JP7555421B2 - Catheter and recanalization catheter system - Google Patents

Description

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 blocked by an obstructing object. Patent documents 1 to 4 disclose a subintimal approach in which a medical device is re-entered from the false lumen to the true lumen for CTO opening (recanalization). The false lumen refers to all dissected lumen other than the true lumen formed by the medical device. In a procedure for CTO opening, a catheter is generally delivered to the position of the CTO lesion using a delivery guidewire, and then a penetration guidewire different from the delivery guidewire is used to re-enter the true lumen. In this regard, the catheter described in Patent Document 1 has separate lumens for the delivery guidewire and the penetration guidewire (occlusion crossing device).

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

Here, it is preferable that the catheter inserted into the blood vessel be as thin as possible. In addition, in a complex procedure such as CTO opening, a lumen for a sensor may be provided in the catheter to perform the procedure under sensor guidance (e.g., IVUS Guide). In such a case, the catheter described in Patent Document 1 requires at least three lumens, which poses the problem of the catheter becoming thicker in diameter. In addition, the catheters described in Patent Documents 2 to 4 do not take into consideration the combined use of a delivery guidewire and a penetration guidewire.

These issues are not limited to the opening of CTOs, but are common to all devices that involve exchanging different medical devices to advance a procedure, such as a delivery guidewire and a penetration guidewire. Furthermore, these issues are not limited to the vascular system, but are common to all devices that are inserted into biological lumens, such as the lymphatic system, biliary system, urinary system, respiratory tract system, digestive system, secretory glands, and reproductive organs.

The present invention has been made to solve at least some of the above-mentioned problems, and aims to reduce the effort and time required to replace medical devices in a catheter that allows procedures to be performed under sensor guidance and that allows procedures to be carried out while replacing different medical devices.

The present invention has been made to solve at least some of the above-mentioned problems and can be realized in the following forms.

(1) According to one aspect 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 in parallel with the first lumen from the base end of the shaft toward the tip end, an end face at the tip of the second lumen in which a tip opening communicating with the second lumen is formed, and a protrusion including the first lumen and protruding toward the tip side from the end face, and a side opening communicating with the second lumen is formed on the base end side of the side surface of the shaft relative to the tip opening, and the side opening is provided with a guide portion that guides the base end of the medical device from inside the second lumen to the outside through the side opening in a first case in which a medical device is inserted into the second lumen from the tip side of the shaft, and that restricts the tip of the medical device from exiting to the outside through the side opening and guides the medical device toward the tip of the second lumen in a second case in which a medical device is inserted into the second lumen from the base end side of the shaft.

According to this configuration, the guide portion is provided at the side opening communicating with the second lumen of the shaft of the catheter. In the first case where a medical device (e.g., a delivery guidewire) is inserted into the second lumen from the distal end side of the shaft, the guide portion guides the base end of the medical device from inside the second lumen to the outside through the side opening. In other words, in the first case where the catheter is used as a rapid exchange type (Rx type), the guide portion guides the base end of the medical device to the outside through the side opening functioning as a guidewire port, thereby improving the usability of the Rx type catheter. In addition, in the second case where a medical device (e.g., a penetration guidewire) is inserted into the second lumen from the proximal end side of the shaft, the guide portion restricts the distal end of the medical device from exiting to the outside through the side opening and guides it toward the distal end of the second lumen. In other words, in the second case when the catheter is used as an over-the-wire type (OTW type), the guidance section guides the tip of the medical device toward the tip of the second lumen, thereby improving usability as an OTW type catheter.
Furthermore, with a catheter of this configuration, the second lumen can be shared by different medical devices, allowing the catheter to be made thinner, making it easier to insert the catheter into a biological lumen (e.g., into a coronary artery, inside a CTO, etc.).
Furthermore, according to the catheter of this configuration, it is possible to simultaneously hold multiple medical devices in one catheter, for example, by inserting an IVUS (a sensor that acquires information on biological tissue by transmitting and receiving ultrasonic waves to biological tissue) into the first lumen and inserting a delivery guidewire or a penetration guidewire into the second lumen. The shaft also has a protruding portion that protrudes toward the tip side from an end face having a tip opening communicating with the second lumen and includes the first lumen. Therefore, by inserting an IVUS into the first lumen and arranging an IVUS transducer (a portion that transmits and receives ultrasonic waves to biological tissue) in the protruding portion, the tip of a medical device (e.g., a delivery guidewire or a penetration guidewire) inserted into the second lumen can be observed by IVUS. This allows the surgeon to recognize the state inside the biological lumen (e.g., CTO) and the position of the tip of the medical device in real time using only two-dimensional images by IVUS. That is, with the catheter of this configuration, a procedure under sensor guidance (e.g., IVUS Guide) can be performed without the need for the skills of separately operating multiple devices or the skills of three-dimensionally reconstructing sensor images and X-ray images, which were previously required for procedures under sensor guidance. Furthermore, with the catheter of this configuration, the procedure can be performed simply by referring to the sensor image, so the frequency of acquiring X-ray images can be reduced, and it is expected that the amount of radiation exposure of the operator and patient associated with X-ray photography and the amount of contrast agent used for X-ray photography can be reduced.
As a result, with a catheter of this configuration, it is possible to perform procedures under sensor guidance, it is possible to proceed with the procedure while replacing different medical devices, and it is possible to reduce the effort and time required to replace medical devices.

(2) In the catheter of the above form, the guide portion may be a flap portion whose base end is fixed to the outer peripheral surface of the shaft and inclined from the outer peripheral surface of the shaft toward the inside of the second lumen, and in the first case, the base end of the medical device may be guided to protrude to the outside by contacting the outer surface of the flap portion, and in the second case, the tip end of the medical device may be prevented from protruding to the outside by contacting the inner surface of the flap portion.
According to this configuration, the guide portion is a flap portion whose base end is fixed to the outer circumferential surface of the shaft and inclined from the outer circumferential surface of the shaft toward the inside of the second lumen. Therefore, by bringing the base end of the medical device into contact with the outer surface of the flap portion, the base end of the medical device can be easily guided to protrude to the outside. Similarly, by bringing the tip end of the medical device into contact with the inner surface of the flap portion, the tip end of the medical device can be easily prevented from protruding to the outside.

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

(4) In the catheter of the above embodiment, the guide portion is composed of a first raised portion which is located on the inner surface of the second lumen toward the distal end of the side opening and on the opposite side to the side on which the side opening is formed, and a second raised portion which is located on the inner surface of the second lumen toward the proximal end of the side opening and on the same side as the side on which the side opening is formed and which raised in a direction away from the side opening. In the first case, the base end of the medical device is brought into contact with the first raised portion to guide the base end of the medical device to protrude to the outside, and in the second case, the tip end of the medical device is brought into contact with the second raised portion to prevent the tip end of the medical device from protruding to the outside.
According to this configuration, the guide portion is composed of a first raised portion, which is a raised portion of the inner circumferential surface of the second lumen, and a second raised portion. Therefore, by bringing the base end of the medical device into contact with the first raised portion, the base end of the medical device can be easily guided to protrude to the outside. Similarly, by bringing the tip end of the medical device into contact with the second raised portion, the tip end of the medical device can be easily prevented from protruding to the outside. Furthermore, according to this configuration, the guide portion can be configured without adding any special members.

(5) In the catheter of the above form, the shaft may further have a third lumen disposed at the tip of the protrusion and extending in the longitudinal direction of the shaft, a first opening communicating with the third lumen being formed on the tip surface of the protrusion, and a second opening communicating with the third lumen and located closer to the tip than the tip opening being formed on the side surface of the protrusion.
According to this configuration, the shaft further has a third lumen disposed at the tip of the protruding portion and extending in the longitudinal direction of the shaft. Therefore, by inserting the delivery guidewire through the third lumen, the delivery guidewire can be fixed at a position distal to the second lumen. By fixing the delivery guidewire, the delivery guidewire can always be present in a constant direction on the image of the sensor. Therefore, the operator can adjust the positional relationship between the catheter and the target site of the biological tissue (the target site where the biological tissue is to be penetrated by the penetration guidewire) by moving the catheter forward and backward and rotating it based on the delivery guidewire while referring to the image of the sensor. In addition, since the third lumen is disposed at the tip of the protruding portion, the catheter can be made thinner, and the catheter can be easily inserted into the biological lumen (for example, into the coronary artery, inside the CTO, etc.).

(6) According to one aspect of the present invention, a recanalization catheter system is provided. The recanalization catheter system includes a catheter according to the above aspect, a sensor inserted into the first lumen and configured to acquire information about biological tissue in the first lumen, and a guidewire inserted into the second lumen and guided to the outside through the tip opening while penetrating biological tissue.

The present invention can be realized in various forms, such as a catheter, a method for manufacturing or using a catheter, a catheter system including a catheter and other devices such as a sensor, a delivery guidewire, or a penetration guidewire, and a method for manufacturing or using a catheter system.

FIG. 1 is an explanatory diagram illustrating the configuration of a recanalization catheter system. 2 is a cross-sectional view of the catheter taken along line AA in FIG. 1. FIG. 2 is a schematic side view of the distal end of the catheter. 4 is a diagram showing the configuration of the guiding portion as viewed from direction B (FIG. 3). FIG. 11A and 11B are diagrams illustrating the operation of the guiding unit in the first case. 13A and 13B are diagrams illustrating the operation of the guiding unit in the second case. FIG. 1 is a schematic diagram of an imaging sensor. FIG. 1 is a diagram illustrating a method of using the recanalization catheter system. FIG. 1 is a diagram illustrating a method of using the recanalization catheter system. FIG. 11 is a schematic side view of the distal end side of a catheter according to a second embodiment. 11 is a diagram showing the configuration of the guiding portion as viewed from direction B (FIG. 10). FIG. FIG. 11 is a schematic side view of the distal end side of a catheter according to a third embodiment. 11A and 11B are diagrams illustrating the operation of the guiding unit in the first case. 13A and 13B are diagrams illustrating the operation of the guiding unit in the second case. FIG. 13 is a schematic side view of the tip end of a catheter according to a fourth embodiment. FIG. 13 is a schematic side view of the distal end side of a catheter according to a fifth embodiment. FIG. 13 is a cross-sectional view of a catheter according to a sixth embodiment.

Figure 1 is an explanatory diagram illustrating the configuration of a 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 using an antegrade approach. The recanalization catheter system 1 includes a catheter 100, an imaging sensor 200, an imaging console 300, and a penetration guidewire 400. Figure 1 shows a schematic side view of the catheter 100, and a portion of the tip side of the imaging sensor 200 inserted into the first inner shaft 102 is shown by a solid line.

1 includes a portion in which the relative size ratio of each component is depicted differently from the actual size for the sake of convenience of explanation. Also, includes a portion in which each component is depicted in an exaggerated manner. Also, FIG. 1 illustrates mutually orthogonal XYZ axes. The X axis corresponds to the longitudinal direction of the catheter 100 and the penetrating guidewire 400, the Y axis corresponds to the height direction of the catheter 100 and the penetrating guidewire 400, and the Z axis corresponds to the width direction of the catheter 100 and the penetrating guidewire 400. The left side (-X axis direction) of FIG. 1 is called the "tip side" of the catheter 100 and each component, and the right side (+X axis direction) of FIG. 1 is called the "base end side" of the catheter 100 and each component. Also, of the two ends of the catheter 100 and each component in the longitudinal direction (X axis direction), one end located on the tip side is called the "tip" and the other end located on the base side is called the "base end". The tip and its vicinity are referred to as the "tip portion," and the base end and its vicinity are referred to as the "base end portion." The tip side is inserted into the living body, and the base end side is operated by an operator such as a doctor. These points are the same in Fig. 1 and subsequent figures.

Figure 2 is a cross-sectional view of the catheter 100 taken along line A-A in Figure 1. Figure 3 is a schematic side view of the distal end of the catheter 100. In Figure 3, the lumen within the catheter 100 is shown by a dashed line, and a portion of the distal end of the imaging sensor 200 inserted into the first inner shaft 102 is shown by a solid line. In addition, in the upper dashed frame of Figure 3, the left dashed frame shows the shafts 101-104 with the guidance section 13 removed. The right dashed frame shows the guidance section 13.

The configuration of the catheter 100 will be described using Figures 1 to 3. As shown in Figure 1, the catheter 100 has shafts 101 to 104, a guide section 13, a distal marker 128, a proximal marker 129, and an adjuster 105. Note that in Figure 1 and the following figures, the guide section 13 is hatched with diagonal lines to distinguish it from other components.

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

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) or the penetration 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 and generally 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 disposed 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 may be formed of, for example, polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, polyesters such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymers, cross-linked ethylene-vinyl acetate copolymers, thermoplastic resins such as polyurethane, polyamide elastomers, polyolefin elastomers, polyurethane elastomers, silicone rubber, latex rubber, etc. In addition, they may be formed of known materials instead of insulating resins.

The braid 115 is a reinforcing member formed by braiding wires. The braid 115 is embedded in the thick part of the outer shaft 101. The wires constituting the braid 115 may be formed of a metal material (for example, stainless steel such as SUS304, nickel-titanium alloy, alloys containing gold, platinum, and tungsten, which are X-ray opaque materials). The wires constituting the braid 115 may be formed of other known metal materials. In addition, instead of the braid 115, a coil body formed by winding wires in a spiral shape may be embedded in the thick part of the outer shaft 101. The wires constituting the coil body may be formed of known metal materials, like the braid 115.

As shown in FIG. 1, the length of the first inner shaft 102 is longer than the lengths of the outer shaft 101 and the second inner shaft 103. The length of the second inner shaft 103 is approximately 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 portion of the tip side of the first inner shaft 102 and an end face 108 of the tip side of the second inner shaft 103 each protrude from the tip of the outer shaft 101.

As shown in FIG. 3, a transducer 201 of an imaging sensor 200 is disposed on a portion of the tip side of the first inner shaft 102 (a portion protruding from the tip of the outer shaft 101). This transducer 201 allows observation of the state of a delivery guide wire 70 (described later in FIG. 5) and a penetration guide wire 400 (described later in FIG. 6) inserted into the second lumen 103L (wire lumen). The imaging sensor 200 transmits ultrasonic waves from the transducer 201 to the biological tissue and receives the reflected sound. For this reason, it is preferable that a portion of the tip side of the first inner shaft 102 (a portion protruding from the tip of the outer shaft 101) is formed of a resin, such as polyethylene, that has a smaller difference in acoustic impedance with biological tissue than the portion of the first inner shaft 102 located inside the outer shaft 101. In addition, a portion of the tip side of the first inner shaft 102 (the portion protruding from the tip of the outer shaft 101) may have a thick portion with a thickness that is thinner than that of the portion of the first inner shaft 102 that is located inside the outer shaft 101.

The end face 108 on the tip side of the second inner shaft 103 is inclined outward from the side closer to the center of the outer shaft 101. In addition, a tip opening 103a that communicates with the second lumen 103L (lumen for wire) is formed on the end face 108.

The tip tip 104 is joined to the tip of the first inner shaft 102. The tip tip 104 is a substantially cylindrical member with an R at the tip. The tip tip 104 can be of any shape, and may be, for example, a substantially truncated cone shape with an outer diameter that decreases from the base end side to the tip 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. In addition, 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 disposed on the tip side of the second opening 104b. In addition, the second opening 104b is disposed on the tip side of the tip opening 103a of the second inner shaft 103. The tip tip 104 is preferably made of a flexible resin material, such as a polyurethane elastomer. The tip tip 104 and the first inner shaft 102 can be joined by, for example, joining resins together by thermal melting or by using an insulating adhesive such as an epoxy adhesive.

Hereinafter, the portion of the tip side of the first inner shaft 102 that protrudes further toward the tip side than the end face 108 and the tip tip 104 will be collectively referred to as the "protrusion 109."

A side opening 103b is formed on the side of the shafts 101-104, closer to the base end than the tip opening 103a. As shown in the dashed frame on the left side of Figure 3, the side opening 103b is formed by a cutout portion SO that is formed by cutting out a portion of the shafts 101-104 (specifically, the outer shaft 101, the second inner shaft 103, the sealing member 114, and the blade 115) in the circumferential direction. As shown in the lower part of Figure 3, a guide portion 13 is provided in the side opening 103b.

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

Figure 4 is a diagram showing the configuration of the guide section 13 as viewed from the B direction (Figure 3). The main body section 131 is an annular member that surrounds the outer shaft 101 in the circumferential direction. As shown in Figure 4, the flap section 132 is a substantially semicircular flat plate-like member that is inclined inward from the base end connected to the main body section 131 toward the tip side. In addition to a substantially semicircular shape, the flap section 132 may be any shape such as a substantially circular shape, a substantially elliptical shape, a substantially rectangular shape, or a substantially polygonal shape. In addition to a flat plate shape, the flap section 132 may be any shape such as a corrugated plate shape, a curved plate shape, a bent plate shape, or a raised shape. As shown in the lower part of Figure 3, when the guide section 13 is fitted into the outer shaft 101, the base end of the flap section 132 is fixed to the outer peripheral surface of the outer shaft 101 and is inclined from the outer peripheral surface of the outer shaft 101 toward the inside of the second lumen 103L. In this 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 a urethane resin or a silicone resin.

Figure 5 is a diagram explaining the operation of the guidance section 13 in the first case. In Figure 5, the delivery guidewire 70 as a medical device is shown with dotted hatching. The case in which the delivery guidewire 70 is inserted into the second lumen 103L from the tip side of the shafts 101-104 and advances inside the second lumen 103L from the tip side toward the base side is called the "first case." In other words, the first case is when the catheter 100 is used as a rapid exchange type (Rx type) catheter.

As shown in FIG. 5, in the first case, the surgeon inserts the base end of the delivery guidewire 70 from the first opening 104a into the third lumen 104L, pulls it out from the second opening 104b, reinserts it from the tip opening 103a into the second lumen 103L, and pulls it out from the side opening 103b. At this time, the guidance unit 13 guides the base end of the delivery guidewire 70 from the inside of the second lumen 103L to the outside through the side opening 103b. Specifically, the flap portion 132 of the guidance unit 13 brings the base end of the delivery guidewire 70 into contact with the outer surface 132o of the flap portion 132, thereby guiding the base end of the delivery guidewire 70 to the outside.

Figure 6 is a diagram explaining the operation of the guidance section 13 in the second case. In Figure 6, the penetrating guidewire 400 as a medical device is shown with dotted hatching. The case in which the penetrating guidewire 400 is inserted into the second lumen 103L from the base end side of the shafts 101-104 and advances inside the second lumen 103L from the base end side to the tip side is called the "second case." In other words, the second case is when the catheter 100 is used as an over-the-wire type (OTW type) catheter.

6, in the second case, the surgeon inserts the tip of the penetration guidewire 400 into the second lumen 103L from the opening 103c (FIG. 1) on the base end side of the second lumen 103L and pulls it out from the tip opening 103a. At this time, the guidance section 13 prevents the tip of the penetration guidewire 400 from coming out through the side opening 103b and guides it toward the tip of the second lumen 103L. Specifically, the flap section 132 of the guidance section 13 brings the tip of the penetration guidewire 400 into contact with the inner surface 132i of the flap section 132, thereby restricting the tip of the penetration guidewire 400 from coming out. As a result, as shown by the dashed line in Figure 6, the penetration guide wire 400 passes over the side opening 103b and advances through the second lumen 103L toward the tip side, allowing the tip of the penetration guide wire 400 to protrude from the tip opening 103a.

Returning to FIG. 1, the explanation will be continued. The distal marker 128 and the proximal marker 129 are disposed on the side of the protruding portion 109 and function as markers indicating the position of the catheter 100 inserted into the blood vessel (specifically, the position of the protruding portion 109). The distal marker 128 is disposed between the first inner shaft 102 and the distal tip 104 in the longitudinal direction (X-axis direction) of the shafts 101-104. The proximal marker 129 is disposed at the proximal end of the protruding portion 109 in the longitudinal direction (X-axis direction) of the shafts 101-104. The distal marker 128 and the proximal marker 129 can be formed from a radiopaque resin material or metal material. For example, when a resin material is used, the distal marker 128 and the proximal marker 129 can be formed by mixing a radiopaque material such as bismuth trioxide, tungsten, or barium sulfate with polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin. For example, when a metal material is used, it can be formed of radiopaque materials such as gold, platinum, tungsten, or alloys containing these elements (for example, platinum-nickel alloys).

As shown in FIG. 1, the adjuster 105 is an operating unit for advancing or retracting the imaging sensor 200 in the first lumen 102L. The adjuster 105 has a dial that can be operated by the surgeon, and by rotating the dial, the imaging sensor 200 inserted in the first lumen 102L advances or retracts. Like the outer shaft 101, the adjuster 105 is formed from an insulating resin or a known material. The material of the adjuster 105 may be the same as the material of the outer shaft 101, or may be different.

Figure 7 is a schematic diagram of the imaging sensor 200. The imaging sensor 200 has a long outer shape and is a "sensor" that acquires information on biological tissue. The imaging sensor 200 has a transducer 201, a driving cable 202, and a connector 203. The transducer 201 is equipped with an ultrasonic probe (also called an ultrasonic vibrator, a piezoelectric body, an ultrasonic transmission/reception element, or an ultrasonic element) that transmits ultrasonic waves toward the biological tissue and receives the ultrasonic waves reflected by the biological tissue. The driving cable 202 has a coaxial line on its inside that electrically connects the transducer 201 and the motor drive 204. The connector 203 connects the coaxial line of the driving cable 202 to 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.

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 and rotates it in the circumferential direction (YZ-axis direction) of the first inner shaft 102 in response to the operation of the adjuster 105. In addition, the imaging console 300 transmits ultrasonic waves from the transducer 201 in response to the operation of the surgeon via an input means (not shown) and causes the transducer 201 to receive reflected waves. The reflected waves received by the transducer 201 are 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 gradations of light and dark according to the intensity of the received reflected waves, and displays the generated image on the display 302. Hereinafter, the image acquired by the imaging sensor 200 and displayed on the display 302 will also be referred to as a "sensor image."

The penetrating guidewire 400 shown in Figure 1 is a long medical device with a pointed portion at its tip. The pointed portion is a portion that is arrowhead-shaped or wedge-shaped from the base end to the tip. The penetrating guidewire 400 can penetrate biological tissue by the pointed portion at its tip. The penetrating guidewire 400 corresponds to a "guidewire that penetrates biological tissue."

8 and 9 are diagrams for explaining a method of using the recanalization catheter system 1. In each of Figs. 8 and 9, a coronary artery 80 as an example of a biological lumen, a CTO 81 occurring in the coronary artery 80, a false lumen 82 (all dissected lumen other than the true lumen formed by the delivery guidewire 70) formed in the intima or subintima of the coronary artery 80, a true lumen 84, and a fibrous capsule or plaque 83 (hereinafter also referred to as "fibrous capsule 83") present between the false lumen 82 and the true lumen 84 are shown. The fibrous capsule 83 may be formed in a fibrous form on the surface of the CTO lesion.

Figure 8 (A) shows the state in which a delivery guide wire 70 is inserted into a coronary artery 80. In Figure 8 (A), the delivery guide wire 70 operated by the surgeon has entered the intima of the coronary artery 80 or has formed a false lumen 82 under the intima.

Figure 8 (B) shows how the catheter 100 is delivered using the delivery guidewire 70. The surgeon inserts the delivery guidewire 70 into the catheter 100 by performing the operation described in Figure 5. As described in Figure 5, in the catheter 100 of this embodiment, the delivery guidewire 70 inserted from the tip opening 103a into the second lumen 103L is pulled out to the outside from the side opening 103b. Therefore, compared to the case where the delivery guidewire 70 is pulled out from the base end opening 103c (hereinafter also referred to as the "conventional case"), the distance over which the delivery guidewire 70 is sent out in the second lumen 103L can be shortened. As a result, it is possible to support the base end of the delivery guidewire 70 during delivery of the catheter 100, and it is possible to prevent the delivery guidewire 70 from slipping or coming off due to catheter insertion. The time required to insert the delivery guidewire 70 can be shortened. Thereafter, the surgeon delivers the catheter 100 along the delivery guide wire 70 to the false lumen 82 as shown in FIG. 8(B).

9A shows how to adjust the positions of the catheter 100 and the imaging sensor 200. The operator adjusts the positions shown in the following a1 to a3.
(a1) Adjustment of the position of the catheter 100 in the longitudinal direction (X-axis direction in FIG. 1). The surgeon moves the catheter 100 along the coronary artery 80 to place the protruding portion 109 of the catheter 100 in an optimal position for penetration of the true lumen 84 by the penetration guidewire 400. Adjustment a1 can be performed while checking the distal marker 128 and 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 (YZ axis direction in FIG. 1). The surgeon rotates the catheter 100 in the circumferential direction to adjust the catheter 100 to the illustrated orientation (i.e., the orientation in which the tip opening 103a is located on the CTO 81 side). Adjustment a2 can be performed while checking the positional relationship between the delivery guidewire 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 (X-axis direction in FIG. 1). The surgeon operates the adjuster 105 to move the transducer 201 to a position suitable for observing the penetration of the penetration guidewire 400. Adjustment a3 can be performed while checking the coronary artery 80 on the sensor image.

Figure 9 (B) shows how the penetration guidewire 400 penetrates biological tissue. First, the surgeon removes the delivery guidewire 70. At this time, in the catheter 100 of this embodiment, the length of the delivery guidewire 70 inserted into the second lumen 103L is shorter than in the conventional case described in Figure 8 (B).

After removing the delivery guidewire 70, the surgeon inserts the penetrating guidewire 400 into the catheter 100 by performing the operation described in FIG. 6. As described in FIG. 6, in the catheter 100 of this embodiment, the tip of the penetrating guidewire 400 is guided by the guide section 13. Therefore, the tip of the penetrating guidewire 400 can be smoothly protruded from the tip opening 103a. Then, while checking the tip of the penetrating guidewire 400 on the sensor image, the surgeon guides the pointed portion of the penetrating guidewire 400 to the optimal site for penetration as described above. Then, the pointed portion of the penetrating guidewire 400 is used to penetrate the biological tissue, and the tip of the penetrating guidewire 400 reaches the true lumen 84.

This method enables the CTO 81 to be opened by the recanalization catheter system 1. The above-mentioned method is merely one example, and the recanalization catheter system 1 can be used in various procedures. For example, the recanalization catheter system 1 may be used not only in an approach from the false lumen 82 to the true lumen 84, but also in an approach penetrating the CTO from the proximal true lumen 84 to the distal true lumen 84.

As described above, according to the catheter 100 of the first embodiment, the guide section 13 is provided in the side opening 103b that communicates with the second lumen 103L among the shafts 101 to 104. In the first case where a medical device (e.g., a delivery guidewire 70) is inserted into the second lumen 103L from the tip side of the shafts 101 to 104, the guide section 13 guides the base end of the delivery guidewire 70 from the inside of the second 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 section 13 guides the base end of the delivery guidewire 70 to the outside through the side opening 103b that functions as a guidewire port, thereby improving the usability as an Rx type catheter. Furthermore, in a second case where a medical device (e.g., the penetrating guidewire 400) is inserted into the second lumen 103L from the base end side of the shafts 101-104, the guidance section 13 restricts the distal end of the penetrating guidewire 400 from coming out through the side opening 103b and guides the distal end of the penetrating guidewire 400 toward the distal end of the second lumen 103L. In other words, in a second case where the catheter 100 is used as an over-the-wire type (OTW type), the guidance section 13 guides the distal end of the penetrating guidewire 400 toward the distal end of the second lumen 103L, thereby improving the usability of the catheter as an OTW type catheter.

In addition, since the second lumen 103L can be shared by different medical devices (e.g., the delivery guidewire 70 and the penetration guidewire 400 described above), the catheter 100 can be made thinner, making it easier to insert the catheter 100 into a biological lumen (e.g., into the coronary artery 80, inside the CTO 81, etc.).

Furthermore, multiple medical devices can be held simultaneously within one catheter 100, for example by inserting an IVUS (a sensor that obtains information about biological tissue by transmitting and receiving ultrasonic waves to biological tissue) into the first lumen 102L and a delivery guidewire 70 or a penetration guidewire 400 into the second lumen 103L. Also, the shafts 101-104 have a protruding portion 109 that protrudes distally beyond an end face 108 in which a distal opening 103a communicating with the second lumen 103L is formed, and the protruding portion 109 includes the first lumen 102L. Therefore, by inserting the imaging sensor 200 (IVUS) into the first lumen 102L and arranging the transducer 201 (a portion for transmitting and receiving ultrasonic waves to and from biological tissue) of the imaging sensor 200 in the protruding portion 109, the tip of a medical device (e.g., a delivery guidewire 70, a penetration guidewire 400, etc.) inserted into the second lumen 103L can be observed by the imaging sensor 200. This allows the surgeon to recognize the state inside the biological lumen (e.g., the CTO 81) and the position of the tip of the medical device in real time only with the two-dimensional image by the imaging sensor 200. That is, according to the catheter 100 of the first embodiment, a procedure under the guidance of the imaging sensor 200 can be realized without the need for the skill of separately operating multiple devices or the skill of three-dimensionally reconstructing a sensor image and an X-ray image, which were conventionally required in a procedure under the guidance of the imaging sensor 200 (e.g., IVUS Guide). Furthermore, according to the catheter 100 of the first embodiment, the procedure can be performed simply by referring to the sensor image of the imaging sensor 200, so that the frequency of acquiring X-ray images can be reduced, which is expected to reduce the amount of radiation exposure of the surgeon and patient associated with X-ray imaging, and reduce the amount of contrast agent used for X-ray imaging.

As a result, with the catheter 100 of the first embodiment, it is possible to perform the procedure under the guidance of the imaging sensor 200, and it is possible to proceed with the procedure while exchanging different medical devices (e.g., the delivery guidewire 70 and the penetration guidewire 400 described above), and it is possible to reduce the effort and time required to exchange medical devices.

According to the catheter 100 of the first embodiment, the guide section 13 is a flap section 132 whose base end is fixed to the outer circumferential surface of the shafts 101-104 (specifically, the outer shaft 101) and inclined from the outer circumferential surface of the outer shaft 101 toward the inside of the second lumen 103L. Therefore, by bringing the base end of the delivery guidewire 70 into contact with the outer surface 132o of the flap section 132, the base end of the delivery guidewire 70 can be easily guided to protrude to the outside. Similarly, by bringing the tip of the penetration guidewire 400 into contact with the inner surface 132i of the flap section 132, the tip of the penetration guidewire 400 can be easily prevented from protruding to the outside.

Furthermore, according to the catheter 100 of the first embodiment, the guide section 13 further includes a main body section 131 that surrounds the shafts 101-104 (specifically, the outer shaft 101) in the circumferential direction and is formed integrally with the flap section 132. Therefore, for example, when the catheter 100 advances through a biological tube with a small radius of curvature (in other words, a biological tube with a sharp curve), the flap section 132 can be prevented from falling off the shafts 101-104 when the shafts 101-104 are curved.

Furthermore, according to the catheter 100 of the first embodiment, the shafts 101 to 104 (specifically, the distal tip 104) further have a third lumen 104L disposed at the distal end of the protrusion 109 and extending in the longitudinal direction of the shafts 101 to 104. Therefore, by inserting the delivery guidewire 70 through the third lumen 104L, the delivery guidewire 70 can be fixed at the distal end side of the second lumen 103L (FIG. 5). By fixing the delivery guidewire 70, the delivery guidewire 70 can always be present in a constant direction on the sensor image of the imaging sensor 200. Therefore, the surgeon can adjust the positional relationship between the catheter 100 and the target site of the biological tissue (the target site where the biological tissue is to be penetrated by the penetration guidewire 400) by moving the catheter 100 in the forward and backward directions or rotating it based on the delivery guidewire 70 while referring to the sensor image. Furthermore, since the third lumen 104L is positioned at the tip of the protrusion 109, the catheter 100 can be made thinner, making it easier to insert the catheter 100 into a biological lumen (e.g., into the coronary artery 80, inside the CTO 81, etc.).

Second Embodiment
FIG. 10 is a schematic side view of the distal end of the catheter 100A of the second embodiment. The configuration of FIG. 10 is the same as that of FIG. 3. FIG. 11 is a view showing the configuration of the guide section 13A as viewed from the direction B (FIG. 10). The recanalization catheter system 1A of the second embodiment includes the catheter 100A instead of the catheter 100 described in the first embodiment. The catheter 100A includes the guide section 13A instead of the guide section 13 in the configuration described in the first embodiment. The guide section 13A is composed of only the flap section 132 and does not include the main body section 131. The edge section 132e of the flap section 132 (FIG. 11: within the dashed line frame) is joined to the end of the cutout section SO of the outer circumferential surface of the outer shaft 101. For the joining, any bonding agent such as an epoxy adhesive may be used, or the joint may be embedded by thermal melting or the like.

In this way, the configuration of the guide section 13A can be modified in various ways, and the guide section 13A can be composed of only the flap section 132. Furthermore, the shape of the flap section 132 can be modified in various ways, as described in the first embodiment. The recanalization catheter system 1A including the catheter 100A of the second embodiment as described above can also achieve the same effects as the first embodiment described above.

Third Embodiment
12 is a schematic side view of the distal end of a catheter 100B according to the third embodiment. The recanalization catheter system 1B according to the third embodiment includes a catheter 100B instead of the catheter 100 described in the first embodiment. The catheter 100B includes a guide section 13B instead of the guide section 13 in the configuration described in the first embodiment.

The guidance section 13B is configured to guide the end of a medical device (delivery guidewire 70 or penetration guidewire 400) inserted into the second lumen 103L. In this embodiment, the guidance section 13B is configured with a first protuberance SP1 and a second protuberance SP2 formed on the inner surface of the second lumen 103L. The first protuberance SP1 is a portion of the inner surface of the second lumen 103L that is closer to the tip side than the side opening 103b and is a region on the opposite side to the side where the side opening 103b is formed (FIG. 12: the region in the -X-axis direction and +Y-axis direction) that protrudes toward the side opening 103b. The second protrusion SP2 is a portion of the inner surface of the second lumen 103L that is proximal to the side opening 103b and is located on the same side as the side opening 103b (the region in the +X-axis direction and the -Y-axis direction in Figure 12) and protrudes in a direction away from the side opening 103b.

Figure 13 is a diagram illustrating the operation of the guidance unit 13B in the first case. The first case is when the catheter 100 is used as an Rx type catheter. As shown in Figure 13, in the first case, the guidance unit 13B guides the base end of the delivery guidewire 70 from the inside of the second lumen 103L to the outside through the side opening 103b. Specifically, the guidance unit 13B guides the base end of the delivery guidewire 70 to come into contact with the first protrusion SP1, thereby guiding the base end of the delivery guidewire 70 to come out to the outside.

14 is a diagram for explaining the operation of the guidance section 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 guidance section 13B suppresses the tip of the penetrating guidewire 400 from going out through the side opening 103b and guides it toward the tip of the second lumen 103L. Specifically, the guidance section 13B restricts the tip of the penetrating guidewire 400 from going out by bringing the tip of the penetrating guidewire 400 into contact with the second protuberance SP2. As a result, as shown by the dashed line in FIG. 14, the penetrating guidewire 400 passes over the side opening 103b and advances through the second lumen 103L toward the tip side, so that the tip of the penetrating guidewire 400 can be protruded from the tip opening 103a.

In this way, the configuration of the guidance section 13B can be modified in various ways, and it may be configured without using the main body section 131 or the flap section 132. In addition, the raised shapes of the first raised section SP1 and the second raised section SP2 can be determined arbitrarily. At least one of the first raised section SP1 and the second raised section SP2 may be formed by depositing an arbitrary bonding agent, brazing material, photocurable resin, etc. on the inner surface of the second lumen 103L. The recanalization catheter system 1B including the catheter 100B of the third embodiment as described above can also achieve the same effects as the first embodiment described above.

Furthermore, according to the catheter 100B of the third embodiment, the guide section 13B is composed of a first raised section SP1 and a second raised section SP2, which are raised sections of the inner circumferential surface of the second lumen 103L. Therefore, by bringing the base end of the medical device (delivery guidewire 70) into contact with the first raised section SP1, the base end of the delivery guidewire 70 can be easily guided to protrude to the outside. Similarly, by bringing the tip end of the medical device (penetration guidewire 400) into contact with the second raised section SP2, the tip end of the penetration guidewire 400 can be easily prevented from protruding to the outside. Furthermore, according to the catheter 100B of the third embodiment, the guide section 13B can be configured without adding any special members.

Fourth Embodiment
15 is a schematic side view of the distal end of a catheter 100C of the fourth embodiment. The catheter 100C of the fourth embodiment includes a catheter 100C instead of the catheter 100 described in the first embodiment. The catheter 100C includes a guide portion 13C instead of the guide portion 13 in the configuration described in the first embodiment. The guide portion 13C is made up of only a flap portion 132C and does not include a main body portion 131. The flap portion 132C is formed using a portion of the shafts 101-104.

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

In this way, the configuration of the guidance section 13C can be modified in various ways, and the flap section 132C can be formed using a portion of the shafts 101-104. The flap section 132C can be formed by any process other than heat processing. The flap section 132C can be formed in any shape as long as it is capable of guiding the medical device as described in Figures 5 and 6. The recanalization catheter system 1C equipped with the catheter 100C of the fourth embodiment as described above can also achieve the same effects as the first embodiment described above. Furthermore, with the catheter 100C of the fourth embodiment, the guidance section 13C can be easily configured without adding any special components.

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

The catheter 100D does not have the tip tip 104 and the second lumen 103L in the configuration described in the first embodiment. In addition, 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 of the first inner shaft 102 facing the extension line of the central axis of the second lumen 103L. In the catheter 100D, when inserting the delivery guide wire 70, first, the delivery guide wire 70 is inserted from the first opening 102a into the first lumen 102L, 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.

In this way, the configuration of the catheter 100D can be modified in various ways, and a configuration similar to that of the first embodiment can be realized by using the first inner shaft 102 without providing the distal tip 104. The recanalization catheter system 1D equipped with the catheter 100D of the fifth embodiment as described above can also achieve the same effects as those of the first embodiment described above. Furthermore, with the catheter 100D of the fifth embodiment, a configuration equivalent to the third lumen 104L of the first embodiment can be easily realized without adding any special members.

Sixth Embodiment
Fig. 17 is a cross-sectional view of a catheter 100E of a sixth embodiment. Fig. 17 shows a cross-sectional view of the catheter 100E taken along line AA in Fig. 1. The recanalization catheter system 1E of the sixth embodiment includes a catheter 100E instead 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 composed of a single shaft 101E. The shaft 101E has a configuration similar to that of 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. The shaft 101E also has a protrusion 109, a first opening 104a, a second opening 104b, a tip opening 103a, a side opening 103b, a base end opening 103c, and an end surface 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.

In this way, the configuration of the catheter 100E can be modified in various ways, and may be configured with a single shaft 101E. The shaft 101E may also include at least some of the components omitted in the sixth embodiment (e.g., the distal tip 104 in which the third lumen 104L is formed). The recanalization catheter system 1E including the catheter 100E of the sixth embodiment as described above can also achieve the same effects as the first embodiment described above.

<Modifications of this embodiment>
The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit and scope of the invention. For example, the following modifications are also possible.

[Modification 1]
In the above first to sixth embodiments, one example of the configuration of the recanalization catheter system 1, 1A to 1E has been shown. However, the configuration of the recanalization catheter system 1 can be modified in various ways. For example, a sensor that acquires images of biological tissue by means other than the transmission and reception of ultrasonic waves may be used as the imaging sensor 200. Also, instead of the imaging sensor 200, an OCT (Optical Coherence Tomography) or a camera may be inserted to acquire images of biological tissue in a blood vessel.

For example, the recanalization catheter systems 1, 1A to 1E may be configured as a system that attempts to open the CTO using a plasma guidewire that performs plasma-based biological tissue ablation, without using the penetrating guidewire 400. 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 distal end of the outer shaft 101. In this way, the plasma guidewire can be used by connecting the electrode provided on the distal end of the outer shaft 101 and the proximal end of the blade 115 to an RF generator.

For example, the recanalization catheter systems 1, 1A-1E may be used in other methods not described above. For example, the recanalization catheter systems may be used in blood vessels other than coronary arteries (e.g., cerebral blood vessels, etc.) and may be used in biological lumens other than blood vessels. For example, the recanalization catheter system 1 may be used for treatments or examinations other than the opening of a CTO.

[Modification 2]
In the first to sixth embodiments, one example of the configuration of the catheters 100, 100A to 100E has been shown. However, the configuration of the catheter 100 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, or the first lumen 102L may be configured to have a smaller diameter than the second lumen 103L. For example, the catheter 100 may have an additional lumen for another medical device or for simultaneously inserting the delivery guidewire 70 and the penetration guidewire 400 in addition to the first lumen 102L and the second lumen 103L.

For example, the portion of the first inner shaft 102 that corresponds to the protruding portion 109 is preferably made of polyamide from the viewpoint of achieving both the ultrasonic transparency of the imaging sensor 200 and the thickness. On the other hand, the portion of the first inner shaft 102 that does not correspond to the protruding portion 109 and the second inner shaft 103, etc. are preferably made of polytetrafluoroethylene (PTFE), polyimide, copolymer of tetrafluoroethylene and perfluoroalkoxyethylene (PFA), etc. from the viewpoint of ensuring rigidity, and the outer shaft 101 and the sealing member 114 are preferably made of polyamide. Also, the distal tip 104 is preferably made of polyurethane from the viewpoint of ensuring flexibility.

The 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 with the conductive blade 115. The end face 108 of the second inner shaft 103 may be flat (perpendicular to the X-axis direction) without being inclined. For example, the catheter may have a coil body made of a conductive metal material as a reinforcing member instead of the blade 115. It may also have both the blade 115 and the coil body. For example, the induction portion 13 may be coated with an insulating resin, or a drug may be applied to the surface.

[Modification 3]
In the above first to sixth embodiments, one example of the configuration of the guidance portion 13, 13A to 13C is shown. However, the configuration of the guidance portion 13 can be modified in various ways. For example, at least one of the main body portion 131 and the flap portion 132 may be formed of a radiopaque material. Also, a radiopaque marker portion may be formed at the position where the guidance portion 13 is to be provided. In this way, the surgeon can grasp the position of the guidance portion 13 on the X-ray image.

For example, the flap portion 132 of the guidance section 13 may be configured to move when pressed by the end of the medical device. Specifically, for example, a portion of the tip side of the flap portion 132 may be configured to move (bend) toward the second lumen 103L when the delivery guidewire 70 contacts the outer surface 132o. Similarly, a portion of the tip side of the flap portion 132 may be configured to move (bend) toward the outside of the catheter 100 when the penetration guidewire 400 contacts the inner surface 132i. This makes it even easier to insert the medical device.

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

Although this aspect has been described above based on embodiments and modified examples, the embodiments of the above-mentioned aspects are intended to facilitate understanding of this aspect and are not intended to limit this aspect. This aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in this aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

Reference Signs List 1, 1A to 1E... Recanalization catheter system 13, 13A to 13C... Guidance section 50... Cable 70... Delivery guide wire 100, 100A to 100E... Catheter 101 to 104, 101E... Shaft 101... Outer shaft 102... First inner shaft 102L... First lumen 102a... First opening 102b... Second opening 103... Second inner shaft 103L... Second lumen 103a... Distal opening 103b... Side opening 103c... Base end opening 104... Distal tip 104L... Third lumen 104a... First opening 104b... Second opening 105... Adjuster 108... End surface 109... Projection 114... Sealing member 115... Blade 128... Distal marker 129... Base end marker 131: Main body portion 132, 132C: Flap portion 132e: Edge portion 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 (7)

A catheter having a shaft,
The shaft is
a first lumen extending in a longitudinal direction of the shaft;
A second lumen disposed in parallel with the first lumen from the proximal end of the shaft toward the distal end thereof;
an end surface having a distal end opening communicating with the second lumen at a distal end of the second lumen;
a protrusion including the first lumen and protruding toward a distal end side beyond the end surface;
A side opening communicating with the second lumen is formed on a side surface of the shaft closer to the base end than the tip opening,
the side opening is provided with a guide portion that, in a first case in which a medical device is inserted into the second lumen from the distal end side of the shaft, guides a base end of the medical device from inside the second lumen to the outside through the side opening, and, in a second case in which a medical device is inserted into the second lumen from the proximal end side of the shaft, restricts the distal end of the medical device from going to the outside through the side opening and guides the distal end of the medical device toward the distal end of the second lumen;
The induction portion is
a flap portion having a base end fixed to an outer circumferential surface of the shaft and inclined from the outer circumferential surface of the shaft toward the inside of the second lumen;
a main body portion that surrounds the shaft in a circumferential direction and is integrally formed with the flap portion;
The main body portion is an annular member that surrounds the shaft in a circumferential direction,
A catheter in which, in the first case, the flap portion guides the base end of the medical device to protrude to the outside by contacting the base end of the medical device with the outer surface of the flap portion, and in the second case, the flap portion prevents the tip end of the medical device from protruding to the outside by contacting the tip end of the medical device with the inner surface of the flap portion . 2. The catheter of claim 1 ,
A catheter, wherein the flap portion has a base end portion extending circumferentially of the main body portion and is a flat plate-shaped member inclined from the base end portion toward the tip end portion toward the second lumen. The catheter according to claim 1 or 2 ,
The catheter, wherein the body portion is radiopaque. The catheter according to any one of claims 1 to 3 ,
A catheter, wherein the flap portion is radiopaque. A catheter having a shaft ,
The shaft is
a first lumen extending in a longitudinal direction of the shaft;
A second lumen disposed in parallel with the first lumen from the proximal end of the shaft toward the distal end thereof;
an end surface having a distal end opening communicating with the second lumen at a distal end of the second lumen;
a protrusion including the first lumen and protruding toward a distal end side beyond the end surface;
A side opening communicating with the second lumen is formed on a side surface of the shaft closer to the base end than the tip opening,
the side opening is provided with a guide portion that, in a first case in which a medical device is inserted into the second lumen from the distal end side of the shaft, guides a base end of the medical device from inside the second lumen to the outside through the side opening, and, in a second case in which a medical device is inserted into the second lumen from the proximal end side of the shaft, restricts the distal end of the medical device from going to the outside through the side opening and guides the distal end of the medical device toward the distal end of the second lumen;
The induction portion is
a first protruding portion in which an area of an inner circumferential surface of the second lumen, which is located distal to the side opening and opposite to the side on which the side opening is formed, protrudes toward the side opening;
a second protruding portion in an inner circumferential surface of the second lumen, the second protruding portion being protruding in a direction away from the side opening, the second protruding portion being protruding in a direction away from the side opening,
In the first case, the proximal end of the medical device is brought into contact with the first protruding portion, thereby guiding the proximal end of the medical device to protrude to the outside;
In the second case, the catheter prevents the tip of the medical device from coming out by contacting the tip of the medical device with the second protruding portion. The catheter according to any one of claims 1 to 5 ,
The shaft further includes a third lumen disposed at a distal end of the protrusion and extending in a longitudinal direction of the shaft,
A first opening communicating with the third lumen is formed on a distal end surface of the protrusion,
A catheter, wherein a second opening is formed on a side surface of the protrusion, the second opening being in communication with the third lumen and being located closer to the tip side than the tip opening. 1. A recanalization catheter system comprising:
A catheter according to any one of claims 1 to 6 ;
A sensor that is inserted into the first lumen and acquires information about a biological tissue in the first lumen;
a guide wire that is inserted into the second lumen and guided to the outside from the distal end opening and penetrates biological tissue;
A recanalization catheter system comprising:

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