WO2022059084A1 - Catheter and recanalization catheter system - Google Patents

Abstract

In this catheter, a shaft includes a first lumen that extends in the longitudinal direction, a second lumen that is disposed alongside the first lumen, an end face that has a distal end opening communicating with the second lumen at a distal end of the second lumen, and a protrusion that includes the first lumen and protrudes more toward the distal end than the end face. The shaft has, on a side face at a position more toward a base end than the distal end opening, a side face opening that communicates with the second lumen, and the side face opening has a guide portion that guides a base end of a medical device outside from the inside of the second lumen via the side face opening in a first case in which the medical device is inserted into the second lumen from the distal end side of the shaft, and restricts the exit of the distal end of the medical device via the side face opening and guides the distal end of the medical device toward the distal end of the second lumen in a second case in which the medical device is inserted into the second lumen from the base end side of the shaft.

Description

Catheter and recanalization catheter system

The present invention relates to a catheter and a recanalization catheter system.

In some cases, such as Chronic Total Occlusion (CTO), the inside of a blood vessel may be obstructed by an obstruction. Patent Documents 1 to 4 disclose a subendometrial approach that reinserts a medical device from a false lumen to a true lumen for CTO opening (recommunication). The false cavity refers to all dissected cavities other than the true cavities formed by the medical device. In the procedure for opening the CTO, the delivery guide wire is generally used to deliver the catheter to the location of the CTO lesion, and then a penetration guide wire different from the delivery guide wire is used to insert the penetration guide wire into the true cavity. Re-enter. In this regard, the catheter described in Patent Document 1 separately includes a lumen for a delivery guide wire and a lumen for a penetrating guide wire (occlusion-crossing device).

Japanese Patent No. 6030655 Japanese Patent No. 6182660 Japanese Patent No. 6118335 Japanese Patent No. 5564416.

Here, it is preferable that the diameter of the catheter inserted into the blood vessel is as small as possible. Further, in a complicated procedure such as opening a CTO, a lumen for the sensor may be provided on the catheter in order to realize the procedure under the guidance of the sensor (for example, IVUS Guide). In such a case, the catheter described in Patent Document 1 requires at least three lumens, so that there is a problem that the diameter of the catheter becomes large. Further, in the catheters described in Patent Documents 2 to 4, no consideration is given to the combined use of the delivery guide wire and the penetrating guide wire.

It should be noted that such a problem is not limited to the opening of the CTO, but is common to all devices such as a delivery guide wire and a penetrating guide wire that proceed with the procedure while exchanging different medical devices. In addition, such problems are not limited to the vascular system, but are general devices inserted into the living lumen, such as the lymph gland system, biliary tract system, urinary tract system, air tract system, digestive system, secretory gland and reproductive organ. Common to.

The present invention has been made to solve at least a part of the above-mentioned problems, it is possible to realize the procedure under the guidance of a sensor, and it is possible to proceed with the procedure while exchanging different medical devices. The purpose is to reduce the labor and time required for replacement of medical devices in a conventional catheter.

The present invention has been made to solve at least a part of the above-mentioned problems, and can be realized as the following forms.

(1) According to one embodiment of the present invention, a catheter having a shaft is provided. In this catheter, the shaft has a first lumen extending in the longitudinal direction of the shaft, a second lumen arranged alongside the first lumen from the proximal end portion of the shaft toward the distal end side, and the first lumen. At the tip of 2 lumens, it has an end face formed with a tip opening communicating with the second lumen, and a protruding portion including the first lumen and protruding toward the tip side from the end face, and has a side surface of the shaft. Of these, a side opening communicating with the second lumen is formed on the proximal side of the tip opening, and a medical device is inserted into the second lumen from the tip side of the shaft in the side opening. In the first case, the proximal end of the medical device is guided from the inside of the second lumen to the outside through the lateral opening, and the medical device is directed from the proximal end side of the shaft. In the second case inserted into the second lumen, a guide portion that restricts the tip of the medical device from exiting through the side opening and guides the tip toward the tip of the second lumen. Is provided.

According to this configuration, a guide portion is provided in the side opening of the shaft of the catheter that communicates with the second lumen. In the first case where the medical device (for example, the delivery guide wire) is inserted into the second lumen from the tip end side of the shaft, the guide portion connects the proximal end portion of the medical device from the inside of the second lumen through the side opening. To guide you to the outside. In other words, the guide guides the proximal end of the medical device out through a side opening that acts as a guide wire port in the first case where the catheter is used as a rapid exchange type (Rx type). Therefore, the usability as an Rx type catheter is improved. Further, in the second case where the medical device (for example, a guide wire for penetration) is inserted into the second lumen from the base end side of the shaft, the guide portion has the tip portion of the medical device to the outside through the side opening. Regulate exit and guide towards the tip of the second lumen. In other words, in the second case where the catheter is used as an over-the-wire type (OTW type), the guide portion guides the tip of the medical device toward the tip of the second lumen, thereby as an OTW type catheter. Improve usability.
Further, according to the catheter having this configuration, since the second lumen can be shared by different medical devices, the diameter of the catheter can be reduced, and the diameter of the catheter can be reduced to the inside of the living lumen (for example, inside the coronary artery, inside the CTO, etc.). The catheter can be easily inserted.
Further, according to the catheter having this configuration, for example, IVUS (a sensor that acquires information on living tissue by transmitting and receiving ultrasonic waves to and receiving ultrasonic waves) is inserted into the first lumen, and a delivery guide is inserted in the second lumen. Multiple medical devices can be held simultaneously within a single catheter, such as inserting a wire or penetrating guide wire. Further, the shaft is a projecting portion that protrudes toward the tip end side of the end face having a tip opening communicating with the second lumen, and has a projecting portion including the first lumen. Therefore, a medical device (eg, delivery) inserted into the second lumen by inserting the IVUS into the first lumen and arranging an IVUS transducer (a site for transmitting and receiving ultrasonic waves to and receiving living tissue) in the protruding portion. The tip of the guide wire, the guide wire for penetration, etc.) can be observed with IVUS. As a result, the surgeon can recognize the state in the living lumen (for example, CTO) and the position of the tip of the medical device in real time only by the two-dimensional image by IVUS. That is, according to the catheter of this configuration, the skill of operating a plurality of devices separately, which is conventionally required for the procedure under the guidance of the sensor (for example, IVUS Guide), and the three-dimensional image of the sensor and the X-ray image are used. Sensor-guided procedures can be performed without the need for target reconstruction skills. Furthermore, according to the catheter of this configuration, since the procedure can be realized only by referring to the image of the sensor, it is possible to reduce the frequency of acquiring the X-ray image, and the amount of exposure of the operator and the patient due to the X-ray imaging. It can be expected that the amount of contrast medium used for X-ray photography will be reduced.
As a result, according to the catheter of this configuration, it is possible to realize the procedure under the guidance of the sensor, and it is possible to proceed with the procedure while exchanging different medical devices, and it is possible to exchange the medical device. The time and effort required can be reduced.

(2) In the catheter of the above embodiment, the guide portion is a flap portion in which the proximal end portion is fixed to the outer peripheral surface of the shaft and is inclined inward from the outer peripheral surface of the shaft toward the inside of the second lumen. In the first case, the proximal end of the medical device is brought into contact with the outer surface of the flap to guide the proximal end of the medical device to the outside, and in the second case, medical treatment is performed. By bringing the tip of the device into contact with the inner surface of the flap, the tip of the medical device may be restricted from coming out.
According to this configuration, the guide portion is a flap portion in which the base end portion is fixed to the outer peripheral surface of the shaft and is inclined inward from the outer peripheral surface of the shaft toward the inside of the second lumen. Therefore, by bringing the proximal end portion of the medical device into contact with the outer surface of the flap portion, the proximal end portion of the medical device can be easily guided to the outside. Similarly, by bringing the tip of the medical device into contact with the inner surface of the flap, it is possible to easily regulate the tip of the medical device from coming out.

(3) In the catheter of the above form, the guide portion may further have a main body portion that surrounds the circumferential direction of the shaft and is integrally formed with the flap portion.
According to this configuration, the guide portion further has a main body portion that surrounds the circumferential direction of the shaft and is integrally formed with the flap portion. Therefore, for example, when the catheter advances through a biological tube having a small radius of curvature (in other words, a biological tube having a sharp curve), it is possible to prevent the flap portion from falling off from the shaft when the shaft is curved.

(4) In the catheter of the above embodiment, the guiding portion is a region of the inner peripheral surface of the second lumen on the distal end side of the side opening and opposite to the side on which the side opening is formed. However, of the first raised portion raised toward the side opening and the inner peripheral surface of the second lumen, the base end side of the side opening and the same side as the side on which the side opening is formed. The region is composed of a second raised portion that is raised in a direction away from the side opening, and in the first case, the proximal portion of the medical device is brought into contact with the first raised portion, whereby the medical treatment is performed. By inducing the base end portion of the device to come out and bringing the tip end portion of the medical device into contact with the second raised portion in the second case, the tip end portion of the medical device comes out to the outside. It may be regulated.
According to this configuration, the guiding portion is composed of a first raised portion in which the inner peripheral surface of the second lumen is raised and a second raised portion. Therefore, by bringing the proximal end portion of the medical device into contact with the first raised portion, the proximal end portion of the medical device can be easily guided to the outside. Similarly, by bringing the tip of the medical device into contact with the second ridge, it is possible to easily regulate the tip of the medical device from coming out. Further, according to this configuration, the guide portion can be configured without adding a special member.

(5) In the catheter of the above embodiment, the shaft is further arranged at the tip of the protrusion and has a third lumen extending in the longitudinal direction of the shaft, and the tip surface of the protrusion has the third lumen. A first opening communicating with 3 lumens may be formed, and a second opening may be formed on the side surface of the protrusion so as to communicate with the third lumen and to be provided on the tip side of the tip opening. ..
According to this configuration, the shaft is further located at the tip of the protrusion and has a third lumen extending longitudinally of the shaft. Therefore, by inserting the delivery guide wire through the third lumen, the delivery guide wire can be fixed on the tip side of the second lumen. By fixing the delivery guide wire, the delivery guide wire can always be present in a fixed direction on the image of the sensor. Therefore, the surgeon moves or rotates the catheter in the anteroposterior direction with reference to the delivery guide wire while referring to the image of the sensor, thereby moving the catheter and the target site of the living tissue (penetration guide wire). The positional relationship with the target site that tries to penetrate the living tissue can be adjusted. Further, since the third lumen is arranged at the tip of the protrusion, the diameter of the catheter can be reduced, and the catheter can be easily inserted into the living lumen (for example, inside the coronary artery, inside the CTO, etc.). can.

(6) According to one embodiment of the present invention, a recanalization catheter system is provided. This recanalization catheter system is inserted into the catheter of the above form, a sensor inserted into the first lumen to acquire information on living tissue in the first lumen, and inserted into the second lumen to the outside from the tip opening. It is provided with a guide wire that is guided and penetrates the living tissue.

It should be noted that the present invention can be realized in various embodiments, for example, a catheter including a catheter, a method for manufacturing or using the catheter, a catheter and a sensor, a delivery guide wire, a penetration guide wire, and other devices. It can be realized in the form of a system, a method of manufacturing or using a catheter system, and the like.

It is explanatory drawing which illustrates the structure of the recanalization catheter system. It is a cross-sectional view of the catheter in the line AA of FIG. It is a schematic side view of the tip side of a catheter. It is a figure which shows the structure of the guide part seen from the B direction (FIG. 3). It is a figure explaining the operation of the guide part in the 1st case. It is a figure explaining the operation of the guide part in the 2nd case. It is a schematic diagram of an imaging sensor. It is a figure explaining the use method of the recanalization catheter system. It is a figure explaining the use method of the recanalization catheter system. It is a schematic side view of the distal end side of the catheter of the 2nd Embodiment. It is a figure which shows the structure of the guide part seen from the B direction (FIG. 10). It is a schematic side view of the distal end side of the catheter of the 3rd Embodiment. It is a figure explaining the operation of the guide part in the 1st case. It is a figure explaining the operation of the guide part in the 2nd case. It is a schematic side view of the distal end side of the catheter of 4th Embodiment. It is a schematic side view of the distal end side of the catheter of the 5th Embodiment. It is a cross-sectional view of the catheter of the sixth embodiment.

FIG. 1 is an explanatory diagram illustrating the configuration of the recanalization catheter system 1. The recanalization catheter system 1 is used, for example, when treating a CTO (Chronic Total Occlusion) occurring in a blood vessel with an anterograde approach. The recanalization catheter system 1 includes a catheter 100, an imaging sensor 200, an imaging console 300, and a penetrating guide wire 400. In FIG. 1, a schematic side view of the catheter 100 is shown, and a part of the tip end side of the imaging sensor 200 inserted into the first inner shaft 102 is shown by a solid line.

FIG. 1 includes a part in which the relative ratio of the sizes of each component is described so as to be different from the actual one for convenience of explanation. In addition, a part of each component is exaggerated and described. Further, FIG. 1 shows XYZ axes that are orthogonal to each other. The X-axis corresponds to the longitudinal direction of the catheter 100 and the penetrating guide wire 400, the Y-axis corresponds to the height direction of the catheter 100 and the penetrating guide wire 400, and the Z-axis corresponds to the width of the catheter 100 and the penetrating guide wire 400. Corresponds to the direction. The left side (-X-axis direction) of FIG. 1 is referred to as the "tip side" of the catheter 100 and each component, and the right side (+ X-axis direction) of FIG. 1 is referred to as the "base end side" of the catheter 100 and each component. Further, among both ends of the catheter 100 and each component in the longitudinal direction (X-axis direction), one end located on the distal end side is referred to as "tip", and the other end located on the proximal end side is referred to as "base end". Further, the tip and its vicinity are referred to as a "tip portion", and the proximal end and its vicinity are referred to as a "base end portion". The distal end side is inserted into the living body, and the proximal end side is operated by a surgeon such as a doctor. These points are also common to FIGS. 1 and later.

FIG. 2 is a cross-sectional view of the catheter 100 in line AA of FIG. FIG. 3 is a schematic side view of the distal end side of the catheter 100. In FIG. 3, the lumen in the catheter 100 is represented by a broken line, and a part of the tip end side of the imaging sensor 200 inserted into the first inner shaft 102 is represented by a solid line. Further, in the upper broken line frame in FIG. 3, the shafts 101 to 104 with the guide portion 13 removed are shown in the left broken line frame. The guide portion 13 is shown in the broken line frame on the right side.

The configuration of the catheter 100 will be described with reference to FIGS. 1 to 3. As shown in FIG. 1, the catheter 100 has shafts 101 to 104, a guide portion 13, a tip marker 128, a proximal marker 129, and a regulator 105. In addition, in FIG. 1 and the following figures, diagonal hatching is attached to the guide portion 13 in order to distinguish it from other members.

As shown in FIG. 2, the shafts 101 to 104 include an outer shaft 101, a first inner shaft 102, a second inner shaft 103, a tip tip 104 (see FIG. 1), a sealing member 114, and a blade 115. And have.

The outer shaft 101, the first inner shaft 102, and the second inner shaft 103 are all hollow and elongated, and have a substantially circular cross section. The first inner shaft 102 and the second inner shaft 103 are inserted into the lumen of the outer shaft 101, and extend substantially parallel to each other along the longitudinal direction of the outer shaft 101. A first lumen 102L is provided inside the first inner shaft 102. The first lumen 102L functions as a “sensor lumen” for inserting the imaging sensor 200 into the shafts 101 to 104. A second lumen 103L is provided inside the second inner shaft 103. The second lumen 103L functions as a "wire lumen" for inserting the delivery guide wire 70 (FIG. 2) and the penetrating guide wire 400 (FIG. 1) into the shafts 101 to 104. Details will be described later. The first lumen 102L and the second lumen 103L are arranged side by side so as to be substantially parallel to each other.

The sealing member 114 seals (fixes) the first inner shaft 102 and the second inner shaft 103 in the outer shaft 101. The sealing member 114 is arranged inside the outer shaft 101 and outside the first inner shaft 102 and the second inner shaft 103. The outer shaft 101, the first inner shaft 102, the second inner shaft 103, and the sealing member 114 are formed of an insulating resin, and are, for example, polyolefins such as polyethylene, polypropylene, and an ethylene-propylene copolymer, and polyethylene tereph. Formed from polyester such as tarat, polyvinyl chloride, ethylene-vinyl acetate copolymer, crosslinked ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer, polyolefin elastomer, polyurethane elastomer, silicone rubber, latex rubber, etc. obtain. In addition, instead of the resin having an insulating property, it may be formed by a known material.

The blade 115 is a reinforcing member formed by braiding a wire. The blade 115 is embedded in the thick portion of the outer shaft 101. The strands constituting the blade 115 can be formed of a metal material (for example, stainless steel such as SUS304, nickel-titanium alloy, alloy containing gold, platinum, and tungsten which are X-ray opaque materials). The strands constituting the blade 115 may be made of a known metal material other than these. Instead of the blade 115, a coil body formed by spirally winding a wire may be embedded in the thick portion of the outer shaft 101. The wire constituting the coil body can be formed of a known metal material like the blade 115.

As shown in FIG. 1, the length of the first inner shaft 102 is longer than the length of the outer shaft 101 and the second inner shaft 103. Further, the length of the second inner shaft 103 is substantially the same as the length of the outer shaft 101, or slightly longer than the length of the outer shaft 101. The outer shaft 101, the first inner shaft 102, and the second inner shaft 103 are fixed with their base ends aligned. That is, as shown in FIG. 1, a part of the first inner shaft 102 on the tip end side and the end face 108 on the tip end side of the second inner shaft 103 each project from the tip end of the outer shaft 101.

As shown in FIG. 3, the transducer 201 of the imaging sensor 200 is arranged in a part on the tip end side of the first inner shaft 102 (a portion protruding from the tip end of the outer shaft 101). With this transducer 201, the state of the delivery guide wire 70 (described later in FIG. 5) inserted into the second lumen 103L (lumen for wire) and the penetrating guide wire 400 (described later in FIG. 6) can be observed. The imaging sensor 200 transmits ultrasonic waves to a living tissue and receives the reflected sound from the transducer 201. Therefore, a part of the first inner shaft 102 on the tip end side (a portion protruding from the tip of the outer shaft 101) has a living tissue as compared with a portion of the first inner shaft 102 located inside the outer shaft 101. It is preferably formed of a resin having a small difference in acoustic impedance, for example, polyethylene. Further, a part of the first inner shaft 102 on the tip end side (a portion protruding from the tip of the outer shaft 101) is a portion of the first inner shaft 102 located inside the outer shaft 101 with the thickness of the thick portion. May be thinner than.

The end surface 108 on the tip end side of the second inner shaft 103 is inclined outward from the side near the center of the outer shaft 101. Further, the end face 108 is formed with a tip opening 103a communicating with the second lumen 103L (lumen for wire).

The tip tip 104 is joined to the tip of the first inner shaft 102. The tip tip 104 is a substantially columnar member having an R at the tip. The tip tip 104 may have any shape, and may be, for example, a substantially truncated cone whose outer diameter is reduced from the base end side toward the tip end side. The tip tip 104 is formed with a third lumen 104L extending in the longitudinal direction (X-axis direction) of the shafts 101 to 104. Further, a first opening 104a communicating with the third lumen 104L is formed on the tip surface of the tip tip 104. A second opening 104b communicating with the third lumen 104L is formed on the side surface of the tip tip 104. As shown in FIG. 1, the first opening 104a is arranged closer to the tip side than the second opening 104b. Further, the second opening 104b is arranged on the tip side of the tip opening 103a of the second inner shaft 103. The tip 104 is preferably made of a flexible resin material, such as a polyurethane elastomer. For the bonding between the tip tip 104 and the first inner shaft 102, for example, bonding between resins by heat melting or bonding with an insulating adhesive such as an epoxy adhesive can be adopted.

Hereinafter, the portion of the tip end side of the first inner shaft 102 that protrudes toward the tip end side from the end surface 108 and the tip tip 104 are collectively referred to as a "protruding portion 109".

Of the side surfaces of the shafts 101 to 104, the side surface opening 103b is formed on the proximal end side of the tip opening 103a. As shown in the broken line frame on the left side of FIG. 3, the side opening 103b is a part of the shafts 101 to 104 (specifically, the outer shaft 101, the second inner shaft 103, the sealing member 114, and the blade 115). Is formed by a notch SO notched in the circumferential direction. As shown in the lower part of FIG. 3, the side opening 103b is provided with a guide portion 13.

The guide portion 13 is a member for guiding the end portion of the medical device (delivery guide wire 70 or penetration guide wire 400) inserted into the second lumen 103L. The guide portion 13 of the present embodiment is fitted at a position on the outer peripheral surface of the outer shaft 101 where the side opening 103b is formed. As shown in the broken line frame on the right side of FIG. 3, the guide portion 13 has a main body portion 131 and a flap portion 132. The guide portion 13 may be fixed to the shafts 101 to 104 by joining the inner peripheral surface of the main body portion 131 and the outer peripheral surface of the outer shaft 101. Any bonding agent such as an epoxy adhesive may be used for bonding, or bonding by heat melting may be used.

FIG. 4 is a diagram showing the configuration of the guide portion 13 as seen from the B direction (FIG. 3). The main body 131 is an annular member that surrounds the outer shaft 101 in the circumferential direction. As shown in FIG. 4, the flap portion 132 is a substantially semicircular flat plate-shaped member that is inclined inward toward the tip end side from the base end portion connected to the main body portion 131. In addition to the substantially semicircular shape, the flap portion 132 may have any shape such as a substantially circular shape, a substantially elliptical shape, a substantially rectangular shape, and a substantially polygonal shape. Further, the flap portion 132 may have an arbitrary shape such as a corrugated plate shape, a curved plate shape, a refracting plate shape, a raised plate shape, or the like, in addition to a flat plate shape. As shown in the lower part of FIG. 3, in a state where the guide portion 13 is fitted to the outer shaft 101, the base end portion of the flap portion 132 is fixed to the outer peripheral surface of the outer shaft 101, and the flap portion 132 is the first from the outer peripheral surface of the outer shaft 101. It is in a state of being inclined toward the inside of the 2 lumen 103L. In the present embodiment, the main body portion 131 and the flap portion 132 are integrally formed. The main body portion 131 and the flap portion 132 can be formed of a stretchable resin material such as urethane resin or silicon resin.

FIG. 5 is a diagram illustrating the operation of the guide unit 13 in the first case. In FIG. 5, the delivery guide wire 70 as a medical device is represented with dot hatching. The case where the delivery guide wire 70 is inserted into the second lumen 103L from the tip side of the shafts 101 to 104 and advances inside the second lumen 103L from the tip side toward the base end side is called a "first case". .. In other words, the first case is a case where the catheter 100 is used as a rapid exchange type (Rx type) catheter.

As shown in FIG. 5, in the first case, the operator inserts the base end portion of the delivery guide wire 70 from the first opening 104a into the third lumen 104L, pulls it out from the second opening 104b, and opens the tip. It is reinserted from 103a into the second lumen 103L and pulled out from the side opening 103b. At this time, the guiding portion 13 guides the base end portion of the delivery guide wire 70 from the inside of the second lumen 103L to the outside through the side opening 103b. Specifically, the flap portion 132 of the guide portion 13 brings the base end portion of the delivery guide wire 70 into contact with the outer surface 132o of the flap portion 132, so that the base end portion of the delivery guide wire 70 comes out. To induce.

FIG. 6 is a diagram illustrating the operation of the guide unit 13 in the second case. In FIG. 6, the penetrating guide wire 400 as a medical device is represented with dot hatching. The "second case" is the case where the penetrating guide wire 400 is inserted into the second lumen 103L from the proximal end side of the shafts 101 to 104 and advances inside the second lumen 103L from the proximal end side toward the distal end side. Called. In other words, the second case is the case where the catheter 100 is used as an over-the-wire type (OTW type) catheter.

As shown in FIG. 6, in the second case, the operator inserts the tip of the penetrating guide wire 400 through the opening 103c (FIG. 1) on the proximal end side of the second lumen 103L into the second lumen 103L. Pull out from the tip opening 103a. At this time, the guiding portion 13 suppresses the tip portion of the penetrating guide wire 400 from coming out through the side opening 103b, and guides the tip portion toward the tip of the second lumen 103L. Specifically, the flap portion 132 of the guide portion 13 brings the tip portion of the penetration guide wire 400 to the outside by bringing the tip portion of the penetration guide wire 400 into contact with the inner side surface 132i of the flap portion 132. To regulate. As a result, as shown by the broken line in FIG. 6, the penetrating guide wire 400 gets over the side opening 103b, advances the second lumen 103L toward the tip side, and opens the tip portion of the penetrating guide wire 400 toward the tip opening 103a. Can be projected from.

Return to Fig. 1 and continue the explanation. The tip marker 128 and the proximal marker 129 are arranged on the side surface of the protrusion 109 and function as a marker indicating the position of the catheter 100 inserted into the blood vessel (specifically, the position of the protrusion 109). The tip marker 128 is provided between the first inner shaft 102 and the tip tip 104 in the longitudinal direction (X-axis direction) of the shafts 101 to 104. The proximal end marker 129 is provided at the proximal end portion of the protruding portion 109 in the longitudinal direction (X-axis direction) of the shafts 101 to 104. The tip marker 128 and the proximal marker 129 can be formed of a resin material or a metal material having radiation impermeable properties. For example, when a resin material is used, it can be formed by mixing a radiation-impermeable material such as bismuth trioxide, tungsten, barium sulfate, etc. with a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicon resin, a fluororesin, or the like. For example, when a metal material is used, it can be formed of a radiation-impermeable material such as gold, platinum, tungsten, or an alloy containing these elements (for example, platinum-nickel alloy).

As shown in FIG. 1, the controller 105 is an operation unit for moving forward and backward of the imaging sensor 200 in the first lumen 102L. The controller 105 includes a dial that can be operated by the operator, and by rotating the dial, the imaging sensor 200 inserted in the first lumen 102L moves forward or backward. Like the outer shaft 101, the regulator 105 is made of an insulating resin or a known material. The material of the regulator 105 may be the same as or different from the material of the outer shaft 101.

FIG. 7 is a schematic diagram of the imaging sensor 200. The imaging sensor 200 is a "sensor" having a long outer shape and acquiring information on living tissue. The imaging sensor 200 has a transducer 201, a driving cable 202, and a connector 203. The transducer 201 transmits an ultrasonic wave toward a living tissue and receives an ultrasonic wave propagating and reflected in the living tissue. An ultrasonic probe (ultrasonic oscillator, piezoelectric body, ultrasonic transmitting / receiving element, ultrasonic element). Also called). The driving cable 202 has a coaxial line inside the driving cable 202 that electrically connects the transducer 201 and the motor drive 204. The connector 203 connects the coaxial line of the driving cable 202 and the motor drive 204 that controls the rotation of the transducer 201. The motor drive 204 is electrically connected to the imaging console 300 by a cable 50.

The imaging console 300 shown in FIG. 1 controls the imaging sensor 200 and generates and displays an image. Specifically, the imaging console 300 moves the transducer 201 in the first lumen 102L in the longitudinal direction (X-axis direction) of the first inner shaft 102 in response to the operation of the controller 105, and the first The inner shaft 102 is rotated in the circumferential direction (YZ axis direction). Further, the imaging console 300 transmits ultrasonic waves from the transducer 201 and receives reflected waves by the transducer 201 in response to an operator's operation via an input means (not shown). The reflected wave received by the transducer 201 is transmitted to the imaging console 300 via the driving cable 202 and the cable 50. The imaging console 300 generates an image (two-dimensional image) with shades of gradation according to the intensity of the received reflected wave, and displays the generated image on the display 302. Hereinafter, the image acquired by the imaging sensor 200 and displayed on the display 302 is also referred to as a “sensor image”.

The penetrating guide wire 400 shown in FIG. 1 is a long medical device having a pointed portion at the tip. The pointed portion is a portion having a wedge shape or a wedge shape from the proximal end side to the distal end side. In the penetrating guide wire 400, the living tissue can be penetrated by the pointed portion provided at the tip. The penetrating guide wire 400 corresponds to a "guide wire penetrating a living tissue".

8 and 9 are diagrams illustrating how to use the recanalization catheter system 1. In FIGS. 8 and 9, the coronary artery 80 as an example of the biological lumen, the CTO 81 generated in the coronary artery 80, and the pseudo-lumen 82 (formed by the delivery guide wire 70) formed in the endometrium or subintimal region of the coronary artery 80. All dissociation cavities other than the true lumen), and the fibrous membrane or plaque 83 (hereinafter also referred to as “fibrous membrane 83”) existing between the true lumen 84 and the false lumen 82 and the true lumen 84. Each is shown. The fibrous film 83 may be formed in a fibrous form on the surface of the CTO lesion.

FIG. 8A shows a state in which the delivery guide wire 70 is inserted into the coronary artery 80. In FIG. 8A, the operator-operated delivery guide wire 70 has entered the endometrium of the coronary artery 80 or has formed a pseudocavity 82 under the endometrium.

FIG. 8B shows how the catheter 100 is delivered using the delivery guide wire 70. The surgeon inserts the delivery guide wire 70 into the catheter 100 by performing the operation described with reference to FIG. As described with reference to FIG. 5, in the catheter 100 of the present embodiment, the delivery guide wire 70 inserted from the tip opening 103a into the second lumen 103L is pulled out from the side opening 103b. Therefore, the distance for delivering the delivery guide wire 70 in the second lumen 103L can be shortened as compared with the case where the delivery guide wire 70 is pulled out from the opening 103c on the proximal end side (hereinafter, also referred to as “conventional case”). As a result, it becomes possible to support the proximal end portion of the delivery guide wire 70 at the time of delivery of the catheter 100, and it is possible to prevent the delivery guide wire 70 from slipping or coming off due to the insertion of the catheter. The time required to insert the can be shortened. The surgeon then delivers the catheter 100 to the pseudocavity 82 along the delivery guide wire 70, as shown in FIG. 8 (B).

FIG. 9A shows how the positions of the catheter 100 and the imaging sensor 200 are adjusted. The surgeon adjusts each position shown in the following a1 to a3.
(A1) Adjustment of the position of the catheter 100 in the longitudinal direction (FIG. 1: X-axis direction). By moving the catheter 100 along the coronary artery 80, the surgeon places the protrusion 109 of the catheter 100 in an optimal position for penetration into the true lumen 84 by the penetrating guide wire 400. Adjustment a1 can be performed while confirming the tip marker 128 and the proximal marker 129 on the X-ray image or the coronary artery 80 on the sensor image.
(A2) Adjustment of the orientation of the catheter 100 in the circumferential direction (FIG. 1: YZ axis direction). By rotating the catheter 100 in the circumferential direction, the operator adjusts the catheter 100 so as to have the indicated orientation (that is, the orientation in which the tip opening 103a is located on the CTO81 side). Adjustment a2 can be performed while confirming the positional relationship between the delivery guide wire 70 and the coronary artery 80 on the sensor image.
(A3) Adjustment of the position of the transducer 201 of the imaging sensor 200 in the longitudinal direction (FIG. 1: X-axis direction). By operating the adjuster 105, the operator moves the transducer 201 so that the transducer 201 is in a suitable position for observing the penetration of the penetrating guide wire 400. Adjustment a3 can be performed while confirming the coronary artery 80 on the sensor image.

FIG. 9B shows how the penetrating guide wire 400 penetrates the living tissue. First, the operator removes the delivery guide wire 70. At this time, in the catheter 100 of the present embodiment, the length of the delivery guide wire 70 inserted in the second lumen 103L is shorter than the conventional case described with reference to FIG. 8B.

After removing the delivery guide wire 70, the operator inserts the penetrating guide wire 400 into the catheter 100 by performing the operation described with reference to FIG. As described with reference to FIG. 6, in the catheter 100 of the present embodiment, the tip portion of the penetrating guide wire 400 is guided by the guiding portion 13. Therefore, the tip of the penetrating guide wire 400 can be smoothly projected from the tip opening 103a. After that, the operator guides the pointed portion of the penetrating guide wire 400 to the above-mentioned optimum site for penetration while confirming the tip of the penetrating guide wire 400 on the sensor image. Then, the pointed portion of the penetrating guide wire 400 is used to penetrate the living tissue, and the tip of the penetrating guide wire 400 is made to reach the true cavity 84.

By such a method, the CTO81 can be opened by the reopening catheter system 1. The method described above is merely an example, and the recanalization catheter system 1 can be used in various procedures. For example, the recanalization catheter system 1 is used not only for the approach from the false lumen 82 to the true lumen 84 but also for the approach through the CTO from the proximal true lumen 84 to the distal true lumen 84. May be done.

As described above, according to the catheter 100 of the first embodiment, the guide portion 13 is provided in the side opening 103b communicating with the second lumen 103L among the shafts 101 to 104. In the first case where the medical device (for example, the delivery guide wire 70) is inserted into the second lumen 103L from the tip end side of the shafts 101 to 104, the guide portion 13 inserts the base end portion of the delivery guide wire 70 into the second lumen 103L. It is guided from the inside of the lumen 103L to the outside through the side opening 103b (FIG. 5). In other words, in the first case where the catheter 100 is used as a rapid exchange type (Rx type), the guide portion 13 exits the proximal end portion of the delivery guide wire 70 from the side opening 103b that functions as a guide wire port. By guiding the catheter in such a manner, the usability as an Rx type catheter is improved. Further, the guide portion 13 is the tip portion of the penetration guide wire 400 when the medical device (for example, the penetration guide wire 400) is inserted into the second lumen 103L from the proximal end side of the shafts 101 to 104. Is restricted from going out through the side opening 103b and guided toward the tip of the second lumen 103L. In other words, the guiding portion 13 guides the tip of the penetrating guide wire 400 toward the tip of the second lumen 103L in the second case where the catheter 100 is used as an over-the-wire type (OTW type). , Improves usability as an OTW type catheter.

Further, since the second lumen 103L can be shared by different medical devices (for example, the delivery guide wire 70 and the penetrating guide wire 400 described above), the diameter of the catheter 100 can be reduced, and the diameter of the catheter 100 can be reduced (for example, in the living lumen (for example). For example, the catheter 100 can be easily inserted into the coronary artery 80, the CTO 81, etc.).

Further, for example, an IVUS (a sensor that acquires information on the living tissue by transmitting and receiving ultrasonic waves to the living tissue) is inserted into the first lumen 102L, and a delivery guide wire 70 or a penetrating guide is inserted into the second lumen 103L. A plurality of medical devices can be simultaneously held in one catheter 100, such as inserting a wire 400. Further, the shafts 101 to 104 are protrusions 109 that protrude toward the tip side of the end surface 108 in which the tip opening 103a communicating with the second lumen 103L is formed, and have a protrusion 109 including the first lumen 102L. ing. Therefore, by inserting the imaging sensor 200 (IVUS) into the first lumen 102L and arranging the transducer 201 (the part that transmits and receives ultrasonic waves to the living tissue) of the imaging sensor 200 in the protruding portion 109, the second lumen The tip of the medical device (for example, the delivery guide wire 70, the penetrating guide wire 400, etc.) inserted through the 103L can be observed by the imaging sensor 200. As a result, the surgeon can recognize the state in the living lumen (for example, CTO81) and the position of the tip of the medical device in real time only by the two-dimensional image obtained by the imaging sensor 200. That is, according to the catheter 100 of the first embodiment, the skill of operating a plurality of devices separately, which is conventionally required in the procedure under the guidance of the imaging sensor 200 (for example, IVUS Guide), and the sensor image and the X are used. The procedure under the guidance of the imaging sensor 200 can be realized without requiring the skill of three-dimensional reconstruction of the line image. Further, according to the catheter 100 of the first embodiment, since the procedure can be realized only by referring to the sensor image of the imaging sensor 200, the frequency of acquiring the X-ray image can be reduced, and the technique associated with the X-ray imaging can be performed. It is expected that the amount of exposure to people and patients will be reduced, and the amount of contrast medium used for X-ray photography will be reduced.

As a result, according to the catheter 100 of the first embodiment, the procedure under the guidance of the imaging sensor 200 can be realized, and different medical devices (for example, the above-mentioned delivery guide wire 70 and the penetrating guide wire 400) can be realized. ) Can be exchanged while proceeding with the procedure, and the labor and time required for exchanging the medical device can be reduced.

Further, according to the catheter 100 of the first embodiment, the induction portion 13 has a proximal end portion fixed to the outer peripheral surface of the shafts 101 to 104 (specifically, the outer shaft 101) from the outer peripheral surface of the outer shaft 101. The flap portion 132 is inclined toward the inside of the second lumen 103L. Therefore, by bringing the base end portion of the delivery guide wire 70 into contact with the outer surface 132o of the flap portion 132, the base end portion of the delivery guide wire 70 can be easily guided to the outside. Similarly, by bringing the tip of the penetrating guide wire 400 into contact with the inner side surface 132i of the flap portion 132, it is possible to easily restrict the tip of the penetrating guide wire 400 from coming out.

Further, according to the catheter 100 of the first embodiment, the guiding portion 13 is a main body portion 131 surrounding the circumferential direction of the shafts 101 to 104 (specifically, the outer shaft 101), and the flap portion 132. It has a body portion 131 integrally formed. Therefore, for example, when the catheter 100 advances through a biological tube having a small radius of curvature (in other words, a biological tube having a sharp curve), the flap portion 132 falls off from the shafts 101 to 104 when the shafts 101 to 104 are curved. Can be suppressed.

Further, according to the catheter 100 of the first embodiment, the shafts 101 to 104 (specifically, the tip tip 104) are further arranged at the tip of the protrusion 109 and extend in the longitudinal direction of the shafts 101 to 104. It has a third lumen 104L. Therefore, by inserting the delivery guide wire 70 through the third lumen 104L, the delivery guide wire 70 can be fixed on the tip side of the second lumen 103L (FIG. 5). By fixing the delivery guide wire 70, the delivery guide wire 70 can always be present in a fixed direction on the sensor image of the imaging sensor 200. Therefore, the surgeon moves or rotates the catheter 100 in the anteroposterior direction with reference to the delivery guide wire 70 while referring to the sensor image, thereby moving the catheter 100 and the target site of the living tissue (for penetration). The positional relationship with the target site (the target site that is going to penetrate the living tissue) can be adjusted with the guide wire 400. Further, since the third lumen 104L is arranged at the tip of the protruding portion 109, the diameter of the catheter 100 can be reduced, and the catheter 100 can be inserted into the living lumen (for example, inside the coronary artery 80, inside the CTO 81, etc.). Can be easily inserted.

<Second Embodiment>
FIG. 10 is a schematic side view of the distal end side of the catheter 100A of the second embodiment. The configuration of FIG. 10 is the same as the configuration of FIG. FIG. 11 is a diagram showing the configuration of the guide portion 13A as seen from the B direction (FIG. 10). The recanalization catheter system 1A of the second embodiment includes a catheter 100A instead of the catheter 100 described in the first embodiment. The catheter 100A includes a guiding portion 13A instead of the guiding portion 13 in the configuration described in the first embodiment. The guide portion 13A includes only the flap portion 132 and does not include the main body portion 131. The edge portion 132e (FIG. 11: inside the broken line frame) of the flap portion 132 is joined to the end portion of the notch portion SO in the outer peripheral surface of the outer shaft 101. Any bonding agent such as an epoxy adhesive may be used for bonding, or it may be embedded by heat melting or the like.

As described above, the configuration of the guiding portion 13A can be variously changed, and the guiding portion 13A may be configured only from the flap portion 132. Further, the shape of the flap portion 132 can be variously changed as described in the first embodiment. The recanalization catheter system 1A provided with the catheter 100A of the second embodiment as described above can also achieve the same effect as that of the first embodiment described above.

<Third Embodiment>
FIG. 12 is a schematic side view of the distal end side of the catheter 100B of the third embodiment. The recanalization catheter system 1B of the third embodiment includes a catheter 100B instead of the catheter 100 described in the first embodiment. In the configuration described in the first embodiment, the catheter 100B includes a guiding portion 13B instead of the guiding portion 13.

The guide portion 13B is configured to guide the end portion of the medical device (delivery guide wire 70 or penetration guide wire 400) inserted into the second lumen 103L. The guide portion 13B of the present embodiment is composed of a first raised portion SP1 formed on the inner peripheral surface of the second lumen 103L and a second raised portion SP2. The first raised portion SP1 is a region of the inner peripheral surface of the second lumen 103L on the tip side of the side opening 103b and opposite to the side on which the side opening 103b is formed (FIG. 12: −X axis). The region in the direction and the + Y-axis direction) is a portion that rises toward the side opening 103b. The second raised portion SP2 is a region of the inner peripheral surface of the second lumen 103L on the base end side of the side surface opening 103b and on the same side as the side on which the side opening 103b is formed (FIG. 12: + X-axis direction). And the region in the −Y axis direction) is a portion that rises in the direction away from the side opening 103b.

FIG. 13 is a diagram illustrating the operation of the guide unit 13B in the first case. The first case is a case where the catheter 100 is used as an Rx type catheter. As shown in FIG. 13, in the first case, the guiding portion 13B guides the base end portion of the delivery guide wire 70 from the inside of the second lumen 103L to the outside through the side opening 103b. Specifically, the guide portion 13B guides the base end portion of the delivery guide wire 70 to come out by bringing the base end portion of the delivery guide wire 70 into contact with the first raised portion SP1.

FIG. 14 is a diagram illustrating the operation of the guide unit 13B in the second case. The second case is a case where the catheter 100 is used as an OTW type catheter. As shown in FIG. 14, in the second case, the guide portion 13B suppresses the tip portion of the penetrating guide wire 400 from coming out through the side opening 103b so as to head toward the tip end of the second lumen 103L. Induce to. Specifically, the guiding portion 13B restricts the tip portion of the penetrating guide wire 400 from coming out by bringing the tip portion of the penetrating guide wire 400 into contact with the second raised portion SP2. As a result, as shown by the broken line in FIG. 14, the penetrating guide wire 400 gets over the side opening 103b, advances the second lumen 103L toward the tip side, and opens the tip end portion of the penetrating guide wire 400 toward the tip opening 103a. Can be projected from.

As described above, the configuration of the guide portion 13B can be variously changed, and the configuration may be configured without using the main body portion 131 and the flap portion 132. Further, the raised shapes of the first raised portion SP1 and the second raised portion SP2 can be arbitrarily determined. At least one of the first raised portion SP1 and the second raised portion SP2 is formed by piling an arbitrary bonding agent, a brazing material, a photocurable resin, or the like on the inner peripheral surface of the second lumen 103L. You may. The recanalization catheter system 1B provided with the catheter 100B of the third embodiment as described above can also achieve the same effect as that of the first embodiment described above.

Further, according to the catheter 100B of the third embodiment, the guiding portion 13B is composed of a first raised portion SP1 in which the inner peripheral surface of the second lumen 103L is raised and a second raised portion SP2. Therefore, by bringing the proximal end portion of the medical device (delivery guide wire 70) into contact with the first raised portion SP1, the proximal end portion of the delivery guide wire 70 can be easily guided to the outside. Similarly, by bringing the tip of the medical device (penetrating guide wire 400) into contact with the second raised portion SP2, it is possible to easily restrict the tip of the penetrating guide wire 400 from coming out. Further, according to the catheter 100B of the third embodiment, the guiding portion 13B can be configured without adding a special member.

<Fourth Embodiment>
FIG. 15 is a schematic side view of the distal end side of the catheter 100C of the fourth embodiment. The catheter 100C of the fourth embodiment includes the catheter 100C in place of the catheter 100 described in the first embodiment. In the configuration described in the first embodiment, the catheter 100C includes a guiding portion 13C instead of the guiding portion 13. The guide portion 13C includes only the flap portion 132C and does not include the main body portion 131. The flap portion 132C is formed by using a part of the shafts 101 to 104.

The flap portion 132C can be formed, for example, as follows. First, a notch SO1 extending in the circumferential direction is provided for the shafts 101 to 104 (specifically, the outer shaft 101, the second inner shaft 103, the sealing member 114, and the blade 115). Next, the shafts 101 to 104 on the proximal end side of the notch SO1 are heated, and the shafts 101 to 104 are contracted (deformed) toward the inside of the second lumen 103L.

As described above, the configuration of the guide portion 13C can be variously changed, and the flap portion 132C may be formed by using a part of the shafts 101 to 104. The flap portion 132C may be formed by any processing other than heat processing. The flap portion 132C can have any shape as long as the medical device can be guided as described with reference to FIGS. 5 and 6. The recanalization catheter system 1C provided with the catheter 100C of the fourth embodiment as described above can also achieve the same effect as that of the first embodiment described above. Further, according to the catheter 100C of the fourth embodiment, the guide portion 13C can be easily configured without adding a special member.

<Fifth Embodiment>
FIG. 16 is a schematic side view of the distal end side of the catheter 100D of the fifth embodiment. The recanalization catheter system 1D of the fifth embodiment includes the catheter 100D in place of the catheter 100 described in the first embodiment.

The catheter 100D does not include the tip tip 104 and the second lumen 103L in the configuration described in the first embodiment. Further, a first opening 102a communicating with the first lumen 102L is formed at the tip of the first inner shaft 102. A second opening 102b communicating with the first lumen 102L is formed on the side surface of the first inner shaft 102 facing the extension line of the central axis of the second lumen 103L. In the catheter 100D, when the delivery guide wire 70 is inserted, the delivery guide wire 70 is first inserted into the first lumen 102L from the first opening 102a, and the delivery guide wire 70 is pulled out from the second opening 102b. Next, the delivery guide wire 70 is inserted from the tip opening 103a into the second lumen 103L, and the delivery guide wire 70 is pulled out from the side opening 103b.

As described above, the configuration of the catheter 100D can be variously changed, and the same configuration as that of the first embodiment may be realized by using the first inner shaft 102 without providing the tip tip 104. The recanalization catheter system 1D provided with the catheter 100D of the fifth embodiment as described above can also achieve the same effect as that of the first embodiment described above. Further, according to the catheter 100D of the fifth embodiment, a configuration corresponding to the third lumen 104L of the first embodiment can be easily realized without adding a special member.

<Sixth Embodiment>
FIG. 17 is a cross-sectional view of the catheter 100E of the sixth embodiment. FIG. 17 shows a cross-sectional view of the catheter 100E in line AA of FIG. The recanalization catheter system 1E of the sixth embodiment includes the catheter 100E in place of the catheter 100 described in the first embodiment.

The catheter 100E does not have the outer shaft 101, the first inner shaft 102, the second inner shaft 103, the tip tip 104, the sealing member 114, and the blade 115 described in the first embodiment, and is a single shaft. It is composed of 101E. The shaft 101E has the same configuration as the shafts 101 to 104 of the first embodiment except that it is composed of a single member. That is, the first lumen 102L, the second lumen 103L, and the third lumen 104L are formed inside the shaft 101E. Further, the shaft 101E has a protrusion 109, a first opening 104a, a second opening 104b, a tip opening 103a, a side opening 103b, a base end side opening 103c, and an end face 108. The guide portion 13 described in the first embodiment is provided at a position corresponding to the side opening 103b of the shaft 101E.

As described above, the configuration of the catheter 100E can be variously changed, and may be configured by a single shaft 101E. Further, the shaft 101E may include at least a part of the members omitted in the sixth embodiment (for example, the tip tip 104 on which the third lumen 104L is formed). The recanalization catheter system 1E provided with the catheter 100E of the sixth embodiment as described above can also achieve the same effect as that of the first embodiment described above.

<Modified example of this embodiment>
The present invention is not limited to the above embodiment, and can be carried out in various embodiments without departing from the gist thereof, and for example, the following modifications are also possible.

[Modification 1]
In the first to sixth embodiments, an example of the configuration of the recanalization catheter systems 1, 1A to 1E is shown. However, the configuration of the recanalization catheter system 1 can be changed in various ways. For example, as the imaging sensor 200, a sensor that acquires an image of a living tissue by means other than starting and receiving ultrasonic waves may be used. Further, instead of the imaging sensor 200, an OCT (Optical Coherence Tomography) or a camera can be inserted to acquire an image of a living tissue in a blood vessel.

For example, the reopening catheter systems 1, 1A to 1E are configured as a system for opening a CTO using a plasma guide wire that ablates a living tissue using plasma without using a penetrating guide wire 400. May be good. In this case, in the catheters 100, 100A to 100E, it is preferable that the blade 115 is made of a conductive metal material and an electrode electrically connected to the blade 115 is provided on the tip end side of the outer shaft 101. Then, the plasma guide wire can be used by connecting the electrode provided on the tip end side of the outer shaft 101 and the proximal end side of the blade 115 to the RF generator.

For example, the recanalization catheter systems 1, 1A to 1E may be used by other methods not described above. For example, the recanalization catheter system may be used for blood vessels other than coronary arteries (eg, cerebral blood vessels, etc.) or in a living lumen other than blood vessels. For example, the recanalization catheter system 1 may be used for other treatments and examinations other than opening the CTO.

[Modification 2]
In the first to sixth embodiments, an example of the configuration of the catheters 100, 100A to 100E is shown. However, the catheter 100 configuration can be modified in various ways. For example, the first lumen 102L and the second lumen 103L of the catheter 100 may have substantially the same diameter, and the first lumen 102L may be configured to have a smaller diameter than the second lumen 103L. .. For example, the catheter 100 comprises a first lumen 102L and a second lumen 103L, as well as additional lumens for other medical devices or for simultaneous insertion of the delivery guide wire 70 and the penetration guide wire 400. You may.

For example, the portion of the first inner shaft 102 corresponding to the protruding portion 109 is preferably formed of polyamide from the viewpoint of achieving both ultrasonic transmission of the imaging sensor 200 and ensuring the wall thickness. On the other hand, of the first inner shaft 102, the portion not corresponding to the protruding portion 109 and the second inner shaft 103 and the like are made of polytetrafluoroethylene (PTFE), polyimide, ethylene tetrafluoride and per, from the viewpoint of ensuring rigidity. It is preferably formed of a copolymer (PFA) with fluoroalkoxyethylene, and the outer shaft 101 and the sealing member 114 are preferably formed of polyamide. Further, the tip 104 is preferably made of polyurethane from the viewpoint of ensuring flexibility.

The wall thickness of the portion of the first inner shaft 102 that does not correspond to the protruding portion 109 is preferably 10 microns or more for insulation from the conductive blade 115. The end surface 108 of the second inner shaft 103 may not be inclined and may be flat (perpendicular to the X-axis direction). For example, the catheter may include a coil body made of a conductive metal material as a reinforcing member instead of the blade 115. Further, both the blade 115 and the coil body may be provided. For example, the guide portion 13 may be coated with a resin having an insulating property, or a chemical agent may be coated on the surface thereof.

[Modification 3]
In the first to sixth embodiments, an example of the configuration of the induction portions 13, 13A to 13C is shown. However, the configuration of the guide portion 13 can be changed in various ways. For example, at least one of the main body portion 131 and the flap portion 132 may be formed of a member having radiation opacity. Further, a marker portion having radiation opacity may be formed at a position where the guidance portion 13 is provided. Then, the operator can grasp the position of the guide portion 13 on the X-ray image.

For example, the flap portion 132 of the guide portion 13 may be configured to move when the end portion of the medical device is pressed. Specifically, for example, a part of the flap portion 132 on the distal end side may be configured to move (bend) toward the second lumen 103L side when the delivery guide wire 70 comes into contact with the outer surface 132o. .. Similarly, a portion of the flap portion 132 on the distal end side may be configured to move (bend) toward the outside of the catheter 100 when the penetrating guide wire 400 comes into contact with the inner side surface 132i. This will make it even easier to insert the medical device.

[Modification 4]
The configurations of the catheters 100, 100A to 100E of the first to sixth embodiments and the configurations of the catheters 100, 100A to 100E of the above-mentioned modifications 1 to 3 may be appropriately combined. The guide portion 13 may be formed by combining the first raised portion SP1 and the second raised portion SP2 described in the third embodiment with the flap portion 132 described in the first or second embodiment. In the configuration described in any of the second, third and fourth embodiments, the shafts 101 to 104 described in the fifth embodiment and the shafts 101 to 104 described in the sixth embodiment may be used.

The present embodiment has been described above based on the embodiments and modifications, but the embodiments of the above-described embodiments are for facilitating the understanding of the present embodiments, and are not limited to the present embodiments. This aspect may be modified or improved without departing from its spirit and claims, and this aspect includes its equivalent. Further, if the technical feature is not described as essential in the present specification, it may be deleted as appropriate.

1,1A to 1E ... Reopening catheter system 13,13A to 13C ... Induction part 50 ... Cable 70 ... Delivery guide wire 100, 100A to 100E ... Catalyst 101 to 104, 101E ... Shaft 101 ... Outer shaft 102 ... First inner shaft 102L ... 1st lumen 102a ... 1st opening 102b ... 2nd opening 103 ... 2nd inner shaft 103L ... 2nd lumen 103a ... Tip opening 103b ... Side opening 103c ... Base end side opening 104 ... Tip tip 104L ... 3rd lumen 104a ... 1st opening 104b ... 2nd opening 105 ... Controller 108 ... End face 109 ... Protruding part 114 ... Sealing member 115 ... Blade 128 ... Tip marker 129 ... Base end marker 131 ... Main body part 132, 132C ... Flap part 132e ... Edge 132i ... Inner surface 132o ... Outer surface 200 ... Imaging sensor 201 ... Transducer 202 ... Driving cable 203 ... Connector 300 ... Imaging console 302 ... Display 400 ... Penetration guide wire

Claims (6)

1. A catheter with a shaft
   The shaft
   The first lumen extending in the longitudinal direction of the shaft and
   A second lumen arranged side by side with the first lumen from the base end portion of the shaft toward the tip end side,
   At the tip of the second lumen, an end face in which a tip opening communicating with the second lumen is formed, and
   It contains the first lumen and has a protrusion that protrudes toward the tip side from the end face.
   A side opening communicating with the second lumen is formed on the base end side of the side surface of the shaft with respect to the tip opening.
   In the first case, when the medical device is inserted into the second lumen from the tip end side of the shaft, the proximal end portion of the medical device is inserted into the side opening from the inside of the second lumen through the side opening. In the second case where the medical device is inserted into the second lumen from the proximal end side of the shaft, the tip of the medical device is external through the side opening. A catheter provided with a guide that regulates access to the second lumen and guides it toward the tip of the second lumen.
2. The catheter according to claim 1.
   The guide portion is a flap portion having a base end portion fixed to the outer peripheral surface of the shaft and inclined inward from the outer peripheral surface of the shaft toward the inside of the second lumen.
   In the first case, by bringing the proximal end of the medical device into contact with the outer surface of the flap, the proximal end of the medical device is guided to the outside.
   In the second case, a catheter that restricts the tip of the medical device from coming out by bringing the tip of the medical device into contact with the inner surface of the flap.
3. The catheter according to claim 2.
   The guide portion is a main body portion that surrounds the circumferential direction of the shaft, and has a main body portion that is integrally formed with the flap portion.
4. The catheter according to claim 1.
   The guide portion is
   Of the inner peripheral surface of the second lumen, the region on the distal end side of the side surface opening and opposite to the side on which the side surface opening is formed is the first raised portion that rises toward the side surface opening. When,
   A second ridge of the inner peripheral surface of the second lumen, which is on the proximal end side of the side opening and is on the same side as the side on which the side opening is formed, is raised in a direction away from the side opening. It is composed of parts and
   In the first case, by bringing the proximal end portion of the medical device into contact with the first raised portion, the proximal end portion of the medical device is guided to come out.
   In the second case, a catheter that restricts the tip of the medical device from coming out by bringing the tip of the medical device into contact with the second ridge.
5. The catheter according to any one of claims 1 to 4.
   The shaft is further located at the tip of the protrusion and has a third lumen extending longitudinally of the shaft.
   A first opening communicating with the third lumen is formed on the tip surface of the protrusion.
   A catheter having a second opening that communicates with the third lumen and is provided on the distal end side of the distal end opening on the side surface of the protruding portion.
6. A recanalization catheter system
   The catheter according to any one of claims 1 to 5.
   A sensor inserted into the first lumen and acquiring information on living tissue in the first lumen,
   A guide wire inserted into the second lumen, guided to the outside from the tip opening, and penetrating the living tissue,
   A recanalization catheter system.
   

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