Catheter

Abstract

A catheter according to the present disclosure comprises: a laser emission body which has a laser emission part capable of emitting a laser; a tubular member which internally partitions an insertion space through which a guide wire can be inserted, and a housing space capable of housing the laser emission body; and an expansion member which covers the outside in a radial direction of the tubular member, and which is capable of expanding and contracting in the radial direction. The tubular member is capable of transmitting, in the radial direction, the laser emitted from the laser emission part of the laser emission body housed in the housing space. The expansion member comprises a window part capable of releasing the laser or a pressure wave caused by the laser to the outside in the radial direction. The tubular member comprises a restriction part which restricts movement in the radial direction of the laser emission body housed in the housing space.

Description

catheter

[0001] The present disclosure relates to catheters.

[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] Japanese Patent Application Publication No. 5-300911 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 that can improve efficiency when treating a target site.

[0006] A catheter according to a first aspect of the present disclosure is a catheter comprising: (1) a laser emitter having a laser emitting portion capable of emitting a laser; a tubular member that defines an insertion space into which a guidewire can be inserted and an accommodation space into which the laser emitter can be accommodated; and 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, wherein the tubular member is capable of transmitting, in the radial direction, the laser emitted from the laser emitting portion of the laser emitter accommodated in the accommodation space, the expansion member has a window portion that can release the laser or a pressure wave caused by the laser to the outside in the radial direction, and the tubular member has a restricting portion that restricts the radial movement of the laser emitter accommodated in the accommodation space.

[0007] A catheter according to one embodiment of the present disclosure is (2) the catheter described in (1) above, in which the regulating portion is the inner surface of the tubular member that defines the storage space and is in close proximity to or in contact with the outer surface of the laser emitter housed in the storage space.

[0008] A catheter according to one embodiment of the present disclosure is the catheter described in (1) or (2) above, wherein: (3) the tubular member includes an insertion tube that defines the insertion space therein and a storage tube that defines the storage space therein, and the insertion tube and the storage tube are integrated in a parallel arrangement.

[0009] A catheter according to one embodiment of the present disclosure is (4) the catheter described in (1) or (2) above, wherein the tubular member has an elongated body defining two holes therein, one of the two holes being the insertion space, and the other of the two holes being the storage space.

[0010] A catheter according to one embodiment of the present disclosure is the catheter described in (1) or (2) above, wherein the tubular member comprises a tube defining the insertion space therein and a covering covering the tube, and the storage space is defined between the outer surface of the tube and the inner surface of the covering.

[0011] A catheter according to one embodiment of the present disclosure is the catheter described in any one of (1) to (5) above, wherein: (6) the laser emitter is movable within the storage space along the longitudinal direction of the tubular member; and the storage space overlaps with the entire longitudinal area of ​​the window portion of the expansion member when viewed along the radial direction.

[0012] A catheter according to one embodiment of the present disclosure is the catheter described in any one of (1) to (6) above, wherein (7) the expansion member has an expansion body portion that is cylindrically expandable, and the window portion is provided in the expansion body portion.

[0013] A catheter according to one embodiment of the present disclosure is (8) a catheter according to any one of (1) to (7) above, wherein the window portion is provided with a shock wave generating portion capable of generating a shock wave as the pressure wave due to the laser emitted from the laser emission portion of the laser emitter contained in the containing space.

[0014] A catheter according to one embodiment of the present disclosure is (9) the catheter described in any one of (1) to (7) above, wherein the tubular member is provided with a light-absorbing layer that generates the pressure wave due to the laser emitted from the laser emission portion of the laser emitter housed in the housing space.

[0015] A treatment method as a second aspect of the present disclosure is (10) a treatment method including: a preparation step of preparing the catheter described in (1) above; an expansion step of expanding the expansion member of the catheter at a target site; and a treatment step of emitting the laser from the laser emission part of the laser emitter toward a shock wave generating part capable of generating shock waves as pressure waves by the laser emitted from the laser emission part of the laser emitter, and treating the target site with the shock waves generated in the shock wave generating part.

[0016] According to the present disclosure, a catheter can be provided that can improve the efficiency when treating a target site.

[0017] 4A is a cross-sectional view showing a catheter according to an embodiment of the present disclosure. FIG. 4B is an exploded view of the catheter shown in FIG. 1. FIG. 4C is a cross-sectional view taken along line II-III in FIG. 1. FIG. 4D is a view showing an example of a procedure performed using the catheter shown in FIG. 1, showing a state in which the catheter is inserted into a blood vessel with the expansion member contracted. FIG. 4E is a view showing a state in which the expansion member is expanded from the state shown in FIG. 4A. FIG. 4F is a view showing a state in which the laser emitter is moved in the proximal direction from the state shown in FIG. 4B. FIG. 4G is a view showing a modification of the catheter shown in FIG. 1. FIG. 4H is a view showing a modification of the catheter shown in FIG. 1. FIG. 4H is a view showing a modification of the catheter shown in FIG. 1. FIG. 4I is a cross-sectional view showing a portion of a catheter according to an embodiment of the present disclosure. FIG. 4I is a cross-sectional view taken along line II-II in FIG. 9. FIG. 4I is a cross-sectional view showing a portion of a catheter according to an embodiment of the present disclosure. FIG. 4I is a cross-sectional view taken along line III-III in FIG. 11. FIG. 12 is a view showing a modification of the catheter shown in FIG. 12.

[0018] Hereinafter, an embodiment of a catheter according to the present disclosure will be illustrated and described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals.

[0019] [First embodiment] Fig. 1 is a diagram showing a catheter 1 as one embodiment of a catheter according to the present disclosure. Fig. 2 is an exploded view of the catheter 1. Fig. 3 is a cross-sectional view taken along line II in Fig. 1. As shown in Figs. 1 to 3, the catheter 1 includes a catheter main body 2 and a laser emitter 3 that can be housed within the catheter main body 2.

[0020] The catheter 1 is a medical instrument that can fracture a calcified region X in a blood vessel BV by inserting the catheter main body 2 and the laser emitter 3 into the blood vessel BV and utilizing a laser emitted from the laser emitter 3 or a pressure wave resulting from the laser (see FIGS. 4A to 4C ). In this embodiment, the calcified region X in the blood vessel BV is exemplified as a target site to be treated by the catheter 1, but the catheter 1 may also be used to treat other target sites.

[0021] As shown in FIGS. 1 and 2 , the catheter main body 2 includes a long tubular member 4, an expansion member 5, and a hub 6. Hereinafter, the longitudinal direction of the tubular member 4 of the catheter 1 will be referred to as the "longitudinal direction A." Furthermore, within the longitudinal direction A, the direction from the distal end of the catheter 1 inserted into a living body toward the proximal end (hand side) of the catheter 1 manipulated by an operator such as a surgeon will be referred to as the "proximal" or "proximal direction A1." Within the longitudinal direction A, the direction from the proximal end of the catheter 1 toward the distal end of the catheter 1 will be referred to as the "distal" or "distal direction A2." Furthermore, within the catheter 1, the direction around the axis of the tubular member 4 will be referred to as the "circumferential direction B." Furthermore, within the catheter 1, the radial direction of the tubular member 4, which is the radial direction of an imaginary circle with the tubular member 4 as its central axis in a cross-sectional view perpendicular to the longitudinal direction A of the tubular member 4, will be referred to as the "radial direction C."

[0022] <Laser emitter 3>

[0023] The laser emitter 3 is configured to be able to be housed in the housing space 23a of the tubular member 4. When housed in the housing space 23a, the laser emitter 3 is able to move within the housing space 23a along the longitudinal direction A. Therefore, by moving the laser emitter 3 housed in the housing space 23a in the longitudinal direction A, the surgeon can irradiate the laser onto a wide range in the longitudinal direction A of the window portion 61 of the expansion member 5.

[0024] The laser emitter 3 includes a laser emitter 11 and a shaft 12 .

[0025] The laser emission unit 11 is capable of emitting a laser in the radial direction C. The type of laser emitted from the laser emission unit 11 is not particularly limited, and may be, 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 emission unit 11 may be 1 to 500 Hz.

[0026] The shaft portion 12 is continuous with the laser emitter 11 in the proximal direction A1. The shaft portion 12 is exposed from the hub 6 in the proximal direction A1 when the laser emitter 3 is housed in the housing space 23a. Therefore, the surgeon can move the laser emitter 3 in the longitudinal direction A by operating the portion of the shaft portion 12 that is exposed from the hub 6 in the proximal direction A1. The movement of the laser emitter 3 in the longitudinal direction A may be performed manually by the surgeon, or may be performed by, for example, a drive unit 15 serving as a drive device connectable to the shaft portion 12.

[0027] The shaft portion 12 of this embodiment includes an optical fiber that transmits light to the laser emission portion 11. In other words, the shaft portion 12 of this embodiment also serves as an optical transmission portion that transmits light to the laser emission portion 11.

[0028] The shaft portion 12 of this embodiment is provided with one marker portion 13 that indicates the position of the laser emission portion 11 in the longitudinal direction A. The presence of the marker portion 13 allows the surgeon to confirm the position of the laser emission portion 11 in the longitudinal direction A by checking the position of the marker portion 13 when moving the laser emitter 3 in the longitudinal direction A. This allows the surgeon to easily align the laser emission portion 11 with respect to the catheter main body 2. Specifically, in this embodiment, the distance in the longitudinal direction A between the distal end of the marker portion 13 and the distal end of the laser emission portion 11 matches the length in the longitudinal direction A of the window portion 61 of the expansion member 5. As will be described later, the position of the distal end of the proximal marker portion 35a of the tubular member 4 matches the position of the proximal end 61a of the window portion 61 of the expansion member 5 in the longitudinal direction A. Therefore, in the catheter 1 of this embodiment, by arranging the distal end of the marker unit 13 at the same position in the longitudinal direction A as the distal end of the proximal marker unit 35a of the tubular member 4, the distal end of the laser emission unit 11 can be arranged at the same position as the distal end 61b of the window unit 61 of the expansion member 5. However, the number and arrangement of the marker units 13 of the shaft unit 12 are not limited to this, as long as they are configured to indicate the position of the laser emission unit 11 in the longitudinal direction A.

[0029] The marker portion 13 is preferably configured to have radiopaque properties. The radiopaque marker portion 13 can be configured from a material with high radiopaque properties, such as platinum, gold, iridium, or tungsten. The marker portion 13 may also be configured to have ultrasound visibility.

[0030] As shown in FIGS. 1 and 2 , the laser emitter 3 may further include a covering portion 14 , a drive portion 15 , and a connector portion 16 .

[0031] The covering portion 14 covers the shaft portion 12. The presence of the covering portion 14 increases the rigidity of the shaft portion 12 and can suppress deflection of the shaft portion 12 when the laser emitter 3 is moved in the longitudinal direction A. The covering portion 14 may cover a portion of the shaft portion 12 that is not housed in the housing space 23a when the catheter 1 is in use. The covering portion 14 can be made of, for example, a metal coil, a resin tube, or the like.

[0032] The drive unit 15 is attached to a portion of the shaft unit 12 that is exposed in the proximal direction A1 from the hub 6. The drive unit 15 is a mechanism for automatically moving the laser emitter 3 in the longitudinal direction A. Specifically, the drive unit 15 automatically moves the laser emitter 3 in the distal direction A2 and the proximal direction A1. The surgeon may directly grip the laser emitter 3 and move the laser emitter 3 in the distal direction A2 and the proximal direction A1 without using the drive unit 15.

[0033] The connector portion 16 is connected to the proximal end of the shaft portion 12. The shaft portion 12 of this embodiment is connected to an external device such as a light source device via the connector portion 16.

[0034] <Catheter main body 2> <<Tubular member 4>> The tubular member 4 defines an insertion space 22a through which the guidewire GW can be inserted, and an accommodation space 23a that can accommodate the laser emitter 3. More specifically, the tubular member 4 of this embodiment includes an outer tube 21, an insertion tube 22 that extends inside the outer tube 21 and defines the insertion space 22a, and a accommodation tube 23 that is integrated with the insertion tube 22 and defines the accommodation space 23a. The outer tube 21, the insertion tube 22, and the accommodation tube 23 are all tubular.

[0035] The outer tube 21 extends along the longitudinal direction A. The outer tube 21 defines an internal flow path 21a that can supply inflation fluid to the fluid accommodation space 5a defined by the expansion member 5. The inflation fluid supplied to the fluid accommodation space 5a of the expansion member 5 can be removed through the flow path 21a by suction or the like. The flow path 21a extends from the proximal end of the outer tube 21, which is connected to the hub 6, to the distal end of the outer tube 21, which is covered by the expansion member 5. The proximal end of the flow path 21a communicates with the intra-hub flow path 71 of the hub 6. The distal end of the flow path 21a communicates with the fluid accommodation space 5a.

[0036] The flow path 21a allows the laser emitter 3 to be inserted along the longitudinal direction A. That is, the flow path 21a is used to supply expansion fluid to the fluid accommodation space 5a, and also to insert the laser emitter 3 into the tubular member 4. Specifically, the laser emitter 3 is inserted into the flow path 21a from the proximal end of the outer tube 21 in the distal direction A2 through the hub insertion hole 73 of the hub 6. Next, the laser emitter 3 is pushed forward in the distal direction A2 within the flow path 21a and inserted into the accommodation space 23a of the accommodation tube 23. As a result, the laser emitter 3 is accommodated in the accommodation space 23a.

[0037] The insertion tube 22 defines an insertion space 22a therein through which the guidewire GW can be inserted. Specifically, the proximal end of the insertion tube 22 is joined to the peripheral wall of the outer tube 21. The insertion tube 22 extends from its proximal end within the flow path 21a of the outer tube 21 and protrudes in the distal direction A2 beyond the distal end of the outer tube 21. In other words, the distal end of the insertion tube 22 is located further distal in the distal direction A2 than the distal end of the outer tube 21. The insertion space 22a continues from a proximal opening 22a1 that opens to the outside at the proximal end of the insertion tube 22 to a distal opening 22a2 that opens to the outside at the distal end of the insertion tube 22.

[0038] The housing tube 23 defines an internal housing space 23a capable of housing the laser emitter 3. The housing tube 23 is integrated with the insertion tube 22 while being arranged in parallel therewith. As shown in FIG. 3 , the insertion tube 22 and the housing tube 23 of this embodiment are integrated by being covered with a covering member 30 such as a heat-shrinkable film. The covering member 30 may be formed of a light-transmitting material that can transmit the laser emitted from the laser emission unit 11. The light-transmitting material constituting the covering member 30 may be the same as the light-transmitting material constituting the transmission unit 40, which will be described later, for example. However, the structure for integrating the insertion tube 22 and the housing tube 23 is not limited thereto. The insertion tube 22 and the housing tube 23 may be integrated with each other by, for example, adhesive bonding.

[0039] The tubular member 4 is capable of transmitting, in the radial direction C, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a. Specifically, the housing tube 23 includes a transmitting portion 40 that is capable of transmitting, in the radial direction C, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a. The laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a passes through the transmitting portion 40 of the housing tube 23 in the radial direction C, and is irradiated onto the window portion 61 of the expansion member 5.

[0040] The laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a is diffused by the lens effect of the transmission unit 40 when it passes through the transmission unit 40 of the housing tube 23. In other words, the presence of the transmission unit 40 makes it possible to irradiate the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a over a wide range toward the window portion 61 of the extension member 5.

[0041] The entire area of ​​the portion of the accommodation tube 23 that is covered by the window portion 61 of the expansion member 5 (i.e., the portion that overlaps with the window portion 61 of the expansion member 5 when viewed along the radial direction C) may be formed by the transmitting portion 40. In this manner, the laser emitted from the laser emission portion 11 of the laser emitter 3 accommodated in the accommodation space 23a can be reliably irradiated onto the window portion 61 of the expansion member 5. In this embodiment, the entire accommodation tube 23 is formed by the transmitting portion 40.

[0042] The transmitting portion 40 may be formed from a light-transmitting material that can transmit the laser emitted from the laser emission portion 11. The light-transmitting material that constitutes the transmitting portion 40 is not particularly limited as long as it is a material that can transmit the laser from the laser emission portion 11, 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, and fluororesin, or mixtures thereof.

[0043] Like the housing tube 23, the insertion tube 22 may also have a transmitting portion 40 that allows the laser emitted from the laser emission portion 11 of the laser emitter 3 housed in the housing space 23a to transmit in the radial direction C. For example, the entire area of ​​the portion of the insertion tube 22 that is covered by the window portion 61 of the expansion member 5 (i.e., the portion that overlaps with the window portion 61 of the expansion member 5 when viewed along the radial direction C) may be formed by the transmitting portion 40. In this way, it is possible to prevent the laser irradiation to the window portion 61 from being partially obstructed by the insertion tubes 22 arranged in parallel to the housing tube 23.

[0044] As shown in FIG. 3 , in this embodiment, the inner surface of the tubular member 4 defining the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23) is configured to be close to the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a in a cross-sectional view perpendicular to the longitudinal direction A. Therefore, the laser emitter 3 contained in the accommodation space 23a comes into contact with the inner surface of the tubular member 4 defining the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23), thereby restricting further movement in the radial direction C. That is, the tubular member 4 includes a restricting portion 50 that restricts movement in the radial direction C of the laser emitter 3 contained in the accommodation space 23a. The restricting portion 50 in this embodiment is the inner surface of the tubular member 4 defining the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23). The presence of such a restricting portion 50 makes it possible to stabilize the position in the radial direction C of the laser emitter 3 contained in the accommodation space 23a.

[0045] The inner surface of the tubular member 4 serving as the restricting portion 50 (in this embodiment, the inner surface 46 of the accommodation tube 23) may be configured to come into contact with the outer surface 3 a of the laser emitter 3 accommodated in the accommodation space 23 a. By doing so, the position in the radial direction C of the laser emitter 3 accommodated in the accommodation space 23 a can be further stabilized.

[0046] The inner surface of the tubular member 4 serving as the restricting portion 50 in this embodiment (the inner surface 46 of the accommodating tube 23 in this embodiment) is configured to be close to or in contact with the outer surface 11 a of the laser emitter 11, which is part of the outer surface 3 a of the laser emitter 3, in a cross section perpendicular to the longitudinal direction A. However, the inner surface of the tubular member 4 serving as the restricting portion 50 (the inner surface 46 of the accommodating tube 23 in this embodiment) may also be configured to be close to or in contact with the outer surface of the shaft portion 12, which is part of the outer surface 3 a of the laser emitter 3, in a cross section perpendicular to the longitudinal direction A. Furthermore, when the covering portion 14 that covers the shaft portion 12 is accommodated in the accommodation space 23 a, the inner surface of the tubular member 4 serving as the restricting portion 50 (the inner surface 46 of the accommodating tube 23 in this embodiment) may also be configured to be close to or in contact with the outer surface of the covering portion 14, which is part of the outer surface 3 a of the laser emitter 3, in a cross section perpendicular to the longitudinal direction A.

[0047] 3 , in this embodiment, the entire inner surface of the tubular member 4 defining the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23) is configured to be in close proximity to or in contact with the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a in a cross-sectional view perpendicular to the longitudinal direction A. However, as long as movement of the laser emitter 3 contained in the accommodation space 23a in the radial direction C can be restricted, only a part of the inner surface of the tubular member 4 defining the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23) may be configured to be in close proximity to or in contact with the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a in a cross-sectional view perpendicular to the longitudinal direction A.

[0048] The accommodation space 23a in this embodiment extends inside the expansion member 5 along the longitudinal direction A. A proximal end 23a1 of the accommodation space 23a is open to the outside of the accommodation tube 23. Therefore, the laser emitter 3 inserted into the flow path 21a of the outer tube 21 is inserted into the accommodation space 23a from the proximal end 23a1 in the distal direction A2. As a result, the laser emitter 3 is accommodated in the accommodation space 23a.

[0049] While housed in the housing space 23a, the laser emitter 3 is movable within the housing space 23a along the longitudinal direction A. Specifically, while housed in the housing space 23a, the laser emitter 3 slides on the inner surface of the tubular member 4 that defines the housing space 23a (in the present embodiment, the inner surface 46 of the housing tube 23), thereby being movable within the housing space 23a along the longitudinal direction A.

[0050] 1 and 2 , the accommodation space 23a in this embodiment is configured to overlap the entire longitudinal direction A of the window portion 61 of the expansion member 5 when viewed along the radial direction C. In other words, in the longitudinal direction A, the proximal end 23a1 of the accommodation space 23a is at the same position as the proximal end 61a of the window portion 61 or at a position more proximal in the direction A1 than the proximal end 61a of the window portion 61, and the distal end 23a2 of the accommodation space 23a is at the same position as the distal end 61b of the window portion 61 or at a position more distal in the direction A2 than the distal end 61b of the window portion 61. Therefore, when viewed along the radial direction C, the laser emitter 3 can move within the accommodation space 23a along the longitudinal direction A from a position overlapping with the proximal end 61a of the window portion 61 to a position overlapping with the distal end 61b of the window portion 61. This makes it easier for the laser emitted from the laser emission part 11 to irradiate the entire area of ​​the window part 61 in the longitudinal direction A.

[0051] In this embodiment, the proximal end 23a1 of the accommodation space 23a is located within the fluid accommodation space 5a of the expansion member 5. This prevents the accommodation space 23a from becoming too long. As a result, it is possible to prevent an increase in sliding resistance between the laser emitter 3 and the tubular member 4 that occurs when the laser emitter 3 accommodated in the accommodation space 23a is moved in the longitudinal direction A.

[0052] The distal end 23a2 of the accommodation space 23a in this embodiment is located within the fluid accommodation space 5a of the expansion member 5. Furthermore, the distal end 23a2 of the accommodation space 23a in this embodiment is open to the outside of the accommodation tube 23. That is, the distal end 23a2 of the accommodation space 23a in this embodiment is connected to the fluid accommodation space 5a of the expansion member 5. Meanwhile, as described above, the inner surface of the tubular member 4 defining the accommodation space 23a (the inner surface 46 of the accommodation tube 23 in this embodiment) is configured to be in close proximity to or in contact with the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a. Therefore, when the laser emitter 3 is contained in the accommodation space 23a, the expansion fluid supplied to the fluid accommodation space 5a of the expansion member 5 is unlikely to flow between the inner surface of the tubular member 4 defining the accommodation space 23a (the inner surface 46 of the accommodation tube 23 in this embodiment) and the outer surface 3a of the laser emitter 3 through the distal end 23a2. That is, by configuring the inner surface of the tubular member 4 (in this embodiment, the inner surface 46 of the accommodating tube 23) that defines the accommodation space 23a to be in close proximity to or in contact with the outer surface 3a of the laser emitter 3 that is accommodated in the accommodation space 23a, it is possible to prevent the expansion fluid supplied to the fluid accommodation space 5a of the expansion member 5 from flowing between the inner surface of the tubular member 4 that defines the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodating tube 23) and the outer surface 3a of the laser emitter 3. As a result, it is possible to prevent the laser emitted from the laser emission unit 11 of the laser emitter 3 that is accommodated in the accommodation space 23a from being refracted, scattered, or the like by the expansion fluid that has flowed between the inner surface of the tubular member 4 that defines the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodating tube 23) and the outer surface 3a of the laser emitter 3.

[0053] The distal end 23a2 of the accommodation space 23a may be closed. This configuration effectively prevents the expansion fluid supplied to the fluid accommodation space 5a of the expansion member 5 from flowing between the inner surface of the tubular member 4 (in this embodiment, the inner surface 46 of the accommodation tube 23) that defines the accommodation space 23a and the outer surface 3a of the laser emitter 3 through the distal end 23a2 of the accommodation space 23a. As a result, the laser emitted from the laser emitter 11 of the laser emitter 3 accommodated in the accommodation space 23a is effectively prevented from being refracted, scattered, or otherwise affected by the expansion fluid that has flowed between the inner surface of the tubular member 4 that defines the accommodation space 23a (in this embodiment, the inner surface 46 of the accommodation tube 23) and the outer surface 3a of the laser emitter 3. The distal end 23a2 of the accommodation space 23a may be closed, for example, by a cap attached to the tubular member 4. Alternatively, the distal end 23a2 of the accommodation space 23a may be closed, for example, by heat-sealing the tubular member 4.

[0054] As shown in FIGS. 1 and 2 , the tubular member 4 of this embodiment includes two markers 35 that indicate the range in which the window 61 of the expansion member 5 extends in the longitudinal direction A. The two markers 35 are spaced apart in the longitudinal direction A. For ease of explanation, the marker 35 located in the proximal direction A1 will be referred to as the "proximal marker 35a," and the marker 35 located in the distal direction A2 will be referred to as the "distal marker 35b." In the longitudinal direction A, the position of the distal end of the proximal marker 35a coincides with the position of the proximal end 61a of the window 61 of the expansion member 5. Furthermore, in the longitudinal direction A, the position of the proximal end of the distal marker 35b coincides with the position of the distal end 61b of the window 61 of the expansion member 5. That is, in this embodiment, the range in the longitudinal direction A between the distal end of the proximal marker portion 35a and the proximal end of the distal marker portion 35b defines the range in which the window portion 61 of the expansion member 5 extends in the longitudinal direction A. Therefore, the surgeon can confirm the range in which the window portion 61 of the expansion member 5 extends in the longitudinal direction A by checking the positions in the longitudinal direction A of the distal end of the proximal marker portion 35a and the proximal end of the distal marker portion 35b. As described above, the distance in the longitudinal direction A between the distal end of the marker portion 13 and the distal end of the laser emission unit 11 matches the length in the longitudinal direction A of the window portion 61 of the expansion member 5. This makes it easy to align the laser emitter 3 with the window portion 61 of the expansion member 5. However, the number and arrangement of the marker portions 35 of the tubular member 4 are not limited to this, as long as the window portion 61 of the expansion member 5 is configured to indicate the range in which it extends in the longitudinal direction A.

[0055] In this embodiment, of the tubular member 4, only the insertion tube 22 is configured to have the marker portion 35, but this is not limited thereto, and only the housing tube 23 may be configured to have the marker portion 35, or both the insertion tube 22 and the housing tube 23 may be configured to have the marker portion 35. Furthermore, the marker portion 35 of the tubular member 4 may be made of, for example, the materials listed as materials for forming the marker portion 13 of the shaft portion 12 of the laser emitter 3 described above.

[0056] <<Expansion Member 5>> The expansion member 5 is supported on the outer surface of the tubular member 4. Specifically, the expansion member 5 of this embodiment is supported across the outer surface of the outer tube 21 and the outer surface of the insertion tube 22. The expansion member 5 of this embodiment surrounds the outside of the tubular member 4 in the radial direction C over the entire area in the circumferential direction B.

[0057] The expansion member 5 is configured to be expandable outward in the radial direction C of the tubular member 4. More specifically, the expansion member 5 of this embodiment is configured as an expandable membrane attached to the outer surface of the tubular member 4. Both ends of the expandable membrane serving as the expansion member 5 in the longitudinal direction A are annularly joined to the outer surface of the tubular member 4 by adhesive bonding, fusion, or the like, over the entire circumferential direction B of the tubular member 4. More specifically, the distal end of the expandable membrane serving as the expansion member 5 is annularly joined to the outer surface of the insertion tube 22 over the entire circumferential direction B. Furthermore, the proximal end of the expandable membrane serving as the expansion member 5 is annularly joined to the outer surface of the outer tube 21 over the entire circumferential direction B. The central portion of the expandable membrane serving as the expansion member 5 in the longitudinal direction A is not joined to the outer surfaces of the insertion tube 22 or the outer tube 21 over the entire circumferential direction B of the tubular member 4, defining a fluid containing space 5a between the central portion and the outer surface of the tubular member 4. When the expansion fluid is supplied to the fluid storage space 5a through the flow path 21a of the tubular member 4 described above, the expansion membrane body serving as the expansion member 5 is pressed by the expansion fluid and expands outward in the radial direction C of the tubular member 4 over the entire circumferential direction B of the tubular member 4.

[0058] In a contracted state (see FIG. 4A ), the expandable membrane body serving as the expansion member 5 is folded and wrapped around the outer surface of the tubular member 4. When expansion fluid is supplied to the fluid storage space 5a, the expandable membrane body serving as the expansion member 5 in the contracted state expands so as to protrude outward in the radial direction C of the tubular member 4. As a result, the expandable membrane body serving as the expansion member 5 enters an expanded state. Conversely, when the expansion fluid is sucked from the fluid storage space 5a, the expansion member 5 in the expanded state enters a contracted state. FIGS. 1 to 3 show the expansion member 5 in an expanded state.

[0059] The expansion member 5 of this embodiment includes an expansion main body portion 62, a proximal reduced diameter portion 63, and a distal reduced diameter portion 64. The expansion main body portion 62 is expandable into a cylindrical shape. The proximal reduced diameter portion 63 is continuous with the expansion main body portion 62 in the proximal direction A1 and reduces in diameter as it moves toward the center in the radial direction C as it moves in the proximal direction A1. The distal reduced diameter portion 64 is continuous with the expansion main body portion 62 in the distal direction A2 and reduces in diameter as it moves toward the center in the radial direction C as it moves in the distal direction A2. The proximal reduced diameter portion 63 and the distal reduced diameter portion 64 of this embodiment are expandable into a conical shape, but are not limited thereto and may be expandable into a hemispherical shape, for example.

[0060] The expansion fluid supplied to the fluid containing space 5a may be a gas or a liquid. Examples of the expansion fluid supplied to the fluid containing space 5a include helium gas, CO ２ Gas, O ２ Examples of the liquid include gases such as gas, saline, and contrast media.

[0061] The expansion member 5 includes a window 61 that can emit the laser emitted from the laser emission unit 11 or pressure waves caused by this laser outward in the radial direction C. Specifically, the expansion member 5 of this embodiment includes a transmission layer 41 that allows the laser emitted from the laser emission unit 11 to transmit in the radial direction C, and a light absorption layer 42 that is located outward in the radial direction C from the transmission layer 41 and is capable of absorbing the laser that has transmitted through the transmission layer 41. The light absorption layer 42 of this embodiment is a shock wave generator 65 that can generate shock waves as pressure waves caused by the laser emitted from the laser emission unit 11. The window 61 of the expansion member 5 of this embodiment is configured by covering the transmission layer 41 with the light absorption layer 42.

[0062] As shown in FIGS. 1 to 3 , the window 61 in this embodiment is provided in a cylindrically expandable expansion body 62. This configuration tends to maintain a constant radial distance C between the window 61 and the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a, regardless of the position in the longitudinal direction A. Therefore, the intensity of the laser emitted from the laser emission unit 11 onto the window 61 also tends to remain constant regardless of the position in the longitudinal direction A. As a result, the intensity of the laser emitted outward from the window 61 in the radial direction C or the pressure wave caused by the laser also tends to remain constant regardless of the position in the longitudinal direction A, improving the efficiency of treatment of the target area. However, the window 61 may be provided in a portion of the expansion member 5 other than the expansion body 62.

[0063] 3 , the window portion 61 may be provided over the entire area of ​​the expansion member 5 in the circumferential direction B. In this way, the laser or pressure waves caused by the laser can be released from the window portion 61 outward in the radial direction C over a wide area in the circumferential direction B. However, the window portion 61 may be provided over only a portion of the expansion member 5 in the circumferential direction B.

[0064] The transparent layer 41 of the expansion member 5 may be, for example, a transparent resin layer. However, the configuration of the transparent layer 41 of the expansion member 5 is not particularly limited as long as it is capable of transmitting the laser irradiated from the laser emission unit 11. Examples of materials that can be used to form the transparent layer 41 include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymer, polyesters such as polyethylene terephthalate, thermoplastic resins such as polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, and polyurethane, polyamides, and various elastomers.

[0065] The light-absorbing layer 42 may be, for example, a black rubber layer, a black resin layer, or the like. However, the configuration of the light-absorbing layer 42 is not particularly limited as long as it is capable of absorbing the laser emitted from the laser emission unit 11 and transmitted through the transmission layer 41. The light-absorbing layer 42 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.

[0066] The window portion 61 of the expansion member 5 may not include the light-absorbing layer 42, and may be configured to transmit the laser emitted from the laser emitter 3 from the inside to the outside in the radial direction C, thereby allowing the laser itself to be emitted outward in the radial direction C. In other words, the catheter according to the present disclosure may be used as a medical device that can emit the laser emitted from the laser emitter 3 outward in the radial direction C, for treatment such as photodynamic therapy (PDT) or photoimmunotherapy (PIT).

[0067] <<Hub 6>> The hub 6 is connected to the proximal end of the tubular member 4. A hub internal flow path 71 that communicates with the flow path 21a of the outer tube 21 is defined within the hub 6. The hub 6 defines a supply port 72 and a hub internal insertion hole 73 that communicate with the hub internal flow path 71. The expansion fluid that expands the expansion member 5 is supplied from the supply port 72 through the hub internal flow path 71 to the flow path 21a of the outer tube 21. The laser emitter 3 is inserted into the flow path 21a from the hub internal insertion hole 73 through the hub internal flow path 71.

[0068] The hub 6 of this embodiment includes a blocking member 75 that can block the hub insertion hole 73 in a state in which the hub 6 is penetrated by the laser emitter 3 in the longitudinal direction A. The provision of such a blocking member 75 can prevent the expansion fluid supplied to the fluid accommodation space 5a of the expansion member 5 from leaking to the outside through the hub insertion hole 73. Furthermore, the blocking member 75 of this embodiment restricts the laser emitter 3 from moving in the radial direction C and the circumferential direction B at the position penetrated by the laser emitter 3, while allowing the laser emitter 3 to move in the longitudinal direction A. The provision of such a blocking member 75 can prevent the laser emitter 3 from swinging, vibrating, or the like in the radial direction C and the circumferential direction B when the laser emitter 3 is moved in the longitudinal direction A. In other words, the blocking member 75 of this embodiment also serves as a guide member that guides the movement of the laser emitter 3 in the longitudinal direction A. This improves operability when moving the laser emitter 3 in the longitudinal direction A. The blocking member 75 can be configured by a sealing member such as a rubber plug, an O-ring, or an X-ring.

[0069] Next, an example of a procedure performed using the catheter 1 will be described with reference to Figures 4A to 4C. Figures 4A to 4C show an example of a procedure for crushing a calcified region X in a blood vessel BV as a treatment of a target site.

[0070] 4A shows the catheter 1 inserted into the blood vessel BV. As shown in FIG. 4A, the catheter 1 is inserted into the blood vessel BV with the expansion member 5 in a contracted state. The catheter 1 is inserted into the blood vessel BV by pushing the catheter 1 in the distal direction A2 while aligning the catheter 1 with the guide wire GW inserted into the insertion space 22a. The expansion member 5 of the catheter 1 is positioned at the calcified region X, which is the target site.

[0071] FIG. 4B shows the state in which the expansion member 5 is expanded from the state shown in FIG. 4A . As shown in FIG. 4B , expanding the expansion member 5 brings the expansion member 5 into contact with the calcified region X, which is the target site, and applies pressure to the calcified region X in the radial direction C. In this state, a laser is emitted from the laser emission unit 11 of the laser emitter 3 housed in the housing space 23a. The laser emitted from the laser emission unit 11 passes through the tubular member 4 in the radial direction C and is irradiated onto the window portion 61 of the expansion member 5. The laser irradiated onto the window portion 61 of the expansion member 5 passes through the transmission layer 41 of the expansion member 5 and is absorbed by the light absorption layer 42, which serves as the shock wave generator 65. In the light absorption layer 42, which serves as the shock wave generator 65, plasma is generated by the absorbed laser. The plasma generated in the light absorption layer 42 is easily trapped within the light absorption layer 42 due to the transmission layer 41, which covers the inside of the light absorption layer 42 in the radial direction C. This allows a laser-induced shock wave, which is a pressure wave caused by the laser, to be sent from the light-absorbing layer 42 outward in the radial direction C. In the catheter 1, the laser-induced shock wave is applied to the calcified region X in the blood vessel BV, thereby causing the calcified region X to fracture.

[0072] Fig. 4C is a diagram showing a state in which the laser emitter 3 has been moved in the proximal direction A1 from the state shown in Fig. 4B. As shown in Fig. 4C, by moving the laser emitter 3 in the proximal direction A1, the laser emitted from the laser emitter 11 can be irradiated over a predetermined range in the longitudinal direction A of the window 61 (over the entire area of ​​the window 61 in the longitudinal direction A in this embodiment). This makes it possible to emit laser-induced shock waves outward in the radial direction C from the window 61 over a wide range in the longitudinal direction A. As a result, the laser-induced shock waves can be applied to the calcified region X of the blood vessel BV over a wide range in the longitudinal direction A.

[0073] In this way, the catheter 1 can achieve a state in which the expansion member 5 comes into contact with the calcified region X, which is the target site. Therefore, the laser emitted from the laser emission unit 11 of the laser emitter 3 or the pressure waves caused by this laser can be reliably applied to the calcified region X in the blood vessel BV. In other words, with the catheter 1, by using the expansion member 5, the laser emitted from the laser emission unit 11 of the laser emitter 3 or the pressure waves caused by this laser can be reliably applied to the target site. This improves the efficiency of treatment of the target site.

[0074] The catheter 1 also includes a restricting unit 50 that restricts movement in the radial direction C of the laser emitter 3 housed in the housing space 23a. This stabilizes the position of the laser emitter 3 housed in the housing space 23a in the radial direction C, thereby stabilizing the distance in the radial direction C between the laser emitter 11 of the laser emitter 3 and the window 61 of the expansion member 5. For example, even if the calcified region X is present in a curved blood vessel, the catheter 1 includes the restricting unit 50 that restricts movement in the radial direction C of the laser emitter 3 housed in the housing space 23a. This prevents variation in the distance in the radial direction C between the laser emitter 11 of the laser emitter 3 and the window 61 of the expansion member 5 within the longitudinal direction A. As a result, the intensity of the laser emitted from the window 61 or the pressure wave caused by the laser can be stabilized. This improves the efficiency of treatment of the target site.

[0075] The catheter 1 of this embodiment can be modified in various ways as follows. The following modifications can also be made to the catheter 101 of a second embodiment and the catheter 201 of a third embodiment, which will be described later.

[0076] The catheter 1 of this embodiment is configured so that the laser is absorbed by the light-absorbing layer 42 of the expansion member 5, thereby emitting pressure waves caused by the laser from the window portion 61, but this is not limiting. For example, the expansion member 5 does not have to include the light-absorbing layer 42. In this case, the expansion member 5 may be configured so that the laser emitted from the laser emission unit 11 of the laser emitter 3 passes through outward in the radial direction C and is emitted toward the target site. In this case, the region of the expansion member 5 that emits the laser outward in the radial direction C may be the window portion 61.

[0077] Furthermore, if the expansion member 5 does not include the light-absorbing layer 42, the shock wave generator 65 may be realized by another configuration. Specifically, as in the modified example shown in FIG. 5 , the expansion member 5 may be expanded by supplying a liquid W containing a substance that converts the laser emitted from the laser emission unit 11 into a pressure wave (hereinafter, sometimes referred to as a "pressure wave conversion substance") to the fluid containing space 5a. In this manner, even if the expansion member 5 does not include the light-absorbing layer 42, the laser emitted from the laser emission unit 11 of the laser emitter 3 can be converted into a pressure wave by the pressure wave conversion substance of the liquid W, thereby allowing the laser-induced pressure wave to be emitted outward in the radial direction C from the expansion member 5. That is, in this case, the liquid W supplied to the fluid containing space 5a is the shock wave generator 65. In this case, the region of the expansion member 5 that emits the laser-induced pressure wave outward in the radial direction C may be the window portion 61. Furthermore, as in the modified example shown in FIG. 15 , the light-absorbing layer 42 may not be provided in the expansion member 5 but may be provided in the tubular member 4. Specifically, in the modification shown in FIG. 15 , a light-absorbing layer 42 serving as a shock wave generating unit 65 is laminated on the outer surface of the covering member 30 of the tubular member 4. Therefore, in the modification shown in FIG. 15 , the laser emitted from the laser emitting unit 11 housed in the housing space 23 a passes through the housing tube 23 and the covering member 30 and is absorbed by the light-absorbing layer 42 serving as the shock wave generating unit 65. In the light-absorbing layer 42 serving as the shock wave generating unit 65, plasma is generated by the absorbed laser. The plasma generated in the light-absorbing layer 42 is easily trapped within the light-absorbing layer 42 due to the covering member 30 covering the inner side of the light-absorbing layer 42 in the radial direction C. This allows laser-induced shock waves, which are pressure waves caused by the laser, to be sent from the light-absorbing layer 42 outward in the radial direction C. This modification, in which the tubular member 4 is provided with a light-absorbing layer 42, may be applied to any catheter configuration according to the present disclosure, such as those exemplified in the embodiments and modifications described herein.

[0078] The liquid W containing the substance that converts the laser beam emitted from the laser emission unit 11 into a pressure wave can be, for example, a dispersion liquid in which fine particles containing a pressure wave conversion substance are dispersed. The fine particles can be formed of a shock wave generating substance alone, a non-shock wave generating substance coated with a shock wave generating substance, or a mixture of a non-shock wave generating substance and a shock wave generating substance. The pressure wave conversion substance may be formed of a metal and / or metal alloy, such as tungsten, tantalum, molybdenum, niobium, platinum, or iridium. The light-absorbing substance may be formed of at least one of magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, or titanium carbide. Furthermore, the pressure wave conversion substance may be formed of at least one of diamond CVD and diamond. The liquid W containing the substance that converts the laser beam emitted from the laser emission unit 11 into a pressure wave is not limited to a dispersion liquid in which fine particles containing a solid pressure wave conversion substance are dispersed, as described above, but may also be a liquid containing a solution that converts the laser beam emitted from the laser emission unit 11 into a pressure wave. An example of such a solution that converts the laser emitted from the laser emission part 11 into a pressure wave is an aqueous solution of indocyanine green and food coloring.

[0079] The shock wave generating unit 65 may be configured to generate shock waves as pressure waves caused by the laser when the laser is irradiated, 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 emitting unit 11 toward the shock wave generating unit 65 is irradiated onto the direction changing unit of the shock wave generating unit 65. The direction changing unit of the shock wave generating unit 65 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 65 is positioned opposite the laser emitting unit 11 of the laser emitter 3 in the direction of laser emission from the laser emitting unit 11. As a result, the laser from the laser emitting unit 11 of the laser emitter 3 is irradiated onto the direction changing unit of the shock wave generating unit 65. The position and shape of the direction changing unit of the shock wave generating unit 65 are adjusted so that the generated shock waves reach the target site. Illustratively, the direction changing section of the shock wave generating section 65 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 11 (in this embodiment, the radial direction C). More specifically, the emission direction of the laser emitted from the laser emission section 11 of the laser emitter 3 is the distal direction A2 of the longitudinal direction A, and the direction changing section of the shock wave generating section 65 is disposed in the distal direction A2 of the laser emission section 11. The direction changing section of the shock wave generating section 65 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 65 by the laser irradiated from the laser emission section 11, 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.

[0080] Furthermore, although the tubular member 4 in this embodiment defines only one storage space 23a, this is not limiting. For example, as in the modified example shown in Fig. 6, the tubular member 4 may define multiple storage spaces 23a. Specifically, in the modified example shown in Fig. 6, the tubular member 4 includes four storage tubes 23 that are integrated with the insertion tubes 22, thereby realizing a configuration in which the tubular member 4 defines four storage spaces 23a. When the tubular member 4 defines multiple storage spaces 23a, as shown in Fig. 6, the catheter 1 may include multiple laser emitters 3 corresponding to the number of storage spaces 23a.

[0081] Furthermore, although the restricting portion 50 in this embodiment is the inner surface of the tubular member 4 that defines the accommodation space 23a, the present invention is not limited to this. For example, as in a modified example shown in FIG. 7 , the restricting portion 50 may be a protrusion 80 provided on the inner surface of the tubular member 4 that defines the accommodation space 23a. Specifically, in the modified example shown in FIG. 7 , in a cross-sectional view perpendicular to the longitudinal direction A, the tips of four protrusions 80 provided on the inner surface 46 of the accommodation tube 23 that defines the accommodation space 23a are configured to be in proximity to or in contact with the laser emitter 3 contained in the accommodation space 23a, thereby restricting movement of the laser emitter 3 contained in the accommodation space 23a in the radial direction C. In the modified example shown in FIG. 7 , the protrusions 80 have a curved convex shape in a cross-sectional view perpendicular to the longitudinal direction A, but the shape of the protrusions 80 is not limited to this.

[0082] Furthermore, the catheter 1 of this embodiment is a so-called rapid exchange type catheter 1 in which the proximal opening 22a1 of the insertion space 22a, through which the guidewire GW can be inserted, is located in the distal direction A2 from the proximal end of the tubular member 4, but is not limited to this. As in a modified example shown in Fig. 8 , the catheter 1 may be a so-called over-the-wire type catheter 1 in which the insertion space 22a extends over the entire area of ​​the tubular member 4 in the longitudinal direction A. In this case, a guidewire insertion opening 85 for inserting the guidewire GW into the insertion space 22a of the tubular member 4 may be formed in the hub 6, as shown in Fig. 8 .

[0083] 9 and 10, a catheter 101 as another embodiment of a catheter according to the present disclosure will be described. The catheter 101 differs from the catheter 1 of the first embodiment described above mainly in that the insertion space 22a and the accommodation space 23a are formed by two holes 115 defined in the elongated body 110. This section will mainly describe the above difference, and will omit a description of the same configuration as the catheter 1 of the first embodiment.

[0084] Fig. 9 is a cross-sectional view showing a portion of the catheter 101. Fig. 10 is a cross-sectional view taken along line II-II in Fig. 9. As shown in Figs. 9 and 10, the tubular member 104 of the catheter main body 102 of this embodiment includes an outer tube 21 and an elongated body 110 that is elongated in the longitudinal direction A. The configuration of the outer tube 21 is similar to that of the outer tube 21 of the first embodiment described above.

[0085] 9 and 10 , the elongated body 110 defines two holes 115. One of the two holes 115 is an insertion space 22a through which the guidewire GW can be inserted. The other of the two holes 115 is an accommodation space 23a through which the laser emitter 3 can be accommodated.

[0086] Specifically, the elongated body 110 of this embodiment has a proximal end portion joined to the peripheral wall of the outer tube 21. The elongated body 110 of this embodiment extends from its proximal end portion within the flow path 21a of the outer tube 21 and protrudes in the distal direction A2 further than the distal end of the outer tube 21. In other words, the distal end of the elongated body 110 of this embodiment is located further distal in the distal direction A2 than the distal end of the outer tube 21. The insertion space 22a as the one hole 115 is continuous from a proximal opening 22a1 that opens to the outside at the proximal end of the elongated body 110 to a distal opening 22a2 that opens to the outside at the distal end of the elongated body 110.

[0087] 9 , the accommodation space 23a serving as the other hole 115 extends inside the expansion member 5 and the outer tube 21 along the longitudinal direction A. A proximal end 23a1 of the accommodation space 23a serving as the other hole 115 is open to the outside of the elongated body 110. Therefore, the laser emitter 3 inserted into the flow path 21a of the outer tube 21 is inserted from the proximal end 23a1 in the distal direction A2 into the accommodation space 23a serving as the other hole 115. As a result, the laser emitter 3 is accommodated in the accommodation space 23a serving as the other hole 115.

[0088] The tubular member 104 is capable of transmitting the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a in the radial direction C. Specifically, the elongated body 110 includes a transmitting portion 40 that is capable of transmitting the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a in the radial direction C. Therefore, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a passes through the transmitting portion 40 of the elongated body 110 in the radial direction C and is irradiated onto the window portion 61 of the expansion member 5.

[0089] More specifically, the entire area of ​​the portion of the elongated body 110 that is covered by the window portion 61 of the expansion member 5 (i.e., the portion that overlaps with the window portion 61 of the expansion member 5 when viewed along the radial direction C) may be made of the transmissive portion 40. The transmissive portion 40 may be made of any of the materials listed as light-transmitting materials in the first embodiment described above.

[0090] 10 , the inner surface 110a of the elongated body 110 that defines the accommodation space 23a is configured to be in close proximity to the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a in a cross-sectional view perpendicular to the longitudinal direction A. Therefore, the laser emitter 3 contained in the accommodation space 23a comes into contact with the inner surface 110a of the elongated body 110 that defines the accommodation space 23a, thereby restricting further movement in the radial direction C. In other words, the tubular member 104 includes a restricting portion 50 that restricts movement in the radial direction C of the laser emitter 3 contained in the accommodation space 23a. The restricting portion 50 in this embodiment is the inner surface 110a of the elongated body 110 that defines the accommodation space 23a. The inner surface 110a of the elongated body 110 that defines the accommodation space 23a may be configured to come into contact with the outer surface 3a of the laser emitter 3 contained in the accommodation space 23a.

[0091] 11 and 12, a catheter 201 will be described as another embodiment of the catheter 1 according to the present disclosure. The catheter 201 differs from the catheter 1 of the first embodiment described above mainly in that the storage space 23a is defined between the outer surface 211a of the tubular body 211 and the inner surface 212a of the covering body 212 that surrounds the tubular body 211. This difference will be mainly described here, and a description of the same configuration as the catheter 1 will be omitted.

[0092] Fig. 11 is a cross-sectional view showing a portion of the catheter 201. Fig. 12 is a cross-sectional view taken along line III-III in Fig. 11. As shown in Fig. 11 and Fig. 12, the tubular member 204 of the catheter main body 202 of this embodiment comprises an outer tube 21, a tubular body 211 defining an insertion space 22a therein, and a covering body 212 covering the periphery of the tubular body 211. The configuration of the outer tube 21 is similar to that of the outer tube 21 of the first embodiment described above.

[0093] The tubular body 211 defines an insertion space 22a therein through which the guidewire GW can be inserted. Specifically, the proximal end of the tubular body 211 is joined to the peripheral wall of the outer tube 21. The tubular body 211 extends from its proximal end within the flow path 21a of the outer tube 21 and protrudes in the distal direction A2 beyond the distal end of the outer tube 21. In other words, the distal end of the tubular body 211 is located further distal in the distal direction A2 than the distal end of the outer tube 21. The insertion space 22a continues from a proximal opening 22a1 that opens to the outside at the proximal end of the tubular body 211 to a distal opening 22a2 that opens to the outside at the distal end of the tubular body 211.

[0094] 12 , the covering 212 covers the periphery of the tube 211 in a cross-sectional view perpendicular to the longitudinal direction A. In the present embodiment, an accommodation space 23a capable of accommodating the laser emitter 3 is defined between an outer surface 211a of the tube 211 and an inner surface 212a of the covering 212. Specifically, the outer surface 211a of the tube 211 in the present embodiment has a concave surface 211a1 that is concave inward in the radial direction C. Furthermore, the inner surface 212a of the covering 212 in the present embodiment has a concave surface 212a1 that is concave outward in the radial direction C. In the present embodiment, the accommodation space 23a capable of accommodating the laser emitter 3 is defined between the concave surface 211a1 of the outer surface 211a of the tube 211 and the concave surface 212a1 of the inner surface 212a of the covering 212. However, the configuration for partitioning the storage space 23a between the outer surface 211a of the tube body 211 and the inner surface 212a of the covering body 212 is not limited to this, and for example, the storage space 23a may be partitioned between a concave surface of either the outer surface 211a of the tube body 211 or the inner surface 212a of the covering body 212 and a non-concave surface of the other of the outer surface 211a of the tube body 211 or the inner surface 212a of the covering body 212.

[0095] 11 , the accommodation space 23a in this embodiment extends inside the expansion member 5 and the outer tube 21 along the longitudinal direction A. A proximal end 23a1 of the accommodation space 23a is open to the outside of the tube body 211 and the covering body 212. Therefore, the laser emitter 3 inserted into the flow path 21a of the outer tube 21 is inserted into the accommodation space 23a from the proximal end 23a1 in the distal direction A2. As a result, the laser emitter 3 is accommodated in the accommodation space 23a.

[0096] 12, the covering body 212 may be formed, for example, by attaching a tube member or the like on which a concave surface 212a1 has been formed in advance to the tubular body 211. Alternatively, the covering body 212 may be formed, for example, as in a modified example shown in FIG. 13, by using a heat-shrinkable film or the like that has been shrunk to fit the outer shapes of the tubular body 211 and the laser emitter 3. In this case, the tubular body 211 and a core material that is fitted into the concave surface 211a1 and has an outer diameter larger than the outer diameter of the laser emitter 3 are covered together with the heat-shrinkable film. Then, after shrinking the heat-shrinkable film, the core material can be removed to form the accommodation space 23a.

[0097] The tubular member 204 is capable of transmitting, in the radial direction C, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a. Specifically, the covering body 212 and the tubular body 211 include a transmitting portion 40 that is capable of transmitting, in the radial direction C, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a. Therefore, the laser emitted from the laser emission unit 11 of the laser emitter 3 housed in the accommodation space 23 a passes through the transmitting portion 40 of the covering body 212 and the tubular body 211 in the radial direction C and is irradiated onto the window portion 61 of the expansion member 5.

[0098] More specifically, the entire area of ​​the covering body 212 and the tube body 211 that is covered by the window portion 61 of the expansion member 5 (i.e., the portion that overlaps with the window portion 61 of the expansion member 5 when viewed along the radial direction C) may be made of the transmissive portion 40. The transmissive portion 40 may be made of any of the materials listed as light-transmitting materials in the first embodiment described above.

[0099] In the present embodiment, the outer surface 211a of the tubular body 211 and the inner surface 212a of the covering body 212, which define the accommodation space 23a, are configured to be close to the outer surface 3a of the laser emitter 3 housed in the accommodation space 23a in a cross-sectional view perpendicular to the longitudinal direction A. Therefore, the laser emitter 3 housed in the accommodation space 23a comes into contact with the outer surface 211a of the tubular body 211 and the inner surface 212a of the covering body 212, which define the accommodation space 23a, and is thereby restricted from moving further in the radial direction C. In other words, the tubular member 204 includes a restricting portion 50 that restricts movement of the laser emitter 3 housed in the accommodation space 23a in the radial direction C. The restricting portion 50 in the present embodiment is the outer surface 211a of the tubular body 211 and the inner surface 212a of the covering body 212, which define the accommodation space 23a. The outer surface 211a of the tube 211 and the inner surface 212a of the covering body 212 that define the storage space 23a may be configured to come into contact with the outer surface 3a of the laser emitter 3 housed in the storage space 23a.

[0100] As shown in FIG. 14, by using a catheter according to the present disclosure, such as those exemplified in the above-described embodiments and modifications, a treatment method including the following steps (I) to (III) can be carried out.

[0101] (I) A preparation step S1 of preparing a catheter according to the present disclosure; (II) An expansion step S2 of expanding the expansion member of the catheter at a target site; and (III) A treatment step S3 of emitting a laser from the laser emission unit of the laser emitter toward a shock wave generating unit capable of generating 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.

[0102] In the treatment step S3, the shock waves generated in the shock wave generating section are emitted from the expansion member, and the shock waves can be reliably applied to the target area that comes into contact with the expansion member.

[0103] The catheter according to the present disclosure is not limited to the specific configurations shown in the above-described embodiments and modifications, and various modifications, alterations, and combinations are possible without departing from the scope of the claims. Therefore, other catheters configured by combining the components of the catheters shown in the above-described embodiments and modifications also fall within the technical scope of the present disclosure.

[0104] The present disclosure relates to catheters.

[0105] 1, 101, 201: Catheter 2, 102, 202: Catheter body 3: Laser emitter 3a: Outer surface of laser emitter 4, 104, 204: Tubular member 5: Expansion member 5a: Fluid accommodating space 6: Hub 11: Laser emitter 11a: Outer surface of laser emitter 12: Shaft 13: Marker of shaft 14: Covering 15: Drive 16: Connector 21: Outer tube 21a: Flow path 22: Insertion tube 22a: Insertion space 22a1: Proximal opening of insertion space 22a2: Distal opening of insertion space 23: Storage tube 23a: Storage space 23a1: Proximal end of storage space 23a2: Distal end of storage space 30: Covering member 35: Marker of tubular member 35a: Proximal marker 35b: Distal marker portion 40: Transmission portion 41: Transmission layer 42: Light absorption layer 46: Inner surface of accommodating tube 50: Restriction portion 61: Window portion 61a: Proximal end of window portion 61b: Distal end of window portion 62: Expandable main body portion 63: Proximal reduced diameter portion 64: Distal reduced diameter portion 65: Shock wave generating portion 71: Inner hub flow path 72: Supply port 73: Inner hub insertion hole 75: Closing member 80: Convex portion 85: Guide wire insertion opening 110: Elongated body 110a: Inner surface of elongated body 115: Hole 211: Tubular body 211a: Outer surface of tubular body 211a1: Concave surface of outer surface of tubular body 212: Cover 212a: Inner surface of cover 212a1: Concave surface of inner surface of cover A: Longitudinal direction A1: Proximal direction A2: Distal direction BV: Blood vessel B: Circumferential direction C: Radial direction GW: Guide wire W: Laser absorbent X: Calcified area

Claims

1. A catheter comprising: a laser emitter having a laser emission part capable of emitting a laser; a tubular member that defines an insertion space through which a guidewire can be inserted and an accommodation space capable of accommodating the laser emitter; and 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, wherein the tubular member is capable of transmitting, in the radial direction, the laser emitted from the laser emission part of the laser emitter accommodated in the accommodation space, the expansion member has a window part that can release the laser or a pressure wave caused by the laser to the outside in the radial direction, and the tubular member has a restriction part that restricts the radial movement of the laser emitter accommodated in the accommodation space.

2. A catheter as described in claim 1, wherein the regulating portion is the inner surface of the tubular member that defines the storage space and is in close proximity to or in contact with the outer surface of the laser emitter housed in the storage space.

3. A catheter according to claim 1 or 2, wherein the tubular member comprises an insertion tube that defines the insertion space therein and a storage tube that defines the storage space therein, and the insertion tube and the storage tube are integrated and arranged in parallel.

4. A catheter as claimed in claim 1 or 2, wherein the tubular member comprises an elongated body defining two holes therein, one of the two holes being the insertion space, and the other of the two holes being the accommodation space.

5. A catheter as described in claim 1 or 2, wherein the tubular member comprises a tube defining the insertion space therein and a covering covering the periphery of the tube, and the storage space is defined between the outer surface of the tube and the inner surface of the covering.

6. A catheter as described in claim 1 or 2, wherein the laser emitter is movable within the accommodation space along the longitudinal direction of the tubular member, and the accommodation space overlaps with the entire longitudinal area of ​​the window portion of the expansion member when viewed along the radial direction.

7. A catheter according to claim 1 or 2, wherein the expansion member comprises an expansion body portion that is cylindrically expandable, and the window portion is provided in the expansion body portion.

8. A catheter as described in claim 1 or 2, wherein the window portion is provided with a shock wave generating portion capable of generating a shock wave as the pressure wave due to the laser emitted from the laser emission portion of the laser emitter contained in the storage space.

9. A catheter as described in claim 1 or 2, wherein the tubular member is provided with a light-absorbing layer that generates the pressure wave due to the laser emitted from the laser emission portion of the laser emitter housed in the housing space.

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