CN111772785A

CN111772785A - Thermal ablation catheter, device and sterilization method thereof

Info

Publication number: CN111772785A
Application number: CN202010860139.9A
Authority: CN
Inventors: 李荐民; 陈志强; 李元景; 张丽; 李玉兰
Original assignee: Tsinghua University
Current assignee: Tsinghua University
Priority date: 2020-08-24
Filing date: 2020-08-24
Publication date: 2020-10-16

Abstract

The present disclosure provides a thermal ablation catheter, a device and a method of sterilizing the same, the thermal ablation catheter comprising: the ablation component is used for releasing energy to the focus part to perform ablation treatment; the sensor unit is attached to the surface of the ablation assembly and used for measuring the current parameters of the surface of the ablation assembly or the focus body; the catheter transmission section comprises a hollow liner tube, and an ablation assembly lead and a sensor unit lead which are arranged in the hollow liner tube, wherein the first end of the catheter transmission section is connected to the ablation assembly and the sensor unit and is used for inserting the ablation assembly and the sensor unit into a cavity with a preset depth through a percutaneous intervention opening for diagnosis and treatment; and the first electric connector is arranged at the second end of the catheter transmission section and is used for realizing the electric connection of the ablation assembly lead wire and the sensor unit lead wire with the handle of the thermal ablation catheter. Through the split type design of the heat ablation catheter, the heat ablation catheter can be separated from the handle, so that the cable and the handle part can be repeatedly utilized, the cost can be reduced, and the sterilization treatment mode is more green and environment-friendly.

Description

Thermal ablation catheter, device and sterilization method thereof

Technical Field

The present disclosure relates to the field of medical devices, and more particularly, to a thermal ablation catheter, device, and method of sterilizing the same.

Background

With the progress of medical technology, the operation gradually develops towards a minimally invasive or non-invasive trend, wherein the catheter interventional thermal ablation treatment is to insert an ablation component through an incision or a cavity inlet on the skin of a patient to enter a focus part through a blood vessel or an inner cavity under the assistance of imaging equipment such as B-mode ultrasonography and CT, the energy is released to the focus part to perform the ablation treatment, and the catheter interventional thermal ablation treatment has an exact curative effect, has smaller wound than that of open surgery, is quick to recover, and has gradually become a mainstream operation mode in the treatment fields of heart diseases such as varicose veins, intractable high blood and atrial fibrillation caused by the abnormal conduction of myocardial signals, vascular obstruction, intraluminal tumors such as esophagus, stomach, cervix and the like.

The thermal ablation system consists of a host machine that generates energy and a conduit that transfers the energy. Generally, the catheter is formed into an integrated catheter by a host signal leading-out cable, an operating handle, a catheter transmission section and an ablation part at the tip of the catheter, and the catheter is sterilized by ethylene oxide and is only used once. The technology for generating energy by the host comprises the following steps: radio Frequency (RF), microwave, laser, ultrasound, etc., each of which converts into heat energy in a direct or indirect manner in the human body through a corresponding ablation catheter (or electrode) to generate local hyperthermia, thereby achieving the goal of coagulative necrosis of diseased tissues, which is organized or absorbed in situ.

As the temperature of 60 ℃ is the minimum heating level temperature for generating irreversible denaturation of protein, the denaturation of protein above 60 ℃ is instantaneous, the temperature in the tissue can reach 60 ℃ by the ablation catheter during treatment, cells begin to die and a necrotic area is generated, for example, when the temperature of local tissue around the catheter exceeds 60 ℃ and reaches 100 ℃, a solidification necrotic area can be generated around the catheter, and a thermotherapy area at 43-60 ℃ is arranged outside the solidification necrotic area, so that normal cells can be recovered in the area. The effective temperature for thermal ablation treatment of the lesion cannot therefore be lower than 60 c, and 60 c is just the risk temperature for damaging nerves and other normal tissues surrounding the lesion. And is therefore critical to accurate control of the degree of ablation.

The existing heat-melting catheter is integrated and not detachable, and after the catheter is only used for one-time trial, the whole catheter is destroyed as medical waste, so that the catheter is not economical and environment-friendly, the medical cost is high, the pressure of patients on bearing the medical cost is high, and the catheter is difficult to popularize in low-income areas. And the integrated design of the catheter makes the catheter incapable of sterilizing according to performance classification, so that the adopted sterilization mode is not environment-friendly and is not economical. At present, commercial catheters are sterilized by ethylene oxide basically, and because ethylene oxide is toxic gas, the emission of the ethylene oxide is harmful to the environment, and the residue of the ethylene oxide is toxic to a human body, the conditions required by the adoption of the ethylene oxide for sterilization are complex, and complex post-treatment and packaging with a dialysis function are required for eliminating the residue, so that the environmental pollution and the cost waste are caused. The cable of pipe, handle, pipe transmission section temperature resistant temperature range are different, for example the pipe transmission section generally can all be able to bear the temperature more than 134 ℃ (medical sterilization temperature), consequently can adopt the pressure steam sterilization of more environmental protection, and cable and handle have the material that can not resist high temperature, can't carry out high temperature sterilization.

In addition, the existing thermal ablation catheter also has a temperature measuring circuit (or other signal lines) arranged on the host, the cable is too long and is easily influenced by the energy transmission line of the catheter and an external electromagnetic field, and a display screen of the existing thermal ablation device is positioned on the host, so that a doctor cannot conveniently read treatment parameters in the operation process.

Disclosure of Invention

Technical problem to be solved

The present disclosure provides a thermal ablation catheter, device and method of sterilization thereof to at least partially solve the above-identified technical problems.

(II) technical scheme

According to an aspect of the present disclosure, there is provided a thermal ablation catheter comprising:

the ablation component is used for releasing energy to the focus part to perform ablation treatment;

the sensor unit is attached to the surface of the ablation assembly and used for measuring the current parameters of the surface of the ablation assembly or the focus body;

the catheter transmission section comprises a hollow liner tube, and an ablation assembly lead and a sensor unit lead which are arranged in the hollow liner tube, wherein the first end of the catheter transmission section is connected to the ablation assembly and the sensor unit and is used for inserting the ablation assembly and the sensor unit into a cavity with a preset depth through a percutaneous intervention opening for diagnosis and treatment;

and the first electrical connector is arranged at the second end of the catheter transmission section and is used for realizing the electrical connection of the lead wire of the ablation assembly and the lead wire of the sensor unit with the handle of the thermal ablation catheter.

According to embodiments of the present disclosure, the thermal ablation catheter is capable of being sterilized with pressurized steam, remaining resistant to 132 ℃ without deformation and denaturation during the use cycle; and/or

The handle is resistant to a predetermined temperature and humidity such that it functions well without damage after sterilization under predetermined conditions, including:

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

repeatedly sterilizing at 134 deg.C for 4min by pressure steam sterilization; and

the test was carried out 20 times with saturated steam at 134 ℃ for 20min each time.

According to an embodiment of the present disclosure, the thermal ablation catheter further comprises:

a luer connector connected to one end of the auxiliary catheter for introducing a medical device or a medicine into the auxiliary catheter;

and the auxiliary catheter penetrates through the interior of the hollow liner tube and reaches the free end part of the ablation assembly, and is communicated with the lesion body at the ablation assembly.

According to an embodiment of the present disclosure, the sensor unit includes at least one of a temperature sensor, an impedance sensor, or a pressure sensor.

According to an embodiment of the present disclosure, the sensor unit includes a thermocouple type temperature sensor including first and second metals disposed within the hollow liner.

According to an embodiment of the present disclosure, the hollow liner material of the conduit transfer section is a polymer insulating material with an inner diameter of 0.3mm to 2.6 mm; and/or the inner diameter of the auxiliary conduit is 0.1-2.4 mm.

According to another aspect of the present disclosure, there is provided a thermal ablation apparatus comprising:

a first split structure employing a thermal ablation catheter as previously described;

a second split structure comprising a handle body and circuitry in detachable electrical connection with the thermal ablation conduit of the first split structure;

and the third split structure comprises a host, wherein a temperature signal processing unit is arranged in the host.

According to an embodiment of the present disclosure, the handle body includes a hand-held portion and an internal member provided to the hand-held portion, the internal member includes:

the temperature measuring circuit is used for converting the analog signal acquired by the temperature sensor into a digital signal in the handle body;

a second electrical connector removably connected with the first electrical connector for connecting the lead wires of the ablation assembly and the sensor unit.

According to an embodiment of the present disclosure, the handle body is provided with a display.

According to the embodiment of the disclosure, the cable is fixedly connected to the handle body, and is electrically connected to the temperature measuring circuit and the second electric connector, so as to lead out the wiring inside the handle body.

According to embodiments of the present disclosure, the first split structure is capable of being sterilized using pressurized steam, remaining resistant to deformation and denaturation at 132 ℃ over a life cycle; and/or the second layered structure is resistant to a predetermined temperature and humidity such that it functions well without damage after sterilization under predetermined conditions, including:

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

According to an embodiment of the present disclosure, the cable has an electromagnetic shielding layer.

According to an embodiment of the disclosure, the cable is connected to the host machine by a first multi-core electrical connector, and the catheter transmission section of the thermal ablation catheter is connected to the handle body by a second multi-core electrical connector.

According to another aspect of the present disclosure, there is provided a method of sterilizing a thermal ablation device as described above, comprising:

after use of the thermal ablation catheter:

detaching and separating the third split structure from the second split structure, and detaching and separating the second split structure from the first split structure;

irradiating the main machine with a third split structure by adopting an ultraviolet lamp, or wiping the main machine with 75% medical alcohol for surface sterilization so as to be repeatedly used after sterilization;

sterilizing the second split structure by adopting pressure steam so as to be repeatedly utilized after sterilization;

and (4) carrying out sterile treatment on the first split structure and then destroying the first split structure.

According to an embodiment of the present disclosure, the method of sterilizing an ablation device further comprises:

prior to shipment of the thermal ablation catheter:

wiping the surface of the third split structure with 75% medical alcohol, packaging the third split structure by adopting a transparent material, and then irradiating and sterilizing the surface by using ultraviolet rays or X rays for delivery application;

cleaning the second split structure, preferably sterilizing by adopting pressure steam, drying and then leaving the factory, and also selecting the existing common sterilization modes such as ethylene oxide and the like for sterilization and leaving the factory;

after cleaning the ablation catheter with the first split structure, the ablation catheter is preferably sterilized by adopting pressure steam and dried and then leaves the factory, and the ablation catheter can also be sterilized by adopting the existing common sterilization modes such as ethylene oxide and the like and leaves the factory.

According to an embodiment of the present disclosure, the sterilizing the second split structure with pressure steam includes at least one of the following methods:

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

repeatedly sterilizing at 134 deg.C for 4min by pressure steam sterilization;

(III) advantageous effects

From the above technical solution, it can be seen that the disclosed thermal ablation catheter, device and sterilization method thereof have at least one of the following beneficial effects:

(1) the heat ablation device is in a split type design, so that the heat ablation catheter can be separated from the handle, the cable and the handle are in a high-temperature resistant design after being split, the cable and the handle can be sterilized by adopting a pressure steam mode, and special packaging is not needed, so that extra cost caused by the fact that expensive special filter paper packaging is adopted to prevent ethylene oxide residue is avoided;

(2) according to the temperature measuring circuit of the thermal ablation device, the sensor is arranged at the ablation assembly, and is converted into the digital signal at the handle for transmission, compared with the traditional catheter, the transmission length of the analog signal is shortened, the interference caused by self and external electromagnetic field emission is reduced, the temperature measurement is more accurate, and the ablation control is more accurate; meanwhile, the cable adopts an electromagnetic shielding design, so that electromagnetic interference can be reduced, and the transmission efficiency of electromagnetic waves can be improved, thereby improving the heat ablation efficiency;

(3) the small-sized display screen is designed on the handle of the catheter, so that the heat ablation device is used for displaying key information in a treatment process, an operator can conveniently read current treatment information while operating the catheter, abnormity appearing in treatment can be conveniently regulated and controlled in real time, and ablation is safer and more effective.

Drawings

Fig. 1 is a schematic structural view of a thermal ablation apparatus according to an embodiment of the disclosure.

Fig. 2 is a schematic view of an application scenario of a thermal ablation apparatus according to an embodiment of the disclosure.

Fig. 3 is a schematic structural diagram of a temperature measuring circuit according to an embodiment of the disclosure.

Fig. 4 is a flow chart of a method of sterilizing a thermal ablation device according to an embodiment of the disclosure.

[ description of main reference numerals in the drawings ] of the embodiments of the present disclosure

10. A first molecular structure; 101. an ablation assembly; 102. a sensor unit; 103. a conduit transfer section; 104. a second multi-fiber electrical connector; 105. a luer fitting; 106. an auxiliary conduit; 20. a second dyad structure; 201. a handle body; 2011. a control switch; 2012. a temperature measuring circuit; 2013. a display; 2015. a first metal; 2016. a second metal; 2017. a wire; 202. a cable; 30. a third split structure; 301. a host; 302. a temperature signal processing unit; 2021. a first multi-fiber electrical connector; 40. a treatment couch; 50. a percutaneous access port; 60. the region of action of the physician.

Detailed Description

The utility model provides a heat ablation catheter, device and sterilization method thereof, the heat ablation catheter adopts split type design, has realized independent sterilization and independent use, can reduce medical electronic waste, can also avoid or reduce ethylene oxide sterilization and remain and the harm risk that the release brought, more important can also reduce cost, alleviates medical expenses burden.

For the purpose of promoting a better understanding of the objects, aspects and advantages of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawings.

Certain embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosure are shown. Indeed, various embodiments of the disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

In one exemplary embodiment of the present disclosure, a thermal ablation apparatus is provided. Fig. 1 is a schematic structural view of a thermal ablation apparatus according to an embodiment of the disclosure. As shown in fig. 1, the thermal ablation apparatus of the present disclosure mainly comprises three split structures, wherein the first split structure 10 is a thermal ablation catheter, the second split structure 20 comprises a handle body 201 and an attached cable 202, and the third split structure 30 comprises a main machine 301.

Specifically, the first split-body structure 10 includes a catheter transmission section 103, a luer connector 105, an auxiliary catheter 106, an ablation assembly 101 and a sensor unit 102, wherein the sensor unit 102 is integrated on the surface of the ablation assembly 101, the leads of the ablation assembly 101 and the sensor unit 102 penetrate through the catheter transmission section 103, the auxiliary catheter 106 also penetrates through the catheter transmission section 103, one end of the auxiliary catheter 106 reaches the ablation assembly 101 and is communicated with the lesion, and the other end of the auxiliary catheter 106 extends out to receive the luer connector 105. The second split structure 20 includes a cable 2 and a handle body 201 which are connected to each other, wherein the cable 202 integrates wires of the ablation assembly 101, the sensor unit 102, the control switch 2011, the display 2013, the temperature measurement circuit 2012 and the like, and the handle body 201 is provided with the control switch 2011, the temperature measurement circuit 2012 and the display 2013. The main unit 301 of the third split structure 30 includes key components such as a power supply system, a main control unit, a user interface, an energy generating unit, and a temperature signal processing unit 302.

The first split structure 10 and the second split structure 20, and the second split structure 20 and the third split structure 30 are electrically connected through a multi-core electrical connector, the multi-core electrical connector is provided with a plurality of independent conductor cores for connecting different signal lines, and a locking structure is provided, so that the multi-core electrical connector is convenient and quick to insert/pull, prevents the pipelines from loosening and falling, and ensures stable and reliable electrical signal output. Specifically, in this embodiment, the cable 202 is connected to the main body 301 through the first multi-core electrical connector 2021, the handle body 201 and the cable 202 are directly electrically connected, the catheter transmission section 103 is electrically connected to the handle body 201 through the second multi-core electrical connector 104, and the catheter transmission section 103 is connected to the ablation assembly 101 in an extending manner.

Because the heat melting device is designed in a split mode and is composed of three split structures which can be connected in a plugging mode or separated in a plugging mode, independent sterilization and recycling can be facilitated, the cost is saved, and medical waste is reduced.

Fig. 2 is a schematic view of an application scenario of a thermal ablation apparatus according to an embodiment of the disclosure. As shown in fig. 2, the main machine 301 is located away from the treatment couch 40 and the doctor action area 60, the handle body 201 and a portion of the cable 202 of the second split structure 20 are located near the patient access port 50 of the treatment couch 40, and the catheter ablation assembly 101 and a portion of the catheter transmission section 103 of the first split structure 10 are inserted into the lesion of the human body from the access port for ablation treatment.

The following describes each part of the thermal ablation apparatus of the present embodiment in detail.

The first split-structure 10 is a thermal ablation catheter comprising an ablation assembly 101, a sensor unit 102, a luer 105, a secondary catheter 106, and a first multi-core electrical connector 104. The ablation assembly 101, the sensor unit 102 and the auxiliary catheter 106 enter the focus body through the human body entrance 16, the current temperature and/or impedance and other parameters of the focus body are acquired through the sensor unit 102 at the focus body and transmitted to the host 301, and the treatment signal of the host 301 is received and transmitted to the ablation assembly 101, so that the focus body is inspected and ablated.

Referring to fig. 2, the catheter delivery segment 103 is used to insert the ablation assembly 101, the sensor unit 102 and the auxiliary catheter 106 through the percutaneous access port 16 into a cavity at a certain depth for diagnosis and treatment. The length of the catheter delivery segment 103 can be designed to vary between 50-150cm depending on the general depth of the cavity being treated (saphenous vein, kidney, liver, gall bladder, uterus). The whole material and process of the conduit can endure 132 ℃ for a long time without deformation and denaturation, and can adopt pressure steam for sterilization. The catheter delivery section 103 has an inner diameter of between 0.3mm and 2.6mm, preferably between 1mm and 1.6mm, for passing the wires of the ablation assembly 101 and sensor unit 102 and the auxiliary catheter 106 from within the tube.

The auxiliary catheter 106 extends from within the catheter delivery segment 103 to the end of the ablation assembly 101 where it communicates with the lesion. Guide wires, liquid medicine or other medical devices can be introduced from the luer 105 of the auxiliary catheter 4 according to the treatment needs of the focus body. The material of the catheter transmission section 103 and the auxiliary catheter 106 is a polymer insulating material with good biocompatibility and good flexibility, preferably a material resistant to high temperature of 200 ℃ such as Peek, PTFE, PI and the like, and the inner diameter of the auxiliary catheter 106 can be 0.1-2.4 mm, preferably 0.5-1 mm, so that a guide wire, a therapeutic drug and the like can pass through.

An ablation assembly 101 is disposed at the free end of the catheter delivery section 103. In particular, the ablation assembly 101 may be any shape of electrode, including a bipolar or multipolar electrode, a heating resistor or antenna, etc. that is looped around the catheter delivery segment 103.

A sensor unit 102 is attached to the surface of the ablation assembly 101 for rapidly measuring current parameters of the surface of the ablation assembly 101 or of the body of the lesion. Wherein the sensor unit 102 may include at least one of a temperature sensor, an impedance sensor, or a pressure sensor.

The second split structure 20 comprises a cable 202 and a handle body 201 which are connected with a host 301, and is used for leading out output and input leads of energy and information from the host 301, transmitting parameters such as the current temperature acquired by the sensor unit 102 and the impedance of the ablation assembly 101 to the host 301, and receiving signals of the host 301 and transmitting the signals to the ablation assembly 101. The cable 202 adopts a cable with a shielding layer, so that the emission of electromagnetic waves in the cable 3 to the surrounding space when the host 301 outputs energy can be effectively reduced, and the electromagnetic interference can be reduced; meanwhile, the transmission efficiency of electromagnetic waves can be improved, so that the heat ablation efficiency is improved. In addition, the shielding layer can reduce the interference of electromagnetic waves in the external environment to the sensor unit 102. Illustratively, the length of the cable 202 is 2m-3m, allowing the surgeon sufficient room for convenient manipulation.

Specifically, in the second split structure, the handle body 201 is made of a shell made of metal materials such as stainless steel and aluminum alloy, PP, fluoroplastic, Peek, silicone rubber or fluororubber, and the circuit board inside the handle body 201 is made of a common high-temperature-resistant PCB board, and the surface of the circuit board is coated with high-temperature-resistant moisture-proof paint such as organic silicon and polyurethane, so that the handle body can be normally used after repeated pressure steam sterilization;

the electric conduction sinle silk that cable 202 adopted includes excellent metal of electric conduction properties such as copper, aluminium, or alloy, and the insulating layer that cable 202 adopted includes crosslinked polyethylene (XLPE), polypropylene (PP), fluoroplastics (polytetrafluoroethylene, gather perfluor ethylene propylene etc.), rubber (silicon rubber, fluororubber) etc. and the filling layer that cable 202 adopted includes materials such as PP, and the shielding layer that cable 202 adopted includes bare copper line, copper clad steel wire, tinned wire etc. therefore cable 202 carries out normal use after pressure steam sterilization repeatedly.

In thermal ablation therapy, temperature is the most intuitive parameter to measure the effectiveness and safety of the therapy. In order to increase the speed of thermometry and allow for minimally invasive treatment, in some embodiments the ablation assembly 101 cannot be too bulky, and the sensor unit 102 preferably comprises a thermocouple-type temperature sensor due to its small size and fast thermal response speed. Fig. 3 is a schematic structural diagram of a temperature measuring circuit according to an embodiment of the disclosure. In order to reduce the susceptibility of the sensor to the long cable and improve the temperature measurement accuracy, as shown in fig. 3, in this embodiment, a temperature measurement circuit 2012 is designed on the handle body 201 for converting the temperature measurement signals of the first metal 2014 and the second metal 2015 into digital signals in the handle body 201, and then the digital signals are transmitted to the temperature signal processing unit 302 of the host 301 through the cable 202 by the common metal wire 2016. The design that this embodiment increased the temperature measurement circuit on being close to patient's handle, the analog quantity with the temperature measurement here converts the digital quantity into, makes the thermocouple temperature measurement avoid long cable easily to be disturbed the problem to it is more accurate to make the temperature measurement, can effectively reduce because of the high temperature normal tissue (including neural) production complication's around the damage focus risk, and because of the low risk that the focus is remained and is relapsed again of low temperature.

The cable 202 has a first multi-connector 2021 at one end for electrical connection with the host 301, and the other end directly connected to the handle body 201. The first multi-core connector 2021 has a locking structure, and this connection mode can facilitate the quick insertion and extraction of the cable or the catheter, and prevent the cable from loosening and falling off, thereby ensuring the stable and reliable output of the electrical signal. The connection of the cable 202 to the handle body 201 can be made by plugging a multi-core connector or by directly welding the cable to the handle body 201.

A small control switch 2011 is configured on the handle body 201 so that the doctor can quickly control the electric signal output of the main machine 301 in the doctor activity area 60. Further, a display 2013 is arranged on the handle body 201. The display 2013 may be a small LCD screen or LED screen for displaying critical treatment information extracted from the host 301 so that the surgeon can quickly read the current treatment parameters in the surgeon's active area 60.

The cable 202 and the first multi-core electrical connector 2021, as well as all components and packaging on the handle body 201, preferably meet predetermined pressure steam sterilization standards such that no perceptible signs of deterioration occur under predetermined conditions, the sterilization is functional and non-destructive, the predetermined conditions including: repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization; repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization; repeatedly sterilizing at 134 deg.C for 4min by pressure steam sterilization; and 20 trials were carried out with saturated steam at 134 ℃ for 20min each.

The function of the main body 301 in the third split structure 30 is to generate and control energy to the thermal ablation catheter, and the energy generation manner may include: alternating current source, direct current source, RF source, microwave source, laser source, ultrasonic source. The host 301 is used to measure and display output power, load, output time, etc. of energy. In addition, the host computer 301 also interacts with the sensor unit 102 in the thermal ablation catheter, displaying temperature, impedance, treatment time during treatment, and storing patient-related physical examination case information.

The host 301 includes key components such as a power supply system, a main control unit, a user interface, and an energy generating unit, in addition to the temperature signal processing unit 302. The host 301 interacts with the handle body 201, the sensor unit 102 and the ablation assembly 101 through the cable 202, displays parameters such as temperature and impedance during RF treatment in real time, and adjusts and outputs signals to the ablation assembly 101 according to the current parameters and target parameters, so that effective treatment of multiple pairs of lesion bodies is realized, and surrounding normal tissues are protected from thermal damage.

According to the embodiment of the present disclosure, when the thermal ablation apparatus is applied to the scenario shown in fig. 2, the following steps are included.

1) The distal end of the catheter delivery segment 103 is inserted into a vein from an access port 16 near the knee joint of the patient and the handle is placed near the body access port 16.

2) The catheter transmission section 103 is adjusted by rotating and pushing and pulling a handle under the assistance of B-ultrasonic imaging equipment, CT imaging equipment and the like, and the ablation assembly 101 is accurately positioned at the initial part (hidden femoral region) of the lesion to be ablated.

3) The operator provides the appropriate therapeutic energy to the ablation assembly 101 through the switch 8.

4) The current parameters in the treatment process are observed in real time through the display 9 on the handle body 201.

5) After the current ablation part is treated, the catheter is positioned to the next treatment part, and ablation is immediately stopped by the switch 8 on the handle when the ablation parameters are found to be abnormal.

6) And after the ablation of the whole focus is finished, the catheter is withdrawn from the interventional port.

It can be seen from the above steps that the small display screen is arranged on the catheter handle, so that the current treatment information can be conveniently read by an operator while operating the catheter, and the special conditions occurring in the treatment can be conveniently regulated and controlled in real time, so that the ablation operation is safer and more effective. Only control switch on the handle on traditional pipe, current treatment parameter, key information such as treatment cycle or time need be read from the display of host computer, it needs to go on at the guide of B ultrasonic or other imaging devices to carry out intracavity ablation treatment, the operation doctor need observe the B ultrasonic imaging condition during treatment, in time adjust or control pipe or handle on one side, in addition the position that the host computer was put is more far away from the doctor, therefore the doctor is inconvenient to go to read the information on the host computer screen again, this embodiment designs small-size display screen on the handle of pipe and is used for showing the key information in the treatment process, in other words has added a pair of eyes for the doctor, make things convenient for the operation doctor to read current treatment information when operating the pipe, so that carry out real-time regulation and control to the abnormality that appears in the treatment, make and melt safelyr effective.

In addition to closed treatment of varicose veins to affected veins, the thermal ablation device disclosed by the invention can be used for intracavity ablation treatment of tumors in gastrointestinal tracts, bile ducts and pancreatic ducts which are not suitable for surgical resection, relieving blockage caused by tumors in stomach, duodenum and rectum, ablation treatment of snore caused by airway polyp, nasal mucosa hypertrophy and congestion, tonsil hyperplasia and adenoid hyperplasia, treatment of heart diseases such as atrial fibrillation, ablation of intrauterine tumors and endometrial cancer, hemostasis of intracavity bleeding or wounds and the like.

According to a second exemplary embodiment of the present disclosure, a method of sterilizing a thermal ablation device as described in the first embodiment is provided. Fig. 4 is a flow chart of a method of sterilizing a thermal ablation device according to an embodiment of the disclosure. As shown in FIG. 4, the method for sterilizing the thermal ablation apparatus after use comprises the following steps.

S1, detaching the third split structure from the second split structure, and detaching and separating the second split structure from the first split structure so as to carry out classification cleaning and sterilization;

s2, irradiating the host 301 with an ultraviolet lamp or wiping the host with 75% medical alcohol to sterilize the surface so that the host can be used repeatedly after sterilization;

s3, sterilizing the cable 202 and the handle body 201 of the second split structure with steam under pressure. Since the second split structure can withstand the pressure steam sterilization mode required by the national standard, the pressure steam sterilization mode can be prioritized. Since a part of the cable 4 of the second split structure extends to and near the treatment couch 15, it is possible to be contacted; in addition, the handle body 201 of the second split structure needs to be operated during an operation, but the inner surface and the outer surface of the second split structure are not directly inserted into a human body and are easy to clean, so that the handle body can be repeatedly used after being sterilized.

And S4, performing sterile treatment on the first split structure and then destroying the first split structure. Because the first split structure is directly entered into the human body, when the first split structure is provided with an inner cavity structure, the blood and body fluid filled or infected in the first split structure are not easy to clean, so the first split structure is only used for one-time use in consideration of biological safety, and can be destroyed after being sterilized by any sterilization equipment conveniently configured in a hospital after use. The first split structure is designed to withstand the pressure steam sterilization mode specified by medical standards, and can be subjected to aseptic treatment in any sterilization mode which does not damage or influence the structure and the function of the split structure when being shipped out, preferably ethylene oxide sterilization and packaging, so that the split structure is disposable in hospitals.

The thermal ablation device being sterilized prior to shipment of the thermal ablation catheter from the factory comprising the steps of:

s1', wiping the surface of the host with the third split structure with 75% medical alcohol, packaging with transparent plastic, and sterilizing the surface by ultraviolet rays or X rays for delivery;

s2', cleaning the cable and the handle of the second split structure, and then preferably sterilizing by adopting pressure steam, drying and then leaving the factory, or sterilizing by adopting the existing common sterilization modes such as ethylene oxide and the like and leaving the factory;

and S3', cleaning the ablation catheter with the first split structure, sterilizing by adopting pressure steam, drying and then delivering from a factory, or sterilizing by adopting the existing common sterilization modes such as ethylene oxide and the like and then delivering from a factory.

According to the embodiment of the disclosure, the cost can be reduced because the heat ablation device adopts a split design. On one hand, the cost can be reduced because the cable and the handle part can be reused, on the other hand, the cable and the handle are designed to be moisture-proof and temperature-resistant after being split, the cable and the handle can be sterilized by adopting a pressure steam mode, and special packaging is not needed, so that the extra cost caused by the fact that expensive special filter paper packaging is adopted to prevent ethylene oxide residue is avoided. In addition, another potential benefit of the proposed sterilization of the cable and handle and the cost reduction of the catheter is that ablation therapy techniques can be deployed by common medical facilities in areas with relatively undeveloped economic conditions.

Moreover, the split type heat ablation device is more green and environment-friendly in sterilization mode. On one hand, the reuse of the cable and the handle part effectively reduces medical electronic garbage, on the other hand, the split design can select a proper sterilization mode according to the material properties and the application requirements of each split, and the harm of ethylene oxide residue to human bodies and the pollution of ethylene oxide release to the environment caused by an ethylene oxide sterilization method can be avoided.

For the purpose of brief description, any technical features of the first embodiment that can be applied to the same are described herein, and the same description is not repeated.

So far, the embodiments of the present disclosure have been described in detail with reference to the accompanying drawings. It is to be noted that, in the attached drawings or in the description, the implementation modes not shown or described are all the modes known by the ordinary skilled person in the field of technology, and are not described in detail. Further, the above definitions of the various elements and methods are not limited to the various specific structures, shapes or arrangements of parts mentioned in the examples, which may be easily modified or substituted by those of ordinary skill in the art.

And the shapes and sizes of the respective components in the drawings do not reflect actual sizes and proportions, but merely illustrate the contents of the embodiments of the present disclosure. Furthermore, in the claims, any reference signs placed between parentheses shall not be construed as limiting the claim.

Unless otherwise indicated, the numerical parameters set forth in the specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the present disclosure. In particular, all numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about". Generally, the expression is meant to encompass variations of ± 10% in some embodiments, 5% in some embodiments, 1% in some embodiments, 0.5% in some embodiments by the specified amount.

Furthermore, the word "comprising" does not exclude the presence of elements or steps not listed in a claim. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

The use of ordinal numbers such as "first," "second," "third," etc., in the specification and claims to modify a corresponding element does not by itself connote any ordinal number of the element or any ordering of one element from another or the order of manufacture, and the use of the ordinal numbers is only used to distinguish one element having a certain name from another element having a same name.

In addition, unless steps are specifically described or must occur in sequence, the order of the steps is not limited to that listed above and may be changed or rearranged as desired by the desired design. The embodiments described above may be mixed and matched with each other or with other embodiments based on design and reliability considerations, i.e., technical features in different embodiments may be freely combined to form further embodiments.

Those skilled in the art will appreciate that the modules in the device in an embodiment may be adaptively changed and disposed in one or more devices different from the embodiment. 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. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and all of the processes or elements of any method or apparatus so disclosed, may be combined in any combination, except combinations where at least some of such features and/or processes or elements 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. Also in the unit claims enumerating several means, several of these means may be embodied by one and the same item of hardware.

Similarly, it should be appreciated that in the foregoing description of exemplary embodiments of the disclosure, various features of the disclosure 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 disclosed aspects. However, the disclosed method should not be interpreted as reflecting an intention that: that is, the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, disclosed aspects lie in less than all features of a single foregoing disclosed embodiment. 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 disclosure.

The above-mentioned embodiments are intended to illustrate the objects, aspects and advantages of the present disclosure in further detail, and it should be understood that the above-mentioned embodiments are only illustrative of the present disclosure and are not intended to limit the present disclosure, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present disclosure should be included in the scope of the present disclosure.

Claims

1. A thermal ablation catheter, comprising:

an ablation assembly (101) for delivering energy to a lesion site for ablation treatment;

a sensor unit (102) attached to a surface of the ablation assembly (101) for measuring a current parameter of the surface of the ablation assembly (101) or of the focus body;

the catheter transmission section (103) comprises a hollow liner tube and an ablation assembly (101) lead and a sensor unit (102) lead inside the hollow liner tube, wherein the first end of the catheter transmission section (103) is connected to the ablation assembly (101) and the sensor unit (102) and is used for inserting the ablation assembly (101) and the sensor unit (102) into a cavity with a preset depth through a percutaneous access port for diagnosis and treatment; and

a first electrical connector provided at the second end of the catheter transmission section (103) for enabling electrical connection of the leads of the ablation assembly (101) and the leads of the sensor unit (102) with the handle of the thermal ablation catheter.

2. The thermal ablation catheter as claimed in claim 1, wherein the thermal ablation catheter can be sterilized with steam under pressure, remaining resistant to 132 ℃ without deformation and denaturation during the use cycle; and/or

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

3. The thermal ablation catheter of claim 1, further comprising:

an auxiliary catheter (106) extending through the interior of the hollow liner to the free end of the ablation assembly (101) where it communicates with the lesion;

a luer connector (105) connected to one end of the auxiliary catheter (106) for introducing a medical device or a drug into the auxiliary catheter (106).

4. The thermal ablation catheter of claim 1,

the sensor unit (102) comprises at least one of a temperature sensor, an impedance sensor or a pressure sensor.

5. The thermal ablation catheter according to claim 4, characterized in that the sensor unit (102) comprises a thermocouple type temperature sensor comprising a first metal (2014) and a second metal (2015) arranged within the hollow liner.

6. The thermal ablation catheter of claim 1,

the hollow liner tube material of the conduit transmission section (103) is a high-molecular insulating material, and the inner diameter is 0.3mm-2.6 mm; and/or

The inner diameter of the auxiliary conduit (106) is 0.1-2.4 mm.

7. A thermal ablation device, comprising:

a first split structure (10) employing the thermal ablation catheter according to any of claims 1-6;

a second split structure (20) comprising a handle body (201) and a cable (202) in detachable electrical connection with the thermal ablation catheter of the first split structure; and

the third split structure (30) comprises a host (301), wherein a temperature signal processing unit (302) is arranged in the host.

8. The thermal ablation device according to claim 7, wherein the handle body (201) of the second split structure (20) comprises a hand-held portion and internal components disposed on the hand-held portion, the internal components comprising:

the temperature measuring circuit (2012) is used for converting the analog signal collected by the temperature sensor into a digital signal in the handle body (201);

a second electrical connector detachably connected with the first electrical connector for connecting the leads of the ablation assembly (101) and the leads of the sensor unit (102).

9. The thermal ablation device according to claim 7, characterized in that the handle body (201) is provided with a display (2013).

10. The handle for a thermal ablation catheter according to claim 7, characterized in that the cable (202) is fixedly connected to the handle body and electrically connected to the thermometric circuit and to a second electrical connector for leading out the wiring inside the handle body (201).

11. Thermal ablation device according to claim 7, characterized in that said first molecular structure (10) is sterilizable using steam under pressure, maintaining a resistance to deformation and denaturation at 132 ℃ during the period of use; and/or

The second layered structure (20) is resistant to a predetermined temperature and humidity so as to function well without damage after sterilization under predetermined conditions, including:

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

12. The thermal ablation device according to claim 7, characterized in that the cable (202) has an electromagnetic shielding layer.

13. The thermal ablation device of claim 7,

the cable (202) is connected to the main machine (301) by a first multi-core electrical connector (11), and the catheter transmission section (103) of the thermal ablation catheter is connected to the handle body (201) by a second multi-core electrical connector (104).

14. A method of sterilizing a thermal ablation device according to any one of claims 7 to 13, comprising:

after use of the thermal ablation catheter:

irradiating the third split structure by adopting an ultraviolet lamp or wiping the third split structure by using 75% medical alcohol for surface sterilization so as to be repeatedly used after sterilization;

sterilizing the second split structure by adopting pressure steam so as to be repeatedly utilized after sterilization; and

15. The method of sterilizing an ablation device according to claim 14, further comprising:

prior to shipment of the thermal ablation catheter:

cleaning the second split structure, sterilizing by adopting pressure steam, drying and leaving the factory; and

and cleaning the ablation catheter with the first split structure, sterilizing by adopting pressure steam, drying and leaving the factory.

16. The method of sterilizing an ablation device as in claim 14, wherein said sterilizing the second segmented structure with pressurized steam comprises at least one of:

repeatedly sterilizing at 120 deg.C for 20min by pressure steam sterilization;

repeatedly sterilizing at 132 deg.C for 4min by pressure steam sterilization;

repeatedly sterilizing at 134 deg.C for 4min by pressure steam sterilization;