Electrode assembly for shock wave generating catheter

Abstract

The present application discloses an electrode assembly for a shock wave generating catheter, the electrode assembly comprising: at least one non-conductive layer, a first electrode and a second electrode, the first electrode and the second electrode being physically separated from each other and connectable to a voltage source; the electrode assembly is provided with a tubular structure, the tubular structure is provided with an outer surface and an inner surface, and the inner surface forms an inner cavity; an outer surface of the electrode assembly is formed by an outermost non-conductive layer of the at least one non-conductive layer, the outermost non-conductive layer being disposed over the first electrode and the second electrode; a first hole extending through the at least one non-conductive layer to expose a portion of the first electrode to an ambient environment; and a second aperture extending through the at least one non-conductive layer to expose a portion of the second electrode to the ambient environment, where the first aperture and the second aperture are configured to allow an arc discharge to pass from the first electrode to the second electrode, or vice versa, upon application of a potential difference between the first electrode and the second electrode by a voltage source. The invention also discloses a shock wave generating unit comprising the electrode assembly, a shock wave generating system comprising one or more shock wave generating units, and a shock wave generating catheter comprising the shock wave generating system.

Description

Technical Field

[0001] The present application relates to an electrode assembly for a shock wave generating catheter. The present application also relates to a shock wave generating unit, a shock wave generating system, and a shock wave generating catheter including one or more electrode assemblies. Background Art

[0002] Previously published documents cited or discussed in this specification should not necessarily be regarded as an admission that such document is part of the prior art or common general knowledge.

[0003] A balloon angioplasty catheter is an interventional device used to dilate blood vessels and soften calcified lesions to restore normal blood flow. Over time, many improvements have been made to traditional devices, one of which is to add a shock wave generating electrode assembly inside the balloon to help soften or break up calcified deposits in the intimal wall of blood vessels. The shock wave generator generates high-power shock waves that impact hard and brittle calcium while the balloon applies physical pressure. The combined effect of the shock waves and balloon pressure has been shown to be more effective in restoring blood vessel patency and maintaining it for a longer time. However, the limitations of current devices are the power of the shock waves generated and the lifespan of the generator that produces the shock waves.

[0004] Therefore, there is a need for alternatives and / or improvements to the electrode assemblies for shock wave generating systems and catheters. Summary of the Invention

[0005] The various aspects and embodiments of the present application are described in the numbered clauses below.

[0006] 1. An electrode assembly for a shock wave generating catheter, the electrode assembly comprising:

[0007] At least one non-conductive layer, a first electrode, and a second electrode, the first electrode and the second electrode being physically separated from each other and connectable to a voltage source;

[0008] The electrode assembly has a tubular structure having an outer surface and an inner surface, the inner surface forming a lumen;

[0009] The outer surface of the electrode assembly is formed by the outermost non-conductive layer of the at least one non-conductive layer, the outermost non-conductive layer being disposed above the first electrode and the second electrode;

[0010] A first hole extending through the at least one non-conductive layer to expose a portion of the first electrode to the surrounding environment;

[0011] A second hole extending through the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment,

[0012] Wherein, the first hole and the second hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode, or vice versa, when a potential difference is applied between the first electrode and the second electrode through a voltage source.

[0013] 2. The electrode assembly according to Clause 1, wherein the inner surface of the electrode assembly is formed by the innermost non-conductive layer.

[0014] 3. The electrode assembly according to Clause 2, wherein the electrode assembly further includes one or more internal non-conductive layers, and each internal non-conductive layer is disposed between the innermost non-conductive layer and the outermost non-conductive layer.

[0015] 4. The electrode assembly according to Clause 3, wherein the electrode assembly further includes at least two internal non-conductive layers, such as including two, three, four, five or six internal non-conductive layers.

[0016] 5. The electrode assembly according to any one of Clauses 3 to 4, wherein the first electrode and the second electrode are each independently embedded in the innermost non-conductive layer or one of the internal non-conductive layers.

[0017] 6. The electrode assembly according to any one of Clauses 2 to 5, wherein the first electrode and the second electrode are respectively embedded in different non-conductive layers.

[0018] 7. The electrode assembly according to any one of Clauses 2 to 6, wherein the first electrode is embedded in the innermost non-conductive layer.

[0019] 8. The electrode assembly according to any one of Clauses 2 to 6, wherein the first electrode and the second electrode are each independently embedded in one of the internal non-conductive layers.

[0020] 9. The electrode assembly according to any one of Clauses 3 to 8, wherein each of the one or more internal non-conductive layers is formed of a polymer independently selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), epoxy resins, and combinations thereof.

[0021] 10. The electrode assembly according to any one of Clauses 3 to 9, wherein the electrode assembly includes:

[0022] A first internal non-conductive layer disposed above the innermost non-conductive layer;

[0023] A second internal non-conductive layer disposed above the first internal non-conductive layer;

[0024] A third internal non-conductive layer disposed above the second internal non-conductive layer; and

[0025] The outermost non-conductive layer is disposed above the third internal non-conductive layer, thereby forming the outer surface of the electrode assembly.

[0026] 11. The electrode assembly according to clause 10, wherein the first internal non-conductive layer is formed of polyimide; the second internal non-conductive layer is formed of epoxy resin; the third internal non-conductive layer is formed of polyimide.

[0027] 12. The electrode assembly according to clause 11, wherein the first electrode is embedded in the innermost non-conductive layer, and the second electrode is embedded in the second internal non-conductive layer.

[0028] 13. The electrode assembly according to any one of clauses 2 to 11, wherein the innermost non-conductive layer is formed of epoxy resin.

[0029] 14. The electrode assembly according to any one of clauses 2 to 12, wherein the outermost non-conductive layer is formed of an impact-resistant material and / or an impact-absorbing material, for example, the outermost non-conductive layer is formed of an impact-resistant and / or impact-absorbing epoxy resin.

[0030] 15. The electrode assembly according to any one of clauses 2 to 14, wherein the first electrode and the second electrode are offset from each other along the longitudinal axis of the electrode assembly.

[0031] 16. The electrode assembly according to clause 1, wherein the inner surface of the electrode assembly is formed by the innermost layer including the first electrode, the second electrode, and a non-conductive member, wherein the non-conductive member physically separates the first electrode and the second electrode from each other.

[0032] 17. The electrode assembly according to clause 16, wherein the electrode assembly further includes one or more internal non-conductive layers, each internal non-conductive layer being disposed between the innermost layer and the outermost non-conductive layer.

[0033] 18. The electrode assembly according to clause 16 or 17, wherein the non-conductive member is formed of one or more materials selected from the group consisting of polymers, ceramics, epoxy resins, adhesives, and combinations thereof.

[0034] Optionally, wherein the polymer is selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), and combinations thereof.

[0035] For example, wherein the polymer includes polyimide.

[0036] 19. The electrode assembly according to any one of clauses 16 to 18, wherein the maximum radius of the non-conductive member corresponds to the maximum radii of the first electrode and the second electrode.

[0037] 20. An electrode assembly according to any one of clauses 16 to 18, wherein the maximum radius of the non-conductive member is greater than the maximum radius of each of the first electrode and the second electrode.

[0038] 21. An electrode assembly according to clause 1, wherein the inner surface of the electrode assembly is formed by the first electrode and a first portion of the innermost non-conductive layer;

[0039] A second portion of the innermost non-conductive layer is disposed between the first electrode and the outermost non-conductive layer;

[0040] The second electrode is disposed between the first portion of the innermost non-conductive layer and the outermost non-conductive layer.

[0041] 22. An electrode assembly according to clause 21, wherein the innermost non-conductive layer is formed of nylon, poly(ether-amide) (e.g., ) or a heat shrink tube (e.g., fluorinated ethylene propylene or polyethylene terephthalate); and

[0042] The outermost non-conductive layer is formed of an impact-resistant and / or shock-absorbing material, e.g., the outermost non-conductive layer is formed of an impact-resistant and / or shock-absorbing epoxy resin.

[0043] 23. An electrode assembly according to any one of the preceding clauses, wherein the first electrode and / or the second electrode is formed of one or more materials selected from the group consisting of tungsten, steel, titanium, cobalt, platinum, iridium, nickel, and alloys thereof.

[0044] 24. An electrode assembly according to any one of the preceding clauses, wherein the first hole and the second hole are offset from each other along the longitudinal axis of the electrode assembly.

[0045] 25. An electrode assembly according to any one of clauses 1 to 23, wherein the first hole and the second hole are offset from each other circumferentially around the electrode assembly.

[0046] 26. An electrode assembly according to any one of the preceding clauses, wherein the first hole and the second hole have substantially the same diameter.

[0047] 27. An electrode assembly according to any one of clauses 1 to 25, wherein the diameters of the first hole and the second hole are different from each other.

[0048] 28. An electrode assembly according to any one of the preceding clauses, wherein the portions of the first electrode and / or the second electrode exposed to the surrounding environment have a surface shape configured to concentrate the arc discharge location.

[0049] 29. An electrode assembly according to clause 28, wherein the surface shape configured to concentrate the arc discharge location includes surface depressions.

[0050] 30. The electrode assembly according to clause 28, wherein the shape of the surface depression is selected from the group including a hemispherical concave surface, a cone, and a cylindrical pit (such as a cylindrical pit).

[0051] 31. The electrode assembly according to clause 28, wherein the surface shape configured to concentrate the arc discharge position includes a surface protrusion.

[0052] Optionally, wherein the surface protrusion has a conical or hemispherical shape.

[0053] 32. The electrode assembly according to any one of the foregoing clauses, wherein the diameters of the first hole and the second hole are both about 0.2 mm to about 1 mm.

[0054] 33. The electrode assembly according to any one of the foregoing clauses, wherein the minimum distance from the edge of the first hole to the edge of the second hole is about 0.05 mm to about 10 mm.

[0055] 34. The electrode assembly according to any one of the foregoing clauses, wherein the thickness of at least one non-conductive layer is about 0.02 mm to about 0.8 mm, and optionally, the thickness of each non-conductive layer is about 0.02 mm to about 0.8 mm.

[0056] 35. The electrode assembly according to any one of the foregoing clauses, further comprising: a third hole that extends through at least one non-conductive layer to expose a part of the first electrode to the surrounding environment;

[0057] a fourth hole that extends through at least one non-conductive layer to expose a part of the second electrode to the surrounding environment,

[0058] wherein the third hole and the fourth hole are configured to allow arc discharge to transfer from the first electrode to the second electrode or vice versa when the first electrode and the second electrode are connected to a high-voltage power supply.

[0059] 36. A shock wave generating unit, comprising the electrode assembly according to any one of the foregoing clauses and an axially extending elongated member that extends through the inner cavity of the electrode assembly. Optionally, wherein the axially extending elongated member includes an outer surface that includes polyimide.

[0060] 37. A shock wave generating system for a shock wave generating catheter, comprising: one or more shock wave generating units according to clause 36;

[0061] a high-voltage power supply, the electrical output terminals of which are electrically connected to the first electrode and the second electrode of one or more shock wave generating units,

[0062] Optionally, wherein the voltage of the high-voltage power supply is 1000 volts to 5000 volts.

[0063] 38. The shock wave generating system according to clause 37, wherein the electrical output terminals of the high-voltage power supply are connected to the first electrode and the second electrode of one or more shock wave generating units by wires that extend along the outer surface of the terminals or through the interior of an axially extending elongated member.

[0064] 39. The shock wave generating system according to clause 37 or 38, further comprising an integrated electronic printed circuit board configured to determine the output voltage of the high-voltage power supply.

[0065] 40. A shock wave generating catheter, comprising:

[0066] The shock wave generating system according to any one of clauses 37 to 39; and

[0067] An inflatable balloon disposed over each of the axially extending elongated member and one or more shock wave generating units. Brief Description of the Drawings

[0068] Figure 1A is a partial cross-sectional view of a shock wave generating unit of the present disclosure having two non-conductive layers.

[0069] Figure 1B is a partial cross-sectional view of a shock wave generating unit of the present disclosure having three non-conductive layers.

[0070] Figure 2A is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a single non-conductive layer,.

[0071] Figure 2B is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a single non-conductive layer, the thickness of which is less than Figure 2A the thickness of the non-conductive layer in the illustrated embodiment.

[0072] Figure 3 is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a non-conductive member with a diameter greater than the diameters of the first electrode and the second electrode.

[0073] Figure 4 is a perspective view of a shock wave generating unit of the present disclosure, wherein the first hole and the second hole are offset from each other circumferentially in the electrode assembly.

[0074] Figure 5 is a perspective view of a shock wave generating unit of the present disclosure, wherein the diameters of the first hole and the second hole are different from each other.

[0075] Figure 6 is a partial cross-sectional view of a shock wave generating unit of the present disclosure, wherein the third hole and the fourth hole extend through a single non-conductive layer.

[0076] Figure 7A is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a hemispherical concave surface pit.

[0077] Figure 7B is Figure 7A an enlarged view of the hemispherical concave surface pit of the shock wave generating unit shown in

[0078] Figure 8 is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a conical surface pit.

[0079] Figure 9 is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a cylindrical indentation surface pit.

[0080] Figure 10A is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a hemispherical surface protrusion.

[0081] Figure 10B is a partial cross-sectional view of a shock wave generating unit of the present disclosure having a conical surface protrusion.

[0082] Figure 11 is a partial cross-sectional view of a shock wave generating unit of the present disclosure, wherein the inner surface of the electrode assembly is formed by a first electrode and a first part of the innermost non-conductive layer. A second electrode is disposed between the first part of the innermost non-conductive layer and the outermost non-conductive layer.

[0083] Figure 12A is a perspective view of a shock wave generating unit of the present disclosure, wherein a first electrode is disposed within the innermost non-conductive layer and has first, second, and third internal non-conductive layers and an outermost non-conductive layer, and the first, second, and third internal non-conductive layers and the outermost non-conductive layer are all disposed above the innermost non-conductive layer. A second electrode is disposed within the second internal non-conductive layer.

[0084] Figure 12B is Figure 12A a cross-sectional view of the shock wave generating unit shown in

[0085] Figure 12C is Figure 12A a cross-sectional view of the shock wave generating unit shown in Detailed Description

[0086] In this embodiment, the term "comprising" may be interpreted as requiring the recited features, but not precluding the presence of other features. Alternatively, the term "comprising" may also relate to cases where only the listed components / features are intended to be present (e.g., the term "comprising" may be replaced by "consisting of" or "consisting essentially of"). It will be appreciated that both a broader and a narrower interpretation may be applied to all aspects and embodiments of the present application. In other words, the term "comprising" and its synonyms may be replaced by "consisting of" or "consisting essentially of" or their synonyms, and vice versa.

[0087] The term "consisting essentially of" and its synonyms may be interpreted herein to refer to materials in which trace impurities may be present. For example, the purity of such materials may be greater than or equal to 90%, such as greater than 95%, such as greater than 97%, such as greater than 99%, such as greater than 99.9% pure, such as greater than 99.99%, such as greater than 99.999%, such as 100% pure.

[0088] Provided herein is an electrode assembly for a shock wave generating catheter, the electrode assembly comprising:

[0089] at least one non-conductive layer, a first electrode, and a second electrode, the first electrode and the second electrode being physically separated from each other and connectable to a voltage source (e.g., a high voltage source);

[0090] The electrode assembly has a tubular structure having an outer surface and an inner surface, the inner surface defining a lumen;

[0091] The outer surface of the electrode assembly is formed by the outermost non-conductive layer of the at least one non-conductive layer, the outermost non-conductive layer being disposed over the first electrode and the second electrode;

[0092] A first hole extends through the at least one non-conductive layer to expose a portion of the first electrode to the surrounding environment;

[0093] A second hole extends through the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment,

[0094] wherein the first hole and the second hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode, or vice versa, when a potential difference is applied between the first electrode and the second electrode by a voltage source.

[0095] In certain embodiments, the electrode assembly includes an axially extending elongate member that extends through the lumen. Generally, the axially extending elongate member includes an outer surface that includes polyimide.

[0096] The term "tubular structure" as used herein encompasses any structure having a tubular form. It may include, but is not limited to, a structure having a substantially circular cross-section, an elliptical cross-section, a regular polygon cross-section with substantially equal sides (e.g., a square cross-section, a pentagon cross-section), or an irregular polygon cross-section with unequal sides. In some embodiments, the electrode assembly has a tubular structure with a substantially circular cross-section.

[0097] The electrode assembly of the present application will be described below with reference to the accompanying drawings. The electrode assembly of the present application includes an axially extending elongated member that extends through the inner cavity of the electrode assembly and may be referred to herein as a shock wave generating unit. The electrode assembly of the present application is described in the context of the shock wave generating unit.

[0098] Figure 1A A shock wave generating unit 100 suitable for generating shock waves according to the present disclosure is shown. The shock wave generating unit includes the electrode assembly of the present application, which has an axially extending elongated member 101 that extends through the inner cavity of the electrode assembly. A first electrode 102 and a second electrode 103 are provided on the outer surface of the axially extending elongated member 101. The electrodes may be connected to a high voltage power source. The electrodes are conductive and may be constructed of a conductive material such as, but not limited to, tungsten, steel, titanium, cobalt, platinum, iridium, nickel, or alloys thereof. A non-conductive member 104 that separates (e.g., is disposed between) the first and second electrodes physically and electrically isolates the two electrodes. The non-conductive member 104 may be constructed of an electrically insulating (i.e., non-conductive) material such as, but not limited to, a thermoplastic elastomer, a ceramic, or a fluoropolymer. The first electrode 102, the second electrode 103, and the non-conductive member 104 may have similar inner and outer diameters to allow them to form a concentric form with the axially extending elongated member 101 and to be radially adhered to each other with respect to their outer surfaces. The consistency of the inner and outer diameters may allow the two electrodes to be completely electrically isolated. A first (inner) non-conductive layer 105 is cylindrically disposed on the first electrode 102, the second electrode 103, and the non-conductive member 104. A second (outermost) non-conductive layer 106 is cylindrically disposed on the first (inner) non-conductive layer 105. The first and second non-conductive layers 105 and 106 may be composed of a non-conductive material such as, but not limited to, a polymer such as polyimide or a fluoropolymer, or an adhesive. The first electrode 102, the second electrode 103, the non-conductive member 104, the first (inner) non-conductive layer 105, and the second (outermost) non-conductive layer together form an electrode assembly having a tubular structure with an outer surface and an inner surface, and the inner surface forms an inner cavity through which the axially extending elongated member 101 extends. The inner surface of the electrode assembly is formed by the first and second electrodes 102, 103 and the non-conductive member 104, wherein the non-conductive member physically separates the first and second electrodes.

[0099] In a variant of the shock wave generating unit 100, the first (inner) non-conductive layer 105 may preferably be constituted by a polyimide sheath for electrical insulation, and the second (outermost) non-conductive layer 106 may preferably be formed of fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE) to resist high temperatures.

[0100] In a second variant of the shock wave generating unit 100, the first (inner) non-conductive layer 105 may preferably be formed of a suitable cured adhesive to fix the first electrode 102 and the second electrode 103 and the non-conductive member 104, and the second (outermost) non-conductive layer 106 may preferably be constituted by a polyimide sheath for optimal electrical insulation.

[0101] In another variant of the shock wave generating unit 100, the first (inner) non-conductive layer 105 may preferably be constituted by a suitable cured adhesive for bonding the first and second electrodes 102 and 103 and the non-conductive member 104, and the second (outermost) non-conductive layer 106 may preferably be constituted by an FEP or PTFE heat shrink tube to further fix the shock wave generating unit 100.

[0102] Variations in the materials used and their combinations can enable the overall device to adopt different mechanical properties to suit different operations. For example, for a durable shock wave generating unit, having an adhesive as the first (inner) non-conductive layer and a heat shrink tube as the second (outermost) non-conductive layer can provide higher abrasion resistance against shock waves.

[0103] In another variant of the shock wave generating unit, as Figure 1B shown, there may be a third (second inner) non-conductive layer 107 disposed between the first (first inner) non-conductive layer 105 and the second (outermost) non-conductive layer 106. Multiple non-conductive layers of different materials can provide higher insulation strength and protection against impact damage caused by the generated shock waves. To generate an electric arc between the two electrodes 102 and 103, conductive points may be provided on each electrode. The first hole 108 and the second hole 109 extend through the insulating layer (i.e., the non-conductive layer), exposing small portions 111 and 112 of each of the electrodes 102 and 103 to the surrounding environment respectively. These exposed areas form conductive regions such that when a voltage pulse is sent in a circuit including the electrodes and a high voltage power supply located outside the device, an electric arc is formed in the conductive liquid between the exposed areas of the two conductive electrodes. The generated electric arc in turn causes cavitation bubbles to form in the conductive liquid, and these cavitation bubbles rapidly expand and contract, thereby generating a powerful shock wave.

[0104] The intensity of the shock wave can be modified by adjusting the depth of the holes in one or more non-conductive layers of the electrode assembly. Holes with a greater depth contribute to focusing the shock wave generated within the channels created by the holes. This focusing effect structurally aggregates and enhances the shock wave intensity, ensuring that less non-incident energy is wasted. The depth of the holes can be adjusted by varying the thickness of one or more non-conductive layers. For example, in Figure 2A the depth of holes 201 and 202 is determined by non-conductive layer 203. The depth can provide a set reflectivity for the shock wave generated in the holes. On the other hand, Figure 2B shows that the depth of holes 204 and 205 is determined by non-conductive layer 206 and is less than the depth shown in Figure 2A . This depth can provide a theoretically lower reflectivity for the shock wave generated therein, as fewer shock waves are aggregated in one direction and are allowed to scatter immediately upon leaving the cylindrical holes. Thus, the depth of the holes can be adjusted in this manner to produce an optimal reflectivity.

[0105] In Figure 2A and 2B the shock wave generating unit is shown to include an electrode assembly that includes a single non-conductive layer 203, 206. Thus, non-conductive layers 203, 206 are considered the outermost non-conductive layers of the electrode assembly shown in these figures.

[0106] Although the depth of the holes can be directly adjusted by changing the thickness of the non-conductive layer, it can also be adjusted by changing the number of non-conductive layers present. Returning to Figure 1A and Figure 1B , multiple non-conductive layers can be used as permitted by the size limitations of the catheter. This has the same effect as changing the thickness of each layer, but the advantage of using multiple layers is that multiple materials can be used in the construction of the shock wave generating unit. As previously mentioned, one layer can be an adhesive for enhancing the bonding strength of all components within the unit, while another layer can be a fluoropolymer providing electrical insulation and resistance to shock wave damage.

[0107] Typically, the thickness of each non-conductive layer of the electrode assembly disclosed herein is about 0.02 millimeters to 0.8 millimeters. For example, the thickness of each non-conductive layer can be at least about 0.2 millimeters, such as about 0.2 millimeters to 0.4 millimeters. The total thickness of all non-conductive layers of the shock wave generating unit is typically at least about 0.4 millimeters, such as about 0.4 millimeters to 1 millimeter, such as about 0.4 millimeters to 0.8 millimeters.

[0108] The depth of the holes can also be adjusted by changing the outer diameter of the electrode. For example, Figure 3The shock wave generating unit 300 is shown, wherein the outer diameters of the first electrode 301 and the second electrode 302 are smaller than the outer diameter of the non-conductive member 304. This allows the conductive surfaces of each electrode to be at a lower position within the device. This can be useful when the overall outer diameter of the catheter is restricted. It should also be noted that the outer diameter of either electrode does not have to be the same as the other. This can allow for holes of different depths and can be useful from a durability perspective, in cases where the catheter design only allows for a permanent positive electrode and a permanent negative electrode. For example, theoretically, the area around the positive electrode tends to be where the spark points of the plasma arc occur. Therefore, the electrodes can be constructed such that the positive electrode has a smaller outer diameter, thereby obtaining a deeper hole. As the depth of the hole increases, more material is burned to produce sparks, making the insulating layer around the positive electrode more durable during operation.

[0109] Another feature that can be adjusted to modify the intensity of the shock waves generated by the shock wave generating unit of the present disclosure is the distance between each hole on the shock wave generating unit. The position of the holes determines the spacing between each hole and thus the spark gap of the electrodes. This spark gap is the distance of the conductive liquid that the arc must pass through in order to electrically connect the conductive electrodes. A larger distance between the holes provides a higher resistance path for the arc and thus generates a shock wave of lower power. Referring back to FIG. 1, two holes 108 and 109 are arranged to be aligned with each other along the circumferential direction of the electrode assembly but offset from each other along the longitudinal axis of the electrode assembly. This is the most basic arrangement of the holes. The distance between the holes can be changed by separating the holes from each other by a greater distance along the longitudinal axis of the electrode assembly. However, due to the space limitations of the catheter, this may not be the most practical method for achieving a larger spark gap between the conductive electrodes. Therefore, alternatively, the holes can be arranged to be offset from each other in the circumferential direction of the electrode assembly and offset from each other along the longitudinal axis of the electrode assembly. Figure 4 An example of this is shown, in which pairs of holes 401 and 402 are offset from each other in the circumferential direction of the electrode assembly and offset from each other along the longitudinal axis of the electrode assembly. The distance between the two holes on the longitudinal axis of the electrode assembly is the same as that shown in FIG. 1, but due to the holes being offset from each other in the circumferential direction of the electrode assembly, the actual distance between them is increased.

[0110] Generally, the distance from the edge of the first hole to the edge of the corresponding second hole in the electrode assembly disclosed herein is about 0.05 mm to 10 mm, such as about 1 mm to 5 mm (such as about 1.5 mm to 3.5 mm, such as about 2 mm to 3 mm).

[0111] Another feature that can be adjusted to modify the intensity of the shock waves generated by the shock wave generating unit of the present disclosure is the size of the holes, and the characteristics of the arc and the characteristics of the generated shock waves can be changed by changing the size of the holes. Figure 5Holes 501 and 502 are shown, where the diameter of hole 502 is greater than that of hole 501. Changing the size of the holes can change the surface area of the electrode exposed. This can change the charge concentration of the current at the positive electrode before the formation of the arc, thereby affecting the intensity of the generated shock wave.

[0112] Generally, the diameters of the first and second holes of the electrode assembly disclosed herein can both be about 0.2 millimeters to 1 millimeter (e.g., about 0.5 millimeter).

[0113] The number of holes in the shock wave generating unit of the present disclosure can also vary to affect the number of regions where an arc may form. Thus, parallel spark gaps can be created, which allows shock waves to be generated at more than one location circumferentially around the catheter. Figure 6 An example of how the shock wave generating unit 600 includes a plurality of holes on its surface is shown. In this case, holes 601 and 602 are opposite to holes 603 and 604 in the circumferential direction. At certain locations in the body, such as within a blood vessel, such a configuration may be useful because it allows multiple target shock waves to be generated by a single voltage pulse discharge. Thus, the catheter does not need to rotate within the blood vessel or the body to target the other side. This also helps to increase the lifespan of the conductive electrodes because now the power is distributed between the two generated arcs.

[0114] To increase the intensity of the shock waves generated by the shock wave generating unit of the present disclosure, the portions of the first and / or second electrodes exposed to the surrounding environment can include a surface shape that is configured to concentrate the location of the arc discharge. This can take the form of introducing pits on the surface of the electrode. Part of the reason for the increased intensity when pits are present is because the cutting depth actually also increases. However, most of the reason is due to the removal of the available surface area for current conduction. As described above, as the surface area decreases, the charge tends to be more concentrated around the remaining available surface area, so more current can cross over to the other conductive electrode, increasing the power of the generated shock wave.

[0115] Figures 7-10 show exemplary surface shapes, which will be discussed below.

[0116] Figure 7A The shock wave generating unit 700 is shown, where pits 703 and 704 are provided on the outer surfaces of the first electrode 701 and the second electrode 702. These pits are concentrically aligned with the holes 705 and 706 on the electrodes 701 and 702 respectively. The pits 703 and 704 are in the form of hemispherical concave surfaces.

[0117] Figure 7BA close-up view of the pits 703 and 704 is further shown, where 708 is the point where charge concentrates when current reaches the electrode 702. Since most of the curved surface of the electrode 702 has been removed, the point 708 becomes the closest conductive point, at which an arc can be formed with another point 707 on the electrode 701 through a conductive liquid. Alternative shapes of the pits can also change the power and consistency of the shock wave generated over time. These shapes affect the final topology of the exposed surface of the electrode after erosion occurs due to arc generation, and thus affect how much of the original power remains after multiple arcs are generated.

[0118] Figure 8 A conical pit is shown, while Figure 9 a simple cylindrical depression is shown, which extends the hole into the electrode material.

[0119] Alternative solutions to the above pits can also be considered, that is, instead of indenting or forming depressions in the surface material of the electrode, protrusions can be used. Figure 10A - Figure 10B Shows what it would look like if the Figure 7A and Figure 8 corresponding shapes were changed to protrusions. By forming a conical or hemispherical protrusion 1001 and 1002 respectively, the charge concentration can be advantageously concentrated at the apex of either type of protrusion, thereby enhancing the power of the generated shock wave.

[0120] In Figure 11 a further embodiment of the shock wave generating unit of the present disclosure is shown. In this embodiment, the inner surface of the electrode assembly is formed by the first electrode 1102 and the first part 1103a of the innermost non-conductive layer 1103a. The second part 1103b of the innermost non-conductive layer 1103 is located between the first electrode 1102 and the outermost non-conductive layer 1104. The second electrode 1101 is located between the first part of the innermost non-conductive layer and the outermost non-conductive layer. This arrangement physically separates the first and second electrodes from each other by the innermost non-conductive layer. In this embodiment, the innermost non-conductive layer can be considered an electrical insulation component. This arrangement can eliminate the need to place a separate physical object between the conductive electrodes, which can bring advantages such as reducing the overall length and profile of the unit, increasing the flexibility of the conduit, and reducing production costs. This embodiment includes a (outermost) non-conductive layer 1104 covering each of the first electrode 1101 and the second electrode 1102.

[0121] In Figure 12A to Figure 12CA further embodiment of the electrode assembly of the present disclosure is shown by way of example of a shock wave generating unit. The shock wave generating unit 1200 includes a plurality of non-conductive layers, more specifically, five non-conductive layers 1204 to 1208, which are arranged on the outer surface of an axially extending elongated member 1203. The first and second electrodes 1201, 1202 are respectively independently embedded in one of the plurality of non-conductive layers. Generally, the elongated member 1203 is made of polyimide.

[0122] In this embodiment, the electrode assembly is formed by five non-conductive layers 1204 to 1208 and the first and second electrodes 1201, 1202. These components together form a tubular structure that has an outer surface and an inner surface, and the inner surface forms an inner cavity. The axially extending elongated member 1203 extends through the inner cavity.

[0123] The inner surface of the electrode assembly is formed by the innermost non-conductive layer 1204. The outer surface of the electrode assembly is formed by the outermost non-conductive layer 1208. The assembly includes inner non-conductive layers 1205, 1206, 1207, which are respectively located between the innermost and outermost non-conductive layers. Figure 12A - Figure 12C Three inner non-conductive layers are shown. The first inner non-conductive layer 1205 is located above the innermost non-conductive layer 1204, the second inner non-conductive layer 1206 is located above the first inner non-conductive layer 1205, and the third inner non-conductive layer 1207 is located above the second inner non-conductive layer 1206. The outermost non-conductive layer 1208 is located above the third inner non-conductive layer, thus forming the outer surface of the electrode assembly.

[0124] The outermost, innermost, and inner non-conductive layers can be made of polymers independently selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), epoxy resins (such as cured epoxy resins or solidified epoxy resins, preferably biocompatible, shock-resistant, and / or vibration-resistant epoxy resins), and combinations of two or more of the above. Generally, the first and third inner non-conductive layers are made of polyimide, and the second inner non-conductive layer is made of epoxy resin. Generally, the innermost non-conductive layer is made of epoxy resin, and the outermost non-conductive layer is made of polyimide. Polyimide and / or epoxy resin can provide excellent shock resistance, high temperature, and electrical insulation for the shock wave generating unit.

[0125] In this embodiment, the first electrode 1201 and the second electrode 1202 are independently arranged (e.g., embedded) in one of the non-conductive layers. Figure 12BIn [the figure], the first electrode 1201 is embedded in the innermost non-conductive layer 1204, and the first, second, third internal, and outermost non-conductive layers 1205 to 1208 are located above the innermost non-conductive layer 1204. The second electrode 1202 is embedded in the second internal non-conductive layer 1206. Preferably, the first electrode and the second electrode are offset relative to each other along the longitudinal axis of the electrode assembly and are generally embedded in different non-conductive layers. Generally, the two electrodes are separated by at least one non-conductive layer made of polyimide. The innermost electrode (e.g., the first electrode embedded in the innermost non-conductive layer) can be thicker than the second electrode, which helps the first electrode resist stronger corrosion caused by stronger shock waves generated in deeper layers of the electrode assembly.

[0126] Since the first electrode 1201 and the second electrode 1202 are respectively embedded in the innermost and second internal non-conductive layers, the first hole 1209 extends through the outermost non-conductive layer and the third, second, and first internal non-conductive layers to expose a part of the first electrode 1201 to the surrounding environment. The second hole 1210 extends through the outermost non-conductive layer and the third internal non-conductive layer to expose a part of the second electrode 1202 to the surrounding environment. Therefore, the first hole 1209 is deeper than the second hole 1210. As described above, a deeper hole can be beneficial for the concentration of shock waves generated from the hole. This concentration effect converges and enhances the shock wave intensity through structural design. On the other hand, a shallower hole theoretically provides a lower level of reflection ability because fewer shock waves are allowed to scatter immediately in a diffused manner after being generated inside the hole. The holes can be arranged to be offset relative to each other along the longitudinal axis of the electrode assembly. In addition, the holes can be arranged to be offset relative to each other in the circumferential direction of the electrode assembly.

[0127] The present application can also be described by the following numbered clauses:

[0128] 1. A shock wave generating unit for a shock wave generating catheter, comprising:

[0129] An axially extending elongated member having an outer surface;

[0130] A first electrode and a second electrode respectively disposed on the outer surface of the elongated member, and the first electrode and the second electrode can be connected to a high-voltage power source;

[0131] A non-conductive member that separates the first electrode and the second electrode;

[0132] At least one non-conductive layer disposed above each of the first electrode and the second electrode;

[0133] A first hole that extends through one or more of the at least one non-conductive layer to expose a part of the first electrode to the surrounding environment;

[0134] A second hole that extends through one or more of the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment,

[0135] wherein the first hole and the second hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode when a high voltage power source applies a potential difference between the first electrode and the second electrode.

[0136] 2. The shock wave generating unit according to clause 1, wherein the first and / or second electrode is made of one or more materials selected from the group consisting of tungsten, steel, titanium, cobalt, platinum, iridium, nickel, and alloys thereof.

[0137] 3. The shock wave generating unit according to clause 1 or 2, wherein the non-conductive member is formed of one or more materials selected from the group consisting of polymers, ceramics, epoxy resins, adhesives, and combinations thereof,

[0138] Optionally, wherein the polymer is selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), and combinations thereof,

[0139] Further optionally, wherein the polymer includes polyimide.

[0140] 4. The shock wave generating unit according to any one of the preceding clauses, wherein at least one of the non-conductive layers disposed on each of the first electrode and the second electrode is made of one or more materials selected from the group consisting of polymers, ceramics, adhesives, and combinations thereof,

[0141] Optionally, wherein the polymer is selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), and combinations thereof,

[0142] Further optionally, wherein the polymer contains polyimide.

[0143] 5. The shock wave generating unit according to clause 4, wherein the outermost non-conductive layer of the at least one non-conductive layer is made of a polymer,

[0144] Optionally, wherein the polymer is selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), and combinations thereof,

[0145] Further optionally, wherein the polymer contains polyimide.

[0146] 6. The shock wave generating unit according to any one of the preceding clauses, wherein:

[0147] At least one non-conductive layer disposed on each of the first electrode and the second electrode includes:

[0148] A first non-conductive layer disposed on each of the first electrode and the second electrode; and

[0149] A second non-conductive layer disposed on each of the first electrode and the second electrode; and

[0150] Both the first hole and the second hole extend through the first non-conductive layer and the second non-conductive layer.

[0151] 7. The shock wave generating unit according to any one of the preceding clauses, wherein:

[0152] At least one non-conductive layer disposed on each of the first electrode and the second electrode includes:

[0153] A first non-conductive layer disposed on each of the first electrode and the second electrode;

[0154] A second non-conductive layer disposed on each of the first electrode and the second electrode; and

[0155] A third non-conductive layer disposed on each of the first electrode and the second electrode;

[0156] Both the first hole and the second hole extend through the first, second, and third non-conductive layers.

[0157] 8. The shock wave generating unit according to clause 6 or 7, wherein:

[0158] The first non-conductive layer is made of polyimide or an adhesive; and

[0159] The second non-conductive layer is made of nylon, polyether block amide (e.g. ) or a heat shrinkable tube (e.g. fluorinated ethylene propylene or polyethylene terephthalate).

[0160] 9. The shock wave generating unit according to any one of the preceding clauses, wherein the maximum radius of the non-conductive member corresponds to the maximum radius of the first electrode and the second electrode.

[0161] 10. The shock wave generating unit according to any one of the preceding clauses, wherein the maximum radius of the non-conductive member is greater than the maximum radius of each of the first electrode and the second electrode.

[0162] 11. The shock wave generating unit according to any one of the preceding clauses, wherein the first hole and the second hole are axially offset from each other.

[0163] 12. The shock wave generating unit according to any one of clauses 1 to 10, wherein the first hole and the second hole are axially collinear.

[0164] 13. A shock wave generating unit according to any one of the preceding clauses, wherein the first hole and the second hole have substantially the same diameter.

[0165] 14. A shock wave generating unit according to any one of clauses 1 to 12, wherein the diameters of the first hole and the second hole are different.

[0166] 15. A shock wave generating unit according to any one of the preceding clauses, further comprising:

[0167] a third hole that extends through one or more of the at least one non-conductive layer to expose a portion of the first electrode to the surrounding environment;

[0168] a fourth hole that extends through one or more of the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment,

[0169] wherein the third hole and the fourth hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode or vice versa when the first electrode and the second electrode are connected to a high voltage power source.

[0170] 16. A shock wave generating unit according to any one of the preceding clauses, wherein the portion of the first electrode and / or the second electrode exposed to the surrounding environment includes a surface shape configured to concentrate the arc discharge position.

[0171] 17. The shock wave generating unit according to clause 16, wherein the surface shape configured to concentrate the arc discharge position includes a surface depression.

[0172] 18. The shock wave generating unit according to clause 17, wherein the shape of the surface depression is selected from the group including a hemispherical concave surface, a cone, and a cylindrical pit (such as a cylindrical pit).

[0173] 19. The shock wave generating unit according to clause 16, wherein the surface shape configured to concentrate the arc discharge position includes a surface protrusion,

[0174] Optionally, wherein the surface protrusion has a conical or hemispherical shape.

[0175] 20. A shock wave generating unit according to any one of the preceding clauses, wherein the non-conductive member forms a non-conductive layer disposed above the second electrode but not above the first electrode; and

[0176] when the fourth hole is present, the second hole and the fourth hole extend through the non-conductive member and through one or more of the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment.

[0177] 21. The shock wave generating unit according to any one of the foregoing clauses, wherein the diameters of both the first hole and the second hole are from about 0.2 millimeters to about 1 millimeter.

[0178] 22. The shock wave generating unit according to any one of the foregoing clauses, wherein the minimum distance from the edge of the first hole to the edge of the second hole is from about 0.05 millimeters to about 10 millimeters.

[0179] 23. The shock wave generating unit according to any one of the foregoing clauses, wherein the thickness of at least one of at least one non-conductive layer disposed on each of the first electrode and the second electrode is from 0.04 to 1 millimeter,

[0180] Optionally, wherein the thickness of each of at least one non-conductive layer disposed on each of the first electrode and the second electrode is from 0.04 to 1 millimeter.

[0181] 24. A shock wave generating system for a shock wave generating catheter, comprising: one or more shock wave generating units according to any one of clauses 1 to 23;

[0182] A high voltage power supply, the electrical output terminals of which are electrically connected to the first electrode and the second electrode of one or more shock wave generating units,

[0183] Optionally, wherein the voltage of the high voltage power supply is from 1000 volts to 5000 volts.

[0184] 25. The shock wave generating system according to clause 24, wherein the electrical output terminals of the high voltage power supply are connected to the first electrode and the second electrode of one or more shock wave generating units through wires, and the wires extend along their outer surfaces from the terminals or extend through the interior of an axially extending elongated member.

[0185] 26. The shock wave generating system according to clause 24 or 25, further comprising an integrated electronic printed circuit board configured to determine the output voltage of the high voltage power supply.

[0186] 27. A shock wave generating catheter, comprising:

[0187] A shock wave generating system according to any one of clauses 24 to 26; and

[0188] An inflatable balloon disposed above each of the axially extending elongated member and one or more shock wave generating units.

[0189] The present application has been described herein in a broad and general manner. Those of ordinary skill in the art will readily understand that all of the parameters, dimensions, materials, and configurations described herein are exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present application are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Accordingly, it is to be understood that the foregoing embodiments are presented by way of example only, and that the present application may be practiced without specifically described and claimed herein within the scope of the appended claims and their equivalents. The present application is directed to each individual feature, system, article, material, kit, and / or method described herein. Moreover, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if the features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present application. Additionally, each narrower genus and subgeneric group falling within the generic disclosure also forms a part of the present application. This includes the generic description of the present application, where any restrictive conditions or negative limitations of the subject matter in the genus are removed, whether or not the removed material is specifically listed herein.

Claims

1. An electrode assembly for a shock wave generating catheter, the electrode assembly comprising: At least one non-conductive layer, a first electrode, and a second electrode, the first electrode and the second electrode being physically separated from each other and connectable to a voltage source; The electrode assembly has a tubular structure, the tubular structure having an outer surface and an inner surface, the inner surface forming a lumen; The outer surface of the electrode assembly is formed by the outermost non-conductive layer of the at least one non-conductive layer, the outermost non-conductive layer being disposed above the first electrode and the second electrode; A first hole extending through the at least one non-conductive layer to expose a portion of the first electrode to the surrounding environment; A second hole extending through the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment, Wherein the first hole and the second hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode, or vice versa, when a potential difference is applied between the first electrode and the second electrode by the voltage source.

2. The electrode assembly according to claim 1, wherein, The inner surface of the electrode assembly is formed by the innermost non-conductive layer.

3. The electrode assembly according to claim 2, wherein, The electrode assembly further includes one or more internal non-conductive layers, each internal non-conductive layer being disposed between the innermost non-conductive layer and the outermost non-conductive layer.

4. The electrode assembly according to claim 3, wherein, The electrode assembly further includes at least two internal non-conductive layers, such as including two, three, four, five, or six internal non-conductive layers.

5. The electrode assembly according to any one of claims 3 to 4, wherein, The first electrode and the second electrode are each independently embedded in the innermost non-conductive layer or one of the internal non-conductive layers.

6. The electrode assembly according to any one of claims 2 to 5, wherein, The first electrode and the second electrode are embedded in different non-conductive layers respectively.

7. The electrode assembly according to any one of claims 2 to 6, wherein, The first electrode is embedded in the innermost non-conductive layer.

8. The electrode assembly according to any one of claims 2 to 6, wherein, The first electrode and the second electrode are each independently embedded in one of the internal non-conductive layers.

9. The electrode assembly according to any one of claims 3 to 8, wherein, Each of the one or more internal non-conductive layers is formed of a polymer independently selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), epoxy resins, and combinations thereof.

10. The electrode assembly according to any one of claims 3 to 9, wherein, The electrode assembly includes: A first internal non-conductive layer disposed above the innermost non-conductive layer; A second internal non-conductive layer disposed above the first internal non-conductive layer; A third internal non-conductive layer disposed above the second internal non-conductive layer; and The outermost non-conductive layer disposed above the third internal non-conductive layer, thereby forming the outer surface of the electrode assembly.

11. The electrode assembly according to claim 10, wherein, The first internal non-conductive layer is formed of polyimide; the second internal non-conductive layer is formed of epoxy resin; the third internal non-conductive layer is formed of polyimide.

12. The electrode assembly according to claim 11, wherein, The first electrode is embedded in the innermost non-conductive layer, and the second electrode is embedded in the second internal non-conductive layer.

13. The electrode assembly according to any one of claims 2 to 11, wherein, The innermost non-conductive layer is formed of epoxy resin.

14. The electrode assembly according to any one of claims 2 to 12, wherein, The outermost non-conductive layer is formed of a shock-resistant material and / or a shock-absorbing material, for example, the outermost non-conductive layer is formed of a shock-resistant and / or shock-absorbing epoxy resin.

15. The electrode assembly according to any one of claims 2 to 14, wherein, The first electrode and the second electrode are offset from each other along the longitudinal axis of the electrode assembly.

16. The electrode assembly according to claim 1, wherein, The inner surface of the electrode assembly is formed by an innermost layer including the first electrode, the second electrode, and the non-conductive member, wherein the non-conductive member physically separates the first electrode and the second electrode from each other.

17. The electrode assembly according to claim 16, wherein, The electrode assembly further includes one or more internal non-conductive layers, each internal non-conductive layer being disposed between the innermost layer and the outermost non-conductive layer.

18. The electrode assembly according to claim 16 or 17, wherein, The non-conductive member is formed of one or more materials selected from the group consisting of polymers, ceramics, epoxy resins, adhesives, and combinations thereof. Optionally, wherein the polymer is selected from the group consisting of thermoplastic elastomers (such as polyimide), fluoropolymers (such as fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE)), and combinations thereof. For example, wherein the polymer includes polyimide.

19. The electrode assembly according to any one of claims 16 to 18, wherein, The maximum radius of the non-conductive member corresponds to the maximum radii of the first electrode and the second electrode.

20. The electrode assembly according to any one of claims 16 to 18, wherein, The maximum radius of the non-conductive member is greater than the maximum radius of each of the first electrode and the second electrode.

21. The electrode assembly according to claim 1, wherein, The inner surface of the electrode assembly is formed by the first electrode and a first portion of the innermost non-conductive layer; A second portion of the innermost non-conductive layer is disposed between the first electrode and the outermost non-conductive layer; The second electrode is disposed between the first portion of the innermost non-conductive layer and the outermost non-conductive layer.

22. The electrode assembly according to claim 21, wherein, The innermost non-conductive layer is formed of nylon, poly(ether-amide) (such as ), or a heat shrinkable tube (such as fluorinated ethylene propylene or polyethylene terephthalate); and The outermost non-conductive layer is formed of an impact-resistant and / or shock-absorbing material, for example, the outermost non-conductive layer is formed of an impact-resistant and / or shock-absorbing epoxy resin.

23. The electrode assembly according to any one of the preceding claims, wherein, The first electrode and / or the second electrode is formed of one or more materials selected from the group consisting of tungsten, steel, titanium, cobalt, platinum, iridium, nickel, and alloys thereof.

24. The electrode assembly according to any one of the preceding claims, wherein, The first hole and the second hole are offset from each other along the longitudinal axis of the electrode assembly.

25. The electrode assembly according to any one of claims 1 to 23, wherein, The first hole and the second hole are offset from each other circumferentially around the electrode assembly.

26. The electrode assembly according to any one of the preceding claims, wherein, The first hole and the second hole have substantially the same diameter.

27. The electrode assembly according to any one of claims 1 to 25, wherein, The diameters of the first hole and the second hole are different from each other.

28. The electrode assembly according to any one of the preceding claims, wherein, The portion of the first electrode and / or the second electrode exposed to the surrounding environment has a surface shape configured to concentrate the arc discharge location.

29. The electrode assembly according to claim 28, wherein, The surface shape configured to concentrate the arc discharge location includes surface depressions.

30. The electrode assembly according to claim 28, wherein, The shape of the surface depression is selected from the group consisting of a hemispherical concave surface, a cone, and a cylindrical pit (such as a cylindrical pit).

31. The electrode assembly according to claim 28, wherein, The surface shape configured to concentrate the arc discharge location includes surface protrusions. Optionally, wherein the surface protrusion has a conical or hemispherical shape.

32. The electrode assembly according to any one of the preceding claims, wherein, The diameters of the first hole and the second hole are each from about 0.2 millimeters to about 1 millimeter.

33. The electrode assembly according to any one of the preceding claims, wherein, The minimum distance from the edge of the first hole to the edge of the second hole is from about 0.05 millimeters to about 10 millimeters.

34. The electrode assembly according to any one of the preceding claims, wherein, The thickness of the at least one non-conductive layer is from about 0.02 millimeters to about 0.8 millimeters, optionally, wherein the thickness of each of the at least one non-conductive layer is from about 0.02 millimeters to about 0.8 millimeters.

35. The electrode assembly according to any one of the preceding claims, further comprising: A third hole that extends through the at least one non-conductive layer to expose a portion of the first electrode to the surrounding environment; A fourth hole that extends through the at least one non-conductive layer to expose a portion of the second electrode to the surrounding environment, wherein the third hole and the fourth hole are configured to allow an arc discharge to transfer from the first electrode to the second electrode or vice versa when the first electrode and the second electrode are connected to a high voltage power source.

36. A shock wave generating unit, comprising the electrode assembly according to any one of the foregoing claims and an axially extending elongated member, the elongated member extending through the inner cavity of the electrode assembly. Optionally, wherein, The axially extending elongate member includes an outer surface that includes polyimide.

37. A shock wave generating system for a shock wave generating catheter, comprising: One or more shock wave generating units according to claim 36; A high voltage power source, the electrical output terminals of which are electrically connected to the first electrode and the second electrode of the one or more shock wave generating units, Optionally, wherein the voltage of the high voltage power source is from 1000 volts to 5000 volts.

38. The shock wave generating system according to claim 37, wherein, The electrical output terminals of the high voltage power source are connected to the first electrode and the second electrode of the one or more shock wave generating units by wires that extend along their outer surfaces from the terminals or extend through the interior of the axially extending elongate member.

39. The shock wave generating system according to claim 37 or 38, further comprising an integrated electronic printed circuit board configured to determine the output voltage of the high voltage power source.

40. A shock wave generating catheter, comprising: The shock wave generating system according to any one of claims 37 to 39; and An inflatable balloon disposed over each of the axially extending elongate member and the one or more shock wave generating units.

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