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WO2025142417A1 - Stent et méthode d'imagerie de stent - Google Patents

Stent et méthode d'imagerie de stent Download PDF

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Publication number
WO2025142417A1
WO2025142417A1 PCT/JP2024/043337 JP2024043337W WO2025142417A1 WO 2025142417 A1 WO2025142417 A1 WO 2025142417A1 JP 2024043337 W JP2024043337 W JP 2024043337W WO 2025142417 A1 WO2025142417 A1 WO 2025142417A1
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WO
WIPO (PCT)
Prior art keywords
stent
marker portion
wire
marker
catheter
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.)
Pending
Application number
PCT/JP2024/043337
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English (en)
Japanese (ja)
Inventor
康平 三木
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.)
TGMedical
TGMedical Inc
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TGMedical
TGMedical Inc
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Filing date
Publication date
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Publication of WO2025142417A1 publication Critical patent/WO2025142417A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping stents

Definitions

  • FIG. 1 is a side view of the stent 1 of the first embodiment.
  • FIG. 2 is a perspective view of the stent 1 shown in FIG. 1.
  • FIG. 3A is a virtual development of a part of the first stent body 10 of the first embodiment.
  • FIG. 3B is a virtual development of a part of the second stent body 20 of the first embodiment.
  • FIG. 3C is a virtual development of a part of the stent 1 of the first embodiment.
  • FIG. 4A is a diagram explaining the outer diameter D1 of the first stent body 10 alone.
  • FIG. 4B is a diagram explaining the outer diameter D2 of the second stent body 20 alone.
  • FIG. 5 is a diagram showing the process of inserting the second stent body 20 into the first stent body 10.
  • FIG. 6 is a cross-sectional view of the stent 1 cut at the position of the arrow s1-s1 in FIG. 1.
  • Materials with high radiopacity that can be used as markers may be metals or synthetic resins.
  • Metal materials include, for example, gold, tantalum, platinum, tungsten, iridium, platinum tungsten, etc., and alloy materials thereof. Also included are radiopaque polymer materials to which radiopaque fillers or the like have been added.
  • a wire made of a composite material having a core material made of the aforementioned metal material coaxially within a nickel-titanium wire can be used.
  • the method of attaching the marker to the stent 1 can be any suitable method that has been used to attach a marker to a conventionally known stent, such as, for example, laser soldering of gold-tin or silver-tin, mechanical crimping, or resin bonding.
  • markers of this embodiment include “ring markers,” “coil markers,” “crimp markers,” “radiopaque wire markers,” and “radiopaque struts or radiopaque wires.” Note that the above-mentioned examples and their names are classified and named by the applicant for convenience, and various marker shapes that are known in the art can be used.
  • a ring marker is, for example, a marker part that is highly radiopaque and has a ring or cylindrical shape and is fixed to a strut or the like by soldering or adhesive.
  • a coil marker is a marker made of a linear member made of a highly radiopaque material that is formed into a coil shape and wrapped around a strut or the like and fixed in place by soldering, adhesive, etc.
  • a crimp marker is, for example, a marker part with a highly radiopaque ring or cylindrical shape that is fixed to a strut or the like by crimping. If a crimp marker is used for the first wire marker part 31 and the second wire marker part 32, there is a risk that the crimping will cause the marker to become eccentric, making it difficult to insert the marker into the catheter, and since there are no slits in the wire part, it is difficult to ensure strength. Therefore, it is preferable to use a ring marker or a coil marker for the first wire marker part 31 and the second wire marker part 32.
  • a radiopaque wire marker is a marker made of highly radiopaque wire that is laid along or wrapped around a strut and the end of the wire is fixed to the strut by soldering, gluing, etc.
  • Radiopaque wire markers are similar in form to the coil markers mentioned above, but are classified differently from coil markers in that they are not wound densely enough to be called a coil.
  • a radiopaque strut or wire is one in which the strut or wire itself is made of a highly radiopaque material, or one in which a highly radiopaque material is tightly attached to the entire or partial surface of the strut by plating, painting, etc.
  • Figure 8 is an exploded, enlarged view of the vicinity of the distal LD2 end of the wire 2.
  • proximal LD1 end 11a of the first strut 11 two first struts 11 are arranged facing each other, and the distal LD2 side of the wire 2 is inserted through the portion where the first struts 11 face each other and welded to the end.
  • the first wire marker portion 31 is a coil marker formed by coiling a linear member made of a highly radiopaque material, and is fixed by welding in a position covering the end portion 11a on the proximal LD1 side of the first strut 11.
  • the first wire marker portion 31 is configured as a tightly wound coil near the center of the first wire marker portion 31, and is configured as a coil wound with spaces between them near both ends of the first wire marker portion 31. This configuration prevents the wire 2 from bending.
  • the proximal LD1 end 21a of the second strut 21 is arranged so that two second struts 21 face each other, and the distal LD2 end of the wire 2 is located at the part where the second struts 21 face each other and is fixed by welding.
  • the second wire marker portion 32 is a ring marker in which a marker part formed into a cylindrical shape from a material with high radiopacity is fixed to the strut by soldering, and is fixed by soldering in a position covering the end portion 21a on the proximal LD1 side of the second stent body 20.
  • the second wire marker portion 32 is disposed at a distance on the distal LD2 side from the first wire marker portion 31.
  • the region between the first wire marker portion 31 and the second wire marker portion 32 is hereinafter referred to as the separation portion 33. It is desirable that the length of the separation portion 33 in the LD direction is, for example, 0.6 mm or more and 2.0 mm or less.
  • the first wire marker portion 31 and the second wire marker portion 32 are positioned at a predetermined interval in the axial direction LD. By being positioned in this manner, the positions of the proximal LD1 ends of the first stent body 10 and the second stent body 20 can be correctly confirmed. In addition, as described below, they can be used as a marker for the retraction position of the catheter C (see FIG. 9, etc.) during radial expansion.
  • the first wire marker portion 31 is configured to have a longer length in the LD direction than the second wire marker portion 32. Therefore, the first wire marker portion 31 and the second wire marker portion 32 can be clearly distinguished and visually recognized. It is desirable that the first wire marker portion 31 is 1.5 times or more longer in the LD direction than the second wire marker portion 32 in order to distinguish and easily recognize the two. It is further desirable that the first wire marker portion 31 is 2 times or more longer in the LD direction than the second wire marker portion 32. For example, it is desirable that the length of the second wire marker portion 32 is 0.5 mm or more and 1.5 mm or less, and the first wire marker portion 31 is 1.5 times or more longer in the LD direction than the second wire marker portion 32.
  • the first stent marker portion 111 is formed in a substantially square pipe shape and is a crimped marker that is crimped to the end portion on the distal LD2 side of the first stent body 10.
  • the first stent body 10 has two ends on the distal LD2 side, so the first stent marker portion 111 is provided in two locations.
  • the second stent marker portion 121 is formed in a substantially square pipe shape, and is a crimp marker that is crimped to the distal LD2 end of the second stent body 20 in a similar manner to the first stent marker portion 111.
  • the second stent body 20 has two distal LD2 ends, so the first stent marker portion 111 is provided in two locations.
  • the first stent marker portion 111 is arranged at a different position in the axial direction LD of the stent from the second stent marker portion 121. More specifically, the second stent marker portion 121 is arranged on the more distal LD2 side than the first stent marker portion 111.
  • the inner cell 22 on the most distal LD2 side is made longer on the distal LD2 side than the other cells (the inner cell 22 and the outer cell 12 on the more proximal LD1 side), so that the second stent marker portion 121 is arranged on the more distal LD2 side than the first stent marker portion 111.
  • the first stent marker portion 111 and the second stent marker portion 121 are marker members of the same shape and size, and are arranged such that the second stent marker portion 121 is positioned more distally LD2 than the first stent marker portion 111 in the axial direction LD of the stent 1.
  • the first stent marker portion 111 and the second stent marker portion 121 are arranged such that the positions in the axial direction of the stent 1 are different throughout the marker.
  • the first stent marker portion 111 and the second stent marker portion 121 may be arranged such that the position in the axial direction of the stent 1 is different from the second stent marker portion 121 in a portion of the marker. More specifically, for example, the axial length of the second stent marker portion 121 may be configured to be longer than the axial length of the first stent marker portion 111, and either or both of the positions of the proximal LD1 end portion and the distal LD2 end portion may be different from the other position.
  • first stent marker portion 111 and the second stent marker portion 121 it is not necessary for all of the first stent marker portion 111 and the second stent marker portion 121 to have the form exemplified in this embodiment, and for example, a part of the first stent marker portion 111 may be arranged at the same position in the axial direction LD as the second stent marker portion 121. Similarly, a part of the second stent marker portion 121 may be arranged at the same position in the axial direction LD as the first stent marker portion 111.
  • the blood vessel lumen is expanded, the patency of the lesion site is ensured, and blood flow can be resumed.
  • removing (retrieving) the stent 1 from the blood vessel lumen after a predetermined period of time has elapsed complications such as restenosis, re-occlusion, and thrombosis due to the placement of the stent can be prevented.
  • the first stent marker portion 111 and the second stent marker portion 121 can be distinguished and recognized, respectively, so that the state of the first stent body 10 and the second stent body 20 can be properly grasped, and the treatment can be performed more safely and reliably.
  • the stent 1 of the first embodiment has excellent shape-following properties, and therefore has high blood vessel protection properties.
  • the stent 1 of the first embodiment can be used not only for blood vessels but also for the treatment of luminal structures in general, such as the esophagus and large intestine.
  • the stent 1 of the first embodiment can also be used to treat cerebral vasospasm. Note that the other stents described below also have the same effects as the stent 1 of the first embodiment.
  • FIG. 9 is a diagram showing an example of an image captured in a diameter reduction imaging step in which the second stent marker portion 121 is imaged in a state in which the stent 1 is reduced in diameter at a planned diameter expansion position in a living body lumen.
  • Fig. 10 is a diagram showing an example of an image captured in a transition imaging step in which the second stent marker portion 121 is imaged in a state in which the stent 1 is in the middle of transitioning from a reduced diameter state to an expanded diameter state at a planned diameter expansion position in a living body lumen.
  • FIG. 11 is a diagram showing an example of an image captured in a diameter expansion imaging step in which the second stent marker portion 121 is imaged in a state in which the stent 1 is expanded in diameter at a diameter expansion position in a living body lumen.
  • Fig. 12 is a diagram showing an example of an image captured in a diameter reduction imaging step.
  • Fig. 13 is a diagram showing an example of an image captured in a transition imaging step.
  • Fig. 14 is a diagram showing an example of an image captured in a diameter expansion imaging step.
  • the catheter C is provided on the distal LD2 side with a catheter marker portion CM that has a high degree of radiopacity, making its position visible under X-ray observation.
  • the catheter marker portion CM is provided at the distal LD2 end of the catheter C or near the distal LD2 end. Note that near the distal LD2 end of the distal end of the catheter C does not necessarily mean the exact end position, but also includes the case where the catheter marker portion CM is provided at a position within 1.5 mm away from the end. Note that the examples shown in Figures 9 to 14 illustrate an example in which the second stent marker portion 121 is shifted toward the distal LD2 side from the first stent marker portion 111 by a larger amount than that shown in Figure 1 of the first embodiment.
  • the imaging results it is possible to confirm the relative positions of the first stent marker portion 111 and the second stent marker portion 121 and the catheter marker portion CM, and the relative positions of the first wire marker portion 31 and the second wire marker portion 32 and the catheter marker portion CM.
  • the second stent marker portion 121 is positioned further toward the distal LD2 side than the first stent marker portion 111, it is possible to distinguish and recognize the first stent marker portion 111 from the second stent marker portion 121. Therefore, it is possible to visually confirm that the expansion of the stent 1 is proceeding appropriately, that the position of the stent 1 has not moved accidentally, and that the expansion of the stent 1 has started.
  • the practitioner uses an X-ray imaging device to capture moving images of the first stent marker portion 111 and the second stent marker portion 121, and the first wire marker portion 31 and the second wire marker portion 32 through X-ray transmission (imaging step during expansion).
  • imaging step during expansion in the imaging step during expansion, the second stent marker portion 121 is positioned shifted toward the distal LD2 side from the first stent marker portion 111, so that the first stent marker portion 111 and the second stent marker portion 121 can be distinguished and recognized from each other.
  • a separation portion 33 is provided between the first wire marker portion 31 and the second wire marker portion 32 with a predetermined gap therebetween. If the catheter marker portion CM is located at a position overlapping the separation portion 33 or at a position on the proximal LD1 side of the separation portion 33, it can be confirmed that the catheter C has been reliably retracted from the range of the stent 1 expanding (the range of the first stent body and the second stent body). Therefore, by performing the imaging step during expansion with the catheter marker portion CM located at a position overlapping the separation portion 33 or at a position on the proximal LD1 side of the separation portion 33, it can be visually confirmed that the stent 1 has completed the appropriate expansion at the appropriate position.
  • the above operations and imaging steps are carried out in reverse order.
  • the catheter C is pushed toward the distal LD2 while preventing the wire 2 from accidentally moving in the LD direction. Whether the wire 2 is moving can be easily and reliably determined by observing the first wire marker portion 31, the second wire marker portion 32, and the separation portion 33.
  • the first wire marker portion 31 and the second wire marker portion 32 can be distinguished from the catheter marker portion CM by being spaced apart from each other by a predetermined distance.
  • the catheter marker portion CM when moving from a reduced diameter state to an expanded diameter state, by moving the catheter marker portion CM to a position where it overlaps with the separation portion 33, it is possible to confirm that the catheter C has moved to a position where the stent can be sufficiently expanded.
  • the separation portion 33 is provided, it is easy to determine that the catheter marker portion CM is in a position where it overlaps with the separation portion 33.
  • the first wire marker portion 31 is configured to be longer in the LD direction than the second wire marker portion 32. Therefore, the first wire marker portion 31 and the second wire marker portion 32 can be clearly distinguished from each other and visually recognized, and for example, the orientation of the proximal side and the distal side can be easily determined even in a blood vessel that repeatedly bends.
  • the tip position on the distal LD2 side of the first wire marker portion 31B in the second embodiment is provided at a position where a separation portion 33 is provided between the first wire marker portion 31 and the second wire marker portion 32, similar to the first wire marker portion 31 in the first embodiment.
  • the rear end position on the proximal LD1 side of the first wire marker portion 31B is provided continuously to the rear end position on the proximal LD1 side of the wire 2. Therefore, the stent 1B in the second embodiment can be visually confirmed up to the rear end position on the proximal LD1 side of the wire 2 under observation using radiation. With this configuration, it is possible to quickly detect the force of pushing or pulling the stent 1B acting on the wire 2. This point will be explained below using a schematic diagram.
  • FIG. 16 is a schematic diagram showing an ideal state in which the stent 1B of the second embodiment is expanded and no unnecessary force is applied to the wire 2.
  • FIG. 17 is a schematic diagram showing a state in which the stent 1B of the second embodiment is expanded and a force is acting to pull the wire 2 toward the proximal LD1 side.
  • FIG. 18 is a schematic diagram showing a state in which the stent 1B of the second embodiment is expanded and a force is acting to push the wire 2 toward the distal LD2 side.
  • FIG. 19 is a schematic diagram showing a state in which the stent 1B of the second embodiment is expanded and a force is acting to push the wire 2 toward the distal LD2 side. Note that the catheter is omitted in FIGS. 16 to 19 to make the state of the wire 2 easier to see.
  • the stent 1B of the second embodiment is a stenosis dilation stent that is used to dilate the lumen of a stenosis in order to ensure patency of the lesion when stenosis occurs in a biological lumen. Therefore, if the position of stent 1B is accidentally moved while in contact with the inner wall of the biological lumen, there is a risk of damaging the inner wall of the biological lumen. Therefore, it is important that the stent 1 is operated in such a way that its position is not accidentally moved when the stent body is deployed.
  • the first wire marker portion 31B may be provided up to the end of the wire 2 on the proximal LD1 side.
  • the first wire marker portion 31B may be provided in a range of 20 mm or more from the end of the distal LD2 side, where the separation portion 33 is provided between the first wire marker portion 31B and the second wire marker portion 32, toward the proximal LD1 side of the wire 2.
  • a specific marker shape has been described as an example.
  • the specific shape of the marker in each embodiment is not limited to the example in the embodiment, and various types of markers that are conventionally known can be used.
  • the ring marker portion may be replaced with a coil marker, or the radiopaque wire portion may be replaced with a coil marker.
  • the strut portion is also described as having a marker. However, this is not limited thereto, and for example, the marker on the strut portion may be omitted.
  • a stent with a two-layer structure has been described as an example.
  • the present invention is not limited to this, and may be, for example, a stent with a one-layer structure.
  • the rear end position of the first wire marker portion 31B on the proximal LD1 side is provided continuously up to the rear end position of the proximal LD1 side of the wire 2.
  • the first wire marker portion 31B may be provided discontinuously.
  • discontinuously means, for example, a form in which multiple first wire marker portions 31B are arranged at intervals in a dashed line shape.

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

Abstract

L'invention concerne un stent qui permet de distinguer et d'identifier un marqueur disposé sur un fil d'autres marqueurs, et une méthode d'imagerie du stent.　Un stent 1 est inséré dans un cathéter C et placé à travers celui-ci, et est utilisé pour une application d'expansion d'une zone sténosée dans une lumière biologique. Le stent 1 comprend un fil 2 et des corps de stent 10, 20 reliés au côté distal du fil 2. Le stent 1 comprend en outre une première partie de marqueur de fil 31 disposée sur le fil 2, et une deuxième partie de marqueur de fil 32 disposée sur le fil 2 et située en position distale par rapport au premier marqueur 31 avec un espace entre ceux-ci dans la direction axiale du stent 1.
PCT/JP2024/043337 2023-12-25 2024-12-09 Stent et méthode d'imagerie de stent Pending WO2025142417A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2023-218655 2023-12-25
JP2023218655 2023-12-25

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WO2025142417A1 true WO2025142417A1 (fr) 2025-07-03

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009525077A (ja) * 2006-01-30 2009-07-09 エックステント・インコーポレーテッド カスタム長のプロテーゼの展開のための装置及び方法
JP2019530516A (ja) * 2016-10-04 2019-10-24 マイクロベンション インコーポレイテッドMicrovention, Inc. ステント送達のための方法及び装置
JP7150202B2 (ja) * 2020-10-20 2022-10-07 株式会社T.G.Medical ステント

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009525077A (ja) * 2006-01-30 2009-07-09 エックステント・インコーポレーテッド カスタム長のプロテーゼの展開のための装置及び方法
JP2019530516A (ja) * 2016-10-04 2019-10-24 マイクロベンション インコーポレイテッドMicrovention, Inc. ステント送達のための方法及び装置
JP7150202B2 (ja) * 2020-10-20 2022-10-07 株式会社T.G.Medical ステント

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