WO2020195870A1 - Outil thérapeutique tubulaire et film pour outil thérapeutique tubulaire - Google Patents

Outil thérapeutique tubulaire et film pour outil thérapeutique tubulaire Download PDF

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Publication number
WO2020195870A1
WO2020195870A1 PCT/JP2020/010704 JP2020010704W WO2020195870A1 WO 2020195870 A1 WO2020195870 A1 WO 2020195870A1 JP 2020010704 W JP2020010704 W JP 2020010704W WO 2020195870 A1 WO2020195870 A1 WO 2020195870A1
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WO
WIPO (PCT)
Prior art keywords
tubular
skeleton
stent graft
film
region
Prior art date
Application number
PCT/JP2020/010704
Other languages
English (en)
Japanese (ja)
Inventor
白濱　憲昭
崇志 吉森
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 JP2021509020A priority Critical patent/JP7473107B2/ja
Publication of WO2020195870A1 publication Critical patent/WO2020195870A1/fr

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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

Definitions

  • the present invention relates to a tubular therapeutic tool and a membrane body for a tubular therapeutic tool.
  • a stent graft has been conventionally known as a tubular therapeutic tool used for treating an aortic aneurysm or aortic dissection occurring in the aorta (see, for example, Patent Documents 1 and 2).
  • the stent graft includes, for example, a skeleton portion using a metal wire and a coating portion that covers the skeleton portion, and has a tubular outer shape as a whole.
  • the stent graft expands by applying an external force from the inside to the outside in the radial direction at a predetermined position in the blood vessel, and is placed in the blood vessel in close contact with the blood vessel.
  • the contact portion between the coating portion and the skeleton portion may rub. It is required to improve the durability of the stent graft against such rubbing between the skeleton portion and the coating portion.
  • An object of the present invention is to provide a tubular therapeutic tool having improved durability against rubbing between the skeleton portion and the coating portion.
  • One aspect of the present invention is It is a tubular treatment tool including a tubular main body portion, and the main body portion has a film portion made of a woven fiber and a skeleton portion provided on one surface of the film portion. A surface treatment portion processed so that the surface of the woven fabric becomes uneven is partially provided on one surface of the film portion.
  • the durability against rubbing between the skeleton portion and the coating portion can be improved.
  • FIG. 1 is a perspective view of the expanded state of the stent graft in one embodiment to which the present invention is applied
  • FIG. 3A is a diagram schematically showing a cross-sectional structure of a portion surrounded by a broken line in FIG. 3
  • FIG. 3B is a sectional view taken along line IVb-IVb of FIG. 4A. It is a figure which shows the outer peripheral surface side of another stent graft developed in a plane.
  • FIG. 1 is a perspective view of the expanded state of the stent graft 10 in one embodiment
  • FIG. 1 (B) is a plan view of the expanded state of the stent graft 10.
  • FIG. 2 is a diagram showing a state (use state) in which the stent graft 10 is placed in a blood vessel.
  • the stent graft 10 shown in FIGS. 1 and 2 is a branch blood vessel compatible main blood vessel stent graft, and has a tubular shape as a whole.
  • the stent graft 10 has openings provided at both ends in the axial direction Ax communicating with each other, and has a tubular flow path inside through which the patient's blood passes in the used state.
  • the stent graft 10 has a so-called self-expanding structure in which the shape of the expanded state is stored, and is introduced into the blood vessel in a state of being contracted inward in the radial direction (not shown).
  • the stent graft 10 is expanded by applying an external force from the inside to the outside in the radial direction at a predetermined position in the blood vessel (for example, a lesion site where an aortic aneurysm or the like is occurring) using an expansion catheter (not shown), and FIG. As shown, it is placed in the main blood vessel V1 in close contact with the inner wall of the blood vessel.
  • the stent graft 10 may be introduced into the blood vessel by a catheter different from the dilation catheter. Further, the stent graft 10 may be introduced into the blood vessel by being attached to the tip of the dilation catheter in a state of being contracted inward in the radial direction.
  • the stent graft 10 has a tubular body portion 10A and a branch portion 10B, respectively.
  • the main body portion 10A has a skeleton portion 11 and a tubular coating portion 12 provided along the skeleton portion 11.
  • a branch portion 10B is provided on the peripheral surface of the main body portion 10A.
  • the branch portion 10B is connected to the main body portion 10A so that the tubular flow path of the main body portion 10A and the internal space of the branch portion 10B communicate with each other.
  • the main body portion 10A of the stent graft 10 is placed in the main blood vessel V1 so that the branch portion 10B faces the branch blood vessel V2.
  • a branch blood vessel stent graft (not shown) is further connected to the branch portion 10B, and a branch blood vessel stent graft is placed in the branch blood vessel V2.
  • a straight tube-shaped stent graft 10 is shown.
  • the stent graft 10 of the present embodiment may have, for example, a shape curved in an arch shape (for example, a shape corresponding to the aortic arch of a patient) or a shape having a twist.
  • the skeleton portion 11 is a self-expanding stent skeleton configured to be deformable from a contracted state contracted inward in the radial direction to an expanded state expanded in the outward direction in the radial direction.
  • the skeleton portion 11 is composed of five skeleton pieces formed in a tubular shape with thin metal wires folded in a zigzag shape along the circumferential direction of the stent graft 10. These skeleton pieces are arranged side by side along the axial direction Ax. The adjacent skeleton pieces may be connected by a connecting member (not shown).
  • Examples of the material of the thin metal wire forming the skeleton portion 11 include known metals or metal alloys typified by stainless steel, nickel-titanium alloy, cobalt-chromium alloy, titanium alloy and the like.
  • the skeleton portion 11 may be made of a material other than metal (for example, ceramic or resin).
  • the cross-sectional shape of the thin metal wire of the skeleton portion 11 is, for example, a circle.
  • the cross-sectional shape of the thin metal wire of the skeleton portion 11 may be a rectangular shape or a shape in which the inside is flat and the outside is a curved surface (for example, a semicircle).
  • the film portion 12 is a tubular film body formed of a woven fiber, and forms the above-mentioned tubular flow path.
  • the material for forming the film portion 12 include a fluororesin such as PTFE (polytetrafluoroethylene) and a polyester resin such as polyethylene terephthalate.
  • the weaving method of the film portion 12 may be plain weave, twill weave, or satin weave.
  • a skeleton portion 11 is provided on the outer periphery of the film portion 12.
  • the film portion 12 is attached so as to close the gap portion of the skeleton portion 11.
  • the skeleton portion 11 is sewn on the outer peripheral surface of the film portion 12 with a thread 13, for example. Therefore, even when an instrument (for example, a catheter for introducing another stent graft) is passed through the inside of the stent graft 10, the instrument can be prevented from being caught on the inner surface of the stent graft 10.
  • an instrument for example, a catheter for introducing another stent graft
  • a recess 14 recessed inward in the radial direction is formed in a part of the pipe wall (in FIGS. 1A and 1B, a substantially central portion in the axial direction of the main body portion 10A).
  • a branch portion 10B is formed at substantially the center of the flat bottom surface of the recess 14 so as to project outward in the radial direction of the main body portion 10A.
  • the branch portion 10B has a tubular shape as described above, and functions as a connection portion for connecting a branch vascular stent graft.
  • the branch portion 10B has a flexibility (flexibility) such that the direction of the opening can be changed by, for example, the blood flow from the main blood vessel V1 to the branch blood vessel V2.
  • the shape of the branch portion 10B is shown as a cylindrical shape, but the shape of the branch portion 10B may be a tapered shape (conical truncated cone shape) in which the diameter is reduced toward the tip side. , Or it may be in the shape of a square cylinder or a truncated cone.
  • the branch portion 10B is formed of, for example, the same material as the coating portion 12, and is configured as one member together with the coating portion 12.
  • the film of the branch portion 10B may be formed of a member separate from the main body portion 10A and may be joined to the film portion 12.
  • the film of the branch portion 10B may be formed of the same material as the film portion 12, or may be formed of a different material.
  • FIGS. 1 and 2 show an example in which the skeleton portion is not arranged on the branch portion 10B, the skeleton portion may be arranged on the peripheral surface of the branch portion 10B.
  • FIG. 3 is a schematic view showing a part of the stent graft 10 in the circumferential direction cut open and the outer peripheral surface side developed in a plane.
  • the vertical direction in FIG. 3 corresponds to the axial direction Ax of the stent graft 10
  • the horizontal direction in FIG. 3 corresponds to the circumferential direction Ci of the stent graft 10.
  • the vertical direction of the paper surface in FIG. 3 corresponds to the radial direction Ra of the stent graft 10.
  • FIG. 4A is a diagram schematically showing a cross-sectional structure of a portion surrounded by a broken line in FIG. 3, and
  • FIG. 4B is a sectional view taken along line IVb-IVb of FIG. 4A.
  • the outer peripheral surface of the coating portion 12 of the stent graft 10 has a first region 21 as a surface-treated portion and a woven fabric of the coating portion 12 which has not been surface-treated.
  • a second area 22 is provided in which the ground is exposed as it is.
  • the first region 21 is provided on the outer peripheral surface of the film portion 12 with reference to the position of the skeleton portion 11, and is arranged so that at least the apex portions of the skeleton portion 11 that are folded back in a zigzag shape correspond to each other. It is set up.
  • FIG. 1 the outer peripheral surface of the coating portion 12 of the stent graft 10 has a first region 21 as a surface-treated portion and a woven fabric of the coating portion 12 which has not been surface-treated.
  • a second area 22 is provided in which the ground is exposed as it is.
  • the first region 21 is provided on the outer peripheral surface of the film portion 12 with reference to the position of the skeleton portion 11, and is arranged so that at least the
  • a plurality of circular first regions 21 are periodically arranged in a predetermined pattern (for example, in a staggered pattern) at intervals, and the first regions 21 are arranged.
  • a predetermined pattern for example, in a staggered pattern
  • the space is the second region 22.
  • the first region 21 is formed so as to have irregularities on the woven fabric or to be recessed from the flat second region 22, and has a surface that is difficult to contact with the skeleton portion 11.
  • the first region 21 and the second region 22 form irregularities on the outer peripheral surface of the film portion 12, and the surface roughness of the outer peripheral surface of the film portion 12 is increased.
  • a contact area between the surface of the second region 22 and the inside of the skeleton portion 11 is secured, but it is difficult to contact the inside of the skeleton portion 11.
  • the contact area is reduced by the amount of the first region 21.
  • the first region 21 is formed, for example, by calendar processing in which the woven fabric is pressed using a roller having a convex surface formed corresponding to the pattern of the first region 21.
  • the second region 22 may be surface-treated so that the surface of the woven fabric becomes flatter in order to facilitate contact with the inside of the skeleton portion 11.
  • it may be pressurized by a portion other than the convex surface of the roller for forming the first region 21, or may be coated with a biocompatible coating agent so as to be flatter.
  • FIGS. 4A and 4B show an example in which the woven fabric of the film portion 12 is subjected to calendar processing to form the first region 21.
  • the skeleton portion 11 is arranged so as to straddle the first region 21 and the second region 22, and the thread is formed on the coating portion 12. It is sewn at 13. Therefore, as shown in FIG. 4A, the inside of the skeleton portion 11 comes into contact with the surface of the second region 22 provided on the outer peripheral surface of the coating portion 12.
  • the main body 10A expands radially outward due to the pressure of blood flowing inside the main body 10A. Therefore, in the state of using the stent graft 10, a force acts on the coating portion 12 in the radial direction, and the outer peripheral surface of the coating portion 12 is pressed against the inside of the skeleton portion 11 so that the two are in close contact with each other. Become.
  • the skeleton portion 11 and the coating portion 12 may be displaced on the peripheral surface of the stent graft 10 due to the influence of such vibration.
  • the outer peripheral surface of the film portion 12 has a large surface roughness due to the unevenness formed by the first region 21 and the second region 22, the contact area between the skeleton portion 11 and the film portion 12 is reduced. Even if the skeleton portion 11 and the coating portion 12 are misaligned due to the pulsation of blood vessels or the like, the amount of wear is reduced.
  • the stent graft 10 of the present embodiment includes a tubular main body portion 10A, and the main body portion 10A is provided on a film portion 12 made of a woven fiber and one surface (for example, an outer peripheral surface) of the film portion 12. It has a skeleton portion 11.
  • a surface-treated portion (for example, the first region 21) is partially provided on one surface of the film portion 12 so that the surface of the woven fabric becomes uneven.
  • the outer peripheral surface of the coating portion 12 is processed so that the surface becomes uneven, so that the surface roughness can be increased, and the skeleton portion 11 and the coating portion 12 Even if the position shift occurs, the film portion 12 can be made less likely to be worn as compared with the configuration in which the first region 21 is not provided. As a result, the durability against rubbing between the skeleton portion 11 and the coating portion 12 can be improved.
  • the contact area between the surface of the second region 22 and the inside of the skeleton portion 11 is secured, it is possible to generate a frictional force that suppresses the positional deviation between the skeleton portion 11 and the coating portion 12.
  • the misalignment between the skeleton portion 11 and the coating portion 12 can be suppressed.
  • by forming the surface of the second region 22 more flat so that it can easily come into contact with the inside of the skeleton portion 11 made of fine metal wires unevenness at the interface between the second region 22 and the skeleton portion 11 is formed. It is possible to cause almost no meshing.
  • the second region 22 of the coating portion 12 can be made less likely to be worn.
  • the stent graft 10 when the inner wall of the flexible blood vessel is deformed so as to be in close contact with the unevenness of the first region 21 and the second region 22, it is formed between the coating portion 12 and the inner wall of the blood vessel.
  • the contact area becomes large and a large frictional force can be generated. Therefore, by providing the first region 21 and the second region 22 on the outer peripheral surface of the film portion 12, the friction when the stent graft 10 is in close contact with the inner wall of the blood vessel can be increased. As a result, it is possible to prevent the stent graft 10 from being displaced from a predetermined position in the blood vessel.
  • the skeleton portion 11 is sewn to the film portion 12, but the present invention is not limited to this, and the skeleton portion 11 is attached to the film portion 12 by, for example, sticking, adhering, or welding with tape. It may be attached. Further, the film portion 12 may be arranged on the outer peripheral side of the skeleton portion 11, or the skeleton portion 11 may be arranged between the two film portions 12 so as to sandwich the skeleton portion 11 from the outside and the inside.
  • each first region 21 may be any shape such as a polygon or an ellipse.
  • the arrangement pattern of the first region 21 in the film portion 12 may be another pattern such as a grid pattern. Further, the positional relationship between the first region 21 and the second region 22 in the film portion 12 illustrated in the above embodiment may be exchanged.
  • a plurality of first regions 21 are formed on the outer peripheral surface of the film portion 12 in a zigzag shape so as to correspond to the shape of the skeleton portion 11, and the plurality of first regions 21 are formed.
  • the skeleton portion 11 may be attached along the region 21 of 1.
  • the first region 21 may be provided at the seam portion where the film portion 12 is easily rubbed.
  • the first region 21 is provided at the position of the folded portion of the skeleton portion 11 having many seams on the outer peripheral surface of the film portion 12, the rubbing of the film portion 12 can be effectively suppressed.
  • the second region 22 may be provided in the seam portion, and in this case, the contact area between the surface of the second region 22 and the inside of the skeleton portion 11 can be more appropriately secured. Therefore, the misalignment between the skeleton portion 11 and the coating portion 12 can be effectively suppressed.
  • Stent graft tubular treatment tool
  • Main body 11
  • Skeleton 12 Coating 13
  • Thread 21
  • Second area 22

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)
  • Prostheses (AREA)

Abstract

Un greffon d'endoprothèse (10) comprend une section de corps tubulaire (10A), la section de corps ayant une section de film (12) comprenant un textile fibreux, et une section de squelette (11) disposée sur une surface de la section de film. Cette surface de la section de film est partiellement pourvue de premières régions (21) ayant reçu un traitement pour rendre la surface du textile rugueuse.
PCT/JP2020/010704 2019-03-26 2020-03-12 Outil thérapeutique tubulaire et film pour outil thérapeutique tubulaire WO2020195870A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021509020A JP7473107B2 (ja) 2019-03-26 2020-03-12 管状治療具

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019-058694 2019-03-26
JP2019058694 2019-03-26

Publications (1)

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WO2020195870A1 true WO2020195870A1 (fr) 2020-10-01

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PCT/JP2020/010704 WO2020195870A1 (fr) 2019-03-26 2020-03-12 Outil thérapeutique tubulaire et film pour outil thérapeutique tubulaire

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WO (1) WO2020195870A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6800089B1 (en) * 2000-05-31 2004-10-05 Advanced Cardiovascular Systems, Inc. Mechanical attachment method of cover materials on stents
JP2008505728A (ja) * 2004-07-12 2008-02-28 ボストン サイエンティフィック リミテッド 生理活性薬剤コーティング及び生分解性鞘を含む複合血管移植片
JP2010515545A (ja) * 2007-01-11 2010-05-13 ロバート ラマール ジュニア ビョーク 経皮的冠動脈インターベンション用の多剤溶出冠動脈ステント

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6800089B1 (en) * 2000-05-31 2004-10-05 Advanced Cardiovascular Systems, Inc. Mechanical attachment method of cover materials on stents
JP2008505728A (ja) * 2004-07-12 2008-02-28 ボストン サイエンティフィック リミテッド 生理活性薬剤コーティング及び生分解性鞘を含む複合血管移植片
JP2010515545A (ja) * 2007-01-11 2010-05-13 ロバート ラマール ジュニア ビョーク 経皮的冠動脈インターベンション用の多剤溶出冠動脈ステント

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JPWO2020195870A1 (fr) 2020-10-01
JP7473107B2 (ja) 2024-04-23

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