Spindle-shaped reticular electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions

Abstract

The present invention relates to a spindle-shaped mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions. The present invention includes a front-end functional part, a flexible catheter part, and a terminal operation part. Among them, the front-end functional part is arranged at the front end of the flexible catheter part, and the terminal operation part is arranged at the rear end of the flexible catheter part. The front-end functional part includes a guiding wire channel outlet, an imaging tracer marker, and a spindle-shaped mesh electrode. The guiding wire channel outlet is arranged at the radial center of the front end of the flexible catheter and is communicated with the wire cavity in the flexible catheter. The imaging tracer marker is arranged on the catheter outside the guiding wire channel outlet. The spindle-shaped mesh electrode can be one or more and is fixed on the flexible catheter of the front-end functional part. The front-end functional part and the flexible catheter part can be inserted into the human body lumen through the operation channel of the endoscope or through interventional techniques. The present invention has the characteristics of being able to freely pass through narrow parts of the lumen, freely adjusting the morphological structure of the electrode, adapting to the lesion structure and morphology in the lumen, and being applicable to minimally invasive diagnosis and treatment of lesions such as tumors in the lumen.

Description

Technical Field

[0001] The present invention relates to the field of medical device equipment, and relates to a minimally invasive diagnosis and treatment electrode that can be placed into the human body lumen through an endoscope or interventional technology. In particular, it relates to a spindle-shaped mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lumen lesions. Background Art

[0002] There are many lumen structure tissues in the human body, such as the digestive tract, urinary tract, respiratory tract, and blood vessels. These lumen structure tissues are often the sites prone to diseases such as tumors. In particular, malignant tumors represented by the biliary tract, pancreas, ureter and other parts seriously threaten human health. However, such diseases usually have insidious onset and lack typical symptoms in the early stage, resulting in most cases being diagnosed in the middle and late stages, and it is difficult to achieve radical treatment through surgical resection. In addition, some benign lesions originating from epithelial cells of lumen tissues, such as atypical hyperplasia, degeneration, necrosis, ulcer formation of mucosal cells, etc., will also cause a series of relatively complex diseases, and there are many limitations and problems in the treatment process.

[0003] Currently, treatment means including endoscopy and interventional technology can directly examine and treat lumen structures such as the digestive tract, urinary tract, and blood vessels, and have the advantages of minimally invasive and safe, providing a convenient path for the minimally invasive treatment of tumors and other lesions occurring in lumen structure tissues. A variety of new minimally invasive diagnosis and treatment devices based on the concept of flexible catheter technology have been successfully applied to the minimally invasive diagnosis and treatment of the above diseases.

[0004] In recent years, a variety of treatment technologies based on bioelectromagnetic principles, including radiofrequency ablation (RFA), pulsed electric fields (PEF), etc., have been widely used in clinical practice. The RFA technology is mainly based on the principle of thermal effect, and the PEF technology is based on the principle of non-thermal ablation. Both of them need to transfer electromagnetic energy to the tumor tissue, and the treatment electrode plays a key role in this process. In particular, the PEF ablation technology can effectively protect the tissue scaffold structure and does not cause thermal damage to the tissue, making it more suitable for local ablation treatment of lumen structure tissue lesions.

[0005] However, the ablation electrodes used in the clinical applications of RFA or PEF mostly adopt a needle-like structure design and are mainly applied to the treatment of solid tumors. When used, one or more electrodes need to be punctured into the tissue, which cannot be applied to lumen structures. In addition, there are risks such as bleeding and tumor dissemination when using needle electrodes. At the same time, the existing rigid electrodes are difficult to adapt to different lumen structures and lesion morphologies, and it is not easy to control the electrode spacing during operation. The treatment process is extremely prone to displacement, which will then change the treatment area distribution and ultimately affect the treatment effect. In addition to treatment, catheterized electrodes can also be used to collect characteristic signals such as the electrical impedance of the tissue in the lumen, and then play a role in diagnosis and treatment evaluation. Summary of the invention

[0006] In order to solve the above-mentioned technical problems existing in the background technology, the present invention provides a shuttle electrode catheter suitable for minimally invasive diagnosis and treatment of lesions such as intraluminal tumors. The shuttle electrode catheter has the characteristics of being able to freely pass through narrow parts of the lumen, being able to freely adjust the electrode structure, being able to adapt to the structure and morphology of the lesions within the lumen, and being able to be used for minimally invasive diagnosis and treatment of lesions such as intraluminal tumors.

[0007] The technical solution of the present invention is: a fusiform mesh electrode catheter suitable for minimally invasive diagnosis and treatment of luminal lesions, which is special in that: the electrode catheter includes a front-end functional part, a flexible catheter part and a terminal operating handle, the front-end functional part is arranged at the front part of the flexible catheter, and the terminal operating handle is arranged at the rear end of the flexible catheter.

[0008] Furthermore, the front-end functional part includes a guide wire channel outlet, an image tracking marker, and a shuttle mesh electrode. The guide wire channel outlet is arranged at the front end of the flexible catheter and is connected to the flexible catheter. The image tracking marker is arranged on the outer side of the guide wire channel outlet. There are one or more shuttle mesh electrodes fixed on the flexible catheter at the rear end of the guide wire channel outlet.

[0009] Furthermore, the material of the image tracer marker is a radiopaque metal material used in medical imaging examination as an imaging marker, and the material of the shuttle mesh electrode is a metal or conductive polymer material with shape memory function.

[0010] Furthermore, a guidewire cavity and a functional cavity are provided in the flexible catheter, the front end of the guidewire cavity is connected to the outlet of the guidewire channel, the rear end is connected to the terminal operating handle, and a guidewire inlet is provided. The functional cavity contains connecting wires, the front end of which is connected to the shuttle mesh electrodes, the rear end is connected to the terminal operating handle, and is connected to an external energy source through a connecting cable.

[0011] Furthermore, the guidewire cavity is arranged at the center of the flexible catheter, and there are multiple functional cavities arranged around the guidewire cavity.

[0012] Furthermore, a guide wire is arranged in the guide wire cavity, and a steel wire, a sheath tube or a guide wire may be arranged in the functional cavity.

[0013] Furthermore, the end operating handle includes an operating handle shell, the front end of the operating handle shell is connected to the flexible catheter, and the operating handle shell is provided with an adjustment device that can adjust the morphological structure of the shuttle mesh electrode. The adjustment device can be but is not limited to a sliding open loop or a roller and other structures. The adjustment device is connected to the shuttle mesh electrode through a steel wire or a sheath, thereby playing a regulating role. The adjustment device can be one or more, moving independently or in conjunction with the shuttle mesh electrode.

[0014] Further, there are two spindle-shaped mesh electrodes, namely a first spindle-shaped mesh electrode and a second spindle-shaped mesh electrode. The first spindle-shaped mesh electrode and the second spindle-shaped mesh electrode are arranged on the flexible catheter at the rear end of the guiding wire channel outlet at a certain interval. There are two adjusting devices, which are respectively connected to the first spindle-shaped mesh electrode and the second spindle-shaped mesh electrode through steel wires or sheaths.

[0015] Further, a multi-core plug is provided at the rear end of the operating handle housing, and the multi-core plug is respectively connected to the spindle-shaped mesh electrode through a wire.

[0016] Further, the material of the flexible catheter can be medical catheter materials such as PTTE, Pebax, PA, PU, PEEK, and nylon, which have good biocompatibility, corrosion resistance, and high voltage resistance.

[0017] The spindle-shaped mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lesions such as tumors in the lumen provided by the present invention is a spindle-shaped mesh electrode catheter suitable for minimally invasive diagnosis and treatment of lesions such as tumors in the lumen, which is placed into the human lumen through endoscopy or interventional techniques and can freely adjust the electrode structure and shape. The treatment electrode used is one or more spindle-shaped mesh electrode arrays arranged axially, and its radial radius is adjustable. It is placed into the target treatment site by combining endoscopy technology or interventional techniques and is manipulated by the end operating handle, and can freely control the deformation level to perform diagnosis and treatment operations on the lumen structure tissue, having the advantages of minimally invasive to the human body, wide application range, and convenient use. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic structural diagram of the present invention;

[0019] Figure 2 is Figure 1 an enlarged view of part A of

[0020] Figure 3 is a schematic diagram of the front-end functional part of the present invention;

[0021] Figure 4 is a sectional view of the first embodiment of the flexible catheter of the present invention;

[0022] Figure 5 is a sectional view of the second embodiment of the flexible catheter of the present invention;

[0023] Figure 6 is a schematic diagram of the spindle-shaped mesh electrode in the expanded state of the present invention;

[0024] Figure 7 is Figure 6 a sectional view taken along line A-A of

[0025] Figure 8 is a schematic diagram of the spindle-shaped mesh electrode in the contracted state of the present invention;

[0026] Figure 9 is Figure 8 the A-A sectional view of

[0027] The description of the reference numerals is as follows:

[0028] 1. Front-end functional part; 2. Flexible catheter; 3. End operating handle; 4. Guide wire channel outlet; 5. Image tracing marker; 6. First fusiform mesh electrode; 7. Second fusiform mesh electrode; 8. Guide wire cavity, 9. Functional cavity; 10. Adjusting device; 11. Multi-core plug. Specific embodiments

[0029] The following further elaborates on the overall solution of the present invention in conjunction with the accompanying drawings and specific embodiments:

[0030] See Figure 1 —9, the structure of the specific embodiment of the present invention includes three parts: a front-end functional part 1, a flexible catheter 2, and an end operating handle 3. The front-end functional part 1 is arranged at the front of the flexible catheter 2, and the end operating handle 3 is arranged at the rear end of the flexible catheter 2, wherein:

[0031] The front-end functional part 1 mainly includes one or more fusiform mesh electrodes, an image tracing marker 5, and a guide wire channel outlet 4. When there are multiple fusiform mesh electrodes, the fusiform mesh electrodes are arranged at certain intervals in sequence on the flexible catheter of the front-end functional part, and their morphological structures can be adjusted through the adjusting device. The material can be shape memory metals such as nickel-iron memory alloy, or other polymer composite materials with electrical conductivity.

[0032] The guide wire channel outlet 4 is arranged at the front end of the flexible catheter 2 and is communicated with the flexible catheter 2, mainly for passing through and guiding the guide wire.

[0033] In this embodiment, taking the front-end functional part 1 including two fusiform mesh electrodes as an example, the fusiform mesh electrodes mainly include: two fusiform deformable first fusiform mesh electrodes 6 and second fusiform mesh electrodes 7 representing different polarities. The first fusiform mesh electrode 6 and the second fusiform mesh electrode 7 are arranged on the flexible catheter 2 at the rear end of the guide wire channel outlet 4 at a certain interval. The structural shapes of the first fusiform mesh electrode 6 and the second fusiform mesh electrode 7 can be changed under the control of the adjusting device 10 on the end operating handle 3.

[0034] Such as Figure 6—9, the shuttle mesh electrode mainly includes two states: expansion and contraction. When the electrode expands, its radial radius gradually increases, and the axial electrode length decreases; when the electrode contracts, its radial radius gradually decreases, and the axial electrode length increases. During the deformation process, the distance between the two electrodes remains unchanged. The first shuttle mesh electrode 6 and the second shuttle mesh electrode 7 can be changed synchronously or asynchronously under the control of the adjustment device 10 of the end operating handle 3.

[0035] The image tracking marker 5 is located near the top of the front functional part 1, and can be specifically arranged on the outer side of the guide wire channel outlet 4, and is mainly made of a metal material that is not radiopaque in medical imaging examinations.

[0036] The flexible catheter 2 is a flexible multi-lumen tube, with a guidewire lumen 8 at the center for passing a guidewire; multiple functional cavities 9 are evenly arranged around the guidewire lumen 8, which can be used to pass functional components such as guide wires or steel wires. The functional cavities are isolated from each other to prevent interference or short circuits. The front end of the guidewire lumen 8 is connected to the guidewire channel outlet 4, and the rear end is connected to the terminal operating handle 3. The front end of the functional lumen 9 is connected to the first shuttle mesh electrode 6 and the second shuttle mesh electrode 7, respectively, and the rear end is connected to the terminal operating handle 3.

[0037] The end operating handle 3 includes an operating handle shell, the front end of which is connected to the flexible catheter 2. An adjusting device 10 is arranged on the operating handle shell, which moves independently or in conjunction with the shuttle mesh electrode. In the present embodiment, there are two adjusting devices 10, which move independently from the shuttle mesh electrode. The two adjusting devices 10 are respectively connected to the first shuttle mesh electrode 6 and the second shuttle mesh electrode 7 through steel wires or sheaths. By respectively adjusting the positions of the two adjusting devices 10, the structural deformation of the first shuttle mesh electrode 6 and the second shuttle mesh electrode 7 can be respectively adjusted.

[0038] The first shuttle mesh electrode 6 and the second shuttle mesh electrode 7 are also connected to the multi-core plug 11 at the end of the operating handle housing through the functional cavity 9 and the wires built into the operating handle housing respectively. The multi-core plug 11 is connected to the energy source or the detection device through the cable.

[0039] The two wires respectively connecting the first shuttle mesh electrode 6 and the second shuttle mesh electrode 7 are not linked to each other.

[0040] The material of the shuttle mesh electrode can be a metal with shape memory function, such as nickel-titanium alloy, or a conductive polymer material.

[0041] The flexible catheter 2 may include but is not limited to PTTE, Pebax, PA, PU, PEEK, nylon and other medical catheter materials with good biocompatibility, corrosion resistance and high voltage resistance.

[0042] The distal operating handle 3 can be made of PVC, engineering plastics, etc., which is prior art.

[0043] The operation steps of the present invention are as follows:

[0044] 1) Preoperatively check and locate the position, size, and infiltration level of lesions such as lumen tumors.

[0045] 2) Place the guiding wire into the wire cavity 8, export it from the guiding wire channel outlet 4, and introduce the guiding wire into the lumen tumor position through an endoscope or interventional technique. Then, guide the front-end functional part 1 and the flexible catheter 2 into the tumor position in sequence along the guiding wire.

[0046] 3) Perform real-time imaging for positioning, and confirm that the front-end functional part 1 has reached the tumor site according to the imaging trace marker 5.

[0047] 4) Tools such as a spraying tube and a foreign body forceps can be sent through the functional cavity 9.

[0048] 5) By adjusting the two adjusting devices 10 on the distal operating handle 3, drive the steel wires in the functional cavity 9 respectively to expand the first fusiform mesh electrode 6 and the second shuttle-shaped mesh electrode 7, place the tumor between the first fusiform mesh electrode 6 and the second fusiform mesh electrode 7, and make full contact with the first fusiform mesh electrode 6 and the second shuttle-shaped mesh electrode 7.

[0049] 6) Connect the impedance measurement device to the multi-core plug 11, and perform bio-impedance detection and analysis on the contact positions of the first fusiform mesh electrode 6 and the second fusiform mesh electrode 7 through a wire.

[0050] 7) Connect the ablation treatment device to the multi-core plug 11, and perform ablation treatment on lesions such as tumors between the first fusiform mesh electrode 6 and the second fusiform mesh electrode 7 through a wire.

[0051] The technical content not specifically described in the content of the present invention and the above embodiments is the same as the prior art.

[0052] The above is only the specific implementation manner disclosed by the present invention, but the protection scope disclosed by the present invention is not limited thereto. The protection scope disclosed by the present invention shall be subject to the protection scope of the claims.

Claims

1. A spindle-shaped reticular electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions, characterized in that: The electrode catheter includes a front-end functional part, a flexible catheter, and a terminal operation handle. The front-end functional part is arranged at the front of the flexible catheter, and the terminal operation handle is arranged at the rear end of the flexible catheter. The front-end functional part includes a guiding guidewire channel outlet, an imaging tracer marker, and a fusiform mesh electrode. The guiding guidewire channel outlet is arranged at the front end of the flexible catheter and is communicated with the flexible catheter. The imaging tracer marker is arranged on the outer side surface of the guiding guidewire channel outlet. A guidewire cavity and a functional cavity are arranged in the flexible catheter. The front end of the guidewire cavity is communicated with the guiding guidewire channel outlet, and the rear end is communicated with the terminal operation handle. The front ends of the functional cavities are respectively communicated with the fusiform mesh electrodes, and the rear ends are communicated with the terminal operation handle. A guiding guidewire is arranged in the guidewire cavity, and a steel wire, a sheath tube or a wire is arranged in the functional cavity. The terminal operation handle includes an operation handle housing. The front end of the operation handle housing is connected to the flexible catheter. An adjusting device for pushing the fusiform mesh electrode is arranged on the operation handle housing. The adjusting device is connected to the fusiform mesh electrode through a steel wire or a sheath tube. There are two fusiform mesh electrodes, namely a first fusiform mesh electrode and a second fusiform mesh electrode, which are wrapped on the flexible catheter at the rear end of the guiding guidewire channel outlet. The first fusiform mesh electrode and the second fusiform mesh electrode are arranged on the flexible catheter at the rear end of the guiding guidewire channel outlet at a certain interval. There are two adjusting devices, which are respectively connected to the first fusiform mesh electrode and the second fusiform mesh electrode through a steel wire or a sheath tube. The material of the fusiform mesh electrode is nickel-iron shape memory alloy.

2. The spindle-shaped reticular electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions according to claim 1, wherein: The material of the imaging tracer marker is a radiopaque metal material used in medical imaging examinations as a marker.

3. The fusiform mesh electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions according to claim 2, wherein: The guidewire cavity is arranged at the center of the flexible catheter, and there are multiple functional cavities, which are arranged around the guidewire cavity.

4. The spindle-shaped mesh electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions according to claim 3, wherein: A multi-core plug is arranged at the rear end of the operation handle housing, and the multi-core plug is respectively connected to the fusiform mesh electrode through a wire.

5. The fusiform mesh electrode catheter applicable to minimally invasive diagnosis and treatment of lumen lesions according to any one of claims 1 to 4, characterized in that: The material of the flexible catheter is a medical catheter material such as PTTE, Pebax, PA, PU, PEEK or nylon, which has good biocompatibility, corrosion resistance and high voltage resistance.

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