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WO2021177303A1 - Stent graft and skeleton for stent graft - Google Patents

Stent graft and skeleton for stent graft Download PDF

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Publication number
WO2021177303A1
WO2021177303A1 PCT/JP2021/007953 JP2021007953W WO2021177303A1 WO 2021177303 A1 WO2021177303 A1 WO 2021177303A1 JP 2021007953 W JP2021007953 W JP 2021007953W WO 2021177303 A1 WO2021177303 A1 WO 2021177303A1
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WO
WIPO (PCT)
Prior art keywords
skeleton
main body
stent graft
film
body skeleton
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2021/007953
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French (fr)
Japanese (ja)
Inventor
崇志 吉森
実明 山本
弘樹 遠藤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SB Kawasumi Laboratories Inc
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Kawasumi Laboratories Inc
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 Kawasumi Laboratories Inc filed Critical Kawasumi Laboratories Inc
Priority to JP2022504398A priority Critical patent/JP7771046B2/en
Publication of WO2021177303A1 publication Critical patent/WO2021177303A1/en
Anticipated expiration legal-status Critical
Priority to JP2025186147A priority patent/JP2026009329A/en
Ceased legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts

Definitions

  • the present invention relates to a stent graft and a skeleton for a stent graft.
  • a stent graft that is placed in a stenosis or an obstruction formed in a living lumen such as a blood vessel, esophagus, bile duct, trachea, or ureter, and expands the lesion site to maintain a patency of the living lumen is known.
  • a stent graft placement for example, the groin is surgically incised to expose the blood vessel, a stent graft placement device is introduced into the blood vessel to deliver it to the lesion site, and the stent graft is released from the sheath to be brought into close contact with the blood vessel wall. It is an indwelling treatment method and has the advantage that the incision is small and the burden on the patient is small (minimally invasive).
  • the stent graft has a tip (for example, the central side) of the stent graft in order to suppress the displacement of the living lumen from the indwelling site and to perform accurate indwelling.
  • the end skeleton is arranged so as to protrude from the film.
  • wrinkles are likely to occur in the film portion to which the end skeleton is connected, and there is a possibility that the adhesion to the living lumen may be lowered.
  • some stent grafts have a skeleton sewn to the coating.
  • the number of sewn portions increases, there is a problem that the flexibility is lowered, the followability to the living lumen is lowered, and the adhesion is lowered.
  • An object of the present invention is to provide a stent graft and a skeleton for a stent graft that can improve the adhesion to a living lumen.
  • the stent graft according to the present invention A stent graft that is placed in the lumen of a living body.
  • a tubular body whose skeleton is covered with a film, and An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
  • the end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
  • the connecting portion has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.
  • the inflection point is connected to the film so that the protruding length of the end skeleton in the expanded state is shorter than the protruding length in the contracted state.
  • the stent graft according to the present invention A stent graft that is placed in the lumen of a living body. It has a tubular main body whose skeleton is covered with a film.
  • the main body skeleton has a first main body skeleton and a second main body skeleton arranged on one end side in the axial direction with respect to the first main body skeleton.
  • the second main body skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction, and is sewn to the film at a portion other than the valleys.
  • the skeleton for stent graft according to the present invention is A skeleton for stent grafts placed in the lumen of a living body.
  • the main body skeleton which is placed in a tubular body covered with a film,
  • An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
  • the end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
  • the connecting portion has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.
  • the adhesion to the living lumen can be improved.
  • FIG. 1 is a diagram showing the appearance of a stent graft.
  • FIG. 2 is a diagram schematically showing an indwelling state of the stent graft.
  • FIG. 3 is an enlarged view of the bare portion.
  • 4A and 4B are diagrams schematically showing the shape and length of the end skeleton in the expanded state and the contracted state, respectively.
  • 5A and 5B are diagrams schematically showing a fixed mode of the second main body skeleton.
  • the present embodiment as an example of the present invention, it is used when the lesion site (for example, aortic aneurysm B) of the descending aorta A (see FIG. 2) is expanded radially outward to treat an occlusion (stenosis).
  • the stent graft 1 to be formed will be described.
  • FIG. 1 is a diagram showing the appearance of the stent graft 1.
  • FIG. 2 is a diagram showing an indwelling state of the stent graft 1.
  • the stent graft 1 has a main body portion 11 and a bare portion 12 arranged at the central end of the main body portion 11. Further, the main body portion 11 has a tubular shape that defines a blood flow path, and has a straight body portion 11a and a seal portion 11b connected to a central end portion of the body portion 11a. doing.
  • the stent graft 1 is placed in the descending aorta A so that the bare portion 12 is on the upstream side (heart side) in the blood flow direction (see FIG. 2).
  • the stent graft 1 is composed of a skeleton 20 and a coating 30.
  • the skeleton 20 is a reinforcing member for maintaining the expanded state of the stent graft 1.
  • the skeleton 20 is formed so as to be self-expandable from a contracted state contracted inward to an expanded state expanded outward in a radial direction substantially orthogonal to the axial direction.
  • the skeleton 20 includes a first main body skeleton 21 arranged on the body portion 11a, a second main body skeleton 22 arranged on the seal portion 11b, and an end skeleton 23 arranged on the bare portion 12.
  • the first main body skeleton 21 and the second main body skeleton 22 are arranged on the peripheral surface of the film 30.
  • the peripheral skeleton 23 is fixed to the coating 30 on the peripheral side, and a part on the central side is exposed from the coating 30.
  • a fixing pin may be provided in the vicinity of the mountain portion 23a (bent portion on the central side) of the end skeleton 23 so as to project outward in the radial direction. As a result, the fixing pin bites into the blood vessel wall, and the displacement of the stent graft 1 can be prevented.
  • one metal wire rod is alternately provided with mountain portions 21a and 22a (bent portions on the central side) and valley portions 21b and 22b (bent portions on the peripheral side). It is composed of a spiral skeleton that is spirally wound while bending in a zigzag shape (Z shape) so as to be formed.
  • the first main body skeleton 21 and the second main body skeleton 22 are each wound in a spiral shape a plurality of times, and are arranged at predetermined intervals along their respective axial directions (extending direction of the stent graft 1).
  • the bending angles of the bending portions (mountain portions 21a, 22a and valley portions 21b, 22b) in the first main body skeleton 21 and the second main body skeleton 22 are set to be the same, and the bending portions of the sides sandwiching the bending portions are set to be the same.
  • the lengths are set differently from each other.
  • the bending angle of the bent portion and the length of the side sandwiching the bent portion are not limited to this as an example, and can be arbitrarily changed as appropriate, and the bending angle may be different.
  • the lengths of the sides may be the same.
  • ends of the metal wires constituting the first main body skeleton 21 and the second main body skeleton 22 may be sewn and fixed to the film 30, for example, or the other parts or ends of the metal wires may be sewn to each other. It may be crimped and fixed.
  • one metal wire rod is repeatedly formed in the circumferential direction with a mountain portion 23a (bent portion on the central side) and a valley portion 23b (bent portion on the peripheral side) via a connecting portion 23c. It is composed of an annulus skeleton bent in this way.
  • the end skeleton 23 may be formed of a laser-cut type annulus skeleton formed by laser processing a metal cylindrical member. Further, the end portion of the metal wire rod constituting the end skeleton 23 may be sewn to the film 30 and fixed, or may be crimped and fixed to other parts or ends of the metal wire rod. good.
  • the cross-sectional areas of the wires forming the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 may be the same or different.
  • "cross-sectional area” may be read as "wire diameter”.
  • the cross-sectional area of the first main body skeleton 21 arranged on the body portion 11a may be set smaller than the cross-sectional area of the second main body skeleton 22 arranged on the seal portion 11b.
  • the outer diameter of the main body 11 in the contracted state can be made smaller, and the storage property of the stent graft 1 in the sheath and the release property from the sheath are further improved. If the adhesion to the blood vessel wall is ensured by at least the expanding force of the seal portion 11b, the inflow (end leak) of blood from the upstream side (central side) in the blood flow direction can be prevented, so that the seal portion 11b
  • the expanding force of the body portion 11a located on the downstream side (peripheral side) in the blood flow direction may be smaller than the expanding force of the sealing portion 11b.
  • the connecting portion 23c connecting the mountain portion 23a and the valley portion 23b is not linear as shown in FIG. 3 and the like, and the protruding length of the end skeleton 23 in the expanded state (FIG. 4A). (See) has a characteristic shape that is shorter than the protruding length in the contracted state (see FIG. 4B).
  • 4A and 4B are development views showing the shape and length of the end skeleton 23, FIG. 4A shows an expanded state, and FIG. 4B shows a contracted state.
  • the connecting portion 23c has an inflection portion (a portion located near the central opening) that changes from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b.
  • "changing from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b" means that the inclination of the contact point gradually decreases and passes through an inclination of 0, as shown in FIG. 4A.
  • the entire connecting portion 23c may be an inflection point, or a part of the connecting portion 23c may be an inflection point.
  • the connecting portion 23c is bent in a substantially "S" shape as a whole together with the mountain portion 23a and the valley portion 23b, for example, and the length of the connecting portion 23c is such that the mountain portion 23a and the valley portion 23b are linear. It is longer than the length when connected.
  • the inflection point of the connecting portion 23c is sewn to the film 30 so that the protruding length in the expanded state is shorter than the protruding length in the contracted state. The explanation will be described later.
  • the second main body skeleton 22 and the end skeleton 23 are aligned on the axis of the stent graft 1. Is located in. As a result, the contractility when contracting the stent graft 1 is improved, and the storage property in the sheath and the release property from the sheath are improved.
  • Examples of the material forming the skeleton 20 include known metals or metal alloys typified by stainless steel, nickel-titanium alloy (nitinol), titanium alloy and the like. Further, an alloy material having X-ray contrast property may be used. In this case, the position of the stent graft 1 can be confirmed from outside the body.
  • the skeleton 20 may be formed of a material other than the metal material (for example, ceramic or resin).
  • the material of the wire forming the skeleton 20, the wire type (for example, a circular wire such as a wire or a square wire obtained by laser cutting), the cross-sectional area (corresponding to the wire diameter in the case of a round wire), the number of bends in the circumferential direction, and The bending shape (the number of peaks and the shape of the peaks), the wire spacing in the axial direction (the amount of skeleton per unit length), and the like can be determined, for example, to the sheath required for each stent graft 1 according to the placement site. It is selected based on storability, release from the sheath, indwellability (corresponding to expanding force), and the like.
  • the membrane 30 is a membrane that forms a blood flow path.
  • the material for forming the film 30 include a silicone resin, a fluororesin such as PTFE (polytetrafluoroethylene), and a polyester resin such as polyethylene terephthalate.
  • the film thickness of the film 30 is preferably 80 ⁇ m or less, for example.
  • the first main body skeleton 21 is arranged on the outer peripheral surface of the film 30.
  • the first main body skeleton 21 arranged on the body portion 11a, which is the main part of the stent graft 1 is buried in the blood vessel wall, and the displacement of the stent graft 1 is effectively prevented.
  • the second main body skeleton 22 is arranged on the inner peripheral surface of the film 30. As a result, the adhesion of the seal portion 11b located on the central side to the blood vessel wall is enhanced, and end leakage from the central side is suppressed.
  • the end skeleton 23 is arranged on the inner peripheral surface of the film 30 on the central side in a state where the central side is exposed.
  • the portion of the end skeleton 23 protruding from the coating 30 is used for engagement with the hook of the delivery system, for example, when the stent graft 1 is placed using the delivery system (not shown) of the tip opening mechanism.
  • the arrangement mode of the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 in the film 30 is an example and is not limited to this, and can be arbitrarily changed as appropriate.
  • the film 30 sandwiches the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 so as to sandwich the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 on the outer peripheral surface side and the inner circumference. It may be arranged on the surface side.
  • the film 30 may be arranged on the outer peripheral surface side of the first main body skeleton 21, may be arranged on the inner peripheral surface side of the second main body skeleton 22, or may be arranged on the inner peripheral surface side of the end skeleton 23. May be placed in.
  • the skeleton 20 is sewn on the outer peripheral surface of the film 30 by the suture thread 40 (for example, polyethylene thread or polyester thread).
  • the suture thread 40 for example, polyethylene thread or polyester thread.
  • the mountain portion 21a and the valley portion 21b are sewn on the film 30.
  • the mountain portion 22a is sewn to the film 30.
  • the vicinity of the valley portion 22b of the second main body skeleton 22 can freely move with respect to the coating film 30, so that the flexibility of the sealing portion 11b is improved and the followability to the living lumen is improved. be able to.
  • the end portion 22d of the second main body skeleton 22 has a portion other than the bent portion sewn to the film 30.
  • the second main body skeleton 22 only the mountain portion 22a is fixed to the film 30, and the degree of freedom for the film 30 in the portion other than the mountain portion 22a is increased.
  • the end portion 22d of the second main body skeleton 22 is firmly fixed to the coating portion 30, there is no escape for the force applied to the end portion 22d, and the degree of freedom of the entire second main body skeleton 22 with respect to the coating portion 30 is reduced. There is a risk of doing so. Therefore, in the present embodiment, the bent portion of the end portion 22d of the second main body skeleton 22 is not fixed, but is sewn and fixed at a portion other than the bent portion.
  • the tip of the second main body skeleton 22 extends toward the position where the valley 22b will exist, and the end 22b is bent toward the mountain 22a so as to have an R shape. Consists of. The vicinity of the R portion of the end portion 22b (peripheral portion of the bent portion) is sewn. As a result, it is possible to prevent the end portion 22d of the second main body skeleton 22 from sticking into the blood vessel wall, and it is possible to prevent the end portion 22d from coming off from the sutured portion. Further, as shown in FIG. 5B, the periphery of the end portion 22d of the second main body skeleton 22 may be covered with the patch 50.
  • the patch 50 is formed of, for example, the same material as the film 30, and is fixed to the film 30 by suturing. As a result, it is possible to reliably prevent the end portion 22d from coming off from the sutured portion.
  • FIGS. 5A and 5B show the end portion on the central side of the second main body skeleton 22, the same end treatment is applied to the end portion on the erasing side. Further, the same end treatment as that of the second main body skeleton 22 may be applied to the end portion of the first main body skeleton 21. Further, the patch 50 may be fixed by adhesion other than fixing by suturing. Alternatively, the patch 50 may be formed of a heat-welded film and fixed to the film 30 by heat welding.
  • the sewing mode of the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 to the film 30 is an example and is not limited to this, and can be arbitrarily changed as appropriate.
  • the connecting portion 21c connecting the mountain portion 21a and the valley portion 21b may be sewn to the film 30.
  • the second main body skeleton 22 in addition to the mountain portion 22a at least one of the valley portion 22b and the connecting portion 22c may be sewn to the film 30.
  • the inflection point of the connecting portion 23c is sewn to the film 30 so that the protruding length in the expanded state is shorter than the protruding length in the contracted state.
  • substantially the center of the inflection portion of the connecting portion 23c is sewn to the film 30, and the mountain portion 23a side of the inflection portion is freely movable with respect to the film 30.
  • the portion located at the open end of the film 30 in the expanded state protrudes from the film 30 in the contracted state (see FIG. 4B).
  • the portion protruding from the film 30 in the contracted state is also located at the open end of the film 30 in the expanded state, and contributes to the expansion of the film 30. Therefore, at the time of expansion, the length (skeleton amount) of the end skeleton 23 located at the open end of the film 30 becomes long in the bare portion 12, and the end skeleton 23 is not arranged at the open end of the film 30. Since the portion is relatively small and the coating film 30 is appropriately expanded, the coating film 30 is less likely to be wrinkled, and the adhesion to the descending portion A of the aorta can be improved. In addition, the central end of the stent graft 1 can be reliably expanded and opened.
  • the end skeleton 23 is shaped so as to extend the inflection point of the connecting portion 23c along the open end portion of the film 30 in the expanded state, that is, the extending direction of the open end portion of the film 30.
  • the film 30 can be expanded more appropriately by lengthening a portion having a small inclination with respect to a relative portion, preferably a portion having a substantially zero inclination.
  • the tip portion (mountain portion 23a) of the end skeleton 23 protrudes from the coating film 30 for a long time, so that a delivery system of a tip opening mechanism for placing the stent graft 1 (not shown). Can be more properly engaged with the hook.
  • the stent graft 1 is a stent graft indwelled in the descending part A (living lumen) of the aorta, and the first main body skeleton 21 and the second main body skeleton 22 (main body skeleton) are covered with a film 30.
  • It includes a tubular main body 11 covered with, and an end skeleton 23 arranged so as to protrude from the coating 30 at a central end (one end in the axial direction) of the main body 11.
  • the end skeleton 23 is formed by bending a wire rod so that a mountain portion 23a and a valley portion 23b repeat in the circumferential direction via a connecting portion 23c.
  • the connecting portion 23c has an inflection point that changes from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b, and the protruding length of the end skeleton 23 in the expanded state is in the contracted state.
  • the inflection point is connected to the film 30 so as to be shorter than the protruding length of the above.
  • the length (skeleton amount) of the end skeleton 23 located near the opening of the film 30 can be secured as long as possible in the expanded state. Therefore, the portion of the open end of the film 30 where the end skeleton 23 is not arranged is relatively small, and the film 30 is appropriately expanded, so that the film 30 is less likely to wrinkle and is in contact with the descending aorta. Adhesion can be improved.
  • the mountain portion 23a side of the connecting portion 23c can freely move with respect to the film 30, and is located at the open end of the film 30 in the expanded state, while protruding from the film 30 in the contracted state. Therefore, the film 30 can be appropriately expanded at the time of expansion, and the contractility in the radial direction is improved so that the film 30 can be easily stored in the sheath.
  • first main body skeleton 21 and the second main body skeleton 22 are formed so that the mountain portions 21a and 22a and the valley portions 21b and 22b repeat in the circumferential direction by bending the wire rod, and the first main body skeleton 21 ,
  • the mountain portions 21a, 22a, 23a of the second main body skeleton 22 and the end skeleton 23, and the valley portions 21b, 22b, 23b are arranged so as to be aligned in the axial direction.
  • the second main body skeleton 22 is sewn to the film 30 at the mountain portion 22a (the portion other than the valley portion 22b).
  • the vicinity of the valley portion 22b of the second main body skeleton 22 can freely move with respect to the coating film 30, so that the flexibility of the sealing portion 11b is improved and the followability to the living lumen is improved. be able to.
  • the second main body skeleton 22 is sewn on the inner peripheral side of the film 30. As a result, the adhesion of the seal portion 11b located on the central side to the living lumen wall is enhanced, and end leakage from the central side is suppressed.
  • the end portion 22d of the second main body skeleton 22 is sewn to the film 30 at a portion other than the bent portion without being sewn to the film 30 at the bent portion.
  • the degree of freedom of the entire second main body skeleton 22 with respect to the coating 30 can be increased by not fixing the bent portion of the end portion 22d, and as a result, the flexibility of the stent graft 1 is improved and the luminal wall of the living body is covered. Adhesion can be improved.
  • the bending angle of the skeleton 20 is set so that the first main body skeleton 21 and the second main body skeleton 22 of the main body 11 and the end skeleton 23 of the bare part 12 have a predetermined expansion force.
  • the bending angle of the skeleton 20 is set so that the first main body skeleton 21 and the second main body skeleton 22 of the main body 11 and the end skeleton 23 of the bare part 12 have a predetermined expansion force.
  • not all skeletons 21-23 need to have a predetermined expanding force.
  • first main body skeleton 21 and the second main body skeleton 22 are spiral skeletons in which one metal wire is spirally wound while being bent in a zigzag shape.
  • a plurality of annular skeletons are axially oriented. It may be arranged so as to be separated from each other.
  • the end skeleton 23 is an annular skeleton in which one metal wire rod is bent in a zigzag shape and extended in the circumferential direction, but for example, it may be wound in a spiral shape.
  • the present invention is not limited to the stent graft 1 placed in the descending aorta A (see FIG. 2), but can be applied to a stent graft placed in a living lumen such as a digestive system lumen or another blood vessel. Further, the stent graft 1 may have a bifurcated or more branched end on the downstream side in the blood flow direction.
  • the main body portion 11 has a curved shape along the lumen shape after indwelling, but the present invention is not limited to this, and may have a straight cylinder shape. , It may have a curved shape depending on the indwelling site.
  • Stent graft 11 Main body 11a Body 11b Seal 12 Bare 20 Skeleton 21 1st main body skeleton 22 2nd main body skeleton 23 End skeleton 21a, 22a, 23a Mountain part 21b, 22b, 23b Tani part 21c, 22c, 23c connection Part 22d End 30 Film

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  • Health & Medical Sciences (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
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Abstract

Provided are a stent graft and a skeleton for a stent graft that can improve adhesion to a living lumen. This stent graft (1) includes an end skeleton (23) disposed to protrude from a coating at one axial end of a tubular body part (11). The end skeleton is formed by bending a wire rod so that a mountain part (23a) and a valley part (23b) are repeated via a connection part (23c) in a circumferential direction, and the connection part has an inflection part that changes from a downward convex shape to an upward convex shape from the mountain part toward the valley part. Then, the inflection part is connected to the coating so that the protrusion length of the end skeleton in an expanded state is shorter than the protrusion length of the end skeleton in a contracted state.

Description

ステントグラフト及びステントグラフト用骨格Stent graft and skeleton for stent graft

 本発明は、ステントグラフト及びステントグラフト用骨格に関する。 The present invention relates to a stent graft and a skeleton for a stent graft.

 従来、血管、食道、胆管、気管、尿管などの生体管腔に生じた狭窄部又は閉塞部に留置され、病変部位を拡径して生体管腔の開存状態を維持するステントグラフトが知られている(例えば、特許文献1参照)。
 ステントグラフト留置術は、例えば、鼠径部を外科的に切開して血管を露出させ、ステントグラフト留置装置を血管内に導入して病変部位まで送達し、シースからステントグラフトを放出して血管壁に密着させて留置する治療法であり、切開部分が小さく患者への負担が少ない(低侵襲性)という利点がある。
Conventionally, a stent graft that is placed in a stenosis or an obstruction formed in a living lumen such as a blood vessel, esophagus, bile duct, trachea, or ureter, and expands the lesion site to maintain a patency of the living lumen is known. (See, for example, Patent Document 1).
In stent graft placement, for example, the groin is surgically incised to expose the blood vessel, a stent graft placement device is introduced into the blood vessel to deliver it to the lesion site, and the stent graft is released from the sheath to be brought into close contact with the blood vessel wall. It is an indwelling treatment method and has the advantage that the incision is small and the burden on the patient is small (minimally invasive).

特表2019-516509号公報Special Table 2019-516509

 ステントグラフトには、特許文献1に開示されているように、生体管腔の留置部位からの位置ずれを抑制したり、正確な留置を行ったりする上で、当該ステントグラフトの先端部(例えば、中枢側端部)に、皮膜から突出するように端部骨格を配置したものがある。しかしながら、このようなステントグラフトでは、端部骨格が接続されている皮膜部分にしわが生じやすく、生体管腔との密着性が低下してしまう虞がある。 As disclosed in Patent Document 1, the stent graft has a tip (for example, the central side) of the stent graft in order to suppress the displacement of the living lumen from the indwelling site and to perform accurate indwelling. At the end), the end skeleton is arranged so as to protrude from the film. However, in such a stent graft, wrinkles are likely to occur in the film portion to which the end skeleton is connected, and there is a possibility that the adhesion to the living lumen may be lowered.

 また、ステントグラフトには、骨格が皮膜に縫着されているものがある。皮膜への骨格の固定を適正に行う上では縫着箇所がより多い方が好ましい。しかしながら、縫着箇所が多くなると、柔軟性が低下し、生体管腔への追従性が低下して密着性が低下してしまうといった問題がある。 In addition, some stent grafts have a skeleton sewn to the coating. In order to properly fix the skeleton to the film, it is preferable that there are more sewing points. However, when the number of sewn portions increases, there is a problem that the flexibility is lowered, the followability to the living lumen is lowered, and the adhesion is lowered.

 本発明の目的は、生体管腔との密着性を向上させることができるステントグラフト及びステントグラフト用骨格を提供することである。 An object of the present invention is to provide a stent graft and a skeleton for a stent graft that can improve the adhesion to a living lumen.

 本発明に係るステントグラフトは、
 生体管腔内に留置されるステントグラフトであって、
 本体骨格が皮膜で覆われてなる筒状の本体部と、
 前記本体部の軸方向の一端部に、前記皮膜から突出するように配置された端部骨格と、を備え、
 前記端部骨格は、線材を屈曲させて、山部と谷部が連結部を介して周方向に繰り返すように形成され、
 前記連結部は、前記山部から前記谷部に向かって下に凸から上に凸に変化する変曲部分を有し、
 前記端部骨格の拡張状態での突出長が、収縮状態での突出長に比較して短くなるように、前記変曲部分が前記皮膜に接続されている。
The stent graft according to the present invention
A stent graft that is placed in the lumen of a living body.
A tubular body whose skeleton is covered with a film, and
An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
The end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
The connecting portion has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.
The inflection point is connected to the film so that the protruding length of the end skeleton in the expanded state is shorter than the protruding length in the contracted state.

 本発明に係るステントグラフトは、
 生体管腔内に留置されるステントグラフトであって、
 本体骨格が皮膜で覆われてなる筒状の本体部を備え、
 前記本体骨格は、第1本体骨格と、前記第1本体骨格よりも軸方向の一端部側に配設された第2本体骨格と、を有し、
 前記第2本体骨格は、線材を屈曲させて、山部と谷部が周方向に繰り返すように形成され、前記谷部以外の部分で前記皮膜に縫着されている。
The stent graft according to the present invention
A stent graft that is placed in the lumen of a living body.
It has a tubular main body whose skeleton is covered with a film.
The main body skeleton has a first main body skeleton and a second main body skeleton arranged on one end side in the axial direction with respect to the first main body skeleton.
The second main body skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction, and is sewn to the film at a portion other than the valleys.

 また、本発明に係るステントグラフト用骨格は、
 生体管腔内に留置されるステントグラフト用の骨格であって、
 筒状の本体部に皮膜で覆われた状態で配置される本体骨格と、
 前記本体部の軸方向の一端部に、前記皮膜から突出するように配置される端部骨格と、を備え、
 前記端部骨格は、線材を屈曲させて、山部と谷部が連結部を介して周方向に繰り返すように形成され、
 前記連結部は、前記山部から前記谷部に向かって下に凸から上に凸に変化する変曲部分を有する。
Further, the skeleton for stent graft according to the present invention is
A skeleton for stent grafts placed in the lumen of a living body.
The main body skeleton, which is placed in a tubular body covered with a film,
An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
The end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
The connecting portion has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.

 本発明によれば、生体管腔との密着性を向上させることができる。 According to the present invention, the adhesion to the living lumen can be improved.

図1は、ステントグラフトの外観を示す図である。FIG. 1 is a diagram showing the appearance of a stent graft. 図2は、ステントグラフトの留置状態を模式的に示す図である。FIG. 2 is a diagram schematically showing an indwelling state of the stent graft. 図3は、ベア部の拡大図である。FIG. 3 is an enlarged view of the bare portion. 図4A、図4Bは、それぞれ、拡張状態及び収縮状態における端部骨格の形状及び長さを模式的に示す図である。4A and 4B are diagrams schematically showing the shape and length of the end skeleton in the expanded state and the contracted state, respectively. 図5A、図5Bは、第2本体骨格の固定態様を模式的に示す図である。5A and 5B are diagrams schematically showing a fixed mode of the second main body skeleton.

 以下、本発明の実施の形態を、図面を参照して詳細に説明する。
 本実施の形態では、本発明の一例として、大動脈下行部A(図2参照)の病変部位(例えば、大動脈瘤B)を径方向外側に押し拡げて閉塞(狭窄)の治療を行う際に使用されるステントグラフト1について説明する。
Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
In the present embodiment, as an example of the present invention, it is used when the lesion site (for example, aortic aneurysm B) of the descending aorta A (see FIG. 2) is expanded radially outward to treat an occlusion (stenosis). The stent graft 1 to be formed will be described.

 図1は、ステントグラフト1の外観を示す図である。図2は、ステントグラフト1の留置状態を示す図である。 FIG. 1 is a diagram showing the appearance of the stent graft 1. FIG. 2 is a diagram showing an indwelling state of the stent graft 1.

 図1に示すように、ステントグラフト1は、本体部11、及び本体部11の中枢側の端部に配置されるベア部12を有する。また、本体部11は、血液の流路を画成する筒形状を有し、ストレート状の胴部11aと、胴部11aの中枢側の端部に連設されたシール部11bと、を有している。ステントグラフト1は、ベア部12が血流方向における上流側(心臓側)となるように大動脈下行部Aに留置される(図2参照)。 As shown in FIG. 1, the stent graft 1 has a main body portion 11 and a bare portion 12 arranged at the central end of the main body portion 11. Further, the main body portion 11 has a tubular shape that defines a blood flow path, and has a straight body portion 11a and a seal portion 11b connected to a central end portion of the body portion 11a. doing. The stent graft 1 is placed in the descending aorta A so that the bare portion 12 is on the upstream side (heart side) in the blood flow direction (see FIG. 2).

 ステントグラフト1は、骨格20及び皮膜30で構成される。
 骨格20は、ステントグラフト1の拡張状態を維持するための補強部材である。骨格20は、軸方向に略直交する径方向において、内側に収縮した収縮状態から、外側に拡張した拡張状態へと自己拡張可能に形成されている。
The stent graft 1 is composed of a skeleton 20 and a coating 30.
The skeleton 20 is a reinforcing member for maintaining the expanded state of the stent graft 1. The skeleton 20 is formed so as to be self-expandable from a contracted state contracted inward to an expanded state expanded outward in a radial direction substantially orthogonal to the axial direction.

 骨格20は、胴部11aに配置される第1本体骨格21、シール部11bに配置される第2本体骨格22、及びベア部12に配置される端部骨格23を含む。第1本体骨格21及び第2本体骨格22は、皮膜30の周面に配置される。端部骨格23は、例えば、末梢側の部分が皮膜30に固定されており、中枢側の一部が皮膜30から露出している。
 なお、端部骨格23の山部23a(中枢側の屈曲部)の近傍には、径方向外側に突出するように固定ピンが設けられていてもよい。これにより、固定ピンが血管壁に食い込んで、ステントグラフト1の位置ずれを防止することができる。
The skeleton 20 includes a first main body skeleton 21 arranged on the body portion 11a, a second main body skeleton 22 arranged on the seal portion 11b, and an end skeleton 23 arranged on the bare portion 12. The first main body skeleton 21 and the second main body skeleton 22 are arranged on the peripheral surface of the film 30. For example, the peripheral skeleton 23 is fixed to the coating 30 on the peripheral side, and a part on the central side is exposed from the coating 30.
A fixing pin may be provided in the vicinity of the mountain portion 23a (bent portion on the central side) of the end skeleton 23 so as to project outward in the radial direction. As a result, the fixing pin bites into the blood vessel wall, and the displacement of the stent graft 1 can be prevented.

 第1本体骨格21及び第2本体骨格22は、例えば、1本の金属線材を山部21a、22a(中枢側の屈曲部)と谷部21b、22b(末梢側の屈曲部)とが交互に形成されるようにジグザグ状(Z形状)に屈曲しながら螺旋状に巻回した螺旋型骨格で構成されている。第1本体骨格21及び第2本体骨格22は、それぞれ複数回螺旋状に巻回されており、それぞれの軸方向(ステントグラフト1の延在方向)に沿って所定の間隔で配置されている。また、本実施の形態では、第1本体骨格21及び第2本体骨格22における屈曲部(山部21a、22a及び谷部21b、22b)の屈曲角度は同じに設定され、屈曲部を挟む辺の長さは互いに異ならせて設定されている。
 なお、上記した屈曲部の屈曲角度及び屈曲部を挟む辺の長さは、一例であってこれに限られるものではなく、適宜任意に変更可能であり、屈曲角度を異ならせてもよいし、辺の長さを同じにしてもよい。また、第1本体骨格21及び第2本体骨格22を構成する金属線材の端部は、例えば、皮膜30に縫着されて固定されてもよいし、金属線材の他の部分や端部どうしでかしめられて固定されてもよい。
In the first main body skeleton 21 and the second main body skeleton 22, for example, one metal wire rod is alternately provided with mountain portions 21a and 22a (bent portions on the central side) and valley portions 21b and 22b (bent portions on the peripheral side). It is composed of a spiral skeleton that is spirally wound while bending in a zigzag shape (Z shape) so as to be formed. The first main body skeleton 21 and the second main body skeleton 22 are each wound in a spiral shape a plurality of times, and are arranged at predetermined intervals along their respective axial directions (extending direction of the stent graft 1). Further, in the present embodiment, the bending angles of the bending portions (mountain portions 21a, 22a and valley portions 21b, 22b) in the first main body skeleton 21 and the second main body skeleton 22 are set to be the same, and the bending portions of the sides sandwiching the bending portions are set to be the same. The lengths are set differently from each other.
The bending angle of the bent portion and the length of the side sandwiching the bent portion are not limited to this as an example, and can be arbitrarily changed as appropriate, and the bending angle may be different. The lengths of the sides may be the same. Further, the ends of the metal wires constituting the first main body skeleton 21 and the second main body skeleton 22 may be sewn and fixed to the film 30, for example, or the other parts or ends of the metal wires may be sewn to each other. It may be crimped and fixed.

 端部骨格23は、例えば、1本の金属線材を、山部23a(中枢側の屈曲部)と谷部23b(末梢側の屈曲部)が連結部23cを介して周方向に繰り返し形成されるように屈曲させた円環骨格で構成されている。なお、端部骨格23は、金属製の円筒部材にレーザー加工を施して形成したレーザーカット型の円環骨格で構成されてもよい。また、端部骨格23を構成する金属線材の端部は、例えば、皮膜30に縫着されて固定されてもよいし、金属線材の他の部分や端部どうしでかしめられて固定されてもよい。 In the end skeleton 23, for example, one metal wire rod is repeatedly formed in the circumferential direction with a mountain portion 23a (bent portion on the central side) and a valley portion 23b (bent portion on the peripheral side) via a connecting portion 23c. It is composed of an annulus skeleton bent in this way. The end skeleton 23 may be formed of a laser-cut type annulus skeleton formed by laser processing a metal cylindrical member. Further, the end portion of the metal wire rod constituting the end skeleton 23 may be sewn to the film 30 and fixed, or may be crimped and fixed to other parts or ends of the metal wire rod. good.

 第1本体骨格21、第2本体骨格22及び端部骨格23を形成する線材の断面積は同じであってもよいし、異なっていてもよい。第1本体骨格21、第2本体骨格22及び端部骨格23が丸線材で形成されている場合、「断面積」を「線径」と読み替えてもよい。
 また、胴部11aに配置される第1本体骨格21の断面積は、シール部11bに配置される第2本体骨格22の断面積よりも小さく設定されていてもよい。これにより、収縮状態における本体部11の外径をより小さくすることができ、ステントグラフト1のシースへの収納性及びシースからの放出性がさらに向上する。
 なお、少なくともシール部11bの拡張力により血管壁への密着性が確保されていれば、血流方向上流側(中枢側)からの血液の流入(エンドリーク)を防止できるので、シール部11bよりも血流方向下流側(末梢側)に位置する胴部11aの拡張力は、シール部11bの拡張力よりも小さくてもよい。
The cross-sectional areas of the wires forming the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 may be the same or different. When the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 are formed of a round wire rod, "cross-sectional area" may be read as "wire diameter".
Further, the cross-sectional area of the first main body skeleton 21 arranged on the body portion 11a may be set smaller than the cross-sectional area of the second main body skeleton 22 arranged on the seal portion 11b. As a result, the outer diameter of the main body 11 in the contracted state can be made smaller, and the storage property of the stent graft 1 in the sheath and the release property from the sheath are further improved.
If the adhesion to the blood vessel wall is ensured by at least the expanding force of the seal portion 11b, the inflow (end leak) of blood from the upstream side (central side) in the blood flow direction can be prevented, so that the seal portion 11b The expanding force of the body portion 11a located on the downstream side (peripheral side) in the blood flow direction may be smaller than the expanding force of the sealing portion 11b.

 また、端部骨格23において、山部23aと谷部23bを連結する連結部23cは、図3等に示すように、直線状ではなく、端部骨格23の拡張状態での突出長(図4A参照)が、収縮状態での突出長(図4B参照)より短くなるような特徴的な形状を有している。図4A、図4Bは、端部骨格23の形状及び長さを示す展開図であり、図4Aは拡張状態、図4Bは収縮状態について示している。 Further, in the end skeleton 23, the connecting portion 23c connecting the mountain portion 23a and the valley portion 23b is not linear as shown in FIG. 3 and the like, and the protruding length of the end skeleton 23 in the expanded state (FIG. 4A). (See) has a characteristic shape that is shorter than the protruding length in the contracted state (see FIG. 4B). 4A and 4B are development views showing the shape and length of the end skeleton 23, FIG. 4A shows an expanded state, and FIG. 4B shows a contracted state.

 具体的には、連結部23cは、山部23aから谷部23bに向かって下に凸から上に凸に変化する変曲部分(中枢側開口の近傍に位置する部分)を有している。ここで、「山部23aから谷部23bに向かって下に凸から上に凸に変化する」とは、図4Aに示すように、接点の傾きが、緩やかに減少し、傾き0を経て、緩やかに増大する場合の他、変曲点を境界にして折曲して傾きが増大する場合を含む。また、連結部23cの全部が変曲部分となっていてもよいし、一部が変曲部分となっていてもよい。 Specifically, the connecting portion 23c has an inflection portion (a portion located near the central opening) that changes from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b. Here, "changing from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b" means that the inclination of the contact point gradually decreases and passes through an inclination of 0, as shown in FIG. 4A. In addition to the case where it gradually increases, it also includes the case where the inclination increases by bending at the inflection point as a boundary. Further, the entire connecting portion 23c may be an inflection point, or a part of the connecting portion 23c may be an inflection point.

 また、連結部23cは、例えば、山部23a及び谷部23bとともに全体として略「S」字状に屈曲しており、連結部23cの長さは、山部23aと谷部23bを直線状に連結したときの長さに比較して長くなっている。なお、端部骨格23は、拡張状態での突出長が、収縮状態での突出長に比較して短くなるように、連結部23cの変曲部分が皮膜30に縫着されているが、詳細な説明は後述する。 Further, the connecting portion 23c is bent in a substantially "S" shape as a whole together with the mountain portion 23a and the valley portion 23b, for example, and the length of the connecting portion 23c is such that the mountain portion 23a and the valley portion 23b are linear. It is longer than the length when connected. In the end skeleton 23, the inflection point of the connecting portion 23c is sewn to the film 30 so that the protruding length in the expanded state is shorter than the protruding length in the contracted state. The explanation will be described later.

 また、第1本体骨格21、第2本体骨格22及び端部骨格23は、それぞれの山部21a、22a、23a同士、及び谷部21b、22b、23b同士が、ステントグラフト1の軸上に並ぶように配置されている。これにより、ステントグラフト1を収縮させる際の収縮性が向上し、シースへの収納性及びシースからの放出性が向上する。 Further, in the first main body skeleton 21, the second main body skeleton 22 and the end skeleton 23, the peaks 21a, 22a, 23a and the valleys 21b, 22b, 23b are aligned on the axis of the stent graft 1. Is located in. As a result, the contractility when contracting the stent graft 1 is improved, and the storage property in the sheath and the release property from the sheath are improved.

 骨格20を形成する材料としては、例えば、ステンレス鋼、ニッケル-チタン合金(ニチノール)、チタン合金等に代表される公知の金属又は金属合金が挙げられる。また、X線造影性を有する合金材料を用いてもよい。この場合、ステントグラフト1の位置を体外から確認することができるようになる。なお、骨格20は、金属材料以外の材料(例えば、セラミックや樹脂等)で形成されてもよい。 Examples of the material forming the skeleton 20 include known metals or metal alloys typified by stainless steel, nickel-titanium alloy (nitinol), titanium alloy and the like. Further, an alloy material having X-ray contrast property may be used. In this case, the position of the stent graft 1 can be confirmed from outside the body. The skeleton 20 may be formed of a material other than the metal material (for example, ceramic or resin).

 骨格20を形成する線材の材料、線種(例えば、ワイヤー等の円形線材、又は、レーザーカットによる角状線材)、断面積(丸線材の場合は線径に相当)、周方向における屈曲回数及び屈曲形状(山部の数及び山部の形状)、並びに、軸方向における線材間隔(単位長さ当たりの骨格量)等は、例えば、留置部位に応じた各ステントグラフト1に要求されるシースへの収納性、シースからの放出性、及び留置性(拡張力に対応)等を基準として選択される。 The material of the wire forming the skeleton 20, the wire type (for example, a circular wire such as a wire or a square wire obtained by laser cutting), the cross-sectional area (corresponding to the wire diameter in the case of a round wire), the number of bends in the circumferential direction, and The bending shape (the number of peaks and the shape of the peaks), the wire spacing in the axial direction (the amount of skeleton per unit length), and the like can be determined, for example, to the sheath required for each stent graft 1 according to the placement site. It is selected based on storability, release from the sheath, indwellability (corresponding to expanding force), and the like.

 皮膜30は、血液の流路を形成する膜体である。皮膜30を形成する材料としては、例えば、シリコーン樹脂、PTFE(ポリテトラフルオロエチレン)等のフッ素樹脂、及びポリエチレンテレフタレート等のポリエステル樹脂等が挙げられる。皮膜30の膜厚は、例えば、80μm以下であることが好ましい。 The membrane 30 is a membrane that forms a blood flow path. Examples of the material for forming the film 30 include a silicone resin, a fluororesin such as PTFE (polytetrafluoroethylene), and a polyester resin such as polyethylene terephthalate. The film thickness of the film 30 is preferably 80 μm or less, for example.

 本実施の形態では、第1本体骨格21は、皮膜30の外周面に配置されている。これにより、ステントグラフト1を留置した際に、ステントグラフト1の主要部分である胴部11aに配置される第1本体骨格21が血管壁に埋没することとなり、ステントグラフト1の位置ずれが効果的に防止される。 In the present embodiment, the first main body skeleton 21 is arranged on the outer peripheral surface of the film 30. As a result, when the stent graft 1 is placed, the first main body skeleton 21 arranged on the body portion 11a, which is the main part of the stent graft 1, is buried in the blood vessel wall, and the displacement of the stent graft 1 is effectively prevented. NS.

 また、第2本体骨格22は、皮膜30の内周面に配置されている。これにより、中枢側に位置するシール部11bの血管壁への密着性が高まり、中枢側からのエンドリークが抑制される。 Further, the second main body skeleton 22 is arranged on the inner peripheral surface of the film 30. As a result, the adhesion of the seal portion 11b located on the central side to the blood vessel wall is enhanced, and end leakage from the central side is suppressed.

 また、端部骨格23は、皮膜30の中枢側の内周面に、中枢側が露出した状態で配置されている。端部骨格23の皮膜30から突出した部分は、例えば、先端先開き機構のデリバリーシステム(図示略)を利用してステントグラフト1を留置する場合に、デリバリーシステムのフックとの係合に用いられる。 Further, the end skeleton 23 is arranged on the inner peripheral surface of the film 30 on the central side in a state where the central side is exposed. The portion of the end skeleton 23 protruding from the coating 30 is used for engagement with the hook of the delivery system, for example, when the stent graft 1 is placed using the delivery system (not shown) of the tip opening mechanism.

 なお、皮膜30における第1本体骨格21、第2本体骨格22及び端部骨格23の配置態様は、一例であってこれに限られるものではなく、適宜任意に変更可能である。例えば、皮膜30は、第1本体骨格21、第2本体骨格22及び端部骨格23を挟み込むように、第1本体骨格21、第2本体骨格22及び端部骨格23の外周面側と内周面側に配置されてもよい。また、皮膜30は、第1本体骨格21の外周面側に配置されてもよいし、第2本体骨格22の内周面側に配置されてもよいし、端部骨格23の内周面側に配置されてもよい。 The arrangement mode of the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 in the film 30 is an example and is not limited to this, and can be arbitrarily changed as appropriate. For example, the film 30 sandwiches the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 so as to sandwich the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 on the outer peripheral surface side and the inner circumference. It may be arranged on the surface side. Further, the film 30 may be arranged on the outer peripheral surface side of the first main body skeleton 21, may be arranged on the inner peripheral surface side of the second main body skeleton 22, or may be arranged on the inner peripheral surface side of the end skeleton 23. May be placed in.

 本実施の形態では、骨格20は、縫合糸40(例えば、ポリエチレン糸又はポリエステル糸)により皮膜30の外周面に縫い付けられている。 In the present embodiment, the skeleton 20 is sewn on the outer peripheral surface of the film 30 by the suture thread 40 (for example, polyethylene thread or polyester thread).

 具体的には、第1本体骨格21は、山部21a及び谷部21bが皮膜30に縫着されている。第2本体骨格22は、山部22aのみが皮膜30に縫着されている。これにより、第2本体骨格22の谷部22bの近傍は、皮膜30に対して自由に移動することができるので、シール部11bの柔軟性が向上し、生体管腔への追従性を向上させることができる。 Specifically, in the first main body skeleton 21, the mountain portion 21a and the valley portion 21b are sewn on the film 30. In the second main body skeleton 22, only the mountain portion 22a is sewn to the film 30. As a result, the vicinity of the valley portion 22b of the second main body skeleton 22 can freely move with respect to the coating film 30, so that the flexibility of the sealing portion 11b is improved and the followability to the living lumen is improved. be able to.

 また、第2本体骨格22の端部22dは、図5A、図5Bに示すように、屈曲部分以外の部分が皮膜30に縫着されている。第2本体骨格22は、山部22aのみが皮膜30に固定されており、山部22a以外の部分の皮膜30に対する自由度が高められている。ここで、第2本体骨格22の端部22dが強固に皮膜部30に固定されていると、端部22dに加わる力の逃げ場がなくなり、第2本体骨格22全体の皮膜30に対する自由度が低下する虞がある。そこで、本実施の形態では、第2本体骨格22の端部22dの屈曲部分を固定せず、屈曲部分以外の部分で縫合固定している。 Further, as shown in FIGS. 5A and 5B, the end portion 22d of the second main body skeleton 22 has a portion other than the bent portion sewn to the film 30. In the second main body skeleton 22, only the mountain portion 22a is fixed to the film 30, and the degree of freedom for the film 30 in the portion other than the mountain portion 22a is increased. Here, if the end portion 22d of the second main body skeleton 22 is firmly fixed to the coating portion 30, there is no escape for the force applied to the end portion 22d, and the degree of freedom of the entire second main body skeleton 22 with respect to the coating portion 30 is reduced. There is a risk of doing so. Therefore, in the present embodiment, the bent portion of the end portion 22d of the second main body skeleton 22 is not fixed, but is sewn and fixed at a portion other than the bent portion.

 具体的には、第2本体骨格22は、その先端が谷部22bが存するであろう位置に向けて延び、R形状を有するように山部22a側に向けて曲げられた部分が端部22bを構成している。端部22bのR部分の近傍(屈曲部分の周辺部)が縫着されている。これにより、第2本体骨格22の端部22dが血管壁に突き刺さるのを抑制できるとともに、縫合部分から端部22dが抜け落ちるのを抑制できる。
 さらに、図5Bに示すように、第2本体骨格22の端部22dの周辺をパッチ50で覆うようにしてもよい。パッチ50は、例えば、皮膜30と同様の材料で形成され、縫合により皮膜30に固定される。これにより、端部22dの縫合部分からの抜けを確実に防止することができる。
Specifically, the tip of the second main body skeleton 22 extends toward the position where the valley 22b will exist, and the end 22b is bent toward the mountain 22a so as to have an R shape. Consists of. The vicinity of the R portion of the end portion 22b (peripheral portion of the bent portion) is sewn. As a result, it is possible to prevent the end portion 22d of the second main body skeleton 22 from sticking into the blood vessel wall, and it is possible to prevent the end portion 22d from coming off from the sutured portion.
Further, as shown in FIG. 5B, the periphery of the end portion 22d of the second main body skeleton 22 may be covered with the patch 50. The patch 50 is formed of, for example, the same material as the film 30, and is fixed to the film 30 by suturing. As a result, it is possible to reliably prevent the end portion 22d from coming off from the sutured portion.

 なお、図5A、図5Bには、第2本体骨格22の中枢側の端部について示しているが、抹消側の端部に対しても、同様の端部処理が適用される。また、第1本体骨格21の端部において、第2本体骨格22と同様の端部処理を適用してもよい。また、パッチ50は、縫合による固定以外に、接着により固定してもよい。また、パッチ50を熱溶着フィルムで形成し、熱溶着により皮膜30に固定してもよい。 Although FIGS. 5A and 5B show the end portion on the central side of the second main body skeleton 22, the same end treatment is applied to the end portion on the erasing side. Further, the same end treatment as that of the second main body skeleton 22 may be applied to the end portion of the first main body skeleton 21. Further, the patch 50 may be fixed by adhesion other than fixing by suturing. Alternatively, the patch 50 may be formed of a heat-welded film and fixed to the film 30 by heat welding.

 なお、第1本体骨格21、第2本体骨格22及び端部骨格23の皮膜30への縫着態様は、一例であってこれに限られるものではなく、適宜任意に変更可能である。例えば、第1本体骨格21は、山部21a及び谷部21bに加えて、山部21aと谷部21bを連結する連結部21cが皮膜30に縫着されてもよい。また、第2本体骨格22は、山部22aに加えて、谷部22b及び連結部22cの少なくとも一方が皮膜30に縫着されてもよい。 The sewing mode of the first main body skeleton 21, the second main body skeleton 22, and the end skeleton 23 to the film 30 is an example and is not limited to this, and can be arbitrarily changed as appropriate. For example, in the first main body skeleton 21, in addition to the mountain portion 21a and the valley portion 21b, the connecting portion 21c connecting the mountain portion 21a and the valley portion 21b may be sewn to the film 30. Further, in the second main body skeleton 22, in addition to the mountain portion 22a, at least one of the valley portion 22b and the connecting portion 22c may be sewn to the film 30.

 端部骨格23は、拡張状態での突出長が収縮状態での突出長に比較して短くなるように、連結部23cの変曲部分が皮膜30に縫着されている。具体的には、連結部23cの変曲部分の略中央が皮膜30に縫着され、変曲部分の山部23a側は皮膜30に対して自由に移動可能となっている。これにより、拡張状態(図4A参照)において皮膜30の開口端部に位置していた部分は、収縮状態(図4B参照)では皮膜30から突出することとなる。言い替えると、収縮状態において皮膜30から突出していた部分も、拡張状態では皮膜30の開口端部に位置し、皮膜30の拡張に寄与することとなる。
 したがって、拡張時には、ベア部12において、皮膜30の開口端部に位置する端部骨格23の長さ(骨格量)が長くなり、皮膜30の開口端部において端部骨格23が配置されていない部分が相対的に少なくなって、皮膜30が適正に拡張されるので、皮膜30にしわが生じにくくなり、大動脈下行部Aとの密着性を向上させることができる。また、ステントグラフト1の中枢側端部を確実に拡張して開口させることができる。
 特に、端部骨格23を、その拡張状態において皮膜30の開口端部に沿って連結部23cの変曲部分を延在するような形状とする、すなわち、皮膜30の開口端部の延在方向に対する傾きが小さい部分、好ましくは、略0である部分を長くすることにより、皮膜30をより適正に拡張することができる。
In the end skeleton 23, the inflection point of the connecting portion 23c is sewn to the film 30 so that the protruding length in the expanded state is shorter than the protruding length in the contracted state. Specifically, substantially the center of the inflection portion of the connecting portion 23c is sewn to the film 30, and the mountain portion 23a side of the inflection portion is freely movable with respect to the film 30. As a result, the portion located at the open end of the film 30 in the expanded state (see FIG. 4A) protrudes from the film 30 in the contracted state (see FIG. 4B). In other words, the portion protruding from the film 30 in the contracted state is also located at the open end of the film 30 in the expanded state, and contributes to the expansion of the film 30.
Therefore, at the time of expansion, the length (skeleton amount) of the end skeleton 23 located at the open end of the film 30 becomes long in the bare portion 12, and the end skeleton 23 is not arranged at the open end of the film 30. Since the portion is relatively small and the coating film 30 is appropriately expanded, the coating film 30 is less likely to be wrinkled, and the adhesion to the descending portion A of the aorta can be improved. In addition, the central end of the stent graft 1 can be reliably expanded and opened.
In particular, the end skeleton 23 is shaped so as to extend the inflection point of the connecting portion 23c along the open end portion of the film 30 in the expanded state, that is, the extending direction of the open end portion of the film 30. The film 30 can be expanded more appropriately by lengthening a portion having a small inclination with respect to a relative portion, preferably a portion having a substantially zero inclination.

 また、ステントグラフト1を収縮させたときに、端部骨格23の先端部(山部23a)が皮膜30から長く突出するため、ステントグラフト1を留置するための先端先開き機構のデリバリーシステム(図示略)のフックとの係合をより適正に行うことができる。 Further, when the stent graft 1 is contracted, the tip portion (mountain portion 23a) of the end skeleton 23 protrudes from the coating film 30 for a long time, so that a delivery system of a tip opening mechanism for placing the stent graft 1 (not shown). Can be more properly engaged with the hook.

 このように、実施の形態に係るステントグラフト1は、大動脈下行部A(生体管腔)内に留置されるステントグラフトであって、第1本体骨格21及び第2本体骨格22(本体骨格)が皮膜30で覆われてなる筒状の本体部11と、本体部11の中枢側端部(軸方向の一端部)に、皮膜30から突出するように配置された端部骨格23と、を備える。端部骨格23は、線材を屈曲させて、山部23aと谷部23bが連結部23cを介して周方向に繰り返すように形成されている。また、連結部23cは、山部23aから谷部23bに向かって下に凸から上に凸に変化する変曲部分を有し、端部骨格23の拡張状態での突出長が、収縮状態での突出長に比較して短くなるように、変曲部分が皮膜30に接続されている。
 これにより、拡張状態において、皮膜30の開口近傍に位置する端部骨格23の長さ(骨格量)をできるだけ長く確保できる。したがって、皮膜30の開口端部において端部骨格23が配置されていない部分が相対的に少なくなり、皮膜30が適正に拡張されるので、皮膜30にしわが生じにくくなり、大動脈下行部Aとの密着性を向上させることができる。
As described above, the stent graft 1 according to the embodiment is a stent graft indwelled in the descending part A (living lumen) of the aorta, and the first main body skeleton 21 and the second main body skeleton 22 (main body skeleton) are covered with a film 30. It includes a tubular main body 11 covered with, and an end skeleton 23 arranged so as to protrude from the coating 30 at a central end (one end in the axial direction) of the main body 11. The end skeleton 23 is formed by bending a wire rod so that a mountain portion 23a and a valley portion 23b repeat in the circumferential direction via a connecting portion 23c. Further, the connecting portion 23c has an inflection point that changes from a downward convex to an upward convex from the mountain portion 23a to the valley portion 23b, and the protruding length of the end skeleton 23 in the expanded state is in the contracted state. The inflection point is connected to the film 30 so as to be shorter than the protruding length of the above.
As a result, the length (skeleton amount) of the end skeleton 23 located near the opening of the film 30 can be secured as long as possible in the expanded state. Therefore, the portion of the open end of the film 30 where the end skeleton 23 is not arranged is relatively small, and the film 30 is appropriately expanded, so that the film 30 is less likely to wrinkle and is in contact with the descending aorta. Adhesion can be improved.

 また、端部骨格23は、変曲部分の略中央が皮膜30に接続されている。これにより、連結部23cの山部23a側は、皮膜30に対して自由に移動でき、拡張状態では皮膜30の開口端部に位置する一方で、収縮状態では皮膜30から突出する。したがって、拡張時に皮膜30を適正に拡張できるとともに、径方向への収縮性が向上しシースに収納しやすくなる。 Further, in the end skeleton 23, substantially the center of the inflection point is connected to the film 30. As a result, the mountain portion 23a side of the connecting portion 23c can freely move with respect to the film 30, and is located at the open end of the film 30 in the expanded state, while protruding from the film 30 in the contracted state. Therefore, the film 30 can be appropriately expanded at the time of expansion, and the contractility in the radial direction is improved so that the film 30 can be easily stored in the sheath.

 また、第1本体骨格21及び第2本体骨格22(本体骨格)は、線材を屈曲させて山部21a、22aと谷部21b、22bが周方向に繰り返すように形成され、第1本体骨格21、第2本体骨格22及び端部骨格23の互いの山部21a、22a、23aどうし及び谷部21b、22b、23bどうしが軸方向に並ぶように配置されている。これにより、ステントグラフト1を収縮させる際の収縮性が向上し、シースへの収納性及びシースからの放出性が向上する。 Further, the first main body skeleton 21 and the second main body skeleton 22 (main body skeleton) are formed so that the mountain portions 21a and 22a and the valley portions 21b and 22b repeat in the circumferential direction by bending the wire rod, and the first main body skeleton 21 , The mountain portions 21a, 22a, 23a of the second main body skeleton 22 and the end skeleton 23, and the valley portions 21b, 22b, 23b are arranged so as to be aligned in the axial direction. As a result, the contractility when contracting the stent graft 1 is improved, and the storage property in the sheath and the release property from the sheath are improved.

 また、第2本体骨格22は、山部22a(谷部22b以外の部分)で皮膜30に縫着されている。これにより、第2本体骨格22の谷部22bの近傍は、皮膜30に対して自由に移動することができるので、シール部11bの柔軟性が向上し、生体管腔への追従性を向上させることができる。 Further, the second main body skeleton 22 is sewn to the film 30 at the mountain portion 22a (the portion other than the valley portion 22b). As a result, the vicinity of the valley portion 22b of the second main body skeleton 22 can freely move with respect to the coating film 30, so that the flexibility of the sealing portion 11b is improved and the followability to the living lumen is improved. be able to.

 また、第2本体骨格22は、皮膜30の内周側に縫着されている。これにより、中枢側に位置するシール部11bの生体管腔壁への密着性が高まり、中枢側からのエンドリークが抑制される。 Further, the second main body skeleton 22 is sewn on the inner peripheral side of the film 30. As a result, the adhesion of the seal portion 11b located on the central side to the living lumen wall is enhanced, and end leakage from the central side is suppressed.

 さらに、第2本体骨格22の端部22dは、その屈曲部分が皮膜30に縫着されずに、当該屈曲部分以外の部分で皮膜30に縫着されている。これにより、端部22dの屈曲部分を固定しないことで第2本体骨格22全体の皮膜30に対する自由度を高めることができ、結果として、ステントグラフト1の柔軟性を向上させ、生体管腔壁への密着性を向上させることができる。 Further, the end portion 22d of the second main body skeleton 22 is sewn to the film 30 at a portion other than the bent portion without being sewn to the film 30 at the bent portion. As a result, the degree of freedom of the entire second main body skeleton 22 with respect to the coating 30 can be increased by not fixing the bent portion of the end portion 22d, and as a result, the flexibility of the stent graft 1 is improved and the luminal wall of the living body is covered. Adhesion can be improved.

 以上、本発明者によってなされた発明を実施の形態に基づいて具体的に説明したが、本発明は上記実施の形態に限定されるものではなく、その要旨を逸脱しない範囲で変更可能である。 Although the invention made by the present inventor has been specifically described above based on the embodiment, the present invention is not limited to the above embodiment and can be changed without departing from the gist thereof.

 例えば、実施の形態では、骨格20の屈曲角度は、本体部11の第1本体骨格21及び第2本体骨格22、並びにベア部12の端部骨格23が所定の拡張力を有するように設定されているが、すべての骨格21~23が所定の拡張力を有していなくてもよい。 For example, in the embodiment, the bending angle of the skeleton 20 is set so that the first main body skeleton 21 and the second main body skeleton 22 of the main body 11 and the end skeleton 23 of the bare part 12 have a predetermined expansion force. However, not all skeletons 21-23 need to have a predetermined expanding force.

 また、第1本体骨格21及び第2本体骨格22は、1本の金属線材をジグザグ状に屈曲しながら螺旋状に巻回した螺旋型骨格としたが、例えば、複数の円環骨格を軸方向に離間して配置した構成としてもよい。また、端部骨格23は、1本の金属線材をジグザグ状に屈曲しながら周方向に延在させた円環骨格としたが、例えば、螺旋状に巻回した構成としてもよい。 Further, the first main body skeleton 21 and the second main body skeleton 22 are spiral skeletons in which one metal wire is spirally wound while being bent in a zigzag shape. For example, a plurality of annular skeletons are axially oriented. It may be arranged so as to be separated from each other. Further, the end skeleton 23 is an annular skeleton in which one metal wire rod is bent in a zigzag shape and extended in the circumferential direction, but for example, it may be wound in a spiral shape.

 本発明は、大動脈下行部A(図2参照)に留置されるステントグラフト1に限らず、消化器系管腔や他の血管などの生体管腔に留置されるステントグラフトに適用することができる。また、ステントグラフト1は、血流方向下流側の端部が二股以上に分枝していてもよい。 The present invention is not limited to the stent graft 1 placed in the descending aorta A (see FIG. 2), but can be applied to a stent graft placed in a living lumen such as a digestive system lumen or another blood vessel. Further, the stent graft 1 may have a bifurcated or more branched end on the downstream side in the blood flow direction.

 また、実施の形態では、留置後に本体部11が管腔形状に沿った湾曲形状を有することになるが、一例であってこれに限られるものではなく、直筒形状を有していてもよいし、留置部位に応じて湾曲した形状を有していてもよい。 Further, in the embodiment, the main body portion 11 has a curved shape along the lumen shape after indwelling, but the present invention is not limited to this, and may have a straight cylinder shape. , It may have a curved shape depending on the indwelling site.

 今回開示された実施の形態はすべての点で例示であって制限的なものではないと考えられるべきである。本発明の範囲は上記した説明ではなくて特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内でのすべての変更が含まれることが意図される。 The embodiments disclosed this time should be considered to be exemplary in all respects and not restrictive. The scope of the present invention is shown by the scope of claims rather than the above description, and it is intended to include all modifications within the meaning and scope equivalent to the scope of claims.

 2020年3月2日出願の特願2020-035005及び2020年3月12日出願の特願2020-042584の日本出願に含まれる明細書、図面および要約書の開示内容は、すべて本願に援用される。 The disclosures of the specifications, drawings and abstracts contained in the Japanese applications of Japanese Patent Application No. 2020-035005 filed on March 2, 2020 and Japanese Patent Application No. 2020-042584 filed on March 12, 2020 are all incorporated herein by reference. NS.

 1 ステントグラフト
 11 本体部
 11a 胴部
 11b シール部
 12 ベア部
 20 骨格
 21 第1本体骨格
 22 第2本体骨格
 23 端部骨格
 21a、22a、23a 山部
 21b、22b、23b 谷部
 21c、22c、23c 連結部
 22d 端部
 30 皮膜
1 Stent graft 11 Main body 11a Body 11b Seal 12 Bare 20 Skeleton 21 1st main body skeleton 22 2nd main body skeleton 23 End skeleton 21a, 22a, 23a Mountain part 21b, 22b, 23b Tani part 21c, 22c, 23c connection Part 22d End 30 Film

Claims (9)

 生体管腔内に留置されるステントグラフトであって、
 本体骨格が皮膜で覆われてなる筒状の本体部と、
 前記本体部の軸方向の一端部に、前記皮膜から突出するように配置された端部骨格と、を備え、
 前記端部骨格は、線材を屈曲させて、山部と谷部が連結部を介して周方向に繰り返すように形成され、
 前記連結部は、前記山部から前記谷部に向かって下に凸から上に凸に変化する変曲部分を有し、
 前記端部骨格の拡張状態での突出長が、収縮状態での突出長に比較して短くなるように、前記変曲部分が前記皮膜に接続されている、ステントグラフト。
A stent graft that is placed in the lumen of a living body.
A tubular body whose skeleton is covered with a film, and
An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
The end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
The connecting portion has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.
A stent graft in which the inflection point is connected to the coating so that the protruding length of the end skeleton in the expanded state is shorter than the protruding length in the contracted state.
 前記変曲部分は、前記拡張状態において前記皮膜の開口端部に沿って延在する、請求項1に記載のステントグラフト。 The stent graft according to claim 1, wherein the inflection point extends along the open end of the coating in the expanded state.  前記変曲部分の略中央が前記皮膜に接続されている、請求項2に記載のステントグラフト。 The stent graft according to claim 2, wherein substantially the center of the inflection point is connected to the coating film.  前記本体骨格は、線材を屈曲させて、山部及び谷部が周方向に繰り返すように形成され、
 前記本体骨格及び前記端部骨格は、互いの前記山部どうし及び前記谷部どうしが軸方向に並ぶように配置されている、請求項1から3のいずれか一項に記載のステントグラフト。
The main body skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction.
The stent graft according to any one of claims 1 to 3, wherein the main body skeleton and the end skeleton are arranged so that the peaks and valleys of each other are aligned in the axial direction.
 前記本体骨格は、第1本体骨格と、前記第1本体骨格よりも軸方向の一端部側に配設された第2本体骨格と、を有し、
 前記第2本体骨格は、線材を屈曲させて、山部と谷部が周方向に繰り返すように形成され、前記谷部以外の部分で前記皮膜に縫着されている、請求項1から4のいずれか一項に記載のステントグラフト。
The main body skeleton has a first main body skeleton and a second main body skeleton arranged on one end side in the axial direction with respect to the first main body skeleton.
2. The stent graft according to any one item.
 生体管腔内に留置されるステントグラフトであって、
 本体骨格が皮膜で覆われてなる筒状の本体部を備え、
 前記本体骨格は、第1本体骨格と、前記第1本体骨格よりも軸方向の一端部側に配設された第2本体骨格と、を有し、
 前記第2本体骨格は、線材を屈曲させて、山部と谷部が周方向に繰り返すように形成され、前記谷部以外の部分で前記皮膜に縫着されている、ステントグラフト。
A stent graft that is placed in the lumen of a living body.
It has a tubular main body whose skeleton is covered with a film.
The main body skeleton has a first main body skeleton and a second main body skeleton arranged on one end side in the axial direction with respect to the first main body skeleton.
The second main body skeleton is a stent graft in which a wire rod is bent so that peaks and valleys repeat in the circumferential direction, and is sewn to the film at a portion other than the valleys.
 前記第2本体骨格は、前記皮膜の内周側に縫着されている、請求項6に記載のステントグラフト。 The stent graft according to claim 6, wherein the second main body skeleton is sewn on the inner peripheral side of the film.  前記本体骨格は、線材を屈曲させて、山部及び谷部が周方向に繰り返すように形成され、
 前記本体骨格の端部は、その屈曲部分が前記皮膜に縫着されずに、当該屈曲部分以外の部分で前記皮膜に縫着されている、請求項6または7に記載のステントグラフト。
The main body skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction.
The stent graft according to claim 6 or 7, wherein the end portion of the main body skeleton is sewn to the coating film at a portion other than the bending portion without being sewn to the coating film.
 生体管腔内に留置されるステントグラフト用の骨格であって、
 筒状の本体部に皮膜で覆われた状態で配置される本体骨格と、
 前記本体部の軸方向の一端部に、前記皮膜から突出するように配置される端部骨格と、を備え、
 前記端部骨格は、線材を屈曲させて、山部と谷部が連結部を介して周方向に繰り返すように形成され、
 前記連結部は、前記山部から前記谷部に向かって下に凸から上に凸に変化する変曲部分を有する、ステントグラフト用骨格。
A skeleton for stent grafts placed in the lumen of a living body.
The main body skeleton, which is placed in a tubular body covered with a film,
An end skeleton arranged so as to protrude from the film is provided at one end of the main body in the axial direction.
The end skeleton is formed by bending a wire rod so that peaks and valleys repeat in the circumferential direction via a connecting portion.
The connecting portion is a skeleton for stent grafting, which has an inflection point that changes from a downward convex to an upward convex from the mountain portion to the valley portion.
PCT/JP2021/007953 2020-03-02 2021-03-02 Stent graft and skeleton for stent graft Ceased WO2021177303A1 (en)

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