WO2017159039A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2017159039A1
WO2017159039A1 PCT/JP2017/002011 JP2017002011W WO2017159039A1 WO 2017159039 A1 WO2017159039 A1 WO 2017159039A1 JP 2017002011 W JP2017002011 W JP 2017002011W WO 2017159039 A1 WO2017159039 A1 WO 2017159039A1
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WO
WIPO (PCT)
Prior art keywords
stent
axis
contracted
balloon
ring
Prior art date
Application number
PCT/JP2017/002011
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English (en)
Japanese (ja)
Inventor
武史 堂園
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2017159039A1 publication Critical patent/WO2017159039A1/fr

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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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure

Definitions

  • the present invention relates to a stent.
  • a stent In order to treat various diseases caused by stenosis or occlusion of a lumen such as a blood vessel, a stent is placed in a living body lumen to expand a lesion such as a stenosis or an occlusion to secure a lumen. It is a medical tool used to do.
  • Patent Document 1 discloses a stent that includes linear struts that form a cylindrical outer periphery and a connecting portion that connects the struts, and is configured to be contractible and expandable.
  • the stent When the stent is placed in the living body lumen, the stent is transferred to the lesioned part in a contracted state, and the stent is expanded and placed in the lesioned part.
  • the stent is required to have a radial force (expansion holding force) in order to maintain a state where the stent is pushed and expanded in the living body lumen.
  • a radial force expansion holding force
  • the stent profile cross-sectional shape in the contracted state is increased, and the permeability when the stent is transferred into the living body lumen is reduced.
  • an object of the present invention is to provide a stent capable of ensuring the radial force necessary for maintaining the expanded state in the living body lumen while improving the passage through the living body lumen.
  • a stent of the present invention is a stent that is disposed in a contracted state on the outer periphery of a balloon that can be expanded and contracted and expands as the balloon expands, and is formed by an annular linear member. And a plurality of ring portions that form a tube-shaped outer periphery by being arranged along the axial direction of the balloon, and connecting portions that connect the adjacent ring portions.
  • the ring portion disposed at the forefront among the plurality of ring portions is a long axis along a first axis inclined with respect to a vertical axis perpendicular to the axial direction of the balloon in a state where the stent is contracted,
  • the stent is formed so as to become smaller as it expands and deforms from the contracted state.
  • the profile of the tip can be made smaller than that of a cylindrical stent. Further, as the stent expands and deforms, the angle formed between the vertical axis and the first axis in the ring portion decreases, and the stent rises in a direction perpendicular to the axial direction of the balloon. The radial force increases. As a result, the stent having the above-described configuration is necessary for maintaining the expanded state of the lesioned part such as the stenosis part in the expanded state while improving the passage through the living body lumen in the contracted state. A radial force can be secured.
  • FIG. 1 is an overall configuration diagram of a stent delivery system according to an embodiment.
  • (A) is a diagram showing the balloon and stent in a deflated state
  • (B) is a diagram in which the balloon and stent shown in (A) are rotated 90 degrees around the axis of the stent.
  • FIG. 3 is a development view in which a part of the outer periphery of the contracted stent is linearly cut along the axial direction and developed. It is a figure which shows the balloon and stent of an expanded state
  • (A) is the figure seen from the same direction as FIG. 2 (A)
  • (B) is the figure seen from the same direction as FIG. 2 (B). It is.
  • FIG. 1 It is a top view for demonstrating the shape of the ring part of the stent which concerns on embodiment, (A) shows the ring part of the contracted state, (B) shows the ring part of the expanded state. It is a schematic diagram for demonstrating the structure of the ring part which concerns on embodiment, (A) shows the stent of the contracted state, (B) shows the stent of the expanded state. It is the schematic which shows the usage example of the stent which concerns on embodiment, and a stent delivery system, (A) is a figure which shows a mode that the stent delivery system is transferred to a constriction part, (B) is a balloon and a stent. (C) is a figure which shows the state which detained the stent in the stenosis part.
  • the stent 200 according to the present embodiment is a so-called balloon expandable stent that is disposed in a contracted state on the outer periphery of a balloon 120 that can be contracted and expanded, and expands and deforms (plastically deforms) by the expansion force of the balloon 120.
  • a stent delivery system including the balloon catheter 100 and the stent 200 is used to deliver the stent 200 to a lesion such as a stenosis occurring in a blood vessel, bile duct, trachea, esophagus, urethra, or other living body lumen. 10 is used.
  • the stent delivery system 10 delivers the stent 200 to the lesioned part in a contracted state, expands it, and puts it in the lesioned part.
  • the side inserted into the living body is referred to as “tip” or “tip side”
  • the proximal side operated by the operator is referred to as “base end” or “base end side”.
  • the distal end portion means a certain range including the distal end (the most distal end) and the periphery thereof
  • the proximal end portion means a certain range including the proximal end (the most proximal end) and the periphery thereof.
  • the balloon catheter 100 includes a long shaft 110, a balloon 120 that is provided on the distal end side of the shaft 110 and can be contracted and expanded, and a hub 130 that is fixed to the proximal end of the shaft 110.
  • the shaft 110 includes an outer tube 111 that is a tubular body having an open front end and a base end, and an inner tube 112 disposed inside the outer tube 111.
  • the expansion fluid may be gas or liquid, and examples thereof include gas such as helium gas, CO 2 gas, and O 2 gas, and liquid such as physiological saline and contrast medium.
  • a guide wire W is inserted into the inner tube 112 through an opening 113 formed on the way between the distal end side and the proximal end side of the shaft 110. It is configured as a so-called rapid exchange type catheter to be introduced. However, the balloon catheter 100 may be configured as a so-called over-the-wire catheter.
  • the distal end portion of the inner tube 112 penetrates through the inside of the balloon 120 and opens at the distal end side of the balloon 120. As shown in FIG. 2A, contrast markers 114a and 114b are installed in the inner tube 112.
  • the outer tube 111 and the inner tube 112 are preferably formed of a material having a certain degree of flexibility.
  • a material having a certain degree of flexibility examples include polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, and ethylene-acetic acid.
  • Polyolefin such as vinyl copolymer, ionomer, or a mixture of two or more of these, thermoplastic resins such as polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, silicone rubber, latex rubber, etc. Is mentioned.
  • the balloon 120 is for expanding and expanding the stent 200 from the inner side.
  • the proximal end portion of the balloon 120 is fixed to the distal end portion of the outer tube 111, and the distal end portion of the balloon 120 is fixed to the distal end portion of the inner tube 112.
  • the balloon 120 is preferably formed of a material having a certain degree of flexibility.
  • a material having a certain degree of flexibility for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or these two kinds
  • Polyolefins such as the above mixtures, soft polyvinyl chloride resins, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, thermoplastic resins such as fluorine resins, silicone rubbers, latex rubbers, and the like can be used.
  • the hub 130 includes a proximal end opening 131 that functions as a port through which the expansion fluid flows in and out.
  • the proximal end opening 131 communicates with an expansion lumen formed in the outer tube 111.
  • constituent material of the hub 130 examples include thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer.
  • the stent 200 has a hollow tube shape.
  • the stent 200 includes a plurality of ring portions 210 that form a tube-shaped outer periphery, and a connecting portion 220 that connects adjacent ring portions 210 to each other.
  • the ring portion 210 is formed by an annular linear member 201 and is arranged at intervals along the tube-shaped axis X direction.
  • the tube-shaped axis X direction is the same as the axial direction of the balloon 120.
  • the tube-shaped axis formed by the ring portion 210 is simply referred to as “axis X”, and the tube-shaped axis X, that is, the axis orthogonal to the axis of the balloon 120 is simply referred to as “vertical axis”. Y ”.
  • the circumferential direction around the tube-shaped axis X is simply described as “circumferential direction C” (see FIG. 5A), and the radial direction of the ring portion 210 is simply described as “radial direction R” (FIG. 5). 5 (A)).
  • the stent 200 is held on the outer periphery of the balloon 120 in a contracted state.
  • the balloon 120 expands as the balloon 120 expands as shown in FIG.
  • the “shrunk state” of the stent 200 indicates a state where the stent 200 is placed so as to cover the outer periphery of the balloon 120 before being expanded, and then contracted and crimped by applying pressure.
  • the “expanded state” of the stent 200 indicates a state in which the stent 200 is expanded as the balloon 120 is expanded until the internal pressure reaches the recommended expansion pressure.
  • the recommended expansion pressure can be appropriately changed according to the product specifications (for example, outer diameter, application, etc.) of the balloon 120 and the stent 200, but can be set to, for example, 8 atm to 12 atm.
  • the ring portion 210 disposed at the forefront among the plurality of ring portions 210 is a first portion inclined with respect to the vertical axis Y as shown in FIG. And has a substantially elliptical shape including a major axis along the axis D1 and a minor axis along the second axis D2 orthogonal to the first axis D1.
  • the ring portion 210 is preferably formed symmetrically with respect to each of the first axis D1 and the second axis D2.
  • plan view means a direction perpendicular to a plane formed by an annular outline formed by the linear member 201 forming the ring portion 210 (FIG. 2A, arrow P in FIG. 4). It is a plan view viewed from the direction indicated by.
  • the ring portion 210 is not limited to the case where the annular outer shape formed by the linear member 201 is on the same plane, and may be three-dimensionally formed in the depth direction of FIG.
  • the angle ⁇ 1 formed between the vertical axis Y and the first axis D1 can be, for example, 30 to 60 degrees.
  • each first axis D1 is Inclined with respect to the vertical axis Y.
  • the angles ⁇ 1 formed between the vertical axis Y and the first axis D1 are preferably the same. Moreover, it is preferable that the direction of the circumferential direction C is mutually corresponded in the some ring part 210. FIG. That is, it is preferable that the plurality of ring portions 210 are provided in parallel to each other along the axial direction of the balloon 120.
  • the apex 211 in the major axis direction of the substantially elliptical shape is curved so as to be folded inwardly of the outer shape of the substantially elliptical shape.
  • a folded portion 212 is provided. Note that “turning back inward from the substantially elliptical outer shape” is not limited to a configuration of turning back in a direction along the inner side in the radial direction R of the ring portion 210 as shown in FIG. You may incline with respect to the direction along radial direction R inner side.
  • the “substantially elliptical shape” is not limited to the elliptical shape, and includes a wide elongated shape formed by a line passing through the end point of the long axis and the end point of the short axis.
  • the shape including the folded portion 212 on the elliptical top portion 211 as in the present embodiment is also included in the substantially elliptical shape.
  • the ratio (L2 / L1) of the length L2 along the second axis D2 to the length L1 along the first axis D1 of the stent 200 is a value less than 1.
  • the ratio (L2 / L1) is not particularly limited as long as it is a value less than 1, but can be set to 0.4 to 0.8, for example.
  • the connecting portion 220 is provided between the straight portion 221 parallel to the first axis D1 of the adjacent ring portions 210, and between the straight portion 221 and the ring portion 210. It has a distal end side bending portion 222a and a proximal end side bending portion 222b (curving portion) that are curved in a convex shape in a direction in which the ring portion 210 and the straight portion 221 extend.
  • the distal-side curved portion 222 a is connected to the distal-side ring portion 210
  • the proximal-side curved portion 222 b is connected to the proximal-side ring portion 210.
  • the distal end side curved portion 222a and the proximal end side curved portion 222b are prevented from hitting the ring portion 210, and the stent 200 is sufficiently
  • the diameter can be reduced.
  • the distal-side bending portion 222a is disposed on the distal-side ring portion 210 side with reference to an extended line 221a that extends a straight line along the straight-line portion 221, and the proximal-side bending is performed.
  • the part 222b is arranged on the ring part 210 side on the base end side.
  • the ratio of the length L2 along the second axis D2 to the dimension of the folded portion 212 of the ring part 210 and the length L1 along the first axis D1 takes into account the relationship with the recommended expansion pressure of the balloon 120 and the like. Can be set to any value.
  • the stent 200 moves in the radial direction along with the deformation of the balloon 120 as shown in FIGS. 4 and 5B. R expands outward.
  • the ring portion 210 deforms so that the first axis D1 rises in the vertical axis Y direction as shown in FIG. 6B.
  • the top portion 211 is easily spread in the direction along the second axis D2.
  • the ring portion 210 is deformed so that the deformation amount in the direction along the second axis D2 is larger than the deformation amount in the direction along the first axis D1, as shown in FIG.
  • the outer shape of the ring portion 210 is easily deformed so as to approach a perfect circle shape.
  • the ratio (L22 / L12) of the length L22 along the second axis D2 to the length L12 along the first axis D1 is the stent 200. Becomes larger than the ratio (L2 / L1) of the contracted state.
  • the length L12 along the first axis D1 is equal to the length L22 along the second axis D2, and the length L12 along the first axis D1 is the first length L12 along the first axis D1.
  • the ratio of the length L22 along the second axis D2 (L22 / L12) is 1.
  • the angle ⁇ 2 formed between the vertical axis Y and the first axis D1 shown in FIG. 6B is equal to the vertical axis Y when the stent 200 shown in FIG. 6A is contracted. Smaller than the angle ⁇ 1 formed between the first axis D1 and the first axis D1.
  • the ring portion 210 in a state where the stent 200 is expanded, is configured such that the angle ⁇ 2 formed between the vertical axis Y and the first axis D1 is 0 (zero) degrees, that is, perpendicular to the first axis D1. It is deformed so that it rises to a position where the axis Y overlaps.
  • the material constituting the stent 200 is preferably a metal having biocompatibility, such as an iron base alloy such as stainless steel, tantalum (tantalum alloy), platinum (platinum alloy), gold (gold alloy), cobalt chromium alloy, or the like. And cobalt base alloys, titanium alloys, niobium alloys and the like.
  • the stent 200 may be, for example, a biodegradable stent composed mainly of a polymer or the like, and the material is not particularly limited as long as it is known as a balloon expandable stent.
  • the balloon 120 holding the stent 200 is delivered to the stenosis N along the guide wire W arranged in the blood vessel V prior to the introduction of the balloon catheter 100.
  • the ring portion 210 of the stent 200 is held by the balloon 120 in a contracted state.
  • the ring portion 210 arranged at the forefront has a substantially elliptical outer shape in a contracted state, and the first axis D1 is inclined with respect to the vertical axis Y. Therefore, the distal end portion of the stent 200 has a shape that tapers toward the distal end. Thereby, the passage property of the stent 200 into the blood vessel V can be improved.
  • the most advanced ring portion 210 not only the most advanced ring portion 210 but also all the ring portions 210 have a substantially elliptical outer shape, and the first axis D1 is inclined with respect to the vertical axis Y. .
  • the profile of the whole stent 200 becomes small, the permeability to the blood vessel V can be further improved.
  • the balloon 120 is expanded.
  • the stent 200 expands so as to expand toward the stenosis N, and is crimped to the stenosis N.
  • the ring portion 210 is deformed so that an angle formed between the vertical axis Y and the first axis D1 of the ring portion 210 is small, that is, the angle rises in a direction perpendicular to the axial direction of the balloon 120.
  • the outer shape of the ring portion 210 formed by the linear member 201 is deformed so as to approach a perfect circle shape.
  • the radial force can be improved as compared with the case where the ring portion 210 is elliptical and the first axis D1 is inclined with respect to the vertical axis Y, the expanded state of the constricted portion N is maintained. The necessary radial force can be ensured.
  • the balloon 120 is deflated, the balloon catheter 100 and the guide wire W are removed from the living body, and the expanded stent 200 is placed in the stenosis portion N to perform the procedure. Exit. Thereby, the expanded state of the constriction N can be maintained.
  • the ring portion 210 arranged at the forefront among the plurality of ring portions 210 in a state where the stent 200 is contracted is orthogonal to the axis X direction, that is, the axis direction of the balloon 120. It has a substantially elliptical outer shape including a long axis along the first axis D1 inclined with respect to the vertical axis Y and a short axis along the second axis D2 orthogonal to the first axis D1. Further, the angle formed between the vertical axis Y and the first axis D1 of the ring portion 210 is formed so as to decrease as the stent 200 expands and deforms from the contracted state.
  • the stent 200 has a shape that tapers toward the tip in a state where the stent 200 is contracted. Thereby, the profile of the front-end
  • the ratio of the lengths L2 and L22 along the second axis D2 to the lengths L1 and L12 along the first axis D1 of the ring portion 210 increases as the stent 200 expands and deforms from the contracted state. Become. That is, with the expansion and deformation, the outer shape of the ring portion 210 formed by the linear member 201 is deformed so as to approach a perfect circle, so that the radial force can be improved.
  • At least one of the ring portions 210 arranged on the proximal end side with respect to the ring portion 210 arranged at the most distal end has a substantially elliptical outer shape in a state where the stent 200 is contracted.
  • the ring portion 210 disposed at the forefront in a state in which the stent 200 is contracted, and the ring portion 210 that is disposed at a proximal end side from the front end and has a substantially elliptical outer shape in the contracted state have a vertical axis.
  • the angles ⁇ 1 formed between Y and the first axis D1 are the same, and the directions in the circumferential direction C coincide with each other. That is, the plurality of ring portions 210 are provided in parallel with each other along the axial direction of the balloon 120.
  • the cross-sectional shape in the axis X direction of the stent 200 can be made uniform. .
  • the radial force of the whole stent 200 can be improved uniformly.
  • the ring portion 210 includes at least a folded portion 212 configured to be bent so as to be folded inward from the substantially elliptical outer shape at the top portion 211 in the first axis D1 direction.
  • the ring portion 210 can be relatively easily deformed so as to approach a perfect circular shape, so that the radial force can be further improved. Therefore, the radial force necessary for maintaining the expanded state of the stenosis can be more reliably held in a state where the stent 200 is expanded.
  • the linear portion 221 is provided between the linear portion 221 parallel to the first axis D1 of the adjacent ring portions 210, and between the linear portion 221 and the ring portion 210. It has the front end side bending part 222a and the base end side bending part 222b which curve in the convex shape toward the direction where the part 221 extends.
  • the distal side curved portion 222a and the proximal side curved portion 222b are prevented from coming into contact with the ring portion 210, and the distance between the ring portion 210 and the straight portion 221 is sufficiently large. Can be shortened. Therefore, since the diameter of the stent 200 can be sufficiently reduced, the passability of the stent 200 into the living body lumen can be further improved.
  • all the ring portions have a substantially elliptical outer shape.
  • the present invention is not limited to this configuration, and only the ring portion arranged at the forefront among a plurality of ring portions is used. Need only have a substantially elliptical outer shape.
  • the ring part demonstrated the structure provided with one folding
  • returning part may be provided with the several folding
  • Stent delivery system 100 balloon catheter, 110 shaft, 120 balloon, 130 hub, 200 stents, 201 linear member, 210 ring part, 211 top, 212 Folding part, 220 connecting part, 221 straight section, 222a distal end side bending portion (curving portion), 222b proximal-side curved portion (curved portion), X stent axis (tube-shaped axis), Y vertical axis of the stent (vertical axis of tube shape), D1 first axis, D2 second axis, ⁇ 1, ⁇ 2 Angles formed between the vertical axis and the first axis.

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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

[Problème] Obtenir un stent qui peut passer plus facilement à travers la lumière d'un organisme vivant et qui peut fournir de façon plus fiable la force radiale nécessaire pour maintenir la lumière d'un organisme vivant dans un état dilaté. [Solution] Un stent 200 comprend une pluralité de parties annulaires 210 et des parties de connexion 220. Parmi la pluralité de parties annulaires, au moins la partie annulaire disposée à l'extrémité distale extrême a une forme externe sensiblement elliptique comprenant un axe long s'étendant le long d'un premier axe D1, qui est incliné par rapport à un axe vertical Y, et un axe court s'étendant le long d'un second axe D2, qui est orthogonal au premier axe, dans un état dans lequel le stent 200 est contracté. En outre, l'angle formé entre l'axe vertical et le premier axe diminue lorsque le stent 200 dans un état contracté se dilate et est déformé.
PCT/JP2017/002011 2016-03-18 2017-01-20 Stent WO2017159039A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016055837A JP2019076121A (ja) 2016-03-18 2016-03-18 ステント
JP2016-055837 2016-03-18

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Publication Number Publication Date
WO2017159039A1 true WO2017159039A1 (fr) 2017-09-21

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PCT/JP2017/002011 WO2017159039A1 (fr) 2016-03-18 2017-01-20 Stent

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WO (1) WO2017159039A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020206048A1 (fr) * 2019-04-01 2020-10-08 The Foundry, Llc Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0956823A (ja) * 1994-02-25 1997-03-04 E Fischell Robert 多数の閉じた円形構造を有するステント
JP2006520648A (ja) * 2003-03-19 2006-09-14 アドヴァンスド バイオ プロスセティック サーフェシーズ リミテッド 中間ストラット相互連結部材を有する管腔ステント

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0956823A (ja) * 1994-02-25 1997-03-04 E Fischell Robert 多数の閉じた円形構造を有するステント
JP2006520648A (ja) * 2003-03-19 2006-09-14 アドヴァンスド バイオ プロスセティック サーフェシーズ リミテッド 中間ストラット相互連結部材を有する管腔ステント

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020206048A1 (fr) * 2019-04-01 2020-10-08 The Foundry, Llc Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation

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