CN117883173A - Simple cold and hot ablation needle and ablation device - Google Patents

Abstract

The invention relates to a simple cold and hot ablation needle and an ablation device, and relates to the technical field of ablation. The simple cold-hot ablation needle comprises the vacuum moving component, the length of a heat exchange area defined between the proximal end of the vacuum moving component and the proximal end of the needle head component can be changed by rotationally pulling (or pushing) the vacuum moving component, and after the adjustment, the vacuum moving component automatically rotates and resets without manual operation, so that the adjustment of the length of the heat exchange area is faster and more convenient, and the structure is simpler.

Description

Simple cold and hot ablation needle and ablation device

Technical Field

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

Background

The cold and hot ablation needle which adopts liquid nitrogen and alcohol as low-temperature working medium and rewarming work to perform low-temperature operation and rewarming operation is becoming a main means for tumor treatment. Conventional cold and hot ablation needles are typically single diameter, single heat transfer zone ablation needles. Therefore, in order to adapt to different focus sizes, a plurality of specifications of ablation needles need to be developed. And the ablation needle is a single-use instrument, thus causing higher cost. Although the conventional cold and hot ablation needles are improved so that the length of the heat exchange area is adjustable, the means for adjusting the heat exchange area by the ablation needles are complex and inconvenient to operate.

Disclosure of Invention

The invention provides a simple cold and hot ablation needle and an ablation device, which are used for solving at least one technical problem.

According to a first aspect of the present invention, there is provided a simplified cryothermal ablation needle comprising:

The handle assembly is provided with a flow inlet pipe;

A needle assembly connected to a proximal end of the handle assembly; and

A vacuum displacement assembly having a distal end disposed in the handle assembly, a proximal end extending into the needle assembly, and an inflow tube extending through the vacuum displacement assembly and into the needle assembly;

Wherein the vacuum displacement assembly is configured to unlock from the handle assembly upon rotation about an axis of the handle assembly as a pivot axis such that the vacuum displacement assembly is movable relative to the handle assembly, the needle assembly, and the inflow tube to vary a length of a heat exchange zone defined between a proximal end of the vacuum displacement assembly and a proximal end of the needle assembly; and the vacuum moving assembly may be rotated in the opposite direction to lock with the handle assembly after the length of the heat exchange zone is changed.

In one embodiment, a moving groove extending along the axial direction of the outer wall of the handle assembly is arranged on the outer wall of the handle assembly, a plurality of fixed grooves communicated with the moving groove are arranged on the inner wall of the moving groove, the fixed grooves extend along the radial direction of the moving groove, and the fixed grooves are arranged at intervals along the axial direction of the moving groove;

The vacuum moving assembly comprises a moving positioning mechanism, the moving positioning mechanism comprises an elastic positioning piece, and when the vacuum moving assembly rotates by taking the axis of the handle assembly as a pivot shaft, the elastic positioning piece is compressed to abut against the inner wall of the moving groove, so that the vacuum moving assembly is unlocked with the handle assembly; the resilient positioning member is moved into the fixed slot such that the vacuum moving assembly is locked with the handle assembly.

In one embodiment, the mobile positioning mechanism further comprises:

a sleeve disposed in the handle assembly;

The sliding block is arranged on the outer wall of the sleeve and extends along the radial direction of the sleeve, and the sliding block can move in the moving groove; and

The rotating lug boss is connected with the sliding block and is positioned at the outer side of the moving groove;

the connecting part of the sliding block and the rotary boss is provided with a connecting hole extending along the circumferential direction of the sleeve, and the elastic locating piece is elastically connected with the connecting hole, so that the elastic locating piece can extend from the connecting hole to the fixing groove or retract into the connecting hole.

In one embodiment, the mobile positioning mechanism further comprises:

The support boss is arranged on the outer wall of the sleeve and is arranged at intervals with the rotating boss in the circumferential direction, and the circumferential side wall of the support boss is contacted with the inner wall of the handle assembly and is used for providing support in the circumferential direction when the vacuum moving assembly and the handle assembly relatively rotate; and

The at least one abutting ring is sleeved on the outer wall of the sleeve and used for being in contact with the inner wall of the handle assembly.

In one embodiment, the vacuum moving assembly further comprises:

a vacuum jacket disposed in the sleeve, the vacuum jacket having a vacuum cavity formed therein;

The inner layer pipe penetrates through the vacuum outer sleeve and is sleeved on the outer side of the inflow pipe, and a first backflow passage is formed by the inner wall of the inner layer pipe and the outer wall of the inflow pipe; and

And the vacuum tube is sleeved on the outer side of the inner layer tube and extends into the vacuum cavity, and the vacuum cavity and the vacuum tube can insulate the first backflow passage from the external environment.

In one embodiment, the handle assembly is further provided with a sealing sleeve and a reflux steering member connected with the distal end of the sealing sleeve, the inner layer pipe penetrates through the sealing sleeve and stretches into the reflux steering member, the first reflux passage is communicated with the reflux steering member, and the inner layer pipe is connected with the sealing sleeve in a sealing way through a first sealing member;

The vacuum moving assembly can move relative to the handle assembly, the needle head assembly and the inflow pipe until the proximal end of the sealing sleeve abuts against the distal end of the vacuum jacket, and the length of the heat exchange area is maximum.

In one embodiment, the handle assembly is further provided with a sealing sleeve and a reflux steering member connected with the distal end of the sealing sleeve, the proximal end of the sealing sleeve is provided with a containing groove extending towards the distal end of the sealing sleeve, and the distal end of the vacuum jacket is arranged in the containing groove and is connected with the containing groove in a sealing way through a second sealing member;

The inner pipe penetrates through the sealing sleeve and stretches into the backflow steering piece, the first backflow passage is communicated with the backflow steering piece, and the inner pipe is connected with the sealing sleeve in a sealing manner through a first sealing piece;

The vacuum moving assembly can move relative to the handle assembly, the needle head assembly and the inflow pipe until the inner side end of the accommodating groove abuts against the distal end of the vacuum jacket, and the length of the heat exchange area is the largest.

In one embodiment, the needle assembly comprises an outer cannula comprising a first tube and a second tube connected to a distal end of the first tube, a piercing needle connected to a proximal end of the first tube;

The inner tube extends into the second tube, the inflow tube extends into the first tube through the second tube, a second backflow passage is formed by the outer wall of the inflow tube and the first tube, the second backflow passage is in fluid communication with the first backflow passage, and the length of the heat exchange area is the distance between the proximal end of the puncture needle and the proximal end of the inner tube.

In one embodiment, the diameter D of the first tube is less than or equal to the diameter D of the second tube.

In one embodiment, the proximal end of the vacuum jacket is provided with a connector, the distal end of the outer sleeve is provided with a connecting groove for accommodating the connector, and the connecting groove is in sealing connection with the connector through a third sealing element.

According to a second aspect of the present invention, the present invention provides an ablation device, including a simple cold-hot ablation needle as described above, and further including a transmission device, where the transmission device is connected to the simple cold-hot ablation needle and the working medium source, respectively.

Compared with the prior art, the invention has the advantages that the length of the heat exchange area defined between the proximal end of the vacuum moving component and the proximal end of the needle head component can be changed by rotationally pulling (or pushing) the vacuum moving component, and after the adjustment, the vacuum moving component automatically rotates and resets without manual operation, so that the adjustment of the length of the heat exchange area is faster and more convenient, and the structure is simpler.

Drawings

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

FIG. 1 is a schematic view of the internal structure of a simplified cryoablation needle in an embodiment of the invention, as seen from the front;

FIG. 2 is a schematic diagram of the internal structure of a simplified cryothermal ablation needle from the side in an embodiment of the invention;

FIG. 3 is a schematic view of the exterior structure of a simplified cryothermal ablation needle from the side in an embodiment of the invention;

FIG. 4 is a schematic exterior structural view of the handle assembly shown in FIG. 3;

FIG. 5 is a cross-sectional view of a simplified cold and hot ablation needle coupled to a delivery device (with the needle assembly not shown) in accordance with one embodiment of the invention;

FIG. 6a is an enlarged view of a portion of the vacuum moving assembly shown in FIG. 5;

FIG. 6b is a schematic view showing the configuration of a baffle on a vacuum moving assembly in an alternative embodiment of the present invention;

FIG. 6c is a schematic view showing the configuration of a baffle on a vacuum moving assembly in another alternative embodiment of the present invention;

FIG. 7 is a cross-sectional view of the vacuum moving assembly of FIG. 5;

FIG. 8 is a cross-sectional view of FIG. 7 at M-M;

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

FIG. 10a is a schematic view of an elastic retainer of a simple cold and hot ablation needle inserted into a fixation groove in an embodiment of the invention;

FIG. 10b is a schematic view of the flexible positioning member of the simple cryoablation needle in motion without insertion into the fixation slot in an embodiment of the invention;

FIG. 11 is a cross-sectional view of a simplified cold and hot ablation needle in another embodiment of the invention (with the needle assembly not shown) after it has been attached to a delivery device;

FIG. 12 is a cross-sectional view of the needle assembly shown in FIG. 1;

fig. 13 is an enlarged view of fig. 1 at II;

Fig. 14 is a schematic view of the structure of an ablation device of the invention.

Reference numerals:

100. A needle assembly;

101. A puncture needle; 102. a first tube; 103. a second tube; 104. an outer sleeve; 105. holding a rotating handle; 106. a connecting groove; 107. a third seal;

207. a handle assembly; 2071. a moving groove; 2072. a fixing groove;

202. Sealing sleeve; 2021. a receiving groove;

203. A first seal; 204. a flow inlet pipe; 205. a return flow diverter; 206. an inflow deflector; 2051. a return diversion passage; 2061. an inflow diversion passage; 2121. a second seal;

21. A vacuum moving assembly; 211. an inner layer tube; 212. a vacuum jacket; 213. a moving positioning mechanism; 214. a baffle; 215. a connector; 216. a guide head; 217. a vacuum chamber; 218. a vacuum tube; 219. a plug portion;

22. an inner sleeve; 221. an upper inner sleeve; 222. a lower inner sleeve; 23. a third spring;

2131. A sleeve; 2132. a slide block; 2133. rotating the boss; 2134. an elastic positioning piece; 2135. a connection hole; 2136. a support boss; 2137. an abutment ring; 2138. a connecting block; 2139. a first spring;

2151. A tapered portion; 2152. a columnar portion; 2153. an arc-shaped portion;

300. a transmission device; 301. an inflow input pipe; 302. and (5) refluxing the output pipe.

Detailed Description

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

As shown in fig. 1-12, in accordance with a first aspect of the present invention, a simple cryothermal ablation needle is provided that includes a handle assembly 207, a needle assembly 100, and a vacuum displacement assembly 21. A gas inlet pipe 204 is provided in the handle assembly 207, and the gas inlet pipe 204 is used for conveying working fluid (such as liquid nitrogen) for low-temperature operation or working fluid (such as alcohol) for rewarming operation.

The needle assembly 100 is connected to the proximal end of the handle assembly 207, for example, by a known detachable connection such as a threaded connection or a snap-fit connection, and the needle assembly 100 is adapted to be inserted into a patient's diseased tissue for treatment purposes by exchanging heat with the target tissue in a heat exchange area using a working medium, so that the needle assembly 100 is a replaceable needle (or disposable needle), the needle assembly 100 can be replaced after treatment, and the handle assembly 207 can be sterilized and reused, thereby greatly reducing manufacturing and use costs.

As shown in fig. 1 and 2, the distal end of vacuum displacement assembly 21 is disposed within handle assembly 207, and the proximal end of vacuum displacement assembly 21 extends into needle assembly 100, and inflow tube 204 extends through vacuum displacement assembly 21 and into needle assembly 100. Wherein vacuum-moving assembly 21 is configured to unlock handle assembly 207 when rotated about the axis of handle assembly 207 such that vacuum-moving assembly 21 is movable relative to handle assembly 207, needle assembly 100, and inflow tube 204 (along the axis of handle assembly 207) to vary the length of the heat transfer zone defined between the proximal end of vacuum-moving assembly 21 and the proximal end of needle assembly 100 (as shown in fig. 2B); and after the length of the heat transfer zone is changed, the vacuum moving assembly 21 may be rotated in the opposite direction to again lock with the handle assembly 207. The length of the heat exchange zone can be conveniently changed by rotationally pulling the vacuum displacement assembly 21, thereby being able to accommodate larger area ablations or smaller area ablations to match different treatment protocols.

Specifically, as shown in fig. 3 and 4, the outer wall of the handle assembly 207 is provided with a moving groove 2071 extending in the axial direction thereof, and the inner wall of the moving groove 2071 is provided with a plurality of fixing grooves 2072 communicating with the moving groove 2071, the plurality of fixing grooves 2072 being arranged at intervals in the axial direction of the moving groove 2071. The plurality of fixing grooves 2072 each extend in the radial direction of the moving groove 2071, and thus the fixing grooves 2072 form a recess portion recessed inward in the radial direction thereof on the inner wall of the moving groove 2071.

As shown in fig. 5-10 a, the vacuum moving assembly 21 includes a moving positioning mechanism 213, the moving positioning mechanism 213 includes an elastic positioning member 2134 (see fig. 9), and when the vacuum moving assembly 21 rotates around the axis of the handle assembly 207 as a pivot axis, the elastic positioning member 2134 is compressed to abut against the inner wall of the moving slot 2071, so that the vacuum moving assembly 21 is unlocked from the handle assembly 207; the resilient retainer 2134, when moved into the insert retaining slot 2072, locks the vacuum moving assembly 21 with the handle assembly 207.

Therefore, when it is necessary to change the length of the heat transfer area, since the vacuum moving assembly 21 and the handle assembly 207 are in a locked state, i.e., the elastic positioning members 2134 are inserted into the fixing slots 2072 (as shown in fig. 10 a), it is necessary to unlock the two first.

At the time of unlocking, a rotational wheel moment may be applied to the vacuum moving assembly 21 to rotate (e.g., clockwise), and then the elastic positioning piece 2134 is compressed to retract from the current fixed slot 2072 and is held in a compressed state by being abutted against the inner wall of the moving slot 2071 (as shown in fig. 10 b), so that the vacuum moving assembly 21 is unlocked from the handle assembly 207. The vacuum moving assembly 21 may be manually operated when rotated.

After the vacuum displacement assembly 21 is unlocked from the handle assembly 207, the vacuum displacement assembly 21 may be pulled to move in the axial direction of the handle assembly 207, e.g., in a direction toward the distal end of the needle assembly 100, such that the distance between the proximal end of the vacuum displacement assembly 21 and the proximal end of the needle assembly 100 increases, i.e., the length of the heat transfer zone increases; and vice versa.

When the vacuum moving assembly 21 moves to the other fixing groove 2072, since the elastic positioning piece 2134 loses the abutting action of the inner wall of the moving groove 2071 and pops up to be inserted into the other fixing groove 2072, the vacuum moving assembly 21 and the handle assembly 207 can be locked again.

Thus, the securing slots 2072 may provide, on the one hand, a locking action between the vacuum displacement assembly 21 and the handle assembly 207; on the other hand, the fixing groove 2072 may indicate a moving distance of the vacuum moving assembly 21. Since the plurality of the fixing grooves 2072 are equally spaced in the axial direction of the moving groove 2071 (the spacing may be, for example, 10mm to 30mm, preferably 20 mm), the distance of each movement of the vacuum moving assembly 21 is a fixed value, and the length of the adjusted heat transfer zone can be conveniently known by calculating the movement of the vacuum moving assembly 21 from the initial fixing groove 2072 through several fixing grooves 2072.

One embodiment of the movement positioning mechanism 213 is as follows.

The moving positioning mechanism 213 as shown in fig. 6a and 7 includes a sleeve 2131, a slider 2132 and a rotational boss 2133. Sleeve 2131 is provided in handle assembly 207. The slider 2132 is provided on the outer wall of the sleeve 2131 and extends in the radial direction of the sleeve 2131, and the slider 2132 is located in the moving groove 2071 and is movable in the moving groove 2071. The rotation boss 2133 is connected to the slider 2132, and the rotation boss 2133 is positioned outside the moving slot 2071. The extension direction of the rotating boss 2133 is perpendicular to the extension direction of the moving slot 2071, so that when the slider 2132 is positioned in the moving slot 2071, the rotating boss 2133 snaps outside of the moving slot 2071 so that the sleeve 2131 does not slide off the handle assembly 207. In addition, the rotating boss 2133 is beneficial for an operator to apply a rotating moment, particularly, two rotating bosses 2133 which are symmetrically arranged can enable two fingers of the operator to be respectively positioned on the two rotating bosses 2133 to uniformly apply force.

The slide 2132 and the rotational boss 2133 may be integrally provided or separately provided. For example, the sliding block 2132 and the rotating boss 2133 may be integrally provided, and a mounting groove for mounting the connecting block 2138 may be provided therebetween. If the two are provided separately, the two may be connected by a connecting block 2138. The width of the connecting block 2138 is substantially the same as the width of the slide 2132.

As shown in fig. 9, the connection block 2138 further includes a connection hole 2135 extending in the circumferential direction of the sleeve 2131, and the elastic positioning piece 2134 is elastically connected to the connection hole 2135, for example, by a first spring 2139, such that the elastic positioning piece 2134 can be extended from the connection hole 2135 into the fixing groove 2072 or retracted into the connection hole 2135.

The number of the sliding blocks 2132 and the rotation bosses 2133 may be two, or more, as required. The elastic positioning pieces 2134 may be provided in the same number as the sliding blocks 2132 as the connection holes 2135.

As shown in fig. 8, the two slide blocks 2132 are disposed symmetrically with respect to the axial direction of the sleeve 2131, and the two rotation bosses 2133 are disposed symmetrically with respect to the axial direction of the sleeve 2131. In order to be able to act synchronously when rotating the vacuum moving assembly 21, the two elastic positioning members 2134 are arranged centrally symmetrically with respect to the sleeve 2131. I.e. the opening directions of the two connecting holes 2135 are opposite, and the extending or retracting directions of the two elastic positioning members 2134 are opposite. Thus, upon rotation of the vacuum displacement assembly 21, the two resilient positioning members 2134 may be simultaneously compressed back into the respective attachment holes 2135; and upon return, the two resilient retainers 2134 may also be simultaneously ejected out of their respective attachment apertures 2135 and inserted into corresponding retaining slots 2072 in the handle assembly 207.

It will be appreciated that the moving slots 2071 (and the respective stationary slots 2072 thereon) may be located on either axial side of the handle assembly 207 in order to mate with the symmetrical two slides 2132.

One of the resilient retainers 2134 serves to lock the vacuum displacement assembly 21 to the handle assembly 207 and the second serves to provide some damping when a rotational torque is applied to the vacuum displacement assembly 21, making the rotation and displacement operation easier for the operator; in addition, a third effect is that when the rotation moment applied to the vacuum moving assembly 21 is removed after the vacuum moving assembly 21 is moved to a desired position, the vacuum moving assembly 21 is reversely rotated (e.g., counterclockwise rotated) by the elastic reaction force of the elastic positioning member 2134, so that the elastic positioning member 2134 protrudes from the connection hole 2135 and is inserted into the other fixing groove 2072 to lock the vacuum moving assembly 21 with the handle assembly 207. That is, a more important function of the elastic positioning members 2134 is to automatically reset the vacuum moving assembly 21, so that when adjusting the length of the heat exchange area, an operator can easily and conveniently rotate and pull (or push) the vacuum moving assembly 21 to the corresponding fixing groove 2072 without manually resetting the vacuum moving assembly 21, thereby making the operation of adjusting the length of the heat exchange area easier and more convenient.

In addition, as shown in fig. 7, the movement positioning mechanism 213 further includes a support boss 2136 and at least one abutment ring 2137. Support bosses 2136 are provided on the outer wall of sleeve 2131 and are circumferentially spaced from rotational bosses 2133, the circumferential side walls of support bosses 2136 being in contact with the inner wall of handle assembly 207 for providing circumferential support upon relative rotation of vacuum moving assembly 21 and handle assembly 207. At least one abutment ring 2137 is provided over the outer wall of sleeve 2131 for contact with the inner wall of handle assembly 207 such that only a portion of the outer wall of movement positioning mechanism 213 is in contact with the inner wall of handle assembly 207 as a whole, thereby reducing friction between vacuum-moving assembly 21 and handle assembly 207 as it is rotated, and also reducing the weight of vacuum-moving assembly 21 such that the weight of the forward end of the ablation needle is reduced for ease of operation.

As shown in fig. 6a and 7, the vacuum moving assembly 21 further includes a vacuum jacket 212, an inner tube 211, and a vacuum tube 218. The vacuum jacket 212 is disposed within the sleeve 2131, with a vacuum cavity 217 formed in the vacuum jacket 212. The inner tube 211 penetrates the vacuum jacket 212 and is fitted over the outer side of the inflow tube 204, and the inner wall of the inner tube 211 and the outer wall of the inflow tube 204 form a first return passage. Vacuum tube 218 is sleeved outside inner tube 211 and extends into vacuum chamber 217, where vacuum chamber 217 and the vacuum environment within vacuum tube 218 may insulate the first return path from the external environment.

As shown in fig. 7, a guide head 216 is attached to the proximal end of vacuum tube 218, and vacuum displacement assembly 21 is guided through guide head 216 into needle assembly 100, such that guide head 216 has a tapered end. A portion of guide head 216 is interposed between vacuum tube 218 and inner tube 211 to connect vacuum tube 218 to inner tube 211. The portion of the inner tube 211 located outside the vacuum chamber 217 is maintained in its adiabatic property by the vacuum tube 218, and the portion of the inner tube 211 located inside the vacuum chamber 217 is maintained in its adiabatic property by the vacuum chamber 217.

As shown in fig. 7, the distal end of the vacuum jacket 212 extends beyond the distal end of the sleeve 2131 and is provided with a plug 219 by which the vacuum jacket 212 can be sealingly secured to the inner tube 211.

The distal end of the inner tube 211 and the distal end of the inlet tube 204 may be connected to the delivery device 300 by the gland 202 and the return deflector 205. Two specific ways of connection are provided below.

In an alternative connection, as shown in fig. 5 and 6a, a sealing sleeve 202 and a reflux diverter 205 connected to the distal end of the sealing sleeve 202 are provided in a handle assembly 207, the distal end of an inner tube 211 extends through the sealing sleeve 202 and into the reflux diverter 205, a first reflux passage communicates with the reflux diverter 205, and the inner tube 211 is sealingly connected to the sealing sleeve 202 by a first seal 203; wherein the vacuum displacement assembly 21 is movable relative to the handle assembly 207, needle assembly 100, and inflow tube 204 to maximize the length of the heat transfer zone when the proximal end of the sealing boot 202 abuts the distal end of the vacuum housing 212.

As shown in fig. 5 and 6a, in the initial state, the distance between the proximal end of the sealing sleeve 202 and the distal end of the vacuum jacket 212 is H1, the distal end of the inner tube 211 extends into the return deflector 205, and the distance between the distal end thereof and the first seal 203 is H2, at which time the heat transfer zone has a minimum length B.

When the vacuum moving assembly 21 is moved to adjust the length of the heat exchanging zone, the proximal end of the sealing sleeve 202 and the distal end of the vacuum jacket 212 may be close to each other, and the distance H1 therebetween may be gradually reduced until it becomes 0, so that it is known that the maximum length of the heat exchanging zone is b+h1. In addition, when moving the vacuum moving assembly 21, the distal end of the inner tube 211 extends deeper into the return diversion member 205, for example, when the distance H1 between the proximal end of the sealing sleeve 202 and the distal end of the vacuum jacket 212 is 0, the distance between the distal end of the inner tube 211 and the first seal 203 is h2+h1.

Thus, according to the adjustable range B-B+H2 of the heat transfer area, the distance between the fixing grooves 2072 can be determined, for example, two fixing grooves 2072 are provided, and the axial distance between the fixing grooves 2072 is H1/2. Further, the return diversion member 205 is a three-way member, and a return diversion passage 2051 is provided at a side portion of the return diversion member for connecting with the transmission device 300, and the return working medium in the return diversion member 205 can flow into the transmission device 300 after being diverted through the return diversion passage 2051. Thus, preferably, when the distance H1 between the proximal end of the gland 202 and the distal end of the vacuum jacket 212 is 0, the distal end of the inner tube 211 is flush with the upper end of the return diversion passage 2051 so that the return flow can smoothly enter the return diversion passage 2051. That is, the distance H1 between the proximal end of the sealing sleeve 202 and the distal end of the vacuum jacket 212 is smaller than or equal to the distance between the distal end of the inner tube 211 and the upper end of the return-flow diverting passage 2051 (in the initial state).

In an alternative connection, as shown in fig. 11, a sealing sleeve 202 and a return steering member 205 connected to the distal end of the sealing sleeve 202 are provided in the handle assembly 207, the proximal end of the sealing sleeve 202 is provided with a receiving groove 2021 extending toward the distal end thereof, and the distal end of the vacuum jacket 212 is provided in the receiving groove 2021 and is sealingly connected to the receiving groove 2021 by a second sealing member 2121.

The inner tube 211 penetrates the sealing sleeve 202 and extends into the reflux diverter 205, the first reflux passage is communicated with the reflux diverter 205, and the inner tube 211 is in sealing connection with the sealing sleeve 202 through the first sealing member 203. Wherein the vacuum moving assembly 21 is movable relative to the handle assembly 207, needle assembly 100 and inflow tube 204 to maximize the length of the heat transfer zone when the inner end of the receiving groove 2021 abuts the distal end of the vacuum housing 212.

As shown in fig. 11, in the initial state, the distance between the inner end of the accommodation groove 2021 and the plug 219 of the vacuum moving assembly 21 is H3, and the distal end of the inner tube 211 extends into the return deflector 205, at which time the heat exchange zone has a minimum length B.

When the length of the heat exchange area is adjusted by moving the vacuum moving unit 21, the plug 219 of the vacuum moving unit 21 and the inner end of the housing groove 2021 are moved closer to each other, and the distance H3 therebetween may be gradually reduced until 0, so that it is known that the maximum length of the heat exchange area is b+h3. In addition, the distal end of the inner tube 211 extends deeper into the return deflector 205 as the vacuum displacement assembly 21 is displaced.

Thus, according to the adjustable range B-B+H2 of the heat transfer area, the distance between the fixing grooves 2072 can be determined, for example, two fixing grooves 2072 are provided, and the axial distance between the fixing grooves 2072 is H3/2.

In addition, other arrangements of the return diversion member 205 may be the same as those of the above-described alternative connection methods, and will not be described herein.

The movement of the vacuum moving assembly 21 to its spring retainer 2134 is inserted into the one of the retaining slots 2072 closest to the proximal end of the needle assembly 100 corresponds to the initial position of the vacuum moving assembly 21, i.e., the length of the heat transfer zone is minimized. The maximum travel of the vacuum displacement assembly 21 is defined by the distance between the proximal end of the sealing sleeve 202 and the distal end of the vacuum housing 212 or the distance between the plug portion 219 of the vacuum displacement assembly 21 and the inboard end of the receiving groove 2021. Therefore, the axial length of the moving groove 2071 should be greater than or equal to the maximum stroke of the vacuum moving assembly 21, i.e., the axial length of the moving groove 2071 should not limit the displacement of the vacuum moving assembly 21.

Since the moving slots 2071 penetrate the handle assembly 207 in the wall thickness direction of the handle assembly 207, when the elastic positioning piece 2134 of the vacuum moving assembly 21 is inserted into one of the fixing slots 2072, in order to avoid the other parts of the moving slots 2071 from being exposed, in an alternative embodiment, as shown in fig. 6b, a baffle 214 may be provided on both axial sides of each of the sliders 2132, the baffle 214 being located inside the handle assembly 207 and being adhered to the inner wall of the handle assembly 207. The baffle 214 extends along the axial direction of the handle assembly 207 and moves with the slide 2132. When the resilient retainer 2134 of the vacuum moving assembly 21 is inserted into one of the fixed slots 2072, the baffle 214 on the upper and lower sides of the slide 2132 can cover the other portions of the moving slot 2071 except the portion where the rotating boss 2133 is located, thereby making the entire ablation needle a complete whole.

Further, the barrier 214 is connected to the slide 2132 by a torsion spring (not shown) that applies a radial force to the barrier 214 such that the barrier 214 is always urged against the inner wall of the handle assembly 207 to ensure that the vacuum moving assembly 21 is not urged radially apart during movement.

It will be appreciated that the shield 214 on each slide 2132 may also be located on the exterior of the handle assembly 207, pushing it against the outer wall of the handle assembly 207 by a torsion spring, again with the effect of ensuring the integrity of the ablation needle.

It is also contemplated that the flapper 214 may be disposed within the interior of the side wall of the handle assembly 207 and resiliently coupled to the side wall of the handle assembly 207, with the flapper 214 bearing against the slide 2132 and/or the rotational boss 2133 under the urging force of a resilient member such as a second spring. As the vacuum moving assembly 21 moves axially upward, the second spring on its axially upper side is compressed such that the flap 214 connected to the second spring is pressed into a deeper position in the sidewall of the handle assembly 207, while the second spring on its axially lower side is extended such that the flap 214 connected to the second spring is pushed out of the sidewall of the handle assembly 207, such that the flap 214 covers the other portions of the moving slot 2071 than the portion of the rotating boss 2133 when the vacuum moving assembly 21 is in each position.

In an alternative embodiment, as shown in fig. 6c, the interior of the handle assembly 207 is sleeved with an inner sleeve 22, the inner sleeve 22 being located between the handle assembly 207 and the vacuum displacement assembly 21,

The rotation boss 2133 of the vacuum moving assembly 21 radially penetrates the inner sleeve 22 and divides the inner sleeve 22 into an upper inner sleeve 221 and a lower inner sleeve 222, wherein an end of the upper inner sleeve 221 is connected to the handle assembly 207 by a third spring 23, and a length of the lower inner sleeve 222 is set such that when the vacuum moving assembly 21 moves up to a maximum position in an axial direction, an end of the lower inner sleeve 222 is flush with or exceeds a lowermost end of the moving groove 2071.

When the vacuum moving assembly 21 moves upwards in the axial direction, the inner sleeve 22 is driven to move together, the upper inner sleeve 221 above the axial direction compresses the third spring 23, and correspondingly, when the vacuum moving assembly 21 moves downwards in the axial direction, the inner sleeve 22 is driven to move together, and the third spring 23 stretches. The radial relative position of the inner sleeve 22 and the handle assembly 207 and the vacuum displacement assembly 21 is maintained by the provision of the third spring 23.

Further, the inner diameter of the lower inner sleeve 222 is set to be larger than the inner diameter of the upper inner sleeve 221, which is beneficial to weight reduction; on the other hand, the outer diameters of the lower inner sleeve 222 and the upper inner sleeve 221 are smaller than the outer diameter of the abutting ring 2137 (or the supporting boss 2136), so that the abutting ring 2137 and the supporting boss 2136 are respectively contacted with the inner wall of the handle assembly 207 to perform a positioning function, and the outer walls of the lower inner sleeve 222 and the lower inner sleeve 222 are not contacted with the inner wall of the handle assembly 207 but have a certain clearance, so that the friction force when the vacuum moving assembly 21 moves can be reduced.

Alternatively, it is also contemplated that the upper inner sleeve 221 and the lower inner sleeve 222 are separate structures, and are respectively connected to two axial sides of the sliding block 2132, and a spring may be disposed at the bottom of the lower inner sleeve 222 to connect with the handle assembly 207.

As shown in fig. 12, the needle assembly 100 comprises an outer cannula 104, the outer cannula 104 comprising a first tube 102 and a second tube 103 connected to the distal end of the first tube 102, wherein the proximal end of the first tube 102 is connected to a piercing needle 101, which piercing needle 101 may be, for example, a triangular-shaped needle for piercing tissue in a target area.

Inner tube 211 (as well as vacuum tube 218 and guide head 216) extends into second tube 103, and intake tube 204 extends into first tube 102 via second tube 103, the outer wall of intake tube 204 and first tube 102 forming a second return passageway that is in fluid communication with the first return passageway, and the length of the heat transfer zone is the distance between the proximal end of piercing needle 101 and the proximal end of inner tube 211.

As shown in fig. 11, in the initial state, the proximal end of the guide head 216 is located at the position where the first tube 102 is connected to the second tube 103, and the outer wall of the inflow tube 204 and the first tube 102 form a second backflow path which is not covered by the vacuum tube 218 and the guide head 216, so that the length of the heat exchange area is the distance between the proximal end of the guide head 216 and the proximal end of the puncture needle 101 (which is also equal to the sum of the length of the first tube 102 and the length of the puncture needle 101).

After rotating and pulling the vacuum moving assembly 21, the inner tube 211, the vacuum tube 218 and the proximal end of the guide head 216 are far away from the connection between the first tube 102 and the second tube 103, i.e. the guide head 216 is far away from the puncture needle 101, so that the portion of the inflow tube 204 covered by the vacuum tube 218 and the guide head 216 is reduced, and the length of the heat exchange area is increased, and thus the length of the heat exchange area is the sum of the distance B between the proximal end of the guide head 216 and the proximal end of the puncture needle 101 and the moving distance of the guide head 216 in the initial state.

It will thus be appreciated that upon rotation and displacement of vacuum displacement assembly 21, the various portions of vacuum displacement assembly 21 shown in fig. 7 are rotated and displaced as a unit, i.e., vacuum displacement assembly 21 is a movable element as a unit, and handle assembly 207, needle assembly 100, and aspiration tube 204 are all stationary elements. The length of the heat transfer zone is thus effectively the distance between the proximal end of the guide head 216 and the proximal end of the needle 101.

Since the first tube 102 needs to exchange heat with the tissue of the target area, a heat radiation fin, such as a flat plate fin or a screw fin, may be provided in the first tube 102 to improve heat exchange efficiency.

As shown in fig. 12, the diameter D1 of the first tube 102 is smaller than or equal to the diameter D2 of the second tube 103. The diameter and length of the first tube 102 and the diameter D2 and length of the second tube 103 may be selected according to actual needs. The diameter D1 of the first tube 102 is less than or equal to the diameter D2 of the second tube 103, and because the vacuum displacement assembly 21 can only be moved until the proximal end of the guide head 216 is located where the first tube 102 is connected to the second tube 103, i.e., the components of the vacuum displacement assembly 21 do not extend into the first tube 102, the diameter of the first tube 102 can be configured to be smaller, thereby facilitating penetration and reducing the weight of the ablation needle.

Furthermore, the same delivery device 300 may be used for the first tubes 102 of different diameters, thereby ensuring that the source of working fluid is consistent; because the diameter of the inflow pipe 204 is fixed, the diameters of the first reflux passage and the second reflux passage are also fixed, so that the speed of the working medium reaching the tip is relatively consistent, the low-temperature performance and the rewarming performance of the ablation needle can be determined by the working medium source, and the size of the ice ball formed in the heat exchange area mainly depends on the heat exchange area of the heat exchange area.

As shown in fig. 12 and 13, and referring to fig. 1 and 7, a connector 215 is provided at a proximal end of the vacuum jacket 212, and a connection groove 106 for receiving the connector 215 is provided at a distal end of the outer sleeve 104, and the connection groove 106 is hermetically connected to the connector 215 by a third sealing member 107.

As shown in fig. 7, the connector 215 includes a tapered portion 2151, a cylindrical portion 2152, and an arcuate portion 2153 connected in sequence, wherein the arcuate portion 2153 is connected to the proximal end of the vacuum jacket 212, and the tapered portion 2151 is disposed outside of the vacuum tube 218. Accordingly, the inner wall of the connecting groove 106 is also provided in a shape matching the tapered portion 2151 and the cylindrical portion 2152 of the connector 215. The tapered portion 2151 can facilitate the connector 215 to be inserted into the connection groove 106 more smoothly, and the columnar portion 2152 can provide a larger fitting area between the outer wall of the connector 215 and the inner wall of the connection groove 106. As shown in fig. 13, the third seal 107 may be provided at the tapered portion 2151 of the connector 215, or at the junction of the tapered portion 2151 and the cylindrical portion 2152 of the connector 215.

As shown in fig. 12, the exterior of the second tube 103 is also sleeved with a gripping twist grip 105, which may be removably connected to the proximal end of the handle assembly 207. The area where the handle 105 is held is the area that the vacuum tube 218 can cover so that the operator's other hand can hold the handle 105 while rotating the vacuum moving assembly 21.

The handle assembly 207 of the simple cold and hot ablation needle is integrated with the vacuum moving assembly 21 capable of adjusting the length of the heat exchange area, so that the structure is more compact, and the miniaturization of the ablation needle is facilitated.

As shown in fig. 14, according to a second aspect of the present invention, the present invention further provides an ablation device including the simple cold and hot ablation needle described above, and further including a transmission device 300, wherein the transmission device 300 is connected to the simple cold and hot ablation needle and the working medium source, respectively.

As shown in fig. 14, the transfer device 300 comprises two parallel inflow input pipes 301 and a return output pipe 302. Referring to fig. 5, the handle assembly 207 is provided with an inflow deflector 206 having an inflow deflector passageway 2061 disposed on a side thereof, the inflow deflector passageway 2061 being connected to the inflow input tube 301, the other end of the inflow deflector 206 being connected to one of the ends of the return deflector 205, and the distal end of the inflow tube 204 extending through the return deflector 205 and into the inflow deflector 206. Thus, intake manifold 204 is in fluid communication with intake manifold 301 via intake diversion element 206 and intake diversion passage 2061, and the working fluid may be sequentially input to intake diversion passage 2061 via intake manifold 301 and diverted into intake manifold 204.

The return output tube 302 is in fluid communication with a return diverter passageway 2051 in the side of the return diverter 205, the other end of the return diverter 205 is inserted into the gland 202, and the inner tube 211 extends into the return diverter 205 through the gland 202 so that the first return passageway is in communication with the return diverter 205.

The working fluid flows out of inlet tube 204 after flowing to the proximal end of inlet tube 204 and back up. The return flow enters the return flow direction device 205 through the second return flow path and the first return flow path described above in this order, and is recovered from the return output pipe 302 after being diverted and entering the return flow direction path 2051.

The outside of the inflow pipe 301 and the return pipe 302 may be covered with a heat insulating material by which the heat insulating property of the transfer device 300 is secured. Alternatively, the exterior of the inflow and return output pipes 301 and 302 may be provided with a vacuum layer to ensure the adiabatic properties of the transfer device 300.

In addition, as shown in fig. 6, the handle assembly 207 is hollow and can accommodate the components of the inflow steering element 206, the reflux steering element 205, the partial inflow tube 204, the sealing sleeve 202, the partial vacuum moving assembly 21 and the like, and can reduce the weight of the front end of the ablation needle and facilitate operation. In order to provide the handle assembly 207 with insulating properties as well, an insulating material may be filled between the interior thereof and the components. It will be appreciated that no insulation may be provided within the axial range of movement of the vacuum moving assembly 21 so as not to impede movement of the vacuum moving assembly 21.

It should be noted that, as used herein, "proximal" refers to an end proximal to the puncture needle 101, and "distal" refers to an end distal to the puncture needle 101.

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

Claims (11)

1. A simple cold and hot ablation needle, comprising:

a handle assembly (207), said handle assembly (207) having a flow inlet tube (204) disposed therein;

a needle assembly (100), the needle assembly (100) being connected to a proximal end of the handle assembly (207); and

A vacuum displacement assembly (21), a distal end of the vacuum displacement assembly (21) being disposed in the handle assembly (207), a proximal end of the vacuum displacement assembly (21) extending into the needle assembly (100), the inflow tube (204) extending through the vacuum displacement assembly (21) and into the needle assembly (100);

Wherein the vacuum displacement assembly (21) is configured to be unlocked from the handle assembly (207) upon rotation about the axis of the handle assembly (207) as a pivot axis such that the vacuum displacement assembly (21) is movable relative to the handle assembly (207), the needle assembly (100) and the inflow tube (204) to vary the length of a heat transfer zone defined between the proximal end of the vacuum displacement assembly (21) and the proximal end of the needle assembly (100); and the vacuum moving assembly (21) is rotatable in the opposite direction to lock with the handle assembly (207) after the length of the heat transfer zone is changed.

2. The simple and easy cryoablation needle of claim 1 wherein the handle assembly (207) is provided with a moving slot (2071) extending axially thereof on an outer wall thereof, a plurality of fixed slots (2072) communicating with the moving slot (2071) are provided on an inner wall of the moving slot (2071), the fixed slots (2072) extend radially of the moving slot (2071), and a plurality of the fixed slots (2072) are provided at intervals axially of the moving slot (2071);

the vacuum moving assembly (21) comprises a moving positioning mechanism (213), the moving positioning mechanism (213) comprises an elastic positioning piece (2134), when the vacuum moving assembly (21) rotates by taking the axis of the handle assembly (207) as a pivot shaft, the elastic positioning piece (2134) is compressed to abut against the inner wall of the moving groove (2071), so that the vacuum moving assembly (21) is unlocked from the handle assembly (207); the resilient retainer (2134) locks the vacuum displacement assembly (21) with the handle assembly (207) when moved into the securing slot (2072).

3. The facile cold-hot ablation needle of claim 2, wherein the mobile positioning mechanism (213) further comprises:

A sleeve (2131), the sleeve (2131) being disposed in the handle assembly (207);

-a slider (2132), said slider (2132) being provided on an outer wall of said sleeve (2131) and extending in a radial direction of said sleeve (2131), said slider (2132) being movable in said movement slot (2071); and

A rotation boss (2133), the rotation boss (2133) being connected to the slider (2132), the rotation boss (2133) being located outside the movement slot (2071);

Wherein, the junction of slider (2132) with rotatory boss (2133) is provided with along connecting hole (2135) of circumference extension of sleeve (2131), elastic locating piece (2134) with connecting hole (2135) elastic connection, make elastic locating piece (2134) can follow connecting hole (2135) stretches out into in fixed slot (2072), perhaps retract connecting hole (2135).

4. A simplified cold and hot ablation needle as claimed in claim 3, characterised in that said mobile positioning mechanism (213) further comprises:

-a support boss (2136), the support boss (2136) being provided on an outer wall of the sleeve (2131) and being circumferentially spaced from the rotation boss (2133), a circumferential side wall of the support boss (2136) being in contact with an inner wall of the handle assembly (207) for providing support in a circumferential direction upon relative rotation of the vacuum displacement assembly (21) and the handle assembly (207); and

At least one abutment ring (2137), the at least one abutment ring (2137) being sleeved on an outer wall of the sleeve (2131) for contact with an inner wall of the handle assembly (207).

5. A simplified cold and hot ablation needle as in claim 3, characterized in that said vacuum moving assembly (21) further comprises:

A vacuum jacket (212) disposed in the sleeve (2131), the vacuum jacket (212) having a vacuum cavity (217) formed therein;

an inner layer pipe (211), wherein the inner layer pipe (211) penetrates through the vacuum jacket (212) and is sleeved on the outer side of the inflow pipe (204), and a first backflow passage is formed by the inner wall of the inner layer pipe (211) and the outer wall of the inflow pipe (204); and

And the vacuum tube (218) is sleeved on the outer side of the inner layer tube (211) and extends into the vacuum cavity (217), and the vacuum cavity (217) and the vacuum tube (218) can insulate the first backflow passage from the external environment.

6. The simple and easy cold and hot ablation needle according to claim 5, wherein a sealing sleeve (202) and a reflux diverter (205) connected with the distal end of the sealing sleeve (202) are further arranged in the handle assembly (207), the inner tube (211) penetrates through the sealing sleeve (202) and stretches into the reflux diverter (205), the first reflux passage is communicated with the reflux diverter (205), and the inner tube (211) is connected with the sealing sleeve (202) in a sealing way through a first sealing piece (203);

Wherein the vacuum displacement assembly (21) is movable relative to the handle assembly (207), the needle assembly (100) and the inflow tube (204) to a length of the heat exchange zone that is maximized when the proximal end of the sealing sleeve (202) abuts the distal end of the vacuum jacket (212).

7. The simple cryoablation needle of claim 5 wherein a sealing sleeve (202) and a reflux diverter (205) coupled to the distal end of the sealing sleeve (202) are further disposed in the handle assembly (207), the proximal end of the sealing sleeve (202) is provided with a receiving groove (2021) extending toward the distal end thereof, and the distal end of the vacuum jacket (212) is disposed in the receiving groove (2021) and is sealingly coupled to the receiving groove (2021) by a second seal (2121);

The inner layer pipe (211) penetrates through the sealing sleeve (202) and extends into the backflow steering piece (205), the first backflow passage is communicated with the backflow steering piece (205), and the inner layer pipe (211) is connected with the sealing sleeve (202) in a sealing manner through a first sealing piece (203);

Wherein the vacuum moving assembly (21) can move relative to the handle assembly (207), the needle assembly (100) and the inflow tube (204) to the position that the length of the heat exchange area is maximum when the inner end of the accommodating groove (2021) is abutted with the distal end of the vacuum jacket (212).

8. The simple cryoablation needle of claim 5 wherein the needle assembly (100) comprises an outer cannula (104), the outer cannula (104) comprising a first tube (102) and a second tube (103) connected to a distal end of the first tube (102), a piercing needle (101) connected to a proximal end of the first tube (102);

the inner tube (211) stretches into the second tube (103), the inflow tube (204) extends into the first tube (102) through the second tube (103), a second backflow passage is formed by the outer wall of the inflow tube (204) and the first tube (102), the second backflow passage is in fluid communication with the first backflow passage, and the length of the heat exchange area is the distance between the proximal end of the puncture needle (101) and the proximal end of the inner tube (211).

9. The facile cold-hot ablation needle of claim 8, wherein a diameter D1 of the first tube (102) is less than or equal to a diameter D2 of the second tube (103).

10. The simple and easy cold and hot ablation needle according to claim 8, wherein a connector (215) is provided at a proximal end of the vacuum jacket (212), a connecting groove (106) for accommodating the connector (215) is provided at a distal end of the outer sleeve (104), and the connecting groove (106) and the connector (215) are connected in a sealing manner by a third sealing member (107).

11. An ablation device comprising a simple cold and hot ablation needle according to any one of claims 1-10, and further comprising a transmission device (300), said transmission device (300) being connected to said simple cold and hot ablation needle and to a source of working medium, respectively.