CN219645860U

CN219645860U - Flexible multimode ablation needle

Info

Publication number: CN219645860U
Application number: CN202320772325.6U
Authority: CN
Inventors: 陈德嵘
Original assignee: Visual Fuxing Medical Device Technology Shanghai Co ltd
Current assignee: Visual Fuxing Medical Device Technology Shanghai Co ltd
Priority date: 2023-04-06
Filing date: 2023-04-06
Publication date: 2023-09-08
Anticipated expiration: 2033-04-06

Abstract

The utility model discloses a flexible multimode ablation needle, and relates to the technical field of cryoablation and radio frequency ablation. A flexible multi-modal ablation needle comprising: an ablation catheter comprising an ablation needle catheter located outermost; the ablation needle head with the puncture function is integrated at the distal end of the ablation catheter and is connected with the ablation needle catheter; the tube sheath is suitable for being sleeved on the outer sides of the ablation needle catheter and the ablation needle head; wherein the sheath is adapted to be moved via the channel catheter to close to the target tissue; the ablation needle catheter and the ablation needle are adapted to move relative to the sheath such that the ablation needle extends out of the sheath, performing a puncturing operation and an ablation operation on the target tissue, the ablation operation including at least a cryoablation operation and a radio frequency ablation operation. According to the technical scheme of the utility model, the puncture function and the two ablation functions of cryoablation and radio frequency ablation are integrated, so that the multimode ablation treatment operation can be performed. And the damage of the ablation needle to the channel catheter can be avoided.

Description

Flexible multimode ablation needle

Technical Field

The utility model relates to the technical field of radio frequency ablation, in particular to a flexible multimode ablation needle.

Background

With the continuous improvement of medical imaging and navigation puncture technologies, modern tumor minimally invasive ablation treatment technologies are rapidly developed. The minimally invasive ablation means for solid tumors, which are commonly used clinically at home and abroad, mainly comprise: cryoablation, radiofrequency ablation, microwave ablation, and the like. Cryoablation is a method for achieving ablation treatment by generating ultra-low temperature at an ablation needle by using a phase transition principle or a Joule-Thomson (J-T) effect so as to absorb a large amount of heat of peripheral tumor tissues and deeply freeze the tumor tissues, so that ice crystals are formed in cells or the cells are severely dehydrated to cause cell death. The radio frequency ablation is a method for achieving ablation treatment by driving ions, polar water molecules and the like in tumor cells to perform high-frequency oscillation, mutual friction and collision through radio frequency current to generate local high temperature and cause degeneration and necrosis of lesion cells.

In recent years, related researches consider that by combining the multi-mode ablation treatment technology of radio frequency ablation with the cryoablation, tumor cells are broken in a warm range under the synergistic effect of thermal stress and mechanical stress by rapidly alternating the freezing and radio frequency heating of tumors, and the problem of large-area coagulative necrosis of the tumors caused by conventional radio frequency high-temperature ablation is avoided, so that the maximization of the release of cell contents can be realized, and finally, lasting and effective immune response is caused. Integrating both cryoablation and radiofrequency ablation functions on one ablation needle is one way to achieve this technology.

It should be noted that the freezing process causes two types of damage to the cells, namely "solution damage" and "intracellular ice damage". Among them, "intracellular ice damage" directly damages cell structures, and is more damaging to cells. Because the cooling rate of the cells is faster, the intracellular ice injury is easier to induce, the faster cooling rate is generally pursued in the tumor cryoablation operation process, so that the tumor is killed more thoroughly, and the operation time can be greatly saved.

In general, cryoablation techniques fall into two broad categories, one by the phase transition principle and the other by the Joule-Thomson (J-T) effect (Joule Thompson Effect). The phase change principle is that liquid nitrogen at the temperature of minus 196 ℃ is conveyed to the needle head of the cryoablation needle through lower driving pressure, and the liquid nitrogen is vaporized into nitrogen to absorb a large amount of heat so as to achieve the purpose of cryoablation. The Joule Thomson effect is that the ultra-high pressure cold source gas is delivered to a nozzle hole (J-T effect is generated) in the cryoablation needle to be directly throttled and expanded to generate low temperature, and the obvious advantage of the ultra-high pressure cold source gas compared with the phase change principle is that the cooling rate is faster, especially after the ultra-high pressure cold source gas is precooled.

A flexible cryoablation needle for tumor ablation through natural orifice is an instrument that generally uses the Joule-Thomson (J-T) effect to produce cryotherapy, requiring a tool tip temperature of-140 to-170 ℃. The conventional flexible cryoablation needle generally adopts carbon dioxide or nitrous oxide as an air source, the air inlet working pressure is generally 4-6 Mpa, the temperature of a cutter head is-40-80 ℃, and the conventional flexible cryoablation needle can only be used for biopsy, foreign matter extraction and cryoablation. Moreover, the conventional flexible cryoablation needle generally adopts a plastic extrusion pipe as the connection of the air inlet conduit and the metal nozzle, and can not bear high pressure and low temperature, the risk of bursting at the conduit and the joint is caused, the connection between the cutter head and the air inlet pipe is disconnected, the cutter head can be punched out, the human tissue is pierced to cause life hazard to a patient, and simultaneously, the ultralow temperature gas leaked at the bursting joint can also cause unexpected injury to the patient.

In order to meet the effectiveness and efficiency of cryoablation, it is desirable that the temperature of the tip of the cryoablation needle reach a lower limit temperature while achieving a faster rate of cooling.

According to the related experimental results, under the condition of the same air inlet pipe pressure and reasonable nozzle diameter, the outlet temperature of a single nozzle of the cryoablation needle can be reduced along with the reduction of the throttle aperture, and the cooling rate of the outlet temperature can be increased along with the increase of the throttle aperture, which is caused by the increase of the throttle aperture, the increase of the carbon dioxide entering the nozzle in unit time and the increase of the generated refrigerating capacity. When the inlet pressure is increased, the temperature of the outlet of the nozzle is reduced, and the cooling rate of the outlet of the nozzle can be obviously increased. Thus, to achieve rapid cooling and minimum temperature, the nozzle design of the cryoablation needle requires an increase in cold source gas inlet pressure, as well as a reasonable nozzle cross-sectional area and placement (small cross-sectional area of the nozzle is achieved, large cold source flow through the nozzle).

Under the condition that the air inlet pressure cannot be increased more, how to utilize the smaller nozzle sectional area to realize that the larger cold source gas flows through the throttling nozzle in unit time so as to achieve lower freezing treatment temperature and faster freezing cooling rate is needed to be solved.

In addition, in the prior art, before ablation is performed through the natural cavity, a puncture needle is generally required to puncture the lesion tissue in advance to form an ablation channel, so that a subsequent ablation needle can enter the center of the lesion tissue through the ablation channel to perform an ablation operation. The two surgical instruments are needed to perform two surgeries, the control consistency requirement on the two surgical instruments is high, the surgical time is long, and the medical cost of patients is high. In addition, if the penetration function is integrated into the ablation needle, the passage of a sharp penetration portion through the catheter may damage the catheter and create an associated surgical risk.

Based on this, there is a need to provide a flexible multi-modal ablation needle that solves one or more of the problems presented in the above-described solutions.

Disclosure of Invention

To this end, the present utility model provides a flexible multi-modal ablation needle and nozzle assembly that solves or at least alleviates one or more of the problems set forth above.

According to a first aspect of the present utility model there is provided a flexible multimode ablation needle comprising: an ablation catheter comprising an ablation needle catheter located outermost; the ablation needle head with the puncture function is integrated at the distal end of the ablation catheter and is connected with the ablation needle catheter; the tube sheath is suitable for being sleeved outside the ablation needle catheter and the ablation needle head; wherein the sheath is adapted to be moved into proximity with a target tissue via a channel catheter; the ablation needle catheter and the ablation needle are suitable for moving relative to the tube sheath so that the ablation needle extends out of the tube sheath to perform puncture operation and ablation operation on target tissues, wherein the ablation operation at least comprises cryoablation operation and radio frequency ablation operation.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation needle comprises a hollow needle body having a polyhedral puncture body for performing a puncture operation on a target tissue through the polyhedral puncture body.

Optionally, in the flexible multimode ablation needle according to the utility model, the polyhedral puncture body is a triangular prism or a conical or polygonal body.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation needle further comprises a nozzle assembly comprising: the nozzle base is arranged at the joint of the needle head body and the ablation catheter and is provided with a nozzle inner hole in an axial through manner; the nozzle shaft is formed by concavely arranging a plurality of axially extending semicircular grooves or grooves which are circumferentially spaced on the surface of the cylinder, the nozzle shaft penetrates through the nozzle inner hole, and the cylinder surface of the nozzle shaft is tightly matched with the hole wall of the nozzle inner hole, so that a plurality of nozzle holes are formed between the plurality of semicircular grooves or grooves and the hole wall.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation catheter further comprises an air inlet pipe positioned at the innermost side, and the distal end of the air inlet pipe is sleeved on the outer wall of the nozzle base so as to be communicated with the plurality of nozzle holes and convey cold source gas.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation needle further comprises an ablation needle base arranged at the junction of the needle body and the ablation catheter; the distal end of the air inlet pipe and the nozzle base are inserted into the ablation needle base together.

Optionally, in the flexible multimode ablation needle according to the utility model, the outer wall of the nozzle base comprises a first cylindrical surface and a second cylindrical surface coaxially joined, the diameter of the first cylindrical surface being larger than the diameter of the second cylindrical surface; the inner surface of the far end of the air inlet pipe is tightly matched with and in sealing connection with the second cylindrical surface of the nozzle base; the inner wall of the ablation needle base is tightly matched with the first cylindrical surface of the nozzle base.

Optionally, in the flexible multimode ablation needle according to the utility model, the inner wall of the ablation needle base has a plurality of slots adapted to form a plurality of air return holes with the first cylindrical surface of the nozzle base.

Optionally, in the flexible multimode ablation needle according to the utility model, an expansion tube is formed at the distal end of the air inlet tube, and an inner hole of the expansion tube is tightly matched with the second cylindrical surface of the nozzle base.

Optionally, in the flexible multimode ablation needle according to the utility model, further comprising: a thermocouple adapted to pass through any one of the slots and to be fixed to the inner wall of the needle body so as to measure the temperature of the ablation process.

Optionally, in the flexible multimode ablation needle according to the utility model, the inner wall of the ablation needle base comprises a first inner bore surface and a second inner bore surface that are engaged with each other; the first inner hole surface is suitable for being coated on the outer surface of the far end of the air inlet pipe; the diameter of the second bore surface is smaller than the diameter of the distal outer surface of the inlet tube to limit movement of the inlet tube and nozzle base toward an end proximate the control handle.

Optionally, in the flexible multimode ablation needle according to the utility model, a part of the ablation needle base is fixed in the needle body in a penetrating way, and another part is fixed in the ablation needle catheter in a penetrating way.

Optionally, in the flexible multimode ablation needle according to the utility model, the outer wall of the ablation needle base is convexly provided with a step surface, the outer wall of the ablation needle base is tightly matched with the inner wall of the needle body, and the step surface is suitable for mutually resisting and sealing connection with the end surface of the needle body.

Optionally, in the flexible multimode ablation needle according to the utility model, the outer wall of the ablation needle base is convexly provided with a plurality of barb steps; the ablation needle catheter is suitable for being sleeved on the barb steps in an interference mode and is aligned with the end face of the needle head body.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation catheter further comprises: the metal hypotube is arranged between the air inlet pipe and the ablation needle catheter and sleeved on the ablation needle base.

Alternatively, the metallic hypotube is made of a nickel-titanium memory alloy or a high elastic alloy.

Optionally, in the flexible multimode ablation needle according to the utility model, the ablation needle base is provided with a connecting column extending towards one end close to the control handle; the far end of the metal hypotube is sleeved on the connecting column and is suitable for being welded and fixed with the connecting column.

Optionally, in the flexible multimode ablation needle according to the utility model, the air inlet pipe is made of red copper or soft stainless steel.

Optionally, in the flexible multimode ablation needle according to the utility model, further comprising: a control handle disposed at a proximal end of the ablation catheter, the control handle comprising a handle body connected to the ablation catheter, a sheath control structure connected to the sheath; wherein the sheath control structure is adapted to push the sheath out through the channel catheter to close to the target tissue by manipulating the sheath; the handle body is pushed to drive the ablation needle catheter and the ablation needle to move relative to the tube sheath, so that the ablation needle extends out of the tube sheath and performs puncture operation and ablation operation on target tissues.

Optionally, in the flexible multimode ablation needle according to the utility model, the control handle further comprises: and the ablation needle limiter is connected with the sheath control structure and is suitable for blocking the handle body from moving relative to the sheath so as to limit the position of the ablation needle extending out of the sheath.

Optionally, in the flexible multimode ablation needle according to the utility model, the control handle further comprises: a connector lock adapted to connect with and lock the channel catheter to secure the flexible multi-modal ablation needle to the channel catheter via the connector lock.

Optionally, in the flexible multimode ablation needle according to the utility model, the connector lock comprises a lock body, and a guide groove is axially arranged on the outer wall of the lock body; the sheath control structure is adapted for sliding connection with the guide slot so as to drive the sheath to move closer to the target tissue.

Optionally, in the flexible multimode ablation needle according to the utility model, the sheath control structure comprises: the control screw is suitable for being fixedly connected with the lock catch body so as to lock the position of the tube sheath.

According to another aspect of the present utility model there is provided a nozzle assembly for a flexible multi-modal ablation needle as described above, the nozzle assembly comprising: the nozzle base is provided with a nozzle inner hole in an axial through manner; the nozzle shaft is formed by concavely arranging a plurality of axially extending semicircular grooves or grooves which are circumferentially spaced on the surface of the cylinder, the nozzle shaft penetrates through the nozzle inner hole, and the cylinder surface of the nozzle shaft is tightly matched with the hole wall of the nozzle inner hole, so that a plurality of nozzle holes are formed between the plurality of semicircular grooves or grooves and the hole wall.

Optionally, in the nozzle assembly according to the present utility model, the flexible multimode ablation needle comprises an air inlet tube, a distal end of which is adapted to be sleeved on an outer wall of the nozzle base so as to communicate with the plurality of nozzle holes and deliver cold source gas.

Optionally, in the nozzle assembly according to the utility model, an ablation needle base is arranged at the junction of the needle body of the flexible multimode ablation needle and the ablation catheter; the distal end of the air inlet pipe and the nozzle base are inserted into the ablation needle base together.

Optionally, in the nozzle assembly according to the present utility model, the outer wall of the nozzle base includes a first cylindrical surface and a second cylindrical surface coaxially joined, and a diameter of the first cylindrical surface is larger than a diameter of the second cylindrical surface; the inner surface of the far end of the air inlet pipe is tightly matched with and in sealing connection with the second cylindrical surface of the nozzle base; the inner wall of the ablation needle base is tightly matched with the first cylindrical surface of the nozzle base.

Optionally, in the nozzle assembly according to the present utility model, the inner wall of the ablation needle base has a plurality of slots adapted to form a plurality of air return holes with the first cylindrical surface of the nozzle base.

Optionally, in the nozzle assembly according to the present utility model, an expansion tube is formed at a distal end of the air inlet tube, and an inner hole of the expansion tube is tightly fitted with the second cylindrical surface of the nozzle base.

According to the technical scheme of the utility model, the flexible multi-mode ablation needle comprises an ablation needle head with a puncture function, an ablation catheter and a tube sheath. The ablation catheter comprises an ablation needle catheter positioned at the outermost side, the ablation needle is integrated at the distal end of the ablation catheter, and the ablation needle can be connected with the distal end of the ablation needle catheter. The sheath can be sleeved outside the ablation needle catheter and the ablation needle, and the sheath can slide relative to the ablation needle catheter and the ablation needle. When the puncture ablation operation is required to be performed on the target tissue, the tube sheath can be pushed to move to be close to the target tissue through the channel catheter, and the ablation needle catheter and the ablation needle are arranged in the tube sheath. Further, the ablation needle catheter and the ablation needle can be pushed to move relative to the sheath so that the ablation needle extends out of the sheath, and thus puncture operation and ablation operation (including cryoablation operation and radio frequency ablation operation) can be performed on target tissue by using the ablation needle. Thus, according to the technical scheme of the utility model, the medical device not only has a puncture function, but also can integrate two ablation functions of cryoablation and radio frequency ablation so as to perform multi-mode ablation treatment operation. And the ablation needle is always positioned in the tube sheath in the process of passing through the channel catheter, so that the ablation needle can be prevented from damaging the channel catheter.

In addition, according to the nozzle assembly, the nozzle base and the nozzle shaft are matched to form a side-by-side multi-nozzle structure, so that the small throttling sectional area of each nozzle is controlled, more cold source gas flows in unit time through the multi-nozzle structure, the flow rate of the cold source gas is improved, and the effects of improving the freezing rate and reducing the freezing temperature can be achieved at the same time. In addition, the complex multi-nozzle structure is realized through the two easily-machined parts of the nozzle base and the nozzle shaft, so that the complex part is split into the two easily-machined parts, the process complexity and the machining cost are reduced, and the manufacturability is improved.

The foregoing description is only an overview of the present utility model, and is intended to be implemented in accordance with the teachings of the present utility model in order that the same may be more clearly understood and to make the same and other objects, features and advantages of the present utility model more readily apparent.

Drawings

To the accomplishment of the foregoing and related ends, certain illustrative aspects are described herein in connection with the following description and the annexed drawings, which set forth the various ways in which the principles disclosed herein may be practiced, and all aspects and equivalents thereof are intended to fall within the scope of the claimed subject matter. The above, as well as additional objects, features, and advantages of the present disclosure will become more apparent from the following detailed description when read in conjunction with the accompanying drawings. Like reference numerals generally refer to like parts or elements throughout the present disclosure.

FIG. 1 illustrates a schematic structural view of a flexible multi-modal ablation needle 400 in accordance with one embodiment of the utility model;

FIG. 2 illustrates a schematic view of a partial structure of an ablation needle 100 of a flexible multi-modality ablation needle 400 within a sheath 210 in accordance with one embodiment of the utility model;

FIG. 3 illustrates a schematic view of a partial structure of an ablation needle 100 of a flexible multi-modality ablation needle 400 extending out of a sheath 210 in accordance with one embodiment of the present utility model;

fig. 4 shows a schematic structural view of an ablation needle 100 in accordance with one embodiment of the present utility model;

FIG. 5 shows a schematic structural view of a needle body 110 in accordance with one embodiment of the present utility model;

FIG. 6 illustrates a schematic structural view of a nozzle base 130 in accordance with one embodiment of the present utility model;

FIG. 7 shows a schematic structural view of a nozzle shaft 140 in one embodiment according to the present utility model;

fig. 8 shows a partial schematic structure of an intake pipe 250 in an embodiment according to the present utility model;

FIG. 9 illustrates a schematic structural view of an ablation needle base 120 in accordance with one embodiment of the present utility model;

FIGS. 10 and 11 are schematic views showing the structure of a control handle 300 according to an embodiment of the present utility model;

Fig. 12 shows an enlarged schematic view of the structure at M in fig. 11.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

In view of the shortcomings of the prior art ablation procedures, the present utility model proposes a flexible multi-modal ablation needle 400. The flexible multimode ablation needle 400 provided by the utility model not only has a puncture function, but also integrates two ablation functions of cryoablation and radio frequency ablation so as to perform multimode ablation operation.

FIG. 1 illustrates a schematic structural view of a flexible multi-modal ablation needle 400 in accordance with one embodiment of the utility model; FIG. 2 illustrates a schematic view of a partial structure of an ablation needle 100 of a flexible multi-modality ablation needle 400 within a sheath 210 in accordance with one embodiment of the utility model; fig. 3 illustrates a schematic view of a partial structure of an ablation needle 100 of a flexible multi-mode ablation needle 400 extending out of a sheath 210 according to one embodiment of the utility model.

According to an embodiment of the present utility model, when it is required to perform a penetrating ablation procedure on human tissue, the flexible multimode ablation needle 400 needs to be previously installed on a channel catheter communicating with the target tissue.

As shown in fig. 1-3, the flexible multi-modal ablation needle 400 may include an ablation needle 100 having a piercing function, an ablation catheter 200, and a sheath 210. Wherein the ablation catheter 200 includes an outermost positioned ablation needle catheter 230. The ablation needle 100 having a puncture function is integrated at the distal end of the ablation catheter 200, and the ablation needle 100 may be connected to the ablation catheter 230 (distal end). In particular, the ablation needle 100 may be fixedly connected directly or indirectly to the ablation needle catheter 230 as a single piece. Here, for convenience of description, an end of the ablation catheter 200 near the ablation needle 100 is taken as a distal end of the ablation catheter 200, and an end of the ablation catheter 200 remote from the ablation needle 100 is taken as a proximal end of the ablation catheter 200.

The sheath 210 may be sleeved outside of the ablation needle catheter 230 and the ablation needle 100, and the sheath 210 may be slid relative to the ablation needle catheter 230 and the ablation needle 100.

It should be noted that, according to the technical solution of the present utility model, during the puncture ablation procedure, the target tissue may be first punctured by using the ablation needle 100 with a puncture function to form an ablation channel, so that the ablation needle 100 may enter the center of the target tissue via the ablation channel to perform an ablation procedure (specifically, may include a cryoablation procedure and/or a radio frequency ablation procedure).

It will be appreciated that the ablation needle 100 with the piercing function requires a sharp structure to perform the piercing function, which results in the possibility that the ablation needle 100 will damage the channel catheter as it passes therethrough. Based on this, in the embodiment of the present utility model, by sleeving the sheath 210 on the outer sides of the ablation needle catheter 230 and the ablation needle 100, it can be used to protect the channel catheter, so as to avoid the ablation needle 100 from damaging the channel catheter during the process of passing through the channel catheter.

Specifically, when a penetrating ablation procedure is desired for the target tissue, the sheath 210 may be moved via the channel catheter (in communication with the target tissue) to close the target tissue by pushing the sheath 210, with the ablation needle catheter 230 and the ablation needle disposed within Guan Qiao (see, for example, the schematic view of the ablation needle 100 disposed within the sheath 210 shown in fig. 2). Next, the ablation needle catheter 230 and the ablation needle 100 may be pushed to move the ablation needle catheter 230 and the ablation needle 100 relative to the sheath 210 so that the ablation needle 100 extends out of the sheath 210 (see, in particular, the schematic structure of the ablation needle 100 extending out of the sheath 210 shown in FIG. 3), so that the target tissue may be subjected to a puncturing operation and an ablating operation by using the ablation needle 100. Thus, according to the technical scheme of the utility model, not only the puncture operation and the ablation operation can be completed once, but also the ablation needle 100 is always positioned in the sheath 210 in the process of passing through the channel catheter, so that the ablation needle 100 can be prevented from damaging the channel catheter.

It should be noted that, according to the flexible multimode ablation needle 400 of the present utility model, after performing a piercing operation on a target tissue through the ablation needle 100, an ablation operation on the target tissue via an ablation channel may include a cryoablation operation and a radio frequency ablation operation.

According to one embodiment of the present utility model, as shown in fig. 1, the flexible multi-modal ablation needle 400 may further include a control handle 300. A control handle 300 is disposed at the proximal end of the ablation catheter 200, the control handle 300 including a handle body 340 coupled to the ablation needle catheter 230, and a sheath control structure 320 coupled to the sheath 210. Here, the proximal end of the ablation catheter 200, i.e., the end of the ablation catheter 200 that is proximal to the control handle 300.

In this embodiment, when a penetrating ablation procedure is desired for the target tissue, the sheath 210 may be advanced out of the target tissue via the access catheter (where one end of the sheath 210 extends out of the access catheter) by manipulating the sheath control structure 320, where the sheath control structure 320 may be integral with the sheath 210. Next, by pushing the handle body 340 to move relative to the sheath 210, the ablation needle catheter 230 connected to the handle body 340 and the ablation needle 100 connected to the ablation needle catheter 230 can be moved synchronously relative to the sheath 210 (here, the handle body 340, the ablation needle catheter 230 and the ablation needle 100 are connected as a whole), so that the ablation needle 100 moves to extend out of the sheath 210, and thus, the ablation needle 100 can be used for performing puncture operation and ablation operation on target tissues. Specifically, in embodiments of the present utility model, the ablation operation may include a cryoablation operation, a radio frequency ablation operation.

In one embodiment, after the sheath 210 is pushed out through the channel catheter to close to the target tissue, the sheath 210 may be locked to fix the position of the sheath 210 extending out of the channel catheter.

As shown in fig. 2 and 3, the ablation needle 100 includes a hollow structured needle body 110.

Fig. 4 shows a schematic structural view of an ablation needle 100 according to an embodiment of the present utility model. Fig. 5 shows a schematic structural view of the needle body 110 according to an embodiment of the present utility model.

As shown in fig. 4 and 5, the needle body 110 of the ablation needle 100 has a polyhedral puncture body 111 so as to perform a puncture operation on a target tissue by the polyhedral puncture body 111. Here, the present utility model is not limited to the specific configuration of the polyhedral puncture body 111, as long as the polyhedral puncture body 111 has a sharp structure capable of realizing a puncturing operation.

In some embodiments, the polyhedral puncture body 111 may be, for example, a triangular prism or a conical body, but the present utility model is not limited thereto, and the polyhedral puncture body 111 may be other polyhedrons having sharp structures.

According to one embodiment of the present utility model, as shown in fig. 2-4, the ablation needle 100 also has a nozzle assembly comprising a nozzle base 130 and a nozzle shaft 140, wherein the nozzle base 130 is arranged at the junction of the needle body 110 and the ablation catheter 200. The nozzle assembly of the present utility model may achieve a side-by-side multiple nozzle configuration with a nozzle base 130 and a nozzle shaft 140.

Specifically, fig. 6 shows a schematic structural view of the nozzle base 130 in one embodiment of the present utility model. As shown in fig. 6, the nozzle base 130 has a nozzle inner hole 134 extending axially therethrough.

Fig. 7 shows a schematic structural view of the nozzle shaft 140 in one embodiment according to the present utility model. As shown in fig. 7, the nozzle shaft 140 may be formed by recessing a plurality of semicircular grooves or recesses 141 in the cylindrical surface 142. In other words, the nozzle shaft 140 includes a cylindrical body, and the cylindrical body surface 142 is concavely formed with a plurality of semicircular grooves or recesses 141. Specifically, the cylindrical surface 142 may be provided with a plurality of semicircular grooves or recesses 141 at intervals in the circumferential direction. Here, each semicircular groove or recess 141 extends axially through the cylinder, consistent with the length of the cylinder.

As shown in fig. 2 to 4, the nozzle shaft 140 may be disposed through the nozzle inner hole 134 of the nozzle base 130, and the cylindrical surface 142 of the nozzle shaft 140 may be closely spaced from the wall of the nozzle inner hole 134, so that a plurality of nozzle holes 140A may be formed between the plurality of semicircular grooves or recesses 141 and the wall of the nozzle inner hole 134, and the plurality of nozzle holes may serve as inlets for the cold source gas. In the present utility model, the two parts are firmly connected, for example, by an interference fit or by welding. Regardless of the manner of engagement, sufficient strength should be achieved to ensure safety and stability under high pressure. In the case of welding, the two parts may be a transition fit, thereby facilitating assembly.

It should be noted that the present utility model is not limited to the specific number of semi-circular grooves or recesses 141 included in the nozzle shaft 140. For example, in one embodiment, the nozzle shaft 140 may include 4 semicircular grooves or recesses 141, i.e., the nozzle shaft 140 may be formed by recessing 4 semicircular grooves or recesses 141 in the surface of the cylinder, and accordingly, 4 nozzle holes 140A may be formed between the 4 semicircular grooves or recesses 141 and the wall of the hole.

According to the nozzle assembly of the present utility model, the nozzle base 130 and the nozzle shaft 140 are combined to form a side-by-side multi-nozzle structure, so that the multi-nozzle structure can realize that more cold source gas flows in unit time and improve the flow rate of the cold source gas while controlling the small throttle sectional area of each nozzle, thereby simultaneously realizing the effects of improving the freezing rate and reducing the freezing temperature.

In addition, the complex multi-nozzle structure is realized by the two easily-machined parts of the nozzle base 130 and the nozzle shaft 140, so that the complex part is split into the two easily-machined parts, the process complexity and the machining cost are reduced, and the manufacturability is increased.

It should be noted that, the connection strength of the two parts of the nozzle base 130 and the nozzle shaft 140 can be ensured by double-end (laser) welding, so as to ensure safety and stability under high-pressure air source. Further, based on the dimensional stability of the machining, the stability of the nozzle hole size can be ensured, and the stability of the freezing performance can be ensured. To ensure more efficient delivery of the cold source gas after the J-T effect to the distal end of the ablation needle 100, the surface of the nozzle shaft may be machined to ensure a smooth surface with low roughness while ensuring that the nozzle shaft has a sufficient aspect ratio. In one embodiment, the aspect ratio of the nozzle shaft can range from 6L/W15, for example. The radial dimension W of the nozzle shaft can be, for example, 0.06 mm.ltoreq.W.ltoreq.0.2 mm, or alternatively, the radial dimension W of the nozzle shaft can be 0.12mm.

According to one embodiment of the present utility model, as shown in fig. 2 and 3, the ablation catheter 200 further includes an air inlet pipe 250 positioned at the innermost side, and a distal end of the air inlet pipe 250 is sleeved on an outer wall of the nozzle base 130, so that the air inlet pipe 250 may communicate with a plurality of nozzle holes, and cold source gas may be delivered through the air inlet pipe 250 to the plurality of nozzle holes so that the cold source gas is delivered to the distal end of the ablation needle 100 through the plurality of nozzle holes.

In one embodiment, as shown in fig. 2 and 3, the ablation needle 100 further comprises an ablation needle base 120, the ablation needle base 120 being disposed at the junction of the needle body 110 and the ablation catheter 200. The distal end of the air inlet tube 250, when secured to the outer wall of the nozzle base 130, may be inserted together within the ablation needle base 120.

In one embodiment, as shown in fig. 6, the outer wall of the nozzle base 130 includes a first cylindrical surface 133 and a second cylindrical surface 132 that are coaxially joined, wherein the diameter of the first cylindrical surface 133 is greater than the diameter of the second cylindrical surface 132.

Specifically, as shown in fig. 2 and 3, the distal inner surface of the air inlet tube 250 may be tightly fitted with, and sealingly connected to, the second cylindrical surface 132 of the nozzle base 130. In one implementation, as shown in fig. 6, an end of the second cylindrical surface 132 away from the first cylindrical surface 133 tapers toward the axis to form a truncated cone surface 131, so that the air inlet pipe 250 slides into and is sleeved on the second cylindrical surface 132 via the truncated cone surface 131, and is in interference fit with the second cylindrical surface.

In one implementation, the material of the air inlet pipe 250 may be soft red copper or soft stainless steel. The distal inner surface of the air inlet pipe 250 and the second cylindrical surface 132 of the nozzle base 130 may be fixedly coupled together by welding.

The inner wall of the ablation needle base 120 may mate with the first cylindrical surface 133 of the nozzle base 130, the distal outer surface of the air inlet tube 250. In addition, a stable structure can be formed by welding around the end surfaces of the ablation needle base 120 and the nozzle base 130.

Fig. 8 shows a partial schematic structure of an intake pipe 250 in an embodiment according to the present utility model. As shown in fig. 8, the distal end (head) of the intake pipe 250 is formed with an expansion pipe 252, and a pipe body step 253 is formed between the outer surface of the expansion pipe 252 and the outer surface of the intake pipe 250. The inner bore 251 of the expansion tube 252 may mate with the second cylindrical surface 132 of the nozzle base 130.

Fig. 9 shows a schematic structural view of an ablation needle base 120 in accordance with one embodiment of the present utility model.

As shown in fig. 9, the inner wall of the ablation needle base 120 is concavely provided with a plurality of slots 121 (which do not penetrate the wall of the ablation needle base 120). Specifically, the inner wall of the ablation needle base 120 may be provided with a plurality of slots 121 at intervals in the circumferential direction. As shown in fig. 4, a plurality of air return holes 120A may be formed between the plurality of slots 121 of the inner wall of the ablation needle base 120 and the first cylindrical surface 133 of the nozzle base 130. In this way, the plurality of air return holes are arranged concentrically with the plurality of air inlets.

In one embodiment, as shown in fig. 9, the inner wall of the ablation needle base 120 includes a first inner bore surface 123 and a second inner bore surface 122 that engage one another. Here, the second bore surface 122 is located near one end of the control handle 300.

Wherein the first bore surface 123 may be coated on the distal outer surface of the air inlet tube 250. The diameter of the second bore surface 122 is smaller than the diameter of the distal outer surface of the air inlet tube 250 (and accordingly, the diameter of the second bore surface 122 is smaller than the diameter of the first bore surface 122), so that the air inlet tube 250 and the nozzle base 130 can be restricted from moving toward the end near the control handle 300.

According to the structure, the connecting structure of the air inlet pipe and the nozzle assembly adopts the principle similar to an expansion bolt, so that the air inlet pipe and the nozzle assembly are connected more stably and reliably.

In one embodiment, as shown in fig. 2 and 3, the flexible multi-modal ablation needle 400 further includes a thermocouple 220, the thermocouple 220 being insertable through any one of the slots 121 of the ablation needle base 120 and secured to the interior wall of the needle body 110 such that the temperature of the target tissue during the ablation process can be measured by the thermocouple 220. For example, the thermocouple 220 may be fixed to the inner wall of the needle body 110 by welding or bonding after passing through the slot 121.

In one embodiment, as shown in fig. 2 and 3, one portion of the ablation needle base 120 is secured through the needle body 110 and another portion is secured through the ablation needle catheter 230.

In one embodiment, as shown in fig. 9, the outer wall 125 of the ablation needle base 120 is provided with a step surface 126, the outer wall 125 of the ablation needle base 120 is tightly matched with the inner wall of the needle body 110, and the step surface 126 is mutually abutted and connected with the end surface 112 of the needle body 110 in a sealing manner. For example, after the step surface 126 is aligned with the end surface of the needle body 110, a continuous weld may be made between the step surface 126 and the end surface 112 of the needle body 110 to ensure a sealed connection between the ablation needle base 120 and the needle body 110 without leakage of gas.

In addition, the outer wall of the ablation needle base 120 is also convexly provided with a plurality of barb steps 127. The ablation needle catheter 230 may be passed over the plurality of barb steps 127 of the outer wall of the ablation needle base 120 by a slight interference fit and aligned with the end face 112 of the needle body 110.

According to one embodiment of the present utility model, the ablation catheter 200 further comprises a metallic hypotube 240, the metallic hypotube 240 is disposed between the air inlet tube 250 and the ablation needle catheter 230, and the metallic hypotube 240 is sleeved over the ablation needle base 120. The metallic hypotube 240 may be made of nitinol or a high elastic alloy.

In one embodiment, the ablation needle base 120 is provided with a connecting post 128 extending toward an end proximate to the control handle 300. The distal end of the metallic hypotube 240 is sleeved over the connecting post 128 and may be welded to the connecting post 128.

It should be noted that, in the embodiment of the present utility model, the air inlet pipe 250 is made of a metal material (such as red copper) with a soft good conductor, so that the air inlet pipe 250 can replace a wire for radio frequency ablation.

Additionally, in one embodiment, ablation needle catheter 230 and sheath 210 may be extruded from a plastic such as tetrafluoroethylene, nylon, pebax, or the like, to provide both electrical and thermal insulation protection.

According to one embodiment of the present utility model, the control handle 300 further includes a connector lock 310, wherein the connector lock 310 may be coupled to and lock the channel catheter such that the flexible multi-modal ablation needle 400 may be secured to the channel catheter by the connector lock 310.

In one implementation, the connector latch 310 includes a latch body 312, a connector portion 311. The connector portion 311 may be fixedly connected to the latch body 312 to secure the flexible multi-modal ablation needle 400 of the present utility model to the channel catheter. Here, the specific connection structure of the interface portion 311 and the latch body 312 is not limited, as long as the connection structure for fixing the flexible multimode ablation needle 400 on the channel catheter can be realized, which is within the scope of the present utility model.

In one embodiment, the outer wall of the latch body 312 may be provided with guide grooves in the axial direction. The sheath control structure 320 is slidably coupled to the guide channel such that by manipulating the sheath control structure 320 to slide along the guide channel, the sheath 210 coupled thereto is moved synchronously (relative to the channel catheter) such that the sheath 210 extends from the channel catheter and moves adjacent the target tissue.

Fig. 10 and 11 respectively show a schematic structural view of a control handle 300 according to an embodiment of the present utility model.

In one embodiment, as shown in fig. 10 and 11, the sheath control structure 320 may include a first connection 323, a cannula 324, the first connection 323 may be fixedly connected with the cannula 324, and the cannula 324 (the end distal from the ablation needle 100) may be fixedly connected with the sheath 210, thereby connecting the sheath control structure 320 with the sheath 210. The first connecting portion 323 of the sheath control structure 320 can be slidably connected with the guiding slot on the lock catch body 312, so that the sheath 210 can be driven to move synchronously by operating the first connecting portion 323 to slide along the guiding slot.

In addition, the sheath control structure 320 may further include a control screw 321, and the control screw 321 may be fixedly connected to the latch body 312. After the sheath 210 is moved to a position close to the target tissue by operating the sheath control structure 320, the position of the sheath 210, i.e., the position where the sheath 210 extends out of the channel catheter, can be locked by fixedly connecting the control screw 321 with the locking body 312, so that the sheath 210 is fixed with respect to the channel catheter.

Specifically, by fixedly connecting the control screw 321 with the first connecting portion 323, the control screw 321 may extend into the guide groove of the lock catch body 312 to fix, so that the entire sheath control structure 320 may be fixed to the lock catch body 312, thereby realizing locking of the sheath control structure 320 and the sheath 210.

In one implementation, as shown in fig. 10 and 11, the first connecting portion 323 is axially sleeved on the latch body 312 and slidably connected with the guide groove of the latch body 312. One end of the sleeve 324, which is adjacent to the ablation needle 100, is fixedly disposed axially through the first connecting portion 323. An internal threaded hole 322 (the internal threaded hole 322 is arranged perpendicular to the axial direction of the latch body 312) that matches the control screw 321 is provided in the first connecting portion 323. The control screw 321 is fixedly connected to the first connecting portion 323 and fixed to the latch body 312 by screwing the control screw 321 to the female screw hole 322, so that the sheath control structure 320 is fixed to the latch body 312 by the control screw 321.

According to one embodiment of the present utility model, as shown in fig. 1, 10 and 11, the control handle 300 further includes an ablation needle limiter 330, the ablation needle limiter 330 being connectable to the sheath control structure 320, movement of the handle body 340 relative to the sheath 210 (and the sheath control structure 320 connected to the sheath 210) being blocked by the ablation needle limiter 330 so as to limit the position of the ablation needle 100 extending out of the sheath 210.

In particular, the ablation needle limiter 330 may include a limit ratchet 332, and the handle body 340 may be blocked from moving relative to the sheath 210 by the connection of the limit ratchet 332 to the sheath control structure 320, so as to control the position of the ablation needle 100 extending out of the sheath 210.

In one embodiment, as shown in fig. 10 and 11, the ablation needle stop 330 includes a second connection 331 that is sleeved over the cannula 324 of the sheath control structure 320. The limit ratchet 332 may be coupled to the sleeve 324 of the sheath control structure 320 via a second coupling portion 331.

Fig. 12 shows an enlarged schematic view of the structure at M in fig. 11. As shown in fig. 12, the interior of the handle body 340 may be fixedly connected to the proximal end of the ablation needle catheter 230 (the sheath 210 does not extend to the proximal end of the ablation needle catheter 230), the air inlet tube 250 is disposed through the ablation needle catheter 230, and a metallic hypotube is disposed between the air inlet tube 250 and the ablation needle catheter 230. Thus, by pushing the handle body 340 relative to the sheath 210, the ablation needle catheter 230 (and the ablation needle 100) fixedly connected with the handle body 340 can be synchronously driven to move relative to the sheath 210. In addition, as shown in fig. 12, the control handle 300 further includes a stop block 334 disposed within the handle body 340, the stop block 334 may be secured to the ablation catheter 230, and the stop block 334 may be sleeved over the cannula 324 (the end distal from the ablation needle 100) of the sheath control structure 320 and may be movable relative to the cannula 324. In one embodiment, the stop 334 may be threadably coupled to the cannula 324 (the end distal from the ablation needle 100), for example, for movement relative to the cannula 324, the sheath control structure 320.

According to the above structure, the handle body 340, the stopper 334, the ablation needle catheter 230 (and the ablation needle 100) are integrally connected, and can move with respect to the sheath control structure 320 and the sheath 210. And, the limit ratchet 332 is connected with the sleeve 324 of the sheath control structure 320 through the second connecting portion 331, so that the movement of the handle body 340, the limit block 334, the ablation needle catheter 230 (and the ablation needle 100) relative to the sheath control structure 320 (sleeve 324) and the sheath 210 can be blocked, and the distance that the ablation needle 100 extends out of the sheath 210 can be controlled.

Furthermore, to achieve a multi-modality ablation procedure, in one embodiment of the present utility model, as shown in fig. 1, 10 and 11, the flexible multi-modality ablation needle 400 further includes a connection cable 350, which connection cable 350 may be connected to a control host. The connection cable 350 may specifically include an air inlet pipe for delivering cold source gas, an air return pipe (communicating with the air return hole), a thermocouple wire, and a radio frequency ablation wire, wherein the radio frequency ablation wire may be integrated into the air inlet pipe.

It is worth noting that according to the flexible multi-mode ablation needle of the utility model, when the flexible multi-mode ablation needle is used for tumor ablation through a natural cavity, the J-T effect of high-pressure gas can be selected to generate low temperature, the temperature of the distal end tool bit of the ablation needle needs to reach-140 to-170 ℃, argon or nitrogen can be used as cold source gas, and the air inlet working pressure is generally above 10 Mpa. In a specific implementation mode, the air inlet working pressure range of the nitrogen can be 8-18 Mpa, and the precooling temperature range can be-80 ℃ to-100 ℃; the working pressure range of the argon gas inlet can be 15-25 Mpa.

In addition, because the outer diameter of the flexible multimode ablation needle passing through the airway and the lung is limited, the diameter of the flexible multimode ablation needle needs to be smaller than 2mm, in order to integrate the ablation needle with the puncture function into the flexible multimode ablation needle and avoid the ablation needle from damaging the channel catheter, the outer diameter of the flexible multimode ablation needle can be further reduced, and a tube sheath is additionally arranged outside the ablation needle and the ablation catheter, so that the protection effect on the channel catheter is realized. After the sheath is added, the outer diameter of the ablation needle catheter can be reduced to about 1.5 mm.

Because the flexible multimode ablation needle not only needs certain flexibility, but also needs certain elasticity and rigidity after the ablation needle head extends out of the ablation catheter, the high-elasticity metal hypotube can be arranged in the ablation catheter at the same time.

According to one aspect of the present utility model, there is also provided a nozzle assembly that may be used with the flexible multi-modal ablation needle 400 as described above.

In an embodiment of the present utility model, the nozzle assembly may include a nozzle base 130 and a nozzle shaft 140. Wherein fig. 6 illustrates a schematic structural view of a nozzle base 130 according to an embodiment of the present utility model, and fig. 7 illustrates a schematic structural view of a nozzle shaft 140 according to an embodiment of the present utility model. The nozzle assembly of the present utility model may achieve a side-by-side multiple nozzle configuration with a nozzle base 130 and a nozzle shaft 140.

In one embodiment, the nozzle base 130 may be disposed at the junction of the needle body 110 of the flexible multi-modal ablation needle 400 and the ablation catheter 200.

As shown in fig. 6, the nozzle base 130 has a nozzle inner hole 134 extending axially therethrough.

As shown in fig. 7, the nozzle shaft 140 may be formed by recessing a plurality of semicircular grooves or recesses 141 in the cylindrical surface 142. In other words, the nozzle shaft 140 includes a cylindrical body, and the cylindrical body surface 142 is concavely formed with a plurality of semicircular grooves or recesses 141. In one embodiment, the cylindrical surface 142 may be provided with a plurality of semi-circular grooves or recesses 141 circumferentially spaced apart. Here, each semicircular groove or recess 141 extends axially through the cylinder, consistent with the length of the cylinder.

It should be noted that the present utility model is not limited to the specific number of semi-circular grooves or recesses 141 included in the nozzle shaft 140. For example, in one embodiment, the nozzle shaft 140 may include 4 semicircular grooves or recesses 141, i.e., the nozzle shaft 140 may be formed by recessing 4 semicircular grooves or recesses 141 in the surface of the cylinder, and accordingly, 4 nozzle holes may be formed between the 4 semicircular grooves or recesses 141 and the wall of the hole.

In one embodiment, as shown in fig. 2 and 3, the ablation catheter 200 of the flexible multi-mode ablation needle 400 further includes an innermost air inlet tube 250, and a distal end of the air inlet tube 250 may be sleeved on an outer wall of the nozzle base 130, such that the air inlet tube 250 may be in communication with a plurality of nozzle holes, and cold source gas may be delivered through the air inlet tube 250 to the plurality of nozzle holes so that the cold source gas is delivered to the distal end of the ablation needle 100 through the plurality of nozzle holes.

In one embodiment, as shown in fig. 2 and 3, the ablation needle 100 of the flexible multi-modality ablation needle 400 further comprises an ablation needle base 120, the ablation needle base 120 being arranged at the junction of the needle body 110 and the ablation catheter 200. The distal end of the air inlet tube 250, when secured to the outer wall of the nozzle base 130, may be inserted together within the ablation needle base 120.

Specifically, as shown in fig. 2 and 3, the distal inner surface of the air inlet tube 250 may be tightly fitted with, and sealingly connected to, the second cylindrical surface 132 of the nozzle base 130. In one implementation, the material of the air inlet pipe 250 may be red copper or soft stainless steel. The distal inner surface of the air inlet pipe 250 and the second cylindrical surface 132 of the nozzle base 130 may be fixedly coupled together by welding.

In one embodiment, as shown in fig. 8, the distal end (head) of the intake pipe 250 is formed with an expansion pipe 252, and a pipe body step 253 is formed between the outer surface of the expansion pipe 252 and the outer surface of the intake pipe 250. The inner bore 251 of the expansion tube 252 may mate with the second cylindrical surface 132 of the nozzle base 130.

In one embodiment, as shown in fig. 9, the inner wall of the ablation needle base 120 is recessed with a plurality of slots 121 (not extending through the wall of the ablation needle base 120). Specifically, the inner wall of the ablation needle base 120 may be provided with a plurality of slots 121 at intervals in the circumferential direction. The plurality of slots 121 on the inner wall of the ablation needle base 120 may form a plurality of air return holes with the first cylindrical surface 133 of the nozzle base 130. Thus, the plurality of air return holes are arranged concentrically with the plurality of air intake holes.

It should be noted that, for the specific configuration of the nozzle assembly (including the nozzle base 130 and the nozzle shaft 140) and the specific application thereof on the flexible multi-modality ablation needle 400, reference is made to the specific description of the flexible multi-modality ablation needle 400 in the foregoing embodiments, and the detailed description thereof will not be repeated herein.

In summary, the flexible multimode ablation needle according to the utility model comprises an ablation needle head with a puncture function, an ablation catheter and a sheath. The ablation catheter comprises an ablation needle catheter positioned at the outermost side, the ablation needle is integrated at the distal end of the ablation catheter, and the ablation needle can be connected with the distal end of the ablation needle catheter. The sheath can be sleeved outside the ablation needle catheter and the ablation needle, and the sheath can slide relative to the ablation needle catheter and the ablation needle. When the puncture ablation operation is required to be performed on the target tissue, the tube sheath can be pushed to move to be close to the target tissue through the channel catheter, and the ablation needle catheter and the ablation needle are arranged in the tube sheath. Further, the ablation needle catheter and the ablation needle can be pushed to move relative to the sheath so that the ablation needle extends out of the sheath, and thus puncture operation and ablation operation (including cryoablation operation and radio frequency ablation operation) can be performed on target tissue by using the ablation needle. Thus, according to the technical scheme of the utility model, the medical device not only has a puncture function, but also can integrate two ablation functions of cryoablation and radio frequency ablation so as to perform multi-mode ablation treatment operation. And the ablation needle is always positioned in the tube sheath in the process of passing through the channel catheter, so that the ablation needle can be prevented from damaging the channel catheter.

According to the nozzle assembly, the nozzle base and the nozzle shaft are matched to form a side-by-side multi-nozzle structure, so that the small throttling sectional area of each nozzle is controlled, more cold source gas flows in unit time through the multi-nozzle structure, the flow rate of the cold source gas is improved, and the effects of improving the freezing rate and reducing the freezing temperature are achieved at the same time. In addition, the complex multi-nozzle structure is realized through the two easily-machined parts of the nozzle base and the nozzle shaft, so that the complex part is split into the two easily-machined parts, the process complexity and the machining cost are reduced, and the manufacturability is improved.

In the description of the present specification, the terms "coupled," "fixed," and the like are to be construed broadly unless otherwise specifically indicated and defined. Furthermore, the terms "front," "rear," "upper," "lower," "inner," "outer," "top," "bottom," and the like refer to an azimuth or positional relationship based on that shown in the drawings, merely to facilitate description of the utility model and to simplify the description, and do not refer to or imply that the devices or units referred to must have a particular orientation, be configured and operated in a particular orientation, and therefore, should not be construed as limiting the utility model.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the utility model may be practiced without these specific details. In some instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Similarly, it should be appreciated that in the foregoing description of exemplary embodiments of the utility model, various features of the utility model are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, the disclosed method should not be construed as reflecting the intention that: i.e., the claimed utility model requires more features than are expressly recited in each claim. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this utility model.

Those skilled in the art will appreciate that the modules or units or components of the devices in the examples disclosed herein may be arranged in a device as described in this embodiment, or alternatively may be located in one or more devices different from the devices in this example. The modules in the foregoing examples may be combined into one module or may be further divided into a plurality of sub-modules.

Those skilled in the art will appreciate that the modules in the apparatus of the embodiments may be adaptively changed and disposed in one or more apparatuses different from the embodiments. The modules or units or components of the embodiments may be combined into one module or unit or component and, furthermore, they may be divided into a plurality of sub-modules or sub-units or sub-components. Any combination of all features disclosed in this specification (including any accompanying claims, abstract and drawings), and all of the processes or units of any method or apparatus so disclosed, may be used in combination, except insofar as at least some of such features and/or processes or units are mutually exclusive. Each feature disclosed in this specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise.

Furthermore, those skilled in the art will appreciate that while some embodiments described herein include some features but not others included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the utility model and form different embodiments.

Furthermore, some of the embodiments are described herein as methods or combinations of method elements that may be implemented by a processor of a computer system or by other means of performing the functions. Thus, a processor with the necessary instructions for implementing the described method or method element forms a means for implementing the method or method element. Furthermore, the elements of the apparatus embodiments described herein are examples of the following apparatus: the apparatus is for carrying out the functions performed by the elements for carrying out the objects of the utility model.

As used herein, unless otherwise specified the use of the ordinal terms "first," "second," "third," etc., to describe a general object merely denote different instances of like objects, and are not intended to imply that the objects so described must have a given order, either temporally, spatially, in ranking, or in any other manner.

While the utility model has been described with respect to a limited number of embodiments, those skilled in the art, having benefit of the above description, will appreciate that other embodiments are contemplated within the scope of the utility model as described herein. Furthermore, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and may not have been selected to delineate or circumscribe the inventive subject matter. Accordingly, many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the appended claims. The disclosure of the present utility model is intended to be illustrative, but not limiting, of the scope of the utility model, which is defined by the appended claims.

Claims

1. A flexible multi-modal ablation needle comprising:

an ablation catheter comprising an ablation needle catheter located outermost;

the ablation needle head with the puncture function is integrated at the distal end of the ablation catheter and is connected with the ablation needle catheter;

the tube sheath is suitable for being sleeved outside the ablation needle catheter and the ablation needle head;

wherein the sheath is adapted to be moved into proximity with a target tissue via a channel catheter; the ablation needle catheter and the ablation needle are suitable for moving relative to the tube sheath so that the ablation needle extends out of the tube sheath to perform puncture operation and ablation operation on target tissues, wherein the ablation operation at least comprises cryoablation operation and radio frequency ablation operation.

2. The flexible multimode ablation needle of claim 1, wherein the ablation needle comprises a hollow needle body having a polyhedral puncture for performing a puncturing operation on target tissue through the polyhedral puncture.

3. The flexible multimode ablation needle of claim 2, wherein the polyhedral puncture body is a triangular prism or a conical or polygonal body.

4. The flexible multimode ablation needle of claim 2, wherein the ablation needle further comprises a nozzle assembly comprising:

The nozzle base is arranged at the joint of the needle head body and the ablation catheter and is provided with a nozzle inner hole in an axial through manner;

the nozzle shaft is formed by concavely arranging a plurality of axially extending semicircular grooves or grooves on the surface of the cylinder body, the semicircular grooves or grooves are circumferentially spaced, the nozzle shaft penetrates through the nozzle inner hole, the surface of the cylinder body of the nozzle shaft is tightly matched with the hole wall of the nozzle inner hole, and therefore a plurality of side-by-side axially extending nozzle holes are formed between the semicircular grooves or grooves and the hole wall.

5. The flexible multimode ablation needle of claim 4, wherein the ablation catheter further comprises an innermost air inlet tube, a distal end of the air inlet tube being sleeved on an outer wall of the nozzle base so as to communicate with the plurality of nozzle holes and deliver cold source gas.

6. The flexible multimode ablation needle of claim 5, wherein the ablation needle further comprises an ablation needle base disposed at a junction of the needle body and the ablation catheter;

the distal end of the air inlet pipe and the nozzle base are inserted into the ablation needle base together.

7. The flexible multimode ablation needle of claim 6, wherein,

The outer wall of the nozzle base comprises a first cylindrical surface and a second cylindrical surface which are coaxially connected, and the diameter of the first cylindrical surface is larger than that of the second cylindrical surface;

the inner surface of the far end of the air inlet pipe is tightly matched with and in sealing connection with the second cylindrical surface of the nozzle base;

the inner wall of the ablation needle base is tightly matched with the first cylindrical surface of the nozzle base.

8. The flexible multimode ablation needle of claim 7, wherein,

the inner wall of the ablation needle base is provided with a plurality of slotted holes, and the slotted holes are suitable for forming a plurality of air return holes with the first cylindrical surface of the nozzle base.

9. The flexible multimode ablation needle of claim 7, wherein,

an expansion pipe is formed at the far end of the air inlet pipe, and an inner hole of the expansion pipe is tightly matched with the second cylindrical surface of the nozzle base.

10. The flexible multimode ablation needle of claim 8, further comprising:

a thermocouple adapted to pass through any one of the slots and to be fixed to the inner wall of the needle body so as to measure the temperature of the ablation process.

11. The flexible multimode ablation needle of claim 7, wherein,

the inner wall of the ablation needle base comprises a first inner hole surface and a second inner hole surface which are mutually connected;

The first inner hole surface is suitable for being coated on the outer surface of the far end of the air inlet pipe;

the diameter of the second bore surface is smaller than the diameter of the distal outer surface of the inlet tube to limit movement of the inlet tube and nozzle base toward an end proximate the control handle.

12. The flexible multimode ablation needle of claim 6, wherein a portion of the ablation needle base is secured within the needle body and another portion is secured within the ablation needle catheter.

13. The flexible multimode ablation needle of claim 12, wherein the outer wall of the ablation needle base is provided with a convex stepped surface, the outer wall of the ablation needle base being in close fit with the inner wall of the needle body, the stepped surface being adapted to abut and sealingly connect with the end face of the needle body.

14. The flexible multimode ablation needle of claim 12, wherein the outer wall of the ablation needle base is convexly provided with a plurality of barb steps;

the ablation needle catheter is suitable for being sleeved on the barb steps in an interference mode and is aligned with the end face of the needle head body.

15. The flexible multi-modality ablation needle of claim 6, wherein the ablation catheter further comprises:

The metal hypotube is arranged between the air inlet pipe and the ablation needle catheter and sleeved on the ablation needle base.

16. The flexible multimode ablation needle of claim 15, wherein,

the ablation needle base is provided with a connecting column in an extending way towards one end close to the control handle;

the far end of the metal hypotube is sleeved on the connecting column and is suitable for being welded and fixed with the connecting column.

17. The flexible multimode ablation needle of claim 5, wherein,

the air inlet pipe is made of red copper or soft stainless steel.

18. The flexible multimode ablation needle of claim 1, further comprising:

a control handle disposed at a proximal end of the ablation catheter, the control handle comprising a handle body connected to the ablation catheter, a sheath control structure connected to the sheath;

wherein the sheath control structure is adapted to push the sheath out through the channel catheter to close to the target tissue by manipulating the sheath; the handle body is pushed to drive the ablation needle catheter and the ablation needle to move relative to the tube sheath, so that the ablation needle extends out of the tube sheath and performs puncture operation and ablation operation on target tissues.

19. The flexible multimodal ablation needle of claim 18, wherein the control handle further comprises:

and the ablation needle limiter is connected with the sheath control structure and is suitable for blocking the handle body from moving relative to the sheath so as to limit the position of the ablation needle extending out of the sheath.

20. The flexible multimodal ablation needle of claim 18, wherein the control handle further comprises:

a connector lock adapted to connect with and lock the channel catheter to secure the flexible multi-modal ablation needle to the channel catheter via the connector lock.

21. The flexible multimode ablation needle of claim 20, wherein the connector latch comprises a latch body, an outer wall of the latch body being axially provided with a guide slot;

the sheath control structure is adapted for sliding connection with the guide slot so as to drive the sheath to move closer to the target tissue.

22. The flexible multimode ablation needle of claim 21, wherein the sheath control structure comprises:

the control screw is suitable for being fixedly connected with the lock catch body so as to lock the position of the tube sheath.

23. The flexible multimode ablation needle of claim 15, wherein the metallic hypotube is made of a nickel-titanium memory alloy or a high elastic alloy.

24. A flexible multimode ablation needle according to claim 4, wherein the ratio L/W of the length L of the nozzle shaft to the radial dimension W is greater than 10, for example in the range 6L/W15.

25. The flexible multimode ablation needle of claim 4, wherein the radial dimension W of the nozzle shaft is in the range of 0.06mm +.w+.0.2 mm.

26. The flexible multimode ablation needle according to claim 5, wherein the inlet working pressure of the inlet tube is in the range of 8-18 Mpa in the case of using nitrogen as the cold source gas.

27. The flexible multimode ablation needle of claim 5, wherein the air inlet working pressure of the air inlet pipe is in the range of 15-25 Mpa in the case of using argon gas as cold source gas.

28. The flexible multimode ablation needle of claim 4, wherein the nozzle orifice is a nozzle orifice of a throttled configuration.