CN115837115A - Impact wave ball bag - Google Patents

Abstract

The application provides a shock wave balloon which is provided with a far end and a near end which are opposite, the shock wave balloon comprises an outer tube and an inner tube, the far end of the outer tube is provided with a balloon body positioned at the periphery of the inner tube, the area between the outer tube and the inner tube and enclosed by the balloon body is a deformable balloon chamber, a first electrode and a second electrode which are mutually acted and used for discharging in the balloon chamber are fixed on the inner tube, and the first electrode and the second electrode respectively extend to the near end through conductors with insulating layers so as to be connected with a driving circuit; the conductors comprise a first conductor and a second conductor according to different electric polarities, each conductor is exposed to the insulating layer in a local area in the balloon chamber, and the exposed parts of the conductors are used as a first electrode and a second electrode respectively; at least one of the first conductor and the second conductor is disposed within the balloon chamber in an annular configuration about an outer circumference of the inner tube. The shock wave ball bag has good flexibility and small radial size, and can pass through a narrow cavity more easily.

Description

Impact wave ball bag

Technical Field

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

Background

In angioplasty, a balloon is used to open calcified lesions in the arterial wall. 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, the stored energy is released, and the process may stress and damage the vessel wall.

In recent years, shock wave balloons have been used to disrupt calcium deposits in arteries or veins. For example, U.S. patent publication No.2009/03127682009, describes a catheter having 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 a balloon is placed adjacent to a calcified region of a vein or artery and a high voltage pulse is applied across the electrodes, a shock wave is formed that propagates through the fluid and strikes the balloon wall and the calcified region. Repeated pulses destroy the calcium without damaging the surrounding soft tissue.

In the scheme, the electrode pair in the shock wave generator uses the cylinder sleeved on the inner tube and the point-like electrode at the middle opening of the cylinder, so that the flexibility of the catheter is reduced, and the difficulty of the catheter passing through a narrow and bent lesion in a blood vessel is increased. In still other balloon catheters, there is a single wire attached to each electrode, resulting in an increase in the overall radial dimension of the balloon.

Disclosure of Invention

In order to overcome the defects in the prior art, the application provides the shock wave ball bag which has better flexibility and smaller radial size and can pass through a narrow cavity more easily.

The shock wave balloon provided by the application is provided with a far end and a near end which are opposite, the shock wave balloon comprises an outer tube and an inner tube, the far end of the outer tube is provided with a balloon body which is positioned at the periphery of the inner tube, an area enclosed by the balloon body between the outer tube and the inner tube is a deformable balloon chamber, a first electrode and a second electrode which are mutually acted and used for discharging in the balloon chamber are fixed on the inner tube, and the first electrode and the second electrode respectively extend towards the near end through conductors with insulating layers to be connected with a driving circuit;

the conductors comprise a first conductor and a second conductor according to different electric polarities, the conductors are exposed to the insulating layer in a local area in the balloon chamber, and the exposed parts of the conductors are used as the first electrode and the second electrode respectively;

at least one of the first conductor and the second conductor is disposed within the balloon chamber in an annular configuration about an outer circumference of the inner tube.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the first electrode and the second electrode are arranged at intervals in the axial direction of the inner tube.

Optionally, at least one of the first electrode and the second electrode is disposed in a plurality of positions, and the electrodes are alternately disposed according to different polarities.

Optionally, at least one of the first electrode and the second electrode is annular.

Optionally, at least one of the first conductor and the second conductor is wound around the inner tube for 1-20 turns in the balloon chamber, and the most lateral turn is exposed to the insulating layer and serves as an electrode.

Optionally, two adjacent turns in the same conductor are closely arranged.

Alternatively, a portion of each turn in the same conductor is exposed to the insulating layer, and the portions of all turns exposed to the insulating layer are adjacent to each other to form the electrodes.

Optionally, the first conductor and the second conductor are mutually avoided at the outer wall of the inner tube, and no overlapping part exists.

Optionally, the first conductor and the second conductor are both of a single structure, one or more electrodes with the same polarity are arranged, and a plurality of the electrodes are connected in series in a circuit.

Optionally, at least one of the first conductor and the second conductor is a plurality of structures, a plurality of conductors with the same electric polarity are connected in parallel, and each conductor forms a corresponding electrode.

Optionally, the first electrode and the second electrode form an electrode pair, the electrode pair may be multiple on the inner tube, and a distance between the two electrode pairs is greater than 0.5cm.

The shock wave ball bag has good flexibility and small radial size, and can pass through a narrow cavity more easily.

Drawings

FIG. 1 is a schematic structural diagram of an embodiment of the present application;

FIG. 2 is a schematic structural diagram of an embodiment of the present application;

FIG. 3 is a schematic diagram of the structure of the conductor of FIG. 1;

FIG. 4 is a schematic structural diagram of an embodiment of the present application;

FIG. 5 is a schematic structural diagram of an embodiment of the present application;

FIG. 6 is a schematic structural diagram of an embodiment of the present application;

FIG. 7 is a schematic structural view of the inner tube of FIG. 1;

FIG. 8 is a schematic structural diagram of an embodiment of the present application;

FIG. 9 is a schematic structural diagram of an embodiment of the present application;

fig. 10 is a schematic structural diagram according to an embodiment of the present application.

The reference numerals in the figures are illustrated as follows:

1. an outer tube; 11. a balloon body; 12. a balloon chamber; 2. an inner tube; 3. a first electrode; 4. a second electrode; 41. a left electrode; 42. a right electrode; 5. an insulating layer; 6. a conductor; 61. a first conductor; 62. a second conductor; 63. a third conductor; 64. a fourth conductor; 65. a first exposed portion; 66. a second exposed site; 7. a drive circuit; 8. a wiring groove; 9. an electrode pair.

Detailed Description

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

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 a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components 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 in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

In the existing shock wave saccule, 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.

To above problem, the application provides a shock wave sacculus, and the compliance is better, convenient operation.

Referring to fig. 1 to 10, the shock wave balloon of the present application has opposite distal and proximal ends, and includes an outer tube 1 and an inner tube 2, the distal end of the outer tube 1 has a balloon body 11 located at the periphery of the inner tube 2, the area enclosed by the balloon body 11 between the outer tube and the inner tube is a deformable balloon chamber 12, a first electrode 3 and a second electrode 4 interacting with each other and used for discharging electricity in the balloon chamber are fixed on the inner tube 2, and the first electrode 3 and the second electrode 4 respectively extend to the proximal end through a conductor 6 with an insulating layer 5 to connect with a driving circuit 7. The conductors include a first conductor 61 and a second conductor 62 according to their electric polarities, each conductor being exposed to the insulating layer 5 at a local region within the balloon chamber 12, the exposed regions serving as the first electrode 3 and the second electrode 4, respectively. At least one of the first and second conductors 61, 62 is disposed within the balloon chamber 12 in an annular configuration about the outer circumference of the inner tube.

It is understood by those skilled in the art that the primary function of the electrodes is to accumulate charge and discharge, the primary function of the conductors is to conduct charge, and the electrodes are also electrically conductive and may be part of the conductors. Thus, the electrodes and conductors of the present application may or may not have a distinct boundary in structure and shape. Theoretically, the portions of the conductor 6 not covered by the insulating layer 5 may be discharged to become electrodes, such as the first exposed portion 65 and the second exposed portion 66 in fig. 3, where the first exposed portion 65 is an exposed portion formed by partial peeling of the insulating layer 5, and the second exposed portion 66 is an exposed portion formed by peeling of a section of the insulating layer 5.

The utility model provides a first electrode 3 and second electrode 4 adopt winding mode to be fixed in inner tube 2, are changeed than tubular structure's electrode and take place the bending, and is less to the compliance influence of sacculus pipe, make the sacculus pipe more easily pass through the narrow chamber way in the human body, and it is more convenient to operate.

The shape and number of the first electrode 3 and the second electrode 4 are not limited in this embodiment, and the electrodes may be coils, dots, welded semicircular rings, circular rings, ellipses, or other irregular shapes with salient points. The material of the electrode can be gold, silver, copper, aluminum, platinum, magnesium and other metals and alloys formed by various processes on a plurality of metals. One or more first electrodes 3 and one or more second electrodes 4 may be provided, and the number of the first electrodes 3 and the number of the second electrodes 4 may be equal or may not be equal. One of the electrodes may discharge toward one or more nearby electrodes of opposite polarity.

Referring to fig. 1, a first electrode 3 and a second electrode 4 are arranged at intervals in the axial direction of an inner tube 2. The positions of the first electrode 3 and the second electrode 4 in the circumferential direction may be the same or different. When the first electrode 3 and the second electrode 4 are at the same position in the circumferential direction, the distance between the first electrode 3 and the second electrode 4 in the axial direction can be set to 0.5 mm-5 mm, and the arc trend is substantially consistent with the vessel trend when the first electrode 3 and the second electrode 4 discharge. As can be understood by those skilled in the art, during discharge, an expansion pressure wave is generated around the plasma region first, and then a cavitation pressure wave is generated around the plasma 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 embodiment are basically vertical to the interface between the calcified layer and the blood vessel wall, and the calcified layer is favorably peeled off.

Referring to fig. 1, at least one of the first electrode 3 and the second electrode 4 is arranged in a plurality of places, and the electrodes are alternately arranged in different polarities. For example, in fig. 1, a first electrode 3 is disposed on each of the proximal side and the distal side of the second electrode 4, and the second electrode 4 can selectively discharge electricity to the proximal side or the distal side, so that the wavefronts of the shock wave in the balloon chamber 12 are relatively uniformly distributed in the axial direction, thereby expanding the effective action range of the shock wave. When the electrodes are arranged, the anode can be arranged between the two cathodes, and the cathode can also be arranged between the two anodes in the axial direction, and the total number of the electrodes can be 3, 4, 5, etc. The number of the electrode pairs in the sacculus chamber 12 is 1-5, and the discharge voltage between two electrodes with opposite polarities in the same electrode pair is 100V-10000V.

The first electrode 3 and the second electrode 4 form a plurality of electrode pairs 9, the electrode pairs 9 can be arranged on the inner tube 2, and the distance between the two electrode pairs 9 is more than 0.5cm.

Referring to fig. 4, 5, at least one of the first electrode 3 and the second electrode 4 is ring-shaped. In fig. 4, the first electrode 3 is a dot-shaped electrode, the second electrode 4 is a ring-shaped electrode, and the central angle surrounded by the ring-shaped electrode may be 360 ° or less than 360 °. When the central angle of the annular electrode is close to 360 degrees, electric arcs generated by discharge can be randomly generated near any generatrix of the conical surface, so that wave sources of shock waves are uniformly distributed in the balloon chamber 12 along the circumferential direction, and the situations that the calcified layer on one side of the vessel wall in the radial direction is excessively peeled and the other side opposite to the vessel wall in the radial direction is insufficiently peeled are effectively avoided. In fig. 5, the first electrode 3 and the second electrode 4 are both ring-shaped, which ensures that the shock wave energy is uniformly distributed in the circumferential direction, and on the other hand, since the discharge point can be any point on the ring-shaped electrode, the distance between the electrodes is kept unchanged along with the continuous etching of the electrode in the discharge process, and compared with the conventional point-to-point discharge, the service life of the electrode can be effectively prolonged.

Referring to fig. 5, at least one of the first and second conductors 61 and 62 is wrapped around the inner tube 1-20 times within the balloon chamber, with the most lateral turn exposed to the insulation layer 5 and acting as an electrode. For example, in fig. 5, the first electrode 3 is located on the side of the coil-shaped first conductor 61 close to the second conductor 62, and the second electrode 43 is located on the side of the coil-shaped second conductor 62 close to the first conductor 61. The more the number of winding turns, the more the position of the electrode is stable, the corresponding bending stress is increased, the closer the joint with the cavity wall is, and the number of the winding turns can be rotated according to the disease part and the pathological change condition. The bare conductor can be wound into a coil, and the outer side of the coil is coated with insulating glue, or the whole section of the bare ring-shaped electrode can be obtained by removing the insulating skin of the existing conductor or burning the paint layer of the enameled wire.

Referring to fig. 5, two adjacent circles of the same conductor are closely arranged, which not only ensures that the electrode is reliably fixed to the inner tube 2, but also enables the electrode pairs to be disposed as much as possible in the balloon chamber 12. Specifically, the distance between two adjacent circles of conductors is less than 1mm.

Referring to fig. 6, portions of the turns in the same conductor are exposed to the insulating layer, and the portions of all the turns exposed to the insulating layer are adjacent to each other to form electrodes. During processing, the conductor can be wound into a spiral shape, and then the insulating layer 5 is stripped at the same circumferential position of the spiral to form an electrode extending along the axial direction, so that the shock wave energy can be further uniformly distributed along the axial direction.

In order to avoid the adhesion short circuit caused by the breakdown of the insulating layer 5 between the first conductor 61 and the second conductor 62, the first conductor 61 and the second conductor 62 are mutually avoided at the outer wall of the inner tube, and no overlapping part exists. Referring to fig. 7, a wiring groove 8 can be formed on the outer side of the pipe wall of the inner pipe 2, the position of the wiring groove 8 corresponds to the intersection point of the first conductor 61 and the second conductor 62, and the part of one conductor 6 corresponding to the intersection point is sunk in the wiring groove 8 to avoid contacting with the other conductor. The first conductor 61 or the second conductor 62 may also be fixed in a hypotube or a groove.

Referring to fig. 8 and 9, the first conductor 61 and the second conductor 62 are each a single structure, and the electrodes having the same polarity are arranged at one or more positions, and the plurality of positions are connected in series in a circuit. The end of the first conductor 61 is connected to the first electrode 3, and the first electrode 3 has a dot structure in fig. 8 and a ring structure in fig. 9. The end of the second conductor 62 connects the left electrode 41 and the right electrode 42 connected in series at two points. The left electrode 41 and the right electrode 42 are led out through the same second conductor 62, so that the number of conducting wires is saved, the profile of the catheter is reduced, the balloon can easily pass through the bent or narrow part of the blood vessel, and the flexibility of the balloon catheter is improved.

Referring to fig. 10, at least one of the first conductor 61 and the second conductor 62 has a plurality of conductors with the same electric polarity, which are connected in parallel, and each of the conductors forms a corresponding electrode. The end of the first conductor 61 is connected to the first electrode 3, the first electrode 3 is in a dot-like configuration, the second conductor 62 includes a third conductor 63 and a fourth conductor 64 which are not electrically connected to each other, the end of the third conductor 63 is connected to the left electrode 41, and the end of the fourth conductor 64 is connected to the right electrode 42. By applying different voltages to the third conductor 63 and the fourth conductor 64, it is possible to artificially control whether the first electrode 3 discharges to the left electrode 41 or the right electrode 42, and the control is more flexible.

In order to reduce the coil's impedance to the discharge current, the conductor 6 connecting the same electrodes may comprise at least two coils wound in opposite directions to cancel the inductance.

The shock wave balloon of the application has one of the following advantages:

1) The impact wave is generated by adopting the potential difference of the electrode pair, and the positive electrode of the electrode pair consists of a coil, so that the flexibility of the saccule is improved. The contact surface of positive negative pole wire has been reduced, the puncture risk is reduced. The use of the guide wire is reduced, and the balloon profile is reduced.

2) Multiple directions or 360 DEG impingement on plaque is achieved.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. The shock wave balloon is provided with a far end and a near end which are opposite, and 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, and the area between the outer tube and the inner tube and enclosed by the balloon body is a deformable balloon chamber;

the conductors comprise a first conductor and a second conductor according to different electric polarities, the conductors are exposed to the insulating layer in a local area in the balloon chamber, and the exposed parts of the conductors are used as the first electrode and the second electrode respectively;

at least one of the first conductor and the second conductor is disposed within the balloon chamber in an annular configuration about an outer circumference of the inner tube.

2. The shock wave balloon of claim 1, wherein the first electrode and the second electrode are spaced apart in an axial direction of the inner tube.

3. The shock wave balloon of claim 1, wherein at least one of the first and second electrodes is arranged in a plurality of places, and the electrodes are alternately arranged in different polarities.

4. The shock wave balloon of claim 1, wherein at least one of the first electrode and the second electrode is annular.

5. The shock wave balloon of claim 1, wherein at least one of the first conductor and the second conductor is wrapped around the inner tube 1-20 times within the balloon chamber, the most lateral turn being exposed to the insulation layer and acting as an electrode.

6. The shock wave balloon of claim 1, wherein adjacent turns in the same conductor are closely spaced.

7. The shock wave balloon of claim 1, wherein a portion of each turn in the same conductor is exposed to the insulating layer, and wherein portions of all turns exposed to the insulating layer are adjacent to each other to form the electrodes.

8. The shock wave balloon of claim 1, wherein the first conductor and the second conductor are offset from each other at the outer wall of the inner tube without a laminated portion.

9. The shock wave balloon of claim 1, wherein the first conductor and the second conductor are each a single structure, and one or more electrodes of the same polarity are arranged in series circuit between the plurality of electrodes.

10. The shock wave balloon of claim 1, wherein at least one of the first conductor and the second conductor is a plurality of conductors, wherein the plurality of conductors having the same electrical polarity are connected in parallel, and wherein each conductor forms a corresponding electrode.

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