An invasive electrode device

Abstract

The present disclosure discloses an invasive electrode device, comprising: an electrode body, wherein a needle tip electrode, a first control mechanism, a second control mechanism and a third control mechanism are arranged in the electrode body. Among them, the first control mechanism is used to control the needle tip electrode to penetrate into or withdraw from the tumor tissue; the second control mechanism is used to control the needle tip electrode to perform high-frequency vibration within the tumor tissue; the third control mechanism is used to control the penetration depth and angle of the needle tip electrode into the tumor tissue. The present disclosure can simultaneously enhance and optimize the electric field distribution, increase the contact effect with the tumor tissue, improve the positioning penetration depth, and thus enhance the treatment effect of irreversible electroporation.

Description

Technical Field

[0001] The present disclosure relates to an electrode, and in particular to an invasive electrode device. Background Art

[0002] The irreversible electroporation treatment of tumors usually uses electrodes to apply microsecond or nanosecond high-voltage pulses to the tumor area. When the electric field strength applied to the cell reaches a certain threshold, the cell membrane will be irreversibly perforated, thereby disrupting the physiological balance inside and outside the cell and causing cell death. Compared with traditional treatment methods, irreversible electroporation for tumor treatment has the following significant advantages: fast treatment, controllable action area (treatment parameters can be obtained through three-dimensional modeling electric field calculation, and the treatment range is accurate and safe), tumor action process is visible, the killing action area is selective, there is no obvious thermal effect during the treatment process, and there are no other side effects and complications. In addition, compared with thermal ablation treatment methods that denature tumor protein antigens, irreversible electroporation preserves the integrity of tumor antigens while treating tumors, can effectively stimulate the body's immune system, and helps to attack micro-metastatic lesions outside the treatment area.

[0003] When carrying out irreversible electroporation treatment, it is necessary to use electrodes (arrays) to construct an ideal and strong electric field distribution in the target patient area, which places high demands on the irreversible electroporation electrodes, requiring the electrode structure, penetration depth, etc. to meet the set values. Therefore, in the experiment and actual treatment process, it is of great significance to ensure that the penetration electrode can accurately control and flexibly adjust the electrode penetration depth and position. However, the existing irreversible electroporation electrodes usually adopt the form of bare needle electrodes, and their maximum field strength and electric field distribution only depend on the electrode curvature radius, which makes it difficult to achieve a strong and ideal electric field distribution. Although a larger area of ​​electric field distribution can be obtained by inserting multiple needle tip electrodes to form an electrode array, it also significantly increases the volume of the device and places higher requirements on the surgical operation process. In addition, with the development of modern medical technology, non-invasive treatment is becoming more and more popular. When carrying out irreversible electroporation treatment of esophageal tumor tissue, it is hoped that while using an endoscope for observation, the tumor tissue can be directly subjected to electrode penetration, tissue ablation and other operations. The existing devices are difficult to meet the requirements of non-invasive, convenient, flexible and precise operation.

[0004] In addition, when the existing irreversible electroporation electrodes are integrated into the endoscope channel for insertion, it is difficult to achieve precise control and reliable puncture of the needle tip electrode. In particular, some tumor tissues, such as esophageal tumors, have tumor tissue cells that are very brittle and require a lot of force for puncture. Conventional electrodes are difficult to apply and need to be equipped with additional force-adding mechanisms to induce the needle tip electrode to reliably puncture the tumor tissue, which greatly reduces the therapeutic effect of electroporation.

[0005] Finally, for irreversible electroporation of early tumor tissue, the needle tip electrode needs to be able to puncture the tumor tissue more accurately, and the electrode needs to be able to adjust the angle and direction within a small range. The above functions are difficult to achieve with existing equipment. Summary of the invention

[0006] In view of the deficiencies in the prior art, the purpose of the present invention is to provide an invasive electrode device that can simultaneously enhance and optimize the electric field distribution, increase the contact effect with tumor tissue, and improve the positioning insertion depth, which is of great significance for improving the effect of irreversible electroporation treatment.

[0007] To achieve the above objectives, the present disclosure provides the following technical solutions:

[0008] An invasive electrode device, comprising:

[0009] Electrode body,

[0010] The electrode body is provided with a needle tip electrode, a first control mechanism, a second control mechanism and a third control mechanism, wherein:

[0011] The first control mechanism is used to control the needle tip electrode to penetrate into or withdraw from the tumor tissue;

[0012] The second control mechanism is used to control the needle tip electrode to vibrate at a high frequency in the tumor tissue;

[0013] The third control mechanism is used to control the depth and angle of the needle tip electrode penetrating into the tumor tissue.

[0014] Preferably, the first control mechanism comprises a tractor.

[0015] Preferably, the second control mechanism includes a high-frequency vibration exciter, and the high-frequency vibration exciter is connected to a vibration excitation power supply.

[0016] Preferably, the third control mechanism comprises a micro-torque controller, and the micro-torque controller is connected to a pulse square wave power supply.

[0017] Preferably, the end of the needle tip electrode is provided with a nanoscale tip.

[0018] Preferably, the electrode device further comprises an electroporation pulse source, and the electroporation pulse source is connected to the needle tip electrode via a flexible guide wire electrode.

[0019] Preferably, an insulating coating is provided outside the electrode body.

[0020] Compared with the prior art, the beneficial effects brought about by the present disclosure are: the present disclosure can simultaneously enhance and optimize the electric field distribution, increase the contact effect with the tumor tissue, and improve the positioning insertion depth, thereby enhancing the treatment effect of irreversible electroporation. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of an invasive electrode provided by an embodiment of the present disclosure;

[0022] Figure 2 yes Figure 1 A partial enlarged schematic diagram of the needle tip electrode in the electrode shown;

[0023] Figure 3 yes Figure 1 A schematic cross-sectional view of the micro torque controller in the electrode shown;

[0024] FIG4( a ) is a schematic diagram of the relative electric field intensity distribution of a conventional needle tip electrode;

[0025] Figure 4(b) is Figure 3 Schematic diagram of relative electric field intensity distribution of the needle tip electrode shown;

[0026] The following are the descriptions of the reference numerals:

[0027] 1. Needle tip electrode; 2. Nano-scale tip; 3. Micro torque controller; 4. Sheath base; 5. Current lead; 6. Insulation coating; 7. Retractor; 8. Retractor sheath; 9. High-frequency vibration exciter; 10. Exciter control lead; 11. Sheath; 12. Flexible guide wire electrode; 13. Operating base. DETAILED DESCRIPTION

[0028] The following will refer to the attached Figure 1 to Figure 4(b) Specific embodiments of the present disclosure are described in detail. Although specific embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0029] It should be noted that certain words are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different nouns to refer to the same component. This specification and claims do not use the difference in nouns as a way to distinguish components, but use the difference in the functions of the components as the criterion for distinction. As mentioned throughout the specification and claims, "including" or "comprising" is an open term, so it should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment of the present disclosure, but the description is based on the general principles of the specification and is not used to limit the scope of the present disclosure. The scope of protection of the present disclosure shall be determined by the attached claims.

[0030] To facilitate understanding of the embodiments of the present disclosure, further explanation will be given below using specific embodiments as examples in conjunction with the accompanying drawings, and each of the accompanying drawings does not constitute a limitation on the embodiments of the present disclosure.

[0031] In one embodiment, if Figure 1 As shown, the present disclosure provides an invasive electrode device, comprising:

[0032] Electrode body,

[0033] The electrode body is provided with a needle tip electrode, a first control mechanism, a second control mechanism and a third control mechanism, wherein:

[0034] The first control mechanism is used to control the needle tip electrode to penetrate into or withdraw from the tumor tissue;

[0035] The second control mechanism is used to control the needle tip electrode to vibrate at a high frequency in the tumor tissue;

[0036] The third control mechanism is used to control the depth and angle of the needle tip electrode penetrating into the tumor tissue.

[0037] The invasive contact electrode proposed in the above embodiment can be arranged through a gastroscopic catheter to approach the digestive tract tumor tissue, etc., wherein the needle tip electrode penetrates the tumor tissue under the action of the first control mechanism, and then the second control mechanism is activated to drive the needle tip electrode to generate high-frequency vibrations in the tumor tissue, thereby producing a macroscopic puncture effect on the tumor tissue. When it is necessary to adjust the insertion angle and depth of the needle tip electrode, the second control mechanism is turned off, and the third control mechanism is activated at the same time to adjust the insertion angle and depth of the needle tip electrode to determine the target position. The invasive electrode device proposed in the above embodiment can assist in achieving more accurate electric field application and adjustment, improve the effect of irreversible electroporation treatment, and thereby achieve non-invasive treatment of specific tumor tissues.

[0038] In another embodiment, the first control mechanism comprises a tractor 7 .

[0039] In this embodiment, a sheath 11 is further provided in the electrode body, one side of the sheath 11 is connected to the tractor 7 through the operating base 13, and the other side is provided with a sheath base 4. A tractor sheath 8 is provided outside the tractor 7, and the tractor sheath 8 can limit the tractor 7, thereby ensuring that the tractor 7 moves along its axial direction. The tractor 7 is connected to the needle tip electrode 1 through the flexible guide wire electrode 12. When the tractor 7 is pulled toward the outside of the tractor sheath 8, the needle tip electrode 1 contracts slightly under the traction of the flexible guide wire electrode 12.

[0040] When a traditional needle tip electrode penetrates tumor tissue, it needs to be equipped with an additional force-adding mechanism, which increases the size and weight of the electrode system, making it impossible to effectively integrate it into an endoscopic catheter, making it unsuitable for non-invasive or minimally invasive surgery applications. As an improvement, this embodiment places a tractor, which also serves as a force-adding mechanism, inside the needle tip electrode, which not only reduces the size and weight of the electrode system, but also makes it more suitable for non-invasive or minimally invasive surgery applications.

[0041] In another embodiment, the second control mechanism includes a high-frequency vibration exciter 9, and the high-frequency vibration exciter 9 is connected to a vibration excitation power supply.

[0042] In this embodiment, the high-frequency vibration exciter 9 uses high-performance piezoelectric ceramics, which can convert the input electrical signal into a mechanical vibration signal. The high-frequency vibration exciter 9 is connected to the vibration excitation power supply through the exciter control lead 10. When the vibration excitation power supply outputs a high-frequency voltage signal, the high-frequency vibration exciter 9 can achieve high-frequency vibrations of several Hz to several kHz, thereby driving the needle tip electrode 1 to generate high-frequency vibrations within the mm scale range. After the needle tip electrode 1 penetrates the tumor tissue, the high-frequency vibration will increase the macroscopic mechanical stimulation of the tumor cells, which can directly produce a killing effect on some tumor cells.

[0043] The high-frequency vibration exciter can effectively improve the puncture ability of the needle tip electrode to the tumor tissue by vibrating the needle tip electrode at high frequency, thereby overcoming the problem that the irreversible electroporation electrode in the prior art is difficult to puncture reliably after piercing the tumor tissue.

[0044] In another embodiment, the third control mechanism includes a micro torque controller 3, and the micro torque controller 3 is connected to a pulse square wave power supply.

[0045] In this embodiment, Figure 2 As shown, the micro torque controller 3 embraces the high-frequency vibration exciter 9 and is connected to a high-voltage pulse square wave power supply with controllable output pulse timing through a current lead 5. The micro torque controller 3 is composed of four pieces of polymer gel, and the gel contains conductive fibers. Under the excitation of the pulse square wave power supply, the conductive fibers will generate Joule heat, thereby improving the mechanical strength of the gel and inducing its expansion and growth in the radial direction. By controlling the current passed into the gel by the pulse square wave power supply, the mechanical strength and relative length of the gel can be changed, thereby changing the torque of the gel on the high-frequency vibration exciter 9, and then adjusting the base end face angle of the high-frequency vibration exciter 9, and realizing the change of direction of the end of the needle tip electrode 1. The penetration depth of the needle tip electrode 1 can be adjusted by increasing or decreasing the current applied by the four pieces of gel by the pulse square wave power supply at the same time, and the depth of penetration into the tumor tissue is mm level.

[0046] When performing irreversible electroporation treatment, the above-mentioned micro-torque controller can be used to change the insertion direction and depth of multiple needle tip electrodes inserted into the tumor tissue, thereby adjusting the distribution of the formed electric field, which can meet the precise control of the action position of irreversible electroporation and improve the treatment effect of irreversible electroporation.

[0047] In another embodiment, a nanoscale tip 2 is provided at the end of the needle tip electrode.

[0048] In this embodiment, the circumferential surface of the end of the needle tip electrode 1 is constructed by in-situ growth in a silver ion solution. Figure 3 The nanoscale tip 2 of the one-dimensional nanowire mace structure shown can increase the contact area and number of contacts with tumor cells. At the same time, when an external power supply applies a pulse voltage to the needle tip electrode 1, the nanoscale tip 2 can significantly enhance the local electric field and improve the effect of irreversible electroporation in killing tumor cells.

[0049] Figure 4(a) is a schematic diagram of the relative electric field intensity distribution of a conventional needle tip electrode; Figure 4(b) is Figure 3 Schematic diagram of relative electric field strength distribution of needle tip electrode shown. The curve in the figure is the contour distribution of relative electric field strength when the same excitation voltage is applied. In Figure 4(a), the traditional needle tip electrode only contains the tip end, so the electric field strength is mainly concentrated at the tip of the needle, showing a relatively regular annular arc distribution. The area below and around the tip of the needle has a relatively regular shape and a weak electric field strength. The electric field lines are extensions of the needle tip electric field lines, and the electric field strength value decreases as the distance from the needle tip increases. The killing mechanism of irreversible electroporation on tumor cells is mainly the change in cell membrane permeability under the action of a strong electric field. Since the strong electric field position of the traditional needle tip electrode is only concentrated at the tip of the needle, its effective action area is also only concentrated in the area near the tip of the needle, thereby limiting the killing efficiency of tumor cells. In Figure 4(b), due to the presence of the nanoscale tip 2, a regionally enhanced electric field distribution is formed at each nanoneedle tip, and since the diameter of the tip end of the one-dimensional nanowire is on the order of several nanometers, which is much smaller than the diameter of the main electrode tip, the local electric field of the nanowire needle electrode can be significantly enhanced, and its relative electric field strength can reach ten or dozens of times that of the needle tip electrode, which plays an important role in improving the killing of tumor cells by the side area of ​​the needle tip electrode.

[0050] By comparing the electric field simulation results of FIG. 4( a ) and FIG. 4( b ), it is further illustrated that the needle tip electrode including the nanoscale tip 2 proposed in this embodiment can enhance the regional electric field, expand the tumor cell killing range, and improve the irreversible electroporation treatment effect.

[0051] In another embodiment, the electrode device further comprises an electroporation pulse source, and the electroporation pulse source is connected to the needle tip electrode 1 via a flexible guide wire electrode 12 .

[0052] In this embodiment, after the needle tip electrode penetrates the tumor tissue and the angle and depth are adjusted, the electroporation pulse source is started, and the pulse source applies a specific high-voltage pulse to the needle tip electrode through the flexible guide wire electrode, thereby performing electroporation treatment on the tumor tissue.

[0053] In another embodiment, an insulating coating 6 is provided outside the electrode body.

[0054] In this embodiment, since the needle tip electrode is provided with an exciter control lead 10 and a current lead 5, an insulating coating is provided outside the electrode body to prevent electrical contact between human tissue and the above leads.

[0055] The present disclosure has been introduced in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the present disclosure. The description of the above embodiments is only used to help understand the method of the present disclosure and its core idea. At the same time, for those skilled in the art, according to the idea of ​​the present disclosure, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present disclosure.

Claims

1. An invasive electrode device, comprising: an electrode body, wherein a tip electrode, a first control mechanism, a second control mechanism and a third control mechanism are arranged in the electrode body, and among them, the first control mechanism is used to control the tip electrode to penetrate into or withdraw from the tumor tissue; the second control mechanism is used to control the tip electrode to perform high-frequency vibration within the tumor tissue; the third control mechanism is used to control the depth and angle of the tip electrode penetrating into the tumor tissue; wherein, the third control mechanism includes a micro torque controller, and the micro torque controller is connected with a pulsed square wave power supply; The micro torque controller hugs the high-frequency vibration exciter and is connected with a high-voltage pulsed square wave power supply with controllable output pulse timing through a current lead; the micro torque controller is composed of four pieces of polymer gel, and the gel contains conductive fibers. Under the excitation of the pulsed square wave power supply, the conductive fibers will generate joule heat, thereby increasing the mechanical strength of the gel and inducing its radial expansion and growth.

2. The electrode device according to claim 1, wherein, the first control mechanism includes a tractor.

3. The electrode device according to claim 1, wherein, the second control mechanism includes a high-frequency vibration exciter, and the high-frequency vibration exciter is connected with a vibration excitation power supply.

4. The electrode device according to claim 1, wherein, a nano-level tip is arranged at the end of the tip electrode.

5. The electrode device according to claim 1, wherein, the electrode device further includes an electroporation pulse source, and the electroporation pulse source is connected with the tip electrode through a flexible wire electrode.

6. The electrode device according to claim 1, wherein, an insulating coating is arranged outside the electrode body.

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