WO2021176672A1 - Delivery shaft and delivery system - Google Patents

Abstract

The purpose of the present invention is to provide a delivery shaft for vascular treatment devices that is capable of being smoothly removed from a stent-graft part following placement of the stent-graft part at a target site, without the distal tip of the shaft causing damage to inner blood vessel walls or causing plaque to break off. This delivery shaft (100) is for conveying a stent-graft part of a vascular treatment device to a target site within the body, and comprises a shaft body (10), a grip (20) which is mounted to the proximal side of the shaft body (10), and a distal tip (30) which is mounted to the distal side of the shaft body (10). The distal tip (30) has a cylinder portion (37), an expanding-diameter portion (31) which is continuous with the distal end of the cylinder portion (37) and expands in diameter toward the distal end direction, and a substantially hemispherical endmost portion (35) which is continuous with the distal end of the expanding-diameter portion (31) and in which the maximum diameter (D₁) of the expanding-diameter portion (31) serves as the diameter thereof.

Description

Delivery shaft and delivery system

The present invention relates to a delivery shaft and a delivery system of a vascular treatment device, and more specifically, the delivery shaft for transporting a stent graft portion constituting the vascular treatment device to a target site in the body, and the delivery shaft has a stent graft portion. It relates to a delivery system equipped with a vascular treatment device.

Artificial blood vessel replacement and stent graft insertion are performed as methods for treating diseases in the thoracic aorta such as aortic aneurysm and aortic dissection.

Here, as an artificial blood vessel used for artificial blood vessel replacement for replacing the aortic arch, an artificial blood vessel with a branch in which four side tubes are derived from the main tube is known (see Patent Document 1 below). ..
On the other hand, various stent grafts used for stent graft interpolation are known. For example, a stent graft having a structure capable of improving convenience during treatment by the OSG (Open Stent Graft) method is applied for in this application. It has been proposed by a person (see Patent Document 2 below).

Recently, in an attempt to improve the efficiency of the procedure, an aortic treatment device, which is a vascular treatment device with a structure in which a branched artificial blood vessel in which four side tubes are derived from the main tube and a stent graft are sutured and integrated. Has been proposed by the applicant (see Patent Document 3 below).

On the other hand, as a device for transporting the stent graft to a target site in the body, a catheter shaft equipped with a self-expandable stent graft, a tip fixed to the tip of the catheter shaft, and a stent graft mounted on the catheter shaft are reduced in diameter. A delivery shaft including a sleeve that restrains the state has been proposed (see Patent Document 4 below).

The sleeve constituting this delivery shaft is formed by winding a sheet so as to wrap the stent graft in a reduced diameter state, and suturing both sides of the sheet so that it can be pulled out with a wire. After the stent graft mounted on the delivery shaft reaches the target site in the body, the restraint by the sleeve is sequentially released from the tip to the base end by pulling the base end of the wire and pulling out the wire. Expands, which places the expanded stent graft in place at the site of interest.

By the way, the tip tip constituting the delivery shaft disclosed in Patent Document 4 has a cannonball shape, and the maximum diameter (base end diameter) of the tip tip is the same as the outer diameter of the stent graft in the reduced diameter state. There is.

Japanese Unexamined Patent Publication No. 7-308330 Japanese Unexamined Patent Publication No. 2017-23464 Japanese Unexamined Patent Publication No. 2019-154666 Japanese Patent No. 6480382

However, in the delivery shaft described in Patent Document 4 above, the bullet-shaped tip tip constituting the delivery shaft may damage the inner wall of the blood vessel or peel off the plaque adhering to the inner wall of the blood vessel. ..

To solve such a problem, it is conceivable to increase the size of the tip.
However, even if the size of the tip is increased, the above problem cannot be solved because the tip is sharp.
Further, if the size of the tip tip (diameter of the proximal end) is made larger than the outer diameter of the stent graft in the reduced diameter state, it is conceivable that the inner wall of the blood vessel is damaged by the proximal edge of the distal tip.

Further, when the delivery shaft described in Patent Document 4 is removed from the stent graft after being placed at the target site, the base end edge of the bullet-shaped tip tip is caught by the stent constituting the stent graft, and the delivery shaft is caught. May not be removed smoothly.

The present invention has been made based on the above circumstances.
An object of the present invention is that the inner wall of the blood vessel is not damaged or the plaque is not peeled off by the tip tip when the stent graft portion constituting the vascular treatment device is transported, and the stent graft portion is smoothly removed after being placed at the target site. The purpose is to provide a delivery shaft for a vascular treatment device that can be used.
Another object of the present invention is that the inner wall of the blood vessel is not damaged or the plaque is not peeled off by the tip tip when the stent graft portion constituting the vascular treatment device is transported, and the stent graft portion is delivered after being placed at the target site. The purpose of the present invention is to provide a delivery system for a vascular treatment device capable of smoothly removing a shaft.

(1) The delivery shaft of the present invention is a delivery shaft for transporting a stent graft portion constituting a vascular treatment device to a target site in the body, and is a grip attached to the shaft body and the proximal end side of the shaft body. And a tip attached to the tip of the shaft body.
The tip has a diameter-expanded portion that expands in the tip direction and
It is characterized by having a substantially hemispherical state-of-the-art portion whose diameter is the maximum diameter of the diameter-expanded portion, which is continuous with the tip of the diameter-expanded portion.

According to the delivery shaft having such a configuration, the tip end portion has a substantially hemispherical shape having the maximum diameter of the enlarged diameter portion as the diameter, so that the tip end portion hits the inner wall of the blood vessel. Even if they come into contact with each other, stress is not concentrated on the contact portion, and the inner wall of the blood vessel is not damaged by the cutting edge, and the plaque adhering to the inner wall of the blood vessel is not peeled off.

Further, on the proximal end side of the most advanced portion of the tip, a diameter-increasing portion that expands in the tip direction (reduces the diameter in the proximal direction) is formed, and extends from the proximal end of the advanced end to the tip of the shaft body. Since the diameter of the tip tip does not change suddenly, the inner wall of the blood vessel is not damaged by the portion located on the proximal end side of the cutting edge.

In addition, a hemispherical cutting edge is continuously formed at the tip of the enlarged diameter portion, and there are no sharp edges or steps at the boundary between the enlarged diameter portion and the cutting edge portion. It won't hurt.

Further, since there is no sharp edge or step at the boundary between the enlarged diameter portion and the cutting edge portion, when the delivery shaft is removed from the stent graft portion after being placed at the target site, the boundary portion constitutes the stent graft portion. The delivery shaft provided with the tip can be smoothly removed in combination with the tapered shape of the enlarged diameter portion whose diameter is reduced in the proximal direction.

In delivery shaft (2) present invention, the maximum diameter D ₁ is 8 ~ 20 mm in the enlarged diameter portion, that the radius of curvature R in the leading end is in the range of 0.25 D ₁ ~ 0.75 D ₁ preferable.

_{According to the delivery shaft having such a configuration, the maximum diameter D 1} of the enlarged diameter portion corresponding to the diameter of the leading end portion of the tip tip is 8 mm or more, and the radius of curvature R at the leading end portion is 0.25 D ₁ to 0. By .75D ₁ , the cutting edge portion has a substantially hemispherical shape with a smooth curved surface, and stress concentration can be reliably prevented at the portion where the cutting edge portion abuts.
Further, when the maximum diameter D ₁ of the enlarged diameter portion is 20 mm or less, the tip tip can be sufficiently inserted into the blood vessel (for example, the descending portion of the aorta) leading to the target site.

(3) In the delivery shaft of the present invention, when the minimum diameter of the enlarged diameter portion is D ₂ and the axial length of the enlarged diameter portion is L, _{the value of D 1} / D ₂ is 1.1 to 10. The value of (D ₁ − D ₂ ) / L is preferably 0.07 to 3.

When _{the value of D 1} / D ₂ is 1.1 or more, the maximum diameter D ₁ in the enlarged diameter portion and the radius of curvature R in the most advanced portion can be sufficiently increased.
On the other hand, when _{the value of D 1} / D ₂ is 10 or less, it is possible to prevent the diameter of the hemisphere, which is the substantial shape of the cutting edge, from becoming excessive.
Further, when _{the value of (D 1} − D ₂ ) / L is 0.07 to 3, it is possible to form a tapered diameter-expanded portion suitable for exerting the effect of the present invention.

(4) In the delivery shaft according to (2) or (3), it is preferable that the diameter expansion ratio of the diameter-expanded portion continuously changes along the axial direction.

In this specification, the “diameter expansion rate of the enlarged diameter portion” refers to the outer diameters of the tip tips at different axial positions A and B in the enlarged diameter portion, respectively, as D _A and D _B (however, D _B > D). when in _a), but the formula: refers to a value represented by [(D _B -D _a) / (position distance a between the position B)] × 100 (%).

Here, the enlarged diameter portion having a constant diameter expansion ratio has a truncated cone shape, and the enlarged diameter portion whose diameter expansion ratio continuously changes along the axial direction is a cone curved outward or inward along the central axis. The shape is similar to that of a cone.
For example, as shown in FIG. 12, the diameter-expanded portion in which the diameter-expanding ratio continuously decreases toward the tip has a shape similar to a truncated cone curved outward along the central axis, and such a diameter-expanded portion. The shape of the boundary between the tip and the cutting edge becomes smoother, and a delivery shaft provided with such a tip can be removed more smoothly from the stent graft after being placed at the target site.

(5) In the delivery shaft of the above (4), it is preferable that the diameter expansion ratio of the diameter-expanded portion continuously increases toward the tip.

As shown in FIG. 13, the diameter-expanded portion in which the diameter-expanding ratio continuously increases toward the tip has a truncated cone-like shape (trumpet shape) curved inward along the central axis, and has such a shape. The tip having the enlarged diameter portion of the above has excellent fitting property with the tip of the stent graft portion.

(6) In the delivery shaft of the present invention, it is preferable that guide wire lumens are formed on the shaft body and the tip.

According to the delivery shaft having such a configuration, it can be inserted into the blood vessel along the guide wire, so that the stent graft portion can be reliably conveyed even if the shape of the blood vessel reaching the target site is complicated. Can be done.

(7) The delivery system of the present invention is a delivery system in which a vascular treatment device having a stent graft portion is mounted on the shaft body of the delivery shaft of the above (2).
The stent graft portion is constrained to a reduced diameter state.
When the outer diameter of the stent graft portion in the reduced diameter state is d ₆₁ and the inner diameter of the stent graft portion in the expanded state is D ₆₁ , the equation: d ₆₁ <D ₁ ≤ 0.8 _{D 61} is satisfied. do.

According to the delivery system having such a configuration, the maximum diameter D ₁ of the enlarged diameter portion is larger than the outer diameter d _{61 in} the reduced diameter state of the stent graft portion, so that the tip of the stent graft portion in the reduced diameter state is the enlarged diameter portion. Since it does not come into contact with the outer peripheral surface and directly contact the inner wall of the blood vessel, it is possible to prevent the tip of the stent graft portion from damaging the inner wall of the blood vessel.
Further, since the maximum diameter D _{1 of the enlarged diameter portion is 80% or less of the inner diameter D 61} of the expanded diameter portion of the stent graft portion, the stent graft portion placed at the target site is compressed by the inner wall of the blood vessel and the diameter is reduced to some extent. Even in this case, the delivery shaft can be reliably removed from the stent graft portion.

(8) In the delivery system of the present invention, a sleeve that restrains the stent graft portion in a reduced diameter state and
It is preferable to provide an operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.

According to the delivery system having such a configuration, after the stent graft portion reaches the target site in the body, the proximal end of the operation wire is pulled to restrain the stent graft portion by the sleeve from the tip to the proximal end. Can be released in sequence.

(9) In the delivery system of (8) above, the sleeve can pull out sutures along the axial direction by the operation wire on both sides of a rectangular sheet wound so as to wrap the stent graft portion in a reduced diameter state. It is formed by suturing to
It is preferable that the tip tip is formed with at least one hole for accommodating and holding the tip of the operation wire.

According to the delivery system having such a configuration, the tip of the operation wire is accommodated and held in the hole formed in the tip, so that the tip of the operation wire does not come into direct contact with the inner wall of the blood vessel. It is possible to prevent the inner wall of the blood vessel from being damaged by the tip of the operating wire.

(10) In the delivery system of the present invention, in the vascular treatment device, the stent graft portion and the artificial blood vessel portion are connected by suture, and at least one side tube of the artificial blood vessel portion is derived from the main tube. It is preferable to consist of artificial blood vessels with branches from the viewpoint of improving the efficiency of the procedure.

According to the delivery shaft of the present invention, the inner wall of the blood vessel is not damaged or the plaque is not peeled off by the tip tip when the stent graft portion constituting the vascular treatment device is transported. In addition, it can be smoothly removed from the stent graft portion after being placed at the target site.
According to the delivery system of the present invention, the inner wall of the blood vessel is not damaged or the plaque is not peeled off by the tip tip when the stent graft portion constituting the vascular treatment device is transported. In addition, the delivery shaft can be smoothly removed from the stent graft portion after being placed at the target site.

It is a front view of the delivery shaft which concerns on one Embodiment of this invention. It is a vertical sectional view of the delivery shaft shown in FIG. It is an end view (III-III end view) of the delivery shaft shown in FIG. It is a cross-sectional view (III-III cross-sectional view) of the delivery shaft shown in FIG. It is an end view (IV-IV end view) of the delivery shaft shown in FIG. It is a cross-sectional view (IV-IV cross-sectional view) of the delivery shaft shown in FIG. It is a partially enlarged front view (detailed view of V part) of the delivery shaft shown in FIG. FIG. 5 is a view taken along the line VI-VI of FIG. FIG. 5 is a cross-sectional view taken along the line VII-VII of FIG. It is explanatory drawing of the branch fixture which comprises the delivery shaft shown in FIG. FIG. 8 is a cross-sectional view (IX-IX cross-sectional view) of the branch fixture shown in FIG. It is a front view of the delivery system which concerns on one Embodiment of this invention. It is a front view of the aorta treatment apparatus constituting the delivery system shown in FIG. It is a schematic diagram which shows the shape of the tip | tip | tip which has the diameter-expanded portion which the diameter-expanding rate continuously decreases toward the tip. It is a schematic diagram which shows the shape of the tip | tip | tip which has the diameter-expanded part which continuously increases the diameter-expanding rate toward the tip.

<Delivery shaft>
The delivery shaft 100 of the present embodiment shown in FIGS. 1 to 7 is a delivery shaft for transporting the stent graft portion of the aortic treatment device (vascular treatment device) to a target site in the body, and is the shaft body 10 and the shaft. A grip 20 mounted on the base end side of the main body 10, a tip tip 30 mounted on the tip end side of the shaft body 10, and a branch fixture 40 fixed to the tip of the grip 20 are provided. Reference numeral 30 denotes a cylindrical portion 37, a diameter-expanded portion 31 that continuously expands in diameter toward the tip of the cylindrical portion 37, and a maximum diameter D of the diameter-expanded portion 31 that is continuous with the tip of the diameter-expanded portion 31. It has a substantially hemispherical state-of-the-art portion 35 having a diameter of _1.

The shaft body 10 constituting the delivery shaft 100 is a flexible tubular structure and has a shape extending along the axial direction (longitudinal direction). As shown in FIG. 2, the shaft main body 10 has a tip region 10A, an intermediate region 10B, and a base end region 10C in this order from the tip to the base end in the axial direction.

The tip region 10A of the shaft body 10 is an aortic treatment device (vascular treatment device) shown in FIG.
This is the area where the stent graft portion 61 of 60 is mounted. The stent graft portion 61 mounted on the tip region 10A is restrained in a reduced diameter state by the sleeve 70 shown in FIG. In FIG. 10, the stent graft portion included in the sleeve 70 is not shown.

The intermediate region 10B of the shaft body 10 is an region to which the main pipe 661 of the artificial blood vessel portion 66 of the aortic treatment device 60 shown in FIG. 11 is attached.

As shown in FIG. 2, the proximal end region 10C of the shaft body 10 is an region accommodated in the grip 20.

As shown in FIGS. 1 and 2, a flare portion 16 is provided between the tip region 10A and the intermediate region 10B. The flare portion 16 has a funnel-shaped shape protruding toward the tip end side. By providing the flare portion 16, it is possible to prevent the stent graft portion 61 from shifting in the proximal direction.

The length (total length) of the shaft body 10 is usually 290 to 605 mm, preferably 340 to 505 mm, and a suitable example is 410 mm.
The length of the tip region 10A can be appropriately set according to the length of the stent graft portion to be mounted, and is usually 20 to 200 mm, preferably 25 to 150 mm, and 125 mm as a suitable example.
The length of the intermediate region 10B is usually 50 to 300 mm, preferably 100 to 200 mm, and a suitable example is 140 mm.

The outer diameter of the tip region 10A is usually 1.0 to 8.0 mm, preferably 1.5 to 6.0 mm, and a suitable example is 3.6 mm.
The outer diameter of the intermediate region 10B is usually 2 to 10 mm, preferably 3 to 8 mm, and a suitable example is 5.0 mm.
The outer diameter (maximum diameter at the tip) of the flare portion 16 can be appropriately set according to the diameter of the stent graft portion in the reduced diameter state, and is usually 3 to 15 mm, preferably 5 to 10 mm, and a suitable example is shown. For example, it is 9.1 mm.

As shown in FIGS. 3A and 3B, the intermediate region 10B of the shaft body 10 includes a tube member 11, a coating layer 12, a core material 13 (131, 132, 133, 134), a reinforcing layer 14, and a resin coating. It includes a layer 15.

As shown in FIGS. 4A and 4B, the tip region 10A of the shaft body 10 includes a tube member 11, a coating layer 12, and a core material 13 (131, 132, 133, 134).

The tube member 11 of the shaft body 10 is composed of a tube having a single lumen structure having lumens 11L formed along the axial direction. The lumen 11L functions as a guide wire lumen in the shaft body 10.
The diameter of the lumen 11L is usually 0.9 to 2.5 mm, and a suitable example is 1.12 mm.

Examples of the constituent material of the tube member 11 include synthetic resins such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon, and polyether block amide.

The coating layer 12 of the shaft body 10 covers the inner peripheral surface of the lumen 11L, and functions as a sliding material when the guide wire is inserted into the lumen 11L.
The thickness of the coating layer 12 is usually 0.03 to 0.08 mm.
Examples of the constituent material of the coating layer 12 include fluororesins such as PFA and PTFE.

The core member 13 of the shaft body 10 is a member having plastic deformability, and extends along the axial direction of the tube member 11 inside the shaft body 10.
Four core members 13 ( core members 131, 132, 133, 134) are provided in parallel with each other in the tube member 11.
The core material 13 (131 to 134) is a columnar member, and is provided over substantially the entire length of the shaft body 10 (each region of the tip region 10A, the intermediate region 10B, and the base end region 10C). As a result, the rigidity of the shaft body 10 is sufficiently ensured, and the operability of the shaft body 10 is improved.

Examples of the constituent material of the core material 13 include a metal having plastic deformability.
Examples of the metal material constituting the core material 13 include stainless steel (SUS), titanium, titanium alloy, cobalt-chromium alloy, nickel-chromium alloy, chromium molybdenum alloy, aluminum, aluminum alloy, magnesium alloy, tantalum alloy, zirconium alloy, and the like. Examples include metals and alloys such as gold, platinum, copper, gold-silver-palladium alloys.

The reinforcing layer 14 of the shaft body 10 is a reinforcing member for ensuring rigidity in the intermediate region 10B and the proximal region 10C. The reinforcing layer 14 is arranged so as to cover the outer peripheral surface of the tube member 11 in the intermediate region 10B and the proximal region 10C.
The reinforcing layer 14 may be formed with one or more slits.
The thickness of the reinforcing layer 14 is usually 0.1 to 0.3 mm.
Examples of the constituent material of the reinforcing layer 14 include a metal material such as stainless steel (SUS).

The resin coating layer 15 of the shaft body 10 is a resin layer that covers the outer peripheral surface of the reinforcing layer 14. Examples of the constituent material of the resin coating layer 15 include polyether block amide and the like.

The grip 20 constituting the delivery shaft 100 of the present embodiment is attached to the base end side (base end region 10C) of the shaft body 10, and is a portion to be grasped (grasped) by the operator when the delivery shaft 100 is used. The grip 20 has a shape extending along the axial direction thereof.

The length of the grip 20 is usually 50 to 200 mm, preferably 60 to 180 mm, and a suitable example is 130 mm.
The outer diameter of the grip 20 is usually 3 to 30 mm, preferably 5 to 25 mm, and a suitable example is 20 mm.
Examples of the constituent material of the grip 20 include synthetic resins such as polycarbonate and acrylonitrile-butadiene-styrene copolymer (ABS).

The tip tip 30 constituting the delivery shaft 100 of the present embodiment is mounted on the tip side of the shaft body 10.
Specifically, as shown in FIG. 7, the tip 30 is mounted on the tip side of the shaft body 10 by inserting the tip portion of the shaft body 10 (tube member 11) into the internal space 30L of the tip tip 30. Has been done.

As shown in FIGS. 5 to 7, the tip tip 30 includes a cylindrical portion 37 having a substantially constant outer diameter and a diameter-expanded portion 31 that continuously expands in diameter toward the tip of the cylindrical portion 37. The tip of the enlarged diameter portion 31 is continuously provided with a substantially hemispherical cutting edge portion 35 having the maximum diameter of the enlarged diameter portion 31 as the diameter.

As shown in FIG. 5, the maximum diameter D ₁ of the enlarged diameter portion 31 coincides with the diameter of the hemisphere which is the substantial shape of the cutting edge portion 35, and the minimum diameter D ₂ of the enlarged diameter portion 31 is the cylindrical portion 37. Matches the outer diameter.

_{The maximum diameter D 1} of the enlarged diameter portion 31 that matches the diameter of the most advanced portion 35 (hemisphere) is usually 8 to 20 mm, preferably 10 to 18.4 mm, and 11.96 mm as a suitable example. ..
The radius of curvature R of the most advanced portion 35 is usually 0.25D ₁ to 0.75D ₁ , preferably 0.33D ₁ to 0.67D ₁ , and a suitable example is 0.50D ₁ .

_{Since the maximum diameter D 1} of the enlarged diameter portion 31 is 8 mm or more and the radius of curvature R at the cutting edge portion is 0.25D ₁ to 0.75D ₁ , the cutting edge portion 35 has a substantially smooth curved surface. It has a hemispherical shape and can reliably prevent stress concentration at the contact portion of the cutting edge portion 35.
Further, when the maximum diameter D ₁ of the enlarged diameter portion 31 is 20 mm or less, the tip tip 30 can be sufficiently inserted into the blood vessel (for example, the descending portion of the aorta) leading to the target site.

_{The minimum diameter D 2} of the enlarged diameter portion 31 corresponding to the outer diameter of the cylindrical portion 37 is usually 2 to 7 mm, preferably 3 to 6 mm, and a suitable example is 4.70 mm.
The axial length L of the enlarged diameter portion 31 is usually 6 to 15 mm, preferably 7 to 11 mm, and a suitable example is 9.10 mm.

The ratio of the maximum diameter to the minimum diameter (D ₁ / D ₂ ) in the enlarged diameter portion 31 is preferably 1.1 to 10, and a suitable example is 2.54 (11.96 mm / 4.70 mm). be.
When _{the value of D 1} / D ₂ is 1.1 or more, the maximum diameter D ₁ in the enlarged diameter portion 31 (the diameter of the hemisphere which is the actual shape of the cutting edge portion 35), and by extension, the cutting edge portion 35 The radius of curvature R in is sufficiently large.
On the other hand, when _{the value of D 1} / D ₂ is 10 or less, it is possible to prevent the diameter of the hemisphere, which is the substantial shape of the cutting edge portion 35, from becoming excessive.

_{The value of the difference between the maximum diameter and the minimum diameter (D 1} − D ₂ ) / L with respect to the axial length L of the enlarged diameter portion 31 is preferably 0.07 to 3, and a suitable example is 0.80. [(11.96 mm-4.70 mm) /9.10 mm].
When the value of (D ₁ − D ₂ ) / L is 0.07 to 3, it is possible to form a tapered diameter-expanded portion suitable for exerting the effect of the present invention.

As shown in FIGS. 5 and 7, the diameter expansion ratio of the diameter-expanded portion 31 of the tip tip 30 is not constant and continuously increases toward the tip.
As a result, the diameter-expanded portion 31 has a truncated cone-like shape (trumpet shape) that is curved inward along the central axis of the tip tip 30.

The tip tip 30 having the enlarged diameter portion 31 having such a truncated cone-like shape is excellent in fitting property with the tip portion of the stent graft portion, and the tip of the stent graft portion is the tip region of the enlarged diameter portion 31 (diameter expansion ratio). Even if the stent graft portion is pressed toward the tip while in contact with the outer peripheral surface of the high region), the tip of the stent graft portion crosses the boundary between the enlarged diameter portion 31 and the most advanced portion 35. There is no.

As shown in FIG. 7, the tip 30 has an internal space 30L into which the tip portion of the shaft body 10 (tube member 11) can be inserted, and an opening in the outer peripheral surface of the cutting edge 35 while communicating with the internal space 30L. A through hole 35L is formed. The lumen 11L of the tube member 11 inserted into the internal space 30L of the tip tip 30 and the through hole 35L form a guide wire lumen in the tip tip 30.

As shown in FIGS. 4B and 7, the tip 30 is formed with six non-through holes 38 at equal angle intervals (60 ° intervals) around the internal space 30L. The non-through hole 38 is a hole for accommodating and holding the tip of the operation wire 80, which will be described later.

As the constituent material of the tip chip 30, all the materials used for the tip tip constituting the conventionally known delivery shaft can be used. For example, flexible polyurethane, soft polyether block amide, soft vinyl chloride, soft polyolefin, etc. Examples thereof include elastomer resins such as styrene-based elastomers.
Further, even a relatively hard material that cannot be used with the bullet-shaped tip tip constituting the conventionally known delivery shaft can be used. Such materials include, for example, rigid polyurethane, rigid polyetherblockamide, rigid polyolefin, polycarbonate, ABS resin, polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), polyetheretherketone (PEEK) and the like. Examples thereof include resins, metals or alloys such as titanium and stainless steel (SUS), and ceramics.

As shown in FIGS. 1 and 2, a branch fixture 40 is fixed to the tip of the grip 20.
As shown in FIG. 10, the branch fixture 40 constituting the delivery shaft 100 of the present embodiment has four side tubes 662 to 665 constituting the artificial blood vessel portion 66 of the aortic treatment device 60 at their respective tips. It is a jig that holds the swords in a bundle.

As shown in FIGS. 8 and 9, the branch fixture 40 has a round hole 44 for inserting the shaft body 10 via the tip of the grip 20 and one side of the round hole 44 (upper side of the drawing). ), And a capsule (oval) -shaped elongated hole 46 for inserting the side tubes 662 to 665, and an operation wire 80, which will be described later, formed on the other side (lower side of the drawing) of the round hole 44. It has a round hole 48 for insertion.

The diameter of the round hole 44 is usually 5 to 25 mm, and a suitable example is 11 mm.
The diameter of the elongated hole 46 is large enough to bundle and hold the tips of the four side pipes 662 to 665, and the diameter in the longitudinal direction is 10 to 41 mm, and a suitable example is 33 mm. .. The diameter in the lateral direction is 9 to 40 mm, and a suitable example is 21 mm.
The diameter of the round hole 48 is a size through which the operation wire 80 can be inserted, and is usually 0.25 to 2 mm, and a suitable example is 0.5 mm.

Examples of the constituent material of the branch fixture 40 include synthetic resins such as polycarbonate and acrylonitrile-butadiene-styrene copolymer (ABS).

According to the delivery shaft of the present embodiment, since the cutting edge portion 35 of the tip tip 30 has a substantially hemispherical shape having a smooth curved surface, the cutting edge portion 35 comes into contact with the inner wall of the blood vessel. However, the stress is not concentrated on the contact portion, and the inner wall of the blood vessel is not damaged by the cutting edge portion 35, and the plaque adhering to the inner wall of the blood vessel is not peeled off.

Further, on the base end side of the cutting edge portion 35 of the tip tip 30, a diameter expanding portion 31 that expands in diameter toward the tip end (reduces diameter in the proximal end direction) is formed, and a cylindrical portion is formed from the base end of the cutting edge portion 35. Since the change in the diameter of the tip tip 30 up to the tip of 37 is continuous and gradual, the inner wall of the blood vessel is affected by the portions (diameter-expanded portion 31 and cylindrical portion 37) located on the proximal end side of the cutting-edge portion 35. It will not be damaged or the plaque attached to the inner wall of the blood vessel will not peel off.

Further, since a hemispherical cutting edge portion 35 is continuously formed at the tip of the diameter expanding portion 31, and there is no sharp edge or step at the boundary between the diameter expanding portion 31 and the cutting edge portion 35, the diameter expanding portion 31 The boundary between the tip and the cutting edge 35 does not damage the inner wall of the blood vessel or exfoliate the plaque attached to the inner wall of the blood vessel.

Further, since there is no sharp edge or step at the boundary between the enlarged diameter portion 31 and the most advanced portion 35, the boundary is described when the delivery shaft 100 is removed from the expanded diameter stent graft portion 61 after being placed at the target site. There is no possibility that the portion will be caught by the stent constituting the stent graft portion 61, and the delivery shaft 100 provided with the tip tip 30 can be smoothly removed in combination with the tapered shape of the diameter-expanded portion 31 whose diameter is reduced in the proximal direction. Can be done.

<Delivery system>
The delivery system 300 of the present embodiment shown in FIG. 10 has the above-mentioned delivery shaft 100, a stent graft portion and an artificial blood vessel portion 66, and has an aorta treatment device 60 mounted on the shaft body of the delivery shaft 100 and an aorta treatment device. The sleeve 70 that restrains the stent graft portion of 60 in a reduced diameter state, the operation wire 80 that releases the restraint of the stent graft portion by the sleeve 70 by pulling the base end thereof, and the base end 81 of the operation wire 80 are fixed. When the outer diameter of the stent graft portion in the reduced diameter state is d ₆₁ and the inner diameter of the stent graft portion in the expanded state is D ₆₁ , the equation: d ₆₁ <D ₁ ≤ 0.8 D. ₆₁ holds.

The delivery system 300 of the present embodiment includes the delivery shaft 100 of the above embodiment, an aortic treatment device 60, a sleeve 70, an operation wire 80, and a clip 90.

As shown in FIG. 11, the aortic treatment device 60 constituting the delivery system 300 includes an artificial blood vessel portion 66 in which four side tubes 662 to 665 are derived from the main tube 661, and a distal end of the artificial blood vessel portion 66. The stent graft portion 61 connected to the distal side of the artificial blood vessel portion 66 by being sutured to the artificial blood vessel portion 66, and the stent graft portion 61 formed so as to extend distally from the distal end 666 of the artificial blood vessel portion 66, and by inversion. It is provided with a rollable skirt-shaped cuff portion 63 that extends proximally from the distal end 666 of the artificial blood vessel portion 66 (the state shown in the figure).

The artificial blood vessel portion 66 is a portion that replaces the aortic arch portion, and includes a main tube 661 and four side tubes 662 to 665 derived from the main tube 661.
The main pipe 661 and the side pipes 662 to 665 are composed of a tubular knitted fabric.
Lateral folds are formed in the main pipe 661 and the side pipes 662 to 665, which are resistant to expansion and contraction and bending, have excellent kink resistance, and are easily adapted to the shape of blood vessels in the human body.

The length (free length) of the main pipe 661 is preferably 100 to 400 mm, and a suitable example is 210 mm.
The inner diameter of the main pipe 661 is preferably 16 to 36 mm, and a suitable example is 26 mm.

Of the side pipes 662 to 665 derived from the main pipe 661, three side pipes form a group, and one side pipe is arranged out of this group.

The length of the side pipes 662 to 665 is preferably 50 to 300 mm, and a suitable example is 210 mm.
The inner diameter of the side hole tube 662 is preferably 5 to 14 mm, and a suitable example is 11 mm.
The inner diameter of the side hole tubes 663 to 664 is preferably 5 to 12 mm, and a suitable example is 9 mm for each.
The inner diameter of the side pipe 665 is preferably 8 to 12 mm, and a suitable example is 9 mm.

As the tubular knitted fabric constituting the artificial blood vessel portion 66 (main pipe 661 and side pipes 662 to 665), a woven fabric of thermoplastic resin fibers or a tubular material made of knitted fabric can be used, and a plain woven fabric of thermoplastic resin fibers is preferable. Can be used for. The wall thickness of the tubular knitted fabric is preferably 1 mm or less, more preferably 0.3 to 0.7 mm.

Examples of the thermoplastic resin forming the thermoplastic resin fiber include polyolefins such as polyethylene, polypropylene and ethylene-α-olefin copolymer, polyamide, polyurethane, polyethylene terephthalate, polybutylene terephthalate, polycyclohexane terephthalate, polyethylene-2,6- Examples thereof include polyesters such as naphthalate and fluororesins such as PTFE and ETFE. Of these, polyesters such as polyethylene terephthalate and fluororesins such as PTFE and ETFE, which are chemically stable, have good durability, and have little structural reaction, are preferable, and a weight average molecular weight of 10,000 to 200,000 is particularly preferable. It is a polyester having a weight average molecular weight of 15,000 to 100,000.

The artificial blood vessel portion 66 is coated with collagen, gelatin, or the like, whereby blood leakage from the artificial blood vessel portion 66 can be prevented.

The main pipe 661 constituting the artificial blood vessel portion 66 is mounted in the intermediate region 10B of the shaft body 10 shown in FIG.

The side tubes 662 to 665 constituting the artificial blood vessel portion 66 are inserted into the elongated holes 46 of the branch fixture 40 in a state where the respective tip portions are bundled, whereby the side tubes 662 to 665 are held. There is.

The tip of the side pipes 662 to 665 inserted into the elongated hole 46 can be easily pulled out from the elongated hole 46.

By holding the side tubes 662 to 665 with the branch fixture 40, these side tubes are tied with a string and the stent graft portion is placed during the complicated work conventionally performed before and after the operation, that is, when the stent graft portion is transported. Later, work such as unraveling this string can be avoided.

The stent graft portion 61 constituting the aorta treatment device 60 includes a self-expandable stent 611 and a graft 612 that covers the outer periphery of the stent 611.
In FIG. 11, the stent graft portion 61 is shown in an enlarged diameter state.
Further, in FIG. 10, the diameter-reduced stent graft portion contained in the sleeve 70 is not shown, but the outer diameter d ₆₁ is shown.

The length of the stent graft portion 61 is preferably 60 to 210 mm, and a suitable example is 110 mm.

_{The outer diameter d 61} of the stent graft portion 61 in the reduced diameter state is smaller than _{the maximum diameter D 1} of the enlarged diameter portion 31 of the tip tip 30 constituting the delivery shaft 100.
As a result, the tip of the stent graft portion 61 in the reduced diameter state does not come into contact with the outer peripheral surface of the enlarged diameter portion 31 of the tip tip 30 and directly contact the inner wall of the blood vessel. It can be prevented from being hurt.
_{The outer diameter d 61} of the stent graft portion 61 in the reduced diameter state is preferably 9 to 18 mm, and a suitable example is 11 mm.
Here, the outer diameter d ₆₁ is the outer diameter of the reduced diameter stent graft portion 61 included in the sleeve 70, and is further smaller than the outer diameter of the sleeve 70 including the stent graft portion 61.

_{The inner diameter D 61} of the stent graft portion 61 in the expanded state is 80% or less of _{the maximum diameter D 1} of the enlarged diameter portion 31 of the tip 30 constituting the delivery shaft 100.
As a result, even when the stent graft portion 61 placed at the target site is compressed by the inner wall of the blood vessel and the diameter is reduced to some extent, the delivery shaft 100 provided with the tip tip 30 is reliably removed from the stent graft portion 61. can do.
_{The inner diameter D 61} of the stent graft portion 61 in the expanded state is preferably 23 to 39 mm, and a suitable example is 27 mm.

The structure of the stent 611 constituting the stent graft portion 61 is not particularly limited, and is a tubular structure made of zigzag wire rods, a knitted fabric or braid of one or more wire rods, or a tubular structure obtained by combining a plurality of these. Examples thereof include a tubular structure obtained by processing a body, a metal plate-shaped or tubular structure by laser processing, or the like.

Materials for the wire rod and metal tubular structure constituting the stent 611 include stainless steel, tantalum, titanium, platinum, gold, tungsten, etc., Ni-Ti-based, Cu-Al-Ni-based, Cu-Zn-Al. A metal wire rod such as a shape memory alloy such as a system can be used, and the surface thereof may be coated with gold, platinum or the like by means such as plating.

The diameter of the wire rod constituting the stent 611 is not particularly limited, but is preferably 0.08 to 1 mm.
The thickness of the metal tubular structure constituting the stent 611 is not particularly limited, but is preferably 0.08 to 1 mm.

The graft 612 constituting the stent graft portion 61 includes a thermoplastic resin formed in a cylindrical shape by a molding method such as extrusion molding or blow molding, a knitted fabric of thermoplastic resin fibers formed in a cylindrical shape, or a cylindrical shape. It is possible to use a thermoplastic resin non-woven article, a cylindrically formed thermoplastic resin sheet, a porous sheet, or the like.

It should be noted that the graft 612 does not have lateral folds, which ensures sufficient adhesion to the inner wall of the blood vessel.

Examples of the thermoplastic resin constituting the graft 612 include the thermoplastic resin exemplified as the one forming the thermoplastic resin fiber constituting the artificial blood vessel portion 66 (tubular knitted fabric).

The stent graft portion 61 (graft 612) is not coated with the biocompatible material applied to the artificial blood vessel portion 66.
Since the stent graft portion 61 that has not been coated is flexible, it is easy to reduce the diameter.
It has good fitting properties with blood vessels and has excellent affinity with living tissues. In addition, it does not adversely affect the diameter expansion operation after long-term storage in the reduced diameter state.

The stent graft portion 61 is mounted in the tip region 10A of the shaft body 10 shown in FIG.

The cuff portion 63 constituting the aortic treatment device 60 is continuously formed at the distal end 666 of the artificial blood vessel portion 66 by the same material (knitted fabric) as the artificial blood vessel portion 66.
That is, the artificial blood vessel portion 66 and the cuff portion 63 are formed by one tubular knitted fabric. Further, the stent graft portion 61 is connected to the artificial blood vessel portion 66 by being sutured to the distal end 666 of the artificial blood vessel portion 66.
As a result, the aortic treatment device 60 has excellent integration between the artificial blood vessel portion 66 and the cuff portion 63, and can surely avoid blood leakage from between the artificial blood vessel portion 66 and the cuff portion 63. can.

The cuff portion 63 constituting the aortic treatment device 60 extends distally from the distal end 666 of the artificial blood vessel portion 66 so as to cover the outer periphery of the proximal end portion of the stent graft portion 61 in the non-inverted state. The open end 631 of the cuff portion 63 is located on the distal side of the distal end 666 of the artificial blood vessel portion 66.

The cuff portion 63 has a skirt shape in which the inner diameter of the opening end 631 is larger than the inner diameter of the base end (distal end 666 of the artificial blood vessel portion 66).
Here, the length of the cuff portion 63 (the enlarged diameter portion of the tubular knitted fabric) is preferably 5 to 30 mm, and a suitable example is 15 mm.

The inner diameter of the cuff portion 63 at the base end is the same as the inner diameter of the main pipe 661 of the artificial blood vessel portion 66.
The inner diameter of the cuff portion 63 at the opening end 631 is preferably 16 to 47 mm, and a suitable example is 28 mm.
Further, the ratio of the inner diameter of the opening end 631 to the inner diameter of the base end of the cuff portion 63 (the inner diameter of the main pipe 661 of the artificial blood vessel portion 66) is preferably 1.05 to 1.3. It is .08 (28 mm / 26 mm).

When the ratio of the inner diameters is 1.05 or more, suture can be easily performed even if the shape (size) of the proximal end of the distal aorta is large. In addition, the cuff portion can be easily turned over.
If the ratio of the inner diameter is excessive (inner diameter of the opening end 631 >> inner diameter of the proximal end), it becomes difficult to sew with the proximal end of the distal aorta, but the ratio of the inner diameter is 1.3 or less. This allows for easy suturing with the proximal end of the distal aorta.

The cuff portion 63 can be turned over so that the inner circumference and the outer circumference are reversed.
FIG. 11 shows a state in which the cuff portion 63 is inverted, and the cuff portion 63 after the inversion extends from the distal end 666 of the artificial blood vessel portion 66 to the proximal side, and the open end of the cuff portion 63 is shown. 631 is located proximal to the distal end 666 of the artificial blood vessel portion 66.

The cuff portion 63 is coated with collagen, gelatin, or the like, whereby blood leakage from the cuff portion 63 can be prevented.

The sleeve 70 constituting the delivery system 300 is a member that restrains the stent graft portion 61 of the aortic treatment device in a reduced diameter state.
The sleeve 70 winds a rectangular sheet (rectangular sheet 70S shown in FIG. 11) so as to wrap the stent graft portion 61 in a reduced diameter state, and sutures are pulled out along the axial direction by operating wires 80 on both sides of the rectangular sheet. It is formed by suturing as much as possible.

The rectangular sheet 70S shown in FIG. 11 is fixed to the outer periphery of the stent graft portion 61 (graft 612) by suturing at at least one point on the center line 70CL, preferably one point on the proximal end side. As a result, in the sleeve 70 shown in FIG. 10, the portion fixed to the outer circumference of the stent graft portion 61 and the portion where both sides of the rectangular sheet 70S are sewn (sewn) with the operation wire 80 are in phase with each other. Is 180 ° different.

In this specification, the term "phase" refers to a position of the delivery shaft (delivery system) in the circumferential direction (hereinafter, simply referred to as "circumferential position") indicated by an angle with respect to a reference position.
Here, when the portion of the artificial blood vessel portion 66 from which the side tubes 662 to 664 are derived is set as the reference position (0 °), the phase of the portion of the sleeve 70 fixed to the outer circumference of the stent graft portion 61 is approximately the same. It is 0 °, and the phase of the portion formed by sewing (sewn) both sides of the rectangular sheet 70S with the operation wire 80 is approximately 180 °.

The operation wire 80 constituting the delivery system 300 is sewn (sewn) on both sides of the rectangular sheet 70S in order to form a sleeve 70 including a stent graft portion in a reduced diameter state.
The suture by the operation wire 80 can be pulled out, and can be pulled out from the operation wire 80 sleeve 70 by pulling the base end of the operation wire 80. When the operation wire 80 is completely pulled out, the sleeve 70 becomes the original rectangular sheet 70S, and the diameter of the stent graft portion released from the restraint by the sleeve 70 is expanded.

As shown in FIG. 10, the operation wire 80 is inserted into the round hole 48 of the branch fixture 40 shown in FIGS. 8 and 9 on the proximal end side thereof.
The phase of the round hole 48 of the branch fixing tool 40 is substantially the same as the phase (approximately 180 °) of the portion formed by sewing (sewn) both sides of the rectangular sheet 70S with the operation wire 80.
That is, the phase (circumferential position) of the operation wire 80 does not substantially change from the tip of the sleeve 70 until it is inserted into the round hole 48 of the branch fixture 40.

Although not shown in FIG. 10, the tip of the operation wire 80 is held so that it can be pulled out by being accommodated in any of the non-through holes 38 (see FIGS. 4B and 7) formed in the tip tip 30. Has been done. A clip 90 is fixed to the base end 81 of the operation wire 80.

The grip 90 constituting the delivery system 300 is fitted into the sleeve 70 and located at the base end thereof in the state before use of the delivery system 300 shown in FIG.
When the delivery system 300 is used, the grip 90 is removed from the sleeve 70 and serves as a grip portion for pulling the base end 81 of the operation wire 80.

To show an example of how to use the delivery system 300 of the present embodiment, first, the clip 90 is removed from the sleeve 70, and the cuff portion 63 of the aortic treatment device 60 is inverted and restrained by the sleeve 70 in a reduced diameter state. The stent graft portion 61 is inserted into the distal aorta (descending aorta) from the transected portion after excision of the aortic arch, the grip 20 is pushed in, and the stent graft portion 61 is transported toward the target site. ..
_{At this time, since the maximum diameter D 1} of the enlarged diameter portion 31 of the tip tip 30 _{is larger than the outer diameter d 61} of the stent graft portion 61 in the reduced diameter portion, the tip of the stent graft portion 61 does not come into direct contact with the inner wall of the blood vessel. The tip of the stent graft 61 does not damage the inner wall of the blood vessel.

After the stent graft portion 61 reaches the target site, the clip 90 is gripped and the base end of the operation wire 80 is pulled while the grip 20 is fixed.
As a result, the tip of the operation wire 80 housed in the non-through hole 38 of the tip tip 30 is pulled out from the non-through hole 38, and then the operation wire 80 moves from the tip of the sleeve 70 toward the base end of the sleeve. The sleeve 70 is sequentially pulled out from the 70, and the sleeve 70 is sequentially deployed from the tip to the proximal end to release the restraint on the stent graft portion, and the stent graft portion 61 sequentially expands in diameter from the distal end toward the proximal end. As a result, the enlarged diameter stent graft 61 is placed in the distal aorta.

Here, since the phase (circumferential position) of the operation wire 80 does not substantially change from the tip of the sleeve 70 until it is inserted into the round hole 48 of the branch fixture 40, the diameter of the stent graft portion 61 to be expanded is increased. Since only the tensile force in the axial direction acts and the force in the circumferential direction does not act, the enlarged diameter stent graft portion 61 is not placed at the target site in a twisted state. As a result, it is possible to prevent problems such as obstruction of the stent graft portion 61 due to twisting and the side tube of the artificial blood vessel portion not being oriented in the desired direction.

Next, the delivery shaft 100 is removed from the aortic treatment device 60 (stent graft portion 61 and artificial blood vessel portion 66).
_{At this time, since the maximum diameter D 1} of the enlarged diameter portion 31 of the tip tip 30 is 80% or less of the inner diameter of the enlarged diameter portion 61 of the stent graft portion 61, the stent graft portion 61 indwelled at the target site is formed by the inner wall of the blood vessel. Even when the diameter is reduced to some extent (for example, about 20% when the diameter is expanded without being compressed), the delivery shaft 100 provided with the tip 30 is reliably removed from the stent graft portion 61. can do.

Next, the position of the open end 631 of the flipping cuff portion 63 is substantially matched with the position of the proximal end of the distal aorta. Next, the diameter of the stent graft portion 61 is enlarged and placed in the distal aorta. Then, the proximal end of the distal aorta and the cuff 63 are sutured with sutures to anastomosate the distal aorta with the artificial blood vessel 66.

Although the embodiments of the delivery shaft and the delivery system of the present invention have been described above, the present invention is not limited to these, and various modifications can be made.
For example, the diameter expansion rate of the diameter expansion portion of the tip tip may be constant.
Further, the delivery shaft does not have to have a branch fixture.
Further, the guide wire lumen may not be formed on the shaft body and the tip.
Further, the artificial blood vessel portion of the aortic treatment device constituting the delivery system does not have to have a side tube.
Further, the aortic treatment device constituting the delivery system may consist only of a stent graft.

100 Delivery shaft 10 Shaft body 10A Tip area 10B Intermediate area 10C Base end area 11 Tube member 11L lumen 12 Coating layer 13 (131 to 134) Core material 14 Reinforcing layer 15 Resin coating layer 16 Flare part 20 Grip 30 Tip tip 30L Through hole 31 Expansion part of tip tip 35 Cutting edge part of tip tip 37 Cylindrical part of tip tip 38 Non-penetrating hole 40 Branch fixture 44 Round hole 46 Long hole 48 Round hole 300 Delivery system 60 Aortic treatment device 61 Stent graft part 611 Stent 612 Graft 63 Cuff 631 Open end of cuff 66 Artificial blood vessel 661 Main pipe 662-665 Side tube 666 Distal end of artificial blood vessel 70 Sleeve 70S Rectangular sheet 70CL Centerline of rectangular sheet 80 Operation wire 90 Clip

Claims (10)

1. A delivery shaft for transporting a stent graft portion constituting a vascular treatment device to a target site in the body, which is attached to a shaft body, a grip attached to the base end side of the shaft body, and a tip side of the shaft body. Equipped with a tip tip
   The tip has a diameter-expanded portion that expands in the tip direction and
   A delivery shaft characterized by having a substantially hemispherical state-of-the-art portion whose diameter is the maximum diameter of the diameter-expanded portion, which is continuous with the tip of the diameter-expanded portion.
2. The maximum diameter D ₁ is 8 ~ 20 mm in the enlarged diameter portion, delivery according to claim 1, the radius of curvature R in the forefront portion is characterized in that in the range of 0.25 D ₁ ~ 0.75 D ₁ shaft.
3. When the minimum diameter of the enlarged diameter portion is D ₂ and the axial length of the enlarged diameter portion is L, _{the values of D 1} / D ₂ are 1.1 to 10, and (D ₁ − D ₂ ). The delivery shaft according to claim 2, wherein the value of / L is 0.07 to 3.
4. The delivery shaft according to claim 2 or 3, wherein the diameter expansion rate of the diameter-expanded portion continuously changes along the axial direction.
5. The delivery shaft according to claim 4, wherein the diameter expansion rate of the diameter-expanded portion continuously increases toward the tip.
6. The delivery shaft according to any one of claims 1 to 5, wherein a guide wire lumen is formed on the shaft body and the tip tip.
7. A delivery system in which a vascular treatment device having a stent graft portion is mounted on the shaft body of the delivery shaft according to claim 2.
   The stent graft portion is constrained to a reduced diameter state.
   When the outer diameter of the stent graft portion in the reduced diameter state is d ₆₁ and the inner diameter of the stent graft portion in the expanded state is D ₆₁ , the equation: d ₆₁ <D ₁ ≤ 0.8 _{D 61} is satisfied. Delivery system to do.
8. A sleeve that restrains the stent graft portion in a reduced diameter state,
   The delivery system according to claim 7, further comprising an operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.
9. The sleeve is formed by suturing both sides of a rectangular sheet wound so as to wrap the diameter-reduced stent graft portion with the operation wire so that the thread can be pulled out along the axial direction.
   The delivery system according to claim 8, wherein the tip tip is formed with at least one hole for accommodating and holding the tip of the operation wire.
10. In the vascular treatment device, the stent graft portion and the artificial blood vessel portion are connected by suture, and the artificial blood vessel portion is composed of a branched artificial blood vessel in which at least one side tube is derived from the main tube. The delivery system according to any one of claims 7 to 9.

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