阅读说明：本技术 适用于管腔病变微创诊疗的梭形网状电极导管 (Fusiform netted electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions ) 是由 任冯刚 张雨驰 赫明 吕毅 龚霄雁 仵正 于 2021-10-28 设计创作，主要内容包括：本发明涉及一种适用于管腔病变微创诊疗的梭形网状电极导管,本发明包括前端功能部、柔性导管部和末端操作部三部分。其中,前端功能部设置在柔性导管部前端,末端操作部设置在柔性导管部后端。前端功能部包括引导导丝通道出口、影像示踪标记、梭形网状电极,引导导丝通道出口设置在柔性导管前端的径向中心,与柔性导管内的导丝腔连通,影像示踪标记设置在引导导丝通道出口外侧导管上,梭形网状电极可以为一个或多个,固定在前端功能部的柔性导管上。前端功能部和柔性导管部可经内窥镜的操作通道或经介入技术置入人体管腔内。本发明具有可自由通过管腔狭小部位、可自由调节电极形态结构、可适应管腔内病变结构和形态、可用于管腔内肿瘤等病变微创诊疗的特点。(The invention relates to a fusiform reticular electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions. Wherein, the front end function portion sets up in flexible pipe portion front end, and terminal operation portion sets up in flexible pipe portion rear end. The front end function part comprises a guide wire channel outlet, an image tracing mark and a fusiform reticular electrode, the guide wire channel outlet is arranged at the radial center of the front end of the flexible catheter and communicated with a guide wire cavity in the flexible catheter, the image tracing mark is arranged on the catheter outside the guide wire channel outlet, and the fusiform reticular electrode can be one or more and is fixed on the flexible catheter of the front end function part. The front functional part and the flexible conduit part can be arranged in the body cavity of a human body through an operation channel of an endoscope or through an interventional technology. The invention has the characteristics of freely passing through the narrow part of the lumen, freely adjusting the electrode shape and structure, being suitable for the structure and shape of lesions in the lumen, and being used for minimally invasive diagnosis and treatment of lesions such as tumors in the lumen.)

1. The utility model provides a fusiformis netted electrode catheter suitable for minimal access diagnosis and treatment of lumen lesion which characterized in that: the electrode catheter comprises a front end functional part, a flexible catheter and a tail end operating handle, wherein the front end functional part is arranged at the front part of the flexible catheter, and the tail end operating handle is arranged at the rear end of the flexible catheter.

2. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 1, wherein: the front end function part comprises a guide wire channel outlet, an image tracing mark and a fusiform reticular electrode, the guide wire channel outlet is arranged at the front end of the flexible catheter and is communicated with the flexible catheter, the image tracing mark is arranged on the outer side surface of the guide wire channel outlet, and one or more fusiform reticular electrodes are wrapped on the flexible catheter at the rear end of the guide wire channel outlet.

3. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 2, wherein: the image tracing mark is made of a radiopaque metal material in medical image examination, and the fusiform mesh electrode is made of a metal or conductive polymer material with a shape memory function.

4. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 3, wherein: the flexible catheter is characterized in that a guide wire cavity and a function cavity are arranged in the flexible catheter, the front end of the guide wire cavity is communicated with an outlet of a guide wire channel, the rear end of the guide wire cavity is communicated with a tail end operating handle, the front end of the function cavity is communicated with the fusiform mesh electrode respectively, and the rear end of the function cavity is communicated with the tail end operating handle.

5. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 4, wherein: the guide wire cavity is arranged in the center of the flexible catheter, and the plurality of functional cavities are arranged around the guide wire cavity in a surrounding mode.

6. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 5, wherein: the guide wire cavity is internally provided with a guide wire, and the functional cavity is internally provided with a steel wire, a sheath tube or a lead.

7. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 6, wherein: the tail end operating handle comprises an operating handle shell, the front end of the operating handle shell is connected with the flexible catheter, an adjusting device capable of pushing the fusiform reticular electrode is arranged on the operating handle shell, the adjusting device is connected with the fusiform reticular electrode through a steel wire or a sheath tube, and one or more adjusting devices move independently or are linked with the fusiform reticular electrode.

8. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 7, wherein: the two fusiform reticular electrodes are divided into a first fusiform reticular electrode and a second fusiform reticular electrode, the first fusiform reticular electrode and the second fusiform reticular electrode are arranged on the flexible guide pipe at the rear end of the outlet of the guide wire channel according to a certain distance, and the two adjusting devices are respectively connected with the first fusiform reticular electrode and the second fusiform reticular electrode through steel wires or sheath pipes.

9. The fusiform mesh electrode catheter suitable for minimally invasive luminal lesion diagnosis and treatment according to claim 8, wherein: the rear end of the operating handle shell is provided with a multi-core plug, and the multi-core plugs are connected through wire fusiform net electrodes respectively.

10. The fusiform mesh electrode catheter for minimally invasive luminal lesion diagnosis and treatment according to any one of claims 1 to 9, wherein: the material of the flexible conduit adopts medical conduit material with good biocompatibility, corrosion resistance and high voltage resistance including but not limited to PTTE, Pebax, PA, PU, PEEK and nylon.

Technical Field

The invention relates to the field of medical equipment, relates to a minimally invasive diagnosis and treatment electrode which can be placed into a human body lumen through an endoscope or an intervention technology, and particularly relates to a fusiform mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions.

Background

In the human body, there are many lumen structure tissues such as digestive tract, urinary tract, respiratory tract and blood vessel, which are often good sites for diseases such as tumor. Particularly, malignant tumors represented by biliary tract, pancreas, ureter and the like seriously threaten human health, but the diseases usually have hidden diseases and lack typical symptoms in early stage, so that diagnosis is already in middle and late stages in most cases, and radical treatment is difficult to realize through surgical excision. Besides, some benign lesions of epithelial cell origin in luminal tissue, such as mucosal cell dysplasia, degeneration, necrosis, ulcer formation, etc., also cause a series of more complex diseases, and have many limitations and problems in the treatment process.

At present, the treatment means including endoscope and interventional technique can directly inspect and treat the lumen structures of digestive tract, urinary tract, blood vessel and the like, has the advantages of micro-invasion, safety and the like, and provides a convenient path for the micro-invasion treatment of lesions such as tumor and the like generated by lumen structure tissues. Various novel minimally invasive diagnosis and treatment instruments based on the flexible catheter technical idea are successfully applied to minimally invasive diagnosis and treatment of the diseases.

In recent years, various therapeutic techniques based on the bio-electromagnetic principle, including Radio Frequency Ablation (RFA), electric pulse ablation (PEF), and the like, are widely used clinically. The RFA technique is based primarily on the principle of thermal effects, while the PEF technique is based on the principle of non-thermal ablation, both of which require the delivery of electromagnetic energy to the tumor tissue where the therapeutic electrodes play a critical role. Particularly, the PEF ablation technology can effectively protect the tissue bracket structure, does not generate thermal damage to the tissue, and is more suitable for local ablation treatment of lumen structure tissue lesion.

However, the ablation electrodes used in clinical applications of RFA or PEF are mainly designed in needle structure, and are mainly used for treating solid tumors, and one or more electrodes need to be punctured into tissues during use, so that the electrodes are not suitable for lumen structures. In addition, the needle electrode has the risk of bleeding, tumor spreading and the like when in use. Meanwhile, the existing rigid electrode is difficult to adapt to different lumen structures and pathological changes, the electrode spacing is difficult to control during operation, and the displacement is easy to occur in the treatment process, so that the distribution of the treatment area is changed and the treatment effect is finally influenced. Besides treatment, the catheterized electrodes can be used for collecting characteristic signals of the intraluminal tissue such as electrical impedance and the like, so as to play a role in diagnosis and treatment evaluation.

Disclosure of Invention

The invention provides a fusiform electrode catheter suitable for minimally invasive diagnosis and treatment of lesions such as tumors in a lumen for solving the technical problems in the background art, and the fusiform electrode catheter has the characteristics of freely passing through a narrow part of the lumen, freely adjusting an electrode structure, adapting to the structure and the shape of the lesions in the lumen, and being suitable for minimally invasive diagnosis and treatment of the lesions such as the tumors in the lumen.

The technical solution of the invention is as follows: a fusiform netted electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions is characterized in that: the electrode catheter comprises a front end functional part, a flexible catheter part and a tail end operating handle, wherein the front end functional part is arranged at the front part of the flexible catheter, and the tail end operating handle is arranged at the rear end of the flexible catheter.

Furthermore, the front end function part comprises a guide wire channel outlet, an image tracing mark and a fusiform reticular electrode, the guide wire channel outlet is arranged at the front end of the flexible catheter and communicated with the flexible catheter, the image tracing mark is arranged on the outer side surface of the guide wire channel outlet, and one or more fusiform reticular electrodes are fixed on the flexible catheter at the rear end of the guide wire channel outlet.

Furthermore, the material of the image tracing mark is a radiopaque metal material selected as an imaging mark in medical image examination, and the material of the fusiform mesh electrode is a metal or conductive polymer material with a shape memory function.

Furthermore, a guide wire cavity and a function cavity are arranged in the flexible catheter, the front end of the guide wire cavity is communicated with an outlet of the guide wire channel, and the rear end of the guide wire cavity is communicated with the tail end operating handle and is provided with a guide wire inlet. The functional cavity is internally provided with connecting leads, the front ends of the functional cavity are respectively communicated with the fusiform reticular electrodes, and the rear ends of the functional cavity are communicated with the tail end operating handle and are connected with an external energy source through connecting cables.

Furthermore, the guide wire cavity is arranged in the center of the flexible catheter, and a plurality of functional cavities are arranged around the guide wire cavity in a surrounding mode.

Furthermore, a guide wire is arranged in the wire guide cavity, and a steel wire, a sheath tube or a lead can be arranged in the functional cavity.

Furthermore, the tail end operating handle comprises an operating handle shell, the front end of the operating handle shell is connected with the flexible catheter, an adjusting device capable of adjusting the shape structure of the fusiform reticular electrode is arranged on the operating handle shell, the adjusting device can be but not limited to a sliding open ring or a roller wheel and other structures, the adjusting device is connected with the fusiform reticular electrode through a steel wire or a sheath tube to play an adjusting role, and one or more adjusting devices can move independently or are linked with the fusiform reticular electrode.

Furthermore, the two fusiform reticular electrodes are divided into a first fusiform reticular electrode and a second fusiform reticular electrode, the first fusiform reticular electrode and the second fusiform reticular electrode are arranged on the flexible catheter at the rear end of the outlet of the guide wire channel according to a certain distance, and the two adjusting devices are respectively connected with the first fusiform reticular electrode and the second fusiform reticular electrode through steel wires or sheath tubes.

Furthermore, a multi-core plug is arranged at the rear end of the operating handle shell and is respectively connected with the multi-core plug through a wire fusiform reticular electrode.

Furthermore, the flexible conduit can be made of medical conduit materials with good biocompatibility, corrosion resistance and high voltage resistance, such as PTTE, Pebax, PA, PU, PEEK, nylon and the like.

The invention provides a fusiform mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lesions such as tumors in a lumen, which is placed in a human body lumen through an endoscope or an intervention technology, can freely adjust the structure and the shape of an electrode, adopts one or more fusiform mesh electrode arrays which are axially arranged, has adjustable radial radius, is placed in a target treatment part through combining the endoscope technology or the intervention technology, and can freely adjust and control the deformation level through the operation of a tail end operation handle so as to carry out diagnosis and treatment operation on a lumen structure tissue, and has the advantages of minimally invasive treatment on a human body, wide application range and convenience in use.

Drawings

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is an enlarged view of portion A of FIG. 1;

FIG. 3 is a schematic diagram of the front end functional section of the present invention;

FIG. 4 is a cross-sectional view of an embodiment of the flexible conduit of the present invention;

FIG. 5 is a cross-sectional view of a second embodiment of the flexible conduit of the present invention;

FIG. 6 is a schematic view of a fusiform showerhead electrode in an expanded state in accordance with the present invention;

FIG. 7 is a cross-sectional view A-A of FIG. 6;

FIG. 8 is a schematic view of a fusiform showerhead electrode in a collapsed state according to the present invention;

fig. 9 is a sectional view a-a of fig. 8.

The reference numerals are explained below:

1. a front end function section; 2. a flexible conduit; 3. a tail end operating handle; 4. a guide wire channel exit; 5. tracing and marking the image; 6. a first fusiform mesh electrode; 7. a second fusiform mesh electrode; 8. a guide wire cavity, 9 and a function cavity; 10. an adjustment device; 11. a multi-core plug.

Detailed Description

The general aspects of the invention will be described in further detail with reference to the following figures and specific examples:

referring to fig. 1-9, the structure of an embodiment of the present invention comprises three parts: front end function portion 1, flexible pipe 2 and terminal operating handle 3, front end function portion 1 sets up in flexible pipe 2 front portion, and terminal operating handle 3 sets up at flexible pipe 2 rear end, wherein:

the front functional part 1 mainly comprises one or more fusiform reticular electrodes, an image tracing mark 5 and a guide wire channel outlet 4. When a plurality of shuttle-shaped mesh electrodes are arranged, the shuttle-shaped mesh electrodes are sequentially arranged on the flexible conduit of the front end functional part at certain intervals, the shape structure of the shuttle-shaped mesh electrodes can be adjusted by an adjusting device, and the shuttle-shaped mesh electrodes can be made of shape memory metals such as nickel-iron memory alloy and the like or other high polymer composite materials with the conductive capability.

The guide wire channel outlet 4 is arranged at the front end of the flexible catheter 2, is communicated with the flexible catheter 2 and is mainly used for passing and guiding a guide wire.

In the present embodiment, in an example where the front-end functional unit 1 includes two shuttle-shaped mesh electrodes, the shuttle-shaped mesh electrodes mainly include: two first shuttle-shaped reticular electrodes 6 and second shuttle-shaped reticular electrodes 7 representing the fusiform deformation with different polarities, wherein the first shuttle-shaped reticular electrodes 6 and the second shuttle-shaped reticular electrodes 7 are arranged on the flexible catheter 2 at the rear end of the guide wire channel outlet 4 at intervals. The structural shapes of the first shuttle-shaped reticular electrode 6 and the second shuttle-shaped reticular electrode 7 can be changed under the control of the adjusting device 10 on the end operating handle 3.

As shown in fig. 6-9, the fusiform mesh electrode mainly comprises two states of expansion and contraction, when the electrode expands, the radial radius of the electrode gradually increases, and the axial electrode length is reduced; when the electrode shrinks, the radial radius of the electrode is gradually reduced, the length of the axial electrode is increased, the distance between the two electrodes is kept unchanged in the deformation process, and the first shuttle-shaped reticular electrode 6 and the second shuttle-shaped reticular electrode 7 can be synchronously or asynchronously changed under the regulation and control of the regulating device 10 of the tail end operating handle 3.

The image tracing mark 5 is located near the top end of the front end functional part 1, can be arranged on the outer side surface of the guide wire channel outlet 4, and is mainly made of radiopaque metal material in medical imaging examination.

The flexible catheter 2 is a flexible multi-cavity tube, the center of which is a guide wire cavity 8 for guiding a guide wire; a plurality of functional cavities 9 are uniformly distributed on the periphery of the center of the guide wire cavity 8 and can be used for passing through functional components such as a lead or a steel wire. The functional cavities are mutually isolated to prevent interference or short circuit, the front end of the guide wire cavity 8 is communicated with the guide wire channel outlet 4, the rear end of the guide wire cavity is communicated with the tail end operating handle 3, the front end of the functional cavity 9 is respectively communicated with the first fusiform reticular electrode 6 and the second fusiform reticular electrode 7, and the rear end of the functional cavity is communicated with the tail end operating handle 3.

The tail end operating handle 3 comprises an operating handle shell, the front end of the operating handle shell is connected to the flexible catheter 2, adjusting devices 10 are arranged on the operating handle shell and move independently or are linked with the fusiform reticular electrodes, in the embodiment, the number of the adjusting devices 10 is two, the adjusting devices and the fusiform reticular electrodes adopt independent movement modes, the two adjusting devices 10 are respectively connected with the first fusiform reticular electrode 6 and the second fusiform reticular electrode 7 through steel wires or sheath tubes, and the structural deformation of the first fusiform reticular electrode 6 and the second fusiform reticular electrode 7 can be respectively adjusted by respectively adjusting the positions of the two adjusting devices 10.

The first fusiform reticular electrode 6 and the second fusiform reticular electrode 7 are further connected to a multi-core plug 11 at the tail end of the operating handle shell through the functional cavity 9 and a lead wire arranged in the operating handle shell respectively, and the multi-core plug 11 is connected with an energy source or detection equipment through a cable.

The two wires connecting the first and second shuttle mesh electrodes 6 and 7, respectively, do not interlock with each other.

The material of the fusiform mesh electrode can be metal with a shape memory function, such as nickel-titanium alloy, or conductive polymer material.

The flexible catheter 2 may include, but is not limited to, PTTE, Pebax, PA, PU, PEEK, nylon, etc. medical catheter materials with good biocompatibility, corrosion resistance, and high voltage resistance.

The distal end operating handle 3 may be made of PVC or engineering plastic, etc., as is known in the art.

The operation steps of the invention are as follows:

1) the position, size and infiltration level of lesions such as lumen tumor are located by preoperative examination.

2) The guide wire is placed into the guide wire cavity 8, guided out from the guide wire channel outlet 4, guided to the lumen tumor position by an endoscope or interventional technique, and the front end functional part 1 and the flexible catheter 2 are sequentially placed into the tumor position by the guide wire.

3) And (5) real-time image development positioning, and confirming that the front end functional part 1 reaches the tumor part according to the image tracing mark 5.

4) Tools such as spray pipes, foreign body clamps and the like can be fed through the functional chamber 9.

5) By adjusting the two adjusting devices 10 on the tail end operating handle 3, the steel wires in the functional cavity 9 are respectively driven to expand the first shuttle-shaped reticular electrode 6 and the second shuttle-shaped reticular electrode 7, and the tumor is placed between the first shuttle-shaped reticular electrode 6 and the second shuttle-shaped reticular electrode 7 and is fully contacted with the first shuttle-shaped reticular electrode 6 and the second shuttle-shaped reticular electrode 7.

6) An electrical impedance measuring device is connected with the multi-core plug 11, and bioelectrical impedance detection and analysis are carried out on the contact positions of the first fusiform reticular electrode 6 and the second fusiform reticular electrode 7 through leads.

7) The ablation treatment equipment is connected with the multi-core plug 11, and ablation treatment is carried out on lesions such as tumors between the first fusiform reticular electrode 6 and the second fusiform reticular electrode 7 through leads.

The present invention and the technical contents not specifically described in the above embodiments are the same as the prior art.

The above embodiments are only specific embodiments disclosed in the present invention, but the scope of the present invention is not limited thereto, and the scope of the present invention disclosed in the present invention should be subject to the scope of the claims.