab that is spaced distally from the proximal end 18Aa and is positioned with the movable block 10Aa sandwiched between the proximal end 18Aa.

The movable block 10Aa is disposed between the support portion 18Ab and the proximal end portion 18Aa of the device body portion 18A in the near and far direction, and is supported by the support portion 18Ab so as to be movable in the near and far direction.
The proximal end portion 18Aa is provided with a plurality of positioning rods 18Ad that protrude distally in the circumferential direction.
The support portion 18Ab includes a plurality of guide tubes 18Ac for accommodating the positioning rods 18Ad in the circumferential direction, the number of which is the same as the number of the positioning rods 18Ad.

The compression spring 16 has an inner diameter larger than that of the guide tube 18Ac, and is disposed between the movable block 10Aa and the proximal end portion 18Aa with its central axis coinciding with the positioning rod 18Ad.
The operating portion 10A includes an engagement ring 10Ab that maintains the position between the movable block 10Aa and the proximal end portion 18Aa.
The engagement ring 10Ab is attached so as to straddle the movable block 10Aa and the proximal end portion 18Aa when the compression spring 16 is in a compressed state as shown in FIG. 12(a).

According to the operation unit 10A configured in this manner, when the practitioner spreads the engagement ring 10Ab radially outward, the compression spring 16 elastically restores its original shape, assisting the operation of the operation unit 10A, and the movable block 10Aa moves distally so as to approach the support portion 18Ab. Specifically, the movable block 10Aa moves distally along the guide tube 18Ac.
Therefore, the inner sheath 3X and the pipe guide 6X connected to the movable block 10Aa via the connector portion 22c of the Y-shaped connector 22 can be moved in the distal direction, and the stent graft 2 can be easily pre-deployed.

The locking mechanism that limits the movement of the movable block 10Aa due to the force of the compression spring 16 is not limited to the engagement ring 10Ab, but may be configured with a swingable member provided on either the movable block 10Aa or the proximal end 18Aa and a protrusion that can engage with the swingable member.

Further, although it has been described that the forward movement of the operation unit 10A (movable block 10Aa) relative to the device main body 18A (proximal end portion 18Aa) is assisted by the bias of the compression spring 16, the present invention is not limited to such a configuration.
For example, a tension spring may be used as the elastic member. In this case, the movable block 10Aa is moved to a position close to the support portion 18Ab by the operation of the practitioner against the bias of the tension spring and locked in place, and then the lock is released, and the bias of the tension spring assists the return movement of the movable block 10Aa.

<Second Modification>
Next, mainly with reference to FIG. 13, an operation unit 10B according to a second modified example will be described.
Fig. 13 is a schematic diagram showing an operation section 10B according to a second modified example. Note that in Fig. 13, the stent graft 2 is omitted, and the details of each section are also shown in a simplified manner.
The operation unit 10B according to this example is connected to an inner movable member 10Ba provided inside the device body 8B, and is disposed so as to be rotatable in the circumferential direction together with the inner movable member 10Ba relative to the device body 8B.

The inner movable member 10Ba is attached to the device body 8B so as to be rotatable in the circumferential direction relative to the device body 8B and slidable in the near and far directions, and a boss 10Bb that protrudes radially outward is formed on a part of the inner movable member 10Ba. The inner sheath 3X and the pipe guide 6X are directly or indirectly connected to the inner movable member 10Ba.
The device body 8B is formed with a guide hole 8Ba for receiving the boss 10Bb and restricting the movement of the boss 10Bb at a boundary surface thereof.
The guide hole 8Ba is formed by a portion extending in the near-far direction and portions extending in the circumferential direction from both ends thereof, and is formed in a concave shape in a side view.
When the sheath 3 is inserted or removed, the inner movable member 10Ba is disposed on the proximal side of the inner movable member 10Ba, as shown in FIG.

During preliminary deployment, the practitioner grasps the operating part 10B and rotates the inner movable member 10Ba in the circular direction until the boss 10Bb formed on the inner movable member 10Ba overlaps with the portion of the guide hole 8Ba that extends in the near-to-far direction.

Then, the practitioner grips the operation portion 10B and moves the inner movable member 10Ba in the distal direction until the boss 10Bb reaches the distal end of the portion of the guide hole 8Ba extending in the distal/proximal direction.
Then, the inner sheath 3X and the pipe guide 6X (push unit 11) fixed to the inner movable member 10Ba move in the distal direction, and the stent graft 2 can be pre-deployed.

Furthermore, the practitioner grips the operation portion 10B and rotates the inner movable member 10Ba in the circumferential direction until the boss 10Bb is separated from the portion of the guide hole 8Ba extending in the near-far direction.
In this way, the boss 10Bb can be prevented from moving proximally by the defining surface of the guide hole 8Ba, and an unexpected return from the pre-deployment state to the normal state can be suppressed.

<Third Modification>
Next, an operation unit 10C according to a third modified example will be described mainly with reference to FIG.
FIG. 14 is a schematic diagram showing an operation unit 10C according to a third modified example.

The operating unit 10C in this example is equipped with a replacement unit (female thread 10Cf that screws into male thread 18Cb formed on support unit 18Ca) that replaces the rotational load around the central axis of the device main body 18C with a distal load to the push unit 11.
In this example, the operating section 10C and the device main body section 18C are screwed together, and when the user rotates the operating section 10C relative to the device main body section 18C, the sheath 3 can move back and forth in the longitudinal direction of the sheath 3.

More specifically, the operating unit 10C includes a block-shaped fixed portion 10Cd fixed to a pipe guide 6X, which is part of the push unit 11, and a rotating portion 10Ce connected to the fixed portion 10Cd so as to be rotatable around the axial direction.
The fixed portion 10Cd and the rotating portion 10Ce are rotatably connected by, for example, a bearing.
In addition, a female screw 10Cf is formed on the distal side of the rotating portion 10Ce, and a male screw 18Cb that screws into the female screw 10Cf formed on the rotating portion 10Ce is formed protruding proximally at the proximal end of the support portion 18Ca of the device main body portion 18C.

During preliminary deployment, the surgeon places the distal end of the female thread 10Cf of the rotating part 10Ce against the proximal end of the male thread 18Cb of the support part 18Ca, and then rotates the rotating part 10Ce, for example clockwise, to thread and move the rotating part 10Ce in the distal direction.
Then, the inner sheath 3X and the pipe guide 6X (push unit 11) fixed to the fixed portion 10Cd, together with the fixed portion 10Cd connected to the rotating portion 10Ce, move in the distal direction, thereby enabling the stent graft 2 to be pre-deployed.

According to the above configuration, the operation unit 10C includes a replacement portion (female thread 10Cf that screws into the male thread 18Cb). Therefore, the practitioner can easily operate the push unit 11 in the distal direction by applying a load in a rotation direction around the central axis of the device main body 18C to the operation unit 10C (rotation portion 10Ce).
In particular, since the operation section 10C and the device main body section 18C are screwed together, it becomes easier to adjust the position of the stent graft 2 to be pre-deployed by finely adjusting the amount of screwing.

<Fourth Modification>
Next, mainly with reference to FIG. 15, an operation unit 10D according to a fourth modified example will be described.
Figure 15 is a schematic diagram showing an operating unit 10D relating to the fourth modified example, where Figure 15(a) is a schematic explanatory diagram showing the initial state, and Figure 15(b) is a schematic explanatory diagram showing the stent graft 2 when pre-deployed.

The operating unit 10D in this example has a replacement unit (a movable block 10Da having a rack portion 10De and a gear 10Db) that replaces the load in the rotational direction (including the rotational direction) around the gear 10Db with a distal load toward the push unit 11.

More specifically, the movable block 10Da is disposed between the support portion 18Db and the proximal end portion 18Da of the device main body portion 18D in the near and far direction, and is supported by the support portion 18Db so as to be movable in the near and far direction.
A rack portion 10De extending in the near-far direction is formed on a part of the side surface of the operation portion 10D (movable block 10Da).
A gear 10Db that meshes with the rack portion 10De is rotatably supported on the device main body portion 18D (the tip portion of a support 18Dc extending from the support portion 18Db).
A lever 10Dc including a handle for a practitioner to rotate the gear 10Db is attached to the gear 10Db. The lever 10Dc extends radially outward from the rotation center of the gear 10Db and is disposed on the distal side in the initial position. During preliminary deployment, the lever 10Dc is disposed on the proximal side by the practitioner's operation.

During pre-deployment, the practitioner moves lever 10Dc from the distal side to the proximal side.
Then, the gear 10Db formed integrally with the lever 10Dc rotates around the tip of the support 18Dc. As the gear 10Db rotates, the movable block 10Da having the rack portion 10De that screws into the gear 10Db moves from a position close to the proximal end portion 18Da of the device main body 18D to a position away from the gear 10Db (distal direction).
At this time, the inner sheath 3X and the pipe guide 6X (push unit 11) fixed to the movable block 10Da move in the distal direction, so that the stent graft 2 can be pre-deployed.

According to the above configuration, the operating unit 10D has a replacement part (movable block 10Da and gear 10Db). Therefore, by applying a load in the rotational direction centered on the gear 10Db to the operating unit 10D, it is possible to easily operate the push unit 11 in the distal direction. In other words, the rack-and-pinion configuration allows the movable block 10Da having the rack part 10De to be operated by rotating the gear 10Db.

<Fifth Modification>
Next, mainly with reference to FIG. 16, an operation unit 10E according to a fifth modified example will be described.
Figure 16 is a schematic diagram showing an operating unit 10E relating to the fifth modified example, where Figure 16(a) is a schematic explanatory diagram showing the initial state, and Figure 16(b) is a schematic explanatory diagram showing the stent graft 2 when pre-deployed.

The operating unit 10E in this example includes a movable block 10Ea, a link 10Ee rotatably connected to the movable block 10Ea, a link 10Ed rotatably connected to the link 10Ee and the device main body 18D and shorter than the link 10Ee, a movable tip 10Eb rotatably attached to the link 10Ee and the link 10Ee, and a lever 10Ec that moves the movable tip 10Eb so that the angle of the link 10Ed and the link 10Ee relative to the movable tip 10Eb is variable.

In other words, the operating unit 10E in this example includes a replacement unit (lever 10Ec, movable tip 10Eb, and links 10Ed and 10Ee) that replaces the load in the rotational direction (including the pivoting direction) around the pin 10Ef (described later) with a distal load on the push unit 11.

More specifically, the movable block 10Ea is disposed between the support portion 18Db and the proximal end portion 18Da of the device body portion 18D in the far-near direction, and is supported by the support portion 18Db so as to be movable in the far-near direction.

The movable tip 10Eb is trapezoidal in side view and is rotatably connected to the links 10Ed and 10Ee with its long side facing the movable block 10Ea and proximal end 18Da and its short side facing the lever 10Ec.
Link 10Ed is connected to the proximal edge of proximal end 18Da, and link 10Ee is connected to the distal edge of movable block 10Ea.

The lever 10Ec is rotatably attached to the support 18Dc by a pin 10Ef provided at the tip of the support 18Dc.
Specifically, the lever 10Ec is composed of a pushing portion 10Eg capable of pushing in the movable tip 10Eb, and a cylindrical handle portion 10Eh that is held by the practitioner.
The pushing portion 10Eg is rotatably connected to the pin 10Ef and is configured to be able to push in the movable tip 10Eb so as to extend long through the links 10Ed and 10Ee in the near and far directions.
The handle portion 10Eh is disposed on the distal side in the initial position, and is disposed on the proximal side during pre-deployment by the operator's operation.

During preliminary deployment, the surgeon moves the handle 10Eh of the lever 10Ec from the distal side to the proximal side. This causes the pusher 10Eg of the lever 10Ec to rotate around the pin 10Ef provided at the tip of the support 18Dc. The pusher 10Eg protrudes toward the movable tip 10Eb as a result of the rotation, and abuts against and presses the movable tip 10Eb, moving the movable tip 10Eb closer to the movable block 10Ea and the proximal end 18Da.
As the movable tip 10Eb approaches the movable block 10Ea and the proximal end portion 18Da, the inclinations of the links 10Ee and 10Ed change so that the length components in the near and far directions become longer.

By changing the inclination of the links 10Ee, 10Ed, the movable block 10Ea, which is disposed so as to be movable in the near and far directions, moves in the distal direction relative to the proximal end portion 18Da fixed to the support portion 18Db.
At this time, the inner sheath 3X and the pipe guide 6X (push unit 11) fixed to the movable block 10Ea move in the distal direction, so that the stent graft 2 can be pre-deployed.
Furthermore, according to the above configuration, by operating the lever 10Ec to operate the links 10Ed and 10Ee associated with the toggle mechanism and move the movable block 10Ea, it is possible to maintain the operating section 10E locked in the pre-deployment position of the stent graft 2 (a state in which the links 10Ed and 10Ee are positioned on the same straight line).

In addition, the delivery device 1 has been described as pulling the outer sheath 3Y connected to the distal end of the operating wire 4 by pulling the operating wire 4, thereby exposing the stent graft 2 from the outer sheath 3Y and placing it within the body, but the present invention is not limited to such a configuration.
For example, it may be an operating wire that allows the practitioner to bend the distal portion of the tubular body (sheath 3) by pushing it.

Even with this configuration, the preliminary deployment mechanism PD can be used to keep the amount of movement of the operating wire 4 small, thereby pushing out the stent graft 2 and causing a portion of the stent graft 2 to protrude from the distal portion of the sheath 3 (outer sheath 3Y).
With this configuration, it is possible to suppress large swings of the sheath 3 caused by large fluctuations in the amount of pulling of the operating wire 4 in the initial stage of the stent graft 2 protruding from the sheath 3. This makes it easier to deploy the stent graft 2 by the deployment mechanism DM and place the stent graft 2 at a desired position.

The various components of the conveying device 1 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 tubular body that is long and flexible and holds a self-expanding medical indwelling device to be placed in the body;
an operating wire that is slidably inserted into the tubular body and that can bend a distal portion of the tubular body by being pulled by a practitioner;
a pre-deployment mechanism that pushes out the retention device to cause a portion of the retention device to protrude from the distal portion of the tubular body;
and a deployment mechanism for deploying the indwelling device when the indwelling device is detached from the tubular body and is retained in the subject's body,
The medical indwelling device delivery device, wherein the pre-deployment mechanism keeps the amount of movement of the operating wire smaller than the amount of movement of the indwelling device when the indwelling device is pushed out.
(2)
A device body portion supporting a portion of a circumferential surface of the tubular body,
a distal end of the operating wire is directly or indirectly fixed to the distal portion of the tubular body, and a proximal end of the operating wire is directly or indirectly held to the device body portion;
The medical retention device delivery device according to (1), wherein the preliminary deployment mechanism is configured in a region different from the region where the operating wire is disposed, and keeps the amount of variation in the distance between the distal end and the proximal end of the operating wire smaller than the amount of movement of the retention device when the retention device is pushed out.
(3)
The preliminary deployment mechanism includes:
an operation unit operable with respect to the tubular body on a distal side in a longitudinal direction of the tubular body by an operation by the practitioner;
A push unit connected to the operation section and to a proximal end of the indwelling device,
The medical indwelling device delivery device according to (2), wherein the push unit is configured to be able to apply a load in a distal direction to the indwelling device by the operation of the operation portion.
(4)
Further, a traction mechanism capable of traction of the operating wire is provided,
The medical indwelling device delivery device according to (3), wherein the push unit is disposed inside the device body and passes through the traction mechanism in the longitudinal direction of the tubular body.
(5)
Further comprising an inner sheath through which a guide wire can be passed,
The push unit has a through hole extending in a longitudinal direction,
The medical indwelling device delivery device according to (3) or (4), wherein the inner sheath is disposed through the through hole.
(6)
The medical indwelling device delivery device according to any one of (3) to (5), wherein the operation unit is provided with a slide unit that allows the operation unit to slide distally relative to the device body.
(7)
The device further includes an elastic member provided between the operation unit and the device body,
The medical indwelling device delivery device according to (6), wherein the forward or backward movement of the operation part relative to the device body part is assisted by the biasing force of the elastic member.
(8)
The medical indwelling device delivery device according to any one of (3) to (5), wherein the operation unit includes a replacement unit that replaces a load in a rotational direction with a load in a distal direction on the push unit.
(9)
A tubular body that is long and flexible and holds a self-expanding medical indwelling device to be placed in the body;
an operating wire that is slidably inserted into the tubular body and that can be pushed by a practitioner to bend a distal portion of the tubular body;
a pre-deployment mechanism that pushes out the retention device to cause a portion of the retention device to protrude from the distal portion of the tubular body;
and a deployment mechanism for deploying the indwelling device when the indwelling device is detached from the tubular body and is retained in the subject's body,
The medical indwelling device delivery device, wherein the pre-deployment mechanism keeps the amount of movement of the operating wire smaller than the amount of movement of the indwelling device when the indwelling device is pushed out.

D1 Medical indwelling device transport device with indwelling device DM Deployment mechanism PD Pre-deployment mechanism PM Traction mechanism 1 Transport device (medical indwelling device transport device)
2. Stent graft (insertion device)
3 Sheath (tubular body)
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 6c Through hole 6X Pipe guide 8, 8B Device body portion 8Ba Guide hole 8X Proximal portion 8Xa Storage portion 8Y Middle portion 8Z Distal portion 8a Storage hole 8b Guide rod 9 Protector 10, 10A, 10B, 10C, 10D, 10E Operating portion 10a Movable block (slide portion, pre-deployment handle)
10b Slide cylinder (slide portion)
10Aa Movable block 10Ab Engagement ring 10Ba Inner movable member 10Bb Boss 10Cd Fixed portion 10Ce Rotating portion 10Cf Female thread (replacement portion)
10Da Movable block 10Db Gear 10Dc Lever 10De Rack portion 10Ea Movable block 10Eb Movable tip 10Ec Lever 10Ed, 10Ee Link 10Ef Pin 10Eg Push-in portion 10Eh Handle portion 11 Push unit 12 Inner worm 13 Outer worm 13X Proximal handle portion 13Z Distal handle portion 13a Inner peripheral screw 13b Outer peripheral screw 13c Proximal piece 13d Through hole 13e Distal piece 13f Through hole 13g Engagement piece 14 Swing arm 14a Claw portion 15 Slide piece 16 Compression spring (elastic member)
18A, 18C, 18D Device body 18Aa Proximal end 18Ab Support 18Ac Guide tube 18Ad Positioning rod 18Ca Support 18Cb Male thread (replacement part)
18Da Proximal end portion 18Db Support portion 18Dc Support 21 Flush port 22 Y-shaped connector 22c Connector portion 100 Delivery device 200 Stent graft 300 Sheath 300b Distal portion 400X, 400Y Operating wire

Claims (4)

A tubular body that is long and flexible and holds a self-expanding medical indwelling device to be placed in the body;
an operating wire that is slidably inserted into the tubular body and that can bend a distal portion of the tubular body by being pulled by a practitioner;
a pre-deployment mechanism that pushes out the indwelling device to cause a distal end portion of the indwelling device to protrude from the distal portion of the tubular body;
a deployment mechanism that deploys the indwelling device when the indwelling device is detached from the tubular body and is retained in the body of a subject;
A device main body that supports a portion of the circumferential surface of the tubular body;
Equipped with
a distal end of the operating wire is directly or indirectly fixed to the distal portion of the tubular body, and a proximal end of the operating wire is directly or indirectly held to the device body portion;
The preliminary deployment mechanism includes:
an operation unit operable with respect to the tubular body on a distal side in a longitudinal direction of the tubular body by an operation by the practitioner;
a push unit connected to the operation section and to a proximal end of the indwelling device;
an elastic member provided between the operation unit and the device body, the elastic member assisting the distal movement of the operation unit relative to the device body by a biasing force due to elastic restoration;
a lock mechanism that switches from a locked state in which the operation unit and the device main body are locked to an unlocked state in which the operation unit and the device main body are unlocked by an operation by the practitioner;
Equipped with
The operation unit is provided with a slide unit that allows the operation unit to slide distally relative to the device body ,
The pushing-out action of the retention device using the preliminary deployment mechanism is an action in which the practitioner operates the operation part to move the operation part distally relative to the tubular body, thereby moving the push unit in the distal direction relative to the tubular body, and the push unit presses the retention device distally due to this movement, so that the retention device moves in the distal direction relative to the tubular body, and the distal end of the retention device is exposed from the tubular body,
During the pushing-out operation, the locking mechanism is switched from the locked state to the unlocked state by the operator's operation, causing the elastic member to elastically restore its original state, and the movement of the operating unit toward the distal side relative to the device main body is assisted by the elastic member . Further, a traction mechanism capable of traction of the operating wire is provided,
2. The medical indwelling device delivery device according to claim 1 , wherein the push unit is disposed inside the device body and passes through the traction mechanism in the longitudinal direction of the tubular body. Further comprising an inner sheath through which a guide wire can be passed,
The push unit has a through hole extending in a longitudinal direction,
3. The medical indwelling device delivery device according to claim 1 , wherein the inner sheath is disposed through the through hole. A tubular body that is long and flexible and holds a self-expanding medical indwelling device to be placed in the body;
an operating wire that is slidably inserted into the tubular body and that can be pushed by a practitioner to bend a distal portion of the tubular body;
a pre-deployment mechanism that pushes out the indwelling device to cause a distal end portion of the indwelling device to protrude from the distal portion of the tubular body;
a deployment mechanism that deploys the indwelling device when the indwelling device is detached from the tubular body and is retained in the body of a subject;
A device main body that supports a portion of the circumferential surface of the tubular body;
Equipped with
a distal end of the operating wire is directly or indirectly fixed to the distal portion of the tubular body, and a proximal end of the operating wire is directly or indirectly held to the device body portion;
The preliminary deployment mechanism includes:
an operation unit operable with respect to the tubular body on a distal side in a longitudinal direction of the tubular body by an operation by the practitioner;
a push unit connected to the operation section and to a proximal end of the indwelling device;
an elastic member provided between the operation unit and the device body, the elastic member assisting the distal movement of the operation unit relative to the device body by a biasing force due to elastic restoration;
a lock mechanism that switches from a locked state in which the operation unit and the device main body are locked to an unlocked state in which the operation unit and the device main body are unlocked by an operation by the practitioner;
Equipped with
The operation unit is provided with a slide unit that allows the operation unit to slide distally relative to the device body,
The pushing-out action of the retention device using the preliminary deployment mechanism is an action in which the practitioner operates the operation part to move the operation part distally relative to the tubular body, thereby moving the push unit in the distal direction relative to the tubular body, and the push unit presses the retention device distally due to this movement, so that the retention device moves in the distal direction relative to the tubular body, and the distal end of the retention device is exposed from the tubular body,
During the pushing-out operation, the locking mechanism is switched from the locked state to the unlocked state by the operator's operation, causing the elastic member to elastically restore its original state, and the movement of the operating unit toward the distal side relative to the device body is assisted by the elastic member .

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