WO2017047569A1 - Stent and stent-graft - Google Patents

Stent and stent-graft Download PDF

Info

Publication number
WO2017047569A1
WO2017047569A1 PCT/JP2016/076923 JP2016076923W WO2017047569A1 WO 2017047569 A1 WO2017047569 A1 WO 2017047569A1 JP 2016076923 W JP2016076923 W JP 2016076923W WO 2017047569 A1 WO2017047569 A1 WO 2017047569A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
graft
length
annular
strut
Prior art date
Application number
PCT/JP2016/076923
Other languages
French (fr)
Japanese (ja)
Inventor
崇志 吉森
和巳 秋田
智和 向井
Original Assignee
川澄化学工業株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 川澄化学工業株式会社 filed Critical 川澄化学工業株式会社
Priority to JP2017539905A priority Critical patent/JP6937240B2/en
Publication of WO2017047569A1 publication Critical patent/WO2017047569A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members

Definitions

  • the present invention relates to improvements in stents and stent grafts used for diseases such as aneurysms. More specifically, in the present invention, in order to treat an expandable disease (such as an aneurysm) and a stenotic disease of an artery or other diseases, a stent graft used for the treatment of the aneurysm or the like is placed at a safe site of the affected area. About stent grafts used as artificial blood vessels
  • the aortic arch is the part where the ascending aorta exiting the left ventricle is bent in an arch shape that continues to the descending aorta, but in about one-quarter of patients with thoracic aortic arches, the aortic arch is steeper than usual. It is said that there is a bend (three-dimensional bending).
  • the applicant of the present invention is a synthetic resin tubular member (referred to as a graft) in which a stent having a previously bent shape configured by connecting annular units and an outer periphery of the stent are combined.
  • the stent graft is suitably used for placement as an artificial blood vessel in the aorta including the aneurysm 8 to prevent the aneurysm from rupturing.
  • the stent graft (referred to as “101SG”) was basically formed so as to be suitable for these three-dimensional bends, but the sharply bent portion of the aortic arch is shown in FIG. 7B. As described above, there are cases where it is difficult to indwell in close contact with the small heel side (the inside of the aortic arch having a small diameter).
  • a gap (referred to as a bird beak) SBV was generated between the side of the heel and the placed stent graft.
  • the blood blood flow F ′
  • the terminal DE side of the stent graft is indicated by G.
  • problems as pushing up, movement of the stent graft, fatigue / breakage of the stent, and internal leakage (end leakage) are caused.
  • Patent Documents 2 and 3 disclose inventions that allow such a phenomenon to be avoided by a stent graft indwelling device system.
  • Patent Document 2 describes an invention of a system for implanting a stent graft (prosthesis) using a specially shaped arcuate control lumen ⁇ 12> and support wires ⁇ 22, 23>.
  • Patent Document 3 describes an invention including a stent graft as described below, a locking member, and one or more diameter-reducing members as a supply system.
  • the stent graft includes a tubular graft that includes first and second longitudinally extending sides disposed opposite each other and connected tangentially. When the locking member is in the locked position, the locking member restrains the surface of the graft relative to the cannula.
  • a first diameter reducing member is slidably connected to a first portion of the graft disposed proximate to the tangent and slidable to a second portion of the graft that is spaced circumferentially away from the tangent. Connected to.
  • the second portion of the graft is pulled toward the first portion of the graft, and the proximal portion of the stent graft has a diameter reducing structure with at least two lobes.
  • Patent Document 4 discloses that the longer part of the graft body ⁇ 20> is aligned with the longer outer curve of the aortic arch and the shorter one of the graft body is aligned with the shorter inner curve of the aortic arch.
  • the prosthesis ⁇ 10> is encouraged to match the shape of the anatomical structure of the aortic arch, allowing accurate and precise placement of the prosthesis ⁇ 10> on the meandering aortic arch
  • the invention to be disclosed is disclosed. That is, the spacing between the first proximal stent ⁇ 30a> and the second proximal stent ⁇ 30b> varies along the outer periphery of the graft body ⁇ 20>.
  • the longitudinal length of the top of the prosthesis is formed longer than the longitudinal length of the bottom of the prosthesis, for example, to form an inclined end.
  • the spacing between the first proximal stent ⁇ 30a> and the second proximal stent ⁇ 30b> along the longitudinal length of the top is the first distance along the longitudinal length of the bottom.
  • the distance between the proximal stent and the second proximal stent is larger.
  • Patent No. 4064724 (Claims, FIGS. 1 to 4)
  • Patent No. 5687216 (Claims, FIGS. 5-1 to 5-3)
  • JP 2012-139500 (Abstract column, FIG. 1)
  • JP 2013-71005 [0047], [0089], FIG. 6, FIG. 8, FIG. 10, FIG. 12, FIG. 14)
  • Patent Document 1 to Patent Document 4 described above has the following problems, and it has been difficult to accurately cope with the steep bend (three-dimensional bending). That is, As described in Patent Document 1, only in the form of a stent skeleton that has been bent in advance and a stent graft that is completely covered with a graft, there is a limit in filling the gap SBV in close contact with the small heel side of the aortic arch. is there. Since Patent Document 2 and Patent Document 3 are inventions of a system for implanting a stent graft (prosthesis) by organically connecting members having specific shapes, it is difficult to acquire a technique for an operator who performs the technique. Issues such as being pointed out. In Patent Document 4, since the struts constituting the stent have the same length and are all covered with the graft, it is difficult to closely contact the steeply bent small side of the aortic arch on the distal side.
  • 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 has a plurality of annular units (4) that expand in the circumferential (CR) direction, and a connecting unit (5) that connects the adjacent annular units (4) in the longitudinal (L) direction.
  • the substantially tubular body is formed by connecting a plurality of annular units (4) with one end in the side (S) direction of the adjacent annular units (4) connected through one end of the connecting unit (5).
  • 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).
  • the annular unit (4) arranged on the terminal side is a terminal-side annular member (4DE)
  • the length of the strut (4ST) constituting the terminal-side annular member (4DE) is set to the side (S).
  • the end-side annular member (4DE) has at least a maximum length (4STLL), a minimum length (4STLS), and an intermediate length (4STLM) as the length of the strut (4ST).
  • a stent formed such that the strut (4ST) has an inclined cut structure such that 4STLL>4STLM> 4STLS from one direction of the side part (S) toward one direction of the other side part (S).
  • the present invention provides the stent (1) according to [1] or [2], wherein the inclination angle ⁇ is 5 ° to 30 °.
  • the inclination angle ⁇ is PL when the vertex of the peak portion M of 4STLL is PL, the vertex of the peak portion M of 4STLM is PM, and the vertex of the peak portion M of 4STLS is PS in FIG.
  • a straight line connecting PM and PS is an inclined line MLS
  • a straight line connecting MLS and the vertices PL of at least a plurality of 4STLL peaks M is a reference line GL, this is an angle formed by MLS and GL, or MLS.
  • the present invention provides a stent graft (1SG) in which the stent (1) according to any one of [1] to [3] is coated with a graft (GF).
  • stent graft Type (II)
  • a stent (11) 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 is covered with a graft (GF).
  • a stent graft (11SG) The substantially tubular body has a plurality of annular units (14) that expand in the circumferential (CR) direction, and a connecting unit (15) that connects the adjacent annular units (14) in the longitudinal (L) direction.
  • the substantially tubular body is formed by connecting a plurality of annular units (14) with one end in the side (S) direction of the adjacent annular units (14) connected through one end of the connecting unit (15) in the longitudinal direction ( L) are arranged in the direction,
  • the annular unit (14) includes a strut (14ST) having a plurality of peaks (M) in one direction of the side (S) and a plurality of valleys (V) in one direction of the other side (S).
  • the outer periphery of the stent (11) formed in the substantially tubular body is covered with a graft (GF) except for one direction of the terminal DE side and the other side S to form a stent graft (11SG).
  • the stent graft (11SG) is the length (GFL) of the graft (GF) on the terminal DE side.
  • a stent graft (11SG) having a cut structure is provided.
  • the stent graft (11SG) according to [5] or [6] is provided, wherein the inclination angle ⁇ ′ is 5 ° to 30 °.
  • the inclination angle ⁇ ′ is, for example, in FIG. 5, where the straight line connecting GFLL, GFLM, and GFLS is GFC, GFC and GFLL at a plurality of positions (or the peak apex (crest of the strut 14ST corresponding to GFLL) (Or MFC) and an end line forming an end corresponding to the GFLL of the terminal-side annular member (terminal-side annular unit) (4DE).
  • the straight line connecting GFLL, GFLM, and GFLS is GFC, GFC and GFLL at a plurality of positions (or the peak apex (crest of the strut 14ST corresponding to GFLL) (Or MFC) and an end line forming an end corresponding to the GFLL of the terminal-side annular member (terminal-side annul
  • the terminal DE side is formed as described in [1] above. Therefore, compared to Patent Documents 1 and 4, the aortic arch is sharply bent on the side of the small curvature. Easy to adhere,
  • the stent 11 (especially the stent graft 11SG) of the present invention has the terminal DE side formed as described in [5] above, and therefore, compared with Patent Documents 1 and 4, the aortic arch is sharply bent at the side of the small curvature Easy to adhere to.
  • the stents 1 and 11 (stent grafts 1SG and 11SG) of the present invention can suitably eliminate problems such as movement of the stent graft after placement of the affected area, stent fatigue / breakage, and internal leakage (end leakage).
  • FIG. 1 is an overall view (front view / schematic diagram) of a stent 1 of the present invention 1 (Type (I)).
  • ⁇ 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 ⁇ .
  • FIG. 1 is an overall view (front view / schematic diagram) of a stent 1 of the present invention 1 (Type (I)).
  • 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 the distal-side annular unit 4DE is expanded in
  • 4A and 4B are schematic views of the stent graft 1SG of the present invention placed in the affected area, and FIG. 4B is a partially enlarged view of FIG.
  • FIG. 5 is an overall view (front view / schematic diagram) of the stent graft 11SG of the present invention 2 (Type (II)).
  • FIG. 6 is a schematic view of the stent graft 11SG of the present invention placed in an affected area.
  • FIGS. 7A and 7B are schematic views of a conventional stent graft 101SG placed in an affected area
  • FIG. 7B is a partially enlarged view of FIG.
  • 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.
  • a part of the above circumferential CR (side S) direction may be described as “one side of the side” and the opposite side of the “one side of the side” as “one direction of the other side”. is there.
  • the third side S3 side may be described as one direction of the side portion, and the opposite fourth side portion S4 side may be described as one direction of the other side portion.
  • symbol which means directions, such as S3 may be described after the code
  • 4STS3 means the strut 4ST on the third side.
  • the “strut” is also referred to as a support, and is a substantially linear line-shaped or wire-shaped member that forms the “annular unit 4” and the “connecting unit 5”.
  • the substantially straight “strut” constituting the “annular unit 4” may be referred to as “annular strut 4ST” in the sense of “the strut constituting the annular unit” or simply “strut 4ST”.
  • members constituting the “connection unit 5” may be referred to as “connection struts 5ST” or simply “struts 5ST”.
  • the stent 1 of the present invention has a so-called substantially tubular form in which an annular unit 4 is connected by a connecting unit 5.
  • the annular unit 4 is constituted by a substantially zigzag pattern as will be described in detail below, and the turning point of this zigzag pattern is a bent portion.
  • the annular unit configured as described above has such a bent portion 4C on the terminal DE side and the base end PE side.
  • the bent portion 4C on the terminal DE side is referred to as “mountain M”, the base end.
  • the bent part 4C on the PE side is referred to as a “valley part V”.
  • the “mountain portion M” and the “valley portion V” in the circumferential CR direction are connected by a so-called “substantially linear strut 4ST”.
  • the annular unit 4 is a member in which a plurality of substantially linear struts 4ST are formed (arranged) in a so-called “substantially zigzag shape” as described above continuously in the circumferential CR direction.
  • This zigzag arrangement is also referred to as “substantially zigzag pattern” or “substantially wave pattern”.
  • peaks M and valleys V are alternately formed.
  • the peak portion M and the valley portion V form a peak portion bent portion M (4C) and a valley portion bent portion V (4C), respectively.
  • the peak portion is a bent portion on the terminal DE side
  • the valley portion is a bent portion on the proximal end PE side.
  • the connecting unit 5 is a member that connects, for example, the nth row (4n), the (n + 1) th row (4n + 1), and the two “annular units 4”.
  • a plurality of so-called substantially straight (usually about 2-4) (two in the illustration of FIG. 1) connecting struts 5ST are included.
  • the annular unit 4 includes five units of an nth column (4n), an n + 1th column (4n + 1), an n + 2 column (4n + 2), an n + 3 column (4n + 3), and an n + 4 column (4n + 4). Is done.
  • the stent 1 has a hook 6 disposed at one end in the circumferential CR (side S) direction on the terminal DE side of the annular unit 4DE on the terminal side of the stent 1. It is preferable.
  • the hook 6 is arranged by shifting the proximal end PE side from the third side portion S3 to the left side of the first side portion S1 / paper surface at a predetermined angle (varies depending on the specifications of each stent skeleton).
  • the hook 6 is a portion that locks the tip 6 to the indwelling position and pulls the stent or the stent graft to the indwelling position.
  • the contrast marker MK is preferably arranged at a predetermined position of the peak portion M and the valley portion V so that the position of the opening of the hook 6 or the graft GF can be easily confirmed.
  • a fin FN also referred to as an extending member
  • 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 is also a preferable aspect that it extends along the direction.
  • the strut 4STS4 in one direction of the other side S (rotated) (the fourth side S4 / the leftmost side and the rightmost side of the paper) (corresponding to the small bay side by definition 6) has a short length 4STL. (As described below, this is referred to as an “inclined cut structure” or simply an “inclined structure”).
  • the conventional stent is very different from the present invention in that all the 4DE struts 4ST are configured to have the same length.
  • FIG. 2 shows an example of forming approximately 80 and FIG. 3 approximately 53.
  • each strut 4ST in one direction first side S1 / left side of paper, second side S2 / right side of paper
  • the length 4STL (4STLS) of the strut 4STS4 in one direction is the largest. It is short.
  • the strut 4ST is moved from one direction (third side S3) (large bay side) of the side S to one direction (fourth side S4 / It has a so-called inclined cut structure that is cut so as to incline toward the leftmost side and the rightmost side (small bay side).
  • the basic reason why the stent has such an inclined cut structure is that the one side portion S3 of the stent is a portion that is in contact with the large bay portion having a long distance but a low degree of curvature.
  • the small bays be kept in close contact with long distances, while the small bays are short with a short length of stent, but with a sharp bend. For this reason, both of them are connected to each other smoothly while maintaining close contact from a large bay to a small bay including a steep bend by adopting an inclined cut structure.
  • the outer periphery of the stent 1 formed as described above (excluding the openings on the terminal DE side and the base PE side).
  • the opening is an inlet for blood flow when the stent is placed in a blood vessel as shown in the figure.
  • graft GF synthetic resin tubular member
  • graft GF coated with graft GF. That is, as shown in FIG. 4, the graft also has an inclined structure corresponding to the inclined structure of the stent.
  • the end DE side of the end-side annular unit 4DE has the inclined cut structure as described above, and the length 4ST (4STLS) of the strut 4ST on the fourth side portion S4 (small heel side). ) Is formed to a minimum, and when placed in the aortic arch as shown in FIG. Thereby, like the conventional stent of FIG. 7, there is no gap (bird beak) SBV formed between the stent 1 and the eyelid side, and the blood flow from the downstream side is promptly introduced into the stent 1. It can be distributed. For this reason, the blood flow does not enter into the SBV as in the conventional case and causes problems such as movement of the stent graft, fatigue, and internal leakage.
  • the stent 1 has the maximum length 4STLL, the minimum length 4STLS, and the intermediate length 4STLM, as described above, in the end-side annular unit 4DE. .
  • the slope cut rate ⁇ is too large, for example, exceeding 90%, the strut length that should be in close contact with the small bay side is almost the same as the strut length on the large bay for the reasons described above.
  • ⁇ is too small, such as less than 30, the strut 4ST is too small to have only a small length strut, and this portion cannot form a sufficient annular body. Therefore, it becomes difficult to coat the stent 1 (the end-side annular unit) with the graft GF.
  • the inclination angle ⁇ is defined as follows. That is, an extension line DEL on the terminal DE side connecting the peak part M of the terminal-side annular unit 4DE, a vertex with the maximum length 4STLL (peak part M), and a vertex with the minimum length 4STLS (peak part M) It is defined by an angle ⁇ at which the connected extension line MLS (or “inclined line”) intersects.
  • ⁇ is too small, for example, less than 5 °, it is difficult for the blood vessel bent sharply to adhere to the side of the eyelid, while when ⁇ is too large, for example, to exceed 30 °, Since the strut 4ST (particularly 4STLS) is too small, it is difficult to coat the stent 1 with the graft GF.
  • FIG. 5 is an example of another stent graft 11SG (stent 11) according to the present invention 2.
  • the stent 11 is substantially the same as (i) the length of the strut ST of the end annular member 4DE.
  • the graft GF which is a synthetic resin annular member, that is, the graft GF covering the stent 11, has the same inclination as the terminal DE side annular unit 4 DE of the stent 1.
  • a part of the terminal DE side annular unit 4DE of the stent 11 is exposed on the terminal DE side and the fourth side S4 side (small bay side) as shown in FIG. It is different in point.
  • the markers MK and fins FN described in FIG. 1 are omitted, but these techniques are naturally applied to the stent graft 11 as well.
  • the stent 11 is configured such that the terminal DE side of the graft GF side (not the stent side) has an inclined structure as described above, and the length of the fourth side portion S4 (small heel side) is (shortest).
  • the gap SBV remains between the stent 11 (terminal-side annular unit 14DE) and the eyelid side.
  • the graft GF having the inclined structure is in close contact with the steep wall surface of the small bay, no substantial gap SBV is formed between the graft GF in the portion. Therefore, the ascending blood flow does not push up the terminal DE side of the stent graft as shown in FIG. 7B and cause the stent graft to move. For this reason, when the stent graft of the present invention is placed in the aortic arch, the graft GF is easily adhered on the small heel side as shown in FIG.
  • the stent graft of Patent Document 4 is composed of all struts having the same length, and the end surface on the terminal DE side is apparently “inclined structure” by the struts having the same length. Since the struts are all covered with the graft (the same length as the struts on the side), the graft is supported (reinforced) by the (long) struts all over the entire surface, even on the side of the heel. In this case, it is difficult to bend along the gavel side and it is difficult to adhere.
  • the annular unit on the end side on the large bay side, it is in close contact with a relatively long and gently curved surface formed by standard length struts, while the distance is short but the curve is steep and small.
  • the bay side sufficient flexibility and adhesion can be obtained only by gradually shortening the strut length toward the small bay side.
  • the aortic arch is divided into a large bay side region LL and a small bay side region SS as shown in FIG. 5 and different struts adapted to the respective regions are used. Can do.
  • the stent graft 11SG according to the invention 2 has a maximum length GFLL, a minimum length GFLS, and an intermediate length GFLM as the length GFL of the graft GF on the terminal DE side, as shown in FIG.
  • the length GFL of the stent graft is from the valley V in the longitudinal L direction (terminal DE-proximal PE direction) of the distal annular unit 14DE to the portion covering the stent toward the peak M. It is defined as the distance of graft GF. (As shown in FIG.
  • the graft GF of the stent graft 11SG reaches from the valley portion V to the mountain portion M (that is, covers all of the struts 14ST) in the portion placed on the large bay side,
  • the portion where the graft GF covers the strut 14ST gradually decreases toward the small bay side, that is, the portion covering the strut 14ST decreases in the order of GFLL ⁇ GFLM ⁇ GFLS, that is, decreases with a certain slope (this slope line). Is represented by GFC.).
  • the graft GF is formed so as to have an inclined cut structure similar to the inclined cut structure of the stent in the first aspect of the invention described above so that GFLL>GFLM> GFLS.
  • ⁇ ′ is too large, for example, more than 90, it is difficult to make close contact with a sharply bent blood vessel, while if ⁇ ′ is too small, for example, less than 30, graft GF is too small. Thus, it becomes difficult to coat the stent 1 with the graft GF.
  • the inclination angle ⁇ is defined by the extension line DEL on the terminal DE side connecting the peak M of the terminal-side annular unit 14DE, the cut start position (GFLL) of the graft GF of the terminal-side annular unit 14DE, and the cut end position (GFLS). It is defined by an angle ⁇ ′ at which the extension line GFC connecting the strut 14ST (on the terminal DE side and the small rod side) intersects.
  • ⁇ ′ is too small, for example, less than 5 °, the sharply bent blood vessel is difficult to adhere on the side of the eyelid, while if ⁇ ′ is too large, for example, to exceed 30 °, the cut The length GFLS of the graft at the end position is too small, and it is difficult to coat the strut 14ST on the small bay side of the terminal-side annular unit of the stent 11 with the graft GF, and to close the covered portion to the small bay side. Become.
  • the material forming the annular strut 4ST, the annular unit 4, the connecting strut 5ST, the connecting unit 5, the hooks 6 and 16, and the fin FN constituting the stents 1 and 11 of the present invention is not particularly limited.
  • stainless steel such as SUS316L. Steel; Superelastic alloy such as Ti—Ni alloy; Titanium-based alloy, Co—Cr-based alloy; preferably formed of metal wire such as Ta, Ti, W, Au.
  • stents are made of polymer materials such as urethane, which are commonly used for stents made of these metals, and 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 the stent because it can provide a function of preventing the formation of thrombus on the surface of the stent.
  • the stents 1 and 11 can be used as they are, the stent graft SG (which is preferably used as an artificial blood vessel) is usually used by using the stent as a skeleton and covering the outer surface with a graft GF which is a synthetic resin annular member. 4) can be formed.
  • the material for forming the graft GF is preferably a film-like or fibrous material.
  • a film made of a fluororesin (PTFE: polytetrafluoroethylene, PFA: tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer) (
  • PTFE polytetrafluoroethylene
  • PFA tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer
  • a synthetic resin tubular member made of a single layer or two or more layers Dacron, Mylar (registered trademark, polyethylene terephthalate) fiber, or the like is used, but is not limited thereto.
  • a stent graft is as follows. That is, a stent ST having a diameter of 40 mm at the time of no load (a bent stent composed of five tubular units as shown in FIG. 1 and having a terminal DE side annular member having an inclined cut structure) is 30 mm (75%). ). A tubular member (graft) made of fluororesin (PTFE) having a diameter of 31 mm is used, and an end portion and an arbitrary portion thereof are fixed and covered on the stent while being sewn to the stent with a suture, thereby forming the stent graft SG.
  • PTFE fluororesin
  • the stent graft thus formed includes the stents 1 and 11 made of metal wires as a skeleton, the spring action of the stent itself, the inclined cut structure at the distal end of the stent, and the flexible synthetic resin tubular member. Since it is constructed by covering and compounding with (graft), it can follow three-dimensional bending of blood vessels, particularly sharp bending on the small bay side.
  • the terminal DE side is formed in an inclined cut structure, so that the stent or the like is easily attached to the sharply bent small heel side of the aortic arch at the distal end of the bird beak. It will not be in a floating state.
  • the stent (stent graft) of the present invention can suitably solve problems such as stent graft movement, stent fatigue / breakage, and internal leakage (endoleak) after placement of the affected part derived from bird beaks.
  • problems such as stent graft movement, stent fatigue / breakage, and internal leakage (endoleak) after placement of the affected part derived from bird beaks.
  • As a medical instrument that is suitably used in the medical field for treating diseases such as sexual diseases (such as aneurysms), its industrial applicability is extremely large.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

[Problem] To provide a stent and a stent-graft that easily bond to a sharply-curved lesser curvature side of a blood vessel, and that can solve problems such as movement of the stent-graft after being implanted in the affected area, stent fatigue/damage, and internal leakage (endoleaks). [Solution] A stent has ring-shaped units 4 that expand in the circumference CR direction, and connecting units 5 that connect the ring-shaped units 4 to one another in the length L direction. The ring-shaped units 4 are arranged in the length L direction and are connected to one another via the connecting units 5. The ring-shaped units 4 form a substantially zigzag shape by connecting struts 4ST in the circumference CR direction. A terminal-side ring-shaped member 4DE forms an inclined-cut structure that has, as lengths 4STL of the struts 4ST, a largest length 4STLL, a smallest length 4STLS, and a length 4STLM midway between 4STLL and 4STLS, wherein 4STLL>4STLM>4STLS from one direction of a side S toward said one direction of another side S.

Description

ステント及びステントグラフトStent and stent graft
　本発明は動脈瘤等の疾患に用いるステント及びステントグラフトの改良に関する。
　より詳しくは本発明は、拡張性疾患（動脈瘤等）及び動脈の狭窄性疾患或いはその他の疾患を治療するために、当該動脈瘤等の治療に用いるステントグラフトを、患部の安全な部位に留置し人工血管として使用するステントグラフトに関する  The present invention relates to improvements in stents and stent grafts used for diseases such as aneurysms.
More specifically, in the present invention, in order to treat an expandable disease (such as an aneurysm) and a stenotic disease of an artery or other diseases, a stent graft used for the treatment of the aneurysm or the like is placed at a safe site of the affected area. About stent grafts used as artificial blood vessels
　大動脈弓とは左心室を出た上行大動脈が下行大動脈に連なる弓状に曲がっている部分であるが、胸部大動脈弓瘤の患者の約４分の１には大当該動脈弓に通常より急峻な曲がり（三次元的屈曲）が有るといわれている。本出願人は、特許文献１において、当該急峻な曲がりに対処するため、環状ユニットを連結して構成したあらかじめ屈曲させた形態を有するステントと当該ステントの外周を合成樹脂製管状部材（グラフトという）で被覆したステントグラフトの発明を開示した。当該ステントグラフトは、図７に示すように動脈瘤８を含む大動脈内に人工血管として留置し当該瘤の破裂を防止するために好適に使用されるものである。 The aortic arch is the part where the ascending aorta exiting the left ventricle is bent in an arch shape that continues to the descending aorta, but in about one-quarter of patients with thoracic aortic arches, the aortic arch is steeper than usual. It is said that there is a bend (three-dimensional bending). In order to cope with the steep bend in Patent Document 1, the applicant of the present invention is a synthetic resin tubular member (referred to as a graft) in which a stent having a previously bent shape configured by connecting annular units and an outer periphery of the stent are combined. The invention of a stent graft coated with s. As shown in FIG. 7, the stent graft is suitably used for placement as an artificial blood vessel in the aorta including the aneurysm 8 to prevent the aneurysm from rupturing.
　当該ステントグラフト（「１０１ＳＧ」と称する。）は、基本的にこれらの三次元的屈曲に好適に適合するように作成されたが、大動脈弓の急峻に屈曲した箇所は、図７（Ｂ）に示すように、小弯側（径が小さい大動脈弓の内側）に密着して留置するのがどうしても困難な場合があった。 The stent graft (referred to as “101SG”) was basically formed so as to be suitable for these three-dimensional bends, but the sharply bent portion of the aortic arch is shown in FIG. 7B. As described above, there are cases where it is difficult to indwell in close contact with the small heel side (the inside of the aortic arch having a small diameter).
　このため、小弯側と留置したステントグラフトとの間に隙間（バードビークと呼ばれる）ＳＢＶが生成していた。
この場合下流側（上行大動脈）から血液が大動脈弓に流入する際に、図７に示すように血液（血流Ｆ´）が生成した隙間ＳＢＶに入り込んで、ステントグラフトの末端ＤＥ側をＧで示すように押し上げ、ステントグラフトの移動、ステント疲労／破損、内部漏れ(エンドリーク)等を含む、不具合を引き起こすという場合があった。 For this reason, a gap (referred to as a bird beak) SBV was generated between the side of the heel and the placed stent graft.
In this case, when blood flows into the aortic arch from the downstream side (ascending aorta), the blood (blood flow F ′) enters the generated gap SBV as shown in FIG. 7, and the terminal DE side of the stent graft is indicated by G. In some cases, such problems as pushing up, movement of the stent graft, fatigue / breakage of the stent, and internal leakage (end leakage) are caused.
　特許文献２及び特許文献３には、このような現象をステントグラフト留置装置システムにより、回避することを可能とする発明が開示されている。（以下、特許文献に記載されている符号は〈　〉をつけて、そのまま記載し、各部材の名称もできるだけそのまま引用した。）すなわち、
　特許文献２には、特異な形態の弓形制御ルーメン〈１２〉と、支持ワイヤ〈２２、２３〉を駆使して、ステントグラフト（プロテーゼ）を植え込むためのシステムの発明が記載されている。
　特許文献３には、供給システムとして、以下のようなステントグラフトと、係止部材と、１つ又はそれよりも多くの直径減少部材とを含む発明が記載されている。すなわち、
　ステントグラフトは、互いに対向して配置され且つ接線で接続される第一及び第二の長手に延びる側部を含む管状グラフトを含む。
係止部材が係止位置にあるとき、係止部材はカニューレに対してグラフトの表面を拘束する。第一の直径減少部材を、接線に近接して配置されるグラフトの第一部分に摺動可能に接続し、且つ、接線から円周方向に離れる方向に離間するグラフトの第二部分に摺動可能に接続している。
第一の直径減少部材が拘束位置にあるとき、グラフトの第二部分はグラフトの第一部分に向かって引かれ、ステントグラフトの近位部分は少なくとも２つのローブを備える直径減少構造を有する。 Patent Documents 2 and 3 disclose inventions that allow such a phenomenon to be avoided by a stent graft indwelling device system. (Hereinafter, the reference numerals described in the patent literature are written as they are with <>, and the names of the respective members are quoted as much as possible.)
Patent Document 2 describes an invention of a system for implanting a stent graft (prosthesis) using a specially shaped arcuate control lumen <12> and support wires <22, 23>.
Patent Document 3 describes an invention including a stent graft as described below, a locking member, and one or more diameter-reducing members as a supply system. That is,
The stent graft includes a tubular graft that includes first and second longitudinally extending sides disposed opposite each other and connected tangentially.
When the locking member is in the locked position, the locking member restrains the surface of the graft relative to the cannula. A first diameter reducing member is slidably connected to a first portion of the graft disposed proximate to the tangent and slidable to a second portion of the graft that is spaced circumferentially away from the tangent. Connected to.
When the first diameter reducing member is in the restrained position, the second portion of the graft is pulled toward the first portion of the graft, and the proximal portion of the stent graft has a diameter reducing structure with at least two lobes.
　特許文献４は、移植片本体〈２０〉の長い方を大動脈弓の長い方の外側湾曲と整合させ且つ該移植片本体の短い方を大動脈弓の短い方の内側湾曲と整合させることによって、患部に配備したときに、人工器官〈１０〉が大動脈弓の解剖学的構造の形状と合致するのが促進され、蛇行している大動脈弓に人工器官〈１０〉の正確で精度の高い配置を可能にする発明を開示している。
すなわち、第一の近位のステント〈３０ａ〉と第二の近位のステント〈３０ｂ〉との間の間隔は、移植片本体〈２０〉の外周に沿って変化している。例えば、人工器官の頂部の長手方向の長さは、例えば、傾斜した端部を形成するために人工器官の底部の長手方向の長さよりも長く形成している。頂部の長手方向の長さに沿った第一の近位のステント〈３０ａ〉と第二の近位のステント〈３０ｂ〉との間の間隔は、底部の長手方向長さに沿った第一の近位のステントと第二の近位のステントとの間の間隔よりも大きく形成している。 Patent Document 4 discloses that the longer part of the graft body <20> is aligned with the longer outer curve of the aortic arch and the shorter one of the graft body is aligned with the shorter inner curve of the aortic arch. When deployed, the prosthesis <10> is encouraged to match the shape of the anatomical structure of the aortic arch, allowing accurate and precise placement of the prosthesis <10> on the meandering aortic arch The invention to be disclosed is disclosed.
That is, the spacing between the first proximal stent <30a> and the second proximal stent <30b> varies along the outer periphery of the graft body <20>. For example, the longitudinal length of the top of the prosthesis is formed longer than the longitudinal length of the bottom of the prosthesis, for example, to form an inclined end. The spacing between the first proximal stent <30a> and the second proximal stent <30b> along the longitudinal length of the top is the first distance along the longitudinal length of the bottom. The distance between the proximal stent and the second proximal stent is larger.
特許第４０６４７２４号（特許請求の範囲、図１から図４）Patent No. 4064724 (Claims, FIGS. 1 to 4) 特許第５６８７２１６号（特許請求の範囲、図５－１～図５－３）Patent No. 5687216 (Claims, FIGS. 5-1 to 5-3) 特開２０１２－１３９５００号（要約の欄、図１）JP 2012-139500 (Abstract column, FIG. 1) 特開２０１３－７１００５号（［００４７］、［００８９］、図６、図８、図１０、図１２、図１４）JP 2013-71005 ([0047], [0089], FIG. 6, FIG. 8, FIG. 10, FIG. 12, FIG. 14)
　上記した特許文献１－特許文献４に記載された先行発明には、以下のような課題があり、当該急峻な曲がり（三次元的屈曲）に的確に対処することは困難であった。すなわち、
　特許文献１に記載のように、予め屈曲させたステント骨格とこれを完全にグラフトで被覆したステントグラフトの形態のみでは、大動脈弓の小弯側に密着させて、隙間ＳＢＶを埋めるのに、限界がある。
　特許文献２及び特許文献３は、特異な形態の各部材を有機的に結合させて、ステントグラフト（プロテーゼ）を植え込むためのシステムの発明であるため、それを実施する術者の手技の習得が困難である等の課題が指摘される。
　特許文献４は、ステントを構成するストラットが同じ長さで、かつグラフトで全て被覆されているので、末端側で大動脈弓の急峻に屈曲した小弯側に密着させるのが、困難である。 The prior invention described in Patent Document 1 to Patent Document 4 described above has the following problems, and it has been difficult to accurately cope with the steep bend (three-dimensional bending). That is,
As described in Patent Document 1, only in the form of a stent skeleton that has been bent in advance and a stent graft that is completely covered with a graft, there is a limit in filling the gap SBV in close contact with the small heel side of the aortic arch. is there.
Since Patent Document 2 and Patent Document 3 are inventions of a system for implanting a stent graft (prosthesis) by organically connecting members having specific shapes, it is difficult to acquire a technique for an operator who performs the technique. Issues such as being pointed out.
In Patent Document 4, since the struts constituting the stent have the same length and are all covered with the graft, it is difficult to closely contact the steeply bent small side of the aortic arch on the distal side.
　そこで本発明者は、以上の課題を解決するために鋭意検討を重ねた結果、以下の発明に到達した。
　以下［１］から［４］は発明１に係るステント（ステントグラフト）（Type (I)）を規定するものである。
[１]本発明は、長手（Ｌ）方向に延びる略管状体に形成され、当該略管状体の内部より円周（ＣＲ）方向に拡張可能なステント（１）であって、
当該略管状体は、円周（ＣＲ）方向に拡張する複数の環状ユニット（４）と、隣り合う当該環状ユニット（４）を長手（Ｌ）方向に接続する連結ユニット（５）とを有し、
　当該略管状体は、前記隣り合う環状ユニット（４）の側部（Ｓ）方向の一端部を前記連結ユニット（５）の一端部を介して接続した、複数の環状ユニット（４）を長手（Ｌ）方向に配列してなるものであり、
　前記環状ユニット（４）は、ストラット（４ＳＴ）を、側部（Ｓ）の一方向に複数個の山部（Ｍ）と他の側部（Ｓ）の一方向に複数個の谷部（Ｖ）を介して交互に接続することにより、円周（ＣＲ）方向に連続して略ジグザク状に形成したものであり、
　末端側に配列された前記環状ユニット（４）を、末端側環状部材（４ＤＥ）とすると、当該末端側環状部材（４ＤＥ）を構成する、ストラット（４ＳＴ）の長さを、側部（Ｓ）の一方向から他の側部（Ｓ）の一方向に向けて、徐々に短く形成するものであって、
　当該末端側環状部材（４ＤＥ）は、そのストラット（４ＳＴ）の長さとして、少なくとも最大の長さ（４ＳＴＬＬ）、最小の長さ（４ＳＴＬＳ）、及びこれらの中間の長さ（４ＳＴＬＭ）を有し、
　側部（Ｓ）の一方向から他の側部（Ｓ）の一方向に向けて、当該ストラット（４ＳＴ）は、４ＳＴＬＬ＞４ＳＴＬＭ＞４ＳＴＬＳとなるように傾斜カット構造となるように形成した、ステント（１）を提供する。 Therefore, as a result of intensive studies in order to solve the above problems, the present inventors have reached the following invention.
The following [1] to [4] define the stent (stent graft) (Type (I)) according to the first aspect.
[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 has a plurality of annular units (4) that expand in the circumferential (CR) direction, and a connecting unit (5) that connects the adjacent annular units (4) in the longitudinal (L) direction. ,
The substantially tubular body is formed by connecting a plurality of annular units (4) with one end in the side (S) direction of the adjacent annular units (4) connected through one end of the connecting unit (5). 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,
When the annular unit (4) arranged on the terminal side is a terminal-side annular member (4DE), the length of the strut (4ST) constituting the terminal-side annular member (4DE) is set to the side (S). From one direction to the other side (S) in one direction,
The end-side annular member (4DE) has at least a maximum length (4STLL), a minimum length (4STLS), and an intermediate length (4STLM) as the length of the strut (4ST). ,
A stent formed such that the strut (4ST) has an inclined cut structure such that 4STLL>4STLM> 4STLS from one direction of the side part (S) toward one direction of the other side part (S). Provide (1).
 [２] 本発明は、傾斜カット率φ［＝（４ＳＴＬＳ／４ＳＴＬＬ）×１００％］は、３０％から９０％である、[１]に記載のステント（１）を提供する。 [2] The present invention provides the stent (1) according to [1], wherein the slope cut rate φ [= (4STLS / 4STLL) × 100%] is 30% to 90%.
 [３] 本発明は、傾斜角度θは、５°～３０°である、[１]または[２]に記載のステント（１）を提供する。（ただし、傾斜角度θは、例えば図２－３において、４ＳＴＬＬの山部Ｍの頂点をＰＬ、４ＳＴＬＭの山部Ｍの頂点をＰＭ、４ＳＴＬＳの山部Ｍの頂点をＰＳとするとき、ＰＬ、ＰＭ、ＰＳを結ぶ直線を傾斜線ＭＬＳとし、ＭＬＳと、少なくとも複数の４ＳＴＬＬの山部Ｍの頂点ＰＬを結んだ直線を基準線ＧＬとすれば、ＭＬＳとＧＬのなす角度である。または、ＭＬＳと、当該末端側環状部材（末端側環状ユニット）（４ＤＥ）の当該４ＳＴＬＬに対応する端部を形成する端面の延長線ＤＥＬのなす角度である。） [3] The present invention provides the stent (1) according to [1] or [2], wherein the inclination angle θ is 5 ° to 30 °. (However, the inclination angle θ is PL when the vertex of the peak portion M of 4STLL is PL, the vertex of the peak portion M of 4STLM is PM, and the vertex of the peak portion M of 4STLS is PS in FIG. If a straight line connecting PM and PS is an inclined line MLS, and a straight line connecting MLS and the vertices PL of at least a plurality of 4STLL peaks M is a reference line GL, this is an angle formed by MLS and GL, or MLS. And an angle formed by an extension line DEL of an end surface that forms an end corresponding to the 4STLL of the terminal-side annular member (terminal-side annular unit) (4DE).
 [４] 本発明は、[１]から[３]のいずれか１つに記載のステント（１）をグラフト（ＧＦ）で被覆した、ステントグラフト（１ＳＧ）を提供する。 [4] The present invention provides a stent graft (1SG) in which the stent (1) according to any one of [1] to [3] is coated with a graft (GF).
　以下［５］から［７］は、発明２に係るステントグラフト（Type (II)）を規定するものである。
 [５]本発明は、長手（Ｌ）方向に延びる略管状体に形成され、当該略管状体の内部より円周（ＣＲ）方向に拡張可能なステント（１１）をグラフト（ＧＦ）で被覆したステントグラフト（１１ＳＧ）であって、
　当該略管状体は、円周（ＣＲ）方向に拡張する複数の環状ユニット（１４）と、隣り合う当該環状ユニット（１４）を長手（Ｌ）方向に接続する連結ユニット（１５）とを有し、
　当該略管状体は、前記隣り合う環状ユニット（１４）の側部（Ｓ）方向の一端部を前記連結ユニット（１５）の一端部を介して接続した、複数の環状ユニット（１４）を長手（Ｌ）方向に配列してなるものであり、
前記環状ユニット（１４）は、ストラット（１４ＳＴ）を、側部（Ｓ）の一方向に複数個の山部（Ｍ）と他の側部（Ｓ）の一方向に複数個の谷部（Ｖ）を介して交互に接続することにより、円周（ＣＲ）方向に連続して略ジグザク状に形成したものであり、
　前記略管状体に形成されたステント（１１）はその外周を末端ＤＥ側及び他の側部Ｓの一方向を除いて、グラフト（ＧＦ）で被覆して、ステントグラフト（１１ＳＧ）としたものであり、
　当該ステントグラフト（１１ＳＧ）は、末端ＤＥ側のグラフト（ＧＦ）の長さ（ＧＦＬ）として、
最大の長さＧＦＬＬ、最小の長さＧＦＬＳ、これらの中間の長さＧＦＬＭを有し、側部Ｓの一方向から他の側部Ｓの一方向に向けて、ＧＦＬＬ＞ＧＦＬＭ＞ＧＦＬＳである傾斜カット構造を形成した、ステントグラフト（１１ＳＧ）を提供する。 Hereinafter, [5] to [7] define the stent graft (Type (II)) according to Invention 2.
[5] In the present invention, a stent (11) 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 is covered with a graft (GF). A stent graft (11SG),
The substantially tubular body has a plurality of annular units (14) that expand in the circumferential (CR) direction, and a connecting unit (15) that connects the adjacent annular units (14) in the longitudinal (L) direction. ,
The substantially tubular body is formed by connecting a plurality of annular units (14) with one end in the side (S) direction of the adjacent annular units (14) connected through one end of the connecting unit (15) in the longitudinal direction ( L) are arranged in the direction,
The annular unit (14) includes a strut (14ST) having a plurality of peaks (M) in one direction of the side (S) and a plurality of valleys (V) in one direction of the other side (S). ) Are alternately connected to each other to form a substantially zigzag shape continuously in the circumferential (CR) direction,
The outer periphery of the stent (11) formed in the substantially tubular body is covered with a graft (GF) except for one direction of the terminal DE side and the other side S to form a stent graft (11SG). ,
The stent graft (11SG) is the length (GFL) of the graft (GF) on the terminal DE side.
Inclination having a maximum length GFLL, a minimum length GFLS, and an intermediate length GFLM from one direction of the side S toward one direction of the other side S, where GFLL>GFLM> GFLS A stent graft (11SG) having a cut structure is provided.
 [６]本発明は、傾斜カット率φ´［＝（ＧＦＬＳ／ＧＦＬＬ）×１００％］は、３０％から９０％である、[５]に記載のステントグラフト（１１ＳＧ）を提供する。 [6] The present invention provides the stent graft (11SG) according to [5], wherein the slope cut rate φ ′ [= (GFLS / GFLL) × 100%] is 30% to 90%.
 [７]傾斜角度θ´は、５°～３０°である、[５]または[６]に記載のステントグラフト（１１ＳＧ）を提供する。（ただし、傾斜角度θ´は、例えば図５等において、ＧＦＬＬ、ＧＦＬＭ、及びＧＦＬＳを結ぶ直線をＧＦＣとすると、ＧＦＣと、複数の位置におけるＧＦＬＬ（又はＧＦＬＬに対応するストラット１４ＳＴの山側頂点（山部Ｍ））を結んだ直線の延長線ＤＥＬとのなす角度である。（又はＧＦＣと当該末端側環状部材（末端側環状ユニット）（４ＤＥ）の当該ＧＦＬＬに対応する端部を形成する端面の延長線ＤＥＬのなす角度である。） [7] The stent graft (11SG) according to [5] or [6] is provided, wherein the inclination angle θ ′ is 5 ° to 30 °. (However, the inclination angle θ ′ is, for example, in FIG. 5, where the straight line connecting GFLL, GFLM, and GFLS is GFC, GFC and GFLL at a plurality of positions (or the peak apex (crest of the strut 14ST corresponding to GFLL) (Or MFC) and an end line forming an end corresponding to the GFLL of the terminal-side annular member (terminal-side annular unit) (4DE). (An angle formed by the extension line DEL.)
　本発明のステント１（ステントグラフト１ＳＧ）は、末端ＤＥ側を、前記［１］のように形成しているので、特許文献１及び４と比較して、大動脈弓の急峻に屈曲した小弯側に密着しやすく、また、
本発明のステント１１（特に、ステントグラフト１１ＳＧ）は、末端ＤＥ側を前記［５］のように形成しているので、特許文献１及び４と比較して、大動脈弓の急峻に屈曲した小弯側に密着しやすい。
　このため本発明のステント１、１１（ステントグラフト１ＳＧ、１１ＳＧ）は、患部留置後のステントグラフトの移動、ステント疲労／破損、内部漏れ(エンドリーク)等の不具合を好適に解消することができる。 In the stent 1 (stent graft 1SG) of the present invention, the terminal DE side is formed as described in [1] above. Therefore, compared to Patent Documents 1 and 4, the aortic arch is sharply bent on the side of the small curvature. Easy to adhere,
The stent 11 (especially the stent graft 11SG) of the present invention has the terminal DE side formed as described in [5] above, and therefore, compared with Patent Documents 1 and 4, the aortic arch is sharply bent at the side of the small curvature Easy to adhere to.
For this reason, the stents 1 and 11 (stent grafts 1SG and 11SG) of the present invention can suitably eliminate problems such as movement of the stent graft after placement of the affected area, stent fatigue / breakage, and internal leakage (end leakage).
図１は本発明１(Type(I))のステント１の全体図（正面図／概略図）である。FIG. 1 is an overall view (front view / schematic diagram) of a stent 1 of the present invention 1 (Type (I)). 図２はステント１の末端側環状ユニット４ＤＥ近傍の一部拡大図（組立時／患部留置時における末端側環状ユニット４ＤＥを円周ＣＲ方向にτ＝３６０°展開した展開図）である。（ここでτは、当該展開図より末端環状ユニットを組み立てた場合において、（当該環状ユニットの周辺の位置を）当該環状ユニットの正面（円形状の開口部）の中心を原点とする極座標表示したときの偏角τを示す。以下同じ。）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 the distal-side annular unit 4DE is expanded in the circumferential CR direction at τ = 360 ° at the time of assembly / affected site 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. 図３はステント１の末端側環状ユニット４ＤＥ近傍の一部拡大図（組立時／患部留置時における末端側環状ユニット４ＤＥを、円周ＣＲ方向にτ＝３６０°展開した展開図）である。FIG. 3 is a partially enlarged view of the vicinity of the distal-side annular unit 4DE of the stent 1 (a developed view in which the distal-side annular unit 4DE at the time of assembly / dwelling of the affected part is developed at τ = 360 ° in the circumferential CR direction). 図４（Ａ）、（Ｂ）は本発明のステントグラフト１ＳＧを、患部に留置したところの概略図で、（Ｂ）は（Ａ）の一部拡大図である。4A and 4B are schematic views of the stent graft 1SG of the present invention placed in the affected area, and FIG. 4B is a partially enlarged view of FIG. 図５は本発明２(Type(II))のステントグラフト１１ＳＧの全体図（正面図／概略図）である。FIG. 5 is an overall view (front view / schematic diagram) of the stent graft 11SG of the present invention 2 (Type (II)). 図６は本発明のステントグラフト１１ＳＧを、患部に留置したところの概略図である。FIG. 6 is a schematic view of the stent graft 11SG of the present invention placed in an affected area. 図７（Ａ）、（Ｂ）は従来のステントグラフト１０１ＳＧを、患部に留置したところの概略図で、（Ｂ）は（Ａ）の一部拡大図である。FIGS. 7A and 7B are schematic views of a conventional stent graft 101SG placed in an affected area, and FIG. 7B is a partially enlarged view of FIG.
　以下、図面を参照しながら本発明を詳細に説明する。
　以下、本発明を明確に説明するため、図１の配置を基準にして次の定義をおく。なお図１は各線記載の複雑化を避けるために、正面方向から背面方向に見て、各ストラット４ＳＴ、５ＳＴは重なるように記載している。図５も同じ。
（定義１）「第１側部Ｓ１側」とは、図１に示すように、紙面の表側、ステントの正面方向を意味する。以下「・・・側」は「・・・方向」と記載する場合がある。
（定義２）「第２側部Ｓ２側」とは、図１に示すように、紙面の裏側、ステントの背面方向を意味する。
（定義３）「末端ＤＥ側」とは、図１に示すように、紙面の左側を意味する。
（定義４）「基端ＰＥ側」とは、図１に示すように、紙面の右側を意味する。
（定義５）「第３側部Ｓ３側」とは、図１に示すように、紙面の上部側を意味する。大動脈弓では、大弯側に相当する。
（定義６）「第４側部Ｓ４側」とは、図１に示すように、紙面の下部側を意味する。大動脈弓では、小弯側に相当する。 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. The same applies to FIG.
(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. In the aortic arch, it corresponds to the greater heel side.
(Definition 6) “Fourth side S4 side” means the lower side of the page as shown in FIG. In the aortic arch, it corresponds to the minor side.
（定義７）「長手Ｌ方向」とは、図１に示すようにステントの長尺方向を意味する。
（定義８）「円周ＣＲ方向」とは、ステントの長手Ｌ方向の中心Ｃから、「側部Ｓ側」に延びる方向を意味し、「側部Ｓ方向」ともいう。
　側部Ｓ方向は、第１側部Ｓ１側、第２側部Ｓ２側、第３側部Ｓ３側、第４側部Ｓ４側、これらの間の全ての方向を含む。
　以上の円周ＣＲ（側部Ｓ）方向の一部を、「側部の一方向」、当該「側部の一方向」と反対側を「他の側部の一方向」と記載する場合がある。
　例えば第３側部Ｓ３側を側部の一方向、反対側の第４側部Ｓ４側を他の側部の一方向と記載する場合がある。
　また各部の符号の次にＳ３等の方向を意味する符号を記載する場合がある。
例えば、４ＳＴＳ３は、第３側部側のストラット４ＳＴを意味する。 (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.
A part of the above circumferential CR (side S) direction may be described as “one side of the side” and the opposite side of the “one side of the side” as “one direction of the other side”. is there.
For example, the third side S3 side may be described as one direction of the side portion, and the opposite fourth side portion S4 side may be described as one direction of the other side portion.
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.
（定義１０）
「ストラット」とは、支柱ともいい、「環状ユニット４ 」及び「連結ユニット５」を形成する略直線状の線状またはワイヤ状の部材である。
なお、「環状ユニット４ 」を構成する略直線状の「ストラット」を「環状ユニットを構成するストラット」と言う意味で「環状ストラット４ＳＴ」といい、または単に「ストラット４ＳＴ」と記載する場合がある。
また、「連結ユニット５」を構成する部材を「連結ストラット５ＳＴ」または単に「ストラット５ＳＴ」と記載する場合がある。 (Definition 10)
The “strut” is also referred to as a support, and is a substantially linear line-shaped or wire-shaped member that forms the “annular unit 4” and the “connecting unit 5”.
Incidentally, the substantially straight “strut” constituting the “annular unit 4” may be referred to as “annular strut 4ST” in the sense of “the strut constituting the annular unit” or simply “strut 4ST”. .
In addition, members constituting the “connection unit 5” may be referred to as “connection struts 5ST” or simply “struts 5ST”.
［環状ユニット４］
　本発明のステント１は、図１に示すように、環状ユニット４を連結ユニット５で接続して構成したいわゆる略管状の形態を有する。
　例えば図１を参照すると、環状ユニット４は、以下に詳述するように略ジクザグパターンにより構成され、このジグザグパターンの折り返し点が屈曲部である。このように構成した環状ユニットは、末端ＤＥ側と、基端ＰＥ側にこのような屈曲部４Ｃを有することになるが、以下、末端ＤＥ側の屈曲部４Ｃを「山部Ｍ」、基端ＰＥ側の屈曲部４Ｃを「谷部Ｖ」と記載する。
　円周ＣＲ方向の「山部Ｍ」と「谷部Ｖ」とは、いわゆる「略直線状のストラット４ＳＴ」で接続している。 [Annular unit 4]
As shown in FIG. 1, the stent 1 of the present invention has a so-called substantially tubular form in which an annular unit 4 is connected by a connecting unit 5.
For example, referring to FIG. 1, the annular unit 4 is constituted by a substantially zigzag pattern as will be described in detail below, and the turning point of this zigzag pattern is a bent portion. The annular unit configured as described above has such 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 M”, the base end. The bent part 4C on the PE side is referred to as a “valley part V”.
The “mountain portion M” and the “valley portion V” in the circumferential CR direction are connected by a so-called “substantially linear strut 4ST”.
　山部Ｍと山部Ｍとの間、谷部Ｖと谷部Ｖとの間には、所定の空間ＳＰがある。
　環状ユニット４は、複数の略直線状のストラット４ＳＴを、円周ＣＲ方向に連続して、上記のようにいわゆる「略ジグザク状」に形成（配置）した部材である。このジクザク状の配置を「略ジグザクパターン」または「略波形状パターン」ともいう。このジクザク状のパターンにより山部Ｍと谷部Ｖが交互に形成されている。上記したように、この山部Ｍと谷部Ｖによりそれぞれ山部屈曲部Ｍ（４Ｃ）、谷部屈曲部Ｖ（４Ｃ）を形成する。（上記したように山部とは末端ＤＥ側の屈曲部であり、谷部とは基端ＰＥ側の屈曲部である。） There is a predetermined space SP between the mountain part M and the mountain part M and between the valley part V and the valley part V.
The annular unit 4 is a member in which a plurality of substantially linear struts 4ST are formed (arranged) in a so-called “substantially zigzag shape” as described above continuously in the circumferential CR direction. This zigzag arrangement is also referred to as “substantially zigzag pattern” or “substantially wave pattern”. By this zigzag pattern, peaks M and valleys V are alternately formed. As described above, the peak portion M and the valley portion V form a peak portion bent portion M (4C) and a valley portion bent portion V (4C), respectively. (As described above, the peak portion is a bent portion on the terminal DE side, and the valley portion is a bent portion on the proximal end PE side.)
　連結ユニット５は、例えば第ｎ列（４ｎ）と第ｎ+１列（４ｎ＋１）と二つの「環状ユニット４」を接続する部材である。いわゆる略直線状の複数個（通常２－４程度）（図１の例示では２個）の連結ストラット５ＳＴで構成される。
　図１においては、環状ユニット４は、第ｎ列（４ｎ）、第ｎ＋１列（４ｎ＋１）、第ｎ＋２列（４ｎ＋２）、第ｎ＋３列（４ｎ＋３）、第ｎ＋４列（４ｎ＋４）の５つのユニットから構成される。 The connecting unit 5 is a member that connects, for example, the nth row (4n), the (n + 1) th row (4n + 1), and the two “annular units 4”. A plurality of so-called substantially straight (usually about 2-4) (two in the illustration of FIG. 1) connecting struts 5ST are included.
In FIG. 1, the annular unit 4 includes five units of an nth column (4n), an n + 1th column (4n + 1), an n + 2 column (4n + 2), an n + 3 column (4n + 3), and an n + 4 column (4n + 4). Is done.
［フック６等］
　ステント１は、図１－３に示したように、ステント１の末端側の環状ユニット４ＤＥの末端ＤＥ側で、円周ＣＲ（側部Ｓ）方向の一端部にフック６を、配置していることが好ましい。
　フック６は、基端ＰＥ側を、第３側部Ｓ３から所定の角度（各ステント骨格のスペックにより変動する）で、第１側部Ｓ１／紙面の左側にずらして配置している。フック６は、これを留置位置に導く先端チップに係止させて、ステントまたはステントグラフトを留置位置に牽引する部位である。
フック６やグラフトＧＦの開口の配置位置を確認しやすいように、好ましくは造影マーカーＭＫを、山部Ｍと谷部Ｖの所定の位置に配置している。（特許第４２９８２４４号参照）
　また血管壁に対する密着性を向上させるためフィンＦＮ（延出部材ともいう）を、末端側環状ユニット４ＤＥの谷部Ｖに装着し、隣りの基端部ＰＥ側の環状ユニット４ｎ＋１方向に、長手Ｌ方向に沿って延設していることも好ましい態様である。（特開２００８－９９９９５、国際公開ＷＯ２００９－１１８９１２参照） [Hook 6 etc.]
As shown in FIG. 1-3, the stent 1 has a hook 6 disposed at one end in the circumferential CR (side S) direction on the terminal DE side of the annular unit 4DE on the terminal side of the stent 1. It is preferable.
The hook 6 is arranged by shifting the proximal end PE side from the third side portion S3 to the left side of the first side portion S1 / paper surface at a predetermined angle (varies depending on the specifications of each stent skeleton). The hook 6 is a portion that locks the tip 6 to the indwelling position and pulls the stent or the stent graft to the indwelling position.
The contrast marker MK is preferably arranged at a predetermined position of the peak portion M and the valley portion V so that the position of the opening of the hook 6 or 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 is also a preferable aspect that it extends along the direction. (See JP 2008-99995, International Publication WO 2009-118912)
［末端ＤＥ側の環状ユニット４ＤＥのストラット４ＳＴ（傾斜カット構造）］
　本発明１において特徴的なことは、図２及び図３（ステント１の末端側環状ユニット４ＤＥ近傍の一部拡大図、組立時／患部留置時において、末端環状ユニット４ＤＥを円周ＣＲ方向に偏角τ＝３６０°展開した展開図である。）に示すように、ストラット４ＳＴの長さに傾斜をつけていることである。すなわち、側部Ｓの一方向（第３側部Ｓ３）（定義５より、大湾側に相当する）の（通常の長さの）ストラット４ＳＴＳ３に対して、（円周ＣＲ方向にτ＝１８０°回転した）他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）（定義６より、小湾側に相当する）のストラット４ＳＴＳ４は、長さ４ＳＴＬを短く形成していることである（以下に説明するように、これを「傾斜カット構造」または単に「傾斜構造」と称する。）。この点、従来のステントにおいては、４ＤＥのストラット４ＳＴがすべて同一の長さのものとして構成されているものであった点において本発明とは非常に異なる。 [Strut 4ST (inclined cut structure) of the annular unit 4DE on the terminal DE side]
2 and 3 (partially enlarged view of the vicinity of the distal-side annular unit 4DE of the stent 1, and the distal annular unit 4DE is displaced in the circumferential CR direction during assembly / affected site placement. As shown in the developed view of the angle τ = 360 °, the length of the strut 4ST is inclined. That is, with respect to the strut 4STS3 (ordinary length) in one direction (third side S3) of the side S (corresponding to the large bay side by definition 5), τ = 180 in the circumferential CR direction. The strut 4STS4 in one direction of the other side S (rotated) (the fourth side S4 / the leftmost side and the rightmost side of the paper) (corresponding to the small bay side by definition 6) has a short length 4STL. (As described below, this is referred to as an “inclined cut structure” or simply an “inclined structure”). In this regard, the conventional stent is very different from the present invention in that all the 4DE struts 4ST are configured to have the same length.
　この点についてさらに詳細に説明する。
　本発明において「ストラット４ＳＴの長さ」（＝４ＳＴＬ）とは、その山部Ｍから谷部Ｖまでのストラットに沿って測定した物理的長さをＹとすると、そのＹの長手方向（Ｌ）成分Ｙ（Ｌ）を意味する。すなわち、４ＳＴＬは、図２に示すように、ストラット４ＳＴの山部Ｍから谷部Ｖまでの長手Ｌ（末端ＤＥ－基端ＰＥ）方向距離と定義する。 This point will be described in more detail.
In the present invention, “the length of the strut 4ST” (= 4STL) means that the physical length measured along the strut from the peak M to the valley V is Y, and the longitudinal direction (L) of the Y Means component Y (L). That is, 4STL is defined as the distance in the longitudinal L (terminal DE-base PE) direction from the peak M to the valley V of the strut 4ST, as shown in FIG.
　側部Ｓの一方向（第３側部Ｓ３）（大湾側に相当する）のストラット４ＳＴＳ３の長さ４ＳＴＬ（４ＳＴＬＬ／最大の長さ）を１００とすると、（円周ＣＲ方向にτ＝１８０°回転した）他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）（小湾側に相当する）のストラット４ＳＴＳ４の長さ４ＳＴＬ（４ＳＴＬＳ／最小の長さ）は、図２では略８０、図３では略５３に形成した例を示している。
（後記するように、傾斜カット率φをφ＝［（４ＳＴＬＳ／４ＳＴＬＬ）×１００％］で定義すると、傾斜カット率φ＝８０％（図２）、φ＝５３（図３）となる。） When the length 4STL (4STLL / maximum length) of the strut 4STS3 in one direction (third side S3) (corresponding to the large bay side) of the side S is 100, (τ = 180 in the circumferential CR direction) Strut 4STS4 length 4STL (4STLS / minimum length) in one direction of the other side S (rotated) (fourth side S4 / leftmost and rightmost on the paper surface) (corresponding to the small bay side) FIG. 2 shows an example of forming approximately 80 and FIG. 3 approximately 53.
(As will be described later, when the slope cut rate φ is defined as φ = [(4STLS / 4STLL) × 100%], the slope cut rate φ = 80% (FIG. 2) and φ = 53 (FIG. 3).
　なお図２及び図３では、各ストラット４ＳＴの長さ４ＳＴＬの寸法を例示するため、最大の長さ４ＳＴＬＬの具体的な寸法の一例を記載した。またさらに、最小の長さ４ＳＴＬＳ、中間の長さ４ＳＴＬＭの長さの具体的な寸法を理解しやすくするために、図２－３の展開図において、これらに対応する末端側環状ユニット４ＤＥの（最大の長さ４ＳＴＬＬの複数の山部Ｍを結んだ）末端ＤＥ側の延長線ＤＥＬまでの寸法を記載している。（なお、ＤＥＬは、当該末端側環状部材（４ＤＥ）の４ＳＴＬＬに対応する端部を形成する端面の延長線でもある。） 2 and 3, an example of specific dimensions of the maximum length 4STLL is shown in order to illustrate the dimension of the length 4STL of each strut 4ST. Furthermore, in order to make it easier to understand the specific dimensions of the minimum length 4STLS and the intermediate length 4STLM, in the development view of FIG. The dimensions up to the extension line DEL on the terminal DE side (which connects a plurality of peaks M having a maximum length of 4STLL) are shown. (Note that DEL is also an extension of the end surface that forms the end corresponding to 4STLL of the terminal-side annular member (4DE).)
　図２及び図３は、側部Ｓの一方向（第３側部Ｓ３）近傍の複数のストラット４ＳＴＳ３の長さ４ＳＴＬ（４ＳＴＬＬ）に対して、（円周ＣＲ方向に偏角τ＝９０°回転した）途中の側部Ｓの一方向（第１側部Ｓ１／紙面の左側、第２側部Ｓ２／紙面の右側）の各ストラット４ＳＴの長さ４ＳＴＬ（４ＳＴＬＭ／中間の長さ）を短くし、さらに（円周ＣＲ方向にτ＝１８０°回転した）他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）のストラット４ＳＴＳ４の長さ４ＳＴＬ（４ＳＴＬＳ）を最も短く形成している。
　側部Ｓの一方向（第３側部Ｓ３）のストラット４ＳＴＳ３の長さ（最大長さ）４ＳＴＬを１００とすると、（円周ＣＲ方向にτ＝９０°回転した）途中の側部Ｓの一方向（第１側部Ｓ１／紙面の左側、第２側部Ｓ２／紙面の右側）の各ストラット４ＳＴの長さ４ＳＴＬ（４ＳＴＬＭ）は、図２では略９０（φ＝９０％）、図３では、略８５（φ＝８５％）、略７０（φ＝７０％）に形成した例を示している。 FIGS. 2 and 3 show that the length 4STL (4STLL) of the plurality of struts 4STS3 in the vicinity of one direction (third side portion S3) of the side portion S (rotation angle τ = 90 ° in the circumferential CR direction). Shorten the length 4STL (4STLM / intermediate length) of each strut 4ST in one direction (first side S1 / left side of paper, second side S2 / right side of paper) in the middle side S Further, the length 4STL (4STLS) of the strut 4STS4 in one direction (the fourth side portion S4 / the leftmost side and the rightmost side of the paper) of the other side portion S (rotated by τ = 180 ° in the circumferential CR direction) is the largest. It is short.
When the length (maximum length) 4STL of the strut 4STS3 in one direction (third side portion S3) of the side portion S is 100, the side portion S of the middle portion (rotated by τ = 90 ° in the circumferential CR direction) The length 4STL (4STLM) of each strut 4ST in the direction (first side portion S1 / left side of the paper surface, second side portion S2 / right side of the paper surface) is approximately 90 (φ = 90%) in FIG. 2, and in FIG. , Approximately 85 (φ = 85%), approximately 70 (φ = 70%).
　ストラット４ＳＴの長さ４ＳＴＬを、側部Ｓの一方向（第３側部Ｓ３）から（円周ＣＲ方向に偏角τ＝１８０°回転した）他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）へ向けて、図２では、１００、９２（φ＝９２％）、８０（φ＝８０％）、図３では、１００、８４（φ＝８４％）、６９（φ＝６９％）、５３（φ＝５３％）のように、順次、段階的に短くした例を示している。
　言い換えれば、ストラット４ＳＴを、側部Ｓの一方向（第３側部Ｓ３）（大湾側）から「τ＝１８０°回転させた」他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）（小湾側）へ向けて、傾斜するようにカットしている、いわゆる傾斜カット構造を有する。 The length 4STL of the strut 4ST is changed from one direction (third side portion S3) of the side portion S to one direction (fourth side portion rotated by a declination τ = 180 ° in the circumferential CR direction). S4 / to the leftmost side and the rightmost side of the paper surface, in FIG. 2, 100, 92 (φ = 92%), 80 (φ = 80%), in FIG. 3, 100, 84 (φ = 84%), In this example, the length is shortened step by step like 69 (φ = 69%) and 53 (φ = 53%).
In other words, the strut 4ST is moved from one direction (third side S3) (large bay side) of the side S to one direction (fourth side S4 / It has a so-called inclined cut structure that is cut so as to incline toward the leftmost side and the rightmost side (small bay side).
　本発明において、ステントをこのように傾斜カット構造とする基本的な理由は、ステントの一側部Ｓ３は、距離は長いものの湾曲度は緩い大湾部に接する部分であり、一方、これから偏角τ＝１８０°回転した側にある他の側部Ｓ４は、短い距離であるが曲がりが急峻な小湾部に接する部分であることを考慮し、この大湾部については、十分長いステントにより密接な接触を長い距離保持し、一方、小湾部については、短い長さのステントにより短い部分であるが急峻な曲がりに対処して密接することが必須である。このため、両者を傾斜カット構造とすることにより大湾から急峻な曲がりを含む小湾への密接を保持しつつ、両者をなめらかに接続するようにしたものである。 In the present invention, the basic reason why the stent has such an inclined cut structure is that the one side portion S3 of the stent is a portion that is in contact with the large bay portion having a long distance but a low degree of curvature. In consideration of the fact that the other side S4 on the side rotated by τ = 180 ° is a portion that is in contact with a small bay portion that is a short distance but sharply bent, this large bay portion is closer to a sufficiently long stent. It is essential that the small bays be kept in close contact with long distances, while the small bays are short with a short length of stent, but with a sharp bend. For this reason, both of them are connected to each other smoothly while maintaining close contact from a large bay to a small bay including a steep bend by adopting an inclined cut structure.
　側部Ｓの一方向（第３側部Ｓ３）のストラット４ＳＴＳ３に対する、他の側部Ｓの一方向（第４側部Ｓ４／紙面の最左側と最右側）のストラット４ＳＴＳ４の傾斜カット率φ［＝（４ＳＴＬＳ／４ＳＴＬＬ）×１００％］は、上記したように図２ではφ＝略８０％、図３ではφ＝略５３％となる。 The inclination cut rate φ [of the strut 4STS4 in one direction of the other side S (the fourth side S4 / the leftmost side and the rightmost side of the paper) with respect to the strut 4STS3 in the one direction (third side S3) of the side S. = (4STLS / 4STLL) × 100%], as described above, φ = approximately 80% in FIG. 2, and φ = approximately 53% in FIG.
 [ステントグラフトの構成]
　本発明においては、以上のように形成したステント１の外周（末端ＤＥ側と基端ＰＥ側の開口部を除く。開口部はステントを図のように血管内に留置したとき血流の入り口、出口を形成する。）を、合成樹脂製管状部材（グラフトＧＦ）で被覆して、ステントグラフフト１ＳＧとする。（図４参照）
　末端側環状ユニット４ＤＥは、前記傾斜カット構造［側部Ｓの一方向（第３側部Ｓ３）近傍から（偏角τ＝１８０°回転した方向にある）他の側部Ｓの一方向（第４側部Ｓ４）に向けて傾斜している。］にあわせて、グラフトＧＦで被覆される。すなわち、図４のように、グラフトも当該ステントの傾斜構造に対応した傾斜構造となる。 [Configuration of stent graft]
In the present invention, the outer periphery of the stent 1 formed as described above (excluding the openings on the terminal DE side and the base PE side). The opening is an inlet for blood flow when the stent is placed in a blood vessel as shown in the figure. Is formed with a synthetic resin tubular member (graft GF) to form a stent graph 1SG. (See Figure 4)
The terminal-side annular unit 4DE has the inclined cut structure [from one side (third side S3) in the vicinity of the side S (in the direction rotated by declination τ = 180 °) in one direction (first Inclined toward the four side portions S4). ] And is coated with graft GF. That is, as shown in FIG. 4, the graft also has an inclined structure corresponding to the inclined structure of the stent.
［効果］
　本発明のステント１は、上記したように、末端側環状ユニット４ＤＥの末端ＤＥ側が前記のように傾斜カット構造で、かつ第４側部Ｓ４（小弯側）のストラット４ＳＴの長さ４ＳＴ（４ＳＴＬＳ）を最小に形成しているので、図４に示すように大動脈弓に留置する際に、小弯側で密着しやすくなる。これにより、図７の従来のステントのように、ステント１と小弯側との間に形成されていた隙間（バードビーク）ＳＢＶがなくなり、下流側からの血流をステント１の内部に速やかに、流通させることができる。このため、従来のようにＳＢＶに血流が入り込んでステントグラフトの移動や疲労及び内部漏れ等の不具合を引き起こすことがない。 [effect]
As described above, in the stent 1 of the present invention, the end DE side of the end-side annular unit 4DE has the inclined cut structure as described above, and the length 4ST (4STLS) of the strut 4ST on the fourth side portion S4 (small heel side). ) Is formed to a minimum, and when placed in the aortic arch as shown in FIG. Thereby, like the conventional stent of FIG. 7, there is no gap (bird beak) SBV formed between the stent 1 and the eyelid side, and the blood flow from the downstream side is promptly introduced into the stent 1. It can be distributed. For this reason, the blood flow does not enter into the SBV as in the conventional case and causes problems such as movement of the stent graft, fatigue, and internal leakage.
　本発明においてステント１は、上記のように、末端側環状ユニット４ＤＥにおいては、そのストラット４ＳＴの長さ４ＳＴＬは、最大の長さ４ＳＴＬＬ、最小の長さ４ＳＴＬＳ、これらの中間の長さ４ＳＴＬＭを有する。
側部Ｓの一方向（第３側部Ｓ３）から（τ＝１８０°回転した）他の側部Ｓの一方向（第４側部Ｓ４）に向けて、４ＳＴＬＬ＞４ＳＴＬＭ＞４ＳＴＬＳである傾斜カット構造を形成している。
　傾斜カット率φ［＝（４ＳＴＬＳ／４ＳＴＬＬ）×１００％］は、φ＝３０％から９０％、好ましくはφ＝４０％から８５％、より好ましくはφ＝５０％から８０％に形成する。
　傾斜カット率φが例えば９０％を越えるようなあまり大きい値の場合は、上記した理由により小湾側に密接すべきストラットの長さが大湾岸のストラットの長さとほとんど変わらないので、急峻に屈曲した血管では小弯側で密着しにくく 、一方、φが３０未満のようにあまり小さい場合は、ストラット４ＳＴが小さすぎて、小さい長さのストラットのみとなり、この部分は十分な環状体を形成できないのでステント１（の末端側環状ユニット）をグラフトＧＦで被覆するのが困難となる。 In the present invention, the stent 1 has the maximum length 4STLL, the minimum length 4STLS, and the intermediate length 4STLM, as described above, in the end-side annular unit 4DE. .
Inclination cut with 4STLL>4STLM> 4STLS from one direction of the side portion S (third side portion S3) toward one direction of the other side portion S (rotated by τ = 180 °) (fourth side portion S4) Forming a structure.
The slope cut rate φ [= (4STLS / 4STLL) × 100%] is formed so that φ = 30% to 90%, preferably φ = 40% to 85%, and more preferably φ = 50% to 80%.
If the slope cut rate φ is too large, for example, exceeding 90%, the strut length that should be in close contact with the small bay side is almost the same as the strut length on the large bay for the reasons described above. However, when φ is too small, such as less than 30, the strut 4ST is too small to have only a small length strut, and this portion cannot form a sufficient annular body. Therefore, it becomes difficult to coat the stent 1 (the end-side annular unit) with the graft GF.
［傾斜角度θ］
　本発明において、また傾斜角度θを、つぎのように定義する。すなわち、末端側環状ユニット４ＤＥの山部Ｍを結んだ末端ＤＥ側の延長線ＤＥＬと、最大の長さ４ＳＴＬＬの頂点（山部Ｍ）と、最小の長さ４ＳＴＬＳの頂点（山部Ｍ）を結んだ延長線ＭＬＳ（又は「傾斜線」という。）の交わる角度θで定義する。（又は、ＭＬＳと、高さ一定の４ＳＴＬＬの複数の頂点（山部）を結んだ線（ライン）（基準線ＧＬ（（Ground line）という。））の交わる角度θで定義する。）
　傾斜角度θは、θ＝５°～３０°、好ましくはθ＝８°～２０°より好ましくはθ＝１０°～１５°に形成する。
　傾斜角度θが例えば５°未満のようなあまり小さい場合は、急峻に屈曲した血管では小弯側で密着しにくく 、一方θが例えば３０°を越えるようなあまり大きい場合は、小湾側近くのストラット４ＳＴ（特に４ＳＴＬＳ）が小さすぎて、ステント１をグラフトＧＦで被覆するのが困難となる。 [Inclination angle θ]
In the present invention, the inclination angle θ is defined as follows. That is, an extension line DEL on the terminal DE side connecting the peak part M of the terminal-side annular unit 4DE, a vertex with the maximum length 4STLL (peak part M), and a vertex with the minimum length 4STLS (peak part M) It is defined by an angle θ at which the connected extension line MLS (or “inclined line”) intersects. (Alternatively, it is defined by the angle θ at which the line (line) connecting the MLS and a plurality of 4STLL vertices (mountains) having a constant height (reference line GL (referred to as (Ground line))) intersects.)
The inclination angle θ is formed such that θ = 5 ° to 30 °, preferably θ = 8 ° to 20 °, more preferably θ = 10 ° to 15 °.
When the inclination angle θ is too small, for example, less than 5 °, it is difficult for the blood vessel bent sharply to adhere to the side of the eyelid, while when θ is too large, for example, to exceed 30 °, Since the strut 4ST (particularly 4STLS) is too small, it is difficult to coat the stent 1 with the graft GF.
［その他のステントグラフト（Type(II）のステント及びステントグラフト］
　つぎに発明２について説明する。
　発明２は、発明１と本質的に同じ技術思想に基づくもので、発明１と同様の効果（ステントグラフトを小湾の急峻部に密着させる）を、ステントを被覆するグラフト側の構成（傾斜カット構造）により実現しようとするものである。すなわち、末端ＤＥの環状部材（環状ユニット）を構成するストラットはすべて標準の長さ（＝４ＳＴＬ）とし、この大湾側の領域（ＬＬ）は端部まで当該環状被覆部材であるグラフトで被覆されるが、一方、小湾側の領域（ＳＳ）においてはグラフト自身を傾斜構造とするものである。この点については、後記する段落［００４２］以下においてさらに具体的に説明する。 [Other stent grafts (Type (II) stents and stent grafts)]
Next, Invention 2 will be described.
Invention 2 is based on essentially the same technical idea as that of Invention 1, and has the same effect as that of Invention 1 (the stent graft is brought into close contact with the steep portion of the small bay). ). That is, all the struts constituting the annular member (annular unit) of the terminal DE have a standard length (= 4 STL), and this large bay side region (LL) is covered with the graft which is the annular covering member to the end. On the other hand, in the region (SS) on the small bay side, the graft itself has an inclined structure. This point will be described in more detail below in paragraph [0042] below.
　図５は本発明２に係るその他のステントグラフト１１ＳＧ（ステント１１）の例で、ステント１１は図１のステント１と比較して、（ｉ）末端環状部材４ＤＥのストラットＳＴの長さは、全て実質的に均一であるが、（ｉｉ）その代わり、合成樹脂製環状部材であるグラフトＧＦ、すなわちステント１１を覆うグラフトＧＦについては末端ＤＥ側を、ステント１の末端ＤＥ側環状ユニット４ＤＥと同様の傾斜カット構造としている点及び、（ｉｉｉ）ステント１１の末端ＤＥ側環状ユニット４ＤＥの一部は末端ＤＥ側及び第４側部Ｓ４側（小湾側）で図６に示したように露出している点で異なる。なお図５は図１で記載したマーカーＭＫ、フィンＦＮの記載は省略しているが当然これらの技術はステントグラフト１１にも適用される。 FIG. 5 is an example of another stent graft 11SG (stent 11) according to the present invention 2. Compared with the stent 1 of FIG. 1, the stent 11 is substantially the same as (i) the length of the strut ST of the end annular member 4DE. (Ii) Instead, the graft GF, which is a synthetic resin annular member, that is, the graft GF covering the stent 11, has the same inclination as the terminal DE side annular unit 4 DE of the stent 1. (Iii) A part of the terminal DE side annular unit 4DE of the stent 11 is exposed on the terminal DE side and the fourth side S4 side (small bay side) as shown in FIG. It is different in point. In FIG. 5, the markers MK and fins FN described in FIG. 1 are omitted, but these techniques are naturally applied to the stent graft 11 as well.
　ステント１１は、（ステント側ではなく）グラフトＧＦ側の末端ＤＥ側が前記のように傾斜構造で、かつ第４側部Ｓ４（小弯側）の長さが（最も）短くなっているように構成したもので、ステントグラフト１１ＳＧは、本出願人が提案した従来のステントグラフト１０１ＳＧと同様に、ステント１１（末端側環状ユニット１４ＤＥ）と小弯側との間に隙間ＳＢＶは一応残るが、図６に示したように、傾斜構造としたグラフトＧＦが小湾の急峻な壁面と密着するので、当該部分のグラフトＧＦとの間には、実質的な隙間ＳＢＶが形成されない。したがって、上行する血流が、図７（Ｂ）に示すようにステントグラフトの末端ＤＥ側を押し上げ、ステントグラフトの移動等を引き起こすことはない。
　このため本発明のステントグラフトを大動脈弓に留置する際に、グラフトＧＦが小弯側で、図６に示すように密着しやすくなる。 The stent 11 is configured such that the terminal DE side of the graft GF side (not the stent side) has an inclined structure as described above, and the length of the fourth side portion S4 (small heel side) is (shortest). In the stent graft 11SG, as in the conventional stent graft 101SG proposed by the present applicant, the gap SBV remains between the stent 11 (terminal-side annular unit 14DE) and the eyelid side. As described above, since the graft GF having the inclined structure is in close contact with the steep wall surface of the small bay, no substantial gap SBV is formed between the graft GF in the portion. Therefore, the ascending blood flow does not push up the terminal DE side of the stent graft as shown in FIG. 7B and cause the stent graft to move.
For this reason, when the stent graft of the present invention is placed in the aortic arch, the graft GF is easily adhered on the small heel side as shown in FIG.
　末端側環状ユニット１４ＤＥの各ストラット１４ＳＴの間には、図１で示したような広いスペースＳＰがあるので、下流側からの血流Ｆは、一部（上方部）露出した末端ＤＥ側環状ユニット１４ＤＥを通って、ステント１１の内部に速やかに、流通させることができる。
　なお特許文献４のステントグラフトは、すべて同じ長さのストラットからなり一応この同一長さのストラットにより末端ＤＥ側の端面のすべてを見かけ上「傾斜構造」としているが、小弯側において、（大弯側のストラットと同じ長さ）ストラットをグラフトで全て覆っているので、当該グラフトは小弯側でも、全面がくまなく当該（長い）ストラットで支持（補強）されているため、急峻に屈曲した血管の場合、小弯側に沿って屈曲しにくく、密着しにくい。 Since there is a wide space SP as shown in FIG. 1 between the struts 14ST of the terminal-side annular unit 14DE, the blood flow F from the downstream side is partially (upper part) exposed. 14DE can be quickly circulated into the stent 11 through the 14DE.
The stent graft of Patent Document 4 is composed of all struts having the same length, and the end surface on the terminal DE side is apparently “inclined structure” by the struts having the same length. Since the struts are all covered with the graft (the same length as the struts on the side), the graft is supported (reinforced) by the (long) struts all over the entire surface, even on the side of the heel. In this case, it is difficult to bend along the gavel side and it is difficult to adhere.
　より詳しくは、末端側の環状ユニットについては、あくまで大湾側では、標準長さのストラットにより形成された比較的長く曲がりの緩やかな面に密接せしめ、一方、距離が短いが曲がりの急峻な小湾側についはストラットの長さを小湾側に向かって徐々に短くすることにより始めて十分な屈曲性、密着性が得られるのである。本発明者の見いだしたところによると、曲がりは緩やかだが距離が長い大湾部と距離は短いが急峻な曲がりの小湾部を同一の長さのストラットで的確に対応することは困難であり、大動脈弓を、図５に示すように大湾側の領域ＬＬと小湾側の領域ＳＳとに分けてそれぞれの領域に適合する異なったストラットを使用することにより始めて本発明の目的を達成することができる。 More specifically, for the annular unit on the end side, on the large bay side, it is in close contact with a relatively long and gently curved surface formed by standard length struts, while the distance is short but the curve is steep and small. On the bay side, sufficient flexibility and adhesion can be obtained only by gradually shortening the strut length toward the small bay side. According to the finding of the present inventor, it is difficult to accurately cope with a large bay portion with a gentle bend but a long distance and a small bay portion with a short but steep bend with the same length of strut, To achieve the object of the present invention, the aortic arch is divided into a large bay side region LL and a small bay side region SS as shown in FIG. 5 and different struts adapted to the respective regions are used. Can do.
　発明２にかかるステントグラフト１１ＳＧは、図５に示すように、末端ＤＥ側のグラフトＧＦの長さＧＦＬとして、最大の長さＧＦＬＬ、最小の長さＧＦＬＳ、これらの中間の長さＧＦＬＭを有する。
　ステントグラフトの長さＧＦＬは、図５に示したごとく末端側環状ユニット１４ＤＥの長手Ｌ方向（末端ＤＥ－基端ＰＥ方向）の谷部Ｖから山部Ｍに向かってステントを覆っている部分までのグラフトＧＦの距離と定義する。
（図５に示したように、大湾側に留置する部分においては、ステントグラフト１１ＳＧのグラフトＧＦは、谷部Ｖから山部Ｍまで達して（すなわち当該ストラット１４ＳＴのすべてを覆って）いるが、小湾側に向かって、グラフトＧＦがストラット１４ＳＴを覆う部分は徐々に少なくなる。すなわち、ストラット１４ＳＴを覆う部分は、ＧＦＬＬ→ＧＦＬＭ→ＧＦＬＳの順に減少する。すなわちある傾斜をもって減少する（この傾斜線をＧＦＣで表す。）。） The stent graft 11SG according to the invention 2 has a maximum length GFLL, a minimum length GFLS, and an intermediate length GFLM as the length GFL of the graft GF on the terminal DE side, as shown in FIG.
As shown in FIG. 5, the length GFL of the stent graft is from the valley V in the longitudinal L direction (terminal DE-proximal PE direction) of the distal annular unit 14DE to the portion covering the stent toward the peak M. It is defined as the distance of graft GF.
(As shown in FIG. 5, the graft GF of the stent graft 11SG reaches from the valley portion V to the mountain portion M (that is, covers all of the struts 14ST) in the portion placed on the large bay side, The portion where the graft GF covers the strut 14ST gradually decreases toward the small bay side, that is, the portion covering the strut 14ST decreases in the order of GFLL → GFLM → GFLS, that is, decreases with a certain slope (this slope line). Is represented by GFC.).)
　このように発明２においては、側部Ｓの一方向（第３側部Ｓ３）（大湾側）からτ＝１８０°回転した他の側部Ｓの一方向（第４側部Ｓ４）（小湾側）に向けて、ＧＦＬＬ＞ＧＦＬＭ＞ＧＦＬＳとなるように、すでに述べた発明１におけるステントの傾斜カット構造と同様な、傾斜カット構造となるようにグラフトＧＦを形成している。
　傾斜カット率φ´［＝（ＧＦＬＳ／ＧＦＬＬ）×１００％］は、φ´＝３０％から９０％、好ましくはφ´＝４０％から８５％、５０％から８０％に形成する。
φ´が例えば９０を越えるようにあまり大きいと、急峻に屈曲した血管では小弯側で密着しにくく 、一方、φ´が例えば３０未満のようなあまり小さい値では、グラフトＧＦがあまり小さくなりすぎて、ステント１をグラフトＧＦで被覆するのが困難となる。 Thus, in invention 2, in one direction (fourth side portion S4) of the other side portion S rotated by τ = 180 ° from one direction (third side portion S3) (large bay side) of the side portion S (small) Toward the bay side, the graft GF is formed so as to have an inclined cut structure similar to the inclined cut structure of the stent in the first aspect of the invention described above so that GFLL>GFLM> GFLS.
The inclination cut rate φ ′ [= (GFLS / GFLL) × 100%] is formed so that φ ′ = 30% to 90%, preferably φ ′ = 40% to 85%, and 50% to 80%.
For example, if φ ′ is too large, for example, more than 90, it is difficult to make close contact with a sharply bent blood vessel, while if φ ′ is too small, for example, less than 30, graft GF is too small. Thus, it becomes difficult to coat the stent 1 with the graft GF.
［傾斜角度θ´］
　また傾斜角度θを、末端側環状ユニット１４ＤＥの山部Ｍを結んだ末端ＤＥ側の延長線ＤＥＬと、末端側環状ユニット１４ＤＥのグラフトＧＦのカット開始位置（ＧＦＬＬ）と、カット終了位置（ＧＦＬＳ）（ストラット１４ＳＴの末端ＤＥ側で、かつ小弯側）を結んだ延長線ＧＦＣの交わる角度θ´で定義する。
　傾斜角度θ´は、θ´＝５°～３０°、好ましくはθ´＝８°～２０°、より好ましくはθ´＝１０°～１５°に形成する。
　この傾斜角度θ´が例えば５°未満のようにあまり小さいと、急峻に屈曲した血管では小弯側で密着しにくく 、一方θ´が例えば３０°を越えるようなあまり大きい値の場合は、カット終了位置におけるグラフトの長さＧＦＬＳが小さすぎて、ステント１１の末端側環状ユニットの小湾側のストラット１４ＳＴをグラフトＧＦで被覆して、当該被覆し部分を小湾側に密着させるのが困難となる。 [Inclination angle θ ′]
Further, the inclination angle θ is defined by the extension line DEL on the terminal DE side connecting the peak M of the terminal-side annular unit 14DE, the cut start position (GFLL) of the graft GF of the terminal-side annular unit 14DE, and the cut end position (GFLS). It is defined by an angle θ ′ at which the extension line GFC connecting the strut 14ST (on the terminal DE side and the small rod side) intersects.
The inclination angle θ ′ is formed so that θ ′ = 5 ° to 30 °, preferably θ ′ = 8 ° to 20 °, more preferably θ ′ = 10 ° to 15 °.
If the inclination angle θ ′ is too small, for example, less than 5 °, the sharply bent blood vessel is difficult to adhere on the side of the eyelid, while if θ ′ is too large, for example, to exceed 30 °, the cut The length GFLS of the graft at the end position is too small, and it is difficult to coat the strut 14ST on the small bay side of the terminal-side annular unit of the stent 11 with the graft GF, and to close the covered portion to the small bay side. Become.
［ステント１、１１の材質（金属材料）］
　本発明のステント１、１１を構成する環状ストラット４ＳＴ、環状ユニット４、連結ストラット５ＳＴ、連結ユニット５、フック６、１６、フィンＦＮを形成する材質は特限定するものでなく、例えばＳＵＳ３１６Ｌ等のステンレス鋼；Ｔｉ－Ｎｉ合金等の超弾性合金；チタン系合金、Ｃｏ－Ｃｒ系合金；Ｔａ、Ｔｉ、Ｗ、Ａｕ等の金属ワイヤにより形成することが好ましい。またこれらの金属より形成されたステントに常用されるウレタン等の高分子材料やヘパリン、ウロキナーゼ等の生理活性物質、アルガトロバン等の抗血栓薬剤の薄膜により、ステント（環状ユニット、ストラット、連結ストラット、フック）の表面を被覆するのも、当該ステントの表面に血栓が生成するのを防止する機能を付与できるので好ましい。 [Material of stents 1 and 11 (metal material)]
The material forming the annular strut 4ST, the annular unit 4, the connecting strut 5ST, the connecting unit 5, the hooks 6 and 16, and the fin FN constituting the stents 1 and 11 of the present invention is not particularly limited. For example, stainless steel such as SUS316L. Steel; Superelastic alloy such as Ti—Ni alloy; Titanium-based alloy, Co—Cr-based alloy; preferably formed of metal wire such as Ta, Ti, W, Au. Also, stents (annular units, struts, connecting struts, hooks) are made of polymer materials such as urethane, which are commonly used for stents made of these metals, and 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 the stent because it can provide a function of preventing the formation of thrombus on the surface of the stent.
［合成樹脂製管状部材（グラフト）］
　またステント１、１１は、これをそのまま使用することもできるが、通常、ステントを骨格としてその外表面を合成樹脂製環状部材であるグラフトＧＦで被覆し、人工血管として好ましく使用されるステントグラフトＳＧ（図４参照）を形成することができる。グラフトＧＦを形成する材質としては、フィルム状又は繊維状の材質が好適であり、例えば、フッ素樹脂（ＰＴＦＥ：ポリテトラフルオロエチレン、ＰＦＡ：テトラフルオロエチレン－パーフルオロアルコキシビニルエーテル共重合体）製フィルム（単層ないし二層以上積層）、ダクロンやマイラー（登録商標、ポリエチレンテレフタレート）繊維等からなる合成樹脂製管状部材が使用されるがこれに限られない。 [Synthetic resin tubular member (graft)]
Although the stents 1 and 11 can be used as they are, the stent graft SG (which is preferably used as an artificial blood vessel) is usually used by using the stent as a skeleton and covering the outer surface with a graft GF which is a synthetic resin annular member. 4) can be formed. The material for forming the graft GF is preferably a film-like or fibrous material. For example, a film made of a fluororesin (PTFE: polytetrafluoroethylene, PFA: tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer) ( A synthetic resin tubular member made of a single layer or two or more layers), Dacron, Mylar (registered trademark, polyethylene terephthalate) fiber, or the like is used, but is not limited thereto.
［ステントグラフトの構成］
　例えば、ステントグラフトの一実施例を示すと、以下のとおりである。すなわち無負荷時に直径が４０ｍｍであったステントＳＴ（図１に示したように５個の管状ユニットからなる屈曲ステントでその末端ＤＥ側環状部材を傾斜カット構造としたもの）を、３０ｍｍ（７５％）に縮径する。直径が３１ｍｍのフッ素樹脂（ＰＴＦＥ）製管状部材（グラフト）を使用し、その端部及び任意の箇所を、縫合糸でステントに縫いつけながらステントに固定・被覆しステントグラフトＳＧを形成することができる。
　このようにして形成されたステントグラフトは、骨格となる金属ワイヤからなるステント１、１１の、それ自体のばね作用、ステント先端部の傾斜カット構造、及び、これを柔軟性のある合成樹脂製管状部材（グラフト）で被覆・複合して構成されたものであるから、血管の３次元的な屈曲、特に小湾側の急峻な屈曲に対し追随できる。 [Configuration of stent graft]
For example, one embodiment of a stent graft is as follows. That is, a stent ST having a diameter of 40 mm at the time of no load (a bent stent composed of five tubular units as shown in FIG. 1 and having a terminal DE side annular member having an inclined cut structure) is 30 mm (75%). ). A tubular member (graft) made of fluororesin (PTFE) having a diameter of 31 mm is used, and an end portion and an arbitrary portion thereof are fixed and covered on the stent while being sewn to the stent with a suture, thereby forming the stent graft SG.
The stent graft thus formed includes the stents 1 and 11 made of metal wires as a skeleton, the spring action of the stent itself, the inclined cut structure at the distal end of the stent, and the flexible synthetic resin tubular member. Since it is constructed by covering and compounding with (graft), it can follow three-dimensional bending of blood vessels, particularly sharp bending on the small bay side.
　本発明のステント（ステントグラフト）は、その末端ＤＥ側を、傾斜カット構造に形成しているので、大動脈弓の急峻に屈曲した小弯側に密着しやすくバードビークの先端部において、ステント等が血管内壁から浮いた状態になることがない。
　このため本発明のステント（ステントグラフト）は、バードビークに由来する患部留置後のステントグラフトの移動、ステント疲労／破損、内部漏れ(エンドリーク)等の不具合を好適に解消することができるので、動脈の拡張性疾患（動脈瘤等）等の疾患を治療するための医療の現場において好適に使用される医療器具として、その産業上の利用可能性は極めた大きい。 In the stent (stent graft) of the present invention, the terminal DE side is formed in an inclined cut structure, so that the stent or the like is easily attached to the sharply bent small heel side of the aortic arch at the distal end of the bird beak. It will not be in a floating state.
For this reason, the stent (stent graft) of the present invention can suitably solve problems such as stent graft movement, stent fatigue / breakage, and internal leakage (endoleak) after placement of the affected part derived from bird beaks. As a medical instrument that is suitably used in the medical field for treating diseases such as sexual diseases (such as aneurysms), its industrial applicability is extremely large.
１、１１ステント
１ＳＧ、１１ＳＧ、１０１ＳＧ　ステントグラフト
４、１４　環状ユニット
４ＤＥ、１４ＤＥ　末端側環状ユニット（末端側環状部材）
４ＳＴ、１４ＳＴ　環状ストラット
４Ｃ　屈曲部
Ｍ　谷部
Ｖ　山部
５　連結部
５ＳＴ　連結ストラット
６　　フック
８　動脈瘤　
ＭＫ　マーカー
ＦＮ　フィン
θ　ステントの傾斜角度
θ’ステントグラフトの傾斜角度
φ　ステントの傾斜カット率　
φ’ステントグラフトの傾斜カット率 1,11 Stent 1SG, 11SG, 101SG Stent graft 4, 14 Annular unit 4DE, 14DE End side annular unit (terminal side annular member)
4ST, 14ST annular strut 4C bent part M valley part V mountain part 5 connecting part 5ST connecting strut 6 hook 8 aneurysm
MK marker FN Fin θ Stent tilt angle θ ′ Stent graft tilt angle φ Stent tilt cut rate
Inclined cut rate of φ 'stent graft

Claims (7)

  1. 　長手（Ｌ）方向に延びる略管状体に形成され、当該略管状体の内部より円周（ＣＲ）方向に拡張可能なステント（１）であって、
    当該略管状体は、円周（ＣＲ）方向に拡張する複数の環状ユニット（４）と、隣り合う当該環状ユニット（４）を長手（Ｌ）方向に接続する連結ユニット（５）とを有し、
    　当該略管状体は、前記隣り合う環状ユニット（４）の側部（Ｓ）方向の一端部を前記連結ユニット（５）の一端部を介して接続し、複数の環状ユニット（４）を長手（Ｌ）方向に配列してなるものであり、
    　前記環状ユニット（４）は、ストラット（４ＳＴ）を、側部（Ｓ）の一方向に複数個の山部（Ｍ）と他の側部（Ｓ）の一方向に複数個の谷部（Ｖ）を介して交互に接続することにより、円周（ＣＲ）方向に連続して略ジグザク状に形成したものであり、
    　末端側に配列された前記環状ユニット（４）を、末端側環状部材（４ＤＥ）とすると、当該末端側環状部材（４ＤＥ）を構成する、ストラット（４ＳＴ）の長さを、側部（Ｓ）の一方向から他の側部（Ｓ）の一方向に向けて、徐々に短く形成するものであって、
    　当該末端側環状部材（４ＤＥ）は、そのストラット（４ＳＴ）の長さとして、少なくとも最大の長さ（４ＳＴＬＬ）、最小の長さ（４ＳＴＬＳ）、及びこれらの中間の長さ（４ＳＴＬＭ）を有し、
    　側部（Ｓ）の一方向から他の側部（Ｓ）の一方向に向けて、当該ストラット（４ＳＴ）は、４ＳＴＬＬ＞４ＳＴＬＭ＞４ＳＴＬＳである傾斜カット構造を形成した、ことを特徴とするステント（１）。     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 has a plurality of annular units (4) that expand in the circumferential (CR) direction, and a connecting unit (5) that connects the adjacent annular units (4) in the longitudinal (L) direction. ,
    The substantially tubular body connects one end portion in the side portion (S) direction of the adjacent annular units (4) via one end portion of the connection unit (5), and the 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,
    When the annular unit (4) arranged on the terminal side is a terminal-side annular member (4DE), the length of the strut (4ST) constituting the terminal-side annular member (4DE) is set to the side (S). From one direction to the other side (S) in one direction,
    The end-side annular member (4DE) has at least a maximum length (4STLL), a minimum length (4STLS), and an intermediate length (4STLM) as the length of the strut (4ST). ,
    A stent characterized in that the strut (4ST) forms an inclined cut structure in which 4STLL>4STLM> 4STLS from one direction of the side portion (S) toward one direction of the other side portion (S). (1).
  2. 　傾斜カット率φ［（４ＳＴＬＳ／４ＳＴＬＬ）×１００％］は、３０％から９０％である、ことを特徴とする請求項１に記載のステント（１）。 The stent (1) according to claim 1, wherein the inclined cut rate φ [(4STLS / 4STLL) x 100%] is 30% to 90%.
  3. 　傾斜角度θは、５°～３０°である、ことを特徴とする請求項１または請求項２に記載のステント（１）。 The stent (1) according to claim 1 or 2, wherein the inclination angle θ is 5 ° to 30 °.
  4. 　請求項１から請求項３のいずれか１項に記載のステント（１）をグラフト（ＧＦ）で被覆した、ことを特徴とするステントグラフト（１ＳＧ）。 A stent graft (1SG), wherein the stent (1) according to any one of claims 1 to 3 is coated with a graft (GF).
  5. 　長手（Ｌ）方向に延びる略管状体に形成され、当該略管状体の内部より円周（ＣＲ）方向に拡張可能なステント（１１）をグラフト（ＧＦ）で被覆したステントグラフト（１１ＳＧ）であって、
    　当該略管状体は、円周（ＣＲ）方向に拡張する複数の環状ユニット（１４）と、隣り合う当該環状ユニット（１４）を長手（Ｌ）方向に接続する連結ユニット（１５）とを有し、
    　当該略管状体は、前記隣り合う環状ユニット（１４）の側部（Ｓ）方向の一端部を前記連結ユニット（１５）の一端部を介して接続した、複数の環状ユニット（１４）を長手（Ｌ）方向に配列してなるものであり、
    　前記環状ユニット（１４）は、ストラット（１４ＳＴ）を、側部（Ｓ）の一方向に複数個の山部（Ｍ）と他の側部（Ｓ）の一方向に複数個の谷部（Ｖ）を介して交互に接続することにより、円周（ＣＲ）方向に連続して略ジグザク状に形成したものであり、
    　前記略管状体に形成されたステント（１１）はその外周を末端ＤＥ側及び他の側部Ｓの一方向を除いて、グラフト（ＧＦ）で被覆して、ステントグラフト（１１ＳＧ）としたものであり、
    　当該ステントグラフト（１１ＳＧ）は、末端ＤＥ側のグラフト（ＧＦ）の長さ（ＧＦＬ）として、
    最大の長さＧＦＬＬ、最小の長さＧＦＬＳ、これらの中間の長さＧＦＬＭを有し、側部Ｓの一方向から他の側部Ｓの一方向に向けて、ＧＦＬＬ＞ＧＦＬＭ＞ＧＦＬＳである傾斜カット構造を形成した、ことを特徴とするステントグラフト（１１ＳＧ）。     A stent graft (11SG) formed by forming a substantially tubular body extending in a longitudinal (L) direction and covering a stent (11) expandable in a circumferential (CR) direction from the inside of the substantially tubular body with a graft (GF). ,
    The substantially tubular body has a plurality of annular units (14) that expand in the circumferential (CR) direction, and a connecting unit (15) that connects the adjacent annular units (14) in the longitudinal (L) direction. ,
    The substantially tubular body is formed by connecting a plurality of annular units (14) with one end in the side (S) direction of the adjacent annular units (14) connected through one end of the connecting unit (15) in the longitudinal direction ( L) are arranged in the direction,
    The annular unit (14) includes a strut (14ST) having a plurality of peaks (M) in one direction of the side (S) and a plurality of valleys (V) in one direction of the other side (S). ) Are alternately connected to each other to form a substantially zigzag shape continuously in the circumferential (CR) direction,
    The outer periphery of the stent (11) formed in the substantially tubular body is covered with a graft (GF) except for one direction of the terminal DE side and the other side S to form a stent graft (11SG). ,
    The stent graft (11SG) is the length (GFL) of the graft (GF) on the terminal DE side.
    Inclination having a maximum length GFLL, a minimum length GFLS, and an intermediate length GFLM from one direction of the side S toward one direction of the other side S, where GFLL>GFLM> GFLS A stent graft (11SG) characterized by forming a cut structure.
  6. 　傾斜カット率φ´［（ＧＦＬＳ／ＧＦＬＬ）×１００％］は、３０％から９０％である、請求項５に記載のステントグラフト（１１ＳＧ）。 The stent graft (11SG) according to claim 5, wherein the inclined cut rate φ '[(GFLS / GFLL) × 100%] is 30% to 90%.
  7. 　傾斜角度θ´は、５°～３０°である、ことを特徴とする請求項５または請求項６に記載のステントグラフト（１１ＳＧ）。 The stent graft (11SG) according to claim 5 or 6, wherein the inclination angle θ 'is 5 ° to 30 °.
PCT/JP2016/076923 2015-09-18 2016-09-13 Stent and stent-graft WO2017047569A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2017539905A JP6937240B2 (en) 2015-09-18 2016-09-13 Stent graft

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015184733 2015-09-18
JP2015-184733 2015-09-18

Publications (1)

Publication Number Publication Date
WO2017047569A1 true WO2017047569A1 (en) 2017-03-23

Family

ID=58288779

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2016/076923 WO2017047569A1 (en) 2015-09-18 2016-09-13 Stent and stent-graft

Country Status (2)

Country Link
JP (2) JP6937240B2 (en)
WO (1) WO2017047569A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022009924A1 (en) 2020-07-07 2022-01-13 国立大学法人広島大学 Stent graft
WO2022009923A1 (en) 2020-07-07 2022-01-13 国立大学法人広島大学 Stent graft
US11471265B2 (en) * 2017-12-27 2022-10-18 Lifetech Scientific (Shenzhen) Co. Ltd. Covered stent

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080195191A1 (en) * 2005-05-24 2008-08-14 Qiyi Luo Flexible Stent-Graft
US20100152835A1 (en) * 2008-12-17 2010-06-17 Med Institute, Inc. Tapered Stent and Flexible Prosthesis

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005099806A1 (en) * 2004-04-16 2005-10-27 Kawasumi Laboratories, Inc. Stent graft indwelling device and fixed chip
ATE533448T1 (en) * 2008-02-11 2011-12-15 Cook William Europ INTRODUCER FOR ENDOVASCULAR IMPLANTS AND STENTS
US9198787B2 (en) * 2010-12-31 2015-12-01 Cook Medical Technologies Llc Conformable prosthesis delivery system and method for deployment thereof
GB2511775A (en) * 2013-03-12 2014-09-17 Cook Medical Technologies Llc Device and Method for Treating Vascular Dissections

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080195191A1 (en) * 2005-05-24 2008-08-14 Qiyi Luo Flexible Stent-Graft
US20100152835A1 (en) * 2008-12-17 2010-06-17 Med Institute, Inc. Tapered Stent and Flexible Prosthesis

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11471265B2 (en) * 2017-12-27 2022-10-18 Lifetech Scientific (Shenzhen) Co. Ltd. Covered stent
US20230016711A1 (en) * 2017-12-27 2023-01-19 Lifetech Scientific (Shenzhen) Co., Ltd. Covered Stent
US12097110B2 (en) * 2017-12-27 2024-09-24 Lifetech Scientific (Shenzhen) Co., Ltd. Covered stent
WO2022009924A1 (en) 2020-07-07 2022-01-13 国立大学法人広島大学 Stent graft
WO2022009923A1 (en) 2020-07-07 2022-01-13 国立大学法人広島大学 Stent graft

Also Published As

Publication number Publication date
JPWO2017047569A1 (en) 2018-07-05
JP2021184831A (en) 2021-12-09
JP6937240B2 (en) 2021-09-22
JP7185739B2 (en) 2022-12-07

Similar Documents

Publication Publication Date Title
US11998463B2 (en) Endoluminal device
JP5719327B2 (en) Helical stent
US10828183B2 (en) Low profile non-symmetrical stent
JP4315806B2 (en) System for securing an intraluminal device
JP2021154134A (en) Stent member
US8663309B2 (en) Asymmetric stent apparatus and method
JP5421320B2 (en) Flexible stent graft
JP4197762B2 (en) Stents and stent grafts for treating bifurcated vessels
JP2019069290A (en) Highly flexible stent
JP6059227B2 (en) Bifurcated stent graft device and deployment
JP7185739B2 (en) stent graft
US20070219610A1 (en) Stent with flap
EP3187148B1 (en) Endograft
JP2004344489A (en) Temporary indwelling stent and stent graft
JP2012517247A (en) Stent
US10772747B2 (en) Vascular implant with asymmetrical stent springs
JP6761117B2 (en) Whole arch concept
JP2008099995A (en) Stent and stent graft
US9320628B2 (en) Endoprosthesis devices including biostable and bioabsorable regions
WO2009118912A1 (en) Stent and stent graft

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16846440

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2017539905

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16846440

Country of ref document: EP

Kind code of ref document: A1