Flexible delivery device for ablation system

Abstract

The present application relates to a kind of flexible delivery device of ablation system, it is related to the field of ablation technology.The flexible delivery device of ablation system of the present application includes distal end side assembly, the first docking device is included in the distal end side assembly, first flow channel and first return flow channel are respectively arranged in the first docking device, the first flow channel is aligned with the inlet tube for transporting working medium to ablation needle and is in fluid communication, the first return flow channel is aligned with the return flow tube for accepting the working medium returned in ablation needle and is in fluid communication;Exhaust hole is also provided in the first docking device, the exhaust hole is respectively in fluid communication with the first flow channel and the first return flow channel.

Description

[0001] This application is a divisional application of Chinese Patent CN202411360123.6, filed on September 27, 2024, entitled "Flexible Delivery Device and Ablation System for Ablation System". Technical Field

[0002] This invention relates to the field of ablation technology, and particularly to a flexible delivery device for an ablation system. Background Technology

[0003] The combined cryo-thermal ablation technique involves alternately delivering cold and hot working fluids to the tumor lesion tissue in the human body, directly applying physical stimulation of deep freezing (minimum temperature -196℃) and heating (above 80℃) to the lesion tissue, causing tumor cells to swell and rupture, and the pathological manifestations of tumor tissue show irreversible congestion, edema, degeneration, and coagulative necrosis.

[0004] Cold and hot combined ablation is typically performed using an ablation needle and a delivery device. The delivery device delivers both cold and hot working fluids to the ablation needle. Currently, the inlet and return tubing in these delivery devices is made of relatively rigid metal. On one hand, welding defects can occur when welding metal tubing, potentially leading to leaks. On the other hand, metal tubing requires extreme care during use; it cannot be bent arbitrarily, as this can easily damage it, especially during procedures requiring imaging of the ablation area and repeated bed movements, which could cause the tubing to bend and leak. Given these issues with metal tubing, replacing it with flexible tubing is being considered. However, ensuring the airtightness of the flexible tubing connections remains a critical technical challenge. Summary of the Invention

[0005] The present invention provides a flexible delivery device for an ablation system, which solves at least one of the above-mentioned technical problems.

[0006] The present invention provides a flexible delivery device for an ablation system, including a distal side component. The distal side component includes a first docking device, wherein the first docking device is provided with a first inlet channel and a first return channel passing through the first docking device. The first inlet channel is aligned with and in fluid communication with an inlet pipe for delivering working fluid to an ablation needle, and the first return channel is aligned with and in fluid communication with a return pipe for receiving working fluid returned from the ablation needle.

[0007] The first docking device is also provided with an exhaust port, which is in fluid communication with the first inlet channel and the first return channel.

[0008] In one embodiment, the diameter of the vent hole is smaller than the diameter of the first inlet channel or the diameter of the first return channel.

[0009] In one embodiment, the radial cross-sectional area S1 of the vent is smaller than the cross-sectional area S2 of the cold working fluid outlet at the tip of the ablation needle.

[0010] In one embodiment, the diameter d of the vent hole is 0.3 mm to 0.5 mm.

[0011] In one embodiment, the exhaust port is inclined, and the axis of the exhaust port has an angle α1 with the axis of the first inlet channel, the angle α1 being in the range of 0° to 90°.

[0012] In one embodiment, one side of the first docking device is provided with a pin for docking with the ablation pin, the first inlet channel extends through the pin, the axis of the pin and the axis of the first inlet channel have an angle θ1 formed by an obtuse angle, the axis of the vent hole and the axis of the first return channel have an angle α2, the value of the angle α2 is in the range of (180°~θ1)~90°.

[0013] In one embodiment, a pin for docking with an ablation needle is provided on one side of the first docking device, and the first inlet channel extends through the pin. The axis of the pin and the axis of the first inlet channel have an angle θ1, which is configured such that the center point of the first inlet channel on the axial section of the first docking device is symmetrical with respect to the overall center of the first docking device with respect to the center point of the first return channel.

[0014] In one embodiment, one side of the first docking device is provided with a pin for docking with an ablation needle, the first inlet channel extends through the pin, the axis of the pin, the axis of the first inlet channel and the axis of the first return channel are parallel to each other, and the axis of the pin is parallel to and offset from the axis of the first return channel.

[0015] In one embodiment, the first docking device is further provided with a first plug portion, which is used to seal the hole formed when constructing the first inlet channel from the side, and the first return channel directly penetrates the first docking device.

[0016] In one embodiment, the distal-side assembly further includes a first connecting device located on one side of the first docking device. The first connecting device employs a connection method suitable for flexible tubes or a connection method suitable for metal tubes to achieve fluid sealing between the inlet tube and the first docking device, and between the return tube and the first docking device.

[0017] Compared with the prior art, the advantages of the present invention are that, since both the inlet and outlet pipes are flexible pipes, they are more flexible and can be bent arbitrarily in the desired direction. Therefore, even if the bed is moved repeatedly during surgery, there will be no leakage problems caused by bending / flattening, which is more conducive to the doctor's operation and thus improves surgical efficiency. For the flexible inlet and outlet pipes, and by deforming the inlet and outlet pipes through the first connecting device to press them tightly onto the first side of the first docking device, the fluid sealing performance between the inlet pipe and the first docking device and between the outlet pipe and the first docking device can be guaranteed, thereby solving the sealing problem at the connection of flexible pipes. Attached Figure Description

[0018] The invention will now be described in more detail with reference to embodiments and the accompanying drawings.

[0019] Figure 1 This is a schematic diagram of the flexible delivery device of the ablation system in an embodiment of the present invention;

[0020] Figure 2a This is a cross-sectional view of the flexible delivery device of the ablation system in an embodiment of the present invention, wherein only the distal side is shown;

[0021] Figure 2b yes Figure 2a Enlarged view of the distal end of the flexible delivery device in the ablation system;

[0022] Figure 3a This is a cross-sectional view of the flexible delivery device of the ablation system in an embodiment of the present invention, wherein only the proximal side is shown;

[0023] Figure 3b yes Figure 3a Enlarged view of the proximal side of the flexible delivery device in the ablation system;

[0024] Figure 4 This is a three-dimensional structural schematic diagram of the flexible delivery device of the ablation system in an embodiment of the present invention;

[0025] Figure 5 This is a schematic diagram of the working fluid flow in the flexible delivery device of the ablation system in an embodiment of the present invention;

[0026] Figure 6This is a three-dimensional structural schematic diagram of the first docking device in one embodiment of the present invention;

[0027] Figure 7 yes Figure 6 A cross-sectional view of the first docking device shown;

[0028] Figure 8 This is a cross-sectional view of the first docking device in one embodiment of the present invention;

[0029] Figure 9 This is a cross-sectional view of the second docking device in one embodiment of the present invention;

[0030] Figure 10 yes Figure 9 A cross-sectional view of the second docking device shown;

[0031] Figure 11 This is a cross-sectional view of the second docking device in another embodiment of the present invention;

[0032] Figure 12 This is an exploded view of the first docking device, the inlet pipe, and the return pipe in one embodiment of the present invention;

[0033] Figure 13 yes Figure 12 The first docking device, inlet pipe, and return pipe are shown in a cross-sectional view after installation.

[0034] Figure 14 This is a three-dimensional structural diagram of the reflux pipe in an embodiment of the present invention;

[0035] Figure 15 This is an exploded view of the first docking device, the inlet pipe, and the return pipe in another embodiment of the present invention;

[0036] Figure 16 yes Figure 15 The first docking device, inlet pipe, and return pipe are shown in a cross-sectional view after installation.

[0037] Figure 17 yes Figure 15 A three-dimensional structural diagram of the first plug shown;

[0038] Figure 18 This is a cross-sectional view of the first docking device, the inlet pipe, and the return pipe after installation in another embodiment of the present invention;

[0039] Figure 19 yes Figure 18 A three-dimensional structural diagram of the second plug is shown;

[0040] Figure 20 This is a cross-sectional view of the first docking device in yet another embodiment of the present invention.

[0041] Figure label:

[0042] 101. Distal side quick-connect assembly;

[0043] 102. Outer cannula; 1021. First protrusion;

[0044] 103. Distal handle housing; 1031. Second protrusion;

[0045] 2. First docking device;

[0046] 21. First plug; 22. Second plug; 23. Compression ring; 24. Fastener; 25. Vent hole;

[0047] 211. First clamping platform; 212. Guide section; 221. Second clamping platform; 222. Conical head;

[0048] 201. First inlet channel; 202. First return channel; 203. Insert pin; 204. First plug section;

[0049] 105. First connecting device; 1051. First pressure plate; 1052. Second pressure plate; 1053. Third pressure plate; 1055. Tapered hole; 1056. Tapered hole;

[0050] 106. Return pipe; 107. Inlet pipe;

[0051] 1061, Second flange; 1071, First flange;

[0052] 108. Heat shrink tubing; 109. Fixing sleeve; 110. Insulation sleeve;

[0053] 111. Proximal handle housing;

[0054] 112. Proximal quick-connect assembly; 1121. Groove; 1122. Third protrusion;

[0055] 113. Second connecting device; 115. Fixing base; 116. Insert tube; 117. Retainer; 118. Clamping element; 119. Sealing element;

[0056] 3. Second docking device; 31. Second inlet flow channel; 32. Second return flow channel; 33. Connector; 34. Second plug. Detailed Implementation

[0057] The invention will now be further described with reference to the accompanying drawings.

[0058] Example 1

[0059] like Figures 1-14As shown, the present invention provides a flexible delivery device for an ablation system, including an inlet pipe 107, a return pipe 106, a distal side assembly, and a proximal side assembly.

[0060] The inlet tube 107 is used to deliver the working fluid to the ablation needle. The working fluid includes a cold working fluid and a hot working fluid. The cold working fluid can be, for example, liquid nitrogen, and the hot working fluid can be, for example, anhydrous ethanol. (Please refer to...) Figure 5 The arrows indicate the flow direction of the working fluid in the flexible conveying device. For example... Figure 5 As shown, after the working fluid is delivered from the inlet pipe 107 to the distal side of the ablation needle, it exchanges heat with the target area in the ablation region on the distal side of the ablation needle. After the heat exchange, the working fluid returns to the proximal side of the ablation needle and enters the return pipe 106. Therefore, the return pipe 106 is used to receive the working fluid returned from the ablation needle.

[0061] like Figure 2a As shown, the distal component is located on the side closest to the ablation needle (e.g. Figure 1 (as shown on the lower side), which is used to connect the inlet tube 107 and the return tube 106 to the ablation needle respectively.

[0062] Specifically, such as Figure 2a As shown, and please refer to Figure 4 , Figure 6 and Figure 7 The remote-side component includes a first docking device 2 and a first connecting device 105.

[0063] The first side of the first docking device 2 (e.g.) Figure 2a The upper side (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively, and the second side of the first docking device 2 (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively. Figure 2a The lower side (shown) is used for fluid communication with the ablation needle. Therefore, the function of the first docking device 2 is to form a bridge between the ablation needle and the inlet pipe 107 and return pipe 106 of the flexible delivery device, that is, to deliver the working medium in the inlet pipe 107 to the ablation needle, and to deliver the working medium in the ablation needle after heat exchange to the return pipe 106.

[0064] The first connecting device 105 is located on the first side of the first docking device 2. For example... Figure 2a As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the first connecting device 105. The first connecting device 105 is configured to deform the inlet pipe 107 and the return pipe 106 to press them against the first side of the first docking device 2, so that there is a fluid seal between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2.

[0065] Furthermore, since both the inlet pipe 107 and the return pipe 106 are plastic pipes, the first connecting device 105 can deform the inlet pipe 107 and the return pipe 106 by squeezing them, thereby pressing the inlet pipe 107 and the return pipe 106 onto the first side of the first docking device 2. This achieves a reliable fluid seal between the inlet pipe 107 and the first docking device 2, and between the return pipe 106 and the first docking device 2.

[0066] On the one hand, the plastic pipes can be made of low-temperature resistant materials (because the inlet pipe 107 and return pipe 106 need to transport cold working fluid, and their operating temperature can reach -196°C), such as polytetrafluoroethylene (PTFE), soluble polytetrafluoroethylene (PFA), or perfluoroalkyl polymers (FEP). Since plastic pipes are generally produced by extrusion molding, there are fewer defects and a higher yield in their production, thus saving costs.

[0067] On the other hand, both the inlet tube 107 and the return tube 106 are made of plastic. Compared to existing solutions using metal tubes as inlet and return lines, the inlet tube 107 and return tube 106 of this invention are more flexible, allowing for arbitrary bending without any limitation on the bending radius. During surgery, when the ablation area needs to be observed and the bed is repeatedly moved, the inlet tube 107 and return tube 106 can be bent and reshaped to adapt to the bed's position, thus solving the leakage problem caused by excessive bending in existing solutions using metal tubes as inlet and return lines.

[0068] like Figure 12 As shown, in this embodiment 1, the first connecting device 105 can be the structural form of the first pressure plate 1051. Please refer to... Figure 13 The first pressure plate 1051 is provided with a through hole for the inlet pipe 107 and the return pipe 106 to pass through. The outer diameter of the first pressure plate 1051 is the same as the outer diameter of the first docking device 2. After the first pressure plate 1051 presses the inlet pipe 107 and the return pipe 106 onto the first docking device 2, the two form a structure with a uniform shape.

[0069] For details, please refer to Figure 12 , Figure 13 and Figure 14 The inlet pipe 107 has a first flange 1071 at its proximal end, and the outer diameter of the first flange 1071 is larger than the outer diameter of the inlet pipe 107. Similarly, the return pipe 106 has a second flange 1061 at its proximal end, and the outer diameter of the second flange 1061 is larger than the outer diameter of the return pipe 106.

[0070] The inlet pipe 107 and the return pipe 106 pass through the first connecting device 105. Therefore, the first connecting device 105 and the first docking device 2 sandwich the first flange 1071 and the second flange 1061 between them. When a fastening force is applied to the first connecting device 105, the first flange 1071 and the second flange 1061 can be squeezed to deform them, thereby pressing them tightly on the first side of the first connecting device 105.

[0071] By pressing the first flange 1071 and the second flange 1061 of the inlet pipe 107 and the return pipe 106 together, the reliability of the seal between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2 can be guaranteed, ensuring that the working fluid will not leak from their connection.

[0072] Furthermore, such as Figure 13 As shown, the sum of the diameters of the first flange 1071 and the second flange 1061 is less than or equal to the diameter of the first docking device 2. That is, when the first flange 1071 and the second flange 1061 are pressed onto the first docking device 2, there will be no overlap between them, because the overlap would cause the first connecting device 105 to not apply force evenly, which may lead to seal failure.

[0073] The first flange 1071 and the second flange 1061 are formed as follows: First, the inlet pipe 107 and the return pipe 106 are respectively passed through the first connecting device 105. Then, the ends of the inlet pipe 107 and the return pipe 106 are flanged using a flange-flanging tool to form the first flange 1071 and the second flange 1061.

[0074] Understandably, the first flange 1071 and the second flange 1061 can also be fixed to the ends of the inlet pipe 107 and the return pipe 106 by means of bonding or welding after the inlet pipe 107 and the return pipe 106 respectively pass through the first connecting device 105.

[0075] like Figure 4 , Figure 12 and Figure 13 As shown, the first connecting device 105 and the first docking device 2 can be fixedly connected by fastener 24. Therefore, as Figure 12 As shown, corresponding connection holes for receiving fasteners 24 can be provided on the first connecting device 105 and the first docking device 2. Understandably, by adjusting the tightening force of the fasteners 24, the degree of compression and deformation of the first flange 1071 and the second flange 1061 between the first connecting device 105 and the first docking device 2 can be adjusted. The number of fasteners 24 can be set as needed.

[0076] Please refer to Figure 6 and Figure 7The first docking device 2 is provided with a first inlet channel 201 and a first return channel 202 that penetrate through the first docking device 2. For example... Figure 13 As shown, the inlet pipe 107 is aligned with and fluidly connected to the first inlet channel 201, and the return pipe 106 is aligned with and fluidly connected to the first return channel 202.

[0077] Furthermore, the inner diameter of the inlet pipe 107 is equal to the inner diameter of the first inlet channel 201, and the inner diameter of the return pipe 106 is equal to the inner diameter of the first return channel 202, so as to ensure that the flow rate of the working fluid is not affected.

[0078] Furthermore, the second side of the first docking device 2 is provided with a pin 203 for docking with the ablation needle, such as... Figure 7 As shown, the first inlet channel 201 extends to the through-pin 203. The pin 203 is inserted into the proximal end of the ablation needle, thereby communicating with the inlet channel of the ablation needle in fluid communication; in addition, the first docking device 2 is located in the return channel of the ablation needle, so the return channel of the ablation needle is in fluid communication with the first return channel 202.

[0079] Therefore, the working fluid in the inlet tube 107 can enter the first inlet channel 201 and be supplied to the distal end of the ablation needle through the insertion pin 203. After heat exchange at the distal end of the ablation needle, the working fluid returns to the proximal end of the ablation needle and enters the first return channel 202 from the return channel of the ablation needle, and then enters the return tube 106.

[0080] In some implementations, such as Figure 7 As shown, the axis of the insertion pin 203 is parallel to the axis of the first return channel 202, and the axis of the insertion pin 203 is parallel to the axis of the first inlet channel 201. The insertion pin 203 is coaxially arranged with the first docking device 2, which ensures the coaxiality between the ablation needle and the flexible delivery device after the insertion pin 203 is inserted into the ablation needle.

[0081] The axis of the first return channel 202 is parallel to and offset from the axis of the insert pin 203, so as to facilitate physical isolation between the first return channel 202 and the first inlet channel 201.

[0082] like Figure 6 and Figure 7 As shown, the first docking device 2 is also provided with a first plug 204, which is used to seal the first inlet channel 201 from the side. In order to facilitate the processing of the first inlet channel 201, a hole can be drilled in the side of the first docking device 2 to form the first inlet channel 201, and the opening formed during drilling can be sealed by the first plug 204, so that the first inlet channel 201 forms a passage that runs through the first docking device 2 in the axial direction.

[0083] In other implementations, such as Figure 8 As shown, the axis of the pin 203 is parallel to the axis of the first return channel 202, and there is an angle θ1 between the axis of the pin 203 and the axis of the first inlet channel 201.

[0084] like Figure 8 As shown, the included angle θ1 can be an obtuse angle. This structure, by tilting the first inlet channel 201, allows for drilling from the end of the first docking device 2 during processing, thereby forming the first inlet channel 201 that penetrates the first docking device 2 (and the pin 203). Therefore, this structure eliminates the need for the aforementioned first plug 204, resulting in a simpler structure, easier processing, and the ability to form the device in a single drilling operation.

[0085] The included angle θ1 can be configured such that the center point of the first inlet channel 201 on the axial section of the first docking device 2 and the center point of the first return channel 202 are symmetrical about the overall center of the first docking device 2, so that the pressing force applied to the first flange 1071 and the second flange 1061 is more uniform, that is, the force on the first flange 1071 and the second flange 1061 is more uniform and there is no overlap of the force.

[0086] Since the first return flow channel 202 directly penetrates the first docking device 2, therefore Figure 7 and Figure 8 In both embodiments shown, the first return channel 202 can be formed by directly drilling a hole from one end of the first docking device 2, or by drilling holes from both ends of the first docking device 2 respectively.

[0087] like Figure 20 As shown, the first docking device 2 is also provided with an exhaust port 25, which is in fluid communication with the first inlet channel 201 and the first return channel 202 respectively.

[0088] The specific structure of the first docking device 2 can be... Figure 6 and Figure 7 The structure shown, where the axis of the insert pin 203 is parallel to the axis of the first inlet channel 201, can also be... Figure 8 The pin 203 shown has an angle θ1 between its axis and the axis of the first inlet channel 201.

[0089] like Figure 20 As shown, the structure in which the axis of the insert 203 forms an angle θ1 with the axis of the first inlet channel 201 is illustrated, wherein the exhaust port 25 is in fluid communication with the first inlet channel 201 and the first return channel 202 respectively.

[0090] By setting the vent 25, the cooling speed of the ablation needle can be increased, making the ice ball in the ablation area of ​​the ablation needle form faster and better, and the freezing and ablation effect better.

[0091] Please continue reading Figure 3a As shown, the proximal component is located on the side furthest from the ablation needle (e.g., Figure 1 (As shown on the upper side), which is used to connect the inlet pipe 107 and the return pipe 106 to the working fluid source, respectively. The working fluid source may, for example, include a cold tank for storing cold working fluid and a hot tank for storing hot working fluid.

[0092] Specifically, such as Figure 3a As shown, and please refer to Figure 9 and Figure 10 The proximal-side assembly includes a second docking device 3 and a second connecting device 113. The first side of the second docking device 3 (e.g., Figure 3a The lower side shown is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively, and the second side of the second docking device 3 (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively. Figure 3a The upper side shown is connected to the working fluid source via a connecting component.

[0093] In general, the second docking device 3 is similar to the first docking device 2 mentioned above. It serves to form a bridge between the working fluid source and the inlet pipe 107 and return pipe 106 of the flexible conveying device, that is, to transport the working fluid in the working fluid source to the inlet pipe 107 and to collect the working fluid in the return pipe 106 into the recovery device (or to discharge it into the atmosphere).

[0094] The second connecting device 113 is located on the first side of the second docking device 3. For example... Figure 3a and Figure 4 As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the second connecting device 113. The second connecting device 113 is configured to deform the distal ends of the inlet pipe 107 and the return pipe 106, thereby pressing them against the first side of the second docking device 3, so that there is a fluid seal between the inlet pipe 107 and the second connecting device 113 and between the return pipe 106 and the second connecting device 113.

[0095] The second connecting device 113 can be similar to the first connecting device 105. For example, the distal ends of the inlet pipe 107 and the distal ends of the return pipe 106 can both be provided with flange structures. By extruding and deforming the flange structures through the second connecting device 113, the distal ends of the inlet pipe 107 and the distal ends of the return pipe 106 are pressed against the first side of the second docking device 3, thereby ensuring fluid sealing between the distal ends of the inlet pipe 107 and the second docking device 3, and between the distal ends of the return pipe 106 and the second docking device 3.

[0096] The formation method of the flange structure can be referred to the formation method of the first flange 1071 and the second flange 1061, and will not be repeated here.

[0097] like Figure 9 and Figure 10 As shown, the second docking device 3 is provided with a second inlet channel 31 and a second return channel 32 that pass through the second docking device 3. The inlet pipe 107 is aligned with the second inlet channel 31 and is in fluid communication with it, and the return pipe 106 is aligned with the second return channel 32 and is in fluid communication with it.

[0098] A connector 33 is also provided on the second side of the second docking device 3, and the second inlet channel 31 extends through the connector 33. The connector 33 is used to connect with the connecting component, thereby enabling the flexible conveying device to communicate with the working fluid source.

[0099] In some implementations, such as Figure 9 and Figure 10 As shown, the axis of connector 33 and the axis of the second return channel 32 are parallel to each other, and the axis of connector 33 is parallel to the axis of the second inlet channel 31.

[0100] This setting method is similar to... Figure 6 and Figure 7 The first docking device 2 shown is configured similarly, that is, the axis of the connector 33 coincides with the axis of the second docking device 3, and the axis of the second docking device 3 coincides with the axis of the first docking device 2. Therefore, it can be ensured that the axis of the ablation needle coincides with the axis of the flexible delivery device, and that the connection can be perfectly aligned.

[0101] The axis of the second inlet channel 31 is parallel to and offset from the axis of the connector 33, so as to facilitate physical isolation between the second inlet channel 31 and the second inlet channel 32.

[0102] like Figure 9 and Figure 10 As shown, the second docking device 3 is also provided with a second plug 34, which is used to seal the second inlet channel 31 from the side. In order to facilitate the processing of the second inlet channel 31, a hole can be drilled in the side of the second docking device 3 to form the second inlet channel 31, and the opening formed during drilling can be sealed by the second plug 34, so that the second inlet channel 31 forms a passage through the second docking device 3 in the axial direction.

[0103] In other implementations, such as Figure 11 As shown, the axis of connector 33 and the axis of the second return channel 32 are parallel to each other, and there is an angle θ2 between the axis of connector 33 and the axis of the second inlet channel 31.

[0104] like Figure 11As shown, the included angle θ2 can be an acute angle. This structure, by tilting the second inlet channel 31, allows for drilling from the end of the second docking device 3 during processing, thereby forming the second inlet channel 31 that penetrates the second docking device 3 (and the connector 33). Therefore, this structure eliminates the need for the aforementioned second plug 34, resulting in a simpler structure, easier processing, and the ability to be formed in a single drilling operation.

[0105] The included angle θ2 can be constructed such that the center point of the second inlet channel 31 on the axial section of the second docking device 3 and the center point of the second return channel 32 are symmetrical about the overall center of the second docking device 3, so that the pressing force applied to the flange structure is more uniform, that is, the flange structure is more uniformly stressed and will not be subjected to overlapping forces.

[0106] Figure 10 and Figure 11 In both embodiments shown, the second return flow channel 32 can be formed by drilling holes from both ends of the second docking device 3, with the axes of the two holes offset from each other. In other words, the second return flow channel 32 is actually formed by connecting two holes with offset axes. Due to the requirements of miniaturization and lightweighting, the volume of the second docking device 3 cannot be too large. Therefore, the space for forming the second return flow channel 32 and the second inlet flow channel 31 on it is extremely limited. Furthermore, it is necessary to consider various constraints such as effective physical isolation between the second return flow channel 32 and the second inlet flow channel 31, preventing interference between the second return flow channel 32 and the connector 33, and requiring the second docking device 3 to have a certain wall thickness to ensure its strength. Therefore, when forming the second return flow channel 32, a method of connecting two offset holes is adopted.

[0107] Please continue reading Figure 2a The flexible delivery device of the ablation system of the present invention further includes an insulating sleeve 110, a fixing sleeve 109 located outside the insulating sleeve 110, and a heat shrink tube 108 sleeved on the fixing sleeve 109. The first docking device 2, the second docking device 3, the inlet pipe 107 and the return pipe 106 are all arranged inside the insulating sleeve 110.

[0108] Since the inlet pipe 107 and return pipe 106 convey cold or hot working fluids, they are inconvenient to operate. Therefore, an insulating sleeve 110 is installed on the outside. This prevents heat exchange between the working fluid and the environment and ensures safe operation. The insulating sleeve 110, inlet pipe 107, and return pipe 106 are fixed by a fixing sleeve 109 and heat shrink tubing 108, making the flexible conveying device flexible and slender overall, and ensuring its aesthetic appearance.

[0109] The flexible delivery device of the ablation system of the present invention further includes a distal handle housing 103, a distal quick-insertion assembly 101, and an insertion cannula sheath 102. For example... Figure 2a and Figure 2b As shown, the proximal end of the cannula sleeve 102 is inserted into the insulating sleeve 110 and abuts against the distal end of the first docking device 2. The pin 203 of the first docking device 2 is located in the cannula sleeve 102, and the first return channel 202 is in fluid communication with the cannula sleeve 102. The cannula sleeve 102 also receives the proximal end of the ablation needle, thereby the cannula sleeve 102 is in fluid communication with the return channel of the ablation needle, so the working fluid returning from the return channel of the ablation needle enters the first return channel 202 through the cannula sleeve 102.

[0110] like Figure 2a and Figure 2b As shown, the heat shrink tubing 108 has a distal handle housing 103 on its exterior. The distal handle housing 103 covers a portion of the heat shrink tubing 108, allowing the user to grip and operate it. Figure 2b As shown, the distal end of the cannula sleeve 102 is located within the distal end handle housing 103. A first protrusion 1021 is provided on the outer wall of the distal end of the cannula sleeve 102, which is used to engage with a groove on the inner wall of the distal end handle housing 103, thereby fixing it to the distal end handle housing 103.

[0111] In addition, a plurality of second protrusions 1031 are provided at intervals on the inner wall of the distal handle housing 103. The second protrusions 1031 are used to abut against the outer wall of the heat shrink tubing 108 to increase the friction between the distal handle housing 103 and the heat shrink tubing 108, so that the distal handle housing 103 and the heat shrink tubing 108 should not move relative to each other.

[0112] The distal quick-connect assembly 101 is connected to the distal side of the cannula sheath 102. The distal quick-connect assembly 101 is used for quick connection with the proximal side of the ablation needle to facilitate quick replacement of ablation needles of different diameters. The distal quick-connect assembly 101 can adopt various quick-connect structures known in the prior art, which will not be described in detail in this invention.

[0113] Please see Figure 3a and Figure 3b The flexible delivery device of the ablation system of the present invention further includes a proximal handle housing 111, a proximal quick-connect assembly 112, a fixing base 115, an insertion tube 116, a retainer 117, and a clamping member 118. The proximal handle housing 111 is disposed on the outside of the proximal side of the heat shrink tubing 108 and covers a portion of the heat shrink tubing 108, and the user can grip and operate it through the distal handle housing 103.

[0114] The proximal quick-connect assembly 112 is inserted into the proximal end of the proximal handle housing 111 and covers the heat shrink tubing 108, which is used for quick connection with the working fluid source. Figure 3b As shown, a third protrusion 1122 is provided on the outer wall of the proximal quick-connect assembly 112, which is used to engage with a groove on the inner wall of the proximal handle housing 111, thereby fixing it to the distal handle housing 103. A plurality of grooves 1121 are also provided at intervals on the outer wall of the proximal quick-connect assembly 112, which are used to connect with the pipeline of the working fluid source.

[0115] Please continue reading Figure 3b The mounting base 115 is fixedly connected to the proximal side of the proximal quick-connect assembly 112. A cannula 116 passes through the mounting base 115, with one end inserted into the connector 33 of the second docking device 3 and the other end inserted into the retainer 117. A clamping member 118 at the proximal end of the retainer 117 secures the retainer 117 to the mounting base 115. The clamping member 118 may be, for example, a clamping nut.

[0116] The clamping member 118 is also provided with a sealing member 119. The clamping member 118 presses the sealing member 119 against the near end of the retainer 117 to ensure a sealed connection between the insertion tube 116 and the working fluid source.

[0117] The assembly process of the ablation needle delivery system in this embodiment 1 is as follows:

[0118] First, a distal quick-connect assembly is fixed at the distal end of the cannula sheath 102, and a first docking device 2 is fixed at its proximal end.

[0119] Next, the distal ends of the inlet pipe 107 and the return pipe 106 are respectively passed through the first pressure plate 1051, and the distal ends of the inlet pipe 107 and the return pipe 106 are respectively flanged to form the second flange 1061 and the first flange 1071. Then, two or more fasteners 24 are passed through the first pressure plate 1051 to fix the first pressure plate 1051 to the first docking device 2, thereby pressing the second flange 1061 and the first flange 1071 tightly onto the end face of the first docking device 2 to ensure good sealing.

[0120] Third, fix the insertion tube 116 to the proximal end of the second docking device 3, then pass the fixing seat 115 through the insertion tube 116 and fix it to the proximal end of the second docking device 3, put the sealing member 119 into the groove of the retainer 117, and then use the clamping member 118 to fix the retainer 117 to the proximal end of the fixing seat 115.

[0121] Fourth, wrap the insulation sleeve 110 around the inlet pipe 107 and the return pipe 106, then fix it with the fixing sleeve 109, and finally put on the heat shrink tubing 108 and heat shrink it.

[0122] Finally, the second connecting device 113 is fixed to the proximal end of the fixing base 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively fitted onto a portion of both ends of the heat shrink tubing 108 to form a flexible delivery device. This delivery tube has a simple structure and manufacturing process, and is more flexible overall, facilitating surgical operations. Doctors experience a better experience during actual surgery, thus improving surgical efficiency and reducing surgical risks.

[0123] Example 2

[0124] like Figures 15-17 As shown, and please refer to Figures 1-11 The present invention provides a flexible delivery device for an ablation system, including an inlet pipe 107, a return pipe 106, a distal side assembly, and a proximal side assembly.

[0125] The inlet tube 107 is used to deliver the working fluid to the ablation needle. The working fluid includes a cold working fluid and a hot working fluid. The cold working fluid can be, for example, liquid nitrogen, and the hot working fluid can be, for example, anhydrous ethanol. (Please refer to...) Figure 5 The arrows indicate the flow direction of the working fluid in the flexible conveying device. For example... Figure 5 As shown, after the working fluid is delivered from the inlet pipe 107 to the distal side of the ablation needle, it exchanges heat with the target area in the ablation region on the distal side of the ablation needle. After the heat exchange, the working fluid returns to the proximal side of the ablation needle and enters the return pipe 106. Therefore, the return pipe 106 is used to receive the working fluid returned from the ablation needle.

[0126] like Figure 2a As shown, the distal component is located on the side closest to the ablation needle (e.g. Figure 1 (as shown on the lower side), which is used to connect the inlet tube 107 and the return tube 106 to the ablation needle respectively.

[0127] Specifically, such as Figure 2a As shown, and please refer to Figure 4 , Figure 6 and Figure 7 The remote-side component includes a first docking device 2 and a first connecting device 105.

[0128] The first side of the first docking device 2 (e.g.) Figure 2a The upper side (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively, and the second side of the first docking device 2 (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively. Figure 2a The lower side (shown) is used for fluid communication with the ablation needle. Therefore, the function of the first docking device 2 is to form a bridge between the ablation needle and the inlet pipe 107 and return pipe 106 of the flexible delivery device, that is, to deliver the working medium in the inlet pipe 107 to the ablation needle, and to deliver the working medium in the ablation needle after heat exchange to the return pipe 106.

[0129] The first connecting device 105 is located on the first side of the first docking device 2. For example... Figure 2a As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the first connecting device 105. The first connecting device 105 is configured to deform the inlet pipe 107 and the return pipe 106 to press them against the first side of the first docking device 2, so that there is a fluid seal between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2.

[0130] Furthermore, since both the inlet pipe 107 and the return pipe 106 are plastic pipes, the first connecting device 105 can deform the inlet pipe 107 and the return pipe 106 by squeezing them, thereby pressing the inlet pipe 107 and the return pipe 106 onto the first side of the first docking device 2. This achieves a reliable fluid seal between the inlet pipe 107 and the first docking device 2, and between the return pipe 106 and the first docking device 2.

[0131] On the one hand, the plastic pipes can be made of low-temperature resistant materials (because the inlet pipe 107 and return pipe 106 need to transport cold working fluid, and their operating temperature can reach -196°C), such as polytetrafluoroethylene (PTFE), soluble polytetrafluoroethylene (PFA), or perfluoroalkyl polymers (FEP). Since plastic pipes are generally produced by extrusion molding, there are fewer defects and a higher yield in their production, thus saving costs.

[0132] On the other hand, both the inlet tube 107 and the return tube 106 are made of plastic. Compared to existing solutions using metal tubes as inlet and return lines, the inlet tube 107 and return tube 106 of this invention are more flexible, allowing for arbitrary bending without any limitation on the bending radius. During surgery, when the ablation area needs to be observed and the bed is repeatedly moved, the inlet tube 107 and return tube 106 can be bent and reshaped to adapt to the bed's position, thus solving the leakage problem caused by excessive bending in existing solutions using metal tubes as inlet and return lines.

[0133] like Figure 15 and Figure 16 As shown, in this embodiment 2, the first connecting device 105 can be in the structural form of the second pressure plate 1052. Please refer to... Figure 16 The second pressure plate 1052 is provided with a tapered hole 1055 for the inlet pipe 107 and the return pipe 106 to pass through. Understandably, the diameter of the tapered hole 1055 in the second pressure plate 1052 gradually increases in the direction toward the first side of the first docking device 2.

[0134] Please Figure 16 As shown, the first docking device 2 is provided with a first inlet flow channel 201 and a first return flow channel 202 that pass through the first docking device 2.

[0135] like Figure 15 and Figure 16 As shown, in this embodiment 2, the first docking device 2 further includes two first plugs 21. (As indicated...) Figure 17 As shown, the first plug 21 includes a first locking platform 211, with the portions of the first plug 21 located on both sides of the first locking platform 211 being inserted into the first inlet channel 201 and the inlet pipe 107 respectively. One side of the first locking platform 211 abuts against the end of the first docking device 2, and the other side of the first locking platform 211 abuts against the end of the inlet pipe 107, thereby allowing the first inlet channel 201 to be in fluid communication with the inlet pipe 107 through the first plug 21.

[0136] Similarly, the portions of the other first plug 21 located on both sides of the first locking platform 211 are respectively inserted into the first return channel 202 and the return pipe 106, and one side of the first locking platform 211 abuts against the end of the first docking device 2, and the other side of the first locking platform 211 abuts against the end of the return pipe 106, thereby allowing the first return channel 202 to be in fluid communication with the return pipe 106 through the first plug 21.

[0137] The first docking device 2 also includes a compression ring 23, which is respectively fitted onto the inlet pipe 107 and the return pipe 106, such as Figure 16 As shown, one side of the extrusion ring 23 has a wedge-shaped portion, the inclination angle of which is approximately the same as the taper angle of the tapered hole 1055.

[0138] Therefore, after inserting the inlet pipe 107 and the return pipe 106 into the tapered hole 1055 from one side of the second pressure plate 1052, the compression ring 23 is respectively fitted onto the inlet pipe 107 and the return pipe 106, with its wedge-shaped part aligned with the tapered hole 1055, and inserted into the tapered hole 1055. Under the pressing action of the second pressure plate 1052, due to the limiting effect of the first locking plate 211 on the first plug 21 on the compression ring 23, the tapered hole 1055 can bring the compression ring 23 inward, and the deformation of the compression ring 23 will squeeze the pipe wall of the inlet pipe 107 and the pipe wall of the return pipe 106, thereby making the compression ring 23 tightly hug the pipe wall of the inlet pipe 107 and the pipe wall of the return pipe 106, achieving a fluid seal at the connection.

[0139] The portion of the first plug 21 inserted into the first inlet channel 201 can form a threaded connection with the first inlet channel 201 or be fixedly connected by welding or other means; the portion of the first plug 21 inserted into the first return channel 202 can form a threaded connection with the first return channel 202 or be fixedly connected by welding or other means.

[0140] Alternatively, the portion of the first plug 21 inserted into the first inlet channel 201 and the first return channel 202 can form an interference fit with the first inlet channel 201 and the first return channel 202 respectively, thereby ensuring fluid sealing between the first plug 21 and the first docking device 2.

[0141] After being tightened, the fasteners 24 pass through the second pressure plate 1052 and the first docking device 2 in sequence, which can fix the two together. The number of fasteners 24 can be set as needed.

[0142] like Figure 17 As shown, the end of the first plug 21 is provided with a guide portion 212, which has a tapered structure, so that the first plug 21 can be easily inserted into the inlet pipe 107 and the return pipe 106.

[0143] Furthermore, the outer diameter of the first plug 21 can be slightly larger than the inner diameter of the inlet pipe 107, and the outer diameter of the first plug 21 can be slightly larger than the inner diameter of the return pipe 106. Therefore, when the first plug 21 is inserted into the inlet pipe 107 and the return pipe 106, the inlet pipe 107 and the return pipe 106 can be deformed (their outer diameters become larger). And since the inlet pipe 107 and the return pipe 106 are respectively inserted into the compression ring 23, after the inlet pipe 107 and the return pipe 106 are deformed, the original clearance fit between them and the compression ring 23 becomes an interference fit, thereby ensuring fluid sealing between the first plug 21 and the inlet pipe 107 and between the first plug 21 and the return pipe 106.

[0144] In summary, in this embodiment 2, the fluid seal between the inlet pipe 107 and the return pipe 106 and the first docking device 2 is achieved through the interaction of the tapered hole 1055 on the second pressure plate 1052 and the wedge-shaped portion of the compression ring 23. Furthermore, the conversion and limiting action of the first plug 21 causes deformation of the inlet pipe 107, the return pipe 106, and the compression ring 23, thereby ensuring the fluid seal performance at the connection points of each component. The components in this embodiment 2 achieve fluid sealing through ingenious matching and connection, resulting in a simple structure, convenient assembly, and easier implementation.

[0145] like Figure 16 As shown, the outer diameter of the compression ring 23 is the same as the outer diameter of the first clamping platform 211 of the first plug 21. Therefore, it can be ensured that the compression ring 23 deforms as a whole when it is compressed, thus ensuring the tightness of its fit with the inlet pipe 107 and the return pipe 106.

[0146] Further reading is available upon request. Figure 7The second side of the first docking device 2 is provided with a pin 203 for docking with the ablation needle. The first inlet channel 201 extends through the pin 203. The pin 203 is inserted into the proximal end of the ablation needle, thereby communicating with the inlet channel of the ablation needle; furthermore, the first docking device 2 is located in the return channel of the ablation needle, so the return channel of the ablation needle is in communication with the first return channel 202.

[0147] Therefore, the working fluid in the inlet tube 107 can enter the first inlet channel 201 through the first plug 21 and be supplied to the distal end of the ablation needle through the pin 203. After heat exchange at the distal end of the ablation needle, the working fluid returns to the proximal end of the ablation needle and enters the first return channel 202 through the first plug 21 from the return channel of the ablation needle, and then enters the return tube 106.

[0148] In some implementations, such as Figure 7 As shown, the axis of the insertion pin 203 is parallel to the axis of the first return channel 202, and the axis of the insertion pin 203 is parallel to the axis of the first inlet channel 201. The insertion pin 203 is coaxially arranged with the first docking device 2, which ensures the coaxiality between the ablation needle and the flexible delivery device after the insertion pin 203 is inserted into the ablation needle.

[0149] The axis of the first return channel 202 is parallel to and offset from the axis of the insert pin 203, so as to facilitate physical isolation between the first return channel 202 and the first inlet channel 201.

[0150] like Figure 6 and Figure 7 As shown, the first docking device 2 is also provided with a first plug 204, which is used to seal the first inlet channel 201 from the side. In order to facilitate the processing of the first inlet channel 201, a hole can be drilled in the side of the first docking device 2 to form the first inlet channel 201, and the opening formed during drilling can be sealed by the first plug 204, so that the first inlet channel 201 forms a passage that runs through the first docking device 2 in the axial direction.

[0151] In other implementations, such as Figure 8 As shown, the axis of the pin 203 is parallel to the axis of the first return channel 202, and there is an angle θ1 between the axis of the pin 203 and the axis of the first inlet channel 201.

[0152] like Figure 8As shown, the included angle θ1 can be an obtuse angle. This structure, by tilting the first inlet channel 201, allows for drilling from the end of the first docking device 2 during processing, thereby forming the first inlet channel 201 that penetrates the first docking device 2 (and the pin 203). Therefore, this structure eliminates the need for the aforementioned first plug 204, resulting in a simpler structure, easier processing, and the ability to be formed in a single drilling operation.

[0153] The included angle θ1 can be configured such that the center point of the first inlet channel 201 on the axial section of the first docking device 2 and the center point of the first return channel 202 are symmetrical about the overall center of the first docking device 2, so that the pressing force applied to the first flange 1071 and the second flange 1061 is more uniform, that is, the force on the first flange 1071 and the second flange 1061 is more uniform and there is no overlap of the force.

[0154] Since the first return flow channel 202 directly penetrates the first docking device 2, therefore Figure 7 and Figure 8 In both embodiments shown, the first return channel 202 can be formed by directly drilling a hole from one end of the first docking device 2, or by drilling holes from both ends of the first docking device 2 respectively.

[0155] like Figure 3a As shown, the proximal component is located on the side furthest from the ablation needle (e.g., Figure 1 (As shown on the upper side), which is used to connect the inlet pipe 107 and the return pipe 106 to the working fluid source, respectively. The working fluid source may, for example, include a cold tank for storing cold working fluid and a hot tank for storing hot working fluid.

[0156] Specifically, such as Figure 3a As shown, and please refer to Figure 9 and Figure 10 The proximal-side assembly includes a second docking device 3 and a second connecting device 113. The first side of the second docking device 3 (e.g., Figure 3a The lower side shown is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively, and the second side of the second docking device 3 (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively. Figure 3a The upper side shown is connected to the working fluid source via a connecting component.

[0157] In general, the second docking device 3 is similar to the first docking device 2 mentioned above. It serves to form a bridge between the working fluid source and the inlet pipe 107 and return pipe 106 of the flexible conveying device, that is, to transport the working fluid in the working fluid source to the inlet pipe 107 and to collect the working fluid in the return pipe 106 into the recovery device (or to discharge it into the atmosphere).

[0158] The second connecting device 113 is located on the first side of the second docking device 3. For example... Figure 3a and Figure 4 As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the second connecting device 113. The second connecting device 113 is configured to deform the distal ends of the inlet pipe 107 and the return pipe 106, thereby pressing them against the first side of the second docking device 3, so that there is a fluid seal between the inlet pipe 107 and the second connecting device 113 and between the return pipe 106 and the second connecting device 113.

[0159] The second connecting device 113 can adopt the same or similar structural form as the first pressure plate 1051 described in Embodiment 1 above. That is, the far end of the inlet pipe 107 and the far end of the return pipe 106 can both be provided with flange structures. By extruding and deforming the flange structure through the second connecting device 113, the far ends of the inlet pipe 107 and the far ends of the return pipe 106 are pressed against the first side of the second docking device 3, thereby ensuring fluid sealing between the far end of the inlet pipe 107 and the second docking device 3, and between the far end of the return pipe 106 and the second docking device 3.

[0160] like Figure 9 and Figure 10 As shown, the second docking device 3 is provided with a second inlet channel 31 and a second return channel 32 that pass through the second docking device 3. The inlet pipe 107 is aligned with the second inlet channel 31 and is in fluid communication with it, and the return pipe 106 is aligned with the second return channel 32 and is in fluid communication with it.

[0161] A connector 33 is also provided on the second side of the second docking device 3, and the second inlet channel 31 extends through the connector 33. The connector 33 is used to connect with the connecting component, thereby enabling the flexible conveying device to communicate with the working fluid source.

[0162] In some implementations, such as Figure 9 and Figure 10 As shown, the axis of connector 33 and the axis of the second return channel 32 are parallel to each other, and the axis of connector 33 is parallel to the axis of the second inlet channel 31.

[0163] This setting method is similar to... Figure 6 and Figure 7 The first docking device 2 shown is configured similarly, that is, the axis of the connector 33 coincides with the axis of the second docking device 3, and the axis of the second docking device 3 coincides with the axis of the first docking device 2. Therefore, it can be ensured that the axis of the ablation needle coincides with the axis of the flexible delivery device, and that the connection can be perfectly aligned.

[0164] The axis of the second inlet channel 31 is parallel to and offset from the axis of the connector 33, so as to facilitate physical isolation between the second inlet channel 31 and the second inlet channel 32.

[0165] like Figure 9 and Figure 10 As shown, the second docking device 3 is also provided with a second plug 34, which is used to seal the second inlet channel 31 from the side. In order to facilitate the processing of the second inlet channel 31, a hole can be drilled in the side of the second docking device 3 to form the second inlet channel 31, and the opening formed during drilling can be sealed by the second plug 34, so that the second inlet channel 31 forms a passage through the second docking device 3 in the axial direction.

[0166] In other implementations, such as Figure 11 As shown, the axis of connector 33 and the axis of the second return channel 32 are parallel to each other, and there is an angle θ2 between the axis of connector 33 and the axis of the second inlet channel 31.

[0167] like Figure 11 As shown, the included angle θ2 can be an acute angle. This structure, by tilting the second inlet channel 31, allows for drilling from the end of the second docking device 3 during processing, thereby forming the second inlet channel 31 that penetrates the second docking device 3 (and the connector 33). Therefore, this structure eliminates the need for the aforementioned second plug 34, resulting in a simpler structure, easier processing, and the ability to be formed in a single drilling operation.

[0168] The included angle θ2 can be constructed such that the center point of the second inlet channel 31 on the axial section of the second docking device 3 and the center point of the second return channel 32 are symmetrical about the overall center of the second docking device 3, so that the pressing force applied to the flange structure is more uniform, that is, the flange structure is more uniformly stressed and will not be subjected to overlapping forces.

[0169] Figure 10 and Figure 11 In both embodiments shown, the second return flow channel 32 can be formed by drilling holes from both ends of the second docking device 3, and the axes of the two holes are offset from each other when drilling holes from both ends of the second docking device 3. That is to say, the second return flow channel 32 is actually formed by connecting two holes with offset axes. Due to the requirements of miniaturization and lightweighting of the device, the volume of the second docking device 3 cannot be too large. Therefore, the space for forming the second return flow channel 32 and the second inlet flow channel 31 on it is extremely limited. In addition, it is necessary to take into account the effective physical isolation between the second inlet flow channel 31 and the second inlet flow channel 32, the prevention of interference between the second return flow channel 32 and the connector 33, and the requirement that the second docking device 3 has a certain wall thickness to ensure its strength. Therefore, when forming the second return flow channel 32, the method of connecting two offset holes is adopted.

[0170] Understandably, the second connecting device 113 can also adopt the same or similar structural form as the second pressure plate 1052 described in Embodiment 2 above. That is, it can be designed so that the tapered hole 1055 of the second pressure plate 1052 and the wedge-shaped part of the extrusion ring 23 cooperate with each other, and through the conversion and limiting effect of the first plug 21, the inlet pipe 107, the return pipe 106 and the extrusion ring 23 are deformed, thereby ensuring the fluid sealing performance between the inlet pipe 107 and the return pipe 106 and the second docking device 3.

[0171] Please continue reading Figure 2a The flexible delivery device of the ablation system of the present invention further includes an insulating sleeve 110, a fixing sleeve 109 located outside the insulating sleeve 110, and a heat shrink tube 108 sleeved on the fixing sleeve 109. The first docking device 2, the second docking device 3, the inlet pipe 107 and the return pipe 106 are all arranged inside the insulating sleeve 110.

[0172] Since the inlet pipe 107 and return pipe 106 convey cold or hot working fluids, they are inconvenient to operate. Therefore, an insulating sleeve 110 is installed on the outside. This prevents heat exchange between the working fluid and the environment and ensures safe operation. The insulating sleeve 110, inlet pipe 107, and return pipe 106 are fixed by a fixing sleeve 109 and heat shrink tubing 108, making the flexible conveying device flexible and slender overall, and ensuring its aesthetic appearance.

[0173] The flexible delivery device of the ablation system of the present invention further includes a distal handle housing 103, a distal quick-insertion assembly 101, and an insertion cannula sheath 102. For example... Figure 2a and Figure 2b As shown, the proximal end of the cannula sleeve 102 is inserted into the insulating sleeve 110 and abuts against the distal end of the first docking device 2. The pin 203 of the first docking device 2 is located in the cannula sleeve 102, and the first return channel 202 is in fluid communication with the cannula sleeve 102. The cannula sleeve 102 also receives the proximal end of the ablation needle, thereby the cannula sleeve 102 is in fluid communication with the return channel of the ablation needle, so the working fluid returning from the return channel of the ablation needle enters the first return channel 202 through the cannula sleeve 102.

[0174] like Figure 2a and Figure 2b As shown, the heat shrink tubing 108 has a distal handle housing 103 on its exterior. The distal handle housing 103 covers a portion of the heat shrink tubing 108, allowing the user to grip and operate it. Figure 2b As shown, the distal end of the cannula sleeve 102 is located within the distal end handle housing 103. A first protrusion 1021 is provided on the outer wall of the distal end of the cannula sleeve 102, which is used to engage with a groove on the inner wall of the distal end handle housing 103, thereby fixing it to the distal end handle housing 103.

[0175] In addition, a plurality of second protrusions 1031 are provided at intervals on the inner wall of the distal handle housing 103. The second protrusions 1031 are used to abut against the outer wall of the heat shrink tubing 108 to increase the friction between the distal handle housing 103 and the heat shrink tubing 108, so that the distal handle housing 103 and the heat shrink tubing 108 should not move relative to each other.

[0176] The distal quick-connect assembly 101 is connected to the distal side of the cannula sheath 102. The distal quick-connect assembly 101 is used for quick connection with the proximal side of the ablation needle to facilitate quick replacement of ablation needles of different diameters. The distal quick-connect assembly 101 can adopt various quick-connect structures known in the prior art, which will not be described in detail in this invention.

[0177] Please see Figure 3a and Figure 3b The flexible delivery device of the ablation system of the present invention further includes a proximal handle housing 111, a proximal quick-connect assembly 112, a fixing base 115, an insertion tube 116, a retainer 117, and a clamping member 118. The proximal handle housing 111 is disposed on the outside of the proximal side of the heat shrink tubing 108 and covers a portion of the heat shrink tubing 108, and the user can grip and operate it through the distal handle housing 103.

[0178] The proximal quick-connect assembly 112 is inserted into the proximal end of the proximal handle housing 111 and covers the heat shrink tubing 108, which is used for quick connection with the working fluid source. Figure 3b As shown, a third protrusion 1122 is provided on the outer wall of the proximal quick-connect assembly 112, which is used to engage with a groove on the inner wall of the proximal handle housing 111, thereby fixing it to the distal handle housing 103. A plurality of grooves 1121 are also provided at intervals on the outer wall of the proximal quick-connect assembly 112, which are used to connect with the pipeline of the working fluid source.

[0179] Please continue reading Figure 3b The mounting base 115 is fixedly connected to the proximal side of the proximal quick-connect assembly 112. A cannula 116 passes through the mounting base 115, with one end inserted into the connector 33 of the second docking device 3 and the other end inserted into the retainer 117. A clamping member 118 at the proximal end of the retainer 117 secures the retainer 117 to the mounting base 115. The clamping member 118 may be, for example, a clamping nut.

[0180] The clamping member 118 is also provided with a sealing member 119. The clamping member 118 presses the sealing member 119 against the near end of the retainer 117 to ensure a sealed connection between the insertion tube 116 and the working fluid source.

[0181] The assembly process of the ablation needle delivery system in this embodiment 2 is as follows:

[0182] First, a distal quick-connect assembly is fixed at the distal end of the cannula sheath 102, and a first docking device 2 is fixed at its proximal end.

[0183] Next, the distal ends of the inlet pipe 107 and the return pipe 106 are respectively passed through the second pressure plate 1052, and a compression ring 23 is sleeved on the inlet pipe 107 and the outside; the two parts of the first clamping platform 211 on the first plug 21 are respectively inserted between the inlet pipe 107 and the first inlet channel 201 and between the return pipe 106 and the first return channel 202. By pressing the second pressure plate 1052, the compression ring 23 is deformed and hugs the inlet pipe 107 and the return pipe 106, and the inlet pipe 107 and the return pipe 106 are hugged tightly to the first plug 21.

[0184] Third, fix the insertion tube 116 to the proximal end of the second docking device 3, then pass the fixing seat 115 through the insertion tube 116 and fix it to the proximal end of the second docking device 3, put the sealing member 119 into the groove of the retainer 117, and then use the clamping member 118 to fix the retainer 117 to the proximal end of the fixing seat 115.

[0185] Fourth, wrap the insulation sleeve 110 around the inlet pipe 107 and the return pipe 106, then fix it with the fixing sleeve 109, and finally put on the heat shrink tubing 108 and heat shrink it.

[0186] Finally, the second connecting device is fixed to the proximal end of the fixing base 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively fitted onto a portion of both ends of the heat shrink tubing 108 to form a flexible delivery device. This delivery tube has a simple structure and manufacturing process, and is more flexible overall, facilitating surgical operations. Doctors experience a better experience during actual surgery, thus improving surgical efficiency and reducing surgical risks.

[0187] Example 3

[0188] like Figure 18 and Figure 19 As shown, based on the above embodiment 2, the present invention also provides another embodiment.

[0189] like Figure 18 As shown, the difference between this embodiment 3 and the above embodiment 2 is that the second plug 22 is used instead of the first plug 21 in this embodiment 3, and the compression ring 23 is not provided in this embodiment 3.

[0190] Similar to Embodiment 2 above, such as Figure 19As shown, the second plug 22 in this embodiment 3 is also provided with a second locking platform 221. The portions of one of the second plugs 22 located on both sides of the second locking platform 221 are respectively inserted into the first inlet channel 201 and the inlet pipe 107, and one side of the second locking platform 221 abuts against the end of the first docking device 2, and the other side of the second locking platform 221 abuts against the end of the inlet pipe 107, thereby allowing the first inlet channel 201 to be in fluid communication with the inlet pipe 107 through the first plug 21.

[0191] Similarly, the portions of the other second plug 22 located on both sides of the second latch 221 are inserted into the first return channel 202 and the return pipe 106, respectively. One side of the second latch 221 abuts against the end of the first docking device 2, and the other side of the second latch 221 abuts against the end of the return pipe 106, thereby allowing the first return channel 202 to be in fluid communication with the return pipe 106 through the second latch 221.

[0192] Furthermore, the difference between this embodiment 3 and the above-described embodiment 2 is that the first connecting device 105 is in the structural form of the third pressure plate 1053. Please refer to... Figure 18 The third pressure plate 1053 is provided with a tapered hole 1056 for the inlet pipe 107 and the return pipe 106 to pass through. Understandably, the tapered hole 1056 can also be in the form of other holes with varying diameters.

[0193] like Figure 19 As shown, the end of the second plug 22 is provided with a tapered head 222, the taper of which is approximately the same as the taper of the tapered hole 1056.

[0194] In this embodiment 3, the outer diameter of the portion of the second plug 22 located on the side of the second clamp 221 is larger than the inner diameter of the inlet pipe 107, and the outer diameter of the portion of the second plug 22 located on the side of the second clamp 221 is larger than the inner diameter of the return pipe 106. Therefore, when it is inserted into the inlet pipe 107 and the return pipe 106 respectively, the second plug 22 can cause the inlet pipe 107 and the return pipe 106 to deform and expand respectively. Furthermore, the tapered head 222 at the end of the second plug 22 can cooperate with the tapered surface of the tapered hole 1056. Therefore, under the pressing action of the third pressure plate 1053, the tapered head 222 at the end of the second plug 22 and the tapered hole 1056 can clamp the pipe wall of the inlet pipe 107 and the pipe wall of the return pipe 106, thereby achieving a fluid seal between the connecting components.

[0195] The assembly process of the ablation needle delivery system in this embodiment 3 is as follows:

[0196] First, a distal quick-connect assembly is fixed at the distal end of the cannula sheath 102, and a first docking device 2 is fixed at its proximal end.

[0197] Next, the distal ends of the inlet pipe 107 and the return pipe 106 are respectively passed through the third pressure plate 1053, and the two parts of the second clamping platform 221 on the second plug 22 are respectively inserted between the inlet pipe 107 and the first inlet channel 201 and between the return pipe 106 and the first return channel 202. By pressing the third pressure plate 1053, the inlet pipe 107 and the return pipe 106 are deformed and expanded respectively, so that the tapered head 222 at the end of the second plug 22 and the tapered hole 1056 can clamp the pipe wall of the inlet pipe 107 and the pipe wall of the return pipe 106.

[0198] Third, fix the insertion tube 116 to the proximal end of the second docking device 3, then pass the fixing seat 115 through the insertion tube 116 and fix it to the proximal end of the second docking device 3, put the sealing member 119 into the groove of the retainer 117, and then use the clamping member 118 to fix the retainer 117 to the proximal end of the fixing seat 115.

[0199] Fourth, wrap the insulation sleeve 110 around the inlet pipe 107 and the return pipe 106, then fix it with the fixing sleeve 109, and finally put on the heat shrink tubing 108 and heat shrink it.

[0200] Finally, the second connecting device is fixed to the proximal end of the fixing base 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively fitted onto a portion of both ends of the heat shrink tubing 108 to form a flexible delivery device. This delivery tube has a simple structure and manufacturing process, and is more flexible overall, facilitating surgical operations. Doctors experience a better experience during actual surgery, thus improving surgical efficiency and reducing surgical risks.

[0201] The similarities between this embodiment 3 and the previous embodiment 2 will not be repeated.

[0202] Example 4

[0203] The present invention also provides a delivery device for an ablation system, including an inlet tube 107, a return tube 106, a distal side assembly, and a proximal side assembly. The inlet tube 107 and the return tube 106 are both flexible tubes as described in the preceding embodiments; or the inlet tube 107 and the return tube 106 are both metal tubes, such as stainless steel tubes.

[0204] The inlet tube 107 is used to deliver the working fluid to the ablation needle. The working fluid includes a cold working fluid and a hot working fluid. The cold working fluid can be, for example, liquid nitrogen, and the hot working fluid can be, for example, anhydrous ethanol. (Please refer to...) Figure 5 The arrows indicate the flow direction of the working fluid in the conveying device. For example... Figure 5 As shown, after the working fluid is delivered from the inlet pipe 107 to the distal side of the ablation needle, it exchanges heat with the target area in the ablation region on the distal side of the ablation needle. After the heat exchange, the working fluid returns to the proximal side of the ablation needle and enters the return pipe 106. Therefore, the return pipe 106 is used to receive the working fluid returned from the ablation needle.

[0205] Specifically, such as Figure 2a As shown, and please refer to Figure 4 , Figure 6 and Figure 7 The remote-side component includes a first docking device 2 and a first connecting device 105.

[0206] The first side of the first docking device 2 (e.g.) Figure 2a The upper side (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively, and the second side of the first docking device 2 (as shown) is in fluid communication with the inlet pipe 107 and the return pipe 106 respectively. Figure 2a The lower side (shown) is used for fluid communication with the ablation needle. Therefore, the function of the first docking device 2 is to form a bridge between the ablation needle and the inlet pipe 107 and the return pipe 106 of the delivery device, that is, to deliver the working medium in the inlet pipe 107 to the ablation needle, and to deliver the working medium in the ablation needle after heat exchange to the return pipe 106.

[0207] The first connecting device 105 is located on the first side of the first docking device 2. The first connecting device 105 can adopt the structural form described in any of the embodiments of the above embodiments 1, 2 and 3 or a combination thereof to achieve fluid sealing between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2; or the first connecting device 105 can also adopt a connection method suitable for metal pipes (such as welding or threaded connection, etc.) to achieve fluid sealing between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2.

[0208] Furthermore, the first docking device 2 can adopt the structural form described in any of the embodiments of Embodiment 1, Embodiment 2 and Embodiment 3 above, or a combination thereof.

[0209] Furthermore, such as Figure 20 As shown, the first docking device 2 is also provided with an exhaust port 25, which is in fluid communication with the first inlet channel 201 and the first return channel 202. For example, a hole can be drilled on the side of the first docking device 2 to obtain the exhaust port 25, which is in fluid communication with the first inlet channel 201 and the first return channel 202 respectively; after obtaining the exhaust port 25, the opening formed during drilling can be sealed by a sealing plug or other structure. The specific implementation of the exhaust port 25 can refer to the implementation of the first inlet channel 201 and / or the second inlet channel 31 in the above embodiments.

[0210] The specific structure of the first docking device 2 can be... Figure 6 and Figure 7 The structure shown, where the axis of the insert pin 203 is parallel to the axis of the first inlet channel 201, can also be... Figure 8The structure is such that the axis of the pin 203 shown has an included angle θ1 with the axis of the first inflow channel 201.

[0211] As Figure 20 shown, the structure form is shown where the axis of the pin 203 has an included angle θ1 with the axis of the first inflow channel 201. Among them, the exhaust holes 25 are in fluid communication with the first inflow channel 201 and the first return channel 202 respectively.

[0212] By providing the exhaust holes 25, the cooling speed of the ablation needle can be increased, making the ice ball in the ablation area of the ablation needle form better and the cryoablation effect better.

[0213] Specifically, during cryoablation, a cryogenic working fluid is delivered to the ablation needle through a flexible delivery device. Since in the initial state, the temperatures of the flexible delivery device and the ablation needle are at room temperature, it takes a certain amount of time to reduce the temperatures of the flexible delivery device and the ablation needle to the target temperature (such as -196°C, -180°C or -170°C, etc.). This process is the initial cooling process. This article focuses on this initial cooling process. During this process, the cryogenic working fluid in the flexible delivery device is in a gaseous state. Therefore, the gaseous cryogenic working fluid can be discharged from the first inflow channel 201 through the exhaust holes 25 into the first return channel 202, which is beneficial to the rapid cooling of the entire flexible delivery device.

[0214] The diameter of the exhaust holes 25 is smaller than the diameter of the first inflow channel 201 or the diameter of the first return channel 202. Preferably, the radial cross-sectional area S1 of the exhaust holes 25 is smaller than the cross-sectional area S2 of the cryogenic working fluid outlet at the tip of the ablation needle. For an ablation needle with a tip diameter less than 2.0 mm, the cross-sectional area S2 of the cryogenic working fluid outlet at the tip is relatively small. During actual cryoablation, the flow rate of the cryogenic working fluid at the cryogenic working fluid outlet at the tip is relatively small, and a large amount of gaseous cryogenic working fluid flows out slowly, resulting in a slow cooling speed. Within a specified time, the size of the ice ball is affected, and继而the ablation effect is affected. By making the radial cross-sectional area S1 of the exhaust holes 25 smaller than the cross-sectional area S2 of the cryogenic working fluid outlet at the tip of the ablation needle, when the temperatures of the flexible delivery device and the ablation needle are reduced to the required temperature, most of the cryogenic working fluid flowing in the flexible delivery device is in a liquid state. Since S1 < S2, most of the liquid cryogenic working fluid will flow towards the cryogenic working fluid outlet at the tip with a larger cross-sectional area, and only a small amount of gaseous cryogenic working fluid will flow along the exhaust holes 25, thus not affecting the formation of the ice ball and promoting the ablation effect.

[0215] Furthermore, the exhaust holes 25 are arranged obliquely, that is, the axis of the exhaust holes 25 has an included angle α1 with the axis of the first inflow channel 201, or the axis of the exhaust holes 25 has an included angle α2 with the axis of the first return channel 202.

[0216] The included angle α1 or α2 needs to be set as small as possible. This is because the size of either angle α1 or α2 affects the consumption of the refrigerant. During the process of the gaseous or liquid refrigerant entering the tip of the ablation needle from the first inlet channel 201, a portion of the refrigerant will flow out from the vent 25. This fluid will resist the fluid flowing back from the tip of the ablation needle to the first return channel 202, reducing the flow velocity of the return fluid and thus decreasing the return fluid flow rate, thereby reducing the consumption of the refrigerant. Understandably, the smaller the included angle α1 or α2 is set, the greater the resistance to the return fluid, and the lower the flow velocity of the return fluid, thus reducing the consumption of the refrigerant.

[0217] The range of the included angle α1 is related to the included angle θ1 between the axis of the insert 203 and the axis of the first inlet channel 201, as mentioned above. For example, the minimum value of the included angle α1 (α 1min When the included angle α1 is 0°, it can be understood that when the axis of the exhaust port 25 is parallel to the axis of the first inlet channel 201, α2 is (180°-θ1); the maximum value of the included angle α1 is (α2-θ1). 1max Since the included angle α1 is 90°, it can be understood that when the included angle α1 is 90°, that is, when the axis of the exhaust hole 25 is perpendicular to the axis of the pin 203, α2 is also 90°. That is to say, the range of included angle α1 is 0°-90°, therefore, the range of included angle α2 is (180°-θ1)-90°.

[0218] Furthermore, the diameter d of the vent hole 25 is related to the cooling rate and the amount of working fluid consumed. The larger the diameter d of the vent hole 25, the faster the cooling rate, but the greater the amount of working fluid consumed. Therefore, preferably, the diameter d of the vent hole 25 is 0.3mm-0.5mm.

[0219] Specifically, the flow rate of the fluid channel satisfies the following relationship:

[0220] Q = μ × A × (△P / ρ) 0.5 (1)

[0221] In equation (1), Q is the flow rate of the fluid channel (i.e., from the first inlet channel 201 to the first return channel 202), μ is a constant, A is the cross-sectional area of ​​the fluid channel (i.e., from the first inlet channel 201 to the first return channel 202), ΔP is the pressure difference between the first inlet channel 201 and the first return channel 202, and ρ is the density of the working fluid.

[0222] Since the cross-sectional areas of the first inlet channel 201 and the first return channel 202 are both larger than the cross-sectional area S2 of the cold working medium outlet at the needle tip, the cross-sectional area A of the fluid passage from the first inlet channel 201 to the first return channel 202 is determined by the cross-sectional area S2 of the cold working medium outlet at the needle tip, which has a smaller cross-sectional area, and the radial cross-sectional area S1 of the exhaust hole 25, where S1 = π(d / 2). 2 .

[0223] According to the above formula (1), μ is a constant and therefore an invariant quantity; the pressure difference ΔP and the density ρ of the working fluid are also invariant quantities. When the vent 25 is not set, i.e. S1 is 0, the fluid only passes through the cold working fluid outlet at the needle tip, i.e., A = S2 in the above formula (1). At this time, the time for the temperature to drop to the target temperature is longer, and the final ice ball diameter is also smaller. When the vent 25 is set, the fluid passes through the cold working fluid outlet at the needle tip and the vent 25 respectively. A can be regarded as the sum of S2 and S1. Therefore, it can be seen that setting the vent 25 will increase A, and Q will increase accordingly.

[0224] Furthermore, since the area S1 of the exhaust port 25 is related to its diameter d, increasing the diameter d of the exhaust port 25 can increase S1, which in turn increases A, thereby increasing Q. That is, the flow rate from the first inlet channel 201 to the first return channel 202 increases, which can accelerate the cooling rate. However, the increase in flow rate will also be accompanied by an increase in the consumption of working fluid.

[0225] The following description will use the following four specific implementation methods as examples.

[0226] Table 1 shows four specific implementations of the first docking device 2.

[0227] Table 1. Four implementation methods of the first docking device 2

[0228]

[0229]

[0230] Understandably, the initial cooling time is the time required for the delivery system and the ablation needle to cool from room temperature to the required treatment temperature (e.g., -196°C, -180°C, or -170°C). According to Table 1 above, in the first embodiment, where the first docking device 2 does not have an vent, an experimental test was conducted with an ablation needle tip diameter of 1.7 mm. The initial cooling time was greater than 10 minutes, the liquid nitrogen consumption was less than 12%, and the size of the resulting ice ball did not meet the requirements.

[0231] Therefore, it can be seen that although the liquid nitrogen consumption in the first embodiment meets the requirement of less than 16%, the initial cooling time does not meet the requirement of less than 8 minutes, and the ice ball size does not meet the requirement of a diameter of at least 15 mm. In other words, the initial cooling time required by the first embodiment is too long and the obtained ice ball size is too small.

[0232] The second implementation method uses an exhaust hole on the first docking device 2. Specifically, the included angle α1 of the exhaust hole 25 is (90±20)°, and the diameter d of the exhaust hole 25 is (0.3±0.05)mm. Similarly, when the diameter of the tip of the ablation needle is 1.7mm, the initial cooling time is about 8 minutes, the liquid nitrogen consumption is 12%-16%, and the size of the obtained ice ball is qualified but too small.

[0233] Therefore, it can be seen that in the second embodiment, the initial cooling time meets the requirement of less than 8 minutes, the liquid nitrogen consumption meets the requirement of less than 16%, and the ice ball size basically meets the requirement of a diameter of at least 15 mm. However, it is also related to the external environment. When the external environment temperature is low, the ice ball size is basically qualified. When the external environment temperature is high, there will be unqualified phenomena (the ice ball size is too small).

[0234] The third implementation method adopts the method of setting an exhaust hole on the first docking device 2. Specifically, the included angle α1 of the exhaust hole 25 is (60±20)°, the diameter d of the exhaust hole 25 is (0.4±0.05)mm, and the experimental test is carried out when the tip diameter of the ablation needle is 1.7mm. The initial cooling time is less than 7min, the liquid nitrogen consumption is about 16%, and the size of the obtained ice ball is qualified.

[0235] Therefore, it can be seen that in the third embodiment, the initial cooling time meets the requirement of less than 8 minutes, the liquid nitrogen consumption basically meets the requirement of less than 16%, and the ice ball size meets the requirement of at least 15 mm in diameter, but there is a case of slightly higher liquid nitrogen consumption.

[0236] The fourth implementation method adopts the method of setting an exhaust hole on the first docking device 2. Specifically, the included angle α1 of the exhaust hole 25 is (50±20)°, the diameter d of the exhaust hole 25 is (0.4±0.05)mm, and the experimental test is carried out when the needle tip diameter of the ablation needle is 1.7mm. The initial cooling time is less than 6.5min, the liquid nitrogen consumption is 12%-16%, and the size of the obtained ice ball is qualified.

[0237] Therefore, it can be seen that in the fourth embodiment, the initial cooling time meets the requirement of less than 8 minutes, the liquid nitrogen consumption meets the requirement of less than 16%, and the ice ball size meets the requirement of a diameter of at least 15 mm.

[0238] In summary, comparing the schemes with and without vent holes reveals that while the scheme with vent holes slightly increases liquid nitrogen consumption, the initial cooling time and the size of the resulting ice ball still meet the requirements for the melting operation. Comparing multiple schemes with vent holes shows that the initial cooling time decreases as the included angle α1 of the vent holes decreases and the diameter d of the vent hole 25 increases. Therefore, considering all factors, the preferred scheme has an included angle α1 of (50±20)° and a diameter d of (0.4±0.05) mm for the vent hole 25.

[0239] Example 5

[0240] According to a second aspect of the present invention, the present invention also provides an ablation system, comprising a delivery device for the ablation system described in the above embodiments or a flexible delivery device for the ablation system, and further comprising an ablation needle and a working fluid source, such as... Figure 1 As shown, the distal and proximal sides of the conveying device or flexible conveying device are respectively connected to the ablation needle and the working fluid source.

[0241] Although the invention has been described with reference to preferred embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, the technical features mentioned in the various embodiments can be combined in any manner as long as there is no structural conflict. The invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A flexible delivery device for an ablation system, characterized in that, include: An inlet tube (107) is used to deliver working fluid to the ablation needle, and the inlet tube (107) is a flexible tube; A return tube (106) for receiving the working fluid returned from the ablation needle, said return tube (106) being a flexible tube; and The distal side assembly, located on the side close to the ablation needle, is used to provide fluid communication between the inlet tube (107) and the return tube (106) and the ablation needle, respectively. The distal-side component includes: A first docking device (2) is provided with a first inlet channel (201) and a first return channel (202) penetrating the first docking device (2). The first inlet channel (201) is aligned with and fluidly connected to an inlet pipe (107) for supplying working fluid to the ablation needle. The first return channel (202) is aligned with and fluidly connected to a return pipe (106) for receiving working fluid returned from the ablation needle. A first connecting device (105) is located on the first side of the first docking device (2). The inlet pipe (107) and the return pipe (106) pass through the first connecting device (105) respectively. The first connecting device (105) is configured to deform the inlet pipe (107) and the return pipe (106) to press them against the first side of the first docking device (2), so that there is a fluid seal between the inlet pipe (107) and the first docking device (2) and between the return pipe (106) and the first docking device (2). The first docking device (2) is also provided with an exhaust hole (25), which is in fluid communication with the first inlet channel (201) and the first return channel (202).

2. The flexible delivery device for the ablation system according to claim 1, characterized in that, The diameter of the exhaust hole (25) is smaller than the diameter of the first inlet channel (201) or the diameter of the first return channel (202).

3. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, The radial cross-sectional area S1 of the vent hole (25) is smaller than the cross-sectional area S2 of the cold working medium outlet at the tip of the ablation needle.

4. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, The diameter d of the exhaust port (25) is 0.3 mm to 0.5 mm.

5. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, The exhaust port (25) is inclined, and the axis of the exhaust port (25) has an angle α1 with the axis of the first inlet channel (201), and the value of the angle α1 is in the range of 0°~90°.

6. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, One side of the first docking device (2) is provided with a pin (203) for docking with the ablation needle. The first inlet channel (201) extends through the pin (203). The axis of the pin (203) and the axis of the first inlet channel (201) have an angle θ1 with an obtuse angle. The axis of the exhaust hole (25) and the axis of the first return channel (202) have an angle α2. The value of the angle α2 is in the range of (180°-θ1)~90°.

7. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, One side of the first docking device (2) is provided with a pin (203) for docking with the ablation needle. The first inlet channel (201) extends through the pin (203). The axis of the pin (203) and the axis of the first inlet channel (201) have an angle θ1. The angle θ1 is configured such that the center point of the first inlet channel (201) on the axial section of the first docking device (2) is symmetrical with respect to the center point of the first return channel (202) about the overall center of the first docking device (2).

8. The flexible delivery device for the ablation system according to claim 1 or 2, characterized in that, One side of the first docking device (2) is provided with a pin (203) for docking with the ablation device. The first inlet channel (201) extends through the pin (203). The axis of the pin (203), the axis of the first inlet channel (201) and the axis of the first return channel (202) are parallel to each other. The axis of the pin (203) is parallel to and offset from the axis of the first return channel (202).

9. The flexible delivery device for the ablation system according to claim 8, characterized in that, The first docking device (2) is also provided with a first plug (204), which is used to seal the hole formed when constructing the first inlet channel (201) from the side. The first return channel (202) directly penetrates the first docking device (2).

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