Corona discharge shock wave balloon catheter and lithotripsy equipment thereof

Abstract

The invention provides a corona discharge shock wave balloon catheter which comprises an inner tube, a balloon is arranged outside the inner tube, and conductive liquid is arranged between the inner tube and the balloon. The positive electrode cable is arranged along the outer wall of the inner pipe, and at least one positive electrode is arranged on the positive electrode cable; the negative electrode cable is arranged along the outer wall of the inner tube, and the negative electrode cable is provided with at least one negative electrode; one negative electrode and at least one positive electrode form a group of electrode pair, the gap between the positive electrode and the negative electrode of the electrode pair is 3-10mm, and the voltage range of the electrode pair is 300-1000V. The positive electrode and the negative electrode of the electrode pair in the balloon catheter are arranged at intervals, and the voltage range of the electrode pair is set, so that the phenomenon of pulse corona discharge instead of pulse arc discharge is generated when the electrode pair works, the working voltage is lower and safer, the service life of the electrodes is longer, the electrodes are easier to process, and the sound pressure is more stable and controllable; the invention further provides stone crushing equipment.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a corona discharge shock wave balloon catheter. Background Art

[0002] In response to calcified lesions in blood vessels, a shock wave balloon catheter device is currently available on the market. The balloon on the catheter is pushed into the calcified area. The basic principle is to apply a certain electric field to the electrodes surrounded by conductive fluid in the balloon. The conductive fluid between the electrodes produces cavitation under the action of the electric field. The bubbles produced by cavitation collapse instantly, generating shock waves, which rupture the calcified plaques, thereby achieving the purpose of breaking up the calcified lesion tissue without causing damage to the vascular endothelium.

[0003] The shock wave balloon catheters currently on the market all generate shock waves by means of pulsed arc discharge. Pulsed arc discharge is when the electrons in the liquid between the electrodes are accelerated under the action of a high voltage and strong electric field, and the liquid molecules near the electrodes are ionized. The ionized electrons in the liquid will be accelerated by the strong electric field between the electrodes to ionize more electrons, forming an electron avalanche. A plasma channel is formed in the area where the liquid molecules are ionized. As the ionization area expands, the liquid is broken down, forming a discharge channel between the electrodes. After the discharge channel is generated, a large discharge current will be generated due to the small discharge resistance. The discharge current heats the liquid around the discharge channel, causing the liquid to cavitate and produce bubbles, which collapse instantly to produce shock waves.

[0004] This type of shock wave balloon catheter that relies on pulse arc discharge to generate shock waves has the following main disadvantages: 1) A high voltage, usually above 3kV, needs to be applied to both ends of the electrode, which poses a high risk of being used in human arteries; 2) A plasma channel needs to be formed between the two electrodes, which results in high temperature, severe electrode ablation, large fluctuations in sound pressure, and a short service life of the electrodes; 3) Pulse arc discharge is sensitive to the electrode spacing, which is between 0.01 and 0.5mm. A slight change in the electrode spacing will cause significant fluctuations in the shock wave sound pressure. The processing accuracy requirements are high, the processing difficulty is high, and the sound pressure is unstable and uncontrollable.

[0005] In view of this, this application is filed. Summary of the invention

[0006] The present invention provides a corona discharge shock wave balloon catheter and a lithotripsy device thereof to solve at least one of the above technical problems.

[0007] A corona discharge shock wave balloon catheter comprises an inner tube, a balloon is arranged outside the inner tube, and a conductive liquid is provided between the inner tube and the balloon; a positive cable is arranged along the outer wall of the inner tube, and at least one positive electrode is arranged on the positive cable; a negative cable is arranged along the outer wall of the inner tube, and at least one negative electrode is arranged on the negative cable; one negative electrode and at least one positive electrode form an electrode pair, the gap between the positive electrode and the negative electrode of the electrode pair is 3-10 mm, and the voltage range of the electrode pair is 300-1000 V.

[0008] Preferably, the negative electrode and 2-4 positive electrodes form an electrode pair.

[0009] Preferably, the voltage range of the electrode pair is 400-600V, and the gap between the positive electrode and the negative electrode in the electrode pair is 4-6mm.

[0010] Preferably, the positive electrode is formed by the exposed metal part of the positive cable or by a metal capillary tube being flattened on the exposed metal part of the positive cable; the negative electrode is formed by the exposed metal part of the negative cable or by a metal capillary tube being flattened on the exposed metal part of the negative cable.

[0011] Preferably, the positive cable and the negative cable are glued to the outer wall of the inner tube.

[0012] It also includes an insulating tube, which is arranged on the outer periphery of the positive cable and the negative cable, glue is injected between the insulating tube and the inner tube, and the insulating tube is provided with conductive openings corresponding to the positive electrode and the negative electrode.

[0013] Preferably, the conductive opening is in a circular, rectangular, petal-shaped, triangular, trapezoidal or irregular shape.

[0014] Preferably, the number of the positive cable is 1, the number of the negative cable is 1, the two cables are respectively parallel to the central axis of the inner tube and symmetrically distributed around the central axis, or the two cables are spirally and parallelly distributed on the inner tube.

[0015] Preferably, the number of the positive cable wires is 2, the number of the negative cable wire is 1, the three cable wires are respectively parallel to the central axis of the inner tube and are evenly distributed on the outer wall of the inner tube, or the three cable wires are spirally and parallelly distributed on the inner tube, or the three cable wires are woven into a tube on the outer wall of the inner tube.

[0016] Preferably, the number of the positive cable wires is 3, the number of the negative cable wire is 1, the four cable wires are respectively parallel to the central axis of the inner tube and are evenly distributed on the outer wall of the inner tube, or the four cable wires are spirally and parallelly distributed on the inner tube, or the four cable wires are woven into a tube on the outer wall of the inner tube.

[0017] The present invention also provides a lithotripsy device, comprising a host and the corona discharge shock wave balloon catheter as described above.

[0018] The corona discharge shock wave balloon catheter of the present invention is set by the gap between the positive and negative electrodes of the electrode pair in the balloon catheter, combined with the voltage range setting of the electrode pair, so that the electrode pair is no longer generated by the pulse arc discharge phenomenon when working, but the pulse corona discharge phenomenon. In the technical scheme of the present invention, it will not form a plasma channel running through the positive and negative electrodes like the conventional shock wave pulse arc discharge. In the pulse corona discharge process of the present invention, the high current density at the electrode will vaporize the nearby liquid, and then ionize it to form a bush-like plasma. The plasma temperature is extremely high, so that the edge liquid is rapidly vaporized, and a bubble is formed outside the plasma. The internal pressure of the bubble continues to increase and expands rapidly. When the high-voltage electric field energy applied to both ends of the electrode is released to a certain extent, the external pressure of the bubble is greater than the internal pressure, and the bubble begins to shrink and eventually ruptures, generating a shock wave, which ruptures the calcified plaque of the blood vessel.

[0019] Therefore, the present invention adopts a pulse discharge structure and principle that is different from the prior art, and can also achieve the effect of generating shock waves to impact the balloon wall, achieving the purpose of treating vascular calcified plaques. In addition, the voltage requirement of the scheme of the present invention is lower, thereby reducing the risk of use in human arteries; there is no need to form a plasma channel between the positive and negative electrodes, which reduces the ablation of the electrodes and reduces the fluctuation of the sound pressure; the requirements for the electrode gap are reduced, and the processing accuracy requirements are lower. Therefore, the present invention provides a shock wave balloon catheter that is safer, has a longer electrode life, is easier to process, and has a more stable and controllable sound pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a first embodiment of the present invention;

[0021] Figure 2 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a second embodiment of the present invention from a first viewing angle;

[0022] Figure 3 yes Figure 2 A schematic diagram of the second perspective structure;

[0023] Figure 4 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a third embodiment of the present invention;

[0024] Figure 5 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a fourth embodiment of the present invention;

[0025] Figure 6 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a fifth embodiment of the present invention;

[0026] Figure 7 2 is a schematic structural diagram of a corona discharge shock wave balloon catheter according to a sixth embodiment of the present invention;

[0027] Figure 8 It is a schematic structural diagram of a corona discharge shock wave balloon catheter according to an eighth embodiment of the present invention.

[0028] Reference numerals:

[0029] 1. Inner tube; 2. Negative cable; 21. Negative electrode; 3. Positive cable; 31. Positive electrode; 4. Insulating tube; 41. Glue; 42. Conductive opening. DETAILED DESCRIPTION

[0030] 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, rather than 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 are within 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 are within the scope of protection of the present invention.

[0031] 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.

[0032] The following is combined with Figures 1 to 8 The specific embodiments of the present invention are described in detail.

[0033] The first embodiment of the present invention:

[0034] Please refer to Figure 1 , and combined with Figures 2 to 6 A corona discharge shock wave balloon catheter comprises an inner tube 1, a balloon is arranged outside the inner tube 1, and a conductive liquid is arranged between the inner tube 1 and the balloon.

[0035] The negative cable 2 is arranged along the outer wall of the inner tube 1 , and is provided with at least one negative electrode 21 ; the positive cable 3 is arranged along the outer wall of the inner tube 1 , and is provided with at least one positive electrode 31 .

[0036] One negative electrode 21 and at least one positive electrode 31 form an electrode pair, the gap between the negative electrode 21 and the positive electrode 31 of the electrode pair is 3-10 mm, and the voltage range of the electrode pair is 300-1000V.

[0037] The electrode spacing of a conventional shock wave balloon catheter is between 0.01-0.5 mm, and the voltage applied to both ends of the electrodes is usually above 3 kV, thereby forming a pulse arc discharge shock wave. The corona discharge shock wave balloon catheter of the present invention sets the gap between the positive and negative electrodes of the electrode pair in the balloon catheter, combined with the voltage range setting of the electrode pair, so that when the electrode pair is working, it is no longer a pulse arc discharge phenomenon, but a pulse corona discharge phenomenon.

[0038] In the technical solution of the present invention, a plasma channel penetrating the positive and negative electrodes will not be formed as in conventional shock wave pulse arc discharge. In the pulse corona discharge process of the present invention, the high current density at the electrode will vaporize the nearby liquid, and then ionize it to form a bush-like plasma. The plasma temperature is extremely high, so that the edge liquid vaporizes rapidly, forming a bubble outside the plasma, and the internal pressure of the bubble continues to increase and expands rapidly. When the high-voltage electric field energy applied to both ends of the electrode is released to a certain extent, the external pressure of the bubble is greater than the internal pressure, and the bubble begins to shrink and eventually ruptures, generating a shock wave, which ruptures the calcified plaque of the blood vessel.

[0039] Therefore, the present invention adopts a pulse discharge structure and principle that is different from the prior art, and can also achieve the effect of generating shock waves to impact the balloon wall, achieving the purpose of treating vascular calcified plaques. In addition, the voltage requirement of the scheme of the present invention is lower, thereby reducing the risk of use in human arteries; there is no need to form a plasma channel between the positive and negative electrodes, which reduces the ablation of the electrodes and reduces the fluctuation of the sound pressure; the requirements for the electrode gap are reduced, and the processing accuracy requirements are lower. Therefore, the present invention provides a shock wave balloon catheter that is safer, has a longer electrode life, is easier to process, and has a more stable and controllable sound pressure.

[0040] Furthermore, the voltage range of the electrode pair is 400-600V, and the gap between the negative electrode 21 and the positive electrode 31 in the electrode pair is 4-6mm. Within this range, the voltage used by the shock wave balloon catheter is lower and safer, and the pulse corona discharge shock wave effect formed by the gap between the positive and negative electrodes is between 4-6mm is better.

[0041] In this embodiment, the voltage range of the electrode pair is 500V, and the gap between the negative electrode 21 and the positive electrode 31 in the electrode pair is controlled between 4 and 6 mm, so as to generate a shock wave of sufficient quality and control the voltage within a very small range.

[0042] Please refer to Figure 1 In this embodiment, the negative electrode 21 is the exposed metal part of the negative cable 2; the positive electrode 31 is the exposed metal part of the positive cable 3, that is, the exposed metal part after a part of the insulating paint layer is removed from the cable, and the molding is simple and convenient.

[0043] In a preferred embodiment, the negative electrode 21 is formed by a metal capillary sleeve and flattened on the exposed metal part of the negative cable 2; the positive electrode 31 is formed by a metal capillary sleeve and flattened on the exposed metal part of the positive cable 3, thereby forming a double-layer metal sheet structure, which makes the corona discharge effect better, and the metal capillary sleeve and flattened structure has an excellent fixing effect.

[0044] In other embodiments, the positive and negative electrodes may also be fixed to the positive and negative cable wires by bonding or welding a single-layer metal sheet to form a single-layer metal sheet structure electrode.

[0045] In this embodiment, a negative electrode 21 and a positive electrode 31 form an electrode pair; a plurality of negative electrodes 21 can be connected in series on the negative cable 2, and a plurality of positive electrodes 31 can be connected in series on the positive cable 3. A plurality of electrode pairs can be formed between the plurality of negative electrodes 21 connected in series on the negative cable 2 and the plurality of positive electrodes 31 connected in series on the positive cable 3, and the negative electrodes 21 and the positive electrodes 31 in the plurality of electrode pairs are the nearest opposite electrodes.

[0046] In this embodiment, the number of the positive cable 3 is 1, and the number of the negative cable 2 is 1. The two cables are respectively parallel to the central axis of the inner tube 1 and are symmetrically distributed with the central axis as the center line.

[0047] In other preferred embodiments, the negative electrode 21 and 2-4 positive electrodes 31 form a set of electrode pairs, which can simultaneously generate shock waves in different directions, impact the calcified lesions from different directions, and enhance the fragmentation effect.

[0048] Second embodiment:

[0049] Based on the first embodiment, please refer to Figures 2-3 , the difference is that the negative cable 2 and the positive cable 3 are glued to the outer wall of the inner tube 1 by non-conductive glue 41.

[0050] This embodiment further includes an insulating tube 4, which is arranged on the outer periphery of the negative cable 2 and the positive cable 3, and glue 41 is injected between the insulating tube 4 and the inner tube 1, and the insulating tube 4 is provided with conductive openings 42 corresponding to the negative electrode 21 and the positive electrode 31. This prevents the positive and negative electrodes and the positive and negative cables from falling off the balloon catheter inner tube 1 during use.

[0051] The insulating tube 4 may be made of polyurethane, nylon, polytetrafluoroethylene, polyimide, etc., and the glue 41 may be epoxy resin glue, UV glue, etc. The conductive opening 42 is in the shape of a circle, rectangle, petal, triangle, trapezoid or irregular shape.

[0052] Consistent with the first embodiment, in this embodiment, the number of the positive cable 3 is 1, the number of the negative cable 2 is 1, and the two cables are respectively parallel to the central axis of the inner tube 1 and symmetrically distributed with the central axis as the center line.

[0053] Third embodiment:

[0054] Based on the second embodiment, please refer to Figure 4 The difference is that the number of the negative electrode cable 2 is 1, and the number of the positive electrode cable 3 is 1. The two cables are spirally and parallelly distributed on the inner tube 1. This distribution method makes it easy to control the gap between the positive and negative electrodes. At the same time, the electrode pairs are more evenly distributed in the circumferential direction of the inner tube, and the shock waves generated in the circumferential direction of the balloon are also more even.

[0055] In other embodiments, when two cables are spirally and parallelly distributed on the inner tube 1, the insulating tube 4 structure is not used, and the structure of reinforcing the positive and negative cable lines in the prior art can be used according to actual needs.

[0056] Fourth embodiment:

[0057] Based on the second embodiment, please refer to Figure 4 The difference is that the number of the negative cable 2 is 1, the number of the positive cable 3 is 2, the three cables are parallel to the central axis of the inner tube 1 and are evenly distributed on the outer wall of the inner tube 1, or the three cables are spirally and parallelly distributed on the inner tube 1.

[0058] In other embodiments, when the three cables are respectively parallel to the central axis of the inner tube 1 and evenly distributed on the outer wall of the inner tube 1, the insulating tube 4 structure is not used, and the structure of reinforcing the positive and negative cable lines in the prior art can be used according to actual needs.

[0059] Fifth embodiment:

[0060] Based on the third embodiment, please refer to Figure 6 , the difference is that the number of the negative cable 2 is 1, the number of the positive cable 3 is 2, the three cables are spirally and parallelly distributed on the inner tube 1, wherein the negative electrode 21 on the three parallel cables is located between the two positive electrodes 31. The gap between the positive and negative electrodes can be more accurately controlled, and an enhanced shock wave is generated at the negative electrode, thereby enhancing the ability to break calcification.

[0061] Furthermore, for the convenience of control, the same number of positive and negative electrodes are arranged at the same position corresponding to the three positive and negative cables 3 .

[0062] In other embodiments, three cables are woven into a tube on the outer wall of the inner tube 1 , so as to obtain a wider coverage and a more uniform shock wave distribution in the circumferential and axial directions of the inner tube 1 .

[0063] In other embodiments, the insulating tube 4 structure is not used, and the structure of reinforcing the positive and negative cable lines in the prior art can be used according to actual needs.

[0064] Sixth embodiment:

[0065] Based on the first embodiment, please refer to Figure 7 , the difference is that the number of the negative cable 2 is 1, the number of the positive cable 3 is 3, and the four cables are woven into a tube on the outer wall of the inner tube 1. Thus, a wider coverage and more uniform shock wave distribution in the circumferential and axial directions of the inner tube 1 are obtained.

[0066] In other embodiments, the four cables are respectively parallel to the central axis of the inner tube 1 and are evenly distributed on the outer wall of the inner tube 1 , and an angle of 90° is formed between the four cables.

[0067] In another embodiment, four cables are spirally and parallelly distributed on the inner tube 1, and the negative electrode cable 2 is located in one of the two middle ones.

[0068] Seventh embodiment:

[0069] Based on the sixth embodiment, please refer to Figure 8, the difference is that this embodiment further includes an insulating tube 4, the insulating tube 4 is arranged on the outer periphery of the negative cable 2 and the positive cable 3, glue 41 is injected between the insulating tube 4 and the inner tube 1, and the insulating tube 4 is provided with conductive openings 42 corresponding to the negative electrode 21 and the positive electrode 31. This prevents the positive and negative electrodes and the positive and negative cables from falling off the balloon catheter inner tube 1 during use.

[0070] 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 corona discharge shock wave balloon catheter, characterized in that: include, An inner tube, a balloon is disposed outside the inner tube, and a conductive liquid is disposed between the inner tube and the balloon; A positive cable is arranged along the outer wall of the inner tube, and at least one positive electrode is arranged on the positive cable; A negative cable line is arranged along the outer wall of the inner tube, and the negative cable line is provided with at least one negative electrode; One of the negative electrodes and at least one of the positive electrodes form an electrode pair, the gap between the positive electrode and the negative electrode of the electrode pair is 3-10 mm, and the voltage range of the electrode pair is 300-1000V.

2. The corona discharge shock wave balloon catheter according to claim 1, characterized in that: The negative electrode and 2-4 positive electrodes form a set of electrode pairs.

3. The corona discharge shock wave balloon catheter according to claim 2, characterized in that: The voltage range of the electrode pair is 400-600V, and the gap between the positive electrode and the negative electrode in the electrode pair is 4-6mm.

4. The corona discharge shock wave balloon catheter according to claim 1, characterized in that: The positive electrode is formed by the exposed metal part of the positive cable or the metal capillary tube is flattened on the exposed metal part of the positive cable; the negative electrode is formed by the exposed metal part of the negative cable or the metal capillary tube is flattened on the exposed metal part of the negative cable.

5. The corona discharge shock wave balloon catheter according to claim 4, characterized in that: The positive cable and the negative cable are glued to the outer wall of the inner tube; It also includes an insulating tube, which is arranged on the outer periphery of the positive cable and the negative cable, glue is injected between the insulating tube and the inner tube, and the insulating tube is provided with conductive openings corresponding to the positive electrode and the negative electrode.

6. The corona discharge shock wave balloon catheter according to claim 5, characterized in that: The conductive opening has a shape of a circle, a rectangle, a petal, a triangle, a trapezoid or an irregular shape.

7. The corona discharge shock wave balloon catheter according to claim 3, characterized in that: The number of the positive cable is 1, the number of the negative cable is 1, the two cables are respectively parallel to the central axis of the inner tube and symmetrically distributed with the central axis as the center line, or the two cables are spirally and parallelly distributed on the inner tube.

8. The corona discharge shock wave balloon catheter according to claim 3, characterized in that: The number of the positive cable lines is 2, the number of the negative cable line is 1, the three cable lines are respectively parallel to the central axis of the inner tube and are evenly distributed on the outer wall of the inner tube, or the three cable lines are spirally and parallelly distributed on the inner tube, or the three cable lines are woven into a tube on the outer wall of the inner tube.

9. The corona discharge shock wave balloon catheter according to claim 3, characterized in that: The number of the positive cable lines is 3, the number of the negative cable line is 1, the four cable lines are respectively parallel to the central axis of the inner tube and are evenly distributed on the outer wall of the inner tube, or the four cable lines are spirally and parallelly distributed on the inner tube, or the four cable lines are woven into a tube on the outer wall of the inner tube.

10. A stone crushing device, characterized in that: The invention comprises a host and a corona discharge shock wave balloon catheter as claimed in any one of claims 1 to 9.

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