WO2019163914A1 - Dispositif d'élimination de matière étrangère - Google Patents

Dispositif d'élimination de matière étrangère Download PDF

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Publication number
WO2019163914A1
WO2019163914A1 PCT/JP2019/006616 JP2019006616W WO2019163914A1 WO 2019163914 A1 WO2019163914 A1 WO 2019163914A1 JP 2019006616 W JP2019006616 W JP 2019006616W WO 2019163914 A1 WO2019163914 A1 WO 2019163914A1
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WO
WIPO (PCT)
Prior art keywords
distal end
foreign matter
tip
end side
axial direction
Prior art date
Application number
PCT/JP2019/006616
Other languages
English (en)
Japanese (ja)
Inventor
周平 松下
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 WO2019163914A1 publication Critical patent/WO2019163914A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions

Definitions

  • the present invention relates to a foreign matter removing device.
  • the blade is likely to directly contact not only the foreign material but also a normal part in the vicinity thereof, so that the blood vessel wall may be damaged. Yes and highly invasive.
  • the foreign matter can be removed only at the tip portion where the blade is provided, and the removal range is narrow. Take it.
  • an object of the present invention is to provide a foreign matter removing device that can remove and pulverize foreign matter in a minimally invasive manner even if it is a hard foreign matter, and can efficiently proceed with the treatment.
  • the foreign matter removing device of the present invention has a tip portion that can rotate around the axial direction, and a communication hole is formed inside the tip portion.
  • the communication hole is bent in the lateral direction intersecting the axial direction from the distal end side in the axial direction, and communicates with the outside in the distal end side and the lateral direction.
  • the foreign matter removing device having the above configuration, a swirling flow is generated with the rotation of the tip portion, and hard foreign matter is removed by the action of the swirling flow. Therefore, the blood vessel wall may be damaged by the blade like cutting. Even if it is a hard foreign substance, a foreign substance can be removed minimally invasively.
  • the foreign matter is not only crushed by the swirling flow, but also attracted to the tip by the circulation of the swirling flow, and further crushed by the rotating tip, so that the foreign matter can be reliably fined and discharged to the outside of the body. Is easy.
  • FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. It is the side view seen from the code
  • FIG. 10 is a cross-sectional view taken along line 10-10 in FIG. It is a figure which shows the example which used the foreign material removal device and the protection device together.
  • the foreign substance removal device 100 includes a hand operation unit 110, an insertion unit 120, and a tip part 130.
  • the guide wire W can be inserted through the insertion hole 111 formed on the proximal end side of the hand operation unit 110 and the insertion hole 131 formed on the distal end side of the distal end portion 130.
  • the hand operation unit 110 is used to operate the foreign matter removal device 100 by the user.
  • the insertion unit 120 is connected to the distal end side of the hand operation unit 110.
  • the insertion portion 120 is long and flexible, and can be inserted into a blood vessel (biological lumen).
  • the diameter of the insertion portion 120 is not particularly limited, but is, for example, 3 mm to 5 mm.
  • a suction port 121 is formed in the vicinity of the distal end portion 130, and a balloon 122 (expansion / contraction body) is provided.
  • the suction port 121 communicates with a suction port 112 provided in the hand operation unit 110.
  • the suction port 112 can be connected to, for example, a syringe (not shown). By pulling the pusher of the syringe connected to the suction port 112, suction at the suction port 121 occurs.
  • the balloon 122 communicates with the supply / discharge port 113 provided in the hand operation unit 110.
  • the supply / discharge port 113 can be connected to, for example, a syringe (not shown).
  • the balloon 122 is shown in a contracted state in FIG. 1, but for example, when a pusher of a syringe connected to the supply / discharge port 113 is pressed and a working fluid such as physiological saline is supplied, It expands so that a diameter may be enlarged in the direction orthogonal to the direction D1. Further, the expanded balloon 122 is contracted by, for example, pulling a pusher of a syringe connected to the supply / discharge port 113 and discharging a working fluid such as physiological saline from the balloon 122.
  • the distal end portion 130 is provided at the distal end of the insertion portion 120.
  • the suction port 121 and the balloon 122 are located on the proximal side with respect to the distal end portion 130 in the axial direction D1.
  • the distal end portion 130 can be rotated around the axial direction D ⁇ b> 1 by the driving force from the hand operation unit 110.
  • the connector 114 provided in the hand operation unit 110 is connected to the pump and, for example, compressed gas is supplied from the pump, the rotating blades in the hand operation unit 110 thereby rotate, and the tip is linked to this.
  • the part 130 rotates.
  • the distal end portion 130 may be rotated by a driving force from a motor provided in the hand operation unit 110.
  • the insertion unit 120 includes a sheath 123 and a drive shaft 124 disposed therein, and the driving force from the hand operation unit 110 is transmitted through the drive shaft 124 to the distal end portion 130. To be told.
  • the drive shaft 124 and the tip portion 130 are integrated, and the tip portion 130 rotates as the drive shaft 124 is rotated by the driving force from the hand operation unit 110.
  • the drive shaft 124 is hollow, and the lumen 125 inside thereof is in communication with the insertion hole 131.
  • the guide wire W is inserted through the lumen 125 and the insertion hole 131.
  • the sheath 123 has a long cylindrical shape and is flexible.
  • a suction port 121 is formed on the outer periphery on the distal end side of the sheath 123.
  • the suction port 121 communicates with the suction port 112 of the hand operation unit 110 through the lumen of the sheath 123.
  • a lumen 127 is formed in the thick portion 126.
  • the lumen 127 communicates with the balloon 122 and extends to the proximal end side to communicate with the supply / discharge port 113 of the hand operation unit 110.
  • the balloon 122 expands and contracts by the inflow / discharge of the working fluid through the lumen 127.
  • a communication hole 132 is formed inside the tip portion 130.
  • the communication hole 132 is bent in the lateral direction intersecting the axial direction D1 from the distal end side in the axial direction D1, and communicates with the outside of the distal end portion 130 in the distal end side and the lateral direction.
  • the distal end side of the distal end portion 130 has a spherical shape, but the shape of the distal end portion 130 is not limited to this, and may be a cylindrical shape.
  • the communication holes 132 are formed at equal intervals in the rotation direction D2 of the distal end portion 130.
  • three communication holes 132 are formed at equal intervals in the rotation direction D2, but the number is not particularly limited.
  • the insertion part 120 is inserted into the blood vessel along the preceding guide wire W, and the blood vessel is blocked or narrowed by the hard foreign substance S. Delivered to.
  • the hard foreign substance S is, for example, a plaque or a thrombus.
  • the insertion portion 120 is stopped and the balloon 122 is expanded. Expansion of the balloon 122 closes the base end side of the foreign matter S. After the balloon 122 is expanded, the surgeon starts to rotate the distal end portion 130.
  • the tip portion 130 rotates, the blood filled in the communication hole 132 is discharged from the lateral opening of the communication hole 132 by the centrifugal force. Moreover, the opening part of the front end side of the communicating hole 132 will be in a negative pressure state by that, and a suction force will arise on the front end side. And the blood which came out of the opening part of the side direction of the communicating hole 132 flows to the front end side with the suction force.
  • a swirling flow F that circulates from the side of the tip portion 130 to the front and further from the front to the tip portion 130 is generated, whereby the foreign matter S is removed from the blood vessel wall V.
  • the swirling flow F is generated over the entire inner circumference of the blood vessel wall V as the distal end portion 130 rotates, so that the foreign matter S is removed at a time along the entire inner circumference of the blood vessel wall V.
  • the foreign matter S is pulverized by the action of the swirl flow F, drawn to the tip portion 130 by the circulation of the swirl flow F, and further crushed by hitting the rotating tip portion 130.
  • the finely crushed foreign matter S is sucked into the suction port 121 and discharged outside the body.
  • the suction at the suction port 121 may be generated simultaneously with the rotation of the distal end portion 130 or may be generated thereafter.
  • the foreign substance removal device 100 of this embodiment removes the hard foreign substance S from the blood vessel wall V by the swirl flow F, the blood vessel wall V is hardly damaged by the blade as in cutting, and the hard foreign substance S can be removed in a minimally invasive manner. .
  • the swirl flow F is generated using blood in the blood vessel (body fluid in the living body lumen), for example, it is not necessary to press a fluid such as physiological saline into the body to generate the swirl flow F. , Can reduce the burden on the patient.
  • the foreign matter S is not only crushed by the swirl flow F but also drawn to the tip 130 by circulation of the swirl flow F. Then, it is further crushed by the rotating tip 130. For this reason, the foreign material S can be reliably made fine and can be easily discharged outside the body.
  • the swirl flow F is generated not only around the tip 130 but also in front of it. For this reason, the removal range of the foreign substance S is wide, and the treatment can be advanced efficiently.
  • the distal end side of the distal end portion 130 has a spherical shape, and the distal end portion 130 is excellent in safety because it is difficult to damage the vascular wall V even if the distal end side hits the vascular wall V.
  • the communication holes 132 are formed at equal intervals in the rotation direction D2, and the swirling flow F is uniformly generated around the tip portion 130. For this reason, the front-end
  • the suction port 121 is formed in the vicinity of the tip portion 130, and the removed foreign matter S is easily sucked. For this reason, it is difficult for the foreign substance S removed in the blood vessel to remain, and it is possible to effectively prevent stenosis, occlusion, and the like due to the remaining foreign substance S.
  • the diffusion of the removed foreign matter S is blocked by the balloon 122. For this reason, it is difficult for the removed foreign matter S to move to other locations, and it is possible to effectively prevent stenosis, blockage, etc. from occurring at other locations.
  • the second embodiment is different from the first embodiment in that a blade 133 is provided in the opening 135 on the distal end side of the communication hole 132.
  • a blade 133 is provided in the opening 135 on the distal end side of the communication hole 132.
  • symbol is used and the overlapping description here is abbreviate
  • the blade 133 may be provided as a separate member at the edge of the opening 135 or may be formed by processing the edge of the opening 135 itself.
  • the opening 135 rotates with the rotation of the tip 130, and the cutting edge 134 of the blade 133 protrudes toward the rotation direction d2 of the opening 135 in the front view shown in FIG.
  • the cutting edge 134 is on the side of the communication hole 132 including the opening 135 in the cross section along the axial direction D1. That is, the cutting edge 134 does not protrude further toward the tip than the opening 135 in the axial direction D1.
  • the blade 133 is provided in the opening 135 and the crushing ability with respect to the foreign matter S is high, the foreign matter S can be crushed more finely.
  • the blade edge 134 protrudes in the rotation direction d2 side, and the blade edge 134 is likely to hit the foreign object S when the tip portion 130 rotates. For this reason, the foreign material S can be pulverized particularly effectively.
  • the cutting edge 134 does not protrude to the tip side from the opening 135 in the cross section along the axial direction D1, it is difficult to damage the blood vessel wall V and is excellent in safety.
  • the target for which the foreign substance removing device of the present invention is used is not limited to a blood vessel, and may be used in a biological lumen other than the blood vessel.
  • the form without the suction port 121 and the balloon 122 of the above embodiment is also included in the scope of the present invention.
  • the foreign matter removing device may be removed from the biological lumen, and the suction device may be inserted into the biological lumen instead.
  • the suction opening 121 is provided in the foreign material removal device 100, such a effort can be saved and a treatment can be advanced smoothly.
  • the bag-like protection device 1000 that can be expanded and contracted may be used together to more effectively prevent the removed foreign matter S from diffusing.
  • 100 foreign matter removal device 110 Hand control unit, 120 insertion part, 121 suction port, 122 balloon (expanded body), 123 sheath, 124 drive shaft, 130 tip, 131 insertion hole, 132 communication holes, 133 blades, 134 cutting edge, 135 Opening on the tip side of the communication hole, D1 axial direction, D2 direction of rotation of the tip, d2 direction of rotation of the opening that rotates with the tip, F swirl flow, S hard foreign matter, V blood vessel wall, W Guide wire.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif d'élimination de matière étrangère avec lequel il est possible d'enlever et de pulvériser une matière étrangère d'une manière minimalement invasive, même si la matière étrangère est une matière étrangère dure, et d'effectuer un traitement de manière efficace. Le dispositif d'élimination de matière étrangère comprend une partie pointe (130) pouvant tourner autour d'une direction axiale (D1). Un trou de communication (132) est formé dans la partie pointe (130). Le trou de communication (132) est plié à partir du côté pointe dans la direction axiale (D1) dans une direction latérale croisant la direction axiale (D1), et communique avec l'extérieur sur le côté pointe et dans la direction latérale.
PCT/JP2019/006616 2018-02-26 2019-02-21 Dispositif d'élimination de matière étrangère WO2019163914A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018032064A JP2021065246A (ja) 2018-02-26 2018-02-26 異物除去デバイス
JP2018-032064 2018-02-26

Publications (1)

Publication Number Publication Date
WO2019163914A1 true WO2019163914A1 (fr) 2019-08-29

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PCT/JP2019/006616 WO2019163914A1 (fr) 2018-02-26 2019-02-21 Dispositif d'élimination de matière étrangère

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JP (1) JP2021065246A (fr)
WO (1) WO2019163914A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090292276A1 (en) * 1996-07-26 2009-11-26 Nash John E System and method of use for agent delivery and revascularizing of grafts and vessels
JP2011087971A (ja) * 1999-06-14 2011-05-06 Gore Enterprise Holdings Inc 頸動脈疾患の処置中に塞栓形成を軽減するための方法および低プロフィール装置
US20130085514A1 (en) * 2011-09-30 2013-04-04 Tyco Healthcare Group Lp Rotating occlusion treatment system
JP2015181509A (ja) * 2014-03-20 2015-10-22 テルモ株式会社 異物除去用デバイス
JP2017533051A (ja) * 2014-11-07 2017-11-09 ナショナル ユニバーシティー オブ アイルランド, ゴールウェイ 血栓切除デバイス

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090292276A1 (en) * 1996-07-26 2009-11-26 Nash John E System and method of use for agent delivery and revascularizing of grafts and vessels
JP2011087971A (ja) * 1999-06-14 2011-05-06 Gore Enterprise Holdings Inc 頸動脈疾患の処置中に塞栓形成を軽減するための方法および低プロフィール装置
US20130085514A1 (en) * 2011-09-30 2013-04-04 Tyco Healthcare Group Lp Rotating occlusion treatment system
JP2015181509A (ja) * 2014-03-20 2015-10-22 テルモ株式会社 異物除去用デバイス
JP2017533051A (ja) * 2014-11-07 2017-11-09 ナショナル ユニバーシティー オブ アイルランド, ゴールウェイ 血栓切除デバイス

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