Small-outer-diameter shock wave catheter and shock wave equipment

Abstract

The small-outer-diameter shock wave catheter comprises an inner tube, an outer tube and an axial shock wave generating device, the axial shock wave generating device is arranged between the inner tube and the outer tube and close to the far end of the outer tube, and the far end of a first outer electrode is closer to the far end of the outer tube relative to the far end of a first inner electrode. When a liquid-electric effect occurs between the first outer electrode and the first inner electrode, shock waves which are transmitted along the axial direction of the catheter are generated, so that the shock waves which are forward in the axial direction can be utilized to vibrate and loosen fully-occluded calcification lesions in blood vessels, and the traction guide wire and the catheter can smoothly pass through the lesion positions. The design that the far end of the shock wave catheter is combined with the axial shock wave generating device is adopted, the passing size of the shock wave catheter is far smaller than that of an existing shock wave balloon catheter, a fully-occluded calcified lesion site can be opened more effectively, and meanwhile the risk of blood vessel damage in an operation is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a small outer diameter shock wave catheter and shock wave equipment. Background Art

[0002] At present, in the interventional treatment of cardiovascular stenosis, when dealing with thrombus, plaque, fibrous plaque or calcification, doctors usually first pass a soft guide wire down the artery and through the occluded area, and then send the angioplasty balloon through the guide wire to the blocked area for expansion. However, many times, doctors are faced with chronic total occlusion calcified lesions (CTO lesions). In this case, the probability of the guide wire passing through the lesion is very low, and coronary artery grinding, cutting and other technologies are required to break through the CTO lesion, which reduces the treatment efficiency and increases the risk of vascular perforation and vascular damage and dissection. And even if the guide wire passes through the CTO lesion, it is difficult to pass through the lesion to achieve the treatment purpose due to the relatively large diameter of the balloon.

[0003] In view of this, this application is filed. Summary of the invention

[0004] The present invention provides a small outer diameter shock wave guide tube and a shock wave device to solve at least one of the above technical problems.

[0005] A small outer diameter shock wave guide tube comprises an inner tube, an outer tube and an axial shock wave generating device.

[0006] The inner tube has a guide wire traction cavity; the outer tube is sleeved outside the inner tube, and the space between the inner wall of the outer tube and the outer wall of the inner tube can be filled with liquid, and the distal end of the outer tube is connected to the inner tube to form a liquid-filled cavity; an axial shock wave generating device is arranged outside the inner tube and is located near the distal end of the outer tube; the axial shock wave generating device includes:

[0007] A first inner electrode is disposed on the inner tube.

[0008] A first wire is electrically connected to the first inner electrode.

[0009] A first outer electrode is disposed around the first inner electrode.

[0010] The first insulating layer is disposed between the first inner electrode and the first outer electrode to separate the first inner electrode from the second outer electrode.

[0011] The distal end of the first outer electrode is closer to the distal end of the outer tube than the distal end of the first inner electrode, or the distal end of the first inner electrode is closer to the distal end of the outer tube than the distal end of the first outer electrode.

[0012] Preferably, the distal end of the first outer electrode is closer to the distal end of the outer tube than the distal end of the first inner electrode; the distal end of the first insulating layer is flush with the distal end of the first inner electrode, or the distal end of the first insulating layer is located between the distal ends of the first outer electrode and the first inner electrode, close to the distal end of the first inner electrode, so that a hydro-electric effect occurs at the end surface of the distal end of the first inner electrode and the end surface of the first outer electrode to generate a shock wave.

[0013] Preferably, the first inner electrode is a sheet metal, and has at least two, a plurality of which are circumferentially spaced apart and arranged outside the inner tube, and the number of the first conductors corresponds to the number of the first inner electrodes.

[0014] Preferably, the first outer electrode is a metal tube or a metal ring sleeved outside the first inner electrode.

[0015] Preferably, the distal end of the first wire is a non-insulated end, and the non-insulated end is the first inner electrode.

[0016] Preferably, the outer wall of the inner tube is provided with a wire groove for accommodating the first wire.

[0017] Preferably, it further comprises a radial shock wave generating device, wherein the radial shock wave generating device is located at a position away from the distal end of the outer tube relative to the axial shock wave generating device.

[0018] Preferably, the radial shock wave generating device includes a second inner electrode, a second insulating layer, a second outer electrode and a second wire, the second inner electrode and the second wire are electrically connected, the second insulating layer is arranged between the second inner electrode and the second outer electrode, and a first through hole is opened in the middle of the second insulating layer, and the second outer electrode has a second through hole corresponding to the first through hole.

[0019] Preferably, the distal end of the outer tube is in a conical tip structure, and the outer surface of the conical tip is provided with a plurality of micropores.

[0020] The present application also provides a shock wave device, comprising the above-mentioned small outer diameter shock wave guide tube and a device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy for the small outer diameter shock wave guide tube.

[0021] A small outer diameter shock wave catheter of the present invention is provided with an axial shock wave generating device between an inner tube and an outer tube and near the distal end of the outer tube. By designing the structure that the distal end of the first outer electrode is closer to the distal end of the outer tube than the distal end of the first inner electrode or the distal end of the first inner electrode is closer to the distal end of the outer tube than the distal end of the first outer electrode, when the electrodes generate a hydro-electric effect in the liquid, a shock wave is generated that is basically forward along the axial direction of the catheter, and the axial direction is toward the distal end of the outer tube, so that the axial forward shock wave can be used to loosen the completely occluded calcified lesions in the blood vessel, so that the traction guide wire and the catheter can smoothly pass through the lesion position.

[0022] Furthermore, the present small outer diameter shock wave catheter does not need to be provided with a balloon, because its smaller outer diameter is more conducive to the shock wave catheter extending into the location of the intravascular calcified lesion, especially the chronic total occlusion calcified lesion loosened by the axial shock wave. The first wire can also be accommodated in the wire groove of the outer wall of the inner tube, and the non-insulated end of the distal end of the first wire is directly used as the first inner electrode, thereby compressing the outer diameter size of the axial shock wave generating device, and further compressing the outer diameter size of the shock wave catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a structural schematic diagram of a small outer diameter shock wave guide tube of the present invention;

[0024] Figure 2 yes Figure 1 A schematic diagram showing the structure of the distal electrode;

[0025] Figure 3 yes Figure 1 A schematic diagram of the structure of the distal end of the catheter;

[0026] Figure 4 yes Figure 1 A schematic diagram of the cross-sectional structure of the distal end of the catheter;

[0027] Figure 5 yes Figure 1 A schematic diagram of the cross-sectional structure of the tapered tip of the outer tube;

[0028] Figure 6 is a schematic cross-sectional structure diagram of the distal end portion of a shock waveguide tube according to a preferred embodiment of the present invention;

[0029] Figure 7 yes Figure 6 A schematic diagram of the cross-sectional structure of the outer tube tip type structure;

[0030] Figure 8 It is a schematic diagram of the overall structure of a hidden outer tube in a preferred embodiment of the present invention;

[0031] Fig. 9It is a schematic structural diagram of an inner tube and a non-insulated end cap according to another preferred embodiment of the present invention.

[0032] Reference numerals:

[0033] 1. Inner tube; 11. Wire groove; 2. Outer tube; 21. Conical tip; 3. Axial shock wave generator; 31. First inner electrode; 32. First wire; 321. Non-insulated end; 33. First outer electrode; 34. First insulating layer; 4. Radial shock wave generator; 41. Second inner electrode; 42. Second wire; 43. Second outer electrode; 44. Second insulating layer; 45. First through hole; 46. Second through hole; 5. Catheter connector; 51. Main unit high voltage pulse interface; 52. Charging interface; 53. Guide wire interface; X. Guide wire. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0035] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicating orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0036] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0037] Please refer to Figures 1 to 5 A small outer diameter shock wave guide tube comprises an inner tube 1, an outer tube 2 and an axial shock wave generating device 3.

[0038] The inner tube 1 has a guide wire X-traction cavity inside; the outer tube 2 is sleeved outside the inner tube 1, the distal end of the inner tube 1 passes through the outer tube 2, and the inner wall of the outer tube 2 and the outer wall of the inner tube 1 can be filled with liquid; the distal end of the outer tube 2 is connected to the outer surface of the inner tube 1 to form a liquid filling cavity, and the connection can be made whether the distal end of the inner tube 1 is flush with the distal end of the outer tube 2, or the distal end of the inner tube 1 passes through the distal end of the outer tube 2, or the tip of the distal end of the outer tube 2 wraps the end face of the distal end of the inner tube 1, so that when the liquid is filled to the inner wall of the outer tube 2 and the outer wall of the inner tube 1, it will not overflow. The liquid can be a mixture of physiological saline and contrast agent or other conductive liquids.

[0039] The axial shock wave generating device 3 is arranged on the outer side of the inner tube 1 and the inner side of the outer tube 2, and is located near the distal end of the outer tube 2; the axial shock wave generating device 3 includes:

[0040] The first inner electrode 31 is arranged on the inner tube 1; the first inner electrode 31 can have various structures, such as being fixed on the inner tube 1 in a sheet shape or being sleeved on the inner tube 1 in a ring shape, as well as other structures that can play the role of an inner electrode.

[0041] The first wire 32 is electrically connected to the first internal electrode 31 , so as to provide pulse energy to the first internal electrode 31 .

[0042] The first outer electrode 33 is arranged around the first inner electrode 31 and has a certain radial gap with the first inner electrode 31. The first outer electrode 33 can have various structures. The outer electrode can be a regular annular shape, a tubular shape, or a ring shape with grooves of different shapes on the surface, or other structures that can function as an outer electrode. The first outer electrode 33 does not need to be connected to a wire. The high-voltage pulse is transmitted to the first inner electrode through the first wire, so that a hydroelectric effect is generated between the inner and outer electrodes.

[0043] The first insulating layer 34 is disposed between the first inner electrode 31 and the first outer electrode 33 to separate the first inner electrode 31 from the second outer electrode 43 .

[0044] In this embodiment, the distal end of the first outer electrode 33 is closer to the distal end of the outer tube 2 than the distal end of the first inner electrode 31, and the distal end of the first inner electrode 31 is flush with the distal end of the first insulating layer 34, thereby forming a hydro-electric effect between the inner side surface at the distal end of the first outer electrode 33 and the end surface at the distal end of the first inner electrode 31, generating a shock wave toward the distal end of the outer tube 2, and the shock wave basically travels along the axial direction of the catheter, so that the axial shock wave can be used to loosen the completely occluded calcified lesions in the blood vessel, so that the traction guide wire X and the outer tube 2 can enter the treatment position.

[0045] In this embodiment, the proximal end of the first insulating layer 34 is closer to the proximal end of the outer tube than the proximal end of the first inner electrode 31, thereby insulating the cross-section of the proximal end of the first inner electrode 31, thereby preventing the proximal end of the first inner electrode 31 from being punctured and destroying the generation of shock waves.

[0046] In other embodiments, the proximal end of the first insulating layer 34 may be flush with the proximal end of the first inner electrode 31 , and the proximal end of the first outer electrode 33 may be shorter than the proximal end of the first insulating layer 34 . It is only necessary for the first insulating layer 34 to insulate the proximal end of the first inner electrode 31 .

[0047] In other embodiments, the distal end of the first insulating layer 34 is located between the distal end of the first outer electrode 33 and the distal end of the first inner electrode 31. It only needs to not affect the arc generated between the inner side surface at the distal end of the first outer electrode 33 and the end surface at the distal end of the first inner electrode 31. The closer the distal end of the first insulating layer 34 is to the distal end of the first inner electrode 31, the better the effect.

[0048] Preferably, the distal end of the first insulating layer 34 is located between the distal end of the first outer electrode 33 and the distal end of the first inner electrode 31, close to the distal end of the first inner electrode 31 so that a hydro-electric effect is generated between the distal end face of the first inner electrode 31 and the first outer electrode 33. That is to say, the distal end of the first insulating layer 34 should be controlled at a position where a hydro-electric effect can be generated between the distal end face of the first inner electrode 31 and the first outer electrode 33. At least the first outer electrode 33 should be controlled to be on an extension line of a line connecting the bottom of the distal end face of the first inner electrode 31 and the distal end of the first insulating layer 34, so that at least part of the distal end face of the first inner electrode 31 can have no direct insulation obstruction with the first outer electrode 33; that is, at least part of the distal end face of the first inner electrode 31 can generate a hydro-electric effect with the first outer electrode 33.

[0049] The small outer diameter shock wave catheter does not need to be provided with a balloon, because its smaller outer diameter is more conducive to the shock wave catheter extending into the location of the calcified lesion in the blood vessel, especially the chronic totally occluded calcified lesion loosened by the axial shock wave.

[0050] In other embodiments, the distal end of the first inner electrode 31 may be closer to the distal end of the outer tube 2 than the distal end of the first outer electrode 33; the distal end of the first inner electrode 31 is roughly flush with the distal end of the first insulating layer 34, so that a hydro-electric effect is generated between the outer side of the distal end of the first inner electrode 31 and the distal end surface of the first outer electrode 33, thereby generating a shock wave toward the distal end of the outer tube 2.

[0051] The number of the first inner electrodes 31 may be one pair, two pairs, three pairs or more, and a plurality of pairs of the first inner electrodes 31 are circumferentially spaced and arranged outside the inner tube 1, and the number of the first wires 32 corresponds to the number of the first inner electrodes 31. In this embodiment, the first inner electrode 31 is a sheet structure, the number of the first inner electrodes 31 is two, and the number of the first wires 32 is two.

[0052] In this embodiment, the first outer electrode 33 is a metal tube sleeved outside the first inner electrode 31, so that one first outer electrode 33 can correspond to multiple first inner electrodes 31; at the same time, the metal tubular structure is adopted, so that the shock wave generated by the end face of the distal end of the first inner electrode 31 and the inner side of the distal end of the first outer electrode 33 can be controlled between the distal end of the first outer electrode 33 and the inner tube 1, so that the shock wave can be more concentrated toward the distal direction of the outer tube 2, thereby improving the axial impact efficiency of the shock wave.

[0053] The outer tube 2 can be a single-layer plastic tube, such as any one of PET, PEBAX, PA, PE and PU; it can also be a multi-layer skeleton structure, such as an inner layer of a stainless steel woven mesh and an outer layer of a plastic material, etc., which can be selected according to actual needs and the structure of the shock wave generating device.

[0054] Please refer to Figure 4 The distal end of the outer tube 2 is a tapered tip 21, which is directly connected to the outer surface of the inner tube 1, and the outer surface of the tapered tip 21 is provided with a plurality of micropores for discharging bubbles. The design of the micropores can timely discharge the bubbles generated by the liquid in the catheter under the action of the shock wave, and dissolve them in the flowing blood without causing blood vessel blockage. The aperture range of the micropores can be 1-100um, preferably 5-10um.

[0055] Multiple micropores can be arranged in different ways, such as rectangular, strip, etc. In the present embodiment, multiple micropores are distributed in a dense mesh. Through the dense mesh multi-micropore design, micropores of specific pore size penetrate the wall of the conical tip 21. The micropores can use their own surface tension to prevent liquid from entering, thereby realizing the function of preventing liquid from passing through and allowing gas to pass through.

[0056] Through the design of the micropores, the gas released from the liquid in the balloon under the action of the shock wave can be discharged from the catheter in time, avoiding bubbles from hindering the shock wave from acting on the calcified lesions and improving the effective performance of the shock wave; and the bubbles generated will enter the flowing blood through the micropores of the filter mesh of a specific size and will be dissolved without causing blood vessel blockage.

[0057] The micropores can be made by laser ablation process, and the material of the conical tip 21 can be any one of PET, PEBAX, PA, PE and PU.

[0058] Please refer to Figure 1 In this embodiment, the catheter connector 5 of the shock wave catheter includes a pressure charging interface 52 for inputting filling liquid, a guide wire interface 53 for pulling the guide wire X, and a host high-voltage pulse interface 51 for connecting the wire.

[0059] Please refer to Figures 6 to 8 In a preferred embodiment, the distal end of the first wire 32 is a non-insulated terminal 321, and the non-insulated terminal 321 is the first inner electrode 31. Since the first wire 32 can also be accommodated in the wire groove 11 of the outer wall of the inner tube 1, and the non-insulated terminal 321 at the distal end of the first wire 32 is directly used as the first inner electrode 31, the outer diameter size of the axial shock wave generating device 3 is compressed, and the outer diameter size of the shock wave guide tube is further compressed.

[0060] Please refer to Fig. 9 Further, in this preferred embodiment, the outer wall of the inner tube 1 is provided with a wire groove 11 for accommodating the first wire 32, and in particular, the wire groove 11 is used to accommodate the non-insulated end 321 of the first wire 32, which can effectively reduce the outer diameter of the axial shock wave generating device 3. The main body of the first wire 32 can be an enameled wire to achieve an insulation effect with a minimum outer diameter. In other embodiments, other insulation methods applicable in the art can also be used.

[0061] In this embodiment, a radial shock wave generating device 4 is further included. The radial shock wave generating device 4 is located at a position away from the distal end of the outer tube 2 relative to the axial shock wave generating device 3 .

[0062] The radial shock wave generating device 4 includes a second inner electrode 41, a second insulating layer 44, a second outer electrode 43 and a second wire 42. The second inner electrode 41 and the second wire 42 are electrically connected. The second insulating layer 44 is disposed between the second inner electrode 41 and the second outer electrode 43. A first through hole 45 connecting the second inner electrode 41 and the second outer electrode 43 is formed on the second insulating layer 44. The second outer electrode 43 is formed with a second through hole 46 corresponding to the first through hole 45. After the axial shock wave generating device 3 at the distal end of the shock wave catheter is used to generate shock waves axially forward, the shock wave catheter can be further advanced into the lesion, and the radial shock wave generating device 4 at the relatively proximal end further treats the area by generating shock waves in the radial direction.

[0063] The first through hole 45 and the second through hole 46 may be rectangular, circular, elliptical or other shapes. The first through hole 45 and the second through hole 46 are preferably opened in the middle of the second insulating layer 44 and the second external electrode 43 .

[0064] Furthermore, the radial shock wave generating device 4 does not need to adopt a balloon structure, and its through size is much smaller than that of the existing IVL balloon catheter, which greatly reduces the outer diameter of the shock wave catheter treatment position; and the design of the head end combined with the shock wave device can more effectively open the thrombus in the fully occluded area, reduce the operation time, and reduce the risk of blood vessel damage during the operation.

[0065] In addition, the present application also provides a shock wave device, including the small outer diameter shock wave guide tube as described above and a device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy to the small outer diameter shock wave guide tube.

[0066] The above are only preferred implementations of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention.

Claims

1. A small outer diameter shock waveguide tube, characterized in that: include, An inner tube having a guide wire traction cavity therein; An outer tube is sleeved on the outer side of the inner tube, and a space between the inner wall of the outer tube and the outer wall of the inner tube can be filled with liquid, and a distal end of the outer tube is connected to the inner tube to form a liquid-filled cavity; An axial shock wave generating device is arranged outside the inner tube and is located near the distal end of the outer tube; the axial shock wave generating device comprises: a first inner electrode, the first inner electrode being arranged on the inner tube; a first wire connected to the first inner electrode; a first outer electrode, the first outer electrode being arranged around the first inner electrode; A first insulating layer is disposed between the first inner electrode and the first outer electrode to separate the first inner electrode from the second outer electrode; The distal end of the first outer electrode is closer to the distal end of the outer tube than the distal end of the first inner electrode, or the distal end of the first inner electrode is closer to the distal end of the outer tube than the distal end of the first outer electrode.

2. The small outer diameter shock waveguide tube according to claim 1, characterized in that: The distal end of the first outer electrode is closer to the distal end of the outer tube than the distal end of the first inner electrode, the distal end of the first insulating layer is flush with the distal end of the first inner electrode, or the distal end of the first insulating layer is located between the distal ends of the first outer electrode and the first inner electrode, close to the distal end of the first inner electrode, so that the end surface of the distal end of the first inner electrode and the end surface of the distal end of the first outer electrode generate a hydro-electric effect to produce a shock wave.

3. The small outer diameter shock wave guide tube according to claim 1, characterized in that: The first inner electrode is a sheet metal and has at least two first inner electrodes. The plurality of first inner electrodes are circumferentially spaced apart and arranged outside the inner tube. The number of the first wires corresponds to the number of the first inner electrodes.

4. The small outer diameter shock wave guide tube according to claim 2 or 3, characterized in that: The first outer electrode is a metal tube or a metal ring sleeved outside the first inner electrode.

5. The small outer diameter shock wave guide tube according to claim 1 or 2, characterized in that: The distal end of the first wire is a non-insulated terminal, and the non-insulated terminal is the first inner electrode.

6. The small outer diameter shock wave guide tube according to claim 5, characterized in that: The outer wall of the inner tube is provided with a wire groove for accommodating the first wire.

7. The small outer diameter shock waveguide tube according to claim 1, characterized in that: It also includes a radial shock wave generating device, which is located at a position away from the distal end of the outer tube relative to the axial shock wave generating device.

8. The small outer diameter shock waveguide tube according to claim 7, characterized in that: The radial shock wave generating device includes a second inner electrode, a second insulating layer, a second outer electrode and a second wire. The second inner electrode and the second wire are electrically connected. The second insulating layer is arranged between the second inner electrode and the second outer electrode. A first through hole is opened in the middle of the second insulating layer. The second outer electrode has a second through hole corresponding to the first through hole.

9. The small outer diameter shock waveguide tube according to claim 1, characterized in that: The distal end of the outer tube is in a conical tip structure, and a plurality of micropores are arranged on the outer surface of the conical tip.

10. A shock wave device, characterized in that: It comprises the small outer diameter shock wave guide tube as claimed in any one of claims 1 to 9 and a device host, wherein the device host is provided with a high-voltage pulse output module for providing pulse energy for the small outer diameter shock wave guide tube.

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