WO2015107833A1 - Cathéter d'imagerie de diagnostic - Google Patents

Cathéter d'imagerie de diagnostic Download PDF

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Publication number
WO2015107833A1
WO2015107833A1 PCT/JP2014/083600 JP2014083600W WO2015107833A1 WO 2015107833 A1 WO2015107833 A1 WO 2015107833A1 JP 2014083600 W JP2014083600 W JP 2014083600W WO 2015107833 A1 WO2015107833 A1 WO 2015107833A1
Authority
WO
WIPO (PCT)
Prior art keywords
drive shaft
seal member
pipe
diagnostic imaging
end side
Prior art date
Application number
PCT/JP2014/083600
Other languages
English (en)
Japanese (ja)
Inventor
健太 三觜
奈保子 加藤
圭一郎 山本
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
Priority to JP2015557746A priority Critical patent/JP6455885B2/ja
Publication of WO2015107833A1 publication Critical patent/WO2015107833A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction

Definitions

  • the present invention relates to a diagnostic imaging catheter.
  • the diagnostic imaging catheter has a long sheath, a drive shaft rotatably accommodated in the sheath, and a test wave transmission / reception unit provided at the tip of the drive shaft (see, for example, Patent Document 1).
  • the inspection wave transmitter / receiver moves in the sheath toward the proximal end while rotating with the drive shaft while transmitting / receiving the inspection wave.
  • a priming solution such as physiological saline is filled in the sheath.
  • the diagnostic imaging catheter is connected to a motor drive unit (MDU) via a hub portion provided at the proximal end.
  • the hub portion rotatably supports a connector fixed to the base end of the drive shaft.
  • the motor drive unit (MDU) rotates the connector, and the drive shaft rotates in conjunction with the rotation of the connector.
  • a seal member such as an O-ring is placed around the drive shaft inside the hub portion.
  • the outer peripheral surface of the pipe is smooth, and it is difficult for a gap to be formed between the pipe and the sealing member.
  • the pipe extends to the base end side and is fixed to the connector, and rotates in conjunction with the rotation of the connector while maintaining a sealing property with the seal member.
  • the present inventors consider that the stability of contact between the seal member and the pipe is further increased and the sealing performance is further improved, and the present invention has been made.
  • the axial blur is absorbed, and the axial blur is not easily transmitted to the arrangement position of the seal member. For this reason, the sealing performance is improved. Therefore, it is possible to effectively prevent liquid leakage to the base end side.
  • the drive shaft has a tube shape constituted by a coil wound around the axis of the drive shaft, and the inside of the reinforcement tube and the coil are filled by a filler filled in the reinforcement tube. If at least one of a configuration in which the inner side is closed and a configuration in which the entire outer periphery of the drive shaft on the base end side with respect to the seal member is covered is provided, the gap between the coil and the coil Since the movement path of the liquid through the inner side is blocked, liquid leakage on the proximal end side of the seal member can be further effectively prevented.
  • FIG. 1 It is a figure which shows schematic structure of the catheter for image diagnosis of 1st Embodiment. It is a figure which shows schematic structure of the catheter for image diagnosis of 1st Embodiment. It is sectional drawing which expands and shows the front-end
  • the diagnostic imaging catheter 100 of the first embodiment includes a drive shaft 102 provided with a test wave transmission / reception unit 101 at the distal end, a sheath 103 containing the drive shaft 102, and the drive shaft 102. And a hub portion 110 provided on the base end side of the.
  • the sheath 103 is inserted into a body cavity such as a blood vessel, a bile duct, a urethra, or a digestive tract.
  • the sheath 103 has flexibility.
  • the constituent material of the sheath 103 include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polystyrene, polyurethane, and polyamide.
  • a reinforcing layer may be provided on the inner surface or the outer surface of the sheath 103.
  • the constituent material of the reinforcing layer include stainless steel, Ni—Ti, or a composite material of a synthetic resin and a metal.
  • the drive shaft 102 extends through the sheath 103, the outer tube 120 connected to the proximal end of the sheath 103, and the inner tube 121 connected to the outer tube 120 to the inside of the hub portion 110.
  • the hub part 110, the inner tube 121, the drive shaft 102, and the inspection wave transmission / reception part 101 move back and forth in the axial direction integrally.
  • the inner tube 121 is pushed into the outer tube 120, and the drive shaft 102 and the inspection wave transmitting / receiving portion 101 move inside the sheath 103 toward the distal end side.
  • the inner tube 121 is pulled out from the outer tube 120, and the drive shaft 102 and the test wave transmitting / receiving unit 101 move to the proximal end side inside the sheath 103.
  • the drive shaft 102 has a tube shape constituted by a coil wound around the axis of the drive shaft 102.
  • the drive shaft 102 has flexibility.
  • a signal line 102 a connected to the inspection wave transmitting / receiving unit 101 passes through the drive shaft 102.
  • the inspection wave transmitting / receiving unit 101 is housed in a housing 101 a fixed to the tip of the drive shaft 102.
  • the inspection wave transmission / reception unit 101 is configured by an ultrasonic transducer and transmits / receives an ultrasonic wave as an inspection wave.
  • the signal line 102a is, for example, a twisted pair cable or a coaxial cable
  • the inspection wave transmitting / receiving unit 101 is electrically connected to the signal line 102a.
  • IVUS the attenuation of ultrasonic waves due to air in the sheath 103 is reduced, and the inspection wave transmission / reception unit 101 efficiently transmits and receives ultrasonic waves, so that physiological saline is filled in the sheath 103 as a priming solution.
  • the inspection wave transmission / reception unit 101 When an image is obtained by optical coherence tomography (OCT), the inspection wave transmission / reception unit 101 includes a lens or a mirror, and transmits / receives near infrared light as an inspection wave.
  • the signal line 102a is an optical fiber that transmits near-infrared light
  • the inspection wave transmission / reception unit 101 is optically connected to the signal line 102a.
  • a contrast medium is filled in the sheath 103 as a priming solution so that the inspection wave transmission / reception unit 101 efficiently transmits and receives near-infrared light by reducing reflection due to a difference in refractive index.
  • the hub portion 110 includes a port 111b (a liquid injection portion) communicating with the insertion passage 111a and a seal member 113 provided around the drive shaft 102 on the proximal end side with respect to the port 111b.
  • a hole 116 communicating with the outside is formed in the hub portion main body 111 on the proximal end side with respect to the seal member 113.
  • the hub portion 110 includes a pipe 112 (reinforcing pipe) inserted between the seal member 113 and the drive shaft 102 so as to cover the drive shaft 102, and other pipes covering the drive shaft 102 on the proximal end side of the pipe 112. 114 (another reinforcing pipe).
  • the hub part 110 has a bearing 111c that rotatably supports the pipe 114.
  • the hub portion 110 has a shaft shake transmission preventing portion 117 provided on the base end side with respect to the seal member 113 in the axial direction of the drive shaft 102.
  • the shaft shake transmission preventing portion 117 is provided between the pipe 112 and the pipe 114.
  • the inner tube 121 is connected to the tip of the hub unit main body 111.
  • the inner tube 121, the insertion passage 111a, and the port 111b communicate with each other.
  • the drive shaft 102 is pulled out from the inner pipe 121, passes through the pipe 112 and the pipe 114, and is fixed to the connector 115 at the proximal end.
  • a signal line 102 a (see FIG. 3) inside the drive shaft 102 is connected to the connector 115.
  • the pipe 114 is fixed to the connector 115 at the base end.
  • the pipe 114 and the drive shaft 102 rotate in conjunction with the rotation of the connector 115.
  • the pipe 112 is separated from the pipe 114 and does not rotate in conjunction with the rotation of the connector 115.
  • the shaft shake transmission preventing portion 117 is formed so as to be exposed without the drive shaft 102 being covered.
  • the flexibility of the drive shaft 102 is higher than that of the pipe 112 and the pipe 114, and thus the shaft shake transmission preventing portion 117 has higher flexibility than the pipe 112 and the pipe 114.
  • the pipe 112 and the pipe 114 serve as a reinforcing pipe that reinforces the drive shaft 102, and the material forming the pipe 112 and the pipe 114 is, for example, a metal such as stainless steel, polyimide, polyether ether ketone, or the like. It is a hard resin.
  • the outer periphery of the drive shaft 102 has a layer structure in which coils 102b, 102c, and 102d wound around the axis of the drive shaft 102 overlap each other.
  • the winding directions of the coils 102b, 102c, and 102d are alternately changed, for example, right-handed, left-handed, and right-handed.
  • the material for forming the coils 102b, 102c, and 102d is, for example, stainless steel or Ni—Ti.
  • the signal line 102a (see FIG. 3) passing through the inside of the drive shaft 102 is omitted.
  • the outer surface of the drive shaft 102 is formed by the coil 102b and has an uneven shape. Due to this uneven shape, if the outer surface of the drive shaft 102 is in direct contact with the seal member 113, there is a possibility that a gap will be formed between them.
  • the pipe 112 is disposed between the drive shaft 102 and the seal member 113, and the outer surface of the drive shaft 102 does not directly contact the seal member 113. Since the outer peripheral surface of the pipe 112 is smooth and easily adheres to the seal member 113, the sealing performance is excellent.
  • the seal member 113 prevents leakage of body fluid such as blood entering the catheter to the proximal end side in addition to the priming liquid injected from the port 111b.
  • the seal member 113 is, for example, an O ring, an X ring, a V ring, or the like.
  • the inside of the pipe 112 and the inside of the coils 102b, 102c, and 102d are closed by the filler 118 filled in the pipe 112.
  • the material for forming the filler 118 is, for example, a resin such as cyanoacrylate, epoxy, acrylic, silicon, polyolefin, or urethane.
  • the diagnostic imaging catheter 100 is used together with the motor driving device 10 connected to the hub portion 110.
  • the motor driving device 10 is connected to the connector 115 inside the hub part 110 and rotates it.
  • the motor driving device 10 includes a motor 10a that is a power source for rotating the drive shaft 102, and a motor 10b that is a power source for moving the drive shaft 102 in the axial direction.
  • the rotational motion of the motor 10b is converted into axial motion by a ball screw 10c connected to the motor 10b.
  • the operation of the motor drive device 10 is controlled by a control device 20 electrically connected thereto.
  • the control device 20 includes a CPU (Central Processing Unit) and a memory as main components.
  • the control device 20 is electrically connected to the monitor 30.
  • CPU Central Processing Unit
  • the user connects the hub unit 110 to the motor driving device 10. Thereafter, the user connects the syringe S containing the priming liquid to the port 111b and presses the pusher of the syringe S to fill the sheath 103 with the priming liquid. Before the priming operation, the user pulls the hub portion 110 to the most proximal side and keeps the inner tube 121 pulled out. The hub portion 110, the inner tube 121, and the outer tube 120 communicate with the sheath 103.
  • the user pushes the hub part 110 until it abuts against the base end of the connecting part 122 and moves the inspection wave transmitting / receiving part 101 to the distal end side.
  • the sheath 103 is inserted along the guide wire W at a target position in the body cavity.
  • the inspection wave transmission / reception unit 101 transmits / receives an inspection wave while moving to the proximal side together with the drive shaft 102. At this time, the inspection wave transmission / reception unit 101 rotates together with the drive shaft 102.
  • the control device 20 controls the motor 10a and controls the rotation of the drive shaft 102 around the axis.
  • the control device 20 controls the motor 10b and controls the movement of the drive shaft 102 in the axial direction.
  • the test wave transmitting / receiving unit 101 transmits a test wave into the body.
  • a signal corresponding to the reflected wave from the body received by the inspection wave transmitting / receiving unit 101 is sent to the control device 20 via the drive shaft 102 and the motor driving device 10.
  • the control device 20 generates a tomographic image of the body cavity based on the signal transmitted from the examination wave transmission / reception unit 101 and displays the generated image on the monitor 30.
  • the flexible shaft shake transmission preventing portion 117 functions like a coupling to prevent shaft shake. Absorb. For this reason, transmission of the shaft blur to the pipe 112 is suppressed. As a result, the stability of contact between the seal member 113 and the pipe 112 is increased and the sealing performance is improved, so that liquid leakage closer to the base end side than the seal member 113 can be effectively prevented.
  • liquid such as priming liquid or body fluid does not enter the motor drive device 10, and the motor drive device 10 operates well.
  • the shaft shake transmission preventing unit 117 absorbs shaft shake and suppresses transmission of shaft shake from the proximal end side to the distal end side. For this reason, fluttering of the inspection wave transmitting / receiving unit 101 attached to the tip of the drive shaft 102 is suppressed. Therefore, a good image can be obtained.
  • the filler 118 closes the inside of the pipe 112 and the inside of the coils 102b, 102c, and 102d, thereby passing the gap between the coils 102b, 102c, and 102d and the inside of the coils 102b, 102c, and 102d.
  • the movement path of the liquid is blocked. For this reason, the liquid leakage at the base end side of the seal member 113 can be further effectively prevented.
  • the drive shaft 102 is covered with the pipe 114 on the base end side with respect to the flexible shaft shake transmission preventing portion 117, and the flexible bending is suppressed. For this reason, the connector 115 is not easily displaced.
  • the hole 116 is formed in the hub part main body 111, even if the liquid leaks to the base end side from the seal member 113, the liquid is discharged to the outside of the hub part main body 111. Accordingly, liquid leakage to the motor drive device 10 can be effectively prevented.
  • the diagnostic imaging catheter 200 of the second embodiment differs from the first embodiment in that it includes a shaft blur transmission preventing unit 217 having a configuration different from that of the first embodiment.
  • the shaft shake transmission preventing portion 217 the drive shaft 102 is not exposed between the pipe 112 and the pipe 114 as in the first embodiment.
  • the catheter 200 for image diagnosis of 2nd Embodiment is as substantially the same as 1st Embodiment.
  • the same configurations in the first embodiment and the second embodiment are denoted by the same reference numerals as those in the first embodiment in the drawings, and redundant description is omitted.
  • the shaft shake transmission preventing portion 217 has a configuration in which the drive shaft 102 is covered with a covering member 217a having higher flexibility than the pipes 112 and 114.
  • the material forming the covering member 217a is, for example, a resin such as polyethylene, polyolefin, fluorine-based polymer, elastomer, nylon, or silicon.
  • the pipe 112, the covering member 217a, and the pipe 114 are integrally formed.
  • the pipe 112, the covering member 217 a, and the pipe 114 cover the entire outer periphery of the drive shaft 102 on the proximal end side with respect to the seal member 113.
  • the filler 118 of the first embodiment inside the pipe 112 is omitted, but the filler 118 may be provided as in the first embodiment.
  • the shaft shake transmission preventing unit 217 functions in the same manner as the shaft shake transmission preventing unit 117 of the first embodiment, the same effects as the first embodiment are achieved.
  • the pipe 112, the covering member 217a, and the pipe 114 cover the entire outer periphery of the drive shaft 102 closer to the base end side than the seal member 113. For this reason, even if liquid intrudes into the drive shaft 102 on the distal end side of the seal member 113, liquid leakage on the proximal end side of the seal member 113 is prevented.
  • the second embodiment is the same as the first embodiment.
  • the diagnostic imaging catheter 300 of the third embodiment has a long pipe 312 on the tip side compared to the pipe 112 of the second embodiment, and a helical shape formed on the outer periphery of the pipe 312 on the tip side. It differs from 2nd Embodiment by the point which has the blade
  • 3rd Embodiment is as substantially the same as 2nd Embodiment, the code
  • the spiral blade 312 a is formed on the outer periphery of a portion of the pipe 312 that extends to the tip side of the seal member 113.
  • the outer periphery of the blade 312a and the inner periphery of the insertion path 111a are close to each other. Since the pipe 312 is formed integrally with the shaft shake transmission preventing portion 217 and the pipe 114, when the connector 115 rotates, the pipe 312 and the blade 312a rotate in conjunction with the rotation.
  • the rotation speed of the connector 115, the pipe 312 and the blade 312a is, for example, 1800 rpm.
  • the blade 312a rotates and functions like an axial flow pump, so that the flow of the priming liquid to the distal end side is generated, and the movement of the priming liquid is forcibly limited not to move toward the proximal end side. Is done. Accordingly, it is possible to effectively prevent liquid leakage to the base end side.
  • the blade 312a is provided on the distal end side with respect to the seal member 113, and the priming liquid directed toward the proximal end side is pushed back to the distal end side before the seal member 113, so that excessive pressure is not easily applied to the seal member 113. Therefore, the seal member 113 can reliably prevent liquid leakage.
  • the third embodiment is the same as the second embodiment.
  • the present invention includes a form in which the pipe 114 in the hub portion 110 is omitted and the drive shaft 102 is exposed between the pipe 112 and the connector 115.
  • the filler 118 inside the pipe 112 is filled at the proximal end of the pipe 112, but it is sufficient that at least a part of the inside of the pipe 112 is filled. The entire inside of 112 may be filled.
  • a spiral groove may be formed on the outer periphery of the pipe 312 instead of the blade 312a of the third embodiment.
  • the pipe 312 is in sliding contact with the inner periphery of the insertion path 111a.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un cathéter d'imagerie de diagnostic (100), qui comprend : une tige d'entraînement (102) ; une section de raccord (110) dans laquelle est formé un canal d'introduction (111a) à travers lequel est introduite la tige d'entraînement, et qui comprend un raccord (115) qui est fixé à l'extrémité de base de la tige d'entraînement ; une section d'instillation de solution (111b) qui est conçue pour communiquer avec le canal d'introduction, et dans laquelle est instillée une solution d'amorçage ; un élément d'étanchéité (113) disposé autour de la tige d'entraînement sur le côté d'extrémité de base de la section d'instillation de solution ; un tube de renforcement (112) introduit entre l'élément d'étanchéité et la tige d'entraînement de façon à recouvrir la tige d'entraînement ; et une partie de prévention de transmission de déviation de tige (117), qui est située sur le côté d'extrémité de base de l'élément d'étanchéité dans la direction axiale de la tige d'entraînement et absorbe des déviations de tige qui surviennent avec la rotation du raccord.
PCT/JP2014/083600 2014-01-16 2014-12-18 Cathéter d'imagerie de diagnostic WO2015107833A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2015557746A JP6455885B2 (ja) 2014-01-16 2014-12-18 画像診断用カテーテル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014005935 2014-01-16
JP2014-005935 2014-01-16

Publications (1)

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WO2015107833A1 true WO2015107833A1 (fr) 2015-07-23

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PCT/JP2014/083600 WO2015107833A1 (fr) 2014-01-16 2014-12-18 Cathéter d'imagerie de diagnostic

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JP (1) JP6455885B2 (fr)
WO (1) WO2015107833A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109528236A (zh) * 2018-12-31 2019-03-29 深圳北芯生命科技有限公司 血管内超声导管的注射装置
CN110809433A (zh) * 2017-06-29 2020-02-18 泰尔茂株式会社 图像诊断用导管

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013133356A1 (fr) * 2012-03-09 2013-09-12 テルモ株式会社 Cathéter

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013133356A1 (fr) * 2012-03-09 2013-09-12 テルモ株式会社 Cathéter

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110809433A (zh) * 2017-06-29 2020-02-18 泰尔茂株式会社 图像诊断用导管
EP3646796A4 (fr) * 2017-06-29 2021-03-17 Terumo Kabushiki Kaisha Cathéter de diagnostic d'image
US11497466B2 (en) 2017-06-29 2022-11-15 Terumo Kabushiki Kaisha Diagnostic imaging catheter
CN110809433B (zh) * 2017-06-29 2023-03-14 泰尔茂株式会社 图像诊断用导管
CN109528236A (zh) * 2018-12-31 2019-03-29 深圳北芯生命科技有限公司 血管内超声导管的注射装置
CN111588411A (zh) * 2018-12-31 2020-08-28 深圳北芯生命科技有限公司 带注入口的注射装置

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JP6455885B2 (ja) 2019-01-23
JPWO2015107833A1 (ja) 2017-03-23

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