Guidewire external shockwave balloon catheter

The external guidewire shockwave balloon catheter expands the balloon by generating vapor bubbles through corona discharge, and combined with external guidewire cutting, it solves the problems of insufficient vascular damage and fragmentation capacity in existing technologies, and achieves precise control and efficient calcification treatment.

CN119236276BActive Publication Date: 2025-11-04CYBER-VP MEDICAL DEVICE (SHENZHEN) CO LTD
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Patent Information

Application Number
CN202411367631.7
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-09-29
Publication Date
2025-11-04
Estimated Expiration
2044-09-29

AI Technical Summary

Technical Problem

Existing balloon catheters are difficult to control precisely during arc discharge, which may lead to vascular and thermal damage. Furthermore, the in-line guidewire results in a large outer diameter of the balloon, which is insufficient to break up calcifications.

Method used

An externally mounted shockwave balloon catheter is used, which uses corona discharge to generate vapor bubbles to inflate the balloon and cuts it through the externally mounted guidewire, thereby reducing the overall outer diameter of the balloon and improving the concentration of pulse energy.

Benefits of technology

It enables precise intravascular treatment, reduces the risk of vascular injury, improves the efficiency of calcification fragmentation and guidewire cutting ability, and enhances the flexibility and safety of the operation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a guide wire external type shock wave balloon catheter, which comprises a balloon, a catheter, and a guide wire. The catheter comprises an inner supporting rod which can be deformed and is used for supporting the balloon, and an outer tube. The inner supporting rod is coaxially arranged in the outer tube, and a gap is arranged between the outer tube and the inner supporting rod. The inner cavity of the balloon is communicated with the gap to pass in electrolyte liquid. The distal end of the inner supporting rod extends from the distal end of the outer tube. The proximal end of the balloon is sealingly connected with the distal end of the outer tube. The distal end of the balloon is provided with a balloon tip. The balloon is sealingly connected with the distal end of the inner supporting rod through the balloon tip. A corona generator is arranged at the position of the inner supporting rod in the balloon. An inlet port which is communicated with a guide wire hole is arranged on the balloon tip. Compared with the prior art, the guide wire external type shock wave balloon catheter has the advantages that the guide wire is arranged on the balloon tip, the balloon can be guided to enter the blood vessel and reach the lesion site, the stress on the inner wall of the blood vessel is more concentrated, and the guide wire can play the role of a cutting guide wire.
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Description

TECHNICAL FIELD

[0001] The present application relates to a medical device, in particular to a liquid corona discharge based guide wire external type shock wave balloon catheter. BACKGROUND

[0002] In the field of medical devices, balloon catheters are mainly used for expanding narrow blood vessels, and this treatment method has been proven to be safe and effective. Currently, balloon catheters mainly inflate the balloon based on the principle of electric arc discharge. Electric arc discharge is a discharge phenomenon that forms a high-density plasma channel through a medium under high voltage. Electric arc discharge is a complete breakdown of the medium between the electrodes under high voltage conditions, forming a continuous high-temperature and high-density plasma channel. Electric arc discharge is a strong discharge phenomenon with high temperature and high current density. Electric arc discharge is a whole effect, and the electric arc penetrates the medium between the electrodes, forming a continuous high-temperature and high-current channel. Under a high enough electric field, the liquid medium is completely broken down to form a high-density plasma channel, and this process is accompanied by intense energy release and high temperature. The shock wave energy of electric arc discharge is huge and difficult to control accurately, which may cause unpredictable damage to the surrounding tissues. The shock wave of electric arc discharge is strong, although it can quickly break up calcified plaques, but the impact on the surrounding blood vessel tissue is large, which may lead to blood vessel injury or other complications. The high-energy shock wave of electric arc discharge may cause high-risk complications such as blood vessel rupture and thrombus formation. During the electric arc discharge process, the high temperature in the electric arc area may spread to the surrounding tissues, causing unnecessary thermal damage. The shock wave of electric arc discharge is strong and difficult to control accurately and accumulate effects, and the existing technology mainly relies on the water hammer effect of the balloon to break up the calcification. Because the balloon is generally a thin film made of high-molecular material, the hardness is soft, and at the same time, the guide wire is placed in the inner tube of the balloon, which may cause the balloon to have a larger outer diameter, enter the calcified part of the blood vessel, and the current after excitation is small, so the expansion force may be insufficient. In the process of clinical treatment, the ability of the catheter to break up calcification may be insufficient. SUMMARY

[0003] The purpose of the present application is to provide a guide wire external type shock wave balloon catheter, and the technical problem to be solved is to reduce the overall through outer diameter of the balloon catheter, and to make the external guide wire produce stress concentration effect, improve the pulse energy, and at the same time realize the cutting effect of the guide wire.

[0004] To solve the above problems, the application adopts the following technical scheme: a guide wire external shock wave balloon catheter, comprising a balloon, a catheter, and a guide wire, the catheter comprises an inner support rod for supporting the balloon and being deformable, and an outer tube, the inner support rod is arranged in the outer tube coaxially, a gap is arranged between the outer tube and the inner support rod, the inner cavity of the balloon is communicated with the gap to pass in electrolyte liquid, the distal end of the inner support rod extends from the distal end of the outer tube, the proximal end of the balloon is sealingly connected with the distal end of the outer tube, the distal end of the balloon is provided with a balloon tip, the balloon is sealingly connected with the distal end of the inner support rod through the balloon tip, a corona generator is arranged at the position of the inner support rod in the balloon to realize corona discharge of the electrolyte liquid in the balloon to produce steam bubbles to expand the balloon, a guide wire hole penetrating through the distal end of the balloon tip is arranged at the distal end of the balloon tip, the guide wire hole is not communicated with the cavity of the balloon, an entrance is arranged on the balloon tip and communicated with the guide wire hole to extend the guide wire into the guide wire hole through the entrance and then extend from the distal end of the balloon tip, so that the guide wire is partially external to the balloon and the catheter, the guide wire is used for guiding the balloon, and after the electrolyte liquid is subjected to corona reaction, the guide wire is used as a cutting guide wire to assist in cutting the lesion site.

[0005] Further, the diameter of the inner support rod is less than or equal to the diameter of the entrance and the guide wire hole.

[0006] Further, the corona generator comprises at least one group of electrodes, the group of electrodes is provided with a discharge area, each group of electrodes comprises at least one first electrode connected with a positive electrode lead and at least one second electrode connected with a negative electrode lead, the first electrode and the second electrode in the group of electrodes are arranged at intervals, the first electrode and the second electrode are provided with a discharge area in contact with the electrolyte liquid filled in the cavity of the balloon to form an electric field between the first electrode and the second electrode, and the first electrode and the second electrode are fixed on the inner support rod.

[0007] Further, the positive electrode lead and the negative electrode lead are provided with exposed areas connected with the first electrode and the second electrode, the exposed areas are sleeved with metal electrode sleeves, and the metal electrode sleeves are connected and fixed with the first electrode and the second electrode.

[0008] Further, the first electrode and the second electrode are annular, grooves are opened on the inner wall edges of the first electrode and the second electrode, and the metal electrode sleeves are fixed on the grooves.

[0009] Further, the outer walls of the first electrode and the second electrode are respectively provided with first insulation layers and second insulation layers at positions other than the discharge areas to expose the discharge areas.

[0010] Further, the first electrode is provided with at least one first through hole, and the second electrode is provided with at least one second through hole, the first through hole and the second through hole respectively form a discharge area, the first insulating layer completely covers the first electrode except the first through hole, and the second insulating layer completely covers the second electrode except the second through hole, so as to form a directional electric field between the first electrode and the second electrode.

[0011] Further, the electrode group is provided with one group, including a first electrode and a second electrode.

[0012] Further, the electrode group is provided with one group, including a first electrode and a second electrode.

[0013] Further, the electrode group is provided with two groups, one of which includes two first electrodes and a second electrode, and the other of which includes a first electrode and a second electrode.

[0014] Compared with the prior art, the present application has the following advantages:

[0015] 1. By arranging an external guide wire on the balloon tip, the guide wire can be guided into the blood vessel and reach the lesion site, and the electric signal sent by the electric source pulse generator can be received by the corona generator under the action of the pulse electric signal, so that the electrolyte liquid generates a corona reaction, the electrolyte liquid generates molecular ionization, the vapor bubble generated by the molecular ionization extrudes the electrolyte liquid to increase the pressure in the balloon, and the balloon is driven to expand radially along the inner tube to make the guide wire adhere to the blood vessel wall, so that the stress of the guide wire on the inner wall of the blood vessel is more concentrated, and the guide wire can play the role of a cutting guide wire.

[0016] 2. At the same time, the external guide wire can increase the accommodation space of the electrolyte in the balloon, thereby reducing the resistance value in the balloon, increasing the pulse current, increasing the vapor bubble, and enhancing the external expansion force.

[0017] 3. The present application also reduces the overall through diameter of the balloon, and the through diameter of the balloon in the folded state is mainly determined by the outer diameter of the inner support tube. Since the inner support rod does not have a guide wire through hole, the outer diameter of the inner support tube can be reduced to more than 1 / 2 of the inner tube of the general balloon in the prior art, so that the balloon can reach a more distal end of the blood vessel lesion. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is a structural schematic diagram of the present application.

[0019] Figure 2 is Figure 1 a sectional view in the A-A direction of

[0020] Figure 3 is Figure 1Cross-sectional view in the direction of B-B.

[0021] Figure 4 is Figure 1 Close-up view of the identification C.

[0022] Figure 5 is the structural schematic of the electrode group of the present application Figure 1 .

[0023] Figure 6 is the structural schematic of the electrode group of the present application Figure 2 .

[0024] Figure 7 is the electric field schematic of the electrode group of the present application.

[0025] Figure 8 is the structural schematic of the two electrodes of the present application.

[0026] Figure 9 is the circuit schematic of the two electrodes of the present application.

[0027] Figure 10 is the structural schematic of the three electrodes of the present application.

[0028] Figure 11 is the circuit schematic of the three electrodes of the present application.

[0029] Figure 12 is the structural schematic of the two electrode groups of the present application.

[0030] Figure 13 is the circuit schematic of the two electrode groups of the present application.

[0031] Figure 14 is the schematic diagram of the present application in the blood vessel.

[0032] Figure 15 is the schematic diagram of the present application after corona discharge.

[0033] Figure 16 is the schematic diagram of the present application for crushing lesions by guide wire. DETAILED DESCRIPTION

[0034] The present application will be further described in detail below in conjunction with the drawings and examples.

[0035] In the present application, the distal end refers to the end far from the surgical operator; the proximal end refers to the end close to the surgical operator.

[0036] As Figures 1 to 4 shown, the present application discloses a guide wire external type shock wave balloon catheter, which comprises an expandable balloon 1, a catheter 2, and a guide wire 3, wherein:

[0037] The catheter 2 comprises an inner support rod 21 with elastic deformability for supporting the balloon 1 and an outer tube 22, the inner support rod 21 is arranged in the outer tube 2 coaxially, a gap is arranged between the outer tube 22 and the inner support rod 21, the inner cavity of the balloon 1 is communicated with the gap to pass in the electrolyte liquid, and the distal end of the inner support rod 21 extends from the distal end of the outer tube 22;

[0038] The proximal end of the balloon 1 is sealingly connected with the distal end of the outer tube 22, the distal end of the balloon 1 is provided with a balloon tip 5, and the balloon 1 is sealingly connected with the distal end of the inner support rod 21 through the balloon tip 5;

[0039] A corona generator is arranged at the position of the inner support rod 21 in the balloon 1 to realize the corona reaction of the electrolyte liquid in the balloon 1 through corona discharge to generate steam bubbles to expand the balloon 1, a guide wire hole 7 penetrating the distal end of the balloon tip 5 is arranged at the distal end of the balloon tip 5, the guide wire hole 7 is not communicated with the cavity of the balloon 1, and an entrance 6 communicated with the guide wire hole 7 is arranged on the balloon tip 5.

[0040] After the guide wire 3 extends into the guide wire hole 7 through the entrance 6, the guide wire 3 extends out of the distal end of the balloon tip 5, so that the guide wire 3 is partially arranged outside the balloon 1 and the catheter 2, the guide wire 3 is used for guiding the balloon 1 and assisting in cutting the lesion part after the electrolyte liquid is subjected to the corona reaction, because the guide wire arranged outside has a certain hardness and toughness, the hardness can cut the calcified tissue to a certain extent, and the toughness ensures that the guide wire will not be easily broken when the cutting force is applied. After the guide wire is sent to the lesion part in the application, the guide wire can accurately transmit the mechanical force generated after the pulse to the cut tissue, and the operator can control the pushing and rotating actions of the guide wire to make the guide wire and the calcified tissue produce relative motion, so as to realize the cutting effect.

[0041] In the application, the inner support rod 21 can be a solid circular rod or a circular rod with a hole, and is made of a high polymer material, such as Nylon (nylon), PI (polyimide) and Pebax (polyether block polyamide).

[0042] The diameter of the inner support rod 21 is less than or equal to the diameter of the entrance 6 and the guide wire hole 7.

[0043] In the application, the corona generator can be realized by the following structure, such as Figures 1 to 3As shown, the corona generator includes at least one set of electrode groups 9, each set of electrode groups 9 including at least one first electrode 91 connected to the positive lead wire and at least one second electrode 92 connected to the negative lead wire, the positive lead wire and the negative lead wire being electrically connected to the existing power pulse generator 4 through the electrical connector, the first electrode 91 and the second electrode 92 in the electrode group 9 being spaced apart, and the first electrode 91 and the second electrode 92 being provided with a discharge area 96 in contact with the electrolyte liquid filled in the cavity of the balloon 1, so as to form an electric field between the first electrode 91 and the second electrode 92. The corona generator receives the pulse electric signal sent by the power pulse generator 4, and corona discharge occurs through the discharge area 96 under the action of the pulse electric signal, so that the electrolyte liquid undergoes corona reaction, the electrolyte liquid is molecularly ionized, and the vapor bubble generated by the molecular ionization is formed at the position of the discharge area 96 and presses the electrolyte liquid, so as to increase the pressure in the balloon 1 and drive the balloon 1 to expand radially along the inner support rod 21. The first electrode 91 and the second electrode 92 are fixed on the inner support rod 21 by pasting or welding.

[0044] As shown in Figure 1 , a PET heat shrink tube 23 can be sleeved between the inner support rod 21 and the lead wire to fix the lead wire on the inner support rod 21. Of course, the inner support rod 21 and the lead wire can also be integrally formed in a co-extrusion manner.

[0045] The corona generator is placed in the electrolyte liquid during use. The corona generator receives the pulse electric signal sent by the power pulse generator 4, so that the electrolyte liquid undergoes corona reaction and is molecularly ionized. The plasma high-temperature vaporization of the surrounding liquid produces a vapor bubble. As the ionization reaction continues, the vapor bubble volume continuously expands and presses the surrounding liquid environment. Due to the characteristics of the liquid that cannot be pressed, the pressure in the balloon 1 is instantaneously increased, driving the balloon 1 to expand radially (as shown in Figure 11 ), until the ionization reaction ends and the expanded balloon returns to normal. The time of the ionization reaction is determined by the set pulse signal duration pulse width parameter.

[0046] As shown in Figure 2 , Figure 3 and Figure 6 , Figure 7 , the positive and negative lead wires are provided with exposed areas connected to the first electrode 91 and the second electrode 92, and the remaining areas of the positive and negative lead wires are wrapped with an insulating layer. The positive and negative lead wires can be sleeved with a metal electrode sleeve 94 along the exposed area of the inner tube. The metal electrode sleeve 94 is flat and is connected and fixed to the exposed area by pasting or pressing, so that the metal electrode sleeve 94 and the exposed area are tightly connected together. The metal electrode sleeve 94 and the first electrode 91 and the second electrode 92 are connected and fixed by welding.

[0047] As shown in Figure 5 and Figure 6As shown in the drawings, the first electrode 91 and the second electrode 92 are annular, specifically, circular annular, Figure 5 and Figure 6 As shown in the drawings, the first electrode 91 and the second electrode 92 are annular, specifically, circular annular, Figure 5 and Figure 6 As shown in the drawings, the first electrode 91 and the second electrode 92 are annular, specifically, circular annular,

[0048] In the present application, as shown in the drawings, Figure 2 and Figure 3 In the present application, as shown in the drawings,

[0049] As an electrode group structure of the present application, as shown in the drawings, the first electrode 91 is provided with at least one first through hole 911, and the second electrode 92 is provided with at least one second through hole 921, the first through hole 911 and the second through hole 921 respectively constitute the discharge area 96, the first insulating layer 912 completely covers the first electrode 91 except the first through hole 911, and the second insulating layer 922 completely covers the second electrode 92 except the second through hole 921, so that the first electrode 91 and the second electrode 92 receive the pulse electric signal sent by the power pulse generator 4 and form a directional electric field between the electrodes, and the electrolyte liquid generates a corona reaction under the action of the pulse electric signal. The potential distribution direction of this kind of electrode group structure is relatively concentrated, which is beneficial to reduce the heating phenomenon, the electron passing path is relatively concentrated, the resistance is relatively large, the current is reduced, the safety is increased, the internal steady state symmetrical pressure of the balloon is beneficial to the uniform expansion of the balloon as a whole. The first insulating layer 912 and the second insulating layer 922 can reduce the contact area of the first electrode 91 and the second electrode 92 with the electrolyte liquid, and release the charge in the controlled discharge area 93. Figure 7 The first through hole 911 is symmetrically arranged on the first electrode 91, the second through hole 921 is symmetrically arranged on the second electrode 92, and the two first through holes 911 and the two second through holes 921 are arranged one by one in correspondence, and the metal electrode sleeve can be arranged at any position of the inner ring wall of the first electrode 91 and the second electrode 92.

[0050] The first through hole 911 is symmetrically arranged on the first electrode 91, the second through hole 921 is symmetrically arranged on the second electrode 92, and the two first through holes 911 and the two second through holes 921 are arranged one by one in correspondence, and the metal electrode sleeve can be arranged at any position of the inner ring wall of the first electrode 91 and the second electrode 92.

[0051] The interval between the first through hole 911 on the first electrode 91 and the second through hole 921 on the second electrode 92 is 3-8mm.

[0052] As can be seen from Figure 7 , the electric field formed in the embodiment is formed in two areas between the two through holes opposite to the two electrodes, from the second through hole 921 on the second electrode 92 to the first through hole 911 on the first electrode 91, and the electrolyte liquid is subjected to corona reaction under the action of the pulse electric signal.

[0053] When the first electrode group forms the electric field, the steam bubbles generated are distributed at the positions of the first through hole 911 and the second through hole 921.

[0054] In the present application, the electrode group is made of high-temperature-resistant materials such as 304 stainless steel, 316 stainless steel, or tungsten-containing alloy, etc.; under the condition of excellent electrical conductivity, the material can withstand the high-temperature plasma corrosion generated in the corona discharge process; the electrode group is provided with a spacing to prevent the generation of electric arc between the electrodes to cause breakdown discharge, and electrolyte liquid needs to be filled between the spacing to form a conductive path environment. Under certain parameters, the longer the spacing, the greater the resistance of the conduction path, and the smaller the current of the formed path.

[0055] As shown in Figure 8 and Figure 9 , when the corona generator includes a group of electrode groups, the electrode group includes a first electrode 91 and a second electrode 92, the first electrode 91 is connected to the positive electrode of the power pulse generator 4, and the second electrode 92 is connected to the negative electrode of the power pulse generator 4; the two electrodes receive the pulse electric signal sent by the power pulse generator 4, and form an electric field between the discharge areas of the two electrodes, and the electrolyte liquid is subjected to corona reaction under the action of the pulse electric signal.

[0056] As shown in Figure 10 and Figure 11 , when the corona generator includes a group of electrode groups, the electrode group includes two first electrodes 91 and a second electrode 92, and the second electrode 92 is arranged between the two first electrodes 91 with equal spacing; wherein the two first electrodes 91 are connected to the positive electrode of the power pulse generator 4, and the second electrode 11 is connected to the negative electrode of the power pulse generator 4; the two first electrodes 91 and the second electrode 92 receive the pulse electric signal sent by the power pulse generator 4, and form an electric field between the discharge areas of the two electrodes, and the electrolyte liquid is subjected to corona reaction under the action of the pulse electric signal.

[0057] As shown in Figure 12 and Figure 13As shown, when the corona generator includes two groups of electrode groups, one group of electrode groups includes two first electrodes 91, one second electrode 92, and the other group of electrode groups includes one first electrode 91 and one second electrode 92: the second electrode 92 in the group of electrode groups 9 provided with three electrodes is arranged between the two first electrodes 91, and the electrode spacing of the two groups of electrode groups is equidistant; wherein the three first electrodes 91 are connected to the positive electrode of the power pulse generator 4, and the two second electrodes 92 are connected to the negative electrode of the power pulse generator 4; the two groups of electrode groups 9 receive the pulse electric signal sent by the power pulse generator 4, and form an electric field between the electrodes thereof, and under the action of the pulse electric signal, the electrolyte liquid undergoes a corona reaction; preferably, the first electrodes 91 and the second electrodes 92 in the two groups of electrode groups are staggered.

[0058] As shown in Figure 9 , Figure 11 and Figure 12 , in the power pulse generator 4, one end of the capacitor C is electrically connected to the IGBT (insulated gate bipolar transistor), the IGBT is divided into two paths, one path is electrically connected to one end of the first resistor R1, and the other path is electrically connected to the relay group K, and the relay group K is electrically connected to the first electrode 91 as the positive electrode; the other end of the first resistor R1 and the other end of the capacitor C are respectively electrically connected to one end of the second resistor R2, and the other end of the second resistor R2 is electrically connected to the second electrode 92.

[0059] The capacitor C stores high-voltage charges, and the first resistor R1 and the second resistor R2 are respectively the working load of the relay group K, which protects the circuit safety; when the high-voltage charges are to be released to the electrodes, the circuit is opened through the cooperation of the IGBT (insulated gate bipolar transistor) and the relay group K, when one of the paths of the relay group K is closed, the IGBT is turned on, and the high-voltage charges stored in the capacitor C are released through the communication circuit to form a high-voltage pulse; when corona is needed to be generated between multiple electrodes at the same time or in sequence, multiple energy storage capacitors and multiple relays are cooperated to manage the opening of the circuit.

[0060] The power pulse generator 4 can set the voltage value (1000-8000V) and the time pulse width value (1-200us) of the release of charges in the circuit.

[0061] The application can be used for treating vascular stenosis and calcified lesions. When used, under the guidance of imaging, the application (shock wave balloon catheter) is introduced into the target site, i.e. the target blood vessel segment, through the guide wire 3, in the process of being introduced into the target site, the guide wire 3 does not enter the balloon 1 and the catheter 2 except entering the balloon tip 5 Figure 14As shown in the figure), the balloon 1 can pass through the narrow and calcified area smoothly in the state of not being filled with electrolyte solution, when the balloon 1 reaches the target position, the balloon 1 is filled with electrolyte liquid to a preset pressure through the catheter, and is attached to the blood vessel wall 200, at this time, the guide wire 3 is pushed to be attached to the blood vessel wall, to ensure that the balloon 1 is in full contact with the lesion area, and the pulsed high pressure is applied, so that the corona discharge is generated by the corona generator, the corona discharge phenomenon makes the electrolyte liquid produce steam bubbles 300, the electrolyte liquid is extruded, the pressure in the balloon 1 is continuously increased, and then the pressure is conducted to the target site and the guide wire 3 Figure 15 As shown in the figure), the local high stress area generated by stress concentration is beneficial to focusing energy, and the lesion 400 (calcification) is crushed in a pushing or rotating manner, Figure 16 As shown in the figure), the local high stress area generated by stress concentration is beneficial to focusing energy, and the lesion 400 (calcification) is crushed in a pushing or rotating manner, According to the degree of lesion and treatment requirements, the corona discharge can be carried out for multiple times, to ensure that the lesion site is completely removed, after each discharge, the balloon 1 can be slightly drained, so that the diameter of the balloon 1 changes, the position of the balloon expansion catheter is adjusted to cover the entire lesion area, after the treatment is completed, the internal liquid is drained, the balloon 1 is withdrawn, and the balloon expansion catheter is withdrawn out of the body, and postoperative imaging examination is carried out to confirm the patency of the blood vessel, so that the treatment effect is good, and the scheme can effectively crush the calcium in the calcified lesion in the blood vessel through the controllable instantaneous radial expansion of the balloon, so as to prepare for the subsequent treatment of the blood vessel.

[0062] The beneficial effects of the present application are as follows:

[0063] 1. In the prior art, the high temperature of the arc area in the arc discharge process will diffuse to the surrounding tissues, causing unnecessary thermal damage, while the present application adopts corona discharge, which significantly improves the effectiveness, safety, ease of operation, reusability and precise control in the process of calcified blood vessel intervention treatment.

[0064] 2. At the same time, compared with the design of the guide wire inside the catheter, the guide wire is more flexible in the operation process, the operator can control the guide wire more directly, can more accurately control the advancement and retreat of the catheter, and can more effectively play the cutting role, when the corona generator generates mechanical stress outwardly, the guide wire generates stress concentration effect, cooperates with the pulse catheter, and is convenient for crushing more stubborn calcification.

[0065] 3. The guide wire outside also increases the accommodation volume of the electrolyte in the balloon, increases the current, increases the steam bubble, generates greater mechanical stress, and thus generates greater energy, thereby improving the crushing and cutting ability of the stubborn calcification in the calcified blood vessel intervention treatment.

Claims

1. A guide wire over-the-wire shock balloon catheter, comprising a balloon (1), a catheter (2), characterized in that: The catheter (2) comprises an inner support rod (21) for supporting the balloon (1) and being deformable, an outer tube (22), the inner support rod (21) being arranged in the outer tube (22) and being coaxial, a gap being arranged between the outer tube (22) and the inner support rod (21), an inner cavity of the balloon (1) being communicated with the gap to pass the electrolyte liquid, a distal end of the inner support rod (21) extending from a distal end of the outer tube (22), a proximal end of the balloon (1) being sealingly connected with the distal end of the outer tube (22), a balloon tip (5) being arranged at a distal end of the balloon (1), the balloon (1) being sealingly connected with the distal end of the inner support rod (21) through the balloon tip (5), a corona generator being arranged at a position of the inner support rod (21) located in the balloon (1) to realize that the electrolyte liquid in the balloon (1) is subjected to corona reaction through corona discharge to generate steam bubbles to expand the balloon (1), a guide wire hole (7) being arranged at the distal end of the balloon tip (5) and penetrating a distal end of the balloon tip (5), the guide wire hole (7) not being communicated with the cavity of the balloon (1), an entrance (6) being arranged on the balloon tip (5) and being communicated with the guide wire hole (7) to extend the guide wire (3) into the guide wire hole (7) through the entrance (6) and then extend the guide wire (3) from the distal end of the balloon tip (5) to partially expose the guide wire (3) outside the balloon (1) and the catheter (2), the guide wire (3) is used for guiding the balloon (1) and assisting in cutting the lesion part after the electrolyte liquid is subjected to corona reaction. The corona generator comprises at least one group of electrodes (9), the group of electrodes (9) is provided with a discharge area (93), each group of the group of electrodes (9) comprises at least one first electrode (91) connected with a positive electrode wire and at least one second electrode (92) connected with a negative electrode wire, the first electrode (91) and the second electrode (92) in the group of electrodes (9) are arranged at intervals, the first electrode (91) and the second electrode (92) are provided with the discharge area (96) which is in contact with the electrolyte liquid filled in the cavity of the balloon (1) to form an electric field between the first electrode (91) and the second electrode (92), the first electrode (91) and the second electrode (92) are fixed on the inner support rod (21); The outer wall of the first electrode (91) and the second electrode (92) is respectively provided with a first insulating layer (912) and a second insulating layer (922) at positions other than the discharge area (96) to expose the discharge area (96); The first electrode (91) is provided with at least one first through hole (911), the second electrode (92) is provided with at least one second through hole (921), the first through hole (911) and the second through hole (921) respectively constitute the discharge area (96), the first insulating layer (912) completely covers positions of the first electrode (91) other than the first through hole (911), the second insulating layer (922) completely covers positions of the second electrode (92) other than the second through hole (921) to form a directional electric field between the first electrode (91) and the second electrode (92).

2. The over-the-wire shock balloon catheter of claim 1, wherein: The diameter of the inner support rod (21) is less than or equal to the diameter of the inlet (6) and the guide wire hole (7).

3. The over-the-wire shock balloon catheter of claim 1, wherein: The positive electrode lead and the negative electrode lead are provided with exposed areas connected with the first electrode (91) and the second electrode (92), and the exposed areas are sleeved with metal electrode sleeves (94) connected with the first electrode (91) and the second electrode (92).

4. The over-the-wire shock balloon catheter of claim 3, wherein: The first electrode (91) and the second electrode (92) are annular, and grooves (95) are formed on the inner wall edges of the first electrode (91) and the second electrode (92), and the metal electrode sleeves (94) are fixed on the grooves (95).

5. The over-the-wire shock balloon catheter according to any one of claims 1 to 4, characterized in that: The electrode group (9) is provided with one group, including one first electrode (91) and one second electrode (92).

6. The external wire guide shockwave balloon catheter according to any one of claims 1-4, characterized in that: The electrode group (9) is provided with one group, including two first electrodes (91) and one second electrode (92), and the second electrode (92) is arranged between the two first electrodes (91).

7. The external wire guide shockwave balloon catheter according to any one of claims 1-4, characterized in that: The electrode group (9) is provided with two groups, one of which includes two first electrodes (91) and one second electrode (92), and the other of which includes one first electrode (91) and one second electrode (92).

Citation Information

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