WO2019189755A1

WO2019189755A1 - Medical system

Info

Publication number: WO2019189755A1
Application number: PCT/JP2019/013987
Authority: WO
Inventors: 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: 2018-03-29
Filing date: 2019-03-29
Publication date: 2019-10-03
Also published as: JP2021101748A

Abstract

[Problem] To provide a medical system that makes it possible to discern the number of times a reusable medical instrument has been used. [Solution] A medical system 1 comprising: a diagnostic imaging catheter 100 provided with a sheath 110 that can be inserted into a lumen in a living body; a CPU 301a that provides a medical instrument with information relating to the number of times the diagnostic imaging catheter has been connected to an external device 300 and used; and a server 400 capable of reading the information contained in the CPU.

Description

Medical system

The present invention relates to a medical system.

With the declining birthrate and aging population, medical expenses in Japan are increasing. On the other hand, in the development of medical instruments, it is desired that each part constituting the medical instrument can be reused as much as possible without assuming a single use as much as possible in order to reduce medical costs. As a technique related to the reuse of medical devices, there is a technique in which a mark that can be reused is printed on a label, and the label is attached to a package that houses a reusable medical device (see Patent Document 1). .

Japanese Patent Laid-Open No. 5-111525

In the case of 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.

Therefore, 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.

According to the medical system, the number of uses of the medical device can be recognized by the information adding unit and the information reading unit.

It is a figure shown about the medical system which concerns on one Embodiment of this invention. It is sectional drawing which shows the front-end | tip part of the catheter for image diagnosis which comprises the medical system of FIG. FIG. 3 is a cross-sectional view showing a proximal end side of the diagnostic imaging catheter of FIG. 2. It is a block diagram which shows the structure of the control system of the medical system of FIG. It is a flowchart which judges whether the reuse of the catheter for image diagnosis is possible. It is a figure shown about the medical system which concerns on 2nd Embodiment. It is sectional drawing which shows the base end side of the catheter for image diagnosis which comprises the medical system of 2nd Embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

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, and 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 according to the present embodiment 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 (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. Have. Details will be described below.

(Medical equipment)
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). However, 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.

As shown in FIG. 1, the diagnostic imaging catheter 100 is driven by being connected to an external device 300.

As shown in FIG. 1 and FIG. 2, 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. On the other hand, 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.

In the description of the specification, 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, and the extending direction of the sheath 110 is referred to as the distal end side. It is called the axial direction.

As shown in FIG. 1, 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.

For example, when the operation of pulling the hub 160 toward the proximal end is performed, 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. When the operation of pulling the hub 160 toward the proximal end is performed, 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.

As shown in FIG. 1, when the inner shaft 130 is pushed most into the distal end side, the distal end portion of the inner shaft 130 reaches the vicinity of the relay connector 170. At this time, the signal transmission / reception unit 145 is located near the distal end of the sheath 110. The relay connector 170 is a connector that connects the sheath 110 and the outer tube 120.

As shown in FIG. 2, 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. In this embodiment, 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.

As shown in FIG. 2, 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.

As the vibrator provided in the ultrasonic transmission / reception unit 145a, for example, 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. As shown in FIG. 2, 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.

As shown in FIG. 2, 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. Further, 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. When the diagnostic imaging catheter 100 is used, 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. When performing the priming process, 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. For example, the styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, 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.

As shown in FIG. 3, 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. When connecting the supply port 162 to the external device 300, 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.

In addition, the 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. In the relay connector 170, the same seal member as the seal member 164a shown in FIG. 3 is provided. 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.

The 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 (see FIG. 2) are inserted into the connection pipe 164b.

(External device)
Referring to FIG. 1, diagnostic imaging catheter 100 is connected to and driven by external device 300.

As described above, the external device 300 is connected to the connector portion 165 (see FIG. 3) provided on the proximal end side of the hub 160.

As shown in FIG. 1, 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.

As shown in FIG. 4, 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. In the present embodiment, when the diagnostic imaging catheter 100 is connected to the external device 300, the server 400 records or overwrites information related to the use history such as the past number of times the catheter is connected. In addition, 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.

Next, an example of using the diagnostic imaging catheter 100 in the medical system 1 according to this embodiment will be described. FIG. 5 is a flowchart showing use restrictions of the diagnostic imaging catheter 100 in the medical system 1.

As described above, the server 400 stores information related to the use frequency limit of the diagnostic imaging catheter 100. Here, the use frequency limit of the diagnostic imaging catheter 100 is set to 5 times. Each time an operator or the like connects the diagnostic imaging catheter 100 to the external device 300, 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).

When the connection count of the diagnostic imaging catheter 100 recorded in the server 400 does not exceed 5 (ST2: NO), the CPU 301a updates the connection count every time the diagnostic imaging catheter 100 is connected to the external device 300 (ST1). .

When the number of connections of the diagnostic imaging catheter 100 recorded in the server 400 exceeds 5 (ST2: YES), the CPU 301a sends a signal not to supply power necessary for image generation to the diagnostic imaging catheter 100. Control (ST3).

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. By reading the information given to the diagnostic imaging catheter 100, 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

As described above, the medical system 1 according to the present embodiment 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 | ascertain the frequency | count of use of the diagnostic imaging catheter 100, and to judge appropriately whether the diagnostic imaging catheter 100 is reusable.

In addition, the 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.

Further, the upper limit number of diagnostic imaging catheters 100 is set in the storage unit 301b of the control device 301. When the number of times that the diagnostic imaging catheter 100 is connected exceeds the upper limit, 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. With this configuration, even if the diagnostic imaging catheter 100 is reused, it can be prevented from being used beyond the upper limit, and the sanitary environment and operation of the diagnostic imaging catheter 100 can be ensured.

Also, 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. When the diagnostic imaging catheter is applied to a dual type or an IVUS type, 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. When the diagnostic imaging catheter is applied to an OCT type catheter, 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. In the first 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. However, the control device 301 may be configured as follows.

In this embodiment, 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. For example, a laser-printed or surface-readable hole can be formed from the information providing unit 165a provided in the diagnostic imaging catheter 100. In addition, you may provide the information provision part 165a in the connection part with the diagnostic imaging catheter 100 in the external apparatus 300 which is MDU.

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.

Other configurations in the second embodiment are the same as those in the first embodiment, and thus description thereof is omitted.

As described above, in the second embodiment, 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.

Note that the present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. In the above description, 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. However, the present invention is not limited to this. In addition to the above, 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.

This application is based on Japanese Patent Application No. 2018-065044 filed on Mar. 29, 2018, the disclosure of which is incorporated by reference in its entirety.

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).

Claims

A medical instrument comprising an elongated body that can be inserted into a body lumen;
Information on the number of times of use of the medical device connected to a predetermined external device, an information giving unit for giving to the medical device;
An information reading unit capable of reading information on the number of times of use included in the information providing unit.
The external device can communicate with a storage device capable of storing information on the number of times of use,
The medical system according to claim 1, wherein the storage device includes information on the number of times of use.
The medical device includes a connection portion that is electrically connected to the external device,
The medical system according to claim 1, wherein information related to the number of times of use is recorded in the connection unit.
The external device is set with an upper limit number of times the medical device can be connected,
The medical system according to any one of claims 1 to 3, wherein the external device electrically cuts off the use of the medical instrument when the number of times the user has used the medical instrument exceeds the upper limit. .
The medical system according to any one of claims 1 to 4, wherein the main body is replaceable each time the medical instrument is used.