CN115317073A

CN115317073A - Intravascular shock wave micro catheter and medical equipment

Info

Publication number: CN115317073A
Application number: CN202210974014.8A
Authority: CN
Inventors: 陈亮亮; 白晓淞; 陈浚
Original assignee: Innermedical Co ltd
Current assignee: Innermedical Co ltd
Priority date: 2022-08-15
Filing date: 2022-08-15
Publication date: 2022-11-11

Abstract

The invention provides an intravascular shock wave microcatheter and medical equipment, the intravascular shock wave microcatheter comprises: an inner tube; the outer sheath pipe is sleeved outside the inner pipe; and the electrode is positioned on the outer surface of the inner tube and at the far end of the inner tube and is used for being connected with the high-voltage pulse output module, after the conducting liquid is filled between the inner tube and the outer sheath tube, the electrode breaks through the conducting liquid at the electrode under the action of the high-voltage pulse to generate mechanical shock waves, and the calcified tissues are gradually crushed from the calcified lesion with serious occlusion or complete occlusion until the calcified lesion area with serious occlusion or complete occlusion in the blood vessel is completely opened. Therefore, the intravascular shock wave micro-catheter can be suitable for calcified lesion areas with serious or complete occlusion in blood vessels, has excellent trafficability, greatly improves the application range of vascular shock wave treatment, and can provide better treatment schemes for patients.

Description

Intravascular shock wave micro catheter and medical equipment

Technical Field

The embodiment of the invention relates to the technical field of medical instruments, in particular to an intravascular shock wave micro catheter and medical equipment.

Background

Atherosclerosis is the main cause of coronary heart disease, cerebral infarction and peripheral vascular disease, fibrous tissue hyperplasia and calcium deposition cause gradual disintegration and calcification of middle layer of artery, resulting in thickening and hardening of artery wall and stenosis of blood vessel cavity. The tissue or organ supplied by the artery will be ischemic or necrotic.

Traditional methods of treating calcified plaques, such as high pressure balloons, cutting balloons, spinous balloons, and rotational atherectomy/atherectomy, have limitations and often have no strategy in media calcification, eccentric calcified nodules, or severe calcification treatment; inspired by urinary lithotripsy, the appearance of an intravascular coronary lithotripsy (IVL) system provides a new idea for clinically treating calcified lesions, so that calcified plaques which cannot be treated before can be solved more efficiently and safely.

The intravascular shock wave lithotripsy (ISL) technique has begun to be applied clinically abroad as an emerging technique in recent years. The intravascular shock wave lithotripsy system mainly comprises an intravascular shock wave therapeutic apparatus and a shock wave balloon. The doctor delivers the shock wave saccule to the calcified lesion part of the blood vessel, then carries out low-pressure expansion on the shock wave saccule, finally starts the intravascular shock wave therapeutic apparatus to release high-pressure pulse to the shock wave saccule to generate shock wave, breaks the calcified plaque on the superficial layer and the deep layer of the blood vessel cavity, and fully expands the blood vessel cavity, thereby achieving the purpose of obviously improving the compliance of the blood vessel.

However, in clinical practice, the shockwave balloon catheter still has the defects that the catheter passing is poor, and the severe occlusion or the completely occlusion calcified lesion cannot be dealt with. For calcified lesions with severe or complete occlusion, no clinically reliable treatment is currently available.

Disclosure of Invention

The embodiment of the invention provides an intravascular shock wave micro catheter and medical equipment, and aims to solve the problem that the traditional shock wave balloon catheter has poor trafficability and cannot treat calcified lesions which are seriously or completely occluded.

In order to solve the technical problem, the invention is realized as follows:

in a first aspect, embodiments of the present invention provide an intravascular shockwave microcatheter, comprising:

an inner tube;

the outer sheath pipe is sleeved outside the inner pipe;

the electrode is positioned on the outer surface of the inner tube, positioned at the far end of the inner tube and used for being connected with the high-voltage pulse output module;

after the conducting liquid is filled between the inner tube and the outer sheath tube, the electrode breaks down the conducting liquid at the electrode under the action of high-voltage pulse to generate mechanical shock wave.

Preferably, the method further comprises the following steps:

a guidewire lumen;

the guide wire cavity is an inner cavity of the inner tube and is used for passing through a guide wire;

the guide wire penetrates into or penetrates out of the guide wire cavity to guide the micro-catheter;

wherein the inner tube extends from a distal end of the outer sheath to a proximal end of the outer sheath.

Preferably, the first and second electrodes are formed of a metal,

the proximal end of the inner tube is provided with a rapid exchange port, and a guide wire can penetrate into or out of the rapid exchange port to guide the micro-catheter; wherein the inner tube extends from a distal end of the outer sheath to the rapid exchange port.

Preferably, the method further comprises the following steps:

a visualization ring located on an inner or outer surface of the distal end of the inner tube, the visualization ring for visualizing a marker to mark the position of the electrode.

Preferably, the proximal end of the outer sheath is designed by adopting a material with pushing force, and the distal end of the outer sheath is designed by adopting a material with softness.

Preferably, the method further comprises the following steps:

a catheter hub; a proximal end located at the outer sheath;

the catheter hub comprises: filling the cavity;

the filling cavity is used for injecting the conductive liquid between the outer sheath tube and the inner tube.

Preferably, the method further comprises the following steps:

a catheter insertion part;

the catheter hub further comprises: a wire lumen;

the wire cavity is connected with the catheter insertion part, and the catheter insertion part is used for being connected with the high-voltage pulse output module.

Preferably, the distal end of the inner tube is sealingly connected to the distal end of the outer sheath.

In a second aspect, there is provided a medical device comprising the microcatheter of the first aspect, further comprising: a high-voltage pulse output module;

the microcatheter further comprises: and the electrode is connected with the high-voltage pulse output module through the lead.

Preferably, the output voltage range of the high-voltage pulse output module is 500V-5000V, and the pulse width is 1-100 mus.

In the embodiment of the invention, a micro catheter and a shock wave technology are combined to design an intravascular shock wave micro catheter, and the intravascular shock wave micro catheter can gradually crush calcified tissues from a calcified lesion with serious occlusion or complete occlusion by means of mechanical shock waves generated by an electrode at the far end of an inner tube until a calcified lesion area with serious occlusion or complete occlusion in a blood vessel is completely opened. Therefore, the intravascular shock wave micro-catheter can be suitable for calcified lesion areas with serious or complete intravascular occlusion, has excellent trafficability, greatly improves the application range of vascular shock wave treatment, and can provide a better treatment scheme for patients.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

FIG. 1 is a schematic diagram of an overall structure of an intravascular shockwave microcatheter according to an embodiment of the present invention;

fig. 1 includes: an electrode 101, a developing ring 102, an outer sheath 103, an inner tube 104, a guide wire 106, a filling cavity 105, a guide wire cavity 106 (the guide wire cavity accommodates the guide wire, and the guide wire cavity is numbered as the same as the guide wire in fig. 1), a catheter patch 108 and a high-voltage pulse output module 109;

FIG. 2 is a schematic diagram of an overall structure of an intravascular shockwave catheter according to an embodiment of the present invention;

fig. 2 includes: the electrode 101, the visualization ring 102, the inner tubing 203, the fast exchange port 204, the outer sheath 205, the lead 106, the filling lumen 105, the lead lumen 106, the catheter patch 108, and the high voltage pulse output module 109.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings, which is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and is therefore not to be construed as limiting the invention. Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

The various features and embodiments described in the embodiments may be combined in any suitable manner, for example, different embodiments may be formed by combining different features/embodiments, and in order to avoid unnecessary repetition, various possible combinations of features/embodiments in the present invention will not be described in detail.

The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The dimensions of the elements in the figures are exaggerated partly for clarity of illustration.

An embodiment of the present invention provides an intravascular shockwave microcatheter, as shown in fig. 1, the intravascular shockwave microcatheter includes:

an inner tube 104; an outer sheath 103, the outer sheath 103 is sleeved outside the inner tube 104; and the electrode 101 is positioned on the outer surface of the inner tube 104 and at the far end of the inner tube 104 and is used for being connected with the high-voltage pulse output module 109, and the high-voltage pulse generated by the high-voltage pulse output module 109 is conducted to the electrode 101 through the lead 106. When the conducting liquid is filled between the inner tube 104 and the outer sheath 103, the electrode 101 breaks down the conducting liquid at the electrode 101 under the action of high voltage pulse, and mechanical shock wave is generated.

It should be noted that the proximal and distal ends of the present invention are referenced to the operator in the procedure. The end away from the operator is the distal end and the end close to the operator is the proximal end.

As shown in FIG. 1, the outer sheath 103 is disposed over the inner tube 104 and surrounds the inner tube 104. The distal ends of the outer sheath 103 and the inner tube 104 are designed to be sealingly connected. The inner tube 104 may be a multi-layered thin-walled tube. The outer sheath 103 may be of a segmented design. Specifically, the near end of the outer sheath tube 103 can be designed by materials with good pushing force, such as a hypotube, a peek, a three-layer composite braided tube and the like, and the far end of the outer sheath tube 103 can be designed by plastic materials with good softness, such as nylon and the like, so that the strength of the shock wave generated by the shock wave microcatheter in the blood vessel can be ensured, and good pushing force is provided for the catheter.

The inner tube 104 is sized according to the outer sheath 103, and the inner tube 104 may be sized between 0.3 and 1.5mm when the outer diameter of the outer sheath 103 is between 0.5 and 3 mm. During operation, the intravascular shock wave microcatheter with proper size can be selected for shock wave lithotripsy operation according to the condition in the blood vessel of a patient.

In the intravascular shockwave microcatheter, an electrode 101 is also provided, the electrode 101 being disposed on the outer surface of the inner tube 104 and being designed at the distal end of the inner tube 104. At least one pair of electrodes 101 may be provided, each pair of electrodes 101 may be connected in series or in parallel, and each pair of electrodes 101 may be connected to the high voltage pulse output module 109 to break down the conductive liquid at the electrodes under the action of a high voltage pulse (the voltage may be in the range of 500V-5000V) to generate a mechanical shock wave. Since the electrode 101 is located at the distal end of the inner tube 104, compared to the conventional intravascular shockwave balloon catheter in which the electrode is located inside the balloon, the intravascular shockwave microcatheter of the present invention can gradually crush calcified tissues from one end of a calcified lesion with severe or complete occlusion until the calcified lesion with severe or complete occlusion in the blood vessel is completely opened. Therefore, the intravascular shock wave micro-catheter can be suitable for calcified lesion areas with serious or complete intravascular occlusion, has excellent trafficability, greatly improves the application range of vascular shock wave treatment, and can provide a better treatment scheme for patients.

In a preferred implementation, as shown in fig. 1, a guidewire lumen, i.e., the inner lumen of the inner tube 104, may also be provided in the intravascular shock wave microcatheter for passage of a guide wire therethrough. The guide wire can pass into or out of the guide wire cavity and is used for guiding the intravascular shock wave microcatheter. And the inner tubing 104 extends from the distal end of the outer sheath 103 to the proximal end of the outer sheath 103, i.e. through said outer sheath 103. It can be understood that, during the treatment process, the electrode 101 generates the shock wave to gradually crush the seriously occluded calcified tissue in the blood vessel, and then the guide wire can be delivered to the far end of the crushed calcified tissue, so that the guide wire smoothly passes through the calcified lesion area and then guides the movement of the shock wave microcatheter in the blood vessel.

In a preferred implementation, as shown in fig. 2, the intravascular shock wave microcatheter may be divided into two parts, namely: a guide wire lumen section and a pusher section. The electrode 101, the visualization ring 102, the inner tube 203, the rapid exchange port 204, and the distal end of the outer sheath 205 belong to a guide wire lumen segment, and the proximal end of the outer sheath 205, the filling lumen 105, the guide wire lumen 106, and the catheter connection portion 108 belong to a push segment. At the guidewire lumen segment, the proximal end of the inner tubing 203 is configured with a rapid exchange port 204, and the inner tubing 203 extends from the distal end of the outer sheath 205 to the rapid exchange port 204. The guide wire can penetrate or penetrate from the quick exchange port 204, at the moment, the inner part of the inner tube 203 can be regarded as a guide wire cavity, therefore, the inner tube 104 does not need to penetrate through the whole outer sheath tube 103 as shown in figure 1, and the diameter of the outer sheath tube 205 can be properly reduced because the pushing section of the microcatheter does not contain the inner tube, thereby the diameter of the pipeline at the pushing section of the intravascular shock wave microcatheter can be reduced, and the trafficability of the intravascular shock wave microcatheter can be further improved.

In a preferred implementation, in an intravascular shockwave microcatheter, a visualization ring 102 may also be provided, with visualization ring 102 being located on an inner or outer surface of the distal end of inner tube 104 (shown in fig. 1) or inner tube 203 (shown in fig. 2), and visualization ring 102 being located in proximity to electrode 101, visualization ring 102 being made of a radiopaque platinum-iridium alloy, and visualization ring 102 being used to visualize the markers to mark the location of electrode 101. And the markers can be visualized by a Digital Subtraction Angiography (DSA) device.

In a preferred implementation, as shown in fig. 1, the intravascular shock wave microcatheter further comprises: a catheter hub; at the proximal end of the outer sheath 103, connected to the outer sheath 103, the catheter hub comprises: filling lumen 105, guidewire lumen 106. The filling lumen 105 is used to inject a conductive liquid between the outer sheath 103 and the inner tube 104 after discharging the air inside the intravascular shock wave microcatheter. A conductive liquid, including but not limited to one of: saline, a contrast agent, and a mixed solution of saline and a contrast agent.

In a preferred implementation, the intravascular shock wave microcatheter further comprises: the catheter plug part 108, the wire cavity 106 and the catheter plug part 108 are connected, and the catheter plug part 108 is used for being connected with the high-voltage pulse output module 109. The lead wire 106 is fed from the lead wire lumen 106, the lead wire 106 may be located on the outer wall of the inner tube 104, and the lead wire 106 communicates with the electrode 101 and the high voltage pulse output module 119 for delivering high voltage pulses to the electrode 101.

In a preferred implementation, the inner tube 104 is a multi-layer thin-walled tube with a groove on the surface, and the wire 106 can be positioned within the groove of the inner tube, thereby reducing the diameter of the inner tube.

The application scene of the intravascular shock wave micro catheter is taken as an example for explanation, the intravascular shock wave micro catheter is provided aseptically, in the operation process, a doctor takes out the intravascular shock wave micro catheter, places a guide wire to the near end of an occlusion type calcification lesion under the guidance of Digital Subtraction Angiography (DSA), places the intravascular shock wave micro catheter to the vicinity of the occlusion type calcification lesion through the guidance of the guide wire, then exhausts air in the catheter through a catheter seat filling cavity 105, and injects conductive liquid into a gap between an outer sheath 103 and an inner tube 104. The conductive liquid can be normal saline, developing solution or mixed solution of normal saline and developing solution. The catheter insertion part 108 is then connected to a high voltage pulse output module 109 (shock wave therapy apparatus) to initiate therapy. In the treatment process, the electrode 101 breaks down the conductive liquid at the electrode 101 to generate shock waves, so that calcified tissues in the blood vessel are gradually crushed, and then the guide wire is delivered to the far end of the crushed calcified tissues, so that the guide wire smoothly passes through a calcified lesion area. Subsequently, the doctor can reconstruct the blood vessel access for the patient by placing a blood vessel stent, a medicine balloon and the like. Therefore, the intravascular shock wave micro-catheter can be suitable for calcified lesion areas with serious or complete intravascular occlusion, has excellent trafficability, greatly improves the application range of vascular shock wave treatment, and can provide a better treatment scheme for patients.

An embodiment of the present invention further provides a medical apparatus, as shown in fig. 1, the medical apparatus includes the intravascular shock wave microcatheter shown in the previous embodiment, and in addition, includes: the intravascular shock wave micro catheter is connected with the high-voltage pulse output module 109 through the catheter insertion part 108, and the high-voltage pulse output module 109 sends high-voltage pulses to the electrode 101 through the lead 106, so that the electrode 101 breaks down conductive liquid at the electrode 101 under the action of the high-voltage pulses to generate mechanical shock waves. The output voltage range of the high-voltage pulse output module 109 is 500V-5000V, and the pulse width is 1-100 mus.

In the intravascular shock wave microcatheter shown in fig. 2, a rapid exchange port 204 is provided, as compared to fig. 1. And in fig. 1, the inner tubing 104 extends from the distal end of the outer sheath 103 to the proximal end of the outer sheath 103 throughout the outer sheath 103. In FIG. 2, the inner tubing 203 extends from the distal end of the outer sheath 205 to the rapid exchange port 204. In addition, the positions, structures, connection relationships, and functions of the remaining components in fig. 2 are completely consistent with those of the components shown in fig. 1, and are not described again here.

Compared with the prior art, the intravascular shock wave micro-catheter provided by the embodiment of the invention can gradually crush calcified tissues from one end of a calcified lesion with serious occlusion or total occlusion until a calcified lesion area with serious occlusion or total occlusion in a blood vessel is completely opened. Therefore, the intravascular shock wave micro-catheter can be suitable for calcified lesion areas with serious or complete intravascular occlusion, has excellent trafficability, greatly improves the application range of vascular shock wave treatment, and can provide a better treatment scheme for patients.

Claims

1. An intravascular shock wave microcatheter, comprising:

an inner tube;

the outer sheath pipe is sleeved outside the inner pipe;

2. The microcatheter of claim 1, further comprising:

a guidewire lumen;

3. The microcatheter of claim 1,

the proximal end of the inner tube is provided with a rapid exchange port, and a guide wire can penetrate into or out of the rapid exchange port to guide the micro-catheter;

wherein the inner tube extends from a distal end of the outer sheath to the rapid exchange port.

4. The microcatheter of claim 1, further comprising:

5. The microcatheter of claim 1,

the proximal end of the outer sheath tube is designed by adopting a material with a pushing force; the distal end of the outer sheath tube is designed by adopting a material with softness.

6. The microcatheter of claim 1, further comprising:

a catheter hub; a proximal end located at the outer sheath;

the catheter hub comprises: filling the cavity;

7. The microcatheter of claim 6, further comprising:

a catheter insertion part;

the catheter hub further comprises: a wire lumen;

8. The microcatheter according to any one of claims 1-7,

the far end of the inner tube is connected with the far end of the outer sheath tube in a sealing mode.

9. A medical device comprising the microcatheter of any of claims 1-8, further comprising: a high-voltage pulse output module;

10. The medical device of claim 9,

the output voltage range of the high-voltage pulse output module is 500V-5000V, and the pulse width is 1-100 mus.