CN219940767U - Cryoablation catheter and system - Google Patents

Abstract

The utility model relates to a cryoablation catheter and a system, comprising a freezing unit, a conveying unit and an operating unit which are connected in sequence; the freezing unit comprises an inner balloon and an outer balloon; the conveying unit comprises an input cavity, an output cavity and a liquid injection cavity; the operation unit comprises an input connector, an output connector and a liquid injection connector; the delivery unit further comprises a rewarming cavity which is in fluid communication with the outer balloon and is used for delivering rewarming fluid to the outer balloon, the operation unit further comprises an L-shaped three-way valve, a rewarming joint and a liquid return joint, the rewarming joint Wen Jietou is connected with the proximal end of the rewarming cavity and is in fluid communication, the liquid inlet end of the L-shaped three-way valve is connected with the proximal end of the liquid injection cavity and is in fluid communication, the two liquid outlet ends of the L-shaped three-way valve are respectively connected with the liquid injection joint and the liquid return joint and are in fluid communication, and the liquid return joint is connected with the cryoablation equipment through a liquid return pipe. According to the embodiment of the utility model, one pipeline can be used for completing the flow of the refrigerating fluid and the rewarming fluid, so that the rewarming time is saved, and the internal space of the ablation catheter can be saved.

Description

Cryoablation catheter and system

Technical Field

The utility model belongs to the field of medical instruments, and particularly relates to a cryoablation catheter and a cryoablation system.

Background

With the continuous rising of the incidence of cardiovascular and cerebrovascular diseases, cryoablation is widely applied and rapidly developed as an important medical instrument for treating cardiovascular and cerebrovascular diseases. In cryoablation techniques, it is often necessary to provide a multi-channel lumen to deliver the filling, cooling, and rewarming fluids required in cryoablation procedures, and the like. For example, in the design of a pipeline, input pipelines and output pipelines of filling liquid, refrigerating liquid and rewarming liquid are usually required to ensure the circulation flow of the liquid, and the channels or the lumens are arranged in an ablation catheter and enter a target area through a natural cavity of a human body to complete the ablation operation. In product design, the diameter of the cryoablation catheter is as small as possible to reduce the damage to human body, and simultaneously, the fluency of the liquid delivery in each channel or lumen is ensured, so that the structural design of each channel or lumen of the ablation catheter is particularly important.

Disclosure of Invention

Based on the above, the cryoablation catheter and the system are provided aiming at the optimized design of the structures of all channels or the cavities of the ablation catheter.

In one aspect, the utility model provides a cryoablation catheter comprising a freezing unit, a delivery unit and an operating unit connected in sequence; the freezing unit comprises an inner balloon and an outer balloon, the inner balloon being disposed within the outer balloon; the conveying unit comprises an input cavity, an output cavity and a liquid injection cavity, wherein the input cavity is used for conveying the refrigerant to the inner balloon, the output cavity is used for discharging the refrigerant from the inner balloon, and the liquid injection cavity is used for conveying filling liquid to the outer balloon; the operation unit comprises an input connector, an output connector and a liquid injection connector, wherein the input connector and the output connector are respectively communicated with the input cavity and the output cavity, and the liquid injection connector is communicated with the liquid injection cavity; the delivery unit still includes the rewarming chamber, the rewarming chamber with outer sacculus fluid intercommunication is used for to the outer sacculus carries rewarming fluid, the operation unit still includes L type three-way valve, rewarming joint and liquid return joint, the rewarming joint with the proximal end of rewarming chamber is connected and fluid communication, the feed liquor end of L type three-way valve with annotate the proximal end of liquid chamber and be connected and fluid communication, two play liquid ends of L type three-way valve respectively with annotate liquid joint with liquid return joint is connected and fluid communication, liquid return joint is connected with cryoablation equipment through the liquid return pipe.

In an alternative embodiment, the delivery unit includes an outer tube and an inner tube, the proximal ends of the outer tube and the inner tube are both connected with the operation unit, the input cavity and the output cavity are cavities arranged in the inner tube, the liquid injection cavity and the rewarming cavity are arranged between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in sealing connection with the distal end of the inner tube, the proximal end and the distal end of the inner balloon are respectively in sealing connection with the distal end portion of the inner tube, and holes communicated with the input cavity and the output cavity are respectively arranged on the tube wall of the inner tube, so that the input cavity and the output cavity are in fluid communication with the inner balloon.

In an alternative embodiment, the delivery unit includes an outer tube, an inner tube, and a wire guide tube, wherein the outer tube, the inner tube, and the proximal end of the wire guide tube are all connected to the operation unit, the input lumen and the output lumen are cavities disposed in the inner tube, the wire guide tube is inserted in the lumen of the inner tube, and the distal end of the wire guide tube extends out of the distal end of the inner tube, the infusion lumen and the rewarming lumen are disposed between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in sealing connection with the distal end of the wire guide tube, the proximal end of the inner balloon is in sealing connection with the distal end of the inner tube, the distal end of the inner balloon is in sealing connection with the distal end portion of the wire guide tube, and the operation unit is further provided with a wire guide port connected with the wire guide tube.

In an alternative embodiment, the conveying unit comprises an outer tube and an inner tube, the proximal ends of the outer tube and the inner tube are both connected with the operation unit, the input cavity and the output cavity are respectively the cavities of the input tube and the output tube, the input tube and the output tube are inserted into the inner tube, the liquid injection cavity and the rewarming cavity are respectively the cavities of the liquid injection tube and the rewarming tube, the liquid injection tube and the rewarming tube are inserted between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in sealing connection with the distal end of the inner tube, the proximal end and the distal end of the inner balloon are respectively in sealing connection with the distal end portion of the inner tube, and holes communicated with the input cavity and the output cavity are respectively arranged on the tube wall of the inner tube, so that the input cavity and the output cavity are in fluid communication with the inner balloon.

In an alternative embodiment, the conveying unit comprises an outer tube, an inner tube and a wire guide tube, the proximal ends of the outer tube, the inner tube and the wire guide tube are all connected with the operation unit, the input cavity and the output cavity are respectively the tube cavities of the input tube and the output tube, the input tube, the output tube and the wire guide tube are inserted into the inner tube, the distal end of the wire guide tube extends out of the distal end of the inner tube, the liquid injection cavity and the wire guide tube are respectively the tube cavities of the liquid injection tube and the wire guide tube, the liquid injection tube and the wire guide tube are inserted between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in fixed connection with the distal end of the wire guide tube, the proximal end of the inner balloon is in sealing connection with the distal end of the inner tube, the distal end of the inner balloon is in fixed connection with the distal end part of the wire guide tube, and the operation unit is further provided with a wire guide tube connected with the wire guide tube.

In an alternative embodiment, the distal port of the input tube is disposed proximate the distal end of the inner balloon and the distal port of the output tube is disposed proximate the proximal end of the inner balloon.

In an alternative embodiment, the refrigeration unit further comprises: and the developing ring is sleeved on the guide wire tube and is positioned between the inner balloon and the outer balloon.

In an alternative embodiment, the inner balloon is a non-compliant balloon and the outer balloon is a compliant balloon or a semi-compliant balloon.

In an alternative embodiment, a vacuum tube is sleeved outside the outer tube, the distal end of the vacuum tube is in sealing connection with the distal end of the outer tube, a vacuum connector is further arranged on the operation unit, one end of the vacuum connector is connected with the proximal end of the vacuum tube, and the other end of the vacuum connector is connected to a vacuum pump for vacuumizing the cryoablation catheter to form a vacuum heat insulation layer.

Another aspect of the embodiments of the present utility model provides a cryoablation system including a cryoablation apparatus and a cryoablation catheter as described above, an operation unit of the cryoablation catheter being connected to the cryoablation apparatus for delivering a refrigerant to the inner balloon through the delivery unit and performing a cryoablation procedure.

Compared with the prior art, the embodiment of the utility model has the advantages that:

1. in the embodiment of the utility model, the liquid injection cavity or the liquid injection pipe and the rewarming cavity or the rewarming pipe of the cryoablation catheter can both convey fluid to the outer balloon, when the conveyed rewarming fluid is filling liquid, the ablation can enter the rewarming stage as soon as possible, and after the rewarming is finished, the liquid can be directly discharged from the liquid injection pipe, so that the rewarming time is saved. When the transported rewarming liquid is fluid with higher temperature from the equipment, the rewarming liquid can be discharged by using the liquid injection pipe, and the flow direction of the rewarming liquid can be switched by the L-shaped three-way valve to enable the rewarming fluid to flow back to the equipment, so that the embodiment of the utility model can switch the flow direction of the liquid outlet end according to the specific conditions of the filling liquid and the rewarming fluid by arranging the L-shaped three-way valve, and can use one pipeline to complete the flow of the refrigerating liquid and the rewarming liquid, thereby saving the rewarming time, saving the inner space of an ablation catheter and improving the competitiveness of products.

2. In the embodiment of the utility model, when the filling liquid is input into the outer balloon, the outer balloon is filled and expanded, and the outer balloon is a compliant balloon or a semi-compliant balloon, so that the outer balloon can be shaped along the shape of the vascular wall, thereby being tightly attached to the vascular wall, effectively blocking the blood flow and improving the cryoablation efficiency. Therefore, the ablation catheter provided by the embodiment of the utility model can adapt to complex vascular structures, adapt to various irregular shapes and different sizes of vascular walls on the premise of not replacing the catheter, and can be in compliance fit with the vascular walls according to the irregular vascular wall shapes, so that the fit degree is improved, and the cryoablation efficiency is improved.

Drawings

FIG. 1 is a schematic illustration of a cryoablation catheter shown in accordance with an exemplary embodiment of the present utility model;

FIG. 2 is a schematic cross-sectional view of a conveyor unit along A-A according to an exemplary embodiment of the present utility model;

FIG. 3a is a schematic view of an L-shaped three-way valve according to an exemplary embodiment of the present utility model, wherein the liquid inlet end of the L-shaped three-way valve is in fluid communication with the liquid injection joint;

FIG. 3b is a schematic view of an L-shaped three-way valve according to an exemplary embodiment of the present utility model, wherein the liquid inlet end of the L-shaped three-way valve is in fluid communication with the liquid return connector;

fig. 4 is a schematic illustration of convective heat transfer from the fluid within the outer balloon during freezing/rewarming of a cryoablation catheter in accordance with an exemplary embodiment of the present utility model.

Reference numerals illustrate: 11-a freezing unit; 12-a conveying unit; 13-an operation unit; 111-an inner balloon; 112-an outer balloon; 113-a developing ring; 121-an input chamber; 122-an output chamber; 123-a liquid injection cavity; 124-a rewarming chamber; 125-an outer tube; 126-inner tube; 127-guidewire tube; 128-wells; 131-input connector; 132-output connector; 133-a liquid injection joint; 134-L type three-way valve; 135-complex Wen Jietou; 136-a liquid return joint; 137-guidewire port; 138-vacuum fitting.

Detailed Description

In order that the above objects, features and advantages of the utility model will be readily understood, a more particular description of the utility model will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present utility model. The present utility model may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the utility model, whereby the utility model is not limited to the specific embodiments disclosed below.

In the description of the present utility model, it should be understood that, if any, these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., are used herein with respect to the orientation or positional relationship shown in the drawings, these terms refer to the orientation or positional relationship for convenience of description and simplicity of description only, and do not indicate or imply that the apparatus or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the utility model.

Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present utility model, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.

In the present utility model, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, the two parts can be fixedly connected, detachably connected or integrated; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present utility model, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.

The following describes the technical scheme provided by the embodiment of the utility model with reference to the accompanying drawings.

The proximal end as used herein refers to the end proximal to the operator and the distal end refers to the end distal to the operator.

As shown in fig. 1 and 2, the present utility model provides a cryoablation catheter.

The cryoablation catheter comprises a freezing unit 11, a conveying unit 12 and an operating unit 13 which are connected in sequence; the freezing unit 11 includes an inner balloon 111 and an outer balloon 112, the inner balloon 111 being disposed within the outer balloon 112; the delivery unit 12 includes an input chamber 121 for delivering a refrigerant to the inner balloon 111, an output chamber 122 for discharging the refrigerant from the inner balloon 111, and a liquid injection chamber 123 for delivering a filling liquid to the outer balloon 112; the operation unit 13 comprises an input joint 131, an output joint 132 and a liquid injection joint 133, wherein the input joint 131 and the output joint 132 are respectively communicated with the input cavity 121 and the output cavity 122, and the liquid injection joint 133 is communicated with the liquid injection cavity 123; the delivery unit 12 further comprises a rewarming chamber 124 in fluid communication with the outer balloon 112 for delivering rewarming fluid to the outer balloon 112, the operating unit 13 further comprises an L-shaped three-way valve 134, a rewarming fitting 135 and a rewarming fitting 136, the rewarming fitting 135 being connected to and in fluid communication with the proximal end of the rewarming chamber 124, the liquid inlet end of the L-shaped three-way valve 134 being connected to and in fluid communication with the proximal end of the liquid injection chamber 123, the two liquid outlet ends of the L-shaped three-way valve 134 being connected to and in fluid communication with the liquid injection fitting 133 and the rewarming fitting 136, respectively, the rewarming fitting 136 being connected to the cryoablation apparatus via a liquid return tube.

In an embodiment of the present utility model, the infusion connector 133 is configured to be connected to an inflation fluid reservoir of the cryoablation device, and the infusion connector 133 is in fluid communication with the infusion lumen 123 via the L-shaped three-way valve 134 for delivering inflation fluid (e.g., saline) into the outer balloon 112 to inflate the outer balloon 112 to conform to the vessel wall. The L-shaped three-way valve 134 in this embodiment is also called an angle-through three-way valve, and the valve is L-shaped and has one inlet and two outlets, which are often used to change the flow direction of fluid. As shown in fig. 3a and 3b, fig. 3a shows the case where the liquid inlet end of the L-shaped three-way valve 134 is in fluid communication with the liquid injection joint 133, and fig. 3b shows the case where the liquid inlet end of the L-shaped three-way valve 134 is in fluid communication with the liquid return joint 136. In this embodiment, when filling liquid is delivered into the outer balloon 112, the liquid inlet end of the L-shaped three-way valve 134 is first communicated with the liquid injection connector 133, i.e., in the state shown in fig. 3a, and filling liquid is delivered from the liquid injection connector 133 to the outer balloon 112 through the liquid injection chamber 123.

The input connector 131 and the output connector 132 in the embodiment of the utility model are used for being connected to a cold source output port and an input port of the cryoablation device and used for delivering the refrigerant to the ablation catheter and recovering the refrigerant. The refrigerant in the cryoablation device enters the input cavity 121 through the input connector 131 and enters the inner balloon 111 through the input cavity 121, the inner balloon 111 is inflated, and after the freezing energy is released in the inner balloon 111, the freezing energy is conveyed to a freezing energy recovery device on the cryoablation device through the output cavity 122. The freezing point of the refrigerant should be lower than the filling liquid, and during the cryoablation phase, the freezing unit 11 injects the refrigerant into the inner balloon 111 through the input chamber 121, causing the inner balloon 111 to rapidly cool down due to the joule thomson effect. Due to heat transfer, the outer balloon 112 is cooled along with the cooling of the inner balloon 111, and the outer balloon 112 contacts with the part to be ablated of the human body, so that the ablation of the target position is realized.

The rewarming chamber 124 of the present embodiment is connected to a rewarming port on the rewarming device through a rewarming joint 135. At the end of the ablation operation, the rewarming device heats the rewarming liquid to a proper temperature through a heating device, then inputs the rewarming liquid into the outer balloon 112, and then flows back to the rewarming device through the liquid injection cavity 123 for continuous circulation so as to accelerate the balloon rewarming. The rewarming liquid can be common liquid, including but not limited to contrast agent, physiological saline and the like, or antifreeze liquid with a low freezing point.

In the embodiment of the present utility model, the filling liquid used to inflate outer balloon 112 during freezing may be the same as the rewarming liquid or may be different from the rewarming liquid. When the two liquids are the same, the operation is simple, and when the cryoablation treatment is finished and the rewarming is needed, the rewarming mode can be directly started, and the filling liquid storage tank and the rewarming liquid storage tank are communicated together to form a circulation loop to continuously provide rewarming liquid. When the two liquids are different, filling liquid is injected during freezing, rewarming liquid is injected during rewarming, meanwhile, the rewarming liquid can discharge the filling liquid in the outer balloon 112, the filling liquid is discharged from the filling connector 133 through the filling cavity 123 in a period of time, after the filling liquid is discharged, the valve of the L-shaped three-way valve 134 is switched to enable the filling cavity 123 to be in fluid communication with the rewarming connector 136, namely, the state shown in fig. 3b, the discharged liquid is rewarming liquid, and the rewarming liquid is discharged to a rewarming storage tank through the rewarming connector 136 to form a circulation loop, and the rewarming liquid is continuously supplied.

The filling liquid of the embodiments of the present utility model may be a common liquid, including but not limited to, physiological saline, contrast agent, etc., which freezes when frozen and provides the transport energy. The filling liquid can also be antifreeze liquid, the freezing point of which is lower, and the freezing can not occur during cryoablation. As shown in fig. 4, a schematic diagram of convective heat transfer from the liquid inside the outer balloon 112 during the freezing/re-warming of the cryoablation catheter of the present utility model is shown. When the conduit is frozen, the antifreeze liquid is still in a liquid state due to the lower freezing point and can flow. The freezing energy is continuously transmitted from the inner balloon 111, the temperature of the liquid is relatively low, a temperature difference exists, convection heat exchange is caused, and the freezing transmission efficiency is better than that of common liquid. Meanwhile, a temperature difference exists between the liquid in the outer balloon 112 and the attached blood vessel wall, and a convective heat transfer exists, so that the low temperature is better transmitted to the blood vessel wall, and the cryoablation efficiency is improved. During the rewarming, the rewarming liquid with higher temperature flows in the outer balloon 112, the temperature in the inner balloon 111 is lower, a heat exchange process exists, the rewarming efficiency is improved, a temperature difference exists between the rewarming liquid temperature in the outer balloon 112 and the temperature in the blood vessel wall, and the same convection heat exchange exists, so that the blood vessel wall contacting the surface of the outer balloon 112 is rewarmed first, the outer balloon 112 can be separated from the blood vessel wall, and the next freezing is prepared, so that the waiting time is saved, and the efficiency is improved.

In the embodiment of the utility model, the liquid injection cavity 123 or the liquid injection pipe and the rewarming cavity 124 or the rewarming pipe of the cryoablation catheter can both convey fluid to the outer balloon 112, when the conveyed rewarming fluid is filling liquid, the ablation can enter the rewarming stage as soon as possible, and after the rewarming is completed, the liquid can be directly discharged from the liquid injection pipe, so that the rewarming time is saved. When the transported rewarming liquid is fluid with higher temperature from the equipment, the rewarming liquid can be discharged by using the liquid injection pipe, and the flow direction of the rewarming liquid can be switched by the L-shaped three-way valve 134 to enable the rewarming liquid to flow back to the equipment, so that the embodiment of the utility model can complete the flow of the refrigerating fluid and the rewarming liquid by arranging the L-shaped three-way valve 134 to switch the flow direction of the liquid outlet end according to the specific conditions of the filling liquid and the rewarming liquid, thereby saving the rewarming time, saving the inner space of the ablation catheter and improving the competitiveness of products.

In an alternative embodiment, referring to fig. 2, the delivery unit 12 includes an outer tube 125 and an inner tube 126, the proximal ends of the outer tube 125 and the inner tube 126 are both connected to the operation unit 13, the input chamber 121 and the output chamber 122 are chambers disposed within the inner tube 126, the infusion chamber 123 and the rewarming chamber 124 are disposed between the inner tube 126 and the outer tube 125, the proximal end of the outer balloon 112 is sealingly connected to the distal end of the outer tube 125, the distal end of the outer balloon 112 is sealingly connected to the distal end of the inner tube 126, the proximal end and the distal end of the inner balloon 111 are sealingly connected to distal end portions of the inner tube 126, respectively, and holes 128 communicating with the input chamber 121 and the output chamber 122 are disposed on the wall of the inner tube 126, respectively, such that the input chamber 121 and the output chamber 122 are in fluid communication with the inner balloon 111. The present embodiment provides an implementation of the input chamber 121, the output chamber 122, the infusion chamber 123, and the rewarming chamber 124.

In an alternative embodiment, the delivery unit 12 includes an outer tube 125, an inner tube 126, and a guidewire tube 127, the proximal ends of the outer tube 125, the inner tube 126, and the guidewire tube 127 are all connected to the operation unit 13, the input lumen 121 and the output lumen 122 are lumens disposed within the inner tube 126, the guidewire tube 127 is inserted within the lumen of the inner tube 126 and the distal end of the guidewire tube 127 extends beyond the distal end of the inner tube 126, the infusion lumen 123 and the rewarming lumen 124 are disposed between the inner tube 126 and the outer tube 125, the proximal end of the outer balloon 112 is in sealing connection with the distal end of the outer tube 125, the distal end of the outer balloon 112 is in sealing connection with the distal end of the guidewire tube 127, the proximal end of the inner balloon 111 is in sealing connection with the distal end of the inner tube 126, the distal end of the inner balloon 111 is in sealing connection with the distal end portion of the guidewire tube 127, and the operation unit 13 is further provided with a guidewire port 137 connected to the guidewire tube 127. The wire guide port 137 can be in sealing connection with the proximal end of the wire guide tube 127 through a dispensing process, the wire guide tube 127 can be used for a guide wire (not shown in the drawing), when the cryoablation catheter is required to be pushed to a focus position, the guide wire is inserted into the wire guide tube 127 through the wire guide port 137, so that the cryoablation catheter can reach the focus position along the guide wire, the pushing of the cryoablation catheter plays a role in guiding and positioning, and a pushing operation of an operator for the cryoablation catheter to reach the focus position is facilitated.

In an alternative embodiment, the delivery unit 12 includes an outer tube 125 and an inner tube 126, the proximal ends of the outer tube 125 and the inner tube 126 are both connected to the operation unit 13, the input lumen 121 and the output lumen 122 are lumens of the input tube and the output tube, respectively, the input tube and the output tube are inserted into the inner tube 126, the infusion lumen 123 and the rewarming lumen 124 are lumens of the infusion tube and the rewarming tube, respectively, the infusion tube and the rewarming tube are inserted between the inner tube 126 and the outer tube 125, the proximal end of the outer balloon 112 is hermetically connected to the distal end of the outer tube 125, the distal end of the outer balloon 112 is hermetically connected to the distal end of the inner tube 126, the proximal end and the distal end of the inner balloon 111 are hermetically connected to the distal end portion of the inner tube 126, and holes 128 communicating with the input lumen 121 and the output lumen 122 are provided on the wall of the inner tube 126, respectively, referring to fig. 4, so that the input lumen 121 and the output lumen 122 are in fluid communication with the inner balloon 111.

In an alternative embodiment, the delivery unit 12 includes an outer tube 125, an inner tube 126, and a wire tube 127, the proximal ends of the outer tube 125, the inner tube 126, and the wire tube 127 are all connected to the operation unit 13, the input lumen 121 and the output lumen 122 are lumens of the input tube and the output tube, respectively, the input tube, the output tube, and the wire tube 127 are inserted into the inner tube 126, and the distal end of the wire tube 127 extends out of the distal end of the inner tube 126, the infusion lumen 123 and the rewarming lumen 124 are lumens of the infusion tube and the rewarming tube, respectively, the infusion tube and the rewarming tube are inserted between the inner tube 126 and the outer tube 125, the proximal end of the outer balloon 112 is in sealing connection with the distal end of the outer tube 125, the distal end of the outer balloon 112 is in fixed connection with the distal end of the wire tube 127, the proximal end of the inner balloon 111 is in sealing connection with the distal end of the inner tube 126, the distal end of the inner balloon 111 is in fixed connection with the distal end portion of the wire tube 127, and the operation unit 13 is further provided with a wire port 137 connected to the wire tube 127.

In an alternative embodiment, the distal port of the input tube is disposed proximate the distal end of the inner balloon 111 and the distal port of the output tube is disposed proximate the proximal end of the inner balloon 111. This is more advantageous for refrigerant input and discharge.

In an alternative embodiment, the freezer unit 11 further includes a developing ring 113, the developing ring 113 being sleeved over the guidewire tube 127 and positioned between the inner balloon 111 and the outer balloon 112. Referring to fig. 1 and 4, the visualization ring 113 may be adhesively secured to the guidewire tube 127 for displaying the specific location within the vessel in which the balloon is located.

In an alternative embodiment, the inner balloon 111 is a non-compliant balloon and the outer balloon 112 is a compliant balloon or semi-compliant balloon. The outer balloon 112 of embodiments of the present utility model may be used to dilate blood vessels, freeze lesions to treat disease. When the freezing is opened, the inner balloon 111 expands after filling. In an application scenario, the expanded inner balloon 111 already partially conforms to the vessel wall, because the inner balloon 111 is a non-compliant balloon, the diameter change is smaller with increasing inflation pressure, while the outer balloon 112 completely conforms to the outer wall of the inner balloon 111 before and after the infusion, and the outer balloon 112 only partially occludes the vessel before the infusion. Because the outer balloon 112 is a compliant balloon or a semi-compliant balloon, after the outer balloon 112 is injected with liquid, the outer balloon 112 can expand along with the increase of the injection pressure, so that the diameter is increased, and the outer balloon can be shaped along the shape of the vessel wall, thereby being tightly attached to the vessel wall, effectively blocking the blood flow and improving the cryoablation efficiency. In another application scenario, the expanded inner balloon 111 has a smaller diameter than the vessel, so there is no portion of the vessel wall in contact therewith. The outer balloon 112 is completely attached to the inner balloon 111 before the outer balloon 112 is injected, so that the outer balloon 112 cannot block the blood flow, and after the outer balloon 112 is injected, the outer balloon 112 is inflated and shaped along the vessel wall, and completely attaches to the vessel wall, thereby effectively blocking the blood flow.

In the embodiment of the present utility model, when the outer balloon 112 is inflated when the inflation liquid is input, the outer balloon 112 is a compliant balloon or a semi-compliant balloon, so that the outer balloon 112 is shaped along the shape of the vessel wall, and thus closely fits the vessel wall, effectively blocks the blood flow, and improves the cryoablation efficiency. Therefore, the ablation catheter provided by the embodiment of the utility model can adapt to complex vascular structures, adapt to various irregular shapes and different sizes of vascular walls on the premise of not replacing the catheter, and can be in compliance fit with the vascular walls according to the irregular vascular wall shapes, so that the fit degree is improved, and the cryoablation efficiency is improved.

In an alternative embodiment, a vacuum connector 138 is further provided on the operating unit 13, the vacuum connector 138 being connected to a vacuum pump for evacuating the cryoablation catheter. In this embodiment, the vacuum connector 138 may be connected to a vacuum tube (not shown in the drawing), the vacuum tube is sleeved outside the outer tube, the distal end of the vacuum tube is in sealing connection with the distal end of the outer tube, one end of the vacuum connector 138 is connected to the proximal end of the vacuum tube, and the other end of the vacuum connector 138 is connected to a vacuum pump for evacuating the cryoablation catheter to form a vacuum insulation layer, or the vacuum connector 138 is directly communicated with the lumen of the delivery unit 12 to evacuate the cryoablation catheter, so that the medium for energy transfer becomes thin, thereby adjusting the efficiency of the cryoenergy transfer.

The embodiment of the present utility model also provides a cryoablation system including a cryoablation apparatus and the cryoablation catheter described above, the operating unit 13 of the cryoablation catheter being connected to the cryoablation apparatus for delivering a refrigerant to the inner balloon 111 through the delivery unit 12 and performing a cryoablation procedure.

Finally, it should be understood that the foregoing description is merely illustrative of the preferred embodiments of the present utility model, and that no limitations are intended to the scope of the utility model, as defined by the appended claims.

Claims (10)

1. A cryoablation catheter comprising a freezing unit, a delivery unit and an operating unit connected in sequence; the freezing unit comprises an inner balloon and an outer balloon, the inner balloon being disposed within the outer balloon; the conveying unit comprises an input cavity, an output cavity and a liquid injection cavity, wherein the input cavity is used for conveying the refrigerant to the inner balloon, the output cavity is used for discharging the refrigerant from the inner balloon, and the liquid injection cavity is used for conveying filling liquid to the outer balloon; the operation unit comprises an input connector, an output connector and a liquid injection connector, wherein the input connector and the output connector are respectively communicated with the input cavity and the output cavity, and the liquid injection connector is communicated with the liquid injection cavity; the device is characterized in that the conveying unit further comprises a rewarming cavity which is in fluid communication with the outer balloon and is used for conveying rewarming fluid to the outer balloon, the operating unit further comprises an L-shaped three-way valve, a rewarming joint and a liquid return joint, the rewarming joint is connected with the proximal end of the rewarming cavity and is in fluid communication, the liquid inlet end of the L-shaped three-way valve is connected with the proximal end of the liquid injection cavity and is in fluid communication, the two liquid outlet ends of the L-shaped three-way valve are respectively connected with the liquid injection joint and the liquid return joint and are in fluid communication, and the liquid return joint is connected with a cryoablation device through a liquid return pipe.

2. The cryoablation catheter as recited in claim 1 wherein the delivery unit comprises an outer tube and an inner tube, the proximal ends of the outer tube and the inner tube are both connected to the operating unit, the input lumen and the output lumen are lumens disposed within the inner tube, the infusion lumen and the rewarming lumen are disposed between the inner tube and the outer tube, the proximal end of the outer balloon is sealingly connected to the distal end of the outer tube, the distal end of the outer balloon is sealingly connected to the distal end of the inner tube, the proximal end and distal end of the inner balloon are sealingly connected to the distal end portion of the inner tube, respectively, and apertures in communication with the input lumen and the output lumen are disposed on the tube wall of the inner tube, respectively, such that the input lumen and the output lumen are in fluid communication with the inner balloon.

3. The cryoablation catheter as recited in claim 1 wherein the delivery unit comprises an outer tube, an inner tube and a guidewire tube, the proximal ends of the outer tube, the inner tube and the guidewire tube are all connected to the operating unit, the input lumen and the output lumen are lumens disposed within the inner tube, the guidewire tube is inserted within the lumen of the inner tube and the distal end of the guidewire tube extends beyond the distal end of the inner tube, the infusion lumen and the rewarming lumen are disposed between the inner tube and the outer tube, the proximal end of the outer balloon is in sealed connection with the distal end of the outer tube, the distal end of the outer balloon is in sealed connection with the distal end of the guidewire tube, the proximal end of the inner balloon is in sealed connection with the distal end of the inner tube, the distal end of the inner balloon is in sealed connection with the distal end portion of the guidewire tube, and the operating unit is further provided with a guidewire port connected to the guidewire tube.

4. The cryoablation catheter as recited in claim 1 wherein the delivery unit comprises an outer tube and an inner tube, the proximal ends of the outer tube and the inner tube are both connected to the operating unit, the input lumen and the output lumen are lumens of an input tube and an output tube, respectively, the input tube and the output tube are inserted into the inner tube, the infusion lumen and the rewarming lumen are lumens of an infusion tube and a rewarming tube, respectively, the infusion tube and the rewarming tube are inserted between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in sealing connection with the distal end of the inner tube, the proximal end and the distal end of the inner balloon are in sealing connection with the distal end portion of the inner tube, respectively, and holes in communication with the input lumen and the output lumen are provided on the tube wall of the inner tube, respectively, such that the input lumen and the output lumen are in fluid communication with the inner balloon.

5. The cryoablation catheter as recited in claim 1 wherein the delivery unit comprises an outer tube, an inner tube and a guidewire tube, the proximal ends of the outer tube, the inner tube and the guidewire tube are all connected to the operating unit, the input lumen and the output lumen are lumens of the input tube and the output tube, respectively, the input tube, the output tube and the guidewire tube are inserted into the inner tube, and the distal end of the guidewire tube extends beyond the distal end of the inner tube, the infusion lumen and the rewarming lumen are lumens of an infusion tube and a rewarming tube, respectively, the infusion tube and the rewarming tube are inserted between the inner tube and the outer tube, the proximal end of the outer balloon is in sealing connection with the distal end of the outer tube, the distal end of the outer balloon is in fixed connection with the distal end of the guidewire tube, the proximal end of the inner balloon is in sealing connection with the distal end of the inner tube, the distal end of the inner balloon is in fixed connection with the distal end portion of the guidewire tube, and the operating unit is further provided with a guidewire port for connection with the operating unit.

6. The cryoablation catheter as recited in claim 5 wherein a distal port of the input tube is disposed proximate to a distal end of the inner balloon and a distal port of the output tube is disposed proximate to a proximal end of the inner balloon.

7. The cryoablation catheter as recited in claim 6 wherein the freezing unit further comprises: a developing ring is provided with a plurality of developing rings,

the developing ring is sleeved on the guide wire tube and is positioned between the inner balloon and the outer balloon.

8. The cryoablation catheter as recited in any one of claims 1 to 7 wherein said inner balloon is a non-compliant balloon and said outer balloon is a compliant or semi-compliant balloon.

9. The cryoablation catheter as recited in claim 1 wherein a vacuum connector is further provided on the operating unit, the vacuum connector being connected to a vacuum pump for evacuating the cryoablation catheter.

10. A cryoablation system comprising a cryoablation apparatus and a cryoablation catheter as in any of claims 1-9, an operating unit of the cryoablation catheter being connected to the cryoablation apparatus for delivering refrigerant to the inner balloon through the delivery unit and performing a cryoablation procedure.