Catheter system

Abstract

The present invention relates to a catheter system comprising: a multi-lumen tube movably inserted into a body lumen along a guide wire inserted therein; an extension tube connected to the distal portion end of the multi-lumen tube, extending longitudinally and having a guide wire inserted therein; a shock wave generating unit spaced apart from the distal portion end of the multi-lumen tube and provided on the outer circumference of the extension tube, comprising an electrode to generate a shock wave; and a balloon portion inflatably provided between the multi-lumen tube and the shock wave generating unit.

Description

Technology Field

[0001] The present invention relates to a catheter system inserted into a body lumen to treat lesions. Background Technology

[0002] Catheters are inserted into the body lumen and used to treat lesions.

[0003] Examples of body lumens include the internal spaces of blood vessels (arteries, veins, capillaries), the digestive tract (esophagus, etc.), the respiratory tract (bronchial tubes, etc.), and the genitourinary tract (ureters, etc.).

[0004] To treat vascular diseases such as occlusive lesions (CTO) or columnar calcified lesions, the catheter may include a shock wave generator capable of rupturing intravascular calcified lesions.

[0005] Shock wave generators may also be used to treat kidney stones in the ureter.

[0006] Shock wave generators are classified into those that generate shock waves propagating in the forward direction and those that generate shock waves propagating in the radial direction.

[0007] A system for generating a shock wave that propagates in a forward direction is disclosed in U.S. Patent No. 10,966,737, U.S. Publication No. 2019 / 0388110, and U.S. Publication No. 2015 / 0320432.

[0008] A system for generating anteriorly propagating shock waves delivers the shock waves in an anterior direction (e.g., from the distal end of a catheter to the distal end) to fragment and open occluded lesions.

[0009] A system for generating a shock wave that propagates in a radial direction is disclosed in U.S. Patent No. 8,888,788.

[0010] A conventional catheter comprising both a shock wave generator for crushing calcified lesions and a balloon for expanding and treating the lesion area is disclosed in International Patent No. 2024 / 049814 (see Prior Art 1, Figs. 1, 2, and 3).

[0011] The catheter disclosed in prior art 1 is a multi-modality catheter (10) for treating calcified lesions.

[0012] The catheter disclosed in prior art 1 includes a catheter body (20), an intravascular lithotripsy (IVL) balloon (12), and a second treatment balloon (14).

[0013] The catheter body (20) is inserted into the blood vessel along the guide wire (GW).

[0014] An intravascular lithotripsy (IVL) balloon (12) is attached to the distal end of a catheter body (20).

[0015] The second treatment balloon (14) is spaced proximally from the intravascular lithotripsy (IVL) balloon (12) along the longitudinal direction of the catheter body (20) and is connected to the distal part of the catheter body (20).

[0016] The endovascular lithotripsy balloon (12) and the second treatment balloon (14) can be inflated independently.

[0017] The catheter body (20) includes a lithotripsy expansion lumen (36), a therapeutic expansion lumen (56), a guidewire lumen (21), and an electrical conductor lumen (51).

[0018] The lithotripsy expansion lumen (36) is inflated by supplying fluid to the endovascular lithotripsy balloon (12).

[0019] The treatment expansion lumen (56) supplies fluid to the second treatment balloon to inflate it.

[0020] The guide wire lumen (21) accommodates the guide wire (GW), and the electric conductor lumen (51) accommodates the electric conductor (44, 46).

[0021] The proximal part of the catheter body (20) is connected to the coupler (60).

[0022] A control handle (64) is connected to the coupler (60) to transmit power to the catheter body (20) and to control the operation of the catheter body (20).

[0023] The control handle (64) is connected to an electric power source (43).

[0024] The coupler (60) includes a first port (66) configured to connect a fluid source (34) in communication with the lithotripsy expansion lumen (36) of the catheter body (20), a second port (68) configured to connect a fluid source (54) in communication with the therapeutic expansion lumen (56), and a third port (70) in communication with the guidewire lumen (21).

[0025] The endovascular lithotripsy balloon (12) includes a balloon body (30) and a shock wave generator (32).

[0026] The shock wave generator (32) includes an electrode. When electrical energy is applied to the electrode, it generates an electric arc to generate a shock wave in the fluid inside the balloon body (30).

[0027] The shock wave generator (32) includes two pairs of first and second electrodes, but may include more or fewer electrodes.

[0028] The first and second electrodes are electrically connected to a power source (43) (high voltage generator) through first and second electric conductors (44, 46) (wires or cables).

[0029] The first and second electrical conductors (44, 46) extend along the catheter body (20) within the electrical conductor lumen (51) of the catheter body (20).

[0030] The electric conductors (44, 46) are insulated, and the first electrode is electrically connected to the negative terminal of the power source (43), and the second electrode is electrically connected to the positive terminal of the power source (43).

[0031] Voltage pulses applied to the first and second electrodes from the power source (43) generate an electric arc between the electrodes within the balloon body (30).

[0032] An electric arc in the fluid inside the balloon body (30) generates a shock wave in the fluid. As the shock wave passes through the fluid and the balloon body (30) and propagates to the calcified lesion, the calcified lesion can be crushed.

[0033] The electric arc vaporizes the fluid inside the balloon body (30) to create bubbles, and a shock wave is generated as a result of the expansion and contraction of these bubbles.

[0034] The shock wave spreads along the blood vessel wall, causing cracks and fragmentation in calcified lesions (calcium) while preserving soft tissue.

[0035] The endovascular lithotripsy balloon (12) crushes the calcified lesion to secure an entry route.

[0036] After securing the entry route, the secondary treatment balloon (14) can enter the lesion site and expand the lesion area and treat the lesion.

[0037] The secondary treatment balloon (14) is designed as a drug-coated balloon (DCB), so that the surface of the balloon body (50) is coated with a therapeutic agent for treating lesions.

[0038] The balloon body (50) can be inflated to deliver the therapeutic agent coated on its surface to the lesion.

[0039] However, the conventional endovascular lithotripsy balloon (12) and secondary treatment balloon (14) are placed and connected around the catheter body (20). Therefore, the area where the endovascular lithotripsy balloon (12) and secondary treatment balloon (14) are placed has the disadvantage of being larger in thickness than the area where the endovascular lithotripsy balloon (12) and secondary treatment balloon (14) are not placed, even when the balloons are not inflated.

[0040] In the case of the endovascular lithotripsy balloon (12), there are types that generate shock waves without including a balloon (e.g., anterior shock wave generator).

[0041] However, the use of a secondary treatment balloon (14) to expand the lesion area inevitably causes the catheter to become thicker, which hinders the catheter's mobility through winding and narrow passages. Prior art literature

[0042] Prior Art 1: International Patent No. 2024 / 049814 The problem to be solved

[0043] The present invention was devised to solve the aforementioned problems and relates to a catheter system capable of minimizing the increase in catheter thickness caused by a balloon portion.

[0044] In addition, the invention relates to a catheter system comprising a multi-lumen tube capable of rapidly supplying fluid for balloon expansion while maintaining structural stability.

[0045] In addition, this invention relates to a catheter system that integrates the functions of lesion fragmentation within the body lumen through a shock wave emission section and therapeutic drug delivery through a balloon section. means of solving the problem

[0046] The catheter system of the present invention comprises: a multi-lumen tube movably inserted into a body lumen along a guide wire inserted therein; an extension tube connected to the distal portion end of the multi-lumen tube, extending longitudinally, and having the guide wire inserted therein; a shock wave generating part spaced apart from the distal portion end of the multi-lumen tube and provided on the outer circumference of the extension tube, including an electrode to generate a shock wave; and a balloon part inflatably provided between the multi-lumen tube and the shock wave generating part. It includes, and inside the multi-lumen tube, a guide wire passage (lumen) in which the guide wire is inserted and which communicates with the extension tube, a fluid passage (lumen) in which fluid is injected to inflate the balloon portion and flows, and a wire passage (lumen) in which a wire is inserted to supply power to the electrode are formed, and the extension tube is formed with a smaller diameter than the multi-lumen tube, and the proximal side of the extension tube is inserted into the guide wire passage and fixed to the distal end of the multi-lumen tube, and the balloon portion can be inflated and deflated on the outer circumference of the extension tube.

[0047] In addition, in the case of the multi-lumen tube in which the guide wire of 0.018 inches is used, the fluid passage occupies an area ranging from 11% to 21% of the total area of ​​the multi-lumen tube in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, and in the case of the multi-lumen tube in which the guide wire of 0.035 inches is used, the fluid passage occupies an area ranging from 9% to 17% of the total area of ​​the multi-lumen tube in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube.

[0048] Additionally, in the case of the multi-lumen tube using the guide wire of 0.018 inches, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the internal width of the region where the internal width in the radial (r1) direction is maximum in the fluid passage is in the range of 0.17 to 0.26 times the diameter of the multi-lumen tube, and the width of the fluid passage in the direction orthogonal to the radial (r1) direction is in the range of 0.66 to 0.86 times the diameter of the multi-lumen tube; and in the case of the multi-lumen tube using the guide wire of 0.035 inches, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the internal width of the region where the internal width in the radial (r2) direction is maximum in the fluid passage is in the range of 0.15 to 0.23 times the diameter of the multi-lumen tube, and the width of the fluid passage in the direction orthogonal to the radial (r2) direction is relative to the diameter of the multi-lumen tube The range is from 0.75 to 0.9 times.

[0049] In addition, the guide wire passage, the fluid passage, and the wire passage are formed to be spaced at least 0.1 mm apart from the outer surface of the multi-lumen tube, and the guide wire passage, the fluid passage, and the wire passage are formed to be spaced at least 0.1 mm apart from each other.

[0050] Additionally, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the fluid passage is crescent-shaped, wrapping around one side of the guide wire passage or the wire passage.

[0051] Additionally, it further includes an outer cover that surrounds the outer circumference of the distal portion of the extension tube; the shock wave generating part is positioned between the outer cover and the extension tube, and a conductive fluid is filled between the outer cover and the extension tube.

[0052] In addition, the balloon portion connects the outer cover and the multi-lumen tube.

[0053] In addition, the outer surface of the balloon portion is coated with a drug to be delivered to a lesion in the body. Effects of the invention

[0054] According to the present invention, the following effects are achieved.

[0055] The increase in the thickness of the catheter caused by the balloon portion can be minimized, making it easy for the catheter to enter and move into narrow and curved passages of the body (narrow blood vessels, areas between calcified lesions, etc.).

[0056] In addition, by forming fluid passages in an optimal ratio within the multi-lumen tube, it rapidly supplies fluid for the inflation of the balloon section while possessing structural stability capable of withstanding the pressure resulting from fluid flow.

[0057] Furthermore, since it generates shock waves from the conductive fluid filled between the outer cover and the extension tube to fragment lesions (such as calcified lesions) within the body lumen, it is structurally simpler and allows for shorter procedure times compared to systems that circulate conductive fluid. The reduction in procedure time also has the effect of decreasing the radiation exposure received by the patient due to X-ray imaging during the procedure.

[0058] In addition, the lesion fragmentation by shock waves can be followed by the expansion of the lesion area and the delivery of therapeutic drugs through the balloon section, making the procedure convenient and shortening the procedure time. Brief explanation of the drawing

[0059] FIGS. 1 to 3 are drawings illustrating a conventional catheter system. FIG. 4 is a drawing showing a catheter system according to a preferred embodiment of the present invention. FIG. 5 is a drawing showing the distal region of the catheter system. Figure 6 is a cross-sectional view of a multi-lumen tube. Figures 7 and 8 are drawings showing the procedure for an intravascular lesion. Specific details for implementing the invention

[0060] Preferred embodiments of the present invention will be described in detail with reference to the attached drawings, provided that technical details that are already well known will be omitted or compressed for the sake of brevity.

[0061] As illustrated in FIGS. 4 to 6, a catheter system (100) according to a preferred embodiment of the present invention comprises a multi-lumen tube (110), an extension tube (120), an outer cover (130), a shock wave generating unit (150), a balloon unit (140), a connecting hub (160), a connecting cable (170), a control handle (172), a power source (180), and a fluid supply source (190).

[0062] A multi-lumen tube (110) is movably inserted into the body lumen along a guide wire (GW) inserted inside.

[0063] The extension tube (120) is connected to the distal portion of the multi-lumen tube (110) and extends longitudinally, with a guide wire (GW) inserted inside.

[0064] The shock wave generating part (150) is provided on the outer circumference of the extension tube (120) spaced apart from the distal portion end of the multi-lumen tube (110).

[0065] The shock wave generating unit (150) generates a shock wave including an electrode (152).

[0066] The balloon portion (140) is provided to be expandable between the multi-lumen tube (110) and the shock wave generating portion (150).

[0067] An outer cover (130) is provided on the distal outer circumference of the extension tube (120), and a shock wave generating part (150) is disposed between the outer cover (130) and the extension tube (120).

[0068] A connecting hub (160) is connected to the proximal portion of the multi-lumen tube (110).

[0069] A fluid supply source (190) for supplying or recovering fluid to inflate the balloon part (140) and a connecting cable (170) are connected to the connecting hub (160).

[0070] The fluid supply source (190) is equipped with an indeflator and can precisely inflate or deflate the balloon portion (140) through the fluid.

[0071] The connecting cable (170) is connected to a power source (180, voltage generator) for power supply.

[0072] The connecting cable (170) serves to transmit power to the wire (175) connected to the electrode (152) of the shock wave generating part (150).

[0073] The power source (180) consists of a power source body and a user interface (touchscreen) and is responsible for the transmission of electrical energy and the control of the number of pulses.

[0074] When treating lesions within the body cavity, the doctor can select the desired number of pulses via the user interface (touchscreen).

[0075] The user interface (touchscreen) can display the operating status of the catheter system in real time.

[0076] The connecting cable (170) can transmit a low-energy high-voltage pulse signal instead of a high frequency or continuous current.

[0077] The connecting cable (170) is equipped with a control handle (172) for controlling power transmission.

[0078] Multiple ports (162, 164, 166) included in the connection hub (160) will be described later.

[0079] The catheter system (100) of the present invention may refer to the area from the outer cover (130) to the multi-lumen tube (110) as the catheter. The connection hub (160) and the components connected to the connection hub (160) (connection cable (170), power source (180), fluid supply source (190), etc.) may refer to the support system section.

[0080] Examples of internal spaces in which the catheter system (100) is used include blood vessels (arteries, veins, capillaries), digestive tract (esophagus, etc.), respiratory organs (bronchial tubes, etc.) and genitourinary organs (ureters, etc.).

[0081] In this embodiment, for the sake of brevity of explanation, the description is based on a catheter system (100) that is inserted into a blood vessel to crush and treat calcified lesions, but is not limited thereto.

[0082] The multi-lumen tube (110) can be formed from a polymer material that is flexible and easily bendable.

[0083] The multi-lumen tube (110) is formed to extend longitudinally from a proximal portion connected to a connecting hub (160) to a distal portion inserted into a body lumen (inside a blood vessel) and moved to a lesion site.

[0084] Inside the multi-lumen tube (110), a guide wire passage (113)(lumen), a fluid passage (111)(lumen), and a wire passage (115)(lumen) are formed.

[0085] The guide wire passage (113) (lumen) is connected to the extension tube (120) and the guide wire (GW) is inserted therein.

[0086] The fluid passage (111)(lumen) is injected with fluid to inflate the balloon portion (140) and flows.

[0087] A wire (175) for supplying power to the electrode (152) is inserted into the wire passage (115) (lumen).

[0088] The guide wire passage (113), fluid passage (111), and wire passage (115) are formed by penetrating longitudinally from the distal to the proximal part of the multi-lumen tube (110).

[0089] The present invention is an OTW (Over-The-Wire) type catheter system (100). A guide wire passage (113) is formed along the entire length of a multi-lumen tube (110) so that a guide wire (GW) can be inserted.

[0090] The proximal part of the multi-lumen tube (110) is inserted into the connecting hub (160).

[0091] The connection hub (160) includes a guide wire port (164) communicating with a guide wire passage (113) of a multi-lumen tube (110), a fluid port (162) communicating with a fluid passage (111), and a power port (166) communicating with a wire passage (115).

[0092] The guide wire port (164) functions as an exit for the guide wire (GW).

[0093] A fluid supply source (190) is connected to the fluid port (162), and a connecting cable (170) is connected to the power port (166).

[0094] The connecting cable (170) is electrically connected to the wire (175) placed inside the wire passage (115).

[0095] When viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110) (see FIG. 6), the guide wire passage (113) and the wire passage (115) are circular spaces, and the fluid passage (111) is a crescent (or banana) shaped space.

[0096] When viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110) (see FIG. 6), the guide wire passage (113) is formed near the center of the multi-lumen tube (110). The fluid passage (111) is formed spaced apart from one side of the guide wire passage (113), and the wire passage (115) is formed spaced apart from the other side of the guide wire passage (113).

[0097] The fluid passage (111) is formed in a crescent shape that surrounds one side of the guide wire passage (113) or the wire passage (115). FIG. 6 illustrates the shape in which the fluid passage (111) surrounds one side of the guide wire passage (113).

[0098] The guide wire passage (113), fluid passage (111), and wire passage (115) are formed so as to be spaced radially at least 0.1 mm apart from the outer surface of the multi-lumen tube (110). Additionally, the guide wire passage (113), fluid passage (111), and wire passage (115) are formed so as to be spaced at least 0.1 mm apart from each other. Through this, sufficient structural stability can be ensured for the multi-lumen tube (110).

[0099] If the fluid passage (111) through which fluid is supplied for the expansion of the balloon portion (140) is formed within 0.1 mm of the outer surface of the multi-lumen tube (110) or within 0.1 mm of the guide wire passage (113) (or wire passage (115)), there is a risk that it will not withstand the pressure due to fluid flow and will be damaged.

[0100] Accordingly, in the present invention, the multi-lumen tube (110) forms the fluid passage (111) at an optimal ratio so as to secure the size (volume, spatial area) of the fluid passage (111) to rapidly supply fluid for the expansion of the balloon portion (140) through the fluid passage (111), while also having structural stability to withstand the pressure resulting from the fluid supply.

[0101] In the present invention, the guide wire passage (113), fluid passage (111), and wire passage (115) are spaced apart by at least 0.1 mm from the outer surface of the multi-lumen tube (110), and the guide wire passage (113), fluid passage (111), and wire passage (115) are spaced apart by at least 0.1 mm from each other, and the fluid passage (111) is formed to be as large as possible.

[0102] The size range of the fluid passage (111) is shown below.

[0103] In an OTW type catheter system (100) such as the present invention, a guide wire (GW) with a diameter of 0.018 inches or 0.035 inches may be used.

[0105] A multi-lumen tube (110) using a <0.018 inch (inch) guide wire (GW)>

[0106] In the case of a multi-lumen tube (110) using a 0.018 inch guide wire (GW), the diameter (d1) is 4.5 Fr (1.5 mm).

[0107] When viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110), the internal width (d2) of the region where the internal width in the radial (r1) direction (radial direction of the multi-lumen tube (110)) is maximum in the fluid passage (111) is formed in a range of 0.17 to 0.26 times (about 0.25 mm to 0.4 mm) relative to the diameter (d1) of the multi-lumen tube (110).

[0108] The width (d3) of the fluid passage (111) in a direction orthogonal to the radius (r1) direction is formed in a range of 0.66 to 0.86 times (about 1 mm to 1.3 mm) relative to the diameter (d1) of the multi-lumen tube (110).

[0109] Accordingly, in the case of a multi-lumen tube (110) in which a 0.018-inch guide wire (GW) is used, in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110), the fluid passage (111) has an area (approximately 0.194 mm) in the range of 11% to 21% of the total area (total area of ​​the cross-section) of the multi-lumen tube (110). 2Up to 0.379mm 2 It is formed to occupy ).

[0111] A multi-lumen tube (110) using a <0.035 inch (inch) guide wire (GW)>

[0112] In the case of a multi-lumen tube (110) in which a 0.035 inch guide wire (GW) is used, the diameter (d1) is 6 Fr (2.0 mm).

[0113] When viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110), the internal width (d2) of the region where the internal width in the radial direction (r2) (radial direction of the multi-lumen tube (110)) is maximum in the fluid passage (111) is formed in a range of 0.15 to 0.23 times (about 0.30 mm to 0.46 mm) relative to the diameter (d1) of the multi-lumen tube (110).

[0114] The width (d3) of the fluid passage (111) in a direction orthogonal to the radius (r2) direction is formed in a range of 0.75 to 0.9 times (about 1.5 mm to 1.8 mm) relative to the diameter (d1) of the multi-lumen tube (110).

[0115] Accordingly, in the case of a multi-lumen tube (110) in which a 0.035-inch guide wire (GW) is used, in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube (110), the fluid passage (111) has an area (approximately 0.295 mm) in the range of 9% to 17% of the total area (total area of ​​the cross-section) of the multi-lumen tube (110). 2 Up to 0.545mm 2 It is formed to occupy ).

[0117] As shown in FIG. 4, an extension tube (120) is inserted and connected to the guide wire passage (113) at the distal end of the multi-lumen tube (110). The proximal side of the extension tube (120) is inserted into the guide wire passage (113) and fixedly connected.

[0118] The extension tube (120) is formed to extend to the distal end of the catheter (catheter system (100)).

[0119] The extension tube (120) is a hollow tube made of a flexible material.

[0120] An extension tube (120) has a guide wire (GW) inserted from the distal side and is connected to the guide wire passage (113) of a multi-lumen tube (110) from the proximal side.

[0121] The guide wire (GW) can pass through the extension tube (120) and enter the guide wire passage (113) of the multi-lumen tube (110).

[0122] A plurality of markers (122) are attached to the outer circumference of the extension tube (120). The markers (122) are placed inside the balloon portion (140).

[0123] The marker (122) is made of a radiation-opaque material and is intended to facilitate the identification of the location of the balloon part (140).

[0124] The outer cover (130) covers the outer circumference of the distal portion of the extension tube (120).

[0125] The distal side of the outer cover (130) is formed at an angle and connected to the distal end of the extension tube (120).

[0126] The distal side of the outer cover (130) can be formed in the shape of a reducer cone.

[0127] A conductive fluid is filled between the outer cover (130) and the extension tube (120), and a shock wave generating part (150) that generates a shock wave is positioned.

[0128] The space between the outer cover (130) and the extension tube (120), and the space inside the balloon section (140) are separated from each other by a barrier wall (135).

[0129] The space between the outer cover (130) and the extension tube (120) is formed as a space independent of the internal space of the balloon part (140) and can be filled with a conductive fluid.

[0130] The conductive fluid may consist of a contrast agent or a mixture of a contrast agent and physiological saline.

[0131] The present invention generates shock waves from a conductive fluid filled between an outer cover (130) and an extension tube (120) to crush lesions (such as calcified lesions) within the body cavity. Therefore, there is no need to provide a separate recovery passage (a discharge passage for discharging fluid outside the body) to circulate the conductive fluid between the outer cover (130) and the extension tube (120), making the structure simple. Additionally, the fluid circulation step is omitted, allowing for a reduction in procedure time. As the procedure time is shortened, the amount of radiation exposure received by the patient (the person receiving the procedure) due to X-ray imaging during the procedure is also reduced.

[0132] A barrier wall (135) is provided on the outer circumference of the extension tube (120) and its outer circumference is connected to the proximal end of the outer cover (130).

[0133] The wires (175) (+ pole wire and - pole wire) that are inserted into the wire passage (115) to supply power can pass through the barrier wall (135) and be connected to the electrode (152) of the shock wave generating part (150).

[0134] The two wires (175) connected to the electrode (152) of the shock wave generating unit (150) are insulated.

[0135] The wire (175) is installed inside the balloon section (140) so as to be in close contact with the outer surface of the extension tube (120) by means of a shrink tube (not shown). The wire (175) extends to the electrode (152) of the shock wave generating section (150).

[0136] The shock wave generating unit (150) includes an electrode (152) (which may include a pair of (+) electrodes and (-) electrodes).

[0137] The shock wave generating unit (150) generates an electric arc in the conductive fluid (contrast agent) inside the outer cover (130) when electric energy (power) is transmitted to the electrode (152) through the wire (175).

[0138] An electric arc generates shock waves within a conductive fluid. An electric arc creates bubbles in the conductive fluid, and shock waves can be generated as a result of the expansion and contraction of these bubbles.

[0139] The shock wave passes through the conductive fluid and the outer cover (130) and propagates to the calcified lesion, so that the calcified lesion can be crushed.

[0140] The shock wave spreads along the blood vessel wall, causing cracks and fragmentation in calcified lesions (calcium) while preserving soft tissue.

[0141] As another example, shock waves may be used to treat kidney stones in the ureter.

[0142] Since the catheter system (100) is not limited to use in blood vessels, it can also be inserted and used in other body lumens (esophagus, trachea, ureter, etc.).

[0143] The shock wave generating unit (150) of the present invention preferably generates a shock wave that propagates in the forward direction (the distal direction of the shock wave generating unit (150)).

[0144] As technology for generating shock waves that propagate in a forward direction is disclosed in U.S. Patent No. 10,966,737, U.S. Publication No. 2019 / 0388110, and U.S. Publication No. 2015 / 0320432, please refer to these, and further explanation will be omitted here.

[0145] Referring to FIG. 5, a balloon part (140) is provided between the multi-lumen tube (110) and the outer cover (130) and connects the multi-lumen tube (110) and the outer cover (130).

[0146] The balloon part (140) can be formed of a flexible polymer material.

[0147] The distal side of the balloon portion (140) is connected by heat joining to the outer circumference of the outer cover (130), and the proximal side of the balloon portion (140) is connected by heat joining to the outer circumference of the multi-lumen tube (110).

[0148] An extension tube (120) is placed inside the balloon section (140).

[0149] The internal space of the balloon section (140) is connected to the fluid passage (111) of the multi-lumen tube (110).

[0150] A fluid (contrast agent) for inflating the balloon portion (140) is delivered into the interior of the balloon portion (140) through the fluid passage (111).

[0151] To inflate the balloon section (140), the fluid inside the balloon section (140) can be recovered through the fluid passage (111).

[0152] In the present invention, an outer cover (130) and a multi-lumen tube (110) are spaced apart from each other along the longitudinal direction of the catheter, and an extension tube (120) having a diameter (outer diameter) smaller than that of the multi-lumen tube (110) is disposed between them. The outer diameter of the extension tube (120) may be formed to be approximately the same as or slightly smaller than the inner diameter of the guide wire passage (113).

[0153] Accordingly, as illustrated in FIG. 5(a), the area between the distal side of the balloon portion (140) that is joined to the outer circumference of the outer cover (130) and the proximal side that is joined to the outer circumference of the multi-lumen tube (110) can be positioned so as to be spaced apart from the extension tube (120) even when not expanded (in a contracted state) so as to be parallel to the outer surface of the multi-lumen tube (110). Therefore, the balloon portion (140) of the present invention can be contracted to have a circumference equal to or smaller than the outer circumference of the multi-lumen tube (110) when moving through the body lumen (e.g., inside a blood vessel), making it easy to enter and move through narrow and curved passages of the body (e.g., areas between calcified lesions within a blood vessel).

[0154] On the other hand, in the prior art such as the aforementioned prior art document 1 (International Patent No. 2024 / 049814), a multi-lumen tube is placed inside a balloon portion (secondary treatment balloon) so that the balloon portion (secondary treatment balloon) wraps around the outer circumference of the multi-lumen tube. Therefore, it is not easy to contract the balloon portion (140) to be equal to the outer circumference of the multi-lumen tube (110) even when it is contracted (in a non-inflated state), and there was a limitation in that it could only move while having a circumference larger than the outer circumference of the multi-lumen tube (110).

[0155] The present invention can minimize the increase in the thickness of the catheter due to the balloon portion (140), making it easy for the catheter to enter and move into narrow and curved passages of the body (narrow blood vessels, areas between calcified lesions, etc.).

[0156] As illustrated in FIG. 5(b), the balloon portion (140) can be inflated when filled with fluid. The expansion of the balloon portion (140) can expand the inside of the blood vessel (body lumen).

[0157] The outer surface of the balloon portion (140) is coated with a drug (therapeutic agent) to be delivered to a lesion in the body lumen (e.g., a calcified lesion within a blood vessel). That is, the balloon portion (140) of the present invention is formed as a drug-coated balloon (DCB).

[0158] The coated drug (therapeutic agent) may include antiproliferative agents, anti-inflammatory agents, anticancer agents, antiplatelet agents, anticoagulants, antifibrinolytic agents, antithrombotic agents, antimitotic agents, antibiotics, anti-allergic agents, and antioxidants.

[0159] The balloon portion (140) enters between the lesions fragmented by the shock wave generating portion (150) and expands to widen the inside of the blood vessel (body lumen). Additionally, the balloon portion (140) is effective in reducing the risk of restenosis (re-occlusion) of the lesion site by delivering a drug coated on its surface to the lesion for treatment.

[0160] Referring to Figures 7 and 8, a method for treating intravascular lesions will be explained.

[0161] As illustrated in FIG. 7, the catheter (the portion extending from the outer cover (130) to the multilumen tube (110)) enters the blood vessel (BV) along the guidewire (GW) and moves to the location of the lesion (CTO) (the occluded lesion (CTO) is illustrated in FIG. 7).

[0162] When the catheter approaches the lesion (CTO), an electric arc is generated through the electrode (152) of the shock wave generating unit (150) to generate a shock wave in the conductive fluid inside the outer cover (130).

[0163] The shock wave is emitted and extends obliquely in the forward direction (distal direction) of the outer cover (130).

[0164] The shock wave causes a crack in the lesion (CTO) and fragments it, thereby securing an entry path for the catheter.

[0165] After that, when the catheter is advanced further through the secured entryway and the balloon portion (140) is advanced to a position between the lesions (CTO), the space of the lesion area can be expanded by inflating the balloon portion (140) as shown in FIG. 8.

[0166] When the balloon portion (140) is inflated, the drug (therapeutic agent) on the surface of the balloon portion (140) can be delivered to the lesion (CTO) to treat the lesion (CTO).

[0167] After the procedure on the intravascular lesion is finished, the balloon portion (140) can be deflated and the catheter can be retrieved from the blood vessel (BV) (body lumen).

[0168] As described above, the present invention allows for the continuous expansion of the lesion area and delivery of therapeutic drugs through the balloon portion (140) following the lesion fragmentation (fragmentation of calcified lesions) by shock waves, making the procedure convenient and shortening the procedure time.

[0169] In this embodiment, treatment for intravascular occlusive lesions was described, but it is not limited thereto and can also be used to treat lesions that are not occlusive.

[0170] The present invention may be particularly preferred for peripheral blood vessels, but can be easily used not only in blood vessels but also in other body lumens such as ureters.

[0171] As described above, the specific description of the present invention has been made through embodiments with reference to the attached drawings, but since the above-described embodiments are merely preferred examples of the present invention, the present invention should not be understood as being limited only to the above-described embodiments, and the scope of the rights of the present invention should be understood as the claims set forth below and their equivalents. Explanation of the symbols

[0172] 100: Catheter System 110: Multi-lumen tube 111: Fluid passage 113: Guidewire passage 115: Wire passage 120: Extension tube 122: Marker 130: Outer cover 135: Barrier wall 140: Balloon Club 150: Shock wave generator 152: Electrode 160: Connection Hub 162: Fluid Port 164: Guidewire port 166: Power port 170: Connection cable 172: Control handle 175: Frontline 180: Power source (voltage generator) 190: Fluid supply source GW: Guidewire CTO: Lesion BV: Blood vessel

Claims

Claim 1 A multi-lumen tube movably inserted into a body lumen along a guide wire inserted inside; an extension tube connected to the distal portion end of the multi-lumen tube, extending longitudinally and having the guide wire inserted inside; a shock wave generating part spaced apart from the distal portion end of the multi-lumen tube and provided on the outer circumference of the extension tube, including an electrode to generate a shock wave; and a balloon part provided to be expandable between the multi-lumen tube and the shock wave generating part. A catheter system comprising: a guide wire passage (lumen) in which the guide wire is inserted and which communicates with the extension tube, a fluid passage (lumen) in which fluid is injected to inflate the balloon portion and flows, and a wire passage (lumen) in which a wire is inserted to supply power to the electrode, wherein the extension tube is formed with a diameter smaller than that of the multi-lumen tube, the proximal side of the extension tube is inserted into the guide wire passage and fixed to the distal end of the multi-lumen tube, and the balloon portion can be inflated and deflated on the outer circumference of the extension tube. Claim 2 A catheter system according to claim 1, wherein in the case of the multi-lumen tube using the guide wire of 0.018 inches, the fluid passage occupies an area ranging from 11% to 21% of the total area of ​​the multi-lumen tube in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, and in the case of the multi-lumen tube using the guide wire of 0.035 inches, the fluid passage occupies an area ranging from 9% to 17% of the total area of ​​the multi-lumen tube in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube. Claim 3 In claim 1, for the multi-lumen tube using the guide wire of 0.018 inches, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the internal width of the region where the internal width in the radial (r1) direction is maximum in the fluid passage is in the range of 0.17 to 0.26 times the diameter of the multi-lumen tube, and the width of the fluid passage in the direction orthogonal to the radial (r1) direction is in the range of 0.66 to 0.86 times the diameter of the multi-lumen tube; and for the multi-lumen tube using the guide wire of 0.035 inches, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the internal width of the region where the internal width in the radial (r2) direction is maximum in the fluid passage is in the range of 0.15 to 0.23 times the diameter of the multi-lumen tube, and the width of the fluid passage in the direction orthogonal to the radial (r2) direction is relative to the diameter of the multi-lumen tube A catheter system in the range of 0.75 to 0.9 times. Claim 4 A catheter system according to claim 2 or 3, wherein the guide wire passage, the fluid passage, and the wire passage are formed to be spaced apart by at least 0.1 mm from the outer surface of the multi-lumen tube, and the guide wire passage, the fluid passage, and the wire passage are formed to be spaced apart by at least 0.1 mm from each other. Claim 5 In paragraph 4, the catheter system is such that, when viewed in a cross-section orthogonal to the longitudinal direction of the multi-lumen tube, the fluid passage is crescent-shaped and surrounds one side of the guide wire passage or the wire passage. Claim 6 A catheter system according to claim 1, further comprising an outer cover surrounding the outer circumference of the distal portion of the extension tube, wherein the shock wave generating part is disposed between the outer cover and the extension tube, and a conductive fluid is filled between the outer cover and the extension tube. Claim 7 In claim 6, the balloon portion is a catheter system connecting the outer cover and the multi-lumen tube. Claim 8 A catheter system according to claim 7, wherein the outer surface of the balloon portion is coated with a drug to be delivered to a lesion in the body.

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