Shock wave balloon catheter with backflow device and medical equipment

Abstract

The utility model provides a shock wave balloon catheter with a backflow device and medical equipment, the shock wave balloon catheter comprises a balloon, a catheter, 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 into 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 channel so as 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 separation and electrolysis of the conductive liquid in the percussion process of an electrode in the balloon are discharged out of the balloon in time through the backflow 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] This utility model relates to the field of medical device technology, specifically to a shockwave balloon catheter with a reflux device and a medical device. Background Technology

[0002] The working principle of intravascular lithotripsy (IVL) is that the conductive liquid inside the balloon is instantly vaporized and rapidly liquefied by an internal electrode. The expansion and bursting of the bubble generates mechanical shock waves at the treatment site, which break up the superficial and deep calcified plaques in the blood vessel lumen, allowing the blood vessel lumen to be fully expanded, thereby achieving the goal of significantly improving vascular compliance.

[0003] The conductive fluid within the IVL catheter provides the ions needed to generate the electric arc, assisting in the transmission of shock waves to the vessel wall. Clinical data shows that during shock wave transmission, if air bubbles are encountered, the impact energy decreases by approximately 20%, and even by about 40% in calcified fracture zones. However, during IVL device use, gas is released from the conductive fluid inside the balloon under the influence of the shock waves, forming bubbles. These bubbles adhere to or suspend within the conductive fluid on the inner wall of the balloon, severely hindering shock wave transmission. Current clinical solutions involve using an external fluid pressure pump to remove the conductive solution from the balloon after a certain number of firings, thus emptying the balloon of gas, and then re-inflating the balloon, repeating this process continuously. This significantly increases the procedure time and reduces treatment efficiency.

[0004] In view of the above, this application is hereby submitted. Utility Model Content

[0005] This invention provides a shockwave balloon catheter with a reflux device and a medical device to solve at least one of the above-mentioned technical problems.

[0006] A shockwave balloon catheter with a reflux device includes a balloon, a catheter, a fluid pump, and a pressure reducing valve. The balloon contains a shockwave generator. The balloon is positioned at the distal end of the catheter, which contains a pressurization channel and a reflux channel. The pressurization channel supplies conductive liquid to the balloon, and the reflux channel recovers conductive liquid from the balloon. The outlet of the fluid pump is connected to the pressurization channel to supply the balloon with conductive liquid at a certain pressure. The inlet of the pressure reducing valve is connected to the reflux channel to maintain the pressure of the conductive liquid within the balloon.

[0007] Preferably, the outlet end of the pressure reducing valve is connected to the inlet end of the fluid pump.

[0008] Preferably, the outer tube of the catheter is a pressurization chamber tube, which is connected to the balloon and sealed to the peripheral wall of the balloon; the pressurization channel is located inside the pressurization chamber tube.

[0009] Preferably, the pressurization chamber is provided with a reflux chamber, which extends into the interior of the balloon, and the reflux channel is located within the reflux chamber.

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

[0011] Preferably, the proximal end of the catheter is provided with a main connector, which includes a wire connection interface, a catheter pressurization interface, and a return interface.

[0012] Preferably, the outer tube of the catheter has a filling chamber and a reflux chamber.

[0013] Preferably, the shock wave generator includes a guidewire lumen and at least one pair of electrodes located outside the guidewire lumen; the electrodes are connected to a wire from inside the catheter.

[0014] Preferably, the device further includes a bubble eliminator connected between the fluid pump and the pressure reducing valve. The bubble eliminator is an ultrasonic bubble eliminator.

[0015] Preferably, the conductive liquid supplied to the balloon by the pressurization channel is a mixture of degassed physiological saline and contrast agent.

[0016] This application also provides a medical device, including a shockwave balloon catheter with a reflux device as described above and a device host. The device host is provided with a high-voltage pulse output module for providing pulse energy to the shockwave balloon catheter. The device host is provided with a liquid chamber for storing 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.

[0017] The shockwave balloon catheter of this invention, equipped with a reflux device, utilizes a reflux channel and a pressure-reducing valve to maintain the pressure of the conductive fluid inside the balloon. This allows gas released from the conductive fluid under shockwave action to be promptly discharged from the balloon through the reflux channel, preventing air bubbles from obstructing the shockwave's effect on calcified lesions and improving the effectiveness of the shockwave. Compared to traditional methods, which involve using an external fluid pressure pump to remove the conductive fluid from the balloon after a certain number of shots and then re-inflating the balloon, this significantly reduces surgical time.

[0018] Furthermore, the conductive liquid supplied to the inside of the balloon by the pressurization channel is a mixture of degassed physiological saline and contrast agent, which can further reduce the generation of bubbles during the firing process. Attached Figure Description

[0019] Figure 1This is a schematic diagram of the structure of a shockwave balloon catheter with a reflux device according to this utility model;

[0020] Figure 2 yes Figure 1 A schematic diagram of the cross-sectional structure of the balloon and catheter sections;

[0021] Figure 3 yes Figure 1 A schematic diagram of the cross-sectional structure of the balloon;

[0022] Figure 4 yes Figure 1 A schematic diagram of the cross-sectional structure of the conduit;

[0023] Figure 5 This is a cross-sectional structural diagram of the balloon and catheter portion of another embodiment of the present invention;

[0024] Figure 6 This is a schematic diagram of the cross-sectional structure of the catheter in another embodiment of this utility model.

[0025] Figure label:

[0026] 1. Balloon; 11. Guidewire lumen; 12. Electrode; 2. Catheter; 21. Inflation lumen; 22. Return lumen; 23. Lead wire; 24. Fluid filling lumen; 3. Main connector; 31. Lead wire connection interface; 32. Catheter inflation interface; 33. Return interface. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this utility model, not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without creative effort are within the scope of protection of this utility model. Therefore, the following detailed description of the embodiments of this utility model provided in the accompanying drawings is not intended to limit the scope of the claimed utility model, but merely represents selected embodiments of this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without creative effort are within the scope of protection of this utility model.

[0028] In the description of this utility model, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0029] The specific embodiments of this utility model are described in detail below with reference to the accompanying drawings.

[0030] Please refer to Figures 1 to 4 A shockwave balloon 1 and catheter 2 with a reflux device includes a balloon 1, a catheter 2, a fluid pump, and a pressure reducing valve.

[0031] The balloon 1 is equipped with a shock wave generator, which is used to instantly vaporize and rapidly liquefy the electrolyte mixture inside the balloon 1. The expansion and bursting of the bubbles generate mechanical shock waves at the treatment site, breaking up calcified plaques in the superficial and deep layers of the blood vessel lumen.

[0032] The balloon 1 is disposed at the distal end of the catheter 2. The catheter 2 is provided with a pressurization channel and a return channel. The pressurization channel is used to supply conductive liquid into the balloon 1, and the return channel is used to recover conductive liquid from the balloon 1. The raw material of the conductive liquid is mainly or entirely an electrolyte mixture solution.

[0033] The outlet end of the fluid pump is connected to the pressurization channel to provide the balloon 1 with a certain pressure of conductive liquid; the inlet end of the pressure reducing valve is connected to the return channel to maintain the pressure of the conductive liquid in the balloon 1.

[0034] The outlet end of the pressure reducing valve is connected to 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 be a direct connection or a connection through other equipment, as long as the liquid at the outlet end of the pressure reducing valve can eventually flow to the fluid pump. For example, in the indirect connection, there is a liquid storage chamber or other structure between the pressure reducing valve and the fluid pump.

[0035] This invention, by setting up a reflux channel and a pressure-reducing valve to maintain the pressure of the conductive liquid inside the balloon 1, allows the balloon 1 catheter 2 to continuously expel the air bubbles accumulated inside the balloon 1 through the reflux channel during use. This reduces the impact of air bubbles on the shock wave transmission to the blood vessel wall, improving treatment efficiency. Compared to the traditional method of using an external fluid pressure pump to extract the electrolyte inside the balloon 1 after a certain number of shots to release air and then refilling the balloon 1, this invention significantly saves surgical time.

[0036] In addition, it can dissipate the heat generated during the operation of the shock wave generator in a timely manner through the return circulation of the conductive liquid, so as to avoid the conductive liquid overheating and affecting the expansion performance of balloon 1, while preventing blood vessels from being burned and improving the safety performance of catheter 2.

[0037] In other embodiments, a large-capacity reservoir can be provided, so that during a single operation, only the conductive liquid needs to be drawn from the reservoir by a fluid pump, eliminating the need for circulation. This also ensures that the conductive liquid released during the firing process and the bubbles formed by electrolysis are continuously and promptly discharged from the balloon 1, preventing bubbles from interfering with the shock wave's effect on the calcified lesion and improving the effectiveness of the shock wave.

[0038] Please refer to Figure 2 The shock wave generating unit 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 a wire 23 from inside the catheter 2. The guidewire lumen 11 extends through both ends of the balloon 1 for engagement with the guidewire traction; in this embodiment, the electrodes 12 include an inner electrode, an outer electrode, and an insulating tube located between the inner and outer electrodes; in other embodiments, they may also be spaced-apart positive and negative electrodes. The wire 23 may be an insulated wire 23, and the inner and outer electrodes are connected to the insulated wire 23 by bonding, welding, or crimping.

[0039] In this embodiment, there is one pair of electrodes 12. In other embodiments, there may be two, three or more pairs of electrodes. The multiple pairs of electrodes may be connected in series or in parallel.

[0040] Please refer to Figure 2 The outer tube of the catheter 2 is a pressurization chamber 21. The pressurization chamber 21 is connected to the balloon 1 and is sealed to the peripheral wall of the balloon 1. The pressurization channel is located inside the pressurization chamber 21, that is, the conductive liquid is transported to the inlet of the balloon 1 through the pressurization chamber 21.

[0041] The pressurization chamber 21 is provided with a return chamber 22, which extends into the interior of the balloon 1. The return channel is located inside the return chamber 22. Therefore, in this embodiment, the return chamber 22 is wrapped by the pressurization channel. The diameter of the return chamber 22 is smaller than that of the pressurization chamber 21. With the help of the pressure reducing valve, the pressure of the conductive liquid inside the balloon 1 can be better maintained.

[0042] The inlet of the reflux chamber 22 is located between the entrance of the balloon 1 and the middle of the balloon 1. In this embodiment, the inlet of the reflux chamber 22 is located at the entrance of the balloon 1, which can absorb the liquid inside the balloon 1 and complete the circulation.

[0043] Please refer to Figure 5 In another embodiment, the inlet of the reflux chamber 22 is located near the center of the balloon 1, thereby better venting the conductive liquid containing air bubbles. To avoid affecting the operation of the shock wave generator, the reflux chamber 22, at least within the balloon 1, is made of any one of PET, PEBAX, PA, PE, and PU. For ease of manufacturing, in this embodiment, the reflux chamber 22 is entirely made of PEBAX material.

[0044] Please refer to Figure 1 The proximal end of the catheter 2 is provided with a main connector 3, which includes a wire connection interface 31, a catheter pressurization interface 32, and a return interface 33. The wire 23 inside the catheter 2 passes through the wire connection interface 31 and is connected to the power supply. The catheter pressurization interface 32 is connected to the pressurization chamber 21. The return interface 33 is connected to the return chamber 22. In one embodiment, the pressure reducing valve is set in the return interface 33, which is easy to install and has a good pressure reducing effect.

[0045] Please refer to Figure 6 In another embodiment, the outer tube of the catheter 2 has a filling chamber 24 and a return chamber 22, that is, the filling chamber 24 and the return chamber 22 are multi-lumen tube structures, which are more flexible.

[0046] Preferably, the system also includes a bubble eliminator connected between the fluid pump and the pressure reducing valve, used to eliminate air bubbles in the conductive liquid flowing out of the return chamber 22. Various devices can be used to eliminate bubbles, such as changing the flow direction of the liquid or the position of the container to help bubbles float to the liquid surface and be discharged by gravity; moderately vibrating or stirring the liquid can cause bubbles to break or merge into larger bubbles, making them easier to discharge; or using the swirling flow or centrifugal force of the liquid to separate the bubbles.

[0047] In a preferred embodiment, the bubble eliminator employs an ultrasonic bubble eliminator. When ultrasound propagates in a liquid, it generates a microfluidic effect, i.e., minute flows within the liquid. These minute flows further promote bubble breakage and dispersion. Simultaneously, the high-frequency vibrations of the ultrasound generate high local shear forces in the liquid, which can disrupt the bubble walls, causing the bubbles to break rapidly. Since the IVL device continuously electrolyzes the solution within the balloon 1 during use, producing residual bubbles, primarily small bubbles, the ultrasonic bubble eliminator is particularly suitable for the shockwave balloon catheter of this application.

[0048] The air bubbles in the balloon originate from the release of the conductive fluid dissolved within the balloon under the influence of shock waves. This conductive fluid is typically a mixture of contrast agent and saline solution, which precipitates upon exposure to shock waves. These air bubbles in the conductive fluid hinder the transmission of shock waves. Current solutions involve increasing the firing interval, such as one second or more, allowing the tiny air bubbles generated during firing to escape from the fluid before the next firing. However, this increased firing interval increases the duration of vascular occlusion and raises surgical risks.

[0049] To address this, this application provides a preferred embodiment where the conductive fluid inside the shockwave balloon catheter is a mixture of degassed physiological saline and contrast agent, which further reduces the generation of air bubbles during firing. This shortens the firing time interval, improving surgical efficiency and safety.

[0050] In addition, this application also provides a medical device, including the shockwave balloon catheter with reflux device as described above and the device main unit. The device main unit also includes a high-voltage pulse output module, which provides pulse energy via a connection to the lead wire 23.

[0051] The above are merely preferred embodiments of this utility model. The protection scope of this utility model is not limited to the above embodiments. All technical solutions that fall within the scope of this utility model's concept are protected by this utility model.

Claims

1. A shockwave balloon catheter with a reflux device, characterized in that, include, The balloon contains a shock wave generator. A catheter with a balloon disposed at its distal end, the catheter having a pressurization channel and a return channel, the pressurization channel for supplying conductive liquid into the balloon, and the return channel for recovering conductive liquid from the balloon. A fluid pump, with its outlet end connected to the pressurization channel, provides the balloon with a conductive liquid at a certain pressure. A pressure reducing valve is provided, with its inlet end connected to the return flow channel, to maintain the pressure of the conductive liquid inside the balloon.

2. The shockwave balloon catheter with reflux device according to claim 1, characterized in that, The outlet end of the pressure reducing valve is connected to the inlet end of the fluid pump.

3. The shockwave balloon catheter with reflux device according to claim 1, characterized in that, The outer tube of the catheter is a pressurization chamber, which is connected to the balloon and sealed to the peripheral wall of the balloon; the pressurization channel is located inside the pressurization chamber.

4. The shockwave balloon catheter with reflux device according to claim 3, characterized in that, The pressurization chamber is provided with a reflux chamber, which extends into the interior of the balloon, and the reflux channel is located within the reflux chamber.

5. The shockwave balloon catheter with reflux device according to claim 4, characterized in that, The inlet of the reflux chamber is located between the entrance of the balloon and the middle of the balloon.

6. The shockwave balloon catheter with reflux device according to claim 4, characterized in that, The proximal end of the catheter is provided with a main connector, which includes a wire connection interface, a catheter pressurization interface, and a return interface.

7. The shockwave balloon catheter with reflux device according to claim 1, characterized in that, The catheter has an inner filling chamber and a return chamber inside its outer tube. The shock wave generating part includes a guidewire chamber and at least one pair of electrodes located outside the guidewire chamber. The electrodes are connected to a wire from inside the catheter.

8. The shockwave balloon catheter with 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 the bubble eliminator is an ultrasonic bubble eliminator.

9. The shockwave balloon catheter with reflux device according to claim 1, characterized in that, The conductive fluid supplied to the balloon by the pressurization channel is a mixture of degassed physiological saline and contrast agent.

10. A medical device, characterized in that, The device includes a shockwave 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 to the shockwave balloon catheter.

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