WO2021051391A1

WO2021051391A1 - Cryogenic-thermal ablation needle

Info

Publication number: WO2021051391A1
Application number: PCT/CN2019/107006
Authority: WO
Inventors: 刘朋; 肖剑; 史岩; 李雪冬; 张锦; 黄乾富
Original assignee: 海杰亚（北京）医疗器械有限公司
Priority date: 2019-09-16
Filing date: 2019-09-20
Publication date: 2021-03-25
Also published as: CN115429415A; CN110575242A; CN115429415B

Abstract

A cryogenic-thermal ablation needle, comprising an ablation needle body (100). The ablation needle body (100) comprises a first inflow tube assembly (120) and a first backflow tube assembly (130). Both the first inflow tube assembly (120) and the first backflow tube assembly (130) are configured as elbow structures, so that the extension directions of both the first inflow tube assembly (120) and the first backflow tube assembly (130) change. Even if a sudden perturbation or vibration acts on a handle region of the ablation needle body, the force is not be immediately transmitted to a needle tip region of the ablation needle body and therefore does not affect a patient. Said elbow structures can reduce disturbance caused by perturbations and other unstable factors on the needle tip region of the ablation needle body, thereby improving the therapeutic stability of the ablation needle body.

Description

Hot and cold ablation needle

Cross-references to related applications

This application claims the priority of the Chinese patent application CN 201910872384.9 named "Cold and Hot Ablation Needle" filed on September 16, 2019, and the entire content of this application is incorporated herein by reference.

Technical field

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

Background technique

Cold and heat ablation is a surgical technique that uses refrigerant and heat medium to eliminate target tissue. During the operation, an ablation needle is used to deliver a low-temperature medium to the patient’s lesion, so as to absorb heat through the evaporation of liquid refrigerant and take away the lesion tissue. The heat reduces the temperature of the target ablation site, thereby destroying the diseased cells and tissues to achieve the purpose of treatment. After the freezing is completed, by controlling the high-temperature heat medium steam to reach the treatment area of the ablation needle, a large amount of heat is released instantly, so that the treatment area can be quickly rewarmed.

For the convenience of production, the current cold and hot ablation needles generally have a straight tube structure, that is, the cold and hot ablation needles extend in one direction as a whole, which makes the size of the cold and hot ablation needles in one direction too large. In addition, if the needle The part and the tip part extend in the same direction, so when the probe delivery tube continuously transfers the medium to the ablation needle, the probe delivery tube will produce a large amplitude of jitter, and this jitter will be transmitted to the tip part of the ablation needle in real time The needle tip deviates from the target lesion tissue, which may affect the treatment effect.

Summary of the invention

The present invention provides a cold and hot ablation needle, which is used to solve the technical problem in the prior art that the disturbance of the handle part of the ablation needle body will be immediately transmitted to the needle tip part and affect the patient.

The present invention provides a cold and hot ablation needle, including an ablation needle body, the ablation needle body includes an inlet and return integrated tube, and the inlet and return integrated tube includes:

The first inlet tube assembly is used to deliver a medium to the needle tip, where the medium performs heat exchange at the needle tip; and

A first return tube assembly, the first return tube assembly is sleeved on the outside of the first inlet tube assembly, and is used to return the medium that completes the heat exchange at the needle tip to the end away from the needle tip;

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 includes a vacuum sealing component, which is sleeved on the outside of the inlet and return integrated pipe for constructing vacuum insulation of the non-treatment area of the ablation needle body.

In one embodiment, the vacuum sealing assembly includes a conversion tee, the end of the inlet and return integrated pipe where the needle point is located extends from the first opening of the conversion tee, and the inlet and return integrated pipe The other end extends from the second opening of the conversion tee, and the third opening of the conversion tee is a vacuum suction port.

In one embodiment, the vacuum sealing assembly further includes:

A first vacuum insulation tube, the first end of the first vacuum insulation tube is connected to the beginning of the first return tube assembly; and

A vacuum sealed joint, the first end of the vacuum sealed joint is connected with the first opening of the conversion tee; the second end of the vacuum sealed joint is connected with the second end of the first vacuum insulation tube;

Wherein, the end of the inlet and return integrated pipe where the needle point is located passes through the first opening of the conversion tee and the vacuum sealed joint in turn, and then extends into the first vacuum insulation pipe.

In one embodiment, solder is provided in the vacuum suction port, and the solder can block the vacuum suction port after the vacuum is completed.

In one embodiment, the vacuum suction port is configured as a stepped hole, and the stepped hole includes a large-diameter part and a small-diameter part sequentially arranged from the outside to the inside, and a stepped surface is provided between the large-diameter part and the small-diameter part, 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 step surface.

In one embodiment, the vacuum sealing assembly further includes:

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

In one embodiment, one end of the first vacuum insulation tube close to the needle tip is connected to a liner tube having a closed needle tip part, the first inlet tube assembly extends into the liner tube, and the first vacuum insulation tube The area from the connection with the liner to the needle tip is a treatment area without vacuum insulation.

In one embodiment, one end of the first vacuum insulation tube close to the needle tip is connected to the liner tube through a vacuum sealed connection tube;

Wherein, both ends of the vacuum sealing connecting pipe are respectively provided with a first sealing portion and a second sealing portion, and the first sealing portion extends into the end of the first vacuum insulation pipe and is insulated from the first vacuum insulation pipe. The end of the heat pipe and the beginning of the small diameter pipe of the first return pipe assembly are hermetically connected, and the second sealing portion is hermetically connected with one end of the liner pipe.

In one embodiment, it further includes a probe delivery tube that is separately connected to the ablation needle body, and the probe delivery tube includes:

The second inlet tube assembly, at least a part of the second inlet tube assembly extends from the end of the first inlet tube assembly away from the needle tip into the inside of the first inlet tube assembly for The input medium of the first inlet pipe assembly;

The second return pipe assembly is used to communicate with the first return pipe assembly, and is used to receive the returning medium in the first return pipe assembly.

In one embodiment, the probe delivery tube further includes:

Quick plug, which is used to sleeve the outside of the quick connector and form a snap connection with the quick connector;

An outer sleeve sleeved on the outside of the second inlet pipe assembly and the second return pipe assembly; and

A connecting sleeve, the quick plug and the outer sleeve are connected by the connecting sleeve.

In one embodiment, the probe delivery tube further includes an inlet/backflow gas sealing port, the inlet/backflow gas sealing port is connected to the connecting sleeve, and at least a part of the second inlet tube assembly extends into the connecting sleeve Wherein, the second return pipe assembly is communicated with the connecting sleeve through the inlet and return gas sealing port.

Compared with the prior art, the advantages of the present invention are:

(1) By configuring both the first inlet pipe assembly and the first return pipe assembly as an elbow structure, the extension directions of the first inlet pipe assembly and the first return pipe assembly are changed, so that the cold and heat are ablated The needle as a whole is not too large in one direction; in addition, it is particularly important that even if sudden disturbance or vibration acts on the handle of the ablation needle body, the force will not be immediately transmitted to the needle tip of the ablation needle body It affects the patient. Therefore, the above-mentioned curved tube structure can reduce the disturbance of unstable factors such as disturbance to the needle tip of the ablation needle body, thereby improving the treatment stability of the ablation needle body.

(2) Since the inlet and return pipes adopt an integrated design (that is, the first inlet pipe assembly and the first return pipe assembly are nested with each other), there is no need to separately match the first inlet pipe and the first return pipe to the external Connecting pipe; thus greatly simplifying the structure of connecting pipelines and storage medium equipment.

(3) The ablation needle body and the probe delivery tube can be quickly inserted through the quick plug, and the installation and disassembly process of the two are simple, which facilitates the operation and further improves the operator's experience.

(4) By setting the vacuum suction port as a stepped hole, the solder can be set in the large diameter part. After the vacuum is completed, the solder can melt and flow to the small diameter part. After the solder solidifies, it can be sealed in the small diameter part to achieve real The formation of the vacuum layer, therefore, the present invention proposes the above-mentioned sealing process, which is conducive to mass production; and simplifies the welding process and reduces the production cost.

Description of the drawings

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

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

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

Fig. 3 is a cross-sectional view of the inlet and return integrated pipe shown in Fig. 2;

Figure 4 is an enlarged view of the lower half of the inlet and return integrated pipes in Figure 3;

Fig. 5 is an enlarged view of the bend of the inlet and return integrated pipe in Fig. 3;

Fig. 6 is an enlarged view of the upper part of the inlet and return integrated pipe in Fig. 3;

Figure 7 is an enlarged view of Figure 1 at L;

Figure 8 is an enlarged view of Figure 2 at M;

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

Figure 10 is a top view of the conversion tee shown in Figure 1;

Figure 11 is a cross-sectional view of the conversion tee shown in Figure 2;

Figure 12 is an enlarged view of Figure 4 at K;

Figure 13 is a cross-sectional view of the ablation needle body in another embodiment of the present invention;

Fig. 14 is a plan view of the vacuum sealed joint shown in Fig. 13.

Reference signs:

100-Ablation needle body; 110-Inlet and return integrated tube;

120-first inlet pipe assembly; 120a-first straight pipe 120b-second straight pipe; 120c-connecting pipe; 120d-third straight pipe; 121-inflow adapter sleeve;

130-first return pipe assembly; 130a large-diameter pipe; 130b-reflux adapter sleeve; 131-return port; 132-small-diameter pipe; 133-inlet return conversion port assembly;

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

150-Vacuum sealing joint; 15-Vacuum sealing component;

160-the first vacuum insulation tube; 161-the scale mark; 162-the first vacuum insulation layer; 163-the heat exchange zone;

164-liner; 165-vacuum-sealed connecting pipe; 165a-first sealing part; 165b-second sealing part; 170-getter;

180-Quick connector; 181-ring groove; 182-seal; 183 clamping part; 184-second vacuum insulation layer; 190-protection cap;

200-probe delivery tube;

210-second inlet pipe assembly; 211-insertion pipe; 212-extension pipe;

220-Second return pipe assembly;

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

240-Quick plug; 250-Outer tube; 260-Inlet and return gas sealing port; 270-cavity.

detailed description

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

The present invention provides a cold and hot ablation needle. In the embodiment shown in FIG. 1, the cold and hot ablation needle includes an ablation needle body 100 and a probe delivery tube 200. First, the ablation needle body 100 will be described in detail below.

As shown in FIGS. 2 and 3, the ablation needle body 100 includes an inlet and return integrated tube 110, and the inside of the inlet and return integrated tube 110 forms a medium inflow channel. The inlet and return integrated pipe 110 includes a first inlet pipe assembly 120 and a first return pipe assembly 130 sleeved on the outside of the first inlet pipe assembly 120. The first inlet pipe assembly 120 is used to deliver the medium to the needle tip portion. The medium is heat exchanged at the needle tip to perform cold and heat ablation on the tissue in the lesion area; the first return tube assembly 130 is used to return the medium that has completed the heat exchange at the needle tip to the end away from the needle tip.

As shown in FIG. 2, the first inlet pipe assembly 120 and the first return pipe assembly 130 are both configured as a bent pipe structure. It can be seen from FIG. 2 that the extension directions of the first inlet pipe assembly 120 and the first return pipe assembly 130 are changed by the bent pipe structure. Since the needle tip part of the ablation needle body 100 (ie end A shown in FIG. 2) is located in the treatment area, it should be noted that the treatment area of the ablation needle body 100 includes the needle tip and the 30-50mm long part of the needle tip, and the rest are Non-treatment area part. The handle part of the ablation needle body 100 (that is, the part near the end B shown in FIG. 2) is connected to the medium source.

Since the B end is connected to the medium source through the probe conveying pipe 200, the probe conveying pipe 200 usually produces disturbances or vibrations when conveying the medium. Then, by adopting the bent pipe structure shown in FIG. 2, even if there is sudden disturbance or The vibration acts on the handle part of the ablation needle body 100, and the force will not be transmitted to the needle tip part of the ablation needle body 100 immediately, which may affect the patient. It should be noted that, since the hot and cold ablation needle is inserted into the predetermined part of the patient during the operation on the patient, without the support frame for support, if the probe delivery tube 200 at the opposite end of the needle tip shakes more severely (due to the probe delivery It is caused by the continuous transmission of the medium in the tube 200), which may affect the position accuracy of the needle tip and cause the needle tip to deviate from the target lesion tissue. Therefore, compared with the existing straight tube structure, the above-mentioned bent tube structure can reduce to a certain extent the influence of unstable factors such as disturbance of the probe delivery tube 200 in the medium transmission process on the needle tip portion of the ablation needle body 100. Thereby improving the stability and reliability of the hot and cold ablation needle during use.

In addition, the first inlet tube assembly 120 and the first return tube assembly 130 are both configured as bent tube structures, so that the ablation needle body 100 does not have an excessively large size in one direction, and can be easily installed and used.

Further, the bending angles of the first inlet pipe assembly 120 and the first return pipe assembly 130 may be acute angles, right angles or obtuse angles. With reference to the embodiment shown in FIG. 3, that is, an embodiment where the bending angle is a right angle, specifically, the first inlet pipe assembly 120 has a first linear pipe 120a extending in the X-axis direction, and a first straight pipe 120a extending in the Y-axis direction. An extended second straight tube 120b and a section of connecting tube 120c connecting the two straight tubes. The first straight tube 120a and the second straight tube 120b form an arc-shaped corner through the connecting tube 120c. Understandably, the above-mentioned arc-shaped corners may also be right-angle corners.

Furthermore, from the perspective of the medium inflow direction (that is, end B flows to end A), the liquid inlet end of the first straight tube 120a (the end far from the end A) and the liquid outlet end of the third straight tube 120d are transferred through the inlet flow The sleeve 121 is connected, and the liquid inlet port of the third straight tube 120d extends from the end B of the first return pipe assembly 130, which is used to connect with the probe delivery tube 200 described below, and the medium enters after passing through the probe delivery tube 200 In the liquid inlet port of the third straight tube 120d.

It should be noted that the medium described in the present invention includes a cold medium and a heat medium, wherein the cold medium is liquid nitrogen, and the heat medium is anhydrous ethanol.

The first inlet tube assembly 120 is nested in the first return tube assembly 130, and the A end of the first inlet tube assembly 120 and the A end of the first return tube assembly 130 are in communication with each other, so that the medium is in the ablation needle body 100 The flow condition is: the medium flows into the first inlet pipe assembly 120 located in the inner layer after passing through the probe delivery pipe 200 (in turn, it passes through the third straight pipe 120d section and the first straight pipe 120a section of the first inlet pipe assembly 120 After the connecting tube 120c section and the second straight tube section 120b), it reaches the needle tip and completes heat exchange with the lesion tissue, and then flows back to the probe delivery tube 200 through the medium return channel, thus realizing medium circulation; the flow of medium inflow can be seen The direction is from the B end to the A end, and the flow direction of the medium reflux is from the A end to the B end.

Preferably, the axes of the first inlet pipe assembly 120 and the first return pipe assembly 130 coincide with each other to facilitate installation and uniform force.

It should be noted that the medium return passage refers to a medium passage formed between the inner wall of the first return pipe assembly 130 and the outer wall of the first inlet pipe assembly 120 and the radial cross section is annular.

As shown in FIG. 6, the B end of the first return pipe assembly 130 is provided with a medium return port 131, and the return medium is transported to the probe delivery pipe 200 through the medium return port 131.

As shown in FIGS. 4 and 5, the first inlet pipe assembly 120 is nested and installed in the first return pipe assembly 130. The first return pipe assembly 130 includes two sections of pipelines, one of which is a large-diameter pipe 130a, and the other It is a small-diameter pipe 132, and the two sections of pipes are communicated in a sealed manner through a reflux adapter sleeve 130b. The purpose of this arrangement is that the diameter of the small-diameter tube 132 is smaller and the needle can be made thinner, so that the trauma to the patient is less, and the minimally invasive intervention can be achieved; but on the other hand, the inner wall of the small-diameter tube 132 and the second straight tube The space between the outer walls of 120b is used as part of the reflux channel. If the volume of the channel is too small, it is not conducive to the return of the medium. Therefore, the small diameter tube 132 and the large diameter tube 130a are connected through the reflux adapter sleeve 130b, so that the ablation needle body 100 can be connected to the small diameter tube 132 and the large diameter tube 130a. Widen the return channel on the appropriate return path (the position shown by the upward arrow in Figure 5 is the return channel after widening) to improve the efficiency of the medium return.

In one embodiment, as shown in FIG. 2, the ablation needle body 100 further includes a vacuum sealing assembly 15. Specifically, the vacuum sealing assembly 15 includes a conversion tee 140, a vacuum sealing joint 150, and a first vacuum insulation tube 160 that are connected in sequence.

As shown in Figures 2 and 10, the end (end A) where the needle tip of the inlet and return integrated pipe 110 is located is from the first opening 142 of the conversion tee 140 (that is, the opening along the negative direction of the Y axis in Figure 2) The other end (end B) of the inlet and return integrated pipe 110 protrudes from the second opening 143 (that is, the opening along the positive direction of the X-axis in FIG. 2) of the conversion tee 140, and the second end of the conversion tee 140 The three openings (that is, the openings along the positive direction of the Y axis in FIG. 2) are vacuum suction ports 141.

In order to better realize that the ablation needle body 100 has good vacuum insulation performance in the non-treatment area (so as to avoid frostbite normal human skin tissue in the non-treatment area when the target tissue is treated by low-temperature cryotherapy, or the frostbite touches the ablation needle non-treatment For the surgical operator in the region), the vacuum sealing assembly 15 further includes a vacuum sealing joint 150. Among them, the large diameter end of the vacuum sealed joint 150 is sealed and connected to the first opening 142 of the conversion tee 140. As an implementation method, it can be connected to either the large diameter end of the vacuum sealed joint 150 or the conversion tee 140. A step is provided on the side wall of the, so as to realize the axial positioning and engagement of the two, so that the two are hermetically connected.

Further, one end of the first vacuum insulation tube 160 is hermetically 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 (that is, the end close to the needle point) is connected to the beginning of the first return tube assembly 130, and at the same time, the other end of the first vacuum insulation tube 160 (that is, the end close to the needle point) is also connected to the end of the first vacuum insulation tube 160 (that is, the end close to the needle point). Part of the liner 164 is welded and sealed (as shown in Figures 4 and 12) to construct a vacuum-insulated treatment area (including the heat exchange zone 163) of the needle tube part, that is, where the first vacuum insulation tube 160 and the liner 164 connect to The area between the needle points is the treatment area.

Specifically, the connection between the first vacuum insulation tube 160 and the liner 164 is as follows: the first end of the first vacuum insulation tube 160 (that is, the end close to the needle tip) is hermetically connected to the liner 164 through the vacuum sealing connecting tube 165.

As shown in FIGS. 4 and 12, specifically, both ends of the vacuum sealing connecting pipe 165 are respectively provided with a first sealing portion 165a and a second sealing portion 165b, wherein the first sealing portion 165a extends into the first vacuum insulation pipe 160 The first end of the first vacuum insulation tube 160 and the beginning of the small-diameter tube 132 of the first return tube assembly 130 are respectively hermetically connected; the second sealing portion 165b is hermetically connected to one end of the liner 164. In other words, the first vacuum insulation tube 160, the vacuum sealed connecting tube 165, and the liner 164 are sealed in sequence, and it is ensured that the three have the same external dimensions after being sealed and connected.

It should be noted that the “start” and “end” described herein are both defined based on the flow direction of the medium in the first return pipe assembly 130 of the description object. It can be determined that the use of the above-mentioned location words is only used to clearly express the relative positional relationship between the adapting components, and does not constitute a substantial limit to the protection scope of this solution.

The reason for providing a vacuum-sealed connection pipe 165 between the first vacuum insulation pipe 160 and the liner 164 is: on the one hand, the vacuum-sealed connection pipe 165 can play a role in strengthening the structure to improve structural reliability; on the other hand, the vacuum The first sealing portion 165a of the sealing connecting tube 165 is hermetically connected with the first vacuum insulation tube 160 and the first return tube assembly 130 to ensure the vacuum retention of the non-treatment area of the needle tube, so as to fully ensure that air will not enter the first vacuum insulation Layer 162 (please refer to FIG. 5 together); on the other hand, the second sealing portion 165b of the vacuum sealing connecting pipe 165 is tightly connected with the liner 164, so as to ensure that the medium does not leak out and avoid causing medical accidents.

In this treatment area (including the heat exchange area 163), there is no thermal insulation layer. When the low temperature/high temperature medium passes through the heat exchange area 163, it absorbs heat or releases heat to perform cold and hot ablation of the lesion tissue. In this way, the needle tube part between the needle tip part and the vacuum sealing joint 150 includes a three-layer tube body from the inside to the outside, and the second straight tube 120b at the innermost layer serves as the medium inlet channel; the small-diameter tube 132 at the middle layer , Between its inner wall and the outer wall of the second straight tube 120b as a medium return channel; the first vacuum insulation tube 160 located in the outermost layer, between it and the outer wall of the small diameter tube 132 as the first vacuum insulation formed after being vacuumed Layer 162 (refer to Figure 5 in conjunction).

In addition, the first vacuum insulation tube 160 may be formed by inserting and connecting two or three sections of pipelines to each other, so as to facilitate processing and manufacturing.

Further, as shown in FIG. 8, the outer wall of the first vacuum insulation tube 160 is provided with scale marks 161 arranged in the radial direction. The scale marks 161 may be provided in multiple, and the plurality of scale marks 161 are arranged along the first vacuum insulation tube. 160 is arranged at equal intervals in the axial direction, which is beneficial to improve the operation accuracy of the surgeon.

Here, the embodiment of the present invention does not limit the connection between the vacuum sealed joint 150 and the first vacuum insulation tube 160 and between the vacuum sealed joint 150 and the inlet and return integrated pipe 110. In fact, no matter what connection method is used, as long as It suffices to ensure a reliable seal between the two connected; in a preferred solution, welding can be used for fixing to facilitate processing.

The third opening of the conversion tee 140 is the vacuum suction port 141. During the vacuum operation, 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 to ensure the vacuuming process The middle solder can be stably placed in the vacuum suction port 141, and after the solder is melted, it can smoothly flow into the vacuum suction port 141 for melting and sealing under the action of its own gravity. In addition, when the vacuum suction port 141 is facing upwards for vacuum processing, since the switching tee 140 connects the pipelines with each other, the entire ablation needle body 100 (except the treatment area) can be constructed with vacuum insulation.

As shown in FIG. 11, the vacuum suction port 141 may be a stepped hole, from the outside to the inside, the stepped hole may include a large diameter portion 141a and a small diameter portion 141b. In the initial state, the solder can be placed in the large diameter portion 141a, and try to avoid shielding the small diameter portion 141b to ensure that the gas in the vacuum layer can be extracted more smoothly, and after the vacuum is completed (small diameter portion 141b It is a vacuum port), the solder can flow to the small diameter part 141b after being melted, and can be blocked in the small diameter part 141b after the solder solidifies, so as to truly realize the formation of a vacuum layer.

There may be a stepped surface 141c between the large-diameter portion 141a and the small-diameter portion 141b. The stepped surface 141c may be a flat surface or a tapered curved surface, or it may be a special-shaped surface formed by a combination of a flat surface and a curved surface. When it is flat, the stepped surface 141c can have the function of guiding the flow toward the small diameter portion 141b. For example, the stepped surface 141c can be a tapered surface that tapers from top to bottom to divert the molten solder so that the solder can be smoother The entry small-diameter portion 141b is blocked. In the embodiment shown in FIG. 11, the step surface 141c may be a flat surface as a whole to facilitate the support of the unmelted solder, and the transition joint between the step surface 141c and the small diameter portion 141b may have a guiding curved surface to melt the solder. Diversion at the time.

In addition, the vacuum suction port 141 can also be set as a through hole of equal diameter or reduced diameter, and a perforated plate can be arranged in it. The perforated plate can support the solder. After the vacuum is completed, the solder can be melted to prevent Each hole on the multi-well plate is blocked.

Further, a getter 170 is provided in the vacuum sealed joint 150, and the getter 170 is arranged around the outer wall of the inlet and return integrated pipe 110, and the getter 170 is used to maintain a good vacuum insulation state. The type of getter is not limited here. It can be determined with reference to the prior art. During the vacuum operation, the getter 170 is activated. The getter can assist in absorbing the gas in the vacuum layer to a greater extent. The vacuum degree of the vacuum layer is improved, and the vacuum degree of the vacuum layer can be maintained for a long time, thereby ensuring the thermal insulation performance of the ablation needle.

In addition, the third opening of the conversion tee 140 is also provided with a protective cap 190 for covering the vacuum suction port 141 inside it, which is beautiful and practical.

As shown in FIG. 1 and FIG. 2, the vacuum sealing assembly 15 further includes a quick connector 180, one end of which is hermetically connected to the second opening 143 of the conversion tee 140, and the other end is connected to the end of the first return pipe 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 and reflux conversion port assembly 133. Thus, the inner wall surface of the quick connector 180 A second vacuum insulation layer 184 is formed between the outer wall surface of the second return pipe assembly 130 in the corresponding area, that is, a second vacuum insulation layer 184 is formed at the handle portion. It should be noted that the inner space of the conversion tee 140, the first vacuum insulation layer 162, and the second vacuum insulation layer 184 are all connected. In this way, the vacuum processing is performed from the vacuum suction port 141 to achieve the vacuum of the entire ablation needle body 100 Thermal insulation performance, ingenious design structure, simple operation, and can ensure the reliability of vacuum insulation of the non-treatment area of the ablation needle.

Further, the quick connector 180 is used to quickly seal and plug with the mating end of the probe delivery tube 200 to realize the treatment medium transmission. Specifically, as shown in FIGS. 2 and 7, a ring groove 181 for accommodating the seal 182 is provided on the outer peripheral wall of the quick connector 180. The sealing member 182, for example, may be an O-shaped sealing ring, which is used to maintain the tightness of the connection between the ablation needle body 100 and the probe delivery tube 200 after being squeezed. Furthermore, the outer peripheral wall of the quick connector 180 is further provided with a clamping portion 183, and the clamping portion 183 is closer to the second opening 143 of the conversion tee 140 than the ring groove 181. Correspondingly, the inner wall of the probe delivery tube 200 is provided with a pressing protrusion (not shown in the figure). In this way, through the cooperation of the pressing protrusion and the clamping portion 183, plus the function of the sealing member 182, the two Realize fast and stable sealing connection.

Specifically, the engaging portion 183 is a groove on the outer peripheral wall of the quick connector 180 that is recessed toward the inner side thereof.

The ablation needle body 100 and the probe delivery tube 200 are separately connected to realize quick insertion and connection, and the installation and disassembly process is simple and convenient, which is convenient for doctors to use and improves doctors' use experience. In an alternative embodiment, as shown in FIGS. 13 and 14, the conversion tee 140 may not be provided, and the quick connector 180 is directly connected to the vacuum sealed connector 150. At this time, the inlet and return integrated pipe 110 may extend in one direction as a whole. In addition, the peripheral wall of the vacuum sealing joint 150 may also have ports oriented in other directions to serve as the vacuum suction port 151. Similarly, a protective cap 190 is also provided on the vacuum suction port 151. In this embodiment, when performing a vacuum operation, it is also necessary to adjust the clamping mode of the return integrated pipe 110 so that the vacuum suction port 151 is arranged upward.

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

Please also refer 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 part of the second inlet tube assembly 210 extends from the end of the first inlet tube assembly 120 away from the needle tip, that is, the end B extends into the inside of the first inlet tube assembly 120 for the first inlet The tube assembly 120 inputs the medium. The second inlet pipe assembly 210 includes an insertion pipe 211 and an extension pipe 212. The joints of the insertion pipe 211 and the extension pipe 212 overlap each other at the side (the insertion pipe 211 and the extension pipe 212 are arranged non-coaxially) to make the two The inside forms a communicating channel. With this arrangement, an appropriate distance between the extension tube 212 and the second return tube assembly 220 can be ensured to effectively ensure that the inflow and the return flow do not affect each other. The insertion tube 211 is inserted into the first inlet tube assembly 120 from the B end. Specifically, the insertion tube 211 is inserted into the inside of the third linear 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 in the first return pipe assembly 130. Specifically, the return port 131 of the first return pipe assembly 130 corresponds to the medium inlet of the second return pipe assembly 220, so that the return medium flows from the return port 131 into the second return pipe assembly 220.

Furthermore, the probe delivery tube 200 further includes a quick plug 240, an outer tube 250 and a connecting sleeve 230. Among them, the quick plug 240 is used to sleeve the outside of the quick connector 180 and form a snap connection with the quick connector 180; the outer sleeve 250 is sleeved on the outside of the second inlet pipe assembly 210 and the second return pipe assembly 220, the quick The plug 240 and the outer sleeve 250 are connected by a connecting sleeve 230.

Furthermore, the quick plug 240 and the second inlet pipe assembly 210 and the quick plug 240 and the second return pipe assembly 220 are all connected by a connecting sleeve 230. Thus, the second inlet pipe assembly 210 and the second return pipe assembly 220 are connected to the B end of the first inlet pipe assembly 120 and the B end of the first return pipe assembly 130, respectively.

As shown in Figure 9, the connecting sleeve 230 is formed by connecting two sections of pipelines, the first connecting sleeve 230a and the second connecting sleeve 230b in sequence. The quick plug 240 is sleeved outside the first connecting sleeve 230a, and the outer sleeve 250 is sleeved. Located outside the second connecting sleeve 230b, the quick connector 180 passes through the first connecting sleeve 230a and extends into the second connecting sleeve 230b.

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

The quick connector 240 functions to axially locate the quick connector 180. The quick connector 180 is provided with an engaging step, and the end of the quick connector 240 completes the axial positioning of the two when the end of the quick connector 240 reaches the engaging step; the quick connector 180 further extends into the first connecting sleeve 230a, and the engaging portion 183 is connected to the first The inner walls of the connecting sleeve 230a are locked with each other, so that the two are locked and connected. When the engagement between the two is completed, the sealing member 182 of the ring groove 181 keeps the two in a sealed connection.

The probe delivery tube 200 further includes an inlet/backflow gas sealing port 260, which is connected to the connecting sleeve 230, and at least a part of the second inlet tube assembly 210 extends into the connecting sleeve 230. Specifically, the insertion tube 211 extends into the first The second connecting sleeve 230b. Since the second connecting sleeve 230b is sleeved on the outside of the first return pipe assembly 130, the insertion tube 211 extends into the second connecting sleeve 230b to be nested with the first inlet pipe assembly inside the first return pipe assembly 130 120 plug-in connection.

The second return pipe assembly 220 communicates with the connecting sleeve 230 through the inlet and return gas sealing port 260. After the ablation needle body 100 is connected to the probe delivery tube 200, the quick connector 180 extends into the quick plug 240 and the connecting sleeve 230 in turn, that is, the outer wall of the quick connector 180 is attached to the inner wall of the quick plug 240 and the inner wall of the connecting sleeve 230, respectively. Together.

With reference to Figure 7, there is a certain distance between the B end of the quick connector 180 and the inner end of the connecting sleeve 230, thereby forming a certain medium-containing cavity 270, so that the flow out of the return port 131 of the first return pipe assembly 130 The medium first enters the cavity 270, and then enters the second return pipe assembly 220 from the cavity 270, and together achieve a certain buffering effect.

It should be noted that the various components of the ablation needle body 100 and the probe delivery tube 200 of the present invention are preferably made of medical grade stainless steel. The ablation needle body 100 has a bent tube structure as a whole, and the probe delivery tube 200 has a straight line as a whole. shape. Without loss of generality, the core invention of this embodiment is not limited to the shape shown in the figure.

In Figures 1-9 of the present invention, the arrows indicate the flow direction of the medium in each tube.

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

First, prepare for the operation. Put the quick plug 240 on the quick connector 180, and make the quick connector 180 extend into the connecting sleeve 230, so that the quick plug 240, the quick connector 180, and the connecting sleeve 230 are snap-connected to connect the ablation needle body 100 and the probe delivery tube 200 connected;

Secondly, after the connection is completed, the freezing medium, such as liquid nitrogen, is output through the probe delivery tube 200. The liquid nitrogen flows through the second inlet tube assembly 210 and the first inlet tube assembly 120 in sequence before reaching the treatment area, and 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 the channel formed by the outer wall of the first inlet pipe assembly 120 and the inner wall of the first vacuum insulation pipe 160, and enters the first return pipe assembly 130, and then from the first return pipe assembly 130. The return port 131 of a return pipe assembly 130 flows out, reaches the cavity 270 between the B end of the quick connector 180 and the connecting sleeve 230, and then flows into the second return pipe assembly 220, thereby completing the circulation of the refrigerating medium.

When the treatment time is reached and a sufficiently large ice ball is formed at the needle tip (treatment area) of end A, the communication between the freezing medium and the probe delivery tube 200 is cut off, and the communication between the thermotherapy medium and the probe delivery tube 200 is turned on to A thermotherapy medium, such as absolute ethanol, is input into the probe delivery tube 200.

The flow route of the hyperthermia medium is the same as the flow route of the freezing medium mentioned above. It first reaches the treatment area, so that the temperature of the treatment area reaches the range of 60℃～200℃, so that the ice balls frozen from the body tissues are rapidly thawed, and the ice balls formed by the body tissues are quickly thawed. Under the action, the diseased tissue is completely necrotic, so as to achieve the purpose of treatment.

Although the present invention has been described with reference to the preferred embodiments, without departing from the scope of the present invention, various modifications can be made thereto and the components therein can be replaced with equivalents. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments can be combined in any manner. The present invention is not limited to the specific embodiments disclosed in the text, but includes all technical solutions falling within the scope of the claims.

Claims

A cold and hot ablation needle, characterized by comprising an ablation needle body (100), the ablation needle body (100) includes an inlet and return integrated tube (110), and the inlet and return integrated tube (110) includes:

The first inlet tube assembly (120) is used to deliver a medium to the needle tip, and the medium performs heat exchange at the needle tip; and

The first return pipe assembly (130), the first return pipe assembly (130) is sleeved on the outside of the first inlet pipe assembly (120), and is used to return the medium that has completed the heat exchange at the needle tip to the place far away The end of the needle tip;

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

The ablation needle body (100) further includes a vacuum sealing component (15), the vacuum sealing component (15) is sleeved on the outside of the inlet and return integrated pipe (110) for constructing the ablation needle body (100). ) Vacuum insulation of non-treatment areas.
The hot and cold ablation needle according to claim 1, wherein the vacuum sealing assembly (15) comprises a conversion tee (140), and the end of the inlet and return integrated pipe (110) where the needle tip is located is from the The conversion tee (140) protrudes from the first opening (142), and the other end of the inlet and return integrated pipe (110) protrudes from the second opening (143) of the conversion tee (140) , The third opening of the conversion tee (140) is a vacuum suction port (141, 151).
The cold and hot ablation needle according to claim 2, wherein the vacuum sealing assembly (15) further comprises:

A first vacuum insulation tube (160), the first end of the first vacuum insulation tube (160) is connected to the beginning of the first return tube assembly (130); and

A vacuum sealed joint (150), the first end of the vacuum sealed joint (150) is connected to the first opening (142) of the conversion tee (140); the second end of the vacuum sealed joint (150) Connected with the second end of the first vacuum insulation tube (160);

Wherein, the end of the inlet and return integrated pipe (110) where the needle point is located passes through the first opening (142) of the conversion tee (140) and the vacuum seal joint (150) in turn, and then extends into the The first vacuum insulation tube (160).
The hot and cold ablation needle according to claim 2 or 3, characterized in that solder is provided in the vacuum suction port (141), and the solder can block the vacuum suction port (141) after the vacuum is completed.
The hot and cold ablation needle according to claim 4, wherein the vacuum suction port (141) is configured as a stepped hole, and the stepped hole includes a large diameter portion (141a) and a small diameter portion (141b) arranged in sequence from the outside to the 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 runs along the step The surface (141c) flows from the large diameter portion (141a) into the small diameter portion (141b).
The hot and cold ablation needle according to claim 2 or 3, wherein the vacuum sealing assembly (15) further comprises:

A quick connector (180), one end of the quick connector (180) is connected to the second opening (143) of the conversion tee (140), and the other end of the quick connector (180) is connected to the first return The ends of the tube assembly (130) are connected.
The cold and heat ablation needle according to claim 3, characterized in that, the end of the first vacuum insulation tube (160) close to the needle tip is sealed and connected to the liner tube (164) with the closed needle tip part, and the first inlet The flow tube assembly (120) extends into the liner (164), and the area between the connection of the first vacuum insulation tube (160) and the liner (164) to the needle tip is a treatment without vacuum insulation area.
The cold and heat ablation needle according to claim 7, characterized in that, the end of the first vacuum insulation tube (160) close to the tip of the needle is connected to the liner tube (164) through a vacuum sealed connection tube (165);

Wherein, both ends of the vacuum sealing connecting pipe (165) are respectively provided with a first sealing portion (165a) and a second sealing portion (165b), and the first sealing portion (165a) extends into the first vacuum insulation. The ends of the heat pipe (160) are respectively connected to the end of the first vacuum insulation pipe (160) and the beginning of the small diameter pipe (132) of the first return pipe assembly (130), and the second seal The part (165b) is hermetically connected with one end of the liner (164).
The hot and cold ablation needle according to any one of claims 1-3, further comprising a probe delivery tube (200) separately connected to the ablation needle body (100), and the probe delivery The tube (200) includes:

The second inlet tube assembly (210), at least a part of the second inlet tube assembly (210) extends into the first inlet tube from the end of the first inlet tube assembly (120) away from the needle tip part The inside of the component (120) is used to input the medium to the first inlet pipe component (120);

The second return pipe assembly (220) is used to communicate with the first return pipe assembly (130), and is used to receive the medium returning from the first return pipe assembly (130).
The cold and hot ablation needle according to claim 9, wherein the probe delivery tube (200) further comprises:

A quick plug (240), which is used to sleeve the outside of the quick connector (180) and form a snap connection with the quick connector (180);

The outer sleeve (250) is sleeved on the outside of the second inlet pipe assembly (210) and the second return pipe assembly (220); and

A connecting sleeve (230), the quick plug (240) and the outer sleeve (250) are connected through the connecting sleeve (230).
The hot and cold ablation needle according to claim 9, wherein the probe delivery tube (200) further comprises an inlet and return gas sealing port (260), and the inlet and return gas sealing port (260) is connected to the connection The sleeve (230) is connected, at least a part of the second inlet pipe assembly (210) extends into the connecting sleeve (230), and the second return pipe assembly (220) passes through the inlet and return gas sealing port (260). ) Is communicated with the connecting sleeve (230).