CN114305649A

CN114305649A - Cold and hot ablation needle system

Info

Publication number: CN114305649A
Application number: CN202111402205.9A
Authority: CN
Inventors: 刘朋; 李雪冬; 肖剑; 黄乾富
Original assignee: Hygea Medical Technology Co Ltd
Current assignee: Hygea Medical Technology Co Ltd
Priority date: 2021-11-19
Filing date: 2021-11-19
Publication date: 2022-04-12
Anticipated expiration: 2041-11-19
Also published as: WO2023087671A1; CN114305649B

Abstract

The invention relates to a cold-hot ablation needle system, relates to the technical field of cold-hot ablation operations, and is used for reducing the cost of the cold-hot ablation needle system. The cold and hot ablation needle system comprises an ablation needle and a transmission device, wherein the ablation needle is rotatably connected with the transmission device through a quick connection interface assembly, the ablation needle comprises a replaceable needle head assembly, a backflow inlet assembly and a vacuum layer assembly penetrated by the backflow inlet assembly, and the replaceable needle head assembly is detachably connected with the vacuum layer assembly, so that after one treatment is finished, the replaceable needle head assembly is detached for scrapping treatment, and the backflow inlet assembly and the vacuum layer assembly can be repeatedly sterilized and used. Therefore, only the replaceable needle head assembly in the ablation needle is a disposable part, and the reflux assembly and the vacuum layer assembly are reusable parts, so that the cost can be reduced.

Description

Cold and hot ablation needle system

Technical Field

The invention relates to the technical field of cold and hot ablation operations, in particular to a cold and hot ablation needle system.

Background

The cold-heat ablation is a surgical medical technology for eliminating target tissues by using a refrigerant and a heating medium, a low-temperature cryosurgery system and an ablation needle are connected by using a transmission device in the operation, a low-temperature medium (taking liquid nitrogen as an example) is conveyed to a focus part of a patient, heat of the focus tissue is taken away by evaporating heat absorption of a liquid refrigerant, the temperature of the target ablation part is reduced, and therefore pathological cell tissues are damaged to achieve the purpose of treatment. After the freezing is finished, the high-temperature heat medium steam is controlled to reach the treatment part of the ablation needle, so that a large amount of heat is released instantly, and the treatment area is quickly rewarming. The low and high temperature media need to reach the required temperature within a specified time in order to achieve the therapeutic goal as quickly as possible.

The existing cold and hot ablation needle is a disposable instrument, all parts cannot be replaced, and the ablation needle needs to be scrapped integrally after being used once, so that the cost is high.

Disclosure of Invention

The invention provides a cold-hot ablation needle system which is used for reducing the cost of the cold-hot ablation needle system.

The invention provides a cold and hot ablation needle system, which comprises an ablation needle and a transmission device, wherein the ablation needle is rotatably connected with the transmission device through a quick connection interface assembly, and comprises a replaceable needle head assembly, a backflow inlet assembly and a vacuum layer assembly penetrated by the backflow inlet assembly;

the first end of the backflow inlet component extends into the replaceable needle head component, and the second end of the backflow inlet component extends into the quick connection interface component and is communicated with the transmission device;

the replaceable needle assembly is removably connected to the vacuum layer assembly.

In one embodiment, the replaceable needle assembly comprises:

the needle head outer pipe comprises a treatment area pipe section and a connecting sleeve, the treatment area pipe section corresponds to the first end of the inflow and backflow component, and the connecting sleeve is connected with the vacuum layer component in a sealing mode;

the temperature measuring element is arranged on the outer wall of the needle head outer tube; and

and the fixing tube is arranged outside the needle head outer tube and the temperature measuring element and is used for enabling the temperature measuring element to be tightly attached to the outer wall of the needle head outer tube.

In one embodiment, the temperature sensing element is located outside the length of the treatment zone tube segment at a distance such that when an iceball formed in the treatment zone tube segment reaches the location of the temperature sensing element, the temperature sensing element feeds back a reference temperature to the control system.

In one embodiment, the treatment region pipe section is a rigid pipe or a flexible metal hose, the front end of the treatment region pipe section is a needle, and the needle is a cylindrical needle point or a triangular prism needle point.

In one embodiment, the quick connect interface assembly comprises a quick connect interface fixedly connected to the delivery device and a locking sleeve fixedly connected to the ablation needle;

the locking sleeve is rotatably and movably sleeved on the outer side of the quick connection interface;

the quick connect interface has a first alignment position and a plurality of indicating positions, the locking sleeve has a second alignment position, and after the quick connect interface assembly is connected with the ablation needle and the transmission device respectively, the second alignment position is aligned with the first alignment position to indicate an initial connection state;

when the locking sleeve drives the ablation needle to rotate, the second alignment position is aligned with one of the indication positions so as to indicate the rotating angle of the ablation needle.

In one embodiment, the transmission device comprises a bus device, wherein a contact pin is arranged in the bus device, and the contact pin is connected with the second end of the backflow inlet component in a matching manner;

the flow resistance between the contact pin and the backflow inlet assembly is larger than that of the treatment tube section.

In one embodiment, the vacuum layer assembly comprises a sealing structure, the sealing structure is a three-way structure, one port of the sealing structure is a sealing port, the sealing port is a stepped hole with at least two steps, a sealing plate is arranged on each step of the stepped hole, and a fixing column is arranged on at least one sealing plate.

In one embodiment, a vacuum adapter sleeve used for being connected with the outer wall of the backflow inlet assembly in a sealing mode is arranged on one port of the sealing structure, a getter is arranged in the vacuum adapter sleeve, and the getter is a normal-temperature getter.

In one embodiment, a quick connection shaft tube is arranged on one port of the sealing structure, and the quick connection shaft tube is used for being inserted into the quick connection interface assembly and connected with the adapter sleeve of the inlet/return flow assembly;

the upper end part and the end part of the circumferential side wall of the quick connection shaft tube are respectively provided with an axial clamping part and a circumferential clamping part;

the locking sleeve is provided with an axial locking structure and a circumferential locking structure arranged along the circumferential direction of the locking sleeve;

when the locking sleeve rotates relative to the transmission device, the axial locking structure is locked with the axial clamping part so as to limit the axial relative displacement between the quick connection interface assembly and the ablation instrument; the circumferential locking structure is locked with the circumferential clamping part so as to limit circumferential relative displacement between the quick connection interface assembly and the ablation instrument;

the locking sleeve moves relative to the transmission device to enable the circumferential locking structure and the circumferential clamping part to be unlocked; and then the locking sleeve rotates relative to the transmission device so as to unlock the axial locking structure and the axial clamping part.

In one embodiment, the transmission device comprises a first delivery pipe for delivering working medium to the ablation needle and a second delivery pipe for receiving and discharging the working medium output by the ablation needle after treatment, and the first delivery pipe and the second delivery pipe are constructed into independent split structures;

the second conveying pipe comprises a conveying sleeve, a heat exchange device is arranged in the conveying sleeve, a path for enabling the treated working medium to flow is arranged in the heat exchange device, and the path comprises one or more of a spiral path, a snake-shaped path, a zigzag path and a wave-shaped path.

Compared with the prior art, the invention has the advantages that:

(1) because the replaceable needle assembly is detachably connected with the vacuum layer assembly, after one-time treatment is finished, the replaceable needle assembly is detached for scrapping treatment, and the reflux inlet assembly and the vacuum layer assembly can be repeatedly sterilized for use. Therefore, only the replaceable needle head assembly in the ablation needle is a disposable part, and the reflux assembly and the vacuum layer assembly are reusable parts, so that the cost can be reduced.

(2) The function of monitoring the treatment action range in an auxiliary mode can be achieved through the temperature measuring element, an operator or a doctor can adjust treatment according to the temperature condition fed back by the temperature measuring element, transition treatment or incomplete treatment is reduced, and meanwhile the CT scanning frequency can be reduced.

(3) The quick connection interface component can realize the quick installation and disassembly between the ablation needle and the transmission device 2, and also realize the visualization function of the puncture needle insertion angle.

(4) The first delivery pipe of transmission device and the second delivery pipe of receiving working medium from melting the needle set up to independent components of a whole that can function independently structure each other, through this kind of unique split type structure, make the structure of melting the transmission device of needle rear end lighter, can reduce operator's operation burden from this, make the operation nimble more convenient.

(5) The cold working medium (cold nitrogen) vaporized in the early treatment period can flow out from the matching gap between the contact pin and the inflow and backflow component, so that the cold working medium can quickly reach the treatment area of the inflow and backflow component, and the cooling speed is improved.

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 an axial cross-sectional view of a thermal ablation needle system in an embodiment of the invention;

FIG. 2 is an axial cross-sectional view of the ablation needle shown in FIG. 1;

FIG. 3 is a schematic view of a replaceable needle assembly in one embodiment of the present invention;

FIG. 4 is a schematic view of a replacement needle assembly in another embodiment of the present invention;

FIG. 5 is a schematic view of a replacement needle assembly in yet another embodiment of the present invention;

FIG. 6 is an enlarged view at I of FIGS. 3 and 7;

FIG. 7 is a schematic view of an iceball initially formed in the treatment area tube segment of the replacement needle assembly shown in FIG. 3;

FIG. 8 is a schematic illustration of an enlarged ice hockey puck in the treatment area tubing segment of the replacement needle assembly shown in FIG. 3;

FIG. 9 is an axial cross-sectional view of the ablation needle of FIG. 1 with the replacement needle tip assembly concealed;

FIG. 10 is a schematic view of a portion of the backflow device of FIG. 9;

FIG. 11 is a schematic structural view of the vacuum layer assembly of FIG. 9;

FIG. 12 is a top view of the first sealing plate of FIG. 11;

FIG. 13 is a top view of the second sealing plate of FIG. 11;

FIG. 14 is a front view of the first sealing plate of FIG. 11;

FIG. 15 is a schematic view of the ablation needle 1 connected to a delivery device via a quick connect interface assembly;

FIG. 16 is a schematic view of the needle insertion angle adjusted by the pointing position and the second alignment position;

FIG. 17 is a schematic view of FIG. 15 as viewed from C-C;

FIG. 18 is a schematic view of FIG. 15 as viewed from D-D;

FIG. 19 is an axial cross-sectional view of the quick connect interface assembly;

FIG. 20 is an enlarged view of FIG. 1 at E;

FIG. 21 is an axial cross-sectional view of the transfer device shown in FIG. 1;

FIG. 22 is an axial cross-sectional view of the second delivery tube shown in FIG. 21;

FIG. 23 is a cross-sectional view of the heat exchange device shown in FIG. 2;

FIG. 24 is a schematic perspective view of a spiral path in one embodiment of the present invention;

FIG. 25 is a schematic perspective view of a spiral path in another embodiment of the present invention;

FIG. 26 is a cross-sectional view of the bus bar assembly shown in FIG. 22;

fig. 27 is a cross-sectional view of the shunt device shown in fig. 22.

Reference numerals:

1-an ablation needle;

10-a replaceable needle assembly; 101-an outer tube; 102-a temperature measuring element; 103-a stationary tube; 104-triangular prism shaped needle tip; 105-a sealing ring; 106-connecting sleeve; 107-treatment zone tube section; 108-cylindrical needle tip; 109-ice hockey;

11-a flow-in and flow-back assembly;

110-straight needle tube body; 111-an inflow pipe; 112-an inner tube; 113-an outer tube; 144-a bushing; 115-vacuum layer; 116-a linker;

117-right angle needle tube body; 118-an adaptor sleeve;

12-a vacuum layer assembly; 122-vacuum adapter sleeve; 123-getter; 124-sealing structure; 125-quick connecting shaft tube; 126-seal interface; 1241-vacuum pumping port; 1242-first sealing plate, 1243-second sealing plate; 1243 a-fixed column; 1242 a-first solder hole, 1243 b-second solder hole;

2-a transmission device;

21-a first delivery pipe; 211-a first conduit; 212-a flexible sleeve; 213-an adapter;

24-a second delivery tube; 241-a delivery cannula; 242-a second conduit; 243-fixed tube;

27-a connecting tube;

22-a confluence device; 221-a collector tube; 221 a-first connection hole; 221 b-second connection hole; 23-a flow splitting device; 231-a sealing body; 232-first via; 233-a projection; 234 — a second via;

25-heat exchange means; 251-path; 252-helical fins; 253-a cylinder; 254-a spiral tube;

224-pin insertion; 226-front end face;

26-a quick connect interface assembly; 261-a quick connect interface; 2611-a first alignment position; 2612-indicate position;

262-a first spring;

263-locking sleeve; 2631-a second alignment position;

264-retaining ring; 267-a trough body; 261 a-step axis; 261 b-retainer groove; 261 c-first step; 261 d-second step; 263 a-mating projection;

266-a first plane; 128-a second plane;

28-axial locking structure; 281-opening; 282-groove; 13-an axial engagement portion; 131-bumps;

29-circumferential locking structure; 291-a spring plunger; 292-a second spring; 14-a circumferential engagement portion; 141-accommodating grooves.

Detailed Description

The invention will be further explained with reference to the drawings.

The invention provides a cold and hot ablation needle system which comprises an ablation needle 1 and a transmission device 2, wherein the ablation needle 1 is rotatably connected with the transmission device 2 through a quick connection interface component 26. The ablation needle 1 may be a straight needle or an ablation needle with a right angle.

The present invention will be described in detail below by taking an ablation needle having a right angle as an example.

The ablation needle 1 includes a replaceable needle tip assembly 10, a flashback inlet assembly 11, and a vacuum layer assembly 12 that is traversed by the flashback inlet assembly 11. Wherein, the inlet and return flow component 11 is a pipe body with a right angle. A first (forward) end of the inflow and outflow set 11 extends from the underside of the vacuum layer set 12 and into the replaceable needle set 10 and a second (rearward) end of the inflow and outflow set 11 extends from the left side of the vacuum layer set 12 and communicates with the transfer set 2 through a quick connect interface set 26. Wherein the replaceable needle assembly 10 is removably connected to the vacuum layer assembly 12.

Based on the current situation that the existing ablation needle generally adopts a fixed and integrated structure, and the head part needs to be contacted with tissues during treatment, so that the whole ablation needle is scrapped after treatment is finished, and the whole ablation needle is a disposable part, so that the cost of the ablation needle is higher, the invention solves the technical problem of the whole scrapping of the existing ablation needle by arranging the replaceable needle head component 10. In the invention, only the replaceable needle assembly 10 is a disposable component, and the reflux inlet assembly 11 and the vacuum layer assembly 12 are reusable components, so that after one treatment is finished, the replaceable needle assembly 10 is detached for scrapping treatment, and the reflux inlet assembly 11 and the vacuum layer assembly 12 can be repeatedly sterilized for use, thereby greatly saving the cost of the ablation needle system.

Further, the ablation needle 1 of the present invention may also have a function of assisting in monitoring the size of the treatment range.

Specifically, referring to FIG. 2 in conjunction with FIGS. 3 and 6, the replaceable needle assembly 10 includes an outer needle tube 101, a temperature sensing element 102, and a mounting tube 103. The needle outer tube 101 comprises a treatment region tube segment 107 and a connecting sleeve 105, wherein the treatment region tube segment 107 corresponds to the first end of the inflow/return flow component 11, and the connecting sleeve 105 is hermetically connected with the vacuum layer component 12. The working fluid in the return flow assembly 11 returns back after flowing to the treatment area pipe section 107 and flows back in the opposite direction, so that the ice ball 109 can be formed by the cold working fluid at the treatment area pipe section 107, and the size (diameter) of the ice ball 109 becomes larger along with the prolongation of the cryotherapy time. Generally, the iceball 109 formed during treatment is a regular oval shape.

As shown in figures 3 and 6, the temperature sensing element 102 is disposed on the outer wall of the needle outer tube 101. The fixing tube 103 is arranged outside the needle outer tube 101 and the temperature measuring element 102, and is used for enabling the temperature measuring element 102 to be tightly attached to the outer wall of the needle outer tube 101.

The temperature measuring element 102 is used for measuring the temperature of the treatment area pipe section 107, the temperature measuring element 102 feeds the temperature of the treatment area pipe section 107 back to the control system, and the control system confirms whether the temperature meets the treatment requirements or not. Therefore, the position of the temperature measuring element 102 is required to meet the requirement of auxiliary monitoring of the treatment effect range.

For example, the temperature sensing element 102 is located outside the length of the treatment zone tubing segment 107 by a distance L that allows the temperature sensing element to feed back a standard temperature (e.g., 0 ℃) to the control system when the puck 109 formed in the treatment zone tubing segment 107 reaches the location of the temperature sensing element 102. For example, the distance may be 5mm to 10 mm. In other words, since the length of the tube segment 107 of the treatment area starts from the needle, the distance between the temperature measuring element 102 and the needle is L, which can be 5mm-10 mm.

The temperature sensing element 102 at this location, when it is just beginning to freeze, has a diameter (major diameter) equal to the length L of the treatment zone tube segment 107 (as shown in FIG. 7); as the cryotherapy time increases, the ice ball 109 becomes progressively larger in size, gradually reaching and even passing over the location of the temperature sensing element 102 (as shown in FIG. 8). When the ice hockey 109 just reaches the position of the temperature measuring element 102, the temperature measuring element 102 feeds back the standard temperature of 0 ℃ to the control system, so that the size of the formed ice hockey 109 can be judged, and the purpose of indirectly judging the size of the focus area covered by the ice hockey 109 can be realized.

Therefore, the operator or doctor can adjust the treatment according to the temperature condition fed back by the temperature measuring element 102, so as to reduce the transition treatment or incomplete treatment, and reduce the CT scanning times.

Preferably, the temperature measuring element 102 may be a strip-shaped thermocouple to facilitate the attachment to the outer wall of the needle outer tube 101.

In addition, in order to ensure that the temperature measuring element 102 is tightly attached to the outer wall of the needle outer tube 101, the fixing tube 103 is preferably a PTFE heat shrinkable tube, and the temperature measuring element 102 can be tightly attached to the outer wall of the needle outer tube 101 due to the heat shrinkage characteristic of the PTFE heat shrinkable tube, so that the accuracy of measurement can be ensured.

Optionally, the treatment zone tube segment 107 is a rigid tube to ensure the rigidity of the ablation needle 1.

Preferably, the treatment area tube segment 107 is a flexible metal hose (as shown in FIG. 5). The number of times that can buckle when flexible metal hose carries out moulding and the angle of buckling do not have the restriction, can not cause the damage because of the number of times of bending is too much or the angle of buckling is too big, therefore flexible metal hose can realize many times, wide-angle deformation to can laminate focus area and unusual electrophysiological cell tissue more effectively.

The forward end of the treatment zone tube segment 107 is a needle, which may be a cylindrical needle tip 108 (as shown in fig. 4 and 5) or a triangular prism needle tip 104 (as shown in fig. 3). Needles with different shapes can be selected according to the types of the focuses.

Figures 3-5 of the present invention only schematically illustrate an example of a combination of a treatment area tube segment 107 and a needle. It will be appreciated that each of the alternatives or preferences for the treatment region tube segment 107 may be combined with each of the alternatives for the needle, for example, the treatment region tube segment 107 is a flexible metal hose and the needle is a triangular prism shaped needle tip 104.

The connecting sleeve 105 of the needle head outer tube 101 is hermetically connected with the vacuum layer assembly 12, and a sealed chamber is formed between the needle head outer tube 101 and the inflow and backflow assembly 11, so that the treated working medium can return back from the inflow and backflow assembly 11.

As shown in fig. 9 and 10, the inflow and outflow assembly 11 includes a straight needle tube 110 located at the lower side of the vacuum layer assembly 12 and a right angle needle tube 117 located inside the vacuum layer assembly 12, and the straight needle tube 110 and the right angle needle tube 117 are hermetically connected in a vacuum adapter sleeve 122 described below. The straight needle pipe body 110 includes an inlet pipe 111, an inner pipe 112 disposed outside the inlet pipe 111, and an outer pipe 113 disposed outside the inner pipe 112, and the working medium in the inlet pipe 111 flows downward from above as shown by arrows in fig. 10. A return passage is formed between the inlet pipe 111 and the inner pipe 112, and the working fluid flowing out from the end of the inlet pipe 111 returns from the return passage. A vacuum layer 115 is formed between the inner tube 112 and the outer tube 113, and the vacuum layer 115 can maintain the temperature of the remaining portion outside the treatment region of the reflux assembly 11.

The lowermost end of the outer tube 113 may also be provided with a bushing 114, one end of the bushing 114 extending between the inner tube 112 and the outer tube 113 and the other end extending beyond the lower end of the inner tube 112. Hub 114 facilitates the smooth installation of replaceable needle assembly 10. Therefore, after the needle head outer tube 101 is sleeved outside the inflow/outflow component 11, a backflow cavity is formed between the inner wall of the needle head outer tube and the outer wall of the inflow tube 111, and the working medium flows into the backflow channel between the inflow tube 111 and the inner tube 112 from the backflow cavity.

It will be appreciated that the treatment region of the inflow and return assembly 11, i.e., the region between the lowermost end of the inflow tube 11 to the lowermost end of the hub 114 (as shown at L1 in fig. 10), corresponds to the treatment region tube segment 107 of the needle outer tube 101.

As shown in fig. 9, the vacuum layer assembly 12 includes a sealing structure 124, and the sealing structure 124 is configured as a three-way structure. One of the ports of the sealing structure 124 is provided with a quick connection shaft tube 125, and the right-angle needle tube body 117 penetrates through the quick connection shaft tube 125.

The outer wall of the right angle needle tube body 117 is sleeved with an adapter sleeve 118, and the inner wall of the quick connection shaft tube 125 is connected with the adapter sleeve 118, so that the right angle needle tube body 117 is fixed. The quick connect shaft tube 125 is insertable into and lockable and unlockable with the quick connect interface assembly 26, the locking and unlocking process being described in detail below.

In addition, a vacuum adapter sleeve 122 for sealing connection with the outer wall of the inflow/backflow component 11 is disposed at the other port of the sealing structure 124, a connecting body 116 is disposed at the lower end of the vacuum adapter sleeve 122, and the connecting sleeve 106 forms a sealing connection with the connecting body 116 through a sealing ring 105, so as to fix the replaceable needle assembly 10 to the vacuum layer assembly 12. The connecting sleeve 106 may be a threaded connecting sleeve, which is in threaded sealing connection with the connecting body 116.

The ablation needle is generally insulated in a vacuum-pumping manner, and the ablation needle 1 is insulated by a vacuum layer except for a treatment region (a treatment region pipe section 107 and a treatment region of the corresponding inflow and backflow assembly 11).

In order to maintain the vacuum in the cavity, a getter is usually required to be placed in the vacuum cavity, the getter used in the prior art is a non-evaporable getter, the getter needs to be activated at high temperature under certain conditions, an activating piece of the getter needs to be met so as to enable the getter to play a role, and the process is complex.

The getter 123 of the present invention is disposed in the vacuum adapter 122, and the getter 123 is a room temperature getter. For example, PdO may be mixed with one of molecular sieve, activated carbon and heat insulating material. Since the getter 123 is a normal temperature getter, it does not need to be activated, and only needs to degas the material of the vacuum chamber in the sealing structure 124, and after the degassing is completed, the sealing can be performed.

As shown in fig. 9, the third port of the sealing structure 124 is a sealing port 126, the sealing port 126 is configured as a stepped hole having at least two steps, a sealing plate is disposed on each step of the stepped hole, and at least one sealing plate is disposed thereon with a fixing column.

The sealing method commonly used at present is vacuum plug which can be repeatedly pumped, oxygen-free copper, glass tube and glass sealing. The vacuum plug is large in size, is sealed through the sealing ring, cannot resist high temperature, has the risk of air leakage and air leakage due to the O-shaped ring, can be used in a relatively large cavity, generally adopts oxygen-free copper, a glass tube or glass sealing for ensuring the vacuum holding time of a small cavity of an ablation needle and reducing the risk of air leakage and air leakage, and the existing sealing is disposable sealing, so that the risk of sealing failure is caused.

Therefore, the sealing failure is avoided, and the prior sealing structure is improved as follows. That is, at least two sealing plates, such as the second sealing plate 1243 and the first sealing plate 1242 (as shown in fig. 11), are stacked in the axial direction of the sealing port 126, and at least one sealing plate (the second sealing plate 1243) is provided with a fixing post 1243 a.

Therefore, by arranging the plurality of sealing plates, secondary or tertiary sealing can be performed after primary sealing fails, so that the waste of products is reduced, and the utilization rate of the products is improved.

Taking the second sealing plate 1243 and the first sealing plate 1242 as an example, please refer to fig. 9, 11-14, the second sealing plate 1243 and the first sealing plate 1242 are respectively disposed on the corresponding steps of the step holes, the second sealing plate 1243 on the uppermost layer is provided with a fixing post 1243a, after the sealing is completed, if the vacuum fails, the glass can be heated, and the fixing post 1243a is pulled by a tool to be removed. After the sealing-in plate is removed, the first sealing-in plate 1242 of the lower layer is placed in the second step hole for sealing-in, so that the rejection rate can be effectively reduced, and the product utilization rate is improved.

And three times of sealing can be arranged according to the requirement, and the invention is not repeated in detail.

The first sealing plate 1242 and the second sealing plate 1243 are disc-shaped structures having small holes (e.g., the first solder hole 1242a and the second solder hole 1243b shown in fig. 12 and 13), so that the solder thereon can cover the small holes after being melted (molten mass), and the sealing interface 126 can be sealed after being solidified.

The diameters of the first solder hole 1242a and the second solder hole 1243b cannot be too large, and the diameters are too large to allow solder to directly flow therethrough and enter the vacuum chamber of the sealing structure 124, thereby causing vacuum sealing failure.

In addition, the problem of excessive flow resistance due to the arrangement of only a single small hole can be solved by arranging a plurality of first solder holes 1242a and second solder holes 1243b with smaller diameters, so that the air suction efficiency is improved.

In some preferred embodiments, the ablation needle 1 of the present invention can also realize the visualization function of the puncture needle insertion angle.

Specifically, as shown in fig. 15-19, the quick-connect interface assembly 26 includes a quick-connect interface 261 fixedly connected to the delivery device 2, a locking sleeve 263 fixedly connected to the ablation needle 1, and a first spring 262 disposed between the locking sleeve 263 and the quick-connect interface 261; the locking sleeve 263 is rotatably and movably sleeved on the outer side of the quick connection interface 261.

As shown in fig. 19, the quick coupling interface 261 includes a stepped shaft 261a and a retainer groove 261b provided on a sidewall of the stepped shaft 261 a. A retainer 264 is provided in the retainer groove 261b, and the movement range of the lock sleeve 263 can be restricted by the retainer 264.

Wherein, the first spring 262 is disposed on the first step 261c of the step shaft 261a, the inner wall of the locking sleeve 263 is provided with a fitting protrusion 263a for fitting with the first step 261c, and the inner wall of the rear end of the locking sleeve 263 is fitted with the second step 261d of the step shaft 261a, thereby defining the first spring 262 between the locking sleeve 263 and the quick-connect interface 261.

The engagement protrusion 263a and the first step 261c and the inner wall of the rear end of the locking sleeve 263 and the second step 261d are in clearance fit, so that a turning moment is applied to the locking sleeve 263, which makes the locking sleeve 263 rotate relative to the quick-connect interface 261 (since the quick-connect interface 261 is fixedly connected to the transmission device 2, the locking sleeve 263 can also be considered to rotate relative to the transmission device 2).

In addition, since the locking sleeve 263 and the quick-connect interface 261 are provided with the first spring 262, by compressing the first spring 262, the locking sleeve 263 can be moved in the axial direction thereof and in a direction close to the quick-connect interface 261 (i.e., in a direction away from the ablation needle 1); conversely, the locking sleeve 263 can move in the opposite direction (i.e., the direction approaching the ablation needle 1) under the restoring force of the first spring 262.

As shown in fig. 16, the quick connect interface 261 has a first alignment position 2611 and a plurality of indication positions 2612, the first alignment position 2611 may be a zero scale mark on the outer wall of the quick connect interface 261, and the plurality of indication positions 2612 may be angle scale marks on the outer wall of the quick connect interface 261.

The locking sleeve 263 has a second alignment position 2631, and the second alignment position 2631 may be a zero-scale line on the outer wall of the locking sleeve 263. After the quick connect interface assembly 26 is connected to the ablation needle 1 and the delivery device 2, respectively, the second alignment position 2631 and the first alignment position 2611 are aligned to indicate the initial connection state. When the locking sleeve 263 drives the ablation needle 1 to rotate, the second alignment position 2631 is aligned with one of the indication positions 2612 to indicate the rotating angle of the ablation needle 1, so that the needle insertion angle can be accurately controlled.

Referring to fig. 9 and fig. 17 to fig. 19, the axial engaging portion 13 and the circumferential engaging portion 14 are respectively disposed on the circumferential side wall and the end of the quick connect shaft tube 125; the locking sleeve 263 is provided with an axial locking structure 28 and a circumferential locking structure 29 arranged along the circumference thereof.

When the locking sleeve 263 rotates relative to the transmission device 2, the axial locking structure 28 is locked with the axial clamping portion 13 to limit the axial relative displacement between the quick connection interface assembly 26 and the ablation needle 1; and the circumferential locking structure 29 automatically locks with the circumferential snap 14 under the restoring force of the first spring 262 to limit the circumferential relative displacement between the quick connect hub assembly 26 and the ablation needle 1.

Conversely, the locking sleeve 263 moves relative to the transmission device 2 in the direction away from the ablation needle 1 to compress the first spring 262, so that the circumferential locking structure 29 is unlocked from the circumferential clamping part 14; the locking sleeve 263 is then rotated relative to the transmission device 2, so that the axial locking structure 28 and the axial engagement portion 13 can be unlocked.

The axial locking structure 28 includes a groove 282 having an opening 281, and more specifically, the groove 282 is a groove provided on the inner wall of the front end of the locking sleeve 263. The axial engaging portion 13 includes a projection 131 (shown in fig. 9 and 15) protruding in the radial direction of the quick-coupling shaft tube 125, and the size of the opening 281 (a shown in fig. 17) is larger than the size of the projection 131 (B shown in fig. 15), so that the projection 131 can extend from the opening 281 into the groove 282; when the locking sleeve 263 is rotated relative to the transfer device 2 after it has been inserted into the recess 282, the projection 131 can be moved out of the opening 281 and slid into another position in the recess 282. Since the size of the other part of the groove 282 except the opening 281 is smaller than that of the projection 131, the projection 131 cannot be released from the groove 282 after reaching the other position of the groove 282 from the opening 281, so that the quick connect interface assembly 26 cannot be axially displaced relative to the ablation needle 1.

Further, the circumferential locking structure 29 includes a spring plunger 291, and the spring plunger 291 is ejectable from a front end surface of the locking sleeve 263. The circumferential engaging portion 14 includes an accommodating groove 141 extending in the axial direction of the ablation needle 1. Therefore, when the locking sleeve 263 rotates relative to the transmission device 2, the spring plunger 291 is ejected by the second spring 292 and inserted into the receiving groove 141, so that the quick connect interface assembly 26 and the ablation needle 1 cannot be displaced relative to each other in the circumferential direction.

When the quick connection interface assembly 26 needs to be unlocked from the ablation needle 1, the locking sleeve 263 moves backward relative to the transmission device 2 by compressing the first spring 262, so that the spring plunger 291 is separated from the accommodating groove 141, and the circumferential locking between the quick connection interface assembly 26 and the ablation needle 1 is released; the locking sleeve 263 is then rotated in the reverse direction until the tab 131 is rotated in the recess 282 into a position aligned with the opening 281 so that it can slide out of the recess 282 through the opening 281, and the axial lock between the quick connect interface assembly 26 and the ablation needle 1 is released.

The first spring 262 may thus be a conventional spring, but may also be a torsion spring in order to accommodate rotation of the locking sleeve 263.

Preferably, in order to enable the operator to quickly align the quick connect interface assembly 26 with the ablation needle 1 by touch only (i.e., the protrusion 131 is aligned with the opening 281), a first plane 266 (shown in fig. 17) is provided on the outer wall of the quick connect interface assembly 26 (specifically, on the outer wall of the locking sleeve 263), and the opening 281 corresponds to the first plane 266 of the locking sleeve 263 and extends in the same direction; the outer wall of the quick connect shaft tube 125 has a second flat surface 128 (as shown in fig. 18), the second flat surface 128 corresponds to the protrusion 131 of the axial engaging portion 13, and when the first flat surface 266 of the locking sleeve 263 is coplanar (aligned) with the second flat surface 128, the protrusion 131 can extend from the opening 281 into the groove 282, so that the second end of the ablation needle 1 can be inserted into the quick connect hub assembly 26 smoothly.

The operator can simply touch without careful observation to align (i.e., co-planar) the first planar surface 266 of the quick connect interface assembly 26 with the second planar surface 128 of the ablation needle 1, with the tab 131 properly aligned with the opening 281, and thus rotating the locking sleeve 263 so that the first planar surface 266 is not co-planar with the second planar surface 128, the tab 131 can be slid into the recess 282 through the opening 281 for locking purposes.

Conversely, when unlocking, the locking sleeve 263 is moved and rotated so that the first plane 266 and the second plane 128 are aligned, and unlocking is performed.

Thus, by means of the quick connect interface assembly 26 in the above described embodiment, a quick locking and unlocking of the ablation needle 1 with the delivery device 2 can be achieved.

The transmission device 2 comprises a bus device 22, and a pin 224 is arranged in the bus device 22, and the pin 224 passes through and is in fit connection with the second end of the backflow inlet assembly 11. The right angle needle tube 117 of the inlet/return assembly 11 is disposed in the vacuum layer assembly 12 with its second end extending outside of the quick connect shaft tube 125. The quick connect shaft tube 125 is connected to the transmission device 2 after passing through the quick connect interface 261 of the quick connect interface assembly 26, and the pin 224 of the transmission device 2 needs to be inserted into the inlet/return flow assembly 11 in the quick connect shaft tube 125 and communicate with the inlet/return flow assembly 11. Therefore, when the connection is made, it is necessary to simultaneously ensure the matching between the quick connection shaft tube 125 and the quick connection interface 261, the quick connection interface 261 and the transmission device 2, and the insertion pin 224 of the transmission device 2 and the inlet/return flow assembly 11 (refer to fig. 20).

To improve the precision of the fit, the quick connect shaft tube 125 is constructed as a tube with a varying diameter (see fig. 9), and correspondingly, the inner wall of the quick connect interface 261 is constructed with a step (see fig. 19). The part with the smaller diameter on the quick connection shaft tube 125 is inserted into the quick connection interface 261 from the front end of the quick connection interface 261 (the quick connection assembly 11 is driven to enter the quick connection interface 261), meanwhile, the inserting needle 224 is inserted into the quick connection assembly 11 from the rear end of the quick connection interface 261, when the inserting needle 224 is inserted into the inflow port of the quick connection assembly 11 for a certain distance (for example, 5mm), the quick connection shaft tube 125 is inserted into the part with the larger diameter to enter the quick connection interface 261, so that the guiding effect is achieved when the connection is continued, the inserting needle 224 can be accurately inserted into the inflow port of the quick connection assembly 11, and the sealed communication between the transmission device 2 and the ablation instrument 1 is ensured.

As shown in fig. 19 and 20, the rear end of the quick-connect interface 261 is provided with a groove 267 that can be fitted with the transmission device 2 (specifically, with the front end face 226 of the bus bar 22).

To meet clinical needs, ablation needles 1 typically come in a variety of diameters, with different diameters varying the resistance of the ablation needle 1. Generally, the ablation needle with a large diameter of the inflow/outflow assembly 11 has a small resistance, and the ablation needle with a small diameter of the inflow/outflow assembly 11 has a large resistance. In order to match the ablation needles with different diameters, the cooling speed and performance are ensured by adjusting the matching of the ablation needles and the transmission device 2.

Specifically, an adapter sleeve 118 is disposed on the inlet 115 at the second end of the inlet/outlet assembly 11, and the adapter sleeve 118 is disposed in the quick-connect shaft tube 125 (specifically, disposed at the rear end of the quick-connect shaft tube 125); as described above, the pin 224 passes through the adapter sleeve 118 and is matingly coupled to the second end of the inlet/outlet assembly 11.

The flow resistance between the contact pin 224 and the inlet/return flow module 11 is greater than the flow resistance of the treatment region pipe section 107 (i.e. the flow resistance of the cold working medium or the hot working medium therein), so as to prevent the cold working medium or the hot working medium from directly flowing back to the transmission device 2 through the gap between the contact pin 224 and the inlet/return flow module 11 and not flowing through the treatment region pipe section 107.

The flow resistance between the pin 224 and the reflow module 11 is related to the depth of insertion of the pin 224 into the reflow module 11 (i.e., the mating length E shown in fig. 20) and the mating clearance between the pin 224 and the reflow module 11. For example, a larger mating length E and a larger mating clearance, or a shorter mating length E and a smaller mating clearance.

As shown in fig. 20, the diameter C and the length D of the pin 224 are fixed, so that the fitting length E and the fitting clearance can be adjusted by adjusting the diameter C1 and the length of the inlet at the second end of the reflow module 11.

In addition, based on the aseptic principle and in order to ensure that there is enough operating space, there is a distance between the combined type cold and hot ablation system and the ablation apparatus 1, so that in the early stage of working medium output, the distance can vaporize a large amount of low-temperature medium, thereby affecting the flow speed and further affecting the cooling speed. The fit clearance between the pin 224 and the reflow module 11 of the present invention solves this problem. Because the fit clearance is arranged between the two, the cold working medium (cold nitrogen) vaporized in the early stage of treatment flows out from the fit clearance, and in addition, the front end face 226 (namely, the end face connected with the contact pin 224) of the confluence device 22 is provided with an air outlet hole, so that the vaporized cold working medium can also flow out from the air outlet hole, the cold working medium can quickly reach the treatment area of the inflow and backflow component 11, and the cooling speed is improved. And the cold nitrogen escaping from the matching gap between the inserting needle 224 and the backflow component 11 can flow out through the second conduit 242 of the transmission device 2, so that the cold nitrogen can also pre-cool the second conduit 242, thereby reducing the resistance of the backflow in the later period and accelerating the cooling speed.

As shown in fig. 21, the delivery device 2 comprises a first delivery tube 21 for delivering the working medium to the ablation needle 1, a connecting tube 27 and a second delivery tube 24 for receiving and discharging the working medium delivered by the ablation needle 1 after treatment. A first end (front end) of connecting tube 27 is connected to quick connect interface assembly 26 and a second end (rear end) of connecting tube 27 is connected to first delivery tube 21 and second delivery tube 24, respectively.

The first delivery pipe 21 and the second delivery pipe 24 are constructed as separate structures independent from each other, in other words, the passages for delivering the working medium to the ablation needle 1 and receiving the working medium from the ablation needle 1 in the invention are mutually independent paths, so that the structure of the connecting pipe 27 connected with the ablation needle 1 is lightened, the operation load of a doctor is reduced, the operation is simpler and more flexible, and the cost can be reduced.

Specifically, as shown in fig. 21-23, the second delivery tube 24 includes a delivery sleeve 241 and a second catheter 242, the delivery sleeve 241 is disposed on the side of the connecting tube 27 far away from the ablation needle 1, and the heat exchange device 25 is disposed in the delivery sleeve 241. The second conduit 242 is fixedly connected to the delivery sheath 241 by a stationary tube 243. The second conduit 242 is welded to the stationary tube 243 at P2.

At least a portion (e.g., a first end) of the second conduit 242 extends into the connecting tube 27 from the second end of the connecting tube 27, and at least a portion (e.g., a second end) of the second conduit 242 extends into the conveying sleeve 241 and is connected to the heat exchanging device 25, so that the treated working medium in the ablation needle 1 can be conveyed to the heat exchanging device 25 through the second conduit 242. After heat exchange, the temperature of the treatment working medium is increased, and the temperature of the outer surface of the second conveying pipe 24 is further ensured to be maintained in an acceptable state.

The temperature of the treated cold working fluid (e.g., liquid nitrogen or a mixture of liquid nitrogen and nitrogen) is low, thereby lowering the temperature of the outer surface of second delivery tube 24; if the working medium with lower temperature is directly discharged through the second conveying pipe 24, the related personnel can be frostbitten, and unnecessary personnel injury can be caused; secondly, the phenomenon of 'white smoke' can be generated when the low-temperature working medium is discharged, and the phenomenon can cause great psychological pressure on doctors and patients, thereby influencing the operation. Therefore, the treated cold working medium needs to be treated to reach the normal temperature.

Similarly, for the hot working fluid (e.g., absolute ethanol) after treatment, the temperature is higher, thus raising the temperature of the outer surface of the second delivery tube 24; and if it is discharged directly, it may burn the relevant personnel and cause unnecessary injury, so it is also necessary to treat these hot working fluids to approach the normal temperature.

As can be seen from the above, in the transfer device 2 of the present invention, the first delivery pipe 21 and the second delivery pipe 24 are configured as separate structures independent of each other, thereby improving the flexibility of the transfer device 2 and improving the user experience. Further, in the present invention, in addition to the separate structure, different measures are taken for the first delivery pipe 21 and the second delivery pipe 24 to maintain the normal temperature state of the outer surfaces thereof.

Specifically, the second duct 24 is provided therein with a heat exchanger 25 for the purpose of maintaining a surface normal temperature state. Therefore, the heat exchanger 25 can effectively relieve the phenomenon that the temperature of the conveying sleeve 241 and the second conduit 242 is too high (hot working medium causes) or too low (cold working medium causes) due to the working medium after heat exchange, and therefore, by arranging the heat exchanger 25, the problem that the pipe of the conveying sleeve 241 and the second conduit 242 cannot bear the temperature (namely, the pipe becomes hard due to too high temperature or too low temperature) can be avoided. Thus, the split structure and the heat exchanger 25 of the present invention are functionally supported and in an interactive relationship with each other. The first duct 21 is provided with a vacuum layer (between the flexible sleeve 212 and the first conduit 211 as described below) to maintain a normal temperature state. The overall volume of the first delivery pipe 21 is smaller and the internal space is larger than that of the existing delivery device integrating the inflow and return paths, so that the vacuum treatment is more facilitated.

Further, another aspect of the heat exchanging device 25 is to cool or heat it without using an additional cooling source or heating source. For example, when the cold working fluid passes through the heat exchanging device 25, the cold working fluid exchanges heat with the heat exchanging device 25, the temperature of the cold working fluid itself increases, and the temperature of the heat exchanging device 25 decreases. At this time, the heat exchange is performed by the heat exchange device 25 on the treated hot working medium, so that the temperature of the hot working medium can be reduced to normal temperature more quickly after the heat exchange is performed on the hot working medium and the heat exchange device 25. Conversely, when the hot working medium passes through the heat exchange device 25, the temperature of the heat exchange device 25 can be increased, so that the heat exchange with the next liquid nitrogen working medium is facilitated.

In order to achieve the purpose that the temperature of the working medium after treatment tends to normal temperature, a path 251 for enabling the working medium after treatment to flow is arranged in the heat exchange device 25, one end of the path 251 is communicated with the second conduit 242, and the other end of the path 251 is communicated with the environment. Wherein, the path 251 includes one or more of a spiral path, a serpentine path, a zigzag path and a wave path.

In some preferred embodiments, path 251 is a helical path.

Fig. 24 shows an example in which the path 251 is a spiral path 251 a. In this embodiment, the heat exchange device 25 includes a cylinder 253 disposed in the conveying jacket 241 and a helical fin 252 extending helically on an outer wall of the cylinder 253 in an axial direction thereof, wherein an axis of the cylinder 253 coincides with an axis of the conveying jacket 241. The edges of the helical fins 252 contact the inner wall of the delivery sleeve 241. Thereby configuring a portion between the outer wall of the cylinder 253 and the inner wall of the delivery sleeve 241 into a helical path 251a by the helical fin 252.

Second conduit 242 communicates with helical path 251a such that the treated working fluid may enter helical path 251a through second conduit 242. By arranging the spiral path 251a, the path of the treated working medium flowing in the heat exchange device 25 is lengthened, so that the retention time of the treated working medium in the heat exchange device 25 is lengthened, and the temperature of the treated working medium flowing through the spiral path 251a can reach normal temperature, thereby meeting the requirement of direct discharge.

Further, the conveying sleeve 241 may be provided as a plastic hose (e.g., a silicone tube or a tetrafluoride tube, etc. resistant to low temperature and high temperature), and the spiral fin 252 may form an interference fit with the inner wall of the conveying sleeve 241. In other words, there is no gap between the helical fins 25 and the inner wall of the delivery sleeve 241 to ensure that the treated working substance is fully inserted into the helical path 251 a.

Preferably, the helical fins 252 are made of a material having a good heat transfer coefficient (e.g., copper, aluminum, etc.).

Fig. 25 shows another example in which the path 251 is a spiral path 251 b. In this embodiment, the heat exchanging device 25 includes a cylinder 253 provided in the conveying casing 241 and a spiral tube 254 spirally extending on an outer wall of the cylinder 253 in an axial direction thereof, wherein an axis of the cylinder 253 coincides with an axis of the conveying casing 241. The spiral tube 254 is a hollow tube, the inside of which is configured into a spiral path 251 b.

In some alternative embodiments, path 251 may also be a waveform path. The waveform path may be one or a combination of sine wave path, cosine wave path and square wave path. The undulating path may be configured by baffles having offset projections and recesses.

In some alternative embodiments, the path 251 may be a combination of any of a spiral path, a serpentine path, a zigzag path, and a wave path. For example, path 251 may be a combination of a spiral path and a serpentine path, which are connected in series with each other, to further increase the flow path of the working fluid to reduce its temperature.

The length and flow pattern of the path 251 in each of the above embodiments can be adjusted according to the output time to meet the heat exchange requirement (temperature requirement at the time of discharge).

It should be noted that the path 251 of the present invention is not limited to the above-mentioned embodiment, and any scheme that reduces the temperature of the working medium by extending the path through which the working medium flows should be considered as falling within the protection scope of the present invention.

Since the path of input and output in the ablation needle 1 is an integrated structure coaxially arranged, in order to realize a split structure of the first delivery tube 21 and the second delivery tube 24, the first delivery tube 21 and the second delivery tube 24 need to merge at the connection tube 27 and split at the second end of the connection tube 27.

Specifically, as shown in fig. 21 and 22, the first delivery pipe 21 and the second delivery pipe 24 are merged by the merging device 22, and are branched by the branching device 23.

The confluence device 22 is arranged inside the connecting pipe 27 and communicated with the ablation needle 1, and the first delivery pipe 21 and the second delivery pipe 24 respectively extend into the connecting pipe 27 from the second end of the connecting pipe 27 and are communicated with the confluence device 22 so as to deliver working medium to the ablation needle 1 or receive working medium from the ablation needle 1.

Referring to fig. 21, 22 and 26, the bus device 22 includes a bus pipe 221 disposed in the connection pipe 27, and one end of the bus pipe 221 protrudes from the connection pipe 27 and is connected to the quick-connect interface assembly 26. The other end of the collecting pipe 221 is provided with a first connection hole 221a for being in fit connection with the first delivery pipe 21 and a second connection hole 221b for being in fit connection with the second guide pipe 242; the first connection hole 221a and the second connection hole 221b are arranged side by side in a radial direction of the manifold 221. The axis of the first connection hole 221a and the axis of the second connection hole 221b are located at both sides of the axis of the manifold 221, respectively.

Further, a pin 224 is disposed in the manifold 221, and the pin 224 is connected to the first connection hole 221a by lapping. The axis of the pin 224 coincides with the axis of the manifold 221. Referring to fig. 1, the axial direction of the rectangular needle body 117 of the ablation needle 1 coincides with the axial direction of the transmission device 2, so that the axis of the insertion needle 224 coincides with the axis of the rectangular needle body 117 of the ablation needle 1, thereby facilitating the matching connection with the corresponding component of the ablation needle 1.

As shown in fig. 22 and 26, the pin 224 is axially overlapped with the first connection hole 221a only partially. The axial direction of the first connection hole 221a and the axial direction of the pin 224 are staggered from each other, so that space can be saved, so that the first connection hole 221a and the second connection hole 221b can be disposed in a narrow space without interference therebetween.

After the confluence device 22 performs confluence, it is necessary to perform a branching at an end of the connection pipe 27 to realize the first and

second delivery pipes

21 and 24 separately constructed. For the purpose of splitting, a splitting device 23 is provided at the second end of the connecting tube 27. Specifically, as shown in fig. 27, the flow distribution device 23 includes a sealing body 231, a first through hole 232, a convex portion 233, and a second through hole 234.

Referring to fig. 21, the sealing body 231 is sealingly disposed at the second end of the connection pipe 27. First through hole 232 is provided in sealing body 231 and axially penetrates sealing body 231, and is used for being connected to first delivery pipe 21 in a fitting manner. A boss 233 extends axially from the end of the sealing body 231 for engagement with the inner wall of the delivery sleeve 241. The second through hole 234 is provided in the sealing body 231 and axially penetrates the sealing body 231 and the boss 233 for fitting connection with the second conduit 242.

The axis of the first through hole 232 and the axis of the second through hole 234 are respectively located at the upper and lower sides of the axis of the sealing body 231 (i.e., the axis of the connection pipe 27), so that the first delivery pipe 21 and the second delivery pipe 24 are divided into two separate bodies at the second end of the connection pipe 27, thereby reducing the volume of the whole device and facilitating the operation of an operator.

First delivery tube 21 includes a flexible sleeve 212 positioned outside of the second end of connecting tube 27, a first conduit 211 disposed in flexible sleeve 212 and extending into connecting tube 27, and an adapter 213 that secures flexible sleeve 212 to shunt device 23. The first guide pipe 211 is welded to the first connection hole 221a at P3 shown in fig. 22; the second guide pipe 242 is welded to the second connection hole 221b at P1 shown in fig. 22 to secure the connection.

The flexible sleeve 212 may be a metal hose, and is vacuum-treated with the first conduit 211 to keep the working medium in the first conduit 211 warm.

The cold working medium may be a single substance such as liquid nitrogen (-196 ℃, boiling point at normal pressure), liquid oxygen (-183 ℃, boiling point at normal pressure), liquid methane (-161 ℃, boiling point at normal pressure), liquid argon (-186 ℃, boiling point at normal pressure), liquid neon (-246 ℃, boiling point at normal pressure), liquid helium (-269 ℃, boiling point at normal pressure), liquefied nitrous (88.5 ℃, boiling point at normal pressure), liquefied carbon dioxide (-79 ℃, boiling point at normal pressure), and chlorofluorocarbon (22 (-50 ℃, boiling point at normal pressure), or a mixture thereof.

The above-mentioned thermal medium may be a single substance such as water vapor (100 ℃, boiling point at normal pressure), methanol vapor (64.7 ℃, boiling point at normal pressure), formic acid vapor (100.8 ℃, boiling point at normal pressure), ethanol vapor (78 ℃, boiling point at normal pressure), acetic acid vapor (117.9 ℃, boiling point at normal pressure), ethyl ester vapor (54.3 ℃, boiling point at normal pressure), propanol vapor (82.5 ℃, boiling point at normal pressure), propionic acid vapor (141.1 ℃, boiling point at normal pressure), propylene ester vapor (101.6 ℃, boiling point at normal pressure), or a mixture thereof. It should be noted that the above boiling point temperature does not represent rewarming temperature, and in some embodiments, for example, a steam pressurization mode is used as a power source to deliver the thermal working medium to the ablation device 1, and the treatment temperature may be higher than the boiling point of the selected thermal working medium.

Therefore, the cold working medium and the hot working medium have wide sources and lower cost, and the covered temperature range is wider, thereby providing a foundation for the improvement of the safety, the economy and the convenience of the surgical operation.

It will be appreciated by those skilled in the art that the components and parts of the ablation needle (or delivery device 2, composite thermal ablation system) not described in detail herein can take the form of structures known in the art.

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 embodiments can be combined in any way as long as there is no structural conflict. It is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

1. A cold and hot ablation needle system is characterized by comprising an ablation needle (1) and a transmission device (2), wherein the ablation needle (1) is rotatably connected with the transmission device (2) through a quick connection interface assembly (26), the ablation needle (1) comprises a replaceable needle head assembly (10), a flow inlet and return assembly (11) and a vacuum layer assembly (12) penetrated by the flow inlet and return assembly (11);

the first end of the backflow inlet component (11) extends into the replaceable needle assembly (10), and the second end of the backflow inlet component (11) extends into the quick connection interface assembly (26) and is communicated with the transmission device (2);

the replaceable needle assembly (10) is removably connected to the vacuum layer assembly (12).

2. The thermoablative needle system of claim 1, wherein the replaceable needle assembly (10) comprises:

the needle head outer tube (101), the needle head outer tube (101) comprises a treatment area tube section (107) and a connecting sleeve (105), the treatment area tube section (107) corresponds to the first end of the inflow and backflow component (11), and the connecting sleeve (105) is connected with the vacuum layer component (12) in a sealing mode;

the temperature measuring element (102) is arranged on the outer wall of the needle head outer tube (101); and

and the fixing tube (103) is arranged outside the needle head outer tube (101) and the temperature measuring element (102) and is used for enabling the temperature measuring element (102) to be tightly attached to the outer wall of the needle head outer tube (101).

3. The thermoablative needle system of claim 2, wherein the temperature sensing element (102) is located outside the length of the treatment zone tube section (107) at a distance such that when an iceball (109) formed by the treatment zone tube section (107) reaches the location of the temperature sensing element (102), the temperature sensing element feeds back a standard temperature to a control system.

4. The thermoablation needle system according to claim 2 or 3, characterized in that the treatment zone tube section (107) is a rigid tube or a flexible metal hose, and the front end of the treatment zone tube section (107) is a needle head which is a cylindrical needle tip (108) or a triangular prism needle tip (104).

5. The needle system according to claim 2 or 3, wherein the quick connect interface assembly (26) comprises a quick connect interface (261) fixedly connected with the transmission device (2) and a locking sleeve (263) fixedly connected with the ablation needle (1);

the locking sleeve (263) is rotatably and movably sleeved on the outer side of the quick connection interface (261);

the quick connect interface (261) has a first alignment position (2611) and a plurality of indication positions (2612), the locking sleeve (263) has a second alignment position (2631), and after the quick connect interface assembly (26) is connected to the ablation needle (1) and the delivery device (2), respectively, the second alignment position (2631) and the first alignment position (2611) are aligned to indicate an initial connection state;

when the locking sleeve (263) drives the ablation needle (1) to rotate, the second alignment position (2631) is aligned with one indication position (2612) to indicate the rotating angle of the ablation needle (1).

6. The needle system according to claim 5, wherein the transmission device (2) comprises a bus device (22), a contact pin (224) is arranged in the bus device (22), and the contact pin (224) is connected with the second end of the flow inlet and return assembly (11) in a matching manner;

the flow resistance between the insertion needle (224) and the inflow and return assembly (11) is larger than the flow resistance of the therapy tube segment (107).

7. The needle system according to claim 6, wherein the vacuum layer assembly (12) comprises a sealing structure (124), the sealing structure (124) is configured as a three-way structure, one of the ports of the sealing structure (124) is a sealing port (126), the sealing port (126) is configured as a stepped hole having at least two steps, a sealing plate is arranged on each step of the stepped hole, and at least one sealing plate is provided with a fixing column.

8. The cold-hot ablation needle system according to claim 7, wherein a vacuum adapter sleeve (122) for being connected with the outer wall of the inflow-backflow component (11) in a sealing manner is arranged on one port of the sealing structure (124), a getter (123) is arranged in the vacuum adapter sleeve (122), and the getter (123) is a normal-temperature getter.

9. The needle system of claim 7, wherein a quick connect shaft tube (125) is disposed at one of the ports of the sealing structure (124), the quick connect shaft tube (125) is configured to be inserted into the quick connect interface assembly (26) and connected to the adaptor sleeve (118) of the inflow/backflow assembly (11);

the upper end part and the end part of the circumferential side wall of the quick connection shaft tube (125) are respectively provided with an axial clamping part (13) and a circumferential clamping part (14);

the locking sleeve (263) is provided with an axial locking structure (28) and a circumferential locking structure (29) arranged along the circumferential direction of the axial locking structure;

when the locking sleeve (263) rotates relative to the transmission device (2), the axial locking structure (28) is locked with the axial clamping part (13) so as to limit the axial relative displacement between the quick connection interface component (26) and the ablation instrument (1); the circumferential locking structure (29) is locked with the circumferential clamping part (14) so as to limit the circumferential relative displacement between the quick connection interface component (26) and the ablation instrument (1);

the locking sleeve (263) can move relative to the transmission device (2) to unlock the circumferential locking structure (29) and the circumferential clamping part (14); the locking sleeve (263) is then rotated relative to the transmission device (2) in order to unlock the axial locking structure (28) from the axial engagement (13).

10. The needle system according to any one of claims 1 to 3, wherein the transmission device (2) comprises a first delivery pipe (21) for delivering working medium to the ablation needle (1) and a second delivery pipe (24) for receiving and discharging the working medium output after treatment in the ablation needle (1), and the first delivery pipe (21) and the second delivery pipe (24) are constructed in a split structure independent of each other;

the second conveying pipe (24) comprises a conveying sleeve (241), a heat exchange device (25) is arranged in the conveying sleeve (241), a path (251) for enabling the treated working medium to flow is arranged in the heat exchange device (25), and the path (251) comprises one or more of a spiral path, a snake-shaped path, a zigzag path and a wave-shaped path.