Shock wave balloon catheter with backflow device and medical equipment

Abstract

The invention provides a shock wave balloon catheter with a backflow device and medical equipment. The shock wave balloon catheter comprises a balloon, a catheter body, a fluid pump and a pressure reducing valve, and a shock wave generating part is arranged in the balloon; the balloon is arranged at the far end of the catheter, a pressurizing flow channel and a backflow flow channel are arranged in the catheter, the pressurizing flow channel is used for supplying conductive liquid to the interior of the balloon, and the backflow flow channel is used for recycling the conductive liquid from the interior of the balloon; the outlet end of the fluid pump is communicated with the pressurizing flow channel so as to provide conductive liquid with certain pressure for the balloon; the inlet end of the pressure reducing valve is communicated with the backflow flow channel to maintain the pressure of the conductive liquid in the balloon, and the outlet end of the pressure reducing valve is communicated with the inlet end of the fluid pump, so that bubbles formed by liquid precipitation and electrolysis in the percussion process of an electrode in the balloon are timely discharged from the balloon through the backflow flow channel; bubbles are prevented from hindering shock waves from acting on calcification lesions, and the effective performance of the shock waves is improved.

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 a reflux device and medical equipment. Background Art

[0002] The working principle of intravascular shock wave lithotripsy (IVL) is that the built-in electrode instantly vaporizes and quickly liquefies the conductive liquid in the balloon, and the bubble expands and explodes to generate mechanical shock 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] The conductive liquid in the IVL catheter provides the ions needed to generate the arc, which helps the shock wave to be transmitted to the blood vessel wall. Clinical data show that during the transmission process of the shock wave, if there is air bubble filling, its impact energy will decrease by about 20%, and even by about 40% in the calcified fracture zone. However, during the use of the IVL device, the gas in the conductive liquid in the balloon is precipitated under the action of the shock wave to form bubbles, and the bubbles are attached to the inner wall of the balloon or suspended in the conductive liquid, which will seriously hinder the transmission of the shock wave. The current clinical solution is to use an extracorporeal fluid pressure pump to extract the conductive solution inside the balloon after a certain number of firings to empty the gas in the balloon, then refill the balloon, and repeat this step continuously. This will greatly increase the operation time and affect the treatment efficiency.

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

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

[0006] A shock wave balloon catheter with a reflux device comprises a balloon, a catheter, a fluid pump and a pressure reducing valve, wherein a shock wave generating part is arranged in the balloon; the balloon is arranged at the distal end of the catheter, and a pressurizing flow channel and a reflux flow channel are arranged in the catheter, wherein the pressurizing flow channel is used to supply a conductive liquid to the interior of the balloon, and the reflux flow channel is used to recover the conductive liquid from the interior of the balloon; the outlet end of the fluid pump is connected with the pressurizing flow channel to provide the balloon with a conductive liquid with a certain pressure; the inlet end of the pressure reducing valve is connected with the reflux flow channel to maintain the pressure of the conductive liquid in the balloon, and the outlet end of the pressure reducing valve is connected with the inlet end of the fluid pump.

[0007] Preferably, the shock wave generating part comprises a guidewire lumen and at least one pair of electrodes located outside the guidewire lumen; the electrodes are connected to a wire from inside a catheter.

[0008] Preferably, the outer tube of the catheter is a pressure-filled lumen, the pressure-filled lumen is in communication with the balloon and is sealed with the peripheral wall of the balloon; and the pressure-filled flow channel is located in the pressure-filled lumen.

[0009] Preferably, a reflux lumen is provided in the inflation lumen, the reflux lumen extends to the interior of the balloon, and the reflux channel is located in the reflux lumen.

[0010] Preferably, the liquid inlet of the reflux cavity is located between the inlet of the balloon and the middle of the balloon.

[0011] Preferably, a main joint is provided at the proximal end of the catheter, and the main joint includes a wire connection interface, a catheter charging interface and a reflux interface.

[0012] Preferably, the outer tube of the catheter has a liquid-filled lumen and a reflux lumen.

[0013] Preferably, it also includes a bubble eliminator, which is connected between the fluid pump and the pressure reducing valve, and is an ultrasonic bubble eliminator.

[0014] Preferably, the conductive liquid supplied by the pressurized flow channel to the interior of the balloon is a mixed liquid of degassed physiological saline and contrast agent.

[0015] The present application also provides a medical device, comprising the shock wave balloon catheter with a reflux device 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, and the device host is provided with a liquid chamber for storing a conductive liquid, the liquid chamber is connected to the inlet end of the fluid pump, and the outlet end of the pressure reducing valve is connected to the liquid chamber.

[0016] The shock wave balloon catheter with a reflux device of the present invention is provided with a reflux flow channel and a pressure reducing valve for maintaining the pressure of the conductive liquid inside the balloon, so that the gas precipitated by the conductive liquid in the balloon under the action of the shock wave is discharged from the balloon in time through the reflux flow channel, thereby preventing bubbles from hindering the shock wave from acting on the calcified lesions and improving the effective performance of the shock wave. Compared with the traditional operation, that is, using an extracorporeal fluid pressure pump to extract the conductive liquid inside the balloon after a certain number of firings to discharge the air and then refill the balloon, the operation time is greatly saved.

[0017] Furthermore, the conductive liquid supplied by the pressurized flow channel to the interior of the balloon is a mixed liquid of degassed physiological saline and contrast agent, which can further reduce the generation of bubbles during the firing process. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a structural schematic diagram of a shock wave balloon catheter with a reflux device of the present invention;

[0019] Figure 2 yes Figure 1 Schematic diagram of the cross-sectional structure of the balloon and catheter parts;

[0020] Figure 3 yes Figure 1 Schematic diagram of the cross-sectional structure of the balloon;

[0021] Figure 4 yes Figure 1 Schematic diagram of the cross-sectional structure of the catheter;

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

[0023] Figure 6 It is a schematic diagram of the cross-sectional structure of a catheter according to another embodiment of the present invention.

[0024] Reference numerals:

[0025] 1. Balloon; 11. Guidewire lumen; 12. Electrode; 2. Catheter; 21. Pressurization lumen; 22. Reflux lumen; 23. Guide wire; 24. Liquid-filled lumen; 3. Main joint; 31. Guide wire connection interface; 32. Catheter pressurization interface; 33. Reflux interface. DETAILED DESCRIPTION

[0026] 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.

[0027] 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 directions or positional relationships are based on the directions or positional relationships shown in the accompanying 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 direction, be constructed and operated in a specific direction, 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.

[0028] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0029] Please refer to Figures 1 to 4 A shock wave balloon 1 and a catheter 2 with a reflux device include a balloon 1, a catheter 2, a fluid pump and a pressure reducing valve.

[0030] A shock wave generating unit is provided inside the balloon 1, which is used to instantly gasify and quickly liquefy the conductive liquid inside the balloon 1. The bubbles expand and burst to generate mechanical shock waves at the treatment site, breaking up the superficial and deep calcified plaques in the blood vessel cavity.

[0031] The balloon 1 is arranged at the distal end of the catheter 2, and a charging channel and a reflux channel are provided in the catheter 2. The charging channel is used to supply conductive liquid to the inside of the balloon 1, and the reflux channel is used to recover conductive liquid from the inside of the balloon 1; the raw material of the conductive liquid is mainly or entirely a mixed solution of physiological saline and contrast agent.

[0032] The outlet end of the fluid pump is connected to the pressurized flow channel to provide the balloon 1 with a conductive liquid with a certain pressure; the inlet end of the pressure reducing valve is connected to the reflux flow channel to maintain the pressure of the conductive liquid in the balloon 1.

[0033] The outlet end of the pressure reducing valve is connected with the inlet end of the fluid pump, so that the conductive liquid can circulate continuously inside the balloon 1. The connection referred to in this article can refer to direct connection or connection through other equipment. It is only necessary that the liquid at the outlet end of the pressure reducing valve can eventually flow to the fluid pump. For example, in indirect connection, there is a liquid storage chamber and other structures between the pressure reducing valve and the fluid pump.

[0034] The present invention provides a reflux flow channel and a pressure reducing valve for maintaining the pressure of the conductive liquid inside the balloon 1 so that the balloon 1 catheter 2 can continuously discharge the bubbles accumulated in the balloon 1 through the reflux flow channel through internal circulation during use, thereby reducing the impact of the bubbles on the shock wave transmitted to the blood vessel wall and improving the treatment efficiency. Compared with the traditional method of using an extracorporeal fluid pressure pump to extract the conductive liquid inside the balloon 1 after a certain number of firings to discharge the air and then refilling the balloon 1, it greatly saves operation time.

[0035] In addition, the heat generated during the operation of the shock wave generating part can be dissipated in time through the reflux circulation of the conductive liquid, thereby preventing the conductive liquid from overheating and affecting the expansion performance of the balloon 1, and preventing blood vessel burns, thereby improving the safety performance of the catheter 2.

[0036] In other embodiments, a large-capacity liquid storage chamber can be provided, so that in one operation, only a fluid pump is required to extract the conductive liquid from the liquid storage chamber without forming a circulation. The bubbles formed by the precipitation and electrolysis of the conductive liquid during the firing process of the electrode 12 can be discharged from the balloon 1 in a timely manner, thereby preventing the bubbles from affecting the shock wave acting on the calcified lesion and improving the effective performance of the shock wave.

[0037] Please refer to Figure 3 The shock wave generating part includes a guidewire lumen 11 and at least one pair of electrodes 12 located outside the guidewire lumen 11; the electrodes 12 are connected to the wire 23 from the catheter 2. The guidewire lumen 11 passes through both ends of the balloon 1 and is used to cooperate with the guidewire traction; in this embodiment, the electrode 12 includes an inner electrode, an outer electrode and an insulating tube located between the inner and outer electrodes; the wire 23 can be an insulated wire 23, and the inner electrode is connected to the insulated wire 23 by bonding, welding or crimping.

[0038] In this embodiment, the electrodes 12 are a pair. In other embodiments, the electrodes 12 may be two pairs, three pairs or more. The multiple pairs of electrodes may be connected in series or in parallel.

[0039] Please refer to Figure 2 The outer tube of the catheter 2 is a pressure-charging lumen 21, which is connected to the balloon 1 and sealed with the peripheral wall of the balloon 1. The pressure-charging channel is located in the pressure-charging lumen 21, that is, the conductive liquid is transported to the entrance of the balloon 1 through the pressure-charging lumen 21.

[0040] Among them, a reflux lumen 22 is provided in the charging lumen 21, and the reflux lumen 22 extends to the interior of the balloon 1. The reflux flow channel is located in the reflux lumen 22. Therefore, in this embodiment, the reflux lumen 22 is wrapped by the charging flow channel, and the diameter of the reflux lumen 22 is smaller than that of the charging lumen 21. In conjunction with the pressure reducing valve, the pressure of the conductive liquid in the balloon 1 can be better maintained.

[0041] The liquid inlet of the reflux lumen 22 is located between the entrance of the balloon 1 and the middle of the balloon 1. In this embodiment, the liquid inlet of the reflux lumen 22 is located at the entrance of the balloon 1, and can absorb the liquid in the balloon 1 to complete the circulation.

[0042] Please refer to Figure 5In another embodiment, the liquid inlet of the reflux cavity 22 is located near the middle of the balloon 1, so as to better drain the conductive liquid with bubbles. In order not to affect the operation of the shock wave generating unit, the reflux cavity 22 at least located in the balloon 1 is made of any one of PET, PEBAX, PA, PE and PU. In order to facilitate manufacturing, in this embodiment, the reflux cavity 22 is made of PEBAX as a whole.

[0043] Please refer to Figure 1 A main connector 3 is provided at the proximal end of the catheter 2, and the main connector 3 includes a wire connection interface 31, a catheter charging interface 32 and a reflux interface 33; the wire 23 in the catheter 2 passes through the wire connection interface 31 to be connected to the host, the catheter charging interface 32 is connected to the charging cavity 21; the reflux interface 33 is connected to the reflux cavity 22. In a certain embodiment, the pressure reducing valve is arranged in the reflux interface 33, which is easy to install and has a good pressure reducing effect.

[0044] Please refer to Figure 6 In another embodiment, the outer tube of the catheter 2 has a liquid-filled lumen 24 and a reflux lumen 22, that is, the liquid-filled lumen 24 and the reflux lumen 22 are multi-lumen structures, which are more flexible.

[0045] Preferably, a bubble eliminator is also included, which is connected between the fluid pump and the pressure reducing valve and is used to eliminate bubbles in the conductive liquid flowing out of the reflux cavity tube 22. There are many devices for achieving bubble elimination, such as changing the flow direction of the liquid or the position of the container, using gravity to help bubbles float to the surface of the liquid and be discharged; moderately vibrating or stirring the liquid can cause bubbles to break or merge into larger bubbles, which are easier to be discharged; and separating bubbles by using the swirling flow or centrifugal force of the liquid.

[0046] In a preferred embodiment, the bubble eliminator adopts an ultrasonic bubble eliminator. When ultrasonic waves propagate in a liquid, micro-flow effects are also generated, i.e., tiny flows in the liquid. These tiny flows can further promote the rupture and dispersion of bubbles. At the same time, the high-frequency vibration of ultrasonic waves can also produce a high degree of local shear force in the liquid, which can destroy the wall membrane of the bubble and cause the bubble to rupture rapidly. Since the IVL device will continuously electrolyze the solution in the balloon 1 during use to precipitate the residual bubbles, which are mainly small bubbles, the ultrasonic bubble eliminator is particularly suitable for the shock wave balloon catheter of the present application.

[0047] The bubbles in the balloon come from the gas released by the conductive liquid in the balloon under the action of shock waves. The conductive liquid is generally a mixed solution of contrast agent and saline. The gas in the balloon will hinder the transmission of shock waves. The existing solution is to increase the firing time interval, such as 1 second or more, so that the tiny bubbles generated by the firing escape from the liquid before the next firing. The problem with this is that the increased firing time interval will increase the blood vessel blockage time and increase the risk of surgery.

[0048] In this regard, the present application provides a preferred solution in which the conductive liquid in the shock wave balloon catheter is a mixture of degassed physiological saline and contrast agent, which can further reduce the generation of bubbles, shorten the firing time interval, and improve the efficiency and safety of the operation.

[0049] In addition, the present application also provides a medical device, including the shock wave balloon catheter with a reflux device as described above and a device host, the device host includes a high-voltage pulse output module, and pulse energy is provided by connecting the high-voltage pulse output module and the wire 23.

[0050] 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 a reflux device, characterized in that: include, The balloon has a shock wave generating part therein; A catheter, a balloon is arranged at the distal end of the catheter, a pressurized flow channel and a reflux flow channel are arranged in the catheter, the pressurized flow channel is used to supply conductive liquid to the inside of the balloon, and the reflux flow channel is used to recover the conductive liquid from the inside of the balloon; a fluid pump, the outlet end of which is connected to the pressurized flow channel so as to provide the balloon with a conductive liquid having a certain pressure; The inlet end of the pressure reducing valve is connected to the reflux flow channel to maintain the pressure of the conductive liquid in the balloon, and the outlet end of the pressure reducing valve is connected to the inlet end of the fluid pump.

2. The shock wave balloon catheter with a reflux device according to claim 1, characterized in that: The shock wave generating part comprises a guide wire lumen and at least one pair of electrodes located outside the guide wire lumen; the electrodes are connected to the wire from the catheter.

3. The shock wave balloon catheter with a reflux device according to claim 1, characterized in that: The outer tube of the catheter is a pressure-filled cavity tube, the pressure-filled cavity tube is communicated with the balloon and is sealed with the peripheral wall of the balloon; the pressure-filled flow channel is located in the pressure-filled cavity tube.

4. The shock wave balloon catheter with a reflux device according to claim 3, characterized in that: A reflux lumen is provided in the pressure filling lumen, the reflux lumen extends to the interior of the balloon, and the reflux channel is located in the reflux lumen.

5. The shock wave balloon catheter with a reflux device according to claim 4, characterized in that: The liquid inlet of the reflux cavity is located between the inlet of the balloon and the middle of the balloon.

6. The shock wave balloon catheter with a reflux device according to claim 4, characterized in that: The proximal end of the catheter is provided with a main joint, which includes a wire connection interface, a catheter charging interface and a reflux interface.

7. The shock wave balloon catheter with a reflux device according to claim 1, characterized in that: The outer tube of the catheter is provided with a liquid-filled cavity and a reflux cavity.

8. The shock wave balloon catheter with a reflux device according to claim 1, characterized in that: It also includes a bubble eliminator, which is connected between the fluid pump and the pressure reducing valve, and is an ultrasonic bubble eliminator.

9. The shock wave balloon catheter with a reflux device according to claim 1, characterized in that: The conductive liquid supplied by the pressurized flow channel to the interior of the balloon is a mixed liquid of degassed physiological saline and contrast agent.

10. A medical device, characterized in that: It comprises a shock wave balloon catheter with a reflux device as described in 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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