CN113768609A

CN113768609A - Cold and hot ablation device

Info

Publication number: CN113768609A
Application number: CN202111323100.4A
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: 2021-11-10
Filing date: 2021-11-10
Publication date: 2021-12-10
Anticipated expiration: 2041-11-10
Also published as: CN113768609B; WO2023082615A1

Abstract

The invention relates to a cold and hot ablation device, relates to the technical field of cold and hot ablation operations, and is used for improving the convenience of operation. The cold and hot ablation device comprises an ablation instrument and a transmission device, and the transmission device and the ablation instrument can be locked by rotating the quick connection interface assembly on the transmission device; conversely, when unlocking is performed, the transmission device and the ablation instrument can be unlocked by reversely rotating the quick connect interface assembly, so that the combination and the disassembly of the transmission device and the ablation instrument are quicker and more convenient.

Description

Cold and hot ablation device

Technical Field

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

Background

The cold and hot ablation operation is a surgical medical technology for eliminating target tissues by using cold working medium and hot working medium, the cold working medium in the combined type cold and hot ablation system can be conveyed to a treatment area of a treatment instrument for freezing operation in the operation, and the heat of focus tissues corresponding to the treatment area is taken away through evaporation and heat absorption of the cold working medium, so that the temperature of a target ablation part is reduced, and lesion cell tissues are damaged to achieve the purpose of treatment. After the freezing is finished, the combined type cold and hot ablation system conveys hot working medium to the treatment area of the treatment instrument, and a large amount of heat is released instantly, so that the treatment area is quickly rewarming.

The combined type cold and hot ablation system can be connected with the ablation instrument by utilizing the transmission device so as to transmit cold working medium or hot working medium. Because the ablation apparatus and the transmission device both relate to inflow and backflow of working media, more time and operation are needed to be spent when the ablation apparatus and the transmission device are connected before an operation, and after the operation is finished, great strength is needed to be spent to separate the ablation apparatus and the transmission device, so that the convenience is greatly reduced.

Disclosure of Invention

The invention provides a cold and hot ablation device which is used for improving the convenience of operation.

The invention provides a cold and hot ablation device, which comprises an ablation instrument and a transmission device, wherein the second end of the transmission device is used for being connected with a combined type cold and hot ablation system;

a rotatable and movable quick-connect interface assembly is connected to a first end of the transmission device, a second end of the ablation instrument extends into the quick-connect interface assembly and is communicated with the transmission device,

wherein the quick connect interface assembly locks with the ablation instrument when rotated relative to the delivery device; the quick connect interface assembly unlocks with the ablation instrument when moved and counter-rotated relative to the transmission device.

In one embodiment, the quick-connect interface assembly comprises a quick-connect interface fixedly connected with the transmission device, a locking sleeve rotatably and movably sleeved outside the quick-connect interface, and a first spring arranged between the locking sleeve and the quick-connect interface;

the locking sleeve is provided with an axial locking structure and a circumferential locking structure arranged along the circumferential direction of the locking sleeve, and the second end of the ablation instrument is provided with an axial clamping part and a circumferential clamping part respectively;

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 and compresses the first spring so as to unlock the circumferential locking structure and the circumferential clamping part; 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 axial locking structure comprises a groove having an opening, the axial engagement portion comprises a projection projecting in a radial direction of the ablation instrument, the opening has a size larger than that of the projection, and the projection can slide into the groove from the opening when the locking sleeve is rotated relative to the delivery device.

In one embodiment, the circumferential locking structure comprises a spring plunger, and the circumferential snap-fit portion comprises a receiving groove extending in an axial direction of the ablation instrument;

when the locking sleeve rotates relative to the transmission device, the spring plunger is ejected out and inserted into the accommodating groove so as to limit circumferential relative displacement between the quick connection interface assembly and the ablation instrument.

In one embodiment, a first plane is disposed on an outer wall of the quick connect interface assembly, the opening corresponds to the first plane, and the two planes extend in the same direction;

the outer wall of the ablation instrument is provided with a second plane, and when the first plane and the second plane are coplanar, the lug can extend into the opening, so that the second end of the ablation instrument can be smoothly inserted into the quick connection interface assembly.

In one embodiment, the ablation device includes a flow inlet and return assembly and a vacuum layer assembly, the flow inlet and return assembly extends through the vacuum layer assembly, and a buffer structure is disposed on the flow inlet and return assembly, and the buffer structure is located in the vacuum layer assembly.

In one embodiment, the first end of the inflow and outflow assembly includes a treatment section and a non-treatment section, the non-treatment section having a diameter greater than a diameter of the treatment section.

In one embodiment, the vacuum layer assembly comprises a sealing structure, a sealing port arranged along the radial direction of the sealing structure, and an adapter port and a quick connection shaft tube which are respectively arranged at two sides of the sealing structure, wherein the adapter port is used for being connected with the outer wall of the backflow inlet assembly, and the quick connection shaft tube is used for being inserted into the quick connection port assembly and being connected with an adapter sleeve of the backflow inlet assembly;

the axial clamping part is arranged on the circumferential side wall of the quick connection shaft tube, and the circumferential clamping part is arranged at the end part of the sealing structure;

the sealing connector is provided with at least two first sealing plates and second sealing plates which are stacked along the axial direction of the sealing connector, and at least one sealing plate is provided with a fixing column.

In one embodiment, the transfer device comprises a backflow passage assembly, a heat insulation layer arranged outside the backflow passage assembly, and an insulation sleeve arranged outside the heat insulation layer, wherein the material of the heat insulation layer is aerogel.

In one embodiment, the adapter sleeve is arranged at the flow inlet of the second end of the flow inlet and return assembly and is connected with the inner wall of the adapter sleeve;

the backflow passage component comprises a contact pin, and the contact pin penetrates through the adapter sleeve and is connected with the second end of the backflow inlet component in a matched mode;

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

In one embodiment, the flow resistance between the pin and the inlet and return assemblies is related to the depth of insertion of the pin into the inlet and return assemblies and the fit clearance between the pin and the inlet and return assemblies.

In one embodiment, the transfer device is further provided with a temperature measuring connector.

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

(1) the transmission device can be locked with the ablation instrument by rotating the quick connection interface assembly on the transmission device; conversely, when unlocking is performed, the transmission device and the ablation instrument can be unlocked by reversely rotating the quick connect interface assembly, so that the combination and the disassembly of the transmission device and the ablation instrument are quicker and more convenient.

(2) Through setting up buffer structure, can effectively absorb because the stress that expend with heat and contract with cold and produce, can alleviate the pulling force or the pressure that advances return assembly 11's inlayer pipe and its connection end pipeline produced because of expend with heat and contract with cold to make the needle tubing keep the rigidity, avoid the welding seam to tear.

(3) The diameter of the treatment section of the ablation instrument is smaller than that of the non-treatment section, so that the ablation instrument is provided with the variable-diameter inflow and backflow assembly (needle tube), and the puncture resistance and the wound can be effectively reduced while the strength of the non-treatment section is ensured.

(4) The problem of single sealing failure can be solved through a plurality of sealing plates and fixed columns, so that the product cost can be reduced.

(5) The transmission device realizes heat insulation through aerogel, and abandons a vacuum heat insulation mode, so that the process is simple, the cost is low, the weight is relatively light, and the flexibility is better. In addition, because the mode of vacuum heat insulation is not adopted, the transmission device can also realize insulation treatment so as to reduce the difficulty of the insulation design of the system end. And a temperature measuring joint can be arranged in the ablation instrument, so that the real-time temperature of the end of the ablation instrument can be better detected.

(6) The flow resistance between the contact pin and the backflow inlet assembly is larger than that of the treatment section of the backflow inlet assembly, so that cold working medium or hot working medium can be prevented from directly flowing back to the backflow channel of the transmission device through a gap between the cold working medium and the hot working medium and not flowing through the treatment section of the backflow inlet assembly. The fit clearance between the contact pin and the inflow and backflow component enables the cold working medium (cold nitrogen) vaporized in the early treatment stage to escape from the fit clearance, so that the cold working medium can quickly reach the treatment section of the inflow and backflow component, and the cooling speed is increased; and the escaped cold nitrogen can flow out through the return channel of the transmission device, so that the cold nitrogen can also have a precooling effect on the return channel, thereby reducing the resistance of later-stage return flow and accelerating the cooling speed.

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 device in an embodiment of the invention;

FIG. 2 is a schematic structural view of an embodiment of the present invention with an ablation instrument coupled to a delivery device via a quick connect interface assembly;

FIG. 3 is the view of FIG. 2 as viewed from A-A;

FIG. 4 is a view of FIG. 2 from B-B;

FIG. 5 is a cross-sectional view of the vacuum layer assembly shown in FIG. 1;

FIG. 6 is a cross-sectional view of the quick connect interface assembly of FIG. 1;

FIG. 7 is a cross-sectional view of an ablation instrument in an embodiment of the invention;

FIG. 8 is a cross-sectional view of the intake and return flow assembly shown in FIG. 7;

FIG. 9 is an enlarged view of FIG. 8 at C;

FIG. 10 is a cross-sectional view of the sealing structure of FIG. 5;

FIG. 11 is a top view of one of the sealing plates of FIG. 10;

FIGS. 12 and 13 are top and front views, respectively, of another sealing plate of FIG. 10;

FIG. 14 is an enlarged view of FIG. 1 at A;

FIG. 15 is a cross-sectional view of a delivery device in an embodiment of the invention;

fig. 16 is a structural view showing an enlarged view of a part of the structure shown in fig. 15;

FIG. 17 is a cross-sectional view of the inlet/return passageway assembly of FIG. 15;

FIG. 18 is an enlarged view of FIG. 17 at F;

fig. 19 is an enlarged view of fig. 1 at B (hatching is not shown).

Reference numerals:

1-an ablation instrument;

11-a flow-in and flow-back assembly; 111-a needle tip; 122 a-treatment segment; 122 b-non-treatment segment; 113-a buffer structure; 114-an adaptor sleeve;

12-a vacuum layer assembly; 121-a sheath; 122-an adapter; 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; 20-a heat insulating layer;

21-an insulating sleeve; 22-an inlet return path assembly;

23-insulating sleeve fixing piece; 231-serration connections; 232-clamping a boss; 233-sealing ring;

24-outer sleeve; 25-a handle; 26-a quick connect interface assembly; 27-temperature measuring joint;

221-a first in-return flow branch; 222-inlet pipe insulation; 223-entering and returning the heat insulating layer; 224-pin insertion; 225-a second inlet flow splitter; 226-front end face; 227-inflow channels; 228-a return channel;

229-a mouthpiece; 229 a-a first overlap tube; 227 a-a second lap joint tube; 226 a-air outlet;

261-a quick connect interface; 262-a first spring; 263-locking sleeve; 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.

As shown in fig. 1, the present invention provides a thermal ablation device, which includes an ablation apparatus 1 and a transmission device 2, wherein a second end of the transmission device 2 is used for connecting to a composite thermal ablation system (not shown). The cold working medium or the hot working medium in the combined type cold and hot ablation system is conveyed to the ablation instrument 1 through the transmission device 2, so that cold and hot ablation treatment can be carried out on the tissues of the target area. In order to facilitate the connection and the disconnection between the ablation instrument 1 and the transmission device 2, so as to reduce the operation steps of a doctor, a rotatable and movable quick-connection interface assembly 26 is arranged at the first end of the transmission device 2, and the second end of the ablation instrument 1 extends into the quick-connection interface assembly 26 and is communicated with the transmission device 2 so as to receive the cold working medium or the hot working medium in the transmission device 2.

Wherein the quick connect interface assembly 26 locks with the ablation instrument 1 when rotated relative to the delivery device 2; the quick connect interface assembly 26 unlocks from the ablation instrument 1 as it moves and rotates relative to the transmission 2. Thus, by rotating the quick connect interface assembly 26, the ablation instrument 1 can be quickly locked with the delivery device 2, while by moving and rotating the quick connect interface assembly 26, the delivery device 2 can be unlocked and disengaged from the ablation instrument 1, thus improving the ease of attachment and detachment between the ablation instrument 1 and the delivery device 2.

Further, since the quick connect interface assembly 26 is rotatable relative to the delivery device 2, when it is locked with the ablation device 1, it is rotated to rotate the ablation device 1 together, so as to adjust the penetration angle of the ablation device 1 into the target area.

One embodiment of a quick connect interface assembly 26 for rotational locking and translational rotational unlocking is provided below, with reference to fig. 2-6. It is to be understood that any suitable modifications and combinations can be made by those skilled in the art without departing from the spirit of the present invention.

As shown in fig. 6, the quick-connect interface assembly 26 includes a quick-connect interface 261 fixedly connected to the transmission device 2, a locking sleeve 263 rotatably and movably sleeved on the quick-connect interface 261, and a first spring 262 disposed between the locking sleeve 263 and the quick-connect interface 261.

Specifically, the quick connect 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).

Furthermore, 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 a direction in which it is axially closer to the quick-connect interface 261 (i.e., in a direction away from the ablation device 1); conversely, the locking sleeve 263 is movable in the opposite direction (i.e., the direction toward the ablation device 1) by the restoring force of the first spring 262.

The locking sleeve 263 is provided with an axial locking structure 28 and a circumferential locking structure 29 arranged along the circumference thereof, and the second end of the ablation instrument 1 (specifically, the second end of the vacuum layer assembly 12 described below, for example) is provided with an axial clamping portion 13 and a circumferential clamping portion 14, respectively.

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 instrument 1; and the circumferential locking structure 29 automatically locks with the circumferential catch 14 under the restoring force of the first spring 262 to limit the circumferential relative displacement between the quick connect interface assembly 26 and the ablation instrument 1.

Conversely, the locking sleeve 263 moves relative to the transmission device 2 in a direction away from the ablation instrument 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.

Referring to fig. 2, 3 and 6, in particular, the axial locking structure 28 includes a groove 282 having an opening 281, and in particular, 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. 2 and 5) protruding in the radial direction of the ablation device 1, and the size of the opening 281 (a shown in fig. 3) is larger than the size of the projection 131 (B shown in fig. 2), 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. Because the size of the recess 282 is smaller than the size of the protrusion 131 except for the opening 281, the protrusion 131 cannot be removed from the recess 282 after reaching other positions of the recess 282 through the opening 281, so that the quick connect interface assembly 26 cannot be axially displaced relative to the ablation instrument 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 instrument 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 instrument 1 cannot be displaced relative to each other in the circumferential direction.

When it is desired to unlock the quick connect interface assembly 26 from the ablation instrument 1, the circumferential lock between the quick connect interface assembly 26 and the ablation instrument 1 is released by compressing the first spring 262 to move the locking sleeve 263 rearward relative to the transmission device 2, thereby disengaging the spring plunger 291 from the receiving groove 141; the locking sleeve 263 is then rotated in the reverse direction until the tab 131 is rotated in the recess 282 into alignment 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 device 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 instrument 1 by touch only (i.e., the tab 131 is aligned with the opening 281), a first plane 266 (shown in fig. 3) 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 ablation device 1 (specifically, the outer wall of the sealing structure 124 described below) is provided with a second plane 128 (as shown in fig. 4), the second plane 128 corresponds to the protrusion 131 of the axial clamping portion 13, and when the first plane 266 of the locking sleeve 263 is coplanar (aligned) with the second plane 128, the protrusion 131 can extend into the groove 282 from the opening 281, so that the second end of the ablation device 1 can be inserted into the quick connect interface 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 instrument 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, with the quick connect interface assembly 26 of the above-described embodiment, rapid locking and unlocking of the ablation instrument 1 to the delivery device 2 may be achieved.

The ablation apparatus 1 of the present invention may be, for example, an ablation needle, which includes a flow inlet/return assembly 11 and a vacuum layer assembly 12, wherein a second end of the flow inlet/return assembly 11 penetrates the vacuum layer assembly 12 and then is connected to the transmission device 2, a cold working medium or a hot working medium enters the second end of the flow inlet/return assembly 11 from the transmission device 2 and flows from the second end to the first end thereof for treatment, and the treated working medium returns to the transmission device 2 in the flow inlet/return assembly 11 in the opposite direction.

In the prior art, a cold working medium or a hot working medium in the inlet/return assembly 11 flows in the inner-layer tube, and in order to improve the operation safety and ensure the treatment temperature of the working medium, an outer-layer tube is arranged outside the inner-layer tube, and a vacuum space is formed between the inner-layer tube and the outer-layer tube. In order to obtain an ablation needle (an ultrafine ablation needle with the thickness of 1.7mm is realized) which is as thin as possible, on the premise of meeting the treatment effect, a thin-wall pipe is selected, and a certain vacuum space is sacrificed, so that in the treatment process, the temperature of the inner layer pipe is extremely low or high due to the fact that a cold working medium and a hot working medium flow through the inner layer pipe, and the temperature of the outer layer pipe is always kept at the normal temperature due to the existence of the vacuum space, so that the temperature difference between the outer layer pipe and the inner layer pipe is large, and the inner layer pipe can expand with heat and contract with cold. However, the two ends of the inner layer of the backflow inlet assembly 11 are fixed by welding, so that the stress caused by thermal expansion and cold contraction can cause the inner layer pipe and the connecting end pipeline thereof to be pulled or pressed, and the acting force can cause the inner layer pipe to deform, so that the welding seam receives certain stress.

To avoid the above problem, the reflow module 11 is provided with a buffer structure 113 in at least a portion of the vacuum layer module 12. For example, the flow inlet and return assembly 11 may include a buffer structure 113 (shown in fig. 7 and 8) disposed in the vacuum layer assembly 12, and the buffer structure 113 may be formed by bending an inner layer pipe, and the buffer structure 113 may be accommodated due to a large space inside the vacuum layer assembly 12. This buffer structure 113 can effectively absorb the stress that produces because of expend with heat and contract with cold, can alleviate the pulling force or the pressure that advances return assembly 11's inlayer pipe and its connection end pipeline and produce because of expend with heat and contract with cold to make the needle tubing keep the rigidity, avoid the welding seam to tear.

In addition, the doctor can select the corresponding type of the ablation needle according to the size of the focus of the target area. For the patient, the thinner the ablation needle, the smaller the puncture force, and the smaller the puncture force, the better the patient experience. However, if the ablation needle is too thin, the rigidity of the ablation needle is reduced, which is disadvantageous for puncture. Therefore, in order to balance the conflicting requirements, the present invention is configured as follows.

As shown in fig. 8 and 9, the first end of the inflow/return assembly 11 includes a treatment section 122a (see section G in fig. 8) and a non-treatment section 122b, and the diameter of the non-treatment section 122b is larger than that of the treatment section 122 a. And the treatment segment 122a and the non-treatment segment 122b are connected by a small angle chamfer. Therefore, the first end (i.e. the front end) of the inflow/backflow component 11 forms a step shape, so that the treatment section 122a becomes thin on the premise of ensuring the treatment effect, the puncture resistance can be effectively reduced, and meanwhile, the non-treatment section 122b becomes thicker than the treatment section 122a, the rigidity during puncture (especially for a thinner ablation needle) can be increased, and the operation of a doctor is facilitated. As shown in FIG. 8, the foremost end of the treatment segment 122a is the needle tip 111 for puncturing.

As shown in fig. 5, the vacuum layer assembly 12 includes a sealing structure 124, a sealing interface 126 disposed along a radial direction of the sealing structure 124, and an adapter 122 and a quick-connect shaft tube 125 respectively disposed at two sides of the sealing structure 124, wherein the adapter 122 is adapted to be connected to an outer wall of the inlet/return flow assembly 11, and the quick-connect shaft tube 125 is adapted to be inserted into the quick-connect interface assembly 26 and connected to the adapter sleeve 114 of the inlet/return flow assembly 11. Specifically, the adaptor sleeve 114 is disposed at the smaller diameter end of the quick connect shaft tube 125 and is attached to the inner wall thereof.

Since the ablation needle needs to be vacuum insulated through the vacuum port 1241 of the vacuum layer assembly 12, a getter 123 is typically placed within the vacuum chamber in order to maintain the vacuum within the chamber. Specifically, the getter 123 is disposed at the rear end of the adapter 122.

In addition, 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 following improvement is made on the ablation needle sealed by glass. That is, at least two second sealing plates 1243 and first sealing plates 1242 (as shown in fig. 10) are stacked in the sealing interface 126 along the axial direction thereof, and a fixing column 1243a is disposed on at least one sealing plate (the second sealing plate 1243).

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. 10-13, the sealing interface 126 is a stepped hole, the second sealing plate 1243 and the first sealing plate 1242 are respectively disposed on corresponding steps of the stepped hole, a fixing post 1243a is disposed on the second sealing plate 1243 on the uppermost layer, after the sealing is completed, if the vacuum fails, the glass may 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. 11 and 12), 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.

As shown in fig. 5, the front end of the adapter 122 may further be sleeved with a sheath 121, and the sheath 121 is in smooth transition connection with the front end of the sealing structure 124.

The axial engaging portion 13 in the above embodiment is disposed on the circumferential side wall of the quick-connect shaft tube 125, and the circumferential engaging portion 14 is disposed at the end of the sealing structure 124 (see fig. 4 and 5).

The intake and return flow assembly 11 is disposed in the vacuum layer assembly 12 with a 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/outlet flow assembly 11 of the quick connect shaft tube 125 and connected to the inlet/outlet 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. 14).

To improve the precision of the fit, the quick connect shaft tube 125 is constructed as a tube with a varying diameter (see fig. 5), and correspondingly, the inner wall of the quick connect interface 261 is constructed with a step (see fig. 6). 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, 5 mm), 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. 6, the rear end of the quick connect interface 261 is provided with a channel 267 that is engageable with the transfer device 2 (specifically, with the front face 226 of the inlet/return passageway assembly 22 as described below).

The transfer device 2 of the present invention will be described in detail below with reference to fig. 15 to 18.

The transmission device 2 adopts metal capillary tubes (stainless steel, copper and nickel) as circulation pipelines, wherein cold working media and hot working media flow through the circulation pipelines, so the outside of the transmission device needs to be kept at a normal temperature state. The existing transport devices are thermally insulated by a vacuum layer. However, the vacuum insulation needs to form a sealed chamber to meet the requirement of vacuum pumping, so welding is needed among parts; and metal parts (vacuum requirements) are required for each part to achieve the sealing requirements, and heating, degassing and vacuumizing are required during operation, so that the cost of vacuum insulation is high, the process is complex, and the conveying device 2 is relatively heavy. Unlike the prior art, the conveying device 2 of the present invention is different from the prior art in that the conveying device 2 of the present invention is insulated by a heat insulating material, i.e., the conveying device 2 of the present invention is a non-vacuum conveying device, which has the advantages of simple process, low cost, relatively light weight and better flexibility than a vacuum conveying device.

Specifically, as shown in fig. 15, the transfer device 2 includes a backflow passage assembly 22, and an insulating layer 20 disposed outside the backflow passage assembly 22. The material of the thermal insulation layer 20 is aerogel. The aerogel has the advantages of light weight, low thermal conductivity, large temperature tolerance range and the like, and the hardening phenomenon caused by low-temperature freezing can not occur, so that the flexibility of the aerogel can be still maintained in the using process.

And further, in order to avoid the leakage current in the combined type cold and hot ablation system from being transmitted to the patient in the treatment process, insulation treatment is needed. However, since the conventional transmission device employs vacuum insulation, the transmission device cannot be insulated and only the combined type cryoablation system side can be insulated. The insulation treatment of the composite type cold and hot ablation system is complex and high in cost. In contrast, the conveyor 2 of the present invention benefits from insulation by a thermal insulating material rather than a vacuum, and thus the conveyor 2 may be insulated.

Specifically, an insulating sleeve 21 may be provided outside the insulating layer 20. Wherein, the insulation sleeve 21 is located at one side of the rear end of the backflow passage component 22, namely, one side close to the combined type cold and hot ablation system. The insulating sheath 21 is required to withstand low temperature and high temperature without deformation and to maintain good insulation at low/rewarming temperatures. Therefore, Polyimide (PI) having good low temperature resistance and good insulation can be used.

Further, an outer sleeve 24 is provided outside the inlet/return passage assembly 22, the outer sleeve 24 is located on the front end side of the inlet/return passage assembly 22, and the outer sleeve 24 and the insulating sleeve 21 are fixed by an insulating sleeve fixing member 23.

Specifically, as shown in fig. 16, the outer wall of the front end of the insulating sheath holder 23 is provided with a serration connector 231, which is engaged with the serration on the inner wall of the outer tube 24 in a direction such that the insulating sheath holder 23 is connected to the outer tube 24 and the outer wall is flush with each other after the connection.

The outer wall of the rear end of the insulating sleeve fixing piece 23 is provided with a clamping boss 232 which is clamped with the inner wall of the insulating sleeve 21, and a sealing ring 233 is arranged between the clamping boss and the insulating sleeve fixing piece to prevent working medium from leaking to the outside from a gap between the insulating sleeve 21 and the insulating sleeve fixing piece 23.

Furthermore, a temperature measuring connector 27 is arranged in the insulating sleeve 21, and the temperature measuring connector 27 can be connected with a temperature measuring thermocouple, so that the real-time temperature of the ablation needle end can be better detected. The existing transmission device adopting vacuum insulation can not place the thermocouple for temperature measurement in the transmission device in order to ensure that the thermocouple does not damage the vacuum of the transmission device, but on the contrary, the temperature measuring joint 27 can be arranged in the transmission device 2 (close to the outlet end of the ablation instrument 1) due to the heat insulation material adopted by the invention, so that the real-time temperature of the end of the ablation instrument 1 can be better detected.

In particular, the temperature measuring connector 27 may be provided in the end portion of the insulating sheath 21 connected to the insulating sheath fixing member 23.

As shown in fig. 17, the inlet/return passageway assembly 22 includes an inlet passage 227 and a return passage 228 disposed in parallel with the inlet passage 227, and the insulation 20 includes an inlet tube insulation 222 wrapped around the inlet passage 227 and an inlet/return insulation 223 commonly wrapped around the inlet passage 227 and the return passage 228. Wherein, the rear end of the inlet/return channel assembly 22 is provided with a mouthpiece 229 for connecting with the combined type cold and heat ablation system, and the mouthpiece 229 is connected with the inlet channel 227 through the first inlet/return flow branch piece 221. The incoming flow and the return flow are separated at the ends by a first incoming-return flow branch 221.

As shown in fig. 19, the front end of the mouthpiece 229 is a first overlapping tube 229a with a diameter smaller than the diameter of the other portion of the mouthpiece 229, and the rear end of the inlet channel 227 is a second overlapping tube 227a with a diameter also smaller than the diameter of the other portion of the inlet channel 227, so that the first overlapping tube 229a and the second overlapping tube 227a can be overlapped and sealed by welding. Fig. 19 shows an embodiment in which the first overlap tube 229a is in the upper part and the second overlap tube 227a is in the lower part, i.e. the axes of the two are not aligned. By this arrangement, more space can be saved, to reduce the volume and weight of the transfer device 2.

With continued reference to fig. 17, the inlet/return flow path assembly 22 further includes a second inlet/return flow splitter 225 disposed at the front ends of the inlet passage 227 and the return passage 228, and fixing the front ends of the inlet passage 227 and the return passage 228.

The second flow splitter 225 is connected to the male pin 224 (or may be of unitary construction) and the forward end of the inlet passage 227 is also connected to the male pin 224 by a similar overlap as described above, with an example of the inlet passage 227 being connected to the male pin 224 as best shown in fig. 14.

As shown in fig. 18, the front end face 226 of the second inlet/outlet flow splitter 225 (i.e. the end face connected to the insertion pin 224) is provided with an air outlet 226a, through which the cold working medium (cold nitrogen) vaporized in the early stage of treatment directly flows out, so as to facilitate the cold working medium to rapidly reach the treatment section 122a of the inlet/outlet flow assembly 11.

With continued reference to fig. 15, the transfer device 2 further includes a handle 25, the handle 25 being located at the front end of the inlet/return passageway assembly 22 adjacent to the quick connect interface assembly 26. The front end of the handle 25 is connected to the rear end of the quick connect interface 261, and the rear end is connected to the outer sleeve 24. The rear end of the handle 25 can be provided with a sawtooth-shaped connecting piece, the inner wall of the outer sleeve 24 is also provided with sawteeth, and the outer sleeve 24 is connected with the handle 25 in an inverted manner, namely, the outer sleeve 24 and the insulating sleeve fixing piece 23 can be connected in a similar manner to the sawtooth-shaped connecting piece between the outer sleeve 24 and the insulating sleeve fixing piece.

As described above, since the inflow passage 227 and the return passage 228 are already coated with the heat insulating material, the coating surfaces thereof are in a normal temperature state, and the range of materials for the outer tube 24 to be fitted over the both is wide as long as the outer tube has a certain strength and flexibility. Preferably, to ensure the flexibility of the outer sleeve 24, the outer sleeve 24 may be a soft silicone tube, a metal-clad hose, a rubber hose, PE, PP, or the like.

In order to meet clinical requirements, ablation needles typically come in a variety of diameters, with different diameters varying the resistance of the ablation needle. 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 delivery device 2.

Specifically, an adapter sleeve 114 is disposed on the inlet 115 at the second end of the inlet/outlet assembly 11, and the adapter sleeve 114 is disposed in the quick-connect shaft tube 125 (specifically, disposed at the rear end of the quick-connect shaft tube 125); the return path assembly 22 includes pins 224. as described above, the pins 224 pass through the adapter sleeve 114 and are matingly connected to the second end of the inlet and return assemblies 11.

The flow resistance between the insertion pin 224 and the inflow/return assembly 11 is greater than the flow resistance of the treatment section 122a of the inflow/return assembly 11 (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 return channel 228 of the delivery device 2 through the gap therebetween and not flowing through the treatment section 122a of the inflow/return assembly 11.

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. 14) 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. 14, 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 D1 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 fitting clearance is formed between the two, the cold working medium (cold nitrogen gas) vaporized in the early treatment period flows out from the fitting clearance and the air outlet hole 226a, so that the cold working medium can quickly reach the treatment section 122a of the inflow and backflow component 11, and the cooling speed is improved. And the cold nitrogen escaping from the fit clearance between the contact pin 224 and the backflow component 11 can flow out through the backflow channel 228 of the transmission device 2, so that the precooling effect can be also realized on the backflow channel 228, the resistance of the backflow in the later period is reduced, and the cooling speed can be accelerated.

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.

For the convenience of understanding, the above-mentioned "first ends" correspond to the front ends of the illustrated components, and the "second ends" correspond to the rear ends of the illustrated components. Wherein, the front end is the end close to the patient, and the back end is the end close to the combined type cold and hot ablation system.

The use of the thermal ablation device of the present invention is as follows.

The transmission device 2 is connected with the ablation apparatus 1 through the quick connection interface component 26, and is guided by the imaging device of the combined type cold and hot ablation system to perform puncture positioning. The positioned system controls the cold working medium to pass through the inflow channel 227, reach the second inflow/backflow shunt member 225, enter the inflow/backflow assembly 11 of the ablation apparatus 1 through the insertion pin 224 at the front end of the second inflow/backflow shunt member 225, and enter the treatment section 122a of the ablation apparatus 1 (section G in fig. 8). The vacuum layer assembly 12 ensures that the rest part of the ablation device 1 is in a normal temperature state during the treatment process, so that the patient and the user cannot be injured.

After heat exchange is performed on the treatment section 122a, the cold working medium is turned back (reflowing) through the cavity between the backflow inlet assembly 11 and the needle tip 111, so that the cold working medium can return to the backflow channel 228 of the transmission device 2 and return to the system end, and then the freezing operation is completed.

And performing rewarming operation after the freezing operation is finished, wherein the flow path of the hot working medium is the same as that of the cold working medium, and a cycle is finished after the hot working medium returns to the system end.

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. The cold and hot ablation device is characterized by comprising an ablation instrument (1) and a transmission device (2), wherein the second end of the transmission device (2) is used for being connected with a combined type cold and hot ablation system;

a rotatable and movable quick-connection interface component (26) is connected to the first end of the transmission device (2), the second end of the ablation instrument (1) extends into the quick-connection interface component (26) and is communicated with the transmission device (2),

wherein the quick connect interface assembly (26) is locked with the ablation instrument (1) when rotated relative to the delivery device (2); the quick connect interface assembly (26) unlocks from the ablation instrument (1) when moved and counter-rotated relative to the transmission device (2).

2. A hot and cold ablation device according to claim 1, wherein the quick connect interface assembly (26) comprises a quick connect interface (261) fixedly connected to the transmission device (2), a locking sleeve (263) rotatably and movably fitted over an outer side of the quick connect interface (261), and a first spring (262) disposed between the locking sleeve (263) and the quick connect interface (261);

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 locking sleeve, and the second end of the ablation instrument (1) is provided with an axial clamping part (13) and a circumferential clamping part (14) respectively;

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) moves relative to the transmission device (2) and compresses the first spring (262) so as 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).

3. A device as claimed in claim 2, characterized in that the axial locking structure (28) comprises a groove (282) with an opening (281), the axial snap-in part (13) comprises a projection (131) projecting in the radial direction of the ablation device (1), the opening (281) has a larger size than the projection (131), and the projection (131) can slide from the opening (281) into the groove (282) when the locking sleeve (263) is rotated relative to the transfer device (2).

4. A device as claimed in claim 2, characterized in that the circumferential locking structure (29) comprises a spring plunger (291), and the circumferential snap-fit portion (14) comprises a receiving groove (141) extending in the axial direction of the ablation instrument (1);

when the locking sleeve (263) rotates relative to the transmission device (2), the spring plunger (291) is ejected and inserted into the accommodating groove (141) to limit the circumferential relative displacement between the quick-connect interface assembly (26) and the ablation instrument (1).

5. A device as claimed in claim 3, wherein the quick connect interface assembly (26) has a first flat surface (266) on the outer wall, and the opening (281) corresponds to the first flat surface (266) and extends in the same direction;

a second plane (128) is arranged on the outer wall of the ablation instrument (1), and when the first plane (266) and the second plane (128) are coplanar, the bump (131) can extend into the opening (281), so that the second end of the ablation instrument (1) can be smoothly inserted into the quick connection interface assembly (26).

6. A hot and cold ablation device according to any one of claims 2-5, wherein the ablation apparatus (1) comprises a flow inlet and return assembly (11) and a vacuum layer assembly (12), the flow inlet and return assembly (11) extends through the vacuum layer assembly (12), and a buffer structure (113) is arranged on the flow inlet and return assembly (11), and the buffer structure (113) is positioned in the vacuum layer assembly (12).

7. A hot and cold ablation device according to claim 6, wherein the first end of the inflow and return flow module (11) includes a treatment section (122 a) and a non-treatment section (122 b), and the diameter of the non-treatment section (122 b) is larger than that of the treatment section (122 a).

8. The cold and hot ablation device according to claim 6, wherein the vacuum layer assembly (12) comprises a sealing structure (124), a sealing port (126) arranged along the radial direction of the sealing structure (124), and an adapter port (122) and a quick connection shaft tube (125) respectively arranged at two sides of the sealing structure (124), wherein the adapter port (122) is used for being connected with the outer wall of the inlet and return flow assembly (11), and the quick connection shaft tube (125) is used for being inserted into the quick connection port assembly (26) and connected with an adapter sleeve (114) of the inlet and return flow assembly (11);

the axial clamping part (13) is arranged on the circumferential side wall of the quick connection shaft tube (125), and the circumferential clamping part (14) is arranged at the end part of the sealing structure (124);

at least two second sealing plates (1243) and first sealing plates (1242) are stacked along the axial direction of the sealing ports (126), and at least one sealing plate is provided with a fixing column.

9. A hot and cold ablation device according to claim 8, wherein said transfer means (2) comprises an inlet and return flow path assembly (22), an insulating layer (20) provided outside said inlet and return flow path assembly (22), and an insulating cover (21) provided outside said insulating layer (20), said insulating layer (20) being made of aerogel.

10. A cold and hot ablation device according to claim 9, characterized in that the adapter sleeve (114) is arranged at the inlet (115) of the second end of the inlet and return flow assembly (11) and connected with the inner wall of the quick-connection shaft tube (125);

the return flow path assembly (22) comprises a pin (224), and the pin (224) penetrates through the adapter sleeve (114) and is in fit connection with the second end of the return flow inlet assembly (11);

the flow resistance between the contact pin (224) and the backflow inlet assembly (11) is larger than that of the treatment section (122 a) of the backflow inlet assembly (11).