WO2021176673A1 - Delivery shaft and delivery system - Google Patents

Abstract

The purpose of the present invention is to provide a delivery shaft that is capable of moving an operation wire to the proximal end side along the axial direction of a shaft body, regardless of the direction in which the proximal end of the operation wire is being pulled. This delivery shaft (100) is for conveying, to a target site within the body, a stent-graft part of a vascular treatment device that has been enclosed in a sleeve and constrained in a contracted state, and comprises a shaft body (10), a grip (20), a distal tip (30), and a wire guide plate (40) fixed to the distal end of the grip (20). The wire guide plate (40) has formed therein a shaft insertion hole (44) through which the shaft body (10) is inserted, a wire insertion hole (48) which is disposed in the proximity of the shaft insertion hole (44) and through which an operation wire for releasing the constraining of the stent-graft part can be inserted, and a branch-holding opening (46) through which the distal ends of side tubes of a synthetic branched graft of the vascular treatment device can be inserted in a bundled state.

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 the suture can be pulled out by an operation wire. After the stent graft mounted on the delivery shaft reaches the target site in the body, the operation wire is pulled out by pulling the base end of the operation wire, so that the restraint by the sleeve is sequentially applied from the tip to the base end. It is released and the stent graft expands, which places the expanded stent graft in place at the site of interest.

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

In the delivery shaft described in Patent Document 4 above, when the restraint by the sleeve is released and the stent graft is expanded, the operation wire can be moved along the axial direction (length direction) of the catheter shaft. It is important to pull the base end of the operation wire along the axial direction.

However, in actual surgery, the proximal end of the operating wire may be pulled in a direction different from the axial direction of the catheter shaft. In this case, the operating wire is based on the axial direction of the catheter shaft. It cannot be moved to the edge side.

If the operating wire cannot be moved along the axial direction of the catheter shaft, not only the operating wire cannot be efficiently removed, but also a circumferential force acts on the stent graft during the tensile operation. Therefore, it is conceivable that the expanded stent graft is placed in a twisted state, resulting in stenosis in its lumen.

Further, when the stent graft portion of the vascular treatment apparatus as described in Patent Document 3 is conveyed by the delivery shaft as described in Patent Document 4, the stent graft portion is twisted to cause a branched artificial blood vessel. The main tube of the part is also twisted, and each of the side tubes derived from the side tube may not be anastomosed with the living blood vessel, or the side tube may be kinked after the anastomosis and the lumen may be occluded.

By the way, when the stent graft portion of the vascular treatment apparatus as described in Patent Document 3 is transported by the delivery shaft, the tip portion of the side tube that becomes an obstacle during the transfer operation is tied with a string and bundled into the main tube. It is necessary to perform complicated work before and after surgery, such as tying up the patent graft, placing the stent graft at the target site, and then untying the tied string.

The present invention has been made based on the above circumstances.
An object of the present invention is a delivery shaft constituting a system for pulling the base end of an operation wire to release restraint of a stent graft portion by a sleeve, regardless of the tension direction of the base end of the operation wire. It is an object of the present invention to provide a delivery shaft that can move the operation wire toward the proximal end side along the direction and does not allow the expanded stent graft portion to be placed in the body in a twisted state.

Another object of the present invention is to tie the tip of the side tube of the branched artificial blood vessel portion with a string when transporting the stent graft portion of the vascular treatment device provided with the branched artificial blood vessel portion to the target site in the body. The purpose is to provide a delivery shaft that does not require complicated operations such as tying it to the main pipe.

Still another object of the present invention is to provide a delivery system provided with a delivery shaft as described above.

(1) The delivery shaft of the present invention is a delivery shaft for transporting a stent graft portion that constitutes a vascular treatment device, which is contained in a sleeve and restrained in a reduced diameter state, to a target site in the body.
The shaft body, the tip tip mounted on the tip end side of the shaft body, the grip mounted on the base end side of the shaft body, and the shaft body fixed to the tip of the grip or near the tip of the grip. Equipped with a wire guide plate
The wire guide plate has a shaft insertion hole through which the shaft body is inserted, and
It is characterized in that at least one wire insertion hole which is arranged in the vicinity of the shaft insertion hole and is capable of inserting an operation wire for releasing the restraint of the stent graft portion by the sleeve is formed.

According to the delivery shaft having such a configuration, by inserting the base end portion of the operation wire into the wire insertion hole, the operation wire is applied regardless of the tension direction of the base end of the operation wire (the direction in which the operator pulls the operation wire). Can be moved toward the proximal end side along the axial direction (length direction) of the shaft body. As a result, during the pulling operation of the base end of the operation wire, the force in the circumferential direction for twisting the stent graft is substantially not applied to the stent graft, so that the stent graft portion is placed in the body in a twisted state. There is no such thing as stenosis in the lumen of the stent graft due to twisting.

Here, the "base end portion" of the operation wire means a portion including the "base end" of the operation wire and having a certain length.

(2) In the delivery shaft of the present invention, in the vascular treatment device, the stent graft portion and a branched artificial blood vessel portion in which at least one side tube is derived from the main tube are connected by suturing.
It is preferable that the wire guide plate is formed with a branch holding hole through which the tip end portion of the side tube can be inserted.

According to the delivery shaft having such a configuration, the main tube of the branched artificial blood vessel portion can be directed in an appropriate direction without twisting, and the side tube derived from this main tube can be directed in an appropriate direction. Each can be reliably anastomosed with a living blood vessel.
In addition, by inserting the tip of the side tube that constitutes the artificial blood vessel with branch into the branch holding hole (if there are multiple side tubes, bundle them), the side tube is provided by a wire guide plate. The tip of the can be detachably held, and there is no need to perform complicated work such as tying the side tube with a string.

(3) In the delivery shaft of the above (2), the branch holding hole of the wire guide plate and one of the wire insertion holes are arranged at positions facing each other with the shaft insertion hole in between. preferable.

According to the delivery shaft having such a configuration, the tips of a plurality of side tubes constituting the branched artificial blood vessel portion are inserted into the branch holding hole so as to be bundled, and the base end portion of the operation wire is inserted into the shaft. By inserting into a wire insertion hole arranged at a position facing the branch holding hole across the hole, the tips (bundles) of a plurality of side tubes constituting the branched artificial blood vessel portion and the operation wire The base end portion of the shaft can be arranged so as to face each other with the shaft body interposed therebetween.

(4) The delivery system of the present invention includes the delivery shaft of (1) above and the delivery shaft.
The blood vessel treatment device mounted on the shaft body of the delivery shaft, and
The sleeve that encloses the stent graft portion of the vascular treatment device and restrains it in a reduced diameter state.
It is provided with the operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.
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 sleeve can be pulled out along the axial direction.
The base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate.

According to the delivery system having such a configuration, the operation wire can be moved to the proximal end side along the axial direction of the shaft body regardless of the pulling direction of the proximal end of the operating wire. As a result, during the pulling operation of the base end of the operation wire, the force in the circumferential direction to twist the stent graft is substantially not applied to the stent graft, so that the stent graft portion of the vascular treatment device is twisted into the body. It is not indwelled and does not cause stenosis in the lumen of the stent graft due to twisting.

(5) The delivery system of the present invention includes the delivery shaft of (2) above and the delivery shaft.
The vascular treatment device having the artificial blood vessel portion with a branch mounted on the shaft body of the delivery shaft, and the vascular treatment device.
The sleeve that encloses the stent graft portion of the vascular treatment device and restrains it in a reduced diameter state.
It is provided with the operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.
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 sleeve can be pulled out along the axial direction.
The tip of the side tube constituting the artificial blood vessel portion is inserted into the branch holding hole so as to be detachably held by the wire guide plate.
The base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate.

According to the delivery system having such a configuration, the main tube of the branched artificial blood vessel portion can be directed in an appropriate direction without twisting, and the side tube derived from this main tube can be directed in an appropriate direction. Each can be reliably anastomosed with a living blood vessel.
Further, since the tip portion of the side tube can be detachably held by the wire guide plate, it is not necessary to perform complicated work such as tying the side tube with a string.

(6) The delivery system of (5) above is provided with the delivery shaft of (3) above.
It is preferable that the base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate arranged at a position facing the branch holding hole with the shaft insertion hole interposed therebetween.

According to the delivery system having such a configuration, the tip ends (bundles) of a plurality of side tubes constituting the branched artificial blood vessel portion and the base end portions of the operation wires are arranged so as to face each other with the shaft body interposed therebetween. Can be made to.

(7) In the delivery system of the present invention, the phase of the wire insertion hole of the wire guide plate into which the base end portion of the operation wire is inserted and both sides of the rectangular sheet are sewn with the operation wire. It is preferable that the phases of the components of the sleeve are substantially the same.

Here, the "phase" refers to the position of the delivery shaft (delivery system) in the circumferential direction indicated by an angle with respect to the reference position.
According to the delivery system having such a configuration, the phase of the operation wire moving to the proximal end side along the axial direction of the shaft body does not change, so that the stent graft portion is twisted during the tension operation. It is possible to reliably prevent the action of a force in the circumferential direction.

(8) In the delivery system of the present invention, it is preferable that the tip has 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.

According to the delivery shaft and delivery system of the present invention, the operation wire can be moved to the proximal end side along the axial direction of the shaft body regardless of the tensile direction of the proximal end of the operational wire. The stent graft portion is not placed in the body in a twisted state, and the lumen of the stent graft portion is not narrowed due to the twist.
Further, when the stent graft portion of the vascular treatment device provided with the branched artificial blood vessel portion is transported to the target site, the main tube of the branched artificial blood vessel portion is not twisted, and the side tube derived from this main tube is not twisted. Can be directed in the proper direction.
Further, it is not necessary to perform complicated work such as tying the side tube of the branched artificial blood vessel portion with a string.

It is a perspective view of the delivery shaft which concerns on one Embodiment of this invention. It is a front view of the delivery shaft shown in FIG. It is a vertical sectional view of the delivery shaft shown in FIG. It is an end view of the delivery shaft shown in FIG. 1 (the end view of III-III of FIG. 2A). It is a cross-sectional view of the delivery shaft shown in FIG. 1 (the cross-sectional view of III-III of FIG. 2A). It is an end view (IV-IV end view of FIG. 2A) of the delivery shaft shown in FIG. It is a cross-sectional view (IV-IV cross-sectional view of FIG. 2A) of the delivery shaft shown in FIG. It is a partially enlarged front view (detailed view of V part of FIG. 2A) 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 wire guide plate which comprises the delivery shaft shown in FIG. FIG. 8 is a cross-sectional view (IX-IX cross-sectional view) of the wire guide plate 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 front view of the delivery system which concerns on one Embodiment of this invention.

<Delivery shaft>
The delivery shaft 100 of the present embodiment shown in FIGS. 1 to 7 is a delivery shaft for transporting a stent graft portion of an aortic treatment device enclosed in a sleeve and restrained in a reduced diameter state to a target site in the body. ..

An aortic treatment device including a stent graft portion transported by a delivery shaft 100 is a vascular treatment in which the stent graft portion and a branched artificial blood vessel portion in which four side tubes are derived from the main tube are connected by suture. It is an apparatus (see FIG. 11).

The delivery shaft 100 is fixed to the shaft body 10, the grip 20 mounted on the base end side of the shaft body 10, the tip tip 30 mounted on the tip end side of the shaft body 10, and the tip of the grip 20. A wire guide plate 40 is provided, and the wire guide plate 40 is arranged in the vicinity of the shaft insertion hole 44 into which the shaft body 10 is inserted and the shaft insertion hole 44, and the restraint of the stent graft portion by the sleeve is released. The tips of four side tubes that are arranged at positions facing the wire insertion hole 48 with the shaft insertion hole 44 sandwiched between the wire insertion hole 48 through which the operation wire for inserting the wire can be inserted and forming the branched artificial blood vessel portion. A branch holding hole 46 that can be inserted so as to bundle the portions is formed.

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. 2B, the shaft body 10 has a tip region 10A, an intermediate region 10B, and a base end region 10C in this order from the tip end to the base end in the axial direction.

The tip region 10A of the shaft body 10 is an region to which the stent graft portion 61 of the aortic treatment device (vascular treatment device) 60 shown in FIG. 11 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. 2B, the base end region 10C of the shaft body 10 is an region that is inserted into the shaft insertion hole 44 of the wire guide plate 40 and accommodated in the grip 20.

As shown in FIGS. 1, 2A and 2B, 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.
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 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, 2A and 2B, a wire guide plate 40 is fixed to the tip of the grip 20.

As shown in FIGS. 8 and 9, the wire guide plate 40 has a shaft insertion hole 44, a wire insertion hole 48 arranged in the vicinity of the shaft insertion hole 44, and a wire insertion hole 44 with the shaft insertion hole 44 interposed therebetween. A branch holding hole 46 arranged at a position facing the hole 48 is formed.

As shown in FIG. 2B, the shaft body 10 (base end region 10C) is inserted into the shaft insertion hole 44 of the wire guide plate 40.

The wire insertion hole 48 of the wire guide plate 40 is a hole for inserting the base end portion of the operation wire. The operation wire is a wire for releasing the restraint of the stent graft portion by the sleeve.

The hole diameter of the wire insertion hole 48 is usually 0.25 to 2 mm, and a suitable example is 0.5 mm.
If the hole diameter of the wire insertion hole 48 is too small, the operation wire cannot be smoothly inserted.
Further, if the hole diameter is excessive, the function of guiding the operation wire so as to move along the axial direction of the shaft body 10 may be impaired.

The wire insertion hole 48 is arranged in the vicinity of the shaft insertion hole 44.
The distance between the central shafts of the wire insertion hole 48 and the shaft insertion hole 44 is usually 5 to 30 mm, and a suitable example is 11 mm.

The branch holding hole 46 of the wire guide plate 40 is a hole for inserting the tip portions of the four side tubes constituting the branched artificial blood vessel portion so as to bundle them.
The branch holding hole 46 has a capsule (oval) shape, and the area of the branch holding hole 46 is large enough to bundle the tips of the four side tubes and hold them detachably.
Here, the hole diameter of the branch holding hole 46 in the longitudinal direction is 10 to 41 mm, and a suitable example is 33 mm. Further, the hole diameter in the lateral direction is 9 to 40 mm, and a suitable example is 21 mm.

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

According to the delivery shaft 100 of the present embodiment, by inserting the base end portion of the operation wire into the wire insertion hole 48, the operation is performed regardless of the tension direction of the base end of the operation wire (the direction in which the operator pulls the operation wire). The wire can be moved toward the proximal end side along the axial direction (longitudinal direction) of the shaft body 10. As a result, during the tension operation of the base end of the operation wire, no force acts in the circumferential direction on the stent graft, so that the stent graft portion is not placed in the body in a twisted state, and is caused by the twist. , There is no stenosis in the lumen of the stent graft.

In addition, since the main tube of the branched artificial blood vessel connected to the stent graft portion is not twisted, the side tube derived from this main tube can be directed in an appropriate direction, and each of the side tubes can be oriented in an appropriate direction. Can be reliably anastomosed with a living blood vessel.

Further, the tip of the side tube is detachably held by the wire guide plate by inserting the tip of the four side tubes constituting the artificial blood vessel with branch into the branch holding hole so as to bundle them. It is possible to do so, and there is no need to perform complicated work such as tying the side pipe with a string.

Further, the tips of the four side tubes constituting the branched artificial blood vessel are inserted into the branch holding hole 46 so as to be bundled, and the base end of the operation wire is inserted into the wire insertion hole 48. The tip ends (bundles) of the four side tubes constituting the branched artificial blood vessel portion and the base end portions of the operation wires can be arranged so as to face each other with the shaft body 10 interposed therebetween.
As a result, when the operation wire is used, the possibility that the operation wire comes into contact with the side pipe is low, and the operability of the operation wire is good. Further, the side tube is less likely to be damaged by being rubbed by the operation wire.

Further, since the cutting edge portion 35 of the tip tip 30 has a substantially hemispherical shape having a smooth curved surface, even if the cutting edge portion 35 abuts on the inner wall of the blood vessel, stress is applied to the abutting portion. There is no concentration, 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, 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 FIGS. 10 and 12 has the above-mentioned delivery shaft 100, a stent graft (61), and an artificial blood vessel portion 66, and is mounted on the shaft body of the delivery shaft 100. A sleeve 70 that encloses the stent graft (61) of the aortic treatment device 60 and restrains the stent graft (61) in a reduced diameter state, and an operation wire that releases the restraint of the stent graft (61) by the sleeve 70 by pulling the base end 81 thereof. The sleeve 70 includes a clip 90 to which the base end 81 of the operation wire 80 is fixed, and the sleeve 70 covers both sides of the rectangular sheet 70S wound so as to wrap the stent graft (61) in the reduced diameter state. The tips of the four side tubes 662 to 665, which are formed by suturing the sleeve 70 so as to be able to be pulled out along the axial direction of the sleeve 70, form a branch holding hole in a bundled state. By being inserted through the 46, it is detachably held by the wire guide plate 40, and the base end portion of the operation wire 80 is inserted into the wire insertion hole 48 of the wire guide plate 40.

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 pipe 662 is preferably 5 to 14 mm, and a suitable example is 11 mm.
The inner diameter of the side pipes 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. 2B.

The side tubes 662 to 665 constituting the artificial blood vessel portion 66 are inserted into the branch holding hole 46 with their respective tips bundled, whereby the side tubes 662 to 665 are attached to and detached from the wire guide plate 40. It is held freely.

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

By holding the side tubes 662 to 665 with the wire guide plate 40, these side tubes are tied with a string during the complicated work conventionally performed before and after the operation, that is, when the stent graft portion is transported, and after the stent graft portion is placed. , 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 FIGS. 10 and 12, the diameter-reduced stent graft portion included 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, the diameter is easily reduced, the fitting property with blood vessels is good, and the affinity with living tissue is also excellent. 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. 2B.

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 includes the stent graft portion 61 of the aortic treatment device 60 and restrains the delivery system 300 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 both sides of the rectangular sheet are wound along the axial direction of the sleeve 70 by an operation wire 80. It is formed by suturing (sewn) so that the thread can be pulled out.

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 delivery system 300 shown in FIG. 10, the rectangular sheet 70S wound so as to wrap the constituent portion of the sleeve 70 fixed to the outer periphery of the stent graft portion 61 and the stent graft portion 61 in the reduced diameter state. The phases of the sleeve 70 are 180 ° different from those of the sleeve 70, which is sewn (sewn) on both sides with the operation wire 80.

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 component portion fixed to the outer circumference of the stent graft portion 61 in the sleeve 70 is approximately omitted. It is 0 °, and the phase of the component portion in which both sides of the rectangular sheet 70S are sewn (sewn) 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 81 of the operation wire 80. When the operation wire 80 is completely removed, the sleeve 70 becomes the original rectangular sheet 70S, and the stent graft portion 61 released from the restraint by the sleeve 70 is in the enlarged diameter state.

As shown in FIGS. 10 and 12, the base end portion of the operation wire 80 is inserted into the wire insertion hole 48 of the wire guide plate 40.
The phase of the wire insertion hole 48 of the wire guide plate 40 substantially coincides with the phase (approximately 180 °) of the component portion of the sleeve 70 formed by sewing (sewn) both sides of the rectangular sheet 70S with the operation wire 80. There is.

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 wire insertion hole 48 of the wire guide plate 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, as shown in FIG. 12, the grip 90 is removed from the sleeve 70, and the grip 90 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 81 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.

At this time, even if the base end 81 (grip 90) of the operation wire 80 is pulled in an arbitrary direction different from the axial direction of the shaft body 10, the operation wire 80 located on the tip side of the wire guide plate 40 is used. , The shaft body 10 (tip region 10A and intermediate region 10B) can be moved to the proximal end side along the axial direction without changing its phase.

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.

According to the delivery system 300 of the present embodiment, since the base end portion of the operation wire 80 is inserted into the wire insertion hole 48 of the wire guide plate 40, the operation wire 80 is inserted regardless of the pulling direction of the base end 81 by the operator. Can be moved toward the proximal end side along the axial direction of the shaft body 10 (tip region 10A and intermediate region 10B). As a result, during the pulling operation of the base end 81 of the operation wire 80, the force in the circumferential direction does not act on the stent graft portion 61 of the aortic treatment device 60, so that the stent graft portion 61 is placed in the body in a twisted state. There is no such thing as stenosis in the lumen of the stent graft portion 61 due to twisting.

Further, the main pipe 661 of the artificial blood vessel portion 66 connected to the stent graft portion 61 is not twisted, and the side pipes 662 to 665 derived from the main pipe 661 can be directed in an appropriate direction. Each of the tubes 662 to 665 can be reliably anastomosed with a living blood vessel.

Further, since the tips of the side tubes 662 to 665 constituting the artificial blood vessel portion 66 can be detachably held by the wire guide plate 40, it is necessary to perform complicated work before and after the operation such as tying the side tubes with a string. There is no.

Further, the tip ends (bundles) of the side tubes 662 to 665 constituting the artificial blood vessel portion 66 and the base end portion of the operation wire 80 can be arranged so as to face each other with the shaft body 10 of the delivery shaft 100 interposed therebetween. ..

Further, the phase of the wire insertion hole 48 into which the base end portion of the operation wire 80 is inserted and the phase of the component portion of the sleeve 70 in which both sides of the rectangular sheet 70S are sewn with the operation wire 80 substantially match. As a result, the phase of the operation wire 80 that moves toward the proximal end side along the axial direction of the shaft body 10 does not change, so that the circumference of the operation wire 80 that is to be twisted with respect to the stent graft portion 61 during the tension operation. It is possible to reliably prevent the action of a directional force.

Further, in the vascular treatment device 60 constituting the delivery system 300, the portion of the artificial blood vessel portion 66 from which the side tubes 662 to 664 are derived and the portion of the stent graft portion 61 to which the rectangular sheet 70S is fixed are substantially the same. Since it is in phase (circumferential position), when the stent graft portion 61 is placed in the distal aorta, the rectangular sheet 70S will be placed on the kyphosis side of the distal aorta. Here, since the indwelling stent graft portion 61 does not shrink in the axial direction on the curvature side, the rectangular sheet 70S is also arranged in an elongated state without wrinkles. As a result, the rectangular sheet 70S can secure sufficient adhesion to the inner wall of the blood vessel.

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, a plurality of wire insertion holes may be formed in the wire insertion holes constituting the delivery shaft.
Further, the artificial blood vessel portion of the vascular treatment device constituting the delivery system does not have to have a side tube.
Further, the vascular treatment device constituting the delivery system may be composed of only the stent graft portion.
Further, the guide wire lumen may not be formed on the shaft body and the tip.
Further, the shape of the tip tip is not particularly limited, and may be a cannonball shape.

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 Expanded part of tip tip 35 Cutting edge part of tip tip 37 Cylindrical part of tip tip 38 Non-through hole 40 Wire guide plate 44 Shaft insertion hole 46 Branch holding hole 48 Wire insertion hole 300 Delivery system 60 Vascular therapy device 61 Stent graft Part 611 Stent 612 Graft 63 Cuff part 631 Cuff part open end 66 Artificial blood vessel part 661 Main pipe 662 to 665 Side tube 666 Distal end of artificial blood vessel part 70 Sleeve 70S Rectangular sheet 70CL Center line of rectangular sheet 80 Operation wire 81 Operation wire Base 90 clips

Claims (8)

A delivery shaft for transporting a stent graft portion that constitutes a vascular treatment device, which is enclosed in a sleeve and restrained in a reduced diameter state, to a target site in the body.
The shaft body, the tip tip mounted on the tip end side of the shaft body, the grip mounted on the base end side of the shaft body, and the shaft body fixed to the tip of the grip or near the tip of the grip. Equipped with a wire guide plate
The wire guide plate has a shaft insertion hole through which the shaft body is inserted, and
A delivery shaft that is arranged in the vicinity of the shaft insertion hole and has at least one wire insertion hole through which an operation wire for releasing the restraint of the stent graft portion by the sleeve can be inserted. In the vascular treatment device, the stent graft portion and a branched artificial blood vessel portion in which at least one side tube is derived from the main tube are connected by suture.
The delivery shaft according to claim 1, wherein the wire guide plate is formed with a branch holding hole through which the tip end portion of the side tube can be inserted. The delivery shaft according to claim 2, wherein the branch holding hole of the wire guide plate and one wire insertion hole are arranged at positions facing each other with the shaft insertion hole interposed therebetween. The delivery shaft according to claim 1 and
The blood vessel treatment device mounted on the shaft body of the delivery shaft, and
The sleeve that encloses the stent graft portion of the vascular treatment device and restrains it in a reduced diameter state.
It is provided with the operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.
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 sleeve can be pulled out along the axial direction.
A delivery system characterized in that a base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate. The delivery shaft according to claim 2 and
The vascular treatment device having the artificial blood vessel portion with a branch mounted on the shaft body of the delivery shaft, and the vascular treatment device.
The sleeve that encloses the stent graft portion of the vascular treatment device and restrains it in a reduced diameter state.
It is provided with the operation wire for releasing the restraint of the stent graft portion by the sleeve by pulling the base end thereof.
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 sleeve can be pulled out along the axial direction.
The tip of the side tube constituting the artificial blood vessel portion is inserted into the branch holding hole so as to be detachably held by the wire guide plate.
A delivery system characterized in that a base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate. The delivery shaft according to claim 3 is provided.
The base end portion of the operation wire is inserted into the wire insertion hole of the wire guide plate arranged at a position facing the branch holding hole with the shaft insertion hole interposed therebetween. The delivery system according to claim 5. The phase of the wire insertion hole of the wire guide plate into which the base end portion of the operation wire is inserted and the phase of the component portion of the sleeve in which both sides of the rectangular sheet are sewn with the operation wire are substantially the same. The delivery system according to any one of claims 4 to 6, wherein the delivery system is consistent with each other. The delivery system according to any one of claims 4 to 7, wherein the tip tip is formed with at least one hole for accommodating and holding the tip end portion of the operation wire.

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