CN119423913A

CN119423913A - A shock wave electrode catheter

Info

Publication number: CN119423913A
Application number: CN202410839856.1A
Authority: CN
Inventors: 曹镇财; 张效凯
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2024-06-26
Filing date: 2024-06-26
Publication date: 2025-02-14

Abstract

The embodiment of the disclosure provides a shock wave electrode catheter, including inner tube and outer tube, the inner tube sets up in the outer tube and follow the distal end of outer tube stretches out, the proximal end of outer tube is connected with the tailstock, the tailstock passes through the cable and is connected with the adapter, the inner tube stretches out set up sacculus portion and a plurality of electrode pair on the pipe shaft of outer tube, sacculus portion cover is established the outside of electrode pair, the electrode pair includes at least one and sets up the distal end of inner tube and be used for the forward electrode pair of forward emission shock wave, still includes at least one and sets up just be used for radial electrode pair of radial emission shock wave on the inner tube. According to the embodiment of the disclosure, the supporting arm of the vessel wall is realized through the balloon, and the calcified tissue at the vascular occlusion is crushed and cracked by transmitting shock waves through the forward electrode pair and the radial electrode pair in the balloon part, so that a good vascular opening effect is achieved.

Description

Shock wave electrode catheter

Technical Field

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

Background

Chronic total occlusion lesions (Chronic total occlusion; CTO) are terms used to describe the high calcification of atherosclerotic blood vessels to the point where the lumen of the vessel is completely occluded. CTO can occur in the heart or peripheral arteries, significantly increasing the risk of heart failure and lower limb amputation. CTO cases in the operating room are also particularly challenging because it is difficult to pass through lesions with conventional guidewires, resulting in nearly twice as much surgical time and perspective exposure.

The advent of new technology and devices has helped the cardiac team increase the chances of successful vascular remodeling in CTO patients. Foremost among these is a set of guidewire threading techniques that follow a standard algorithm to accommodate different lesion morphologies. With a specially made pass-through guidewire, a skilled operator can pass through the CTO in a greatly shortened time. Once passed, standard angioplasty balloon dilation and stenting procedures can be performed.

However, there is still an important problem in that the guidewire is able to pass through the lesion, but the balloon angioplasty catheter is not able to pass due to its large profile. These lesions, known as balloon-penetrations, require the use of further special devices, known as penetrations or penetrating catheters. These devices are tracked over a guidewire and when a balloon-impenetrable lesion is reached, a larger passageway is created through which the balloon angioplasty catheter can pass using various techniques.

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

Simple mechanical methods from drilling through lesions with high Revolutions Per Minute (RPM) catheters, and in addition, ablation and elimination of calcified material with laser and radio frequency energy. In the present invention, the inventor proposes a pass-through system that uses forward shock wave energy to break up and split calcified plaque so that a lesion balloon can pass through, while radial shock wave energy can again break up calcified plaque within the vessel wall, effecting balloon angioplasty.

The existing angioplasty is to put an expandable balloon in the blood vessel, and the mechanical stress of rapid expansion of the balloon acts on calcified foci to break them. However, the balloon dilation operation is only suitable for centralized large calcified deposits, and can not treat calcified foci scattered or penetrating into ventricles, and the calcium removal efficiency is low and incomplete. If the patient's arterial vessel is severely calcified, or the stenosed vessel segment is long, the balloon dilation is less effective. Rapid balloon expansion can lead to abrupt pressure changes in the vessel wall, which can easily damage the vessel and even cause thrombosis. In addition, balloon inflation requires very high pressures (sometimes pressures up to 20 to 30 atmospheres gauge, even 40 atmospheres gauge). Such pressure typically results in a significant increase in the probability of rebound stenosis, dissection, perforation, rupture of the blood vessel. Such surgical events are particularly severe in eccentric calcified lesion cases because the balloon pressure is acting on soft tissue that is not calcified.

When the plaque in the blood vessel of the patient is hard and has a high stenosis degree, the balloon can not pass through the calcified area at all, and the treatment effect can not be achieved.

Disclosure of Invention

An object of embodiments of the present disclosure is to provide a shock wave electrode catheter to solve the problems in the prior art. In order to solve the technical problems, the embodiments of the present disclosure adopt the following technical solutions:

The embodiment of the disclosure provides a shock wave electrode catheter, including inner tube and outer tube, the inner tube sets up in the outer tube and follow the distal end of outer tube stretches out, the proximal end of outer tube is connected with the tailstock, the tailstock passes through the cable and is connected with the adapter, the inner tube stretches out set up sacculus portion and a plurality of electrode pair on the pipe shaft of outer tube, sacculus portion cover is established the outside of electrode pair, the electrode pair includes at least one and sets up the distal end of inner tube and be used for the forward electrode pair of forward emission shock wave, still includes at least one and sets up just be used for radial electrode pair of radial emission shock wave on the inner tube.

In some embodiments, when the radial electrode pairs are plural, the plural radial electrode pairs are sequentially arranged along the extending direction of the inner tube.

In some embodiments, the forward electrode pair includes an outer electrode and at least one inner electrode, the outer electrode and each of the inner electrodes forming one of the forward electrode pairs.

In some embodiments, the outer electrode is cylindrical, the inner electrode is cylindrical, 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.

In some embodiments, the radial electrode pair includes 2 radial electrodes disposed opposite each other, the 2 radial electrodes being spaced apart by a predetermined gap.

In some embodiments, an insulating ring is disposed outside of the radial electrode pair for encapsulation.

In some embodiments, the insulating ring is tubular, a packaging hole is formed in the middle of a wall surface of the insulating ring, a first discharge hole and a second discharge hole are respectively formed in two sides of the packaging hole, and the first discharge hole and the second discharge hole respectively correspond to 2 radial electrodes on the radial electrode pair.

In some embodiments, the packaging hole is in a long groove structure, and the length direction of the packaging hole is perpendicular to the extending direction of the inner tube.

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

In some embodiments, the inner tube is a hollow tube for forming a guidewire lumen to accommodate a guidewire therethrough, the distal end of the inner tube is provided with a tip, one end of the balloon portion is connected to the tip, and the other end is connected to the distal end of the inner tube.

Aiming at the situation that plaque in a blood vessel of a patient is harder and the stenosis degree is heavier, the embodiment of the present disclosure realizes that the support arm of the blood vessel wall simultaneously breaks and cracks calcified tissues at the vascular occlusion position by transmitting shock waves through the forward electrode pair and the radial electrode pair in the balloon part through the balloon, so that the lesion position with higher stenosis degree can be smoothly passed, and a good vascular opening effect is achieved.

Drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments described in the present disclosure, and other drawings may be obtained according to these drawings without inventive effort to a person of ordinary skill in the art.

FIG. 1 is a schematic view of a shock wave electrode catheter according to an embodiment of the present disclosure;

FIG. 2 is a schematic illustration of the arrangement of a balloon portion and electrode pairs in a shock wave electrode catheter according to an embodiment of the present disclosure;

FIG. 3 is a schematic diagram of the structure of a forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

FIG. 4 is a schematic view of the structure of the outer electrodes of the forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

FIG. 5 is a schematic view of the structure of the outer electrodes of the forward electrode pair in a shock wave electrode catheter according to an embodiment of the present disclosure;

FIG. 6 is a schematic view of an arrangement of radial electrode pairs in a shock wave electrode catheter according to an embodiment of the present disclosure;

Fig. 7 is a schematic structural view of an insulating ring in a shock wave electrode catheter according to an embodiment of the present disclosure.

Reference numerals:

100-shock wave electrode catheter, 101-balloon, 102-outer tube, 103-de-stressing tube, 104-tailstock, 105-cable, 106-adapter, 107-tip, 108-first electrode pair, 109-outer electrode, 110 a-first inner electrode, 110 b-second inner electrode, 111 a-first through hole, 111 b-second through hole, 111c third through hole, 111 d-fourth through hole, 111 e-fifth through hole, 112-inner tube, 113-second electrode pair, 113 a-first radial electrode, 113 b-second radial electrode, 114-second electrode pair, 114 a-third radial electrode, 114 b-fourth radial electrode, 114c third radial electrode, 114d fourth radial electrode, 115-insulating ring, 115 a-first discharge hole, 115 b-second discharge hole, 116-encapsulation hole.

Detailed Description

Various aspects and features of the disclosure are described herein with reference to the drawings.

It should be understood that various modifications may be made to the embodiments of the application herein. Therefore, the above description should not be taken as limiting, but merely as exemplification of the embodiments. Other modifications within the scope and spirit of this disclosure will occur to persons of ordinary skill in the art.

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

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 accompanying drawings.

It should also be understood that, although the present disclosure has been described with reference to some specific examples, a person skilled in the art will certainly be able to achieve many other equivalent forms of the present disclosure, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

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

Specific embodiments of the present disclosure will be described hereinafter with reference to the drawings, however, it should be understood that the embodiments disclosed are merely examples of the disclosure which may be practiced in various ways. Well-known and/or repeated functions and constructions are not described in detail to avoid obscuring the disclosure in unnecessary or unnecessary detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

The specification may use the word "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may each refer to one or more of the same or different embodiments in accordance with the disclosure.

The presently disclosed embodiments provide a shock wave electrode catheter 100 for use in achieving vascular punch-through and vascular shaping by launching directional shock waves within a blood vessel. As shown in fig. 1-7, the shock wave electrode catheter 100 comprises an inner tube 112 and an outer tube 102, wherein the inner tube 112 is disposed within the outer tube 102 and extends from the distal end of the outer tube 102, where the inner tube 112 is a hollow tube forming a guidewire lumen to accommodate a guidewire having a diameter of 0.010-0.035inch therethrough. The distal end of the inner tube 112 is provided with a tip 107, which tip 107 facilitates the insertion of the shock wave electrode catheter 100 into a blood vessel.

Furthermore, the proximal end of the outer tube 102 is connected to a tailstock 104, where the tailstock 104 is preferably connected to the proximal end of the outer tube 102 by a de-stressing tube 103. The tailstock 104 is connected to an adapter 106 via a cable 105.

In order to support the blood vessel when the shock wave electrode catheter 100 is inserted into the human body, the balloon portion 101 is disposed on the inner tube 112, and the balloon portion 101 is inflated after filling to contact with the wall of the blood vessel to support the blood vessel. In this embodiment, one end of the balloon portion 101 is connected to the tip 107 to form a first fastening point, and the other end is connected to the distal end of the outer tube 102 to form a second fastening point, where the fastening means may be by gluing, welding, binding, or the like. Thus, the balloon portion 101 on the inner tube 112 not only covers the distal end of the inner tube 102, but also covers the tube body of the inner tube 112 extending out of the outer tube 102. Here, a channel through which the liquid flows is provided between the outer tube 102 and the inner tube 112, so that the interior of the balloon portion 101 is filled with the liquid, and a certain pressure is applied to fill the balloon.

Further, at least one forward electrode pair for transmitting shock waves forward is disposed at the distal end of the inner tube 112, and at least one radial electrode pair for transmitting shock waves radially is disposed on the tube body of the inner tube 112 extending out of the outer tube 102. Wherein, when the radial electrode pairs are plural, the plural radial electrode pairs are sequentially arranged along the extending direction of the inner tube 112. Wherein the balloon portion 101 is wrapped and arranged outside the forward electrode pair and outside the radial electrode pair. The shock waves emitted by the forward electrode pair here pass through the balloon portion 101 to contact the vessel wall, and the shock waves emitted by the radial electrode pair pass through the balloon portion 102 to contact the vessel wall. The forward electrode pair serves as a plaque on electrode pair to transmit shock waves forward, and the radial electrode pair serves as a plaque rupture electrode pair to transmit shock waves radially.

The balloon portion 101 may be a compliant balloon made of natural latex, silica gel, TPU or other soft materials, or the balloon portion 101 may be a semi-compliant or non-compliant balloon made of PET, PP, polyethylene, polyamide or other high polymer materials.

In this embodiment, the first electrode pair 108 disposed at the distal end of the inner tube 112 is a forward electrode pair, and 2 radial electrode pairs, namely, the second electrode pair 113 and the third electrode pair 114, are disposed on the inner tube 112.

Specifically, the forward electrode pair, i.e. the first electrode pair, comprises an outer electrode 109 and at least one inner electrode, wherein the outer electrode 109 forms one of the forward electrode pairs with each of the inner electrodes. Here, when the number of the inner electrodes is plural, the outer electrode 109 forms plural pairs of the forward electrodes with plural inner electrodes. Wherein the external electrode 109 has a cylindrical shape with a diameter of 0.1-1.0mm and a wall thickness of 0.03-0.3mm. The outer electrode 109 of this embodiment may be made of stainless steel, tungsten, platinum iridium, nickel, iron, steel, and/or other conductive materials. Wherein the outer electrode 109 is a negative electrode and the inner electrode is a positive electrode.

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

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

In this embodiment, the outer electrode 109 and the inner electrode are connected to an outer electrode lead and an inner electrode lead, respectively, by welding, which in this embodiment extend to the proximal end of the outer tube 102 to connect with the cable 105.

In one embodiment, a first through hole 111a, a second through hole 111b and a third through hole 111c are provided on the bottom surface of the external electrode 109, wherein the first through hole 111a is used as the inner pipe through hole and is positioned at the center of the bottom surface, and is used for passing through the inner pipe 112, the diameter of the first through hole 111a can be 0.2mm-2.0mm, and the second through hole 111b and the third through hole 111c are respectively provided on the bottom surface of the external electrode 109 and are positioned at two sides of the first through hole 111a for coaxially fixing the internal electrode, and the diameter of the electrode through hole can be 0.2mm-1.0mm.

Specifically, a first internal electrode 110a and a second internal electrode 110b are inserted into the second through hole 111b and the third through hole 111c, respectively, and the first internal electrode 110a and the second internal electrode 110b are connected to corresponding positive electrode leads, respectively. In the present embodiment, the forward negative electrode 111 is combined with the first and second internal electrodes 110a and 110b to form 2 pairs of the forward electrodes that generate and emit forward shock waves. Here, the end surfaces of the first and second internal electrodes 110a and 110b are flush with or slightly recessed from the second and third through holes 111b and 111 c.

Further, each of the radial electrode pairs includes 2 radial electrodes spaced apart from each other by a predetermined interval, and the 2 radial electrodes may be positive and negative electrodes with each other, wherein a gap between the 2 radial electrodes is 0.1-2.0mm. The electrode material of the radial electrode can be stainless steel, tungsten, platinum iridium, nickel, iron, steel and/or other conductive materials. In the present 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. Wherein the positive and negative properties of 2 of the radial electrodes in each of the radial electrode pairs may be reversed.

In a preferred embodiment, 1-8 of the forward electrode pairs may be provided in the shock wave electrode catheter, and there may be more of the radial electrode pairs along the length of its inner tube 112, such as 3-6 pairs, to facilitate rupture of calcified plaque along the length of the vessel.

According to the embodiment of the disclosure, the shock waves can be sent directionally through the forward electrode pair and the radial electrode pair, so that the action position of the shock waves is ensured, and the damage of the shock wave energy is reduced. In addition, the embodiment of the disclosure can selectively excite different electrode pairs to send shock waves, for example, one electrode pair can be selected to send shock waves, the electrode pairs can be excited sequentially, all the electrode pairs can be excited simultaneously, the operation of an operator in the operation is greatly facilitated,

Further, an insulating ring 115 is disposed on the outer side of each radial electrode pair and is used for packaging two radial electrodes in the radial electrode pair, the insulating ring 115 is tubular, a packaging hole 116 is disposed in the middle of a wall surface of the insulating ring 115, a first discharge hole 115a and a second discharge hole 115b are respectively disposed on two sides of the packaging hole 116, and the first discharge hole 115a and the second discharge hole 115b respectively correspond to 2 radial electrodes in the radial electrode pair. The insulating ring 115 is made of polyimide, PTFE, polyamide, PET, or other nonconductive material, and has a relatively high insulating strength.

Specifically, the shock wave energy generated from 2 radial electrodes in each of the radial electrode pairs is directed to be released through the first and second discharge holes 115a and 115b, respectively, thereby generating a full constraint and energy collecting effect on the energy.

In addition, the packaging hole 116 has a long groove structure, and the length direction thereof is perpendicular to the extending direction of the inner tube 112.

The two adjacent insulating rings 115 may be disposed at an angle different from each other in the axial direction, preferably, the two adjacent insulating rings 115 may be disposed at an angle different from each other by 90 ° in the axial direction, and the angle between the two insulating rings 115 may be determined by the extending direction of the elongated slot structure, so that it is possible to facilitate the transmission of shock waves to plaque at different positions on the blood vessel.

When the embodiment is applied to a blood vessel, an occlusion plaque is arranged on the wall of the blood vessel, an opening forward electrode pair and a radial electrode pair formed by the radial electrodes are formed through the cooperation of the outer electrode and the inner electrode, so that the advantages of the plaque opening electrode pair and the plaque crushing electrode pair can be compatible, forward shock waves are emitted through the forward electrode pair, radial shock waves are emitted through the radial electrode pair to crush the occlusion plaque and form a crushed plaque, and the catheter can smoothly pass through a lesion position with higher stenosis.

Specifically, the distal end angle of the balloon portion 101 is larger, the distal end of the balloon portion 101 can be attached to the plaque in the blood vessel in a relatively tight and forward direction, and the outer surface of the balloon portion 101 can be in radial contact with the vessel wall and the calcified lesion region of the blood vessel. By applying an instantaneous high voltage to the forward electrode pair and the radial electrode pair in the balloon portion 101 to generate an arc, a shock wave accompanying expansion and collapse of bubbles generated by the arc is generated, and the shock wave generated by the electrode pair is radially conducted to the surface of the balloon portion 101 via the liquid in the balloon portion 101, and is further conducted to calcified lesions via the surface of the balloon portion 101.

When the impact wave is transmitted to the calcified lesion, the compression stress of the impact wave can cause the calcified tissue at the vascular occlusion to be softened and cracked, so that the impact wave electrode catheter can pass through the vascular occlusion, and then radial impact waves are generated for further crushing and cracking the calcified tissue by the radial electrode pair, thereby achieving good vascular opening effect. Furthermore, the proper strength of the shock wave can be sufficient to destroy the calcified tissue without placing an additional burden on the soft tissue surrounding the calcified tissue.

Moreover, although operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the present disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.

Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are example forms of implementing the claims.

While various embodiments of the present disclosure have been described in detail, the present disclosure is not limited to these specific embodiments, and various modifications and embodiments can be made by those skilled in the art on the basis of the concepts of the present disclosure, which modifications and modifications should fall within the scope of the claims of the present disclosure.

Claims

1. The utility model provides a shock wave electrode catheter, its characterized in that includes inner tube and outer tube, the inner tube sets up in the outer tube and follow the distal end of outer tube stretches out, the proximal end and the tailstock of outer tube are connected, the tailstock passes through the cable and is connected with the adapter, the inner tube stretches out set up sacculus portion and a plurality of electrode pair on the pipe shaft of outer tube, sacculus portion cover is established the outside of electrode pair, the electrode pair includes at least one and sets up the distal end of inner tube and be used for the forward electrode pair of forward emission shock wave, still includes at least one and set up just be used for radial electrode pair of radial emission shock wave on the inner tube.

2. The shock wave electrode catheter according to claim 1, wherein when the radial electrode pairs are plural, the plural radial electrode pairs are sequentially arranged along the extending direction of the inner tube.

3. The shock wave electrode catheter of claim 1, wherein the forward electrode pair comprises an outer electrode and at least one inner electrode, the outer electrode and each of the inner electrodes forming one of the forward electrode pairs.

4. The shock wave electrode catheter according to claim 3, wherein the outer electrode has a cylindrical shape, the inner electrode has a cylindrical shape, and an inner tube through hole for passing the inner tube and an electrode through hole for fixing the inner electrode are provided on a bottom surface of the outer electrode.

5. The shock wave electrode catheter according to claim 1, wherein the radial electrode pair comprises 2 radial electrodes arranged opposite each other, 2 of the radial electrodes being spaced apart by a predetermined gap.

6. The shock wave electrode catheter according to claim 5, wherein an insulating ring for encapsulation is provided outside the pair of radial electrodes.

7. The shock wave electrode catheter according to claim 6, wherein the insulating ring is tubular, a packaging hole is formed in the middle of the wall surface of the insulating ring, a first discharge hole and a second discharge hole are respectively formed in two sides of the packaging hole, and the first discharge hole and the second discharge hole respectively correspond to 2 radial electrodes on the radial electrode pair.

8. The shock wave electrode catheter according to claim 7, wherein the encapsulation hole has a long groove structure, and a length direction of the encapsulation hole is perpendicular to an extending direction of the inner tube.

9. The shock wave electrode catheter according to claim 6, wherein two adjacent insulating rings are arranged with a 90 ° difference in axial direction.

10. The shock wave electrode catheter according to claim 1, wherein the inner tube is a hollow tube for forming a guidewire lumen for receiving a guidewire therethrough, a tip is provided at a 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.