Balloon catheter
By using a superhydrophobic insulating tube and electrode pairs arranged along the blood vessel direction in a balloon catheter, combined with prominent electrodes and mid-frequency short pulse excitation, the problems of difficulty in expanding calcified lesions and uneven drug release in existing technologies have been solved, achieving a more efficient and safer treatment effect.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- KOSSEL MEDTECH (SUZHOU) CO LTD
- Filing Date
- 2021-11-18
- Publication Date
- 2026-07-21
AI Technical Summary
Existing balloon catheters are difficult to fully dilate when treating moderate or severe calcified lesions, are prone to retraction, leading to restenosis, and high-pressure dilation may damage blood vessels. Uneven drug release increases surgical risks. Coaxial electrodes have low energy utilization and large device size, making them difficult to pass through stenotic lesions.
A balloon catheter is designed using an insulating tube made of superhydrophobic material. Electrode pairs are arranged along the direction of the blood vessel. A plasma arc is generated using protruding electrodes and mid-frequency short pulse excitation. The electrode spacing is controlled to reduce voltage, improve energy utilization and device safety.
It improves the ability to break up calcified lesions, reduces the energy output of the device, enhances surgical safety, reduces equipment damage, simplifies the passage through narrow lesions, and extends the service life.
Smart Images
Figure CN116322534B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a balloon catheter. Background Technology
[0002] Vascular calcification is a common pathological manifestation in atherosclerosis, hypertension, diabetic vascular lesions, vascular damage, chronic kidney disease, and aging. In recent years, the incidence of vascular calcification has been increasing year by year due to the influence of diet and lifestyle.
[0003] Currently, balloon angioplasty, guided by medical imaging equipment, uses precise instruments such as catheters and guidewires to insert a balloon catheter into the lesion area of atherosclerosis or stenosis in the body. Inflation of the balloon expands the narrowed area of the blood vessel or non-vascular passage, improving blood flow and providing local treatment for cardiovascular diseases. However, for moderate or severe calcified lesions, even with high balloon inflation pressure (usually 20-30 atm), it is difficult to completely dilate the calcified lesion, and it is prone to recoil after dilation, causing restenosis. High-pressure dilation can cause sudden pressure changes in the blood vessel wall, easily leading to vascular damage and rupture. Furthermore, the high density of calcified lesions results in slow drug absorption and poor treatment efficacy. While easily disintegrating carriers facilitate drug release, they gradually disintegrate during delivery, releasing less drug to the treatment site, thus failing to achieve a therapeutic effect. Conversely, while non-disintegrating carriers reduce drug loss during balloon delivery, the drug release time after the balloon reaches the treatment site is longer, prolonging the procedure and increasing surgical risks.
[0004] To address this issue and achieve better treatment results, current balloon catheters utilize a coaxial structure of positive and negative electrodes for shockwave therapy. The shockwave is generated and propagated perpendicular to the line connecting the positive and negative electrodes. With this coaxial electrode design, the strongest shockwave energy is delivered along the blood vessel, resulting in lower energy reaching the calcified lesion site, leading to low energy utilization. When breaking up the calcified lesion, the device outputs significant energy, increasing surgical risk. Furthermore, this electrode has a large outer diameter, resulting in a large overall size of the balloon catheter. Since calcified lesions are generally located in narrow areas, the coaxial electrode reduces the balloon catheter's ability to pass through the lesion. Additionally, with coaxial electrodes, the shockwave is emitted randomly around the electrode circumference. For common localized vascular calcifications, higher shockwave energy or more treatment sessions are needed, further increasing surgical risk.
[0005] Furthermore, the current shock wave pulse voltage is relatively high, about 3000 volts. The high voltage causes the fluid between the electrode pairs to completely break down and discharge, resulting in a large current. On the one hand, this places high demands on the insulation materials and the materials used. On the other hand, when the balloon is damaged, the high voltage or high current passing through the human body can create an uncontrollable danger. Summary of the Invention
[0006] Therefore, it is necessary to provide a balloon catheter that addresses the issues of high energy requirements and large size of the aforementioned balloon catheters.
[0007] This invention provides a balloon catheter, comprising an inner tube, an insulating tube, a balloon body, a conductive component, a conductive fluid, and at least one electrode pair, wherein:
[0008] The insulating tube is sleeved on the inner tube and located inside the capsule. The insulating tube is made of a superhydrophobic material with a surface water contact angle greater than 150°.
[0009] The inner tube penetrates the capsule and is filled with the conductive liquid between itself and the capsule.
[0010] At least one electrode pair, each electrode pair including a first electrode and a second electrode forming positive and negative electrodes, the first electrode and the second electrode being spaced apart and sleeved on the insulating tube, and respectively electrically connected to the conductive component.
[0011] In one embodiment, the number of electrode pairs is multiple, and multiple first electrodes and multiple second electrodes in the multiple electrode pairs are connected in series; or, multiple first electrodes in the multiple electrode pairs are connected in parallel, and multiple second electrodes are connected in parallel.
[0012] In one embodiment, at least one of the first and second electrodes is a protruding electrode, which includes at least one electrode protrusion that protrudes from the end of the insulating tube. Current can be generated at the end of the insulating tube. By controlling the distance between the two protruding electrodes to be less than 0.1mm-0.80mm, and when the distance between the tips of the two electrodes is controlled at 0.5mm, the voltage can be reduced from the original 3000V high voltage to within 1000V. By setting the protruding electrodes and controlling the distance between the electrodes, the shock wave pulse can be significantly reduced.
[0013] Preferably, the insulating tube is fitted onto the protruding electrode, and a plasma arc is generated at the tip using medium-frequency short pulse excitation. The protruding electrode of the insulating tube is pre-discharged to generate seed electrons, which increases the density of seed electrons around it, thereby forming a diffuse and uniform amplification, which can reduce the electrode discharge voltage to below 400V.
[0014] In one embodiment, the protruding electrode includes a first shaft end and a plurality of electrode protrusions, the first shaft end being sleeved on an insulating tube, and the electrode protrusions being disposed on the side of the first shaft end away from the end of the insulating tube.
[0015] In one embodiment, a plurality of the electrodes protrude on both sides of the axis of the first shaft end.
[0016] In one embodiment, a plurality of the electrodes protrude from one side of the axis of the first shaft end.
[0017] In one embodiment, a plurality of the electrodes protrude circumferentially and are evenly distributed at the first axial end.
[0018] In one embodiment, the protruding electrode includes multiple sets of spaced third electrodes, each third electrode including an electrode protrusion and a second shaft end, the second shaft end being fixed to the outside of the insulating tube, the second shaft ends of each of the protruding electrodes being connected in parallel, and the electrode protrusion being disposed on the side of the second shaft end away from the end of the insulating tube.
[0019] In one embodiment, the balloon catheter further includes an outer tube connected to one end of the balloon body. The conductive component includes a catheter seat, a lead assembly, and an external power source. The lead assembly includes multiple leads electrically connected to the first electrode or the second electrode. The catheter seat is connected to the outer tube and has an internal accommodating space. The lead assembly includes multiple leads electrically connected to the first electrode or the second electrode and passes through the accommodating space of the balloon body, the outer tube, and the catheter seat to connect to the external power source.
[0020] In one embodiment, the protruding tip of the electrode is shaped as a rectangle, trapezoid, arc, or ellipse.
[0021] Beneficial effects:
[0022] 1. In the above-mentioned balloon catheter, by limiting the interval between the first electrode and the second electrode and placing them opposite each other on the insulating tube, the electrode pairs are arranged along the direction of the blood vessel. The shock wave energy generated by the electrode pairs is dispersed and propagated perpendicular to the axial direction of the blood vessel, which improves the ability to break up calcified lesions, reduces the energy dissipated in the blood vessel, reduces the output energy of the device, and improves the safety of the operation.
[0023] 2. In the above-mentioned balloon catheter, by limiting the interval between the first electrode and the second electrode and placing them opposite each other on the insulating tube, the electrode pairs are arranged along the direction of the blood vessel, reducing the size of the electrode pairs, reducing the overall size of the balloon catheter, and making it easier to pass through the lesion site.
[0024] 3. In the above-mentioned balloon catheter, by limiting the first electrode and the second electrode to be sleeved on the insulating tube, the electrode pair is fixed on the insulating tube, which reduces the damage to the insulating tube, inner tube and other components when the shock wave occurs, and improves the service life of the balloon catheter.
[0025] 4. The above-mentioned insulating tube is made of superhydrophobic material, which reduces the wetting ability of conductive liquid on the insulating tube. When the product is working, it is beneficial to resist the corrosion of the insulating tube by the high voltage between the electrode pairs.
[0026] 5. In the above-mentioned balloon catheter, by defining at least one of the first electrode and the second electrode as a protruding electrode, the position of the shock wave generation is between the protruding tips of the electrode pair, thereby improving the positional stability of the shock wave generation.
[0027] 6. The tip shape of the above-mentioned protruding electrode is rectangular, trapezoidal, arc-shaped, or elliptical arc-shaped, which can ensure the stability of the shock wave emission position and the lifespan of the electrode pair to meet the needs of actual clinical use. Attached Figure Description
[0028] Figure 1 A schematic diagram of the structure of a balloon catheter provided by the present invention;
[0029] Figure 2 A schematic diagram of the operation of a balloon catheter provided by the present invention;
[0030] Figure 3 A schematic diagram of the electrical connection of an electrode pair in a balloon catheter provided by the present invention;
[0031] Figure 4 This is a schematic diagram of the electrical connection of another electrode pair in a balloon catheter provided by the present invention;
[0032] Figure 5 A schematic diagram of the distribution of electrode pairs in a balloon catheter provided by the present invention;
[0033] Figure 6 A schematic diagram showing the distribution of another electrode pair in a balloon catheter provided by the present invention;
[0034] Figure 7 This is a schematic diagram showing the distribution of another electrode pair in a balloon catheter provided by the present invention;
[0035] Figure 8 This is a schematic diagram of the structure of a protruding electrode in a balloon catheter provided by the present invention;
[0036] Figure 9 This invention provides a schematic diagram of the structure of another protruding electrode in a balloon catheter;
[0037] Figure 10This is a schematic diagram of the structure of a protruding electrode in a balloon catheter provided by the present invention;
[0038] Figure 11 This is a schematic diagram of the structure of another protruding electrode in a balloon catheter provided by the present invention.
[0039] Figure label:
[0040] 10. Balloon catheter;
[0041] 110. Inner tube;
[0042] 120. Insulating tube;
[0043] 130. Cyst;
[0044] 140. Conductive component; 141. Wire group; 1411. First wire; 1412. Second wire; 1413. Third wire; 1414. Fourth wire; 1415. Fifth wire; 142. External power supply;
[0045] 150. Conductive liquid;
[0046] 160. Electrode pair; 161. First electrode; 162. Second electrode; 163. Protruding electrode; 1631. Electrode protrusion; 1632. First shaft end; 1633. Third electrode; 1634. Second shaft end;
[0047] 170. Outer tube;
[0048] 181. Liner wire; 182. Terminal tube; 183. Imaging ring; 184. Catheter seat;
[0049] 20. Blood vessels; 21. Calcified lesions. Detailed Implementation
[0050] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.
[0051] In the description of this 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," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.
[0052] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0053] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.
[0054] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.
[0055] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.
[0056] The technical solutions provided by the embodiments of the present invention are described below with reference to the accompanying drawings.
[0057] like Figure 1 as well as Figure 2 As shown, the present invention provides a balloon catheter 10 for balloon dilation to treat calcification of blood vessel 20. The balloon catheter 10 includes an inner tube 110, an insulating tube 120, a balloon body 130, a conductive component 140, a conductive fluid 150, and at least one electrode pair 160, wherein:
[0058] An insulating tube 120 is fitted onto the inner tube 110 and is located within the capsule 130. Specifically, the insulating tube 120 is made of a superhydrophobic material, which can be ceramic, polytetrafluoroethylene, polyimide, phenolic resin, polyvinyl chloride, polyethylene, polypropylene, neoprene rubber, silicone resin, polyester, mica powder, or derivatives of the above materials. However, the material of the insulating tube 120 is not limited to these; it can also be other materials capable of achieving the insulation support process. Furthermore, 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 can be 151°, 153°, 155°, 157°, 159°, or 160°. Of course, the surface water contact angle of the insulating tube 120 is not limited to these values and can also be other values within the range greater than 150°.
[0059] The inner tube 110 penetrates the capsule 130, and the space between the inner tube 110 and the capsule 130 is filled with conductive liquid 150.
[0060] At least one electrode pair 160, each electrode pair 160 including a first electrode 161 and a second electrode 162 forming positive and negative electrodes, the first electrode 161 and the second electrode 162 being spaced apart and opposite to each other on the insulating tube 120, and the first electrode 161 and the second electrode 162 being electrically connected to the conductive component 140 respectively; in a specific arrangement, the number of electrode pairs 160 can be one, two, three, four or more; in each electrode pair 160, the first electrode 161 can be a positive electrode and the second electrode 162 can be a negative electrode, or, in each electrode pair 160, the first electrode 161 can be a negative electrode. The second electrode 162 can be a positive electrode; the first electrode 161 and the second electrode 162 are arranged alternately, and the gap between the first electrode 161 and the second electrode 162 can be 0.1mm-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, or 1mm. Of course, the gap between the first electrode 161 and the second electrode 162 is not limited to the above range values, and can also be other values that meet the spacing requirements.
[0061] In the balloon catheter 10 described above, a high voltage is applied to the electrode pair 160 through the conductive component 140. Due to the electrohydraulic effect and cavitation effect, a shock wave is generated near the electrode pair 160. The energy of the shock wave is transmitted to the calcified lesion 21 in the wall of the blood vessel 20 through the conductive fluid 150. The energy of the shock wave is used to break up the calcified lesion 21, thereby achieving treatment of the lesion site. Since the first electrode 161 and the second electrode 162 are spaced apart and sleeved on the insulating tube 120, the electrode pair 160 is arranged along the direction of the blood vessel 20. On the one hand, this ensures that the shock wave energy generated by the electrode pair 160 is dispersed and propagated perpendicular to the axial direction of the blood vessel 20, which is conducive to the transmission of the shock wave to the calcified lesion 21, improving the ability to break up the calcified lesion 21, and reducing the energy dissipated in the blood vessel 20, thereby improving the energy utilization rate of the shock wave, reducing the output energy of the device, and improving the safety of the operation. On the other hand, it can reduce the size of the electrode pair 160 and reduce the overall size of the balloon catheter 10, making it easier to pass through the lesion location. Furthermore, 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, reducing the damage to the insulating tube 120, inner tube 110 and other components when the shock wave occurs, and improving the service life of the balloon catheter 10. In addition, by making the insulating tube 120 a superhydrophobic material, the wetting ability of the conductive liquid 150 on the insulating tube 120 is reduced. When the balloon catheter 10 is working, it is beneficial to resist the corrosion of the insulating tube 120 by the high voltage between the electrode pairs 160.
[0062] The sound pressure generated by the shock wave of the capsule at a 130° angle was tested using a hydrophone. The results are shown in Table 1. The shock wave sound pressure generated by the electrode pairs arranged at a 160° interval is 2.5 times that generated by the shock wave sound pressure generated by the coaxial electrodes.
[0063] Table 1. Shock wave acoustic pressure on the surface of the balloon with different electrode arrangements.
[0064]
[0065] The data in the table above shows that when an electrode pair 160 is arranged side by side along the direction of blood vessel 20, the direction of the generated shock wave is perpendicular to the wall of blood vessel 20. The path of the shock wave to the calcified lesion 21 is the shortest, and the energy dissipation is also the least.
[0066] The conductive component 140 has various structural forms, such as Figure 1 as well as Figure 2 As shown, in a preferred embodiment, the balloon catheter 10 further includes an outer tube 170 connected to one end of the balloon body 130. The conductive component 140 includes a wire assembly 141 and an external power supply 142. The wire assembly 141 includes multiple wires, which are electrically connected to the first electrode 161 or the second electrode 162. The catheter seat is connected to the outer tube 170, and an accommodating space is formed inside the catheter seat. The wire assembly 141 includes multiple wires, which are electrically connected to the first electrode 161 or the second electrode 162. The wires pass through the balloon body 130, the outer tube 170, and the accommodating space of the catheter seat and are connected to the external power supply 142.
[0067] In the aforementioned balloon catheter 10, the outer tube 170 leads the lead wire 141 from inside the balloon body 130 to the lead wire seat, and then leads it out to be connected to an external power supply 142 to apply voltage to the first electrode 161 and the second electrode 162. In a specific configuration, the end of the balloon catheter 10 away from the catheter seat 184 also includes a liner wire 181 and a terminal tube 182. The terminal tube 182 is inserted into and connected to the balloon body 130 as a whole. The end of the balloon catheter 10 away from the catheter seat includes a radiopaque ring 183, which is disposed inside the balloon body 130 and located on the inner tube 110.
[0068] To facilitate the electrical connection between the first electrode 161, the second electrode 162, and the conductive component 140, such as Figure 3 as well as Figure 4 As shown, in a preferred embodiment, there are multiple electrode pairs 160, with multiple first electrodes 161 and multiple second electrodes 162 in the multiple electrode pairs 160 connected in series; or, multiple first electrodes 161 in the multiple electrode pairs 160 are connected in parallel, and at the same time, multiple second electrodes 162 in the multiple electrode pairs 160 are connected in parallel.
[0069] In the aforementioned balloon catheter 10, among the multiple electrode pairs 160, all the first electrodes 161 and all the second electrodes 162 are connected in series via the first wire 1411 in the lead wire group 141, and then electrically connected to the external power supply 142 via the second wire 1412 and the third wire 1413. This allows multiple electrode pairs 160 to simultaneously receive high voltage, thereby synchronously generating shock waves to break up the calcified lesion 21 and quickly treat the lesion. In the multiple electrode pairs 160, all the first electrodes 161 are connected in parallel via the fourth wire 1414 in the lead wire group 141 and then electrically connected to the external power supply 142. All the second electrodes 162 are connected in parallel via the third wire 1413 in the lead wire group 141 and then electrically connected to the external power supply 142. This allows multiple electrode pairs 160 to generate shock waves at lower voltages, reducing the equipment's output energy and improving surgical safety.
[0070] To improve the location stability of the shock wave, such as Figure 3 , Figure 4 , Figure 5 as well as Figure 6 As shown, 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, which is located away from the end of the insulating tube 120. In specific configurations, the first electrode 161 can be a protruding electrode 163, or the second electrode 162 can be a protruding electrode 163, or both the first electrode 161 and the second electrode 162 can be protruding electrodes 163. The number of electrode protrusions 1631 in the protruding electrode 163 can be one, two, three, four, or more. In the balloon catheter 10 described above, current can be generated at the end of the insulating tube 120. By controlling the distance between the two protruding electrodes 163 to be less than 0.1mm-0.80mm, when the distance between the tips of the two electrodes is controlled at 0.5mm, the voltage can be controlled from the original 3000V high voltage to within 1000V. Therefore, by setting the protruding electrode 163 and controlling the distance between the electrodes, the shock wave pulse can be significantly reduced. By defining at least one of the first electrode 161 and the second electrode 162 as a protruding electrode 163, the shock wave is generated between the tip of the protruding electrode 1631 of the electrode pair 160 and the other electrode, or between the tips of the two protruding electrodes 1631, thus improving the positional stability of the shock wave generation. Preferably, the insulating tube 120 is fitted onto the protruding electrode 163, and a plasma arc is generated at the tip using a medium-frequency short pulse excitation. Pre-discharge is controlled at the protruding electrode of the insulating tube 120 to generate seed electrons, increasing the density of seed electrons around it, thereby forming a diffuse and uniform amplification, which can reduce the electrode discharge voltage to below 400V.
[0071] The protruding electrode 163 has various structural forms, one preferred embodiment is as follows: Figure 3 , Figure 4 , Figure 5 as well as Figure 6 As shown, the protruding electrode 163 includes a first shaft end 1632 and multiple electrode protrusions 1631. The first shaft end 1632 is sleeved on the insulating tube 120, and the electrode protrusions 1631 are located on the side of the first shaft end 1632 away from the insulating tube 120. In a specific configuration, the first shaft end 1632 is electrically connected to the conductive component 140. The first shaft end 1632 and the electrode protrusions 1631 can be an integral structure, manufactured through processes such as casting and cutting. Alternatively, the first shaft end 1632 and the electrode protrusions 1631 can be separate structures, fixed together by processes such as welding and threaded connection. In the above-described balloon catheter 10, the protruding electrode 163 is defined as having one first shaft end 1632 and multiple electrode protrusions 1631 to facilitate the installation of the protruding electrode 163 and the insulating tube 120.
[0072] There are various ways to arrange multiple protruding electrodes 1631, specifically, such as... Figure 5 As shown, multiple electrode protrusions 1631 are located on both sides of the axis of the first axial end 1632, and the spacing between the teeth can be flexibly selected to be uniform or non-uniform. In specific settings, the multiple electrode protrusions 1631 can be symmetrically arranged on both sides of the axis of the first axial end 1632, or they can be asymmetrically arranged on both sides of the axis of the first axial end 1632. In the above-mentioned balloon catheter 10, by limiting the multiple electrode protrusions 1631 to be located on both sides of the axis of the first axial end 1632, shock waves can be generated on both sides of the axis of the first axial end 1632, so as to cut the lesions around the inner wall of the blood vessel 20.
[0073] There are various ways to set up multiple electrode protrusions 1631. Specifically, multiple electrode protrusions 1631 are located on one side of the axis of the first shaft end 1632, so that shock waves can be generated on one side of the axis of the first shaft end 1632 to cut the lesion site on one side of the inner wall of the blood vessel 20. This is suitable for the treatment of diseases with local calcification lesions 21 around the blood vessel 20. In clinical use, the electrode position is aligned with the calcification lesion 21 and delivered. After reaching the lesion site, a shock wave is emitted. The shock wave energy can be accurately and effectively released at the lesion site. Of course, for lesions with local calcification around the blood vessel 20, a single-tooth protruding electrode 163 can also be selected.
[0074] There are various ways to arrange multiple protruding electrodes 1631, such as... Figure 6 As shown, specifically, multiple electrode protrusions 1631 are evenly distributed circumferentially at the first axial end 1632. After multiple shock waves are generated, shock waves can be generated in the circumferential direction, and the shock wave energy at any point on the circumference is relatively balanced, so as to be suitable for the treatment of lesions with complete circumferential calcification of blood vessels.
[0075] The protruding electrode 163 has various structural forms, such as Figure 7 As shown, in a preferred embodiment, the protruding electrode 163 includes multiple sets of third electrodes 1633, which are spaced apart. Each third electrode 1633 includes an electrode protrusion 1631 and a second shaft end 1634. The second shaft end 1634 is fixed to the outside of the insulating tube 120 by means of snap-fit connection, interlocking, or other methods. The second shaft ends of each protruding electrode 163 are connected in parallel. The electrode protrusion 1631 is located on the side of the second shaft end 1634 away from the end of the insulating tube 120. In specific configuration... The number of third electrodes 1633 can be two, three, four or more groups. Multiple groups of third electrodes 1633 can be evenly distributed along the circumferential direction of the insulating tube 120. Of course, the distribution of multiple groups of third electrodes 1633 is not limited to this. The second shaft end 1634 and the electrode protrusion 1631 can be an integral structure, prepared by casting, cutting and other processes. The second shaft end 1634 and the electrode protrusion 1631 can be a separate structure, fixed together by welding, threaded connection and other processes.
[0076] In the balloon catheter 10 described above, the protruding electrode 163 includes multiple sets of third electrodes 1633, each third electrode 1633 including an electrode protrusion 1631 and a second axial end 1634, so that the protruding electrode 163 can be positioned on the insulating tube 120 to be suitable for the treatment of diseases of the local calcified lesions 21 around the blood vessel 20.
[0077] The tip shape of electrode protrusion 1631 has various forms, such as Figure 8 , Figure 9 , Figure 10 as well as Figure 11 As shown, in a preferred embodiment, the tip shape of the electrode protrusion 1631 is one of rectangular, trapezoidal, arc-shaped, or elliptical arc-shaped. This ensures both the stability of the shock wave emission position and the lifespan of the electrode 160 to meet the requirements of actual clinical use. It avoids the use of pointed or needle-shaped electrodes, as high voltage can corrode the electrode tips, causing the electrode spacing to increase, energy instability, and reducing product lifespan. The tip shapes of all electrode protrusions 1631 on the insulating tube 120 can be the same, or they can all be different. Some electrode protrusions 1631 on the insulating tube 120 can have the same tip shape, while others can have different tip shapes. Of course, the tip shape and arrangement of the electrode protrusions 1631 are not limited to this, and other shapes and arrangements that meet the requirements can also be used.
[0078] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0079] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.
Claims
1. A balloon catheter, characterized in that, It includes an inner tube, an insulating tube, a capsule, a conductive component, a conductive liquid, and at least one electrode pair, wherein: The insulating tube is sleeved on the inner tube and located inside the capsule. The insulating tube is made of a superhydrophobic material with a surface water contact angle greater than 150°. The inner tube penetrates the capsule and is filled with the conductive liquid between itself and the capsule. At least one electrode pair, each electrode pair including a first electrode and a second electrode forming positive and negative electrodes, the first electrode and the second electrode being spaced apart and sleeved on the insulating tube, and respectively electrically connected to the conductive component; the first electrode and the second electrode are both protruding electrodes, both of the first electrode and the second electrode including electrode protrusions, the electrode protrusions being away from the end of the insulating tube, when the distance between the tip of the electrode protrusion of the first electrode and the tip of the electrode protrusion of the second electrode is controlled at 0.5mm, the breakdown voltage between the electrode pairs can be controlled to within 1000V; The electrode pair is configured such that the shock wave energy it generates propagates perpendicular to the axial direction of the blood vessel.
2. The balloon catheter according to claim 1, characterized in that, The number of electrode pairs is multiple, and the first electrodes of the multiple electrode pairs are connected in series and the second electrodes are connected in series; or, the multiple first electrodes of the multiple electrode pairs are connected in parallel and the multiple second electrodes are connected in parallel.
3. The balloon catheter according to claim 1, characterized in that, The protruding electrode includes a first shaft end and a plurality of electrode protrusions. The first shaft end is sleeved on an insulating tube, and the electrode protrusions are disposed on the side of the first shaft end away from the end of the insulating tube.
4. The balloon catheter according to claim 3, characterized in that, The plurality of electrodes protrude on both sides of the axis of the first shaft end.
5. The balloon catheter according to claim 3, characterized in that, The plurality of electrodes protrude on one side of the axis of the first shaft end.
6. The balloon catheter according to claim 3, characterized in that, The plurality of electrodes protrude from the first axial end and are evenly distributed circumferentially.
7. The balloon catheter according to claim 1, characterized in that, The protruding electrode includes multiple sets of spaced third electrodes. Each third electrode includes an electrode protrusion and a second shaft end. The second shaft end is fixed to the outside of the insulating tube. The second shaft ends of each protruding electrode are connected in parallel. The electrode protrusion is located on the side of the second shaft end away from the end of the insulating tube.
8. The balloon catheter according to claim 1, characterized in that, It also includes an outer tube connected to one end of the capsule. The conductive component includes a catheter seat, a wire assembly, and an external power supply. The wire assembly includes multiple wires, which are electrically connected to the first electrode or the second electrode. The catheter seat is connected to the outer tube and has an internal accommodating space. The wire assembly includes multiple wires, which are electrically connected to the first electrode or the second electrode and pass through the accommodating space of the capsule, the outer tube, and the catheter seat to connect to the external power supply.
9. The balloon catheter according to claim 1, characterized in that, The protruding tip of the electrode can be rectangular, trapezoidal, circular arc, or elliptical arc.