CN110575242A

CN110575242A - cold and hot ablation needle

Info

Publication number: CN110575242A
Application number: CN201910872384.9A
Authority: CN
Inventors: 刘朋; 肖剑; 史岩; 李雪冬; 张锦; 黄乾富
Original assignee: Haijiya (beijing) Medical Devices Co Ltd
Current assignee: Haijiya (beijing) Medical Devices Co Ltd
Priority date: 2019-09-16
Filing date: 2019-09-16
Publication date: 2019-12-17
Also published as: CN115429415B; WO2021051391A1; CN115429415A

Abstract

The invention relates to the technical field of treatment, in particular to a cold and hot ablation needle, which is used for solving the technical problem that disturbance at a handle part of an ablation needle body is immediately transmitted to a needle point part of the ablation needle body to influence a patient in the prior art. The cold and hot ablation needle comprises the first inflow pipe assembly and the first return pipe assembly, the first inflow pipe assembly and the first return pipe assembly are both constructed into the bent pipe structure, so that the extension directions of the first inflow pipe assembly and the first return pipe assembly are changed, even if sudden disturbance or vibration acts on the handle part of the ablation needle body, acting force cannot be immediately transmitted to the needle point part of the ablation needle body to influence a patient, and therefore disturbance of unstable factors such as disturbance on the needle point part of the ablation needle body can be reduced through the bent pipe structure, and the treatment stability of the ablation needle body is improved.

Description

Cold and hot ablation needle

Technical Field

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

Background

The cold and hot ablation is a surgical medical technology for eliminating target tissues by using a refrigerant and a heating medium, and a low-temperature medium is required to be conveyed to a focus part of a patient by using an ablation needle in the operation so as to absorb heat through evaporation of a liquid refrigerant, take away heat of the focus tissue and reduce the temperature of a target ablation part, thereby damaging diseased cell tissues and achieving 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.

in addition, if the needle head part and the needle tip part extend along one direction, when the probe conveying pipe continuously conveys media into the ablation needle, the probe conveying pipe can generate large-amplitude jitter, and the jitter can be transmitted to the needle tip part of the ablation needle in real time to enable the needle tip to deviate from target lesion tissues, so that the treatment effect can be influenced.

disclosure of Invention

The invention provides a cold and hot ablation needle, which is used for solving the technical problem that disturbance at a handle part of an ablation needle body is immediately transmitted to a needle point part of the ablation needle body to influence a patient in the prior art.

The invention provides a cold and hot ablation needle, which comprises an ablation needle body, wherein the ablation needle body comprises a backflow inlet integrated pipe, and the backflow inlet integrated pipe comprises:

The first inflow pipe component is used for conveying a medium to the needle point part, and the medium carries out heat exchange at the needle point part; and

the first reflux pipe assembly is sleeved outside the first inflow pipe assembly and used for returning a medium which completes heat exchange at the needle point part to the end part far away from the needle point part;

Wherein the first inlet pipe assembly and the first return pipe assembly are both configured as a bent pipe structure;

The ablation needle body further comprises a vacuum sealing assembly, the vacuum sealing assembly is sleeved outside the inflow and backflow integrated pipe and used for constructing vacuum heat insulation of a non-treatment area of the ablation needle body.

In one embodiment, the vacuum sealing assembly comprises a switching tee joint, one end of the integrated pipe for feeding and returning, where the needle tip is located, extends out of a first opening of the switching tee joint, the other end of the integrated pipe for feeding and returning extends out of a second opening of the switching tee joint, and a third opening of the switching tee joint is a vacuum suction port.

In one embodiment, the vacuum seal assembly further comprises:

A first vacuum insulation pipe, a first end of which is connected with the initial end of the first return pipe assembly; and

the first end of the vacuum sealing joint is connected with the first opening of the conversion tee joint; a second end of the vacuum sealing joint is connected with a second end of the first vacuum insulation pipe;

and one end of the needle tip part in the feeding and refluxing integrated pipe sequentially penetrates through the first opening of the conversion tee joint and the vacuum sealing joint and then extends into the first vacuum heat-insulating pipe.

In one embodiment, the vacuum suction port is provided with solder, and the solder can block the vacuum suction port after the vacuumizing is finished.

In one embodiment, the vacuum suction port is configured as a stepped hole including a large diameter portion and a small diameter portion arranged in this order from outside to inside, a stepped surface is provided between the large diameter portion and the small diameter portion, the solder is provided in the large diameter portion, and the solder flows from the large diameter portion into the small diameter portion along the stepped surface.

In one embodiment, the vacuum seal assembly further comprises:

and one end of the quick connector is connected with the second opening of the conversion tee joint, and the other end of the quick connector is connected with the tail end of the first return pipe assembly.

In one embodiment, one end of the first vacuum insulation pipe close to the needle point part is connected with a liner pipe with a closed needle point part in a sealing mode, the first inflow pipe assembly extends into the liner pipe, and the area between the first vacuum insulation pipe and the liner pipe and the needle point part is a treatment area without vacuum insulation.

in one embodiment, one end of the first vacuum heat insulation pipe close to the needle point part is in sealing connection with the liner pipe through a vacuum seal connecting pipe;

the vacuum sealing connecting pipe is characterized in that a first sealing part and a second sealing part are respectively arranged at two ends of the vacuum sealing connecting pipe, the first sealing part extends into the end part of the first vacuum heat-insulating pipe and is in sealing connection with the end part of the first vacuum heat-insulating pipe and the beginning end of the small-diameter pipe of the first return pipe assembly, and the second sealing part is in sealing connection with one end of the liner pipe.

In one embodiment, the ablation device further comprises a probe delivery pipe connected with the ablation needle body in a split mode, and the probe delivery pipe comprises:

The second inflow pipe assembly, at least a part of the second inflow pipe assembly stretches into the first inflow pipe assembly from the end of the first inflow pipe assembly far away from the needle point position, and is used for inputting a medium to the first inflow pipe assembly;

and the second return pipe assembly is communicated with the first return pipe assembly and is used for receiving the medium returned from the first return pipe assembly.

in one embodiment, the probe delivery tube further comprises:

The quick plug is sleeved outside the quick connector and forms clamping connection with the quick connector;

the outer sleeve is sleeved outside the second inflow pipe component and the second return pipe component; and the quick plug is connected with the outer sleeve through the connecting sleeve.

in one embodiment, the probe conveying pipe further comprises a backflow inlet airtight seal, the backflow inlet airtight seal is connected with the connecting sleeve, at least one part of the second backflow pipe assembly extends into the connecting sleeve, and the second backflow pipe assembly is communicated with the connecting sleeve through the backflow inlet airtight seal.

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

(1) the first inflow pipe assembly and the first return pipe assembly are both constructed into bent pipe structures, so that the extension directions of the first inflow pipe assembly and the first return pipe assembly are changed, and the cold and hot ablation needle is prevented from being overlarge in one direction; in addition, even if sudden disturbance or vibration acts on the handle part of the ablation needle body, acting force cannot be immediately transmitted to the needle point part of the ablation needle body to affect a patient, so that the disturbance of unstable factors such as disturbance to the needle point part of the ablation needle body can be reduced through the bent pipe structure, and the treatment stability of the ablation needle body is improved.

(2) Because the inlet and return pipelines adopt an integrated design (namely the first inlet pipe component and the first return pipe component are mutually sleeved), the first inlet pipeline and the first return pipe do not need to be respectively matched with external connecting pipes; the structure of the connecting lines and the medium storage device is greatly simplified.

(3) the ablation needle body and the probe delivery pipe can be rapidly inserted and connected through the quick plug, and the installation and the disassembly processes of the ablation needle body and the probe delivery pipe are simple, so that the operation is convenient, and the use experience of an operator is further improved.

(4) The vacuum suction port is arranged into the stepped hole, the solder can be arranged in the large-diameter part, after the vacuumizing is finished, the solder can flow to the small-diameter part after being melted, and the solder can be blocked at the small-diameter part after being solidified, so that the formation of a vacuum layer is really realized, and therefore, the sealing process is provided, and the batch production is facilitated; and the welding process is simplified, and the production cost is reduced.

Drawings

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

FIG. 1 is a cross-sectional view of a cold and hot ablation needle in an embodiment of the invention;

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

FIG. 3 is a cross-sectional view of the manifold shown in FIG. 2;

FIG. 4 is an enlarged view of the lower half of the inlet/return manifold of FIG. 3;

FIG. 5 is an enlarged view of the bend of the inlet/return manifold of FIG. 3;

FIG. 6 is an enlarged view of the upper half of the inlet/return manifold of FIG. 3;

FIG. 7 is an enlarged view of FIG. 1 at L;

FIG. 8 is an enlarged view of FIG. 2 at M;

FIG. 9 is a cross-sectional view of the probe delivery tube shown in FIG. 1;

FIG. 10 is a top view of the transition tee shown in FIG. 1;

FIG. 11 is a cross-sectional view of the transition tee shown in FIG. 2;

FIG. 12 is an enlarged view of FIG. 4 at K;

FIG. 13 is a cross-sectional view of an ablation needle body in another embodiment of the invention;

fig. 14 is a top view of the vacuum sealing joint shown in fig. 13.

reference numerals:

100-an ablation needle body; 110-a feed-return integrated pipe;

120-a first inlet manifold assembly; 120 a-first linear tube 120 b-second linear tube; 120 c-connecting tube; 120 d-a third linear tube; 121-inflow adapter sleeve;

130-a first return tube assembly; 130a large diameter tube; 130 b-a reflux adaptor sleeve; 131-a return port; 132-a small diameter tube; 133-a flow-in and flow-back conversion port assembly;

140-conversion tee; 141. 151-vacuum suction port; 142-a first opening; 143-a second opening; 141 a-large diameter section; 141 b-a small diameter portion; 141 c-step surface;

150-vacuum sealing joint; 15-vacuum sealing assembly;

160-first vacuum insulation piping; 161-scale mark; 162-a first vacuum insulation layer; 163-a heat exchange zone;

164-a liner tube; 165-vacuum sealed connecting tube; 165 a-first seal; 165 b-a second seal; 170-a getter;

180-a quick coupling; 181-ring groove; 182-a seal; 183 a snap-in part; 184-a second vacuum insulation layer; 190-a protective cap;

200-a probe delivery tube;

210-a second inlet manifold assembly; 211-insertion tube; 212-an extension tube;

220-a second return line assembly;

230-connecting sleeve; 230 a-first coupling sleeve; 230 b-a second connecting sleeve;

240-quick plug; 250-outer sleeve; 260-entering reflux airtight sealing; 270-cavity.

Detailed Description

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

The invention provides a cold-hot ablation needle, and in the embodiment shown in fig. 1, the cold-hot ablation needle comprises an ablation needle body 100 and a probe delivery pipe 200. The ablation needle body 100 will be described in detail first.

As shown in fig. 2 and 3, the ablation needle body 100 includes a reflux inlet manifold 110, and a medium reflux inlet channel is formed inside the reflux inlet manifold 110. The inflow and backflow integrated pipe 110 comprises a first inflow pipe assembly 120 and a first backflow pipe assembly 130 sleeved outside the first inflow pipe assembly 120, wherein the first inflow pipe assembly 120 is used for conveying a medium to the needle point part, so that the medium exchanges heat at the needle point part to perform cold and hot ablation on the tissue of the focus region; the first return tube assembly 130 is used to return the medium that completes the heat exchange at the needle tip site to the end away from the needle tip site.

as shown in fig. 2, the first inlet pipe assembly 120 and the first return pipe assembly 130 are each configured as an elbow structure. As can be seen from fig. 2, the extending directions of the first inflow pipe assembly 120 and the first return pipe assembly 130 are changed by the elbow structure. Since the needle point part (i.e., the end a shown in fig. 2) of the ablation needle body 100 is located in the treatment region, it should be noted that the treatment region of the ablation needle body 100 includes the needle point and a part of the needle point 30-50mm long upwards, and the rest is a non-treatment region part. The handle portion of the ablation needle body 100 (i.e., near the B-end portion shown in fig. 2) is connected to a media source.

since the end B is connected to the medium source through the probe delivery tube 200, the probe delivery tube 200 usually generates disturbance or vibration when delivering the medium, and by using the elbow structure shown in fig. 2, even if sudden disturbance or vibration is applied to the handle portion of the ablation needle body 100, the acting force will not be immediately transmitted to the tip portion of the ablation needle body 100 to affect the patient. It should be noted that, when a patient is operated, after the thermal ablation needle is inserted into a predetermined position of the patient, if the probe delivery tube 200 at the opposite end of the needle tip is shaken severely (due to the continuous transmission of the medium in the probe delivery tube 200) without the support frame, the position accuracy of the needle tip may be affected, and the needle tip may be deviated from the target lesion tissue. Therefore, compared with the existing straight tube structure, the bent tube structure can reduce the influence of unstable factors such as disturbance of the probe delivery tube 200 in the medium transmission process on the needle point part of the ablation needle body 100 to a certain extent, thereby improving the stability and reliability of the cold and hot ablation needle in the using process.

In addition, the first inflow tube assembly 120 and the first return tube assembly 130 are both configured as an elbow structure, so that an excessive dimension in one direction of the ablation needle body 100 is not required, and the installation and the use are convenient.

further, the bending angles of the first inlet pipe assembly 120 and the first return pipe assembly 130 may be acute, right or obtuse. In connection with the embodiment shown in fig. 3, that is, an embodiment with a right-angled bend angle, specifically, the first inlet pipe assembly 120 has a first straight pipe 120a extending along the X-axis direction, a second straight pipe 120b extending along the Y-axis direction, and a connecting pipe 120c connecting the two straight pipes. The first and second linear pipes 120a and 120b form an arc-shaped corner by the connection pipe 120 c. It will be appreciated that the radiused corners described above may also be right angle corners.

Further, when viewed in the medium inlet direction (i.e., the end B flows to the end a), the inlet end (the end far from the end a) of the first straight pipe 120a is connected to the outlet end of the third straight pipe 120d through the inlet adapter sleeve 121, and the inlet port of the third straight pipe 120d extends from the end B of the first return pipe assembly 130, and is used for connecting to a probe conveying pipe 200 described below, and the medium enters the inlet port of the third straight pipe 120d after passing through the probe conveying pipe 200.

It should be noted that the media of the present invention include refrigerant media and heating media, wherein the refrigerant media is, for example, liquid nitrogen; the heat medium is, for example, absolute ethanol.

the first inflow tube assembly 120 is nested in the first return tube assembly 130, and the end a of the first inflow tube assembly 120 and the end a of the first return tube assembly 130 are communicated with each other, so that the medium flows in the ablation needle body 100 under the following conditions: after passing through the probe delivery pipe 200, the medium flows into the first inflow pipe assembly 120 located at the inner layer (sequentially passes through the third straight pipe 120d section, the first straight pipe 120a section, the connecting pipe 120c section and the second straight pipe 120b section of the first inflow pipe assembly 120), reaches the needle tip part, completes heat exchange with the lesion tissue, and then flows back to the probe delivery pipe 200 through the medium backflow channel, so that medium circulation is realized; it can be seen that the inflow direction of the medium flows from the end B to the end a, and the backflow direction of the medium flows from the end a to the end B.

preferably, the axes of the first intake pipe assembly 120 and the first return pipe assembly 130 coincide with each other for easy installation and uniform force application.

the medium return passage is a medium passage having a circular ring-shaped radial cross section formed between an inner wall of the first return pipe assembly 130 and an outer wall of the first inlet pipe assembly 120.

referring to fig. 6, a medium backflow port 131 is formed at the end B of the first backflow pipe assembly 130, and the backflow medium is conveyed into the probe conveying pipe 200 through the medium backflow port 131.

Referring to fig. 4 and 5, the first inlet pipe assembly 120 is nested in the first return pipe assembly 130, and the first return pipe assembly 130 includes two sections of pipes, one of which is a large-diameter pipe 130a, and the other is a small-diameter pipe 132, and the two sections of pipes are in sealed communication through a return adapter sleeve 130 b. The purpose of the arrangement is that the small-diameter tube 132 has smaller tube diameter and can make the needle thinner, so that the wound applied to the patient is smaller, and minimally invasive intervention is realized; on the other hand, however, the space between the inner wall of the small diameter tube 132 and the outer wall of the second straight tube 120b is used as a part of the backflow channel, and the backflow of the medium is not facilitated if the channel volume is too small, so that the backflow channel can be widened on the appropriate backflow path of the ablation needle body 100 by communicating the small diameter tube 132 with the large diameter tube 130a through the backflow adaptor sleeve 130b (the position indicated by the upward arrow in fig. 5 is the backflow channel after widening), so as to improve the efficiency of medium backflow.

in one embodiment, as shown in fig. 2, the ablation needle body 100 further includes a vacuum seal assembly 15. Specifically, the vacuum sealing assembly 15 includes a transfer tee 140, a vacuum sealing nipple 150, and a first vacuum insulation tube 160 connected in series.

as shown in fig. 2 and 10, one end (end a) of the in-and-return manifold 110 where the needle tip is located extends from a first opening 142 of the three-way switch 140 (i.e., the opening along the negative direction of the Y axis in fig. 2), the other end (end B) of the in-and-return manifold 110 extends from a second opening 143 of the three-way switch 140 (i.e., the opening along the positive direction of the X axis in fig. 2), and the third opening (i.e., the opening along the positive direction of the Y axis in fig. 2) of the three-way switch 140 is a vacuum suction port 141.

to better achieve good vacuum insulation performance of the ablation needle body 100 in the non-treatment region (so as to prevent the non-treatment region from freezing and injuring normal skin tissue of a human body or touching a surgical operator in the non-treatment region of the ablation needle during cryo-treatment of the target tissue), the vacuum sealing assembly 15 further comprises a vacuum sealing joint 150. The large diameter end of the vacuum sealing joint 150 is connected with the first opening 142 of the three-way switch 140 in a sealing manner, and as an implementation manner, the large diameter end of the vacuum sealing joint 150 or the side wall of one of the three-way switch 140 may be provided with a step, so that the axial positioning and the clamping of the two are realized, and the two are connected in a sealing manner.

Further, one end of the first vacuum insulation piping 160 is sealingly connected to the small-diameter end of the vacuum sealing joint 150 (as shown in fig. 8). The other end of the first vacuum insulation tube 160 (i.e., the end near the needle point) is connected to the beginning of the first return tube assembly 130, and the other end of the first vacuum insulation tube 160 (i.e., the end near the needle point) is also welded and sealed to the liner tube 164 having a closed needle point portion (as shown in fig. 4 and 12) to construct a treatment region of the needle tube portion without vacuum insulation (including the heat exchange region 163), i.e., the region between the point of the needle point and the connection of the first vacuum insulation tube 160 and the liner tube 164 is the treatment region.

specifically, the first vacuum insulation tube 160 is connected to the liner tube 164 in the following manner: the first end (i.e., the end near the needle tip) of the first vacuum insulation tube 160 is sealingly connected to the liner tube 164 by a vacuum seal connection tube 165.

as shown in fig. 4 and 12, specifically, a first sealing portion 165a and a second sealing portion 165b are respectively disposed at two ends of the vacuum-tight connecting pipe 165, wherein the first sealing portion 165a extends into a first end of the first vacuum-tight pipe 160 and is respectively connected with the first end of the first vacuum-tight pipe 160 and a start end of the small-diameter pipe 132 of the first return pipe assembly 130 in a sealing manner; the second seal 165b is sealingly connected to one end of the liner 164. In other words, the first vacuum insulation pipe 160, the vacuum tight coupling pipe 165 and the liner pipe 164 are sequentially and hermetically connected, and the three are ensured to have the same external dimensions after being hermetically connected.

it should be noted that "beginning" and "end" are defined herein with reference to describing the direction of flow of the medium within the subject first return assembly 130. It is to be understood that the use of the above directional terms is only used to clearly express the relative position relationship between the fitting components, and does not substantially limit the scope of the present invention.

The reason why the vacuum tight coupling tube 165 is provided between the first vacuum insulation tube 160 and the liner tube 164 is: on one hand, the vacuum sealing connection pipe 165 can play a role of reinforcing the structure to improve the structural reliability; on the other hand, the first sealing portion 165a of the vacuum sealing connection tube 165 is connected to the first vacuum insulation tube 160 and the first return tube assembly 130 in a sealing manner to ensure the vacuum retention of the non-treatment region of the needle tube portion, so as to ensure that air does not enter the first vacuum insulation layer 162 (refer to fig. 5); on the other hand, the second sealing portion 165b of the vacuum sealing connection tube 165 is tightly connected to the liner tube 164, so as to prevent the medium from leaking out and avoid causing medical accidents.

In the treatment region (including the heat exchange region 163), no thermal insulation layer is provided, and the low/high temperature medium absorbs or releases heat when passing through the heat exchange region 163, so as to perform ablation on lesion tissues. Thus, the needle tube portion from the needle tip portion to the vacuum sealing joint 150 includes three layers of tube bodies from inside to outside, and the second straight tube 120b is located at the innermost layer and serves as a medium inlet channel; the small diameter tube 132 positioned in the middle layer, and the space between the inner wall of the small diameter tube 132 and the outer wall of the second straight tube 120b is used as a medium backflow channel; and a first vacuum insulation pipe 160 positioned at the outermost layer, which is formed between the outer wall of the small diameter pipe 132 as a first vacuum insulation layer 162 (refer to fig. 5 in conjunction) formed after the evacuation.

in addition, the first vacuum insulation piping 160 may be formed by inserting two or three piping sections into each other for convenience in processing and manufacturing.

Further, as shown in fig. 8, the outer wall of the first vacuum insulation tube 160 is provided with a plurality of scale marks 161 arranged along the radial direction, and the plurality of scale marks 161 are arranged at equal intervals along the axial direction of the first vacuum insulation tube 160, which is beneficial to improving the precision of the surgical operation of the operator.

Here, the embodiments of the present invention do not limit the connection manner between the vacuum tight joint 150 and the first vacuum insulation piping 160 and between the vacuum tight joint 150 and the inlet/return manifold 110, and in fact, whatever connection manner is adopted, as long as the reliable sealing between the two connected is ensured; in the preferred scheme, can adopt the welded mode to link firmly to convenient processing.

The third opening of the switching tee 140 is a vacuum suction port 141, and when the vacuum pumping operation is performed, the ablation needle body 100 can be clamped in the posture shown in fig. 2, so that the vacuum suction port 141 can face upwards, the solder can be stably placed in the vacuum suction port 141 in the vacuum pumping process, and the solder can smoothly flow into the vacuum suction port 141 under the action of the gravity of the solder to be sealed by melting. When the vacuum suction port 141 is directed upward and vacuumized, the three-way switch 140 allows the respective lines to communicate with each other, so that the entire ablation needle body 100 (except for the treatment area) can be vacuum-insulated.

As shown in fig. 11, the vacuum suction port 141 may be a stepped hole, and the stepped hole may include a large diameter portion 141a and a small diameter portion 141b from the outside inward. In the initial state, the solder can be disposed in the large diameter portion 141a, and the small diameter portion 141b is prevented from being shielded as much as possible, so as to ensure that the gas in the vacuum layer can be extracted more smoothly, and after the vacuum extraction is finished (the small diameter portion 141b is a vacuum extraction port), the solder can flow to the small diameter portion 141b after being melted, and the solder can be blocked in the small diameter portion 141b after being solidified, so as to really realize the formation of the vacuum layer.

A step surface 141c may be provided between the large diameter portion 141a and the small diameter portion 141b, the step surface 141c may be a plane, or may be a tapered curved surface, or may be a special-shaped surface formed by combining a plane and a curved surface, when the step surface 141c is a non-plane surface, the step surface 141c may have a function of guiding the flow toward the small diameter portion 141b, for example, the step surface 141c may be a tapered surface that is tapered from top to bottom to guide the flow of the molten solder, so that the solder can more smoothly enter the small diameter portion 141b for plugging. In the embodiment shown in fig. 11, the stepped surface 141c may be a plane surface as a whole to support the unmelted solder, and the transition between the stepped surface 141c and the small diameter portion 141b may have a guiding curved surface to guide the flow of the solder when the solder is melted.

In addition, the vacuum suction port 141 may be a through hole with an equal diameter or a variable diameter, and a porous plate may be disposed therein, and the porous plate may support the solder, and after the vacuum pumping is completed, the solder may be melted to block each hole of the porous plate.

Further, the getter 170 is disposed in the vacuum sealing joint 150, and the getter 170 is disposed around the outer wall of the inlet/return integrated pipe 110, so that a good vacuum insulation state is maintained by the getter 170. The type of the getter is not limited herein, and can be specifically determined by referring to the prior art, when the vacuum pumping operation is performed, the getter 170 is activated, and the getter can assist in absorbing gas in the vacuum layer, so as to increase the vacuum degree of the vacuum layer to a greater extent, and can maintain the vacuum degree of the vacuum layer for a longer time, thereby ensuring the heat insulation performance of the ablation needle.

In addition, a protective cap 190 is disposed on the third opening of the three-way switch 140 for covering the vacuum suction port 141 therein, which is beautiful and practical.

As shown in fig. 1 and 2, the vacuum seal assembly 15 further includes a quick connector 180 having one end sealingly connected to the second opening 143 of the transfer tee 140 and another end connected to the end of the first return tube assembly 130.

specifically, one end of the quick connector 180 is hermetically connected to the second opening 143, and the other end is hermetically connected to the end of the first return pipe assembly 130 through the outer peripheral wall 133 of the inlet/return conversion port assembly 133, so that a second vacuum insulation layer 184 is formed between the inner wall surface of the quick connector 180 and the outer wall surface of the second return pipe assembly 130 in the corresponding region, i.e., the second vacuum insulation layer 184 is formed at the handle portion. It should be noted that the inner space of the switching tee 140, the first vacuum insulation layer 162 and the second vacuum insulation layer 184 are all communicated, so that the vacuum suction port 141 is vacuumized, the vacuum insulation performance of the whole ablation needle body 100 can be realized, the design structure is ingenious, the operation is simple, and the vacuum insulation reliability of the non-treatment region of the ablation needle can be ensured.

Further, the quick connector 180 is adapted to be quickly and sealingly engaged with the mating end of the probe delivery tube 200 to effect the delivery of the treatment medium. Specifically, as shown in fig. 2 and 7, the outer peripheral wall of the quick coupling 180 is provided with a ring groove 181 for receiving a sealing member 182. The sealing member 182, which may be an O-ring seal, for example, is compressed to maintain the seal between the ablation needle body 100 and the probe delivery tube 200. Further, the outer peripheral wall of the quick coupling 180 is further provided with a snap-in portion 183, and the snap-in portion 183 is closer to the second opening 143 of the three-way switch 140 than the annular groove 181. Correspondingly, the inner wall of the probe delivery tube 200 is provided with a pressing protrusion (not shown), so that the pressing protrusion cooperates with the clamping portion 183 and the sealing member 182 functions to realize a fast and stable sealing connection therebetween.

specifically, the engagement portion 183 is a groove recessed toward the inside of the outer peripheral wall of the quick coupling 180.

The ablation needle body 100 is connected with the probe conveying pipe 200 in a split mode, rapid insertion can be achieved, the installation and disassembly processes are simple and convenient, and therefore the use of a doctor is facilitated, and the use experience of the doctor is improved. In an alternative embodiment, as shown in FIGS. 13 and 14, the transfer tee 140 may not be provided and the quick connector 180 may be directly connected to the vacuum sealing connector 150. At this time, the entirety of the inlet/return manifold 110 may extend in one direction. Further, the peripheral wall of the vacuum sealing joint 150 may have a port in another orientation as the vacuum suction port 151, and similarly, the protective cap 190 is provided on the vacuum suction port 151. In this embodiment, when performing the vacuuming operation, it is also necessary to adjust the clamping manner of the inlet/outlet manifold 110 so that the vacuum suction port 151 is disposed upward.

The probe transport tube 200 will be described in detail below.

Referring also to fig. 9, the probe delivery tube 200 includes a second inlet tube assembly 210 and a second return tube assembly 220. Specifically, at least a portion of the second inlet tube assembly 210 extends from the end of the first inlet tube assembly 120 away from the needle tip, i.e., the B-end, into the interior of the first inlet tube assembly 120 for inputting a medium into the first inlet tube assembly 120. The second inlet pipe assembly 210 includes an insertion pipe 211 and an extension pipe 212, and the connection portion of the insertion pipe 211 and the extension pipe 212 is overlapped at the side portion (the insertion pipe 211 and the extension pipe 212 are non-coaxially disposed) so that a communicating passage is formed inside the two. Thus, the extension pipe 212 and the second return pipe assembly 220 can be spaced at a proper distance, and the inlet and return flow can be effectively prevented from being influenced by each other. The insertion tube 211 is inserted into the first inlet tube assembly 120 from the B end, and specifically, the insertion tube 211 is inserted into the inside of the third straight tube 120d to a certain depth.

The second return pipe assembly 220 is used to communicate with the first return pipe assembly 130, and is used to receive the medium returned from the first return pipe assembly 130. Specifically, the return port 131 of the first return pipe assembly 130 corresponds to the media inlet of the second return pipe assembly 220, so that the returned media flows into the second return pipe assembly 220 from the return port 131.

Further, the probe delivery tube 200 includes a quick plug 240, an outer sleeve 250, and a coupling sleeve 230. The quick plug 240 is used for being sleeved outside the quick connector 180 and is in clamping connection with the quick connector 180; the outer sleeve 250 is sleeved outside the second inlet pipe assembly 210 and the second return pipe assembly 220, and the fast plug 240 and the outer sleeve 250 are connected through the connecting sleeve 230.

Further, the fast plug 240 and the second inlet pipe assembly 210 and the fast plug 240 and the second return pipe assembly 220 are connected by a connecting sleeve 230. Thereby connecting the second inlet pipe assembly 210 and the second return pipe assembly 220 to the B-side of the first inlet pipe assembly 120 and the B-side of the first return pipe assembly 130, respectively.

As shown in fig. 9, the connection sleeve 230 is formed by connecting two sections of pipes, which are a first connection sleeve 230a and a second connection sleeve 230b in sequence, the fast plug 240 is sleeved outside the first connection sleeve 230a, the outer sleeve 250 is sleeved outside the second connection sleeve 230b, and the fast joint 180 passes through the first connection sleeve 230a and extends into the second connection sleeve 230 b.

The first connection sleeve 230a and the second connection sleeve 230b may be connected by welding or the like.

The quick connector 240 functions to locate axially with the quick connector 180. The quick connector 180 is provided with a clamping step, and the axial positioning of the quick connector 240 and the quick connector is completed when the end of the quick connector reaches the clamping step; the quick connector 180 further extends into the first connection sleeve 230a, and the engaging portion 183 thereof engages with the inner wall of the first connection sleeve 230a, so that the two complete engaging connection. When the two are completely clamped, the sealing element 182 of the annular groove 181 keeps the two in sealing connection.

the probe delivery tube 200 further includes a feed and return hermetic seal 260, the feed and return hermetic seal 260 being coupled to the coupling sleeve 230, and at least a portion of the second feed tube assembly 210 extending into the coupling sleeve 230, and in particular, the insertion tube 211 extending into the second coupling sleeve 230 b. Since the second connection sleeve 230b is sleeved outside the first return pipe assembly 130, the insertion tube 211 extending into the second connection sleeve 230b can be inserted into and connected with the first inlet pipe assembly 120 nested inside the first return pipe assembly 130.

The second return line assembly 220 communicates with the connection hub 230 through the inlet return hermetic seal 260. After the ablation needle body 100 is connected with the probe delivery pipe 200, the quick connector 180 sequentially extends into the quick connector 240 and the connecting sleeve 230, that is, the outer wall of the quick connector 180 is respectively attached to the inner wall of the quick connector 240 and the inner wall of the connecting sleeve 230.

Referring to fig. 7, the end B of the quick coupling 180 is spaced from the inner end of the connection sleeve 230 to form a cavity 270 for accommodating the medium, so that the medium flowing out from the return port 131 of the first return pipe assembly 130 firstly enters the cavity 270, and then enters the second return pipe assembly 220 from the cavity 270, so as to achieve a certain buffering effect.

Each of the components of the ablation needle body 100 and the probe delivery tube 200 according to the present invention is preferably made of stainless steel conforming to the medical grade, and the ablation needle body 100 is formed in an elbow structure as a whole and the probe delivery tube 200 is formed in a straight line as a whole. Without loss of generality, the core inventive point of the present embodiment is not limited to the shape shown in the figures.

In fig. 1-9 of the present invention, arrows indicate the flow direction of the media in the respective tubes.

The method of using the cold-hot ablation needle of the present invention will be described in detail below.

First, preoperative preparation is performed. Sleeving the quick plug 240 on the quick connector 180, extending the quick connector 180 into the connecting sleeve 230, and enabling the quick plug 240, the quick connector 180 and the connecting sleeve 230 to be connected in a clamping manner, so that the ablation needle body 100 is connected with the probe delivery pipe 200;

Secondly, outputting a freezing medium, such as liquid nitrogen, through the probe conveying pipe 200 after connection, wherein the liquid nitrogen sequentially flows through the second inflow pipe assembly 210 and the first inflow pipe assembly 120 and then reaches a treatment area, heat exchange is realized in the treatment area, and then the liquid nitrogen returns;

specifically, near the a-end, the liquid nitrogen first returns through a passage formed by the outer wall of the first inflow pipe assembly 120 and the inner wall of the first vacuum insulation pipe 160 and enters the first return pipe assembly 130, and then flows out of the return port 131 of the first return pipe assembly 130 to the cavity 270 between the B-end of the quick coupling 180 and the connection sleeve 230, and then flows into the second return pipe assembly 220, thereby completing the circulation of the freezing medium.

When the treatment time is reached, the ice ball formed at the tip (treatment area) of the needle at the a end is large enough, and then the communication between the freezing medium and the probe delivery pipe 200 is cut off, and the communication between the thermal treatment medium and the probe delivery pipe 200 is opened, so as to input the thermal treatment medium, such as absolute ethyl alcohol, into the probe delivery pipe 200.

the flow path of the thermal therapy medium is the same as that of the freezing medium, and the thermal therapy medium firstly reaches the treatment area, so that the temperature of the treatment area reaches 60-200 ℃, the iceball frozen by the organism tissue is rapidly thawed, and the lesion tissue is thoroughly necrotized under the alternating action of cold and heat, thereby achieving the treatment purpose.

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 is characterized by comprising an ablation needle body (100), wherein the ablation needle body (100) comprises a feeding and returning integrated tube (110), and the feeding and returning integrated tube (110) comprises:

a first inlet tube assembly (120) for delivering a medium to the needle tip site, the medium exchanging heat at the needle tip site; and

The first backflow pipe assembly (130) is sleeved outside the first inflow pipe assembly (120), and is used for enabling a medium which completes heat exchange at the needle point part to return to the end part far away from the needle point part;

Wherein the first inlet pipe assembly (120) and the first return pipe assembly (130) are each configured as a bent pipe structure;

The ablation needle body (100) further comprises a vacuum sealing assembly (15), wherein the vacuum sealing assembly (15) is sleeved outside the inflow and backflow integrated pipe (110) and used for constructing vacuum heat insulation of a non-treatment area of the ablation needle body (100).

2. The needle assembly (15) of claim 1, wherein the vacuum sealing assembly (15) comprises a switching tee (140), one end of the integrated tube (110) for feeding and returning the needle tip is located at extends from a first opening (142) of the switching tee (140), the other end of the integrated tube (110) for feeding and returning extends from a second opening (143) of the switching tee (140), and a third opening of the switching tee (140) is a vacuum suction port (141, 151).

3. The needle assembly of claim 2, wherein the vacuum seal assembly (15) further comprises:

A first vacuum insulation pipe (160), a first end of the first vacuum insulation pipe (160) being connected to a beginning of the first return pipe assembly (130); and

A vacuum sealing joint (150), wherein a first end of the vacuum sealing joint (150) is connected with a first opening (142) of the conversion tee (140); a second end of the vacuum sealing joint (150) is connected with a second end of the first vacuum insulation pipe (160);

one end of the feeding and returning integrated pipe (110) where the needle point is located sequentially penetrates through the first opening (142) of the conversion tee joint (140) and the vacuum sealing joint (150) and then extends into the first vacuum heat-insulating pipe (160).

4. The needle according to claim 2 or 3, wherein solder is provided in the vacuum suction port (141), and the solder can block the vacuum suction port (141) after the evacuation is finished.

5. the needle for cold and hot ablation according to claim 4, wherein the vacuum suction port (141) is configured as a stepped hole including a large diameter portion (141a) and a small diameter portion (141b) which are arranged in this order from outside to inside, a stepped surface (141c) is provided between the large diameter portion (141a) and the small diameter portion (141b), the solder is provided in the large diameter portion (141a), and the solder flows from the large diameter portion (141a) to the small diameter portion (141b) along the stepped surface (141 c).

6. The needle assembly of claim 2 or 3, wherein the vacuum seal assembly (15) further comprises:

One end of the quick joint (180) is connected with the second opening (143) of the conversion tee joint (140), and the other end of the quick joint (180) is connected with the tail end of the first return pipe assembly (130).

7. The needle of claim 3, wherein the first vacuum insulation tube (160) is sealingly connected at one end near the needle tip to a liner tube (164) having a closed needle tip portion, the first inlet tube assembly (120) extends into the liner tube (164), and the region between the point where the first vacuum insulation tube (160) is connected to the liner tube (164) and the needle tip portion is a treatment region without vacuum insulation.

8. The needle assembly of claim 7, wherein the first vacuum insulation tube (160) is sealingly connected to the liner tube (164) at an end thereof adjacent to the needle tip by a vacuum seal connection tube (165);

The vacuum sealing connecting pipe (165) is provided with a first sealing part (165a) and a second sealing part (165b) at two ends respectively, the first sealing part (165a) extends into the end part of the first vacuum heat-insulating pipe (160) and is in sealing connection with the end part of the first vacuum heat-insulating pipe (160) and the initial end of the small-diameter pipe (132) of the first backflow pipe assembly (130) respectively, and the second sealing part (165b) is in sealing connection with one end of the lining pipe (164).

9. The cold and hot ablation needle according to any one of claims 1 to 3, further comprising a probe delivery tube (200) detachably connected to the ablation needle body (100), wherein the probe delivery tube (200) comprises:

the second inflow pipe assembly (210), at least one part of the second inflow pipe assembly (210) extends into the first inflow pipe assembly (120) from the end part of the first inflow pipe assembly (120) far away from the needle point position, and is used for inputting a medium to the first inflow pipe assembly (120);

and the second return pipe assembly (220) is communicated with the first return pipe assembly (130) and is used for receiving the medium returned from the first return pipe assembly (130).

10. the needle assembly of claim 9, wherein the probe delivery tube (200) further comprises:

the quick plug (240) is sleeved outside the quick connector (180) and forms clamping connection with the quick connector (180);

An outer sleeve (250) which is sleeved outside the second inlet pipe component (210) and the second return pipe component (220); and

A connecting sleeve (230), wherein the quick plug (240) and the outer sleeve (250) are connected through the connecting sleeve (230).

11. The needle assembly of claim 9, wherein the probe delivery tube (200) further comprises a flow inlet and return hermetic seal (260), the flow inlet and return hermetic seal (260) being connected to the connection sleeve (230), at least a portion of the second flow inlet tube assembly (210) extending into the connection sleeve (230), the second flow inlet tube assembly (220) being in communication with the connection sleeve (230) through the flow inlet and return hermetic seal (260).