Ultrasonic balloon recanalization catheter

Abstract

The utility model discloses an ultrasonic balloon recanalization catheter which comprises a catheter body. The first vibration unit is fixed to the far end of the catheter body and used for eliminating axial calcified plaques and providing a channel for a guide wire; the second vibration unit is arranged outside the catheter body in a surrounding mode and used for eliminating radial calcified plaques. The ultrasonic vibration is transmitted to the metal cap through the ultrasonic transmission piece, the metal cap can remove calcification lesions axially blocking the blood vessel, a channel is provided for the guide wire, follow-up other treatment instruments can enter the blood vessel for treatment, and compared with the prior art, safety is better, and safety risks are reduced. Meanwhile, the balloon provided with the ultrasonic generating element can transfer ultrasonic energy to saline water and the balloon to directly act on the blood vessel wall, namely the calcified plaque in the radial direction, so that the calcified plaque in the blood vessel is completely removed.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an ultrasonic balloon recanalization catheter. Background Art

[0002] Vascular calcification is a disease of vascular stenosis and hardening caused by the accumulation of plaques in human blood vessels. The so-called plaques are composed of fibrous tissue, fat and calcium. Vascular calcification can cause various harms to the human body. At present, in the interventional treatment of vascular CTO complete occlusion lesions, the technical route used in the clinic is the guidewire passing technology. However, during the clinical treatment process, the guidewire cannot pass through the hard calcified lesions. Therefore, the guidewire pierces the intima of the blood vessel wall and enters the middle membrane of the blood vessel wall. It causes greater damage to the blood vessel wall at the lesion site, resulting in a high failure rate of the operation. Utility Model Content

[0003] The purpose of the utility model is to solve the above problems and provide an ultrasonic balloon recanalization catheter.

[0004] In order to achieve the above-mentioned purpose, the utility model specifically adopts the following technical solutions:

[0005] An ultrasonic balloon recanalization catheter, characterized by comprising:

[0006] a catheter body;

[0007] A first vibration unit, fixed to the distal end of the catheter body, for eliminating axial calcified plaques and providing a channel for the guide wire;

[0008] The second vibration unit is arranged in a ring outside the catheter body and is used for eliminating radial calcified plaques.

[0009] As a further description of the above technical solution, the vibration unit 1 includes a metal cap fixedly connected to the distal end of the catheter body, a blind hole is opened in the metal cap, an ultrasonic transmission component arranged along the axial direction of the catheter body is fixed in the blind hole, and the other end of the ultrasonic transmission component is connected to an ultrasonic generating device.

[0010] As a further description of the above technical solution, the second vibration unit at least includes a balloon sleeved on the outside of the catheter body, and the inner cavity of the balloon is provided with at least one group of ultrasonic generating elements.

[0011] As a further description of the above technical solution, the catheter body includes an outer tube 1 and an outer tube 2;

[0012] The distal end of the balloon is fixedly connected to the first outer tube, and the proximal end of the balloon is fixedly connected to the second outer tube.

[0013] As a further description of the above technical solution, the proximal end of the outer tube 2 is fixedly connected to the connecting seat 1;

[0014] The connecting seat 1 is a three-way connecting seat, including a first oblique end, a second oblique end and a straight end;

[0015] The first oblique end is connected to the second outer tube and is used to connect a pressure device and fill the balloon with liquid;

[0016] The second oblique end is used to accommodate the passage of a wire, and the wire is used to connect the ultrasonic sound-generating element and the ultrasonic generating device.

[0017] As a further description of the above technical solution, the straight end is connected to the second connecting seat, and the first connecting seat is used for liquid to flow through the entire catheter to be discharged from the distal liquid outlet of the outer tube.

[0018] As a further description of the above technical solution, the head end of the metal cap is conical.

[0019] As a further description of the above technical solution, the ultrasonic generating device includes a control unit 1 and a control unit 2, wherein the control unit 1 is electrically connected to the ultrasonic transducer for controlling the vibration of the ultrasonic transmission element, and the control unit 2 is electrically connected to the ultrasonic generating element through a wire for controlling the ultrasonic generating element to emit ultrasonic waves.

[0020] As a further description of the above technical solution, the pulse ultrasonic frequency emitted by the control unit 1 is 20kHZ-30kHZ, and the pulse ultrasonic frequency emitted by the control unit 2 is 20KHz-2MHz.

[0021] As a further description of the above technical solution, the ultrasonic sound-generating element is fixed to the surface of the outer tube 1 through a carrier ring.

[0022] The beneficial effects of the utility model are as follows:

[0023] 1. The utility model transmits ultrasonic vibration to the metal cap through the ultrasonic transmission part, and the metal cap can remove the calcified lesions that block the blood vessels axially, provide a channel for the guide wire, and help other subsequent treatment devices such as drug balloons and stents to enter the blood vessels for treatment. Compared with the existing technology, it has better safety and reduces safety risks. At the same time, the balloon provided with an ultrasonic generating element in this application can use ultrasonic energy to transmit to saline and the balloon surface to directly act on the blood vessel wall, that is, the calcified plaque in the radial direction, so as to completely remove the calcified plaque in the blood vessel.

[0024] In order to more clearly illustrate the structural features and functions of the present invention, the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of the ultrasonic balloon recanalization catheter proposed by the utility model;

[0026] Figure 2 It is a partially enlarged schematic diagram of the distal end of the catheter of the utility model.

[0027] Figure numerals: 01, metal cap; 02, outer tube one; 03, ultrasonic transmission element; 04, balloon; 05, ultrasonic generating element; 06, wire; 07, outer tube two; 08, connecting seat one; 081, oblique end one; 082, oblique end two; 083, straight end; 09, connecting seat two; 010, oblique liquid outlet; 011, ultrasonic transducer; 012, ultrasonic generating device. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solution and advantages of the embodiments of the present utility model clearer, the technical solution in the embodiments of the present utility model will be clearly and completely described below in conjunction with the drawings in the embodiments of the present utility model.

[0029] like Figure 1-Figure 2 As shown, in one embodiment, an ultrasonic balloon 04 recanalization catheter specifically includes a vibration unit 1 arranged at the distal head of the catheter body. In this embodiment, an important component of the vibration unit 1 is the metal cap 01, and a blind hole is arranged in the metal cap 01. An ultrasonic transmission component 03 is fixedly installed in the blind hole. The ultrasonic transmission component 03 is used to connect an ultrasonic transducer 011 and an ultrasonic generating device 012 to transmit the generated mechanical vibration to the metal cap 01. The metal cap 01 is used to ablate the calcified lesion plaque in the axial direction of the blood vessel, thereby providing a channel for the subsequent use of the guide wire, and facilitating other subsequent treatment devices such as drug balloons, stents, etc. to enter the blood vessel for treatment. Compared with the prior art of piercing the inner membrane of the blood vessel wall to enter the middle membrane of the blood vessel wall, it is safer and can effectively reduce safety risks.

[0030] In addition, a vibration unit 2 is provided on the outer distal end of the catheter body. The vibration unit 2 includes a balloon 04 that can be filled with physiological saline. An ultrasonic generating element 05 is fixed inside the balloon 04. The ultrasonic generating element 05 extends longitudinally along the inside of the catheter body through a wire 06 to the ultrasonic generating device 011 to transmit ultrasonic energy.

[0031] Furthermore, the catheter body includes an outer tube 1 02 and an outer tube 2 07, and a specific description is given of the vibration unit 1. The metal cap 01 is conical so that the metal cap 01 can be inserted into the middle of the lesion plaque, located at the farthest end of the entire catheter, i.e., the head end, and contains a blind hole inside. The blind hole can be fixed to the ultrasonic transmission component 03 by laser welding / capacitor welding / resistance welding, etc. The ultrasonic transmission component 03 extends the entire catheter longitudinally and is connected to the ultrasonic transducer 011 and the ultrasonic generating device 012, and is used to convert the ultrasonic energy transmitted by the ultrasonic generating device 012 into mechanical energy through the ultrasonic transducer 011, and then transmit it to the metal head end through the ultrasonic transmission component 03, and finally realize the vibration of the metal head end, thereby realizing the opening of the axial calcified lesions in the blood vessel. The connection method between the metal cap 01 and the outer tube 1 02 can be adhesive / hot air welding / laser welding, etc., which can be selected according to actual conditions. At the same time, the ultrasonic transmission element 03 is arranged inside the outer tube 1 02, and the proximal end of the outer tube 1 02 is connected to the connecting seat 2 09. The connecting seat 2 09 is a Y-shaped connecting seat, which specifically includes a straight end 083 and an oblique end. The straight end 083 is used for the ultrasonic transmission element 03 to connect the ultrasonic transducer 011 and the ultrasonic generating device 012, and the oblique end is used to connect the pressure device to achieve liquid perfusion circulation. The outer tube 1 02 has two oblique openings 10 at a distance of 1-5mm from the head end at the far end, which are used for the liquid flowing in from the oblique end of the connecting seat 2 09 to flow out, and finally realize the liquid circulation throughout the catheter, so as to achieve the cooling of the entire catheter during the ultrasonic process and the cavitation effect of the head end vibration operation.

[0032] Further, the vibration unit 2 is described in detail. The vibration unit 2 specifically includes an ultrasonic balloon 04. The balloon 04 is located at the distal end of the catheter body and is arranged in a ring outside the catheter. The distal port of the balloon 04 is connected to the outer wall of the outer tube 1 02, and the proximal port is connected to the outer wall of the outer tube 2 07. The outer tube 2 07 is extended axially and connected to the connecting seat 1 08. Specifically, it can be connected by laser welding / hot air welding / ultrasonic welding and adhesive. As for the connecting seat 1 08, it includes two oblique ends and a straight end 083. The straight end 083 is connected to the connecting seat 2 09 through the outer tube 1 02, and the oblique end 1 081 is connected to the outer tube 2 07, which is used to connect the pressure device to fill the distal balloon 04 with liquid; the oblique end 2 082 is used to pass the wire 06 and connect to the ultrasonic generating device 012. The ultrasonic generating element 05 is arranged on the outer tube 02 and is located in the inner cavity of the balloon 04. The ultrasonic generating element 05 can be one group or multiple groups, and is arranged at intervals along the catheter direction in the inner cavity of the balloon 04. The ultrasonic generating element 05 extends longitudinally along the catheter inside the second outer tube through the connecting wire 06, and is connected to the ultrasonic generating device 012 through the oblique end of the connecting seat 08. The ultrasonic generating element 05 is a chip element capable of generating ultrasonic waves, and the ultrasonic generating element 05 is fixed on the outer tube 02 through a carrier ring; the carrier ring is fixedly sleeved on the outer tube 02, and the ultrasonic generating element 05 is fixed to the carrier ring by gluing. The carrier ring is one or more of platinum-iridium alloy, platinum ring, stainless steel, and nickel-titanium alloy. In addition, the carrier ring can also be a ceramic ring with a metal layer coated on the surface, and the material of the ceramic ring is preferably aluminum oxide or aluminum zirconate titanate.

[0033] Further, the ultrasonic generating device 012 is described in detail. The ultrasonic generating device 012 is equipped with two control units, wherein the control unit 1 is connected to the ultrasonic transducer 011, and is used to control the vibration of the ultrasonic transmission element 03 to achieve the vibration and cavitation effect of the entire catheter. The control unit 2 is connected to the wire 06, and is used to control the ultrasonic generating element 05 to achieve the ultrasonic wave passing through the liquid in the balloon 04 and the balloon 04 to directly act on the calcified plaque of the blood vessel, thereby achieving the purpose of removing the calcified plaque. There are two frequencies generated by the ultrasonic generating device 012, wherein the ultrasonic wave output by the control unit 1 is a pulse ultrasonic wave, and the ultrasonic wave frequency is 20kHZ-30kHZ; the ultrasonic wave output by the second control unit is also a pulse ultrasonic wave, and the ultrasonic wave frequency is 20KHz-2MHz, and the working voltage is 220V-500V.

[0034] Working principle: first, the ultrasonic catheter tip is delivered to the lesion site of the CTO calcified plaque, then saline is perfused into the oblique end of the connecting seat 09, and then the control unit 1 of the ultrasonic generating device 012 is turned on to convert the ultrasonic energy into mechanical energy through the ultrasonic transducer 011, and transmit it to the metal cap 01 through the ultrasonic transmission element 03, so that the entire catheter realizes ultrasonic vibration and liquid cavitation effect; when the vascular calcified plaque is cleared and a channel is opened for the guide wire, the control unit 1 of the ultrasonic generating device 012 is turned off, and then the balloon 04 is delivered to the lesion site with calcified plaque on the vascular wall, and then saline is perfused into the oblique end of the connecting seat 08, so that the balloon 04 is filled and fits the inner wall of the blood vessel, and the control unit 2 of the ultrasonic generating device 012 is started to transmit the ultrasonic energy to the ultrasonic generating element 05 in the balloon 04 through the guide wire 06, so that the emitted ultrasonic wave directly acts on the vascular calcified site through the fluid and the balloon 04, so as to achieve the purpose of removing the calcified plaque on the vascular wall. The ultrasonic permeability of this technical solution is better, the plaque removal is more direct, and the safety is higher.

[0035] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An ultrasonic balloon recanalization catheter, characterized in that: include; a catheter body; A first vibration unit, fixed to the distal end of the catheter body, for eliminating axial calcified plaques and providing a channel for the guide wire; The second vibration unit is arranged in a ring outside the catheter body and is used for eliminating radial calcified plaques.

2. The ultrasonic balloon recanalization catheter according to claim 1, characterized in that: The vibration unit 1 includes a metal cap fixedly connected to the distal end of the catheter body, a blind hole is opened in the metal cap, an ultrasonic transmission component arranged along the axial direction of the catheter body is fixed in the blind hole, and the other end of the ultrasonic transmission component is connected to an ultrasonic generating device.

3. The ultrasonic balloon recanalization catheter according to claim 2, characterized in that: The second vibration unit at least comprises a balloon sleeved on the outside of the catheter body, and the inner cavity of the balloon is provided with at least one group of ultrasonic generating elements.

4. The ultrasonic balloon recanalization catheter according to claim 3, characterized in that: The catheter body includes an outer tube 1 and an outer tube 2; The distal end of the balloon is fixedly connected to the first outer tube, and the proximal end of the balloon is fixedly connected to the second outer tube.

5. The ultrasonic balloon recanalization catheter according to claim 4, characterized in that: The proximal end of the outer tube 2 is fixedly connected to the connecting seat 1; The connecting seat 1 is a three-way connecting seat, including a first oblique end, a second oblique end and a straight end; The first oblique end is connected to the second outer tube and is used to connect a pressure device and fill the balloon with liquid; The second oblique end is used to accommodate the passage of a wire, and the wire is used to connect the ultrasonic sound-generating element and the ultrasonic generating device.

6. The ultrasonic balloon recanalization catheter according to claim 5, characterized in that: The straight end is connected to the second connection seat, and the first connection seat is used for liquid to flow through the entire catheter to be discharged to the distal liquid outlet of the first outer tube.

7. The ultrasonic balloon recanalization catheter according to claim 2, characterized in that: The head end of the metal cap is conical.

8. The ultrasonic balloon recanalization catheter according to claim 6, characterized in that: The ultrasonic generating device includes control unit 1 and control unit 2. Control unit 1 is electrically connected to the ultrasonic transducer for controlling the vibration of the ultrasonic transmission element. Control unit 2 is electrically connected to the ultrasonic generating element through a wire for controlling the ultrasonic generating element to emit ultrasonic waves.

9. The ultrasonic balloon recanalization catheter according to claim 8, characterized in that: The pulse ultrasonic frequency emitted by the control unit 1 is 20kHZ-30kHZ, and the pulse ultrasonic frequency emitted by the control unit 2 is 20KHz-2MHz.

10. The ultrasonic balloon recanalization catheter according to claim 8, characterized in that: The ultrasonic generating element is fixed to the surface of the outer tube through a carrier ring.

Images