Catheter

The catheter's innovative design with a movable laser emitter and expandable member ensures efficient delivery of laser-induced shock waves for effective treatment of calcified areas by maintaining consistent intensity and coverage.

WO2026038514A1PCT designated stage Publication Date: 2026-02-19TERUMO KK
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Patent Information

Application Number
PCT/JP2025/028005
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-08-13
Filing Date
2025-08-06
Publication Date
2026-02-19

AI Technical Summary

Technical Problem

Existing catheters face inefficiencies in applying the required force for treating target sites, such as calcified areas in blood vessels, as they struggle to effectively deliver laser-induced shock waves or pressure waves.

Method used

A catheter design featuring a tubular member, an expandable expansion member with a window portion, a laser emitter, and a connector that allows the laser emitter to move longitudinally while being restricted in radial and circumferential directions, ensuring consistent laser emission and shock wave generation for targeted treatment.

Benefits of technology

The design enhances the efficiency of treating target sites by maintaining consistent laser intensity and shock wave generation, improving the effectiveness of procedures like fracturing calcified regions in blood vessels.

✦ Generated by Eureka AI based on patent content.

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Abstract

A catheter according to the present disclosure comprises a tubular member, an expansion member, a laser emitter, and a connector. The expansion member is provided with a window part from which a laser or a pressure wave caused by the laser can be externally emitted in the radial direction. The connector is provided with a cover part that covers the periphery of a laser-emitting part, and at least the cover part of the connector consists of a single light-transmitting material through which the laser emitted from the laser-emitting part can be transmitted in the radial direction. The connector is attached to the tubular member so as to be capable of moving relative to the tubular member along the longitudinal direction of the tubular member. The laser emitter is attached to the connector such that movement in the radial direction is restricted, and is capable of moving relative to the tubular member along the longitudinal direction in an integrated manner with the connector.
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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 Laid-Open 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 connecting body connecting the tubular member and the laser emitter, wherein the expansion member has a window portion that can emit the laser or a pressure wave caused by the laser outward in the radial direction; the connecting body has a cover portion that covers the periphery of the laser emitter, and at least the cover portion of the connecting body is made of only a single light-transmitting material that can transmit the laser emitted from the laser emitter in the radial direction; the connecting body is attached to the tubular member so as to be movable relative to the tubular member along the longitudinal direction of the tubular member; and the laser emitter is attached to the connecting body so that movement in the radial direction is restricted, and is movable relative to the tubular member along the longitudinal direction together with the connecting body.

[0007] A catheter according to one embodiment of the present disclosure is the catheter described in (1) above, wherein: (2) the connector is attached to the tubular member so as to surround the tubular member; the inner surface of the connector is in close proximity to or in contact with the outer surface of the tubular member; and the radial movement of the connector is restricted, thereby restricting the radial movement of the laser emitter attached to the connector.

[0008] A catheter according to one embodiment of the present disclosure is (3) the catheter described in (1) or (2) above, in which the cover portion of the connector covers the entire area of ​​the laser emission portion of the laser emitter.

[0009] A catheter according to one embodiment of the present disclosure is the catheter described in any one of (1) to (3) above, wherein (4) the longitudinal length of the connector is smaller than the longitudinal length of the expansion member.

[0010] A catheter according to one embodiment of the present disclosure is (5) a catheter according to any one of (1) to (4) above, which is provided with a movement restriction portion that restricts the laser emitter from moving relative to the tubular member in the circumferential direction of the tubular member.

[0011] A catheter according to one embodiment of the present disclosure is (6) the catheter according to any one of (1) to (5) above, wherein the connector includes a marker portion that indicates the position of the laser emission portion.

[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) a catheter according to any one of (1) to (7) above, wherein the connector is provided with a light-absorbing layer that generates the pressure wave by the laser emitted from the laser emission portion of the laser emitter attached to the connector.

[0015] A catheter according to a second aspect of the present disclosure is (10) a catheter comprising: a tubular member defining an insertion space therein through which a guide wire can be inserted; an expansion member covering the outside of the tubular member in the radial direction and capable of expanding and contracting in the radial direction; a laser emitter having a laser emission unit capable of emitting a laser; and a connector connecting the tubular member and the laser emitter, wherein the expansion member has a window portion capable of emitting the laser or a pressure wave caused by the laser to the outside in the radial direction; the connector is attached to the tubular member so as to be movable relative to the tubular member in the longitudinal direction of the tubular member; the laser emitter is attached to the connector so that movement of the laser emitter in the radial direction is restricted and is movable integrally with the connector relative to the tubular member in the longitudinal direction; and the longitudinal length of the connector is shorter than the longitudinal length of the expansion member.

[0016] a catheter according to a third aspect of the present disclosure, comprising: (11) a tubular member defining an insertion space therein through which a guide wire can be inserted; an expansion member covering the outside of the tubular member in the radial direction and capable of expanding and contracting in the radial direction; a laser emitter having a laser emission unit capable of emitting a laser; and a connector connecting the tubular member and the laser emitter, wherein the expansion member has a window portion capable of emitting the laser or a pressure wave caused by the laser to the outside in the radial direction; the connector being attached to the tubular member so as to be movable relative to the tubular member in the longitudinal direction of the tubular member; the laser emitter being attached to the connector so that movement of the laser emitter in the radial direction is restricted and is movable integrally with the connector relative to the tubular member in the longitudinal direction; and a movement restricting portion restricting movement of the laser emitter in the circumferential direction of the tubular member.

[0017] a fourth aspect of the present disclosure, the treatment method, is (12) a treatment method using a catheter, the catheter comprising: a tubular member defining an insertion space therein through which a guide wire can be inserted; an expansion member covering the outside in the radial direction of the tubular member and capable of expanding and contracting in the radial direction; a laser emitter having a laser emission part capable of emitting a laser; and a connector connecting the tubular member and the laser emitter, the expansion member having a window part that can emit the laser or a pressure wave caused by the laser outward in the radial direction, the connector having a cover part that covers the periphery of the laser emission part, the connector being attached to the tubular member so as to be movable relative to the tubular member along the longitudinal direction of the tubular member, the laser emitter being attached to the connector so that movement in the radial direction is restricted and is movable relative to the tubular member along the longitudinal direction together with the connector, the treatment method comprising: a preparation step of preparing the catheter; and an expansion step of expanding the expansion member of the catheter at a target site. a treatment step of emitting a 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 area with the shock waves generated in the shock wave generating part.

[0018] According to the present disclosure, a catheter can be provided that can improve the efficiency when treating a target site.

[0019] 5A is a cross-sectional view showing a catheter according to an embodiment of the present disclosure. FIG. 5B is a cross-sectional view taken at the position of line II in FIG. 1. FIG. 5C is a cross-sectional view taken at the position of line II-II in FIG. 1. FIG. 5D is a cross-sectional view taken at the position of line II-II in FIG. 1. FIG. 5E is a cross-sectional view taken at the position of line II-II in FIG. 1. FIG. 5F is a cross-sectional view taken at the position of line II-II in FIG. 5C, showing a modified example of the catheter shown in FIG. 1. FIG. 5G is a cross-sectional view taken at the position of line II-II in FIG. 5C, showing a modified example of the catheter shown in FIG. 1.

[0020] 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.

[0021] Fig. 1 is a cross-sectional view showing a catheter 1 as one embodiment of a catheter according to the present disclosure. Fig. 2 is a cross-sectional view taken along line II in Fig. 1. Fig. 3 is a cross-sectional view taken along line II-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 housed within the catheter main body 2.

[0022] 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. 5A to 5C ). 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.

[0023] As shown in FIGS. 1 and 2 , the catheter main body 2 includes a long tubular member 4, an expansion member 5, a hub 6, and a connector 8. 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."

[0024] <Laser emitter 3>

[0025] The laser emitter 3 is inserted into the catheter main body 2. The laser emitter 3 includes a laser emitter 11 and a shaft portion 12. The laser emitter 11 is capable of emitting a laser in the radial direction C. The type of laser emitted from the laser emitter 11 is not particularly limited, and may be, for example, a microsecond pulse laser, a nanosecond pulse laser, a picosecond laser, or a femtosecond pulse laser. The repetition frequency of the pulse laser emitted from the laser emitter 11 may be 1 to 500 Hz. In this embodiment, the length in the longitudinal direction A of the laser emitter 11 is shorter than the length in the longitudinal direction A of the window portion 61 of the expansion member 5.

[0026] The shaft portion 12 is continuous with the laser emitter 11 in the proximal direction A1. The shaft portion 12 is exposed in the proximal direction A1 from the hub 6 when the laser emitter 3 is inserted through the catheter main body 2. 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 in the proximal direction A1 from the hub 6. 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] 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 .

[0029] 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 makes it possible to suppress deflection of the shaft portion 12 when the laser emitter 3 is moved in the longitudinal direction A. The covering portion 14 of this embodiment covers substantially the entire area of ​​the shaft portion 12 in the longitudinal direction A, from the distal end of the shaft portion 12 to the proximal end of the shaft portion 12 that is exposed in the proximal direction A1 from the hub 6. The covering portion 14 can be configured of, for example, a metal coil, a resin tube, or the like.

[0030] The covering unit 14 in this embodiment has one marker unit 13. When moving the laser emitter 3 in the longitudinal direction A, the surgeon can confirm the position of the laser emission unit 11 in the longitudinal direction A by checking the position of the marker unit 13. This allows the surgeon to easily align the laser emission unit 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 unit 13 and the distal end of the laser emission unit 11 matches the length in the longitudinal direction A of the window 61 of the expansion member 5. As will be described later, the position of the distal end of the proximal marker unit 35a of the tubular member 4 in the longitudinal direction A matches the position of the proximal end 61a of the window 61 of the expansion member 5. 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 covering unit 14 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. Furthermore, the marker units 13 may be provided on the shaft unit 12.

[0031] 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.

[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 therein through which the guidewire GW can be inserted. Specifically, the tubular member 4 of this embodiment includes an outer tube 21 and an insertion tube 22 that extends inside the outer tube 21 and defines the insertion space 22a. Both the outer tube 21 and the insertion tube 22 are 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 laser emitter 3 is inserted through the flow path 21a along the longitudinal direction A. That is, the flow path 21a is used to supply the expansion fluid to the fluid accommodation space 5a, and also to insert the laser emitter 3 into the inside of the tubular member 4. Specifically, the laser emitter 3 is inserted from the proximal end of the outer tube 21, extends within the flow path 21a, and protrudes in the distal direction A2 beyond the distal end of the outer tube 21. That is, the laser emitter 3 penetrates the flow path 21a of the outer tube 21 in the longitudinal direction A. In this state, the laser emitter 11 of the laser emitter 3 is disposed in the fluid accommodation space 5a of the expansion member 5.

[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] As shown in FIG. 1 , 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. Specifically, the two markers 35 of this embodiment are provided on the insertion tube 22. 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.

[0039] <<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.

[0040] 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 above-mentioned tubular member 4, 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.

[0041] In a contracted state (see FIG. 5A ), 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 and 2 show the expansion member 5 in an expanded state.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] As shown in Figures 1 and 2, 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 disposed in the fluid storage space 5a of the expansion member 5, 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 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 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.

[0046] 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.

[0047] 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.

[0048] 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, synthetic rubber such as 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.

[0049] 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).

[0050] <<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 from the hub internal insertion hole 73 through the hub internal flow path 71 into the flow path 21a of the outer tube 21.

[0051] 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.

[0052] The connector 8 connects the tubular member 4 and the laser emitter 3. The connector 8 is attached to the tubular member 4 so as to be movable relative to the tubular member 4 along the longitudinal direction A. Specifically, the connector 8 of this embodiment is attached to the insertion tube 22 so as to cover the periphery of the insertion tube 22 in a cross-sectional view perpendicular to the longitudinal direction A (see FIG. 2 ), and is supported on the outer surface 25 of the insertion tube 22. While supported on the outer surface 25 of the insertion tube 22, the connector 8 slides on the outer surface 25 of the insertion tube 22, thereby being movable relative to the tubular member 4 along the longitudinal direction A.

[0053] More specifically, the connector 8 of this embodiment is attached to the insertion tube 22 so as to cover the entire periphery of the insertion tube 22 in a cross-sectional view perpendicular to the longitudinal direction A. Therefore, the connector 8 of this embodiment has a ring shape.

[0054] The connector 8 of this embodiment is attached to a portion of the insertion tube 22 that is located within the fluid housing space 5a of the expansion member 5. In other words, the connector 8 of this embodiment is disposed within the fluid housing space 5a of the expansion member 5. The connector 8 of this embodiment is movable within the fluid housing space 5a of the expansion member 5 along the longitudinal direction A.

[0055] The laser emitter 3 is attached to the connecting body 8. The connecting body 8 includes a cover portion 9 that covers the periphery of the laser emitter 11 in a cross section perpendicular to the longitudinal direction A.

[0056] Of the connecting body 8, at least the cover portion 9 is made of a light-transmitting material that allows the laser emitted from the laser emission portion 11 to pass through in the radial direction C. Therefore, the laser emitted from the laser emission portion 11 arranged in the fluid storage space 5a of the expansion member 5 passes through the cover portion 9 of the connecting body 8 in the radial direction C and is irradiated onto the window portion 61 of the expansion member 5.

[0057] When the laser emitted from the laser emission unit 11 passes through the cover unit 9 of the connecting body 8, it is diffused by the lens effect of the light-transmitting material that makes up the cover unit 9. In other words, by allowing the laser emitted from the laser emission unit 11 to pass through the cover unit 9, the laser emitted from the laser emission unit 11 can be irradiated over a wide range onto the window unit 61 of the expansion member 5.

[0058] The cover portion 9 of the connecting body 8 of this embodiment is made of only a single light-transmitting material. This makes it possible to suppress refraction, scattering, etc. of the laser emitted from the laser emission portion 11 when passing through the cover portion 9, compared to when the cover portion 9 is made of multiple light-transmitting materials. In the connecting body 8 of this embodiment, the portions other than the marker portion 10, which will be described later, are made of a single light-transmitting material.

[0059] The cover unit 9 of this embodiment covers the entire area of ​​the laser emission unit 11 in the longitudinal direction A. This allows the laser emitted from the laser emission unit 11 to be reliably transmitted through the cover unit 9 regardless of its position in the longitudinal direction A. Furthermore, the cover unit 9 of this embodiment covers the entire area around the laser emission unit 11 in a cross-sectional view perpendicular to the longitudinal direction A. This allows the laser emitted from the laser emission unit 11 to be reliably transmitted through the cover unit 9 over the entire area around the laser emission unit 11.

[0060] The light-transmitting material constituting the cover portion 9 of the connecting body 8 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 polymeric 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.

[0061] The insertion tube 22 may also be configured to allow the laser emitted from the laser emission unit 11 of the laser emitter 3 to transmit therethrough in the radial direction C. Specifically, for example, the entire area of ​​the portion of the insertion tube 22 that is covered by the window 61 of the expansion member 5 (i.e., the portion that overlaps with the window 61 of the expansion member 5 when viewed along the radial direction C) may be made of the above-mentioned light-transmitting material. In this way, it is possible to prevent the insertion tube 22 from partially obstructing the irradiation of the laser with the window 61.

[0062] The laser emission unit 11 in this embodiment is embedded in the peripheral wall of the connecting body 8. In other words, the cover portion 9 of the connecting body 8 and the laser emission unit 11 are in contact with each other without forming a gap. This makes it possible to prevent the expansion fluid supplied to the fluid accommodation space 5a of the expansion member 5 from flowing between the cover portion 9 of the connecting body 8 and the laser emission unit 11. As a result, it is possible to prevent the laser emitted from the laser emission unit 11 from being refracted, scattered, or the like by the expansion fluid that has flowed between the cover portion 9 of the connecting body 8 and the laser emission unit 11. In this embodiment, of the laser emitter 3, the entire laser emission unit 11 and the distal end portion of the shaft portion 12 that is continuous with the laser emission unit 11 in the proximal direction A1 are embedded in the peripheral wall of the connecting body 8.

[0063] The laser emitter 3 is movable integrally with the connecting body 8 relative to the tubular member 4 in the longitudinal direction A. Therefore, by moving the laser emitter 3 together with the connecting body 8 in the longitudinal direction A, the surgeon can irradiate the laser emitted from the laser emitter 11 over a wide range in the longitudinal direction A of the window portion 61 of the expansion member 5.

[0064] More specifically, the laser emission unit 11 is movable along the longitudinal direction A together with the connecting body 8 within the fluid containing space 5a of the expansion member 5. When viewed along the radial direction C, the laser emission unit 11 of the present embodiment is movable along the longitudinal direction A together with the connecting body 8 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. Therefore, by moving the laser emission unit 11 in the longitudinal direction A, the surgeon can irradiate the entire area of ​​the window portion 61 with the laser emitted from the laser emission unit 11.

[0065] The laser emitter 3 is attached to the connecting body 8 so that movement in the radial direction C is restricted. This stabilizes the position of the laser emitter 3 in the radial direction C. As a result, 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 can be stabilized.

[0066] Specifically, the connector 8 of this embodiment is attached to the tubular member 4 so as to cover the periphery of the tubular member 4 (the insertion tube 22 in this embodiment). As shown in FIG. 2 , an inner surface 8a of the connector 8, which covers the periphery of the tubular member 4 (the insertion tube 22 in this embodiment), is close to the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment). Therefore, the connector 8 comes into contact with the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment), thereby restricting further movement of the connector 8 in the radial direction C. That is, the movement of the connector 8 in the radial direction C is restricted by the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment). Meanwhile, the laser emitter 3 is attached to the connector 8. The laser emitter 3 of this embodiment is fixed to the connector 8 by being embedded in the connector 8. Therefore, the movement of the laser emitter 3 in the radial direction C is indirectly restricted by the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment) via the connector 8 .

[0067] The inner surface 8a of the connector 8 that covers the periphery of the tubular member 4 may be configured to come into contact with the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment). By doing so, the position in the radial direction C of the laser emitter 3 attached to the connector 8 can be more stabilized. As a result, 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 can be more stabilized.

[0068] In this embodiment, the entire inner surface 8a of the connector 8 that covers the periphery of the tubular member 4 (the insertion tube 22 in this embodiment) is configured to be in close proximity to or in contact with the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment) in a cross-sectional view perpendicular to the longitudinal direction A. However, as long as movement of the connector 8 in the radial direction C can be restricted, only a portion of the inner surface 8a of the connector 8 that covers the periphery of the tubular member 4 (the insertion tube 22 in this embodiment) may be configured to be in close proximity to or in contact with the outer surface of the tubular member 4 (the outer surface 25 of the insertion tube 22 in this embodiment) in a cross-sectional view perpendicular to the longitudinal direction A.

[0069] The length of the connector 8 in the longitudinal direction A in this embodiment is smaller than the length of the expansion member 5 in the longitudinal direction A. This prevents the length of the connector 8 in the longitudinal direction A from becoming unnecessarily large. As a result, it is possible to prevent an increase in sliding resistance between the connector 8 and the tubular member 4 that occurs when the connector 8 moves along the longitudinal direction A. Furthermore, the length of the connector 8 in the longitudinal direction A in this embodiment is smaller than the length of the window portion 61 of the expansion member 5 in the longitudinal direction A. This further prevents the length of the connector 8 in the longitudinal direction A from becoming unnecessarily large. As a result, it is possible to further prevent an increase in sliding resistance between the connector 8 and the tubular member 4 that occurs when the connector 8 moves along the longitudinal direction A.

[0070] The connecting body 8 of this embodiment includes one marker unit 10 that indicates the position of the laser emission unit 11 in the longitudinal direction A. The presence of this marker unit 10 allows the surgeon to easily confirm the position of the laser emission unit 11 in the longitudinal direction A. Specifically, the marker unit 10 of this embodiment is provided in a portion of the connecting body 8 other than the cover unit 9. That is, the marker unit 10 is provided in a portion of the connecting body 8 that does not overlap with the laser emission unit 11 when viewed along the radial direction C. The position of the distal end of the marker unit 10 of this embodiment in the longitudinal direction A coincides with the position of the proximal end of the laser emission unit 11 in the longitudinal direction A. However, the number and arrangement of the marker units 10 provided on the connecting body 8 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.

[0071] 3 , the catheter 1 of this embodiment further includes a movement restricting section 50 that restricts the movement of the laser emitter 3 relative to the tubular member 4 in the circumferential direction B. By providing such a movement restricting section 50, the movement of the laser emitter 3 relative to the tubular member 4 in the circumferential direction B can be restricted, and the distance in the radial direction C between the laser emitter 11 and the window section 61 of the expansion member 5 can be stabilized.

[0072] Specifically, an accommodating recess 51 that accommodates the shaft portion 12 of the laser emitter 3 is formed on the outer surface of the tubular member 4 in this embodiment. The accommodating recess 51 in this embodiment is formed on the outer surface 25 of the insertion tube 22. The accommodating recess 51 in this embodiment is a recess that is recessed inward in the radial direction C. At a position where the laser emitter 3 is accommodated in the accommodating recess 51, movement of the laser emitter 3 in the circumferential direction B relative to the tubular member 4 is restricted. In other words, the movement restricting portion 50 in this embodiment is the accommodating recess 51.

[0073] The accommodating recess 51 serving as the movement restricting portion 50 in this embodiment is provided in a portion of the insertion tube 22 that is not located within the fluid accommodating space 5a of the expansion member 5. This prevents the accommodating recess 51 from interfering with the movement of the connecting body 8 in the longitudinal direction A. However, the specific configuration of the accommodating recess 51 serving as the movement restricting portion 50, such as its arrangement and size, may be changed as appropriate depending on the relationship with other elements, etc.

[0074] Furthermore, as in a modified example shown in Fig. 4 , the movement restricting unit 50 may be formed by the connector 8 and the tubular member 4. Fig. 4 is a cross-sectional view of a modified example of the catheter 1, taken at the same position as in Fig. 2 . In the modified example shown in Fig. 4 , a convex portion 54 that convexly projects inward in the radial direction C is provided on the inner surface 8a of the connector 8 that covers the insertion tube 22. Furthermore, a concave portion 55 that concaves inward in the radial direction C is provided on the outer surface 25 of the insertion tube 22. In this example, the convex portion 54 and the concave portion 55 engage with each other, thereby restricting movement of the connector 8 in the circumferential direction B relative to the tubular member 4. As a result, movement of the laser emitter 3 attached to the connector 8 in the circumferential direction B relative to the tubular member 4 is also restricted. In this example, a convex portion 54 is provided on the inner surface 8a of the connector 8, and a concave portion 55 is provided on the outer surface 25 of the insertion tube 22, but conversely, a convex portion may be provided on the outer surface 25 of the insertion tube 22, and a concave portion that engages with the convex portion of the insertion tube 22 may be provided on the inner surface 8a of the connector 8. In other words, the movement restricting portion 50 may be composed of a convex portion provided on one of the outer surface of the tubular member 4 and the inner surface 8a of the connector 8, and a concave portion provided on the other of the outer surface of the tubular member 4 and the inner surface 8a of the connector 8.

[0075] 5A to 5C, an example of a procedure performed using the catheter 1 will be described. Figures 5A to 5C show an example of a procedure for crushing a calcified region X in a blood vessel BV as a treatment of a target site.

[0076] Fig. 5A shows the catheter 1 inserted into the blood vessel BV. As shown in Fig. 5A, 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.

[0077] FIG. 5B shows the state in which the expansion member 5 is expanded from the state shown in FIG. 5A . As shown in FIG. 5B , 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, which is disposed in the fluid storage space 5a of the expansion member 5. The laser emitted from the laser emission unit 11 passes through the connecting body 8 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 inner side 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.

[0078] 5C is a diagram showing a state in which the laser emitter 3 has been moved in the proximal direction A1 together with the connector 8 from the state shown in FIG. 5B. As shown in FIG. 5C, by moving the laser emitter 3 in the proximal direction A1 together with the connector 8, 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.

[0079] 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.

[0080] Furthermore, the laser emitter 3 is attached to the connecting body 8 so that movement in the radial direction C is restricted. This stabilizes the position of the laser emitter 3 in the radial direction C, and thus stabilizes 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 laser emitter 3 is attached to the connecting body 8 so that movement in the radial direction C is restricted, thereby preventing variation in the longitudinal direction A of 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. 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.

[0081] The catheter 1 of this embodiment can be modified in various ways as follows.

[0082] 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.

[0083] 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. 6 , 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 storage 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 emitting a pressure wave caused by the laser outward in the radial direction C from the expansion member 5. In other words, in this case, the liquid W supplied to the fluid storage space 5a serves as the shock wave generator. In this case, the region of the expansion member 5 that emits the pressure wave caused by the laser outward in the radial direction C may be the window portion 61. Furthermore, as in the modified example shown in FIG. 9 , the light-absorbing layer 42 may not be provided in the expansion member 5 but may be provided in the connecting body 8. Specifically, in the modified example shown in FIG. 9 , a light-absorbing layer 42 serving as a shock wave generating unit 65 is laminated on the outer surface of the cover 9 of the connecting body 8. Therefore, in the modified example shown in FIG. 9 , the laser emitted from the laser emission unit 11 passes through the cover 9 of the connecting body 8 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 more likely to remain within the light-absorbing layer 42 due to the cover 9 located inside 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 modified example, in which the light-absorbing layer 42 is provided on the connecting body 8, can be applied to any catheter configuration according to the present disclosure, such as those exemplified in the embodiments and modified examples described herein.

[0084] 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.

[0085] The shock wave generating unit 65 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 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 emission unit 11 of the laser emitter 3 in the direction of laser emission from the laser emission unit 11. As a result, the laser from the laser emission 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.

[0086] 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. 7 , the catheter 1 may be a so-called over-the-wire type catheter in which the insertion space 22a extends over the entire area of ​​the tubular member 4 in the longitudinal direction A. In this case, as shown in Fig. 7 , the hub 6 may be formed with a guidewire insertion opening 85 for inserting the guidewire GW into the insertion space 22a of the tubular member 4.

[0087] As shown in FIG. 8, 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.

[0088] (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.

[0089] 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.

[0090] 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. For example, in the above-described embodiments, the tubular member 4 is configured to include an outer tube 21 and an insertion tube 22 extending inside the outer tube 21, but is not limited to this. For example, the tubular member 4 may be configured to further include a tube other than the insertion tube 22 extending inside the outer tube 21. In this case, the connector 8 may be attached to a tube other than the above-described insertion tube 22 so as to be movable relative to the tubular member 4 along the longitudinal direction A.

[0091] The present disclosure relates to catheters.

[0092] 1: Catheter 2: Catheter body 3: Laser emitter 4: Tubular member 5: Expansion member 5a: Fluid containing space 6: Hub 8: Connector 8a: Inner surface of connector 9: Cover 10: Marker 11: 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 25: Outer surface of insertion tube 41: Transmission layer 42: Light absorption layer 50: Movement restricting portion 51: Receiving recess 54: Convex portion 55: Recess 61: Window 61a: Proximal end of window 61b: Distal end of window 62: Expansion main body 63: Proximal reduced diameter portion 64: Distal reduced diameter section 65: Shock wave generating section 71: Flow path inside hub 72: Supply port 73: Insertion hole inside hub 75: Closure member 85: Guide wire insertion opening A: Longitudinal direction A1: Proximal direction A2: Distal direction B: Circumferential direction BV: Blood vessel C: Radial direction GW: Guide wire W: Laser absorbing liquid X: Calcified area

Claims

1. A catheter comprising: a tubular member defining an insertion space therein through which a guide wire can be inserted; an expansion member covering the radial outside of said tubular member and capable of expanding and contracting in said radial direction; a laser emitter having a laser emission unit capable of emitting a laser; and a connecting body connecting said tubular member and said laser emitter, wherein said expansion member has a window unit capable of emitting said laser or a pressure wave caused by said laser outward in said radial direction; said connecting body having a cover unit covering the periphery of said laser emission unit, at least said cover unit of said connecting body being made only of a single light-transmitting material that can transmit the laser emitted from the laser emission unit in the radial direction; said connecting body being attached to said tubular member so as to be movable relative to said tubular member along the longitudinal direction of said tubular member; and said laser emitter being attached to said connecting body so that movement in the radial direction is restricted, and being movable relative to said tubular member along the longitudinal direction together with said connecting body.

2. A catheter as described in claim 1, wherein the connector is attached to the tubular member so as to surround the tubular member, and the inner surface of the connector is in close proximity to or in contact with the outer surface of the tubular member, thereby restricting the radial movement of the connector, thereby restricting the radial movement of the laser emitter attached to the connector.

3. A catheter according to claim 1 or 2, wherein the cover portion of the connecting body covers the entire area of ​​the laser emission portion of the laser emitter.

4. The catheter according to claim 1 or 2, wherein the longitudinal length of the connector is smaller than the longitudinal length of the expansion member.

5. A catheter as described in claim 1 or 2, comprising a movement restriction portion that restricts the laser emitter from moving relative to the tubular member in the circumferential direction of the tubular member.

6. A catheter according to claim 1 or 2, wherein the connecting body is provided with a marker portion that indicates the position of the laser emission portion.

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 that generates a shock wave as the pressure wave by the laser emitted from the laser emission portion of the laser emitter attached to the connecting body.

9. A catheter as described in claim 1 or 2, wherein the connecting body is provided with a light-absorbing layer that generates the pressure wave by the laser emitted from the laser emission portion of the laser emitter attached to the connecting body.

Citation Information

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