Multi-pole ablation device with electrical isolation

Abstract

The invention belongs to the technical field of medical ablation, and provides a multi-pole ablation device with electrical isolation, which mainly comprises an ablation catheter with a far end and a near end; the ablation electrodes can be configured with ablation energy, the ablation electrodes are arranged at the far end of the ablation catheter, and the ablation electrodes are arranged at intervals; the electrical isolation structure is arranged between the two adjacent ablation electrodes, and when the polarities of the two adjacent ablation electrodes are opposite, the electrical isolation structure can avoid electrical short circuit between the two adjacent ablation electrodes with the opposite polarities. By the adoption of the structure, the ablation effect is improved, meanwhile, the problems that the distance between ablation electrodes of a traditional dual-electrode ablation device is short, and short circuit is likely to be caused can be effectively solved, the ablation depth is improved, ablation energy is prevented from being transmitted and lost through human tissue, and the ablation efficiency is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical device ablation, and in particular relates to a multi-polar ablation device with electrical isolation. Background Art

[0002] At present, ablation treatment can be divided into monopolar electrode ablation and bipolar electrode ablation. During monopolar electrode ablation, the current flows from the monopolar electrode (positive electrode) through the patient's treatment area through the entire body to the negative electrode plate. The current path is long and may cause damage to surrounding tissues. In contrast, multipolar ablation uses multiple electrodes, and the current flows directly between multiple electrodes, which reduces the current path and reduces the risk of damage to surrounding tissues. Because of its short ablation distance, multipolar ablation causes less damage to surrounding tissues, and the tissue impedance is small, the ablation energy treatment effect is more obvious. However, due to the short spacing between multipolar electrodes, there is more tissue fluid in the human body or the creepage gap between the two poles is short, which can easily cause a short circuit between the multipolar electrodes or the ablation energy is conducted along the mucus on the tissue surface, resulting in a shallow ablation depth or no ablation effect or creepage, and cannot achieve a good treatment effect. Summary of the Invention

[0003] The present invention provides a multipolar ablation device with electrical isolation to solve the problem in the above technical background that the distance between two electrodes of the multipolar ablation structure is short, resulting in shallow ablation depth or creepage short circuit.

[0004] In order to achieve the above object, the present invention adopts the following technical solutions:

[0005] A multipolar ablation device with electrical isolation, comprising:

[0006] an ablation catheter having a distal end and a proximal end;

[0007] A plurality of ablation electrodes, capable of being configured with ablation energy, wherein the plurality of ablation electrodes are spaced apart and arranged at the distal end of the ablation catheter;

[0008] The electrical isolation structure is arranged between two adjacent ablation electrodes with opposite polarities, and the electrical isolation structure is an expandable structure.

[0009] In some embodiments, the electrical isolation structure is an inflatable balloon, which is disposed on the ablation catheter. The ablation catheter is provided with a first channel, which is in communication with the inflatable balloon.

[0010] In some embodiments, when the inflatable balloon is in a deflated state, the inflatable balloon adheres to the surface of the ablation catheter, and when the inflatable balloon is in an inflated state, the outer diameter of the inflatable balloon is not less than the outer diameter of the ablation electrode.

[0011] In some embodiments, the electrical isolation device is provided with an abutting section and a tapered section, and the tapered section is located at both ends of the abutting section.

[0012] In some embodiments, the ablation electrode includes a first electrode and a second electrode. The first electrode is disposed at the distal end of the ablation catheter, the second electrode is disposed on the ablation catheter, and a preset distance is provided between the first electrode and the second electrode.

[0013] In some embodiments, it further includes a control wire movably disposed within the ablation catheter and a first sleeve movably sleeved outside the ablation catheter. One end of the control wire is connected to the free end of the ablation electrode, one end of the second electrode is connected to the ablation catheter, and the other end of the second electrode is connected to the distal end of the first sleeve.

[0014] In some embodiments, both the first electrode and the second electrode are self-expanding structures. A second sleeve is sleeved outside the ablation catheter, and an outer sheath is sleeved outside the second sleeve. The second sleeve and the ablation catheter can move relative to each other, and the second sleeve and the outer sheath can move relative to each other. The first electrode can be received within the second sleeve, and the second electrode can be received within the outer sheath.

[0015] In some embodiments, the electrical isolation structure includes an expandable stent and an insulating film, and the insulating film is laid on the outer surface of the expandable stent.

[0016] In some embodiments, the expandable stent and the ablation electrode have the same structure.

[0017] In some embodiments, the first electrode is a puncture needle structure, the second electrode is a sleeve structure, and one end of the ablation catheter passes through the second electrode of the sleeve structure and is connected to the first electrode of the puncture needle structure.

[0018] In some embodiments, the ablation catheter and the second ablation electrode of the sleeve structure can move relative to each other.

[0019] In some embodiments, it further includes a circuit detection device, which is electrically connected to the first electrode and the second electrode respectively, and the circuit detection device is used to detect the potential difference between the first electrode and the second electrode.

[0020] Compared with the prior art, the beneficial effects brought by this application are:

[0021] By providing an electrical isolation structure between multiple ablation electrodes with opposite polarities, the present invention effectively avoids the risk of short circuit caused by too short a distance between the positive and negative ablation electrodes, or the risk of reduction in ablation energy transmitted to the human body due to the transmission of ablation energy along the surface of tissue fluid. By providing the electrical isolation structure, the ablation depth is increased and the ablation efficiency is improved. At the same time, the electrical isolation structure is an expandable structure that can contract and fit onto the ablation catheter, facilitating the delivery of the entire device into the human body cavity.

[0022] Additional aspects and advantages of the present application will be given in part in the following description, will become apparent from the following description, or will be learned through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Schematic diagram of a multi-polar ablation device with electrical isolation according to the present invention;

[0024] Figure 2 Schematic structural diagram of Embodiment 1 of the present invention;

[0025] Figure 3 Schematic structural diagram of Embodiment 2 of the present invention;

[0026] Figure 4 is Figure 3 cross-sectional view of;

[0027] Figure 5 is Figure 4 enlarged view at A in;

[0028] Figure 6 is Figure 4 enlarged view at B in;

[0029] Figure 7 Schematic cross-sectional view of the ablation catheter according to the present invention;

[0030] Figure 8 Cross-sectional view of another modified embodiment of the ablation catheter according to the present invention;

[0031] Figure 9 Schematic structural diagram of the electrical isolation structure in a contracted state according to the present invention;

[0032] Figure 10 Schematic structural diagram of Embodiment 3 of the present invention;

[0033] Figure 11 is Figure 10 enlarged cross-sectional view at C in;

[0034] Figure 12 is Figure 10 enlarged cross-sectional view at D in;

[0035] Figure 13Schematic diagram of Embodiment 4 of the present invention;

[0036] Figure 14 is Figure 13 a cross-sectional view. Detailed implementation manners

[0037] The following further describes the present application in detail with reference to specific drawings. In the description of this embodiment, unless otherwise specified, the orientation or positional relationship indicated by terms such as "left" and "right" is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the present application must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0038] In the prior art, during monopolar electrode ablation, the current flows from the monopolar electrode (positive electrode) through the patient's treatment site through the entire body to the negative electrode plate. The current path is relatively long, which may cause damage to surrounding tissues. In contrast, multi-polar ablation uses multiple electrodes, and the current directly flows between the multiple electrodes, reducing the current path and the risk of damage to surrounding tissues. Because of its short ablation distance, multi-polar causes less damage to surrounding tissues, and the tissue impedance is small, so the ablation energy treatment effect is more obvious. However, due to the short distance between the multi-polar baskets, there is more tissue fluid in the human body or the creepage distance between bipolar electrodes is short, which easily causes short circuits between multi-polar electrodes or the phenomenon that the ablation energy conducts along the mucus on the tissue surface, resulting in a shallow ablation depth or no ablation effect or creepage, and the desired treatment effect cannot be achieved. Therefore, in order to avoid the above phenomena, the present invention provides the following ablation device.

[0039] As Figure 1 shown, a multi-polar ablation device with electrical isolation provided by the present invention mainly includes an ablation catheter 100, which has a distal end and a proximal end, and a plurality of ablation electrodes 200, which are spaced apart and arranged at the distal end of the ablation catheter 100. In this embodiment, the distal end is the Figure 1 left side direction in

[0040] In one embodiment, as Figure 2As shown, multiple ablation electrodes 200 are expandable basket structures. The number of ablation electrodes 200 is two, including a first electrode 201 and a second electrode 202, and a preset distance is provided between the first electrode 201 and the second electrode 202. Specifically, the first electrode 201 is disposed at the distal end of the ablation catheter 100, the second electrode 202 is disposed on the ablation catheter 100, and the ablation catheter 100 is divided into two independent parts. An expandable stent is disposed between the first electrode 201 and the second electrode 202, and an insulating film 301 is laid on the outer surface of the expandable stent to form an electrical isolation structure 300. The expandable stent divides the ablation catheter 100, and both ends thereof are connected to the ablation catheter 100. In this embodiment, it should be particularly noted that the expandable stent has the same structure as the first electrode 201 and the second electrode 202. Among them, a control wire 1000 is disposed in the ablation catheter 100. The control wire 1000 can move relative to the ablation catheter 100. One end of the control wire 1000 is connected to one end of the ablation electrode 200 at the most distal end of the ablation catheter 100. In this embodiment, the distal end is Figure 2 the left side in the direction shown, and the other end passes through the ablation catheter 100 and is connected to an external power structure. By moving the control wire 1000 relative to the ablation catheter 100, the two ends of the first electrode 201 at the most distal end are driven to approach each other, thereby driving the expandable stent and the second electrode 202 to expand. Further, the expandable stent provided with the insulating film 301 can also abut against the inner wall of the human body cavity, thereby isolating tissue fluid and preventing ablation energy from being transmitted through the tissue fluid.

[0041] In this embodiment, the shape and structure of the ablation electrode 200 are not limited, and it can be an expandable structure, such as spherical, spindle-shaped, water droplet-shaped or cylindrical.

[0042] Optionally, in this embodiment, the ablation electrode 200 and the expandable stent can also be balloon structures, and the ablation electrode 200 and the expandable stent are expanded by injecting liquid or gas into the balloon.

[0043] In one embodiment, as Figure 10 shown, the ablation electrode 200 is an expandable basket structure. The ablation electrode 200 includes a first electrode 201 and a second electrode 202. Among them, the polarities of the first electrode 201 and the second electrode 202 are opposite, and the first electrode 201 is disposed at the distal end of the ablation catheter 100;

[0044] A first sleeve 101 is movably sleeved on the ablation catheter 100. Relative movement can be performed between the first sleeve 101 and the ablation catheter 100, and the second electrode 202 is disposed at the distal end of the first sleeve 101;

[0045] The inflatable balloon 302 is disposed on the ablation catheter 100. In this embodiment, the inflatable balloon 302 and the ablation catheter 100 are provided with a first connection point 3021 and a second connection point 3022. As Figure 9 shown, the inflatable balloon is hermetically connected to the ablation catheter 100 by means of gluing, welding, hot melting, etc. The inflatable balloon 302 is provided with a first cavity, and a first channel 1001 is provided on the ablation catheter 100. As Figure 7 shown, the first channel 1001 communicates with the first cavity of the inflatable balloon 302. In this embodiment, a first diversion hole is provided at a corresponding position on the side wall of the ablation catheter 100, so as to communicate the first channel 1001 and the first cavity. When the inflatable balloon 302 is in an expanded state, at this time, the inflatable balloon 302 forms the aforementioned electrical isolation structure 300, realizing electrical insulation between the first electrode 201 and the second electrode 202, and avoiding the phenomenon of electrical short circuit. When the inflatable balloon is in a contracted state, at this time, as Figure 9 shown, the inflatable balloon 302 fits on the surface of the ablation catheter 100, so that the ablation catheter 100 can reach the lesion without obstruction.

[0046] In this embodiment, the inflatable balloon 302 can be expanded by injecting liquid or filling gas. The inflatable balloon 302 is made of an insulating material, such as TPU, Pebax, silicone, PA12, etc.

[0047] Furthermore, the inflatable balloon 302 is provided with an abutting section 3023. When the inflatable balloon 302 is expanded, the outer diameter of its abutting section 3023 is not less than the outer diameters of the first electrode 201 and the second electrode 202 after expansion. In order to ensure better isolation performance in the human body cavity and avoid the ablation energy being transmitted through the tissue fluid in the human body cavity, resulting in a shallower ablation energy depth. Therefore, when the outer diameter of the inflatable balloon 302 is larger, it can effectively ensure that the inflatable balloon 302 abuts against the inner wall of the human body cavity, isolating the flow of human tissue fluid, thereby avoiding the transmission of energy from the tissue fluid.

[0048] In this embodiment, in order to ensure the ablation effect, the outer diameter of the inflatable balloon 302 after expansion is the same as the outer diameters of the first electrode 201 and the second electrode 202 after expansion, which not only ensures that the first electrode 201 and the second electrode 202 are in contact with the inner wall of the human body cavity, improving the ablation effect, but also ensures that the inflatable balloon 302 abuts against the inner wall of the human body cavity, avoiding the flow of tissue fluid and achieving the electrical isolation effect. Furthermore, the abutting section 3023 of the inflatable balloon 302 and its two ends are provided with tapered transition sections 3024, ensuring that the inflatable balloon 302 can tightly adhere to the surface of the ablation catheter 100 when in a contracted state.

[0049] In one embodiment, as Figures 10 - 12As shown, the ablation electrode 200 is a passive expansion structure. A second channel 1003 is provided on the ablation catheter 100. The second channel 1003 is independent of the first channel 1001. As Figure 7 and Figure 8 shown, a movable wire drawing 1004 is provided in the second channel 1003. One end of the wire drawing 1004 passes through the ablation catheter 100 and is fixedly connected to one end of the first electrode 201. The other end of the first electrode 201 converges and is connected to one end of the ablation catheter 100. One end of the second electrode 202 is fixedly connected to one end of the first sleeve 101, and the other end of the second electrode 202 is fixedly connected to the ablation catheter 100. As Figures 11 - 12 shown, a third connection point 2021 is provided between the second electrode 202 and the ablation catheter 100, and the fixing method can be glue bonding, welding, etc.

[0050] In this embodiment, by moving the ablation catheter 100 relative to the first sleeve 101, the expansion of the second electrode 202 is realized. By moving the wire drawing 1004 relative to the ablation catheter 100, the expansion of the first electrode 201 is realized. The inflatable balloon 302 is filled and expanded by the foregoing structure, and will not be elaborated here.

[0051] Furthermore, in order to ensure that the first electrode 201 is uniformly stressed during expansion and ensure its structural stability, the axis of the second channel 1003 coincides with the central axis of the ablation catheter 100, so that the two ends of the first electrode 201 are uniformly stressed when approaching.

[0052] Furthermore, in order to avoid damage to the human body cavity tissue during the delivery of the ablation catheter 100, a smooth guiding structure is provided at the connection end of the wire drawing 1004 and the first electrode 201. Specifically, one end of the first electrode 201 converges, contracts and is fixed at the head end 10041 of the flexible material. The wire drawing is fixedly connected to the head end 10041 of the flexible material. A combined structure of an arc surface or an inclined surface and an arc surface is provided at the head end 10041 of the flexible material to form a smooth guiding structure.

[0053] Furthermore, in order to reduce the arrangement of power lines, the wire drawing 1004 is made of a conductive material, and the external ablation energy is transmitted from the wire drawing 1004 to the first electrode 201. In this embodiment, since the wire drawing 1004 needs to be set in a movable state, in order to ensure the stability of the electrical connection between the wire drawing 1004 and the first electrode 201, electrode rings are provided at both ends of the first electrode 201, which are made of a conductive material. The wire drawing 1004 is fixedly connected to the first electrode ring provided on the head end 10041 made of a flexible material. At the same time, the wire drawing 1004 also passes through the second electrode ring provided on the ablation catheter 100, and the size of the wire drawing 1004 is adapted to the inner hole diameter of the second electrode ring, so as to realize the sliding electrical connection between the wire drawing 1004 and the second electrode ring.

[0054] In one embodiment, as Figures 3 - 6 shown, the ablation electrode 200 is an actively expandable structure. One end of the first electrode 201 is gathered, contracted, and fixed to the distal end of the ablation catheter 100. In this example, a first wire 1002 is disposed within the ablation catheter 100 to transfer energy to the first electrode 201. One end of the second electrode 202 is gathered, contracted, and fixed to the distal end of the first sleeve 101. A second sleeve 102 is sleeved outside the first sleeve 101, and the second sleeve 102 and the first sleeve 101 can move relative to each other.

[0055] Specifically, both the first electrode 201 and the second electrode 202 are basket weaving structures made of shape memory alloy. The first electrode 201 can be received in the first sleeve 101 following the ablation catheter 100, and the second electrode 202 can be received in the second sleeve 102 following the first sleeve 101. When reaching the lesion site, the first sleeve 101 and the second sleeve 102 move successively, so that the first electrode 201 extends out of the first sleeve 101 and the second electrode 202 extends out of the second sleeve 102. Under the property of the shape memory alloy, it automatically expands and abuts against the inner wall of the human body cavity. In this embodiment, the shape memory alloy can be NI-TI alloy. In this embodiment, by the relative movement between the ablation catheter 100 and the first sleeve 101, the distance between the first electrode 201 and the second electrode 202 can be adjusted to meet the conditions for ablating lesions of different sizes. The electrical isolation structure 300 is composed of an expandable balloon 302, as described in the foregoing embodiment, and will not be elaborated herein.

[0056] Furthermore, since the first electrode 201 needs to be received in the first sleeve 101, the first electrode 201 is provided with an abutting section 2011 and a transition section 2012. When the first electrode 201 disengages from the first sleeve 101, the abutting section 2011 of the first electrode 201 is in a cylindrical structure, and the transition section 2012 of the first electrode 201 is in a conical structure. By adopting the above structure, since the shape of the abutting section 2011 of the first electrode 201 is similar to the shape of the human body cavity, it not only ensures the abutting effect of the first electrode 201, but also, during the process of the first electrode 201 being received in the first sleeve 101, the conical transition section 2012 can ensure the resistance between the first electrode 201 and the first sleeve 101 and guide the contraction of the first electrode 201, so that the first electrode 201 contracts smoothly. Similarly, the structure principle of the second electrode 202 is similar to that of the first electrode 201, and will not be elaborated herein.

[0057] As a variant structure of the above embodiment, the ablation electrode can also be a non-deformable columnar structure, such as Figures 13 - 14As shown, a first electrode 201 of a puncture structure is disposed at the distal end of the ablation catheter 100, and a second electrode 202 of a sleeve structure is sleeved on the ablation catheter 100. An inflatable balloon 302 is disposed between the first electrode 201 and the second electrode 202. After the inflatable balloon 302 is inflated, a columnar structure is formed, which is close to the outer diameters of the first electrode 201 and the second electrode 202. The ablation catheter 100 is provided with a first channel 1001 and a second channel 1003. The first channel 1001 is communicated with the inflatable balloon 302, and the second channel 1003 penetrates through the ablation catheter 100. A wire can be disposed in the second channel 1003 to realize the transfer of external ablation energy to the first electrode 201. The first electrode 201 of the puncture structure has a puncturing ability and can puncture into the human lesion tissue for ablation. In this embodiment, a first insulating layer 5031 is disposed on the sleeve of the tubular metal structure and a part of it is exposed to form the second electrode 202. In this embodiment, the first insulating layer 5031 is made of materials such as PI, PTFE, and PEEK.

[0058] Further, the ablation catheter 100 can move relative to the second electrode 202. By moving the ablation catheter 100, the first electrode 201 is driven to move, so as to realize the adjustment of the distance between the first electrode 201 and the second electrode 202, and further realize the expansion of the pulsed electric field coverage area to realize the ablation of different lesion tissues.

[0059] In one embodiment, a circuit detection device is further included. The circuit detection device is electrically connected to the first electrode 201 and the second electrode 202 respectively, and is mainly used to detect the potential difference between the first electrode 201 and the second electrode 202. A comparison unit is disposed in the circuit detection device, and a preset potential difference threshold is set in the comparison unit. When the circuit detection device detects the potential difference between the first electrode 201 and the second electrode 202 and compares it with the preset potential difference threshold in the comparison unit, when the measured potential difference is less than the preset potential difference threshold, it will prompt that there is a short circuit between the first electrode 201 and the second electrode 202, and at this time, the ablation energy cannot be released. By continuously inflating the electrical isolation structure 300 to enhance the insulation effect of the electrical isolation structure 300, and then re-detecting the potential difference between the first electrode 201 and the second electrode 202 until the measured potential difference meets the preset potential difference threshold, the ablation energy can be released to perform ablation treatment on the lesion. Detecting the potential difference by the circuit detection device is a prior art and will not be elaborated here. By setting the circuit detection device, the short circuit between the first electrode 201 and the second electrode 202 can be effectively avoided, thus ensuring the safety of the ablation process.

[0060] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, several improvements and refinements can be made without departing from the principle of the present invention. These improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A multi-pole ablation device provided with electrical isolation, characterized in that, Comprising: An ablation catheter having a distal end and a proximal end; A plurality of ablation electrodes capable of being configured to ablate energy, the plurality of ablation electrodes being spaced apart and disposed at the distal end of the ablation catheter; An electrical isolation structure disposed between two adjacent ablation electrodes with opposite polarities, the electrical isolation structure being an inflatable structure.

2. The multi-polar ablation device with electrical isolation according to claim 1, wherein, The electrical isolation structure is an inflatable balloon, the inflatable balloon is disposed on the ablation catheter, and a first channel is provided on the ablation catheter, and the first channel communicates with the inflatable balloon.

3. The multi-pole ablation device with electrical isolation according to claim 2, characterized in that, When the inflatable balloon is in a contracted state, the inflatable balloon fits on the surface of the ablation catheter, and when the inflatable balloon is in an inflated state, the outer diameter of the inflatable balloon is not less than the outer diameter of the ablation electrode.

4. A multi-polar ablation device with electrical isolation according to claim 2, characterized in that, The electrical isolation device is provided with an abutting section and a tapered section, and the tapered section is located at both ends of the abutting section.

5. A multi-polar ablation device with electrical isolation according to claim 2, characterized in that, The ablation electrode includes a first electrode and a second electrode, the first electrode is disposed at the distal end of the ablation catheter, the second electrode is disposed on the ablation catheter, and a preset distance is provided between the first electrode and the second electrode.

6. A multi-pole ablation device with electrical isolation according to claim 5, characterized in that, It further includes a control wire movably disposed inside the ablation catheter and a first sleeve movably sleeved outside the ablation catheter. One end of the control wire is connected to the free end of the ablation electrode, one end of the second electrode is connected to the ablation catheter, and the other end of the second electrode is connected to the distal end of the first sleeve.

7. A multi-polar ablation device with electrical isolation according to claim 5, characterized in that, Both the first electrode and the second electrode are self-expanding structures. A second sleeve is sleeved outside the ablation catheter, and an outer sheath is sleeved outside the second sleeve. The second sleeve and the ablation catheter can move relative to each other, and the second sleeve and the outer sheath can move relative to each other. The first electrode can be received inside the second sleeve, and the second electrode can be received inside the outer sheath.

8. A multi-polar ablation device with electrical isolation according to claim 1, characterized in that, The electrical isolation structure includes an inflatable stent and an insulating film, and the insulating film is laid on the outer surface of the inflatable stent.

9. A multi-pole ablation device with electrical isolation according to claim 8, characterized in that, The inflatable stent has the same structure as the ablation electrode.

10. A multi-polar ablation device with electrical isolation according to claim 5, characterized in that, The first electrode is a puncture needle structure, the second electrode is a sleeve structure, and one end of the ablation catheter passes through the second electrode of the sleeve structure and is connected to the first electrode of the puncture needle structure.

11. A multi-polar ablation device with electrical isolation according to claim 10, characterized in that, The ablation catheter and the second ablation electrode of the sleeve structure can move relative to each other.

12. A multi-polar ablation device with electrical isolation according to claim 5, characterized in that, It further includes a circuit detection device, the circuit detection device is electrically connected to the first electrode and the second electrode respectively, and the circuit detection device is used to detect the potential difference between the first electrode and the second electrode.

Images