CN116077136A

CN116077136A - Improved shock wave balloon

Info

Publication number: CN116077136A
Application number: CN202111315618.3A
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Hangzhou Juzheng Medical Technology Co ltd
Current assignee: Hangzhou Juzheng Medical Technology Co ltd
Priority date: 2021-11-08
Filing date: 2021-11-08
Publication date: 2023-05-09

Abstract

The application provides an improved shock wave balloon, which comprises an outer tube and an inner tube, wherein the far end of the outer tube is provided with a balloon body positioned at the periphery of the inner tube, a deformable balloon chamber is arranged in a region surrounded by the balloon body between the outer tube and the inner tube, a plurality of electrode pairs for discharging in the balloon chamber are fixed on the inner tube, each electrode pair comprises a first electrode and a second electrode which interact, and the first electrode and the second electrode of each electrode respectively extend to the near end through conductors with insulating layers so as to be connected with a driving circuit; the first electrode and/or the second electrode are/is provided with a converging state which is attached to the inner tube and a working state which is far away from the inner tube, and the first electrode and/or the second electrode in the working state forms a guiding space which is used for guiding the running direction of the electrode to the shock wave formed by discharging through being far away from the inner tube. According to the method, the impact waves are guided to gather in the same preset direction through tilting of the working state of the electrode, and the impact force of the balloon is increased.

Description

Improved shock wave balloon

Technical Field

The present application relates to the field of medical devices, and in particular to an improved shock wave balloon.

Background

In angioplasty, a balloon is used to open calcified lesions in the wall of an artery. When the balloon is inflated to expand a lesion in the vessel wall, the inflation pressure stores a large amount of energy in the balloon until the calcified lesion ruptures or ruptures, releasing the stored energy, a process that may stress and damage the vessel wall.

In recent years, shock wave balloons have been used to disrupt calcium deposition in arteries or veins. For example, U.S. patent publication No.2009/03127682009 describes a catheter having a balloon at a distal end, such as a balloon, arranged to be inflated with a fluid. A shock wave generator is provided within the balloon, in the form of, for example, an electrode pair coupled to a high pressure source at the proximal end of the catheter by a connector. When the balloon is placed adjacent to the calcified region of the vein or artery and a high voltage pulse is applied across the electrode, a shock wave is formed that propagates through the fluid and impinges on the balloon wall and the calcified region. Repeated pulses destroy calcium without damaging surrounding soft tissue.

The larger gauge size in the shock wave generator, especially on the axial section of the balloon catheter, results in a decrease in the compliance of the balloon catheter and an increase in the difficulty of crossing the stenotic curved lesion in the vessel. Each electrode of the existing product is connected by a wire, so that the whole specification of the balloon is increased. And the wire of the existing shock wave balloon passes under the electrode, and the wire is easy to break down when in high-voltage pulse to cause power short circuit although an insulating layer exists.

Disclosure of Invention

In view of the shortcomings of the prior art, the present application provides an improved shock wave balloon having opposite distal and proximal ends, the improved shock wave balloon comprising an outer tube and an inner tube, the distal end of the outer tube having a balloon body at the periphery of the inner tube, the area between the outer tube and the inner tube surrounded by the balloon body being a deformable balloon chamber, a plurality of electrode pairs for discharging in the balloon chamber being fixed on the inner tube, each electrode pair comprising first and second electrodes that interact, the first and second electrodes of each electrode extending proximally through conductors with insulating layers, respectively, to connect a drive circuit;

the first electrode and/or the second electrode are/is provided with a converging state which is attached to the inner tube and a working state which is far away from the inner tube, and the first electrode and/or the second electrode which are in the working state form a guiding space which is far away from the inner tube and is used for guiding the running direction of the electrode to the shock wave formed by discharging.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, the first electrode and/or the second electrode are elongated, and in a working state, one end of the first electrode is attached to the inner tube, and the other end of the second electrode is far away from the inner tube to form the guiding space.

Optionally, an included angle between the axial extension line of the first electrode and/or the second electrode and the surface of the inner tube is a working angle, the range of the working angle is 1-89 degrees, and the distance between the first electrode and the second electrode in the axial direction of the inner tube is 0.3-6mm.

Optionally, the balloon maintains the first electrode and/or the second electrode in a contracted state prior to inflation; after the balloon body is expanded, the first electrode and/or the second electrode realize the working state through self stress or external stress.

Optionally, the first electrode and the second electrode are both in a converging state of being attached to the inner tube and a working state of being tilted compared with the inner tube, and in the working state, the first electrode and the second electrode are in consistent or different shapes, and the guiding spaces of the first electrode and the second electrode are mutually communicated.

Optionally, the first electrode has a converging state of being attached to the inner tube and a working state of being tilted compared with the inner tube, and the second electrode is fixedly arranged on the inner tube and is located in the guiding space of the first electrode.

Optionally, the first electrode is in a strip shape, and the end part of the distal end of the first electrode in the working state is aligned with the second electrode at the axial position of the inner tube. .

Optionally, the second electrode is annular and sleeved on the inner tube, and the first electrode is provided with a plurality of second electrodes in the circumferential direction of the inner tube and corresponds to different positions of the second electrode respectively.

Optionally, the second electrode is an electrode point fixed on the inner tube, and the first electrode and the second electrode are arranged in pairs.

Optionally, a plurality of electrode pairs are fixed on the inner tube, and the first electrode and the second electrode in each electrode pair are arranged in the same or independent mode.

According to the technical scheme, the shock wave is generated by adopting the potential difference of the electrode pair, the electrode pair positive electrode consists of a conducting wire, and the flexibility of the saccule is improved. The contact surface of the positive and negative electrode leads is reduced, and the breakdown risk is reduced. Electrode use is reduced, and balloon specification is reduced; the impact wave is guided to gather along the same preset direction by tilting the working state of the electrode, so that the impact force of the saccule is increased.

Specific advantageous technical effects will be further explained in the detailed description in connection with specific structures or steps.

Drawings

FIG. 1 is a schematic view of an improved shock wave balloon according to an embodiment of the present application;

FIG. 2 is a schematic view of an internal structure of an electrode pair according to an embodiment of the present application;

FIG. 3 is an enlarged schematic view of the guide space of FIG. 2;

FIG. 4 is a schematic view of an internal structure of an electrode pair according to another embodiment of the present application;

FIG. 5 is a schematic view of an internal structure of an electrode pair according to another embodiment of the present disclosure;

fig. 6 to 9 are schematic cross-sectional views of a first electrode according to various embodiments of the present application.

Reference numerals in the drawings are described as follows:

11. a distal end; 12. a proximal end;

2. an outer tube; 21. a balloon body; 22. a balloon chamber;

3. an inner tube; 31. an electrode pair; 32. a first electrode; 33. a second electrode; 34. a conductor; 35. a guide space.

Detailed Description

The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

In the existing shock wave balloon, the electrode adopts a cylindrical structure, the flexibility of the catheter is poor, and the difficulty of the catheter passing through a narrow cavity is high.

Aiming at the problems, the application provides an improved shock wave balloon which has the advantages of good flexibility, convenient operation, strong shock wave directivity and good use effect.

Referring to fig. 1 to 3, the present application discloses an improved shock wave balloon having opposite distal and

proximal ends

11 and 12, the improved shock wave balloon comprising an outer tube 2 and an inner tube 3, the distal end 11 of the outer tube 2 having a balloon body 21 at the periphery of the inner tube 3, the region between the outer tube 2 and the inner tube 3 surrounded by the balloon body 21 being a deformable balloon chamber 22, a plurality of electrode pairs 31 for discharging in the balloon chamber 22 being fixed on the inner tube 3, each electrode pair 31 comprising a first electrode 32 and a second electrode 33 which interact, the first electrode 32 and the second electrode 33 of each electrode respectively extending to the proximal end 12 through a conductor 34 with an insulating layer to connect a driving circuit;

the first electrode 32 and/or the second electrode 33 have a converging state of being attached to the inner tube 3 and an operating state of being away from the inner tube 3, and the first electrode 32 and/or the second electrode 33 in the operating state forms a guiding space 35 away from the inner tube 3, and the guiding space 35 is used for guiding the running direction of the shock wave formed by the discharge of the electrode pair 31.

The first electrode 32 and/or the second electrode 33 which are far away from each other are not in contact with the positive electrode wire and the negative electrode wire, so that the risk of short circuit caused by electrode breakdown of an insulating layer is avoided; while the electrode remote from the inner tube 3 resembles a deflector, part of the shock wave may be guided to converge in one direction, increasing the directionality of the wave, the guiding space 35 being embodied in the figure as a triangular area between the electrode and the inner tube. The electrode is formed by a wire guide wire, and the electrode is not additionally added, so that the flexibility of the balloon can be increased, and the specification of the balloon is reduced. The primary function of the electrode is to accumulate charge and discharge, the primary function of the conductor 34 is to conduct charge, and the electrode is also electrically conductive and may be part of the conductor 34. Thus, the electrodes and conductors 34 in this application may or may not have distinct boundaries in structure and shape. In theory, the discharge phenomenon may occur in all the portions of the conductor 34 not covered with the insulating layer, and the portions may become electrodes.

According to the technical scheme disclosed by the application, the shock wave is generated by adopting the potential difference of the electrode pair 31, the positive electrode of the electrode pair 31 is composed of a conducting wire, and the flexibility of the saccule is improved. The contact surface of the positive and negative electrode leads is reduced, and the breakdown risk is reduced. Electrode use is reduced, and balloon specification is reduced; the impact wave is guided to gather along the same preset direction by tilting the working state of the electrode, so that the impact force of the saccule is increased.

In a specific implementation far from the inner tube 3, reference may be made to an embodiment in which the first electrode 32 and/or the second electrode 33 are elongated and, in an operating state, one end is attached to the inner tube 3 and the other end is far from the inner tube 3 to form a guiding space 35. In the present embodiment, the first electrode 32 and/or the second electrode 33 is/are distanced from the inner tube 3 by the arrangement of the extending direction of a part of itself. In the specific product, it is shown that the first electrode 32 and/or the second electrode 33 are tilted with respect to the inner tube 3. In particular dimensions, in the embodiment shown with reference to fig. 3, the angle between the axial extension of the first electrode 32 and/or of the second electrode 33 itself and the surface of the inner tube 3 is an operating angle a, ranging from 1 to 89 degrees. The working angle is further preferably 20 to 85 degrees. The axial extension of the first electrode 32 and/or the second electrode 33 itself is embodied as a connection between the distal-most end 11 of the first electrode 32 and/or the second electrode 33 and the contact point of the first electrode 32 and/or the second electrode 33 with the inner tube 3. The distance between the first electrode 32 and/or the second electrode 33 and the inner tube 3 is a distance of 0.3-6mm in geometry. The distance away in the figures is embodied as the largest dimension of the guiding space in the inner radial direction. In other embodiments, the distance may particularly preferably be 0.5 to 5mm. The first electrode 32 and the second electrode 33 are spaced apart from each other in the axial direction of the inner tube 3 by a distance of 0.3 to 6mm. The pitch distance may further preferably be 0.5 to 5mm.

The arrangement of the electrodes away from the inner tube 3 will interact with the movement of the balloon to some extent. In reference to an embodiment, balloon 21 maintains first electrode 32 and/or second electrode 33 in a contracted state prior to inflation; after the balloon body 21 is expanded, the first electrode 32 and/or the second electrode 33 are brought into an operating state by self stress or external stress. In the present embodiment, the self stress may be expressed as an elastic force of the first electrode 32 and/or the second electrode 33, for example, the first electrode 32 and/or the second electrode 33 is provided as a metal material having a memory effect, or a conductive material having a certain elasticity, and the state is switched by the elastic force of the self deformation. Likewise, the first electrode 32 and/or the second electrode 33 may also be subjected to a state switching by an external stress, which may in particular be manifested as a function of other components, such as a pulling of a balloon or other component. In one embodiment, a material capable of changing its shape under different conditions, such as temperature, humidity, pressure, etc., is provided between the electrode and the inner tube 3 and drives the electrode to change state.

In reference to an embodiment, the first electrode 32 and the second electrode 33 have a converging state of being attached to the inner tube 3 and a working state of being tilted compared with the inner tube 3, and in the working state, the first electrode 32 and the second electrode 33 are configured in a consistent or different manner, and the guiding spaces 35 of the first electrode 32 and the second electrode 33 are communicated with each other. In this embodiment, the first electrode 32 and the second electrode 33 can both switch their own working states, and to a specific extent, they can be cooperatively arranged. In the embodiment shown in fig. 2, the first electrode 32 and the second electrode 33 are in the same form in the operating state. In other embodiments, the first electrode 32 and the second electrode 33 may be configured differently to meet different design requirements during operation.

Similarly, when a plurality of electrode pairs 31 are fixed on the inner tube 3, the first electrode 32 and the second electrode 33 in each electrode pair 31 are arranged in the same or independent manner. The electrode pairs 31 which are arranged in the same manner can mutually enhance the working effect; similarly, the independently arranged electrode pairs 31 can differentiate the working effects, thereby providing a structural basis for the working effects of different shock wave balloons. For example, during discharge, an expansion pressure wave is generated around the plasma region, then a cavitation pressure wave is generated around the ion body region, the tensile strength of the calcified layer is obviously smaller than the compressive strength, and the peeling effect of the cavitation pressure wave on the calcified layer is obvious. The propagation directions of the expansion pressure wave and the cavitation pressure wave of the present embodiment are substantially perpendicular to the interface between the calcified layer and the blood vessel wall, facilitating the peeling of the calcified layer.

Referring to the embodiment shown in fig. 4 to 5, the first electrode 32 has different states, and the second electrode 33 is fixedly arranged. In a specific arrangement, the first electrode 32 has a converging state of being attached to the inner tube 3 and a working state of being tilted compared with the inner tube 3, and the second electrode 33 is fixedly arranged on the inner tube 3 and located in the guiding space 35 of the first electrode 32. This arrangement is beneficial for improving the discharge effect and for achieving guidance of the direction of the shock wave. From another point of view, the first electrode 32 is oriented in the operative state towards the second electrode 33. In the drawing, the first electrode 32 has an elongated shape, and the distal end of the first electrode 32 in the operating state is aligned with the second electrode 33 at the axial position of the inner tube 3. Alignment herein is not limited to absolute alignment in a geometric sense, but emphasizes that the two positions match each other. For example, in the following, when the second electrode 33 is annular, at least a part of the second electrode 33 penetrates the guide space 35 of the first electrode 32, so that the distal end of the first electrode 32 in the operating state is aligned with the second electrode 33 at the axial position of the inner tube 3. In the drawings, the orientation of the electrodes refers to the lateral direction of the extending direction of the electrodes, rather than the axial direction of the electrodes, and this arrangement has the advantage of having a larger facing area between the different electrodes, thereby improving the discharge effect.

In the differential arrangement of the second electrode 33, referring to fig. 4, the second electrode 33 is annular and sleeved on the inner tube 3, and the first electrode 32 is provided with a plurality of second electrodes 33 corresponding to different positions in the circumferential direction of the inner tube 3. The central angle of the ring electrode can be 360 degrees or less than 360 degrees. The second electrode 33 may realize control of the discharge effect by the electrode by the provision of its own insulating layer.

For example, in one embodiment, when the central angle of the annular electrode is close to 360 degrees and no insulating layer is disposed in the circumferential direction, the electric arc generated by the discharge can be randomly generated near any one of the generatrixes of the conical surface, so that the wave source of the shock wave is more uniformly distributed in the balloon chamber 22 in the circumferential direction, and the situation that the calcified layer on one radial side of the vascular wall is excessively stripped and the calcified layer on the other radial opposite side is insufficiently stripped is effectively avoided. On the other hand, the arrangement ensures that the shock wave energy is uniformly distributed in the circumferential direction, and meanwhile, as the discharge point can be any point on the annular electrode, the distance between the electrodes is basically kept unchanged along with continuous etching of the electrode in the discharge process, and compared with the traditional tip-to-tip discharge, the service life of the electrode can be effectively prolonged.

In another embodiment, the second electrode 33 is covered with an insulating layer except for the positions of the second electrode 33 corresponding to the first electrode 32. Thereby realizing the accurate control of the discharge position and direction of the electrode and providing a structural basis for the direction control of the shock wave.

In the differential arrangement of the second electrode 33, referring to fig. 5, the second electrode 33 is an electrode point fixed to the inner tube 3, and the first electrode 32 and the second electrode 33 are arranged in pairs. The placement of the electrode points can optimize the layout within the balloon, thereby providing a structural basis for achieving smaller balloon specifications. In a specific implementation, the electrode points may be dots, round blocks, square dots, square blocks, welded semicircular rings, circular rings, ovals or other irregular shapes with bumps on the outer peripheral surface of the inner tube 3.

The material of the electrode can be gold, silver, copper, aluminum, platinum and other metals and alloys formed by various processes. The electrode is made of conductive material, such as stainless steel, shape memory alloy, and the like, preferably shape memory alloy. As can be seen from fig. 6 to 9, the first electrode 32 may be cylindrical or elongated cylindrical, and the cross-section may be square, circular, semicircular, crescent, etc., and the second electrode 33 is similar. In an embodiment, when the cross section of the electrode is non-circular, the largest axial cross section of the electrode faces the electrode of different polarity, e.g. when the cross section of the electrode is crescent-shaped, the circle center side of the crescent-shape of the electrode faces the electrode of different polarity. The arrangement has the advantage of having a larger area of opposition between the different electrodes, thereby improving the discharge effect.

The total number of electrode pairs 31 may be 1, 2, 3, 4, 5, etc. The discharge voltage between the electrodes of the same electrode pair 31 with opposite polarities is 100V-10000V. The number of the first electrodes 32 and the second electrodes 33 may be equal or unequal in the single electrode pair 31. Electrodes having a plurality of numbers may be connected in series, or may be connected in parallel. The electrodes of the same polarity in the different electrode pairs 31 may be connected in series or may be connected in parallel.

The insulation of the conductor 34 may be achieved using wires with an insulating layer. The insulation of the electrode can be realized by brushing a layer of insulating glue on the surface layer of the tube wall of the inner tube 3 contacting the electrode and the corresponding position of the electrode 31. In arrangement, conductors 34 of different polarity and corresponding electrodes do not meet each other, avoiding the risk of breakdown in multiple uses. The first electrode 32 mentioned above may serve as a positive electrode or a negative electrode, and the second conductor 34 is of the opposite polarity to the first conductor 34.

The optimized arrangement of the electrodes reduces the conductors 34 connected with the electrode pairs 31, and reduces the specification and the size of the balloon catheter, particularly the specification and the size on the axial section of the balloon catheter. The conductor 34 may be fixed to the catheter surface, in a groove in the outer surface of the inner tube 3, or in a hypotube.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the claims. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application is to be determined by the claims appended hereto.

Claims

1. An improved shock wave balloon having opposite distal and proximal ends, the improved shock wave balloon comprising an outer tube and an inner tube, the distal end of the outer tube having a balloon body at the periphery of the inner tube, the region between the outer tube and the inner tube surrounded by the balloon body being a deformable balloon chamber, characterized in that a plurality of electrode pairs for discharging in the balloon chamber are fixed on the inner tube, each electrode pair comprising a first electrode and a second electrode that interact, the first electrode and the second electrode of each electrode extending proximally through conductors with insulating layers, respectively, to connect a drive circuit;

2. The improved shock wave balloon according to claim 1, wherein the first electrode and/or the second electrode is elongated and in an operating state, one end is attached to the inner tube and the other end is remote from the inner tube to form the guiding space.

3. The improved shock wave balloon according to claim 1, wherein the included angle between the axial extension of the first electrode and/or the second electrode and the inner tube surface is an operating angle, the operating angle ranges from 1 to 89 degrees, and the distance between the first electrode and the second electrode in the axial direction of the inner tube is 0.3-6mm.

4. The improved shock wave balloon of claim 1, wherein the balloon body maintains the first electrode and/or the second electrode in a contracted state prior to inflation; after the balloon body is expanded, the first electrode and/or the second electrode realize the working state through self stress or external stress.

5. The improved shock wave balloon according to claim 1, wherein the first electrode and the second electrode each have a converging state of being attached to the inner tube and a working state of being tilted compared with the inner tube, in which the first electrode and the second electrode are arranged in a uniform or different form, and the guide spaces of the first electrode and the second electrode are communicated with each other.

6. The improved shock wave balloon according to claim 1, wherein the first electrode has a contracted state of conforming to the inner tube and an operational state of tilting compared to the inner tube, and the second electrode is fixedly disposed on the inner tube and within the guide space of the first electrode.

7. The improved shock wave balloon of claim 6, wherein the first electrode is elongate and the distal end of the first electrode is aligned with the second electrode in an axial position of the inner tube in an operative state.

8. The improved shock wave balloon according to claim 6, wherein the second electrode is annular and sleeved on the inner tube, and the first electrode is provided with a plurality of electrodes in the circumferential direction of the inner tube and corresponds to different positions of the second electrode respectively.

9. The improved shock wave balloon of claim 6, wherein the second electrode is an electrode point affixed to the inner tube, the first electrode and the second electrode being disposed in pairs.

10. The improved shock wave balloon according to claim 1, wherein a plurality of electrode pairs are fixed on the inner tube, and the first electrode and the second electrode in each electrode pair are arranged in the same or independent manner.