CN115463317B

CN115463317B - Shock wave balloon catheter

Info

Publication number: CN115463317B
Application number: CN202211011982.5A
Authority: CN
Inventors: 胡军; 刘斌; 林振健; 李斌
Original assignee: Sonosemi Medical Co Ltd
Current assignee: Sonosemi Medical Co Ltd
Priority date: 2022-08-23
Filing date: 2022-08-23
Publication date: 2023-08-29
Anticipated expiration: 2042-08-23
Also published as: CN115463317A

Abstract

The application provides a shock wave balloon catheter, which comprises an outer tube and a metal wire, wherein a first end of the metal wire is arranged in the outer tube, a second end of the metal wire extends out of the outer tube, a tail end tube is fixedly arranged at a second end of the metal wire, a balloon is fixedly and hermetically connected between the outer tube and the tail end tube, and the metal wire is accommodated in the balloon; an insulating layer is coated on the outer wall of the metal wire, and an electrode assembly is further arranged on the outer wall of the insulating layer and comprises at least one electrode; an electrode pair can be formed between the metal wire and the electrode or between the electrode and the electrode; under the action of high-voltage power supply, high-voltage pulse can be generated between the electrode pairs, so that shock waves are generated in the balloon. According to the shock wave balloon catheter provided by the application, the metal wire is adopted to replace the common inner tube, so that the radial cross-sectional dimension of the balloon catheter can be effectively reduced, and the balloon catheter can smoothly pass through the focus position.

Description

Shock wave balloon catheter

Technical Field

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

Background

As shown in fig. 1, a conventional angioplasty balloon catheter is provided with two wholly or partially coaxial lumens through an inner tube 113 and an outer tube 102, a first lumen being a guidewire lumen, provided by the lumen of the inner tube 113, into which a guidewire which has been delivered to a target site in advance is inserted, and then the balloon catheter is delivered along the guidewire to a balloon 111 to reach a lesion site; the second lumen is a filling lumen provided by the inner lumen of the outer tube 102 disposed outside the inner tube 113 through which filling medium passes to the interior of the balloon 111 causing the balloon 111 to fill and expand. As the balloon 111 expands to dilate calcified lesions in the vessel wall, the balloon 111 gradually releases pressure until the calcified lesions rupture. However, for lesions with severe calcification, simple balloon 111 expansion tends to be difficult to open the calcified lesions, thereby affecting the therapeutic effect.

In recent years, the liquid-electric lithotripsy technique, which has been widely used clinically to destroy calcified deposits or stones in the urethra or biliary tract, has been applied to destroy calcified lesions in blood vessels. As shown in fig. 1, the shock wave balloon catheter is formed by placing one or a plurality of pairs of discharge electrodes in a conventional angioplasty balloon to form a set of shock wave generators, and then connecting the electrodes to a high-voltage pulse power supply host 107 at the other end of the balloon catheter through wires. When the balloon 111 is placed at a calcified lesion in a blood vessel, the power supply host 107 may selectively destroy the calcified lesion in the blood vessel by applying a high-voltage pulse voltage to the shock wave generator in the balloon 111 to release the shock wave. The shock wave balloon catheter can better treat most serious calcified lesions which are difficult to treat by the traditional angioplasty balloon, and smoothly open the calcified lesions.

Currently, the commercial shock wave balloon catheters employ the dual lumen design of conventional angioplasty balloons, while the electrode assemblies are radially mounted in a stacked relationship between the inner surface of balloon 111 and the outer surface of inner tube 113, which results in a balloon catheter implant having a larger radial cross-sectional dimension relative to conventional angioplasty balloons, thereby reducing the ability of the balloon catheter to pass through the lesion site.

Disclosure of Invention

The application aims to provide a shock wave balloon catheter, which can reduce the radial cross section size of an implanted part of the balloon catheter and is beneficial to the smooth passing of the balloon catheter through a focus position.

Embodiments of the present application are implemented as follows:

an object of the present application is to provide a shock wave balloon catheter, which comprises an outer tube and a metal wire, wherein a first end of the metal wire is arranged in the outer tube, a second end of the metal wire extends out of the outer tube, a tail end tube is fixedly arranged at a second end of the metal wire, a balloon is fixedly and hermetically connected between the outer tube and the tail end tube, and the metal wire between the outer tube and the tail end tube is accommodated in the balloon; an insulating layer is coated on the outer wall of the metal wire, and an electrode assembly is further arranged on the outer wall of the insulating layer and comprises at least one electrode;

an electrode pair can be formed between the metal wire and the electrode or between the electrode and the electrode; under the action of high-voltage power supply, high-voltage pulse can be generated between the electrode pairs, so that shock waves are generated in the balloon.

Further, the radial dimension of the metal wire is 0.1-0.9 mm, the yield strength is more than or equal to 200Mpa, and the elastic modulus is more than or equal to 70Gpa; the end tube is internally provided with a guide wire cavity penetrating along the axial direction, the guide wire cavity is used for penetrating a guide wire, and an inlet of the guide wire cavity is positioned on the side wall close to the proximal end of the end tube.

Further, the electrode assembly comprises a first electrode, and the metal wire and the first electrode are respectively connected to two poles of the high-voltage power supply through leads; the insulating layer is provided with a first opening penetrating through the insulating layer, the first electrode is provided with a second opening communicated with the first opening, so that the metal wire and the first electrode can be conducted to form an electrode pair, and the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The method comprises the steps of carrying out a first treatment on the surface of the The discharge gap of the electrode pair is 0.01 to 3mm, and the capacitance is 0.01 to 2 mu F.

Further, the electrode assembly further includes an insulating member disposed between the insulating layer and the first electrode, and having a third opening communicating with the first and second openings; the discharge gap between the electrode pairs can be adjusted by adjusting the wall thickness of the insulator.

Further, the first electrode has a plurality of annular structures; the plurality of first electrodes are sleeved on the outer side of the insulating layer along the radial direction of the metal wire respectively, and electrode pairs are formed between the metal wire and the plurality of first electrodes respectively.

A second object of the present application is to provide a shock wave balloon catheter, wherein the electrode assembly includes a first electrode, an insulating member, and a second electrode, and the second electrode is attached to the outer wall of the insulating layer; the insulating piece coats the second electrode, and a fourth opening opposite to the second electrode is formed in the insulating piece; the first electrode is of an annular structure, sleeved outside the insulating piece and the second electrode, and provided with a fifth opening opposite to the fourth opening; forming the first electrode and the second electrodeForming electrode pairs; the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The discharge gap is 0.01 to 3mm and the capacitance is 0.01 to 2. Mu.F.

Further, a through hole is formed in the insulating layer, and the metal wire is conducted with the second electrode through the through hole and is used as a conducting wire for electrically connecting the second electrode with a high-voltage power supply.

Further, the plurality of second electrodes are arranged on the outer wall of the insulating layer at intervals along the circumferential direction or the axial direction of the metal wire; electrode pairs are respectively formed between the first electrode and the plurality of second electrodes.

Or the electrode assembly comprises a first electrode, an insulating piece and a second electrode, wherein the first electrode and the second electrode are of annular structures and are sleeved outside the insulating layer along the axial direction of the metal wire at intervals; the insulating piece is coated outside the first electrode or the second electrode, and a through sixth opening is formed in the insulating piece, so that an electrode pair is formed between the first electrode and the second electrode; the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The discharge gap is 0.01 to 3mm and the capacitance is 0.01 to 2. Mu.F.

Further, the electrode assemblies are provided with a plurality of groups, and the electrode assemblies are axially arranged at intervals along the metal wire. The beneficial effects of the embodiment of the application include:

the shock wave balloon catheter can generate high-voltage pulse between the electrode pairs under the action of high-voltage power supply, so that shock waves are generated in the balloon. In the actual use process, liquid is introduced into the balloon through the runner, so that the balloon is gradually inflated to be in contact with the inner wall of the blood vessel, at the moment, the power host supplies power to the electrode pair, so that the electrode pair can release shock waves to destroy the focus on the inner wall of the blood vessel under the condition of being electrified, and the calcified focus can be opened, so that the treatment of the calcified in the blood vessel is realized. Compared with the shock wave balloon catheter in the prior art, the shock wave balloon catheter provided by the application has the advantages that the metal wire is adopted to replace the common inner tube, so that the radial cross section size of the balloon catheter can be effectively reduced, and the balloon catheter can smoothly pass through the focus position; in addition, the wire is used as an electrode or a lead wire, so that the number of components of the implanted part of the balloon catheter can be reduced, the structure of the balloon catheter is simplified, and the radial section size of the balloon catheter is further reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of a prior art shock wave balloon catheter;

FIG. 2 is a schematic view of a shock wave balloon catheter according to a first embodiment of the present application;

FIG. 3 is a second schematic view of a shock wave balloon catheter according to a first embodiment of the present application;

FIG. 4 is a radial cross-sectional view of a balloon region of a shock wave balloon catheter in accordance with a first embodiment of the present application;

FIG. 5 is an enlarged view of a portion of the balloon area of FIG. 3;

FIG. 6 is a schematic cross-sectional view at A-A of FIG. 5;

FIG. 7 is a schematic view of a shock wave balloon catheter according to a second embodiment of the present application;

FIG. 8 is a schematic cross-sectional view at B-B in FIG. 7;

FIG. 9 is a schematic view of a shock wave balloon catheter according to a third embodiment of the present application;

FIG. 10 is a schematic cross-sectional view at C-C of FIG. 9;

FIG. 11 is a schematic view of a shock wave balloon catheter according to a fourth embodiment of the present application;

fig. 12 is a schematic structural view of a shock wave balloon catheter according to a fifth embodiment of the present application.

Icon: 10-a shock wave balloon catheter; 11. 102-an outer tube; 113-an inner tube; 12-wire; 121-an insulating layer; 13-end tube; 131-lumen access; 132-lumen outlet; 111. 14-a balloon; 15-an electrode assembly; 151-a first electrode; 152-insulating ring; 153-a second electrode; 107. 16-a power supply host; 17-hypotubes; 18-a stress relief tube; 19-a catheter hub; 20-a guide wire; d radial cross-sectional dimension of the region where the balloon is located.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present application, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present application and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present application. Furthermore, the terms "first," "second," "third," and the like are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal," "vertical," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present application, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be connected between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art.

Referring to fig. 2 to 4 in combination, a shock wave balloon catheter 10 according to a first embodiment of the present application includes an outer tube 11 and a wire 12, wherein a first end of the wire 12 (i.e. an end of the wire 12 close to an operator, which may also be referred to as a proximal end of the wire 12) is disposed inside the outer tube 11, a second end (i.e. an end of the wire 12 close to a lesion of a patient, which may also be referred to as a distal end of the wire 12) extends out of the outer tube 11, a distal tube 13 is fixedly disposed at the second end of the wire 12, a balloon 14 is sealingly connected between the outer tube 11 and the distal tube 13, and the wire 12 disposed between the outer tube 11 and the distal tube 13 is accommodated in the balloon 14; an insulating layer 121 is coated on the outer wall of the metal wire 12, and an electrode assembly is further arranged on the outer wall of the insulating layer 121 and comprises at least one electrode; when there are a plurality of the electrodes or a plurality of the electrodes, an electrode pair may be formed between the electrodes and the wire 12; under the action of the high voltage power source, a high voltage pulse may be generated between the electrode pairs, thereby generating a shock wave in the balloon 14.

Alternatively, the yield strength of the wire 12 is greater than or equal to 200Mpa, the elastic modulus is greater than or equal to 70Gpa to ensure reliable support of the wire 12.

The application uses the metal wire to replace the inner tube in the conventional balloon catheter, and the metal wire has better supporting performance relative to the inner tube, so that the radial dimension of the metal wire can be set smaller than that of the inner tube. This allows the radial dimension of the balloon catheter implant, particularly for the location of the balloon, to be greatly reduced to facilitate smooth passage of the balloon catheter through the lesion location.

The radial cross-sectional shape of the wire 12 is not particularly limited, and may be circular, elliptical or irregular, so long as it is sufficient that a flow passage allowing fluid to pass through is formed between the wire 12 and the inner cavity of the outer tube 11 after being inserted into the inner cavity of the outer tube 11. In this embodiment, the radial cross-section of the wire 12 is circular, and the inner diameter of the outer tube 11 is larger than the outer diameter of the wire 12, so that the wire 12 can be accommodated in the outer tube 11, and a flow channel for filling medium (typically liquid) to pass through can be formed between the inner wall of the outer tube 11 and the outer wall of the wire 12, and the wire 12 is of a solid structure and can be made of a metal material with a certain elasticity, such as copper. Regarding the area of the lumen formed by the outer tube 11 and the wire 12, those skilled in the art should be able to make reasonable designs and choices according to practical circumstances, and there is no particular limitation. Alternatively, the radial dimension of the wire 12 is 0.1 to 0.9mm. Illustratively, the lumen area of the outer tube 11 and the wire 12 is greater than 0.2mm ² So that the liquid is introduced into the balloon 14 through the flow passage at a preset flow rate, thereby enabling the balloon 14 to be rapidly inflated to be in fitting contact with the inner wall of the blood vessel.

Specifically, the first end of wire 12 sets up in outer tube 11, the second end of wire 12 stretches out outside outer tube 11 to towards keeping away from one side of outer tube 11 and extend, the second end of wire 12 is fixed to be provided with terminal pipe 13, outer tube 11 and terminal pipe 13 are the interval setting, and the both ends of sacculus 14 respectively with outer tube 11 and terminal pipe 13 fixed connection, so that can seal up sacculus 14 through the outer wall of outer tube 11 and the outer wall of terminal pipe 13, the cladding has insulating layer 121 on the outer wall of wire 12, ensure the electric safety of this shock wave sacculus pipe through insulating layer 121.

The insulating layer 121 may be an insulating coating coated on the outer wall of the wire 12, for example, the insulating coating may be made of plastic or rubber, or an insulating coating coated on the outer wall of the wire 12, for example, a Polyimide (PI) coating, so as to further improve the supporting performance of the wire 12.

Referring to fig. 2 and 3, a guide wire cavity penetrating along the axial direction is arranged in the terminal tube 13, the guide wire cavity is used for penetrating the guide wire 20, the guide wire cavity is provided with a cavity channel inlet 131 and a cavity channel outlet 132, and the cavity channel inlet 131 is arranged on the distal end wall of the terminal tube 13; the lumen outlet 132 is provided on the proximal side wall of the tip tube 13.

In the actual use process, the guide wire 20 is firstly conveyed to the target position in advance, then the tail end pipe is arranged on the guide wire 20 in a penetrating mode, the tail end pipe is conveyed along the guide wire 20, and the whole balloon catheter implantation part is conveyed to the balloon 14 to reach the lesion position. Compared with the shock wave balloon catheter in the prior art, the shock wave balloon catheter 10 provided by the application has the advantages that the guide wire 20 directly enters through the cavity entrance 131 of the tail end pipe 13 and passes out of the cavity exit 132, so that the guide wire passing through the tail end pipe 13 is realized, the wire 12 does not need to be provided with a hollow structure like an inner pipe to provide a cavity for the guide wire 20 to pass through, on one hand, the reliable supporting performance of the wire 12 can be ensured, and on the other hand, the radial section size of the implanted part of the balloon catheter can be further reduced.

In this process, the balloon 14 is always in a contracted and wound state, and then liquid is introduced into the balloon 14 through the runner, so that the balloon 14 is gradually inflated to be in contact with the inner wall of the blood vessel, at this time, the power host 16 supplies power to the electrode pair, so that the electrode pair releases shock waves to destroy the focus on the inner wall of the blood vessel under the condition of power supply, and the calcified focus can be opened, thereby realizing the treatment of calcification in the blood vessel. The above-mentioned implanted portion of the balloon catheter refers to a portion of the balloon catheter implanted into the lumen of the human body, and thus, the radial cross-sectional dimension of the implanted portion of the balloon catheter refers to the cross-sectional dimension of the portion of the balloon catheter implanted into the lumen of the human body, and in general, the maximum radial cross-sectional dimension thereof is mainly considered, and reference is made to fig. 4, i.e., the radial cross-sectional dimension d of the region where the balloon 14 is located after the balloon 14 is shrunk and wound. Compared with the shock wave balloon catheter in the prior art, the shock wave balloon catheter provided by the application can effectively reduce the radial section size of the balloon catheter implantation part by adopting the metal wire 12 to replace the common inner tube 113, thereby being beneficial to the smooth passing of the balloon catheter through the focus position.

From the clinical point of view, there are still some other problems in applying electrohydrodynamic lithotripsy to conventional angioplasty balloons for treating intravascular calcifications: on the one hand, the sound pressure value of the shock wave is not high enough, so that some calcified lesions need to release excessive high-pressure pulses, and even a plurality of shock wave balloon catheters are adopted to destroy calcification, thereby prolonging the operation time and increasing the operation cost of patients; on the other hand, the uniformity of the sound pressure value of the shock wave is poor, and the lesions with the same calcification degree have larger fluctuation of the high-voltage pulse times required for treatment, which is not beneficial to the operation of clinicians.

From the mechanism of the electrohydraulic lithotripsy technology, the magnitude of the sound pressure value is related to the voltage, capacitance and electrode discharge gap. The higher the voltage and the capacitance, the higher the sound pressure value, and the electrode discharge gap is increased at the same time, so that the radial section size of the balloon catheter implantation part is increased; in addition, decreasing the resistance of the power circuit may also increase the sound pressure value, for example, by changing to a conductor material having a lower resistivity, or increasing the cross-sectional area of the conductor material. However, if the cross-sectional area of the conductor material is increased, an increase in the radial cross-sectional dimension of the balloon catheter implant is also caused; and under the optimal electrode discharge gap, the resistance of the power utilization loop is reduced and the durability of the electrode is improved by increasing the sectional area of the conductor material, so that the uniformity of the shock wave can be well improved. However, in all of the above solutions, the radial cross-sectional dimension of the balloon catheter implant is inevitably greatly increased, resulting in a decrease in the ability of the balloon catheter to pass through the lesion site.

In order to solve the above problems, the present application provides a shock wave balloon catheter, which uses a metal wire 12 instead of a common inner tube 113, so as to reduce the radial cross-sectional dimension d of the balloon region, and the metal wire 12 can also be used as an electrode pair between one electrode and other electrodes in the electrode assembly to release shock waves, or as a wire for electrically connecting the shock wave generating device with the power host 107. Compared with the prior art, the metal wire 12 provided by the application can reduce the number of components of the balloon catheter implantation part no matter being used as an electrode or a conducting wire, thereby further reducing the radial section size of the balloon catheter implantation part.

In the first embodiment of the present application, the wire is used as an electrode, and referring to fig. 5, the electrode assembly includes two first electrodes 151 having a ring structure, and the two first electrodes 151 are disposed on the outer wall of the insulating layer 121 at intervals in the axial direction. At this time, the wire 12 is used as one electrode of the electrode pair, and the first electrode 151 is used as the other electrode of the electrode pair, so that the wire 12 forms two electrode pairs between the two first electrodes 151, respectively.

The electrode pairs are connected with the power host 16 through guide wires, after the liquid flowing in through the flow channel fills the balloon 14, the metal wires 12 are respectively conducted with the two first electrodes 151, pulse voltage signals are released through the power host 16, and pulse shock waves can be released by the two electrode pairs.

In this embodiment, the structure of one electrode pair formed therein will be described in detail, taking the example of the electrode pair. Referring to fig. 6, the insulating layer 121 is provided with a first opening (not labeled in the figure) therethrough; a second opening (not labeled in the figure) is formed on the sidewall of the first electrode 151; the second opening communicates with the first opening, and when the liquid fills the balloon, the wire 12 and the first electrode 151 are conducted between the first opening and the second opening to form an electrode pair.

In the present application, the discharge area of the electrode pair may be set to 7.5x10 ^-4 mm ² To 3.5mm ² The discharge area is the effective area between the two electrodes through liquid conduction.

In the present application, the discharge gap of the electrode pair is 0.01 to 3mm, and the capacitance is 0.01 to 2. Mu.F. The discharge gap of the electrode pair can be adjusted by adjusting the thickness of the insulating layer 121, or by providing first insulating rings with different wall thicknesses between the insulating layer 121 and the first electrode 151. The capacitance between the electrode pairs can be adjusted by the output voltage of a high voltage power supply, which in the present application is 0.5 to 30kV.

Referring to fig. 7 and 8, the second embodiment of the present application provides another shock wave balloon catheter, which is different from the first embodiment in that the number of the first electrodes 151 is one, the electrode assembly 15 further includes an insulation ring 152, the insulation ring 152 is disposed between the insulation layer 121 and the first electrodes 151, and the distance between the wire 12 and the first electrodes 151 can be adjusted by disposing the first insulation ring 152, thereby adjusting the discharge gap of the first electrode pair.

In this embodiment, the insulating ring 152 is provided with a third opening through which the first opening and the second opening are communicated; when the balloon is filled with liquid, the wire 12 and the first electrode 151 may be in communication through the first, second and third openings.

According to the application, different insulating ring sizes can be designed according to actual requirements to realize adjustment of discharge gaps, so that shock wave balloon catheter products with different discharge performances are obtained.

It should be noted that, the present application may also provide more than two electrode pairs according to the treatment requirement. When the wire is used as the electrode, a plurality of first electrodes may be provided, and the plurality of first electrodes may be disposed outside the insulating layer at intervals along the axial direction of the wire, with a plurality of electrode pairs being formed between the wire and the plurality of first electrodes. The electrode pair is formed only by the discharge area between the electrodes being 7.5x10 ^-4 mm ² To 3.5mm ² The method comprises the steps of carrying out a first treatment on the surface of the The discharge gap is 0.01 to 3mm and the capacitance is 0.01 to 2. Mu.F.

In the application, the metal wire can also be used as a wire for connecting the shock wave generating device with a power supply host. When the metal wire is used as the conducting wire, the quantity of the conducting wire can be reduced, so that the structure of the shock wave balloon catheter is simplified, and the radial section size of the shock wave balloon catheter is effectively reduced.

Referring to fig. 9 and 10, the third embodiment of the present application further provides a shock wave balloon catheter, which is different from the first embodiment in that the electrode assembly 15 includes a first electrode 151, an insulating ring 152, and two second electrodes 153; the two second electrodes 153 are in a rod-shaped structure, and are attached to opposite sides of the outer wall of the insulating layer 121 along the axial direction of the metal wire 12; the insulating ring 152 is coated outside the two second electrodes 153; the first electrode 151 has an annular structure and is sleeved outside the member in the radial direction; the insulating ring 152 is provided with a fourth opening and a fifth opening which penetrate through the insulating ring and respectively face the two second electrodes 153; a sixth opening and a seventh opening are arranged on the first electrode 151, the sixth opening faces the fourth opening, and the seventh opening faces the fifth opening; the first electrodes 151 are formed as electrode pairs between two second electrodes 153, respectively.

In this embodiment, the insulating layer 121 is further provided with a through hole, and the metal wire 12 is electrically connected to at least one of the two second electrodes through the through hole and is used as a wire connected to the power host.

The technical scheme can reduce the lead wire connected between the shock wave generating device and the power host, thereby effectively reducing the radial section size of the implanted part of the balloon catheter.

It should be noted that the number of electrode pairs can be set according to actual needs.

For example, in an alternative embodiment of the present application, the electrode pair is one. In particular, the difference from the third embodiment is only that only one second electrode is attached to the outer wall of the insulating layer along the axial direction of the wire, and an electrode pair may be formed between the second electrode and the first electrode.

In another alternative embodiment of the present application, a plurality of second electrodes are attached to the outer wall of the insulating layer along the axial direction of the metal wire, where the plurality of second electrodes are uniformly distributed along the circumferential direction of the metal wire, and a plurality of electrode pairs may be formed between the plurality of electrodes and the first electrode.

The second electrode may have various structures, and may be provided in a sheet-like structure or a ring-like structure.

The application can adopt the same insulating ring to cover the outside of a plurality of second electrodes, or can respectively cover each second electrode by a plurality of insulating pieces.

Referring to fig. 11, a fourth embodiment of the present application also provides a shock wave balloon catheter, which is different from the third embodiment in that the present embodiment includes a plurality of electrode pairs formed by a first electrode and a second electrode. The multiple groups of electrode pairs are axially spaced along the metal wire, and the structure of the multiple groups of electrode pairs is the same as that of the electrode pairs in the third embodiment, and will not be described herein.

Referring to fig. 12, the fifth embodiment of the present application further provides a shock wave balloon catheter, which is different from the third embodiment in that the electrode assembly 15 includes a first electrode 151, a second electrode 153, and an insulating cover (not shown in the drawings), where the first electrode 151 and the second electrode 153 each have a ring structure, and are sleeved outside the insulating layer along the axial direction of the wire; the insulating cover is covered outside the first electrode, and is provided with an eighth opening penetrating through the insulating cover; when the liquid fills the balloon, an electrode pair is formed between the first electrode 151 and the second electrode 153.

The insulating layer is provided with a through hole to conduct the metal wire with the first electrode 151, thereby serving as a guide wire for connecting the first electrode 151 with a power supply host. In this embodiment, the sixth opening area is 3.5mm ² The method comprises the steps of carrying out a first treatment on the surface of the The discharge gap of the electrode pair was 3mm.

As shown in fig. 2 and 3, the shock wave balloon catheter further includes a hypotube 17 disposed adjacent to the outer tube 11, and a first end of the wire 12 is inserted into the hypotube 17 through the outer tube 11 to ensure the safety of the shock wave balloon catheter. In addition to this, the shock wave balloon catheter may further comprise a destressing tube 18 and a catheter hub 19 to connect the outer tube 11 and the catheter hub 19 or the hypotube 17 and the catheter hub 19 through the destressing tube 18, thereby weakening the stress therebetween.

Example 1

The shock wave balloon catheter provided by the application is characterized in that a first electrode, an insulating ring and a second electrode are sleeved outside a metal wire coated with an insulating layer in sequence. Specifically, the wire 12 is a copper wire with an outer diameter of 0.38mm (PI coating thickness 0.03 mm); the first electrode selects stainless steel circular rings with aperture of 0.45mm and wall thickness of 0.05mm, the insulating ring selects PI rings (optimal electrode gap) with thickness of 0.03mm, the second electrode selects stainless steel rings with aperture of 0.62mm and wall thickness of 0.05mm, and all the structures are arranged on the metal wire in a viscose mode. And assembling the sacculus, the outer tube, the hypotube, the stress-relieving tube and the catheter seat outside the metal wire in a laser welding and adhesive mode. The inner diameter of the outer tube is 0.78mm, the outer diameter is 1.0mm, the nominal diameter of the balloon is 3.0mm, the nominal length is 20mm, and the radial section dimension d of the area where the balloon is positioned is 0.76mm after the balloon is folded. The insulating layer of the metal wire is provided with a through hole so as to lead the metal wire to be communicated with the inner electrode; the external electrode is connected with the power supply host through a wire. The power supply host output voltage was 2kv and the capacitance was 0.05 μf.

The hydrophone (sensitivity: 850mV/Mpa, frequency range: 01 to 20 Mhz) was used to measure the mean value of sound pressure 1.1Mpa and the number of shock wave lives 440 times at a distance of 3cm from the center of the balloon to the outer electrode.

Comparative example 1

With the conventional PTCA balloon catheter structure, a shock wave generating device, which is an electrode assembly composed of a first electrode, an insulating cover, and a second electrode, is mounted on the inner tube 113. Specifically, the inner tube 113 has an inner diameter of 0.45mm and an outer diameter of 0.60mm, the first electrode is a stainless steel ring with an aperture of 0.67mm and a wall thickness of 0.05mm, the insulating cover is a PI ring (optimal electrode gap) with a thickness of 0.03mm, and the second electrode is a stainless steel ring with a hole with an aperture of 0.84mm and a wall thickness of 0.05mm, and is mounted on the inner tube 113 by means of adhesive. The balloon 111, the outer tube 102, the hypotube, the de-stressing tube and the catheter hub are assembled outside the inner tube 113 by laser welding, adhesive means. The outer tube 102 has an inner diameter of 1.0mm and an outer diameter of 1.25mm, the balloon 111 has a nominal diameter of 3.0mm and a nominal length of 20mm, and the radial cross-sectional dimension of the region where the balloon 111 is located after the balloon 111 is folded is 0.99mm. The first electrode and the second electrode are connected to the power supply host 107 through one wire, respectively. The power supply host 107 outputs a voltage of 2kv and a capacitance of 0.05 μf.

The average value of the test sound pressure was 0.6MPa and the number of times of life of the shock wave was 205 times at 3cm from the center of the third opening (or the second opening) using a hydrophone (sensitivity: 850mV/MPa, frequency range: 01 to 20 Mhz).

The above description is only of the preferred embodiments of the present application and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

In addition, the specific features described in the above embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, various possible combinations are not described further.

Claims

1. The shock wave balloon catheter is characterized by comprising an outer tube and a metal wire, wherein a first end of the metal wire is arranged in the outer tube, a second end of the metal wire extends out of the outer tube, a tail end tube is fixedly arranged at a second end of the metal wire, a balloon is fixedly and hermetically connected between the outer tube and the tail end tube, and the metal wire between the outer tube and the tail end tube is accommodated in the balloon; the radial dimension of the metal wire is 0.1 to 0.9mm, the yield strength is more than or equal to 200Mpa, and the elastic modulus is more than or equal to 70Gpa; a guide wire cavity penetrating along the axial direction is arranged in the tail end pipe, the guide wire cavity is used for penetrating a guide wire, and an inlet of the guide wire cavity is positioned on the side wall close to the proximal end of the tail end pipe;

an insulating layer is coated on the outer wall of the metal wire, and an electrode assembly is further arranged on the outer wall of the insulating layer and comprises at least one electrode;

2. The shock wave balloon catheter according to claim 1, wherein the electrode assembly comprises a first electrode, the wire and the first electrode being connected to the high voltage by wires, respectivelyTwo poles of the power supply; the insulating layer is provided with a first opening penetrating through the insulating layer, the first electrode is provided with a second opening communicated with the first opening, so that the metal wire and the first electrode can be conducted to form an electrode pair, and the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The method comprises the steps of carrying out a first treatment on the surface of the The discharge gap of the electrode pair is 0.01 to 3mm, and the capacitance is 0.01 to 2 mu F.

3. The shock wave balloon catheter according to claim 2, wherein the electrode assembly further comprises an insulating member disposed between the insulating layer and the first electrode, having a third opening disposed thereon in communication with the first and second openings; the discharge gap between the electrode pairs can be adjusted by adjusting the wall thickness of the insulator.

4. The shock wave balloon catheter according to claim 2, wherein the first electrode is plural and has a ring-like structure; the plurality of first electrodes are sleeved on the outer side of the insulating layer along the radial direction of the metal wire respectively, and electrode pairs are formed between the metal wire and the plurality of first electrodes respectively.

5. The shock wave balloon catheter according to claim 1, wherein the electrode assembly comprises a first electrode, an insulating member and a second electrode, the second electrode being attached to the outer wall of the insulating layer; the insulating piece coats the second electrode, and a fourth opening opposite to the second electrode is formed in the insulating piece; the first electrode is of an annular structure, sleeved outside the insulating piece and the second electrode, and provided with a fifth opening opposite to the fourth opening; forming an electrode pair between the first electrode and the second electrode; the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The discharge gap is 0.01 to 3mm and the capacitance is 0.01 to 2. Mu.F.

6. The shock wave balloon catheter according to claim 5, wherein the insulating layer is provided with a through hole, and the wire is connected to the second electrode through the through hole, and is used as a wire for electrically connecting the second electrode to a high-voltage power supply.

7. The shock wave balloon catheter according to claim 6, wherein a plurality of second electrodes are provided, and the plurality of second electrodes are circumferentially or axially spaced along the wire on the outer wall of the insulating layer; electrode pairs are respectively formed between the first electrode and the plurality of second electrodes.

8. The shock wave balloon catheter according to claim 1, wherein the electrode assembly comprises a first electrode, an insulator and a second electrode, each of the first and second electrodes having a ring-like structure, and being axially spaced around the insulator along the wire; the insulating piece is coated outside the first electrode or the second electrode, and a through sixth opening is formed in the insulating piece, so that an electrode pair is formed between the first electrode and the second electrode; the discharge area of the electrode pair is 7.5x10 ^-4 To 3.5mm ² The discharge gap is 0.01 to 3mm and the capacitance is 0.01 to 2. Mu.F.

9. The shock wave balloon catheter according to claim 5 or 8, wherein the electrode assemblies have a plurality of sets, the plurality of sets of electrode assemblies being axially spaced along the wire.