Shock wave balloon catheter with movable electrode and medical equipment

Abstract

The invention provides a shock wave balloon catheter with a movable electrode and a medical device.The shock wave balloon catheter comprises a balloon, an outer tube, an electrode assembly, an insulated wire, a transmission tube and a catheter connector, the balloon is located at the far 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, and the transmission tube is used for transmitting the pulse energy to the electrode assembly; the catheter connector is used for pressurizing the balloon with liquid, the far end of the transmission tube penetrates through the outer tube to be connected with the electrode assembly, and the near end of the transmission tube extends to the catheter connector to be connected with a driving mechanism, so that equipment driving or manual control over circumferential rotation or axial translation of the electrode assembly in the balloon is achieved. The method is used for solving the problem that the shock wave intensity is not uniformly distributed in the circumferential direction and the axial direction, and effective treatment can be formed on a calcified part.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a shock wave balloon catheter with movable electrodes and medical equipment. Background Art

[0002] The working principle of intravascular shock wave lithotripsy (IVL) is that the built-in electrodes instantly vaporize and quickly liquefy the conductive solution in the balloon. The bubble expands and explodes to generate mechanical acoustic pressure waves at the treatment site, breaking up the superficial and deep calcified plaques in the blood vessel lumen, allowing the blood vessel lumen to fully expand, thereby achieving the purpose of significantly improving vascular compliance.

[0003] In clinical use, when intravascular ultrasound indicates grade IV, the range of annular calcification exceeds 270°, or optical coherence tomography indicates that the angle of annular calcification exceeds 180°, that is, when the calcification score reaches 4 points, IVL balloon catheter interventional treatment can be the preferred method. However, the IVL balloon catheters currently on the market can only release shock waves in a fixed direction each time they are fired. Due to the limitations of the electrode structure, the pressure waves generated by each pulse firing in the balloon cannot completely and evenly cover the calcification range in the axial and circumferential directions. The catheter position needs to be moved multiple times to increase the shock wave coverage range for treatment, which will greatly increase the operation time and affect the treatment efficiency. At the same time, this operation that requires manual location search still cannot guarantee that each firing will have a sufficient therapeutic effect on the calcified area.

[0004] In view of this, this application is filed. Summary of the invention

[0005] The present invention provides a shock wave balloon catheter with movable electrodes and a medical device to solve at least one of the above technical problems.

[0006] A shock wave balloon catheter with movable electrodes comprises a balloon, an outer tube, an electrode assembly, an insulated wire, a transmission tube and a catheter interface, wherein 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 liquid into the balloon, the distal end of the transmission tube passes through the outer tube and is connected 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.

[0007] Preferably, a driving mechanism is provided at the catheter interface position, and the other end of the transmission tube is connected to the driving mechanism, and the driving mechanism is used to drive the transmission tube to rotate and / or translate axially.

[0008] Preferably, the catheter interface has a charging interface; the driving mechanism has a movable terminal that movably cooperates with the catheter interface, the movable terminal includes a tube seat, a needle seat fixedly connected to the tube seat, and a pin located in the 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 pin.

[0009] Preferably, the transmission tube includes 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 mounted on the connecting piece.

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

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

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

[0013] Preferably, it further comprises a pushing tube, wherein the pushing tube is connected to the proximal end of the outer tube, and the transmission tube is located inside the pushing tube.

[0014] Preferably, 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, the outer electrode ring is sleeved on the outside of the insulating tube, the insulating tube is provided with through grooves at both side edges of the outer electrode ring, and both ends of the inner electrode extend to below the through grooves.

[0015] The present application also provides a medical device, comprising the shock wave balloon catheter as described above and a device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy for the shock wave balloon catheter.

[0016] The shock wave balloon catheter with movable electrodes of the present invention is connected by setting an electrode assembly and a transmission tube, the proximal end of the transmission tube extends to the catheter interface, and is connected to a device outside the catheter or manually to control the rotation and axial translation of the electrode assembly in the balloon, so as to solve the problem of uneven circumferential and axial distribution of shock wave intensity, and can effectively treat calcified areas.

[0017] Furthermore, the guidewire cavity of the catheter is externally disposed on the tip tube, so that no guidewire cavity is required inside the balloon, which reduces the difficulty of connecting the electrode assembly and the transmission tube, simplifies the internal structure of the balloon, makes manufacturing easier, and also further reduces the pass size of the balloon catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic structural diagram of a shock wave balloon catheter with movable electrodes according to the present invention;

[0019] Figure 2 yes Figure 1 A schematic diagram of the structure of the distal electrode portion;

[0020] Figure 3 yes Figure 1 A schematic diagram of the structure of a mobile terminal;

[0021] Figure 4 yes Figure 2 A schematic diagram of the enlarged structure of part A;

[0022] Figure 5 is a schematic diagram of the cross-sectional structure of the balloon and catheter parts of an embodiment of the present invention;

[0023] Figure 6 yes Figure 5 A schematic diagram of the enlarged structure of part B;

[0024] Figure 7 It is a schematic diagram of the cross-sectional structure of the balloon and catheter parts of other embodiments of the present invention.

[0025] Reference numerals:

[0026] 1. Balloon; 11. Guide wire; 12. Development ring;

[0027] 2. Outer tube; 21. Push tube;

[0028] 3. Electrode assembly; 31. Outer electrode ring; 32. Inner electrode; 33. Insulation tube; 331. Through slot; 34. Insulated wire;

[0029] 4. Catheter interface; 42. Pressurization interface; 43. Interface housing; 431. Radial limiting groove; 432. Axial limiting groove.

[0030] 5. driving mechanism; 52. moving end; 521. tube seat; 522. needle seat; 523. insertion pin; 524. limit block;

[0031] 6. Spring tube; 61. Metal wire; 63. Insulation tube;

[0032] 7. Tip tube; 71. Guidewire cavity; 72. Guidewire inlet; 73. Guidewire outlet;

[0033] 8. Inner tube; 81. Spring assembly; Guide wire X. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present invention.

[0035] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicating orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0036] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0037] Please refer to Figures 1 to 6 A shock wave balloon catheter with movable electrodes comprises 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 pressurize the balloon 1 with liquid. The space between 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 inside the balloon 1, thereby generating a shock wave.

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

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

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

[0042] In this embodiment, a driving mechanism 5 is provided at the position of the catheter interface 4, and the proximal end of the transmission tube is connected to the driving mechanism 5, and the driving mechanism 5 is used to drive the transmission tube to rotate and translate axially. 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 emit shock waves uniformly in the balloon 1. In other embodiments, the driving mechanism 5 is only used to drive the transmission tube to rotate without axial translation, or the driving mechanism 5 is only used to drive the transmission tube to translate axially without rotation.

[0043] The transmission tube and the driving mechanism 5 may 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 this embodiment, a charging interface 42 is provided on one side of the catheter interface 4, and the charging interface is used to pressurize 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 to the outer tube 2 and the push tube 21 so as not to rotate relative to the balloon 1.

[0045] The driving mechanism 5 includes a fixed base and a movable terminal 52; the fixed base is fixedly connected and matched with the catheter interface 4, and the movable terminal 52 is matched in the catheter interface 4; the movable terminal 52 includes a tube seat 51, a needle seat 522 fixedly connected to the tube seat 51, and a pin 523 located in the pin seat 522; the insulated wire 34 is fixedly connected with the transmission tube, and the transmission tube is fixedly nested in the tube seat 521, and the insulated wire 34 synchronously passes through the tube seat 52 and enters the needle seat 522 area, and is electrically connected with the pin 523, so that the insulated wire 34 is connected to the host through the pin 523. In this embodiment, the insulated wire 34 is limited in the spring tube 6.

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

[0047] Thus, the driving mechanism 5 can drive the needle seat 522 of the movable terminal 52 to drive the tube seat 51, the pin 523, the insulated wire 34 and the transmission tube to move synchronously, while the outer tube 2 connected to the charging interface 42 remains relatively stationary, and the movable terminal 52 can rotate and axially translate relative to the fixed base.

[0048] In this embodiment, the charging interface 42 and the interface housing 43 of the catheter interface 4 are integrated, and the movable end 52 of the driving mechanism 5 and the interface housing 43 have a rotation and translation limit structure, which includes a limit groove located on the interface housing 43 and a limit block 524 located on the driving movable end 52; prevent the movable end 52 from excessively moving relative to the interface housing 43. For details, please refer to Figure 2 The limiting grooves include radial limiting grooves 41 and axial limiting grooves 432; they can allow the movable terminal 52 to rotate and translate axially relative to the interface housing 43, and can prevent the movable terminal 52 from excessively moving relative to the interface housing 43.

[0049] In this embodiment, the proximal end of the outer tube 2 is connected to a push tube 21, and the transmission tube is located in the push tube 21. The outer tube 2 can be a single-layer plastic tube, 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 tubes such as any one of PET, PEBAX, PA, PE and PU.

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

[0051] In this embodiment, the transmission tube includes a spring tube 6 and a connector, the connector is located at one end of the spring tube 6 close to the balloon 1, and the electrode assembly 3 is installed on the connector. The spring tube 6 itself has the flexibility to bend with the blood vessel, and the initial section of the spring tube 6 has the flexibility to drive the end to move. As the main part of the transmission tube, it can improve the transmission quality and is suitable for the application scenario of the shock wave balloon catheter. The connector is located at the end of the spring tube 6 to facilitate the installation of the electrode assembly 3. The electrode assembly 3 needs to be insulated from the spring tube 6, so the connector can be made of an insulating material, and an insulating layer is provided between the electrode assembly and the connector.

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

[0053] Preferably, the connecting member is a metal wire 61 extending from the spring tube 6 toward one end of the balloon 1, an insulating member is provided between the electrode assembly 3 and the metal wire 61, and the integral structure of the extended metal wire 61 and the spring tube 6 is more stable. In this embodiment, the metal wire 61 is provided with an insulating tube 63, and the electrode assembly 3 is mounted on the insulating tube 63.

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

[0055] By placing the guidewire cavity 71 outside the tip tube 7, the guidewire cavity 71 is not required inside the balloon 1, which reduces the difficulty of connecting the electrode assembly 3 and the transmission tube, simplifies the internal structure of the balloon 1, makes manufacturing easier, and further reduces the passing size of the balloon catheter.

[0056] Furthermore, a lead wire 11 is provided outside the balloon 1, one end of the lead wire 11 is connected to the tip tube 7, the other end of the lead wire 11 is connected to the outer tube 2, and a developing ring 12 is provided on the lead wire 11. This further simplifies the structure inside the balloon 1 and facilitates the movement of the electrode assembly 3.

[0057] Please refer to Figure 4 In this embodiment, the electrode assembly 3 includes an outer electrode ring 31, an inner electrode 32 and an insulating tube 33. The insulating tube 33 is sleeved on the outside of the inner electrode 32, and the outer electrode ring 31 is sleeved on the outside of the insulating tube 33. The insulating tube 33 is provided with through grooves 331 at the two side edges of the outer electrode ring 31, and the two ends of the inner electrode 32 extend to the bottom of the through grooves 331.

[0058] In this embodiment, the through groove 331 is symmetrical in the circumferential direction of the insulating tube 33, that is, two through grooves 331 are provided in the same circumferential direction of the insulating tube 33, so as to facilitate the emission of shock waves in two directions, which is compatible with the limiting structure in this embodiment.

[0059] In other embodiments, one or more through grooves 331 may be provided in the circumferential direction of the insulating tube 33 , but they need to be compatible with the rotation angle of the rotary drive mechanism 5 to ensure that 360° uniform emission of shock waves can be obtained.

[0060] The inner electrode 32 may be a single-layer or double-layer metal sheet, and the material may be stainless steel or other metal materials. The metal sheet of the inner electrode 32 is welded, bonded or crimped onto the insulated wire 34 .

[0061] In this embodiment, the inner electrode 32 can be a single-layer metal sheet, and the insulating tube 33 is sleeved on the outer side of the single-layer metal sheet as an intermediate isolation layer sleeve. 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 ranging from 0.01 to 0.1 mm. The inner electrode 32, the insulating tube 33, and the outer electrode ring 31 are stacked radially. A slot is made on the insulating tube 33 at a certain distance from the edges of both sides of the outer electrode ring 31 to form a through slot 331 with a distance range of 0.1 to 0.5 mm. The slot shape is a rectangular hole slot with a size range of: length 0.1 to 0.5 mm; width 0.1 to 0.5 mm. The metal sheet of the inner electrode 32 below can leak out through the through slot 331, thereby forming a fixed breakdown point on both sides. The inner electrode 32 is connected to two insulated wires 34, and the outer surface of the insulated wires 34 has an insulating layer.

[0062] The insulated wire 34 extends in the charging chamber along the axial direction of the catheter to the proximal end of the entire catheter and is connected to the shock wave host. When the liquid fills the balloon 1 through the charging chamber and the host applies a high voltage of 100-10000V, breakdown occurs at the double-sided through grooves 331 between the inner electrode 32 connected by the first insulated wire 34 and the outer electrode ring 31, as well as between the inner electrode 32 and the outer electrode ring 31 connected by the second insulated wire 34, i.e., a liquid-electric effect, thereby generating a shock wave.

[0063] In addition, the present application also provides a medical device, including the shock wave balloon catheter as described above and a device host, wherein 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 implementations of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention.

Claims

1. A shock wave balloon catheter with movable electrodes, characterized in that: It 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 is connected to the electrode assembly, and the proximal end of the transmission tube extends at least to the catheter interface for connection with a driving mechanism.

2. The shock wave balloon catheter with movable electrodes according to claim 1, characterized in that: A driving mechanism is provided at the catheter interface position, and the proximal end of the transmission tube is connected to the driving mechanism, and the driving mechanism is used to drive the transmission tube to rotate and / or translate axially.

3. The shock wave balloon catheter with movable electrodes according to claim 2, characterized in that: The catheter interface has a charging interface; the driving mechanism has a movable terminal that drives and cooperates with the catheter interface, and the movable terminal includes a tube seat, a needle seat fixedly connected to the tube seat, and a pin located in the 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 pin.

4. The shock wave balloon catheter with movable electrode according to claim 1, characterized in that: The transmission tube includes 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.

5. The shock wave balloon catheter with movable electrode according to claim 3, characterized in that: The connecting member is made of insulating material or an insulating layer is provided between the electrode assembly and the connecting member.

6. The shock wave balloon catheter with movable electrodes according to claim 1, characterized in that: The distal end of the balloon is provided with a tip tube, and the tip tube is provided with a guidewire cavity, and a guidewire outlet and a guidewire inlet located at two ends of the guidewire cavity.

7. The shock wave balloon catheter with movable electrodes according to claim 6, characterized in that: A guide wire is arranged outside the balloon, the distal end of the guide wire is connected to the tip tube, the proximal end of the guide wire is connected to the outer tube, and a developing ring is arranged on the guide wire.

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

9. The shock wave 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 is provided with through grooves at both side edges of the outer electrode ring, and both ends of the inner electrode extend to below the through grooves.

10. A device comprising the shock wave balloon catheter according to any one of claims 1 to 9 and a device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy for the shock wave balloon catheter.

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