阅读说明：本技术 一种带通体保护层的热消融导管及热消融装置 (Heat ablation catheter with whole body protection layer and heat ablation device ) 是由 李荐民 陈志强 李元景 张丽 李玉兰 于 2021-01-20 设计创作，主要内容包括：本公开提供了一种带通体保护层的热消融导管及热消融装置,所述热消融导管包括：消融组件,用于对病灶部位释放能量进行消融治疗；导管传输段,用于将所述消融组件通过经皮介入口插入到预定深度的病灶体内进行诊疗；连接器,用于将消融组件引线电连接于热消融导管的操作手柄或主机；保护层,通体贯穿所述热消融导管,在所述热消融导管的远端采用可固化类胶进行封装,并在所述热消融导管的近端被封装在所述连接器的接头内。本公开通过在导管通体采用保护层设计,实现了全导管外套一体化,均匀无突变,导管光滑,确保导管在组织内移动时光滑、顺溜,又避免了消融组件加热时对组织的黏连。(The present disclosure provides a thermal ablation catheter with an entire body protective layer and a thermal ablation device, the thermal ablation catheter including: the ablation component is used for releasing energy to the focus part to perform ablation treatment; the catheter transmission section is used for inserting the ablation assembly into a focus body with a preset depth through a percutaneous access port for diagnosis and treatment; a connector for electrically connecting the ablation assembly lead to an operating handle or host of the thermal ablation catheter; a protective layer extending entirely through the thermal ablation catheter, encapsulated with a curable gel-like compound at a distal end of the thermal ablation catheter, and encapsulated within the joint of the connector at a proximal end of the thermal ablation catheter. The catheter outer sleeve is designed by adopting the protective layer on the whole catheter body, so that the integration of the whole catheter outer sleeve is realized, the catheter is uniform and has no sudden change, the catheter is smooth, the smoothness of the catheter in the tissue movement is ensured, and the adhesion of the ablation assembly to the tissue in the heating process is avoided.)

1. A thermal ablation catheter with a through body covering, comprising:

an ablation assembly (100) disposed at a distal end of the thermal ablation catheter for delivering energy to a focal site for ablation therapy;

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 for inserting the ablation assembly (100) into a focus body with a preset depth through a percutaneous access port for diagnosis and treatment;

a connector (20) disposed at a second end of the catheter transmission section (200) for electrically connecting an ablation assembly lead to an operating handle or a host of a thermal ablation catheter; and

a protective layer (18) extending entirely through the thermal ablation catheter, encapsulated with a curable gel-like compound at the distal end of the thermal ablation catheter, and encapsulated within the joint of the connector (20) at the proximal end of the thermal ablation catheter.

2. Thermal ablation catheter with a protective layer for a body according to claim 1, wherein the protective layer (18) is made of teflon-like, polyimide or ceramic non-stick material with biocompatibility, good thermal conductivity, a friction coefficient in the range of 0.05-0.5 and a temperature resistance of more than 140 ℃.

3. The thermal ablation catheter with the body protection layer according to claim 1, wherein the protection layer (18) is made of a heat shrinkable tube, is sleeved on the periphery of the thermal ablation catheter, and is formed on the surface of the thermal ablation catheter after being processed and molded.

4. The thermal ablation catheter with body covering according to claim 1, wherein the covering (18) extends 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.

5. The thermal ablation catheter with body covering according to claim 1, wherein the ablation assembly (100) has an encapsulation head (19), the encapsulation head (19) being encapsulated with a curable glue-like substance to seal the covering (18) and the tip of the thermal ablation catheter and to form a circular arc-shaped smooth transition at the tip of the thermal ablation catheter.

6. The thermal ablation catheter with body covering according to claim 5, wherein the curable glue is a UV curable glue or an epoxy glue.

7. The thermal ablation catheter with body protection according to claim 1, wherein the ablation assembly (100) comprises a hollow liner (6), a heating resistance wire (5) uniformly wound around the outer circumference of the hollow liner, and at least one thermocouple arranged between the turns of the heating resistance wire solenoid, wherein the thermocouple is used for rapid measurement of the current parameters of the ablation assembly surface or the body of the lesion.

8. The thermal ablation catheter with body protection according to claim 7, wherein the hollow liner (6) is made of a biocompatible, flexible high-temperature-resistant insulating material Peek, PTFE or PI.

9. The thermal ablation catheter with a protective layer for a body as claimed in claim 7, wherein the coils of the heating resistance wire (5) uniformly wound around the outer circumference of the hollow liner tube are in close contact with each other, and the surface of the heating resistance wire (5) is provided with an insulating layer for insulating the coils from each other.

10. The thermal ablation catheter with body covering according to claim 9, wherein the insulation layer is made of a high temperature resistant polyimide material.

11. The thermal ablation catheter with a body protection layer according to claim 7, wherein the heating resistance wire (5) uniformly wound around the outer circumference of the hollow liner tube is folded back by using a resistance wire at the distal end of the thermal ablation catheter to form a double wire, the double wire is wound side by side on the hollow liner tube to form a single-layer solenoid, and a lead hole is formed in the wall of the hollow liner tube near the single-layer solenoid to lead two electrode leads at the tail end of the heating resistance wire (5) side by side to the inner cavity of the hollow liner tube, and the two electrode leads 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 respectively connected with the positive electrode and the.

12. The thermal ablation catheter with a body protector according to claim 7, wherein the thermocouple comprises two electrodes with tail ends extending away from each other, the two electrodes have their head ends removed from the insulating layer and are oppositely adjacent to each other to form a small parallel adjacent section, and the parallel adjacent two electrode sections are welded together by sandwich welding to form the temperature measuring end of the sandwich structure.

13. The thermal ablation catheter with a body protection layer according to claim 12, wherein the temperature measuring end of the thermocouple is arranged on the hollow liner tube between the two turns of the heating resistance wire, the diameter of the two electrodes of the thermocouple is the same as that of the heating resistance wire, the height and thickness of the sandwich welding part do not exceed the diameter of the electrodes, and the temperature measuring end of the sandwich structure is flatly paved on the outer wall of the hollow liner tube to form a structure which is in the same circumferential surface with the turns of the heating resistance wire.

14. The thermal ablation catheter with body protector according to claim 13, wherein 2 or 1 through holes are provided on the hollow liner wall for leading two electrodes of a thermocouple from the 2 or 1 through holes, respectively, to the hollow liner lumen, running out from the hollow liner lumen to the proximal end of the thermal ablation catheter.

15. The thermal ablation catheter with body covering according to claim 12, wherein the welding material used for the sandwich welding is a material that is electrically conductive and resistant to high temperatures above 150 ℃.

16. The thermal ablation catheter with body shielding according to claim 7, wherein the catheter transmission section (200) comprises an elongated hollow liner and ablation assembly leads inside the hollow liner, the ablation assembly leads comprising a heating resistance wire lead and a thermocouple lead, the heating resistance wire lead and the thermocouple lead being integrated on a connector (20) after being led out of the elongated hollow liner, the connector (20) being connected to an operating handle or a host of the thermal ablation catheter.

17. The thermal ablation catheter with body covering according to claim 16,

two electrodes of the heating resistance wire (5) enter the elongated hollow lining tube from the through hole and are cut off, and then two tail ends of the heating resistance wire are respectively connected with a non-resistive elongated lead; and/or

If the two electrodes of the thermocouple are made of resistive materials, the two electrodes are cut off after entering the elongated hollow liner tube from the through hole, and then two tail ends of the two electrodes are respectively connected with a non-resistive elongated lead wire.

18. A thermal ablation device comprising the thermal ablation catheter with a body covering of any of claims 1-17.

Technical Field

The present disclosure relates to the field of medical devices, and more particularly to a thermal ablation catheter with an entire body protection layer and a thermal ablation device.

Background

Minimally invasive therapy, the most common thermal ablation, has gradually become a main operation in the treatment fields of heart diseases such as atrial fibrillation, intractable hypertension, vascular obstruction, intraluminal tumors such as esophagus and cervix, and the like, which are gradually caused by the insufficiency of saphenous vein of lower limb and the malfunction of cardiac muscle signal conduction, because the invasiveness is reduced, the pain is relieved, the complication incidence rate is low, the recovery is fast, and the downtime is short.

The energy application method of the thermal ablation comprises Radio Frequency (RF), laser, microwave, ultrasound and the like, and each method is directly or indirectly converted into heat energy in a human body through a corresponding ablation catheter to generate local high temperature, so that the purpose of coagulative necrosis of lesion tissues is achieved, and the necrotic tissues are organized or absorbed in situ. Among them, the RF technology has the overwhelming advantage in the thermal ablation technology in view of the heating characteristics of the human tissue by the frequency of 300-500 KHz. Uniformity and smoothness of the outer surface of the RF ablation catheter are critical to the efficacy of ablation, and RF ablation is divided into two forms, direct RF and indirect RF.

Wherein, the traditional direct RF ablation catheter adopts a double-electrode or single-electrode design (requiring an additional body electrode pad), such as patents CN 101495048A, CN 104068930A, WO 2017/000362A 1 and CN 102908191A, and applies an RF field to human tissue through an electrode to directly heat human body impedance, and the catheter does not allow a protective layer with excellent biocompatibility to be arranged on the surface of a metal electrode (due to the limitation of the physical principle, adding an insulating protective layer to the electrode is equivalent to adding two capacitors between the two electrodes, and the RF of 300 plus 500KHz can not pass through the capacitors), because the tissue is heated and contracted and solidified when the electrode is used for heating the tissue, the contracted tissue is tightly attached to the energy application part of the catheter and even is adhered to the surface of the catheter, if the surface of the catheter can not be uniform and smooth, the catheter is difficult to extract and even takes away the adhered tissue on the catheter, when the catheter is adhered with tissues, the catheter needs to be drawn out of a focus body to be cleaned, and then ablation treatment can be continued, and in severe cases, the adhered tissues taken away by the catheter cause tissue or blood vessel bleeding, and complications such as blood vessel perforation and the like.

For catheters using RF indirect ablation, such as the catheters of CN 109907822A, CN 101495048A, and US 7517349B 2, or the structure thereof is irregular, or the surface thereof is not uniform, so that a protective layer with uniform and smooth configuration on the whole body cannot be realized, and only a part of the protective layer is added at the energy application end or the energy application part, and the design has protrusions or grooves at the joints of the protective layer, so that the whole body cannot be smooth.

In addition because be in the human body, consequently protective layer seam department requires sealed, and the partial technology requirement of here is higher, if sealed do not well, inside the liquid in the tissue can get into ablation subassembly from the seam on the one hand, the high temperature that ablation subassembly produced can make the liquid gasification that enters produce the bubble and make the protective layer swell out the deformation, on the one hand in the protective layer the fixed glue of using on the subassembly can leak out after receiving high temperature fusion and bring the potential safety hazard.

In summary, the existing catheters for interventional ablation are not designed to be applied to the variant vascular structures, and have high treatment risk.

Disclosure of Invention

Technical problem to be solved

The present disclosure provides a thermal ablation catheter with an entire body protection layer and a thermal ablation device to at least partially solve the technical problems set forth above.

(II) technical scheme

According to one aspect of the present disclosure, there is provided a thermal ablation catheter with an entire body protective layer, comprising:

an ablation assembly 100 disposed at a distal end of the thermal ablation catheter for delivering energy to a focal site for ablation therapy;

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 for inserting the ablation assembly 100 into a lesion body with a predetermined depth through a percutaneous access port for diagnosis and treatment;

a connector 20 disposed at a second end of the catheter transmission section 200 for electrically connecting an ablation assembly lead to an operating handle or a main machine of a thermal ablation catheter; and

a protective covering 18, which extends entirely through the thermal ablation catheter, is encapsulated with a curable gel-like compound at the distal end of the thermal ablation catheter and encapsulated within the fitting of the connector 20 at the proximal end of the thermal ablation catheter.

According to the embodiment of the present disclosure, the protective layer 18 is made of teflon, polyimide or ceramic non-stick pan materials with good biocompatibility and thermal conductivity, a friction coefficient in the range of 0.05-0.5, and temperature resistance of more than 140 ℃.

According to the embodiment of the present disclosure, the protective layer 18 is made of a heat shrinkable tube, and is sleeved on the periphery of the heat ablation catheter, and the protective layer is formed on the surface of the heat ablation catheter after the protective layer is formed.

According to an embodiment of the present disclosure, the protective layer 18 extends from the distal end of the thermal ablation catheter through the ablation assembly 100, the catheter transmission segment 200, and to the connector 20.

According to the embodiment of the present disclosure, the ablation assembly 100 has an encapsulation head 19, and the encapsulation head 19 is encapsulated by 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. Wherein the curable glue is ultraviolet light curing glue or epoxy glue.

According to an embodiment of the present disclosure, the ablation assembly 100 comprises a hollow liner 6, a heating resistance wire 5 uniformly wound around the outer circumference of the hollow liner, and at least one thermocouple disposed between the heating resistance wire solenoid turns, wherein the thermocouple is used to rapidly measure a current parameter of the ablation assembly surface or the body of the lesion.

According to the embodiment of the present disclosure, the hollow liner 6 is made of a high-temperature-resistant insulating material Peek, PTFE or PI with good biocompatibility and flexibility.

According to the embodiment of the disclosure, the coils of the heating resistance wire 5 uniformly wound on the outer circumference of the hollow liner tube are in close contact, and an insulating layer is arranged on the surface of the heating resistance wire 5 to insulate the coils. Wherein, the insulating layer adopts the polyimide material of high temperature resistance.

According to the embodiment of the disclosure, the heating resistance wire 5 uniformly wound on the outer circumference of the hollow liner tube is folded back at the far end of the thermal ablation catheter by adopting one resistance wire to form double wires, the double wires are wound on the hollow liner tube side by side to form a single-layer solenoid, the wall of the hollow liner tube near the single-layer solenoid is provided with a lead hole, so that two electrode leads side by side at the tail end of the heating resistance wire 5 are led to the inner cavity of the hollow liner tube, are led to the near end of the thermal ablation catheter from the inner cavity of the hollow liner tube and extend out, and are respectively connected with the anode and the cathode of.

According to the embodiment of the disclosure, the thermocouple comprises two electrodes with tail ends extending back to back, the head ends of the two electrodes are removed from an insulating layer and are reversely attached to form a small section of parallel attached section, the two parallel attached electrode sections are welded together in a sandwich welding mode, and a temperature measuring end of a sandwich structure is formed.

According to the embodiment of the disclosure, the temperature measuring end of the thermocouple is arranged on the hollow liner tube between the two turns of the heating resistance wire, the diameters of two electrodes of the thermocouple are the same as the diameters of the heating resistance wire, the height and the thickness of the sandwich welding part do not exceed the diameters of the electrodes, and the temperature measuring end of the sandwich structure is paved on the outer wall of the hollow liner tube to form a structure which is in the same circumferential surface with the turns of the heating resistance wire.

According to an embodiment of the present disclosure, 2 or 1 through holes are provided on the hollow liner wall for leading two electrodes of a thermocouple from the 2 or 1 through holes to the hollow liner inner cavity, respectively, extending from the hollow liner inner cavity to the proximal end of the thermal ablation catheter.

According to the embodiment of the disclosure, the welding material adopted by the sandwich welding is a conductive material which can resist high temperature of more than 150 ℃.

According to an embodiment of the present disclosure, the catheter transmission section 200 includes an elongated hollow liner and an ablation assembly lead inside the hollow liner, the ablation assembly lead includes a heating resistance wire lead and a thermocouple lead, the heating resistance wire lead and the thermocouple lead are integrated on the connector 20 after being led out from the elongated hollow liner, and the connector 20 is connected to an operation handle or a host of the thermal ablation catheter.

According to the embodiment of the disclosure, two electrodes of the heating resistance wire 5 enter the elongated hollow liner tube from the through hole and are cut off, and then two tail ends are respectively connected with a non-resistive elongated lead; and/or

If the two electrodes of the thermocouple are made of resistive materials, the two electrodes are cut off after entering the elongated hollow liner tube from the through hole, and then two tail ends of the two electrodes are respectively connected with a non-resistive elongated lead wire.

According to another aspect of the present disclosure, there is provided a thermal ablation device comprising the thermal ablation catheter with a body covering.

(III) advantageous effects

According to the technical scheme, the thermal ablation catheter with the body protection layer and the thermal ablation device provided by the disclosure have at least one of the following beneficial effects:

1. according to the heat ablation catheter with the body protection layer and the heat ablation device, the protection layer penetrating through the whole catheter is added on the catheter, the defects that the surface packaging process of a catheter ablation component is complex, the surface of the catheter is uneven and not smooth are overcome, the manufacturing difficulty of the catheter is reduced, and the safety, effectiveness and simplicity of treatment are improved.

2. The utility model provides a heat of band-pass body protective layer melts pipe and heat and melts device, through adopting the protective layer design at the pipe entire body, has realized the integration of whole pipe overcoat, and even no sudden change, the pipe is smooth, guarantees that the pipe is smooth, smooth when organizing to remove, to the adhesion of tissue when having avoided melting the subassembly heating again.

3. According to the heat ablation catheter with the protective layer and the heat ablation device, the protective layer design is adopted on the whole catheter body, the outer diameter of the whole catheter body is consistent, and the uniformity and no sudden change of the whole catheter body are guaranteed.

4. The heat ablation catheter with the protective layer and the heat ablation device have the advantages that the protective layer design is adopted on the whole catheter body, the whole catheter body is easy to seal by adding the protective layer compared with the existing product which is only added with a part of the protective layer at the position of the ablation assembly, and the process is simple.

5. According to the heat ablation conduit with the body protection layer and the heat ablation device, the arc-shaped smooth transition surface is formed at the end of the heat ablation conduit, so that the conduit is enabled to move smoothly in a blood vessel, and the blood vessel tissue is not scratched and rubbed.

Drawings

FIG. 1 is a schematic diagram of the overall structure of a thermal ablation catheter with a body covering in accordance with an embodiment of the present disclosure.

FIG. 2 is a partial schematic structural view of a thermal ablation catheter with a body covering in accordance with an embodiment of the present disclosure.

Fig. 3 is a schematic structural view of the thermocouple of fig. 2.

FIG. 4 is a schematic cross-sectional view of the thermocouple of FIG. 2 with the temperature measuring end disposed axially of the conduit.

[ reference numerals ]

100: an ablation assembly; 200: a conduit transfer section; 300: a temperature measuring end;

1. an electrode A; 2. a B electrode; 3. welding flux; 4. an insulating layer;

5. heating resistance wires; 6. a hollow liner tube;

7. 8, 9, lead holes;

10. 11, 12, 13: a contact point;

14. 15, 16, 17: a lead wire;

18. a protective layer; 19. a packaging head; 20. a connector is provided.

Detailed Description

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.

Hereinafter, embodiments of the present disclosure will be described with reference to the accompanying drawings. It should be understood that the description is illustrative only and is not intended to limit the scope of the present disclosure. In the following detailed description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the disclosure. It may be evident, however, that one or more embodiments may be practiced without these specific details. Moreover, in the following description, descriptions of well-known structures and techniques are omitted so as to not unnecessarily obscure the concepts of the present disclosure.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. The terms "comprises," "comprising," and the like, as used herein, specify the presence of stated features, steps, operations, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, or components.

All terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art unless otherwise defined. It is noted that the terms used herein should be interpreted as having a meaning that is consistent with the context of this specification and should not be interpreted in an idealized or overly formal sense.

In one exemplary embodiment of the present disclosure, a thermal ablation catheter with an entire body protective covering is provided. As shown in fig. 1 to 2, fig. 1 is a schematic view of the overall structure of a thermal ablation catheter with a body protector according to an embodiment of the present disclosure, and fig. 2 is a schematic view of a partial structure of the thermal ablation catheter with a body protector according to an embodiment of the present disclosure. The present disclosure provides a thermal ablation catheter with a whole body protection layer, comprising an ablation component 100, a catheter transmission section 200, a connector 20 and a protection 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 a focus part for ablation treatment; a first end of the catheter transmission section 200 is connected to the ablation assembly 100, and is used for inserting the ablation assembly 100 into a lesion body with a preset depth through a percutaneous access port for diagnosis and treatment; a connector 20 is disposed at the second end of the catheter transmission section 200 for electrically connecting the ablation assembly lead to an operating handle or host of the thermal ablation catheter; a protective covering 18, which extends entirely through the thermal ablation catheter, is encapsulated with a curable gel-like compound at the distal end of the thermal ablation catheter and encapsulated within the fitting of the connector 20 at the proximal end of the thermal ablation catheter.

In an embodiment of the present disclosure, the protective covering 18 extends from the distal end of the thermal ablation catheter through the ablation assembly 100, the catheter transmission segment 200, and to the connector 20, the protective covering 18 being encapsulated with a curable gel-like compound at the distal end of the thermal ablation catheter and encapsulated within the fitting of the connector 20 at the proximal end of the thermal ablation catheter. The protective layer 18 is generally made of a material having biocompatibility and good thermal conductivity, a friction coefficient in the range of 0.05-0.5, and a temperature resistance of more than 140 ℃, and includes, but is not limited to, teflon, polyimide or ceramic non-stick pan materials, and can be coated on the outer circumference of the thermal ablation catheter.

Optionally, the protective layer 18 may also be a heat shrink tube made of teflon material, which is sleeved on the periphery of the heat ablation catheter, and the protective layer is formed on the surface of the heat ablation catheter after processing and forming, at this time, the thickness of the ablation assembly may be 0.1mm, and the thickness of the catheter transmission section is equal to the wire diameter of the heating resistance wire with the thickness of 0.1mm at the ablation assembly.

According to the heat ablation catheter with the protective layer, the protective layer design is adopted on the whole catheter body, so that the outer diameter of the whole catheter body is consistent, and the whole catheter body is ensured to be uniform and free of sudden change. The utility model provides a heat ablation catheter of band body protective layer through adopting the protective layer design at the catheter entire body, has realized the integration of whole pipe overcoat, and even no sudden change, the pipe is smooth, guarantees that the pipe is smooth, smooth when organizing to remove, to the adhesion of tissue when having avoided melting the subassembly heating again.

Referring to fig. 1 to 2, the ablation assembly 100 disposed at the distal end of the thermal ablation catheter has an encapsulation head 19, and the encapsulation head 19 is encapsulated by curable glue to seal the protective layer 18 and the tip of the thermal ablation catheter, and form a smooth transition surface in the shape of a circular arc at the tip of the thermal ablation catheter, so as to avoid scraping when the catheter moves in the tissue. Optionally, the curable adhesive may be an ultraviolet light curable adhesive, or may be various adhesives suitable for application to a human body, such as an epoxy adhesive.

According to the heat ablation catheter with the body protection layer and the heat ablation device, the protection layer penetrating through the whole catheter is added on the catheter, so that the defects that the surface packaging process of a catheter ablation component is complex, the surface of the catheter is uneven and not smooth are overcome, the manufacturing difficulty of the catheter is reduced, and the safety, effectiveness and simplicity of treatment are improved.

As shown in fig. 1 and 2, the ablation assembly 100 comprises a hollow liner 6, a heating resistance wire 5 uniformly wound around the outer circumference of the hollow liner 6, and at least one thermocouple disposed between the heating resistance wire solenoid turns, wherein the thermocouple is used to rapidly measure a current parameter of the surface of the ablation assembly or the body of the lesion.

In the embodiment of the present disclosure, the ablation assembly 100 has a length of about 1-10cm, and the hollow liner 6 is made of a biocompatible, flexible, high temperature resistant insulating material Peek, PTFE, or PI.

In the embodiment of the disclosure, the coils of the heating resistance wire 5 uniformly wound around the outer circumference of the hollow liner tube are in close contact, and an insulating layer 4 is arranged on the surface of the heating resistance wire 5 to insulate the coils. Optionally, the insulating layer 4 is made of a high temperature resistant polyimide material.

In the embodiment of the present disclosure, the heating resistance wire 5 uniformly wound around the outer circumference of the hollow liner tube may be a resistance wire that is folded back at the distal end of the thermal ablation catheter to form a double wire, the double wire is wound around the hollow liner tube side by side to form a single-layer solenoid, and a wire hole is provided on the wall of the hollow liner tube near the single-layer solenoid, so as to guide two electrode wires arranged side by side at the tail end of the heating resistance wire 5 to the inner cavity of the hollow liner tube, and the two electrode wires 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 respectively. The design enables the current directions between the adjacent wire turns to be opposite, the advantage is that the inductance of the heating resistance wire is reduced on the premise of maintaining the heating power, the design and the control of the host are simpler, on the other hand, the electromagnetic field generated by the thermal resistance can be offset, the interference on other electric devices, especially thermocouple sensors, can be avoided, in addition, the external work mode electromagnetic interference can be effectively offset, and the treatment measurement and the control are more accurate.

One or more thermocouples may be provided according to the length of the ablation assembly 100 for rapidly measuring current parameters of the ablation assembly surface or the body of the lesion. In the embodiment of the present disclosure, the thermocouple is different from a conventional thermocouple in structural design as shown in fig. 3 and 4. The thermocouple comprises two electrodes with tail ends extending back to back, namely an electrode A1 and an electrode B2, wherein the head ends of the two electrodes are removed of an insulating layer and are reversely attached to form a small parallel attached section, the two parallel attached electrode sections are welded together by using a welding flux 3 in a sandwich welding mode, and a temperature measuring end 300 of a sandwich structure is formed.

As shown in fig. 2 and 4, the temperature measuring end 300 of the thermocouple is arranged on the hollow liner tube 6 between two turns of the heating resistance wire, the diameters of two electrodes of the thermocouple are the same as the diameter of the heating resistance wire 5, the height and the thickness of the sandwich welding part do not exceed the diameters of the electrodes, and the temperature measuring end 300 of the sandwich structure is flatly laid on the outer wall of the hollow liner tube 6 to form a structure which is in the same circumferential surface with the turns of the heating resistance wire 5.

In the embodiment of the disclosure, the welding material adopted by the sandwich welding is a conductive material which can resist high temperature of more than 150 ℃. The temperature measuring end 300 of the thermocouple is arranged on the hollow liner tube 6 between the two circles of the heating resistance wires, on one hand, the temperature measuring end 300 and the two adjacent circles of the heating resistance wires are in a symmetrical layout structure, so that the measured value of the thermocouple can reflect the real temperature of the surface of the ablation assembly 100, on the other hand, in order to ensure that the circumference of the ablation assembly 100 is uniform and has no sudden change, the temperature measuring end of the thermocouple and the wire turns of the heating resistance wires are required to be on the same circumferential surface, in order to achieve the requirement, the diameters of the two electrodes of the thermocouple are the same as the diameter of the heating resistance wires 5, the height and the thickness of the sandwich welding part are not more than the diameters of the electrodes, and the temperature measuring end 300 of the sandwich structure is tiled on the outer wall of the.

In an embodiment of the present disclosure, 2 or 1 through holes may be provided on the hollow liner wall for leading two electrodes of a thermocouple from the 2 or 1 through holes to the hollow liner lumen, respectively, running from the hollow liner lumen to the proximal end of the thermal ablation catheter.

In an embodiment of the present disclosure, the catheter delivery segment 200 has a length of between about 500cm and about 100cm for inserting the ablation assembly 100 through a percutaneous access port into a lesion at a predetermined depth for diagnosis and treatment. As shown in fig. 2, the catheter transmission section 200 comprises an elongated hollow liner tube and an ablation assembly lead wire in the inner cavity of the hollow liner tube, the ablation assembly lead wire comprises a heating resistance wire lead wire and a thermocouple lead wire, the heating resistance wire lead wire and the thermocouple lead wire are integrated on the connector 20 after being led out from the elongated hollow liner tube, and the connector 20 is connected to an operating handle or a host of the thermal ablation catheter.

In some embodiments of the disclosure, two electrodes of the heating resistance wire 5 enter the extended hollow liner tube from the through hole and are cut off, and then two tail ends are respectively connected with a non-resistance extension lead wire; in other embodiments of the present disclosure, if the two electrodes of the thermocouple are made of resistive material, the two electrodes are cut off after entering the elongated hollow liner from the through hole, and then a non-resistive elongated lead is connected to each of the two ends.

In the disclosed embodiment, the diameter of the heating resistance wire, the thermocouple and the extension lead thereof is about 0.1-0.2mm, the diameter of the thermal ablation catheter tube body is about 1-2.6mm, the diameter of the catheter tube body can be guided by an interventional sheath of the prior art specification (5Fr-gFr), the diameter of the catheter tube body is about 1mm-1.5mm in the embodiment for renal artery ablation, and the diameter of the catheter tube body is about 1.5mm-2.6mm in the embodiment for lower extremity great saphenous vein ablation. The wall thickness of the hollow liner tube is between 0.1mm and 0.5mm, and the inner diameter of the hollow liner tube is between 0.8mm and 2.4mm, so that the hollow liner tube can penetrate through the ablation assembly lead wire, the thermocouple lead wire and the auxiliary tube, and the hollow liner tube is preferably made of high-temperature-resistant insulating materials with good biocompatibility and flexibility, preferably made of high-temperature-resistant materials such as Peek, PTFE, PI and the like.

The present disclosure also provides a thermal ablation device for a thermal ablation catheter including the band body protection layer based on the thermal ablation catheter with the band body protection layer shown in fig. 1 to 4. The thermal ablation device may further comprise, in addition to the thermal ablation catheter with the body covering as shown in fig. 1 to 4, an operating handle or a main unit of the thermal ablation catheter electrically connected to the connector 20. Since the operating handle or main body of the thermal ablation catheter is the same as the operating handle or main body of the prior art, it is not described here in detail.

According to the heat ablation catheter with the body protection layer and the heat ablation device, the protection layer penetrating through the whole catheter is added on the catheter, the defects that the surface packaging process of a catheter ablation component is complex, the surface of the catheter is uneven and not smooth are overcome, the manufacturing difficulty of the catheter is reduced, and the safety, effectiveness and simplicity of treatment are improved. Through adopting the protective layer design at the pipe entire body, realized the integration of whole pipe overcoat, even no sudden change, the pipe is smooth, guarantees that the pipe is smooth, smooth when removing in the tissue, to the adhesion of tissue when having avoided melting the subassembly heating again.

The present disclosure has been described in detail so far with reference to the accompanying drawings. From the above description, those skilled in the art should clearly recognize the present disclosure.

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. In addition, the above definitions of the respective elements are not limited to the specific structures, shapes or modes mentioned in the embodiments, and those skilled in the art may easily modify or replace them.

Of course, the present disclosure may also include other parts according to actual needs, and since the parts are not related to the innovation of the present disclosure, the details are not described herein.

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.

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.

Further, in the drawings or description, the same drawing reference numerals are used for similar or identical parts. Features of the embodiments illustrated in the description may be freely combined to form new embodiments without conflict, and each claim may be individually referred to as an embodiment or features of the claims may be combined to form a new embodiment, and in the drawings, the shape or thickness of the embodiment may be enlarged and simplified or conveniently indicated. Further, elements or implementations not shown or described in the drawings are of a form known to those of ordinary skill in the art. Additionally, while exemplifications of parameters including particular values may be provided herein, it is to be understood that the parameters need not be exactly equal to the respective values, but may be approximated to the respective values within acceptable error margins or design constraints.

Unless a technical obstacle or contradiction exists, the above-described various embodiments of the present disclosure may be freely combined to form further embodiments, which are all within the scope of protection of the present disclosure.

While the present disclosure has been described in connection with the accompanying drawings, the embodiments disclosed in the drawings are intended to be illustrative of the preferred embodiments of the disclosure, and should not be construed as limiting the disclosure. The dimensional proportions in the drawings are merely schematic and are not to be understood as limiting the disclosure.

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

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.