Shock wave electrode catheter

Abstract

The shock wave electrode catheter comprises an inner tube and an outer tube, the inner tube is arranged in the outer tube and extends out of the far end of the outer tube, the near end of the outer tube is connected with a tail seat, the tail seat is connected with an adapter through a cable, a balloon part and a plurality of electrode pairs are arranged on a tube body, extending out of the outer tube, of the inner tube, and the balloon part is connected with the adapter through a cable. The balloon part is arranged on the outer side of the electrode pair in a sleeving mode, and the electrode pair comprises at least one forward electrode pair which is arranged at the far end of the inner tube and used for emitting shock waves forwards and further comprises at least one radial electrode pair which is arranged on the inner tube and used for emitting shock waves in the radial direction. According to the embodiment of the invention, the supporting arm of the blood vessel wall is realized through the balloon, and meanwhile, the forward electrode pair and the radial electrode pair in the balloon part are used for emitting shock waves to crush and split calcified tissues at a blood vessel occlusion part, so that a good blood vessel opening effect is achieved.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular to a shock wave electrode catheter. Background Art

[0002] Chronic total occlusion (CTO) is a term used to describe atherosclerotic vessels that are highly calcified to the point where the vessel lumen is completely blocked. CTOs can occur in the heart or in peripheral arteries and significantly increase the risk of heart failure and lower limb amputation. CTO cases in the operating room are also particularly challenging because the lesion is difficult to cross with a traditional guidewire, resulting in a nearly two-fold increase in procedure time and fluoroscopic exposure.

[0003] The advent of new technologies and devices has helped the heart team increase the chances of successful revascularization in patients with CTOs. Chief among these is a set of guidewire crossing techniques that follow a standard algorithm to accommodate different lesion morphologies. Using specially designed crossing guidewires, skilled operators can cross CTOs in a greatly reduced time. Once crossed, standard angioplasty balloon dilatation and stent placement can be performed.

[0004] However, there remains a significant problem where the guidewire is able to pass through a lesion but the balloon angioplasty catheter cannot due to its larger profile. These lesions, known as balloon-traversable lesions, require the use of further specialized devices, known as traversing devices or penetrating catheters. These devices are tracked over the guidewire and, when reaching the balloon-impenetrable lesion, utilize various techniques to create a larger channel through which the balloon angioplasty catheter can pass.

[0005] Since the advent of chronic total occlusion technology in percutaneous coronary intervention (PCI), many devices and techniques have been described over time.

[0006] From the simple mechanical method of drilling through the lesion with a high RPM catheter, there are also laser and radiofrequency energy to ablate and eliminate calcified materials. In the present invention, the inventors propose a penetration system that uses forward shock wave energy to break up and split the calcified plaque so that the lesion balloon can pass through, while the radial shock wave energy can break up the calcified plaque in the vessel wall again to achieve balloon angioplasty.

[0007] The existing angioplasty surgery is to place an expandable balloon in the blood vessel, and the mechanical stress of the rapid expansion of the balloon acts on the calcification to break it. However, balloon dilatation surgery is only suitable for large centralized calcified deposits, and cannot handle calcification foci that are dispersed or deep into the ventricle. The calcium removal efficiency is low and incomplete. If the patient's arterial calcification is more serious, or the narrowed blood vessel segment is longer, the effect of balloon dilatation is relatively poor. Rapid balloon expansion can cause a sudden change in pressure on the blood vessel wall, which can easily damage the blood vessel and even cause thrombosis. In addition, balloon dilatation requires very high pressure (sometimes the pressure can reach 20 to 30 standard atmospheres, or even 40 standard atmospheres). Such pressure usually leads to a significant increase in the probability of rebound stenosis, dissection, perforation, and rupture of the blood vessel. Such surgical events are particularly serious in cases of eccentric calcified lesions because the pressure of the balloon acts on soft tissue without calcification.

[0008] When the patient's intravascular plaque is hard and the degree of stenosis is severe, it is possible that the balloon cannot pass through the calcified area at all, let alone have any therapeutic effect. Summary of the invention

[0009] The purpose of the embodiments of the present disclosure is to provide a shock wave electrode catheter to solve the problems existing in the prior art. In order to solve the technical problems, the embodiments of the present disclosure adopt the following technical solutions:

[0010] The embodiment of the present disclosure provides a shock wave electrode catheter, comprising an inner tube and an outer tube, wherein the inner tube is arranged inside the outer tube and extends from the distal end of the outer tube, the proximal end of the outer tube is connected to a tail seat, and the tail seat is connected to an adapter via a cable, a balloon portion and a plurality of electrode pairs are arranged on the tube body of the inner tube extending from the outer tube, the balloon portion is sleeved on the outside of the electrode pairs, the electrode pairs include at least one forward electrode pair arranged at the distal end of the inner tube and used for emitting shock waves forward, and also include at least one radial electrode pair arranged on the inner tube and used for emitting shock waves radially.

[0011] In some embodiments, when there are multiple radial electrode pairs, the multiple radial electrode pairs are arranged sequentially along the extension direction of the inner tube.

[0012] In some embodiments, the forward electrode pair includes an outer electrode and at least one inner electrode, and the outer electrode and each inner electrode form one forward electrode pair.

[0013] In some embodiments, the outer electrode is cylindrical, the inner electrode is cylindrical, and the bottom surface of the outer electrode is provided with an inner tube through hole for the inner tube to pass through and an electrode through hole for fixing the inner electrode.

[0014] In some embodiments, the radial electrode pair includes two radial electrodes that are disposed opposite to each other, and the two radial electrodes are separated by a predetermined gap.

[0015] In some embodiments, an insulating ring for packaging is disposed outside the radial electrode pair.

[0016] In some embodiments, the insulating ring is tubular, and a packaging hole is set in the middle of its wall, and a first discharge hole and a second discharge hole are respectively set on both sides of the packaging hole, and the first discharge hole and the second discharge hole respectively correspond to the two radial electrodes on the radial electrode pair.

[0017] In some embodiments, the packaging hole is a long slot structure, and its length direction is perpendicular to the extension direction of the inner tube.

[0018] In some embodiments, two adjacent insulating rings are arranged 90° apart in the axial direction.

[0019] In some embodiments, the inner tube is a hollow tube used to form a guidewire cavity to accommodate the guidewire passing therethrough, a tip is provided at the distal end of the inner tube, one end of the balloon portion is connected to the tip, and the other end thereof is connected to the distal end of the inner tube.

[0020] The disclosed embodiment aims at the situation that the intravascular plaque of the patient is hard and the stenosis is severe. The support arm of the blood vessel wall is realized by the balloon. At the same time, the forward electrode pair and the radial electrode pair in the balloon part emit shock waves to break up and lyse the calcified tissue at the occluded blood vessel, so that the lesion site with higher stenosis can be smoothly passed, thereby achieving a good effect of opening the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0022] Figure 1 It is a schematic structural diagram of a shock wave electrode catheter according to an embodiment of the present disclosure;

[0023] Figure 2 It is a schematic diagram of the arrangement of the balloon part and the electrode pair in the shock wave electrode catheter of the embodiment of the present disclosure;

[0024] Figure 3 It is a schematic structural diagram of a forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

[0025] Figure 4It is a schematic structural diagram of an outer electrode in a forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

[0026] Figure 5 It is a schematic structural diagram of an outer electrode in a forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

[0027] Figure 6 It is a schematic diagram of the arrangement of radial electrode pairs in the shock wave electrode catheter according to an embodiment of the present disclosure;

[0028] Figure 7 It is a schematic diagram of the structure of the insulating ring in the shock wave electrode catheter according to the embodiment of the present disclosure.

[0029] Reference numerals:

[0030] 100-shock wave electrode catheter; 101-balloon; 102-outer tube; 103-stress relief tube; 104-tailstock; 105-cable; 106-adapter; 107-tip; 108-first electrode pair; 109-outer electrode; 110a-first inner electrode; 110b-second inner electrode; 111a-first through hole; 111b-second through hole; 111c third through hole; 111d-fourth through hole; 111e-fifth through hole; 112-inner tube; 113-second electrode pair; 113a-first radial electrode; 113b-second radial electrode; 114-second electrode pair; 114a-third radial electrode; 114b-fourth radial electrode; 114c third radial electrode; 114d fourth radial electrode; 115-insulating ring; 115a-first discharge hole; 115b-second discharge hole; 116-packaging hole. DETAILED DESCRIPTION

[0031] Various aspects and features of the present disclosure are described herein with reference to the drawings.

[0032] It should be understood that various modifications may be made to the embodiments of the present application. Therefore, the above description should not be considered as limiting, but only as an example of an embodiment. Other modifications within the scope and spirit of the present disclosure will occur to those skilled in the art.

[0033] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the general description of the present disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

[0034] These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment given as a non-limiting example, with reference to the attached drawings.

[0035] It should also be understood that, although the present disclosure has been described with reference to some specific examples, those skilled in the art will be able to realize many other equivalent forms of the present disclosure that have the features described in the claims and are therefore within the scope of protection defined thereby.

[0036] The above and other aspects, features and advantages of the present disclosure will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0037] Specific embodiments of the present disclosure are described hereinafter with reference to the accompanying drawings; however, it should be understood that the embodiments claimed are merely examples of the present disclosure, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid obscuring the present disclosure with unnecessary or redundant details. Therefore, the specific structural and functional details claimed herein are not intended to be limiting, but merely serve as a basis and representative basis for the claims to teach those skilled in the art to use the present disclosure in a variety of ways with substantially any suitable detailed structure.

[0038] This specification may use the phrases "in one embodiment," "in another embodiment," "in a further embodiment," or "in other embodiments," all of which may refer to one or more of the same or different embodiments according to the present disclosure.

[0039] The present disclosure provides a shock wave electrode catheter 100, which is used to transmit directional shock waves in a blood vessel to achieve blood vessel perforation and angioplasty. Figure 1-Figure 7 As shown, the shock wave electrode catheter 100 includes an inner tube 112 and an outer tube 102, wherein the inner tube 112 is disposed inside the outer tube 102 and extends from the distal end of the outer tube 102, wherein the inner tube 112 is a hollow tube, and the hollow tube forms a guidewire cavity to accommodate a guidewire with a diameter of 0.010-0.035 inches. A tip 107 is disposed at the distal end of the inner tube 112, and the tip 107 facilitates the shock wave electrode catheter 100 to extend into a blood vessel.

[0040] In addition, the proximal end of the outer tube 102 is connected to the tailstock 104. Preferably, the tailstock 104 is connected to the proximal end of the outer tube 102 via a stress relief tube 103. In addition, the tailstock 104 is connected to an adapter 106 via a cable 105.

[0041] In order to support the blood vessel when the shock wave electrode catheter 100 is inserted into the human body, a balloon portion 101 is provided on the inner tube 112, and the balloon portion 101 expands after being filled to contact the blood vessel wall of the blood vessel to achieve support. In this embodiment, one end of the balloon portion 101 is connected to the tip 107 to form a first fixed point, and the other end is connected to the distal end of the outer tube 102 to form a second fixed point. The fixing method here can be adhesive, welding, binding, etc. In this way, the balloon portion 101 on the inner tube 112 can not only cover the distal end of the inner tube 102, but also cover the tube body of the inner tube 112 extending out of the outer tube 102. Here, there is a cavity for liquid to flow in between the outer tube 102 and the inner tube 112, which is used to fill the interior of the balloon portion 101 with liquid and apply a certain pressure to fill the balloon.

[0042] Furthermore, at least one forward electrode pair for emitting shock waves forward is disposed at the distal end of the inner tube 112, and at least one radial electrode pair for emitting shock waves radially is disposed on the body of the inner tube 112 extending out of the outer tube 102. Wherein, when there are multiple radial electrode pairs, the multiple radial electrode pairs are arranged in sequence along the extension direction of the inner tube 112. Wherein, the balloon portion 101 is coated on the outside of the forward electrode pair and the outside of the radial electrode pair. Here, the shock waves emitted by the forward electrode pair pass through the balloon portion 101 to contact the blood vessel wall, and the shock waves emitted by the radial electrode pair pass through the balloon portion 102 to contact the blood vessel wall. Here, the forward electrode pair serves as a plaque-opening electrode pair to send shock waves forward, and the radial electrode pair serves as a plaque-breaking electrode pair to send shock waves radially.

[0043] The balloon portion 101 here can be a compliant balloon, and its material can be a soft material such as natural latex, silicone, TPU, etc.; the balloon portion 101 can also be a semi-compliant or non-compliant balloon, and its material can be a polymer material such as PET, PP, polyethylene, polyamide, etc.

[0044] In this embodiment, the first electrode pair 108 disposed at the distal end of the inner tube 112 is a forward electrode pair, and two radial electrode pairs are disposed on the inner tube 112 , namely a second electrode pair 113 and a third electrode pair 114 .

[0045] Specifically, the forward electrode pair, that is, the first electrode pair, includes an outer electrode 109 and at least one inner electrode, wherein the outer electrode 109 forms a forward electrode pair with each inner electrode. When there are multiple inner electrodes, the outer electrode 109 forms multiple forward electrode pairs with multiple inner electrodes. The outer electrode 109 is cylindrical, with a diameter of 0.1-1.0 mm and a wall thickness of 0.03-0.3 mm. The outer electrode 109 of this embodiment can be made of stainless steel, tungsten, platinum-iridium, nickel, iron, steel and / or other conductive materials. The outer electrode 109 is a negative electrode and the inner electrode is a positive electrode.

[0046] Further, an inner tube through hole for the inner tube 112 to pass through and an electrode through hole for fixing the inner electrode are provided on the bottom surface of the outer electrode 109, and each inner electrode fixed through the electrode through hole forms a forward electrode pair with the outer electrode 109. The number of the electrode through holes here matches the number of the inner electrodes, and the number of the electrode through holes determines the number of the inner electrodes.

[0047] The inner electrode is cylindrical, with a diameter of 0.1-0.8 mm and a length of 0.2-2.0 mm. The electrode material of the inner electrode can be stainless steel, tungsten, platinum iridium, nickel, iron, steel and / or other conductive materials.

[0048] In this embodiment, the outer electrode 109 and the inner electrode are connected to the outer electrode wire and the inner electrode wire respectively by welding. The outer electrode wire and the inner electrode wire in this embodiment extend to the proximal end of the outer tube 102 to be connected to the cable 105.

[0049] In a specific embodiment, a first through hole 111a, a second through hole 111b and a third through hole 111c are arranged on the bottom surface of the outer electrode 109, wherein the first through hole 111a serves as the inner tube through hole and is located at the center of the bottom surface, and is used to pass the inner tube 112, and the diameter of the first through hole 111a may be 0.2mm-2.0mm; the second through hole 111b and the third through hole 111c are respectively arranged on the bottom surface of the outer electrode 109 and are located on both sides of the first through hole 111a for coaxially fixing the inner electrode, and the diameter of the electrode through hole here may be 0.2mm-1.0mm.

[0050] Specifically, the first inner electrode 110a and the second inner electrode 110b are inserted into the second through hole 111b and the third through hole 111c, respectively, and the first inner electrode 110a and the second inner electrode 110b are connected to corresponding positive electrode wires. In this embodiment, the forward negative electrode 111 and the first inner electrode 110a and the second inner electrode 110b form two forward electrode pairs that generate and emit forward shock waves. The end surfaces of the first inner electrode 110a and the second inner electrode 110b are flush with or slightly concave to the second through hole 111b and the third through hole 111c.

[0051] Further, each of the radial electrode pairs includes two radial electrodes at a predetermined interval, and the two radial electrodes can be positive and negative electrodes to each other, and the gap between the two radial electrodes here is 0.1-2.0 mm. The electrode material of the radial electrode can be stainless steel, tungsten, platinum iridium, nickel, iron, steel and / or other conductive materials. In this embodiment, the second electrode pair 113 includes a first radial electrode 113a and a second radial electrode 113b, and the third electrode pair 114 includes a third radial electrode 114a and a fourth radial electrode 114b. Among them, the positive and negative properties of the two radial electrodes in each radial electrode pair can be reversed.

[0052] In a preferred embodiment, 1-8 forward electrode pairs may be provided in the shock wave electrode catheter, and more radial electrode pairs, such as 3-6 pairs, may be provided along the length of the inner tube 112 to facilitate rupturing of calcified plaques along the length of the blood vessel.

[0053] The embodiment of the present disclosure transmits shock waves in a directionable manner through the forward electrode pair and the radial electrode pair, which not only ensures the action position of the shock wave, but also reduces the damage caused by the shock wave energy. In addition, the embodiment of the present disclosure can selectively stimulate different electrode pairs to send shock waves, for example, a certain electrode pair can be selected to send shock waves, or electrode pairs can be stimulated in sequence, or all electrode pairs can be stimulated at the same time, which greatly facilitates the operator's operation during the operation.

[0054] Furthermore, an insulating ring 115 is arranged outside each radial electrode pair, which is used to encapsulate the two radial electrodes in the radial electrode pair. The insulating ring 115 is tubular, and an encapsulation hole 116 is arranged in the middle of the wall of the insulating ring 115. A first discharge hole 115a and a second discharge hole 115b are arranged on both sides of the encapsulation hole 116, respectively. The first discharge hole 115a and the second discharge hole 115b correspond to the two radial electrodes in the radial electrode pair. The insulating strength of the insulating ring 115 here is relatively high, and the material of the insulating ring is polyimide, PTFE, polyamide, PET or other non-conductive materials.

[0055] Specifically, the shock wave energy generated by the two radial electrodes in each radial electrode pair is released directionally through the first discharge hole 115a and the second discharge hole 115b, respectively, thereby producing a complete confinement and energy focusing effect on the energy.

[0056] In addition, the packaging hole 116 is a long slot structure, and its length direction is perpendicular to the extension direction of the inner tube 112 .

[0057] The two adjacent insulating rings 115 may differ in angle along the axial direction. Preferably, the two adjacent insulating rings 115 are arranged 90° apart in the axial direction. The angle between the two insulating rings 115 can be determined by the extension direction of the long groove structure, which makes it easier to emit shock waves to plaques at different locations on the blood vessel.

[0058] When this embodiment is used in a blood vessel, there is an occlusive plaque on the vascular wall of the blood vessel. The outer electrode and the inner electrode cooperate to form an opening forward electrode pair and the radial electrode forms a radial electrode pair, which can be compatible with the advantages of the plaque opening electrode pair and the plaque crushing electrode pair. The forward shock wave is emitted by the forward electrode pair and the radial shock wave is emitted by the radial electrode pair to crush the occlusive plaque and form a crushed plaque, so that the catheter can smoothly pass through the lesion location with a higher degree of stenosis.

[0059] Specifically, the distal end of the balloon part 101 has a large angle, and the distal end of the balloon part 101 can be closely attached to the blocked plaque in the blood vessel in the forward direction, and the outer surface of the balloon part 101 can also be in radial contact with the blood vessel wall and the calcified lesion area of ​​the blood vessel. An arc is generated by applying an instantaneous high voltage to the forward electrode pair and the radial electrode pair in the balloon part 101, and a shock wave is generated by the expansion and collapse of the bubble generated by the arc. The shock wave generated by the electrode pair is radially conducted to the surface of the balloon part 101 through the liquid inside the balloon part 101, and then conducted to the calcified lesion through the surface of the balloon part 101.

[0060] When the shock wave is transmitted forward to the calcified lesion, the compression stress of the shock wave will cause the calcified tissue inside the vascular occlusion to soften and lyse, so that the shock wave electrode catheter can pass through the vascular occlusion, and then the radial electrode pair generates radial shock waves to further break and lyse the calcified tissue, achieving a good effect of opening the blood vessel. In addition, the shock wave of appropriate intensity can destroy the calcified tissue without causing additional burden on the soft tissue around the calcified tissue.

[0061] The disclosed embodiment aims at the situation that the intravascular plaque of the patient is hard and the stenosis is severe. The support arm of the blood vessel wall is realized by the balloon. At the same time, the forward electrode pair and the radial electrode pair in the balloon part emit shock waves to break up and lyse the calcified tissue at the occluded blood vessel, so that the lesion site with higher stenosis can be smoothly passed, thereby achieving a good effect of opening the blood vessel.

[0062] In addition, although each operation is described in a specific order, this should not be understood as requiring these operations to be performed in the specific order shown or in a sequential order. Under certain circumstances, multitasking and parallel processing may be advantageous. Similarly, although some specific implementation details are included in the above discussion, these should not be interpreted as limiting the scope of the present disclosure. Some features described in the context of a separate embodiment can also be implemented in a single embodiment in combination. On the contrary, the various features described in the context of a single embodiment can also be implemented in multiple embodiments individually or in any suitable sub-combination mode.

[0063] Although the subject matter has been described in language specific to structural features and / or methodological logical actions, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. On the contrary, the specific features and actions described above are merely example forms of implementing the claims.

[0064] Multiple embodiments of the present disclosure are described in detail above, but the present disclosure is not limited to these specific embodiments. Those skilled in the art can make various variations and modifications to the embodiments based on the concepts of the present disclosure, and these variations and modifications should all fall within the scope of protection required by the present disclosure.

Claims

1. A shock wave electrode catheter, characterized in that: The invention comprises an inner tube and an outer tube, wherein the inner tube is arranged inside the outer tube and extends from the distal end of the outer tube, the proximal end of the outer tube is connected to a tail seat, and the tail seat is connected to an adapter through a cable, a balloon part and a plurality of electrode pairs are arranged on the tube body of the inner tube extending from the outer tube, the balloon part is sleeved on the outside of the electrode pair, the electrode pair comprises at least one forward electrode pair arranged at the distal end of the inner tube and used for emitting shock waves forward, and also comprises at least one radial electrode pair arranged on the inner tube and used for emitting shock waves radially.

2. The shock wave electrode catheter according to claim 1, characterized in that: When there are a plurality of radial electrode pairs, the plurality of radial electrode pairs are arranged in sequence along the extending direction of the inner tube.

3. The shock wave electrode catheter according to claim 1, characterized in that: The forward electrode pair includes an outer electrode and at least one inner electrode, and the outer electrode and each inner electrode form one forward electrode pair.

4. The shock wave electrode catheter according to claim 3, characterized in that: The outer electrode is cylindrical, the inner electrode is columnar, and an inner tube through hole for the inner tube to pass through and an electrode through hole for fixing the inner electrode are arranged on the bottom surface of the outer electrode.

5. The shock wave electrode catheter according to claim 1, characterized in that: The radial electrode pair includes two radial electrodes that are arranged opposite to each other, and the two radial electrodes are spaced apart by a predetermined gap.

6. The shock wave electrode catheter according to claim 5, characterized in that: An insulating ring for packaging is arranged outside the radial electrode pair.

7. The shock wave electrode catheter according to claim 6, characterized in that: The insulating ring is tubular, and a packaging hole is arranged in the middle of its wall surface. A first discharge hole and a second discharge hole are arranged on both sides of the packaging hole, respectively. The first discharge hole and the second discharge hole correspond to the two radial electrodes on the radial electrode pair.

8. The shock wave electrode catheter according to claim 7, characterized in that: The packaging hole is a long slot structure, and its length direction is perpendicular to the extension direction of the inner tube.

9. The shock wave electrode catheter according to claim 6, characterized in that: Two adjacent insulating rings are arranged 90° apart in the axial direction.

10. The shock wave electrode catheter according to claim 1, characterized in that: The inner tube is a hollow tube used to form a guidewire cavity to accommodate the guidewire passing therethrough. A tip is arranged at the distal end of the inner tube, one end of the balloon part is connected to the tip, and the other end thereof is connected to the distal end of the inner tube.

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