WO2019189755A1 - Système médical - Google Patents

Système médical Download PDF

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Publication number
WO2019189755A1
WO2019189755A1 PCT/JP2019/013987 JP2019013987W WO2019189755A1 WO 2019189755 A1 WO2019189755 A1 WO 2019189755A1 JP 2019013987 W JP2019013987 W JP 2019013987W WO 2019189755 A1 WO2019189755 A1 WO 2019189755A1
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WO
WIPO (PCT)
Prior art keywords
diagnostic imaging
information
imaging catheter
medical
external device
Prior art date
Application number
PCT/JP2019/013987
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English (en)
Japanese (ja)
Inventor
昌典 時田
ロディヤン・ギブラン・スンタヌ
祥之 原
敬悟 筒井
奈保子 加藤
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 WO2019189755A1 publication Critical patent/WO2019189755A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • 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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the present invention relates to a medical system.
  • Patent Document 1 it is possible to determine whether or not a medical instrument can be reused by checking the label. However, that alone cannot determine how much a reusable medical device can be reused.
  • an object of the present invention is to provide a medical system that can recognize the number of times a reusable medical device is used.
  • the medical system according to the present invention that achieves the above object relates to a medical instrument having an elongated main body that can be inserted into a living body lumen, and the number of times the medical instrument is used by being connected to a predetermined external device.
  • An information providing unit that provides information to the medical device, and an information reading unit that can read the information included in the information providing unit.
  • the number of uses of the medical device can be recognized by the information adding unit and the information reading unit.
  • FIG. 3 is a cross-sectional view showing a proximal end side of the diagnostic imaging catheter of FIG. 2.
  • FIG. 1 is a plan view showing a state in which an external device 300 is connected to the diagnostic imaging catheter 100 according to the present embodiment.
  • FIG. 2 is a diagram showing a configuration on the distal end side of the diagnostic imaging catheter 100 according to the embodiment
  • FIG. 3 is a diagram showing a configuration on the proximal end side of the diagnostic imaging catheter 100 according to the embodiment.
  • FIG. 4 is a block diagram illustrating a configuration of a control system of the medical system 1 of FIG.
  • the medical system 1 will be briefly described with reference to FIG. 1.
  • the diagnostic imaging catheter 100 including the elongated sheath 110 that can be inserted into a living body lumen, and the diagnostic imaging catheter 100 as an external device 300.
  • a server 400 corresponding to an “information adding unit and a storage device” 400 that gives information about the number of times of use that is connected and used to the diagnostic imaging catheter 100, and a control device 301 that can read the information included in the server 400.
  • the medical instrument according to the present embodiment is a dual-type diagnostic imaging catheter 100 having both functions of an intravascular ultrasonic diagnostic method (IVUS) and an optical coherence tomographic diagnostic method (OCT).
  • IVUS intravascular ultrasonic diagnostic method
  • OCT optical coherence tomographic diagnostic method
  • the medical instrument that can be connected to the external device 300 is not limited to the above, and may be, for example, an IVUS catheter or a catheter (for example, a therapeutic catheter) that is used for purposes other than obtaining diagnostic images.
  • the diagnostic imaging catheter 100 will be described with reference to FIGS.
  • the diagnostic imaging catheter 100 is driven by being connected to an external device 300.
  • the diagnostic imaging catheter 100 generally includes an elongated sheath (corresponding to a “main body”) 110 inserted into a body cavity of a living body, and a proximal end side of the sheath 110.
  • the outer tube 120 provided in the outer tube 120, the inner shaft 130 inserted into the outer tube 120 so as to be able to move forward and backward, and a signal transmitting / receiving unit 145 that transmits and receives signals are provided at the distal end to be rotatably provided in the sheath 110. It has a shaft 140, a unit connector 150 provided on the proximal end side of the outer tube 120 and configured to receive the inner shaft 130, and a hub 160 provided on the proximal end side of the inner shaft 130. .
  • the sheath 110 of the diagnostic imaging catheter 100 is a liquid contact member that is inserted into a living body lumen and comes into contact with a body fluid or the like.
  • the drive shaft 140 includes parts necessary for forming a tomographic image, and since these parts are relatively expensive, reuse is desired. Therefore, in the present embodiment, the sheath 110 is a disposable member (single-use member) that is exchanged every time it is connected to the external device 300, whereas the drive shaft 140 has an upper limit number of times. It is configured as a reuse member that can be reused by prescribing.
  • the side of the diagnostic imaging catheter 100 that is inserted into the body cavity is referred to as the distal end side
  • the hub 160 provided in the diagnostic imaging catheter 100 is referred to as the proximal end side
  • the extending direction of the sheath 110 is referred to as the distal end side. It is called the axial direction.
  • the drive shaft 140 extends to the inside of the hub 160 through the sheath 110, the outer tube 120 connected to the proximal end of the sheath 110, and the inner shaft 130 inserted into the outer tube 120. ing.
  • the hub 160, the inner shaft 130, the drive shaft 140, and the signal transmission / reception unit 145 are connected to each other so as to move forward and backward integrally in the axial direction. Therefore, for example, when the hub 160 is pushed toward the distal end side, the inner shaft 130 connected to the hub 160 is pushed into the outer tube 120 and the unit connector 150, and the drive shaft 140 and signal transmission / reception are performed. The portion 145 moves inside the sheath 110 toward the distal end.
  • the inner shaft 130 is pulled out from the outer tube 120 and the unit connector 150 as indicated by an arrow a1 in FIG.
  • the drive shaft 140 and the signal transmission / reception unit 145 move inside the sheath 110 toward the proximal end as indicated by an arrow a2 in FIG.
  • the relay connector 170 is a connector that connects the sheath 110 and the outer tube 120.
  • the drive shaft 140 includes a flexible tube body 141, and an electric signal cable 142 (corresponding to an “electric wire”) connected to the signal transmission / reception unit 145 and an optical fiber therein. 143 is arranged.
  • the tube body 141 can be constituted by, for example, multilayer coils having different winding directions around the axis.
  • Examples of the material constituting the coil include stainless steel and Ni—Ti (nickel / titanium) alloy.
  • the electrical signal cable 142 is connected to an electrode terminal provided in a connector portion 165 described later as shown in FIG.
  • the electric signal cable 142 is configured to include two signal lines for transmitting and receiving a high-frequency voltage.
  • the signal transmission / reception unit 145 includes an ultrasonic transmission / reception unit 145a that transmits / receives ultrasonic waves and an optical transmission / reception unit 145b that transmits / receives light.
  • the ultrasonic transmission / reception unit 145a includes a vibrator, and has a function of transmitting an ultrasonic wave based on a pulse signal into a body cavity and receiving an ultrasonic wave reflected from a living tissue in the body cavity.
  • the ultrasonic transmission / reception unit 145 a is electrically connected to an electrode terminal (not shown) on the proximal end side of the diagnostic imaging catheter 100 via the electric signal cable 142.
  • a piezoelectric material such as ceramics or quartz can be used.
  • the optical transmitter / receiver 145b continuously transmits the transmitted measurement light into the body cavity and continuously receives the reflected light from the living tissue in the body cavity.
  • the optical transceiver 145b is provided at the tip of the optical fiber 143, and has a ball lens (optical element) having a lens function for condensing light and a reflection function for reflecting light.
  • the signal transmitting / receiving unit 145 is accommodated in the housing 146 as shown in FIG.
  • the proximal end side of the housing 146 is connected to the drive shaft 140.
  • the housing 146 is provided with an opening on the cylindrical surface of a cylindrical metal pipe so as not to obstruct the progress of the ultrasonic waves transmitted / received by the ultrasonic transmitter / receiver 145a and the light transmitted / received by the optical transmitter / receiver 145b. It has a different shape.
  • the sheath 110 includes a lumen 110a into which the drive shaft 140 is inserted so as to be movable back and forth.
  • a guide wire insertion member 114 including a guide wire lumen 114a through which the guide wire W can be inserted is attached to the distal end portion of the sheath 110 in parallel with the lumen 110a provided in the sheath 110.
  • the sheath 110 and the guide wire insertion member 114 can be integrally configured by heat fusion or the like.
  • the guide wire insertion member 114 is provided with a marker 115 having X-ray contrast properties.
  • the marker 115 is composed of a metal coil having high radiopacity such as Pt and Au.
  • a communication hole 116 that communicates the inside and the outside of the lumen 110a is formed at the distal end of the sheath 110.
  • a reinforcing member 117 for firmly joining and supporting the guide wire insertion member 114 is provided at the distal end portion of the sheath 110.
  • the reinforcing member 117 is formed with a communication passage 117 a that communicates the inside of the lumen 110 a arranged on the proximal end side with respect to the reinforcing member 117 and the communication hole 116. Note that the reinforcing member 117 may not be provided at the distal end portion of the sheath 110.
  • the communication hole 116 is a priming liquid discharge hole for discharging the priming liquid.
  • a priming process for filling the sheath 110 with a priming solution is performed in order to reduce attenuation of ultrasonic waves due to air in the sheath 110 and efficiently transmit and receive ultrasonic waves.
  • the priming liquid can be discharged from the communication hole 116 to the living body lumen, and the gas such as air can be discharged from the inside of the sheath 110 together with the priming liquid.
  • the sheath 110, the guide wire insertion member 114, and the reinforcing member 117 are formed of a flexible material, and the material is not particularly limited.
  • the material is not particularly limited.
  • Various thermoplastic elastomers such as polyimide, polybutadiene, trans polyisoprene, fluororubber, chlorinated polyethylene, etc. are listed, and one or a combination of two or more of these (polymer alloy, polymer blend) , Laminates, etc.) can also be used.
  • a hydrophilic lubricating coating layer that exhibits lubricity when wet can be disposed on the outer surface of the sheath 110.
  • the hub 160 communicates with a hub body 161 having a hollow shape, a connector case 161a connected to the proximal end side of the hub body 161, and a lumen 110a of the sheath 110, and allows liquid to the lumen 110a.
  • the protrusions 163a and 163b for determining the position (direction) of the hub 160, the connection pipe 164b for holding the drive shaft 140, and the connection pipe 164b are rotated.
  • a bearing 164c that is freely supported, a seal member 164a that prevents the priming liquid from leaking toward the proximal end from between the connection pipe 164b and the bearing 164c, and an electrode terminal and an optical connector connected to the external device 300 are provided internally. And a connector portion 165 disposed in the.
  • the hub body 161 communicates with the lumen 110a of the sheath 110 and includes an internal space 166a through which liquid from the port 162 flows as shown in FIG.
  • the base space of the inner shaft 130 is accommodated in the internal space 166a of the hub body 161, and the electric signal cable 142 and the optical fiber 143 of the drive shaft 140 are inserted therethrough.
  • a device for supplying priming liquid such as a syringe S is connected to the port 162 of the hub 160.
  • connection pipe 164b and the bearing 164c are accommodated in the internal space 166a.
  • the drive shaft 140 is drawn from the inner shaft 130 in the internal space 166 a of the hub body 161.
  • the protective tube 133 is disposed inside the outer tube 120.
  • the protective tube 133 extends to the end of the outer tube 120, the relay connector 170 and the sheath 110.
  • the same seal member as the seal member 164a shown in FIG. 3 is provided in the relay connector 170.
  • the protective tube 133 is inserted through the inside of the seal member, thereby preventing the priming liquid from leaking out.
  • the protective tube 133 has a function of preventing the drive shaft 140 from being damaged due to interference between the inner shaft 130 and the drive shaft 140.
  • the connector case 161a is a component that is provided on the proximal end side of the hub 160 and connected to the hub body 161 as shown in FIG.
  • the connector case 161 a includes an internal space 166 a that houses the connector portion 165.
  • a cap cover (corresponding to a “connecting portion”) 165 g is disposed on the proximal end side of the drive shaft 140.
  • An optical connector is accommodated in the cap cover 165g.
  • the cap cover 165g can be connected to an external device (MDU: Motor Driving Unit) 300.
  • An information recording unit 169 such as an IC tag is attached to the optical connector housed in the cap cover 165g, and when connected to the external device 300, the control device 301 of the external device 300 can acquire information on the catheter. .
  • the information recording unit 169 is not particularly limited as long as it can hold information and can read information held from outside, and may be, for example, a barcode or other electronic tag.
  • connection pipe 164b holds the drive shaft 140 in order to transmit the rotation of the electrode terminal and the optical connector rotated by the external device 300 to the drive shaft 140.
  • An electric signal cable 142 and an optical fiber 143 are inserted into the connection pipe 164b.
  • diagnostic imaging catheter 100 is connected to and driven by external device 300.
  • the external device 300 is connected to the connector portion 165 (see FIG. 3) provided on the proximal end side of the hub 160.
  • the external device 300 includes a motor 300a that is a power source for rotating the drive shaft 140 and a motor 300b that is a power source for moving the drive shaft 140 in the axial direction. Have. The rotational motion of the motor 300b is converted into axial motion by a ball screw 300c connected to the motor 300b.
  • the operation of the external device 300 is controlled by a control device 301 electrically connected thereto.
  • the control device 301 includes a CPU (Central Processing Unit) 301a and a memory as main components.
  • the control device 301 is electrically connected to the monitor 302.
  • the control device 301 is electrically connected to the server 400 as shown in FIG.
  • the control device 301 includes a CPU (corresponding to an “information adding unit”) 301a, a storage unit 301b, an input / output I / F 301c, and a communication unit 301d.
  • the CPU 301a transmits a command to each component so as to manage information regarding the operation of the diagnostic imaging catheter 100 and the number of times the diagnostic imaging catheter 100 is used.
  • the storage unit 301b is configured by a memory or the like, and is used for temporarily storing information related to the operation or reuse of the diagnostic imaging catheter 100.
  • the input / output I / F 301 c is configured to be able to input / output information from the outside to the control device 301.
  • the communication unit 301d configures the control device 301 to be connectable to a network.
  • the server 400 provides information on the reuse of the diagnostic imaging catheter 100.
  • the server 400 records or overwrites information related to the use history such as the past number of times the catheter is connected.
  • the upper limit number of times is input to the server 400 so that the diagnostic imaging catheter 100 is not reused beyond the upper limit that can be used.
  • FIG. 5 is a flowchart showing use restrictions of the diagnostic imaging catheter 100 in the medical system 1.
  • the server 400 stores information related to the use frequency limit of the diagnostic imaging catheter 100.
  • the use frequency limit of the diagnostic imaging catheter 100 is set to 5 times.
  • the CPU 301a of the control device 301 records or overwrites the current number of uses in the storage unit 301b and the server 400 (ST1).
  • the CPU 301a updates the connection count every time the diagnostic imaging catheter 100 is connected to the external device 300 (ST1). .
  • the user can check the past use frequency history of the diagnostic imaging catheter 100 by accessing the server 400 every time the procedure using the diagnostic imaging catheter 100 is started or every time the procedure is completed.
  • the server 400 determines the product specification of the diagnostic imaging catheter 100 (for example, any catheter such as an IVUS catheter, an OCT catheter, or a dual type catheter is used). It is also possible to determine whether or not
  • the medical system 1 uses the diagnostic imaging catheter 100 including the sheath 110 that can be inserted into the living body lumen, and the diagnostic diagnostic catheter 100 connected to the external device 300 and used.
  • a CPU 301a that gives information about the number of times to the diagnostic imaging catheter 100 and a server 400 that can read the information included in the CPU 301a are configured. By comprising in this way, it becomes possible to grasp
  • control device 301 of the external device 300 can communicate with the server 400, and information regarding the number of times the diagnostic imaging catheter 100 is used is recorded in the server 400. Therefore, by obtaining information on the number of times the diagnostic imaging catheter 100 is used, it is possible to more appropriately determine whether or not the diagnostic imaging catheter 100 is reusable.
  • the upper limit number of diagnostic imaging catheters 100 is set in the storage unit 301b of the control device 301.
  • the CPU 301a of the control device 301 that constitutes the external device 300 is configured to electrically block the usage of the diagnostic imaging catheter 100.
  • the sheath 110 of the diagnostic imaging catheter 100 is replaced every time it is used. Therefore, it is possible to improve the specifications regarding cleanliness by exchanging the parts that come into contact with body fluids at the time of use, even if they are devices that are supposed to be reused.
  • the communication hole 116 is often provided. In that case, the cleanliness of the drive shaft 140 can be maintained by sterilizing and washing the drive shaft 140 when the sheath 110 is replaced.
  • the communication hole 116 is often not provided. In that case, the cleanliness of the drive shaft 140 can be maintained without performing sterilization and cleaning as described above.
  • (Second Embodiment) 6 and 7 are diagrams for explaining the medical system 1a according to the second embodiment.
  • the control device 301 that configures the external device 300 has been described with respect to the server 400 that records information on the number of times of use of the diagnostic imaging catheter 100.
  • the control device 301 may be configured as follows.
  • the CPU 301a of the control device 301 instructs the cap cover 165g included in the hub 160 to record the number of times the diagnostic imaging catheter 100 is used.
  • the recording method on the cap cover 165g is not particularly limited.
  • a laser-printed or surface-readable hole can be formed from the information providing unit 165a provided in the diagnostic imaging catheter 100.
  • the information regarding the number of times of use recorded in the cap cover 165g can be detected by installing a detector such as a photodetector at the connection portion of the external apparatus 300 corresponding to the MDU with the diagnostic imaging catheter 100.
  • the function information is recorded on the cap cover 165g corresponding to the connection portion of the diagnostic imaging catheter 100 in accordance with the number of times the diagnostic imaging catheter 100 is used. Therefore, an increase in the number of parts necessary for reusing the diagnostic imaging catheter 100 can be suppressed.
  • the present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims.
  • the number of times that the diagnostic imaging catheter 100 is connected to the external device 300 as the reuse of the diagnostic imaging catheter 100 is used as an index for determining reuse.
  • the present invention is not limited to this.
  • the total number of scans, the total number of acquired frames, the total connection time, the total connection time corresponding to the total number of rotations of the drive shaft 140 when performing image formation using the diagnostic imaging catheter 100, and the drive shaft 140 are retracted from the sheath 110. Whether or not reuse is possible may be determined based on the distance, the number of times of signal transmission / reception, and the like.
  • 1, 1a medical system 100 catheter for diagnostic imaging (medical device), 110 sheath (main body), 140 drive shaft, 143 optical fiber, 165a Information giving unit, 165g Cap cover (connection part), 169 Information recording section, 301a CPU (information providing unit), 400 server (information reading unit, storage device).

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Abstract

Le problème décrit par la présente invention est de fournir un système médical qui permet de discerner le nombre de fois qu'un instrument médical réutilisable a été utilisé. A cet effet, l'invention concerne un système médical 1 comprenant : un cathéter d'imagerie de diagnostic 100 pourvu d'une gaine 110 qui peut être insérée dans une lumière dans un corps vivant; un CPU 301a qui fournit un instrument médical avec des informations relatives au nombre de fois où le cathéter d'imagerie de diagnostic a été connecté à un dispositif externe 300 et utilisé; et un serveur 400 apte à lire les informations contenues dans le CPU.
PCT/JP2019/013987 2018-03-29 2019-03-29 Système médical WO2019189755A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2018-065044 2018-03-29
JP2018065044A JP2021101748A (ja) 2018-03-29 2018-03-29 医療システム

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WO2019189755A1 true WO2019189755A1 (fr) 2019-10-03

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PCT/JP2019/013987 WO2019189755A1 (fr) 2018-03-29 2019-03-29 Système médical

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022190361A1 (fr) * 2021-03-12 2022-09-15 日本ライフライン株式会社 Système d'endoscope

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011177430A (ja) * 2010-03-03 2011-09-15 Terumo Corp 医療用マニピュレータシステム
WO2016136406A1 (fr) * 2015-02-26 2016-09-01 オリンパス株式会社 Sur-tube et système de manipulateur médical

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011177430A (ja) * 2010-03-03 2011-09-15 Terumo Corp 医療用マニピュレータシステム
WO2016136406A1 (fr) * 2015-02-26 2016-09-01 オリンパス株式会社 Sur-tube et système de manipulateur médical

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022190361A1 (fr) * 2021-03-12 2022-09-15 日本ライフライン株式会社 Système d'endoscope

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