Flexible delivery device for ablation system

Abstract

The invention relates to a flexible conveying device of an ablation system, and relates to the technical field of ablation. The flexible conveying device of the ablation system comprises a far-end side assembly, the far-end side assembly comprises a first butt-joint device, and a first inflow runner and a first backflow runner which penetrate through the first butt-joint device are arranged in the first butt-joint device; the first inflow channel is aligned with and is in fluid communication with an inflow pipe used for conveying a working medium to the ablation needle, and the first backflow channel is aligned with and is in fluid communication with a backflow pipe used for receiving the working medium returned from the ablation needle; an exhaust hole is further formed in the first butt joint device, and the exhaust hole is in fluid communication with the first inflow runner and the first backflow runner.

Description

[0001] This application is a divisional application of Chinese patent CN202411360123.6, whose application date is September 27, 2024 and whose name is “Flexible delivery device and ablation system for ablation system”. Technical Field

[0002] The present invention relates to the technical field of ablation, and in particular to a flexible conveying device of an ablation system. Background Art

[0003] Cold-hot combined ablation is a technique that delivers cold and hot fluids alternately to tumor lesions in the human body, directly giving the lesions physical stimulation of deep freezing (lowest temperature -196°C) and heating (above 80°C), causing tumor cells to swell and rupture, and the tumor tissue pathology to show irreversible congestion, edema, degeneration and coagulative necrosis.

[0004] Generally, hot and cold combined ablation is performed through an ablation needle and a delivery device, and the cold and hot working fluids are delivered to the ablation needle through the delivery device. The inlet and return pipes in the existing delivery devices are made of relatively hard metal materials. On the one hand, when welding the pipes, metal materials may also have welding defects, which may cause leakage and other problems; on the other hand, metal pipes need to be used very carefully during actual use and cannot be bent at will, otherwise the metal pipes are easily damaged, especially during surgery when the ablation area needs to be observed by imaging. When the bed is moved repeatedly, the metal pipes may be bent and there is a risk of leakage. Based on the above-mentioned problems with metal pipes, it is considered to replace the pipes in the delivery device with flexible pipes, but how to ensure the sealing of the flexible pipe joints is a technical problem that needs to be solved urgently. Summary of the invention

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

[0006] The present invention provides a flexible delivery device of an ablation system, comprising a distal side component, wherein the distal side component comprises a first docking device, wherein a first inlet flow channel and a first return flow channel penetrating the first docking device are respectively provided in the first docking device, wherein the first inlet flow channel is aligned with and fluidically connected to an inlet tube for delivering a working medium to an ablation needle, and the first return flow channel is aligned with and fluidically connected to a return tube for receiving a working medium returned from the ablation needle;

[0007] The first docking device is also provided with an exhaust hole, and the exhaust hole is respectively connected with the first inlet flow channel and the first return flow channel.

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

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

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

[0011] In one embodiment, the exhaust hole is arranged obliquely, and an angle α1 is formed between the axis of the exhaust hole and the axis of the first inlet flow channel, and the value range of the angle α1 is 0° to 90°.

[0012] In one embodiment, a pin for connecting to an ablation needle is provided on one side of the first docking device, and the first inlet flow channel extends to pass through the pin. An obtuse angle θ1 is formed between the axis of the pin and the axis of the first inlet flow channel, and an angle α2 is formed between the axis of the exhaust hole and the axis of the first return flow channel. The value range of the angle α2 is (180°~θ1)~90°.

[0013] In one embodiment, a pin for connecting to an ablation needle is provided on one side of the first docking device, and the first flow inlet channel extends to pass through the pin. An angle θ1 is formed between the axis of the pin and the axis of the first flow inlet channel, and the angle θ1 is configured so that the center point of the first flow inlet channel on the axial cross-section of the first docking device and the center point of the first return flow channel are symmetrical about the overall center of the first docking device.

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

[0015] In one embodiment, a first plug is further provided on the first docking device, and the first plug is used to seal the hole formed when the first inlet flow channel is constructed from the side, and the first return flow channel directly passes through the first docking device.

[0016] In one embodiment, the distal side component also includes a first connecting device, which is located on one side of the first docking device. The first connecting device adopts 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 advantage of the present invention is that since both the inlet pipe and the return pipe are flexible pipes, they are softer and can be bent arbitrarily in the desired direction. Therefore, even if the bed is moved repeatedly during surgery, there will be no leakage caused by bending / flattening, so it is more conducive to the doctor's operation, thereby improving the efficiency of the operation; for the flexible inlet pipe and return pipe; and through the first connecting device, the inlet pipe and the return pipe are deformed and pressed onto the first side of the first docking device, so that the fluid sealing performance between the inlet pipe and the first docking device and between the return pipe and the first docking device can be guaranteed, thereby solving the sealing problem of the flexible pipeline connection. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Hereinafter, the present invention will be described in more detail based on embodiments and with reference to the accompanying drawings.

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

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

[0021] Figure 2b yes Figure 2a A partial enlarged view of the distal end side of the flexible delivery device of the ablation system;

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

[0023] Figure 3b yes Figure 3a A partial enlarged view of the proximal side of the flexible delivery device of the ablation system;

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

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

[0026] Figure 6is a schematic diagram of the three-dimensional structure of a 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 is a cross-sectional view of a first docking device in one embodiment of the present invention;

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

[0030] Fig.10 yes Fig. 9 a cross-sectional view of the second docking device shown;

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

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

[0033] Fig.13 yes Fig.12 A cross-sectional view of the first docking device and the inlet pipe and the return pipe after installation;

[0034] Fig.14 is a schematic diagram of the three-dimensional structure of a reflux pipe in an embodiment of the present invention;

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

[0036] Fig.16 yes Fig.15 A cross-sectional view of the first docking device and the inlet pipe and the return pipe after installation;

[0037] Fig.17 yes Fig.15 A schematic diagram of the three-dimensional structure of the first plug shown;

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

[0039] Fig.19 yes Fig.18 A schematic diagram of the three-dimensional structure of the second plug shown;

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

[0041] Reference numerals:

[0042] 101. Far-end quick-connect assembly;

[0043] 102. cannula outer sleeve; 1021. first protrusion;

[0044] 103. distal handle shell; 1031. second protruding portion;

[0045] 2. The first docking device;

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

[0047] 211, first clamping platform; 212, guide portion; 221, second clamping platform; 222, conical head;

[0048] 201, first inflow channel; 202, first return flow channel; 203, insertion pin; 204, first plug;

[0049] 105, first connecting device; 1051, first pressing plate; 1052, second pressing plate; 1053, third pressing plate; 1055, taper hole; 1056, tapered hole;

[0050] 106, return pipe; 107, inlet pipe;

[0051] 1061, second flange; 1071, first flange;

[0052] 108. heat shrink tube; 109. fixing sleeve; 110. insulation sleeve;

[0053] 111, proximal side handle housing;

[0054] 112, proximal quick-insertion assembly; 1121, groove; 1122, third protrusion;

[0055] 113, second connecting device; 115, fixing seat; 116, cannula; 117, retaining frame; 118, pressing member; 119, sealing member;

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

[0057] The present invention will be further described below in conjunction with the accompanying drawings.

[0058] Example 1

[0059] like Figure 1-Figure 14As shown, the present invention provides a flexible delivery device for an ablation system, comprising an inlet tube 107, a return tube 106, a distal side component and a proximal side component.

[0060] The inlet pipe 107 is used to deliver working fluid to the ablation needle. The working fluid includes cold working fluid and hot working fluid. The cold working fluid may be liquid nitrogen, for example, and the hot working fluid may be anhydrous ethanol, for example. Figure 5 , the arrows show the flow direction of the working medium in the flexible conveying device. Figure 5 As shown, after the working fluid is transported from the inlet tube 107 to the distal side of the ablation needle, heat exchange is performed between the ablation area and the target area 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 tube 106. Therefore, the return tube 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 close to the ablation needle (such as Figure 1 The lower side as shown) is used to connect the inlet tube 107 and the return tube 106 to the ablation needle fluid respectively.

[0062] Specifically, if Figure 2a Please combine Figure 4 , Figure 6 and Figure 7 The distal side component includes a first docking device 2 and a first connecting device 105.

[0063] The first side of the first docking device 2 (eg Figure 2a The upper side shown in FIG. 100 ) is respectively connected to the inlet pipe 107 and the return pipe 106, and the second side of the first docking device 2 (as shown in FIG. Figure 2a Therefore, the first docking device 2 serves to form a bridge between the ablation needle and the inlet pipe 107 and the return pipe 106 of the flexible delivery device, that is, to deliver the working fluid in the inlet pipe 107 to the ablation needle, and to deliver the working fluid in the ablation needle after heat exchange to the return pipe 106.

[0064] The first connecting device 105 is located at the first side of the first docking device 2. Figure 2a As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the first connecting device 105, and the first connecting device 105 is constructed to be able to deform the inlet pipe 107 and the return pipe 106 so as to press them onto the first side of the first docking device 2, so that the inlet pipe 107 and the first docking device 2 and the return pipe 106 and the first docking device 2 are fluid-tight.

[0065] Furthermore, the inlet pipe 107 and the return pipe 106 are both plastic pipes, so the first connecting device 105 can deform the end of the inlet pipe 107 and the end of 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, thereby achieving reliable 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.

[0066] On the one hand, the plastic pipe can be made of a low-temperature resistant material (because the inlet pipe 107 and the return pipe 106 need to transport cold working fluids, and their operating temperature can reach -196°C), such as polytetrafluoroethylene (PTFE), soluble polytetrafluoroethylene (PFA) or perfluoroalkyl polymer (FEP), etc. Since the plastic pipe is generally formed by extrusion, there are fewer defects in its production and a high yield rate, so costs can be saved.

[0067] On the other hand, both the inlet pipe 107 and the return pipe 106 are plastic pipes. Compared with the existing metal pipes as the inlet pipe and the return pipe, the inlet pipe 107 and the return pipe 106 of the present invention are relatively soft, can be bent arbitrarily, and have no limit on the bending radius. During the operation, when the ablation area needs to be observed by imaging and the bed is moved repeatedly, the inlet pipe 107 and the return pipe 106 can be bent and changed accordingly to adapt to the position of the bed, thereby solving the leakage problem caused by excessive bending of the existing metal pipes as the inlet pipe and the return pipe.

[0068] like Fig.12 As shown, in this embodiment 1, the first connecting device 105 can be a first pressing plate 1051. Fig.13 The first pressing plate 1051 is provided with through holes for the inlet pipe 107 and the return pipe 106 to pass through. The outer diameter of the first pressing plate 1051 is the same as the outer diameter of the first docking device 2. After the first pressing 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 appearance.

[0069] Specifically, please refer to Fig.12 , Fig.13 and Fig.14 The proximal end of the inlet pipe 107 is provided with a first flange 1071, and the outer diameter of the first flange 1071 is larger than the outer diameter of the inlet pipe 107. Similarly, the proximal end of the return pipe 106 is provided with a second flange 1061, 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, so the first connecting device 105 and the first docking device 2 clamp the first flange 1071 and the second flange 1061 therebetween. When a tightening 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 against 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, the reliability of the sealing 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 ensured, ensuring that the working fluid will not leak from the connection.

[0072] Furthermore, if Fig.13 As shown, the sum of the diameter of the first flange 1071 and the diameter of 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 overlapping portion between the two, because the overlapping portion will cause the first connecting device 105 to be unable to apply force thereto uniformly, which may cause sealing 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, and then the end of the inlet pipe 107 and the end of the return pipe 106 are flanged using a flanging tool to form the first flange 1071 and the second flange 1061.

[0074] It is understandable that the first flange 1071 and the second flange 1061 may also be fixed to the end of the inlet pipe 107 and the end of the return pipe 106 by 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 , Fig.12 and Fig.13 As shown, the first connecting device 105 and the first docking device 2 can be fixedly connected by the fastener 24. Fig.12 As shown, corresponding connection holes for receiving the fasteners 24 may be provided on the first connection device 105 and the first docking device 2. It can be understood that by adjusting the fastening force of the fasteners 24, the degree of compression and deformation between the first flange 1071 and the second flange 1061 can be adjusted between the first connection device 105 and the first docking device 2. The number of the 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 flow channel 201 and a first return flow channel 202 that penetrate the first docking device 2. Fig.13 As shown, the inlet pipe 107 is aligned with and fluidically connected to the first inlet flow channel 201 , and the return pipe 106 is aligned with and fluidically connected to the first return flow channel 202 .

[0077] Furthermore, the inner diameter of the inlet pipe 107 is equal to the inner diameter of the first inlet flow channel 201, and the inner diameter of the return pipe 106 is equal to the inner diameter of the first return flow channel 202, so as to ensure that the flow velocity of the working medium 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 inflow channel 201 extends to penetrate the insertion needle 203. The insertion needle 203 is inserted into the proximal end of the ablation needle, thereby communicating with the inflow channel of the ablation needle; in addition, the first docking device 2 is located in the return flow channel of the ablation needle, so that the return flow channel of the ablation needle is fluidically connected with the first return flow channel 202.

[0079] Therefore, the working fluid in the inlet tube 107 can enter the first inlet channel 201 and be provided to the distal side of the ablation needle through the insertion needle 203. After heat exchange at the distal side of the ablation needle, the working fluid returns to the proximal side 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 embodiments, Figure 7 As shown, the axis of the insertion needle 203 is parallel to the axis of the first return flow channel 202, and the axis of the insertion needle 203 is parallel to the axis of the first inlet flow channel 201. The insertion needle 203 is coaxially arranged with the first docking device 2, so that the coaxiality between the ablation needle and the flexible delivery device can be ensured after the insertion needle 203 is inserted into the ablation needle.

[0081] The axis of the first return flow channel 202 is parallel to the axis of the insertion pin 203 and staggered with each other, so as to facilitate the physical isolation between the first return flow channel 202 and the first inlet flow 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 flow channel 201 from the side. In order to facilitate the processing of the first inlet flow channel 201, a hole can be punched on the side of the first docking device 2 to form the first inlet flow channel 201, and the opening formed by the punching is sealed with the first plug 204, so that the first inlet flow channel 201 forms a passage that runs through the first docking device 2 in the axial direction.

[0083] In other embodiments, Figure 8 As shown, the axis of the pin 203 and the axis of the first return flow channel 202 are parallel to each other, and an angle θ1 is formed between the axis of the pin 203 and the axis of the first inlet flow channel 201 .

[0084] like Figure 8 As shown, the angle θ1 may be an obtuse angle. In this structure, by making the first inlet flow channel 201 inclined, a hole can be punched from the end of the first docking device 2 during processing, thereby forming the first inlet flow channel 201 that penetrates the first docking device 2 (and the plug 203). Therefore, with this structure, there is no need to set the first plug 204 described above, so the structure is simpler, the processing is more convenient, and the hole can be drilled and formed in one time.

[0085] The angle θ1 can be constructed so that the center point of the first inlet channel 201 on the axial cross-section of the first docking device 2 is symmetrical with the center point of the first return channel 202 about the overall center of the first docking device 2, so that the crimping force applied on 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 overlapping force.

[0086] Since the first return flow channel 202 directly passes through the first docking device 2, Figure 7 and Figure 8 In the two embodiments shown, the first return flow channel 202 can be formed by directly punching holes at one end of the first docking device 2 , or by punching holes at both ends of the first docking device 2 .

[0087] like Fig. 20 As shown, the first docking device 2 is further provided with an exhaust hole 25 , which is fluidically connected to the first inlet flow channel 201 and the first return flow channel 202 , respectively.

[0088] The specific structure of the first docking device 2 can be Figure 6 and Figure 7 The axis of the pin 203 shown in the figure is parallel to the axis of the first inlet flow channel 201. Figure 8 The axis of the pin 203 shown in the figure has an angle θ1 with the axis of the first inlet flow channel 201 .

[0089] like Fig. 20 As shown, a structural form is shown in which the axis of the pin 203 and the axis of the first inlet flow channel 201 have an angle θ1, wherein the exhaust hole 25 is fluidly connected to the first inlet flow channel 201 and the first return flow channel 202 respectively.

[0090] By providing the exhaust hole 25, the cooling speed of the ablation needle can be increased, so that the ice ball in the ablation area of ​​the ablation needle can be formed faster and better, and the cryoablation effect can be better.

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

[0092] Specifically, if Figure 3a Please combine Fig. 9 and Fig.10 The proximal side assembly includes a second docking device 3 and a second connecting device 113. The first side (eg Figure 3a The lower side shown in FIG. 1 is connected to the inlet pipe 107 and the return pipe 106 respectively, and the second side of the second docking device 3 (as shown in FIG. Figure 3a The upper side shown) is connected to the working fluid source fluid through a connecting component.

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

[0094] The second connecting device 113 is located at the first side of the second docking device 3. Figure 3a and Figure 4 As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the second connecting device 113, and the second connecting device 113 is constructed to be able to deform the distal ends of the inlet pipe 107 and the return pipe 106 so as to press them onto the first side of the second docking device 3, so that the inlet pipe 107 and the second connecting device 113 and the return pipe 106 and the second connecting device 113 are fluid-tight.

[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 return pipe 106 can also be provided with flange structures. The flange structures are squeezed and deformed by the second connecting device 113, so that the distal ends of the inlet pipe 107 and the return pipe 106 are pressed against the first side of the second docking device 3, thereby ensuring the 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 refer to the formation method of the first flange 1071 and the second flange 1061, which will not be repeated here.

[0097] like Fig. 9 and Fig.10 As shown, the second docking device 3 is respectively provided with a second inlet flow channel 31 and a second return flow channel 32 penetrating the second docking device 3 , the inlet pipe 107 is aligned with the second inlet flow channel 31 and fluidly connected, and the return pipe 106 is aligned with the second return flow channel 32 and fluidly connected.

[0098] A connector 33 is also provided on the second side of the second docking device 3, and the second inlet flow channel 31 extends to and passes through the connector 33. The connector 33 is used to connect with a connecting component, so that the flexible conveying device can be in fluid communication with the working medium source.

[0099] In some embodiments, Fig. 9 and Fig.10 As shown, the axis of the connector 33 and the axis of the second return flow channel 32 are parallel to each other, and the axis of the connector 33 and the axis of the second inlet flow channel 31 are parallel to each other.

[0100] This setting is similar to Figure 6 and Figure 7 The first docking device 2 shown is set up in a similar manner, that is, the axis of the connecting head 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, thereby ensuring that the axis of the ablation needle coincides with the axis of the flexible delivery device, ensuring that they can be fully aligned during connection.

[0101] The axis of the second inlet flow channel 31 is parallel to the axis of the connector 33 and staggered with each other, so as to facilitate physical isolation between the second inlet flow channel 31 and the second inlet flow channel 31 .

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

[0103] In other embodiments, Fig.11 As shown, the axis of the connector 33 and the axis of the second return flow channel 32 are parallel to each other, and an angle θ2 is formed between the axis of the connector 33 and the axis of the second inlet flow channel 31 .

[0104] like Fig.11As shown, the angle θ2 may be an acute angle. In this structure, by making the second inlet flow channel 31 inclined, a hole can be punched from the end of the second docking device 3 during processing, thereby forming the second inlet flow channel 31 that passes through the second docking device 3 (and the connector 33). Therefore, with this structure, there is no need to set the second plug 34 described above, so the structure is simpler, the structure processing is more convenient, and the holes can be drilled and formed in one time.

[0105] The angle θ2 can be constructed so that the center point of the second inlet channel 31 on the axial cross-section of the second docking device 3 is symmetrical with the center point of the second return channel 32 about the overall center of the second docking device 3, so that the pressing force applied on the flange structure is more uniform, that is, the force on the flange structure is more uniform and there is no overlapping force.

[0106] Fig.10 and Fig.11 In the two embodiments shown, the second return flow channel 32 can be formed by punching holes from both ends of the second docking device 3, and when the holes are punched from both ends of the second docking device 3, the axes of the two holes are staggered. In other words, the second return flow channel 32 is actually formed by docking two holes whose axes are staggered. Due to the requirements of miniaturization and lightweight of the device, the volume of the second docking device 3 cannot be too large, so the space for forming the second return flow channel 32 and the second inlet flow channel 31 thereon is extremely limited, and it is also necessary to take into account the effective physical isolation between the second return flow channel 32 and the second inlet flow channel 31, the second return flow channel 32 and the connector 33 cannot interfere with each other, and the second docking device 3 needs to have a certain wall thickness to ensure its use strength and other various constraints. When forming the second return flow channel 32, a method of docking two holes staggered from each other is adopted.

[0107] Please continue to see Figure 2a The flexible delivery device of the ablation system of the present invention also includes an insulating sleeve 110, a fixed sleeve 109 located outside the insulating sleeve 110, and a heat shrink tube 108 sleeved on the fixed sleeve 109, wherein 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 the return pipe 106 transport cold or hot working medium, it is not convenient to operate. The insulation sleeve 110 is set on the outside of the inlet pipe 107 and the return pipe 106, which can avoid heat exchange between the working medium and the environment and ensure safe operation. The insulation sleeve 110 and the inlet pipe 107 and the return pipe 106 can be fixed by the fixing sleeve 109 and the heat shrink tube 108, so that the flexible conveying device can be soft and slender as a whole and ensure its appearance is beautiful.

[0109] The flexible delivery device of the ablation system of the present invention further comprises a distal handle shell 103, a distal quick-insert assembly 101 and a cannula jacket 102. Figure 2a and Figure 2b As shown, the proximal side of the cannula jacket 102 is inserted into the insulating jacket 110 and abuts against the distal end of the first docking device 2. The insertion needle 203 of the first docking device 2 is located in the cannula jacket 102, and the first return flow channel 202 is in fluid communication with the cannula jacket 102. The cannula jacket 102 also receives the proximal side of the ablation needle, so that the cannula jacket 102 is in fluid communication with the return flow channel of the ablation needle, and thus the working fluid returned from the return flow channel of the ablation needle enters the first return flow channel 202 via the cannula jacket 102.

[0110] like Figure 2a and Figure 2b As shown, a distal handle shell 103 is disposed outside the heat shrink tube 108, and the distal handle shell 103 covers a portion of the heat shrink tube 108, and the user can grasp and operate the distal handle shell 103. Figure 2b As shown, the distal end of the cannula sleeve 102 is located in the distal handle shell 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 the groove on the inner wall of the distal handle shell 103, so as to be fixed to the distal handle shell 103.

[0111] In addition, a plurality of second protrusions 1031 are arranged at intervals on the inner wall of the distal handle shell 103. The second protrusions 1031 are used to abut against the outer wall of the heat shrink tube 108 to increase the friction between the distal handle shell 103 and the heat shrink tube 108, so that relative movement between the distal handle shell 103 and the heat shrink tube 108 is not likely to occur.

[0112] The distal quick-insert assembly 101 is connected to the distal side of the cannula jacket 102, and is used to quickly connect to the proximal side of the ablation needle to facilitate the rapid replacement of ablation needles of different diameters. The distal quick-insert assembly 101 can adopt various quick-insert structural forms known in the prior art, which will not be described in detail in the present invention.

[0113] See also Figure 3a and Figure 3b The flexible delivery device of the ablation system of the present invention further includes a proximal handle shell 111, a proximal quick-insert assembly 112, a fixing seat 115, a cannula 116, a retaining frame 117 and a pressing member 118. The proximal handle shell 111 is disposed outside the proximal side of the heat shrink tube 108 and covers a portion of the heat shrink tube 108, and the user can grasp and operate it through the distal handle shell 103.

[0114] The proximal quick-insertion assembly 112 is inserted into the proximal end of the proximal handle shell 111 and covers the heat shrink tube 108, and 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-insertion assembly 112, which is used to engage with the groove on the inner wall of the proximal handle shell 111, so as to be fixed to the distal handle shell 103. A plurality of grooves 1121 are also provided at intervals on the outer wall of the proximal quick-insertion assembly 112, and the grooves 1121 are used to cooperate and connect with the pipeline of the working fluid source.

[0115] Please continue to see Figure 3b The fixing seat 115 is fixedly connected to the proximal side of the proximal quick-insertion assembly 112. The cannula 116 penetrates the fixing seat 115, one end of the cannula 116 is inserted into the connector 33 of the second docking device 3, and the other end is inserted into the retaining frame 117. The clamping member 118 at the proximal end of the retaining frame 117 can fix the retaining frame 117 on the fixing seat 115. The clamping member 118 can be, for example, a clamping nut.

[0116] A sealing member 119 is also provided in the pressing member 118 , and the pressing member 118 presses the sealing member 119 against the proximal end of the retaining frame 117 to ensure a sealed connection between the cannula 116 and the pipeline of the working fluid source.

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

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

[0119] Next, the distal ends of the inlet pipe 107 and the return pipe 106 are respectively passed through the first pressing 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 pressing plate 1051 to fix the first pressing plate 1051 to the first docking device 2, so that the second flange 1061 and the first flange 1071 are respectively pressed against the end surface of the first docking device 2 to ensure good sealing.

[0120] Third, fix the cannula 116 at the proximal end of the second docking device 3, then pass the fixing seat 115 through the cannula 116 and fix it at the proximal end of the second docking device 3, put the seal 119 into the groove of the retaining frame 117, and then use the clamping member 118 to fix the retaining frame 117 to the proximal end of the fixing seat 115.

[0121] Fourth, wrap the heat-insulating sleeve 110 on the inlet pipe 107 and the return pipe 106, and then fix them with the fixing sleeve 109, and finally put on the heat shrinkable tube 108 and heat shrink them.

[0122] Finally, the second connecting device 113 is fixed to the proximal end of the fixing seat 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively covered on a part of both ends of the heat shrink tube 108 to form a flexible delivery device, the delivery tube has a simple structure, a simple process, and is softer as a whole, which is convenient for surgical operation. Doctors have a better experience during actual surgery, so the surgical efficiency can be improved and the surgical risk can be reduced.

[0123] Example 2

[0124] like Figure 15-17 Please combine Figure 1-Figure 11 The present invention provides a flexible delivery device of an ablation system, comprising an inlet tube 107, a return tube 106, a distal side component and a proximal side component.

[0125] The inlet pipe 107 is used to deliver working fluid to the ablation needle. The working fluid includes cold working fluid and hot working fluid. The cold working fluid may be liquid nitrogen, for example, and the hot working fluid may be anhydrous ethanol, for example. Figure 5 , the arrows show the flow direction of the working medium in the flexible conveying device. Figure 5 As shown, after the working fluid is transported from the inlet tube 107 to the distal side of the ablation needle, heat exchange is performed between the ablation area and the target area 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 tube 106. Therefore, the return tube 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 close to the ablation needle (such as Figure 1 The lower side as shown) is used to connect the inlet tube 107 and the return tube 106 to the ablation needle fluid respectively.

[0127] Specifically, if Figure 2a Please combine Figure 4 , Figure 6 and Figure 7 The distal side component includes a first docking device 2 and a first connecting device 105.

[0128] The first side of the first docking device 2 (eg Figure 2a The upper side shown in FIG. 100 ) is respectively connected to the inlet pipe 107 and the return pipe 106, and the second side of the first docking device 2 (as shown in FIG. Figure 2a Therefore, the first docking device 2 serves to form a bridge between the ablation needle and the inlet pipe 107 and the return pipe 106 of the flexible delivery device, that is, to deliver the working fluid in the inlet pipe 107 to the ablation needle, and to deliver the working fluid in the ablation needle after heat exchange to the return pipe 106.

[0129] The first connecting device 105 is located at the first side of the first docking device 2. Figure 2a As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the first connecting device 105, and the first connecting device 105 is constructed to be able to deform the inlet pipe 107 and the return pipe 106 so as to press them onto the first side of the first docking device 2, so that the inlet pipe 107 and the first docking device 2 and the return pipe 106 and the first docking device 2 are fluid-tight.

[0130] Furthermore, the inlet pipe 107 and the return pipe 106 are both plastic pipes, so the first connecting device 105 can deform the end of the inlet pipe 107 and the end of 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, thereby achieving reliable 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.

[0131] On the one hand, the plastic pipe can be made of a low-temperature resistant material (because the inlet pipe 107 and the return pipe 106 need to transport cold working fluids, and their operating temperature can reach -196°C), such as polytetrafluoroethylene (PTFE), soluble polytetrafluoroethylene (PFA) or perfluoroalkyl polymer (FEP), etc. Since the plastic pipe is generally formed by extrusion, there are fewer defects in its production and a high yield rate, so costs can be saved.

[0132] On the other hand, both the inlet pipe 107 and the return pipe 106 are plastic pipes. Compared with the existing metal pipes as the inlet pipe and the return pipe, the inlet pipe 107 and the return pipe 106 of the present invention are relatively soft, can be bent arbitrarily, and have no limit on the bending radius. During the operation, when the ablation area needs to be observed by imaging and the bed is moved repeatedly, the inlet pipe 107 and the return pipe 106 can be bent and changed accordingly to adapt to the position of the bed, thereby solving the leakage problem caused by excessive bending of the existing metal pipes as the inlet pipe and the return pipe.

[0133] like Fig.15 and Fig.16 As shown, in this embodiment 2, the first connecting device 105 can be a second pressing plate 1052. Fig.16 The second pressing plate 1052 is provided with a tapered hole 1055 for passing the inlet pipe 107 and the return pipe 106. It can be understood that the diameter of the tapered hole 1055 in the second pressing plate 1052 gradually increases along the direction toward the first side of the first docking device 2.

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

[0135] like Fig.15 and Fig.16 As shown, in this embodiment 2, the first docking device 2 also includes two first plugs 21. Fig.17 As shown, the first plug 21 includes a first card platform 211, wherein the parts of the first plug 21 located on both sides of the first card platform 211 are respectively inserted into the first inlet flow channel 201 and the inlet pipe 107, and one side of the first card platform 211 is abutted against the end of the first docking device 2, and the other side of the first card platform 211 is abutted against the end of the inlet pipe 107, thereby enabling the first inlet flow channel 201 to be fluidically connected with the inlet pipe 107 through the first plug 21.

[0136] Similarly, the parts of another first plug 21 located on both sides of the first card platform 211 are respectively inserted into the first return channel 202 and the return pipe 106, and one side of the first card platform 211 abuts against the end of the first docking device 2, and the other side of the first card platform 211 abuts against the end of the return pipe 106, thereby enabling the first return channel 202 to be fluidically connected with the return pipe 106 through the first plug 21.

[0137] The first docking device 2 further includes an extrusion ring 23, which is respectively sleeved on the inlet pipe 107 and the return pipe 106. Fig.16 As shown, one side of the pressing ring 23 has a wedge-shaped portion, and the inclination angle of the wedge-shaped portion is substantially the same as the cone angle of the tapered hole 1055 .

[0138] Therefore, after the inlet pipe 107 and the return pipe 106 are inserted into the tapered hole 1055 from one side of the second pressing plate 1052, the extrusion ring 23 is respectively sleeved on the inlet pipe 107 and the return pipe 106, with its wedge-shaped portion aligned with the tapered hole 1055, and inserted into the tapered hole 1055. Under the pressing action of the second pressing plate 1052, due to the limiting action of the first clamping platform 211 on the first plug 21 on the extrusion ring 23, the tapered hole 1055 can shrink the extrusion ring 23 inward, and the deformation of the extrusion ring 23 will squeeze the tube wall of the inlet pipe 107 and the tube wall of the return pipe 106, so that the extrusion ring 23 is tightly held on the tube wall of the inlet pipe 107 and the tube wall of the return pipe 106, and the fluid sealing of the connection is achieved.

[0139] The portion of the first plug 21 inserted into the first inlet channel 201 can be threadedly connected to the first inlet channel 201 or fixedly connected by welding or the like; the portion of the first plug 21 inserted into the first return channel 202 can be threadedly connected to the first return channel 202 or fixedly connected by welding or the like.

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

[0141] After pressing, the fastener 24 passes through the second pressing plate 1052 and the first docking device 2 in sequence, and the two can be fixedly connected. The number of fasteners 24 can be set as needed.

[0142] like Fig.17 As shown, a guide portion 212 is provided at the end of the first plug 21 . The guide portion 212 is a conical structure, which can facilitate the first plug 21 to be inserted into the inlet pipe 107 and the return pipe 106 .

[0143] In addition, 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 (the outer diameters of the two become larger); and because the inlet pipe 107 and the return pipe 106 are respectively inserted into the extrusion ring 23, after the inlet pipe 107 and the return pipe 106 are deformed, the original clearance fit between them and the extrusion ring 23 becomes an interference fit, thereby ensuring the 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 ensured by the cooperation between the tapered hole 1055 on the second pressure plate 1052 and the wedge-shaped portion of the extrusion ring 23; and through the switching 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 of the connection between the components. The various components in this embodiment 2 are fluid-tightly connected through clever cooperation, with a simple structure, convenient assembly, and easier implementation.

[0145] like Fig.16 As shown, the outer diameter of the extrusion ring 23 is the same as the outer diameter of the first clamping platform 211 of the first plug 21, so that the extrusion ring 23 can be deformed as a whole when being extruded, ensuring the tightness of the fit between it and the inlet pipe 107 and the return pipe 106.

[0146] For further information, please see Figure 7The second side of the first docking device 2 is provided with a pin 203 for docking with the ablation needle. The first inflow channel 201 extends to penetrate the pin 203. The pin 203 is inserted into the proximal end of the ablation needle, thereby communicating with the inflow channel of the ablation needle; in addition, the first docking device 2 is located in the return flow channel of the ablation needle, so that the return flow channel of the ablation needle is in fluid communication with the first return flow 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 provided to the distal side of the ablation needle through the insertion needle 203. The working fluid after heat exchange on the distal side of the ablation needle returns to the proximal side of the ablation needle, and enters the first return channel 202 from the return channel of the ablation needle through the first plug 21, and then enters the return tube 106.

[0148] In some embodiments, Figure 7 As shown, the axis of the insertion needle 203 is parallel to the axis of the first return flow channel 202, and the axis of the insertion needle 203 is parallel to the axis of the first inlet flow channel 201. The insertion needle 203 is coaxially arranged with the first docking device 2, so that the coaxiality between the ablation needle and the flexible delivery device can be ensured after the insertion needle 203 is inserted into the ablation needle.

[0149] The axis of the first return flow channel 202 is parallel to the axis of the insertion pin 203 and staggered with each other, so as to facilitate the physical isolation between the first return flow channel 202 and the first inlet flow 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 flow channel 201 from the side. In order to facilitate the processing of the first inlet flow channel 201, a hole can be punched on the side of the first docking device 2 to form the first inlet flow channel 201, and the opening formed by the punching is sealed with the first plug 204, so that the first inlet flow channel 201 forms a passage that runs through the first docking device 2 in the axial direction.

[0151] In other embodiments, Figure 8 As shown, the axis of the pin 203 and the axis of the first return flow channel 202 are parallel to each other, and an angle θ1 is formed between the axis of the pin 203 and the axis of the first inlet flow channel 201 .

[0152] like Figure 8As shown, the angle θ1 may be an obtuse angle. In this structure, by making the first inlet flow channel 201 inclined, a hole can be punched from the end of the first docking device 2 during processing, thereby forming the first inlet flow channel 201 that passes through the first docking device 2 (and the plug 203). Therefore, with this structure, there is no need to set the first plug 204 described above, so the structure is simpler, the structure processing is more convenient, and the holes can be drilled and formed in one time.

[0153] The angle θ1 can be constructed so that the center point of the first inlet channel 201 on the axial cross-section of the first docking device 2 is symmetrical with the center point of the first return channel 202 about the overall center of the first docking device 2, so that the crimping force applied on 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 overlapping force.

[0154] Since the first return flow channel 202 directly passes through the first docking device 2, Figure 7 and Figure 8 In the two embodiments shown, the first return flow channel 202 can be formed by directly punching holes at one end of the first docking device 2 , or by punching holes at both ends of the first docking device 2 .

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

[0156] Specifically, if Figure 3a Please combine Fig. 9 and Fig.10 The proximal side assembly includes a second docking device 3 and a second connecting device 113. The first side (eg Figure 3a The lower side shown in FIG. 1 is connected to the inlet pipe 107 and the return pipe 106 respectively, and the second side of the second docking device 3 (as shown in FIG. Figure 3a The upper side shown) is connected to the working fluid source fluid through a connecting component.

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

[0158] The second connecting device 113 is located at the first side of the second docking device 3. Figure 3a and Figure 4 As shown, the inlet pipe 107 and the return pipe 106 respectively pass through the second connecting device 113, and the second connecting device 113 is constructed to be able to deform the distal ends of the inlet pipe 107 and the return pipe 106 so as to press them onto the first side of the second docking device 3, so that the inlet pipe 107 and the second connecting device 113 and the return pipe 106 and the second connecting device 113 are fluid-tight.

[0159] The second connecting device 113 can adopt a structure that is the same as or similar to the first pressure plate 1051 described in the above-mentioned embodiment 1, that is, the distal ends of the inlet pipe 107 and the return pipe 106 can also be provided with flange structures. The flange structures are squeezed and deformed by the second connecting device 113, so that the distal ends of the inlet pipe 107 and the return pipe 106 are pressed against the first side of the second docking device 3, thereby ensuring the 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.

[0160] like Fig. 9 and Fig.10 As shown, the second docking device 3 is respectively provided with a second inlet flow channel 31 and a second return flow channel 32 penetrating the second docking device 3 , the inlet pipe 107 is aligned with the second inlet flow channel 31 and fluidly connected, and the return pipe 106 is aligned with the second return flow channel 32 and fluidly connected.

[0161] A connector 33 is also provided on the second side of the second docking device 3, and the second inlet flow channel 31 extends to and passes through the connector 33. The connector 33 is used to connect with a connecting component, so that the flexible conveying device can be in fluid communication with the working medium source.

[0162] In some embodiments, Fig. 9 and Fig.10 As shown, the axis of the connector 33 and the axis of the second return flow channel 32 are parallel to each other, and the axis of the connector 33 and the axis of the second inlet flow channel 31 are parallel to each other.

[0163] This setting is similar to Figure 6 and Figure 7 The first docking device 2 shown is set up in a similar manner, that is, the axis of the connecting head 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, thereby ensuring that the axis of the ablation needle coincides with the axis of the flexible delivery device, ensuring that they can be fully aligned during connection.

[0164] The axis of the second inlet flow channel 31 is parallel to the axis of the connector 33 and staggered with each other, so as to facilitate physical isolation between the second inlet flow channel 31 and the second inlet flow channel 31 .

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

[0166] In other embodiments, Fig.11 As shown, the axis of the connector 33 and the axis of the second return flow channel 32 are parallel to each other, and an angle θ2 is formed between the axis of the connector 33 and the axis of the second inlet flow channel 31 .

[0167] like Fig.11 As shown, the angle θ2 may be an acute angle. In this structure, by making the second inlet flow channel 31 inclined, a hole can be punched from the end of the second docking device 3 during processing, thereby forming the second inlet flow channel 31 that passes through the second docking device 3 (and the connector 33). Therefore, with this structure, there is no need to set the second plug 34 described above, so the structure is simpler, the structure processing is more convenient, and the holes can be drilled and formed in one time.

[0168] The angle θ2 can be constructed so that the center point of the second inlet channel 31 on the axial cross-section of the second docking device 3 is symmetrical with the center point of the second return channel 32 about the overall center of the second docking device 3, so that the pressing force applied on the flange structure is more uniform, that is, the force on the flange structure is more uniform and there is no overlapping force.

[0169] Fig.10 and Fig.11 In the two embodiments shown, the second return flow channel 32 can be formed by punching holes from both ends of the second docking device 3, and when the holes are punched from both ends of the second docking device 3, the axes of the two holes are staggered. In other words, the second return flow channel 32 is actually formed by docking two holes whose axes are staggered. Due to the requirements of miniaturization and lightweight of the device, the volume of the second docking device 3 cannot be too large, so the space for forming the second return flow channel 32 and the second inlet flow channel 31 thereon is extremely limited, and it is also necessary to take into account the effective physical isolation between the second inlet flow channel 31 and the second inlet flow channel 31, the second return flow channel 32 and the connector 33 cannot interfere with each other, and the second docking device 3 needs to have a certain wall thickness to ensure its use strength and other various constraints. When forming the second return flow channel 32, a method of docking two holes staggered from each other is adopted.

[0170] It can be understood that the second connecting device 113 can also adopt a structural form that is the same or similar to the second pressure plate 1052 described in the above-mentioned embodiment 2, that is, the tapered hole 1055 of the second pressure plate 1052 and the wedge-shaped portion of the extrusion ring 23 can be made to cooperate with each other, and through the switching and limiting action 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 to see Figure 2a The flexible delivery device of the ablation system of the present invention also includes an insulating sleeve 110, a fixed sleeve 109 located outside the insulating sleeve 110, and a heat shrink tube 108 sleeved on the fixed sleeve 109, wherein 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 the return pipe 106 transport cold or hot working medium, it is not convenient to operate. The insulation sleeve 110 is set on the outside of the inlet pipe 107 and the return pipe 106, which can avoid heat exchange between the working medium and the environment and ensure safe operation. The insulation sleeve 110 and the inlet pipe 107 and the return pipe 106 can be fixed by the fixing sleeve 109 and the heat shrink tube 108, so that the flexible conveying device can be soft and slender as a whole and ensure its appearance is beautiful.

[0173] The flexible delivery device of the ablation system of the present invention further comprises a distal handle shell 103, a distal quick-insert assembly 101 and a cannula jacket 102. Figure 2a and Figure 2b As shown, the proximal side of the cannula jacket 102 is inserted into the insulating jacket 110 and abuts against the distal end of the first docking device 2. The insertion needle 203 of the first docking device 2 is located in the cannula jacket 102, and the first return flow channel 202 is in fluid communication with the cannula jacket 102. The cannula jacket 102 also receives the proximal side of the ablation needle, so that the cannula jacket 102 is in fluid communication with the return flow channel of the ablation needle, and thus the working fluid returned from the return flow channel of the ablation needle enters the first return flow channel 202 via the cannula jacket 102.

[0174] like Figure 2a and Figure 2b As shown, a distal handle shell 103 is disposed outside the heat shrink tube 108, and the distal handle shell 103 covers a portion of the heat shrink tube 108, and the user can grasp and operate the distal handle shell 103. Figure 2b As shown, the distal end of the cannula sleeve 102 is located in the distal handle shell 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 the groove on the inner wall of the distal handle shell 103, so as to be fixed to the distal handle shell 103.

[0175] In addition, a plurality of second protrusions 1031 are arranged at intervals on the inner wall of the distal handle shell 103. The second protrusions 1031 are used to abut against the outer wall of the heat shrink tube 108 to increase the friction between the distal handle shell 103 and the heat shrink tube 108, so that relative movement between the distal handle shell 103 and the heat shrink tube 108 is not likely to occur.

[0176] The distal quick-insert assembly 101 is connected to the distal side of the cannula jacket 102, and is used to quickly connect to the proximal side of the ablation needle to facilitate the rapid replacement of ablation needles of different diameters. The distal quick-insert assembly 101 can adopt various quick-insert structural forms known in the prior art, which will not be described in detail in the present invention.

[0177] See also Figure 3a and Figure 3b The flexible delivery device of the ablation system of the present invention further includes a proximal handle shell 111, a proximal quick-insert assembly 112, a fixing seat 115, a cannula 116, a retaining frame 117 and a pressing member 118. The proximal handle shell 111 is disposed outside the proximal side of the heat shrink tube 108 and covers a portion of the heat shrink tube 108, and the user can grasp and operate it through the distal handle shell 103.

[0178] The proximal quick-insertion assembly 112 is inserted into the proximal end of the proximal handle shell 111 and covers the heat shrink tube 108, and 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-insertion assembly 112, which is used to engage with the groove on the inner wall of the proximal handle shell 111, so as to be fixed to the distal handle shell 103. A plurality of grooves 1121 are also provided at intervals on the outer wall of the proximal quick-insertion assembly 112, and the grooves 1121 are used to cooperate and connect with the pipeline of the working fluid source.

[0179] Please continue to see Figure 3b The fixing seat 115 is fixedly connected to the proximal side of the proximal quick-insertion assembly 112. The cannula 116 penetrates the fixing seat 115, one end of the cannula 116 is inserted into the connector 33 of the second docking device 3, and the other end is inserted into the retaining frame 117. The clamping member 118 at the proximal end of the retaining frame 117 can fix the retaining frame 117 on the fixing seat 115. The clamping member 118 can be, for example, a clamping nut.

[0180] A sealing member 119 is also provided in the pressing member 118 , and the pressing member 118 presses the sealing member 119 against the proximal end of the retaining frame 117 to ensure a sealed connection between the cannula 116 and the pipeline of the working fluid source.

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

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

[0183] Secondly, the distal ends of the inlet pipe 107 and the return pipe 106 are respectively passed through the second pressing plate 1052, and an extrusion 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 flow channel 201 and between the return pipe 106 and the first return flow channel 202, and the extrusion ring 23 is deformed by pressing the second pressing plate 1052, and the inlet pipe 107 and the return pipe 106 are tightly embraced, and the inlet pipe 107 and the return pipe 106 are tightly embraced with the first plug 21.

[0184] Third, fix the cannula 116 at the proximal end of the second docking device 3, then pass the fixing seat 115 through the cannula 116 and fix it at the proximal end of the second docking device 3, put the seal 119 into the groove of the retaining frame 117, and then use the clamping member 118 to fix the retaining frame 117 to the proximal end of the fixing seat 115.

[0185] Fourth, wrap the heat-insulating sleeve 110 on the inlet pipe 107 and the return pipe 106, and then fix them with the fixing sleeve 109, and finally put on the heat shrinkable tube 108 and heat shrink them.

[0186] Finally, the second connecting device is fixed to the proximal end of the fixing seat 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively covered on a part of both ends of the heat shrink tube 108 to form a flexible delivery device, the delivery tube has a simple structure, a simple process, and is softer as a whole, which is convenient for surgical operation. Doctors have a better experience during actual surgery, so the surgical efficiency can be improved and the surgical risk can be reduced.

[0187] Example 3

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

[0189] like Fig.18 As shown, the difference between the present embodiment 3 and the above-mentioned embodiment 2 is that the second plug 22 is used in the present embodiment 3 to replace the first plug 21, and the extrusion ring 23 is not provided in the present embodiment 3.

[0190] Similar to the above-mentioned embodiment 2, Fig.19As shown, the second plug 22 in this embodiment 3 is also provided with a second clamping platform 221. The parts of the second plug 22 located on both sides of the second clamping platform 221 are respectively inserted into the first inlet flow channel 201 and the inlet pipe 107, and one side of the second clamping platform 221 abuts against the end of the first docking device 2, and the other side of the second clamping platform 221 abuts against the end of the inlet pipe 107, thereby enabling the first inlet flow channel 201 to be fluidically connected with the inlet pipe 107 through the first plug 21.

[0191] Similarly, the parts of another second plug 22 located on both sides of the second card platform 221 are respectively inserted into the first return channel 202 and the return pipe 106, and one side of the second card platform 221 abuts against the end of the first docking device 2, and the other side of the second card platform 221 abuts against the end of the return pipe 106, thereby enabling the first return channel 202 to be fluidically connected with the return pipe 106 through the second card platform 221.

[0192] In addition, the difference between the present embodiment 3 and the above-mentioned embodiment 2 is that the first connecting device 105 is a structural form of the third pressing plate 1053. Fig.18 The third pressing plate 1053 is provided with a tapered hole 1056 for the inlet pipe 107 and the return pipe 106 to pass through. It can be understood that the tapered hole 1056 can also be in the form of other holes with variable diameters.

[0193] like Fig.19 As shown, a conical head 222 is provided at the end of the second plug 22 , and the taper of the conical head 222 is substantially the same as the taper of the conical hole 1056 .

[0194] In the present embodiment 3, the outer diameter of the portion of the second plug 22 located on the side of the second clamping plate 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 clamping plate 221 is larger than the inner diameter of the return pipe 106, so when the second plug 22 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. And the conical head 222 at the end of the second plug 22 can match the conical surface of the conical hole 1056, so under the pressing action of the third pressing plate 1053, the conical head 222 at the end of the second plug 22 and the conical hole 1056 can clamp the pipe wall of the inlet pipe 107 and the pipe wall of the return pipe 106, thereby realizing the fluid seal between the connecting parts.

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

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

[0197] Secondly, 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 flow channel 201 and between the return pipe 106 and the first return flow channel 202. By pressing the third pressure plate 1053, the inlet pipe 107 and the return pipe 106 are respectively deformed and expanded, so that the conical head 222 and the conical hole 1056 at the end of the second plug 22 can clamp the tube wall of the inlet pipe 107 and the tube wall of the return pipe 106.

[0198] Third, fix the cannula 116 at the proximal end of the second docking device 3, then pass the fixing seat 115 through the cannula 116 and fix it at the proximal end of the second docking device 3, put the seal 119 into the groove of the retaining frame 117, and then use the clamping member 118 to fix the retaining frame 117 to the proximal end of the fixing seat 115.

[0199] Fourth, wrap the heat-insulating sleeve 110 on the inlet pipe 107 and the return pipe 106, and then fix them with the fixing sleeve 109, and finally put on the heat shrinkable tube 108 and heat shrink them.

[0200] Finally, the second connecting device is fixed to the proximal end of the fixing seat 115, and the distal handle shell 103 and the proximal handle shell 111 are respectively covered on a part of both ends of the heat shrink tube 108 to form a flexible delivery device, the delivery tube has a simple structure, a simple process, and is softer as a whole, which is convenient for surgical operation. Doctors have a better experience during actual surgery, so the surgical efficiency can be improved and the surgical risk can be reduced.

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

[0202] Example 4

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

[0204] The inlet pipe 107 is used to deliver working fluid to the ablation needle. The working fluid includes cold working fluid and hot working fluid. The cold working fluid may be liquid nitrogen, for example, and the hot working fluid may be anhydrous ethanol, for example. Figure 5 , the arrow shows the flow direction of the working medium in the conveying device. Figure 5 As shown, after the working fluid is transported from the inlet tube 107 to the distal side of the ablation needle, heat exchange is performed between the ablation area and the target area 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 tube 106. Therefore, the return tube 106 is used to receive the working fluid returned from the ablation needle.

[0205] Specifically, if Figure 2a Please combine Figure 4 , Figure 6 and Figure 7 The distal side component includes a first docking device 2 and a first connecting device 105.

[0206] The first side of the first docking device 2 (eg Figure 2a The upper side shown in FIG. 100 ) is respectively connected to the inlet pipe 107 and the return pipe 106, and the second side of the first docking device 2 (as shown in FIG. Figure 2a Therefore, the first docking device 2 serves 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 fluid in the inlet pipe 107 to the ablation needle, and to deliver the working fluid in the ablation needle after heat exchange to the return pipe 106.

[0207] The first connecting device 105 is located at the first side of the first docking device 2. The first connecting device 105 can adopt the structural form described in any 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 may adopt the structural form described in any of the above-mentioned embodiments 1, 2 and 3 or a combination thereof.

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

[0210] The specific structure of the first docking device 2 can be Figure 6 and Figure 7 The axis of the pin 203 shown in the figure is parallel to the axis of the first inlet flow channel 201. Figure 8The structure is such that the axis of the pin 203 shown forms an angle θ1 with the axis of the first inflow channel 201.

[0211] As Fig. 20 shown, a structure is shown where the axis of the pin 203 forms an angle θ1 with the axis of the first inflow channel 201, wherein 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 rate of the ablation needle can be increased, enabling a better ice ball formation in the ablation area of the ablation needle and a better cryoablation effect.

[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.), and 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, so 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 for 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 the outflow of a large amount of gaseous cryogenic working fluid is slow, resulting in a slow cooling rate, affecting the size of the ice ball within a specified time and继而 affecting the ablation effect. 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 forms an angle α1 with the axis of the first inflow channel 201, or the axis of the exhaust holes 25 forms an angle α2 with the axis of the first return channel 202.

[0216] The angle α1 or the angle α2 needs to be set as small as possible. Because the size of the angle α1 or the angle α2 will affect the consumption of the cold working fluid. In the process of the gas phase or liquid phase cold working fluid entering the needle tip of the ablation needle from the first inlet flow channel 201, a part of the cold working fluid will flow out from the exhaust hole 25. The fluid here will produce resistance to the fluid flowing back from the needle tip of the ablation needle to the first return flow channel 202, and reduce the flow rate of the return fluid, thereby reducing the return fluid flow rate, thereby reducing the consumption of the cold working fluid. It can be understood that the smaller the angle α1 or the angle α2 is set, the greater the resistance to the return fluid, and the flow rate of the return fluid will be reduced accordingly, thereby reducing the consumption of the cold working fluid.

[0217] The value range of the angle α1 is related to the angle θ1 between the axis of the pin 203 and the axis of the first inlet flow channel 201 as described above. For example, the minimum value of the angle α1 (α 1min ) is 0°. It can be understood that when the angle α1 is 0°, that is, the axis of the exhaust hole 25 is parallel to the axis of the first inlet flow channel 201, α2 is (180°-θ1); the maximum value of the angle α1 (α 1max ) is 90°. It can be understood that when the angle α1 is 90°, that is, 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 value range of the angle α1 is 0°-90°, and therefore, the value range of the angle α2 is (180°-θ1)-90°.

[0218] In addition, the diameter d of the exhaust hole 25 is related to the cooling speed and the consumption of the working fluid. The larger the diameter d of the exhaust hole 25, the faster the cooling speed, but the greater the consumption of the working fluid, so preferably, the diameter d of the exhaust 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 formula (1), Q is the flow rate of the fluid channel (i.e., from the first inlet flow channel 201 to the first return flow channel 202), μ is a constant, A is the cross-sectional area of ​​the fluid channel (i.e., from the first inlet flow channel 201 to the first return flow channel 202), ΔP is the pressure difference between the first inlet flow channel 201 and the first return flow channel 202, and ρ is the density of the working fluid.

[0222] Since the cross-sectional areas of the first inlet flow channel 201 and the first return flow channel 202 are both larger than the cross-sectional area S2 of the cold working medium outlet at the tip of the needle, the cross-sectional area A of the fluid passage from the first inlet flow channel 201 to the first return flow channel 202 is determined by the cross-sectional area S2 of the cold working medium outlet at the tip of the needle with 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 a constant; the pressure difference △P and the density ρ of the working fluid are also constants. When the exhaust hole 25 is not provided, that is, S1 is 0, the fluid only passes through the cold working fluid outlet at the tip of the needle, that is, 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 exhaust hole 25 is provided, the fluid passes through the cold working fluid outlet at the tip of the needle and the exhaust hole 25 respectively, and A can be regarded as the sum of S2 and S1. Therefore, it can be seen that the provision of the exhaust hole 25 will increase A, and Q will increase accordingly.

[0224] In addition, since the area S1 of the exhaust hole 25 is related to its diameter d, increasing the diameter d of the exhaust hole 25 can increase S1, and A increases accordingly, thereby increasing Q accordingly, that is, the flow rate from the first inlet flow channel 201 to the first return flow channel 202 increases, thereby accelerating the cooling speed; however, the increase in flow rate will also be accompanied by an increase in the consumption of the working fluid.

[0225] The following four specific implementation modes are used as examples for explanation.

[0226] As shown in Table 1, four specific implementations of the first docking device 2 are shown.

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

[0228]

[0229]

[0230] It can be understood that the initial cooling time is the time taken for the delivery system and the ablation needle to be cooled from room temperature to the required treatment temperature (e.g., -196°C, -180°C, or -170°C). According to Table 1 above, the first embodiment adopts the method of not providing an exhaust hole on the first docking device 2, and the experimental test is carried out when the diameter of the needle tip of the ablation needle is 1.7 mm. Its initial cooling time is greater than 10 minutes, the liquid nitrogen consumption is less than 12%, and the size of the obtained ice ball does 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 at least 15 mm in diameter. That is to say, the initial cooling time required for the first embodiment is relatively long and the size of the obtained ice ball is too small.

[0232] The second embodiment adopts a method of setting an exhaust hole on the first docking device 2. Specifically, the 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, the experimental test is carried out when the diameter of the needle tip of the ablation needle is 1.7 mm. 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 small.

[0233] Therefore, it can be seen that in the second implementation mode, 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 at least 15 mm in diameter. 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, unqualified phenomena will occur (the ice ball size is too small).

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

[0236] The fourth embodiment adopts a method of setting an exhaust hole on the first docking device 2. Specifically, the angle α1 of the exhaust hole 25 is (50±20)°, and the diameter d of the exhaust hole 25 is (0.4±0.05) mm. Similarly, experimental tests are carried out when the diameter of the needle tip of the ablation needle is 1.7 mm. The initial cooling time is less than 6.5 minutes, the liquid nitrogen consumption is 12%-16%, and the size of the ice ball obtained 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 at least 15 mm in diameter.

[0238] In summary, by comparing the schemes with and without exhaust holes, it can be seen that although the scheme with exhaust holes will slightly increase the consumption of liquid nitrogen, its initial cooling time and the size of the obtained ice ball are qualified and can meet the requirements of the ablation operation; by comparing multiple schemes with exhaust holes, it can be seen that with the trend of decreasing angle α1 of the exhaust hole and increasing diameter d of the exhaust hole 25, the initial cooling time shows a downward trend. Therefore, on the whole, the exhaust hole 25 with an angle α1 of (50±20)° and a diameter d of (0.4±0.05) mm is the preferred scheme.

[0239] Example 5

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

[0241] Although the present invention has been described with reference to preferred embodiments, various modifications may be made thereto and parts thereof may be replaced by equivalents without departing from the scope of the present invention. In particular, the various technical features mentioned in the various embodiments may be combined in any manner as long as there are no structural conflicts. The present 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: The distal end assembly comprises a first docking device (2), wherein the first docking device (2) is provided with a first inlet flow channel (201) and a first return flow channel (202) penetrating the first docking device (2), wherein the first inlet flow channel (201) is aligned with and fluidically connected to an inlet pipe (107) for delivering a working medium to an ablation needle, and the first return flow channel (202) is aligned with and fluidically connected to a return pipe (106) for receiving a working medium returned from the ablation needle; The first docking device (2) is also provided with an exhaust hole (25), and the exhaust hole (25) is respectively in fluid communication with the first inlet flow channel (201) and the first return flow channel (202).

2. The flexible delivery device of 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 flow channel (201) or the diameter of the first return flow channel (202).

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

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

5. The flexible delivery device of the ablation system according to claim 1 or 2, characterized in that: The exhaust hole (25) is arranged obliquely, and an angle α1 is formed between the axis of the exhaust hole (25) and the axis of the first inlet flow channel (201), and the value range of the angle α1 is 0° to 90°.

6. The flexible delivery device of the ablation system according to claim 1 or 2, characterized in that: A pin (203) for connecting to an ablation needle is provided on one side of the first docking device (2), the first inlet flow channel (201) extends to pass through the pin (203), an obtuse angle θ1 is formed between the axis of the pin (203) and the axis of the first inlet flow channel (201), an angle α2 is formed between the axis of the exhaust hole (25) and the axis of the first return flow channel (202), and the value range of the angle α2 is (180° to θ1) to 90°.

7. The flexible delivery device of the ablation system according to claim 1 or 2, characterized in that: A pin (203) for connecting to an ablation needle is provided on one side of the first docking device (2), and the first inlet flow channel (201) extends to pass through the pin (203), and an angle θ1 is formed between the axis of the pin (203) and the axis of the first inlet flow channel (201), and the angle θ1 is configured so that the center point of the first inlet flow channel (201) on the axial section of the first docking device (2) and the center point of the first return flow channel (202) are symmetrical about the overall center of the first docking device (2).

8. The flexible delivery device of the ablation system according to claim 1 or 2, characterized in that: A pin (203) for connecting to an ablation needle is disposed on one side of the first docking device (2), and the first inlet flow channel (201) extends to pass through the pin (203), and the axis of the pin (203), the axis of the first inlet flow channel (201) and the axis of the first return flow channel (202) are parallel to each other, and the axis of the pin (203) is parallel to the axis of the first return flow channel (202) and is staggered with each other.

9. The flexible delivery device of the ablation system according to claim 8, characterized in that: The first docking device (2) is also provided with a first plug portion (204), and the first plug portion (204) is used to seal the hole formed when the first inlet flow channel (201) is constructed from the side, and the first return flow channel (202) directly passes through the first docking device (2).

10. The flexible delivery device of the ablation system according to claim 1 or 2, characterized in that: The distal side component also includes a first connecting device (105), which is located on one side of the first docking device (2). The first connecting device (105) uses a connection method suitable for a flexible tube or a connection method suitable for a metal tube to achieve fluid sealing between the inlet tube (107) and the first docking device (2) and between the return tube (106) and the first docking device (2).

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