CN119385675A

CN119385675A - Flexible delivery device for ablation system

Info

Publication number: CN119385675A
Application number: CN202411756179.3A
Authority: CN
Inventors: 杜泽奎; 熊飞; 江荣华; 肖剑; 刘朋; 李雪冬; 郭亚平; 杨晶晶; 罗富良; 黄乾富
Original assignee: Hygea Medical Technology Co Ltd
Current assignee: Hygea Medical Technology Co Ltd
Priority date: 2024-09-27
Filing date: 2024-09-27
Publication date: 2025-02-07
Also published as: CN118845196A; CN118845196B

Abstract

The present invention relates to a flexible delivery device of an ablation system, and to the field of ablation technology. The flexible delivery device of the ablation system of the present invention includes a distal side component, and the distal side component includes a first docking device, and the first docking device is respectively provided with a first inlet flow channel and a first return flow channel that penetrate the first docking device, 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 flow tube for receiving a working medium returned from the ablation needle; the first docking device is also provided with an exhaust hole, and the exhaust hole is respectively fluidly connected to the first inlet flow channel and the first return flow channel.

Description

Flexible delivery device for ablation system

The application is a divisional application of Chinese patent CN202411360123.6 with the application date of 2024, 09, 27 and the name of ' flexible conveying device of ablation system ' and the name of ablation system '.

Technical Field

The invention relates to the technical field of ablation, in particular to a flexible conveying device of an ablation system.

Background

The cold-hot composite ablation technology is characterized in that cold working medium and hot working medium are alternately delivered to human tumor lesion tissues, and physical stimulation of deep freezing (at least-196 ℃) and heating (at least 80 ℃) is directly given to the lesion tissues, so that tumor cells are swollen and ruptured, and the tumor histopathology presents irreversible congestion, edema, denaturation and coagulation necrosis processes.

The cold-hot compound ablation is generally implemented through an ablation needle and a conveying device, and cold working medium and hot working medium are conveyed into the ablation needle through the conveying device. The inflow pipeline and the return pipeline in the existing conveying device are made of harder metal materials. On the one hand, the metal material is likely to have welding defects when being welded on the pipelines, and the defects can cause leakage and the like, on the other hand, the pipelines of the metal material need to be very careful and can not be bent at will in the actual use process, otherwise, the pipelines of the metal material are easy to be damaged, especially the ablation area needs to be observed by images in the operation process, and the pipelines of the metal material can be bent and have leakage risks when the sickbed is repeatedly moved. The above problems of the pipeline based on the metal material are considered to be the mode of replacing the pipeline in the conveying device with the flexible pipeline, but how to ensure the tightness of the connection part of the flexible pipeline is a technical problem to be solved.

Disclosure of Invention

The present invention provides a flexible delivery device for an ablation system for solving at least one of the above-mentioned problems.

The invention provides a flexible conveying device of an ablation system, which comprises a distal side assembly, wherein the distal side assembly comprises a first butting device, a first inflow channel and a first backflow channel which penetrate through the first butting device are respectively arranged in the first butting device, the first inflow channel is aligned with and is in fluid communication with an inflow pipe for conveying working medium to an ablation needle, and the first backflow channel is aligned with and is in fluid communication with a backflow pipe for receiving the working medium returned from the ablation needle;

The first butt joint device is also provided with an exhaust hole which is respectively in fluid communication with the first inflow channel and the first backflow channel.

In one embodiment, the diameter of the vent hole is smaller than the diameter of the first inflow channel or the diameter of the first return channel.

In one embodiment, the vent radial cross-sectional area S1 is less than the cross-sectional area S2 of the cold working medium outlet at the needle tip of the ablation needle.

In one embodiment, the diameter d of the vent hole is 0.3 mm-0.5 mm.

In one embodiment, the exhaust hole is obliquely arranged, an included angle alpha ₁ is formed between the axis of the exhaust hole and the axis of the first inflow channel, and the included angle alpha ₁ ranges from 0 degrees to 90 degrees.

In one embodiment, a contact pin for being in contact with an ablation needle is arranged on one side of the first contact device, the first inflow runner extends to penetrate through the contact pin, an included angle theta ₁ which is an obtuse angle is formed between the axis of the contact pin and the axis of the first inflow runner, an included angle alpha ₂ is formed between the axis of the exhaust hole and the axis of the first backflow runner, and the included angle alpha ₂ is in a range of (180-theta ₁) to 90 degrees.

In one embodiment, one side of the first docking device is provided with a contact pin for docking with an ablation needle, the first inflow channel extends to penetrate through the contact pin, an included angle theta ₁ is formed between the axis of the contact pin and the axis of the first inflow channel, and the included angle theta ₁ is configured so that the center point of the first inflow channel on the axial section of the first docking device is symmetrical to the center point of the first reflux channel with respect to the whole center of the first docking device.

In one embodiment, one side of the first docking device is provided with a contact pin for docking with an ablation needle, the first inflow channel extends to penetrate through the contact pin, the axis of the first inflow channel and the axis of the first return channel are parallel to each other, and the axis of the contact pin is parallel to the axis of the first return channel and staggered from each other.

In one embodiment, the first docking device is further provided with a first plug portion for sealing a hole formed when the first inflow channel is configured from the side, and the first return channel directly penetrates the first docking device.

In one embodiment, the distal assembly further comprises a first connection means located on one side of the first docking means, the first connection means being adapted to fluidly seal between the intake conduit and the first docking means and between the return conduit and the first docking means by means of a connection adapted to a flexible conduit or a connection adapted to a metal conduit.

Compared with the prior art, the invention has the advantages that the inflow pipe and the return pipe are flexible pipes, and can be bent at will according to the expected direction, so that the problem of leakage caused by bending/flattening and the like is avoided even if a sickbed is repeatedly moved in operation, the operation of doctors is facilitated, the operation efficiency is improved, the inflow pipe and the return pipe are flexible, and the inflow pipe and the return pipe are deformed through the first connecting device so as to be pressed on the first side of the first abutting device, so that the fluid sealing performance between the inflow pipe and the first abutting device and between the return pipe and the first abutting device can be ensured, and the problem of tightness of the connecting part of a flexible pipeline is solved.

Drawings

The invention will be described in more detail hereinafter on the basis of embodiments and with reference to the accompanying drawings.

FIG. 1 is a schematic structural view of a flexible delivery device of an ablation system in an embodiment of the invention;

FIG. 2a is a cross-sectional view of a flexible delivery device of an ablation system in an embodiment of the invention, with only a distal portion shown;

FIG. 2b is an enlarged view of a portion of the distal side of the flexible delivery device of the ablation system of FIG. 2 a;

FIG. 3a is a cross-sectional view of a flexible delivery device of an ablation system in an embodiment of the invention, with only a proximal side portion shown;

FIG. 3b is an enlarged view of a portion of the proximal side of the flexible delivery device of the ablation system of FIG. 3 a;

FIG. 4 is a schematic perspective view of a flexible delivery device of an ablation system in an embodiment of the invention;

FIG. 5 is a schematic flow diagram of a working medium of a flexible delivery device of an ablation system in an embodiment of the invention;

FIG. 6 is a schematic perspective view of a first docking mechanism according to one embodiment of the present invention;

FIG. 7 is a cross-sectional view of the first docking device of FIG. 6;

FIG. 8 is a cross-sectional view of a first docking mechanism in one embodiment of the present invention;

FIG. 9 is a cross-sectional view of a second docking mechanism in one embodiment of the present invention;

FIG. 10 is a cross-sectional view of the second docking device of FIG. 9;

FIG. 11 is a cross-sectional view of a second docking mechanism in another embodiment of the present invention;

FIG. 12 is an exploded view of a first docking device and a flow and return tube in one embodiment of the present invention;

FIG. 13 is a cross-sectional view of the first docking device and the inlet and return tubes of FIG. 12 after installation;

FIG. 14 is a schematic perspective view of a return tube in an embodiment of the invention;

FIG. 15 is an exploded view of a first docking device and a return and inlet pipe in another embodiment of the present invention;

FIG. 16 is a cross-sectional view of the first docking device and the inlet and return tubes of FIG. 15 after installation;

fig. 17 is a schematic perspective view of the first plug shown in fig. 15;

FIG. 18 is a cross-sectional view of yet another embodiment of the present invention after installation of the first docking device and the inlet and return tubes;

fig. 19 is a schematic perspective view of the second plug shown in fig. 18;

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

Reference numerals:

101. A distal quick insert assembly;

102. 1021, a first boss;

103. A distal side handle housing; 1031, a second boss;

2. A first docking device;

21. First plug, 22, second plug, 23, extrusion ring, 24, fastener, 25, exhaust hole;

211. first clamping table 212, guide part 221, second clamping table 222 and conical head;

201. 202, a first backflow runner, 203, a pin, 204, a first plug part;

105. First connecting means 1051, first pressure plate, 1052, second pressure plate, 1053, third pressure plate, 1055, tapered bore, 1056, tapered bore;

106. a return line 107, an inlet line;

1061. 1071, a first flange;

108. heat shrinking pipe 109, fixing sleeve 110 and heat insulating sleeve;

111. A proximal side handle housing;

112. a proximal side quick insert assembly; 1121, grooves, 1122, third protrusions;

113. The second connecting device 115, the fixing seat 116, the cannula 117, the retainer 118, the pressing piece 119 and the sealing piece;

3. a second docking device; 31, a second inflow channel, 32, a second backflow channel, 33, a connector, 34 and a second plug part.

Detailed Description

The invention will be further described with reference to the accompanying drawings.

Example 1

As shown in fig. 1-14, the present invention provides a flexible delivery device for an ablation system that includes a inflow tube 107, a return tube 106, a distal assembly, and a proximal assembly.

The inflow pipe 107 is used for delivering a working medium to the ablation needle, wherein the working medium comprises a cold working medium and a hot working medium, the cold working medium can be liquid nitrogen, for example, and the hot working medium can be absolute ethyl alcohol, for example. Referring to fig. 5, arrows show the direction of flow of the working fluid in the flexible transport device. As shown in fig. 5, after the working fluid is delivered from the inflow tube 107 to the distal end side of the ablation needle, heat exchange is performed between the ablation region on the distal end side of the ablation needle and the target region, and the working fluid after heat exchange returns to the proximal end side of the ablation needle and enters the return tube 106, so that the return tube 106 is used for receiving the working fluid returned in the ablation needle.

As shown in fig. 2a, the distal side assembly is located on the side near the ablation needle (the lower side as shown in fig. 1) for placing the inflow tube 107 and the return tube 106 in fluid communication with the ablation needle, respectively.

Specifically, as shown in fig. 2a, and referring to fig. 4, 6 and 7, the distal assembly comprises a first docking means 2 and a first connection means 105.

A first side (upper side as shown in fig. 2 a) of the first docking device 2 is in fluid communication with the inflow tube 107 and the return tube 106, respectively, and a second side (lower side as shown in fig. 2 a) of the first docking device 2 is for fluid communication with the ablation needle. The first docking device 2 thus functions to form a bridge between the ablation needle and the inflow tube 107 and the return tube 106 of the flexible delivery device, i.e. to deliver the working medium in the inflow tube 107 to the ablation needle and to deliver the heat exchanged working medium in the ablation needle to the return tube 106.

The first connecting means 105 is located on a first side of the first docking means 2. As shown in fig. 2a, the inlet pipe 107 and the return pipe 106 extend through the first connection means 105, respectively, and the first connection means 105 are configured to deform the inlet pipe 107 and the return pipe 106 so as to press them against the first side of the first docking means 2, such that a fluid tight seal is provided between the inlet pipe 107 and the first docking means 2 and between the return pipe 106 and the first docking means 2.

Further, both the inlet pipe 107 and the return pipe 106 are plastic pipes, whereby the first connection means 105 can be deformed by pressing the ends of the inlet pipe 107 and the return pipe 106, thereby pressing the inlet pipe 107 and the return pipe 106 against the first side of the first docking means 2, whereby a reliable fluid-tight seal between the inlet pipe 107 and the first docking means 2 and between the return pipe 106 and the first docking means 2 can be achieved.

In one aspect, the plastic tube may be made of a low temperature resistant material (because the inlet tube 107 and the return tube 106 need to carry cold working fluid, which may be at-196C), such as Polytetrafluoroethylene (PTFE), soluble Polytetrafluoroethylene (PFA), or perfluoroalkyl polymers (FEP), etc. Since plastic pipes are generally formed by extrusion, the defects in production are few, the yield is high, and therefore the cost can be saved.

On the other hand, the inflow pipe 107 and the return pipe 106 are plastic pipes, and compared with the scheme that the existing metal pipes are used as the inflow pipe and the return pipe, the inflow pipe 107 and the return pipe 106 are softer, can realize arbitrary bending, and have no limitation on bending radius. When the patient bed is repeatedly moved in the operation process by observing the ablation area through images, the inflow pipe 107 and the return pipe 106 can be correspondingly bent to change the shape so as to adapt to the position of the patient bed, thereby solving the problem of leakage caused by excessive bending of the scheme of taking the existing metal pipe as the inflow pipeline and the return pipeline.

As shown in fig. 12, in the present embodiment 1, the first connecting device 105 may be in the form of a first pressing plate 1051, and referring to fig. 13, through holes for passing the inflow pipe 107 and the return pipe 106 are provided in the first pressing plate 1051. The outer diameter of the first pressing plate 1051 is the same as the outer diameter of the first docking device 2, and after the first pressing plate 1051 presses the inflow pipe 107 and the return pipe 106 against the first docking device 2, the inflow pipe and the return pipe form a uniform-appearance structure.

Specifically, referring to fig. 12, 13 and 14, a first flange 1071 is provided at the proximal end of the inlet tube 107, and the outer diameter of the first flange 1071 is larger than the outer diameter of the inlet tube 107. Likewise, the proximal end of return tube 106 is provided with a second flange 1061, the outer diameter of second flange 1061 being greater than the outer diameter of return tube 106.

The inlet pipe 107 and the return pipe 106 extend through the first connecting means 105, so that the first connecting means 105 and the first docking means 2 sandwich the first flange 1071 and the second flange 1061 therebetween, and when a tightening force is applied to the first connecting means 105, the first flange 1071 and the second flange 1061 are pressed to deform and thereby press them against the first side of the first connecting means 105.

By pressing the first flange 1071 and the second flange 1061 of the intake pipe 107 and the return pipe 106, the reliability of the seal between the intake pipe 107 and the first abutting means 2 and between the return pipe 106 and the first abutting means 2 can be ensured, and it is ensured that the working medium does not leak from the joint thereof.

Further, as shown in fig. 13, the sum of the diameter of the first flange 1071 and the diameter of the second flange 1061 is smaller than or equal to the diameter of the first docking device 2. I.e. the first flange 1071 and the second flange 1061 are pressed onto the first docking device 2 without overlapping portions therebetween, which may cause the first connection device 105 to not uniformly apply force thereto, possibly resulting in a failure of the seal.

The first flange 1071 and the second flange 1061 are formed by first penetrating the intake pipe 107 and the return pipe 106 through the first connecting device 105, respectively, and then flanging the end portions of the intake pipe 107 and the return pipe 106 using a flanging tool, thereby forming the first flange 1071 and the second flange 1061.

It will be appreciated that the first flange 1071 and the second flange 1061 may also be secured to the ends of the inlet pipe 107 and the return pipe 106 by bonding or welding, etc., after the inlet pipe 107 and the return pipe 106, respectively, extend through the first connecting means 105.

As shown in fig. 4, 12 and 13, the first connecting means 105 and the first docking means 2 may be fixedly connected by means of a fastener 24. Accordingly, as shown in fig. 12, corresponding connection holes for receiving the fasteners 24 may be provided on the first connection device 105 and the first docking device 2. It will be appreciated that by adjusting the tightening force of the fastener 24, the degree of compression and deformation of the first and second flanges 1071, 1061 between the first coupling device 105 and the first docking device 2 may be adjusted. The number of fasteners 24 may be set as desired.

Referring to fig. 6 and 7, a first inflow channel 201 and a first return channel 202 penetrating the first docking device 2 are respectively disposed in the first docking device 2. As shown in fig. 13, the inlet line 107 is aligned with and in fluid communication with a first inlet flow channel 201 and the return line 106 is aligned with and in fluid communication with a first return flow channel 202.

Further, the inner diameter of the inflow pipe 107 is equal to the inner diameter of the first inflow channel 201, and the inner diameter of the return pipe 106 is equal to the inner diameter of the first return channel 202, so as to ensure that the flow speed of the working medium is not affected.

Further, the second side of the first docking device 2 is provided with a pin 203 for docking with an ablation needle, as shown in fig. 7, the first inflow channel 201 extends to the penetrating pin 203. The needle 203 is inserted into the proximal end of the ablation needle so as to be in fluid communication with the inflow pathway of the ablation needle, and further the first docking device 2 is positioned in the return pathway of the ablation needle so that the return pathway of the ablation needle is in fluid communication with the first return pathway 202.

Thus, the working fluid in the inflow tube 107 may enter the first inflow channel 201 and be supplied to the distal side of the ablation needle through the contact pin 203, where the heat exchanged working fluid is folded back 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 into the return tube 106.

In some embodiments, as shown in fig. 7, the axis of the pin 203 and the axis of the first return flow channel 202 are parallel to each other, and the axis of the pin 203 and the axis of the first inlet flow channel 201 are parallel to each other. The contact pin 203 and the first docking device 2 are coaxially arranged, so that coaxiality between the ablation needle and the flexible conveying device can be ensured after the contact pin 203 is inserted into the ablation needle.

The axis of the first return flow channel 202 is parallel to the axis of the pin 203 and offset from each other to facilitate physical isolation between the first return flow channel 202 and the first inlet flow channel 201.

As shown in fig. 6 and 7, the first docking device 2 is further provided with a first plug 204, and the first plug 204 is used to seal the first inflow channel 201 from the side. In order to facilitate the processing of the first inflow channel 201, a hole may be perforated at a side portion of the first docking device 2 to form the first inflow channel 201, and an opening formed at the time of perforation may be sealed with the first plug portion 204, so that the first inflow channel 201 forms a passage penetrating the first docking device 2 in an axial direction.

In other embodiments, as shown in fig. 8, the axis of the pin 203 and the axis of the first backflow channel 202 are parallel to each other, and an included angle θ ₁ is formed between the axis of the pin 203 and the axis of the first inflow channel 201.

As shown in fig. 8, the included angle θ ₁ may be an obtuse angle. In this structure, by inclining the first inflow path 201, during machining, holes can be punched from the end of the first butt joint device 2, thereby forming the first inflow path 201 penetrating the first butt joint device 2 (and the pin 203). Therefore, the first plug 204 is not needed, so that the structure is simpler, the processing is more convenient, and the drilling and forming can be performed once.

The included angle θ ₁ may be configured such that the center point of the first inflow channel 201 on the axial cross-section of the first docking device 2 and the center point of the first return channel 202 are symmetrical about the entire center of the first docking device 2, thereby making the crimping force applied by them on the first flange 1071 and the second flange 1061 more uniform, i.e., the stress of the first flange 1071 and the second flange 1061 more uniform, and do not overlap the stress.

Since the first return flow path 202 directly penetrates the first docking device 2, in both embodiments shown in fig. 7 and 8, the first return flow path 202 may be formed by directly punching from one end of the first docking device 2, or the first return flow path 202 may be formed by oppositely punching from both ends of the first docking device 2.

As shown in fig. 20, an exhaust hole 25 is further provided in the first docking device 2, and the exhaust hole 25 is in fluid communication with the first inflow channel 201 and the first return channel 202, respectively.

The specific structure of the first docking device 2 may be a structure in which the axis of the pin 203 and the axis of the first inflow channel 201 shown in fig. 6 and 7 are parallel to each other, or may be a structure in which the axis of the pin 203 and the axis of the first inflow channel 201 shown in fig. 8 have an angle θ ₁.

As shown in fig. 20, the axis of the pin 203 is shown to have an angle θ ₁ with the axis of the first inlet flow channel 201, wherein the exhaust vent 25 is in fluid communication with the first inlet flow channel 201 and the first return flow channel 202, respectively.

By arranging the vent holes 25, the cooling speed of the ablation needle can be improved, so that the formation of the ice ball in the ablation area of the ablation needle is faster and better, and the cryoablation effect is better.

With continued reference to fig. 3a, the proximal assembly is located on the side remote from the ablation needle (upper side as viewed in fig. 1) for placing the inflow 107 and return 106 tubes in fluid communication with a source of working fluid, respectively. The source of working fluid may include, for example, a cold tank storing a cold working fluid and a hot tank storing a hot working fluid.

Specifically, as shown in fig. 3a, and referring to fig. 9 and 10 in combination, the proximal assembly comprises a second docking means 3 and a second connection means 113. A first side (lower side as shown in fig. 3 a) of the second docking device 3 is in fluid communication with the inflow pipe 107 and the return pipe 106, respectively, and a second side (upper side as shown in fig. 3 a) of the second docking device 3 is in fluid communication with the source of working fluid via the connection means.

In general, the second docking device 3 has similarities to the first docking device 2 described above in that it is used to bridge the flow inlet 107 and the return 106 of the working medium source and the flexible delivery device, i.e. to deliver the working medium in the working medium source into the flow inlet 107 and to collect the working medium in the return 106 into the recovery device (or to discharge it to the atmosphere).

The second connection means 113 is located on a first side of the second docking means 3. As shown in fig. 3a and 4, the inlet pipe 107 and the return pipe 106 extend through the second connection means 113, respectively, the second connection means 113 being configured to deform the distal end of the inlet pipe 107 and the distal end of the return pipe 106 so as to press them against the first side of the second docking means 3, such that a fluid tight seal is provided between the inlet pipe 107 and the second connection means 113 and between the return pipe 106 and the second connection means 113.

The second connection means 113 may be similar to the first connection means 105, e.g. the distal end of the inlet pipe 107 and the distal end of the return pipe 106 may both be provided with flange structures, whereby the distal end of the inlet pipe 107 and the distal end of the return pipe 106 are pressed against the first side of the second docking means 3 by the compression deformation of the flange structures by the second connection means 113, thereby ensuring a fluid-tight seal between the distal end of the inlet pipe 107 and the second docking means 3 and between the distal end of the return pipe 106 and the second docking means 3.

The forming manner of the flange structure may refer to the forming manner of the first flange 1071 and the second flange 1061, which is not described herein.

As shown in fig. 9 and 10, the second docking device 3 is provided with a second inflow channel 31 and a second return channel 32 penetrating the second docking device 3, respectively, the inflow tube 107 being aligned with and in fluid communication with the second inflow channel 31, and the return tube 106 being aligned with and in fluid communication with the second return channel 32.

The second docking device 3 is further provided with a connector 33 on the second side, and the second inflow channel 31 extends to penetrate the connector 33. The connection head 33 is adapted to be connected to a connection member so that the flexible delivery device can be in fluid communication with a source of working fluid.

In some embodiments, as shown in fig. 9 and 10, 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.

This arrangement is similar to the arrangement of the first docking device 2 shown in fig. 6 and 7, i.e. the axis of the connector 33 coincides with the axis of the second docking device 3 and the axis of the second docking device 3 coincides with the axis of the first docking device 2, so that it is ensured that the ablation needle coincides with the axis of the flexible delivery device and that the connection is perfectly aligned.

The axis of the second inflow channel 31 is parallel to the axis of the connector 33 and is offset from each other so as to facilitate physical isolation between the second inflow channel 31 and the second inflow channel 31.

As shown in fig. 9 and 10, the second docking device 3 is further provided with a second plug portion 34, and the second plug portion 34 is used to seal the second inflow channel 31 from the side. In order to facilitate the processing of the second inflow path 31, a hole may be perforated at the side of the second docking device 3 to form the second inflow path 31, and the opening formed at the time of perforation may be sealed with the second plug portion 34, so that the second inflow path 31 forms a passage penetrating the second docking device 3 in the axial direction.

In other embodiments, as shown in fig. 11, the axis of the connector 33 and the axis of the second backflow channel 32 are parallel to each other, and an included angle θ ₂ is formed between the axis of the connector 33 and the axis of the second inflow channel 31.

As shown in fig. 11, the included angle θ ₂ may be an acute angle. In this structure, by inclining the second inflow path 31, during machining, holes can be punched from the end of the second butt joint device 3, thereby forming the second inflow path 31 penetrating the second butt joint device 3 (and the joint 33). Therefore, the second plug portion 34 is not required, so that the structure is simpler, the structure is more convenient to process, and the drilling and forming can be performed once.

The included angle θ ₂ may be configured such that the center point of the second inflow channel 31 on the axial section of the second docking device 3 and the center point of the second return channel 32 are symmetrical with respect to the entire center of the second docking device 3, so that the crimping force applied on the flange structure by the second inflow channel is more uniform, i.e., the stress of the flange structure is more uniform, and the stresses are not overlapped.

In both embodiments shown in fig. 10 and 11, the second return flow path 32 may be formed by punching holes from both ends of the second docking device 3, and the axes of the holes may be offset from each other when punching holes from both ends of the second docking device 3. That is, the second return flow path 32 is actually formed by the abutting of two holes whose axes are offset from each other. The second docking device 3 is not too large in size and weight because of the device miniaturization and light weight, so that the space for forming the second backflow channel 32 and the second inflow channel 31 is extremely limited, and the effective physical isolation between the second backflow channel 32 and the second inflow channel 31, the inability to interfere with each other between the second backflow channel 32 and the connector 33, and the constraint conditions that the second docking device 3 needs to have a certain wall thickness to ensure the use strength and the like are considered, and when the second backflow channel 32 is formed, the two mutually staggered holes are mutually docked.

With continued reference to fig. 2a, the flexible delivery device of the ablation system of the invention further comprises an insulation sleeve 110, a fixing sleeve 109 located outside the insulation sleeve 110, and a heat shrink tubing 108 sleeved on the fixing sleeve 109, wherein the first docking device 2, the second docking device 3, the inflow tube 107, and the return tube 106 are all disposed inside the insulation sleeve 110.

Because cold working medium or hot working medium is conveyed in the inflow pipe 107 and the return pipe 106, the operation is inconvenient, and the heat insulation sleeve 110 is sleeved outside the cold working medium or the hot working medium, so that heat exchange between the working medium and the environment can be avoided, and the safe operation can be ensured. The heat insulation sleeve 110, the inflow pipe 107 and the return pipe 106 can be fixed through the fixing sleeve 109 and the heat shrinkage pipe 108, so that the whole flexible conveying device is soft and slim, and the appearance of the flexible conveying device is attractive.

The flexible delivery device of the ablation system of the invention further comprises a distal handle housing 103, a distal quick-connect assembly 101 and a cannula housing 102. As shown in fig. 2a and 2b, the proximal side of the cannula housing 102 is inserted into the thermal insulation sleeve 110 and abuts the distal end of the first docking device 2. The pin 203 of the first docking device 2 is located in the cannula housing 102, and the first return flow channel 202 is in fluid communication with the cannula housing 102. Cannula housing 102 also receives the proximal side of the ablation needle such that cannula housing 102 is in fluid communication with the return flow path of the ablation needle, and thus the working fluid returned from the return flow path of the ablation needle enters first return flow path 202 via cannula housing 102.

As shown in fig. 2a and 2b, the outside of the heat shrink tubing 108 is provided with a distal side handle housing 103, the distal side handle housing 103 covering a portion of the heat shrink tubing 108, which can be grasped and manipulated by a user through the distal side handle housing 103. As shown in fig. 2b, the distal side of cannula housing 102 is located in distal side handle housing 103. The outer wall of the distal end side of the cannula housing 102 is provided with a first boss 1021 for engagement with a recess on the inner wall of the distal end side handle housing 103 so as to be fixable with the distal end side handle housing 103.

In addition, a plurality of second protruding portions 1031 are further disposed on the inner wall of the distal handle shell 103 at intervals, and the second protruding portions 1031 are used for abutting against the outer wall of the heat shrinkage tube 108, so as to increase friction between the distal handle shell 103 and the heat shrinkage tube 108, and make relative movement between the distal handle shell 103 and the heat shrinkage tube 108 difficult.

Distal quick-connect assembly 101 is coupled to the distal side of cannula housing 102, and distal quick-connect assembly 101 is configured for quick-connection to the proximal side of an ablation needle to facilitate quick replacement of ablation needles of different diameters. The distal-side quick connector assembly 101 may take various forms of quick connector structures known in the art, and the present invention will not be described in detail.

Referring to fig. 3a and 3b, the flexible delivery device of the ablation system of the invention further comprises a proximal handle housing 111, a proximal quick insert assembly 112, a retaining hub 115, a cannula 116, a retainer 117 and a compression member 118. The proximal handle case 111 is provided outside the proximal side of the heat shrink tube 108 and covers a portion of the heat shrink tube 108, and a user can grasp and operate through the distal handle case 103.

A proximal quick insert assembly 112 is inserted into the proximal end of proximal handle housing 111 and overlies heat shrink tubing 108 for quick connection to a source of working fluid. As shown in fig. 3b, a third protrusion 1122 is provided on the outer wall of the proximal quick connector assembly 112 for engaging with a groove on the inner wall of the proximal handle shell 111, thereby being capable of being fixed to the distal handle shell 103. A plurality of grooves 1121 are also provided on the outer wall of the proximal quick connector assembly 112 at intervals, the grooves 1121 being adapted for mating connection with the tubing of the working fluid source.

With continued reference to fig. 3b, the anchor block 115 is fixedly coupled to the proximal side of the proximal quick connector assembly 112. The cannula 116 extends through the fixing base 115, one end of the cannula 116 is inserted into the connector 33 of the second docking device 3, the other end is inserted into the retainer 117, and the pressing member 118 at the proximal end of the retainer 117 can fix the retainer 117 to the fixing base 115. The compression member 118 may be, for example, a compression nut.

A seal 119 is also provided in the compression member 118, and the compression member 118 compresses the seal 119 against the proximal end of the retainer 117 to ensure a sealed connection of the cannula 116 to the tubing of the working fluid source.

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

first, the distal-side quick-connect assembly is secured to the distal end of the cannula housing 102 and the first docking device 2 is secured to the proximal end thereof.

Next, the distal end of the inflow tube 107 and the distal end of the return tube 106 are passed through the first pressing plate 1051, respectively, and the distal end of the inflow tube 107 and the return tube 106 are burred, respectively, to form a second flange 1061 and a first flange 1071. The two or more fasteners 24 are then used to penetrate through the first pressing plate 1051, so that the first pressing plate 1051 is fixed with the first docking device 2, and the second flange 1061 and the first flange 1071 can be respectively pressed against the end surface of the first docking device 2, so as to ensure good tightness.

Third, the cannula 116 is secured to the proximal end of the second docking device 3, then the anchor block 115 is passed through the cannula 116 and secured to the proximal end of the second docking device 3, the seal 119 is placed into the recess of the retainer 117, and then the retainer 117 is secured to the proximal end of the anchor block 115 with the compression member 118.

Fourth, the heat insulation sleeve 110 is wrapped on the inflow pipe 107 and the return pipe 106, then fixed by the fixing sleeve 109, and finally the heat shrinkage pipe 108 is sleeved and heat shrunk.

Finally, the second connecting device 113 is fixed to the proximal end of the fixing base 115, and the distal handle case 103 and the proximal handle case 111 are respectively sleeved on a part of two ends of the heat shrinkage tube 108 to form a flexible conveying device, and the conveying tube has a simple structure, a simple process, and a softer whole, and is convenient for operation. The doctor experiences better in actual operation, so that the operation efficiency can be improved, and the operation risk can be reduced.

Example 2

As shown in fig. 15-17, and referring to fig. 1-11, the present invention provides a flexible delivery device for an ablation system, including a inflow tube 107, a return tube 106, a distal assembly, and a proximal assembly.

As shown in fig. 15 and 16, in the present embodiment 2, the first connecting device 105 may be in the form of a second pressure plate 1052, and in conjunction with fig. 16, a tapered hole 1055 is provided in the second pressure plate 1052 for passing the inlet pipe 107 and the return pipe 106. It will be appreciated that the tapered aperture 1055 in the second platen 1052 progressively increases in diameter in a direction towards the first side of the first docking means 2.

As shown in fig. 16, the first docking device 2 is provided with a first inflow channel 201 and a first return channel 202 penetrating the first docking device 2, respectively.

As shown in fig. 15 and 16, in the present embodiment 2, the first docking device 2 further includes two first plugs 21. As shown in fig. 17, the first plug 21 includes a first clamping block 211, wherein portions of the first plug 21 located at both sides of the first clamping block 211 are respectively inserted into the first inflow channel 201 and the inflow pipe 107, and one side of the first clamping block 211 is abutted against the end of the first docking device 2, and the other side of the first clamping block 211 is abutted against the end of the inflow pipe 107, whereby the first inflow channel 201 can be in fluid communication with the inflow pipe 107 through the first plug 21.

Likewise, the portions of the other first plug 21 on both sides of the first land 211 are inserted into the first return flow passage 202 and the return pipe 106, respectively, and one side of the first land 211 abuts against the end portion of the first docking device 2, and the other side of the first land 211 abuts against the end portion of the return pipe 106, whereby the first return flow passage 202 can be made to be in fluid communication with the return pipe 106 through the first plug 21.

The first docking device 2 further comprises a squeezing ring 23, wherein the squeezing ring 23 is sleeved on the inflow pipe 107 and the return pipe 106 respectively, and as shown in fig. 16, one side of the squeezing ring 23 is provided with a wedge-shaped part, and the inclination angle of the wedge-shaped part is approximately the same as the cone angle of the tapered hole 1055.

Thus, after the inlet pipe 107 and the return pipe 106 are inserted into the tapered hole 1055 from the side of the second platen 1052, the squeeze ring 23 is respectively fitted over the inlet pipe 107 and the return pipe 106 with its wedge portions aligned with the tapered hole 1055 and inserted into the tapered hole 1055. Under the compression action of the second pressing plate 1052, the first clamping table 211 on the first plug 21 has a limiting effect on the extrusion ring 23, the tapered hole 1055 can have an inward folding effect on the extrusion ring 23, and the deformation of the extrusion ring 23 can squeeze the wall of the inflow pipe 107 and the wall of the return pipe 106, so that the extrusion ring 23 is tightly held on the wall of the inflow pipe 107 and the wall of the return pipe 106, and fluid sealing at the joint is realized.

The portion of the first plug 21 inserted into the first inflow channel 201 may be in threaded connection with the first inflow channel 201 or fixedly connected by welding or the like, and the portion of the first plug 21 inserted into the first return channel 202 may be in threaded connection with the first return channel 202 or fixedly connected by welding or the like.

Or the portions of the first plug 21 inserted into the first inflow channel 201 and the first return channel 202 may form an interference fit with the first inflow channel 201 and the first return channel 202, respectively, so that a fluid seal between the first plug 21 and the first docking device 2 may be ensured.

After compression, the fastener 24 passes through the second platen 1052 and the first docking mechanism 2 in sequence, and may fixedly connect the two. The number of fasteners 24 may be set as desired.

As shown in fig. 17, the end of the first plug 21 is provided with a guide portion 212, and the guide portion 212 has a tapered structure, which can facilitate the insertion of the first plug 21 into the inflow pipe 107 and the return pipe 106.

In addition, the outer diameter of the first plug 21 may be slightly larger than the inner diameter of the inflow pipe 107, and the outer diameter of the first plug 21 may be slightly larger than the inner diameter of the return pipe 106, so that the inflow pipe 107 and the return pipe 106 may be deformed (the outer diameters of the inflow pipe 107 and the return pipe 106 become larger) when the first plug 21 is inserted into the inflow pipe 107 and the return pipe 106, and the original clearance fit between the inflow pipe 107 and the return pipe 106 and the extrusion ring 23 becomes interference fit after the inflow pipe 107 and the return pipe 106 are respectively inserted into the extrusion ring 23, thereby ensuring fluid tightness between the first plug 21 and the inflow pipe 107 and between the first plug 21 and the return pipe 106.

In summary, in embodiment 2, the fluid tightness between the inlet pipe 107 and the return pipe 106 and the first abutting device 2 is ensured by the cooperation of the tapered hole 1055 on the second pressing plate 1052 and the wedge-shaped part of the pressing ring 23, and the fluid tightness at the connection position of each component is ensured by the deformation of the inlet pipe 107 and the return pipe 106 and the pressing ring 23 due to the switching and limiting actions of the first plug 21. The components in the embodiment 2 realize fluid sealing through ingenious matching connection, and the device has the advantages of simple structure, convenient assembly and more convenient implementation.

As shown in fig. 16, the outer diameter of the extrusion ring 23 is the same as the outer diameter of the first clamping table 211 of the first plug 21, so that the extrusion ring 23 is ensured to be deformed integrally when being extruded, and the tightness of the fit between the extrusion ring and the inflow pipe 107 and the return pipe 106 is ensured.

Further, with continued reference to fig. 7, the second side of the first docking device 2 is provided with a pin 203 for docking with an ablation needle. The first inflow channel 201 extends to a through pin 203. The needle 203 is inserted into the proximal end of the ablation needle so as to be in fluid communication with the inflow pathway of the ablation needle, and further the first docking device 2 is positioned in the return pathway of the ablation needle so that the return pathway of the ablation needle is in fluid communication with the first return pathway 202.

Thus, the working medium in the inflow tube 107 can enter the first inflow channel 201 through the first plug 21 and be supplied to the distal side of the ablation needle through the pin 203, and the working medium after heat exchange at the distal side of the ablation needle is folded back to the proximal side of the ablation needle and enters the first return channel 202 through the first plug 21 from the return channel of the ablation needle and then into the return tube 106.

As shown in fig. 8, the included angle θ ₁ may be an obtuse angle. In this structure, by inclining the first inflow path 201, during machining, holes can be punched from the end of the first butt joint device 2, thereby forming the first inflow path 201 penetrating the first butt joint device 2 (and the pin 203). Therefore, the first plug 204 is not needed, so that the structure is simpler, the structure processing is more convenient, and the first plug can be drilled and formed once.

As shown in fig. 3a, the proximal assembly is located on the side remote from the ablation needle (upper side as shown in fig. 1) for placing the inflow tube 107 and the return tube 106 in fluid communication with the source of working fluid, respectively. The source of working fluid may include, for example, a cold tank storing a cold working fluid and a hot tank storing a hot working fluid.

The second connecting means 113 may take the same or similar form as the first pressure plate 1051 described in the above embodiment 1, i.e. the distal end of the inflow tube 107 and the distal end of the return tube 106 may likewise both be provided with flange structures, whereby the distal end of the inflow tube 107 and the distal end of the return tube 106 are pressed against the first side of the second docking device 3 by the compression deformation of the flange structures by the second connecting means 113, thereby ensuring a fluid-tight seal between the distal end of the inflow tube 107 and the second docking device 3 and between the distal end of the return tube 106 and the second docking device 3.

In both embodiments shown in fig. 10 and 11, the second return flow path 32 may be formed by punching holes from both ends of the second docking device 3, and the axes of the holes may be offset from each other when punching holes from both ends of the second docking device 3. That is, the second return flow path 32 is actually formed by the abutting of two holes whose axes are offset from each other. The second docking device 3 is not too large in size and weight, so that the space for forming the second backflow channel 32 and the second inflow channel 31 is extremely limited, and the effective physical isolation between the second inflow channel 31 and the second inflow channel 31, the inability to interfere with each other between the second backflow channel 32 and the connector 33, and the constraint conditions that the second docking device 3 needs to have a certain wall thickness to ensure the use strength and the like are considered, and when the second backflow channel 32 is formed, two mutually staggered holes are mutually docked.

It will be appreciated that the second connecting device 113 may also take the same or similar structure as the second pressing plate 1052 described in the above embodiment 2, that is, the tapered hole 1055 of the second pressing plate 1052 and the wedge-shaped portion of the pressing ring 23 cooperate with each other, and the inlet pipe 107 and the return pipe 106 and the pressing ring 23 are deformed by the switching and limiting actions of the first plug 21, so as to ensure the fluid tightness between the inlet pipe 107 and the return pipe 106 and the second abutting device 3.

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

Next, the distal end of the inflow pipe 107 and the distal end of the return pipe 106 are respectively passed through the second pressing plate 1052, and the extrusion ring 23 is fitted over the inflow pipe 107 and the outside, and the two parts of the first clamping block 211 on the first plug 21 are respectively inserted between the inflow pipe 107 and the first inflow flow path 201 and between the return pipe 106 and the first return flow path 202, and by pressing the second pressing plate 1052, the extrusion ring 23 is deformed and the inflow pipe 107 and the return pipe 106 are held tightly, and the inflow pipe 107 and the return pipe 106 are held tightly with the first plug 21.

Finally, the second connecting device is fixed to the proximal end of the fixing base 115, and the distal handle case 103 and the proximal handle case 111 are respectively sleeved on a part of the two ends of the heat shrinkage tube 108 to form a flexible conveying device, and the conveying tube has a simple structure, a simple process, and a softer whole, and is convenient for operation. The doctor experiences better in actual operation, so that the operation efficiency can be improved, and the operation risk can be reduced.

Example 3

As shown in fig. 18 and 19, the present invention also provides another embodiment on the basis of the above-described embodiment 2.

As shown in fig. 18, this embodiment 3 is different from the above-described embodiment 2 in that the second plug 22 is used in place of the first plug 21 in this embodiment 3, and the pressing ring 23 is not provided in this embodiment 3.

Similarly to the above-described embodiment 2, as shown in fig. 19, the second plug 22 in the present embodiment 3 is also provided with the second card stage 221. The portions of one of the second plugs 22 located at both sides of the second clamping stage 221 are respectively inserted into the first inflow channel 201 and the inflow pipe 107, and one side of the second clamping stage 221 is abutted against the end portion of the first abutting device 2, and the other side of the second clamping stage 221 is abutted against the end portion of the inflow pipe 107, so that the first inflow channel 201 can be in fluid communication with the inflow pipe 107 through the first plug 21.

Similarly, the portions of the other second plug 22 on both sides of the second land 221 are inserted into the first return flow passage 202 and the return pipe 106, respectively, and one side of the second land 221 abuts against the end portion of the first docking device 2, and the other side of the second land 221 abuts against the end portion of the return pipe 106, whereby the first return flow passage 202 can be made to be in fluid communication with the return pipe 106 through the second land 221.

In addition, this embodiment 3 is also different from the above-described embodiment 2 in that the first connecting means 105 is in the form of a third pressing plate 1053, and in conjunction with fig. 18, a tapered hole 1056 for passing the inflow pipe 107 and the return pipe 106 is provided in the third pressing plate 1053. It will be appreciated that the tapered bore 1056 may also be in the form of other variable diameter bores.

As shown in fig. 19, the end of the second plug 22 is provided with a tapered head 222 having a taper substantially the same as the taper of the tapered bore 1056.

In embodiment 3, the outer diameter of the portion of the second plug 22 located on the side of the second catch 221 is larger than the inner diameter of the inflow pipe 107, and the outer diameter of the portion of the second plug 22 located on the side of the second catch 221 is larger than the inner diameter of the return pipe 106, so that the second plug 22 can deform and expand the inflow pipe 107 and the return pipe 106, respectively, when it is inserted into the inflow pipe 107 and the return pipe 106, respectively. And the conical head 222 at the end of the second plug 22 can be matched with the conical surface of the conical hole 1056, so that under the compression 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 inflow pipe 107 and the pipe wall of the return pipe 106, thereby realizing fluid sealing between the connecting parts.

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

Next, the distal end of the inflow pipe 107 and the distal end of the return pipe 106 are respectively passed through the third pressing plate 1053, the two parts of the second clamping seat 221 on the second plug 22 are respectively inserted between the inflow pipe 107 and the first inflow channel 201 and between the return pipe 106 and the first return channel 202, and the inflow pipe 107 and the return pipe 106 are respectively deformed and expanded by pressing the third pressing plate 1053, so that the conical head 222 and the conical hole 1056 at the end of the second plug 22 can clamp the pipe wall of the inflow pipe 107 and the pipe wall of the return pipe 106.

The same points of this embodiment 3 as those of the above embodiment 2 will not be described again.

Example 4

The present invention also provides a delivery device for an ablation system comprising a inflow tube 107, a return tube 106, a distal assembly and a proximal assembly. Wherein the inlet pipe 107 and the return pipe 106 are flexible pipes as described in the embodiments above, or wherein the inlet pipe 107 and the return pipe 106 are metal pipes, such as stainless steel pipes.

The inflow pipe 107 is used for delivering a working medium to the ablation needle, wherein the working medium comprises a cold working medium and a hot working medium, the cold working medium can be liquid nitrogen, for example, and the hot working medium can be absolute ethyl alcohol, for example. Referring to fig. 5, arrows show the direction of flow of the working fluid in the delivery device. As shown in fig. 5, after the working fluid is delivered from the inflow tube 107 to the distal end side of the ablation needle, heat exchange is performed between the ablation region on the distal end side of the ablation needle and the target region, and the working fluid after heat exchange returns to the proximal end side of the ablation needle and enters the return tube 106, so that the return tube 106 is used for receiving the working fluid returned in the ablation needle.

A first side (upper side as shown in fig. 2 a) of the first docking device 2 is in fluid communication with the inflow tube 107 and the return tube 106, respectively, and a second side (lower side as shown in fig. 2 a) of the first docking device 2 is for fluid communication with the ablation needle. The first docking device 2 thus has the effect of creating its bridge between the ablation needle and the inflow tube 107 and the return tube 106 of the delivery device, i.e. delivering the working medium in the inflow tube 107 into the ablation needle and delivering the heat exchanged working medium in the ablation needle into the return tube 106.

The first connecting means 105 is located on a first side of the first docking means 2. The first connection means 105 may be configured to provide a fluid tight seal between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2 as described in any of the embodiments 1,2 and 3 or a combination thereof, or the first connection means 105 may be configured to provide a fluid tight seal between the inlet pipe 107 and the first docking device 2 and between the return pipe 106 and the first docking device 2 by means of a connection suitable for a metal pipe, such as welding or screwing.

Further, the first docking device 2 may take the form of any of the embodiments 1, 2 and 3 described above or a combination thereof.

Further, as shown in fig. 20, an exhaust hole 25 is further provided in the first docking device 2, and the exhaust hole 25 is in fluid communication with the first inflow channel 201 and the first return channel 202, respectively. For example, holes may be perforated at the side of the first docking device 2 to obtain the exhaust holes 25 respectively in fluid communication with the first inflow flow path 201 and the first return flow path 202, and after the exhaust holes 25 are obtained, the openings formed at the time of perforation may be sealed by a structure such as a sealing plug. For a specific implementation of the exhaust hole 25, reference may be made to the implementation of the first inflow channel 201 and/or the second inflow channel 31 in the above embodiments.

By arranging the vent holes 25, the cooling speed of the ablation needle can be improved, so that the ice ball in the ablation area of the ablation needle is better in forming and better in cryoablation effect.

Specifically, when cryoablation is performed, a cold working medium is conveyed to an ablation needle through a flexible conveying device. Since the temperature of the flexible delivery device and the ablation needle is at an ordinary temperature in the initial state, a certain time is required to lower the temperature of the flexible delivery device and the ablation needle to a target temperature (e.g., -196 ℃, -180 ℃, or-170 ℃), etc.), which is an initial temperature lowering process. In this process, the cold working medium in the flexible conveying device is in a gas phase, so that the cold working medium in the gas phase can be discharged from the first inflow channel 201 to the first return channel 202 through the exhaust hole 25, thereby facilitating the rapid cooling of the whole flexible conveying device.

The diameter of the exhaust hole 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 S ₁ of the vent 25 is less than the cross-sectional area S2 of the cold working medium outlet at the needle tip of the ablation needle. For the ablation needle with the needle tip diameter smaller than 2.0mm, the cross section area S2 of the cold working medium outlet at the needle tip is smaller, when the cryoablation is actually carried out, the flow of the cold working medium at the cold working medium outlet at the needle tip is smaller, and a large amount of gas-phase cold working medium flows out slowly, so that the cooling speed is slow, the size of the ice hockey ball is influenced within a specified time, and the ablation effect is influenced. By making the radial cross-sectional area S ₁ of the vent hole 25 smaller than the cross-sectional area S ₂ of the needle tip cold working medium outlet of the ablation needle, most of the cold working medium flowing in the flexible conveying device is liquid phase after the temperature of the flexible conveying device and the ablation needle is reduced to the required temperature, and because of S ₁<S₂, most of the liquid-phase cold working medium flows to the needle tip cold working medium outlet with larger cross-sectional area, only a small part of the gas-phase cold working medium flows along the vent hole 25, so that the formation of the ice hockey ball is not influenced, and the ablation effect is promoted.

Further, the exhaust hole 25 is disposed obliquely, that is, an included angle α ₁ is formed between the axis of the exhaust hole 25 and the axis of the first inflow channel 201, or an included angle α ₂ is formed between the axis of the exhaust hole 25 and the axis of the first return channel 202.

The angle α ₁ or the angle α ₂ needs to be set as small as possible. Because the size of either angle α ₁ or angle α ₂ affects the amount of cold working medium consumed. During the process that the cold working medium in gas phase or liquid phase enters the needle tip of the ablation needle from the first inflow channel 201, a part of the cold working medium flows out from the exhaust hole 25, the fluid in the position can generate resistance to the fluid flowing back from the needle tip of the ablation needle to the first backflow channel 202, and the flowing speed of the backflow fluid is reduced, so that the flow rate of the backflow fluid is reduced, and the consumption of the cold working medium is reduced. It will be appreciated that the smaller the angle α ₁ or the angle α ₂ is, the greater the resistance to backflow fluid, and the flow rate of the backflow fluid will be correspondingly reduced, so that the consumption of cold working medium can be reduced.

The value range of the angle α ₁ is related to the angle θ ₁ between the axis of the pin 203 and the axis of the first inflow channel 201, for example, the minimum value (α _1min) of the angle α ₁ is 0 °, it is understood that when the angle α ₁ is 0 °, that is, the axis of the exhaust hole 25 is parallel to the axis of the first inflow channel 201, where α ₂ is (180 ° - θ ₁), and the maximum value (α _1max) of the angle α ₁ is 90 °, it is understood that when the angle α ₁ is 90 °, that is, the axis of the exhaust hole 25 is perpendicular to the axis of the pin 203, where α ₂ is also 90 °. That is, the included angle α ₁ is in the range of 0 ° -90 °, and therefore, the included angle α ₂ is in the range of (180 ° - θ ₁) -90 °.

In addition, the diameter d of the exhaust hole 25 is related to the cooling rate and the consumption of the working medium. The larger the diameter d of the exhaust hole 25, the faster the cooling speed, but the larger the consumption amount of the working medium is accompanied, so that the diameter d of the exhaust hole 25 is preferably 0.3mm to 0.5mm.

Specifically, the flow rate of the fluid passage satisfies the following relationship:

Q=μ×A×(△P/ρ) ^0.5 (1)

In the formula (1), Q is the flow rate of the fluid channel (i.e., from the first inflow channel 201 to the first return channel 202), μ is a constant, a is the cross-sectional area of the fluid channel (i.e., from the first inflow channel 201 to the first return channel 202), Δp is the pressure difference between the first inflow channel 201 and the first return channel 202, and ρ is the density of the working medium.

Since the cross-sectional areas of the first inflow channel 201 and the first return channel 202 are both larger than the cross-sectional area S ₂ of the needle-tip cold working medium outlet, the cross-sectional area a of the fluid passage from the first inflow channel 201 to the first return channel 202 is determined by the cross-sectional area S ₂ of the needle-tip cold working medium outlet having a smaller cross-sectional area and the radial cross-sectional area S ₁ of the exhaust hole 25, wherein S ₁＝π(d/2)².

As is clear from the above equation (1), μ is a constant and thus a constant amount, the pressure difference Δp and the density ρ of the working fluid are also constant, and when the vent hole 25 is not provided, that is, S ₁ is 0, the fluid passes only through the tip end cold working fluid outlet, that is, a=s ₂ in the above equation (1), the time at which the temperature is reduced to the target temperature is long and the final ice ball diameter is also small, and when the vent hole 25 is provided, the fluid passes through the tip end cold working fluid outlet and the vent hole 25, respectively, and a can be regarded as the sum of S ₂ and S ₁, and therefore, it is clear that when the vent hole 25 is provided, a is increased, and Q is correspondingly increased.

Further, since the area S ₁ of the exhaust hole 25 is related to the diameter d thereof, increasing the diameter d of the exhaust hole 25 increases S ₁, and a increases accordingly, and Q increases accordingly, that is, the flow rate from the first inflow flow path 201 to the first return flow path 202 increases, whereby the temperature decrease rate can be increased, but the increase in the flow rate is accompanied by the increase in the consumption amount of the working medium.

The following four embodiments will be exemplified.

As shown in table 1, four specific embodiments of the first docking device 2 are shown.

Table 1 four embodiments of the first docking device 2

It is understood that the initial cool down time is the time taken to bring the delivery system and the ablation needle down from ambient conditions to the desired treatment temperature (e.g., -196 ℃, -180 ℃, or-170 ℃). As can be seen from table 1, in the first embodiment, the first docking device 2 is not provided with the vent hole, and the experimental test is performed when the diameter of the tip of the ablation needle is 1.7mm, the initial cooling time is more than 10min, the liquid nitrogen consumption is less than 12%, and the obtained ice ball has an unsatisfactory size.

Therefore, it is known 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 8min, and the ice ball size does not meet the requirement of at least 15mm in diameter, that is, the initial cooling time required in the first embodiment is long, and the obtained ice ball size is too small.

In the second embodiment, an exhaust hole is formed in the first docking device 2, specifically, an included angle alpha ₁ of the exhaust hole 25 is (90+/-20) °, the diameter d of the exhaust hole 25 is (0.3+/-0.05) mm, and experimental tests are performed when the diameter of the needle tip of the ablation needle is 1.7mm, the initial cooling time is about 8min, the liquid nitrogen consumption is 12% -16%, and the obtained ice ball is qualified in size but smaller.

Therefore, it is known that the initial cooling time in the second embodiment meets the requirement of less than 8min, the consumption of liquid nitrogen meets the requirement of less than 16%, and the size of the ice ball basically meets the requirement of at least 15mm in diameter, but the ice ball is also related to the external environment, the temperature of the external environment is low, the ice ball is basically qualified, and when the temperature of the external environment is higher, the disqualification phenomenon (the situation that the size of the ice ball is smaller) occurs.

In the third embodiment, an exhaust hole is formed in the first docking device 2, specifically, an included angle alpha ₁ of the exhaust hole 25 is (60±20) °, the diameter d of the exhaust hole 25 is (0.4±0.05) mm, and experimental tests are performed when the diameter of the needle tip of the ablation needle is 1.7mm, the initial cooling time is less than 7min, the liquid nitrogen consumption is about 16%, and the obtained ice ball has a qualified size.

Therefore, it is known that the initial cooling time in the third embodiment meets the requirement of less than 8min, the consumption of liquid nitrogen basically meets the requirement of less than 16%, and the size of the ice hockey puck meets the requirement of at least 15mm in diameter, but the consumption of liquid nitrogen is slightly higher.

In the fourth embodiment, an exhaust hole is formed in the first docking device 2, specifically, an included angle alpha ₁ of the exhaust hole 25 is (50+/-20) °, the diameter d of the exhaust hole 25 is (0.4+/-0.05) mm, and experimental tests are performed when the diameter of the needle tip of the ablation needle is 1.7mm, the initial cooling time is less than 6.5min, the liquid nitrogen consumption is 12% -16%, and the obtained ice ball is qualified in size.

Therefore, it is known that the initial cooling time in the fourth embodiment meets the requirement of less than 8min, the liquid nitrogen consumption meets the requirement of less than 16%, and the ice ball size meets the requirement of at least 15mm in diameter.

In summary, comparing the scheme with the vent hole with the scheme without the vent hole, the scheme with the vent hole slightly increases the consumption of liquid nitrogen, but the initial cooling time and the obtained ice ball size are qualified to meet the requirement of the ablation operation, and comparing the schemes with the vent holes, the initial cooling time shows a decreasing trend under the trend that the included angle alpha ₁ of the vent hole is reduced and the trend that the diameter d of the vent hole 25 is increased. Therefore, in view of the above, it is preferable that the angle α ₁ of the exhaust hole 25 is (50±20) °, and the diameter d of the exhaust hole 25 is (0.4±0.05) mm.

Example 5

According to a second aspect of the present invention, there is also provided an ablation system comprising a delivery device of the ablation system or a flexible delivery device of the ablation system according to the embodiments described above, further comprising an ablation needle and a source of working medium, as shown in fig. 1, the distal and proximal sides of the delivery device or flexible delivery device being in fluid communication with the ablation needle and the source of working medium, respectively.

While the invention has been described with reference to a preferred embodiment, various modifications may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In particular, the technical features mentioned in the respective embodiments may be combined in any manner as long as there is no structural conflict. The present invention is not limited to the specific embodiments disclosed herein, but encompasses all technical solutions falling within the scope of the claims.

Claims

1. A flexible delivery device of an ablation system, characterized in that it comprises a distal side component, wherein the distal side component comprises a first docking device (2), wherein the first docking device (2) is respectively 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. A flexible delivery device for an ablation system according to claim 1 or 2, characterized in that a pin (203) for docking with 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 θ ₁ is formed between the axis of the pin (203) and the axis of the first inlet flow channel (201), an angle α 2 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 α 2} _is (180°～θ ₁ )～90°.

7. A flexible delivery device for an 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 flow inlet 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 flow inlet channel (201), and the angle _θ1 is constructed so that the center point of the first flow inlet 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. A flexible delivery device for an ablation system according to claim 1 or 2, characterized in that a pin (203) for docking with 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), 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 is characterized in that a first plug portion (204) is also provided on the first docking device (2), 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. A flexible delivery device for an ablation system according to claim 1 or 2, characterized in that the distal side component also includes a first connecting device (105), the first connecting device (105) is located on one side of the first docking device (2), and the first connecting device (105) adopts 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).