CN218515802U

CN218515802U - Radio frequency ablation catheter kit, radio frequency ablation device and radio frequency ablation system

Info

Publication number: CN218515802U
Application number: CN202220824893.1U
Authority: CN
Inventors: 孙加源; 谢芳芳; 陈军祥; 刘帅洋; 叶霖; 张琴
Original assignee: Shanghai Chest Hospital
Current assignee: Shanghai Chest Hospital
Priority date: 2022-04-11
Filing date: 2022-04-11
Publication date: 2023-02-24
Anticipated expiration: 2032-04-11

Abstract

The utility model provides a radiofrequency ablation catheter external member, radiofrequency ablation equipment, radiofrequency ablation system belongs to the radiofrequency ablation field based on electromagnetic navigation technology. The utility model discloses a pipe unit, sheath pipe and electromagnetic sensing unit. The catheter unit comprises an ablation electrode, the sheath comprises a working channel used for establishing the catheter unit, the working channel is used for the catheter unit to penetrate in and out, and the position of the ablation electrode relative to the working channel is adjustable. The electromagnetic sensing unit is located at the first end of the sheath and is arranged to be relatively fixed with the working channel, and the electromagnetic sensing unit is used for positioning the ablation electrode which extends out of the first end of the sheath. The utility model discloses it is adjustable to utilize the distance between ablation electrode and the electromagnetic sensing unit, has improved this positional information's accuracy when having realized the positional information who obtains ablation electrode in real time.

Description

Radio frequency ablation catheter kit, radio frequency ablation device and radio frequency ablation system

Technical Field

The utility model relates to a radiofrequency ablation field based on electromagnetic navigation technology especially relates to a radiofrequency ablation pipe external member, radiofrequency ablation equipment, radiofrequency ablation system.

Background

Radio frequency thermal ablation is a minimally invasive tumor in-situ treatment technology, which converts radio frequency signals into a temperature field and treats human tissues through thermal effect. When the radiofrequency ablation therapy is applied, the ablation electrode is directly inserted into focal tissues, the high-frequency alternating current at the tip of the ablation electrode is emitted into the focal tissues, and ions in the focal tissues are changed along with the change of the current direction, so that heat is generated, and local tissues of the focal are heated. When the temperature of the tissue exceeds 60 ℃, the cells die, and finally the tumor tissue is coagulated and inactivated.

In the existing interventional radio frequency thermal ablation based on the electromagnetic navigation technology, a path reaching a lesion position is planned, then a solid catheter with an electromagnetic positioning sensor is used, and a bronchoscope and other equipment are operated to enable the catheter to reach the lesion position through a position signal transmitted back by the electromagnetic positioning sensor and a navigation function of related software. In navigation software, a plurality of image viewing angles are usually displayed, and as the catheter is advanced, bent or withdrawn, the real-time position change of the electromagnetic positioning sensor is reflected in each viewing angle picture.

The electromagnetic positioning sensor comprises a coil, and corresponding position information is acquired through a current signal generated by a cutting magnetic field. Due to the morphological limitations of coils and coil combinations, electromagnetic positioning sensors are often built into solid catheters in the form of a positioning core wire. The positioning catheter with the electromagnetic positioning sensor needs to be withdrawn from the positioning catheter by virtue of a sheath tube after the positioning catheter and the sheath tube pass through a natural cavity in a body to reach a target position, the sheath tube is used as an established working channel, and various treatment tools (such as catheters for ablation) and sampling tools (such as biopsy forceps and biopsy needles) can reach the target position through the sheath tube to carry out corresponding operation.

As described above, the current electromagnetic positioning sensor needs to be withdrawn from the patient after reaching the lesion site, and then perform other operations such as treatment or sampling, which results in the loss of guidance of the positioning signal during the operation, and the working channel established by the sheath is likely to be displaced, resulting in ineffective treatment and sampling.

Some prior arts may integrate the electromagnetic positioning sensor at the head end of the treatment tool or the sampling tool, however, one of the most common defects in the application of the electromagnetic navigation technology is that a metal object near the electromagnetic navigation device may affect the magnetic field for positioning, so that the magnetic field is distorted, thereby causing a deviation of the positioning signal obtained by the positioning sensor. At present, strict requirements are still provided for placing peripheral metal objects in the use process of electromagnetic navigation equipment. Since the ablation electrode is made of metal, the distortion of the magnetic field is difficult to avoid. When the electromagnetic positioning sensor is integrated at the head end of the treatment tool or the sampling tool, the positioning signal is affected by the ablation electrode, resulting in reduced positioning accuracy. In addition, in the ablation process, a temperature sensor is integrated in the catheter for ablation, when the electromagnetic positioning sensor is in a working environment with high temperature for a long time, the working life of the electromagnetic positioning sensor is greatly influenced, and the change of the temperature can cause the impedance change of the coil, so that the positioning accuracy of the electromagnetic navigation is further influenced.

Based on the above situation, there is an urgent need to develop a radio frequency ablation catheter kit based on electromagnetic navigation technology, in which the electromagnetic positioning sensor is less affected by the metal components of the ablation electrode, and can be far away from the temperature field generated by the ablation electrode in the radio frequency ablation process.

Disclosure of Invention

The utility model provides a radio frequency melts pipe external member, radio frequency melting equipment, radio frequency melting system has solved and has withdrawn from electromagnetic positioning sensor behind the arrival kitchen range position and lead to the treatment invalid with the sample, lead to the problem that positioning accuracy is low with electromagnetic positioning sensor integration in treatment instrument and sampling tool department.

In order to solve the technical problem, the utility model provides a radiofrequency ablation catheter kit, include:

a catheter unit including an ablation electrode;

the sheath tube is used for establishing a working channel for the catheter unit, the working channel is used for the catheter unit to penetrate in and out, and the position of the ablation electrode relative to the working channel is adjustable;

and the electromagnetic sensing unit is positioned at the first end of the sheath and is arranged to be relatively fixed with the working channel, and the electromagnetic sensing unit is used for positioning the ablation electrode which extends out of the first end.

Optionally, the sheath is a single-layer tube.

Optionally, the sheath tube is a multilayer tube, and adjacent layers are attached to each other;

the sheath tube comprises a mounting groove for accommodating the electromagnetic sensing unit, and the mounting groove occupies one or more layers of the sheath tube in the radial direction;

any one layer or any multiple layers of the sheath pipe are made of high polymer materials;

the radio frequency ablation catheter kit further comprises a bending control section capable of bending and deforming, and adjacent sheath tubes are connected through the bending control section; the bending control section comprises a bending control wire, and the bending control section generates bending deformation by stretching the bending control wire.

Optionally, the sheath pipe is the double-layer pipe, the sheath pipe includes inlayer and laminating the skin that the outer wall of inlayer set up, the skin is equipped with and is used for the holding electromagnetic sensing unit's mounting groove, the opening orientation of mounting groove the inlayer.

Optionally, the electromagnetic sensing unit includes a coil disposed around the working channel;

the coil is fixed on the inner wall of the working passage or fixed on the periphery of the working passage;

the electromagnetic sensing unit further comprises a cable fixed in the sheath, and the coil transmits positioning information to the outside through the cable.

Optionally, the catheter unit further comprises an ablation catheter, and the ablation electrode is fixed at one end of the ablation catheter;

the ablation electrode is hollow, the opening end of the ablation electrode is hermetically connected with the ablation catheter, and the closed end of the ablation electrode protrudes out of the end part of the ablation catheter;

the opening end of the ablation electrode is sleeved on the outer surface of the ablation catheter in a sealing mode or is inserted into the inner surface of the ablation catheter in a sealing mode.

Optionally, the catheter unit further includes a cooling tube inserted into the ablation catheter, a first channel is formed in the cooling tube, a second channel is formed between an outer wall of the cooling tube and an inner wall of the ablation catheter, one of the first channel and the second channel is used for inputting cooling liquid to the closed end of the ablation electrode, and the other channel is used for allowing the cooling liquid at the closed end of the ablation electrode to flow back out.

Optionally, the catheter unit further includes a temperature sensor for outputting temperature information of the ablation electrode, and the temperature sensor is attached to the ablation electrode;

the ablation catheter is provided with a fixing groove for accommodating the temperature sensor;

the catheter unit further includes a cable through which the temperature sensor outputs the temperature information.

Optionally, the wall surface of the working channel and the outer surface of the conduit unit are made of the same polymer material.

The utility model also provides a radiofrequency ablation equipment, include:

the radio frequency ablation catheter kit of any one of the above;

the radiofrequency ablation body is used for controlling the ablation electrode to generate radiofrequency current.

The utility model also provides a radio frequency ablation system, include:

an ablation device as described above;

an electromagnetic navigation device for providing navigation information to the radio frequency ablation catheter kit.

The utility model provides a radiofrequency ablation catheter kit utilizes the sheath pipe to establish the working channel who supplies the pipe unit to penetrate and wear out, makes electromagnetic sensing unit and sheath pipe relatively fixed, makes the position of ablating electrode and sheath pipe adjustable, has realized adjusting the function of ablating the position relation that electrode and electromagnetic sensing unit through adjusting ablation electrode and sheath pipe. In the treatment or sampling process, after the ablation electrode is positioned to a proper position by using the sheath, the distance between the electromagnetic sensing unit and the ablation electrode is increased by adjusting the relative position of the sheath and the ablation electrode, so that the electromagnetic sensing unit is not interfered by the ablation electrode, or the interference of the ablation electrode on the electromagnetic sensing unit is within an acceptable range, and the electromagnetic sensing unit is not required to be taken out of a living body, so that the position of the ablation electrode can be obtained in real time by using the electromagnetic sensing unit in the treatment or sampling process, the situation of position deviation of the catheter unit can be timely obtained and adjusted, and support is provided for ensuring effective treatment and sampling.

And simultaneously, the utility model discloses also be different from the technique of integrating the electromagnetic sensing unit on treatment instrument and sampling tool, can enlarge its and the electromagnetic sensing unit between distance before melting electrode emission current to still improve the accuracy of this positional information through the material that reduces melting electrode and the interference of temperature field to the electromagnetic sensing unit when guaranteeing to obtain the positional information of melting electrode in real time.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without inventive exercise.

Fig. 1 is a cross-sectional view of a radio frequency ablation catheter kit in accordance with an embodiment of the present invention;

fig. 2 is a flow chart of a method of using the radio frequency ablation system.

Description of reference numerals:

100-radio frequency ablation catheter kit

1-catheter Unit

11-ablation electrode

111-tube body

112-treatment part

12-ablation catheter

13-Cooling tube

14-first channel

15-second channel

16-temperature sensor

17-cable

2-sheath tube

21-working channel

22-first end

23-mounting groove

24-inner layer

25-outer layer

3-electromagnetic sensor unit

31-cable

32-position sensor

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

The terms "first," "second," "third," "fourth," and the like (if any) in the description and claims of the present invention and in the above-described drawings are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used is interchangeable under appropriate circumstances such that the embodiments of the invention described herein are capable of operation in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

The embodiment of the utility model provides a radiofrequency ablation catheter kit 100 is used in intervention formula radiofrequency ablation, if radiofrequency ablation through the lung and radiofrequency ablation through the blood vessel.

Please refer to fig. 1 for understanding. The utility model discloses radiofrequency ablation catheter kit 100 of the embodiment includes catheter unit 1, sheath pipe 2 and electromagnetic sensing unit 3. The catheter unit 1 comprises an ablation electrode 11, the ablation electrode 11 being adapted to emit a radio frequency current for raising the temperature of the lesion site. The sheath 2 is used for establishing a working channel 21 for the catheter unit 1, the working channel 21 is used for the catheter unit 1 to pass in and out, so that the catheter unit 1 can smoothly reach a target position, the position of the ablation electrode 11 relative to the working channel 21 can be adjusted, and therefore the positional relationship between the ablation electrode 11 and the electromagnetic sensing unit 3 can be adjusted conveniently, and the specific application can be realized by enabling the catheter unit 1 to move relative to the sheath 2 along the working channel 21. The electromagnetic sensing unit 3 is located at the first end 22 of the sheath 2 and is arranged to be fixed relative to the working channel 21, and the electromagnetic sensing unit 3 is used for positioning the ablation electrode 11 which is extended out of the first end 22 of the sheath 2.

The utility model discloses utilize sheath pipe 2 to establish the working channel 21 that supplies catheter unit 1 to penetrate and wear out, make electromagnetic sensing unit 3 and sheath pipe 2 relatively fixed, make ablation electrode 11 and sheath pipe 2's position adjustable to can adjust ablation electrode 11 and electromagnetic sensing unit 3's positional relation through adjusting ablation electrode 11 and sheath pipe 2. In the treatment or sampling process, after the sheath 2 is used for positioning the ablation electrode 11 to a proper position, the relative position of the sheath 2 and the ablation electrode 11 is adjusted to increase the distance between the electromagnetic sensing unit 3 and the ablation electrode 11, so that the electromagnetic sensing unit 3 is not interfered by the ablation electrode 11, or the interference of the ablation electrode 11 on the electromagnetic sensing unit 3 is within an acceptable range, and the electromagnetic sensing unit 3 does not need to be taken out of a living body, so that the position of the ablation electrode 11 can be obtained in real time by using the electromagnetic sensing unit 3 in the treatment or sampling process, the situation that the catheter unit 1 is subjected to position deviation can be obtained in time and adjusted, and support is provided for ensuring effective treatment and sampling.

For the technique of integrating electromagnetic sensing unit 3 on treatment instrument and sampling tool, the utility model discloses can transfer its and the electromagnetic sensing unit 3 between the distance before the 11 emission current of ablation electrode to guarantee to obtain in real time that the positional information of ablation electrode 11 still through reducing the material of ablation electrode 11 and temperature field to electromagnetic sensing unit 3's interference the accuracy that this positional information was improved.

As shown in fig. 1, in the embodiment of the present invention, the sheath 2 is made of an insulating material, the hollow portion of the sheath 2 forms the working channel 21, and the electromagnetic sensing unit 3 is fixed on the sheath 2 and moves along with the movement of the sheath 2.

The structure of the sheath 2 and the relationship between the sheath and the electromagnetic sensing unit 3 can be realized in various ways, wherein the structure of the sheath 2 is generally divided into a single-layer tube and a multi-layer tube, and the two structures are respectively explained as follows:

in some embodiments, the sheath 2 is a single-layer tube, wherein the sheath 2 is made of a polymer material, and the electromagnetic sensing unit 3 is fixedly mounted on an inner wall of the sheath 2, or is embedded in the sheath 2 in the process of processing the sheath 2, that is, the electromagnetic sensing unit 3 is located between the inner wall and the outer wall of the sheath 2.

In other embodiments, the sheath 2 is a multi-layer tube, and adjacent layers are attached to each other, for example, the adjacent layers are combined together by a composite process. The sheath 2 comprises a mounting groove 23 for accommodating the electromagnetic sensing unit 3, and the mounting groove 23 occupies one or more layers of the sheath 2 in the radial direction; any one layer or any plurality of layers of the sheath tube 2 is made of high polymer materials. The number of layers of the sheath tube 2 can be 2, 3, 4, 5, etc., fig. 1 illustrates a mode that the sheath tube 2 is a double-layer tube, wherein the sheath tube 2 comprises an inner layer 24 and an outer layer 25 attached to the outer wall of the inner layer 24, the outer layer 25 is provided with an installation groove 23, the opening of the installation groove 23 faces the inner layer 24, and the inner layer 24 and the outer layer 25 are both made of polymer composite materials; when in production and manufacturing, the electromagnetic sensing unit 3 is pre-embedded between the inner layer 24 and the outer layer 25 in the process of compounding the inner layer 24 and the outer layer 25; the mounting groove 23 may be reserved on the outer layer 25 in advance, that is, the mounting groove 23 is provided on the formed outer layer 25, or the mounting groove 23 is not reserved on the outer layer 25, but is realized by pressing the electromagnetic sensing unit 3 on the outer layer 25 in the compounding process.

In some embodiments where the sheath 2 is a multi-layer tube, the rf ablation catheter kit 100 further includes bend-controlling sections that are capable of bending deformation, with adjacent sheaths 2 connected by the bend-controlling sections; the bending control section comprises a bending control wire, and the bending control wire is stretched to enable the bending control section to generate bending deformation. The bending control section can be bent and deformed under the action of external force to adapt to the bending shape of natural air passages such as air pipes, blood vessels and the like in a living body, and the bending control wire can keep the shape of the bending control section after the external force disappears or is reduced, so that the catheter unit 1 can conveniently penetrate in and out; each bending control section can be provided with a single wire or a plurality of wires, and when a plurality of wires are adopted, the wires are arranged at intervals or crossed to form a net structure.

In the embodiment of the present invention, the electromagnetic sensing unit 3 includes the positioning sensor 32 with one or more coils, the positioning sensor 32 is disposed around the working channel 21, and generates the current signal through the cutting magnetic field, and the analytic current signal obtains the position information of the positioning sensor 32, and further combines the relative position relationship between the positioning sensor 32 and the ablation electrode 11 to obtain the position of the ablation electrode 11. For a specific application, an insulating housing may be provided to protect the position sensor 32. Positioning sensor 32 is fixed in on the inner wall of working passageway 21 or be fixed in the periphery of working passageway 21, and in the embodiment shown in fig. 1, positioning sensor 32 is located the outside of the inner wall of working passageway 21, sets up in the periphery of working passageway 21 promptly, admittedly, as the replacement means, offers mounting groove 23 on the inner wall of working passageway 21, and it is also within the scope of protection of the utility model to fix positioning sensor 32 in mounting groove 23.

In the embodiment of the present invention, the electromagnetic sensing unit 3 further includes a cable 31 embedded in the sheath tube 2, one end of the cable 31 is electrically connected to the positioning sensor 32, the other end is connected to the external device (such as the electromagnetic navigation device) of the rf ablation catheter kit 100, the positioning sensor 32 transmits the positioning information to the controller (such as the control structure of the electromagnetic navigation device) through the cable 31, and the positioning information includes the current signal. The cable 31 may be embedded in the sheath tube 2 or may be embedded in the wall surface of the working passage 21.

Please continue to refer to fig. 1 for understanding. In the embodiment of the present invention, the catheter unit 1 further includes an ablation catheter 12, and the ablation electrode 11 is fixed at one end of the ablation catheter 12. Wherein, after the ablation catheter 12 is threaded into the working channel 21, the position of the ablation electrode 11 relative to the electromagnetic sensing unit 3 can be adjusted by dragging the ablation catheter 12. In the embodiment shown in fig. 1, the ablation catheter 12 is a single-layer tube made of polymer material, in other embodiments, the ablation catheter 12 may be a multi-layer tube, and any one or more layers are made of polymer material; it is preferable that the material corresponding to the outer surface of the ablation catheter 12 and the material corresponding to the inner surface of the sheath 2 are the same polymer material to reduce the friction between the two.

Please continue to refer to fig. 1 for understanding. In the embodiment of the present invention, the ablation electrode 11 is hollow inside and has an open end and a closed end, the open end is hermetically connected to the ablation catheter 12, the closed end protrudes from the end of the ablation catheter 12, and the closed end is used for emitting current to make the focus generate a temperature field.

In the embodiment shown in fig. 1, the ablation electrode 11 comprises a tubular body 111 and a treatment portion 112, wherein an open end is positioned on the tubular body 111 and a closed end is positioned on the treatment portion 112; the tube 111 is used for connecting the treatment part 112 and the ablation catheter 12, the wall surface of the tube 111 is attached to and hermetically connected with the ablation catheter 12, in this embodiment, the tube 111 is hermetically sleeved on the outer surface of the ablation catheter 12, and in other embodiments, as an alternative, the tube 111 may be hermetically inserted on the inner surface of the ablation catheter 12; the treatment part 112 is used for emitting current, the treatment part 112 encloses a semi-enclosed space, the edge of the treatment part 112 is in seamless transition with one end of the tube body 111, the inner surface and the outer surface of the treatment part 112 are both spherical surfaces, and preferably, the thickness of each part of the treatment part 112 is uniform. In this embodiment, the tube 111 and the treatment portion 112 are integrally formed and made of metal, and when the treatment portion 112 is applied specifically, the treatment portion emits radio frequency current to the focus to raise the temperature of the focus, thereby causing apoptosis.

Please continue to refer to fig. 1 for understanding. The embodiment of the utility model provides an in, catheter unit 1 is still including pegging graft cooling tube 13 in ablating pipe 12, forms first passageway 14 in the cooling tube 13, forms second passageway 15 between the outer wall of cooling tube 13 and the inner wall of ablating pipe 12, and first passageway 14 and second passageway 15 form and ablate electrode 11 and carry out refrigerated coolant liquid way, and the coolant liquid flows in coolant liquid way and controls the temperature that ablates electrode 11, and normal saline can be chooseed for use to the coolant liquid.

Please continue to refer to fig. 1 for understanding. In the embodiment of the present invention, the cooling tube 13 protrudes from the end surface of the ablation catheter 12 and extends into the space surrounded by the treatment portion 112, and the cooling liquid enters the treatment portion 112 from the first channel 14, enters the second channel 15 again, and flows back to the outside. In other embodiments, the cooling liquid may alternatively be introduced into the space surrounded by the treatment portion 112 from the second passage 15 and flow back out from the first passage 14.

Please continue to refer to fig. 1 for understanding. In the embodiment of the utility model, catheter unit 1 still includes the temperature sensor 16 who is used for exporting the temperature information of ablation electrode 11, and temperature sensor 16 sets up with the body 111 laminating of ablation electrode 11, through the good heat conductivity of radio frequency electrode head end metal, obtains the inside temperature of tissue that ablation electrode 11 located.

Please continue to refer to fig. 1 for understanding. In the embodiment of the present invention, the ablation catheter 12 is provided with a fixing groove for accommodating the temperature sensor 16, and the shape of the fixing groove is adapted to the temperature sensor 16, so as to ensure the stability of the temperature sensor 16. In the embodiment shown in fig. 1, the retaining grooves are provided on the ablation catheter 12, which is less expensive to manufacture if the temperature sensor 16 is mounted, while in other embodiments the retaining grooves may alternatively be provided on the ablation electrode 11.

Please continue to refer to fig. 1 for understanding. The embodiment of the utility model provides an in, pipe unit 1 still includes cable 17, and temperature sensor 16 is connected to cable 17's one end, and outside controller (like electromagnetic navigation equipment's control structure) is connected to the other end, and temperature sensor 16 passes through cable 17 to controller output temperature information.

There is also provided a method of use for the radio frequency ablation catheter kit referred to in any of the embodiments above, the method of use comprising, prior to controlling the firing current of the ablation electrode 11:

s10, inserting the catheter unit 1 into the working channel 21, and acquiring relative position information of the catheter unit 1 and the sheath 2; wherein, the relative position information of the ablation catheter 12 and the sheath 2 can be realized by any one of the following modes: firstly, marks are made on a catheter unit 1 in advance, reference positions are arranged on a sheath 2, the relative position information of an ablation catheter 12 and the sheath 2 when each mark corresponds to the reference position is prestored, and when the ablation catheter 12 is inserted into the sheath 2, the reference positions correspond to the marks, so that the position relation between the ablation catheter 12 and the sheath 2 can be obtained, and further the relative position information of the ablation catheter 12 and the sheath 2 can be obtained; in the second mode, preset marks and reference positions are not arranged on the ablation catheter 12 and the sheath 2, but the relative position information of the ablation catheter 12 and the sheath 2 is obtained by measuring the length of the ablation catheter 12 extending out of the sheath 2.

S20, in the process of positioning the sheath tube 2, the catheter unit 1 moves along with the sheath tube 2, and positioning information output by the electromagnetic sensing unit 3 is obtained in real time; when the positioning information output by the electromagnetic sensing unit 3 fluctuates, the catheter unit 1 is moved relative to the working channel 21 to increase the distance between the ablation electrode 11 and the electromagnetic sensing unit 3 until the positioning information output by the electromagnetic sensing unit 3 is stable;

s30, after the sheath tube 2 is positioned, controlling the end part of the ablation electrode 11 to extend out of the sheath tube 2 so as to realize the positioning of the ablation electrode 11;

s40, controlling the sheath 2 to retract for a first distance to increase the distance between the ablation electrode 11 and the electromagnetic sensing unit 3, so as to reduce or eliminate the influence of the ablation electrode 11 on the electromagnetic sensing unit 3;

s50, the sheath 2 is controlled to retract for a second distance to enable the electromagnetic sensing unit 3 to be separated from the temperature field generated by the ablation electrode 11, so that the influence of the temperature field of the ablation electrode 11 on the electromagnetic sensing unit 3 is weakened or eliminated; the temperature field can be understood as an ellipsoidal space surrounding the ablation electrode 11; the values of the second distance and the first distance are determined according to the actual working environment, and the values of the second distance and the first distance may be equal or unequal.

The embodiment of the utility model provides a radiofrequency ablation equipment still provides, including the radiofrequency ablation catheter kit 100 and the radiofrequency ablation main part that any above-mentioned embodiment relates to, the radiofrequency ablation main part is used for controlling ablation electrode 11 to generate radiofrequency current. The radiofrequency ablation main body is realized by adopting the prior art, such as a radiofrequency ablator or other treatment devices based on the radiofrequency ablation technology. The radiofrequency ablation main body comprises an electric generator which is connected with the ablation electrode 11 and is used for generating radiofrequency current; the radiofrequency ablation main body also comprises a measurement and control unit which monitors the change of parameters such as impedance, temperature and the like of a focus so as to automatically adjust the output power of radiofrequency ablation and enable tumor tissues to rapidly generate coagulative necrosis in a large range.

The embodiment of the present invention further provides a radiofrequency ablation system, including the radiofrequency ablation catheter kit 100, the radiofrequency ablation main body, and the electromagnetic navigation device related to any of the above embodiments, and it can also be understood that the radiofrequency ablation system includes the radiofrequency ablation device and the electromagnetic navigation device described above. Among other things, the electromagnetic navigation device is used to provide navigation information to the radio frequency ablation catheter kit 100, such as: the electromagnetic navigation equipment builds a three-dimensional model according to the CT image data, plans an intervention route, receives the positioning information of the electromagnetic sensing unit 3 and navigates the movement of the sheath 2 along the intervention route. The electromagnetic navigation device can be implemented by using the prior art, and the construction thereof is not described in detail here.

There is also provided a method for using the rf ablation system according to any of the above embodiments, in order to more clearly illustrate the method for using the rf ablation system, taking an example of interventional therapy via a natural airway of a lung, and referring to fig. 2, the following steps are performed:

the target position of ablation is defined by using the electromagnetic navigation device, and the interventional route of the radio frequency ablation catheter kit 100 is planned. In detail, the lung CT image data of the patient is imported into the electromagnetic navigation equipment, a three-dimensional model of the trachea is established, a path reaching the lesion position through each stage of the trachea is planned based on the three-dimensional model, and the path is an intervention route.

The radio frequency ablation catheter kit 100 and the electromagnetic navigation device are connected, wherein the cable 31 in the electromagnetic sensing unit 3 and the cable 17 of the temperature sensor 16 in the catheter unit 1 are respectively connected with corresponding interfaces on the electromagnetic navigation device, so that the positioning information and the temperature information can be transmitted to the electromagnetic navigation device in real time.

The ablation catheter 12 is inserted into the working channel 21 of the sheath tube 2, and the end of the ablation catheter 12 is caused to protrude out of the sheath tube 2, thereby obtaining the relative positional relationship between the ablation catheter 12 and the sheath tube 2. Wherein, the relative position relationship between the ablation catheter 12 and the sheath 2 can be realized by any one of the following modes: firstly, marks are made on a catheter unit 1 in advance, reference positions are set on a sheath 2, the position relation between an ablation catheter 12 and the sheath 2 when each mark corresponds to the reference position is prestored, and when the ablation catheter 12 is inserted into the sheath 2, the reference position corresponds to the mark, so that the position relation between the ablation catheter 12 and the sheath 2 can be obtained; in the second mode, the ablation catheter 12 and the sheath 2 are not preset with marks and reference positions, and the position relationship between the ablation catheter 12 and the sheath 2 is obtained by measuring the length of the ablation catheter 12 extending out of the sheath 2.

Inserting the radiofrequency ablation catheter kit 100 into a living body along an interventional route, judging whether the ablation electrode 11 affects the stability of the positioning signal, namely observing whether the ablation electrode 11 causes the output positioning information of the electromagnetic sensing unit 3 to fluctuate by utilizing electromagnetic navigation equipment, controlling the relative movement of the sheath 2 and the ablation catheter 12 (making one of the two stationary and pushing or pulling the other one) if the ablation electrode 11 fluctuates, increasing the distance between the ablation electrode 11 and the electromagnetic sensing unit 3 until the positioning signal is stable, and continuing to move the radiofrequency ablation catheter kit 100 along the interventional route until the end part of the sheath 2 reaches a target position.

The positional relationship between the sheath 2 and the ablation catheter 12 is further adjusted so that the ablation electrode 11 just protrudes out of the sheath 2, i.e., the treatment portion 112 protrudes out of the sheath 2.

The position of the ablation catheter 12 is kept unchanged, the sheath 2 is withdrawn, so that the positioning signal output by the positioning sensor 32 is not influenced by the ablation electrode 11, and the coil 32 is separated from the range of the temperature field of the ablation electrode 11, thereby avoiding the influence of high temperature on the positioning accuracy of the electromagnetic sensing unit 3 in the ablation process.

And starting the radio frequency ablation main body, setting ablation treatment time and an ablation temperature range interval, performing ablation treatment on the focus, and reading temperature information fed back by the temperature sensor 16 in real time.

When the real-time temperature is lower than the ablation temperature range interval, ablation treatment is continued until the real-time temperature is higher than the treatment temperature interval, at the moment, the first channel 14 or the second channel 15 is filled with normal saline to cool the ablation electrode 11, and if the temperature information fed back in the cooling process is lower than the ablation temperature range interval again, filling and cooling are stopped temporarily, ablation is continued, and the temperature of the lesion tissue is continuously increased. This step is repeated until the ablation treatment time is reached. It should be noted that fig. 2 is provided with a dashed box, and the content in the dashed box corresponds to the present step, i.e., the steps in the dashed box are performed circularly during the ablation treatment time.

After the ablation treatment time is over, the position of the rf ablation catheter set 100 is temporarily maintained, and the ablation effect, for example, the state of cells under observation, is confirmed by a technique such as imaging. If the effect meets the expectation, the ablation is stopped, the radio frequency ablation catheter kit 100 is withdrawn or the radio frequency ablation catheter kit 100 is operated to go to the next target position to continue the ablation treatment process.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention.

Claims

1. A radio frequency ablation catheter kit, comprising:

a catheter unit including an ablation electrode;

the sheath is used for establishing a working channel for the catheter unit, the working channel is used for the catheter unit to penetrate in and out, and the position of the ablation electrode relative to the working channel is adjustable;

2. The radio frequency ablation catheter kit of claim 1, wherein the sheath is a single layer tube.

3. The radio frequency ablation catheter kit of claim 1, wherein the sheath is a multi-layer tube with adjacent layers in abutting relationship;

any one layer or any plurality of layers of the sheath tube is made of high polymer materials;

the radio frequency ablation catheter kit further comprises a bending control section capable of bending and deforming, and the adjacent sheath tubes are connected through the bending control section; the bending control section comprises a bending control wire, and the bending control section generates bending deformation by stretching the bending control wire.

4. The radio frequency ablation catheter kit of claim 1, wherein the sheath is a double-layer tube, the sheath comprises an inner layer and an outer layer arranged to fit the outer wall of the inner layer, the outer layer is provided with a mounting groove for accommodating the electromagnetic sensing unit, and the mounting groove is opened towards the inner layer.

5. The radio frequency ablation catheter kit of claim 1,

the electromagnetic sensing unit comprises a coil arranged around the working passage;

6. The radio frequency ablation catheter kit of claim 1, wherein the catheter unit further comprises an ablation catheter, the ablation electrode being secured to one end of the ablation catheter;

the open end of the ablation electrode is sleeved on the outer surface of the ablation catheter in a sealing mode or is inserted into the inner surface of the ablation catheter in a sealing mode.

7. The radio frequency ablation catheter kit of claim 6, wherein the catheter unit further comprises a cooling tube inserted into the ablation catheter, a first channel is formed in the cooling tube, a second channel is formed between an outer wall of the cooling tube and an inner wall of the ablation catheter, one of the first channel and the second channel is used for inputting cooling liquid to the closed end of the ablation electrode, and the other channel is used for returning the cooling liquid at the closed end of the ablation electrode.

8. The radio frequency ablation catheter kit of claim 6, wherein the catheter unit further comprises a temperature sensor for outputting temperature information of the ablation electrode, the temperature sensor being disposed in close proximity to the ablation electrode;

9. The radio frequency ablation catheter kit of any one of claims 1-8, wherein the wall of the working channel and the outer surface of the catheter unit are made of the same polymeric material.

10. A radio frequency ablation device, comprising:

the radio frequency ablation catheter kit of any one of claims 1-9;

11. A radio frequency ablation system, comprising:

the radiofrequency ablation device of claim 10;