阅读说明：本技术 具有异形端头的热消融导管、热消融装置及其操作方法 (Thermal ablation catheter with profiled tip, thermal ablation device and method of operating same ) 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：本公开提供了一种具有异形端头的热消融导管、热消融装置及其操作方法,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；所述消融组件具有一偏心形封装头,所述偏心形封装头采用可固化类胶进行封装,以密封所述热消融导管的端头,并在所述热消融导管的端头形成一偏心的弧形光滑过渡面。本公开通过在导管端头采用偏心设计,采用异形圆弧封装,能够克服导管进入分叉或异型结构血管或组织存在的风险,确保导管移动流畅,对组织无剐蹭,提高了导管的安全性、有效性和易用性。(The present disclosure provides a thermal ablation catheter with a profiled tip, a thermal ablation device, and methods of operating the same, the thermal ablation catheter comprising: 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; the ablation assembly has an eccentric encapsulation head encapsulated with a curable glue to seal the tip of the thermal ablation catheter and form an eccentric curved smooth transition surface at the tip of the thermal ablation catheter. According to the catheter, the eccentric design is adopted at the end of the catheter, and the special-shaped arc packaging is adopted, so that the risk of the catheter entering a bifurcated or special-shaped structure blood vessel or tissue can be overcome, the smooth movement of the catheter is ensured, the tissue is not scratched, and the safety, effectiveness and usability of the catheter are improved.)

1. A thermal ablation catheter with a shaped tip, 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; and

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;

wherein the ablation assembly (100) has an eccentric encapsulation head (19), the eccentric encapsulation head (19) being encapsulated with a curable glue to seal the tip of the thermal ablation catheter and form an eccentric curved smooth transition surface at the tip of the thermal ablation catheter.

2. The thermal ablation catheter with shaped tip according to claim 1, wherein the thermal ablation catheter further comprises an eccentric marking (21), the eccentric marking (21) corresponding to the eccentric orientation of the eccentrically shaped packaging head (19), by means of which eccentric marking (21) the eccentric direction of the thermal ablation catheter can be indicated, guiding the thermal ablation catheter when it is advanced.

3. The thermal ablation catheter with shaped tip according to claim 2, wherein the eccentric marker (21) is provided at the proximal end of the thermal ablation catheter.

4. The thermal ablation catheter with shaped tip according to claim 3, wherein the eccentric marker (21) is provided at the proximal end of the thermal ablation catheter comprising:

the eccentric mark (21) is arranged at the second end of the conduit transmission section (200), or

The eccentric mark (21) is arranged on the connector (20), or

The eccentric mark (21) is arranged on the operating handle.

5. The thermal ablation catheter with a shaped tip according to claim 1, wherein the curable glue-like is a uv curable glue or an epoxy glue.

6. The thermal ablation catheter with shaped tip 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 heating resistance wire solenoid turns, wherein the thermocouple is used for rapid measurement of current parameters of the ablation assembly surface or the lesion body.

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

8. The thermal ablation catheter with shaped ends as claimed in claim 6, wherein the coils of the resistance heater (5) uniformly wound around the outer circumference of the hollow liner tube are in close contact with each other, and the surface of the resistance heater (5) is provided with an insulating layer for insulating the coils from each other.

9. The thermal ablation catheter with a shaped tip according to claim 8, wherein the insulating layer is a high temperature resistant polyimide material.

10. The thermal ablation catheter with the special-shaped end head as claimed in claim 6, 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.

11. The thermal ablation catheter with a shaped tip according to claim 6, wherein the thermocouple comprises two electrodes with tail ends extending away from each other, the two electrodes are separated from each other by an insulating layer and are oppositely close to each other to form a small parallel close section, and the parallel close sections are welded together by sandwich welding to form the temperature measuring end of the sandwich structure.

12. The thermal ablation catheter with a shaped tip as claimed in claim 11, 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 two electrodes of the thermocouple have the same diameter as 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 laid 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.

13. The thermal ablation catheter with a shaped tip according to claim 12, 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.

14. The thermal ablation catheter with a shaped tip as claimed in claim 11, wherein the welding material used for the sandwich welding is a material that is electrically conductive and resistant to high temperatures above 150 ℃.

15. The thermal ablation catheter with shaped tip according to claim 6, 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 exiting from the elongated hollow liner, the connector (20) being connected to an operating handle or a host of the thermal ablation catheter.

16. The thermal ablation catheter with a shaped tip according to claim 15, wherein,

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.

17. The thermal ablation catheter with shaped tip according to claim 1, further comprising a protective layer (18), said protective layer (18) extending from the distal end of the thermal ablation catheter through the ablation assembly (100), the catheter transmission section (200) and up to the connector (20), said protective layer (18) being 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.

18. The thermal ablation catheter with profiled tip according to claim 17, 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 temperature resistance greater than 140 ℃.

19. The thermal ablation catheter with the profiled tip as claimed in claim 17, wherein the protective layer (18) is made of heat-shrinkable tubing, and is sleeved on the periphery of the thermal ablation catheter, and the protective layer is formed on the surface of the thermal ablation catheter after the thermal ablation catheter is formed.

20. A thermal ablation device comprising the thermal ablation catheter with a shaped tip of any of claims 1-19.

21. A method of operating the thermal ablation catheter with a shaped tip of any of claims 1-19, comprising:

the thermal ablation catheter is advanced in the vessel with the aid of an imaging device, the eccentric position of the thermal ablation catheter is directed towards the target branch vessel according to the eccentric identification of the proximal end of the thermal ablation catheter when the tip of the distal end of the thermal ablation catheter is about to reach the vessel bifurcation, and then the thermal ablation catheter is advanced into the target branch vessel under real-time monitoring of the imaging device.

22. A method of operating the thermal ablation catheter with a shaped tip of any of claims 1-19, comprising:

the thermal ablation catheter is moved forward in the blood vessel with the aid of an imaging device, the eccentric position of the thermal ablation catheter is directed to the side away from the plaque according to the eccentric identification of the proximal end of the thermal ablation catheter when the tip of the distal end of the thermal ablation catheter approaches the plaque in the blood vessel, and then the thermal ablation catheter is moved forward with the real-time monitoring of the imaging device, so that the tip of the distal end of the thermal ablation catheter passes through the plaque site.

Technical Field

The present disclosure relates to the field of medical devices, and more particularly to a thermal ablation catheter with a profiled tip, a thermal ablation device, and methods of operating the same.

Background

With the progress of medical technology, the operation gradually develops towards a minimally invasive or non-invasive trend, wherein the catheter interventional thermal ablation treatment is implemented by inserting an ablation component into a focus part through a blood vessel or an inner cavity through an incision or a cavity inlet on the skin of a patient under the assistance of imaging equipment such as B-mode ultrasound, CT and the like, and releasing energy to the focus part for ablation treatment.

The energy applying 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 aim of coagulative necrosis of lesion tissues is fulfilled, and the necrotic tissues are organized or absorbed in situ. The RF technology has unique advantages in the thermal ablation technology in view of the heating characteristic of the frequency of 300-500KHz to human tissues, the RF ablation is divided into two forms of direct RF and indirect RF, wherein the traditional direct RF ablation catheter adopts a double-electrode or single-electrode design, and an RF field is applied to the human tissues through electrodes to directly heat the human body impedance; the indirect RF ablation catheter adopts a wound spiral-tube resistor, the solenoid resistor is heated by RF, the heat generated by the resistor is transferred to human tissues, the temperature of the ablation part of the catheter is maintained at a fixed temperature by controlling the power of an RF source, and the standard ablation treatment period is 20 seconds.

In the existing commercial RF catheters, whether direct RF catheters or indirect RF catheters, the tip of the catheter is designed to be round or flat. In the process of catheter interventional thermal ablation, the primary consideration when a doctor makes a treatment plan is the structure of an ablated tissue, before intervention operation is performed, the anatomical structure of an ablated blood vessel must be considered carefully, for example, in the case of varicose intervention catheter ablation treatment, the bifurcation, the tortuous circuitous degree, the twist, the plaque and the stenosis of a vein are existed, the bifurcation structure and the tortuous degree of the blood vessel can influence the smooth insertion of the catheter, the deformed blood vessel can also obstruct the insertion of the catheter, and the risk is higher particularly when a non-special catheter system (a catheter which is not specially designed for certain tissue ablation) is used. When performing vascular interventional procedures with this type of catheter system or with catheters that do not take into account the characteristics of the vessel, risks may include perforation or rupture of the vessel during the procedure due to a mismatch in the catheter diameter or tip end and vessel diameter, especially for bifurcated vessels or for severely tortuous veins. Therefore, it is necessary to design a special catheter system conforming to the vascular structure or the common variant vessels for ablation surgery of diseases such as varicose veins, refractory hypertension caused by abnormal excitation of renal artery sympathetic nerves, heart disease caused by abnormal cardiac signal conduction, etc., so that many patients with vascular abnormalities can be treated properly.

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 a profiled tip, a thermal ablation device and a method of operating the same 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 a shaped tip 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; and

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;

wherein the ablation assembly 100 has an eccentric shaped encapsulation head 19, and the eccentric shaped encapsulation head 19 is encapsulated with a curable glue to seal the tip of the thermal ablation catheter and form an eccentric curved smooth transition surface at the tip of the thermal ablation catheter.

According to an embodiment of the present disclosure, the thermal ablation catheter further comprises an eccentric marking 21, the eccentric marking 21 corresponding to the eccentric orientation of the eccentrically shaped encapsulation head 19, by means of which eccentric marking 21 the eccentric direction of the thermal ablation catheter can be indicated, which is guided when being advanced.

According to an embodiment of the present disclosure, the eccentric mark 21 is disposed at a proximal end of the thermal ablation catheter, specifically comprising: the eccentric mark 21 is arranged at the second end of the catheter transmission section 200, or the eccentric mark 21 is arranged on the connector 20, or the eccentric mark 21 is arranged on the operating handle.

According to the embodiment of the disclosure, the curable glue is ultraviolet curing glue or epoxy glue and other various glues suitable for being applied to a human body.

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. The insulating layer is made of high-temperature-resistant polyimide material.

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 an embodiment of the present disclosure, the thermal ablation catheter further comprises a protective covering 18, the protective covering 18 extending from the distal end of the thermal ablation catheter through the ablation assembly 100, the catheter transmission segment 200 and up to the connector 20, the protective covering 18 being encapsulated with a curable glue-like 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.

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 another aspect of the present disclosure, there is provided a thermal ablation device comprising the thermal ablation catheter with a shaped tip.

According to another aspect of the present disclosure, there is provided a method of operating a thermal ablation catheter having a shaped tip, comprising: the thermal ablation catheter is advanced in the vessel with the aid of an imaging device, the eccentric position of the thermal ablation catheter is directed towards the target branch vessel according to the eccentric identification of the proximal end of the thermal ablation catheter when the tip of the distal end of the thermal ablation catheter is about to reach the vessel bifurcation, and then the thermal ablation catheter is advanced into the target branch vessel under real-time monitoring of the imaging device.

According to another aspect of the present disclosure, there is provided a method of operating a thermal ablation catheter having a shaped tip, comprising: the thermal ablation catheter is moved forward in the blood vessel with the aid of an imaging device, the eccentric position of the thermal ablation catheter is directed to the side away from the plaque according to the eccentric identification of the proximal end of the thermal ablation catheter when the tip of the distal end of the thermal ablation catheter approaches the plaque in the blood vessel, and then the thermal ablation catheter is moved forward with the real-time monitoring of the imaging device, so that the tip of the distal end of the thermal ablation catheter passes through the plaque site.

(III) advantageous effects

From the above technical solution, it can be seen that the thermal ablation catheter with a profiled tip, the thermal ablation device and the operation method thereof provided by the present disclosure have at least one of the following advantages:

1. according to the heat ablation catheter with the special-shaped end, the heat ablation device and the operation method of the heat ablation catheter with the special-shaped end, the special-shaped arc packaging design is adopted for the catheter end, so that the catheter is enabled to move smoothly in a blood vessel, and no scratch is caused to blood vessel tissues.

2. According to the thermal ablation catheter with the special-shaped tip, the thermal ablation device and the operation method thereof, the eccentric design is adopted on the catheter tip, and the special-shaped arc packaging is adopted, so that the risk of the existing thermal ablation catheter entering a bifurcated or special-shaped structure blood vessel or tissue can be overcome, and the safety, effectiveness and usability of the catheter entering the blood vessel are improved.

3. According to the thermal ablation catheter with the special-shaped tip, the thermal ablation device and the operation method thereof, the eccentric mark design is adopted at the near end, and the eccentric tip design is adopted at the far end of the catheter, so that the risk that the existing thermal ablation catheter enters blood vessels or tissues with bifurcations or other special-shaped structures can be overcome, the thermal ablation catheter can smoothly enter some special-shaped blood vessels, the range of entering blood vessel types can be expanded, and the safety, effectiveness and usability of the catheter entering the blood vessels can be improved.

4. According to the heat ablation catheter with the special-shaped end, the heat ablation device and the operation method of the heat ablation device, the whole catheter and the jacket are integrated by adopting the protective layer design on the whole catheter, the catheter is uniform and free of sudden change, the catheter is smooth, the smoothness and smoothness of the catheter in moving in tissues are ensured, and the adhesion of an ablation assembly to the tissues in heating is avoided.

5. According to the heat ablation catheter with the special-shaped end head, the heat ablation device and the operation method of the heat ablation catheter, the protective layer design is adopted on the whole catheter body, the outer diameter of the whole catheter body is consistent, and the whole catheter body is uniform and free of sudden change.

Drawings

Figure 1 is a schematic diagram of an overall structure of a thermal ablation catheter with a shaped tip in accordance with an embodiment of the present disclosure.

Fig. 2 is a schematic view of an eccentric tip at the distal end of the thermal ablation catheter of fig. 1.

Fig. 3 is a schematic view of an alternative eccentric tip at the distal end of the thermal ablation catheter of fig. 1.

Figure 4 is a partial schematic structural view of a thermal ablation catheter having a shaped tip in accordance with an embodiment of the present disclosure.

Fig. 5 is a schematic structural view of the thermocouple of fig. 4.

FIG. 6 is a schematic cross-sectional view of the thermocouple of FIG. 4 with the temperature measuring end thereof disposed in the axial direction of the conduit.

Figure 7 is a schematic view of a progression of a thermal ablation catheter with a shaped tip from a main vessel into a bifurcated vessel in accordance with an embodiment of the present disclosure.

Figure 8 is a schematic view of a thermal ablation catheter with a shaped tip running from a main vessel into a branch vessel in accordance with an embodiment of the present disclosure.

Figure 9 is a schematic diagram illustrating the strike pattern of a plaque encountered in a blood vessel.

[ 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; 21. eccentric identification;

22. the vessel wall; 23. a blood vessel; 24. plaques.

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 a shaped tip is provided. As shown in fig. 1-4, fig. 1 is a schematic overall structure view of a thermal ablation catheter with a shaped tip according to an embodiment of the disclosure, and fig. 4 is a schematic partial structure view of the thermal ablation catheter with a shaped tip according to an embodiment of the disclosure. The present disclosure provides a thermal ablation catheter with a shaped tip, comprising an ablation assembly 100, a catheter transmission segment 200 and a connector 20, wherein the ablation assembly 100 is disposed at the distal end of the thermal ablation catheter as an energy application end for delivering energy to a focal site for ablation therapy; 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 provided at the second end of the catheter transmission section 200 for electrically connecting the ablation assembly lead to the operating handle or host of the thermal ablation catheter.

Referring to fig. 1 to 3, the ablation assembly 100 disposed at the distal end of the thermal ablation catheter has an eccentric encapsulation head 19, and the eccentric encapsulation head 19 is encapsulated with a curable glue to seal the tip of the thermal ablation catheter and form an eccentric curved smooth transition surface at the tip of the thermal ablation catheter. 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. Fig. 2 is a schematic view of an eccentric tip of the distal end of the thermal ablation catheter of fig. 1, and fig. 3 is a schematic view of another eccentric tip of the distal end of the thermal ablation catheter of fig. 1, which differs from the thermal ablation catheter of fig. 1 in that the curable adhesive is encapsulated at a different location to form an eccentric encapsulation head 19, but both of which are capable of sealing the distal end of the thermal ablation catheter and forming an eccentric curved smooth transition surface at the distal end of the thermal ablation catheter.

According to the heat ablation catheter with the special-shaped end, the special-shaped arc packaging design is adopted at the catheter end, so that the catheter is ensured to move smoothly in a blood vessel, and the blood vessel tissue is not scratched. Furthermore, the end of the catheter is eccentrically designed and is packaged by adopting the special-shaped arc, so that the risk of the existing thermal ablation catheter entering a bifurcated or special-shaped structure blood vessel or tissue can be overcome, and the safety, effectiveness and usability of the catheter entering the blood vessel are improved.

As shown in fig. 1, the thermal ablation catheter further comprises an eccentric marking 21, the eccentric marking 21 corresponding to the eccentric orientation of the eccentrically shaped packaging head 19, by means of which eccentric marking 21 the eccentric direction of the thermal ablation catheter can be indicated, which is guided during the advancement of the thermal ablation catheter. The eccentric marker 21 is arranged at the proximal end of the thermal ablation catheter, alternatively the eccentric marker 21 may be arranged at the second end of the catheter transmission segment 200, i.e. the end connected to the connector 20, or on the operating handle of the thermal ablation catheter. By adopting the design of the eccentric mark 21, the heat ablation catheter has a guiding function when advancing in a blood vessel, is convenient to turn and enter a branch blood vessel easily, is convenient to turn and avoid obstacles when encountering plaques and bumps, avoids the risks of scraping and rubbing when moving in the blood vessel or tissue, and ensures that the catheter can smoothly reach a target tissue.

As shown in fig. 1 and 4, 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. 5 and 6. 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. 4 and 6, 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. 4, 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 an embodiment of the present disclosure, the thermal ablation catheter further comprises a protective covering 18, the protective covering 18 extending 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 glue-like 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. 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 special-shaped end, 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 with dysmorphism end 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, has avoided again melting the adhesion of subassembly heating to the tissue.

In the disclosed embodiment, the diameter of the heating resistance wire, the thermocouple, and the extension wire thereof is about 0.1-0.2mm, the diameter of the thermal ablation catheter tube is about 1-2.6mm, the catheter tube diameter can be guided through an interventional sheath of the existing specification (5Fr-8Fr), the catheter tube diameter is about 1mm-1.5mm in the embodiment for renal artery ablation, and 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.

Based on the thermal ablation catheter with a shaped tip shown in fig. 1-6, the present disclosure also provides a thermal ablation device comprising the thermal ablation catheter with a shaped tip. In addition to the thermal ablation catheter with a shaped tip as shown in fig. 1 to 6, the thermal ablation device may further comprise 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.

Based on the thermal ablation catheter with the shaped tip and the thermal ablation device, shown in fig. 1 to 6, the present disclosure also provides an operation method of the thermal ablation catheter with the shaped tip, which is a method for operating the thermal ablation catheter with the shaped tip of the present disclosure to intervene in a bifurcated vessel, as shown in fig. 7 and 8, the method includes: the thermal ablation catheter is moved forward in a blood vessel under the assistance of B-mode ultrasound, CT and other imaging equipment, when the tip of the distal end of the thermal ablation catheter is about to reach a blood vessel bifurcation, the eccentric position of the thermal ablation catheter is pointed to a target branch blood vessel according to the eccentric identification of the proximal end of the thermal ablation catheter, and then the thermal ablation catheter is moved forward into the target branch blood vessel under the real-time monitoring of the B-mode ultrasound, CT and other imaging equipment.

Based on the thermal ablation catheter with the shaped tip and the thermal ablation device, shown in fig. 1 to 6, the present disclosure also provides an operation method of the thermal ablation catheter with the shaped tip, which is a method for operating the thermal ablation catheter with the shaped tip of the present disclosure to intervene in a shaped blood vessel or tissue, as shown in fig. 9, the method includes: the thermal ablation catheter is moved forward in the blood vessel with the assistance of B-mode ultrasound, CT and other imaging devices, when the tip at the distal end of the thermal ablation catheter is close to the plaque in the blood vessel, the eccentric position of the thermal ablation catheter is pointed to the side far away from the plaque according to the eccentric identification of the proximal end of the thermal ablation catheter, and then the thermal ablation catheter is moved forward through the plaque position by real-time monitoring of the B-mode ultrasound, CT and other imaging devices.

According to the thermal ablation catheter with the special-shaped tip, the thermal ablation device and the operation method thereof, the eccentric mark design is adopted at the near end, and the eccentric tip design is adopted at the far end of the catheter, so that the risk that the existing thermal ablation catheter enters blood vessels or tissues with bifurcations or other special-shaped structures can be overcome, the thermal ablation catheter can smoothly enter some special-shaped blood vessels, the range of entering blood vessel types can be expanded, and the safety, effectiveness and usability of the catheter entering the blood vessels can be improved.

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.