Shock wave balloon catheter with external guide wire

Abstract

The shock wave balloon catheter comprises a balloon, a catheter body and the guide wire, the catheter body comprises a deformable inner supporting rod and an outer tube which are used for supporting the balloon, the inner supporting rod is arranged in the outer tube and is coaxial with the outer tube, a gap is formed between the outer tube and the inner supporting rod, an inner cavity of the balloon is communicated with the gap so that electrolyte liquid can be introduced, and the guide wire is arranged in the inner cavity of the balloon. The far end of the inner supporting rod extends out of the far end of the outer tube, the near end of the balloon is connected with the far end of the outer tube in a sealed mode, the far end of the balloon is provided with a balloon tip, the balloon is connected with the far end of the inner supporting rod in a sealed mode through the balloon tip, a corona generator is arranged at the position, located on the balloon, of the inner supporting rod, and an inlet communicated with the guide wire hole is formed in the balloon tip. Compared with the prior art, the external guide wire is arranged at the tip end of the balloon, so that stress on the inner wall of a blood vessel is more concentrated while the balloon is guided to enter the blood vessel and reach a diseased region, and the effect that the guide wire serves as a cutting guide wire is achieved.

Description

Technical Field

[0001] The invention relates to a medical device, in particular to a guidewire externalized shock wave balloon catheter based on liquid corona discharge. Background Art

[0002] In the field of medical devices, balloon catheters are mainly used to dilate narrow blood vessels, and this treatment method has been proven to be sufficiently safe and effective. At present, balloon catheters mainly inflate balloons based on the principle of arc discharge. Arc discharge is a discharge phenomenon that forms a high-density plasma channel through a medium under high voltage. Arc discharge is a strong discharge phenomenon with the characteristics of high temperature and high current density. Arc discharge is an overall effect. The arc penetrates the medium between the electrodes to form a continuous high-temperature and high-current channel. Under a sufficiently high electric field, the liquid medium is completely broken down to form a high-density plasma channel. This process is accompanied by violent energy release and high temperature generation. The shock wave energy of arc discharge is huge and difficult to control accurately, which may cause unforeseen damage to surrounding tissues; the shock wave effect of arc discharge is strong, and although it can quickly break up calcified plaques, it has a greater impact on surrounding vascular tissues, which may cause vascular damage or other complications; the high-energy shock wave of arc discharge may cause high-risk complications such as blood vessel rupture and thrombosis; during arc discharge, the high temperature in the arc area may spread to surrounding tissues, causing unnecessary thermal damage. The shock wave effect of arc discharge is strong at one time, and it is difficult to perform multiple precise control and cumulative effect treatments. The existing technology mainly relies on the water hammer effect at the moment of outward expansion of the balloon to break up calcification, because the balloon is generally a thin film made of polymer material with a soft hardness. At the same time, since the guide wire is built into the inner tube of the balloon, the balloon will pass through a larger outer diameter and enter the calcified part of the blood vessel. The current after the excitation pulse is small, and the outward expansion force may be insufficient. During clinical treatment, the catheter may not be able to break up calcification. Summary of the invention

[0003] The purpose of the present invention is to provide a shock wave balloon catheter with an external guidewire. The technical problem to be solved is to reduce the overall outer diameter of the balloon catheter and to make the external guidewire produce stress concentration, thereby increasing the pulse energy and enabling the guidewire to achieve cutting effect.

[0004] To solve the above problems, the present invention adopts the following technical solutions: a guidewire external shock wave balloon catheter, comprising a balloon, a catheter, and a guidewire, wherein the catheter comprises an inner support rod and an outer tube for supporting the balloon and being deformable, wherein the inner support rod is arranged inside the outer tube and is coaxial, wherein a gap is arranged between the outer tube and the inner support rod, wherein the inner cavity of the balloon is connected to the gap to allow electrolyte liquid to pass through, wherein the distal end of the inner support rod extends from the distal end of the outer tube, wherein the proximal end of the balloon is sealedly connected to the distal end of the outer tube, wherein a balloon tip is arranged at the distal end of the balloon, wherein the balloon is sealedly connected to the distal end of the inner support rod via the balloon tip, wherein the inner support rod is located at the distal end of the balloon. A corona generator is provided at the position of the balloon to achieve a corona reaction of the electrolyte liquid in the balloon through corona discharge, thereby generating steam bubbles to expand the balloon. A guide wire hole is provided at the distal end of the balloon tip and passes through the distal end of the balloon tip. The guide wire hole is not connected to the cavity of the balloon. An entry port connected to the guide wire hole is provided on the balloon tip, so that after the guide wire is inserted into the guide wire hole through the entry port, it is extended from the distal end of the balloon tip, so that the guide wire portion is placed outside the balloon and the catheter. In addition to guiding the balloon, the guide wire is also used as a cutting guide wire to assist in cutting the lesion after the electrolyte liquid has a corona reaction.

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

[0006] Furthermore, the corona generator includes at least one electrode group, and a discharge area is arranged on the electrode group. Each electrode group includes at least one first electrode connected to the positive electrode wire and at least one second electrode connected to the negative electrode wire. The first electrode and the second electrode in the electrode group 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 so that an electric field is formed between the first electrode and the second electrode. The first electrode and the second electrode are fixed on the inner support rod.

[0007] Furthermore, the positive and negative electrode wires are provided with exposed areas connected to the first electrode and the second electrode, and the exposed areas are covered with metal electrode sleeves, which are connected and fixed to the first electrode and the second electrode.

[0008] Furthermore, the first electrode and the second electrode are ring-shaped, and grooves are formed on the inner wall edges of the first electrode and the second electrode, and the metal electrode sleeves are fixed on the grooves.

[0009] Furthermore, in the outer walls of the first electrode and the second electrode, other positions except the discharge area are respectively provided with a first insulating layer and a second insulating layer to expose the discharge area.

[0010] Furthermore, at least one first through hole is provided on the first electrode, and at least one second through hole is provided on the second electrode, the first through hole and the second through hole respectively constitute a discharge area, the first insulating layer completely covers the other positions of the first electrode except the first through hole, and the second insulating layer completely covers the other positions of 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] Furthermore, the electrode group is provided as a group, including a first electrode and a second electrode.

[0012] Furthermore, the electrode group is provided as a group, including two first electrodes and one second electrode, and the second electrode is provided between the two first electrodes.

[0013] Furthermore, the electrode group is provided with two groups, wherein one electrode group includes two first electrodes and one second electrode, and the other electrode group includes one first electrode and one second electrode.

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

[0015] 1. By setting an external guide wire on the tip of the balloon, the balloon is guided into the blood vessel and reaches the lesion site, while the corona generator receives the pulse electric signal sent by the power pulse generator. Under the action of the pulse electric signal, the electrolyte liquid undergoes a corona reaction, the electrolyte liquid produces molecular ionization, and the steam bubbles generated by the molecular ionization squeeze the electrolyte liquid to increase the pressure inside the balloon, drive the balloon to expand radially along the inner tube, so that the guide wire can be close 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 function as a cutting guide wire;

[0016] 2. At the same time, the external guide wire can increase the space for electrolytes inside the balloon, thereby reducing the internal resistance of the balloon, increasing the pulse current, enlarging the steam bubble, and enhancing the outward expansion force.

[0017] 3. The present invention also reduces the overall outer diameter of the balloon. The outer 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 of the present invention 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 a general balloon in the prior art, so that the balloon can reach a more distal end of the vascular lesion. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0019] Figure 2 yes Figure 1 Cross-sectional view along the AA direction.

[0020] Figure 3 yes Figure 1Cross-sectional view along the BB direction.

[0021] Figure 4 yes Figure 1 A partial enlarged view of the area marked with C.

[0022] Figure 5 The structure of the electrode group of the present invention is shown in FIG. Figure 1 .

[0023] Figure 6 The structure of the electrode group of the present invention is shown in FIG. Figure 2 .

[0024] Figure 7 Schematic diagram of the electric field of the electrode group of the present invention.

[0025] Figure 8 It is a schematic diagram of the structure of two electrodes of the present invention.

[0026] Fig. 9 It is a circuit diagram of two electrodes of the present invention.

[0027] Fig.10 It is a schematic structural diagram of the present invention with three electrodes.

[0028] Fig.11 It is a circuit diagram of the present invention with three electrodes.

[0029] Fig.12 It is a schematic diagram of the structure of two electrode groups of the present invention.

[0030] Fig.13 It is a circuit diagram of two electrode groups of the present invention.

[0031] Fig.14 It is a schematic diagram of the present invention entering into a blood vessel.

[0032] Fig.15 It is a schematic diagram after corona discharge of the present invention.

[0033] Fig.16 Schematic diagram of the guide wire of the present invention crushing the lesion. DETAILED DESCRIPTION

[0034] The present invention is further described in detail below with reference to the accompanying drawings and embodiments.

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

[0036] like Figures 1 to 4 As shown, the present invention discloses a guidewire external shock wave balloon catheter, comprising an expandable balloon 1, a catheter 2, and a guidewire 3, wherein:

[0037] The catheter 2 includes an inner support rod 21 and an outer tube 22 for supporting the balloon 1 and having elastic deformation. The inner support rod 21 is arranged in the outer tube 2 and is coaxial. A gap is provided between the outer tube 22 and the inner support rod 21. The inner cavity of the balloon 1 is connected to the gap to allow electrolyte liquid to pass through. 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 sealed and connected to the distal end of the outer tube 22. The distal end of the balloon 1 is provided with a balloon tip 5. The balloon 1 is sealed and connected to the distal end of the inner support rod 21 via the balloon tip 5.

[0039] A corona generator is provided at the position where the inner support rod 21 is located in the balloon 1, so as to realize a corona reaction in the electrolyte liquid in the balloon 1 through corona discharge, thereby generating steam bubbles to expand the balloon 1; a guide wire hole 7 penetrating the distal end of the balloon tip 5 is provided at the distal end thereof, the guide wire hole 7 is not connected to the cavity of the balloon 1, and an entry port 6 connected to the guide wire hole 7 is provided on the balloon tip 5.

[0040] After the guide wire 3 is inserted into the guide wire hole 7 through the entrance 6, it extends from the distal end of the balloon tip 5, so that the guide wire 3 is partially placed outside the balloon 1 and the catheter 2. In addition to being used to guide the balloon 1, the guide wire 3 is used as a cutting guide wire to assist in cutting the lesion after the electrolyte liquid has a corona reaction. Since the external guide wire has a certain hardness and toughness, its hardness can cut the calcified tissue to a certain extent, and the toughness of the guide wire ensures that it will not break easily when the cutting force is applied. After the present invention is delivered to the lesion site through the external guide wire, the guide wire can accurately transmit the mechanical force generated after the pulse to the cut tissue, and the operator controls the pushing and rotating action of the guide wire to make the guide wire and the calcified tissue produce relative movement, thereby achieving a cutting effect.

[0041] In the present invention, the inner support rod 21 can be a solid round rod or a round rod with a central hole. The inner support rod 21 is made of polymer materials, such as Nylon, PI (polyimide), and Pebax (polyether block polyamide).

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

[0043] In the present invention, the corona generator can be implemented by the following structures: Figures 1 to 3As shown, the corona generator includes at least one electrode group 9, each electrode group 9 includes at least one first electrode 91 connected to the positive wire and at least one second electrode 92 connected to the negative wire, the positive wire and the negative wire are electrically connected to the existing power pulse generator 4 through electrical connectors, the first electrode 91 and the second electrode 92 in the electrode group 9 are arranged at intervals, and a discharge area 96 in contact with the electrolyte liquid filled in the cavity of the balloon 1 is provided on the first electrode 91 and the second electrode 92, so that an electric field is formed 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 under the action of the pulse electric signal, corona discharge is performed through the discharge area 96 to cause a corona reaction in the electrolyte liquid, the electrolyte liquid produces molecular ionization, and steam bubbles generated by the molecular ionization are formed at the position of the discharge area 96, and the electrolyte liquid is squeezed to increase the pressure in the balloon 1, driving the balloon 1 to expand radially along the inner support rod 21, and the first electrode 91 and the second electrode 92 are fixed to the inner support rod 21 by gluing or welding.

[0044] like Figure 1 As shown, a PET heat shrink tube 23 may be provided between the inner support rod 21 and the wire to fix the wire on the inner support rod 21. Of course, the inner support rod 21 and the wire may also be integrally formed by co-extrusion.

[0045] The corona generator is placed in the electrolyte liquid when in use. The corona generator receives the pulse electrical signal sent by the power pulse generator 4, causing the electrolyte liquid to undergo a corona reaction, causing the liquid to produce molecular ionization; the plasma generated by the molecular ionization vaporizes the surrounding liquid at high temperature to produce steam bubbles; as the ionization reaction continues, the volume of the steam bubbles continues to expand and squeeze the surrounding liquid environment. Due to the non-squeezable nature of the liquid, the internal pressure of the balloon 1 is forced to increase instantly, driving the balloon 1 to expand radially (such as Fig.11 The time of the ionization reaction is determined by the setting pulse signal duration and pulse width parameters.

[0046] like Figure 2 , Figure 3 and Figure 6 , Figure 7 As shown, exposed areas connected to the first electrode 91 and the second electrode 92 are provided on the positive and negative electrode wires, and the remaining areas of the positive and negative electrode wires are wrapped with insulating layers. The positive and negative electrode wires can be provided with metal electrode sleeves 94 along the exposed areas of the inner tubes. The metal electrode sleeves 94 are flat and are connected and fixed to the exposed areas by gluing or pressing, so that the metal electrode sleeves 94 are tightly connected to the exposed areas. The metal electrode sleeves 94 are connected and fixed to the first electrode 91 and the second electrode 92 by welding.

[0047] like Figure 5 and Figure 6As shown, in the present invention, the first electrode 91 and the second electrode 92 are ring-shaped, specifically circular ring-shaped, Figure 5 and Figure 6 Taking the first electrode 91 as an example, a groove 95 is formed on the inner wall edge of the first electrode 91 and the second electrode 92, and the metal electrode sleeve 94 is welded on the groove 95. Specifically, the overall size of the groove 95 can be smaller than the overall size of the metal electrode sleeve 94, so as to form a contact position on the first electrode 91 and the second electrode 92 that can be welded with the metal electrode sleeve 94. Figure 5 and Figure 6 At the position of “X” shown in FIG. 8 , the metal electrode sleeve 94 is connected with the first electrode 91 and the second electrode 92 .

[0048] In the present invention, Figure 2 and Figure 3 As shown, in the outer walls of the first electrode 91 and the second electrode 92, the first insulating layer 912 and the second insulating layer 922 are respectively provided at positions other than the discharge region 96 to expose the discharge region 96 and insulate the remaining positions, so that the electrodes receive the pulse electrical signals sent by the power pulse generator 4 and form a directional electric field between the electrodes.

[0049] As an electrode group structure of the present invention, Figure 7 As shown, at least one first through hole 911 is provided on the first electrode 91, and at least one second through hole 921 is provided on the second electrode 92. The first through hole 911 and the second through hole 921 respectively constitute a discharge area 96. The first insulating layer 912 completely covers the other positions of the first electrode 91 except the first through hole 911, and the second insulating layer 922 completely covers the other positions of 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, so that the electrolyte liquid undergoes a corona reaction under the action of the pulse electric signal. The potential distribution direction of this electrode group structure is relatively concentrated, which is conducive to reducing the heating phenomenon, the electron passing path is relatively concentrated, the resistance is relatively large, the current is reduced, the safety is increased, and it is conducive to the steady-state symmetrical pressurization inside the balloon, so that the balloon expands uniformly as a whole. The first insulating layer 912 and the second insulating layer 922 can reduce the contact area between the first electrode 91 and the second electrode 92 and the electrolyte liquid, and release the charge in the controlled discharge area 93.

[0050] The first through hole 911 is symmetrically arranged on the first electrode 91 , and the second through hole 921 is symmetrically arranged on the second electrode 92 . The two first through holes 911 and the two second through holes 921 are arranged in one-to-one correspondence. 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 3-8 mm.

[0052] from Figure 7 It can be seen that the electric field formed in this embodiment forms two regions of electric field between the two through holes opposite to each other of the two electrodes, from the second through hole 921 of the second electrode 92 toward the first through hole 911 of the first electrode 91, causing the electrolyte liquid to undergo a corona reaction under the action of the pulse electric signal.

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

[0054] In the present invention, the electrode group is made of high temperature resistant materials such as 304 stainless steel, 316 stainless steel or tungsten alloy; the material can withstand the high temperature plasma thermal erosion generated during the corona discharge process while meeting the requirements of excellent conductivity; the electrode group is set with a spacing to prevent arcing between electrodes and causing breakdown discharge, and the spacing needs to be filled with electrolyte liquid to form a conductive path environment. Under certain parameters, the longer the spacing, the greater the resistance of the conductive path, and the smaller the path current formed.

[0055] like Figure 8 and Fig. 9 As shown, 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 electrical signal of the power pulse generator 4, and an electric field is formed between the discharge areas of the electrodes, and the electrolyte liquid undergoes a corona reaction under the action of the pulse electrical signal.

[0056] like Fig.10 and Fig.11 As shown, when the corona generator includes a group of electrode groups, the electrode group includes two first electrodes 91 and one 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 one second electrode 92 receive the pulse electrical signal sent by the power pulse generator 4, and form an electric field between the discharge areas of the two electrodes, so that the electrolyte liquid undergoes a corona reaction under the action of the pulse electrical signal.

[0057] like Fig.12 and Fig.13As shown, when the corona generator includes two groups of electrode groups, one of the electrode groups includes two first electrodes 91 and one second electrode 92, and the other electrode group includes a first electrode 91 and a second electrode 92: in one electrode group 9 with three electrodes, the second electrode 92 is arranged between the two first electrodes 91, and the electrodes of the two electrode groups are arranged at equal distances; 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 electrode groups 9 receive the pulse electrical signal sent by the power pulse generator 4, and form an electric field between their respective electrodes, so that the electrolyte liquid undergoes a corona reaction under the action of the pulse electrical signal; preferably, the first electrodes 91 and the second electrodes 92 in the two electrode groups are arranged alternately.

[0058] like Fig. 9 , Fig.11 and Fig.12 As shown, one end of the capacitor C in the power pulse generator 4 is electrically connected to the IGBT (insulated gate bipolar transistor), and 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] Capacitor C stores high-voltage charges, and the first resistor R1 and the second resistor R2 are respectively the working loads at both ends of the relay group K to protect the circuit safety; when the high-voltage charge needs to be released to the electrode, the circuit is opened and closed by the cooperation of IGBT (insulated gate bipolar transistor) and relay group K. When one of the switches of relay group K is closed, the IGBT is turned on, and the high-voltage charge stored in capacitor C is released through the connecting circuit to form a high-voltage pulse; when corona needs to be generated between multiple pairs of electrodes simultaneously or sequentially, multiple energy storage capacitors and multiple relays are coordinated to manage the circuit opening and closing.

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

[0061] The present invention can be used to treat vascular stenosis and calcified lesions. When in use, under the guidance of imaging, the present invention (shock wave balloon catheter) is introduced into the target site, i.e., the target blood vessel segment, through the guide wire 3. During the introduction into the target site, the guide wire 3 does not enter the balloon 1 and the catheter 2 except for entering the balloon tip 5 ( Fig.14When the balloon 1 is not filled with electrolyte solution, the balloon 1 can smoothly pass through the narrow and calcified areas; when the balloon 1 reaches the target position, the electrolyte liquid is filled into the balloon 1 through the catheter to a preset pressure, so that it adheres to the blood vessel wall 200. At this time, the guide wire 3 is pushed to fit the blood vessel wall to ensure that the balloon 1 is in full contact with the lesion area. A pulsed high voltage is applied to make the corona generator generate corona discharge. The corona discharge phenomenon causes the electrolyte liquid to generate steam bubbles 300, which squeeze the electrolyte liquid and increase the pressure in the balloon 1 continuously, thereby transmitting the pressure to the target part and the guide wire 3 ( Fig.15 As shown in FIG. 1 ), the local high stress area generated by stress concentration is conducive to focusing energy, and the lesion 400 (calcification) is crushed by pushing or rotating ( Fig.16 As shown), the efficiency of calcification crushing is improved. Stress concentration will also bring about a large local mechanical force, which can cooperate with the corona generating device to crush the calcified material and expand the blood vessel cavity; according to the degree of the lesion and the treatment needs, multiple corona discharges can be performed to ensure that the lesion site is completely cleared. After each discharge, the balloon 1 can discharge liquid slightly to change its diameter, and the position of the balloon dilatation catheter is adjusted to cover the entire lesion area. After the treatment is completed, the internal liquid is drained, the balloon 1 is retracted, and the balloon dilatation catheter is withdrawn from the body. After the operation, an imaging examination is performed to confirm that the blood vessels are unobstructed, thereby achieving a good therapeutic effect; this solution can effectively crush the calcium in the calcified lesions in the blood vessels through the controllable instantaneous radial expansion of the balloon, preparing for subsequent vascular treatment.

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

[0063] 1. In the prior art, during arc discharge, the high temperature in the arc area will spread to the surrounding tissues, causing unnecessary thermal damage. However, the present invention adopts corona discharge, which significantly improves the effectiveness, safety, ease of operation, reusability and precise control during the interventional treatment of calcified blood vessels.

[0064] 2. At the same time, compared with the design of the guidewire inside the catheter, the external guidewire is more flexible during the operation. The operator can control the guidewire more directly, and can control the advancement and withdrawal of the catheter more accurately, and can play a more effective cutting role. When the corona generator generates mechanical stress outward, the guidewire produces a stress concentration effect, which cooperates with the pulse catheter to break up more stubborn calcifications.

[0065] 3. The externalization of the guidewire will also increase the volume of electrolytes inside the balloon, increase the current, increase the size of the steam bubbles, generate greater mechanical stress, and thus generate greater energy, thereby improving the ability to crush and cut stubborn calcifications during interventional treatment of calcified blood vessels.

Claims

1. A guidewire external shock wave balloon catheter, comprising a balloon (1) and a catheter (2), characterized in that: The catheter (2) also includes a guide wire (3). The catheter (2) includes an inner support rod (21) and an outer tube (22) for supporting the balloon (1). The inner support rod (21) is coaxially arranged in the outer tube (2). A gap is arranged between the outer tube (22) and the inner support rod (21). The inner cavity of the balloon (1) is connected to the gap so as to allow electrolyte liquid to flow in. The distal end of the inner support rod (21) extends from the distal end of the outer tube (22). The proximal end of the balloon (1) is sealedly connected to the distal end of the outer tube (22). The distal end of the balloon (1) is provided with a balloon tip (5). The balloon (1) is sealedly connected to the distal end of the inner support rod (21) via the balloon tip (5). A corona generator is provided at the position where the inner support rod (21) is located in the balloon (1). The invention realizes that the electrolyte liquid in the balloon (1) generates a corona reaction through corona discharge, and generates steam bubbles to expand the balloon (1). A guide wire hole (7) penetrating the distal end of the balloon tip (5) is provided at the distal end of the balloon tip (5), and the guide wire hole (7) is not connected to the cavity of the balloon (1). An entry port (6) connected to the guide wire hole (7) is provided on the balloon tip (5), so that the guide wire (3) is inserted into the guide wire hole (7) through the entry port (6) and then extends from the distal end of the balloon tip (5), so that the guide wire (3) is partially placed outside the balloon (1) and the catheter (2). In addition to being used to guide the balloon (1), the guide wire (3) is also used as a cutting guide wire to assist in cutting the lesion after the electrolyte liquid generates a corona reaction.

2. The guidewire externalized shock wave balloon catheter according to claim 1, characterized in that: The diameter of the inner support rod (21) is smaller than or equal to the diameter of the inlet (6) and the guide wire hole (7).

3. The guidewire externalized shock wave balloon catheter according to claim 2, characterized in that: The corona generator comprises at least one electrode group (9), and a discharge area (93) is arranged on the electrode group (9). Each electrode group (9) comprises at least one first electrode (91) connected to a positive electrode wire and at least one second electrode (92) connected to a negative electrode wire. The first electrodes (91) and the second electrodes (92) in the electrode group (9) are arranged at intervals. The first electrodes (91) and the second electrodes (92) are provided with a discharge area (96) in contact with an electrolyte liquid filled in a cavity of the balloon (1), so that an electric field is formed between the first electrodes (91) and the second electrodes (92). The first electrodes (91) and the second electrodes (92) are fixed on an inner support rod (21).

4. The guidewire externalized shock wave balloon catheter according to claim 3, characterized in that: The positive and negative electrode wires are provided with exposed areas connected to the first electrode (91) and the second electrode (92), and the exposed areas are covered with a metal electrode sleeve (94), which is connected and fixed to the first electrode (91) and the second electrode (92).

5. The guidewire externalized shock wave balloon catheter according to claim 4, characterized in that: The first electrode (91) and the second electrode (92) are annular in shape, and grooves (95) are provided on the inner wall edges of the first electrode (1) and the second electrode (92), and the metal electrode sleeve (94) is fixed on the groove (95).

6. The guidewire externalized shock wave balloon catheter according to claim 5, characterized in that: In the outer walls of the first electrode (91) and the second electrode (92), other positions except the discharge region (96) are respectively provided with a first insulating layer (912) and a second insulating layer (922) to expose the discharge region (96).

7. The guidewire externalized shock wave balloon catheter according to claim 6, characterized in that: 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 a discharge region (96), the first insulating layer (912) completely covers other positions of the first electrode (91) except the first through hole (911), and the second insulating layer (922) completely covers other positions of the second electrode (92) except the second through hole (921), so as to form a directional electric field between the first electrode (91) and the second electrode (92).

8. The guidewire externalized shock wave balloon catheter according to any one of claims 3 to 7, characterized in that: The electrode group (9) is provided with a group, including a first electrode (91) and a second electrode (92).

9. The guidewire externalized shock wave balloon catheter according to any one of claims 3 to 7, characterized in that: The electrode group (9) is provided with a group, comprising two first electrodes (91) and a second electrode (92), wherein the second electrode (92) is provided between the two first electrodes (91).

10. The guidewire externalized shock wave balloon catheter according to any one of claims 3 to 7, characterized in that: The electrode groups (9) are provided in two groups, wherein one electrode group (9) comprises two first electrodes (91) and one second electrode (92), and the other electrode group (9) comprises one first electrode (91) and one second electrode (92).

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