JP7282645B2 - Catheter system and support device - Google Patents

Description

The present invention relates to catheter systems and support devices.

For example, Patent Literature 1 discloses a balloon catheter for treating a lesion (stenosis or occlusion) of a fallopian tube. This balloon catheter includes a flexible outer tube, an inner tube arranged in the lumen of the outer tube so as to be axially movable with respect to the outer tube, and a distal end portion of the outer tube and the inner tube. and an annular balloon connecting the distal end portions to each other.

Japanese Patent No. 3921108

In falloplasty using a balloon catheter, a balloon that is inflated radially inward of the outer tube is led out to the distal end of the outer tube to push the affected part (occlusion or constriction) of the fallopian tube. Perform a balloon derivation step to expand.

Specifically, in the balloon derivation step, the balloon and the oviductoscope are advanced with respect to the outer tube while the balloon is inflated and adhered (supported) to the oviscope. At this time, since the balloon protrudes in the distal direction from the distal opening of the outer tube while its distal end portion is turned over, the forward movement distance of the balloon is half the forward movement distance of the oviductoscope. When the operator (surgeon) confirms that the tip of the oviscope has reached the tip of the balloon from the image of the oviscope displayed on the monitor, the pressure of the fluid for inflating the balloon is reduced. to retract the salpingoscope with respect to the balloon.

As described above, in the conventional balloon catheter, the balloon is pressed against the fallopian tube scope, so that the fallopian tube scope (endoscope) is easily damaged. In addition, since the operator needs to check the image of the oviscope displayed on the monitor during the balloon derivation process, there is a possibility that the balloon derivation process cannot be performed efficiently.

The present invention has been made in consideration of such problems, and provides a catheter system and a support device that can reduce damage to the endoscope and efficiently perform the balloon withdrawal process. With the goal.

One aspect of the present invention includes a flexible outer tube, an inner tube disposed in a lumen of the outer tube so as to be axially movable with respect to the outer tube, and a distal end of the outer tube. and an annular balloon that connects the inner tube and the distal end of the inner tube. projecting distally from a distal opening of the outer tube while being everted, the catheter system comprising a support device for use with the balloon catheter, the support device being inside the balloon A wire-like support that supports the balloon that is inflated radially inward of the outer tube while being inserted into the outer tube, and a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon is detected. a detection unit that determines whether or not the tip of the support is exposed from the tip of the balloon based on the change in the physical quantity; and if the tip of the support is exposed from the tip of the balloon and a notification unit that notifies when the determination unit determines.

Another aspect of the present invention includes a flexible outer tube, an inner tube disposed in a lumen of the outer tube so as to be axially movable with respect to the outer tube, and an outer tube. In a balloon catheter having a ring-shaped balloon that connects a distal end portion and a distal end portion of the inner tube, the balloon is pushed in the distal direction by being transmitted from the inner tube to the balloon. protrudes distally from the distal end opening of the outer tube while being turned over, the support device used together with the balloon catheter being inserted inside the balloon, the outer tube A wire-like support supporting the balloon that is inflated radially inward; a detection unit that detects a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon; a determination unit for determining whether or not the tip of the support is exposed from the tip of the balloon based on the above, and notifies when the determination unit determines that the tip of the support is exposed from the tip of the balloon. and a notification unit that performs the support device.

According to the present invention, since the support of the support device is inserted inside the balloon instead of the endoscope, the endoscope is not pressed against the balloon during the balloon extraction step. Therefore, damage to the endoscope can be reduced. In addition, since the notification unit notifies when the tip of the support is exposed from the tip of the balloon, the operator does not need to check the monitor. Therefore, the balloon extraction process can be performed efficiently.

1 is a schematic configuration diagram of a catheter system according to an embodiment of the present invention; FIG. FIG. 2 is a partially omitted vertical cross-sectional view of FIG. 1 ; Figure 2 is a block diagram of the support device of Figure 1; FIG. 2 is a first explanatory view of salpingoscopic salpingoplasty using the catheter system of FIG. 1; FIG. 2 is a second explanatory view of salpingoscopic salpingoplasty using the catheter system of FIG. 1; 3 is a third explanatory view of salpingoscopic salpingoplasty using the catheter system of FIG. 1; FIG. FIG. 4 is a fourth explanatory view of salpingoscopic salpingoplasty using the catheter system of FIG. 1; FIG. 5 is a fifth explanatory view of salpingoscopic salpingoplasty using the catheter system of FIG. 1;

BEST MODE FOR CARRYING OUT THE INVENTION Preferred embodiments of a support device and a catheter system including the same according to the present invention will be described below with reference to the accompanying drawings.

A catheter system 10 according to an embodiment of the present invention is used, for example, in salpingoscopic salpingoplasty for treating a lesion (stenosis, obstruction, or the like) of the fallopian tube. However, the catheter system 10 may be used for treating lesions in body organs other than fallopian tubes, such as blood vessels, bile ducts, trachea, esophagus, urethra, and other organs.

As shown in FIG. 1, catheter system 10 includes balloon catheter 12 and support device 14 for use with balloon catheter 12 .

1 and 2, the balloon catheter 12 comprises an outer catheter 16, a slider 18 provided on the outer catheter 16, an inner catheter 20 inserted into the outer catheter 16, and a tip portion of the inner catheter 20. A balloon 22 and an operation unit 23 are provided.

The outer catheter 16 has an elongated flexible outer tube 24 , an outer tube hub 26 provided at the proximal end of the outer tube 24 , and a fixing screw 28 provided on the outer tube hub 26 . The total length of the outer tube 24 is preferably set to 100 mm or more and 1500 mm or less, more preferably 200 mm or more and 1000 mm or less.

In FIG. 2, the outer tube 24 includes an outer tube body 30 and a distal tip 32 provided at the distal end of the outer tube body 30 . Materials constituting the outer tube main body 30 and the distal tip 32 include, for example, polyolefins (eg, polyethylene, polypropylene, polybutene, etc.), olefin elastomers, polyesters (eg, polyethylene terephthalate, etc.), polyester elastomers, soft polychlorinated Flexible polymeric materials such as vinyl, polyurethane, urethane-based elastomer, polyamide, amide-based elastomer, polytetrafluoroethylene, fluororesin elastomer, polyimide, ethylene-vinyl acetate copolymer, and silicone rubber can be used.

The outer tube main body 30 is a tubular body having a first lumen 30a penetrating from the distal end to the proximal end. The outer tube body 30 has a substantially constant inner diameter and a substantially constant outer diameter from the distal end to the proximal end. The outer diameter of the outer tube 24 is preferably set to 1.8 mm or more and 10 mm or less, more preferably 2.3 mm or more and 8 mm or less. The inner diameter of the outer tube 24 is preferably set to 1.2 mm or more and 7.8 mm or less, and more preferably set to 1.5 mm or more and 5.8 mm or less. The tip side of the outer tube main body 30 is shaped so as to be curved in an arc shape along the axial direction.

The outer surface of the distal tip 32 is curved to prevent damage to the balloon catheter 12 and living tissue. The distal tip 32 is formed with a balloon lead-out hole 32a for leading the balloon 22 in the distal direction from the distal tip 32 .

The outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). Examples of hard resins include polycarbonates, acrylic resins, polyesters, polyolefins, styrene resins, polyamides, polysulfones, polyarylates, and polyetherimides.

The outer tube hub 26 is formed in a hollow shape with a size that is easy to operate manually. The outer tube hub 26 has a first space 34 communicating with the first lumen 30a of the outer tube 24, a first insertion hole 36 located on the proximal end side of the first space 34 and through which the inner catheter 20 is inserted, An introduction port 38 communicating with the first space 34 is formed.

The introduction port 38 introduces into the first space 34 a balloon operating fluid supplied from a syringe (not shown) or the like. The balloon operating fluid is a fluid for inflating the balloon 22 radially inwardly of the outer tube 24, and is, for example, physiological saline. The outer tube hub 26 is provided with a first seal member 42 that prevents the fluid in the first space 34 from leaking out through the first insertion hole 36 .

Fixing screw 28 fixes inner catheter 20 to outer tube hub 26 by screwing into threaded hole 44 formed in the proximal end of outer tube hub 26 . The material of the fixing screw 28 is the same as that of the outer tube hub 26 .

The slider 18 is provided on the outer peripheral surface of the outer tube 24 so as to be movable (slidable) in the axial direction of the outer tube 24 . The overall length of the slider 18 is shorter than the overall length of the outer tube 24 . The slider 18 has an elongated tubular slider body 46 and a slider hub 48 provided at the proximal end of the slider body 46 . Each of the slider body 46 and the slider hub 48 is made of the same material as the outer tube hub 26 described above.

The slider hub 48 is formed in an annular shape with a size that allows easy manual operation.

When the slider 18 is moved to the most proximal side with respect to the outer tube 24 (the proximal end of the slider 18 is positioned at the distal end of the outer tube hub 26), the distal end side of the outer tube 24 is positioned closer to the slider 18 than the slider 18. is also exposed on the tip side and curved in an arc shape in the axial direction. When the slider 18 is moved to the extreme tip side with respect to the outer tube 24 (the tip of the slider 18 is positioned at the tip of the outer tube 24), the tip side of the outer tube 24 conforms to the shape of the slider body 46. extending in a straight line along the

The inner catheter 20 includes an elongate inner tube 50 and an inner tube hub 52 provided at the proximal end of the inner tube 50 . The total length of the inner tube 50 is preferably set to 100 mm or more and 1500 mm or less, more preferably 200 mm or more and 1000 mm or less.

The inner tube 50 is made of a relatively hard resin (eg, fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or metal (eg, stainless steel, titanium, titanium alloy, etc.). The inner tube 50 is a tubular body having a second lumen 50a penetrating from the distal end to the proximal end. Inner tube 50 has a substantially constant inner diameter and a substantially constant outer diameter from distal end to proximal end. The outer diameter of the inner tube 50 is preferably set to 0.8 mm or more and 6.8 mm or less, more preferably 1 mm or more and 5 mm or less. The thickness of the inner tube 50 is preferably set to 0.025 mm or more and 1 mm or less, more preferably 0.03 mm or more and 0.5 mm or less.

The inner tube 50 is inserted through the first space 34 and the first insertion hole 36 of the outer tube hub 26 and is disposed in the first lumen 30a of the outer tube 24 . The tip of the inner tube 50 is located in the proximal direction from the tip of the outer tube 24 . Between the inner tube 50 and the outer tube 24 is an outer lumen 54 through which the balloon operating fluid flows.

A support 74 forming the support device 14 is inserted into the second lumen 50a of the inner tube 50 . An inner lumen 56 (perfusion lumen) through which perfusion fluid flows is formed between the inner tube 50 and the support 74 in a state where the support 74 is inserted into the second lumen 50a of the inner tube 50. be. The perfusion fluid is, for example, saline.

The inner tube hub 52 is made of the same material as the outer tube hub 26 . The inner tube hub 52 is hollow. The inner tube hub 52 has a second space 58 communicating with the second lumen 50a of the inner tube 50, a second insertion hole 60 located on the proximal end side of the second space 58 and through which the support 74 is inserted, An introduction port 62 communicating with the second space 58 is formed. When the fallopian tube scope 15 is used instead of the support 74, the fallopian tube scope 15 is inserted through the second insertion hole 60 (see FIG. 4).

The introduction port 62 introduces a perfusion fluid supplied from a perfusion pump (not shown) or the like into the second space 58 . The inner tube hub 52 is provided with a second seal member 66 that prevents the fluid in the second space 58 from leaking out through the second insertion hole 60 .

The balloon 22 is an annular member that connects the tip of the outer tube 24 and the tip of the inner tube 50 to each other. The balloon 22 inflates radially inwardly of the outer tube 24 . In other words, the balloon 22 is formed to be elastically deformable in the radial direction. The constituent material of the balloon 22 includes, for example, natural rubber, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane, polyurethane elastomer, polyisoprene, polyamide, polyamide elastomer, Examples include polyimide, polytetrafluoroethylene, and silicone rubber. The balloon 22 is preferably made of polyamide elastomer, urethane elastomer, or polyester elastomer.

One end of the balloon 22 is adhered or fused to the distal end of the outer tube 24 . In other words, one end of the balloon 22 is adhered or fused to the outer tube 24 in the vicinity of the proximal end of the balloon lead-out hole 32a. The other end of the balloon 22 is adhered or fused to the tip of the outer surface of the inner tube 50 . However, the other end of the balloon 22 may be adhered or fused to the tip of the inner surface of the inner tube 50 .

The balloon 22 protrudes distally from the distal opening 24a of the outer tube 24 through the balloon lead-out hole 32a by moving the inner tube 50 relative to the outer tube 24 in the distal direction. The balloon 22 is formed so that the color of the inner surface of the balloon 22 is different from the color of the inner surface of the fallopian tube (for example, yellowish green).

A bag-like outer space S with a closed tip is formed between the balloon 22 and the outer tube 24 . The inside of the balloon 22 is open in the distal direction.

The operating portion 23 is provided at the proximal end portion of the inner tube hub 52 to move the support 74 forward and backward (moving along the axial direction). When the fallopian tube scope 15 is used instead of the support 74, the operating part 23 advances and retreats the fallopian tube scope 15 (moves along the axial direction) (see FIG. 4). The operating portion 23 has a pair of feed rollers 70 arranged to sandwich a support 74 (tuboscope 15), and a cover portion 72 that rotatably supports the feed rollers 70. As shown in FIG. The outer peripheral surface of the feed roller 70 contacts the outer peripheral surface of the support 74 (the oviductoscope 15).

1 and 2, the support device 14 has a wire-like (linear) support 74 and a device main body 76 (see FIG. 3) provided at the proximal end of the support 74 . The support 74 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.). The support 74 has approximately the same contour as the fallopianoscope 15 used with the balloon catheter 12 . The support 74 includes a distal support portion 74a inserted inside the balloon 22 and a proximal support portion 74b provided closer to the proximal side than the distal support portion 74a. The outer diameter of the tip side support portion 74a is set to 0.6 mm, for example. The outer diameter of the proximal side support portion 74b is larger than the outer diameter of the distal side support portion 74a.

The proximal support portion 74 b is inserted into the second lumen 50 a of the inner tube 50 , the second space 58 of the inner tube hub 52 and the second insertion hole 60 . The base end support portion 74b is sandwiched by a pair of feed rollers 70 of the operation portion 23. As shown in FIG. The surface roughness of the outer peripheral surface of the proximal side support portion 74b is greater than the surface roughness of the outer peripheral surface of the distal side support portion 74a.

As shown in FIG. 3 , the device main body 76 has a detection section 78 , a control section 80 , a notification section 82 and a power source 84 .

The detector 78 detects the light intensity (physical quantity) that changes before and after the tip of the support 74 is exposed from the tip of the balloon 22 . Specifically, the detection section 78 includes a light emitting section 86 (transmitting section), a first light guide path 88 (first transmission line), a second light guide path 90 (second transmission line), and a light receiving section 92 (receiving section). . An LED is preferably used for the light emitting unit 86, but a fluorescent lamp, an incandescent lamp, or the like may also be used.

The first light guide path 88 and the second light guide path 90 are provided inside the support 74 and extend over the entire length of the support 74 . Each of the first light guide 88 and the second light guide 90 is, for example, an optical fiber. However, the first light guide path 88 and the second light guide path 90 may be formed by one optical fiber. In this case, the light emitted from the light emitting section 86 and the reflected light pass through the same optical fiber. That is, the first light guide path 88 also serves as the second light guide path 90 . The first light guide path 88 guides the light emitted by the light emitting section 86 to the tip of the support 74 . Reflected light of the light led out from the first light guide path 88 is guided to the second light guide path 90 . The light receiving section 92 receives the reflected light led out from the second light guide path 90 . A photodiode is preferably used as the light receiving unit 92, but the configuration is not limited to this.

The control unit 80 is a computer including a microcomputer, and has a CPU (Central Processing Unit) and memories such as ROM and RAM. Acts as an implementer.

The control unit 80 controls driving of the light emitting unit 86 and the notification unit 82 . Control unit 80 includes a determination unit 94 . The determination unit 94 determines whether the tip of the support 74 is exposed from the tip of the balloon 22 based on the change in the intensity (physical quantity) of the reflected light (detection signal from the light receiving unit 92).

The notification unit 82 notifies when the determination unit 94 determines that the tip of the support 74 is exposed from the tip of the balloon 22 . The notification unit 82 is, for example, an indicator light, a speaker, a vibration unit, and the like. That is, the notification unit 82 notifies that the tip of the support 74 is exposed from the tip of the balloon 22 by light, sound, or vibration. When the notification unit 82 is a vibrating unit, it vibrates the device main body 76 . A power supply 84 supplies power to the control unit 80 and the like.

Next, salpingoscopic salpingoplasty using the catheter system 10 configured as described above will be described.

In the salpingoscopic salpingoplasty, as shown in FIG. 4, the operator (surgeon) inserts the balloon catheter 12 transcervically to the fundus 200 of the uterus, and inserts the tip of the outer tube 24 into the fallopian tube 202. It is brought close to the fallopian tube ostium 202a (insertion step). Then, the operator rotates the feed roller 70 of the operation unit 23 to advance the fallopian tube scope 15 and observe the fallopian tube ostium 202a by the image of the fallopian tube scope 15 displayed on a monitor (not shown).

Subsequently, a balloon deriving step is performed in which the balloon 22 inflated radially inwardly of the outer tube 24 is led out to the distal end side of the outer tube 24 to expand the lesion 204 of the fallopian tube 202 . That is, as shown in FIG. 5 , the fallopian tube 15 is removed from the balloon catheter 12 and the support 74 of the support device 14 is inserted into the balloon catheter 12 . That is, the operator advances the support 74 inside the balloon 22 by rotating the feed roller 70 of the operation section 23 . At this time, the distal end of the support 74 is located on the proximal side by a predetermined length from the distal end of the balloon 22 . After that, a balloon operating fluid is supplied to the introduction port 38 (pressurization step).

The balloon operating fluid is then supplied from the introduction port 38 to the outer space S of the balloon 22 via the first space 34 and the outer lumen 54 . The balloon 22 is pressed radially inward by the balloon operating fluid supplied to the outer space S and is elastically deformed. That is, the portion of the balloon 22 located on the outer peripheral side of the support 74 is in close contact with the outer peripheral surface of the support 74 . Inner surfaces of portions of the balloon 22 that are located on the distal end side of the distal end of the support 74 are in contact with each other.

Then, as shown in FIG. 6, the operator operates the inner tube hub 52 and the operation part 23 while loosening the fixing screw 28 to advance the inner tube 50 and the support 74 with respect to the outer tube 24 ( forward process). Then, the balloon 22 pushed in the distal direction by the inner tube 50 advances with respect to the outer tube 24 together with the support 74 and is led out in the distal direction of the outer tube 24 through the balloon lead-out hole 32a.

At this time, since one end of the balloon 22 is fixed to the distal end of the outer tube 24, the balloon 22 advances while the distal end is turned upside down. That is, the balloon 22 is turned upside down at its tip so that the inner surface faces outward. Therefore, the balloon 22 is advanced by half the distance the support 74 is advanced.

Also, the control unit 80 causes the light emitting unit 86 to emit light. Then, the light emitted by the light emitting section 86 is led out from the tip of the support 74 via the first light guide path 88 . The light emitted from the tip of the support 74 is reflected by the object positioned on the tip side of the support 74 (the inner surface of the balloon 22 or the inner surface of the fallopian tube 202), and the reflected light is introduced into the second light guide path 90. be. The reflected light introduced into the second light guide path 90 is guided to the light receiving section 92 .

At this time, the determination unit 94 determines whether the intensity of the reflected light received by the light receiving unit 92 is greater than the reference intensity. Here, the intensity of the reflected light when the tip of the support 74 is located inside the balloon 22 (covered by the balloon 22) is the intensity of the reflected light when the tip of the support 74 is exposed from the balloon 22. greater than the intensity of

Specifically, when the intensity of the reflected light received by the light receiving unit 92 is greater than the threshold, the determining unit 94 determines that the tip of the support 74 is not exposed from the tip of the balloon 22 (the tip of the support 74 is not exposed to the balloon). 22 has not been reached). On the other hand, when the received light intensity is equal to or less than the reference intensity, the determination unit 94 determines that the tip of the support 74 is exposed from the tip of the balloon 22 (the tip of the support 74 has reached the tip of the balloon 22). do. Note that the threshold is stored in the memory of the control unit 80 . The reference intensity is set to a magnitude corresponding to the intensity of the light emitted from the light emitting section 86 and reflected on the inner surface of the balloon 22 .

When the determination unit 94 determines that the tip of the support 74 is exposed from the tip of the balloon 22, the notification unit 82 notifies. Specifically, the notification unit 82 , for example, lights or flashes an indicator lamp (indicator lamp), outputs sound, or vibrates the device main body 76 . This allows the operator to know that the tip of support 74 is exposed from the tip of balloon 22 without carefully checking the monitor.

Subsequently, as shown in FIG. 7, the balloon operating fluid is decompressed and the perfusion fluid is supplied to the introduction port 62 (decompression step). Next, the operator retracts the support 74 by a predetermined distance (retreat process). After that, the pressurizing process and the advancing process described above are performed again. Then, as shown in FIG. 8 , when the balloon 22 reaches the lesion 204 , the balloon 22 spreads the lesion 204 . That is, the narrowing or obstruction of the fallopian tube 202 is improved.

After widening the lesion 204 , the operator removes the support 74 from the balloon catheter 12 and inserts the oviscope 15 into the balloon catheter 12 . Then, the patient removes the balloon catheter 12 while confirming the improved state of the lesion 204 and the state of the fallopian tube 202 from the image of the fallopian tube 15 displayed on the monitor (withdrawal step). Before removing the balloon catheter 12, a physiological saline solution is injected through the introduction port 62, and then the fallopian tube 15 is inserted. You may This completes the salpingoscopic salpingoplasty.

In this case, the balloon catheter 12 according to this embodiment has the following effects.

The support device 14 includes a wire-like support member 74 that supports the balloon 22 that is inflated radially inward of the outer tube 24 while being inserted inside the balloon 22 , and the tip of the support member 74 is the tip portion of the balloon 22 . A detection unit 78 that detects a physical quantity that changes before and after being exposed from, a determination unit 94 that determines whether or not the tip of the support 74 is exposed from the tip of the balloon 22 based on the change in the physical quantity, and a notification unit 82 that notifies when the determination unit 94 determines that the tip of the balloon 22 is exposed from the tip of the balloon 22 .

With such a configuration, since the support 74 of the support device 14 is inserted inside the balloon 22 in place of the fallopian tube 15, the fallopian tube 15 is pressed against the balloon 22 during the balloon withdrawal process. There is no Therefore, damage to the oviductoscope 15 can be reduced. In addition, since the notification unit 82 notifies when the tip of the support 74 is exposed from the tip of the balloon 22, the operator does not need to check the monitor. Therefore, the balloon extraction process can be performed efficiently.

The detection section 78 includes a light emitting section 86, a first light guide path 88 that guides the light emitted by the light emitting section 86 to the tip of the support 74, and a second light guide path that guides the reflected light of the light led out from the first light guide path 88. It has a light guide path 90 and a light receiving section 92 that receives reflected light guided out from the second light guide path 90 , and the first light guide path 88 and the second light guide path 90 are provided inside the support 74 . there is

With such a configuration, it can be determined whether or not the tip of the support 74 is exposed from the tip of the balloon 22 with a simple configuration.

The detection section 78 may be formed so that the light emitting section 86 and the light receiving section 92 are provided inside the tip portion of the support 74 and the first light guide path 88 and the second light guide path 90 are omitted. In this case, the light-emitting section 86 and the light-receiving section 92 may be electrically connected to the control section 80 via, for example, conductors arranged inside the support 74 .

The physical quantity detected by the detector 78 is not limited to light intensity, and may be sound intensity, pressure, temperature, or electrical resistance. That is, the detector 78 may detect the intensity of sound that changes when the tip of the support 74 is exposed from the tip of the balloon 22 .

In this case, the detection unit 78 includes, for example, a transmission unit that generates a sound wave, a first transmission unit that guides the sound wave generated by the sound wave generation unit to the tip of the support 74, and a transmission unit that transmits the sound wave derived from the first transmission unit. It has a second transmitting section to which the reflected wave is guided, and a receiving section for receiving the reflected wave guided from the second transmitting section. Further, the detection section 78 may have the transmission section and the reception section provided inside the tip portion of the support body 74 and omit the first transmission section and the second transmission section. In this case, the transmitter and receiver may be electrically connected to the controller 80 via conductors arranged inside the support 74, for example.

The detector 78 may detect pressure that changes when the tip of the support 74 is exposed from the tip of the balloon 22 . In this case, the detection section 78 has a pressure sensor provided at the tip of the support 74 . Note that the pressure sensor may be electrically connected to the control unit 80 via a lead arranged inside the support 74 .

The detector 78 may detect the temperature that changes when the tip of the support 74 is exposed from the tip of the balloon 22 . In this case, the detector 78 has a temperature sensor provided at the tip of the support 74 . Note that the temperature sensor may be electrically connected to the control unit 80 via a lead arranged inside the support 74 .

The detector 78 may detect the electrical resistance that changes when the tip of the support 74 is exposed from the tip of the balloon 22 . In this case, the detection unit 78 has a sensor that measures the electrical resistance between the electrode provided at the distal end of the support 74 and the counter electrode plate attached to the body surface of the patient. Specifically, the electrical resistance detected by the detection unit 78 in a state where the electrode provided at the tip of the support 74 is inside the balloon 22 is It is higher than the electric resistance detected by the detection part 78 in the state exposed from the part.

The present invention is not limited to the embodiments described above, and various modifications are possible without departing from the gist of the present invention.

The above embodiment can be summarized as follows.

The above embodiment comprises a flexible outer tube (24) and an inner tube (50) disposed within a lumen (30a) of said outer tube so as to be axially movable relative to said outer tube. and an annular balloon (22) that connects the distal end portion of the outer tube and the distal end portion of the inner tube, wherein the balloon is configured such that the pushing force in the distal direction is applied to the inner tube. A catheter system (10) in which a distal end portion of the balloon is turned over and protrudes distally from a distal end opening (24a) of the outer tube by being transmitted from a tube to the balloon, the balloon catheter and It comprises a support device (14) used together, said support device being a wire-like support body ( 74), a detection unit (78) that detects a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon, and a detection unit (78) that detects the change in physical quantity between the tip of the support and the tip of the balloon based on the change in the physical quantity. a determination unit (94) that determines whether or not the tip of the support is exposed from the tip of the balloon; A catheter system comprising:

In the catheter system described above, the physical quantity may be light intensity, sound intensity, pressure, heat, or electrical resistance.

In the catheter system described above, the detection section includes a light emitting section (86), a first light guide path (88) that guides the light emitted by the light source section to the tip of the support, and a and a light receiving section (92) for receiving the reflected light derived from the second light guide path, wherein the first light guide path and The second light guide path may be provided inside the support.

In the catheter system described above, the notification section may notify by light, sound, or vibration that the tip of the support is exposed from the tip of the balloon.

The above embodiment includes an outer tube having flexibility, an inner tube arranged in a lumen of the outer tube so as to be axially movable with respect to the outer tube, and a distal end portion of the outer tube. and a ring-shaped balloon connecting the distal end portion of the inner tube to the distal end portion of the balloon by transmitting a pushing force toward the distal end of the balloon from the inner tube to the balloon. a support device used together with the balloon catheter, which protrudes distally from the distal end opening of the outer tube while being turned over, and is inserted inside the balloon in the radial direction of the outer tube. a wire-shaped support for supporting the balloon that is inflated in the direction; a detection unit that detects a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon; a determination unit that determines whether or not the tip of the support is exposed from the tip of the balloon; and a notification unit that notifies when the determination unit determines that the tip of the support is exposed from the tip of the balloon. and a support device.

DESCRIPTION OF SYMBOLS 10... Catheter system 12... Balloon catheter 14... Support device 24... Outer tube 30a... First lumen (lumen) 50... Inner tube 74... Support body 78... Detection part 82... Notification part 86... Light emission part 88... First Light guide path 90 Second light guide path 92 Light receiving section 94 Judging section

Claims (5)

An outer tube having flexibility, an inner tube disposed in a lumen of the outer tube so as to be axially movable with respect to the outer tube, a distal end portion of the outer tube, and a distal end portion of the inner tube. and a ring-shaped balloon connecting the inner tube with the balloon catheter, wherein the balloon is turned up at its distal end by a pushing force in the distal direction being transmitted from the inner tube to the balloon. while protruding in the distal direction from the distal opening of the outer tube, wherein
a support device for use with the balloon catheter;
The support device is
a wire-shaped support that supports the balloon that is inserted inside the balloon and expands radially inwardly of the outer tube;
a detection unit that detects a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon;
a determination unit that determines whether or not the tip of the support is exposed from the tip of the balloon based on the change in the physical quantity;
a reporting unit that reports when the determination unit determines that the tip of the support is exposed from the tip of the balloon. The catheter system of claim 1, wherein
The catheter system, wherein the physical quantity is light intensity, sound intensity, pressure, heat, or electrical resistance. The catheter system of claim 2, wherein
The detection unit is
a light emitting unit;
a first light guide path that guides the light emitted by the light emitting unit to the tip of the support;
a second light guide path through which reflected light of the light led out from the first light guide path is guided;
a light receiving unit that receives the reflected light derived from the second light guide path,
A catheter system, wherein the first light guide and the second light guide are provided inside the support. The catheter system according to any one of claims 1 to 3,
The catheter system according to claim 1, wherein the notifying section notifies, by light, sound or vibration, that the tip of the support is exposed from the tip of the balloon. An outer tube having flexibility, an inner tube arranged in a lumen of the outer tube so as to be axially movable with respect to the outer tube, a distal end portion of the outer tube, and a distal end portion of the inner tube. and a ring-shaped balloon connecting the two parts to each other, wherein the balloon is turned upside down by a pushing force in the distal direction being transmitted from the inner tube to the balloon. A support device for use with the balloon catheter, projecting distally from a distal opening of the outer tube,
a wire-shaped support that supports the balloon that is inserted inside the balloon and expands radially inwardly of the outer tube;
a detection unit that detects a physical quantity that changes before and after the tip of the support is exposed from the tip of the balloon;
a determination unit that determines whether or not the tip of the support is exposed from the tip of the balloon based on the change in the physical quantity;
and a reporting unit that reports when the determination unit determines that the tip of the support is exposed from the tip of the balloon.

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