Thermal ablation catheter with full-body protective layer and thermal ablation device

Abstract

The present disclosure provides a thermal ablation catheter and a thermal ablation device with a protective layer throughout the body, wherein the thermal ablation catheter includes: an ablation component, used to release energy to the lesion site for ablation treatment; a catheter transmission section, used to insert the ablation component through a percutaneous intervention port into the lesion body at a predetermined depth for diagnosis and treatment; a connector, used to electrically connect the ablation component lead to the operating handle or main unit of the thermal ablation catheter; a protective layer, which runs through the thermal ablation catheter, is encapsulated with a curable adhesive at the distal end of the thermal ablation catheter, and is encapsulated in the joint of the connector at the proximal end of the thermal ablation catheter. The present disclosure adopts a protective layer design throughout the catheter to achieve full catheter sheath integration, uniformity without mutations, and smoothness of the catheter, ensuring that the catheter moves smoothly and smoothly in the tissue, and avoiding adhesion of the ablation component to the tissue when heated.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular to a thermal ablation catheter and a thermal ablation device with a full-body protective layer. Background Art

[0002] Minimally invasive treatment, the most common thermal ablation, is less invasive than traditional open surgery, with less pain, lower complication rate, faster recovery, and shorter downtime. It has gradually become the main surgery in the treatment of heart diseases such as saphenous vein insufficiency in the lower limbs, atrial fibrillation caused by abnormal myocardial signal conduction, refractory hypertension, vascular obstruction, and intracavitary tumors of the esophagus and cervix.

[0003] Energy application methods for thermal ablation include radio frequency (RF), laser, microwave, ultrasound, etc. Each method converts heat energy directly or indirectly into heat energy in the human body through the corresponding ablation catheter, generating local high temperature, thereby achieving the purpose of coagulative necrosis of the diseased tissue, and the necrotic tissue is ossified or absorbed in situ. Among them, RF technology has an overwhelming advantage in thermal ablation technology due to the heating characteristics of human tissue at a frequency of 300-500KHz. The uniformity and smoothness of the outer surface of the RF ablation catheter are crucial to the ablation effect. RF ablation is divided into two forms: direct RF and indirect RF.

[0004] Among them, conventional direct RF ablation catheters are designed with dual electrodes or single electrodes (requiring external body electrode pads), such as patents CN 101495048 A, CN 104068930A, WO2017 / 000362 A1, CN 102908191 A. RF field is applied to human tissue through electrodes, causing the human body impedance to directly generate heat. This type of catheter does not allow a protective layer with excellent biocompatibility to be set on the surface of its metal electrode (due to the limitation of its physical principle, adding an insulating protective layer to the electrode is equivalent to adding two capacitors between the two electrodes, and 300-500KHz RF cannot pass through the capacitor). When the electrode heats the tissue, the tissue contracts and coagulates due to the heat. The contracted tissue adheres closely to the energy application site of the catheter or even adheres to the surface of the catheter. If the surface of the catheter cannot be made uniform and smooth throughout, it will be difficult to withdraw the catheter, and it may even take away the tissue adhered to the catheter. When the catheter is adhered to the tissue, the catheter needs to be withdrawn from the lesion and cleared before continuing the ablation treatment. In severe cases, the adhered tissue taken away by the catheter may cause tissue or blood vessel bleeding, as well as complications such as vascular perforation.

[0005] For catheters using RF indirect ablation, such as patents CN 109907822 A, CN 101495048 A, and US7517349 B2, or their structures are irregular or their surfaces are uneven, it is impossible to configure a uniform and smooth protective layer throughout the entire body, and the protective layer can only be partially added at the energy application end or the energy application location. This design has protrusions or grooves at the connection of the protective layer, and it is impossible to achieve overall smoothness.

[0006] In addition, since it is inside the human body, the seams of the protective layer are required to be sealed. Some of the process requirements here are relatively high. If the sealing is not done well, on the one hand, the liquid in the tissue will enter the ablation component from the seams, and the high temperature generated by the ablation component will cause the liquid entering to vaporize and produce bubbles, causing the protective layer to bulge and deform. On the other hand, the fixing glue used on the components in the protective layer will leak out after being fused by high temperature, posing a safety hazard.

[0007] In summary, the existing catheters used for interventional ablation are not designed to be easily applied to variant vascular structures and the treatment risks are relatively high. Summary of the invention

[0008] 1. Technical issues to be resolved

[0009] The present disclosure provides a thermal ablation catheter and a thermal ablation device with a full-body protective layer to at least partially solve the technical problems raised above.

[0010] (II) Technical solution

[0011] According to one aspect of the present disclosure, there is provided a thermal ablation catheter with a full-body protective layer, comprising:

[0012] The ablation component 100 is disposed at the distal end of the thermal ablation catheter and is used to release energy to the lesion site for ablation treatment;

[0013] A catheter transmission section 200, wherein a first end of the catheter transmission section 200 is connected to the ablation assembly 100, and is used to insert the ablation assembly 100 into a lesion at a predetermined depth through a percutaneous access port for diagnosis and treatment;

[0014] A connector 20, disposed at the second end of the catheter transmission section 200, for electrically connecting the ablation assembly lead to the operating handle or main unit of the thermal ablation catheter; and

[0015] The protective layer 18 passes through the thermal ablation catheter, is encapsulated with a curable adhesive at the distal end of the thermal ablation catheter, and is encapsulated in the joint of the connector 20 at the proximal end of the thermal ablation catheter.

[0016] According to an embodiment of the present disclosure, the protective layer 18 is made of Teflon, polyimide or ceramic non-stick material with good biocompatibility and thermal conductivity, a friction coefficient in the range of 0.05-0.5 and a temperature resistance greater than 140°C.

[0017] According to an embodiment of the present disclosure, the protective layer 18 is a heat shrink tube, which is sleeved on the outer circumference of the thermal ablation catheter and is formed to form a protective layer on the surface of the thermal ablation catheter after processing.

[0018] According to an embodiment of the present disclosure, the protective layer 18 runs through the ablation assembly 100 , the catheter transmission section 200 and up to the connector 20 starting from the distal end of the thermal ablation catheter.

[0019] According to an embodiment of the present disclosure, the ablation assembly 100 has a packaging head 19, and the packaging head 19 is packaged with a curable adhesive to seal the protective layer 18 and the end of the thermal ablation catheter, and form a circular arc-shaped smooth transition surface at the end of the thermal ablation catheter. The curable adhesive is a UV curable adhesive or an epoxy adhesive.

[0020] According to an embodiment of the present disclosure, the ablation component 100 includes a hollow liner 6, a heating resistor wire 5 evenly wound around the outer circumference of the hollow liner tube, and at least one thermocouple arranged between the turns of the heating resistor wire spiral, wherein the thermocouple is used to quickly measure the current parameters of the ablation component surface or lesion body.

[0021] According to an embodiment of the present disclosure, the hollow liner 6 is made of a biocompatible, flexible, high-temperature resistant polymer insulating material such as Peek, PTFE or PI.

[0022] According to the embodiment of the present disclosure, the turns of the heating resistance wire 5 uniformly wound on the outer circumference of the hollow liner are in close contact with each other, and the surface of the heating resistance wire 5 has an insulating layer to insulate the turns of the coils from each other. The insulating layer is made of high temperature resistant polyimide material.

[0023] According to an embodiment of the present disclosure, the heating resistance wire 5 evenly wound on the outer circumference of the hollow liner tube adopts a resistance wire that is folded back at the distal end of the thermal ablation catheter to form a double wire, and the double wires are wound side by side on the hollow liner tube to form a section of a single-layer solenoid. A lead hole is provided on the wall of the hollow liner tube near the single-layer solenoid to lead the two electrode leads side by side at the tail end of the heating resistance wire 5 into the inner cavity of the hollow liner tube, and extend from the inner cavity of the hollow liner tube to the proximal end of the thermal ablation catheter to be connected to the positive and negative electrodes of the host respectively.

[0024] According to an embodiment of the present disclosure, the thermocouple includes two electrodes whose tail ends extend back to back, and the head ends of the two electrodes have their insulation layers removed and are close to each other in the opposite directions to form a small parallel close section. The two parallel close electrode sections are welded together by sandwich welding to form a temperature measuring end with a sandwich structure.

[0025] According to an embodiment of the present disclosure, the temperature measuring end of the thermocouple is arranged on the hollow liner between two turns of the heating resistance wire, the diameter of the two electrodes of the thermocouple is the same as the diameter of the heating resistance wire, the height and thickness of the sandwich welding part do not exceed the diameter of the electrode, and the temperature measuring end of the sandwich structure is laid flat on the outer wall of the hollow liner, forming a structure on the same circumferential surface as the turns of the heating resistance wire.

[0026] According to an embodiment of the present disclosure, two or one through holes are provided on the wall of the hollow liner tube, for respectively leading two electrodes of the thermocouple from the two through holes or the one through hole to the inner cavity of the hollow liner tube, and routing from the inner cavity of the hollow liner tube to extend out from the proximal end of the thermal ablation catheter.

[0027] According to an embodiment of the present disclosure, the welding material used in the sandwich welding is a material that is conductive and resistant to high temperatures above 150°C.

[0028] According to an embodiment of the present disclosure, the catheter transmission section 200 includes an extended hollow liner and an ablation component lead inside the hollow liner, the ablation component lead includes a heating resistor wire lead and a thermocouple lead, the heating resistor wire lead and the thermocouple lead are led out of the extended hollow liner and integrated on the connector 20, and the connector 20 is connected to the operating handle or main unit of the thermal ablation catheter.

[0029] According to an embodiment of the present disclosure, the two electrodes of the heating resistor wire 5 are cut off after entering the extended hollow liner from the through hole, and then a non-resistive extension lead is connected to each of the two tail ends; and / or

[0030] If the two electrodes of the thermocouple are made of resistive materials, the two electrodes are cut off after entering the extended hollow liner from the through hole, and then a non-resistive extended lead wire is respectively connected to the two tail ends.

[0031] According to another aspect of the present disclosure, a thermal ablation device comprising the thermal ablation catheter with a through-body protective layer is provided.

[0032] (III) Beneficial effects

[0033] It can be seen from the above technical solutions that the thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present disclosure have at least one of the following beneficial effects:

[0034] 1. The thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present invention overcome the disadvantages of complex surface packaging process of the catheter ablation component and uneven and rough catheter surface by adding a protective layer that runs through the entire catheter, thereby reducing the difficulty of manufacturing the catheter and improving the safety, effectiveness and simplicity of treatment.

[0035] 2. The thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present invention adopt a protective layer design throughout the catheter, thereby achieving an integrated catheter jacket, uniformity without mutations, and a smooth catheter, ensuring that the catheter moves smoothly and smoothly in the tissue, and avoiding adhesion of the ablation component to the tissue when heated.

[0036] 3. The thermal ablation catheter and thermal ablation device provided by the present disclosure have a protective layer throughout the catheter, which achieves a consistent outer diameter throughout the catheter and ensures that the catheter is uniform and has no mutations.

[0037] 4. The thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present disclosure adopt a protective layer design throughout the catheter. The full-body protective layer of the catheter is easier to seal than the existing products that only add a partial protective layer at the ablation component, and the process is simple.

[0038] 5. The thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present disclosure form a circular arc-shaped smooth transition surface at the end of the thermal ablation catheter, thereby ensuring that the catheter moves smoothly in the blood vessel without scratching the blood vessel tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 Schematic diagram of the overall structure of a thermal ablation catheter with a full-body protective layer according to an embodiment of the present disclosure.

[0040] Figure 2 It is a partial structural schematic diagram of a thermal ablation catheter with a full-body protective layer according to an embodiment of the present disclosure.

[0041] Figure 3 for Figure 2 Schematic diagram of the structure of the thermocouple.

[0042] Figure 4 for Figure 2 Schematic diagram of the cross section in which the temperature measuring end of the thermocouple is arranged in the axial direction of the catheter.

[0043] [Reference Signs]

[0044] 100: ablation component; 200: catheter transmission section; 300: temperature measurement end;

[0045] 1. Electrode A; 2. Electrode B; 3. Solder; 4. Insulation layer;

[0046] 5. Heating resistance wire; 6. Hollow liner;

[0047] 7, 8, 9, lead holes;

[0048] 10, 11, 12, 13: contacts;

[0049] 14, 15, 16, 17: leads;

[0050] 18. Protective layer; 19. Packaging head; 20. Connector. DETAILED DESCRIPTION

[0051] In order to make the objectives, technical solutions and advantages of the present disclosure more clearly understood, the present disclosure is further described in detail below in combination with specific embodiments and with reference to the accompanying drawings.

[0052] Certain embodiments of the present disclosure will be described more fully below with reference to the accompanying drawings, some but not all of which will be shown. In fact, the various embodiments of the present disclosure may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present disclosure satisfies applicable legal requirements.

[0053] Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings. However, it should be understood that these descriptions are exemplary only and are not intended to limit the scope of the present disclosure. In the following detailed description, for ease of explanation, many specific details are set forth to provide a comprehensive understanding of the embodiments of the present disclosure. However, it is apparent that one or more embodiments may also be implemented without these specific details. In addition, in the following description, descriptions of known structures and technologies are omitted to avoid unnecessary confusion of the concepts of the present disclosure.

[0054] The terms used herein are only for describing specific embodiments and are not intended to limit the present disclosure. The terms "comprise", "include", etc. used herein indicate the existence of the features, steps, operations and / or components, but do not exclude the existence or addition of one or more other features, steps, operations or components.

[0055] All terms (including technical and scientific terms) used herein have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein should be interpreted as having a meaning consistent with the context of this specification, and should not be interpreted in an idealized or overly rigid manner.

[0056] In an exemplary embodiment of the present disclosure, a thermal ablation catheter with a through-body protective layer is provided. Figure 1 to Figure 2 As shown, Figure 1 Schematic diagram of the overall structure of a thermal ablation catheter with a full-body protective layer according to an embodiment of the present disclosure. Figure 2This is a partial structural schematic diagram of a thermal ablation catheter with a full-body protective layer according to an embodiment of the present disclosure. The present disclosure provides a thermal ablation catheter with a full-body protective layer, including an ablation component 100, a catheter transmission section 200, a connector 20 and a protective layer 18, wherein the ablation component 100 is arranged at the distal end of the thermal ablation catheter as an energy application end for releasing energy to the lesion site for ablation treatment; the first end of the catheter transmission section 200 is connected to the ablation component 100, and is used to insert the ablation component 100 into the lesion body at a predetermined depth through a percutaneous intervention port for diagnosis and treatment; the connector 20 is arranged at the second end of the catheter transmission section 200, and is used to electrically connect the ablation component lead to the operating handle or main unit of the thermal ablation catheter; the protective layer 18 runs through the thermal ablation catheter, is encapsulated with a curable adhesive at the distal end of the thermal ablation catheter, and is encapsulated in the joint of the connector 20 at the proximal end of the thermal ablation catheter.

[0057] In the embodiment of the present disclosure, the protective layer 18 runs through the ablation assembly 100, the catheter transmission section 200 and the connector 20 from the distal end of the thermal ablation catheter, and the protective layer 18 is encapsulated with a curable adhesive at the distal end of the thermal ablation catheter, and is encapsulated in the joint of the connector 20 at the proximal end of the thermal ablation catheter. The protective layer 18 is generally made of a material with good biocompatibility and thermal conductivity, a friction coefficient in the range of 0.05-0.5 and a temperature resistance greater than 140°C, including but not limited to Teflon, polyimide or ceramic non-stick pan materials, and can be coated on the periphery of the thermal ablation catheter.

[0058] Optionally, the protective layer 18 can also be made of a heat shrink tube made of Teflon material, which is sleeved on the outer periphery of the thermal ablation catheter and formed into a protective layer on the surface of the thermal ablation catheter after processing. At this time, the thickness at the ablation component can be 0.1 mm, and the thickness of the catheter transmission section is equal to the thickness of the ablation component, which is 0.1 mm, and the wire diameter of the heating resistor wire.

[0059] The thermal ablation catheter with a full-body protective layer provided by the present disclosure has a uniform outer diameter throughout the catheter by adopting a protective layer design throughout the catheter, ensuring that the catheter is uniform and has no mutations throughout the catheter. The thermal ablation catheter with a full-body protective layer provided by the present disclosure has a uniform outer diameter throughout the catheter by adopting a protective layer design throughout the catheter, ensuring that the catheter is integrated with the outer sheath, uniform and has no mutations, and the catheter is smooth, ensuring that the catheter moves smoothly and smoothly in the tissue, and avoiding adhesion of the ablation component to the tissue when heated.

[0060] See also Figure 1 to Figure 2The ablation assembly 100 disposed at the distal end of the thermal ablation catheter has a packaging head 19, and the packaging head 19 is packaged with a curable adhesive to seal the protective layer 18 and the end of the thermal ablation catheter, and form a circular arc-shaped smooth transition surface at the end of the thermal ablation catheter to prevent the catheter from being scratched when moving in the tissue. Optionally, the curable adhesive can be ultraviolet light curing adhesive, or epoxy adhesive or other adhesives suitable for human body application.

[0061] The thermal ablation catheter and thermal ablation device with a full-body protective layer provided by the present invention overcome the disadvantages of complex surface packaging process of the catheter ablation component and uneven and rough catheter surface by adding a protective layer that runs through the entire catheter, thereby reducing the difficulty of manufacturing the catheter and improving the safety, effectiveness and simplicity of treatment.

[0062] like Figure 1 and Figure 2 As shown, the ablation component 100 includes a hollow liner 6, a heating resistor wire 5 uniformly wound around the outer circumference of the hollow liner 6, and at least one thermocouple arranged between the turns of the heating resistor wire spiral, wherein the thermocouple is used to quickly measure the current parameters of the ablation component surface or lesion body.

[0063] In the embodiment of the present disclosure, the length of the ablation component 100 is about 1-10 cm, and the hollow liner 6 is made of a biocompatible, flexible, high-molecular, high-temperature resistant insulating material such as Peek, PTFE or PI.

[0064] In the embodiment of the present disclosure, the turns of the heating resistance wire 5 uniformly wound on the outer circumference of the hollow liner are in close contact with each other, and the surface of the heating resistance wire 5 has an insulating layer 4 to insulate the turns of the coils from each other. Optionally, the insulating layer 4 is made of high temperature resistant polyimide material.

[0065] In the embodiment of the present disclosure, the heating resistor wire 5 uniformly wound on the outer circumference of the hollow liner can be formed by folding back a resistor wire at the distal end of the thermal ablation catheter to form a double wire, and the double wires are wound side by side on the hollow liner to form a section of a single-layer solenoid. A lead hole is provided on the hollow liner wall near the single-layer solenoid to lead the two electrode leads side by side at the tail end of the heating resistor wire 5 into the inner cavity of the hollow liner, and extend from the inner cavity of the hollow liner to the proximal end of the thermal ablation catheter, and respectively connect to the positive and negative electrodes of the host. Such a design makes the current directions between adjacent turns opposite, which has the advantage of reducing the inductance of the heating resistor wire under the premise of maintaining the heating power, making the design and control of the host simpler. On the other hand, it can also offset the electromagnetic field generated by the thermal resistor, and will not interfere with other electrical devices, especially thermocouple sensors. In addition, it can also effectively offset the external industrial electromagnetic interference, making the treatment measurement and control more accurate.

[0066] One or more thermocouples may be provided according to the length of the ablation assembly 100 to quickly measure the current parameters of the ablation assembly surface or the lesion. In the embodiment of the present disclosure, the thermocouple is different from the conventional thermocouple. Figure 3 and Figure 4 The thermocouple comprises two electrodes, namely, electrode A 1 and electrode B 2, whose tail ends extend in opposite directions. The head ends of the two electrodes are provided with insulating layers removed and are placed in opposite directions to form a small parallel close section. The two parallel close electrode sections are welded together with solder 3 in a sandwich welding manner to form a temperature measuring end 300 of a sandwich structure.

[0067] like Figure 2 and Figure 4 As shown, the temperature measuring end 300 of the thermocouple is arranged on the hollow liner 6 between two turns of the heating resistance wire, the diameter of the two electrodes of the thermocouple is the same as the diameter of the heating resistance wire 5, the height and thickness of the sandwich welding part do not exceed the diameter of the electrode, and the temperature measuring end 300 of the sandwich structure is laid flat on the outer wall of the hollow liner 6, forming a structure on the same circumferential surface as the turns of the heating resistance wire 5.

[0068] In the embodiment of the present disclosure, the welding material used in the sandwich welding is a conductive material that can withstand high temperatures above 150°C. The temperature measuring end 300 of the thermocouple is arranged on the hollow liner 6 between two turns of the heating resistance wire. On the one hand, the temperature measuring end 300 and the two adjacent turns of the heating resistance wire are symmetrically arranged to ensure that the measured value of the thermocouple can reflect the actual temperature of the surface of the ablation component 100. On the other hand, in order to ensure that the circumference of the ablation component 100 is uniform and has no sudden changes, the temperature measuring end of the thermocouple and the turns of the heating resistance wire are required to be on the same circumferential surface. In order to achieve this requirement, the diameters of the two electrodes of the thermocouple are the same as the diameter of the heating resistance wire 5. The height and thickness of the sandwich welding part do not exceed the diameter of the electrode. The temperature measuring end 300 of the sandwich structure is laid flat on the outer wall of the hollow liner 6, forming a structure on the same circumferential surface as the turns of the heating resistance wire 5.

[0069] In an embodiment of the present disclosure, two or one through holes may be provided on the wall of the hollow liner tube, for respectively leading two electrodes of the thermocouple from the two through holes or the one through hole to the inner cavity of the hollow liner tube, and routing from the inner cavity of the hollow liner tube to extend out from the proximal end of the thermal ablation catheter.

[0070] In the embodiment of the present disclosure, the length of the catheter transmission section 200 is about 500 cm-100 cm, and is used to insert the ablation assembly 100 into the lesion at a predetermined depth through a percutaneous access port for diagnosis and treatment. Figure 2As shown, the catheter transmission section 200 includes an extended hollow liner and an ablation component lead in the inner cavity of the hollow liner, and the ablation component lead includes a heating resistor wire lead and a thermocouple lead. The heating resistor wire lead and the thermocouple lead are led out of the extended hollow liner and integrated on the connector 20, and the connector 20 is connected to the operating handle or main unit of the thermal ablation catheter.

[0071] In the embodiments of the present disclosure, the inner cavity of the hollow liner is used for the leads of the heating resistance wire and the thermocouple. In order to avoid the situation where the heating resistance wire generates heat for a long time in the liner and cannot effectively transfer the heat out and burn the electrode or the catheter, in some embodiments of the present disclosure, the two electrodes of the heating resistance wire 5 are cut off after entering the extended hollow liner from the through hole, and then a non-resistive extension lead is connected to each of the two tail ends; in other embodiments of the present disclosure, if the two electrodes of the thermocouple are resistive materials, the two electrodes are cut off after entering the extended hollow liner from the through hole, and then a non-resistive extension lead is connected to each of the two tail ends.

[0072] In the embodiments of the present disclosure, the diameters of the heating resistor wire, the thermocouple, and the extension wire thereof are approximately between 0.1-0.2 mm, and the diameter of the thermal ablation catheter body is approximately between 1-2.6 mm, which can pass through the interventional guide sheath of existing specifications (5Fr-gFr). In the embodiments for renal artery ablation, the diameter of the catheter body is approximately between 1 mm and 1.5 mm, and in the embodiments for lower extremity great saphenous vein ablation, the diameter of the catheter body is approximately between 1.5 mm and 2.6 mm. The wall thickness of the hollow liner is approximately between 0.1 and 0.5 mm, and the inner diameter of the hollow liner is correspondingly approximately between 0.8 mm and 2.4 mm, so as to pass through the ablation component lead, thermocouple lead, and auxiliary tube. The hollow liner is preferably made of a polymer high-temperature resistant insulating material with good biocompatibility and flexibility, preferably Peek, PTFE, PI and other high-temperature resistant materials.

[0073] based on Figures 1 to 4 The present disclosure also provides a thermal ablation device including the thermal ablation catheter with a full-body protective layer. The thermal ablation device includes the thermal ablation catheter with a full-body protective layer. Figures 1 to 4 In addition to the thermal ablation catheter with a full-body protective layer, the thermal ablation catheter may also include an operating handle or a main unit electrically connected to the connector 20. Since the operating handle or main unit of the thermal ablation catheter is the same as that in the prior art, it will not be described in detail here.

[0074] The thermal ablation catheter and thermal ablation device provided by the present disclosure with a protective layer throughout the entire catheter overcomes the drawbacks of the complicated surface packaging process of the catheter ablation component and the uneven and rough surface of the catheter by adding a protective layer that runs through the entire catheter, reduces the difficulty of manufacturing the catheter, and improves the safety, effectiveness and simplicity of treatment. By adopting a protective layer design throughout the catheter, the entire catheter jacket is integrated, uniform and without mutations, and the catheter is smooth, ensuring that the catheter moves smoothly and smoothly in the tissue, and avoiding adhesion of the ablation component to the tissue when heated.

[0075] So far, the present disclosure has been described in detail in conjunction with the accompanying drawings. Based on the above description, those skilled in the art should have a clear understanding of the present disclosure.

[0076] It should be noted that the implementation methods not shown or described in the drawings or the text of the specification are all forms known to ordinary technicians in the relevant technical field and are not described in detail. In addition, the above definitions of each element are not limited to the various specific structures, shapes or methods mentioned in the embodiments, and ordinary technicians in the field can simply change or replace them.

[0077] Of course, according to actual needs, the present disclosure may also include other parts, which are irrelevant to the innovation of the present disclosure and will not be described here.

[0078] Moreover, the shapes and sizes of the components in the figures do not reflect the real size and proportion, but only illustrate the contents of the embodiments of the present disclosure. In addition, in the claims, any reference symbols between brackets shall not be constructed as limiting the claims.

[0079] Unless otherwise indicated, the numerical parameters in this specification and the appended claims are approximate values ​​and can vary according to the desired properties obtained through the content of the present disclosure. Specifically, all numbers used in the specification and claims to express the content of the composition, reaction conditions, etc., should be understood to be modified by the term "about" in all cases. In general, the meaning of the expression is to include a variation of ±10% in some embodiments, ±5% in some embodiments, ±1% in some embodiments, and ±0.5% in some embodiments by a specific number.

[0080] 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.

[0081] In addition, unless the steps are specifically described or must occur in sequence, the order of the above steps is not limited to the above list, and can be changed or rearranged according to the required design. And the above embodiments can be mixed and matched with each other or with other embodiments based on design and reliability considerations, that is, the technical features in different embodiments can be freely combined to form more embodiments.

[0082] Those skilled in the art will appreciate that the modules in the devices in the embodiments may be adaptively changed and set in one or more devices different from the embodiments. The modules or units or components in the embodiments may be combined into one module or unit or component, and in addition they may be divided into multiple submodules or subunits or subcomponents. All features disclosed in this specification (including the accompanying claims, abstracts and drawings) and all processes or units of any method or device disclosed in this manner may be combined in any combination, except that at least some of such features and / or processes or units are mutually exclusive. Unless otherwise expressly stated, each feature disclosed in this specification (including the accompanying claims, abstracts and drawings) may be replaced by an alternative feature that provides the same, equivalent or similar purpose. Furthermore, in a unit claim that lists several devices, several of these devices may be embodied by the same hardware item.

[0083] Similarly, it should be understood that in order to streamline the present disclosure and aid in understanding one or more of the various disclosed aspects, in the above description of the exemplary embodiments of the present disclosure, the various features of the present disclosure are sometimes grouped together into a single embodiment, figure, or description thereof. However, this disclosed method should not be interpreted as reflecting the following intention: the claimed disclosure requires more features than the features explicitly recited in each claim. More specifically, as reflected in the claims below, the disclosed aspects are less than all the features of the single embodiment disclosed above. Therefore, the claims that follow the specific embodiment are hereby expressly incorporated into the specific embodiment, with each claim itself serving as a separate embodiment of the present disclosure.

[0084] In addition, in the drawings or descriptions, similar or identical parts use the same figure numbers. The technical features in the various embodiments exemplified in the specification can be freely combined to form new solutions without conflict. In addition, each claim can be used as an embodiment alone or the technical features in each claim can be combined as a new embodiment, and in the drawings, the shape or thickness of the embodiment can be expanded and simplified or conveniently indicated. Furthermore, the elements or implementations not shown or described in the drawings are in a form known to a person of ordinary skill in the art. In addition, although demonstrations of parameters containing specific values ​​may be provided herein, it should be understood that the parameters do not need to be exactly equal to the corresponding values, but can be approximated to the corresponding values ​​within an acceptable error tolerance or design constraint.

[0085] Unless there are technical obstacles or contradictions, the above-mentioned various embodiments of the present disclosure can be freely combined to form additional embodiments, and these additional embodiments are all within the protection scope of the present disclosure.

[0086] Although the present disclosure is described in conjunction with the accompanying drawings, the embodiments disclosed in the accompanying drawings are intended to exemplify the preferred embodiments of the present disclosure and should not be construed as limiting the present disclosure. The dimensional ratios in the accompanying drawings are merely illustrative and should not be construed as limiting the present disclosure.

[0087] Although some embodiments of the present general inventive concept have been shown and described, it will be appreciated by those skilled in the art that changes may be made to these embodiments without departing from the principles and spirit of the present general inventive concept, the scope of which is defined by the claims and their equivalents.

[0088] The specific embodiments described above further illustrate the purpose, technical solutions and beneficial effects of the present disclosure. It should be understood that the above description is only a specific embodiment of the present disclosure and is not intended to limit the present disclosure. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present disclosure should be included in the protection scope of the present disclosure.

Claims

1. A thermal ablation catheter with a full-body protective layer, comprising: An ablation component (100), arranged at the distal end of the thermal ablation catheter, is used to release energy to the lesion site for ablation treatment; A catheter transmission section (200), wherein a first end of the catheter transmission section (200) is connected to the ablation component (100) and is used to insert the ablation component (100) into a lesion at a predetermined depth through a percutaneous access port for diagnosis and treatment; A connector (20), arranged at the second end of the catheter transmission section (200), used to electrically connect the ablation component lead to the operating handle or main unit of the thermal ablation catheter; and A protective layer (18) passes through the thermal ablation catheter, is encapsulated at the distal end of the thermal ablation catheter using a curable adhesive, and is encapsulated in the joint of the connector (20) at the proximal end of the thermal ablation catheter, forming a circular arc-shaped smooth transition surface at the end of the thermal ablation catheter; The ablation assembly (100) comprises a hollow liner (6), a heating resistor wire (5) uniformly wound around the outer circumference of the hollow liner, and at least one thermocouple arranged between the turns of the heating resistor wire spiral; the thermocouple comprises two electrodes with their tail ends extending in opposite directions, the head ends of the two electrodes are provided with insulation layers removed and are placed in reverse proximity to form a small parallel proximity section, and the two parallel proximity electrode sections are welded together by sandwich welding to form a temperature measuring end with a sandwich structure.

2. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The protective layer (18) is made of Teflon, polyimide or ceramic non-stick pan material with good biocompatibility and thermal conductivity, a friction coefficient in the range of 0.05-0.5 and a temperature resistance greater than 140°C.

3. The thermal ablation catheter with a full-body protective layer according to claim 1, wherein: The protective layer (18) is a heat shrink tube, which is sleeved on the outer circumference of the thermal ablation catheter and forms a protective layer on the surface of the thermal ablation catheter after processing and shaping.

4. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The protective layer (18) starts from the distal end of the thermal ablation catheter and passes through the ablation component (100), the catheter transmission section (200) and up to the connector (20).

5. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The ablation component (100) has a packaging head (19), and the packaging head (19) is packaged with a curable adhesive to seal the protective layer (18) and the end of the thermal ablation catheter.

6. The thermal ablation catheter with a through-body protective layer according to claim 5, wherein: The curable adhesive is UV curable adhesive or epoxy adhesive.

7. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The thermocouple is used to quickly measure current parameters of the surface of the ablation component or the lesion.

8. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The hollow liner (6) is made of biocompatible, high-temperature resistant polymer insulating material Peek, PTFE or PI with good flexibility.

9. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The turns of the heating resistance wire (5) uniformly wound around the outer circumference of the hollow liner are in close contact with each other, and an insulating layer is provided on the surface of the heating resistance wire (5) so that the turns are insulated from each other.

10. The thermal ablation catheter with a through-body protective layer according to claim 9, wherein: The insulating layer is made of high temperature resistant polyimide material.

11. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The heating resistor wire (5) uniformly wound on the outer circumference of the hollow liner tube adopts a resistor wire that is folded back at the distal end of the thermal ablation catheter to form a double wire, and the double wires are wound side by side on the hollow liner tube to form a section of a single-layer solenoid. A lead hole is provided on the hollow liner tube wall near the single-layer solenoid to lead the two electrode leads arranged side by side at the tail end of the heating resistor wire (5) into the inner cavity of the hollow liner tube, and are routed from the inner cavity of the hollow liner tube to the proximal end of the thermal ablation catheter and extend out to be connected to the positive and negative electrodes of the host respectively.

12. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The temperature measuring end of the thermocouple is arranged on the hollow liner between two turns of the heating resistance wire. The diameter of the two electrodes of the thermocouple is the same as the diameter of the heating resistance wire. The height and thickness of the sandwich welding part do not exceed the diameter of the electrode. The temperature measuring end of the sandwich structure is laid flat on the outer wall of the hollow liner, forming a structure on the same circumferential surface as the turns of the heating resistance wire.

13. The thermal ablation catheter with a through-body protective layer according to claim 12, wherein: Two or one through holes are provided on the wall of the hollow liner tube, for respectively leading two electrodes of the thermocouple from the two through holes or the one through hole to the inner cavity of the hollow liner tube, and then routing the electrodes from the inner cavity of the hollow liner tube to the proximal end of the thermal ablation catheter and extending out.

14. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The welding material used in the sandwich welding is a conductive material that can withstand high temperatures above 150°C.

15. The thermal ablation catheter with a through-body protective layer according to claim 1, wherein: The catheter transmission section (200) includes an extended hollow liner and an ablation component lead inside the hollow liner, the ablation component lead includes a heating resistor wire lead and a thermocouple lead, the heating resistor wire lead and the thermocouple lead are led out of the extended hollow liner and integrated on a connector (20), and the connector (20) is connected to an operating handle or a main unit of the thermal ablation catheter.

16. The thermal ablation catheter with a through-body protective layer according to claim 15, wherein: The two electrodes of the heating resistance wire (5) are cut off after entering the extended hollow liner from the through hole, and then connected to a non-resistive extension lead at each of the two tail ends; and / or If the two electrodes of the thermocouple are made of resistive materials, the two electrodes are cut off after entering the extended hollow liner from the through hole, and then a non-resistive extended lead wire is respectively connected to the two tail ends.

17. A thermal ablation device comprising the thermal ablation catheter with a through-body protective layer according to any one of claims 1 to 16.

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