Ultrasonic balloon ablation catheter

Abstract

The invention discloses an ultrasonic balloon ablation catheter which comprises a multi-cavity catheter. A super-compliance balloon is arranged at one end of the multi-cavity catheter, and ultrasonic transducers arranged in an array are arranged in the super-compliance balloon; the super-compliance balloon is wrapped with a flexible silk screen, one end of the flexible silk screen is connected with a silk screen control system, and the silk screen control system controls the size of the flexible silk screen so as to control the expansion size of the super-compliance balloon. Electrodes are distributed on the flexible silk screen, are used for detecting the adherence state of the flexible silk screen in real time and can send out electrical stimulation signals so as to detect the nerve ablation effect. By arranging the super-compliance balloon, the super-compliance balloon can be completely attached to the wall in a long and complex blood vessel, meanwhile, the super-compliance balloon is wrapped with the flexible silk screen, and the size and the tightness degree of the flexible silk screen can be controlled and adjusted, so that the super-compliance balloon can be limited to be infinitely enlarged, and the blood vessel can be completely attached to the wall. The risk of damage to a thin blood vessel wall can be reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an ultrasonic balloon ablation catheter. Background Art

[0002] Ultrasonic ablation catheters convert electrical energy into ultrasonic energy. These ultrasonic waves propagate in human tissues and exert their effects through mechanical effects, thermal effects, and cavitation effects. Among them, the mechanical effect can cause tissue cells to vibrate and rub, leading to cell structure damage; the thermal effect can increase the temperature of local tissues. When it reaches a certain temperature, tissue proteins denature and cells die; the cavitation effect is that under the action of ultrasound, tiny bubbles in the tissue form, expand, and burst, generating a strong impact force that destroys the diseased tissue.

[0003] In the related art, the cooling of the transducer is often carried out by passing circulating cooling water into the balloon to reduce the heat generated by the transducer on the blood vessel wall to reduce damage to the blood vessel. However, this method requires the balloon to be in close contact with the blood vessel wall in order to quickly and effectively remove the heat. However, the related art cannot effectively make the balloon close to the blood vessel wall at any blood vessel position. Summary of the invention

[0004] The purpose of the present invention is to provide an ultrasonic balloon ablation catheter to solve the problems in the prior art.

[0005] To this end, the present invention provides an ultrasonic balloon ablation catheter, comprising:

[0006] Multilumen catheters;

[0007] A super-compliant balloon is disposed at one end of the multi-lumen catheter, and an array-arranged ultrasonic transducer is disposed inside the super-compliant balloon;

[0008] The ultra-compliant balloon is wrapped with a flexible mesh on the outside, one end of the flexible mesh is connected to a mesh control system, and the mesh control system controls the size of the flexible mesh to control the size of the expansion of the ultra-compliant balloon;

[0009] Electrodes are distributed on the flexible wire mesh, and the electrodes are used to detect the wall-attaching state of the flexible wire mesh in real time. The electrodes can send out electrical stimulation signals to detect the nerve ablation effect.

[0010] As a further description of the above technical solution, the ultrasonic transducer array is provided in plurality, and the plurality of ultrasonic transducers are distributed outside the multi-lumen catheter inside the super-compliant balloon.

[0011] As a further description of the above technical solution, the wire mesh control system includes a wire mesh tightening ring mounted on the outside of a multi-lumen catheter, the wire mesh tightening ring is connected to one end of the flexible wire mesh, a wire mesh recovery cavity is opened in the multi-lumen catheter, a control wire is arranged in the multi-lumen tube, one end of the control wire is connected to the flexible wire mesh, and the other end of the control wire is connected to a control slider.

[0012] As a further description of the above technical solution, the flexible silk screen is woven from PE braided wire, nylon braided wire, PTFE suture or natural silk braided wire.

[0013] As a further description of the above technical solution, the flexible wire mesh is mesh-shaped or lantern-shaped.

[0014] As a further description of the above technical solution, the electrodes are sensing electrodes, and a plurality of sensing electrodes are evenly distributed on the flexible wire mesh.

[0015] As a further description of the above technical solution, the ultrasonic transducer is a single-electrode transducer or a multi-electrode transducer.

[0016] As a further description of the above technical solution, the other end of the multi-lumen tube is connected to a handle, and the handle is connected to a circulating water inlet and a circulating water outlet, and the circulating water inlet and the circulating water outlet are connected to the interior of the super-compliant balloon through a channel in the multi-lumen tube.

[0017] As a further description of the above technical solution, the multi-lumen tube includes an inner layer, a middle layer and an outer layer;

[0018] The inner layer is a PTFE lining;

[0019] The middle layer is stainless steel or nickel-titanium metal braided wire;

[0020] The outer layer is made of nylon or Pebax material.

[0021] As a further description of the above technical solution, the handle and the control slider are made of any one of PC, ABS or PP.

[0022] Beneficial effects:

[0023] The present invention provides an ultrasonic balloon ablation catheter, which can completely adhere to the wall of a long and complex blood vessel by providing a super-compliant balloon. At the same time, a flexible wire mesh is wrapped on the outside of the super-compliant balloon, and the size and tightness of the flexible wire mesh can be controlled to limit the super-compliant balloon from becoming infinitely larger, thereby reducing the risk of damage to thinner blood vessel walls. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 This is a schematic structural diagram of the ultrasonic balloon ablation catheter provided by the present invention.

[0026] Figure 2 This is a schematic structural diagram of another embodiment of the ultrasonic balloon ablation catheter provided by the present invention.

[0027] Figure 3 This is a schematic structural diagram of another embodiment of the ultrasonic balloon ablation catheter provided by the present invention.

[0028] Figure 4 This is a schematic diagram of the use of the ultrasonic balloon ablation catheter provided by the present invention in a blood vessel.

[0029] Figure 5 A schematic diagram of the use of the ultrasonic balloon ablation catheter provided by the present invention in a tortuous blood vessel.

[0030] In the figure: 1. multi-lumen catheter; 2. ultra-compliant balloon; 3. ultrasonic transducer; 4. flexible wire mesh; 5. wire mesh control system; 501. wire mesh tightening ring; 502. wire mesh recovery cavity; 503. control line; 504. control slider; 6. electrode; 7. handle; 8. circulating water inlet; 9. circulating water outlet. DETAILED DESCRIPTION

[0031] The content of the present invention can be more easily understood by selecting the following detailed description of the preferred implementation method of the present invention and the embodiments included. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs. When there is a conflict, the definition in this specification shall prevail.

[0032] The embodiment of the present invention provides an ultrasonic balloon ablation catheter, which solves the problem that the ultrasonic balloon in the prior art needs to be close to the blood vessel wall to effectively remove the heat generated by the ultrasonic transducer to the blood vessel, but the ultrasonic balloon cannot effectively fit with the inner wall of the blood vessel in a tortuous blood vessel, resulting in the inability to effectively remove the heat radiated by the ultrasonic transducer to the blood vessel, which may cause damage to the blood vessel. In order to solve this problem in the related art, the ultrasonic balloon is generally pressurized so that the balloon can fully contact with the inner wall of the blood vessel to achieve sufficient cooling and heat dissipation. However, for tortuous and thin blood vessel walls, although the ultrasonic balloon can be fully fitted with the blood vessel wall by pressurizing the ultrasonic balloon, it also increases the risk of damage to the thinner blood vessel wall to a certain extent. The embodiment of the present application sets a super-compliant balloon so that it can be completely attached to the wall in a long and complex blood vessel, and at the same time, a flexible wire mesh is wrapped on the outside of the super-compliant balloon, and the flexible wire mesh can be controlled to adjust the size and tightness, so as to limit the super-compliant balloon from becoming infinitely larger, and reduce the risk of damage to the thinner blood vessel wall.

[0033] Specific reference is made to the following embodiments:

[0034] like Figure 1-5 As shown, an ultrasonic balloon ablation catheter comprises:

[0035] It includes a multi-cavity catheter 1, which is the main body of the whole structure and is used to carry other structures. At the same time, a plurality of flow channels are arranged inside the multi-cavity catheter 1, and the flow channels serve as circulation channels for cooling medium;

[0036] A super-compliant balloon 2 is provided at one end of the multi-lumen catheter 1, and an array-arranged ultrasonic transducer 3 is provided inside the super-compliant balloon 2. The balloon structure is very soft, and can be smoothly and completely attached to the wall in a long and complex structure blood vessel, which has a better cooling effect on the blood vessel wall. It satisfies the ablation of blood vessels of different diameters with the same catheter, and even the ablation of complex and tortuous blood vessels with large curvature. The array-type ultrasonic transducer 3 can meet the ultra-long ablation of the renal artery, and can ablate multiple points at a time, with higher ablation efficiency.

[0037] The ultra-compliant balloon 2 is wrapped with a flexible mesh 4 on the outside, and one end of the flexible mesh 4 is connected to a mesh control system 5, which controls the size of the flexible mesh 4 to control the size of the expansion of the ultra-compliant balloon 2. Specifically, the flexible mesh 4 on the outside of the balloon is designed to be wrapped around the outer wall of the balloon, and the tightness of the flexible mesh 4 can be adjusted by the mesh control slider 504 of the handle 7. By limiting the size of the mesh, the ultra-compliant balloon 2 is limited from becoming infinitely larger under cyclic cooling, reducing the risk of damage to thinner blood vessel walls.

[0038] The flexible mesh 4 is provided with electrodes 6, which are used to detect the wall-attaching state of the flexible mesh 4 in real time and can send out electrical stimulation signals to detect the effect of nerve ablation. The electrodes 6 can be sensing electrodes 6, which are evenly distributed on the flexible mesh 4. The electrodes 6 can sense whether the mesh is closely attached to the blood vessel wall and thus determine whether the balloon is completely attached to the blood vessel wall. At the same time, the electrodes 6 can also send out electrical stimulation signals to stimulate the renal artery nerves and observe the changes in the patient's blood pressure to determine the effect of nerve ablation. While ensuring full wall adhesion, the damage to the thinner blood vessel wall can be effectively reduced.

[0039] Optionally, the wire mesh control system 5 includes a wire mesh tightening ring 501 sleeved on the outside of the multi-lumen catheter 1, the wire mesh tightening ring 501 is connected to one end of the flexible wire mesh 4, a wire mesh recovery cavity 502 is provided in the multi-lumen catheter 1, a control line 503 is provided in the multi-lumen tube, one end of the control line 503 is connected to the flexible wire mesh 4, and the other end of the control line 503 is connected to the control slider 504. In the initial state of the flexible wire mesh 4, part of the wire mesh is tightened in the multi-lumen tube, and the wire mesh control line 503 is pulled by manually adjusting the position of the control slider 504, and then the wire mesh control line 503 passes through the wire mesh tightening ring 501 to release or recycle part of the wire mesh collected in the four-lumen tube, thereby controlling the size of the wire mesh, thereby controlling the limit size of the super-compliant balloon 2.

[0040] Optionally, the ultrasonic transducer 3 may adopt a single-electrode 6-transducer or a multi-electrode 6-transducer structure. The multi-electrode 6-transducer array can achieve overall ablation of a longer segment of the renal artery with higher ablation efficiency.

[0041] Optionally, the flexible wire mesh 4 is woven from PE braided wire, nylon braided wire, PTFE suture or natural silk braided wire. Specifically, the flexible wire mesh 4 is woven from polymer fiber with good biocompatibility. The flexible wire mesh 4 made of flexible non-metallic material can prevent the metal material from absorbing ultrasonic energy, thereby preventing the wire mesh from heating and damaging the inner wall of the blood vessel. In some embodiments, Figure 2-Figure 3 As shown, the flexible mesh 4 can be in a mesh shape or a lantern shape.

[0042] Alternatively, if Figure 1 As shown, the other end of the multi-lumen tube is connected to a handle 7, to which a circulating water inlet 8 and a circulating water outlet 9 are connected. The circulating water inlet 8 and the circulating water outlet 9 are connected to the interior of the super-compliant balloon 2 through a channel in the multi-lumen tube. The expansion rate and maximum expansion volume of the super-compliant balloon 2 can be controlled by coordinating the water inlet and outlet of the circulating water inlet 8 and the circulating water outlet 9.

[0043] Optionally, the multi-lumen tube includes an inner layer, a middle layer and an outer layer, wherein the inner layer is a PTFE liner, the middle layer is a stainless steel or nickel-titanium metal braided wire, and the outer layer is a nylon or Pebax material. The specific material can be selected according to actual needs.

[0044] Optionally, the handle 7 and the control slider 504 are made of any one of PC, ABS or PP, which can be selected according to actual needs.

[0045] How to use Figure 4-Figure 5 As shown:

[0046] S1, the initial state before catheter treatment is the balloon folded state, and the super-compliant balloon 2 is delivered to the target position of the renal artery according to the standard intervention method.

[0047] S2, when the catheter reaches the treatment position, the screen control slider 504 of the handle 7 is placed at the farthest position to ensure that the initial allowable size of the balloon is small, then the cooling circulating water pipe is connected to the balloon cooling water interface, the peristaltic pump is started to cool the circulating water, and the size and wall adhesion of the balloon are observed through the sensing electrode 6 or DSA image. If the balloon is not attached to the wall, the slider is slowly released to allow the flexible screen 4 partially received in the multi-lumen tube to be released and enlarged in size. At the same time, the restraint of the super-compliant balloon 2 is released, and it will become larger with the continuous injection of circulating water until the balloon is observed to be attached to the wall, then the slider is stopped from being released and fixed, so that the size of the balloon is fixed. In some embodiments, the super-compliant balloon 2 can be filled with a mixture of contrast solution and saline so that the size of the balloon can be observed under the contrast device, and the ablation host is operated to start ablation.

[0048] S3, after the ablation is finished, the peristaltic pump rotates in the opposite direction to pump out the cooling water of the balloon, and the balloon shrinks naturally, and the slider 504 is manually controlled to retract the wire mesh part into the four-lumen tube. At this time, the balloon is in the initial state again, and the ablation position can be adjusted to repeat the above ablation.

[0049] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An ultrasonic balloon ablation catheter, characterized in that: including a multi-lumen catheter; A super-compliant balloon is disposed at one end of the multi-lumen catheter, and an array-arranged ultrasonic transducer is disposed inside the super-compliant balloon; The ultra-compliant balloon is wrapped with a flexible mesh on the outside, one end of the flexible mesh is connected to a mesh control system, and the mesh control system controls the size of the flexible mesh to control the size of the expansion of the ultra-compliant balloon; Electrodes are distributed on the flexible wire mesh, and the electrodes are used to detect the wall-attaching state of the flexible wire mesh in real time. The electrodes can send out electrical stimulation signals to detect the nerve ablation effect.

2. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The ultrasonic transducer array is provided with a plurality of ultrasonic transducers, and the plurality of ultrasonic transducers are distributed outside the multi-lumen catheter inside the super-compliant balloon.

3. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The wire mesh control system includes a wire mesh tightening ring sleeved on the outside of the multi-lumen catheter, the wire mesh tightening ring is connected to one end of the flexible wire mesh, a wire mesh recovery cavity is opened in the multi-lumen catheter, a control line is arranged in the multi-lumen tube, one end of the control line is connected to the flexible wire mesh, and the other end of the control line is connected to the control slider.

4. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The flexible wire mesh is woven from PE braided wire, nylon braided wire, PTFE suture or natural silk braided wire.

5. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The flexible wire mesh is in a mesh or lantern shape.

6. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The electrodes are sensing electrodes, and a plurality of sensing electrodes are evenly distributed on the flexible wire mesh.

7. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The ultrasonic transducer is a single-electrode transducer or a multi-electrode transducer.

8. The ultrasonic balloon ablation catheter according to claim 3, characterized in that: The other end of the multi-lumen tube is connected to a handle, and the handle is connected to a circulating water inlet and a circulating water outlet. The circulating water inlet and the circulating water outlet are connected to the interior of the super-compliant balloon through a channel in the multi-lumen tube.

9. The ultrasonic balloon ablation catheter according to claim 1, characterized in that: The multi-lumen tube comprises an inner layer, a middle layer and an outer layer; The inner layer is a PTFE lining; The middle layer is stainless steel or nickel-titanium metal braided wire; The outer layer is made of nylon or Pebax material.

10. The ultrasonic balloon ablation catheter according to claim 8, characterized in that: The handle and the control slider are made of any one of PC, ABS or PP.

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