A short-circuit-proof pulse balloon dilatation catheter

Abstract

This invention discloses a short-circuit-preventing pulsed balloon dilation catheter, belonging to the field of balloon catheter technology. This short-circuit-preventing pulsed balloon dilation catheter includes a catheter component and a balloon component disposed distal to the catheter component; an electrode assembly, which includes an outer electrode component, an inner electrode component, an insulating component, and a through-hole component. The through-hole component and the inner electrode component together form an electric field region. By incorporating a short-circuit-preventing component made of shape memory alloy and providing a groove on the surface of the outer electrode component that is compatible with the short-circuit-preventing component, when the balloon catheter is in the delivery state, the short-circuit-preventing component is housed in the groove on the surface of the outer electrode component, without increasing the outer diameter of the electrode assembly. When the balloon catheter is in the treatment state, the short-circuit-preventing component transforms into a hollow cylinder located outside the through-hole component, thereby extending the radial depth of the through-hole component, preventing short circuits, and ensuring the safety of the procedure.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a short-circuit-preventing pulse balloon dilation catheter. Background Technology

[0002] Coronary atherosclerotic heart disease (CAD) can be treated with medication, interventional procedures, and surgery. Among these, interventional therapy is increasingly favored by clinicians and patients due to its significant efficacy, minimal invasiveness, and less patient discomfort. Its overall efficacy is the same as that of coronary artery bypass grafting and is significantly better than drug therapy alone. It has become an indispensable and important means of treating CAD. Balloon catheters are commonly used instruments in surgery. For example, patent document CN104582597A discloses a shockwave balloon catheter with multiple shockwave sources, which uses shockwave sources to treat the lesion location.

[0003] The outer diameter of the electrode used by the ultrasound generator in existing balloon catheters is relatively large. When the gap between the catheter and the balloon is small at the site of coronary calcification, the catheter has difficulty passing through, and the balloon may not be able to fully expand and adhere to the inner wall of the blood vessel when it is inflated, thus failing to achieve the desired therapeutic effect. This problem can be improved by reducing the outer diameter of the electrode. However, due to the reduction in the outer diameter of the electrode, the air that is originally used as a medium for the discharge of the outer and inner electrodes in the outer electrode hole may be pushed out of the outer electrode hole, causing the contrast fluid to seep in and cause a short circuit, thus rendering the catheter ineffective. Summary of the Invention

[0004] The purpose of this invention is to provide a short-circuit-resistant pulse balloon dilation catheter to solve the problems mentioned in the background art regarding the use of existing balloon catheters.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a short-circuit prevention pulse balloon dilation catheter, comprising a catheter component and a balloon component disposed at the distal end of the catheter component;

[0006] An electrode assembly, comprising an outer electrode component, an inner electrode component, an insulating component, and a through-hole component, wherein the through-hole component and the inner electrode component together form an electric field region;

[0007] The anti-short-circuit component, made of shape memory alloy, is housed in a groove on the surface of the external electrode component when the balloon catheter is in the delivery state. When the balloon catheter is in the treatment state, the anti-short-circuit component transforms into a hollow cylinder located outside the circular hole component, thereby extending the radial depth of the circular hole component and increasing the volume of the electric field region.

[0008] Preferably, the short-circuit protection component has a fixing part, which is fixed to the bottom surface of the groove to realize heat transfer between the short-circuit protection component and the external electrode component.

[0009] Preferably, there are two short-circuit protection components, which are symmetrically arranged on both sides of the circular hole component.

[0010] Preferably, the short-circuit protection component is a "T"-shaped sheet, and the short-circuit protection component includes a first bent portion and a second bent portion.

[0011] Preferably, the first curved portion is a rectangular sheet, with end A of the first curved portion fixed to the bottom surface of the groove, and end B of the second curved portion connected to the middle of one side of the second curved portion.

[0012] Preferably, the second curved portion includes a connecting edge connected to the first curved portion, a free edge opposite to the connecting edge, and two side edges.

[0013] Preferably, the connecting edge is an arc-shaped edge, and its curvature matches the curvature of the outer surface of the outer electrode component.

[0014] Preferably, the circular hole component extends from the outer surface of the outer electrode component to the outer surface of the inner electrode component.

[0015] Preferably, the materials of the outer electrode component and the inner electrode component include a platinum-iridium alloy.

[0016] Preferably, the material of the balloon component includes nylon.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] By incorporating a short-circuit protection component made of shape memory alloy and providing a groove on the surface of the external electrode component that is compatible with the short-circuit protection component, when the balloon catheter is in the delivery state, the short-circuit protection component is housed in the groove on the surface of the external electrode component, without increasing the outer diameter of the electrode assembly. When the balloon catheter is in the treatment state, the short-circuit protection component transforms into a hollow cylinder located outside the circular hole component, thereby extending the radial depth of the circular hole component and increasing the outer diameter of the electrode in the treatment state, preventing short circuits and ensuring the safety of the surgery. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the balloon catheter of the present invention in the therapeutic state;

[0020] Figure 2 This is a schematic diagram of the balloon catheter of the present invention in the delivery state;

[0021] Figure 3 This is a cross-sectional view of the electrode assembly of the present invention;

[0022] Figure 4This is a schematic diagram of the outer electrode component structure before deformation of the anti-short circuit component of the present invention;

[0023] Figure 5 This is a schematic diagram of the external electrode component structure after deformation of the short-circuit protection component of the present invention. Figure 1 ;

[0024] Figure 6 This is a schematic diagram of the external electrode component structure after deformation of the short-circuit protection component of the present invention. Figure 2 .

[0025] In the figure: 100, catheter component; 200, balloon component; 201, filling section; 300, electrode assembly; 301, external electrode component; 302, internal electrode component; 303, insulating component; 304, circular hole component; 304a, first section; 304b, second section; 400, groove; 401, short-circuit protection component; 402, first bend; 402a, end A; 402b, end B; 403, second bend; 403a, connecting edge; 403b, free edge; 403c, side. Detailed Implementation

[0026] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not 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 efforts are within the scope of protection of the present invention.

[0027] Reference Figure 1-6 A short-circuit-prevention pulse balloon dilation catheter (hereinafter referred to as balloon catheter) includes a catheter component 100 and a balloon component 200 disposed at the distal end of the catheter component 100. A filling section 201 is formed between the balloon component 200 and the catheter component 100. The balloon component 200 is dilated by filling the filling section 201 with liquid (such as contrast fluid). Correspondingly, the balloon catheter has two modes: delivery mode and treatment mode. When the balloon catheter is in the delivery mode, no filling fluid is injected into the filling section 201, the balloon component 200 is not dilated, and the overall diameter of the balloon catheter is small, which facilitates the movement of the balloon catheter in the blood vessel. When the balloon component 200 is in the treatment mode, the filling section 201 is filled with filling fluid, the balloon component 200 is dilated and contacts the outer wall of the blood vessel. At the same time, the balloon catheter also includes an electrode assembly 300, which is disposed in the filling section 201 and arranged along the length direction of the catheter component 100. The treatment is performed by generating ultrasound through the electrode assembly 300.

[0028] The electrode assembly 300 includes an outer electrode component 301, an inner electrode component 302, and an insulating component 303. The inner electrode component 302 and the outer electrode component 301 are made of conductive metal materials such as platinum-iridium alloy, while the insulating component 303 is made of insulating material. The electrode assembly 300 has a layered covering structure. The outer electrode component 301 and the inner electrode component 302 are located in the outer layer and the inner layer, respectively, and the insulating component 303 is located in the middle layer. The insulation separates the inner electrode component 302 and the outer electrode component 301 to avoid direct contact between them. Specifically, the insulating component 303 is an insulating tube, whose inner surface is attached to the outer surface of the inner electrode component 302, and whose outer surface is attached to the inner surface of the outer electrode component 301. The outer electrode component 301 is sleeve-shaped, that is, the outer electrode component 301 is sleeved on the insulating component 303. The inner electrode component 302 is a flat arc-shaped plate that is tightly attached to the inner circumferential surface of the insulating component 303.

[0029] Furthermore, the electrode assembly 300 has a circular hole component 304 along the diametrical direction of the outer electrode component 301. This circular hole component 304 extends from the outer surface of the outer electrode component 301 to the outer surface of the inner electrode component 302, meaning it penetrates the sidewalls of both the outer electrode component 301 and the insulating component 303. More specifically, the circular hole component 304 includes a first section 304a with a wall thickness approximately the same as that of the outer electrode component 301 and a second section 304b with a wall thickness approximately the same as that of the insulating component 303. The cross-sectional diameters of the first section 304a and the second section 304b can be... Unlike other components, the circular hole component 304 extends all the way to the outer surface of the inner electrode component 302. That is, the inner end of the circular hole component 304 (i.e., the end near the center of the cross-section of the conduit component 100) is closed by the inner electrode component 302. The outer end of the through hole component is connected to the filling interval 201. At this time, the inner electrode component 302 and the through hole component together form an electric field interval with one end open. By applying a high voltage pulse to the inner electrode component 302 and the outer electrode component 301, and using the air in the electric field interval as the discharge medium, a pulsed sound wave is formed, thereby treating the calcified lesion area.

[0030] Furthermore, the electrode assembly 300 also includes a short-circuit protection component 401, and a groove 400 adapted to the short-circuit protection component 401 is formed on the outer surface of the outer electrode component 301, that is, the short-circuit protection component 401 can be "stored" in the groove 400. Preferably, the short-circuit protection component 401 is a sheet-like body made of shape memory, and the thickness of the sheet-like body is approximately half the thickness of the outer electrode component 301. Correspondingly, the thickness of the groove 400 is also half the thickness of the outer electrode component 301. The short-circuit protection component 401 has a fixed part and a free part. The fixed part is fixed to the surface of the groove 400 by welding or other means, thereby connecting the outer electrode component 301 and the short-circuit protection component 401. When the temperature of the outer electrode component 301 rises due to power, the short-circuit protection component 401 heats up synchronously. The free part deforms accordingly according to the temperature change of the short-circuit protection component 401, thereby realizing the change of the shape of the electrode assembly 300.

[0031] Specifically, the anti-short-circuit component 401 is provided in two symmetrical positions on both sides of the outer end of the through-hole component. When the balloon catheter is in the delivery state, that is, when the balloon component 200 is not inflated, the anti-short-circuit component 401 is entirely located inside the groove 400, and will not cause an increase in the outer diameter of the catheter component 100. When the balloon catheter is in the treatment state, that is, after the balloon component 200 is inflated, the two anti-short-circuit components 401 located on both sides of the circular hole component 304 deform and close together to form a hollow cylinder. The specifications of the hollow cylinder and the circular hole portion are consistent. The components 304 have the same specifications and are located on the outside of the circular hole component. By using the hollow cylinder formed after the anti-short circuit component 401 is closed as the extension of the circular hole component 304, the radial depth of the circular hole component 304 is increased, thereby increasing the volume of the electric field region in the electrode assembly 300. Correspondingly, the volume of the electric field region is increased simultaneously, so that during the discharge process of the outer electrode component 301 and the inner electrode component 302, air as the discharge medium is always present in the electric field region, preventing liquid from entering the circular hole component 304 and causing a short circuit.

[0032] Furthermore, the cross-section of the short-circuit protection component 401 is approximately "T"-shaped, including a first bent portion 402 and a second bent portion 403. The first bent portion 402 is a rectangular sheet. One end of the first bent portion 402 is fixed to the bottom surface of the groove 400 by welding or other means, denoted as end A 402A. The other end is connected to the middle of one side of the second bent portion 403, denoted as end B 402B. Preferably, the first bent portion 402 and the second bent portion 403 are integrally formed. Specifically, the second... The curved portion 403 is also a single sheet. The side where the second curved portion 403 contacts the first curved portion 402 is designated as the connecting edge 403a, the side opposite to the connecting edge 403a is designated as the free edge 403b, and the remaining sides are designated as side edges 403c. The connecting edge 403a, the free edge 403b, and the two side edges 403c together form the second curved portion 403. Furthermore, the connecting edge 403a is arc-shaped, and its curvature matches the curvature of the outer surface of the external electrode component 301, meaning its surface energy... The surface of the external electrode component 301 is in contact with the surface of the anti-short circuit component 401. When the anti-short circuit component 401 deforms, the B end 402B of the first bending part 402 deforms, causing the second bending section to bend inward. At the same time, the free edge 403b on the second bending section deforms from a straight line into a semicircle. The other parts of the second bending part 403 deform synchronously with the free edge 403b. At this time, the free edge 403b, the connecting edge 403a, and the two side edges 403c of the second bending part 403 together form a semi-hollow cylinder. The surfaces of the connecting edge 403a and the outer electrode component 301 are in contact with each other. At the same time, the sides 403c of the second curved part 403 in the symmetrically arranged anti-short circuit component 401 are in contact with each other after deformation. That is, the two anti-short circuit components 401 form a hollow cylinder on the outside of the circular hole component 304, thereby extending the radial depth of the circular hole component 304. When the inner electrode component 302 and the outer electrode component 301 discharge, the air in the electric field interval will not leave the electric field interval under the push of external force, causing a short circuit.

[0033] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A short-circuit-preventing pulse balloon dilation catheter, characterized in that: include The catheter assembly and the balloon assembly disposed at the distal end of the catheter assembly; An electrode assembly, comprising an outer electrode component, an inner electrode component, an insulating component, and a through-hole component, wherein the through-hole component and the inner electrode component together form an electric field region; The anti-short-circuit component, made of shape memory alloy, is housed in a groove on the surface of the external electrode component when the balloon catheter is in the delivery state. When the balloon catheter is in the treatment state, the anti-short-circuit component transforms into a hollow cylinder located outside the through-hole component, thereby extending the radial depth of the through-hole component and increasing the volume of the electric field region. The short-circuit protection component is a "T"-shaped sheet, and the short-circuit protection component includes a first bent portion and a second bent portion; The first curved portion is a fixing portion, which is fixed to the bottom surface of the groove.

2. The anti-short-circuit pulse balloon dilation catheter according to claim 1, characterized in that: The short-circuit protection component has a fixing part to realize heat transfer between the short-circuit protection component and the external electrode component.

3. A short-circuit prevention pulse balloon dilation catheter according to claim 1 or 2, characterized in that: Two short-circuit protection components are provided and are symmetrically arranged on both sides of the through hole component.

4. The anti-short-circuit pulse balloon dilation catheter according to claim 1, characterized in that: The first curved part is a rectangular sheet. End A of the first curved part is fixed to the bottom surface of the groove, and end B of the second curved part is connected to the middle of one side of the second curved part.

5. The anti-short-circuit pulse balloon dilation catheter according to claim 4, characterized in that: The second curved portion includes a connecting edge connected to the first curved portion, a free edge opposite to the connecting edge, and two side edges.

6. The anti-short-circuit pulse balloon dilation catheter according to claim 5, characterized in that: The connecting edge is an arc-shaped edge, and its curvature matches the curvature of the outer surface of the external electrode component.

7. The anti-short-circuit pulse balloon dilation catheter according to claim 1, characterized in that: The through-hole component extends from the outer surface of the outer electrode component to the outer surface of the inner electrode component.

8. The anti-short-circuit pulse balloon dilation catheter according to claim 1, characterized in that: The materials of the outer electrode component and the inner electrode component include a platinum-iridium alloy.

9. The anti-short-circuit pulse balloon dilation catheter according to claim 1, characterized in that: The balloon component is made of nylon.

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