CN116322534A

CN116322534A - Balloon catheter

Info

Publication number: CN116322534A
Application number: CN202180063040.9A
Authority: CN
Inventors: 秦泗海; 向章; 陈佳; 胡清; 李文松
Original assignee: Kossel Medtech Suzhou Co ltd
Current assignee: Kossel Medtech Suzhou Co ltd
Priority date: 2021-11-18
Filing date: 2021-11-18
Publication date: 2023-06-23
Also published as: WO2023087198A1

Abstract

The invention relates to a balloon catheter, which comprises an inner tube, an insulating tube, a balloon body, a conductive assembly, a conductive liquid and at least one electrode pair, wherein: the insulating tube is sleeved on the inner tube and is positioned in the bag body; the inner tube penetrates through the capsule body, and a conductive liquid is filled between the inner tube and the capsule body; each electrode pair comprises a first electrode and a second electrode which form an anode and a cathode, the first electrode and the second electrode are sleeved on the insulating tube at intervals and are respectively connected with the conductive component; in the balloon catheter, the impact wave energy generated by the electrode pair diverges and propagates perpendicular to the axial direction of the blood vessel, so that the breaking treatment capacity of calcified lesions is improved, the energy dissipated in the blood vessel is reduced, the output energy of equipment is reduced, and the operation safety is improved; and the electrode pair size is reduced, the outline size of the balloon catheter is reduced, the balloon catheter can pass through a lesion position more easily, the damage to the insulating tube, the inner tube and other parts when the shock wave occurs is reduced, and the service life of the balloon catheter is prolonged.

Description

Balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter.

Background

Vascular calcification (vascular calcification) is a common pathological manifestation commonly found in atherosclerosis, hypertension, diabetic vascular lesions, vascular injury, chronic kidney disease, aging, etc., and in recent years, the occurrence of vascular calcification tends to increase year by year due to the influence of diet, lifestyle, etc.

At present, the balloon dilation is carried out by using precise instruments such as a catheter, a guide wire and the like to send the balloon catheter into a lesion area of atherosclerosis or stenosis in a human body under the guidance of medical imaging equipment, and the balloon is inflated to dilate and reconstruct the stenosis part of a blood vessel or a non-blood vessel pipeline by the balloon so as to dilate the blood vessel to improve the blood flow, thereby carrying out local treatment on the disease states such as cardiovascular diseases and the like in the human body. However, for moderate or severe calcified lesions, even if the balloon inflation pressure is high, usually 20atm to 30atm, it is difficult to fully dilate the calcified lesion, and the balloon is very easily retracted after dilation to cause restenosis; and the high-pressure expansion is adopted, so that the pressure on the wall of the blood vessel is suddenly changed, and the damage and the rupture of the blood vessel are easily caused. In addition, the calcified lesions have high density, slow absorption of the medicine and poor treatment effect, and the easily disintegrated carrier is favorable for releasing the medicine, but gradually disintegrates in the process of delivering the medicine, so that the medicine is released, the medicine quantity reaching the treatment part is less, and the effect of treatment is not realized; while the carrier which is not easy to disintegrate reduces the loss of the medicine in the balloon conveying process, the medicine is released for a long time after the balloon reaches the part to be treated, so that the operation time is prolonged, and the operation risk is increased.

In order to solve the problem, the treatment with better effect can be realized, the current balloon catheter adopts the shock wave balloon catheter with the positive and negative electrode coaxial structure, the direction of shock wave generation and transmission is the vertical direction of positive and negative electrode connecting lines, the direction of the strongest shock wave energy is along the direction of blood vessels for the electrode design with the positive and negative electrode coaxial structure, the energy transmitted to the calcified lesion position is smaller, the energy utilization rate is low, when the calcified lesion is broken, the output energy of equipment is larger, the operation risk is increased, the outer diameter of the electrode is large, the final balloon catheter is large in external dimension, the calcified lesion position of blood vessels is generally narrow, and the capacity of the balloon catheter with the coaxial structure electrode for passing through the lesion is reduced. And the coaxial structure electrode, the shock wave is launched at the random position of electrode circumference, to the local calcification lesion of blood vessel common in clinic, need to improve the shock wave energy, or increase the treatment frequency, has increased the operation risk.

The current impulse voltage of the impulse wave is high, about 3000V, the fluid between the electrode pairs is completely broken down and discharged by the high voltage, the current is high, on one hand, high requirements are put on insulating materials and materials, and on the other hand, when the balloon is damaged, the high voltage or the high current can generate uncontrollable danger through a human body.

Disclosure of Invention

In view of this, it is necessary to provide a balloon catheter in order to solve the problems of high energy and large size required for the balloon catheter.

The invention provides a balloon catheter, which comprises an inner tube, an insulating tube, a balloon body, a conductive assembly, a conductive liquid and at least one electrode pair, wherein:

the insulating tube is sleeved on the inner tube and is positioned in the bag body, the insulating tube is made of super-hydrophobic material, and the surface water contact angle is larger than 150 degrees;

the inner tube penetrates through the capsule body, and the conductive liquid is filled between the inner tube and the capsule body;

and each electrode pair comprises a first electrode and a second electrode which form positive and negative electrodes, and the first electrode and the second electrode are sleeved on the insulating tube at intervals and are respectively and electrically connected with the conductive component.

In one embodiment, the number of the electrode pairs is a plurality, and the first electrodes and the second electrodes of the electrode pairs are connected in series; or, a plurality of first electrodes in a plurality of the electrode pairs are connected in parallel, and a plurality of second electrodes are connected in parallel.

In one embodiment, at least one of the first electrode and the second electrode is a protruding electrode, the protruding electrode comprising at least one electrode protrusion protruding from an end of the insulating tube. The current can be generated at the end part of the insulating tube, the distance between the two protruding electrodes is controlled to be smaller than 0.1mm-0.80mm, when the distance between the tips of the two electrodes is controlled to be 0.5mm, the voltage can be controlled to be within 1000V from the original 3000V high voltage, and the shock wave pulse can be greatly reduced through the arrangement of the protruding electrodes and the distance between the control electrodes.

Preferably, the insulating tube is sleeved on the protruding electrode, the middle-frequency short pulse is used for exciting to generate plasma arcs at the tip, the protruding electrode of the insulating tube is controlled to pre-discharge to generate seed electrons, so that the density of the seed electrons around the insulating tube is increased, and therefore diffuse uniform amplification is formed, and the discharge voltage of the electrode can be reduced to be within 400V.

In one embodiment, the protruding electrode comprises a first shaft end and a plurality of electrode protrusions, the first shaft end is sleeved on the insulating tube, and the electrode protrusions are arranged on one side of the first shaft end away from the end portion of the insulating tube.

In one embodiment, a plurality of the electrode protrusions are located on either side of the first shaft end axis.

In one embodiment, a plurality of the electrode protrusions are located on one side of the first shaft end axis.

In one embodiment, a plurality of the electrode protrusions are uniformly distributed in the circumferential direction of the first axial end.

In one embodiment, the protruding electrodes include a plurality of groups of third electrodes arranged at intervals, the third electrodes include electrode protrusions and second shaft ends, the second shaft ends are fixed on the outer side of the insulating tube, the second shaft ends of each protruding electrode are connected in parallel, and the electrode protrusions are arranged on one side of the second shaft ends away from the end of the insulating tube.

In one embodiment, the balloon catheter further comprises an outer tube, the outer tube is connected to one end of the balloon body, the conductive assembly comprises a catheter seat, a wire set and an external power supply, the wire set comprises a plurality of wires, the wires are electrically connected with the first electrode or the second electrode, the catheter seat is connected with the outer tube, a containing space is formed inside the wire set, the wires are electrically connected with the first electrode or the second electrode, and the wires pass through the balloon body, the outer tube and the containing space of the catheter seat to be connected with the external power supply.

In one embodiment, the tip of the electrode protrusion is one of rectangular, trapezoidal, circular arc, and elliptical arc.

The beneficial effects are that:

1. In the balloon catheter, the first electrode and the second electrode are sleeved on the insulating tube at intervals, so that the electrode pairs are arranged along the blood vessel direction, impact wave energy generated by the electrode pairs diverges and propagates perpendicular to the axial direction of the blood vessel, the breaking treatment capacity of calcified lesions is improved, the energy dissipated in the blood vessel is reduced, the output energy of equipment is reduced, and the operation safety is improved.

2. In the balloon catheter, the first electrode and the second electrode are sleeved on the insulating tube at intervals, so that the electrode pairs are arranged along the blood vessel direction, the electrode pair size is reduced, the outline size of the balloon catheter is reduced, and the balloon catheter can pass through a lesion position more easily.

3. In the balloon catheter, the first electrode and the second electrode are sleeved on the insulating tube, so that the electrode pair is fixed on the insulating tube, damage to the insulating tube, the inner tube and other parts when shock waves occur is reduced, and the service life of the balloon catheter is prolonged.

4. The insulating tube is made of super-hydrophobic material, so that the infiltration capacity of the conductive liquid to the insulating tube is reduced, and the insulating tube is favorably resisted from high voltage between the electrode pairs during product work.

5. In the balloon catheter, at least one of the first electrode and the second electrode is defined as the protruding electrode, and the position where the shock wave is generated is between the protruding tips of the electrodes of the electrode pair, so that the position stability of the shock wave is improved.

6. The tip of the protruding electrode is rectangular, trapezoidal, circular arc-shaped and elliptical arc-shaped, so that the stability of the shock wave emission position can be ensured, and the service life of the electrode pair can be ensured to meet the clinical practical use requirement.

drawings

FIG. 1 is a schematic view of a balloon catheter according to the present invention;

FIG. 2 is a schematic diagram of the operation of a balloon catheter according to the present invention;

FIG. 3 is a schematic view of electrical connection of an electrode pair in a balloon catheter according to the present invention;

FIG. 4 is a schematic diagram of electrical connection of another electrode pair in a balloon catheter according to the present invention;

FIG. 5 is a schematic diagram showing the distribution of electrode pairs in a balloon catheter according to the present invention;

FIG. 6 is a schematic diagram showing the distribution of another electrode pair in a balloon catheter according to the present invention;

FIG. 7 is a schematic view showing a distribution of a further electrode pair in a balloon catheter according to the present invention;

FIG. 8 is a schematic view of a protruding electrode in a balloon catheter according to the present invention;

FIG. 9 is a schematic view of another protruding electrode in a balloon catheter according to the present invention;

FIG. 10 is a schematic view of a balloon catheter according to another embodiment of the present invention;

fig. 11 is a schematic structural view of another protruding electrode in a balloon catheter according to the present invention.

Reference numerals:

10. a balloon catheter;

110. an inner tube;

120. an insulating tube;

130. a bladder;

140. a conductive assembly; 141. a wire set; 1411. a first wire; 1412. a second wire; 1413. A third wire; 1414. a fourth wire; 1415. a fifth wire; 142. an external power supply;

150. a conductive liquid;

160. an electrode pair; 161. a first electrode; 162. a second electrode; 163. protruding electrodes; 1631. the electrode protrudes; 1632. a first shaft end; 1633. a third electrode; 1634. a second axial end;

170. an outer tube;

181. lining wires; 182. a tip tube; 183. a developing ring; 184. a catheter holder;

20. a blood vessel; 21. calcified lesions.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

The following describes the technical scheme provided by the embodiment of the invention with reference to the accompanying drawings.

As shown in fig. 1 and 2, the present invention provides a balloon catheter 10, the balloon catheter 10 is used for balloon dilatation to treat calcification of a blood vessel 20, the balloon catheter 10 comprises an inner tube 110, an insulating tube 120, a balloon body 130, a conductive component 140, a conductive liquid 150 and at least one electrode pair 160, wherein:

the insulating tube 120 is sleeved on the inner tube 110, and the insulating tube 120 is positioned in the bag body 130; in a specific arrangement, the insulating tube 120 is made of a super-hydrophobic material, and the specific material may be ceramic, polytetrafluoroethylene, polyimide, phenolic resin, polyvinyl chloride, polyethylene, polypropylene, chloroprene rubber, silicone resin, polyester, mica powder, and derivative materials mixed with the above materials, however, the material of the insulating tube 120 is not limited thereto, and may be other materials capable of realizing an insulating and supporting process. And the surface water contact angle of the insulating tube 120 is greater than 150 °, specifically, the surface water contact angle of the insulating tube 120 may be 151 °, 153 °, 155 °, 157 °, 159 °, 160 °, although the surface water contact angle of the insulating tube 120 is not limited thereto and may be other values within the range of greater than 150 °.

The inner tube 110 penetrates the balloon 130, and a conductive liquid 150 is filled between the inner tube 110 and the balloon 130.

At least one electrode pair 160, each electrode pair 160 including a first electrode 161 and a second electrode 162 forming an anode and a cathode, the first electrode 161 and the second electrode 162 being sleeved on the insulating tube 120 at intervals opposite to each other, and the first electrode 161 and the second electrode 162 being electrically connected to the conductive member 140, respectively; in a specific arrangement, the number of electrode pairs 160 is one, two, three, four, or more than four; the first electrode 161 of each electrode pair 160 may be a positive electrode, the second electrode 162 may be a negative electrode, or the first electrode 161 of each electrode pair 160 may be a negative electrode, and the second electrode 162 may be a positive electrode; the first electrode 161 and the second electrode 162 are disposed at a distance, and the gap between the first electrode 161 and the second electrode 162 may be 0.1mm to 1mm, preferably, the gap between the first electrode 161 and the second electrode 162 is 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, although the gap between the first electrode 161 and the second electrode 162 is not limited to the above range, and may be other values satisfying the distance requirement.

In the balloon catheter 10, a high voltage is applied to the electrode pair 160 through the conductive member 140, and a shock wave is generated near the electrode pair 160 due to the electro-hydraulic effect and cavitation effect, and the energy of the shock wave is transmitted to the calcified lesion 21 on the wall of the blood vessel 20 through the conductive liquid 150, so that the calcified lesion 21 is broken up by the energy of the shock wave, thereby realizing the treatment of the lesion part. The first electrode 161 and the second electrode 162 are sleeved on the insulating tube 120 at intervals, so that the electrode pairs 160 are arranged along the direction of the blood vessel 20, on one hand, the impact wave energy generated by the electrode pairs 160 is ensured to be divergently transmitted perpendicular to the axial direction of the blood vessel 20, the impact wave is favorably transmitted to the calcified lesions 21, the breaking treatment capacity of the calcified lesions 21 is improved, the energy dissipated in the blood vessel 20 is reduced, the utilization rate of the impact wave energy is improved, the output energy of the equipment is reduced, and the operation safety is improved; on the other hand, the size of the electrode pair 160 can be reduced, the external dimension of the balloon catheter 10 can be reduced, and the lesion position can be more easily passed; and by limiting the first electrode 161 and the second electrode 162 to be sleeved on the insulating tube 120, the electrode pair 160 is fixed on the insulating tube 120, so that damage to the insulating tube 120, the inner tube 110 and other components when shock waves occur is reduced, and the service life of the balloon catheter 10 is prolonged. In addition, by defining the insulating tube 120 as a superhydrophobic material, the wettability of the insulating tube 120 by the conductive liquid 150 is reduced, and the balloon catheter 10 is beneficial to resist erosion of the insulating tube 120 by high voltage between the electrode pair 160 during operation.

The acoustic pressure generated by the shock wave of the capsule 130 was measured using the hydrophone, and as a result, as shown in table 1, the shock wave acoustic pressure generated by the spaced-apart opposite arrangement of the electrode pairs 160 was 2.5 times the shock wave acoustic pressure generated by the coaxial electrodes.

TABLE 1 shock wave sound pressure on balloon surface with electrodes in different arrangements

From the above table data, it can be seen that one electrode pair 160 is arranged side by side along the direction of the blood vessel 20, the propagation direction of the generated shock wave is perpendicular to the wall of the blood vessel 20, the path of the shock wave transmitted to the calcified lesion 21 is shortest, and the energy dissipation is also minimized.

The conductive assembly 140 has various structural forms, as shown in fig. 1 and 2, the balloon catheter 10 further includes an outer tube 170, the outer tube 170 is connected to one end of the balloon 130, the conductive assembly 140 includes a conductive wire set 141 and an external power source 142, the conductive wire set 141 includes a plurality of conductive wires, the conductive wires are electrically connected to the first electrode 161 or the second electrode 162, the catheter seat is connected to the outer tube 170, and a receiving space is formed inside the catheter seat, the conductive wire set 141 includes a plurality of conductive wires, the conductive wires are electrically connected to the first electrode 161 or the second electrode 162, and the conductive wires pass through the balloon 130, the outer tube 170, and the receiving space of the catheter seat to be connected to the external power source 142.

In the balloon catheter 10, the outer tube 170 leads the lead 141 from the balloon 130 to the lead holder, and further to the external power source 142, so as to apply voltage to the first electrode 161 and the second electrode 162. In a specific arrangement, the end of the balloon catheter 10 away from the catheter hub 184 further comprises a lining wire 181 and an end tube 182, the end tube 182 is inserted into and integrally connected with the balloon body 130, the end of the balloon catheter 10 away from the catheter hub comprises a developing ring 183, the developing ring 183 is arranged in the balloon body 130, and the developing ring 183 is positioned on the inner tube 110.

In order to facilitate the electrical connection between the first electrode 161, the second electrode 162 and the conductive member 140, as shown in fig. 3 and 4, in a preferred embodiment, the number of the electrode pairs 160 is plural, and the plurality of first electrodes 161 and the plurality of second electrodes 162 in the plurality of electrode pairs 160 are connected in series; alternatively, the plurality of first electrodes 161 of the plurality of electrode pairs 160 are connected in parallel, and at the same time the plurality of second electrodes 162 of the plurality of electrode pairs 160 are connected in parallel.

In the balloon catheter 10, among the plurality of electrode pairs 160, all the first electrodes 161 and all the second electrodes 162 are connected in series through the first wires 1411 in the wire set 141 and then electrically connected with the external power supply 142 through the second wires 1412 and the third wires 1413, so that the plurality of electrode pairs 160 can obtain high voltage at the same time, and further can synchronously generate shock waves, and break up calcified lesions 21 at the same time, thereby rapidly realizing the treatment of the lesion positions. Among the plurality of electrode pairs 160, all the first electrodes 161 are electrically connected with the external power supply 142 after being connected in parallel through the fourth wires 1414 in the wire set 141, and all the second electrodes 162 are electrically connected with the external power supply 142 after being connected in parallel through the third wires 1413 in the wire set 141, so that the plurality of electrode pairs 160 can generate shock waves under lower voltage, the output energy of the device is reduced, and the operation safety is improved.

In order to improve the positional stability of the occurrence of the shock wave, as shown in fig. 3, 4, 5 and 6, in a preferred embodiment, at least one of the first electrode 161 and the second electrode 162 is a protruding electrode 163, the protruding electrode 163 includes at least one electrode protrusion 1631, and the electrode protrusion 1631 is away from the end of the insulating tube 120; when specifically provided, the first electrode 161 may be the protruding electrode 163, or the second electrode 162 may be the protruding electrode 163, or both the first electrode 161 and the second electrode 162 may be the protruding electrode 163; the number of electrode protrusions 1631 in the protruding electrode 163 may be one, two, three, four, or more than four. In the balloon catheter 10, the current can be generated at the end of the insulating tube 120, the distance between the two protruding electrodes 163 is controlled to be smaller than 0.1mm-0.80mm, and when the distance between the two electrode tips is controlled to be 0.5mm, the voltage can be controlled to be within 1000V from the original 3000V high voltage, so that the shock wave pulse can be greatly reduced by the arrangement of the protruding electrodes 163 and the distance between the control electrodes. By defining at least one of the first electrode 161 and the second electrode 162 as the protruding electrode 163, the position where the shock wave is generated between the tip of the electrode protrusion 1631 of the electrode pair 160 and the other electrode or between the tips of the two electrode protrusions 1631, the positional stability where the shock wave occurs is improved. Preferably, the insulating tube 120 is arranged to be sleeved on the protruding electrode 163, and the medium-frequency short pulse excitation is used for generating plasma arcs at the tip, so that the pre-discharge at the protruding electrode of the insulating tube 120 is controlled to generate seed electrons, the density of the seed electrons around the insulating tube is increased, and therefore, the dispersive uniform amplification is formed, and the electrode discharge voltage can be reduced to be within 400V.

The protruding electrode 163 has various structural forms, and as shown in fig. 3, 4, 5 and 6, the protruding electrode 163 includes a first shaft end 1632 and a plurality of electrode protrusions 1631, the first shaft end 1632 is sleeved on the insulating tube 120, and the electrode protrusions 1631 are disposed on one side of the first shaft end 1632 away from the end of the insulating tube 120. When the electrode is specifically arranged, the first shaft end 1632 is electrically connected with the conductive component 140, the first shaft end 1632 and the electrode protrusion 1631 can be in an integrated structure, the electrode is prepared by casting, cutting and other processes, the first shaft end 1632 and the electrode protrusion 1631 can be in a split structure, and the electrode is fixed into a whole by welding, threaded connection and other processes. In the balloon catheter 10 described above, the protruding electrode 163 is provided in the form of a first axial end 1632 and a plurality of electrode protrusions 1631, so as to facilitate the installation between the protruding electrode 163 and the insulating tube 120.

The plurality of electrode protrusions 1631 may be arranged in various manners, specifically, as shown in fig. 5, the plurality of electrode protrusions 1631 are located at two sides of the axis of the first shaft end 1632, and the interval between the teeth may be flexibly selected to be uniformly arranged or non-uniformly arranged. In a specific arrangement, the plurality of electrode protrusions 1631 may be symmetrically disposed on both sides of the axis of the first shaft end 1632, and the plurality of electrode protrusions 1631 may also be asymmetrically disposed on both sides of the axis of the first shaft end 1632; in the balloon catheter 10, the plurality of electrode protrusions 1631 are defined on two sides of the axis of the first shaft end 1632, so that the two sides of the axis of the first shaft end 1632 can excite the shock waves, thereby facilitating the cutting of the lesion around the inner wall of the blood vessel 20.

The multiple electrode protrusions 1631 are arranged in multiple manners, specifically, the multiple electrode protrusions 1631 are located at one side of the axis of the first shaft end 1632, so that shock waves can be excited at one side of the axis of the first shaft end 1632, and one side lesion position of the inner wall of the blood vessel 20 can be conveniently cut, so that the method is suitable for disease treatment of the local calcified lesions 21 in the circumferential direction of the blood vessel 20, when in clinical use, the electrode positions are conveyed aiming at the calcified lesions 21, and after reaching the lesion positions, the shock waves are emitted, and the shock waves can be accurately and effectively released at the lesion positions; of course, for lesions with calcification locally in the circumferential direction of the blood vessel 20, a single-toothed protruding electrode 163 may also be used.

The plurality of electrode protrusions 1631 may be arranged in a plurality of ways, as shown in fig. 6, specifically, the plurality of electrode protrusions 1631 are uniformly distributed in the circumferential direction of the first shaft end 1632, and after a plurality of impacts are excited, shock waves can be generated in the circumferential direction, and it is ensured that the shock wave energy at any point of the circumference is relatively uniform, so as to be suitable for the treatment of the lesion of the circumferential complete calcification of the blood vessel 20.

The protruding electrodes 163 have various structural forms, as shown in fig. 7, in a preferred embodiment, the protruding electrodes 163 include a plurality of groups of third electrodes 1633, the groups of third electrodes 1633 are arranged at intervals, the third electrodes 1633 include electrode protrusions 1631 and second shaft ends 1634, the second shaft ends 1634 are fixed on the outer side of the insulating tube 120 through a snap connection, a concave-convex fit or the like, the second shaft ends of each protruding electrode 163 are connected in parallel, and the electrode protrusions 1631 are arranged on one side of the second shaft ends 1634 away from the end of the insulating tube 120; in a specific arrangement, the number of the third electrodes 1633 may be two, three, four or more than four, and the plurality of the third electrodes 1633 may be uniformly distributed along the circumferential direction of the insulating tube 120, which is, of course, not limited to this way; the second shaft end 1634 and the electrode protrusion 1631 may be in an integral structure, and may be manufactured by casting, cutting, etc., and the second shaft end 1634 and the electrode protrusion 1631 may be in a split structure, and may be fixed into an integral structure by welding, screwing, etc.

In the balloon catheter 10, the protruding electrode 163 includes a plurality of sets of third electrodes 1633, and the third electrodes 1633 include an electrode protrusion 1631 and a second axial end 1634, so that the protruding electrode 163 is disposed at a set position on the insulating tube 120, so as to be suitable for treating diseases of the local calcified lesions 21 in the circumferential direction of the blood vessel 20.

The tip shape of the electrode protrusion 1631 has various forms, as shown in fig. 8, 9, 10 and 11, in a preferred embodiment, the tip shape of the electrode protrusion 1631 is one of rectangular, trapezoidal, circular arc and elliptical arc, so that stability of the shock wave emission position can be ensured, and life of the electrode pair 160 can be ensured to meet the clinical practical use requirement, the use of a tip or needle electrode is avoided, the electrode tip can be corroded by high voltage, the electrode spacing becomes large, energy is unstable, the service life of the product is reduced, the tip shapes of all the electrode protrusions 1631 on the insulating tube 120 can be the same, the tip shapes of all the electrode protrusions 1631 on the insulating tube 120 can be different, the tip shapes of one part of the electrode protrusions 1631 on the insulating tube 120 are the same, and the tip shapes of the other part of the electrode protrusions 1631 can be different.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

A balloon catheter, which is characterized by comprising an inner tube, an insulating tube, a balloon body, a conductive component, a conductive liquid and at least one electrode pair, wherein:

the insulating tube is sleeved on the inner tube and is positioned in the bag body, the insulating tube is made of super-hydrophobic material, and the surface water contact angle is larger than 150 degrees;

the inner tube penetrates through the capsule body, and the conductive liquid is filled between the inner tube and the capsule body;

and each electrode pair comprises a first electrode and a second electrode which form positive and negative electrodes, and the first electrode and the second electrode are sleeved on the insulating tube at intervals and are respectively and electrically connected with the conductive component.
The balloon catheter of claim 1, wherein the number of electrode pairs is plural, and a plurality of first electrodes and a plurality of second electrodes of the plurality of electrode pairs are connected in series; or, a plurality of first electrodes in a plurality of the electrode pairs are connected in parallel, and a plurality of second electrodes are connected in parallel.
The balloon catheter of claim 1, wherein at least one of the first electrode and the second electrode is a protruding electrode comprising at least one electrode protrusion, the electrode protrusion being distal from an end of the insulating tube.
A balloon catheter according to claim 3, wherein the protruding electrode comprises a first shaft end and a plurality of electrode protrusions, the first shaft end being sleeved on an insulating tube, the electrode protrusions being arranged on a side of the first shaft end remote from an end of the insulating tube.
The balloon catheter of claim 4, wherein a plurality of the electrode projections are located on either side of the first shaft-end axis.
The balloon catheter of claim 4, wherein a plurality of the electrode projections are located on one side of the first shaft-end axis.
The balloon catheter of claim 4, wherein a plurality of the electrode projections are evenly distributed circumferentially at the first axial end.
A balloon catheter according to claim 3, wherein the protruding electrodes comprise a plurality of sets of third electrodes arranged at intervals, the third electrodes comprising the electrode protrusions and a second axial end, the second axial end being fixed outside the insulating tube, the second axial ends of each protruding electrode being connected in parallel, the electrode protrusions being arranged on the side of the second axial end remote from the end of the insulating tube.
The balloon catheter of claim 1, further comprising an outer tube connected to one end of the balloon, the conductive assembly comprising a catheter hub, a wire set, and an external power source, the wire set comprising a plurality of wires, the wires being electrically connected to the first electrode or the second electrode, the catheter hub being connected to the outer tube and having a receiving space formed therein, the wire set comprising a plurality of wires, the wires being electrically connected to the first electrode or the second electrode and being connected to the external power source through the balloon, the outer tube, and the receiving space of the catheter hub.
The balloon catheter of claim 1, wherein the tip of the electrode protrusion is one of rectangular, trapezoidal, circular arc, elliptical arc in shape.