WO2017086284A1

WO2017086284A1 - Stent and stent graft

Info

Publication number: WO2017086284A1
Application number: PCT/JP2016/083749
Authority: WO
Inventors: 崇志吉森
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: JPWO2017086284A1; JP6832290B2

Abstract

[Problem] To achieve a stent which, even when formed with a hook on the small curvature side, has a shape that curves along the aortic arch in the longitudinal direction. [Solution] At one end in the circumferential CR direction on the terminal DE side of a terminal-side annular unit 4DE of this stent, a hook 6 is arranged near the small curvature-side curve CS. A first annular unit 4DE/4n on the terminal DE side and a second annular unit 4n+1 on the terminal DE side are connected by means of a linking strut 5STS1 arranged to one direction of a side portion S and a linking strut 5STS2 arranged to one direction of the other side portion S with respect to the center C of the small curvature-side curve CS in the longitudinal L direction. The end terminal DE sides of the linking strut 5STS1 and the linking strut 5STS2 connect to a valley portion V of the annular unit 4DE/4n, and the base terminal PE sides thereof connect to a peak portion V of the annular unit 4n+1. The connection positions of the terminal DE sides and the base PE sides of the linking strut 5STS1 and the linking strut 5STS2 are connected in positions that are non-overlapping seen from the longitudinal L direction.

Description

Stent and stent graft

The present invention relates to improvements in stents and stent grafts (hereinafter sometimes referred to as stent grafts and the like) used in the treatment of diseases such as aneurysms.
More specifically, the present invention relates to a stent graft or the like used for the treatment of an aneurysm or the like in order to treat an expandable disease (such as an aneurysm) and a stenotic disease of an artery or other diseases. The present invention relates to a stent graph or the like that is placed in a site and used as an artificial blood vessel.

In patent document 1, the patent applicant disclosed an invention of a stent form (skeleton) that can improve the safety and followability of a stent graft or the like at a treatment site of a patient, regarding a stent for an aortic aneurysm and a stent graft. Specifically, in order to cope with the bending of the aortic arch, a stent having a previously bent shape constituted by connecting annular units and the outer periphery of the stent are made of a synthetic resin tubular member (referred to as “graft”). The invention of a coated stent graft has been disclosed.
Furthermore, Patent Document 2 discloses an invention of a stent and a stent graft that can be placed at an accurate position of an affected part. In the present invention, as shown in FIG. 10, a hook is formed on the large collar side of the terminal-side annular unit. The hook is locked to the leading tip for transporting the stent graft or the like to the affected area. As described above, the locking hook is usually formed on the large collar side, and the stent graft is pulled and placed along the curved wall surface on the large collar side.

Patent No. 4064724 (Claims, FIG. 1) Japanese Patent No. 4773341 (8th page, FIG. 10)

However, in some cases, the state of the affected area of an individual patient, for example, the bent state of the aorta, the indwelling position of the stent graft, etc. may not always be standard or normal (for example, as shown in FIG. 4 described later, In order to adopt and apply a specific treatment technique suitable for these (when the bending curve CS on the gavel side is very steep), it was necessary to form a hook on the gavel side.

Accordingly, the present inventors moved the hook 106 of the annular unit 104DE (104n) on the end side from the large ridge side to the small ridge side as shown in FIGS. 4 to 5, and together with the hook (of the annular unit) The connecting struts were also moved and arranged. (The hook is formed so as to straddle the adjacent mountain portions of the annular struts constituting the terminal annular unit (that is, straddling the mountain portions as fulcrums), and the connecting strut is the terminal where the hook is formed. (The valley of the side annular strut is connected to the peak of the second end-side annular unit opposite to this.)

However, in this situation, the position of the connecting strut 105ST of the second end-side annular unit 104n + 1 having the above-mentioned relationship with the movement of the hook to the gavel side is simply moved to the gavel side as it is. However, the stent graft, which is a tubular member that is bent in advance, does not have a curved shape along the aortic arch, which is contrary to expectation, and as shown in FIG. It has been found that there is an unexpected problem that it becomes a very unnatural shape that protrudes in the direction of the third side S3) and bends out of control. This makes it impossible to construct a stent graft for placement in a stable form at a safe position of the affected area.

Therefore, as a result of intensive investigations to solve the above-mentioned new problems, the present inventor unexpectedly affected the form of the end annular unit of the stent due to the delicate connection form of the connecting strut formed near the hook. By identifying this arrangement, the problems of the present invention were solved, and the following invention was achieved.

[1] The present invention is a stent (1) 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,
The substantially tubular body of the stent (1) includes an annular unit (4) that expands in the circumferential (CR) direction, and a connecting unit (5) that connects the adjacent annular units (4) in the longitudinal (L) direction. Have
The annular unit (4) is formed by connecting one end in the side (S) direction via one end of the connecting unit (5) and arranging a plurality of annular units (4) in the longitudinal (L) direction. Is,
The substantially tubular body has two connection struts (5ST) of the connection unit (5),
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). ) To form a substantially zigzag shape continuously in the circumferential (CR) direction,
The stent (1) has a large curvature curve (CL) and a small curvature curve (CS),
A hook (6) is arranged at one end in the circumferential (CR) direction on the terminal (DE) side of the terminal side annular unit (4DE) and in the vicinity of the small curvature curve (CS),
The first end (DE) side cyclic unit (4DE / 4n) and the second end (DE) side cyclic unit (4n + 1) are:
For the center (C) in the longitudinal (L) direction of the gavel side bending curve (CS),
The connection strut (5STS1) arranged in one direction of the side part (S) and the connection strut (5STS2) arranged in one direction of the other side part (S),
The connecting strut (5STS1) and connecting strut (5STS2) are:
Each end (DE) side is connected to the valley (V) of the annular unit (4DE / 4n),
Each base end (PE side) is connected to the peak (V) of the annular unit (4n + 1),
The connecting strut (5STS1) and the connecting strut (5STS2) are connected to the stent (1) in which the connecting positions of the terminal (DE) side and the base end (PE) side do not overlap when viewed in the longitudinal (L) direction. provide.

[2] In the present invention, the connecting strut (5STS1) is connected to one direction of the side (S) of the valley (V) on the terminal (DE) side and the peak on the base (PE) side. (M) connected to one side of the other side (S),
The connecting strut (5STS2) is connected to one side of the other side (S) of the valley (V) on the terminal (DE) side, and on the side of the peak (M) on the base end (PE) side. The stent (1) according to [1] connected to one direction of the section (S) is provided.

[3] The present invention provides a stent graft in which the stent (1) according to [1] or [2] is coated with a synthetic resin tubular member.

According to the present invention, by specifying the connecting position of the two connecting struts 5ST, even if a hook is formed on the side of the gavel, without causing the deformation of the terminal annular unit, which is normally inevitable, Thus, it is possible to obtain a stent corresponding to a sharp bend on the small heel side and having a curved shape along the aortic arch in the longitudinal direction.
Therefore, it is possible to provide a stent (stent graft) that can be widely adapted according to the state of various affected areas (for example, the bent state of the aorta, the placement position of the stent graft, etc.) of each patient.

FIG. 1 is an overall view (front view / schematic diagram) of a stent 1 of the present invention. FIG. 2 is a partially enlarged view of the vicinity of the distal-side annular unit 4DE of the stent 1 (a developed view in which τ = 360 ° is developed in the circumferential CR direction at the time of assembly / affected part placement). (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 an overall view (front view / schematic diagram) of a stent 101 of a comparative example. FIG. 5 is a partially enlarged view of the vicinity of the distal-side annular unit 4DE of the stent 101 (a developed view developed in the circumferential CR direction during assembly / dwelling of the affected area).

Hereinafter, the present invention will be described in detail with reference to the drawings.
First, 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 substantially overlap each other when viewed from the front to the back in order to avoid complication of the description 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 an annular strut 4ST on the third side portion side, and MS3 means a peak portion M on the third side portion side.
Further, for example, with respect to the center line VC-MC connecting the center MC of the peak M and the center VC of the valley V, the terminal DE side of the connecting strut 5ST is set to the fourth side of the valley VS2 on the second side S2 side. The position connected to the part S4 side is described as <VS2S4> (see FIG. 2-3).

(Definition 11)
The “strut” is also called a strut, and is a substantially linear or wire-like 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 sense of “strut constituting 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.
The stent 1 of the present invention has a so-called substantially tubular form as shown in FIG.

[Annular unit 4]
The annular unit 4 is an annular member in which a plurality of (annular) struts 4ST are formed (arranged) 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 FIGS. 1 and 2, the annular unit 4 has a bent portion 4 </ b> C 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 “valley V” in the circumferential CR direction are connected by a so-called substantially linear “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, for example, the nth row (4n), the (n + 1) th row (4n + 1), and two “annular units 4”. It is composed of a plurality of so-called substantially linear (two in the illustration of FIG. 1) connecting struts 5ST.

As shown in FIG. 1, the stent 1 of the present invention has an end DE side of the annular unit 4DE on the end side of the stent 1, one end portion (S4) in the circumferential CR (side S) direction, and the small heel side. A hook 6 is disposed in the vicinity of the bending curve CS. (Note: S1 and S2 are τ = 90 ° (where S1 is clockwise and S2 is counterclockwise, assuming that the position of S4 in the developed view 2 is the origin of polar coordinate display (deviation angle τ = 0 °)). τ = 90 °), and S3 is τ = 180 °, so if the position of S4 forming the hook is substantially opposite to the wall surface on the side of the gavel, τ = 180 ° of S3 (The position is almost the position facing the wall surface on the large ridge side.) (The arrangement of the hook 6 will be described in detail later.)

In the annular unit, the annular unit 4DE / 4n on the first end DE side and the annular unit 4n + 1 on the second end DE side are connected by two connecting struts. Specifically, as shown in FIG. 2, for example, the connecting strut 5STS1 arranged in one direction of the side portion S and the other side portion S with respect to the center C in the longitudinal direction L of the gavel side bending curve CS. The connecting struts 5STS2 arranged in one direction are connected by two struts.

The connecting struts 5STS1 and the connecting struts 5STS2 are connected to the valley portions V (VS1, VS2) of the annular unit 4DE / 4n on the terminal DE side, respectively, and the base end PE side is connected to the second side. Are connected to peak portions M (MS1, MS2) of the annular unit 4n + 1.
The connecting strut 5STS1 and the connecting strut 5STS2 are such that the connecting positions of the terminal DE side and the base PE side do not overlap when viewed in the longitudinal L direction (that is, even if one strut is moved directly to the other strut, Connected in an arrangement that cannot be overlapped).
The connection (also referred to as joining) between the connecting strut 5ST and the mountain portion M (the valley portion V) is not particularly limited. For example, the connection strut 5ST is connected by fixing means (not shown) such as heat welding or caulking with a metal pipe. (Join).

Hereinafter, the connection mode of the connecting strut 5ST will be described in more detail.
As shown in FIG. 2, the connecting strut 5STS1 is connected to one direction of the side S of the valley V at the terminal DE side, and one side of the other side S of the peak M at the base PE side. Connected with direction. Further, the connecting strut 5STS2 is connected to one direction of the other side S of the valley V on the terminal DE side, and connected to one direction of the side S of the peak M on the base end PE side. (The significance of this ("one direction of the side") will be discussed in more detail later).

[Hook 6 etc.]
The hook 6 has a proximal side PE side at a predetermined angle (varies depending on the specifications of each stent skeleton) from the center C (fourth side part S4) in the longitudinal L direction of the gavel side bending curve CS, and the first side part S1. / It is shifted to the right side of the page. By arranging in this way, basically the stent (stent graft) is hooked to the tip tip and pulled by the stent 6 and smoothly transported along the curved surface of the small gavel along the curved surface of the sharp gavel. It is considered that the hook and the tip can be in direct contact with the blood vessel wall surface during transportation and are not damaged.

However, as described above, in this case, as shown in FIG. 4, the terminal annular unit coupled with the hook bends into an unnatural shape that cannot be expected, and stable placement cannot be realized. There is.

With regard to this point, referring to FIG. 2 (a partially enlarged view of the vicinity of the distal-side annular unit 4DE of the stent 1 in FIG. 1 and a developed view in the circumferential CR direction). With respect to the center C (fourth side portion S4, τ = 0 °) in the longitudinal L direction of the heel side bending curve CS, the first end DE side annular unit 4DE / 4n and the second end DE side The annular unit 4n + 1 has one side S (first side S1, clockwise τ = 90 °) and the other side S one direction (second side S2, counterclockwise τ = 90 °). ), Two peaks M and valleys V are shown respectively.

As shown in FIG. 2, the peak part M and the valley part V on the side passing through the center C or close to the center C are described as the peak part MS4 and the valley part VS4, respectively, and one direction of the side part S (first The peak portions M and valley portions V on the side close to one side (second side portion S2) of the side portion S1) and the other side portion S are described as peak portions MS1, MS2, valley portions VS1, VS2, respectively. .
As will be described in detail below, according to the present invention, the shape of the ridges M and valleys V of the annular strut has not been deeply studied. However, in order to clearly define the characteristics of the present invention, it is required to specify the shape of the peak portion M and valley portion V in more detail and specify the connection position. That is, (i) the mountain portion M needs to be treated as being composed of a mountain top portion that gently bends upward and two “posts” that extend downward from a substantially vertical direction from both sides of the mountain top portion. (Ii) It has been found that the valley V needs to be treated as being composed of a valley bottom that gently curves downward and two “posts” that rise substantially vertically from both sides of the valley bottom.

FIG. 3 is a partially enlarged view of FIG. 2 (however, the description of the peak part MS4 and the valley part VS4, which are the peak part M and the valley part V on the side close to the center C, and the strut 4ST forming these parts is omitted). is doing.)
Further explanation will be given along the viewpoint described above. Attention is paid to the peak M (MS1) shown at the bottom in the annular strut on the right side of the center line C (τ = 0 °) (S1, clockwise τ = 90 °). Then, it has a support | pillar on the right side (S1 side) and the left side (S4 side), respectively. The column on the S1 side of the mountain portion MS1 is denoted as <MS1S1>, and the column on the S4 side of the mountain portion MS1 is denoted as <MS1S4>. (See Figure 3)

Similarly, in the annular strut on the right side (S1, clockwise τ = 90 °) of the center line C (τ = 0 °), when attention is paid to the valley V (VS1) shown on the upper side, the right side (S1 side) ) And left side (S4 side). The column on the S1 side of the valley VS1 is expressed as <VS1S1>, and the column on the S4 side is expressed as <VS1S4>.

On the other hand, in the annular strut on the left side of the center line C (τ = 0 °) (S2, counterclockwise τ = 90 °), when attention is paid to the peak M (MS2) shown at the bottom, the right side (S4 side) Each has a support on the left side (S2 side). The column on the S4 side of the mountain portion MS2 is expressed as <MS2S4>, and the column on the S2 side is expressed as <MS2S2>.

Similarly, in the annular strut on the left side (S2, counterclockwise τ = 90 °) of the center line C (τ = 0 °), when attention is paid to the valley V (VS2) shown at the top, the right side (S4 Side) and left side (S2 side). The column on the S4 side of the valley VS2 is denoted as <VS2S4>, and the column on the S2 side is denoted as <VS2S2>.

Based on the above, in the present invention, the connecting positions of the two connecting struts 5STS1 and 5STS2 and each of the peak portions M and the valley portions V are configured as follows.
As described above, for example, when attention is paid to the valley portion VS1 on the first side portion S1 side (τ = 90 ° clockwise) with respect to the center C (fourth side portion S4), the center C (fourth side portion) The connection position (the column on the S4 side of the valley VS1) on the side close to (S4) (S4 side column) is indicated as <VS1 S4 >.
Further, the connection position (the column on the S1 side of the peak portion MS1) on the side close to the first side portion S1 in the peak portion MS1 on the right first side portion S1 side with respect to the center C (fourth side portion S4) MS1 S1 > is displayed.
Furthermore, the valley VS2 and peak MS2 on the second side S2 on the left side with respect to the center C (fourth side S4) are the same (that is, the columns to be connected are <VS2S4> (VS2), respectively. S4 side column), <MS2S2> (MS2 S2 side column).
The above description is the same as the description of the stent 101 of the reference example (FIG. 5).

The stent 1 of the present invention shown in FIGS. 1, 2, and 3 and the stent 101 of the comparative example shown in FIGS. 4 and 5 are both end portions in the circumferential CR direction on the terminal DE side of the terminal annular units 4DE and 104DE. In addition, the

hooks

6 and 106 are arranged in the vicinity of the small curvature curve CS.
However, the stent 1 of the present invention and the stent 101 of the comparative example are different in the connection positions of the two connection struts 5ST and 105ST constituting the connection units 5 and 105 as follows. That is, the differences are as follows.

First, the stent 101 of the comparative example shown in FIGS. 4 and 5 includes two connecting struts 105STS1 and 105STS2 that connect the annular unit 104DE (104n) on the terminal DE side and the annular unit 104n + 1 on the second terminal DE side. The connection position of the terminal DE side and the base end PE side is “the same position” when viewed in the longitudinal L direction.
The connecting strut 105STS1 (on the first side S1 side of the center line C) connects the terminal DE side and the base end PE side with struts in the same side S direction (first side S1 direction). This is referred to as 105STS1.

On the other hand, the connecting strut 105STS2 which is the other connecting strut (on the second side S2 side of the center line C) is a column in the same side S direction (second side S2 direction) on the terminal DE side and the base PE side. They are connected with each other.
The two connecting struts 105STS1 and 105STS2 formed (connected and disposed) in this way are arranged such that the valleys of the (annular) struts 104ST of the annular unit 104DE (104n) are viewed in the longitudinal L direction when viewed from the terminal DE side and the base end PE side. They are connected so as to be substantially parallel to a center line VC-MC connecting the center VC of the portion V and the center MC of the peak portion M of the annular unit 104n + 1. When connected in this way, the two connecting struts 105STS1 and 105STS2 can overlap each other.

That is, with respect to the center line VC-MC, the right connecting strut 105STS1 is on the terminal DE side (on the first side S1 side of the center line C) and the first side of the valley VS1 on the first side S1 side. S1 side (the column on the S1 side of the valley VS1): <VS1S1> is connected and the base PE side is connected to the first side S1 side of the peak MS1 on the first side S1 side (S1 side of the peak MS1). The column is connected by <MS1S1>.
Also, the left connecting strut 105STS2 (on the second side S2 side of the stent center axis C) is the terminal DE side, and the second side S2 side of the valley VS2 on the second side S2 side: (S2 of the valley VS2) Side stake): <VS2S2> and the base end PE side is connected to the second side S2 side ridge portion MS2 second side S2 side (peak portion MS2 side S2 side support): <MS2S2> Connected.

On the other hand, as described above, the stent 1 of the present invention shown in FIGS. 1, 2 and 3 is small at one end in the circumferential CR direction on the terminal DE side of the terminal annular unit 4DE. The point that the hook 6 is arranged in the vicinity of the heel side bending curve CS is common.
However, the two struts (connecting struts) connected to the first end DE-side circular unit 4DE (4n) and the second end DE-side circular unit 4n + 1 have side S as viewed from the center C. In two connecting struts 5STS1 and 5STS2 in one direction (first side portion S1 direction) and the other side S in one direction (second side portion S2 direction), the terminal DE side and the base end PE side The connection positions are arranged so as to be in a positional relationship that does not overlap when viewed in the longitudinal L direction (that is, both struts are mirror images of the center line C and cannot be superimposed). Has been established.

More specifically, as shown in FIG. 3, the connecting strut 5STS1 is a pillar in one direction (first side S1 side) of the mountain portion MS1 as viewed from the center line C: <MS1S1> And, it is connected to a column: <VS1S4> in the side S direction (fourth side S4 side) of the valley VS1 that is different in position. [That is, a column in one direction (first side S1 direction) of the side portion S of the mountain portion MS1: <MS1S1> and a column in one direction (fourth side portion S4 direction) of the side portion S of the valley portion VS1: It is connected to <VS1S4>. ]

In addition, the connecting strut 5STS2 is a column in one direction (second side S2 side) of the other side of the mountain portion MS2 when viewed from the center line C: <MS2S2> A column in the side S direction (fourth side S4 side) is connected to <VS2S4>.
[In short, a column in one direction (second side S2 direction) of the side portion S of the mountain portion MS2: <MS2S2> and one direction (fourth side portion) of the other side portion S of the side portion S of the valley portion VS2. S4 direction) strut: connected to <VS2S4>. ]

That is, as shown in FIG. 3, with respect to the center line VC-MC, the connecting strut 5STS1 (on the first side S1 side of the center line C) is on the end DE side, and on the valley VS1 on the first side S1 side. Of the two trough pillars, the pillars on the fourth side S4 side are connected by <VS1S4>, and the base PE side is connected to the two peak parts of the mountain part MS1 on the first side S1 side. Of these, the columns on the first side S1 side are connected by <MS1S1>.
The connecting strut 5STS2 connects the terminal DE side (on the second side S2 side of the center line C) with a column on the fourth side S4 side of the trough VS2 on the second side S2 side: <VS2S4> The proximal end PE side is connected by a column: <MS2S2> on the second part side S2 side of the peak part MS2 on the second side part S2.

In the present invention, as described above, the hook 6 is formed on the side of the gavel as shown in FIG. 1 by arranging the connecting positions of the two connecting struts 5ST as defined in the present invention. However, a stent having a curved shape along the aortic arch in the longitudinal direction is obtained without causing deformation of the terminal annular unit, which is unavoidable in normal cases, and corresponding to a sharp bend on the small heel side. be able to.

[Other Embodiments]
In the embodiment shown in FIG. 3, the connecting strut 5STS1 connecting the valley VS1 and the mountain MS1 connects the valley pillar <VS1S4> and the mountain pillar <MS1S1>, and the valley VS2 The connecting strut 5STS2 connecting the mountain portion MS2 connects the trough support column <VS2S4> and the mountain support column <MS2S2>.
On the other hand, it is easily understood that the struts of the valley V and the struts of the mountain M to be connected may be used as the struts on the other side.
That is, the connecting strut 5STS1 connecting the valley VS1 and the mountain MS1 connects the valley pillar <VS1S1> and the mountain pillar <MS1S4>, and connects the valley VS2 and the mountain MS2. The connecting strut 5STS2 may connect the trough column <VS2S2> and the mountain column <MS2S4>.
Even when the connecting struts are arranged at such connecting positions, the connecting struts 5STS1 and 5STS2 are mirror images of each other and cannot be overlapped with each other, so that the object of the present invention can be achieved.

[Material of stent 1 (metal material)]
The material for forming the annular strut 4ST, the annular unit 4, the connecting strut 5ST, the connecting unit 5, and the hook 6 constituting the stent 1 of the present invention is not particularly limited, for example, stainless steel such as SUS316L; Ti—Ni alloy, etc. It is preferably formed of a metal wire made of titanium alloy, Co—Cr alloy, Ta, Ti, W, Au or the like. In addition, stents (annular units, annular struts, connecting struts, hooks) are made of polymer materials, such as urethane, which are commonly used for stents made of these metals, bioactive substances such as heparin and urokinase, and thin films of antithrombotic drugs such as argatroban. It is also preferable to cover the surface of (2) because it can provide a function of preventing thrombus formation on the surface of the stent.

[Synthetic resin tubular member (graft)]
Although the stent 1 can be used as it is, the stent graft can be formed by covering the outer surface of the stent 1 with a graft which is a synthetic resin tubular member. The material for forming the graft is preferably a film-like or fibrous material. For example, a film made of a fluororesin (PTFE: polytetrafluoroethylene, PFA: tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer) (single layer) Or a laminate of two or more layers), a synthetic resin tubular member (graft) made of Dacron, Mylar (registered trademark, polyethylene terephthalate) fiber or the like to form a stent graft.

[Configuration of stent graft]
For example, as an example, a stent having a diameter of 40 mm at no load is reduced to 30 mm (75%). A stent graft can be formed by sewing and fixing and covering the end of a tubular member (graft) made of fluororesin (PTFE) having a diameter of 31 mm and an arbitrary portion with a suture.
In the stent graft, the stent 1 itself has a spring action, and is covered with a flexible synthetic resin tubular member (graft) and combined to form a stent graft. It can follow dimensional bending.

According to the present invention, by specifying the connection position of the two connecting struts 5ST that connect the terminal annular unit and the second annular unit opposite to the terminal annular unit, even if a hook is formed on the side of the gavel, the terminal annular unit Without causing deformation, it is possible to obtain a stent corresponding to a sharp bend on the side of the eyelid and having a curved shape along the aortic arch in the longitudinal direction. In this way, since a stent (stent graft) that can be widely adapted according to the state of various affected areas of individual patients (for example, the bent state of the aorta, the placement position of the stent graft, etc.) can be provided, The availability is enormous.

1, 101 Stent (1 is the present invention, 101 is a comparative example)
3 fixing means 4 annular unit 4DE terminal side annular unit 4ST annular strut 4C bent portion C center of L in the longitudinal direction of the stent (center axis in the longitudinal direction of the stent tubular body)
CR Circumference CL Large heel side bending curve CS Small heel side bending curve VC-MC Center line M passing through the center VC of each opposing valley and the center MC of the mountain part Valley V Mountain part 5 Connection part

5ST Connection strut

6, 106 hook

Claims

A stent (1) formed in a substantially tubular body extending in a longitudinal (L) direction and expandable in a circumferential (CR) direction from the inside of the substantially tubular body,
The substantially tubular body of the stent (1) includes an annular unit (4) that expands in the circumferential (CR) direction, and a connecting unit (5) that connects the adjacent annular units (4) in the longitudinal (L) direction. Have
The annular unit (4) is formed by connecting one end in the side (S) direction via one end of the connecting unit (5) and arranging a plurality of annular units (4) in the longitudinal (L) direction. Is,
The substantially tubular body has two connection struts (5ST) of the connection unit (5),
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). ) To form a substantially zigzag shape continuously in the circumferential (CR) direction,
The stent (1) has a large curvature curve (CL) and a small curvature curve (CS),
A hook (6) is arranged at one end in the circumferential (CR) direction on the terminal (DE) side of the terminal side annular unit (4DE) and in the vicinity of the small curvature curve (CS),
The first end (DE) side cyclic unit (4DE / 4n) and the second end (DE) side cyclic unit (4n + 1) are:
For the center (C) in the longitudinal (L) direction of the gavel side bending curve (CS),
The connection strut (5STS1) arranged in one direction of the side part (S) and the connection strut (5STS2) arranged in one direction of the other side part (S),
The connecting strut (5STS1) and connecting strut (5STS2) are:
Each end (DE) side is connected to the valley (V) of the annular unit (4DE / 4n),
Each base end (PE side) is connected to the peak (V) of the annular unit (4n + 1),
The connection strut (5STS1) and the connection strut (5STS2) are characterized in that the connection positions of the terminal (DE) side and the base end (PE) side are connected at positions that do not overlap in the longitudinal (L) direction. Stent (1).
The connecting strut (5STS1) is connected to one side (S) of the valley (V) on the terminal (DE) side, and on the other side of the peak (M) on the base end (PE) side. Connected to one direction of the section (S),
The connecting strut (5STS2) is connected to one side of the other side (S) of the valley (V) on the terminal (DE) side, and on the side of the peak (M) on the base end (PE) side. The stent (1) according to claim 1, wherein the stent (1) is connected to one direction of the portion (S).
A stent graft, wherein the stent (1) according to claim 1 or 2 is covered with a synthetic resin tubular member.