Catheter system

Abstract

A catheter system according to the present disclosure comprises a laser emitter equipped with a laser emission unit, and a catheter that defines an insertion space through which the laser emitter can be inserted. The catheter is equipped with a window part through which a laser emitted from the laser emission unit or a pressure wave caused by the laser can be released toward the radially outside of the catheter. The longitudinal-direction length of the laser emission unit is less than the longitudinal-direction length of the window part. The catheter is equipped with a first marker, and the laser emitter is equipped with a second marker that makes it possible to identify that the laser emission unit is arranged at the position of the window part in the longitudinal direction by being aligned with the first marker in the longitudinal direction. The second marker is disposed near the laser emission unit in the longitudinal direction.

Description

Catheter System

[0001] The present disclosure relates to a catheter system.

[0002] Conventionally, probes that convert laser light into shock waves and utilize the shock wave stress to perform various treatments have been known. Patent Document 1 discloses this type of probe. Also known is a probe that converts the vaporization expansion force of a liquid obtained by spark discharge in a liquid atmosphere into mechanical force to perform treatment. Patent Document 2 discloses this type of probe.

[0003] JP-A-5-300911 Publication Special Publication No. 2015-522344

[0004] However, the probes described in Patent Documents 1 and 2 still have room for improvement in terms of efficiency in ensuring that the force required for treatment is applied to the target site when treating the target site, such as crushing a calcified area in a blood vessel.

[0005] An object of the present disclosure is to provide a catheter system that can improve efficiency when treating a target site.

[0006] A catheter system according to a first aspect of the present disclosure comprises: (1) a laser emitter having a laser emission unit capable of emitting a laser; and a catheter defining an insertion space within which the laser emitter can be inserted, wherein the catheter comprises a window unit capable of releasing the laser emitted from the laser emission unit of the laser emitter located in the insertion space or a pressure wave caused by the laser toward the outside of the catheter in a radial direction of the catheter, wherein, when the direction in which the laser emitter and the catheter extend while the laser emitter is inserted into the insertion space of the catheter is defined as a longitudinal direction, the length of the laser emission unit in the longitudinal direction is shorter than the length of the window unit in the longitudinal direction; the catheter comprises a first marker; and the laser emitter comprises a second marker that is aligned with the first marker in the longitudinal direction, thereby enabling identification that the laser emission unit is positioned at the position of the window unit in the longitudinal direction. The second marker is a catheter system that is arranged proximal to the laser emission unit in the longitudinal direction.

[0007] One embodiment of the catheter system of the present disclosure is (2) the catheter system described in (1) above, wherein the catheter comprises a tubular member that defines the insertion space therein, and an expansion member that covers the radial outside of the tubular member and is capable of expanding and contracting in the radial direction, the window portion is provided in the expansion member, and the first marker is positioned on the tubular member at a position proximal to the expansion member in the longitudinal direction.

[0008] A catheter system according to one embodiment of the present disclosure is (3) the catheter system described in (2) above, in which the laser emitter is positioned in a region in the longitudinal direction where the distal end of the window portion is located by aligning the second marker with the first marker.

[0009] A catheter system according to one embodiment of the present disclosure is the catheter system described in (3) above, wherein (4) the catheter is provided with a third marker proximal to the first marker in the longitudinal direction, and the laser emitter of the laser emitter is positioned in the region where the proximal end of the window portion is located in the longitudinal direction by aligning the second marker with the third marker.

[0010] A catheter system according to one embodiment of the present disclosure is (5) a catheter system described in any one of (2) to (4) above, wherein each of the first marker and the second marker has radiographic contrast or ultrasound visibility.

[0011] A catheter system according to one embodiment of the present disclosure is (6) a catheter system according to any one of (2) to (4) above, wherein each of the first marker and the second marker is configured to be visually identifiable.

[0012] A catheter system according to one embodiment of the present disclosure is (7) the catheter system described in (1) above, wherein the catheter comprises a tubular member that defines the insertion space therein, and an expansion member that covers the radial outside of the tubular member and is capable of expanding and contracting in the radial direction, the window portion is provided in the expansion member, the first marker and the second marker each have X-ray contrast or ultrasound visibility, and the first marker is positioned in a position on the tubular member that is covered by the expansion member.

[0013] A catheter system according to one embodiment of the present disclosure is (8) the catheter system described in (7) above, in which the laser emitter is positioned in a region in the longitudinal direction where the distal end of the window portion is located by aligning the second marker with the first marker.

[0014] A catheter system according to one embodiment of the present disclosure is (9) the catheter system described in (8) above, wherein the catheter is provided with a third marker proximal to the first marker in the longitudinal direction, and the laser emitter of the laser emitter is positioned in the region where the proximal end of the window portion is located in the longitudinal direction by aligning the second marker with the third marker.

[0015] A catheter system according to one embodiment of the present disclosure is (10) the catheter system described in (9) above, wherein the third marker is positioned on the tubular member at a position proximal to the expansion member in the longitudinal direction.

[0016] A catheter system according to one embodiment of the present disclosure is (11) the catheter system described in (9) above, wherein the third marker is positioned at a position of the tubular member that is covered by the expansion member.

[0017] A catheter system according to one embodiment of the present disclosure is (12) the catheter system described in (7) above, in which the laser emitter is positioned in a region in the longitudinal direction where the proximal end of the window portion is located by aligning the second marker with the first marker.

[0018] A catheter system according to one embodiment of the present disclosure is (13) the catheter system described in (8) above, wherein the laser emitter of the laser emitter is positioned in a region where the distal end of the window portion is located in the longitudinal direction by aligning the second marker with the first marker at a predetermined distance proximal to the longitudinal direction.

[0019] A catheter system according to one embodiment of the present disclosure is (14) the catheter system described in (1) above, wherein the catheter comprises a tubular member defining the insertion space therein, the window portion is provided in the tubular member, and the first marker is positioned proximal to the window portion in the longitudinal direction.

[0020] A catheter system according to one embodiment of the present disclosure is (15) the catheter system described in (14) above, wherein the laser emitter is positioned in a region in the longitudinal direction where the distal end of the window is located by aligning the second marker with the first marker.

[0021] A catheter system according to one embodiment of the present disclosure is (16) the catheter system described in claim (15) above, wherein the catheter is provided with a third marker located proximal to the first marker in the longitudinal direction, and the laser emitter is positioned in a region where the proximal end of the window portion is located in the longitudinal direction by aligning the second marker with the third marker.

[0022] A catheter system according to one embodiment of the present disclosure is (17) a catheter system according to any one of (14) to (16) above, wherein each of the first marker and the second marker has radiographic contrast or ultrasound visibility.

[0023] A catheter system according to one embodiment of the present disclosure is (18) a catheter system according to any one of (14) to (16) above, wherein each of the first marker and the second marker is configured to be visually identifiable.

[0024] A catheter system according to one embodiment of the present disclosure is (19) the catheter system described in any one of (1) to (18) above, wherein the window portion is provided with a shock wave generating portion capable of generating a shock wave as the pressure wave by the laser emitted from the laser emission portion of the laser emitter.

[0025] A treatment method as a second aspect of the present disclosure is (20) a treatment method using a catheter system, wherein the catheter system comprises: a laser emitter having a laser emission part capable of emitting a laser; and a catheter defining an insertion space inside into which the laser emitter can be inserted, wherein the catheter comprises: a tubular member defining the insertion space inside; and an expansion member covering the outside of the tubular member in the radial direction and capable of expanding and contracting in the radial direction, wherein the expansion member comprises a window part that can release the laser emitted from the laser emission part of the laser emitter located in the insertion space or a pressure wave caused by the laser toward the outside of the catheter in the radial direction, wherein when the direction in which the laser emitter and the catheter extend in a state in which the laser emitter is inserted into the insertion space of the tubular member of the catheter is defined as the longitudinal direction, the length of the laser emission part in the longitudinal direction is shorter than the length of the window part in the longitudinal direction, the catheter comprises a first marker on the tubular member, the first marker being positioned proximal and / or distal to the expansion member in the longitudinal direction; and the laser emitter comprises a second marker that is aligned with the first marker in the longitudinal direction, thereby making it possible to identify that the laser emission unit is positioned at the position of the window in the longitudinal direction; and the treatment method includes: a preparation step of preparing the catheter system; an expansion step of expanding the expansion member of the catheter of the catheter system at a target site; and a treatment step of emitting a laser from the laser emission unit of the laser emitter toward a shock wave generating unit that can generate shock waves as pressure waves by the laser emitted from the laser emission unit of the laser emitter, and treating the target site with the shock waves generated in the shock wave generating unit.

[0026] According to the present disclosure, a catheter system can be provided that can improve the efficiency of treating a target site.

[0027] 1 is a diagram showing a catheter according to an embodiment of the present disclosure. FIG. 1 is a cross-sectional view of the catheter taken at line II in FIG. 1. FIG. 2 is a diagram showing a state in which the expansion member of the catheter shown in FIG. 1 is expanded. FIG. 3 is a cross-sectional view of the catheter shown in FIG. 3 at the same position as FIG. 2. FIG. 4 is a partial cross-sectional view of the catheter shown in FIG. 3 taken along a plane along the longitudinal direction. FIG. 5 is a diagram showing a state in which the laser emitter has been moved to the longitudinal proximal side relative to the catheter from the state shown in FIG. 5. FIG. 6 is a diagram showing a modified example of the catheter shown in FIG. 5. FIG. 7 is a partial cross-sectional view of the catheter according to an embodiment of the present disclosure taken along a plane along the longitudinal direction. FIG. 8 is a diagram showing a modified example of the catheter shown in FIG. 8. FIG. 9 is a partial cross-sectional view of the catheter according to an embodiment of the present disclosure taken along a plane along the longitudinal direction, showing a state in which the laser emitter is arranged in a region where the proximal end of the window is located. FIG. 10 is a diagram showing a state in which the laser emitter shown in FIG. 10 is arranged in a region where the distal end of the window is located. FIG. 11 is a side view of the catheter according to an embodiment of the present disclosure, showing a state in which the laser emitter is arranged in a region where the distal end of the window is located. FIG. 12 is a diagram showing a state in which the laser emitter shown in FIG. 12 is arranged in a region where the proximal end of the window is located. FIG. 13 is an explanatory diagram for explaining the principle of generation of laser-induced shock waves. 1 is a flowchart illustrating a treatment method according to one embodiment of the present disclosure.

[0028] Hereinafter, an embodiment of a catheter system according to the present disclosure will be described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals.

[0029] First Embodiment Fig. 1 is a diagram showing a catheter system 100 as one embodiment of a catheter system according to the present disclosure. Fig. 1 shows the catheter system 100 inserted into a blood vessel BV. The catheter system 100 is a medical instrument that is inserted into the blood vessel BV and is capable of fracturing a calcified region X in the blood vessel BV by utilizing shock waves as pressure waves generated by laser irradiation. The catheter system 100 is inserted into the blood vessel BV along a guidewire. In this embodiment, the calcified region X in the blood vessel BV is exemplified as a target site to be treated by the catheter system 100, but the catheter system 100 may also be used to treat other target sites.

[0030] As shown in Fig. 1, the catheter system 100 includes a laser emitter 20 and a catheter 1. The catheter 1 of this embodiment includes a tubular member 2 and an expansion member 3. Fig. 1 shows the catheter system 100 percutaneously inserted into a patient's blood vessel BV, with the expansion member 3 of the catheter 1 introduced up to the position of a lesion, which is a target site where a calcified region X has formed. Fig. 1 also shows the expansion member 3 in a contracted state. In the contracted state, the expansion member 3 is guided through the blood vessel BV to the lesion.

[0031] Hereinafter, in the catheter system 100, the direction in which the laser emitter 20 and the catheter 1 extend when the laser emitter 20 is inserted into the insertion space 6 of the catheter 1 will be referred to as the "longitudinal direction A." Furthermore, in the catheter system 100, the direction around the axis of the catheter 1 will be referred to as the "circumferential direction B." Furthermore, in the catheter system 100, the radial direction of the catheter 1, which is the radial direction of an imaginary circle whose central axis is the catheter 1 in a cross section perpendicular to the longitudinal direction A, will be referred to as the "radial direction C." Furthermore, within the longitudinal direction A, the direction from the base end (hand side) of the catheter system 100 operated by an operator such as a surgeon toward the distal end of the catheter system 100 inserted into a living body will be referred to as the "distal" or "distal side A1," and the direction from the distal end of the catheter system 100 toward the base end of the catheter system 100 will be referred to as the "proximal" or "proximal side A2."

[0032] Fig. 2 is a cross-sectional view of the catheter system 100 taken at the position of line II in Fig. 1. Figs. 3 to 5 show the expanded state of the expansion member 3 in the contracted state shown in Figs. 1 and 2. Specifically, Fig. 3 shows the expanded state of the expansion member 3 in the contracted state shown in Fig. 1 within the blood vessel BV. Fig. 4 is a cross-sectional view taken at the same position as Fig. 2, showing the expansion member 3 in an expanded state. Fig. 5 is a partial cross-sectional view taken along the longitudinal direction A of the catheter system 100 in which the expansion member 3 is in an expanded state. For ease of explanation, Fig. 5 shows a side view of everything except the outer tube 12 of the tubular member 2 and the expansion member 3.

[0033] As shown in FIG. 5, the laser emitter 20 includes a laser emitter 23 capable of emitting a laser.

[0034] 2, 4, and 5, the catheter 1 defines an insertion space 6 therein through which the laser emitter 20 can be inserted. More specifically, in the catheter 1 of this embodiment, the tubular member 2 defines the insertion space 6 therein.

[0035] As shown in Figure 5, the catheter 1 is provided with a window 45 that can emit a laser beam emitted from the laser emission unit 23 of the laser emitter 20 located in the insertion space 6, or a pressure wave caused by the laser beam, outward in the radial direction C to the outside of the catheter 1. The laser beam or pressure wave emitted from the window 45 is used to treat the target site. The window 45 in this embodiment is provided in the expansion member 3. Furthermore, as will be described in detail later, the window 45 in this embodiment is configured to emit a shock wave as a pressure wave caused by the laser.

[0036] As shown in FIG. 5, the length Z1 of the laser emission part 23 in the longitudinal direction A is smaller than the length Z2 of the window part 45 in the longitudinal direction A.

[0037] The catheter 1 includes a first marker 14c. The laser emitter 20 also includes a second marker 26 that is aligned with the first marker 14c in the longitudinal direction A, thereby making it possible to identify that the laser emitter 23 is positioned at the position of the window portion 45 in the longitudinal direction A. The second marker 26 is positioned on the proximal side A2 of the laser emitter 23 in the longitudinal direction A. In other words, the laser emitter 23 is positioned on the distal side A1 of the second marker 26 in the longitudinal direction A. The first marker 14c and the second marker 26 of this embodiment are contrast markers that are radiopaque. The first marker 14c and the second marker 26 are not limited to being radiopaque, and may be, for example, ultrasonically visible.

[0038] In the catheter system 100, the laser emitter 20 is movable in the longitudinal direction A relative to the catheter 1. Therefore, by moving the laser emitter 20 in the longitudinal direction A relative to the catheter 1, the laser emitter 23 can be positioned within the range of the region in the longitudinal direction A where the window 45 is located.

[0039] In the catheter system 100, by utilizing the first marker 14c of the catheter 1 and the second marker 26 of the laser emitter 20, it is possible to externally identify that the laser emission unit 23 is located at the position of the window 45 in the longitudinal direction A. That is, an operator of the catheter system 100, such as a surgeon, can easily confirm that the laser emission unit 23 is located at the position of the window 45 in the longitudinal direction A by moving the laser emitter 20 in the longitudinal direction A relative to the catheter 1 while checking the positional relationship between the first marker 14c and the second marker 26. This makes it possible to reliably emit the laser emitted from the laser emission unit 23 or the pressure waves resulting from this laser outward in the radial direction C from the window 45, thereby enabling the laser or pressure waves emitted from the window 45 to be efficiently used for treating the target site. As a result, the efficiency of treating the target site can be improved.

[0040] As shown in FIG. 3 , in the catheter system 100 of this embodiment, the expansion member 3 of the catheter 1 is positioned over a calcified region X in a blood vessel BV as a target site. Next, the expansion member 3 contacts the calcified region X and expands to apply pressure in the radial direction C. At this time, the window 45 of the expansion member 3 comes into contact with the calcified region X as a target site. The laser emitter 20 moves through the insertion space 6 defined inside the tubular member 2 of the catheter 1, and the first marker 14 c and the second marker 26 are aligned, thereby positioning the laser emission unit 23 at the window 45 in the longitudinal direction A. In this state, a laser is emitted from the laser emission unit 23 outward in the radial direction C. As shown in FIG. 5 , the tubular member 2 of this embodiment includes a laser transmission portion 2 a 1 that allows the laser emitted from the laser emission portion 23 to transmit outward in the radial direction C. The laser that has passed through the laser transmission portion 2 a 1 is irradiated onto the window 45 of the expansion member 3.

[0041] The window 45 of the expansion member 3 of this embodiment is capable of emitting shock waves as pressure waves caused by the laser emitted from the laser emitter 20 outward in the radial direction C. Specifically, the window 45 of the expansion member 3 of this embodiment is equipped with a shock wave generating unit 40a (see FIG. 5 ) that is capable of generating shock waves as pressure waves by the laser emitted from the laser emitter 23 of the laser emitter 20. The laser that is emitted from the laser emitter 23 of the laser emitter 20 and transmitted through the laser transmitting portion 2a1 of the tubular member 2 is irradiated onto the shock wave generating unit 40a of the window 45 of the expansion member 3. This laser irradiation causes the shock wave generating unit 40a to generate shock waves that are radiated outward in the radial direction C. This shock wave acts on the calcified region X, which is the target site, thereby fracturing the calcified region X.

[0042] In the catheter system 100 of this embodiment, the expansion member 3 generates shock waves as pressure waves caused by the laser, but the configuration is not limited to this. As will be described in detail later, the expansion member 3 may be configured, for example, to transmit shock waves generated on the inner side of the expansion member 3 in the radial direction C to the outer side in the radial direction C, thereby releasing the shock waves to the outer side in the radial direction C.

[0043] Furthermore, the window portion 45 of the expansion member 3 may be configured to transmit the laser emitted from the laser emitter 20 from the inside to the outside in the radial direction C, thereby enabling the laser itself to be emitted outward in the radial direction C. In other words, the catheter system according to the present disclosure may be used as a medical device that can emit the laser emitted from the laser emitter 20 outward in the radial direction C, for treatments such as photodynamic therapy (PDT) and photoimmunotherapy (PIT).

[0044] Furthermore, although the catheter 1 of this embodiment includes the expansion member 3, the configuration is not limited to this. The catheter 1 may also be configured without the expansion member 3. In such a case, the window 45 may be provided in a component of the catheter 1 other than the expansion member 3, such as the tubular member 2 (see FIGS. 12 and 13 ).

[0045] The catheter system 100 of this embodiment will be described in further detail below with reference to Figures 1 to 6. Figure 6 is a diagram showing a state in which the laser emitter 20 has been moved to the proximal side A2 in the longitudinal direction A relative to the catheter 1 from the state shown in Figure 5.

[0046] <Laser Emitter 20> As shown in FIG. 5, the laser emitter 20 of this embodiment includes a laser emitter main body 21 and a connector portion 22 attached to the proximal end of the laser emitter main body 21.

[0047] The laser emitting body 21 comprises a laser emitting section 23 located at its distal end, a drive transmission connector 24 located at its proximal end and covered by a connector section 22, and a long laser non-emitting section 25 extending between the laser emitting section 23 and the drive transmission connector 24.

[0048] The laser emission section 23 of this embodiment is a portion of the laser fiber 31 (see FIGS. 2 and 4 ) capable of emitting a laser beam that is not covered with the fiber coating layer 32 (see FIGS. 2 and 4 ). In contrast, the laser non-emission section 25 of this embodiment is a portion of the laser fiber 31 (see FIGS. 2 and 4 ) capable of emitting a laser beam that is covered with the fiber coating layer 32 (see FIGS. 2 and 4 ). The material of the fiber coating layer 32 may be any light-blocking material that can block the laser beam emitted from the laser fiber 31, and may be, for example, a resin layer such as an ultraviolet-curable resin (UV-curable resin), a metal layer such as a coil, or the like. The fiber coating layer 32 may be a single layer, or multiple layers may be laminated.

[0049] The connector 22 is configured to be connectable to a drive device connected to an optical source. When the connector 22 is connected to the drive device, the laser fiber 31 is optically connected to the drive device. When the connector 22 is connected to the drive device, the drive device is able to drive the laser emitting body 21 in at least one of the longitudinal direction A and the circumferential direction B via the drive transmission connector 24.

[0050] More specifically, the connector part 22 of this embodiment includes a connector main body 22a connectable to the drive device and an inner cylindrical part 22b protruding from the connector main body 22a toward the distal side A1. The proximal end of the laser emitting main body 21 is fitted and fixed within the inner cylindrical part 22b of the connector part 22. The inner cylindrical part 22b of the connector part 22 of this embodiment includes a flange part 22b1 protruding outward in the radial direction C.

[0051] The laser emission unit 23 may be configured to emit a laser beam only in a partial region in the circumferential direction B, toward the outside in the radial direction C. In such a case, by rotating the laser emission main body 21 in the circumferential direction B using a driving device, the laser beam emitted from the laser emission unit 23 toward the outside in the radial direction C can be emitted over the entire area in the circumferential direction B. The irradiation range L1 (see FIG. 14 ) in the circumferential direction B of the light absorption layer 40 a 3 (see FIG. 5 ) of the extension member 3, onto which the laser beam from the laser emission unit 23 of the laser emitter 20 is irradiated, may be set appropriately. Furthermore, by moving the laser emission main body 21 in the longitudinal direction A while rotating it in the circumferential direction B using a driving device, the laser beam can be emitted from the laser emission unit 23 over the entire area in the circumferential direction B over a predetermined range in the longitudinal direction A. Furthermore, the laser emission unit 23 may be configured to emit a laser beam radially over the entire area in the circumferential direction B. In such a case, by using a driving device to move the laser emitting body 21 in the longitudinal direction A without rotating it in the circumferential direction B, it is possible to emit laser from the laser emitting section 23 over a predetermined range in the longitudinal direction A and over the entire area in the circumferential direction B.

[0052] The laser emitter 20 is inserted into the insertion space 6 inside the catheter 1. To improve the insertability of the laser emitter 20 through the insertion space 6, the non-laser emitting section 25 preferably includes a coating section whose outer surface is formed with a hydrophilic coating. The coating section may be, for example, a hydrophilic polymer. Examples of hydrophilic polymers that can be used include cellulose-based polymers, polyethylene oxide-based polymers, maleic anhydride-based polymers (e.g., maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymers), acrylamide-based polymers (e.g., polyacrylamide, glycidyl methacrylate-dimethylacrylamide block copolymers), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and derivatives thereof. The coating section may be formed, for example, by dip coating.

[0053] The laser emitter 20 of this embodiment may be configured to emit a laser capable of generating laser-induced shock waves in the light absorption layer 40a3 (see FIG. 5 ), which will be described later, of the expansion member 3 of the catheter 1, and may be configured to emit, for example, a microsecond pulse laser, a nanosecond pulse laser, a picosecond laser, a femtosecond pulse laser, etc. The repetition frequency of the pulse laser emitted from the laser emitter 20 may be, for example, 1 to 500 Hz.

[0054] The laser emitter 20 includes a second marker 26 at a position on the proximal side A2 with respect to the laser emission unit 23. The second marker 26 of this embodiment is attached to the outer surface of the non-laser emission unit 25 at a position on the proximal side A2 with respect to the laser emission unit 23. The second marker 26 of this embodiment is an X-ray contrast marker. Specifically, the second marker 26 may be formed of, for example, a material that is highly X-ray opaque. The second marker 26 can be made of, for example, a material that is highly X-ray opaque, such as platinum, gold, iridium, or tungsten. The second marker 26 is not limited to a configuration that has X-ray contrast and may be, for example, a configuration that has ultrasound visibility.

[0055] <Catheter 1> As shown in Figures 1 to 6, the catheter 1 of this embodiment includes a tubular member 2 and an expansion member 3. The tubular member 2 of this embodiment defines an insertion space 6 therein. The expansion member 3 covers the outside of the tubular member 2 in the radial direction C, and can expand and contract in the radial direction C.

[0056] <<Tubular Member 2>> As shown in FIGS. 5 and 6, the tubular member 2 of this embodiment includes an inner portion 2a, a distal end portion 2b, and a main body portion 2c.

[0057] The inner portion 2a is a portion that is covered by the expansion member 3 on the inside in the radial direction C with respect to the expansion member 3. The inner portion 2a includes a laser transmitting portion 2a1 that can transmit, in the radial direction C, a laser emitted from the laser emission portion 23 of the laser emitter 20 located in the insertion space 6.

[0058] The light-transmitting material that makes up the laser transmitting portion 2a1 is not particularly limited as long as it is a material that can transmit the laser from the laser emitting portion 23 of the laser emitter 20, and examples thereof include polymer materials such as polyolefin (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these), polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, and mixtures thereof. The laser transmitting portion 2a1 may be transparent in the radial direction C, for example.

[0059] In this embodiment, the inner portion 2a includes a laser transmitting portion 2a1 and a light-shielding portion 2a2. The laser transmitting portion 2a1 is a portion of the light-transmitting material that is not covered with a light-shielding material having a lower transmittance than the light-transmitting material. In contrast, the light-shielding portion 2a2 is a portion of the light-transmitting material that is covered with a light-shielding material. The light-shielding material is not particularly limited as long as it has a lower transmittance of the laser from the laser emission portion 23 of the laser emitter 20 than the light-transmitting material that constitutes the laser transmitting portion 2a1. Examples of light-shielding materials that can be used include various metal materials such as titanium oxide, barium sulfate, zinc oxide, silver, and aluminum. Furthermore, the light-shielding material may be a resin containing particles of the above-mentioned metal materials, carbon black, or the like.

[0060] The laser transmitting portion 2a1 of the inner portion 2a is formed over the entire area in the circumferential direction B. The laser transmitting portion 2a1 of the inner portion 2a may be formed, for example, over only a part of the inner portion 2a in the longitudinal direction A. In such a case, the remaining part of the inner portion 2a in the longitudinal direction A may be constituted by the light-shielding portion 2a2. Furthermore, the laser transmitting portion 2a1 of the inner portion 2a may be formed, for example, over the entire area of ​​the inner portion 2a in the longitudinal direction A. Therefore, the inner portion 2a may be constituted, for example, by only the laser transmitting portion 2a1.

[0061] As shown in Figures 5 and 6, the insertion space 6 in this embodiment extends in the longitudinal direction A at the position of the inner portion 2a of the tubular member 2 so as to include the central axis O of the expansion member 3 in the expanded state.

[0062] The distal end portion 2 b is a portion that is connected to the inner portion 2 a on the distal side A1 in the longitudinal direction A relative to the expansion member 3 .

[0063] The main body portion 2c is a portion that is continuous with the inner portion 2a on the proximal side A2 in the longitudinal direction A relative to the expansion member 3.

[0064] Here, the tubular member 2 of this embodiment includes an inner tube 11 and an outer tube 12 that surrounds the inner tube 11. In other words, the inner portion 2a, distal end portion 2b, and main body portion 2c of the tubular member 2 of this embodiment are configured by the inner tube 11 and the outer tube 12. The inner tube 11 and the outer tube 12 of this embodiment are arranged so that their respective central axes substantially coincide with the central axis O of the expansion member 3.

[0065] The tubular member 2 of this embodiment defines a flow path 10 therein, in addition to the insertion space 6 described above. The flow path 10 is used when supplying fluid to the fluid storage space 5 defined by the expansion member 3. The insertion space 6 of this embodiment is defined inside the inner tube 11 of the tubular member 2. The flow path 10 of this embodiment is defined between the inner tube 11 and the outer tube 12. The tubular member 2 may further define a guidewire insertion hole. The guidewire insertion hole may be defined so as to extend parallel to the insertion space 6 inside the inner tube 11, for example, and may extend to a branch portion (not shown) different from the fluid supply / discharge port 12b1 of the outer tube hub 12b, or may open on a side surface of the outer tube 12.

[0066] More specifically, the inner tube 11 of this embodiment includes a distal protruding portion 11a that protrudes toward the distal side A1 from the outer tube 12, a proximal protruding portion 11b that protrudes toward the proximal side A2 from the outer tube 12, and an intermediate portion 11c that connects the distal protruding portion 11a and the proximal protruding portion 11b and whose outer side in the radial direction C is covered by the outer tube 12. The insertion space 6 of this embodiment extends over the distal protruding portion 11a, the proximal protruding portion 11b, and the intermediate portion 11c. The flow path 10 of this embodiment is defined between the intermediate portion 11c of the inner tube 11 and the outer tube 12.

[0067] The expansion member 3 of this embodiment is supported on the outer surface of the tubular member 2. Specifically, the expansion member 3 is supported on the outer surface of the inner tube 11 and the outer surface of the outer tube 12. More specifically, the expansion member 3 of this embodiment is supported across the outer surface of the distal protruding portion 11a of the inner tube 11 and the outer surface of the outer tube main body 12a (described later) of the outer tube 12. As will be described in detail later, the expansion member 3 of this embodiment includes an expansion section 3a that defines a fluid containing space 5 on the inside in the radial direction C and covers the outside of the distal protruding portion 11a of the inner tube 11 in the radial direction C, a distal joint section 3b that is continuous with the distal side A1 of the expansion section 3a and is joined to the outer surface of the distal protruding portion 11a of the inner tube 11, and a proximal joint section 3c that is continuous with the proximal side A2 of the expansion section 3a and is joined to the outer surface of the outer tube main body 12a of the outer tube 12. That is, the inner portion 2a of the tubular member 2 in this embodiment is the portion of the inner tube 11 and the outer tube 12 that is covered by the expansion portion 3a, distal joint 3b, and proximal joint 3c of the expansion member 3. In this embodiment, the distal protruding portion 11a of the inner tube 11 is provided with a laser transparent portion 2a1 at a position that is covered by the expansion portion 3a of the expansion member 3. In addition, the distal end portion 2b of the tubular member 2 in this embodiment is the portion of the distal protruding portion 11a of the inner tube 11 that is not covered by the expansion member 3.

[0068] 5 and 6 , the proximal protruding portion 11b of the inner tube 11 of this embodiment has a holding portion 51 that holds the laser emitter 20 inserted into the insertion space 6 so that the laser emitter 20 can move in the longitudinal direction A. Specifically, the holding portion 51 of this embodiment has an outer tube portion 51a, a distal wall portion 51b that closes the distal side A1 of the outer tube portion 51a, and a proximal wall portion 51c that closes the proximal side A2 of the outer tube portion 51a. A through hole that penetrates the distal wall portion 51b in the longitudinal direction A is formed in the distal wall portion 51b. Furthermore, a through hole that penetrates the proximal wall portion 51c in the longitudinal direction A is formed in the proximal wall portion 51c. The laser emitter 20 of this embodiment is movable in the longitudinal direction A relative to the catheter 1 from a position where the flange 22b1 formed on the inner cylindrical portion 22b of the connector portion 22 abuts against the distal wall portion 51b in the longitudinal direction A to a position where the flange 22b1 abuts against the proximal wall portion 51c in the longitudinal direction A. By moving the laser emitter 20 within this range in the longitudinal direction A, the laser emitter 23 can be moved in the longitudinal direction A at the position of the inner portion 2a.

[0069] In this embodiment, the flow path 10 extends from the fluid supply / discharge port 12b1 formed in the main body 2c of the tubular member 2 to the fluid storage space 5 defined inside the expansion member 3 in the radial direction C. A fluid supply / discharge device such as an indeflator or a syringe can be connected to the fluid supply / discharge port 12b1 via a medical tube or the like. Therefore, a fluid such as a liquid is supplied to the fluid storage space 5 from the fluid supply / discharge device through the flow path 10. When a fluid is supplied to the fluid storage space 5, the expansion member 3 can expand outward in the radial direction C. In contrast, the fluid contained in the fluid storage space 5 is discharged through the flow path 10 to the fluid supply / discharge device. When the fluid is discharged from the fluid storage space 5, the expansion member 3 can contract inward in the radial direction C.

[0070] As described above, the flow path 10 of this embodiment is defined between the inner pipe 11 and the outer pipe 12. Specifically, the flow path 10 of this embodiment is defined between the middle portion 11c of the inner pipe 11 and the outer pipe 12. The fluid supply / discharge port portion 12b1 is formed in the outer pipe 12.

[0071] More specifically, the outer tube 12 of this embodiment includes an outer tube main body 12a and an outer tube hub 12b. The outer tube hub 12b is attached to the proximal side A2 of the outer tube main body 12a. The outer tube hub 12b includes the above-mentioned fluid supply / discharge port 12b1 and proximal end port 12b2. The flow path 10 of this embodiment extends from the fluid supply / discharge port 12b1 of the outer tube hub 12b to the fluid containing space 5.

[0072] The proximal protrusion 11b of the inner tube 11 protrudes from the proximal end opening 12b2 of the outer tube hub 12b toward the proximal side A2. A sealing member 13 such as an O-ring or X-ring closes the gap between the inner surface of the middle portion 11c of the inner tube 11 and the outer surface of the laser emitting body 21. The provision of the sealing member 13 makes it easier for the laser emitting body 20 to slide, and also makes it possible to prevent fluids such as liquids from leaking from the proximal end opening 12b2 through the insertion space 6 to the proximal side A2.

[0073] 5 and 6, the inner portion 2a of the tubular member 2 of this embodiment is provided with a distal contrast marker 14a and a proximal contrast marker 14b. The distal contrast marker 14a and the proximal contrast marker 14b may be attached, for example, to the outer surface of the distal protruding portion 11a of the inner tube 11 of the tubular member 2. More specifically, the distal contrast marker 14a is located near the distal end of the window portion 45. The position of the distal end of the window portion 45 in the longitudinal direction A generally coincides with the position of the distal end of the laser transparent portion 2a1 in the longitudinal direction A. The proximal contrast marker 14b is located near the proximal end of the window portion 45. The position of the proximal end of the window portion 45 in the longitudinal direction A generally coincides with the position of the proximal end of the laser transparent portion 2a1 in the longitudinal direction A. That is, the distal contrast marker 14a and the proximal contrast marker 14b allow confirmation of the region in the longitudinal direction A where the window portion 45 is located. The distal contrast marker 14a and the proximal contrast marker 14b are radiopaque. Specifically, the distal contrast marker 14a and the proximal contrast marker 14b may be formed, for example, from a material that is highly radiopaque. The distal contrast marker 14a and the proximal contrast marker 14b may be made, for example, from a material that is highly radiopaque, such as platinum, gold, iridium, or tungsten. The distal contrast marker 14a and the proximal contrast marker 14b are not limited to being radiopaque and may be, for example, ultrasonically visible.

[0074] As described above, the catheter 1 is also provided with the first marker 14c. Furthermore, the catheter 1 of this embodiment is also provided with the third marker 14d, located proximal to the first marker 14c on the proximal side A2 in the longitudinal direction A. Like the first marker 14c, the third marker 14d is an X-ray contrast marker. The first marker 14c and the third marker 14d may be formed, for example, from a material that is highly X-ray opaque. The first marker 14c and the third marker 14d may be formed, for example, from a material that is highly X-ray opaque, such as platinum, gold, iridium, or tungsten. The first marker 14c and the third marker 14d are not limited to being X-ray opaque, and may be, for example, ultrasonically visible.

[0075] The tubular member 2 of this embodiment is preferably formed from a flexible material, but the material is not particularly limited. Examples of materials constituting the tubular member 2 include various thermoplastic elastomers such as styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, and chlorinated polyethylene-based elastomers, and combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.) can also be used.

[0076] <<Expansion Member 3>> As described above, the expansion member 3 is supported on the outer surface of the tubular member 2. Specifically, the expansion member 3 of this embodiment is supported across the outer surface of the distal protruding portion 11a of the inner tube 11 and the outer surface of the outer tube 12 so as to straddle the distal end of the outer tube 12 in the longitudinal direction A.

[0077] The expansion member 3 in this embodiment is supported on the outer surface of the tubular member 2 in a state in which it surrounds the outside of the tubular member 2 in the radial direction C. In other words, the expansion member 3 surrounds the outside of the outer surface of the tubular member 2 in the radial direction C over the entire area in the circumferential direction B of the tubular member 2.

[0078] The expansion member 3 is configured to be expandable outward in the radial direction C of the tubular member 2. More specifically, the expansion member 3 of this embodiment is configured as an expandable membrane body attached to the outer surface of the tubular member 2. Both ends in the longitudinal direction A of the expandable membrane body serving as the expansion member 3 are annularly joined to the outer surface of the tubular member 2 by adhesive bonding, fusion, or the like, over the entire circumferential direction B of the tubular member 2. More specifically, the distal end of the expandable membrane body serving as the expansion member 3 is annularly joined to the outer surface of the distal protrusion 11a of the inner tube 11 over the entire circumferential direction B. Furthermore, the proximal end of the expandable membrane body serving as the expansion member 3 is annularly joined to the outer surface of the distal end of the outer tube main body 12a of the outer tube 12 over the entire circumferential direction B. The central portion in the longitudinal direction A of the expandable membrane body serving as the expansion member 3 is not joined to the outer surfaces of the inner tube 11 and the outer tube 12 over the entire circumferential direction B of the tubular member 2, and defines an annular fluid storage space 5 between the expandable membrane body and the outer surface of the tubular member 2. When fluid is supplied to the fluid storage space 5 through the flow path 10 of the tubular member 2 described above, the expandable membrane body serving as the expansion member 3 is pressed by the fluid and expands outward in the radial direction C over the entire circumferential direction B.

[0079] As shown in Figure 2, in a contracted state, the expandable membrane body serving as the expansion member 3 is folded and wrapped around the outer surface of the tubular member 2. When fluid is supplied to the fluid storage space 5, the expandable membrane body serving as the expansion member 3 in the contracted state expands, spreading its folds and protruding outward in the radial direction C of the tubular member 2. As a result, as shown in Figures 3 to 6, the expandable membrane body serving as the expansion member 3 enters an expanded state. Conversely, when fluid is discharged from the fluid storage space 5 by suction or the like, the expanded expansion member 3 enters the contracted state shown in Figures 1 and 2.

[0080] The fluid supplied to the fluid containing space 5 may be a gas or a liquid, and examples thereof include gases such as helium gas, CO2 gas, and O2 gas, and liquids such as saline and contrast medium. Furthermore, as will be described in detail later, the fluid supplied to the fluid containing space 5 may be a liquid that can generate a pressure wave due to the laser emitted from the laser emitter 20.

[0081] In this embodiment, the expansion member 3 is configured as an expandable membrane attached to the outer surface of the tubular member 2, but is not limited to this configuration. The expansion member 3 may also be an annular bag supported on the outer surface of the tubular member 2. In other words, the fluid storage space 5 of the expansion member 3 may be a space defined only by the bag that serves as the expansion member 3. In this way, the expansion member 3 may be configured as a balloon that can be expanded and contracted by a fluid, and the expansion member 3 may be configured as an expandable membrane or a bag.

[0082] More specifically, the expansion member 3 of this embodiment includes an expansion section 3a, a distal joint section 3b, and a proximal joint section 3c. The expansion section 3a is expandable in the radial direction C by fluid supplied to the fluid storage space 5. The expansion section 3a of this embodiment includes a cylindrically expandable expansion main body section 3a1, a distal tapered expansion section 3a2 connected to the distal side A1 of the expansion main body section 3a1 and having an expanded diameter in the expanded state that decreases from the proximal side A2 toward the distal side A1 in the longitudinal direction A, and a proximal tapered expansion section 3a3 connected to the proximal side A2 of the expansion main body section 3a1 and having an expanded diameter in the expanded state that decreases from the distal side A1 toward the proximal side A2 in the longitudinal direction A. The distal joint section 3b is connected to the distal side A1 of the distal tapered expansion section 3a2 of the expansion section 3a and is joined to the outer surface of the tubular member 2. Specifically, the distal joint 3b in this embodiment is joined to the outer surface of the distal protruding portion 11a of the inner tube 11 of the tubular member 2. The proximal joint 3c is continuous with the proximal side A2 of the proximal tapered expansion portion 3a3 of the expansion portion 3a, and is joined to the outer surface of the tubular member 2. Specifically, the proximal joint 3c in this embodiment is joined to the outer surface of the distal end portion of the outer tube body 12a of the outer tube 12 of the tubular member 2.

[0083] The expansion member 3 of this embodiment has a window portion 45 that can release pressure waves caused by the laser emitted from the laser emission portion 23 of the laser emitter 20 located in the insertion space 6 outward in the radial direction C. The window portion 45 of this embodiment is the expansion main body portion 3a1.

[0084] The expansion main body 3a1 serving as the window 45 of the expansion member 3 of this embodiment includes a shock wave generating unit 40a capable of generating shock waves as pressure waves by the laser emitted from the laser emission unit 23 of the laser emitter 20. The shock wave generating unit 40a will be described in detail below.

[0085] As shown in FIG. 5, in the expansion member 3 of this embodiment, the entire expansion main body portion 3a1 is the shock wave generating portion 40a.

[0086] As shown in FIG. 5 , the expansion body portion 3a1 of the expansion member 3 of this embodiment includes a first transparent layer 40a1 and a second transparent layer 40a2 that are transparent to the laser emitted from the laser emitter 20 in the radial direction C, and a light-absorbing layer 40a3 that is located outside the first transparent layer 40a1 and the second transparent layer 40a2 in the radial direction C and is capable of absorbing the laser that has passed through the first transparent layer 40a1 and the second transparent layer 40a2. While the expansion body portion 3a1 of the expansion member 3 of this embodiment includes the first transparent layer 40a1 and the second transparent layer 40a2, this configuration is not limited thereto. The expansion body portion 3a1 of the expansion member 3 may include, for example, only one transparent layer located inward from the light-absorbing layer 40a3 in the radial direction C. Alternatively, the expansion body portion 3a1 of the expansion member 3 may include, for example, three or more transparent layers located inward from the light-absorbing layer 40a3 in the radial direction C.

[0087] Furthermore, in the expansion member 3 of this embodiment, the light absorbing layer 40a3 is the outer surface layer of the expansion main body portion 3a1, but another transparent layer may be laminated on the outer side of the light absorbing layer 40a3 in the radial direction C. However, as in this embodiment, it is preferable that the light absorbing layer 40a3 is the outer surface layer of the expansion main body portion 3a1. In this way, attenuation of laser-induced shock waves due to another transparent layer on the outer side of the light absorbing layer 40a3 in the radial direction C can be suppressed.

[0088] In the expansion main body portion 3a1 of the expansion member 3 of this embodiment, a first transmission layer 40a1, a second transmission layer 40a2, and a light absorption layer 40a3 are layered in this order from the inside to the outside in the radial direction C. As a result, as shown in FIG. 14 , the laser emitted from the laser emission portion 23 of the laser emitter 20 housed inside the inner portion 2a of the tubular member 2 passes through the laser transmission portion 2a1, the fluid housed in the fluid storage space 5, and the first transmission layer 40a1 and second transmission layer 40a2 of the expansion main body portion 3a1 of the expansion member 3, and is absorbed by the light absorption layer 40a3 of the expansion main body portion 3a1 of the expansion member 3. In the light absorption layer 40a3, plasma is generated by the absorbed laser. The plasma generated in the light absorption layer 40a3 is easily trapped within the light absorption layer 40a3 due to the first transmission layer 40a1 and second transmission layer 40a2 that cover the inside of the light absorption layer 40a3 in the radial direction C. This allows laser-induced shock waves to be sent from the light-absorbing layer 40a3 outward in the radial direction C, i.e., toward the outside of the expansion member 3. In other words, the expansion member 3 of this embodiment can emit laser-induced shock waves as pressure waves caused by the laser emitted from the laser emission unit 23 of the laser emitter 20 outward in the radial direction C. In the catheter system 100 of this embodiment, the laser-induced shock waves can be directed at the calcified region X in the blood vessel BV, thereby causing the calcified region X to fracture.

[0089] Furthermore, the catheter system 100 can achieve a state in which the expansion member 3 of the catheter 1 comes into contact with the calcified region X, which is the target site. Therefore, the above-mentioned laser-induced shock waves can be reliably applied to the calcified region X in the blood vessel BV. In other words, the catheter system 100 can ensure the force required for treating the target site by utilizing laser-induced shock waves, and by using the expansion member 3, the laser-induced shock waves can be reliably applied to the target site.

[0090] The first transparent layer 40a1 and the second transparent layer 40a2 of the expansion member 3 may be, for example, transparent resin layers. The second transparent layer 40a2 may be, for example, a base material layer of the expandable membrane body that constitutes the expansion member 3. The first transparent layer 40a1 may be, for example, an inner surface layer that constitutes the inner surface in the radial direction C of the expandable membrane body that constitutes the expansion member 3. The inner surface layer serving as the first transparent layer 40a1 may be arranged to provide protection, flexibility, etc. to the inner surface of the expandable membrane body.

[0091] However, the first transmission layer 40a1 and the second transmission layer 40a2 of the expansion member 3 are not particularly limited in their configuration, as long as they are capable of transmitting the laser irradiated from the laser emission unit 23 of the laser emitter 20. Examples of materials that can be used to form the first transmission layer 40a1 and the second transmission layer 40a2 include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers; polyesters such as polyethylene terephthalate; thermoplastic resins such as polyvinyl chloride, ethylene-vinyl acetate copolymers, cross-linked ethylene-vinyl acetate copolymers, and polyurethanes; polyamides; and various elastomers. The total thickness of the one or more transmission layers (the thickness of the two layers, the first transmission layer 40a1 and the second transmission layer 40a2 in this embodiment) can be, for example, 1 to 500 μm. However, the total thickness of the one or more transmission layers is preferably 5 to 100 μm, and more preferably 10 to 50 μm.

[0092] The light absorbing layer 40a3 may be, for example, a black rubber layer, a black resin layer, etc. The light absorbing layer 40a3 is an outer surface layer that forms the outer surface of the expandable membrane body that constitutes the expansion member 3 in the radial direction C.

[0093] However, the light-absorbing layer 40a3 may be configured in any manner as long as it is capable of absorbing the laser emitted from the laser emission unit 23 of the laser emitter 20 and transmitted through the first transmission layer 40a1 and the second transmission layer 40a2. The light-absorbing layer 40a3 may be made of, for example, black rubber such as natural rubber or synthetic rubber EPDM, nitrile, chloroprene, or neoprene, or a flexible resin containing a black component such as carbon black, carbon nanotubes, carbon nanohorns, or black perylene pigment. The thickness of the light-absorbing layer 40a3 may be, for example, 1 to 500 μm. However, the thickness of the light-absorbing layer 40a3 is preferably 5 to 100 μm, and more preferably 10 to 50 μm.

[0094] At least one of the first transmission layer 40a1 and the second transmission layer 40a2 and the light absorption layer 40a3 preferably extend over the entire area in the circumferential direction B of the tubular member 2. In this way, laser-induced shock waves can be emitted from the light absorption layer 40a3 outward in the radial direction C over a wider area in the circumferential direction B.

[0095] The shock wave generating unit 40a may be, for example, a liquid contained in the fluid containing space 5. Such a liquid may be, for example, a liquid containing a shock wave generating substance. The shock wave generating substance may be, for example, a metal and / or metal alloy having a relatively high melting temperature, such as tungsten, tantalum, molybdenum, niobium, platinum, and / or iridium. The shock wave generating substance may be, for example, magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, titanium carbide, etc. The shock wave generating substance may be in any form as long as it can be contained together with the liquid in the fluid containing space 5. However, it is preferable that the shock wave generating substance be in the form of fine particles dispersible in the liquid. The fine particles may be, for example, composed solely of the shock wave generating substance. Alternatively, the fine particles may be, for example, a non-shock wave generating substance coated with the shock wave generating substance. Furthermore, the fine particles may be, for example, a mixture of the non-shock wave generating substance and the shock wave generating substance. However, as in this embodiment, the shock wave generating unit 40a is preferably provided in the expansion member 3. In this way, the laser-induced shock waves emitted from the shock wave generator 40a outward in the radial direction C can be applied to the target site, i.e., the calcified region X (see FIG. 1, etc.), without attenuation. The liquid containing the shock wave-generating substance is not limited to the liquid with dispersed fine particles as described above, but may also contain a solution that converts laser light into pressure waves. An example of such a solution is an aqueous solution of indocyanine green and food coloring.

[0096] The shock wave generating unit 40a may be configured to generate shock waves as pressure waves caused by the laser when irradiated with the laser, and to include a direction changing unit that directs the generated shock waves in a direction different from the laser emission direction. The laser emitted from the laser emission unit 23 toward the shock wave generating unit 40a is irradiated onto the direction changing unit of the shock wave generating unit 40a. The direction changing unit of the shock wave generating unit 40a generates shock waves from the irradiated laser and can emit the generated shock waves in a direction different from the laser emission direction so that they act on the target site. Specifically, the direction changing unit of the shock wave generating unit 40a is positioned opposite the laser emission unit 23 in the direction of laser emission from the laser emission unit 23 of the laser emitter 20. As a result, the laser from the laser emission unit 23 of the laser emitter 20 is irradiated onto the direction changing unit of the shock wave generating unit 40a. The position and shape of the direction changing unit of the shock wave generating unit 40a are adjusted so that the generated shock waves reach the target site. Illustratively, the direction changing section of the shock wave generating section 40a may have an inclined surface that is inclined with respect to the emission direction of the laser so that the laser-induced pressure wave is emitted in a direction perpendicular to the emission direction of the laser from the laser emission section 23 (in the present embodiment, the radial direction C). More specifically, the emission direction of the laser emitted from the laser emission section 23 of the laser emitter 20 is set to the distal side A1 of the longitudinal direction A, and the direction changing section of the shock wave generating section 40a is disposed on the distal side A1 of the laser emission section 23. The direction changing section of the shock wave generating section 40a has an inclined surface that is inclined with respect to the longitudinal direction A. In this manner, shock waves are generated in the direction changing section of the shock wave generating section 40a by the laser irradiated from the laser emission section 23, and the inclined surface of the direction changing section allows the generated shock waves to be emitted outward in the radial direction C toward the target site.

[0097] Furthermore, the shock wave generating section 40a of the expansion member 3 is not limited to the configuration of this embodiment as long as it is capable of generating shock waves using the laser emitted from the laser emission section 23 of the laser emitter 20 and releasing them outward in the radial direction C.

[0098] Furthermore, the expansion main body portion 3a1 serving as the window portion 45 of the expansion member 3 of this embodiment is capable of emitting shock waves as pressure waves caused by the laser emitted from the laser emission portion 23 of the laser emitter 20, but is not limited to this configuration. The window portion 45 may be capable of emitting the laser itself emitted from the laser emission portion 23 of the laser emitter 20 outward in the radial direction C, instead of or in addition to pressure waves caused by the laser emitted from the laser emission portion 23 of the laser emitter 20.

[0099] Next, alignment of the catheter 1 and the laser emitter 20 in the longitudinal direction A will be described with reference to FIGS.

[0100] As described above, according to the catheter system 100, by aligning the first marker 14c of the catheter 1 with the second marker 26 of the laser emitter 20, it is possible to identify that the laser emitter 23 is positioned at the window portion 45 in the longitudinal direction A.

[0101] Specifically, the first marker 14c of the present embodiment is disposed on the tubular member 2 at a position on the proximal side A2 in the longitudinal direction A relative to the expansion member 3. In other words, the periphery of the first marker 14c is not covered by the expansion member 3. This improves the visibility of the first marker 14c from the outside compared to a configuration in which the periphery of the first marker 14c is covered by the expansion member 3. In the catheter system 100 of the present embodiment, as shown in FIG. 5 , the laser emission unit 23 of the laser emitter 20 is disposed in the region in the longitudinal direction A where the window 45 is located by aligning the second marker 26 with the first marker 14c. More specifically, the laser emission unit 23 of the present embodiment is disposed in the region in the longitudinal direction A where the distal end 45a of the window 45 is located by aligning the second marker 26 with the first marker 14c.

[0102] The "alignment" of the first marker 14c and the second marker 26 referred to here means that the relative positional relationship between the first marker 14c and the second marker 26 in the longitudinal direction A is uniquely determined, and the specific manner of alignment is not particularly limited. Therefore, the alignment of the first marker 14c and the second marker 26 is not limited to a manner in which they are aligned by at least partially overlapping each other in the longitudinal direction A. For example, the first marker 14c and the second marker 26 may be aligned in a manner in which the relative positional relationship between them in the longitudinal direction A is uniquely determined without overlapping each other in the longitudinal direction A. One example of such alignment is a manner in which the first marker 14c and the second marker 26 are arranged adjacent to each other in the longitudinal direction A. Another example of such alignment is a manner in which the first marker 14c and the second marker 26 are arranged a predetermined distance apart in the longitudinal direction A. The "predetermined distance" referred to here may be set, for example, using the length in the longitudinal direction A of either the first marker 14c or the second marker 26. In other words, the first marker 14c and the second marker 26 may be aligned by being spaced apart from each other in the longitudinal direction A by the length in the longitudinal direction A of either the first marker 14c or the second marker 26. The first marker 14c and the second marker 26 of this embodiment are configured to be aligned by their entirety overlapping each other in the longitudinal direction A.

[0103] 6 , in the catheter system 100 of this embodiment, the laser emission unit 23 of the laser emitter 20 is positioned in the region where the proximal end 45b of the window 45 is located in the longitudinal direction A by aligning the second marker 26 with the third marker 14d. As with the alignment of the first marker 14c and the second marker 26 described above, the "alignment" of the third marker 14d and the second marker 26 here only needs to uniquely determine the relative positional relationship between the third marker 14d and the second marker 26 in the longitudinal direction A, and the specific mode of alignment is not particularly limited. The third marker 14d and the second marker 26 of this embodiment are configured to be alignable by their entirety overlapping each other in the longitudinal direction A.

[0104] In this way, in the catheter system 100 of this embodiment, by utilizing the first marker 14c and the third marker 14d of the catheter 1 and the second marker 26 of the laser emitter 20, which are positioned at different positions in the longitudinal direction A on the proximal side A2 of the expansion member 3, the laser emitter 23 of the laser emitter 20 can be easily moved in the longitudinal direction A from a position corresponding to the distal end 45a of the window portion 45 to a position corresponding to the proximal end 45b of the window portion 45.

[0105] In this embodiment, the first marker 14c, the second marker 26, and the third marker 14d are contrast markers that are radiopaque and are configured to be visible through an X-ray image displayed on a monitor. However, the first marker 14c, the second marker 26, and the third marker 14d are not limited to contrast markers that are radiopaque. The first marker 14c, the second marker 26, and the third marker 14d may be configured to be ultrasonically visible.

[0106] Fig. 7 is a diagram showing a modified example of the catheter system 100 described above. As shown in Fig. 7, the first marker 14c and the second marker 26 may be provided on the proximal side A2 of the expansion member 3, on an operation unit that is operated by a surgeon ex vivo. Therefore, as shown in Fig. 7, each of the first marker 14c and the second marker 26 may be configured to be visually identifiable. The first marker 14c of the catheter 1 shown in Fig. 7 is the proximal end 11b1 of the proximal protrusion 11b of the inner tube 11 of the tubular member 2. The second marker 26 of the laser emitter 20 shown in Fig. 7 is a first scale portion 22b2 formed on the outer surface of the inner cylindrical portion 22b of the connector portion 22. In the example shown in Figure 7, the proximal end 11b1 of the inner tube 11 of the tubular member 2 as the first marker 14c and the first scale portion 22b2 of the inner tube portion 22b of the connector portion 22 as the second marker 26 are aligned in the longitudinal direction A, so that the laser emission portion 23 of the laser emitter 20 is positioned in the area in the longitudinal direction A where the distal end portion 45a of the window portion 45 is located.

[0107] 7, the laser emitter 20 may include a third marker 14d located on the distal side A1 of the second marker 26. The third marker 14d shown in FIG. 7 is a second scale portion 22b3 formed on the outer surface of the inner cylindrical portion 22b of the connector portion 22. The second scale portion 22b3 serving as the third marker 14d is located on the proximal side A2 of the first scale portion 22b2 serving as the second marker 26. In the example shown in FIG. 7, the proximal end 11b1 of the inner tube 11 of the tubular member 2 serving as the first marker 14c and the second scale portion 22b3 of the inner cylindrical portion 22b of the connector portion 22 serving as the third marker 14d are aligned in the longitudinal direction A, whereby the laser emitter 23 of the laser emitter 20 is located in the region where the proximal end 45b of the window portion 45 is located in the longitudinal direction A.

[0108] 7 , the laser emitter 20 may further include one or more other scale portions 22b4 between the first scale portion 22b2 serving as the second marker 26 and the second scale portion 22b3 serving as the third marker 14d. The laser emitter 23 is disposed at a predetermined position in the region between the distal end 45a and the proximal end 45b of the window portion 45 in the longitudinal direction A by aligning the one or more other scale portions 22b4 with the proximal end 11b1 serving as the first marker 14c. The distance between any two adjacent scale portions in the longitudinal direction A among the first scale portion 22b2, the second scale portion 22b3, and the one or more other scale portions 22b4 may be set to a constant distance, such as 0.5 mm. This makes it easier to check the movement distance of the laser emitter 20 in the longitudinal direction A relative to the catheter 1. In addition, although the proximal protrusion 11b including the retaining portion 51 of the inner tube 11 in this embodiment is formed as a single unit, the present invention is not limited to this configuration. For example, the proximal protrusion 11b of the inner tube 11 may be configured such that a portion including the retaining portion 51 and a portion not including the retaining portion 51 are formed as separate bodies and then attached to each other.

[0109] Second Embodiment Next, a catheter system 200 as another embodiment of the catheter system according to the present disclosure will be described with reference to Fig. 8. Fig. 8 is a partial cross-sectional view of the catheter system 200 taken along the longitudinal direction A. For ease of explanation, Fig. 8 shows everything except the outer tube 12 of the tubular member 2 and the expansion member 3 in a side view.

[0110] 1 to 6 in that the position of the first marker 14c of the catheter 1 is different and that the proximal radiographic marker 14b also serves as the first marker 14c of the catheter 1, but the other components are the same. Therefore, the following description will mainly focus on the above differences, and a description of the components of the catheter system 200 that are common to the catheter system 100 shown in FIGS. 1 to 6 will be omitted.

[0111] The first marker 14c and the third marker 14d of the catheter 1 of this embodiment, and the second marker 26 of the laser emitter 20 are contrast markers that are X-ray opaque, similar to the catheter system 100 shown in Figures 1 to 6.

[0112] The first marker 14c in this embodiment is disposed at a position on the tubular member 2 that is covered by the expansion member 3. As shown in Fig. 8 , the laser emission unit 23 of the laser emitter 20 is disposed in a region in the longitudinal direction A where the distal end portion 45a of the window portion 45 is located, by aligning the second marker 26 with the first marker 14c.

[0113] Furthermore, the first marker 14c in this embodiment is the proximal radiopaque marker 14b that indicates the position of the proximal end of the window portion 45. That is, in this embodiment, the proximal radiopaque marker 14b also serves as the first marker 14c. However, the first marker 14c may be provided separately from the proximal radiopaque marker 14b.

[0114] The catheter 1 of this embodiment is provided with a third marker 14d on the proximal side A2 of the first marker 14c in the longitudinal direction A. In the catheter system 200 of this embodiment, the laser emission unit 23 of the laser emitter 20 is positioned in the region in the longitudinal direction A where the proximal end 45b of the window portion 45 is located, by aligning the second marker 26 with the third marker 14d.

[0115] 8 , the third marker 14d in this embodiment is disposed at a position on the proximal side A2 in the longitudinal direction A with respect to the expansion member 3, but is not limited to this configuration. The third marker 14d may be disposed at a position on the tubular member 2 that is covered by the expansion member 3, as long as it is possible to align the laser emission unit 23 with the region where the proximal end 45b of the window portion 45 is located.

[0116] In this way, in the catheter system 200 of this embodiment, by utilizing the first marker 14c and the third marker 14d of the catheter 1 and the second marker 26 of the laser emitter 20, the laser emitter 23 of the laser emitter 20 can be easily moved in the longitudinal direction A from a position corresponding to the distal end 45a of the window portion 45 to a position corresponding to the proximal end 45b of the window portion 45.

[0117] In this embodiment, the first marker 14c, the second marker 26, and the third marker 14d have X-ray contrast properties, but are not limited to this configuration and may have, for example, ultrasonic visibility.

[0118] FIG. 9 illustrates a modified example of the catheter system 200 shown in FIG. 8 . In the catheter system 200 shown in FIG. 8 , the proximal contrast marker 14 b also serves as the first marker 14 c. However, as shown in FIG. 9 , the distal contrast marker 14 a may also serve as the first marker 14 c. In such a case, the laser emitter 23 of the laser emitter 20 is positioned such that the second marker 26 is spaced a predetermined distance proximally A2 from the distal contrast marker 14 a (the first marker 14 c), thereby locating the second marker 26 in the region where the distal end 45 a of the window 45 is located in the longitudinal direction A. The predetermined distance may be set to, for example, the length of the second marker 26 in the longitudinal direction A. The surgeon can confirm the length of the second marker 26 in the longitudinal direction A on the X-ray image displayed on the monitor. Therefore, the surgeon can easily operate the second marker 26 so that its position is located at a distance A2 from the distal contrast marker 14a as the first marker 14c by the length of the second marker 26 in the longitudinal direction A.

[0119] Furthermore, as shown in FIG. 9, when the distal radiopaque marker 14a is also used as the first marker 14c, the proximal radiopaque marker 14b may also be used as the third marker 14d.

[0120] Third Embodiment Next, a catheter system 300 as another embodiment of the catheter system according to the present disclosure will be described with reference to Figs. 10 and 11. Figs. 10 and 11 are partial cross-sectional views of the catheter system 300 taken along the longitudinal direction A. For convenience of explanation, Figs. 10 and 11 show side views of components other than the outer tube 12 of the tubular member 2 and the expansion member 3. Fig. 10 shows a state in which the laser emission unit 23 of the laser emitter 20 is disposed in a region in which the proximal end 45b of the window 45 is located in the longitudinal direction A. Fig. 11 shows a state in which the laser emission unit 23 of the laser emitter 20 is disposed in a region in which the distal end 45a of the window 45 is located in the longitudinal direction A.

[0121] 1 to 6 , the catheter system 300 differs in that the first marker 14c of the catheter 1 is used to align the laser emission unit 23 with the proximal end 45b of the window 45, the third marker 14d of the catheter 1 is used to align the laser emission unit 23 with the distal end 45a of the window 45, the positions of the first marker 14c and the third marker 14d of the catheter 1 are different, the first marker 14c of the catheter 1 is also used as the proximal angiography marker 14b, and the third marker 14d of the catheter 1 is also used as the distal angiography marker 14a, but the other components are common to both. Therefore, the following description will mainly focus on the above differences, and a description of the components of the catheter system 300 that are common to the catheter system 100 shown in FIGS. 1 to 6 will be omitted.

[0122] The first marker 14c and the third marker 14d of the catheter 1 of this embodiment, and the second marker 26 of the laser emitter 20 are contrast markers that are X-ray opaque, similar to the catheter system 100 shown in Figures 1 to 6.

[0123] The first marker 14c in this embodiment is disposed at a position on the tubular member 2 that is covered by the expansion member 3. As shown in Fig. 10 , the laser emission unit 23 of the laser emitter 20 is disposed in the region in the longitudinal direction A where the proximal end portion 45b of the window portion 45 is located, by aligning the second marker 26 with the first marker 14c.

[0124] Furthermore, the first marker 14c in this embodiment is the proximal radiopaque marker 14b that indicates the position of the proximal end of the window portion 45. That is, in this embodiment, the proximal radiopaque marker 14b also serves as the first marker 14c. However, the first marker 14c may be provided separately from the proximal radiopaque marker 14b.

[0125] The catheter 1 of this embodiment is provided with a third marker 14d on the distal side A1 of the first marker 14c in the longitudinal direction A. As shown in Fig. 11 , in the catheter system 300 of this embodiment, the second marker 26 is aligned with the third marker 14d, so that the laser emission unit 23 of the laser emitter 20 is positioned in the region in the longitudinal direction A where the distal end portion 45a of the window portion 45 is located.

[0126] The third marker 14d in this embodiment is positioned at a position of the tubular member 2 that is covered by the expansion member 3. More specifically, the third marker 14d in this embodiment is a distal contrast marker 14a that indicates the position of the distal end of the window portion 45. That is, in this embodiment, the distal contrast marker 14a also serves as the third marker 14d. Here, the laser emitter 23 of the laser emitter 20 in this embodiment is positioned in a region where the distal end portion 45a of the window portion 45 is located in the longitudinal direction A by aligning the second marker 26 with the distal contrast marker 14a (the third marker 14d) at a predetermined distance proximal to the proximal side A2. The predetermined distance may be set to, for example, the length of the second marker 26 in the longitudinal direction A. The surgeon can confirm the length of the second marker 26 in the longitudinal direction A on the X-ray image displayed on the monitor. Therefore, the surgeon can easily operate the second marker 26 so that the position of the second marker 26 is located at a position on the proximal side A2 away from the distal radiographic marker 14a serving as the third marker 14d by the length of the second marker 26 in the longitudinal direction A. For example, the length of the distal radiographic marker 14a serving as the third marker 14d in the longitudinal direction A may be used as the predetermined distance.

[0127] The catheter system 300 of this embodiment has substantially the same configuration as the catheter system 200 of the second embodiment shown in Fig. 9 , which is a modified example of the catheter system 200. However, the catheter system 200 shown in Fig. 9 uses the first marker 14c to position the laser emission unit 23 at the distal end 45a of the window 45, whereas the catheter system 300 of this embodiment uses the first marker 14c to position the laser emission unit 23 at the proximal end 45b of the window 45, which is a different purpose of use. Furthermore, the catheter system 200 shown in Fig. 9 uses the third marker 14d to position the laser emission unit 23 at the proximal end 45b of the window 45, whereas the catheter system 300 of this embodiment uses the third marker 14d to position the laser emission unit 23 at the distal end 45a of the window 45, which is a different purpose of use.

[0128] In this way, in the catheter system 300 of this embodiment, by utilizing the first marker 14c and the third marker 14d of the catheter 1 and the second marker 26 of the laser emitter 20, the laser emitter 23 of the laser emitter 20 can be easily moved in the longitudinal direction A from a position corresponding to the distal end 45a of the window portion 45 to a position corresponding to the proximal end 45b of the window portion 45.

[0129] In this embodiment, the first marker 14c, the second marker 26, and the third marker 14d have X-ray contrast properties, but are not limited to this configuration and may have, for example, ultrasonic visibility.

[0130] Fourth Embodiment Next, a catheter system 400 will be described as another embodiment of the catheter system according to the present disclosure. Figures 12 and 13 are side views of the catheter system 400. More specifically, Figure 12 shows a state in which the laser emission unit 23 of the laser emitter 20 is disposed in a region in which the distal end 45a of the window 45 is located in the longitudinal direction A. Figure 13 shows a state in which the laser emission unit 23 of the laser emitter 20 is disposed in a region in which the proximal end 45b of the window 45 is located in the longitudinal direction A.

[0131] The catheter system 400 differs from the catheter system 200 shown in Fig. 8 in that the catheter 401 does not include the expansion member 3 and the window portion 45 is provided in the tubular member 2, but the other configurations are the same. Therefore, the above differences will be mainly described here, and a description of the configuration of the catheter system 400 that is common to the catheter system 200 shown in Fig. 8 will be omitted.

[0132] As shown in Figures 12 and 13, the catheter 401 of this embodiment includes a tubular member 2 that defines an insertion space 6 therein, but does not include an expansion member 3 (see Figure 8, etc.) that covers the outside of the tubular member 2 in the radial direction C. In the catheter 401 of this embodiment, a window 45 is provided in the tubular member 2. The window 45 of this embodiment is a laser-transparent portion 2a1. In other words, the window 45 of this embodiment does not include the shock wave generating portion 40a (see Figure 5). However, the window 45 of the tubular member 2 of this embodiment may be configured to include the shock wave generating portion 40a.

[0133] The first marker 14c in this embodiment is disposed on the proximal side A2 of the window portion 45 in the longitudinal direction A. Then, by aligning the second marker 26 with the first marker 14c, the laser emission unit 23 of the laser emitter 20 is disposed in the region where the window portion 45 is located in the longitudinal direction A. More specifically, as shown in Fig. 12 , in the catheter system 400 of this embodiment, by aligning the second marker 26 with the first marker 14c, the laser emission unit 23 of the laser emitter 20 is disposed in the region where the distal end portion 45a of the window portion 45 is located in the longitudinal direction A.

[0134] Furthermore, the first marker 14c in this embodiment is the proximal radiopaque marker 14b that indicates the position of the proximal end of the window portion 45. That is, in this embodiment, the proximal radiopaque marker 14b also serves as the first marker 14c. However, the first marker 14c may be provided separately from the proximal radiopaque marker 14b.

[0135] The catheter 401 of this embodiment includes a third marker 14d on the proximal side A2 of the first marker 14c in the longitudinal direction A. As shown in Fig. 13 , in the catheter system 400 of this embodiment, the second marker 26 is aligned with the third marker 14d, so that the laser emission unit 23 of the laser emitter 20 is positioned in the region where the proximal end 45b of the window 45 is located in the longitudinal direction A.

[0136] In this way, in the catheter system 400 of this embodiment, by utilizing the first marker 14c and the third marker 14d of the catheter 401 and the second marker 26 of the laser emitter 20, the laser emitter 23 of the laser emitter 20 can be easily moved in the longitudinal direction A from a position corresponding to the distal end 45a of the window portion 45 to a position corresponding to the proximal end 45b of the window portion 45.

[0137] In this embodiment, the first marker 14c, the second marker 26, and the third marker 14d are radiopaque, but are not limited to this configuration and may be ultrasonically visible. Furthermore, the first marker 14c, the second marker 26, and the third marker 14d may each be provided on an operating unit that is operated by an operator ex vivo, similar to the configuration shown in Fig. 7 . That is, the first marker 14c, the second marker 26, and the third marker 14d may each be configured to be visually identifiable.

[0138] As shown in FIG. 15, by using the catheter system according to the present disclosure, such as those exemplified in the first to third embodiments, a treatment method including the following steps (I) to (III) can be carried out.

[0139] (I) A preparation step S1 of preparing a catheter system according to the present disclosure. (II) An expansion step S2 of expanding an expansion member of a catheter of this catheter system at a target site. (III) A treatment step S3 of emitting a laser from a laser emission unit of a laser emitter toward a shock wave generating unit capable of generating shock waves as pressure waves by a laser emitted from the laser emission unit of a laser emitter, and treating the target site with the shock waves generated in the shock wave generating unit.

[0140] In the treatment step S3, the shock waves generated in the shock wave generating section are released from the expansion member, and the shock waves can be reliably applied to the target area that comes into contact with the expansion member.

[0141] The catheter system according to the present disclosure is not limited to the specific configurations shown in the above-described embodiment and modified examples, and various modifications, changes, and combinations are possible without departing from the scope of the claims. In the above-described embodiment and modified examples, the third marker 14d is provided on the laser emitter 20 only in the configuration shown in Fig. 7, but the third marker 14d may also be provided on the laser emitter 20 in configurations other than the configuration shown in Fig. 7.

[0142] The present disclosure relates to a catheter system.

[0143] 1, 401: Catheter 2: Tubular member 2a: Inner portion 2a1: Laser-transmitting portion 2a2: Light-shielding portion 2b: Distal end portion 2c: Main body portion 3: Expansion member 3a: Expansion portion 3a1: Expansion main body portion 3a2: Distal tapered expansion portion 3a3: Proximal tapered expansion portion 3b: Distal joint portion 3c: Proximal joint portion 5: Fluid containing space 6: Insertion space 10: Flow path 11: Inner tube 11a: Distal protrusion portion 11b: Proximal protrusion portion 11b1: Proximal end of inner tube (an example of a first marker) 11c: Intermediate portion 12: Outer tube 12a: Outer tube main body 12b: Outer tube hub 12b1: Fluid supply / discharge port portion 12b2: Proximal end port portion 13: Sealing member 14a: Distal contrast marker 14b: Proximal contrast marker 14c: First marker 14d: Third marker 20: Laser emitter 21: Laser emitter main body 22: Connector portion 22a: Connector main body 22b: Inner cylinder portion 22b1: Flange portion 22b2: First scale portion (an example of a second marker) 22b3: Second scale portion 22b4: Another scale portion 23: Laser emitter 24: Drive transmission connector 25: Laser non-emission portion 26: Second marker 31: Laser fiber 32: Fiber coating layer 40a: Shock wave generating portion 40a1: First transmission layer 40a2: Second transmission layer 40a3: Light absorption layer 45: Window portion 45a: Distal end portion of window portion 45b: Proximal end portion of window portion 51: Holding portion 51a: Outer cylinder portion 51b: Distal wall portion 51c: Proximal wall portion 100, 200, 300, 400: Catheter system A: Longitudinal direction A1: Distal side A2: Proximal side B: Circumferential direction C: Radial direction BV: Blood vessel L1: Irradiation range O: Central axis of expansion member X: Calcified region Z1: Length of laser emission portion in longitudinal direction Z2: Length of window portion in longitudinal direction

Claims

a laser emitter having a laser emitter capable of emitting a laser; a catheter defining an insertion space therein through which the laser emitter can be inserted, the catheter includes a window portion that can release the laser emitted from the laser emission portion of the laser emitter located in the insertion space or a pressure wave caused by the laser toward the outside of the catheter in a radial direction of the catheter, when the direction in which the laser emitter and the catheter extend in a state in which the laser emitter is inserted into the insertion space of the catheter is defined as a longitudinal direction, the length of the laser emitter in the longitudinal direction is shorter than the length of the window portion in the longitudinal direction, the catheter comprises a first marker; the laser emitter includes a second marker that is aligned with the first marker in the longitudinal direction, thereby making it possible to identify that the laser emission unit is disposed at the position of the window portion in the longitudinal direction; A catheter system, wherein the second marker is positioned proximal to the laser emission unit in the longitudinal direction. 　 The catheter comprises: a tubular member defining the insertion space therein; an expansion member that covers the outside of the tubular member in the radial direction and is capable of expanding and contracting in the radial direction, The window portion is provided in the expansion member, The catheter system according to claim 1 , wherein the first marker is disposed on the tubular member at a position proximal to the expansion member in the longitudinal direction.

3. The catheter system according to claim 2, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the distal end portion of the window portion is located by aligning the second marker with the first marker. 　 the catheter includes a third marker located proximal to the first marker in the longitudinal direction; The catheter system according to claim 3 , wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the proximal end of the window portion is located by aligning the second marker with the third marker. 　 The catheter system according to claim 2 , wherein each of the first marker and the second marker is radiopaque or ultrasound visible. 　 The catheter system according to claim 2 , wherein the first marker and the second marker are configured to be visually identifiable. 　 The catheter comprises: a tubular member defining the insertion space therein; an expansion member that covers the outside of the tubular member in the radial direction and is capable of expanding and contracting in the radial direction, the window portion is provided in the expansion member, each of the first marker and the second marker has radiographic contrast or ultrasound visibility; The catheter system according to claim 1 , wherein the first marker is disposed at a position of the tubular member that is covered by the expansion member.

8. The catheter system according to claim 7, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the distal end portion of the window portion is located by aligning the second marker with the first marker. 　 the catheter includes a third marker located proximal to the first marker in the longitudinal direction; 9. The catheter system according to claim 8, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the proximal end of the window portion is located by aligning the second marker with the third marker. 　 The catheter system according to claim 9 , wherein the third marker is disposed on the tubular member at a position proximal to the expansion member in the longitudinal direction. 　 The catheter system according to claim 9 , wherein the third marker is disposed at a position of the tubular member that is covered by the expansion member.

8. The catheter system according to claim 7, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where a proximal end portion of the window portion is located by aligning the second marker with the first marker.

9. The catheter system according to claim 8, wherein the laser emission section of the laser emitter is positioned in a region where the distal end of the window section is located in the longitudinal direction by aligning the second marker with the first marker at a predetermined distance proximal to the longitudinal direction. 　 The catheter includes a tubular member defining the insertion space therein, the window portion is provided in the tubular member, The catheter system according to claim 1 , wherein the first marker is disposed proximal to the window in the longitudinal direction. 　 The catheter system according to claim 14, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the distal end of the window portion is located by aligning the second marker with the first marker. 　 the catheter includes a third marker located proximal to the first marker in the longitudinal direction; 16. The catheter system according to claim 15, wherein the laser emission portion of the laser emitter is positioned in a region in the longitudinal direction where the proximal end of the window portion is located by aligning the second marker with the third marker. 　 The catheter system according to claim 14 , wherein each of the first marker and the second marker is radiopaque or ultrasound visible. 　 The catheter system according to claim 14 , wherein the first marker and the second marker are configured to be visually identifiable.

5. The catheter system according to claim 1, wherein the window portion includes a shock wave generating portion capable of generating a shock wave as the pressure wave by the laser emitted from the laser emission portion of the laser emitter.

Images