A cryoablation catheter and method of operation thereof

Abstract

The application discloses a kind of frozen ablation catheter and its working method, comprising: frozen probe, first channel and second channel being communicated with frozen probe;Wherein, to form the shunt channel of first channel and second channel between first channel and second channel, shunt channel forms shunt inlet at first channel, and shunt channel forms shunt outlet at second channel;When refrigerant enters second channel from first channel through shunt channel, local low pressure is formed at shunt outlet.The application carries out different degrees of shunt in advance to high-speed flowing refrigerant, uses the local low pressure area formed by the entrainment phenomenon generated by high-speed fluid to determine whether the balloon of frozen probe exists breakage leakage by monitoring the pressure change in catheter.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to a cryoablation catheter. Background Technology

[0002] Cryoablation products are typically tested in vitro to ensure there are no leaks before being introduced into the human body for target tissue ablation. However, during the insertion of the cryoablation catheter into the body, there is a possibility that the cryoprobe at the end of the catheter may be damaged during delivery, leading to refrigerant leakage during the procedure and posing a safety hazard. Therefore, it is essential to reconfirm the product's leakage status after it enters the body and before cryoablation, but current technology lacks an effective and easily observable method for this purpose.

[0003] Furthermore, during the refrigerant delivery process, the refrigerant undergoes a phase change, generating a large amount of gas. This gas creates resistance, hindering the delivery of the refrigerant to the cryoprobe. This prevents the cryoprobe from reaching ultra-low temperatures in a short time, thus requiring pre-cooling of the delivery pipeline. This stage is called the pre-cooling stage. The smaller the diameter of the delivery pipeline, the greater the resistance to refrigerant delivery and the longer the pre-cooling time, leading to a prolonged ablation procedure and a poor clinical experience. This is especially true for thin-diameter cryoablation catheters used for ablation of lesions in slender organ cavities (such as bronchial tubes in the lungs), where a considerable pre-cooling time is required initially. To shorten the pre-cooling time, the operating pressure or refrigerant flow rate can be increased. However, increasing the operating pressure or flow rate may lead to excessive pressure inside the cryoablation product, posing a risk of product rupture. Summary of the Invention

[0004] In view of this, the present invention provides a cryoablation catheter, which connects the first channel and the second channel by arranging a fluid diversion and return device, so that the diverted gas forms a local low-pressure zone, and the presence of damage or leakage of the cryoablation probe is determined by monitoring the pressure change in the catheter.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] This invention provides a cryoablation catheter, comprising:

[0007] Cryoprobe;

[0008] A first channel connected to the cryoprobe for supplying coolant to the interior of the cryoprobe;

[0009] A second channel connected to the freezing probe for drawing coolant from the interior of the freezing probe;

[0010] A diversion channel is formed between the first channel and the second channel, connecting the first channel and the second channel. The diversion channel forms a diversion inlet at the first channel and a diversion outlet at the second channel.

[0011] When the refrigerant enters the second channel from the first channel through the diversion channel, a local low pressure is formed at the diversion outlet.

[0012] The aforementioned cryoablation catheter includes a valve at the shunt channel for controlling the opening, closing, and / or regulating the flow rate of the shunt channel.

[0013] In the aforementioned cryoablation catheter, both the shunt inlet and the shunt outlet are arranged facing away from the cryoprobe.

[0014] In the aforementioned cryoablation catheter, the shunt inlet is arranged in the direction in which the refrigerant flows toward the cryoprobe, and the shunt outlet is arranged in the direction in which the refrigerant flows out of the cryoprobe.

[0015] In the aforementioned cryoablation catheter, the first channel is provided with a valve for controlling the opening, closing, and / or regulating the flow rate of the shunt channel;

[0016] The valve is located between the cryoprobe and the diversion channel.

[0017] In the aforementioned cryoablation catheter, the shunt inlet is arranged toward the cryoprobe, and the shunt outlet is arranged toward the direction opposite to the cryoprobe.

[0018] In the aforementioned cryoablation catheter, the shunt inlet is arranged opposite to the direction in which the refrigerant flows toward the cryoprobe, and the shunt outlet is arranged toward the direction in which the refrigerant flows out of the cryoprobe.

[0019] The aforementioned cryoablation catheter includes:

[0020] A fluid diversion and return component connecting the first channel and the second channel, the fluid diversion and return component being a tubular structure, the fluid diversion and return component providing the diversion channel;

[0021] The fluid diversion and return component has a first end connected to the first channel and a second end connected to the second channel, with the diversion inlet formed at the first end and the diversion outlet formed at the second end.

[0022] The above-mentioned cryoablation catheter, wherein the first channel includes: a refrigerant inlet connected to the cryoprobe, a fluid inlet channel connected to the refrigerant inlet, and an extension inlet tube connected to the fluid inlet channel;

[0023] The second channel includes: a refrigerant circuit connected to the freezing probe, a fluid circuit channel connected to the refrigerant circuit, and an extension circuit pipe connected to the fluid circuit channel;

[0024] The diversion channel is connected to one of the refrigerant inlet, the fluid inlet channel, and the extended inlet pipe;

[0025] The diversion channel is connected to one of the refrigerant circuit, the fluid circuit channel, and the extension circuit pipe.

[0026] In the aforementioned cryoablation conduit, the refrigerant circuit is sleeved outside the refrigerant inlet; or, the refrigerant inlet is sleeved outside the refrigerant circuit; or, the refrigerant inlet and the refrigerant circuit are arranged side by side.

[0027] The fluid inlet channel and the fluid return channel are arranged side by side.

[0028] The aforementioned cryoablation catheter further includes a negative pressure pump connected to the second channel.

[0029] This invention provides a method for operating a cryoablation catheter, characterized in that it is applicable to any of the cryoablation catheters described above, and the method includes:

[0030] Refrigerant is supplied to the cryogenic probe through the first channel;

[0031] A portion or all of the refrigerant enters the second channel through the diversion channel, forming a local low pressure at the diversion outlet;

[0032] The pressure changes inside the cryoprobe are monitored to determine if there is a leak in the cryoprobe.

[0033] The above-mentioned method for using cryoablation catheters includes:

[0034] The refrigerant sequentially enters the second channel through the first channel and the diversion channel, forming a local low pressure at the diversion outlet, and simultaneously enters the second channel through the first channel and the freezing probe.

[0035] Alternatively, the valve located between the refrigeration probe and the diversion channel is closed, and the refrigerant sequentially enters the second channel through the first channel and the diversion channel, forming a local low pressure at the diversion outlet;

[0036] Alternatively, the negative pressure pump connected to the second channel can be turned on, and the refrigerant can enter the second channel sequentially through the first channel and the diversion channel, forming a local low pressure at the diversion outlet, and simultaneously entering the second channel sequentially through the first channel and the freezing probe.

[0037] This invention provides another, more specific cryoablation catheter, comprising:

[0038] Cryoprobe;

[0039] A first channel connected to the cryoprobe for supplying coolant to the interior of the cryoprobe;

[0040] A second channel connected to the freezing probe for drawing coolant from the interior of the freezing probe;

[0041] And a fluid diversion and return component connecting the first channel and the second channel;

[0042] The fluid diversion and return component has a first end connected to the first channel and a second end connected to the second channel;

[0043] The second end of the fluid diversion and return component is inserted into the second channel, and the second channel forms a front side of the second channel near the freezing probe and a rear side of the second channel away from the freezing probe at the fluid diversion and return component;

[0044] The port at the second end is positioned facing the rear of the second channel;

[0045] When the refrigerant enters the second channel from the first channel through the fluid diversion and return component, a local low pressure is formed on the front side of the second channel.

[0046] In the aforementioned cryoablation catheter, the port at the first end is arranged toward the rear side of the first channel, away from the cryoprobe.

[0047] The aforementioned cryoablation catheter, wherein the cryoprobe includes:

[0048] Cryoprobe body;

[0049] A refrigerant outlet pipe is located inside the body of the cryogenic probe. The interior of the refrigerant outlet pipe is connected to the first channel. A liquid spray hole is provided on the refrigerant outlet pipe. A cryogenic cavity is formed between the exterior of the refrigerant outlet pipe and the interior of the cryogenic probe body. The cryogenic cavity is connected to the second channel.

[0050] The freezing probe head is located inside the freezing probe body and at the end of the refrigerant outlet pipe.

[0051] The aforementioned cryoablation catheter includes a catheter body segment, wherein the catheter body segment comprises:

[0052] A refrigerant inlet is connected to the freezing probe, and the interior of the refrigerant inlet forms part of the first channel.

[0053] A refrigerant circuit, connected to the freezing probe, wherein the interior of the refrigerant circuit forms part of the second channel, and the refrigerant circuit surrounds the refrigerant inlet; and

[0054] A heat-insulating pipe covering the refrigerant inlet and the refrigerant circuit.

[0055] The aforementioned cryoablation catheter includes a fluid shunt structure, wherein the fluid shunt structure comprises:

[0056] A fluid inlet channel, which is connected to the refrigerant inlet, and the fluid inlet channel forms part of the first channel;

[0057] A fluid circuit channel, which is connected to the refrigerant circuit, and the fluid circuit channel forms part of the second channel;

[0058] A heat-insulated suction channel is connected to the heat-insulated pipe.

[0059] In the aforementioned cryoablation catheter, the fluid shunt structure further includes a fluid shunt main body, which is a columnar structure with two fluid cavities formed along the axial direction of the columnar structure. One fluid cavity serves as the fluid inlet channel, and the other fluid cavity serves as the fluid return channel.

[0060] One end of the refrigerant inlet is inserted into the fluid inlet channel of the fluid splitter body, thereby connecting with the fluid inlet channel;

[0061] One end of the refrigerant circuit is sleeved outside the fluid distribution body, thereby connecting with the fluid circuit structure;

[0062] The heat-insulating suction channel is also opened along the axial direction of the columnar structure.

[0063] The aforementioned cryoablation catheter, wherein the fluid shunt structure further includes:

[0064] An external handle assembly that covers a portion of the refrigerant inlet and the refrigerant circuit, and that also covers at least a portion of the fluid distribution body assembly.

[0065] The aforementioned cryoablation catheter includes a catheter extension section, wherein the catheter extension section comprises:

[0066] An extended inlet pipe is connected to the fluid inlet channel, and the interior of the extended inlet pipe forms part of the first channel;

[0067] An extension loop pipe is connected to the fluid loop channel, and the interior of the extension loop pipe forms part of the second channel;

[0068] A heat insulation layer is provided, which covers the extension inlet pipe and the extension return pipe, and the heat insulation suction channel is connected to the interior of the heat insulation layer.

[0069] In the aforementioned cryoablation catheter, the first end of the fluid diversion and return element is connected to one of the refrigerant inlet, the fluid inlet channel, and the extended inlet tube;

[0070] The second end of the fluid diversion and return component is inserted into one of the refrigerant circuit, the fluid circuit channel, and the extension circuit pipe.

[0071] In the aforementioned cryoablation catheter, the fluid diversion and return component is provided with a valve for controlling the opening or closing of the fluid diversion and return component.

[0072] In the aforementioned cryoablation catheter, the fluid shunt and return element comprises:

[0073] The first end, the second end, and the connecting portion connecting the first end and the second end;

[0074] The connecting portion penetrates the wall of the fluid distribution main body and surrounds the outside of the fluid distribution main body;

[0075] The valve is located at the connection part.

[0076] The aforementioned cryoablation catheter further includes a handle, the handle comprising: an inlet connecting tube connected to the extended inlet tube, an outlet connecting tube connected to the extended outlet tube, and a handle heat insulation element sleeved on the extended inlet tube and the extended outlet tube.

[0077] In the aforementioned cryoablation catheter, one end of the handle heat insulation member is inserted into the heat insulation layer.

[0078] In the aforementioned cryoablation catheter, the handle further includes: a handle sleeve and a handle seat, the handle sleeve and the handle seat being detachably connected, and the interiors of the handle sleeve and the handle seat forming an accommodating space for accommodating the inlet connecting tube, the outlet connecting tube, a portion of the extended inlet tube and a portion of the extended outlet tube, and the handle heat insulation element.

[0079] The cryoablation catheter described above further includes two interfaces, both of which pass through the handle seat and are respectively connected to the inlet connection tube and the outlet connection tube.

[0080] The aforementioned cryoablation catheter includes a fluid shunt structure, wherein the fluid shunt structure comprises:

[0081] A fluid distribution main component, the fluid distribution main component has a columnar structure, and a fluid cavity is opened along the axial direction of the columnar structure. The fluid cavity is a fluid inlet channel, the fluid inlet channel is connected to the refrigerant inlet, and the fluid inlet channel forms part of the first channel;

[0082] An air intake adapter, one end of which is connected to the fluid inlet channel;

[0083] The flow divider seal is sleeved outside the fluid flow divider body and is sealed between the flow divider seal and the air intake adapter. One end of the flow divider seal is connected to the refrigerant circuit. The interior of the flow divider seal is a fluid circuit channel, which forms part of the second channel.

[0084] The aforementioned cryoablation catheter includes a catheter extension section, wherein the catheter extension section comprises:

[0085] An extended inlet pipe is provided, with the other end of the intake adapter connected to the extended inlet pipe, and the interior of the extended inlet pipe forming part of the first channel;

[0086] An extension circuit pipe, one end of the diversion seal is connected to the extension circuit pipe, and the interior of the extension circuit pipe forms part of the second channel;

[0087] A heat insulation layer, which covers the extension inlet pipe and the extension return pipe;

[0088] It also includes: a central heat insulation pipe, which connects the heat insulation pipe and the heat insulation layer.

[0089] In the aforementioned cryoablation catheter, one end of the fluid shunt return component is inserted into the fluid shunt main body and connected to the fluid inlet channel;

[0090] The other end of the fluid diversion and return component is inserted into the extension loop pipe and connected to the extension loop pipe.

[0091] In the aforementioned cryoablation conduit, the fluid splitting main body is provided with a valve for controlling the connection or closure between the refrigerant inlet and the fluid inlet channel of the fluid splitting main body.

[0092] In the aforementioned cryoablation catheter, the fluid diversion and return component extends along the axial direction of the cryoablation catheter, and a bend is formed in the middle of the fluid diversion and return component.

[0093] In the aforementioned cryoablation catheter, the port at the first end is arranged facing the front side of the first channel near the cryoprobe.

[0094] The port at the second end is arranged toward the rear side of the second channel, away from the cryoprobe.

[0095] This invention provides a method for operating a cryoablation catheter, applicable to any of the cryoablation catheters described above, the method comprising:

[0096] Refrigerant is supplied to the cryogenic probe through the first channel;

[0097] A portion or all of the refrigerant enters the second channel through the fluid diversion and return component, forming a local low pressure on the front side of the second channel.

[0098] The pressure changes inside the cryoprobe are monitored to determine if there is a leak in the cryoprobe.

[0099] This invention provides another cryoablation catheter, comprising:

[0100] Cryoprobe;

[0101] A first channel connected to the cryoprobe for supplying coolant to the interior of the cryoprobe;

[0102] A second channel connected to the freezing probe for drawing coolant from the interior of the freezing probe;

[0103] A diversion channel is formed between the first channel and the second channel, connecting the first channel and the second channel. The diversion channel forms a diversion inlet at the first channel and a diversion outlet at the second channel.

[0104] In the aforementioned cryoablation conduit, when the refrigerant enters the second channel from the first channel via the diversion channel, a local low pressure is formed at the diversion outlet.

[0105] In the aforementioned cryoablation catheter, negative pressure is provided at the second channel via a negative pressure device.

[0106] The above-mentioned cryoablation catheter includes: a fluid diversion structure, wherein the fluid diversion structure is provided with a fluid inlet channel, a fluid return channel, and the diversion channel connecting the fluid inlet channel and the fluid return channel;

[0107] The fluid inlet channel forms part of the first channel, and the fluid return channel forms part of the second channel.

[0108] In the aforementioned cryoablation catheter, the fluid inlet channel and the fluid return channel are arranged side by side.

[0109] The aforementioned cryoablation conduit further includes: a refrigerant inlet and a refrigerant circuit, wherein the refrigerant inlet is connected to one end of the fluid inlet channel, and the refrigerant circuit is connected to one end of the fluid circuit channel.

[0110] In the aforementioned cryoablation catheter, the refrigerant inlet and the refrigerant circuit are arranged close to the cryoprobe.

[0111] The aforementioned cryoablation catheter further includes: an extension inlet tube and an extension return tube, wherein the extension inlet tube is connected to the other end of the fluid inlet channel, and the extension return tube is connected to the other end of the fluid return channel.

[0112] In the aforementioned cryoablation catheter, the extended inlet tube and the extended return tube are arranged away from the cryoprobe.

[0113] In the aforementioned cryoablation catheter, the negative pressure device is a negative pressure pump, and the extension circuit tube is connected to the negative pressure pump to provide local low pressure within the second channel.

[0114] The present invention, by employing the above-mentioned technology, has the following positive effects compared with the prior art:

[0115] (1) The present invention pre-divides the high-speed flowing refrigerant to different degrees; a portion of the diverted gas will form a local low-pressure area at its outlet by using the ejection phenomenon generated by the high-speed fluid. The ejection effect will cause the pressure inside the conduit to change. The pressure change inside the conduit can be monitored to determine whether the balloon of the cryogenic probe is damaged or leaking.

[0116] (2) The formation of the local low-pressure zone in this invention drives the vaporized refrigerant in the duct to move faster toward the outlet, resulting in a faster refrigerant flow rate and a shorter pre-cooling time.

[0117] (3) The distribution path of the present invention can directly discharge the vaporized refrigerant, which reduces the refrigerant transport resistance to a certain extent and also shortens the precooling time. Attached Figure Description

[0118] Figure 1 This is a schematic diagram of the first embodiment of the cryoablation catheter of the present invention.

[0119] Figure 2 This is a schematic diagram of the cryoprobe and catheter body segment of the first embodiment of the cryoablation catheter of the present invention.

[0120] Figure 3 This is a schematic diagram of the catheter body segment and fluid diversion structure of the first embodiment of the cryoablation catheter of the present invention.

[0121] Figure 4 This is the cryoablation catheter of the present invention. Figure 3 AA section view diagram.

[0122] Figure 5 This is the cryoablation catheter of the present invention. Figure 3 A magnified view of a portion of the image.

[0123] Figure 6 This is a schematic diagram of the handle of the first embodiment of the cryoablation catheter of the present invention.

[0124] Figure 7 This is a schematic diagram of a second embodiment of the cryoablation catheter of the present invention.

[0125] Figure 8 This is a schematic diagram of the third embodiment of the cryoablation catheter of the present invention.

[0126] Figure 9 This is a schematic diagram of the fourth embodiment of the cryoablation catheter of the present invention.

[0127] In the attached diagram: 1. Cryogenic probe; 11. Cryogenic probe tip; 12. Cryogenic probe body; 13. Refrigerant outlet pipe; 131. Injection hole; 2. Conduit body section; 21. Insulation pipe; 22. Refrigerant circuit; 23. Refrigerant inlet; 3. Fluid diversion structure; 31. External handle; 32. Fluid diversion main body; 321. Fluid circuit channel; 322. Fluid inlet channel; 323. Insulated suction channel; 3 24. Diversion channel; 33. Fluid diversion and return component; 34. Inlet adapter; 35. Diversion seal; 36. Central heat insulation pipe; 37. Valve; 4. Conduit extension section; 41. Insulation layer; 42. Extension loop pipe; 43. Extension inlet pipe; 44. Loop adapter; 5. Handle; 51. Handle sleeve; 52. Handle seat; 53. Interface; 54. Outlet connection pipe; 55. Inlet connection pipe; 57. Handle heat insulation component. Detailed Implementation

[0128] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0129] In the description of this invention, it should be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "left", "right", "inner", "outer", "front", "rear", "lateral", and "vertical" are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this invention, and are not intended to indicate or imply that the device or component referred to must have a specific orientation, and therefore should not be construed as a limitation of this invention.

[0130] It should be noted that the terms "horizontal" and "vertical" in this invention are used to describe approximate positional relationships, and not strictly "horizontal plane" or "vertical plane".

[0131] In this application, the front side generally refers to the side closer to the cryoprobe 1, and the rear side generally refers to the side closer to the handle 5.

[0132] First embodiment:

[0133] Please see Figures 1 to 6The image shows a cryoablation catheter of a first preferred embodiment, which mainly includes: a cryoprobe 1, a catheter body section 2, a fluid diversion structure 3, a catheter extension section 4, and a handle 5; specifically, it includes: a cryoprobe 1, a first channel and a second channel, wherein the first channel is connected to the cryoprobe 1 and is used to provide coolant to the interior of the cryoprobe 1; the second channel is connected to the cryoprobe 1 and is used to draw coolant out from the interior of the cryoprobe 1; it also includes a diversion channel connecting the first channel and the second channel, which is provided by a fluid diversion and return component 33.

[0134] The fluid diversion and return component 33 has a first end connected to the first channel and a second end connected to the second channel. Preferably, a diversion inlet of the diversion channel is formed at the first end, and a diversion outlet of the diversion channel is formed at the second end.

[0135] The second end of the fluid diversion and return component 33 is inserted into the second channel, and the second channel is formed at the fluid diversion and return component 33 with a front side close to the freezing probe 1 and a rear side away from the freezing probe 1.

[0136] The port at the second end of the fluid diversion and return component 33 is arranged facing the rear side of the second channel.

[0137] When the refrigerant enters the second channel from the first channel through the fluid diversion and return component 33, a local low pressure is formed on the front side of the second channel.

[0138] Preferably, in the operating state, the refrigerant first enters the second channel from the first channel via the fluid diversion and return component 33. At this time, the refrigerant has not yet entered the freezing probe 1. Since a local low pressure has been formed at the front of the second channel, this local low pressure zone guides the various media in the freezing probe 1 to accelerate towards the outlet, resulting in a faster refrigerant flow rate and a shorter pre-cooling time.

[0139] On the other hand, when the refrigerant is about to be delivered to the inlet of the distribution channel (i.e., at the fluid distribution return component 33), the vaporized refrigerant can be preferentially discharged from the distribution channel, which reduces the refrigerant delivery resistance to a certain extent and also shortens the pre-cooling time.

[0140] Furthermore, as a preferred embodiment, the freezing probe 1 includes: a freezing probe head end 11, a freezing probe body 12, and a refrigerant outlet pipe 13.

[0141] The refrigerant outlet pipe 13 is located inside the freezing probe body 12. The interior of the refrigerant outlet pipe 13 is connected to the first channel. A spray hole 131 is opened on the refrigerant outlet pipe 13. A freezing cavity is formed between the exterior of the refrigerant outlet pipe 13 and the interior of the freezing probe body 12. The freezing cavity is connected to the second channel.

[0142] The freezing probe head 11 is located inside the freezing probe body 12 and at the end of the refrigerant outlet pipe 13.

[0143] Preferably, the cryoprobe body 12 is a balloon.

[0144] More preferably, the front side of the balloon is fixed to the tip 11 of the cryoprobe, and the rear side of the balloon is fixed to the refrigerant circuit 22 described below.

[0145] Furthermore, as a preferred embodiment, it includes a conduit body segment 2, which includes a refrigerant inlet 23 connected to the freezing probe 1, and the interior of the refrigerant inlet 23 forms part of a first channel.

[0146] Furthermore, in a preferred embodiment, the conduit body segment 2 includes: a refrigerant circuit 22, which is connected to the freezing probe 1, and the interior of the refrigerant circuit 22 forms part of a second channel, and the refrigerant circuit 22 surrounds the refrigerant inlet 23.

[0147] In this embodiment, the refrigerant circuit 22 is fitted outside the refrigerant inlet 23.

[0148] In other embodiments, the refrigerant inlet 23 may be arranged in parallel with the refrigerant circuit 22, or the refrigerant inlet 23 may be sleeved outside the refrigerant circuit 22.

[0149] Furthermore, as a preferred embodiment, the conduit body segment 2 includes: a heat-insulating pipe 21 covering the refrigerant inlet 23 and the refrigerant circuit 22.

[0150] Furthermore, as a preferred embodiment, a fluid diversion structure 3 is included, which includes a fluid inlet channel 322 connected to a refrigerant inlet channel 23, and the fluid inlet channel 322 forms part of a first channel.

[0151] Furthermore, as a preferred embodiment, the fluid diversion structure 3 includes: a fluid loop channel 321, which is connected to the refrigerant loop 22, and forms part of the second channel.

[0152] Furthermore, as a preferred embodiment, the fluid diversion structure 3 includes: a heat-insulated suction channel 323, which is connected to the heat-insulated pipe 21.

[0153] Furthermore, as a preferred embodiment, the fluid diversion structure 3 also includes a fluid diversion main body 32, which has a columnar structure and two fluid cavities are opened along the axial direction of the columnar structure of the fluid diversion main body 32. One fluid cavity is a fluid inlet channel 322, and the other fluid cavity is a fluid return channel 321.

[0154] Specifically, one end of the refrigerant inlet 23 is inserted into the fluid inlet channel 322 of the fluid distribution body 32, thereby connecting with the fluid inlet channel 322.

[0155] Specifically, one end of the refrigerant circuit 22 is fitted outside the fluid distribution main body 32, thereby connecting with the fluid circuit structure 321.

[0156] More specifically, the heat-insulated suction channel 323 is also opened along the axial direction of the columnar structure.

[0157] Furthermore, as a preferred embodiment, the fluid diversion structure 3 also includes:

[0158] The outer handle 31 covers a portion of the refrigerant inlet 23 and the refrigerant circuit 22, and also covers at least a portion of the fluid distribution body 32.

[0159] Preferably, the outer handle 31 provides a rigid handle housing space.

[0160] Specifically, the outer handle 31 includes a first part, a second part, and a third part connected in sequence, wherein the first part is arranged toward the direction close to the cryoprobe 1, and the second part is arranged toward the direction away from the cryoprobe 1.

[0161] More specifically, the inner diameter of the first part matches the outer diameter of the refrigerant circuit 22, the interior of the second part forms the handle accommodating space, the inner diameter of the second part is larger than the outer diameter of the refrigerant circuit 22, and the inner diameter of the third part matches the outer diameter of the insulation layer 41 described below.

[0162] Furthermore, as a preferred embodiment, it includes a catheter extension section 4, which includes an extension inlet tube 43 connected to a fluid inlet channel 322, and the interior of the extension inlet tube 43 forms part of a first channel.

[0163] Furthermore, in a preferred embodiment, the conduit extension section 4 includes: an extension loop pipe 42, which is connected to the fluid loop channel 321, and the interior of the extension loop pipe 42 forms part of a second channel.

[0164] Specifically, it also includes: a loop adapter 44, which connects the fluid loop channel 321 to the extension loop pipe 42.

[0165] Furthermore, as a preferred embodiment, the conduit extension section 4 includes: a heat insulation layer 41, which covers the extension inlet pipe 43 and the extension return pipe 42, and the heat insulation suction channel 323 is connected to the interior of the heat insulation layer 41.

[0166] Preferably, the air inside the heat-insulating suction channel 323, heat-insulating pipe 21, and heat-insulating layer 41 can be extracted to form a vacuum heat insulation effect.

[0167] Furthermore, as a preferred embodiment, the first end of the fluid diversion and return component 33 is connected to one of the refrigerant inlet 23, the fluid inlet channel 322, and the extended inlet pipe 43;

[0168] Furthermore, as a preferred embodiment, the second end of the fluid diversion and return component 33 is inserted into one of the refrigerant circuit 22, the fluid circuit channel 321, and the extension circuit pipe 42.

[0169] In other words, it should be noted that the fluid diversion structure 3 can be set at any position, such as the conduit body section 2, the conduit extension section 4, or the handle 5 described below, to divert different amounts of phase change gas in advance, reduce refrigerant delivery resistance, and shorten pre-cooling time.

[0170] In this embodiment, the first end of the fluid diversion and return component 33 is inserted into the fluid inlet channel 322, thereby connecting with the fluid inlet channel 322.

[0171] In this embodiment, the second end of the fluid diversion and return component 33 is inserted into the fluid loop channel 321, thereby connecting with the fluid loop channel 321.

[0172] Preferably, the outlet end, i.e. the second end, of the fluid diversion and return component 33 can be a nozzle to increase the fluid velocity at the outlet through the Venturi effect and enhance the ejection effect in the local low-pressure area.

[0173] More preferably, as an embodiment, the end face of the second end of the fluid diversion and return member 33 is located further away from the cryoablation catheter in the axial position than the axial position of the loop adapter 44 in the cryoablation catheter, which has a better ejection effect.

[0174] In other words, please see Figure 3 As shown, the end of the second end of the fluid diversion and return component 33 is located on the right side of the loop adapter 44.

[0175] More preferably, as a supplement to this embodiment, the outlet end of the fluid diversion and return component 33 may be inserted into the loop adapter 44.

[0176] Furthermore, as a preferred embodiment, the fluid diversion and return component 33 is provided with a valve 37 for controlling the opening or closing of the pipeline of the fluid diversion and return component 33.

[0177] More specifically, valve 37 can be a two-way valve, a cryogenic solenoid valve, or a throttle valve, etc., used to control the opening and closing of the pipeline of fluid diversion and return component 33 and / or regulate the flow rate of fluid diversion and return component 33.

[0178] When valve 37 is open, fluid flows through fluid diversion and return element 33 into extension circuit pipe 42 for discharge.

[0179] Once the pipeline is fully pre-cooled, valve 37 can be closed to disconnect the fluid diversion and return component 33 from the extension loop pipe 42, thereby preventing refrigerant diversion and maximizing the utilization of the refrigerant.

[0180] Furthermore, as a preferred embodiment, the fluid diversion and return component 33 includes: a first end, a second end, and a connecting portion connecting the first end and the second end.

[0181] Preferably, the length of the first end of the fluid diversion and return member 33 is less than the length of its second end.

[0182] Furthermore, as a preferred embodiment, the connecting portion penetrates the wall of the fluid diversion body 32 and surrounds the fluid diversion body 32.

[0183] Preferably, the connecting part has an annular structure with an opening.

[0184] For a more preferred option, please refer to Figure 3 As shown, the inner wall of the outer handle 31 has a groove for accommodating the connecting portion of the fluid diversion and return component 33. This groove limits the connecting portion of the fluid diversion and return component 33 from the front end to the rear end. Figure 3 Limits in the left and right directions.

[0185] Specifically, the groove is located at the third part of the outer handle 31.

[0186] Furthermore, in a preferred embodiment, the valve 37 is located at the connection of the fluid diversion and return member 33.

[0187] Furthermore, as a preferred embodiment, it also includes: a handle 5, which includes: an inlet connecting pipe 55 connected to the extended inlet pipe 43, an outlet connecting pipe 54 connected to the extended outlet pipe 42, and a handle heat insulation member 57 sleeved on the extended inlet pipe 43 and the extended outlet pipe 42.

[0188] Preferably, one end of the handle heat insulation member 57 is inserted into the heat insulation layer 41.

[0189] Furthermore, as a preferred embodiment, the handle 5 also includes: a handle sleeve 51 and a handle base 52, which are detachably connected. The interior of the handle sleeve 51 and the handle base 52 forms an accommodating space for accommodating the inlet connecting pipe 55, the outlet connecting pipe 54, a portion of the extended inlet pipe 43 and a portion of the extended outlet pipe 42, and the handle heat insulation member 57.

[0190] Furthermore, in a preferred embodiment, the handle 5 also includes two interfaces 53, both of which pass through the handle base 52 and are respectively connected to the inlet connecting pipe 55 and the outlet connecting pipe 54.

[0191] This embodiment also provides a method for operating a cryoablation catheter, the method including: providing refrigerant to the cryoprobe 1 through a first channel; a portion or all of the refrigerant entering a second channel through a fluid diversion and return element 33, forming a low pressure in a local area of ​​the second channel; monitoring the pressure change inside the cryoprobe 1 to determine whether there is a leak in the cryoprobe.

[0192] Second embodiment:

[0193] Please see Figure 7 The image shows a second preferred embodiment of the cryoablation catheter, which is similar to the first embodiment, including: a cryoprobe 1, a first channel and a second channel, wherein the first channel is connected to the cryoprobe 1 and is used to provide coolant to the interior of the cryoprobe 1; the second channel is connected to the cryoprobe 1 and is used to draw coolant out from the interior of the cryoprobe 1; and a fluid diversion and return element 33 connecting the first channel and the second channel is also included.

[0194] The fluid diversion and return component 33 has a first end connected to the first channel and a second end connected to the second channel.

[0195] The second end of the fluid diversion and return component 33 is inserted into the second channel, and the second channel is formed at the fluid diversion and return component 33 with a front side close to the freezing probe 1 and a rear side away from the freezing probe 1.

[0196] The port at the second end of the fluid diversion and return component 33 is arranged facing the rear side of the second channel.

[0197] When the refrigerant enters the second channel from the first channel through the fluid diversion and return component 33, a local low pressure is formed on the front side of the second channel.

[0198] Furthermore, as a preferred embodiment, the freezing probe 1 includes: a freezing probe head end 11, a freezing probe body 12, and a refrigerant outlet pipe 13.

[0199] The refrigerant outlet pipe 13 is located inside the freezing probe body 12. The interior of the refrigerant outlet pipe 13 is connected to the first channel. A spray hole 131 is opened on the refrigerant outlet pipe 13. A freezing cavity is formed between the exterior of the refrigerant outlet pipe 13 and the interior of the freezing probe body 12. The freezing cavity is connected to the second channel.

[0200] The freezing probe head 11 is located inside the freezing probe body 12 and at the end of the refrigerant outlet pipe 13.

[0201] Furthermore, as a preferred embodiment, it includes a conduit body segment 2, which includes a refrigerant inlet 23 connected to the freezing probe 1, and the interior of the refrigerant inlet 23 forms part of a first channel.

[0202] Furthermore, in a preferred embodiment, the conduit body segment 2 includes: a refrigerant circuit 22, which is connected to the freezing probe 1, and the interior of the refrigerant circuit 22 forms part of a second channel, and the refrigerant circuit 22 surrounds the refrigerant inlet 23.

[0203] Furthermore, as a preferred embodiment, the conduit body segment 2 includes: a heat-insulating pipe 21 covering the refrigerant inlet 23 and the refrigerant circuit 22.

[0204] Furthermore, as a preferred embodiment, a fluid diversion structure 3 is included, which includes:

[0205] The fluid distribution main body 32 has a columnar structure and a fluid cavity is formed along the axial direction of the columnar structure. The fluid cavity is a fluid inlet channel and is connected to the refrigerant inlet 23. The fluid inlet channel forms part of the first channel.

[0206] The intake adapter 34 has one end connected to the fluid inlet channel;

[0207] The diversion seal 35 is sleeved outside the fluid diversion body 32 and is sealed between the diversion seal 35 and the air inlet adapter 34. One end of the diversion seal 35 is connected to the refrigerant circuit 22. The interior of the diversion seal 35 is a fluid circuit channel, which forms part of the second channel.

[0208] Furthermore, as a preferred embodiment, it includes a conduit extension section 4, which includes an extension inlet pipe 43. The other end of the air intake adapter is connected to the extension inlet pipe, and the interior of the extension inlet pipe forms part of a first channel.

[0209] Furthermore, in a preferred embodiment, the conduit extension section 4 includes: an extension circuit pipe 42, one end of the shunt seal being connected to the extension circuit pipe, and the interior of the extension circuit pipe forming part of a second channel.

[0210] Furthermore, as a preferred embodiment, the conduit extension section 4 includes: a heat insulation layer 41, which covers the extension inlet pipe 43 and the extension return pipe 42.

[0211] Furthermore, as a preferred embodiment, it also includes: a central heat insulation pipe 36, which connects the heat insulation pipe 21 and the heat insulation layer 41.

[0212] Furthermore, as a preferred embodiment, one end of the fluid diversion and return component 33 is inserted into the fluid diversion main component 32 and connected to the fluid inlet channel.

[0213] Furthermore, as a preferred embodiment, the other end of the fluid diversion and return component 33 is inserted into the extension loop pipe 42 and connected to the extension loop pipe 42.

[0214] Furthermore, as a preferred embodiment, the fluid splitter body 32 is provided with a valve 37 for controlling the connection or closure between the refrigerant inlet 23 and the fluid inlet channel of the fluid splitter body 32.

[0215] Furthermore, as a preferred embodiment, the fluid diversion and return component 33 extends along the axial direction of the cryoablation catheter, and a bend is formed in the middle of the fluid diversion and return component 33.

[0216] Furthermore, as a preferred embodiment, the fluid diversion structure 3 further includes: an outer handle 31, which covers a portion of the refrigerant inlet 23 and the refrigerant circuit 22, and the outer handle 31 also covers at least a portion or all of the fluid diversion body 32.

[0217] Furthermore, as a preferred embodiment, it also includes: a handle 5, which includes: an inlet connecting pipe 55 connected to the extended inlet pipe 43, an outlet connecting pipe 54 connected to the extended outlet pipe 42, and a handle heat insulation member 57 sleeved on the extended inlet pipe 43 and the extended outlet pipe 42.

[0218] Preferably, one end of the handle heat insulation member 57 is inserted into the heat insulation layer 41.

[0219] Furthermore, as a preferred embodiment, the handle 5 also includes: a handle sleeve 51 and a handle base 52, which are detachably connected. The interior of the handle sleeve 51 and the handle base 52 forms an accommodating space for accommodating the inlet connecting pipe 55, the outlet connecting pipe 54, a portion of the extended inlet pipe 43 and a portion of the extended outlet pipe 42, and the handle heat insulation member 57.

[0220] Furthermore, in a preferred embodiment, the handle 5 also includes two interfaces 53, both of which pass through the handle base 52 and are respectively connected to the inlet connecting pipe 55 and the outlet connecting pipe 54.

[0221] In this embodiment, during the pre-cooling stage, valve 37 is closed, which disconnects the extended inlet pipe 43, the air inlet adapter 34 from the refrigerant inlet 23. The refrigerant flows through the extended inlet pipe 43, the air inlet adapter 34, the fluid diversion main body 32, the fluid diversion return component 33, and the extended circuit pipe 42. The high-speed flowing refrigerant forms a low-pressure area at the outlet of the fluid diversion return component 33, which drives the fluid in the refrigerant circuit 22 to the extended circuit pipe 42, causing the pressure of the freezing probe 1 to drop. By monitoring the pressure change in the freezing probe 1, it is determined whether there is a leak in the freezing probe 1, thereby improving the safety of product use.

[0222] In this embodiment, the formation of the low-pressure zone further increases the flow rate of the refrigeration probe 1 and the refrigerant circuit 22, shortening the pre-cooling time.

[0223] In this embodiment, a valve 37 is provided on the fluid diversion and return component 33 to control the on / off state and flow rate of the fluid diversion and return component 33 and the extension loop pipe 42.

[0224] Specifically, in this embodiment, during the pre-cooling stage, the refrigerant cannot enter the refrigerant inlet 23 or the freezing probe 1, and will not affect the freezing probe.

[0225] Third embodiment:

[0226] Please see Figure 8 As shown, a third preferred embodiment of the cryoablation catheter is presented, which is substantially the same as the second embodiment, except that valve 37 is not provided.

[0227] This embodiment has a simple structure and low manufacturing cost.

[0228] Fourth embodiment:

[0229] Please see Figure 9 As shown, a fourth preferred embodiment of the cryoablation catheter is illustrated, whose catheter structure (i.e., fluid inlet channel 322 and fluid return channel 321, extension inlet tube 43 and extension return tube 42, etc.) is similar to that of the first to third embodiments described above.

[0230] Of course, the fourth embodiment may also include, for example, the handle 5 and related structures indicated in the first embodiment.

[0231] The main difference between the fourth embodiment and the other embodiments is that a diversion channel 324 is formed between the fluid loop channel 321 and the fluid inlet channel 322.

[0232] More specifically, it directly forms a diversion channel 324 between the fluid loop channel 321 and the fluid inlet channel 322.

[0233] Specifically, the cryoablation catheter of the fourth preferred embodiment includes: a cryoprobe 1, a first channel connected to the cryoprobe 1 for supplying coolant to the interior of the cryoprobe 1, and a second channel connected to the cryoprobe 1 for leading coolant out from the interior of the cryoprobe 1.

[0234] A diversion channel 324 is formed between the first channel and the second channel, connecting the first channel and the second channel. The diversion channel 324 forms a diversion inlet at the first channel and a diversion outlet at the second channel.

[0235] Furthermore, as a preferred embodiment, when the refrigerant enters the second channel from the first channel via the diversion channel 324, a local low pressure is formed at the diversion outlet.

[0236] Furthermore, as a preferred embodiment, negative pressure is provided at the second channel via a negative pressure device.

[0237] Furthermore, as a preferred embodiment, it includes: a fluid diversion structure 3, the fluid diversion structure 3 including a fluid diversion main body 32, the fluid diversion main body 32 having a fluid inlet channel 322, a fluid return channel 321, and a diversion channel 324 connecting the fluid inlet channel 322 and the fluid return channel 321.

[0238] Furthermore, as a preferred embodiment, the fluid inlet channel 322 forms part of the first channel, and the fluid loop channel 321 forms part of the second channel.

[0239] Furthermore, as a preferred embodiment, the fluid inlet channel 322 and the fluid return channel 321 are arranged side by side.

[0240] Specifically, the gas generated by the phase change of the refrigerant creates high pressure in the fluid inlet channel 322, hindering the input of refrigerant. The generated gas is discharged through the diversion channel 324 into the fluid return channel 321, thus reducing the pressure in the fluid inlet channel 322.

[0241] Furthermore, as a preferred embodiment, it also includes: a refrigerant inlet 23 and a refrigerant circuit 22, wherein the refrigerant inlet 23 is connected to one end of the fluid inlet channel 322, and the refrigerant circuit 22 is connected to one end of the fluid circuit channel 321.

[0242] Furthermore, as a preferred embodiment, the refrigerant inlet 23 and the refrigerant circuit 22 are arranged close to the refrigeration probe 1.

[0243] Furthermore, as a preferred embodiment, it also includes: an extended inlet pipe 43 and an extended return pipe 42, wherein the extended inlet pipe 43 is connected to the other end of the fluid inlet channel 322, and the extended return pipe 42 is connected to the other end of the fluid return channel 321.

[0244] Furthermore, as a preferred embodiment, the extended inlet pipe 43 and the extended return pipe 42 are arranged away from the cryoprobe 1.

[0245] Specifically, under the action of the pressure source, the refrigerant is rapidly delivered to the fluid inlet channel 322, enters the refrigerant inlet 23 and the freezing probe 1, and shortens the pre-cooling time.

[0246] Furthermore, as a preferred embodiment, the negative pressure device is a negative pressure pump, and the extension circuit pipe 42 is connected to the negative pressure pump to provide local low pressure in the second channel.

[0247] When the gas continuously enters the fluid return channel 321, it flows continuously along the direction of the extension circuit pipe 42 under the guidance of the negative pressure pump connected to the extension circuit pipe 42, so that the pressure in the fluid return channel 321 and the extension circuit pipe 42 is lower than that in the refrigerant circuit 22 and the freezing probe 1.

[0248] By monitoring the pressure changes inside the refrigeration probe 1, it is determined whether there is a leak in the refrigeration probe 1, ensuring product safety. It can also drive the fluid in the refrigerant circuit 22 to flow to the extension circuit pipe 42, accelerate the refrigerant delivery, and further shorten the pre-cooling time.

[0249] Furthermore, as a preferred embodiment, it also includes a heat insulation pipe 21 disposed outside the refrigerant inlet 23 and the refrigerant circuit 22.

[0250] Furthermore, as a preferred embodiment, it also includes a heat insulation layer 41 disposed on the outside of the extension inlet pipe 43 and the extension outlet pipe 42.

[0251] Furthermore, in a preferred embodiment, the heat insulation pipe 21 is connected to the heat insulation layer 41.

[0252] Furthermore, as a preferred embodiment, the heat insulation pipe 21 and the heat insulation layer 41 cover the fluid diversion body 32.

[0253] Furthermore, as a preferred embodiment, the fluid diversion body 32 is an integral structure.

[0254] Preferably, the fluid inlet channel 322 and the fluid return channel 321 are channels formed on the fluid diversion body 32, while the diversion channel 324 is a channel that passes through the wall of the fluid inlet channel 322 and the wall of the fluid return channel 321, thereby connecting the two.

[0255] Furthermore, it should be noted that the features in the above four embodiments can be combined with each other without contradiction to form more embodiments.

[0256] The above description is merely a preferred embodiment of the present invention and does not limit the implementation and protection scope of the present invention. Those skilled in the art should realize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A cryoablation catheter, characterized in that, include: Cryoprobe; A first channel connected to the cryoprobe for supplying coolant to the interior of the cryoprobe; A second channel connected to the freezing probe for drawing coolant from the interior of the freezing probe; A diversion channel is formed between the first channel and the second channel, connecting the first channel and the second channel. The diversion channel forms a diversion inlet at the first channel and a diversion outlet at the second channel. When the refrigerant enters the second channel from the first channel through the diversion channel, a local low pressure is formed at the diversion outlet; A fluid diversion and return component connecting the first channel and the second channel, the fluid diversion and return component being a tubular structure, the fluid diversion and return component providing the diversion channel; The fluid diversion and return component has a first end connected to the first channel and a second end connected to the second channel, with the diversion inlet formed at the first end and the diversion outlet formed at the second end; The first channel includes: a refrigerant inlet connected to the freezing probe, a fluid inlet channel connected to the refrigerant inlet, and an extension inlet pipe connected to the fluid inlet channel; The second channel includes: a refrigerant circuit connected to the freezing probe, a fluid circuit channel connected to the refrigerant circuit, and an extension circuit pipe connected to the fluid circuit channel; The diversion channel is connected to one of the refrigerant inlet, the fluid inlet channel, and the extended inlet pipe; The diversion channel is connected to one of the refrigerant circuit, the fluid circuit channel, and the extension circuit pipe.

2. The cryoablation catheter according to claim 1, characterized in that, The diversion channel is equipped with a valve for controlling the opening, closing, and / or regulating the flow rate of the diversion channel.

3. The cryoablation catheter according to claim 2, characterized in that, Both the diversion inlet and the diversion outlet are arranged facing away from the cryoprobe.

4. The cryoablation catheter according to claim 1, characterized in that, The first channel is equipped with a valve for controlling the opening, closing, and / or regulating the flow rate of the diversion channel; The valve is located between the cryoprobe and the diversion channel.

5. A cryoablation catheter according to claim 4, characterized in that, The diversion inlet is arranged toward the cryoprobe, and the diversion outlet is arranged in a direction opposite to the cryoprobe.

6. The cryoablation catheter according to claim 1, characterized in that, Also includes: A negative pressure pump, which is connected to the second channel.

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