Electrode-movable shockwave balloon catheter and medical device

Abstract

The application provides an electrode movable shock wave balloon catheter and medical equipment, which comprises a balloon, an outer tube, an electrode assembly, an insulated wire, a transmission tube and a catheter interface, the balloon is located at the distal end of the outer tube, the electrode assembly is located in the balloon, the insulated wire is used for transmitting pulse energy to the electrode assembly, the catheter interface is used for charging the balloon with liquid, the distal end of the transmission tube is connected with the electrode assembly through the outer tube, and the proximal end of the transmission tube is connected with a driving mechanism at the catheter interface to realize equipment driving or manual control of the electrode assembly in the balloon to rotate circumferentially or translate axially, so that the problem of uneven distribution of shock wave intensity in the circumferential direction and the axial direction is solved, and effective treatment can be formed on the calcified part.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an electrode-movable shock wave balloon catheter and a medical device. BACKGROUND

[0002] The working principle of intravascular lithotripsy (IVL) is that the built-in electrode instantaneously gasifies and quickly liquefies the conductive solution in the balloon, the gas bubble expands and bursts to generate mechanical acoustic pressure waves at the treatment site, which crushes the superficial and deep calcified plaque in the blood vessel lumen, so as to achieve the purpose of significantly improving the compliance of the blood vessel.

[0003] In clinical use, when the intravascular ultrasound indicates grade IV, the range of annular calcification is more than 270°, or the optical coherence tomography indicates that the angle of annular calcification is more than 180°, that is, the calcification score reaches 4 points, the IVL balloon catheter intervention treatment can be the preferred method. However, the common IVL balloon catheter on the market can only release shock waves in a fixed direction each time, and due to the limitation of the electrode structure, the pressure waves generated by each pulse in the balloon cannot completely and uniformly cover the calcification range in the axial and circumferential directions, so the catheter position needs to be moved multiple times to increase the shock wave coverage range for treatment. This will greatly increase the operation time and affect the treatment efficiency, and at the same time, this manual position-finding operation cannot guarantee that each shot has a sufficient treatment effect on the calcification site.

[0004] Therefore, the present application is proposed. SUMMARY

[0005] The present application provides an electrode-movable shock wave balloon catheter and a medical device to solve at least one of the above technical problems.

[0006] An electrode-movable shock wave balloon catheter, comprising a balloon, an outer tube, an electrode assembly, an insulated wire, a transmission tube, and a catheter interface, the balloon is located at the distal end of the outer tube, the electrode assembly is located in the balloon, the insulated wire is used to transmit pulse energy to the electrode assembly, the catheter interface is used to charge the balloon with liquid, the distal end of the transmission tube passes through the outer tube and is connected with the electrode assembly, and the proximal end of the transmission tube extends to at least the catheter interface for connection with a driving mechanism.

[0007] Preferably, the driving mechanism is arranged at the catheter interface position, the other end of the transmission tube is connected with the driving mechanism, and the driving mechanism is used to drive the rotation and / or axial translation of the transmission tube.

[0008] Preferably, the catheter interface has a pressurizing interface; the driving mechanism has a moving tip matched with the catheter interface, the moving tip comprises a tube base, a needle base fixedly connected with the tube base, and a needle located in the needle base; the insulated wire is fixedly connected with the transmission tube, the transmission tube is fixedly connected with the tube base, and the insulated wire is connected with the needle.

[0009] Preferably, the transmission tube comprises a spring tube and a connecting piece, the connecting piece is located at one end of the spring tube close to the balloon, and the electrode assembly is installed on the connecting piece.

[0010] Preferably, the connecting piece is made of insulating material or an insulating layer is arranged between the electrode assembly and the connecting piece.

[0011] Preferably, the distal end of the balloon is provided with a tip tube, the tip tube is provided with a guide wire cavity, and a guide wire outlet and a guide wire inlet are located at both ends of the guide wire cavity.

[0012] Preferably, a guide wire is arranged outside the balloon, the distal end of the guide wire is connected with the tip tube, the proximal end of the guide wire is connected with the outer tube, and a developing ring is arranged on the guide wire.

[0013] Preferably, the application further comprises a pushing tube, the pushing tube is connected with the proximal end of the outer tube, and the transmission tube is located in the pushing tube.

[0014] Preferably, the electrode assembly comprises an outer electrode ring, an inner electrode, and an insulating tube, the insulating tube is sleeved outside the inner electrode, the outer electrode ring is sleeved outside the insulating tube, through grooves are arranged on both sides of the insulating tube and spaced from the edges of the outer electrode ring, and both ends of the inner electrode extend to below the through grooves.

[0015] The application further provides a medical device, which comprises the shock wave balloon catheter and a device host, the device host is provided with a high-voltage pulse output module for providing pulse energy for the shock wave balloon catheter.

[0016] The electrode movable shock wave balloon catheter of the application is connected with the electrode assembly and the transmission tube, the proximal end of the transmission tube extends to the catheter interface, and the electrode assembly is controlled to rotate and axially translate in the balloon by being connected with a device outside the catheter or being manually controlled, so as to solve the problem of uneven distribution of shock wave intensity in the circumferential direction and the axial direction, and to effectively treat calcified parts.

[0017] Further, the guide wire cavity of the catheter is arranged outside the tip tube, so that the guide wire cavity is not needed inside the balloon, the connection difficulty of the electrode assembly and the transmission tube is reduced, the internal structure of the balloon is simplified, the manufacturing is simpler, and the through size of the balloon catheter is further reduced. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is a structural schematic diagram of an electrode movable shock wave balloon catheter of the present application;

[0019] Figure 2 is a structural schematic diagram of a distal electrode part of Figure 1 ;

[0020] Figure 3 is a structural schematic diagram of a moving tip of Figure 1 ;

[0021] Figure 4 is an enlarged structural schematic diagram of A part of Figure 2 ;

[0022] Figure 5 is a balloon and catheter part cross-sectional structural schematic diagram of an embodiment of the present application;

[0023] Figure 6 is an enlarged structural schematic diagram of B part of Figure 5 ;

[0024] Figure 7 is a balloon and catheter part cross-sectional structural schematic diagram of other embodiments of the present application.

[0025] Reference signs:

[0026] 1, balloon; 11, guide wire; 12, developing ring;

[0027] 2, outer tube; 21, push tube;

[0028] 3, electrode assembly; 31, outer electrode ring; 32, inner electrode; 33, insulating tube; 331, through slot; 34, insulating wire;

[0029] 4, catheter interface; 42, pressure charging interface; 43, interface housing; 431, radial limiting slot; 432, axial limiting slot.

[0030] 5, driving mechanism; 52, moving tip; 521, tube seat; 522, needle seat; 523, insertion needle; 524, limiting block;

[0031] 6, spring tube; 61, metal wire; 63, insulating tube;

[0032] 7, tip tube; 71, guide wire cavity; 72, guide wire inlet; 73, guide wire outlet;

[0033] 8, inner tube; 81, spring assembly; guide wire X. DETAILED DESCRIPTION

[0034] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some but not all of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0035] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specified.

[0036] The specific embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0037] Please refer to Figures 1 to 6 An electrode-movable shock wave balloon catheter, comprising a balloon 1, an outer tube 2, an electrode assembly 3, an insulated wire 34, a transmission tube and a catheter interface 4.

[0038] The balloon 1 is located at the distal end of the outer tube 2, the electrode assembly 3 is located inside the balloon 1, the insulated wire 34 is used to transmit pulse energy to the electrode assembly 3, and the catheter interface 4 is used to charge the balloon 1 with liquid. The balloon 1 and the outer tube 2 can be filled with liquid, such as a mixed solution of contrast agent and physiological saline, etc., and a closed space is formed inside the balloon 1. The electrode assembly 3 generates a liquid-electric effect in the balloon 1, thereby generating a shock wave.

[0039] The distal end of the transmission tube is connected with the electrode assembly 3 through the outer tube 2, so that the electrode assembly 3 can move synchronously with the transmission tube; the proximal end of the transmission tube extends at least to the catheter interface 4 for connection with the driving mechanism, so as to be controlled by the driving mechanism to move, which can be single rotation or single axial translation; preferably, both rotation and axial translation are possible. Thus, the electrode assembly 3 can be controlled by the device to rotate or axially translate in the balloon 1 by the driving mechanism outside the catheter, so as to solve the problem of uneven distribution of shock wave intensity in the circumferential and axial directions, and to form effective treatment on calcified parts.

[0040] The connection between the transmission tube and the electrode assembly 3 can be interference fastening, welding, gluing or other fixed connection, as long as the electrode assembly 3 can move synchronously with the transmission tube.

[0041] The driving mechanism can be installed in the catheter interface or outside the catheter interface, and can be connected with the transmission tube directly or indirectly to control the movement of the transmission tube.

[0042] In the embodiment, the catheter interface 4 is provided with a driving mechanism 5, the proximal end of the transmission tube is connected with the driving mechanism 5, and the driving mechanism 5 is used to drive the rotation and axial translation of the transmission tube. The driving mechanism 5 is used to control the movement of the transmission tube, and the circumferential direction and axial position of the electrode can be continuously adjusted during use, so that the circumferential electrode assembly 3 can uniformly emit shock waves in the balloon 1. In other embodiments, the driving mechanism 5 is only used to drive the rotation of the transmission tube without axial translation, or the driving mechanism 5 is only used to drive the axial translation of the transmission tube without rotation.

[0043] The transmission tube and the driving mechanism 5 can be directly connected or indirectly connected, as long as the driving mechanism 5 can drive the transmission tube to move synchronously.

[0044] Please refer to Figure 1 and Figure 3 In the embodiment, one side of the catheter interface 4 is provided with a pressure charging interface 42, which is used to charge liquid into the balloon through the outer tube 2 and the push tube 21 at the proximal end of the outer tube 2; the catheter interface 4 is fixed with the outer tube 2 and the push tube 21, so as not to rotate relative to the balloon 1.

[0045] The driving mechanism 5 comprises a fixed base and a moving end head 52; the fixed base is fixedly connected with the catheter interface 4, and the moving end head 52 is matched in the catheter interface 4; the moving end head 52 comprises a tube seat 51, a needle seat 522 fixedly connected with the tube seat 51, and an insertion needle 523 located in the needle seat 522; the insulated wire 34 is fixedly connected with the transmission pipe, the transmission pipe is fixedly nested in the tube seat 521, and the insulated wire 34 synchronously passes through the tube seat 52 into the needle seat 522 area and is electrically connected with the insertion needle 523, so that the insulated wire 34 is connected with the host through the insertion needle 523. In the embodiment, the insulated wire 34 is limited in the spring pipe 6.

[0046] The tube seat 51 and the needle seat 522 can be directly fixed or indirectly fixed, and the insulated wire 34 can be fixed in the inner cavity of the transmission pipe or the outer wall of the transmission pipe, which is selected according to actual needs and is not limited here.

[0047] Therefore, the driving mechanism 5 can drive the needle seat 522 of the moving end head 52 to synchronously move the tube seat 51, the insertion needle 523, the insulated wire 34 and the transmission pipe, while the outer tube 2 connected with the pressure charging interface 42 remains relatively static, and the moving end head 52 can rotate and axially translate relative to the fixed base.

[0048] In the embodiment, the pressure charging interface 42 and the interface shell 43 of the catheter interface 4 are integrated, the moving end head 52 of the driving mechanism 5 and the interface shell 43 have a rotation and translation limiting structure, which comprises a limiting groove located in the interface shell 43 and a limiting block 524 located on the driving moving end head 52; the limiting block 524 prevents the moving end head 52 from excessively moving relative to the interface shell 43. For details, please refer to Figure 2 The limiting groove comprises a radial limiting groove 41 and an axial limiting groove 432; the limiting groove can allow the moving end head 52 to rotate and axially translate relative to the interface shell 43, and can prevent the moving end head 52 from excessively moving relative to the interface shell 43.

[0049] In the embodiment, the proximal end of the outer tube 2 is connected with a push tube 21, and the transmission pipe is located in the push tube 21. The outer tube 2 can be a single-layer plastic pipe material, such as any one of PET, PEBAX, PA, PE and PU, and the push tube 21 can be a stainless steel hypotube or other plastic pipe material, such as any one of PET, PEBAX, PA, PE and PU.

[0050] Please refer to Figure 7 In other preferred embodiments, the transmission pipe can adopt a distal end of an inner tube 8 connected with a spring assembly 81, and then connected with the electrode assembly 3.

[0051] In the embodiment, the transmission tube comprises a spring tube 6 and a connecting piece, the connecting piece is located at one end of the spring tube 6 close to the balloon 1, and the electrode assembly 3 is installed on the connecting piece. The spring tube 6 itself has flexibility that can bend with the blood vessel, and has flexibility that the initial section of the spring tube 6 drives the end to move, as the main part of the transmission tube, it can improve the transmission quality and is suitable for the application scene of the shock wave balloon catheter. The connecting piece is located at the end of the spring tube 6, which is convenient for the installation of the electrode assembly 3. The electrode assembly 3 needs to be insulated from the spring tube 6, so the connecting piece can be made of insulating material, and an insulating layer is arranged between the electrode assembly and the connecting piece.

[0052] In other embodiments, the connecting piece can be a connecting tube fixedly connected to the end of the spring tube 6 by welding, interference fit or other processes, and the connecting tube can also be made of insulating material to facilitate installation between the electrode assembly 3.

[0053] Preferably, the connecting piece is a metal wire 61 extending out from the spring tube 6 towards one end of the balloon 1, and an insulating piece is arranged between the electrode assembly 3 and the metal wire 61. The integrated structure of the extending metal wire 61 and the spring tube 6 is more stable. In the embodiment, the metal wire 61 is sleeved with an insulating tube 63, and the electrode assembly 3 is installed on the insulating tube 63.

[0054] Please refer to Figure 6 In the embodiment, the balloon 1 is provided with a sharp tube 7 away from one end of the outer tube 2, the sharp tube 7 is provided with a guide wire cavity 71, and a guide wire X outlet 73 and a guide wire inlet 72 are arranged at both ends of the guide wire cavity 71.

[0055] By arranging the guide wire cavity 71 outside the sharp tube 7, the balloon 1 does not need the guide wire cavity 71 inside, which reduces the connection difficulty of the electrode assembly 3 and the transmission tube, simplifies the internal structure of the balloon 1, and makes the manufacturing more simple, and further reduces the through size of the balloon catheter.

[0056] Further, the balloon 1 is provided with a guide wire 11, one end of the guide wire 11 is connected to the sharp tube 7, the other end of the guide wire 11 is connected to the outer tube 2, and a developing ring 12 is arranged on the guide wire 11. Thus, the structure inside the balloon 1 is further simplified, and the movement of the electrode assembly 3 is facilitated.

[0057] Please refer to Figure 4 In the embodiment, the electrode assembly 3 comprises an outer electrode ring 31, an inner electrode 32 and an insulating tube 33, the insulating tube 33 is sleeved outside the inner electrode 32, the outer electrode ring 31 is sleeved outside the insulating tube 33, the insulating tube 33 is provided with a through slot 331 at both side edges of the outer electrode ring 31, and both ends of the inner electrode 32 extend to below the through slot 331.

[0058] In the embodiment, the through slot 331 is symmetrical in the circumferential direction of the insulating tube 33, that is, two through slots 331 are formed in the same circumferential direction of the insulating tube 33, facilitating the emission of shock waves in two directions, which is matched with the limiting structure in the embodiment.

[0059] In other embodiments, one or more through slots 331 can be formed in the circumferential direction of the insulating tube 33, which needs to be matched with the rotation angle of the rotary driving mechanism 5 to ensure that 360° uniform shock waves can be emitted.

[0060] The inner electrode 32 can be a single-layer or double-layer metal sheet, which can be made of stainless steel or other metal materials. The inner electrode 32 is welded, bonded or crimped on the insulating wire 34.

[0061] In the embodiment, the inner electrode 32 can be a single-layer metal sheet. The insulating tube 33 is sleeved on the outer side of the single-layer metal sheet as an intermediate isolation layer. The insulating tube 33 can wrap one end of the inner electrode 32 connected to the cable. The outer electrode ring 31 is a metal tube, which can be made of stainless steel or other metal materials. The outer electrode ring 31 is sleeved on the outer side of the intermediate isolation insulating tube 33. The insulating tube 33 separates the inner and outer electrodes by a small distance, which is in the range of 0.01-0.1 mm. The inner electrode 32, the insulating tube 33 and the outer electrode ring 31 are radially stacked. The through slot 331 is formed by slotting the insulating tube 33 at a distance of 0.1-0.5 mm from the edges of the outer electrode ring 31. The slot shape is a rectangular hole, and the size range is: length 0.1-0.5 mm; width 0.1-0.5 mm. Through the through slot 331, the metal sheet of the inner electrode 32 below can be leaked, thereby forming a double-sided fixed breakdown point. The inner electrode 32 is connected to two insulating wires 34, and the outer surface of the insulating wire 34 has an insulating layer.

[0062] The insulating wire 34 extends in the axial direction of the catheter to the proximal end of the whole catheter and is connected to the shock wave host in the pressurized cavity. When the liquid fills the balloon 1 through the pressurized cavity, the host applies a high voltage of 100-10000v, and the inner electrode 32 connected by the first insulating wire 34 and the outer electrode ring 31 and the inner electrode 32 connected by the second insulating wire 34 and the outer electrode ring 31 occur breakdown at the double-sided through slot 331, that is, liquid electricity effect, thereby generating a shock wave.

[0063] In addition, the application also provides a medical device, which comprises the shock wave balloon catheter and the device host as described above. The device host is provided with a high-voltage pulse output module for providing pulse energy for the shock wave balloon catheter.

[0064] The above are only preferred embodiments of the present application, and the protection scope of the present application is not limited to the above-mentioned embodiments, and any technical scheme falling within the concept of the present application shall fall within the protection scope of the present application.

Claims

1. A shockwave balloon catheter with movable electrodes, characterized in that, The device includes a balloon, an outer tube, an electrode assembly, an insulated wire, a transmission tube, and a catheter interface. The balloon is located at the distal end of the outer tube, the electrode assembly is located inside the balloon, the insulated wire is used to transmit pulse energy to the electrode assembly, the catheter interface is used to pressurize the balloon with liquid, the distal end of the transmission tube passes through the outer tube and connects to the electrode assembly, and the proximal end of the transmission tube extends at least to the catheter interface for connection with a drive mechanism. A drive mechanism is provided at the catheter interface, and the proximal end of the transmission tube is connected to the drive mechanism. The drive mechanism is used to drive the transmission tube to rotate and / or translate axially. The catheter interface has a pressurization port. The drive mechanism has a movable end that drives and engages within the catheter interface. The movable end includes a tube seat, a needle seat fixedly connected to the tube seat, and a needle located within the fixed needle seat. The insulated wire is fixedly connected to the transmission tube, the transmission tube is fixedly connected to the tube seat, and the insulated wire is connected to the needle.

2. The shockwave balloon catheter with movable electrodes according to claim 1, characterized in that, The transmission tube includes a spring tube and a connector. The connector is located at one end of the spring tube near the balloon, and the electrode assembly is mounted on the connector.

3. The shockwave balloon catheter with movable electrodes according to claim 2, characterized in that, The connector is made of insulating material or an insulating layer is provided between the electrode assembly and the connector.

4. The shockwave balloon catheter with movable electrodes according to claim 1, characterized in that, The distal end of the balloon is provided with a tip tube, which has a guidewire lumen, and guidewire outlets and inlets located at both ends of the guidewire lumen.

5. The electrode-movable shockwave balloon catheter according to claim 4, characterized in that, The balloon is provided with a guide wire on its outer side. The distal end of the guide wire is connected to the tip tube, and the proximal end of the guide wire is connected to the outer tube. The guide wire is provided with a radiopaque ring.

6. The shockwave balloon catheter with movable electrodes according to claim 1, characterized in that, It also includes a push tube, which is connected to the proximal end of the outer tube, and the transmission tube is located inside the push tube.

7. The shockwave balloon catheter with movable electrodes according to claim 1, characterized in that, The electrode assembly includes an outer electrode ring, an inner electrode, and an insulating tube. The insulating tube is sleeved on the outside of the inner electrode, and the outer electrode ring is sleeved on the outside of the insulating tube. The insulating tube has through grooves at intervals on both sides of the outer electrode ring, and the two ends of the inner electrode extend below the through grooves.

8. A medical device, characterized in that, The device includes the shockwave balloon catheter as described in any one of claims 1 to 7 and the device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy to the shockwave balloon catheter.

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