WO2017086285A1

WO2017086285A1 - Stent graft

Info

Publication number: WO2017086285A1
Application number: PCT/JP2016/083750
Authority: WO
Inventors: 崇志吉森; 伊藤　美保; 崇志末松; 和巳秋田; 可名金子
Original assignee: 川澄化学工業株式会社
Priority date: 2015-11-20
Filing date: 2016-11-15
Publication date: 2017-05-26
Also published as: JPWO2017086285A1; JP6937242B2

Abstract

[Problem] To provide a stent graft from which, when extracting a wire after placement of the stent graft at the affected area, the wire can be easily removed without catching on a retaining ring, and which facilitates procedures. [Solution] A hook 6 is arranged at one end of a terminal-side annular unit 4DE to the terminal DE side in the circumferential CR direction. Wire holding units (7HR, 8HR) are arranged, with respect to the center 6C of the hook 6 in the longitudinal L direction, at a peak M or near the peak M of a strut 4ST in the direction of a side portion S, and at a peak M or near the peak M of a strut 4ST in the direction of another side portion S. The wire holding units (7HR, 8HR) are made of sutures, and two or more strands are used bundled together as the wire material, and at least one part thereof is wound and formed into a loop.

Description

Stent graft

The present invention relates to a stent graft used for the treatment of diseases such as aneurysms. More specifically, the present invention relates to a stent graft used for treating an aneurysm or the like in order to treat an expandable disease (aneurysm), an arterial stenosis disease or other disease, and is used in a safe site of an affected area. The present invention relates to a stent graft that can be reliably placed and used as an artificial blood vessel or the like and can reduce pain and burden on a patient.

The present patent applicant disclosed the invention of a stent graft and a stent graft indwelling device in Patent Document 1 and Patent Document 2.
In Patent Document 1, a stent graft in which the outer periphery of a stent having a previously bent shape constituted by connecting annular units is specifically covered with a synthetic resin tubular member (graft) in order to cope with a sharp bend of the aorta. Disclosed.

In Patent Document 2, as described in paragraphs [0077] to [0079] in the column “Detailed Description of the Invention” and FIGS. 8 (A) and 8 (B), adjustment of the suture made to the stent graft is performed. The indwelling position and its delicate angle are adjusted by using the wire 40 and adjusting the tension of the wire. In order to hold the wire 40, two

metal holding rings

67 and 68 are formed on the hook portion 66 provided at the distal end of the stent graft for locking and pulling the stent graft. As described in paragraphs [0082] to [0087], the suture adjusting wire 40 is passed through, and as described in paragraphs [0098] to [0111], the stent graft is applied to the affected area. After indwelling, the wire 40 was pulled out.

Japanese Patent No. 4773341 (Claims 5, 10, FIGS. 1, 9, 10) Patent No. 5230616 ([0077] to [0079], [0082] to [0087], [0098] to [0111], FIGS. 8A and 8B)

The configuration including the adjusting means using such a wire makes it possible to suitably control the placement position and angle of the stent graft. However, when applied to an actual medical site, when the adjustment wire 40 is pulled out after the stent graft is placed in the affected area, the suture wire 40 is caught by the

metal holding rings

67 and 68 and cannot be pulled out. The present inventors have found for the first time that there are cases (although very few) and sometimes it is difficult to pull out. Furthermore, it was found that there was a possibility of breaking the wire if it was pulled forcibly in this state.

Therefore, as a result of intensive studies in order to solve the above-described novel problems, the present inventor has reached the following invention.
[1] The present invention includes a stent (1ST) formed in a substantially tubular body extending in the longitudinal (L) direction and expandable in the circumferential (CR) direction from the inside of the substantially tubular body,
A stent graft (1) in which an outer periphery of the expandable stent (1ST) is coated with a graft (GF),
The substantially tubular body forming the stent (1ST) includes a plurality of annular units (4) that expand in the circumferential (CR) direction and a connecting unit that connects the adjacent annular units (4) in the longitudinal (L) direction. (5)
The substantially tubular body has one end portion in the side portion (S) direction of the adjacent annular units (4) connected via one end portion of the connection unit (5), and a plurality of annular units (4) are elongated ( L) are arranged in the direction,
The annular unit (4) includes a strut (4ST) having a plurality of peaks (M) in one direction of the side portion (S) and a plurality of valley portions (V) in one direction of the other side portion (S). ) Are alternately connected to each other to form a substantially zigzag shape continuously in the circumferential (CR) direction.
A hook (6) is arranged at one end in the circumferential (CR) direction on the terminal (DE) side of the terminal unit (4DE) on the terminal side,
The hook (6) has two proximal ends (6PE) extending downward,
The base end (6PE) has two substantially straight lines (6ST),
Of the two substantially straight lines (6ST), one connects the base end (PE) with the vicinity of the unidirectional peak (MS1) of the side (S) of the strut (4ST),
The other one connects the base end (PE) with the vicinity of the unidirectional peak (MS3) of the side (S) of the strut (4ST),
Further, in the case where the holding ring (7HR, 8HR) which is a ring-shaped holding portion for holding the adjustment wire is provided in the hook (6), the arrangement of the holding ring (7HR, 8HR) of the wire is as follows:
With respect to the center (6C) in the longitudinal (L) direction of the hook (6),
The peak (MS1) of the strut (4STS1) in one direction of the side (S) or the vicinity of the peak (MS1) and the peak of the strut (4STS3) in one direction of the other side (S) (MS3) or in the vicinity of the mountain (MS3),
The holding ring (7HR, 8HR) of the wire is made of suture, and is used as a wire bundle of at least two or more, and at least a part of the wire is wound to form a loop. A stent graft (1) is provided.

[2] In the present invention, the loop-shaped holding ring (7HR, 8HR) is formed by winding a part of the suture wire having both ends and bundling at least two bundles. One end is connected to one end of the wire in the vicinity of the peak (M) or peak (M) of the strut (4ST) to which the base end (PE) side of the hook (6) is attached. A stent graft (1) according to [1] having a fixed end (8ST) is provided.

[3] In the present invention, the base end (PE) side and the end (DE) of the loop-shaped holding ring (7HR, 8HR) formed by winding a part of at least two pieces of suture wire bundles bundled together. The stent graft (1) according to [1] or [2], in which a plurality of knots (8BPE, 8BDE) are formed on each of the) side by the wire.

[4] The stent graft according to any one of [1] to [3], wherein the fixed end (8ST) of the wire is sutured to the graft (GF) covering the stent (1ST). 1) is provided.

[5] In the present invention, the end-side retaining ring (9DE) on the end (DE) side of the wire is provided near the peak (M) of the one end-side annular member (4DE) or in the vicinity of the peak (M). A plurality of side annular members (4DE) are arranged in the circumferential (CR) direction, and the base end of the wire is located near the valley (V) or the valley (V) of the other base end side annular member (4PE). The stent graft (1) according to any one of [1] to [4], in which two (PE) side proximal-side holding rings (9PE) are arranged.

In the stent graft of the present invention, the holding ring (7HR, 8HR) of the adjusting wire 40 is formed of a suture wire as described in [1], so that the wire 40 is placed after the stent graft 1 is placed in the affected area. When the wire is pulled out, the suture wire 40 is not caught on the holding ring (7HR, 8HR), and it is easy to pull out and the procedure becomes easy.
Further, as described in [1] above, the holding rings (7HR, 8HR) are formed of a wire material obtained by bundling a plurality of (two or more) sutures, so that the strength is stable.

FIG. 1 is an overall view (front view / schematic diagram) of a stent graft 1 of the present invention. FIG. 2 is a partially enlarged view of the vicinity of the terminal-side annular unit 4DE of the stent graft 1 (a developed view developed by τ = 360 ° in the circumferential CR direction). (Where τ is displayed in polar coordinates with the center of the front (circular opening) of the annular unit as the origin when the terminal annular unit is assembled from the developed view (position around the annular unit). Is the angle of deviation τ. FIG. 3 is a partially enlarged view of FIG. FIG. 4 is a photograph showing an example of the attachment state of the retaining ring. FIG. 5 is a partially enlarged view of the vicinity of the distal annular unit 104DE of the known stent graft 101. FIG.

Hereinafter, the present invention will be described in detail with reference to the drawings.
Hereinafter, in order to clearly describe the present invention, the following definition is given with reference to the arrangement of FIG. In FIG. 1, the struts 4ST and 5ST are described so as to overlap each other when viewed from the front direction to the back direction in order to avoid complication of each line.
(Definition 1) "The 1st side part S1 side" means the front side of a paper surface and the front direction of a stent, as shown in FIG. Hereinafter, "... side" may be described as "... direction".
(Definition 2) "The 2nd side part S2 side" means the back side of a paper surface, and the back direction of a stent, as shown in FIG.
(Definition 3) “Terminal DE side” means the left side of the page as shown in FIG.
(Definition 4) “The base PE side” means the right side of the page as shown in FIG.
(Definition 5) “The third side S3 side” means the upper side of the paper surface as shown in FIG.
(Definition 6) “Fourth side S4 side” means the lower side of the page as shown in FIG.

(Definition 7) The “longitudinal L direction” means the longitudinal direction of the stent as shown in FIG.
(Definition 8) The “circumferential CR direction” means a direction extending from the center C in the longitudinal L direction of the stent to the “side S side”, and is also referred to as “side S direction”.
The side S direction includes the first side S1 side, the second side S2 side, the third side S3 side, the fourth side S4 side, and all directions therebetween.
(Definition 9)
A part of the circumferential CR (side S) direction is described as “one side direction”, and the side opposite to or different from the “one side direction” is described as “one side direction”. There is a case.
For example, the third side S3 side is set in one direction of the side, and the opposite fourth side S4 is set in one direction in the other side (via the first side S1 or the second side S2 in the middle). May be described.
For example, the first side portion S1 side (or the second side portion S2 side) is set in one direction of the side portion, and the fourth side portion S4 side (or the third side portion S3 side) on the other side is set in the other side portion. Sometimes referred to as direction.
(Definition 10)
Moreover, the code | symbol which means directions, such as S3, may be described after the code | symbol of each part.
For example, 4STS3 means the strut 4ST on the third side, and MS3 means the peak M on the third side.

(Definition 11)
The “strut” is also referred to as a support and is a member that forms the “annular unit 4” and the “connecting unit 5”.
The “strut” constituting the “annular unit 4” may be referred to as “annular strut 4ST” or simply “strut 4ST” in the meaning of “strut forming the annular unit”.
Members constituting the “connection unit 5” may be described as “connection struts 5ST” or simply “struts 5ST”.

Hereinafter, an example of an embodiment of the present invention will be described with reference to the drawings based on the above definition.
As shown in FIG. 1, the stent 1 of the present invention is formed by connecting annular units by connecting members (struts) so as to have a so-called substantially tubular form along a central axis thereof.

[Annular unit 4]
The annular unit 4 is a member formed by annularly forming (arranging) a plurality of struts 4ST in a so-called “substantially zigzag shape” continuously in the circumferential CR direction. (This is also referred to as “substantially zigzag pattern” or “substantially wavy pattern”.)
For example, referring to FIG. 1, the annular unit 4 has a bent portion 4C on the terminal DE side and the base end PE side. Hereinafter, the bent portion 4C on the terminal DE side is referred to as “mountain portion M”, and the bent portion on the base end PE side is referred to as “valley portion V”. (Of the bent portion 4C, the peak portion M may be expressed as 4C (M) and the valley portion V may be expressed as 4C (V).)
The “mountain M” and the “valley V” in the circumferential CR direction are connected by a so-called “substantially linear (annular) strut 4ST” so as to form a substantially zigzag pattern.
There is a predetermined space SP between adjacent mountain parts M and mountain parts M, and between valley parts V and valley parts V.

"Connecting unit 5"
The “connection unit” is a member that connects two “annular units 4” in the n-th column (4n) and the (n + 1) -th column (4n + 1), for example. It is composed of a plurality of so-called substantially linear (two in the illustration of FIG. 1) connecting struts 5ST.

[Hook 6 etc.]
Referring to FIG. 2 (partially expanded development portion of the distal-side annular unit 4DE of the stent graft 1), in the stent 1ST, the circumference CR (side portion S) is located on the distal-side DE side of the distal-side annular unit 4DE of the stent 1ST. ) A hook 6 for locking to the tip is disposed at one end in the direction. (See Figure 3 for more details.)

The hook 6 (hereinafter also referred to as “hook portion”) has a base PE side, and a predetermined angle (each stent skeleton) from the center LC in the longitudinal L direction when the stent 1ST is viewed from the third side S3 direction. The first side portion S1 / (left side of the paper surface) is shifted and arranged. (Note: If the position of S3 (position of C) in the developed view 2 is the origin of polar coordinate display (deviation angle τ = 0 °), S1 and S2 are τ = 90 ° (where S1 is clockwise, S2 Are counterclockwise positions respectively at τ = 90 °), S4 is τ = 180 °, and the position of S3 (in the vicinity) where the hook is formed is substantially opposite to the wall surface on the large ridge side. Then, the position of S4 at τ = 180 ° is substantially at the position facing the wall surface on the side of the gavel.)

It is also possible for the hook 6 to arrange the contrast marker MK at a predetermined position of the peak portion M and the valley portion V so that the position of the opening of the graft GF can be easily confirmed. (See Japanese Patent No. 4298244)
In addition, a fin FN (also referred to as an extending member) is attached to the valley V of the distal-side annular unit 4DE in order to improve the adhesion to the blood vessel wall, and the longitudinal L in the direction of the annular unit 4n + 1 on the adjacent proximal end PE side. It can also extend along the direction. (See JP 2008-99995, International Publication WO 2009-118912)

FIG. 5 shows a stent graft 101 of a comparative example described later. The stent graft has an adjustment hook 66 as in the present invention. The hook is made of metal on the base end PE of the hook 66 (this is called the base end portion 66PE of the hook, and consists of two substantially straight portions 66ST) as the holding rings 67, 68 of the adjustment wire 40.

Rings

67 and 68 are arranged. The holding rings 67 and 68 are made of the same material (usually metal) as the strut 104ST, and are wound around one end thereof to form a loop (annular or annular).

On the other hand, in the stent graft 1 of the present invention, as shown in FIGS. 2 to 4 (particularly FIG. 4), the wire constituting the retaining ring is used as the retaining ring (formed at the proximal end) of the adjustment hook. As a suture. Then, at least a part of the wire (suture) is wound in a loop shape (annular or annular) and used as the wire holding rings 7HR and 8HR. (7HR and 8HR may be referred to as “hook holding ring”.)

The holding rings 7HR and 8HR are formed at two positions, similarly to the stent graft 101 of the comparative example, and are formed at substantially the same positions.
In order to identify the two retaining rings, in FIGS. 2 to 4, one direction of the side portion S (the first side portion S1 side, the clockwise rotation from the center with respect to the center 6C in the longitudinal L direction of the hook 6). The holding ring in the direction in which the second side S is formed is denoted by 7HR, and the holding ring in one direction of the other side S (the third side S3 side, the direction rotating counterclockwise from the center) is denoted by 8HR.

Basically, it is preferable to use a plurality of sutures bundled at least two in consideration of strength. As will be described later in the examples, two are basically sufficient, but three to four is also a preferred embodiment.

[Details of hook 6 and retaining ring]
As shown in FIG. 3, the hook 6 has an upper end portion 6DE and a lower base end portion 6PE. The upper end portion 6DE has a substantially curved shape or a substantially straight shape, and the leading end tip is locked to this portion. The lower base end portion 6PE has two substantially straight portions 6ST extending downward from both ends of the substantially curved end portion.
The base end PE side (consisting of two substantially straight portions) of the lower base end portion 6PE is fixed by fixing means 3 by heat welding, caulking with a metal pipe, or the like in the vicinity of the peak portion M of the strut 4ST.
More specifically, two substantially straight portions 6ST of the base end portion 6PE below the hook 6 have one base end PE in one direction of the side portion S of the strut 4ST (first side portion S1 direction). The other end connects the base end portion PE with the vicinity of the peak portion MS3 in one direction (the third side portion S3 direction) of the other side portion S of the strut 4ST.

[How to attach the retaining ring]
The retaining rings 7HR and 8HR are attached to the peaks MS1 and MS3 of the strut 4ST to which the proximal end PE side of the hook 6 (6PE, having two substantially straight portions 6ST) is attached, or the peaks MS1 and MS3. Install in the vicinity of as follows.
As shown in FIGS. 2 to 4, the holding rings 7 HR and 8 HR are crests of the strut 4 STS 1 in one direction of the side S (the first side S 1 side) with respect to the center 6 C in the longitudinal L direction of the hook 6. It arrange | positions in MS1 thru | or peak part MS1 vicinity, and arrange | positions in peak part MS3 thru | or peak part MS3 vicinity of strut 4STS3 of one direction (3rd side part S3 side) of the other side part S.

[Preferred embodiment of retaining ring 7HR, 8HR]
FIG. 4 is a photograph showing a state in which the retaining ring 8HR is attached to the peak portion MS3 of the strut, and shows a positional relationship with the substantially straight portion 6ST of the base end portion 6PE of the hook 6. (Here, only 8HR will be described according to the photograph). In FIG. 4, a holding ring 8 HR of a wire wound in a loop shape (annular shape, annular shape) is formed in a substantially intermediate portion (substantially central portion) of the wire (suture).
As understood from the figure, one end (one end on the base end PE side) of the wire rod (suture) is wound around the peak portion MS3 of the strut 4ST in a loop shape (annular shape, annular shape) and tied. The fixed end is 8ST.
Further, the other end portion (one end portion on the end DE side) end 8ET of the wire (suture) is not fixed and is free.

More specifically, as shown in FIG. 4, the wire rod (suture) includes (i) a plurality of (3 to 4) knots 8B (from the base end PE side) from the fixed end 8ST coupled to the peak portion MS3 of the strut 4ST. ) (8BPE) is formed, (ii) is then wound into a loop (annular, annular) to form a wire retaining ring 8HR, and (iii) a plurality (3 to 4) knots 8B (terminal DE side) ) (8BDE).
(Iv) When the fixed end 8ST is further formed, it is preferably sutured to the graft GF covering the stent 1ST.

The wire hook part holding rings 7HR and 8HR are formed by winding at least a part of at least two wires (sutures) bundled in a loop shape (annular or annular) as described above. As described above, other forms and arrangement positions are not limited to those shown in the drawings as long as they are arranged in the peak portion MS1 of the strut 4STS1, the peak portion MS3 of the strut 4STS3, or in the vicinity thereof.

[Other retaining rings 9DE, 9PE]
As shown in FIGS. 1 to 3, the stent 1ST includes a plurality of retaining rings 9DE on the terminal DE side of the wire in the vicinity of the crest M of the one end-side annular member 4DE, or the end-side annular member 4DE. It arrange | positions in the circumference CR direction. These other retaining rings 9DE are referred to as “terminal-side retaining rings”.
As shown in FIG. 1, the holding ring 9PE on the base end PE side of the wire is separated from the trough V of the other base end side annular member 4PE or in the vicinity of the trough V by two places, approximately τ = 180 °. It is arranged. 9PE is referred to as a “base end side retaining ring”.
The arrangement position of one holding ring 9PE on the base end PE side is arranged at a position corresponding to the arrangement position of the hook 6 of the distal side annular member 4DE.

The retaining rings 9DE and 9PE use a suture as a wire, and the wire (suture) is wound in a loop shape (annular or annular) so that the peak portion M or the peak portion of one end-side annular member 4DE It arrange | positions in the vicinity and arrange | positions in the vicinity of the trough part V thru | or the trough part V of the other proximal end side annular member 4PE.
Furthermore, it is preferable to sew the graft GF covering the stent 1 when it is wound in a loop shape (annular or annular).
In addition, unlike the hook part holding rings 7HR and 8HR, the wire rods of the terminal side holding ring 9DE and the base side holding ring 9PE have little friction with the wire and may be one (made of only a monofilament).

[Stent 1ST material (metal material)]
The material for forming the annular strut 4ST, the annular unit 4, the connecting strut 5ST, the connecting unit 5, the hook 6 and the fin FN of the stent 1ST of the present invention is not particularly limited. Stainless steel such as SUS316L; Ti—Ni alloy or the like It is preferably formed of a metal wire made of Ta, Ti, W, Au or the like. In addition, stents (annular units, struts, connecting struts, hooks) made of these metals may be coated with polymer materials such as urethane, bioactive substances such as heparin and urokinase, and thin films of antithrombotic drugs such as argatroban. It is preferable because it can provide a function of preventing the formation of thrombus on the surface of the stent.

[Material of graft (synthetic resin tubular member)]
Although the stent 1ST can be used as it is, the stent graft SG is usually used as an artificial blood vessel, which is used as an artificial blood vessel, with the stent as a skeleton and the outer surface thereof is coated with a graft GF, which is a synthetic resin tubular member. Is preferably formed. As the material for forming the graft GF, a film-like or fibrous material is suitable. For example, a film (single layer) made of a fluororesin (PTFE: polytetrafluoroethylene, PFA: tetrafluoroethylene perfluoroalkyl vinyl ether copolymer) is used. Or a laminate of two or more layers), Dacron, Mylar (registered trademark, polyethylene terephthalate) fiber, or the like is used, but is not limited thereto.

[Configuration example of stent graft]
For example, as an example, the stent 1ST having a diameter of 40 mm when no load is applied is reduced to 30 mm (75%), and the end of the graft made of fluororesin (PTFE) having a diameter of 31 mm and an arbitrary portion are sutured. The stent 1ST can be covered and formed into a stent graft by sewing and fixing. The stent 1ST has its own spring action, and is covered with a graft material GF, which is a flexible material, to form a stent graft. Therefore, the stent 1ST can follow the three-dimensional bending of blood vessels.

[Wire: Suture material]
In the present invention, not only the adjusting wire but also a retaining ring, which has been conventionally formed of metal, is formed by using a suture thread and is formed in a specific form.
First, generally, as a suture material used as a wire, any non-bioabsorbable material or biodegradable material commonly used as a suture can be used as long as it has a certain level of strength. These are commercially available and can be easily obtained and used.
Although it does not specifically limit as a non-absorbable material, For example, silk, a polypropylene, polyester, nylon etc. are used. In addition, a fluororesin is particularly preferable because it has excellent slidability. Among these, polyvinylidene fluoride (PVDF) is particularly preferable because it has excellent smoothness and high tensile strength.
Examples of the degradable material include, but are not limited to, polyglycolic acid, polylactic acid, polydioxanone, and caprolactone.

The suture may be a monofilament or a blade, but when used as a retaining ring, a monofilament suture excellent in smoothness is preferable.
The thickness (φ (diameter)) of the suture used for the retaining ring is not particularly limited, but at least φ = 0.05−1.0 mm, preferably 0.08−0.8 mm, more preferably About 0.1-0.5 mm. The thickness of the adjusting wire is at least φ = 0.1-1.0 mm, preferably 0.2-0.8 mm, more preferably about 0.3-0.5 mm.

[Example 1, Comparative Example 1]
(1) (Pullout resistance test of wire 40)
The stent graft 1 (Example 1) of the present invention shown in FIG. 4 and the conventional stent graft 101 (Comparative Example 1) disclosed by the applicant shown in FIG. According to the description, the hook holding rings 7HR and 8HR (made of two bundled sutures (material)), the distal side holding ring 9DE, the proximal side holding ring 9PE (made by one suture) (in the case of the above embodiments) ); Hook holding rings 67, 68 (made of metal), distal end holding ring 69, proximal end holding ring 69A (made of a single suture) (in the case of the comparative example above); The pull-out resistance of the wire 40 was measured. The results are shown in Table 1.

(2) (Contents of used sutures, etc.)
Polyvinylidene fluoride (manufactured by Kono Seisakusho, trade name: PVDF suture-K, monofilament) is used as a suture thread for the hook holding ring 7HR, 8HR, etc. and the adjustment wire 40. Two sutures were stacked.
The suture used for the retaining rings 7HR, 8HR, etc. is a monofilament with a thickness of 5-0 (0.1 to 0.149 mm), and the suture used for the adjusting wire 40 is 2: 0 (0 .27-0.349 mm) monofilaments were used.

(3) (Measurement of pull-out resistance Fa)
The pulling resistance was measured as follows.
A pulsatile flow was given using warm water at 37 ° C. in a blood vessel model simulating a blood vessel shape. The stent graft 1 was released into the blood vessel model, and the resistance at the time of removal of the adjustment wire 40 was measured with a digital force gauge (manufactured by Nidec Simpo Co., Ltd.) to obtain the pullout resistance Fa.
The experiment was conducted on 11 test examples (number of samples) (n = 11). The results are shown in Table 1. That is, the average (μ), SD (standard deviation) (σ), maximum value (Pmax), and minimum value (Pmin) of the pullout resistance Fa (N) are collectively shown for the examples and comparative examples.
From Table 1, it was confirmed that the present invention (Example 1) was more smoothly pulled out than the conventional case (Comparative Example 1) by about 60% lower pulling resistance Fa.

[Example 2, Comparative Example 2]
(1) (Breaking strength test of holding rings 7HR and 8HR)
When the hook holding ring (7HR, 8HR) of the adjustment wire 40 of the stent graft 1 (FIG. 4) of the present invention is made of one wire (Comparative Example 2), it is made of a wire obtained by bundling two wires. In this case (Example 2), when the wire 40 was pulled out, a hooked state was created, and the breaking strength of the retaining rings (7HR, 8HR) was measured. The results are shown in Table 2.

(2) (Break strength)
The breaking strength Fb of the retaining ring was measured as follows. As a measuring instrument, Strograph EL (manufactured by Toyo Seiki Seisakusho) was used as a tensile tester.
The hook part holding ring (7HR, 8HR) and the suture thread for the adjusting wire 40 were the same as those used in the above (extraction resistance test of the wire 40).
As described in Patent Document 2 [0085] and [0086], first, the adjustment wire 40 is passed through the hook holding rings (7HR, 8HR) as shown in FIG. 3 (in this test, measurement is not affected). Therefore, the adjustment wire 40 was not passed through the retaining ring 9PE on the proximal end PE side.), And passed through the stent graft 1 from the proximal end PE side toward the distal DE side.

(3) In this way, the proximal PE side of the stent graft 1 through which the adjusting wire is passed through the hook holding ring is up, the distal DE side is down, and the hook 6 on the distal DE side is pulled down. Then, the wire 40 on the side to be folded and fixed is fixed to the stand. That is, the fixed wire is the wire 40 on the side fixed between the stent graft 60 and the sheath 30 by attaching the sheath 30 to the outer periphery of the stent graft 60 as described in Patent Document 2 [0084]. .

Subsequently, the wire 40 on the drawing side is fixed to the upper chuck. As described in Patent Document 2 [0086] [0087], the wire on the side that is fixed between the insertion port 82 of the wire 40 and the fixing cap 83 and can be easily pulled out by pulling the wire end 41 from the insertion port 82. 40.
In the above state, the holding ring (7HR, 8HR) was pulled until it broke, and the breaking strength Fb when at least one of the holding rings (7HR, 8HR) broke was measured.
The measurement conditions were as follows: load: 250 N, pulling speed: 100 mm / min, and distance between upper and lower chucks: 230 mm. The number of tests was 3 (n = 3) in the comparative example and 10 (n = 10) in the example.
The results are shown in Table 2. That is, the average (μ), SD (standard deviation) (σ), maximum value (Pmax), and minimum value (Pmin) of the breaking strength Fb (N) are collectively shown for the examples and comparative examples.

(Discussion)
From the results in Table 2, the breaking strength is about 45% greater when the wire is made of two wires bundled together (Example 2) than when the wire is made of a single wire (Comparative Example). Has been confirmed to be stable and safer to use.
Furthermore, statistically, the 3σ (σ is a standard deviation) of the breaking strength of Example 2 is 10.17N, and μ−3σ (μ is an average value) is 10.36N. Therefore, in the case of Example 2, the result that it did not fracture at a load of 10.36 N or less with a probability of 99.7% was obtained.

DESCRIPTION OF SYMBOLS 1,101 Stent graft 1ST Stent 3 Fixing means 4 Annular unit 4DE Terminal side annular unit 4ST Annular strut 4C Bending part M Valley part V Mountain part 5 Connection unit

5ST Connection strut

6, 66 Hook or hook part 7HR, 8HR, 67, 68 ( Hook part holding ring or holding part 8B (of wire) knot 8ST (of wire) fixed end 8ET (of wire) terminal 9DE, 69DE End side holding ring 9PE Base

side holding ring

67, 68 Holding ring 6PE, 66PE Hook proximal end MK marker FN fin GF graft 6ST, 66ST substantially straight portion 6C central axis C in the longitudinal direction of the hook 6 central axis 40 in the longitudinal direction of the stent adjustment wire
69, 69A End retaining ring

Claims

A substantially tubular body extending in the longitudinal (L) direction, having a stent (1ST) expandable in the circumferential (CR) direction from the inside of the substantially tubular body;
A stent graft (1) in which an outer periphery of the expandable stent (1ST) is coated with a graft (GF),
The substantially tubular body forming the stent (1ST) includes a plurality of annular units (4) that expand in the circumferential (CR) direction and a connecting unit that connects the adjacent annular units (4) in the longitudinal (L) direction. (5)
The said substantially tubular body connects the one end part of the side part (S) direction of the said adjacent cyclic | annular unit (4) via the one end part of the said connection unit (5), and makes several cyclic | annular units (4) long (L ) Is arranged in the direction,
The annular unit (4) includes a strut (4ST) having a plurality of peaks (M) in one direction of the side portion (S) and a plurality of valley portions (V) in one direction of the other side portion (S). ) Are alternately connected to each other to form a substantially zigzag shape continuously in the circumferential (CR) direction.
A hook (6) is arranged at one end in the circumferential (CR) direction on the terminal (DE) side of the terminal unit (4DE) on the terminal side,
The hook (6) has two proximal ends (6PE) extending downward,
The base end (6PE) has two substantially straight lines (6ST),
Of the two substantially straight lines (6ST), one connects the base end (PE) with the vicinity of the unidirectional peak (MS1) of the side (S) of the strut (4ST),
The other one connects the base end (PE) with the vicinity of the unidirectional peak (MS3) of the side (S) of the strut (4ST),
Further, in the case where the holding ring (7HR, 8HR) which is a ring-shaped holding portion for holding the adjustment wire is provided in the hook (6), the arrangement of the holding ring (7HR, 8HR) of the wire is as follows:
With respect to the center (6C) in the longitudinal (L) direction of the hook (6),
The peak (MS1) of the strut (4STS1) in one direction of the side (S) or the vicinity of the peak (MS1) and the peak of the strut (4STS3) in one direction of the other side (S) (MS3) or in the vicinity of the mountain (MS3),
The holding ring part (7HR, 8HR) of the wire is made of suture, and is used as a wire bundle of at least two or more, and at least part of the wire is wound to form a loop, and the holding ring A stent graft (1) characterized in that
A loop-shaped holding ring (7HR, 8HR) is formed by winding a part of a suture wire rod having both ends and bundled at least two, and one end of the wire rod is A fixed end (8ST) is formed by connecting one end of the wire to the peak (M) or the vicinity of the peak (M) of the strut (4ST) to which the proximal end (PE) side of the hook (6) is attached. Stent graft (1) according to claim 1, characterized in that.
At least each of the loop-shaped retaining ring (7HR, 8HR) formed by winding a part of the suture wire bundle that is bundled at least two, the base end (PE) side and the terminal end (DE) side, The stent graft (1) according to claim 1 or 2, wherein a plurality of knots (8BPE, 8BDE) are formed by a wire.
The stent graft (1) according to any one of claims 1 to 3, wherein the fixed end (8ST) of the wire is sutured to a graft (GF) covering the stent (1ST). .
The terminal side retaining ring (9DE) on the terminal (DE) side of the wire is connected to the peak part (M) of the one terminal side annular member (4DE) or in the vicinity of the peak part (M), and the terminal side annular member (4DE) Arranged in the circumferential (CR) direction, the base end on the base end (PE) side of the wire in the vicinity of the trough (V) or the trough (V) of the other base end side annular member (4PE) The stent graft (1) according to any one of claims 1 to 4, wherein two side holding rings (9PE) are arranged at two locations.