CN217853181U - Shock wave sacculus pipe device and medical equipment - Google Patents

Abstract

The present disclosure provides a shock wave balloon catheter device comprising a balloon, an inner tube and an outer tube. The balloon includes an inner layer and an outer layer, the inner layer having a hardness different from the hardness of the outer layer. The balloon is wrapped around the inner tube, and the distal end of the inner tube is connected to the distal end of the balloon. The outer sleeve is arranged outside the inner tube and is connected with the near end of the saccule. The present disclosure also provides a medical device comprising the above shock wave balloon catheter apparatus. The disclosed shock wave balloon catheter device can emit high-intensity shock waves to rupture calcified plaques, and can provide high expansion pressure to fully complete expansion of lesions so as to open blood vessels.

Description

Shock wave sacculus pipe device and medical equipment

Technical Field

The present disclosure relates to a shock wave balloon catheter device, and more particularly, to a shock wave catheter device and a medical apparatus including a balloon having a double-layer structure.

Background

Atherosclerosis is a narrowing and hardening disease of the arteries caused by plaque build-up. The plaque is composed of fibrous tissue, fat, and calcium. The accumulated calcified plaque prevents the normal flow of blood, reducing the supply of oxygen and nutrients to the body. Causing related diseases of the arteries supplying blood to key parts of the body, including the brain, heart and limbs. In recent years, the method of the liquid-electric effect is used for destroying calcified focus structures attached to walls of diseased blood vessels, namely, intravascular shock wave lithotripsy is an effective means for destroying highly calcified focuses.

SUMMERY OF THE UTILITY MODEL

The present disclosure provides a shock wave balloon catheter device. The device can emit high-intensity shock waves to crack calcified plaques. The device can also provide high expansion pressure to fully complete the expansion of the lesion, thereby opening the blood vessel.

A shock wave balloon catheter device includes a balloon, an inner tube, at least one shock wave electrode assembly, and an outer tube. The balloon includes an inner layer and an outer layer, the inner layer having a hardness different from the hardness of the outer layer. The inner tube runs through the sacculus, and the distal end of inner tube is connected with the distal end of sacculus. The shock wave electrode assembly is disposed outside the inner tube. The outer tube is sleeved outside the inner tube and connected with the near end of the saccule.

In one embodiment, the outer layer has a hardness greater than the hardness of the inner layer.

In one embodiment, the outer layer is nylon, polyethylene terephthalate, or polyethylene; the inner layer is polyether block polyamide copolymer, polyvinyl chloride, polyurethane or silicon rubber.

In one embodiment, the outer layer has a hardness of 71D to 90D and the inner layer has a hardness of 35D to 70D.

In one embodiment, the mass ratio of the outer layer to the inner layer ranges from 1:3 to 3:1.

In one embodiment, the outer layer is nylon 12, the inner layer is a polyether block polyamide copolymer, and the mass ratio of nylon 12 to polyether block polyamide copolymer is 1:1.

In one embodiment, the shock wave electrode assembly includes an inner electrode and an outer electrode and is configured to generate a high voltage pulse between the inner electrode and the outer electrode under a high voltage power supply to generate a mechanical shock wave in the balloon; the shock wave balloon catheter device further comprises a connecting lead, the connecting lead comprises a first electrode lead and a second electrode lead, the first electrode lead and the second electrode lead extend along the axial direction of the connecting lead, the inner electrode is connected with the first electrode lead, the outer electrode is connected with the second electrode lead, and the first electrode lead and the second electrode lead are configured to be respectively connected with two poles of a high-voltage power supply.

In one embodiment, the shockwave electrode assembly further comprises an insulating layer between the inner electrode and the outer electrode, the inner electrode having a protruding pin disposed on a surface thereof, the insulating layer having a first hole disposed thereon, the outer electrode having a second hole disposed thereon, the second hole having a diameter greater than a diameter of the first hole, the protruding pin, the first hole and the second hole being configured such that the protruding pin extends through the first hole and into the second hole to form an annular discharge channel between the outer electrode and the inner electrode.

In one embodiment, the shock wave balloon catheter device includes a plurality of shock wave electrode assemblies arranged at intervals along an axial direction of the inner tube.

In one embodiment, a plurality of shock wave electrode assemblies are arranged in series.

In one embodiment, the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or are angularly arranged in the circumferential direction.

The present disclosure also provides a medical device, which includes the shock wave balloon catheter device of the above embodiment, a high voltage generator, the shock wave balloon catheter device further includes a connecting wire, a distal end of the connecting wire is connected with the shock wave electrode assembly, and a proximal end of the connecting wire is connected with the high voltage generator; the pulse voltage of the high voltage generator is 500V-10 kV, the pulse voltage width is 200 ns-20 mus, the pulse current of the high voltage generator is 50A-400A, and the pulse current width is 10 ns-2 mus.

In one embodiment, each of the shockwave electrode assemblies generates shockwaves having a sound pressure intensity of 2MPa to 20MPa and a discharge frequency of 0.1Hz to 10Hz.

In the shock wave balloon catheter device disclosed by the embodiment of the disclosure, calcified plaques can be effectively crushed under the action of shock waves, and meanwhile, the balloon adopts a double-layer structure design with different hardness of an inner layer and an outer layer, so that the balloon has better compliance and adherence while the explosion pressure of the balloon is effectively increased; the calcified plaque is firstly crushed through the action of the shock wave, then the balloon is further expanded by using higher filling pressure, and the blood vessel can be effectively opened through repeated circulating operation of shock wave and balloon high-pressure expansion, so that the high-pressure balloon is prevented from being re-placed for expansion, the operation time is shortened, the operation cost is reduced, and the risk of occurrence of related complications is reduced; and the increase of sacculus expansion pressure makes the decay of shock wave weaken to a certain extent, and this produces the promotion effect to shock wave transmission, and the high expansion pressure of sacculus and shock wave synergism make shock wave sacculus pipe device still can produce higher acoustic pressure intensity, can smash the calcification plaque more effectively.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description only relate to some embodiments of the present disclosure and do not limit the present disclosure.

Fig. 1 is a schematic structural view of a shock wave balloon catheter device according to one embodiment of the present disclosure.

Fig. 2 is a schematic structural view of a balloon according to one embodiment of the present disclosure.

Fig. 3 is a cross-sectional view of the balloon of fig. 2.

FIG. 4 is a cross-sectional schematic view of a shockwave electrode assembly according to one embodiment of the present disclosure.

Fig. 5 is a graph of sound pressure intensity at different pulse voltages for a shockwave electrode assembly and a conventional shockwave electrode assembly according to one embodiment of the present disclosure.

Figure 6 is a schematic cross-sectional view of a shock wave balloon catheter device provided with a shock wave two-electrode assembly.

Figure 7 shows a schematic of a shock wave balloon catheter device with two shock wave two-electrode assemblies.

FIG. 8A is a schematic cross-sectional view of one of the shockwave two-electrode assemblies of FIG. 7, showing its first hole orientation arrangement.

FIG. 8B is a schematic cross-sectional view of another shockwave two-electrode assembly of FIG. 7, showing its first hole orientation arrangement.

Fig. 9 is a graph of sound pressure intensity at different filling pressures for a shockwave electrode assembly according to one embodiment of the present disclosure.

Figure 10 shows the effect of the expansion of different shock wave balloon catheter devices.

Fig. 11 is a schematic structural view of a medical device according to an embodiment of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The use of "first," "second," and similar terms in the embodiments of the disclosure is not intended to indicate any order, quantity, or importance, but rather to distinguish one element from another. The use of the terms "a" and "an" or "the" and similar referents do not denote a limitation of quantity, but rather denote the presence of at least one. Likewise, the word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. In the following description, spatial and orientational terms such as "upper", "lower", "front", "rear", "top", "bottom", "vertical" and "horizontal" may be used to describe embodiments of the invention, but it is understood that these terms are merely used to facilitate the description of the embodiments shown in the drawings and do not require that the actual apparatus be constructed or operated in a particular orientation. In the following description, the use of terms such as "connected," "coupled," "secured," and "attached" may refer to two elements or structures being directly connected without other elements or structures therebetween, or indirectly connected through intervening elements or structures, unless expressly stated otherwise herein.

When the traditional balloon angioplasty is adopted for treating the calcified vascular lesions, the vascular sections of the calcified lesions are hard and have poor compliance, so that the balloons are difficult to fully expand and even can generate serious conditions such as balloon rupture and the like, therefore, the calcified lesion sections are expanded by the balloons under high pressure, but the probability of complications such as vascular dissection, perforation, rupture, no re-flow and the like is obviously increased.

The intravascular shock wave technology in the prior art is an effective means for solving vascular calcification, and particularly, the electrodes and the high-voltage generator are used together to destroy calcified lesions in the artery wall. In this type of procedure, in order to increase the shock wave generation effect, the shock wave is caused to pass through the balloon wall to the occlusion area, usually using a highly flexible balloon made of a less rigid material, such as a polyether block polyamide copolymer, the expansion pressure of which is usually below 16 atm. During the use in the full low pressure medium of high compliance sacculus makes the sacculus adhere to the vascular wall, applys a series of high-voltage pulse to the electrode in the sacculus through high voltage generator to produce the shock wave in the conducting fluid, the shock wave passes the sacculus wall and reaches the jam region, makes the calcification plaque rupture. However, the inventors of the present disclosure found that calcified lesions may not be completely fragmented due to the large fluctuation in the intensity of the shock wave generated by the electrodes. The electrodes may produce unpredictable sparks and shock waves that can also potentially damage the high softness balloon. This increases the risk of balloon leakage and causes the inflation pressure of the injured balloon to be typically only within 10 atmospheres of standard pressure, thereby failing to fully inflate the lesion. In addition, with the limited high softness balloon dilation pressure, clinical results indicate that there is an approximately 20% proportion of patients with calcified lesions that do not achieve effective dilation. In this case, to further open the vessel, the shockwave balloon catheter needs to be withdrawn, the high pressure balloon replaced, and the balloon inflated at high pressure to accomplish effective dilation of the lesion. The expansion time of the saccule in the whole treatment process can reach several minutes, and the operation time can reach several hours. This condition not only increases the procedure and procedure time, but may also lead to serious cardiac adverse events such as myocardial ischemia, hemodynamic disorders, and other surgical complications.

To solve the above problem, some prior art solutions increase the burst pressure of the balloon by increasing the wall thickness of the balloon with high softness, thereby providing sufficient expansion pressure. But the larger wall thickness can increase the loss of shock waves in the transmission process, reduce the energy acting on pathological changes and simultaneously reduce the adherence and the trafficability of the balloon. Therefore, the prior art hardly meets the requirements of the balloon on high expansion pressure and high shock wave sound pressure intensity at the same time.

Embodiments of the present disclosure provide a shock wave balloon catheter device that solves some of the above technical problems, and the embodiments of the present disclosure and examples thereof will be described in detail below with reference to the accompanying drawings.

Fig. 1 is a schematic illustration of a shock wave balloon catheter device according to one embodiment of the present disclosure. Fig. 2 is a schematic structural view of a balloon according to one embodiment of the present disclosure. Fig. 3 is a cross-sectional view of the balloon of fig. 2. As shown, shock wave balloon catheter device 100 includes an inner tube 110, a balloon 120, an outer tube 130, and a shock wave electrode assembly 200. The shock wave electrode assembly 200 is disposed on the inner tube 110, the details of which will be described later. In one embodiment, the number of shockwave electrode assemblies is multiple, as desired. Inner tube 110 extends through balloon 120, and the distal end of inner tube 110 is connected to the distal end of balloon 120. In one embodiment, the distal end of balloon 120 is welded to inner tube 110. The outer tube 130 fits over the outer portion of the inner tube 110 and is connected to the proximal end of the balloon 120. In one embodiment, the proximal portion of the balloon 120 is welded to the outer tube 130. The gap between the inner tube 110 and the outer tube 130 forms a channel for receiving the conductive fluid. Inside the balloon 120 is an inflation lumen 140.

Balloon 120 has a two-layer structure with an inner layer 122 and an outer layer 124. The inner layer 122 and the outer layer 124 are made of materials with different hardness, for example, shore hardness is used as a hardness basis. Here, a material having a high hardness is referred to as a "hard material", and a material having a low hardness is referred to as a "soft material". The hard material comprises one or more of nylon, polyethylene terephthalate and polyethylene. The soft material comprises one or more of polyether block polyamide copolymer, polyvinyl chloride, polyurethane and silicon rubber. According to the balloon 120 of the embodiment of the present disclosure, the outer layer may be made of a soft material (i.e., the inner layer is made of a hard material, in which case the double-layered structure is inner-hard and outer-soft), or may be made of a hard material (i.e., the inner layer is made of a soft material, in which case the double-layered structure is inner-soft and outer-hard). Specifically, a balloon with a double-layer structure with soft inside and hard outside can bear higher pressure. And the double-layer structure balloon with hard inside and soft outside has higher compliance and small damage to blood vessels. In one embodiment, the inner layer 122 is made of a soft material and the outer layer 124 is made of a hard material, i.e., the hardness of the inner layer 122 is less than the hardness of the outer layer 124. At this time, the soft material provides the balloon 120 with a certain flexibility, which facilitates the balloon 120 to pass through tortuous lesions. While also providing some adherence to the balloon 120. The hard material increases the burst resistance of the balloon 120, enabling the balloon 120 to provide high inflation pressure to fully complete the expansion of the lesion and open the vessel. For a traditional balloon with high softness, the wall thickness of the balloon needs to be increased to increase the burst pressure of the balloon so as to provide sufficient expansion pressure, but the larger wall thickness increases the loss of shock waves in the propagation process, reduces the energy applied to lesions, and simultaneously reduces the adherence and the trafficability of the balloon.

The balloon 120 of the embodiment of the present disclosure adopts a double-layer structure, which exhibits better adherence on the one hand, that is, when the balloon 120 is filled with a low-pressure medium, the balloon 120 can be better attached to the vessel wall. On the other hand, on the premise that the balloon has the same burst pressure, compared with the balloon made of polyether block polyamide copolymer, the balloon with the double-layer structure has smaller wall thickness, so that the loss of shock wave energy in the transmission process is reduced. This enables more energy to be transferred to the lesion, thereby better breaking up the calcified plaque.

The balloon 120 of the disclosed embodiment is made of soft and hard materials, and the balloon burst pressure, compliance and adherence are related to the hardness of the material itself and the mass ratio of the soft and hard materials. The hardness of the soft material is 35D-70D, and the hardness of the hard material is 71D-90D; wherein the hardness of the soft material is preferably 69D, and the hardness of the hard material is preferably 81D. Wherein, the mass of the soft material accounts for 25 to 75 percent of the total mass of the saccule 120, and the mass of the hard material accounts for 25 to 75 percent of the total mass of the saccule 120. That is, the mass ratio of soft material to hard material in the balloon 120 of embodiments of the present disclosure ranges from 1:3 to 3:1. By adjusting this mass ratio, the burst pressure, compliance and adherence of the balloon 120 can be significantly changed.

In order to ensure the pressure intensity and energy transmission of shock waves, the conventional intravascular shock wave lithotripsy technology generally adopts a high-flexibility balloon made of polyether block polyamide copolymer, for example, when the balloon 120 is made of a soft material completely, that is, the balloon 120 is a soft material balloon, test results show that the compliance of the balloon with the same wall thickness is 5.0% -8%, the balloon 120 has semi-compliance and good adherence, and the burst pressure of the balloon 120 is 10 atm-16 atm, but the burst pressure cannot meet the requirement of effective expansion of calcified lesions; in order to increase the balloon expansion pressure, when the polyether block polyamide copolymer material in the prior art is replaced with a material with higher hardness, for example, when the balloon 120 is completely made of a hard material, that is, the balloon 120 is a hard material balloon, the test result shows that the compliance of the balloon with the same wall thickness is 0% -0.5%, the burst pressure of the balloon 120 is 24 atm-30 atm, but the balloon 120 is a non-compliant balloon and has poor adherence, and the balloon made of the hard material affects the shock wave sound pressure intensity and the energy transmission effect; and in order to improve the expansion pressure of the saccule, when the bursting pressure of the saccule is improved by increasing the wall thickness of the high-softness saccule, the larger wall thickness can increase the loss of shock waves in the transmission process, reduce the energy acting on pathological changes and simultaneously reduce the adherence and the trafficability of the saccule. Therefore, the inventors of the present application found that it is difficult to simultaneously satisfy the compliance and adherence of the balloon, and the requirements for high expansion pressure and high shock wave sound pressure intensity in the current technology.

The sacculus 120 of this disclosed embodiment adopts the bilayer structure design that inlayer and outer hardness are different, can satisfy the demand to sacculus high burst pressure and high shock wave acoustic pressure intensity when guaranteeing sacculus compliance and adherence. For example, where the compliance of balloon 120 is 0.5% -3.0%, balloon 120 is semi-compliant. Therefore, by adjusting the mass ratio of the hard material to the soft material, the balloon with the double-layer structure has the good compliance and adherence of the balloon with the soft material on one hand, and also has the high burst pressure of the balloon with the hard material on the other hand, and the burst pressure of the balloon 120 is 30atm.

In one embodiment, the inner layer 122 is made of a soft material polyether block polyamide copolymer (Pebax) and the outer layer 124 is made of a hard material nylon 12, and the two bladders are tightly bonded as shown in fig. 2 and 3. The Pebax material of the inner layer 122 can provide the balloon 120 with flexibility, which is beneficial for passing tortuous lesions, and the nylon 12 of the outer layer 124 can increase the burst resistance of the balloon 120, so that the balloon 120 can provide high expansion pressure. However, it is considered that the excessive expansion pressure may cause trauma to the vessel wall, resulting in vessel rebound, dissection and thrombus formation. In a preferred embodiment, the mass ratio of Pebax to nylon 12 is 1, the hardness of Pebax is 69D, the hardness of nylon 12 is 81D, the burst pressure of the balloon 120 is 20atm, and the compliance is 1.5%. In another embodiment, the mass ratio of Pebax to nylon 12 is 1, the hardness of Pebax is 63D, and the hardness of nylon 12 is 81D.

It should be noted that "compliance" herein refers to the rate of change of the diameter of the balloon 120 with increasing inflation pressure over the range of the operating pressure interval. In other words, the balloon 120 has a nominal diameter at a nominal pressure, and the compliance is equal in magnitude to the increase in the diameter of the balloon 120 per increase in filling pressure by one atmosphere divided by the nominal diameter. At present, the range of compliance is defined without a strictly uniform partition, but only by empirical values in a small percentage of the community. Generally, the balloon 120 may be considered non-compliant when the filling pressure is increased, with the diameter of the balloon being substantially constant. "adherence" refers to the degree of tightness of fit of the balloon 120 when adhered to a vessel wall after being inflated with a medium of pressure, which is primarily related to the amount of deformation of the balloon 120. In other words, a balloon 120 that is easily deformed will more easily conform to the lesion. Furthermore, adherence is associated with compliance, specifically, the adherence is best for a balloon 120 with compliance and the adherence is worst for a balloon 120 with non-compliance. "burst pressure" refers to the maximum inflation pressure achieved by the balloon 120 during inflation.

Calcified plaque is a heterogeneous and anisotropic substance with pores and fissures of various scale levels randomly distributed inside. For severe calcified lesions, balloon dilatation alone has limited success. Thus, the destruction of highly calcified lesions is currently performed using intravascular shock wave lithotripsy. However, calcified lesions may not be completely fragmented due to the large fluctuations in shock wave intensity produced by existing electrode structures. The present disclosure thus employs a shockwave electrode assembly 200, a schematic cross-sectional view of which is shown in FIG. 4. The shockwave electrode assembly 200 includes an inner electrode 210, an outer electrode 230, and an insulating layer 220 positioned between the inner electrode 210 and the outer electrode 230. The inner electrode 210 has a protruding pin 212 formed on a surface thereof, and the insulating layer 220 has a first hole 222 formed therein. The outer electrode 230 is provided with a second hole 232, and the diameter of the second hole 232 is larger than that of the first hole 222. The protruding pin 212 extends through the first hole 222 and into the second hole 232 such that an annular gap is formed between the outer electrode 230 and the protruding pin 212, the gap enabling a discharge circuit to be formed between the outer electrode 230 and the inner electrode 210. Specifically, the shock wave balloon catheter device 100 further includes a connection wire (see the connection wire 320 of fig. 11) including a first electrode wire and a second electrode wire (not shown) extending in an axial direction thereof, the inner electrode being connected to the first electrode wire, the outer electrode being connected to the second electrode wire, and the first electrode wire and the second electrode wire being configured to be connected to both poles of the high voltage power source, respectively. Under the high voltage power, a high voltage pulse is generated between the inner electrode 210 and the outer electrode 230, thereby generating a mechanical shock wave in the balloon 120. When the shockwave electrode assembly 200 is placed in a liquid, given a suitable pulsed voltage, the electrode assembly can breakdown the filling liquid. A positionally stable electrical spark is generated between the protruding pin 212 and the outer electrode 230 to generate a shock wave. A shock wave electrode assembly is disposed outside the inner tube, which shock wave travels through the liquid inside the balloon 120, striking the balloon wall and calcified regions. Repeated pulses can destroy the structure of the calcified focus, dilate stenotic vessels without damaging surrounding soft tissues. The stable spark also reduces the potential for balloon damage, thereby ensuring the feasibility of increasing balloon compression resistance. The inventors of the present disclosure experimentally studied the sound pressure intensity of a general shockwave electrode assembly not provided with a protruding pin and the shockwave electrode assembly 200 of the present disclosure under application of different pulse voltages, as shown in fig. 5. The shockwave electrode assembly 200 according to the present disclosure can more efficiently generate a high-intensity sound pressure, i.e., exhibit a higher sound pressure intensity, than a general shockwave electrode assembly at the same pulse voltage. This is more advantageous for effectively destroying calcified lesions and improving the therapeutic effect of the shock wave balloon catheter device 100.

In one embodiment, the inner electrode 210 is a sheet-like structure. The insulating layer 220 and the outer electrode 230 are ring-shaped structures. A shockwave electrode assembly 200 includes a plurality of inner electrodes 210, an insulating layer 220 including a plurality of first apertures 222, and an outer electrode 230 including a plurality of second apertures 232. The number of the inner electrodes 210, the first holes 222 and the second holes 232 is equal. In actual procedures, there may be multiple calcified lesions to be treated, and therefore a shockwave electrode assembly 200 with multiple inner electrodes 210 may be used to create multiple discharge regions on the shockwave balloon catheter device 100. On one hand, the capability of the shock wave balloon catheter device 100 to treat a plurality of calcified lesions at the same time is improved, and on the other hand, the uniformity of the distribution of the shock wave in the circumferential space of the inner tube 110 can be improved, thereby being beneficial to the treatment of calcified lesions. Such a shockwave electrode assembly 200 having a structure of a plurality of inner electrodes 210 is hereinafter referred to as a "shockwave multi-electrode assembly". In other words, the shockwave multi-electrode assembly is one example of a shockwave electrode assembly 200 according to the present disclosure. Fig. 6 shows a schematic cross-sectional view of a shock wave balloon catheter device 100 provided with a shock wave two-electrode assembly. As shown, the two inner electrodes 210-1 and 210-2 of the shockwave two-electrode assembly are disposed outside the inner tube, with the two inner electrodes 210-1 and 210-2 oriented 180 degrees. In addition, the distribution of the multiple inner electrodes 210 of the shock wave multi-electrode assembly in the circumferential direction of the inner tube 110 can be adjusted according to the actual position distribution of the calcified lesions to be treated, which is not limited by the present disclosure.

In one embodiment, in the shock wave balloon catheter device 100, a plurality of shock wave multi-electrode assemblies are arranged at intervals in the axial direction of the inner tube 110. If there are multiple calcified lesions to be treated, and spaced apart by a certain distance. If the shock wave balloon catheter device 100 adopts a single shock wave multi-electrode assembly, the shock wave balloon catheter device 100 needs to be conveyed to different positions of calcified lesions to be processed one by one, and the operation is inconvenient. Thus, in view of the above, a shock wave balloon catheter device 100 having a plurality of shock wave multi-electrode assemblies 200 arranged at intervals in the axial direction of the inner tube 110 may be employed. In one embodiment, a plurality of shock wave multi-electrode assemblies 200 are arranged in series. Fig. 7 shows a schematic of a shock wave balloon catheter device 100 with two shock wave two-electrode assemblies 200. Meanwhile, the distribution of different shock wave electrode assemblies 200 in the axial direction of the inner tube 110 is adjusted according to the actual position distribution of the calcified lesion to be treated, which is not limited by the present disclosure. As shown in fig. 7, 8A and 8B, a first shockwave electrode assembly 200A is fixed to the inner tube 110, and a second shockwave electrode assembly 200B spaced apart from the first shockwave electrode assembly 200A is rotated by 90 degrees in the circumferential direction of the inner tube 110 with respect to the first shockwave electrode assembly 200A, so that the first hole 222A-1 of the first shockwave electrode assembly and the first hole 222B-1 of the second shockwave electrode assembly are oriented at 90 degrees. Accordingly, in the shock wave balloon catheter device 100 in which a plurality of shock wave two-electrode assemblies are arranged, the orientations of the first holes 222 of the adjacent shock wave two-electrode assemblies may be arranged at any angle according to actual needs, and the present disclosure is not limited thereto. For example, the orientations of the first holes 222 of the three shockwave two-electrode assemblies are sequentially spaced by 60 degrees, and the orientations of the first holes 222 of the four shockwave two-electrode assemblies are sequentially spaced by 45 degrees. Further, in the shock wave balloon catheter device 100 in which a plurality of shock wave multi-electrode assemblies are arranged, an arrangement similar to the above-described method can also be performed, and a detailed description thereof will be omitted.

According to the experimental study of the inventor, the double-layer balloon 120 according to the embodiment of the present invention has a beneficial effect of improving the sound pressure intensity of the shock wave emitted from the shock wave electrode assembly 200.

Fig. 9 shows the acoustic pressure intensity of the shock waves emitted by the shock wave electrode assembly 200 at different inflation pressures of the balloon. Under the condition of fixed pulse voltage, water is selected as filling liquid medium, the filling pressure in the double-layer saccule 120 is increased from 0atm to 20atm, and the sound pressure intensity of the generated shock wave shows the trend of increasing first and then decreasing. This is mainly a combined effect of the following two aspects. On one hand, the continuous increase of filling pressure leads to the enhancement of the blocking effect of the water medium on the formation of the shock wave through channel, thus leading to the increase of the energy loss of shock wave through discharge and the reduction of the sound pressure intensity generated by the shock wave. On the other hand, from the point of view of shock wave transmission, the increase in filling pressure somewhat attenuates shock wave attenuation, which contributes to shock wave transmission. When the filling pressure is low (0 atm-6 atm), the effect of the filling pressure in promoting the shock wave transmission is stronger than the inhibiting effect on the shock wave breakdown. Therefore, the sound pressure intensity of the shock wave increases with the increase of the filling pressure, and when the filling pressure is 6atm, the sound pressure intensity of the shock wave is maximum and reaches a peak value. When the filling pressure is increased continuously (6 atm-20 atm), the effect of the filling pressure on promoting the shock wave transmission is limited, so that the suppression effect of the filling pressure on the shock wave breakdown is obviously higher than the effect of promoting the shock wave transmission, and the trend of gradually weakening the sound pressure intensity of the shock wave is shown. And each set of discharge parameters corresponds to an optimal filling pressure value, so that the lesion cracking effect is the best.

According to the utility model discloses a double-deck sacculus 120 when guaranteeing that shock wave can produce best acoustic pressure intensity, still has higher filling pressure, and double-deck sacculus 120 and shock wave subassembly 200 synergism can effectively treat calcification pathological change. The pulse shock wave is driven by high-energy plasma to act on calcified lesion. Due to the good energy transfer characteristic of the filled water medium, a vibration effect is generated at the calcified cracks. This causes the original hydraulic fractures and the initial fractures to expand and develop, and the final fractures are communicated with each other to form macroscopic through fractures. The high-voltage pulse discharge is repeatedly performed in a short time. Under the synergistic effect of multiple pulses formed by filling pressure and high-voltage discharge, the extension length of the crack of the calcified lesion is increased. The number of cracks increases and it is more easily broken. In principle, under the condition of ensuring the sound pressure intensity, higher expansion force can be obtained by selecting higher filling pressure, so that better calcified lesion fragmentation effect is achieved.

The shock wave balloon catheter device 100 of the embodiment of the present disclosure has the combined design of the balloon 120 and the shock wave electrode assembly 200 of the above-mentioned double-layer structure, which can both meet the requirement that the device emits shock waves under high filling pressure and can also ensure the adherence effect of the balloon.

The inventors of the present disclosure studied the expansion effect of the same shock wave balloon catheter device 100 in the following three cases using a plaster ring as a calcification model, and recorded the fracture condition of the plaster ring under different conditions. In a first set of experiments, the shockwave electrode assembly 200 emitted shockwaves at a filling pressure of 0atm. In a second set of experiments, the shock wave balloon catheter device 100 used only 6atm of filling pressure. In a third set of experiments, the shockwave electrode assembly 200 emitted shockwaves at a filling pressure of 6 atm. It was found that the shock wave balloon catheter device 100 failed to break the gypsum ring in both the first and second set of experiments. In a third set of experiments, the shock wave electrode assembly 200 was fired several times at a fill pressure of 6atm to fracture the gypsum ring. These results indicate that there is indeed a synergy between balloon 120 expansion and shock waves. The shock wave electrode assembly 200 emits shock waves at higher pressures, which may be more conducive to the generation of calcified cracks, thereby destroying calcified lesions.

Furthermore, the inventors of the present disclosure also investigated the expansion effect of the shock wave balloon catheter device 100 having a different configuration, as shown in fig. 10. The dilation effect tests were all performed at the same pulse voltage and the same filling pressure. Test results show that with the shock wave balloon catheter device 100 of the present disclosure, compared to a soft balloon, a double-layer balloon can break up a calcification model with fewer discharge times; compared with a shockwave electrode assembly without a protruding pin structure, the shockwave electrode assembly 200 of the embodiment of the disclosure can break up the calcification model with fewer discharge times under the same pulse voltage condition. Double-deck sacculus is because unique structural feature, on the one hand, in the blasting pressure of effective increase sacculus for the sacculus has better compliance and adherence, and on the other hand, under the prerequisite that makes the sacculus have the same blasting pressure, compare with soft sacculus, the sacculus wall thickness that uses double-deck structure is littleer, and less wall thickness has reduced the loss of shock wave energy in the transmission process, makes more energy can transmit to pathological change, thereby better breaking calcified plaque. The shock wave balloon catheter device 100, in which the shock wave electrode assembly 200 and the balloon 120 of the double-layered structure are arranged, can effectively break up calcified plaque, and has an excellent expansion effect, and can be applied to angioplasty.

The shock wave balloon catheter device 100 according to the present disclosure has a high burst pressure, up to 20 standard atmospheres, due to its unique double layer balloon design. After the emitted shock wave has cracked the lesion, the balloon 120 may be further expanded directly. The higher expansion pressure avoids the condition that the traditional shock wave balloon catheter device needs to be put into a high-pressure balloon again for matching use due to insufficient expansion. The highly efficient and stable shockwave electrode assembly 200 provides high acoustic pressure strength throughout the shockwave waveguide device 100, and the two-layer structure of the balloon 120 provides sufficient expansion pressure. The synergistic effect of the two can fully expand pathological changes and get through blood vessels. Thereby reducing the number of surgical steps, shortening the surgical time, and reducing the risk of surgical complications.

In addition, the inventor also provides a medical device. As shown in fig. 11, the medical apparatus includes the shock wave balloon catheter device 100 described above, a high voltage generator 310, and a catheter hub 330. The shock wave balloon catheter device 100 further comprises a connecting wire 320, the distal end of the connecting wire 320 being connected to the shock wave electrode assembly 200 via a catheter hub 330. The proximal end of the connecting wire 320 is connected to the high voltage generator 310. The high voltage generator needs to meet the following parameter requirements: the pulse voltage of the high-voltage generator is 500V-10 kV, and the pulse voltage width is 200 ns-20 mus; the pulse current of the high-voltage generator is 50-400A, and the pulse current width is 10 ns-2 mus. In one embodiment, each shockwave electrode assembly 200 generates shockwaves having an acoustic pressure intensity of 2MPa to 20MPa and a discharge frequency of 0.1Hz to 10Hz. In one embodiment, the connection lead 320 includes a first electrode lead connected to the inner electrode 210 and a second electrode lead connected to the outer electrode 230.

In operation, current is transmitted to the inner electrode 210 via the first electrode lead, and the inner electrode 210 is in circuit with the outer electrode 230 via the filled conductive fluid. The high voltage pulse breaks down the conductive fluid, creating a shock wave in the axial direction of the first bore 222. The current then travels to the outer electrode 230 and back to the high voltage generator along the second electrode lead. The shock wave generated by the shock wave electrode assembly 200 is propagated through the liquid inside the balloon 120, striking the balloon wall and calcified regions. Repeated pulsing can destroy the structure of calcific foci, dilate stenotic vessels, without damaging surrounding soft tissues. In addition, in the medical equipment provided by the embodiment of the disclosure, the balloon adopts a double-layer structure design, so that the balloon has better compliance and adherence while the bursting pressure of the balloon is effectively increased. Furthermore, the shock wave balloon catheter device also produces a higher sound pressure intensity. Calcified plaques can be more easily crushed by the synergistic effect of high sound pressure intensity and high filling pressure. Therefore, the medical equipment disclosed by the embodiment of the disclosure can more effectively damage the calcified focus structure attached to the wall of a diseased blood vessel and improve the treatment effect on the blocked disease.

The following points need to be explained:

(1) The drawings of the embodiments of the disclosure only relate to the structures related to the embodiments of the disclosure, and other structures can refer to common designs.

(2) Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.

The above is only a specific embodiment of the present disclosure, but the scope of the present disclosure is not limited thereto, and the scope of the present disclosure should be determined by the scope of the claims.

Claims (13)

1. A shock wave balloon catheter device, comprising:

a balloon comprising an inner layer and an outer layer, the inner layer having a hardness different from the hardness of the outer layer;

an inner tube extending through the balloon, a distal end of the inner tube being connected to a distal end of the balloon;

at least one shock wave electrode assembly disposed outside the inner tube;

and the outer tube is sleeved outside the inner tube and is connected with the near end of the saccule.

2. The shock wave balloon catheter device of claim 1, wherein the outer layer has a hardness greater than the hardness of the inner layer.

3. The shock wave balloon catheter device according to claim 2, wherein the outer layer is nylon, polyethylene terephthalate, or polyethylene;

the inner layer is polyether block polyamide copolymer, polyvinyl chloride, polyurethane or silicon rubber.

4. The shockwave balloon catheter device of claim 2, wherein said outer layer has a hardness of 71D to 90D and said inner layer has a hardness of 35D to 70D.

5. The shockwave balloon catheter device of claim 2, wherein the mass ratio of said outer layer to said inner layer ranges from 1:3 to 3:1.

6. The shockwave balloon catheter device of claim 1, wherein said outer layer is nylon 12, said inner layer is a polyether block polyamide copolymer, and the mass ratio of nylon 12 to polyether block polyamide copolymer is 1:1.

7. The shock wave balloon catheter device of claim 1,

the shock wave electrode assembly includes an inner electrode and an outer electrode and is configured to generate a high voltage pulse between the inner electrode and the outer electrode under a high voltage power supply to generate a mechanical shock wave in the balloon;

the shock wave balloon catheter device further comprises a connecting wire, the connecting wire comprises a first electrode wire and a second electrode wire which extend along the axial direction of the connecting wire, the inner electrode is connected with the first electrode wire, the outer electrode is connected with the second electrode wire, and the first electrode wire and the second electrode wire are configured to be respectively connected with two poles of the high-voltage power supply.

8. The shockwave balloon catheter device of claim 7, wherein said shockwave electrode assembly further comprises an insulating layer positioned between said inner electrode and said outer electrode, wherein a raised pin is disposed on a surface of said inner electrode, wherein a first hole is disposed on said insulating layer, wherein a second hole is disposed on said outer electrode, wherein a diameter of said second hole is greater than a diameter of said first hole, wherein said raised pin, said first hole, and said second hole are configured such that said raised pin extends through said first hole and into said second hole, thereby forming an annular discharge channel between said outer electrode and said inner electrode.

9. The shock wave balloon catheter device according to claim 1, comprising a plurality of the shock wave electrode assemblies arranged at intervals along an axial direction of the inner tube.

10. The shock wave balloon catheter device of claim 9, wherein a plurality of the shock wave electrode assemblies are arranged in series.

11. The shock wave balloon catheter device of claim 9, wherein a plurality of the shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or are angularly arranged in the circumferential direction.

12. A medical device comprising a shock wave balloon catheter device according to any one of claims 1-11, a high voltage generator, the shock wave balloon catheter device further comprising a connecting wire, a distal end of the connecting wire being connected to the shock wave electrode assembly, a proximal end of the connecting wire being connected to the high voltage generator; the pulse voltage of the high-voltage generator is 500V-10 kV, the pulse voltage width is 200 ns-20 mus, the pulse current of the high-voltage generator is 50A-400A, and the pulse current width is 10 ns-2 mus.

13. The medical device of claim 12, wherein each of said shockwave electrode assemblies produces shockwaves having an acoustic pressure intensity of 2Mpa to 20Mpa and an electrical discharge frequency of 0.1Hz to 10Hz.

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