Pulse ablation electrode conveying device and pulse ablation device

Abstract

The invention relates to the technical field of ablation, in particular to a pulse ablation electrode conveying device and a pulse ablation device.The conveying device comprises a handle assembly, a rotating assembly, a traction assembly, an adapter assembly and a conveying pipe assembly, the adapter assembly is rotationally connected with the rotating assembly, and the adapter assembly is slidably connected with the handle assembly; the switching assembly is used for converting the rotating motion of the rotating assembly into the linear motion of the traction assembly; the first end of the conveying pipe assembly can be connected with the far end of the electrode assembly, the second end of the conveying pipe assembly is fixedly connected with the rotating assembly, and the second end of the traction assembly is connected with the far end of the electrode assembly; under the action of external force, the rotating assembly rotates relative to the handle assembly, the rotating assembly drives the switching assembly, the traction assembly and the conveying pipe assembly to move relative to the handle assembly, and the distance between the far end of the electrode assembly and the rotating assembly is adjusted. By optimizing the operation efficiency, the complexity and operation difficulty of surgical equipment are reduced, and the ablation success rate is increased.

Description

Technical Field

[0001] The present application relates to the field of ablation technology, and in particular to a pulse ablation electrode delivery device and a pulse ablation device. Background Art

[0002] The pulse ablation device uses the principle of pulse ablation electric field. It mainly applies a short and high pulse voltage between two electrodes made of special materials to change the original membrane potential of the cell and produce irreversible nanoscale holes in the lipid bilayer of the membrane, destroying the homeostasis of the cell and causing cell death.

[0003] Pulse ablation devices are mainly used for the treatment of cardiac electrophysiological diseases and tumors such as liver cancer, lung cancer, and kidney cancer. Existing pulse ablation devices have many shortcomings in tumor treatment, especially the clinical application of tumor ablation through natural cavity intervention is limited. In the existing technology, the electrode has a small contact area with lesions of irregular shape or position, and the electrode arrangement and delivery are difficult. In addition, the delivery success rate of pulse ablation electrodes is low, and the surgical safety and operation efficiency are low. Summary of the invention

[0004] In order to solve the above technical problems, the present application optimizes the operating efficiency, reduces the complexity of surgical equipment and the difficulty of operation, and improves the success rate of ablation.

[0005] The present application provides a pulse ablation electrode delivery device, comprising:

[0006] Handle assembly,

[0007] A rotating assembly capable of rotating relative to the handle assembly;

[0008] a traction assembly disposed within the rotating assembly;

[0009] an adapter assembly disposed in the handle assembly, the adapter assembly being rotatably connected to the rotating assembly, the adapter assembly being slidably connected to the handle assembly, the first end of the traction assembly being fixedly connected to the adapter assembly, and the adapter assembly being used to convert the rotational motion of the rotating assembly into the linear motion of the traction assembly;

[0010] A delivery tube assembly, wherein the first end of the delivery tube assembly can be connected to the distal end of the electrode assembly, the second end of the delivery tube assembly is fixedly connected to the rotating assembly, and the second end of the traction assembly extends from the second end of the delivery tube assembly into the delivery tube assembly and is connected to the distal end of the electrode assembly;

[0011] Under the action of external force, the rotating assembly rotates relative to the handle assembly, and the rotating assembly drives the adapter assembly, the traction assembly and the delivery tube assembly to move relative to the handle assembly to adjust the distance between the distal end of the electrode assembly and the rotating assembly.

[0012] Further, the adapter assembly moves between a first extreme position and a second extreme position of the handle assembly;

[0013] When the adapter assembly moves to the first extreme position, the distance between the distal end of the electrode assembly and the rotating assembly is a first distance;

[0014] When the adapter assembly moves to the second extreme position, the distance between the distal end of the electrode assembly and the rotating assembly is a second distance, wherein the first distance is greater than the second distance.

[0015] Furthermore, one of the outer wall of the adapter assembly and the inner wall of the handle assembly is provided with a slide groove, and the other is provided with a sliding block that cooperates with the slide groove.

[0016] Further, the rotating assembly includes a fixed part and a rotating part;

[0017] The first end of the fixing member is fixedly connected to the second end of the conveying pipe assembly, and the second end of the fixing member can rotate relative to the rotating member.

[0018] Further, a first abutment portion is provided at a second end of the fixing member, and a second abutment portion cooperating with the first abutment portion is provided at one end of the rotating member facing the fixing member;

[0019] The first abutting portion and the second abutting portion are capable of abutting and fitting with each other.

[0020] Furthermore, the first abutting portion is made of elastic material;

[0021] And / or, the second abutting portion is made of elastic material.

[0022] Further, the rotating member includes a first rotating part and a second rotating part;

[0023] The first end of the first rotating part is rotatably connected to the fixing member, and the second end of the first rotating part is fixedly connected to the second rotating part;

[0024] The adapter assembly is sleeved on the second rotating part, and the second rotating part is rotatably connected to the adapter assembly.

[0025] Furthermore, a limiting portion is provided on the first rotating portion, and when the adapter assembly moves to a first limit position, the adapter assembly abuts against the limiting portion.

[0026] Further, the delivery pipe assembly includes an outer pipe, at least one intermediate pipe and an inner pipe;

[0027] From inside to outside, the traction assembly, the inner tube, the at least one intermediate tube and the outer tube are sequentially sleeved, the outer tube is fixedly connected to the intermediate tube, the inner tube is slidably connected to the intermediate tube, and the traction assembly is slidably connected to the inner tube;

[0028] The first end of the inner tube can be fixedly connected to the distal end of the electrode assembly, and the distal end of the outer tube can be fixedly connected to the proximal end of the electrode assembly.

[0029] Further, the handle assembly includes a handle housing, an electrode wire and a connector assembly;

[0030] The electrode wire is disposed in the handle housing, a first end of the electrode wire is electrically connected to the connector assembly, the connector assembly is located at one end of the handle housing, and the connector assembly is electrically connected to an ablation mechanism capable of providing a pulse set;

[0031] The second ends of the electrode wires are electrically connected to at least two electrodes respectively.

[0032] Another aspect of the present invention also protects a pulse ablation device, including an ablation mechanism, an electrode assembly and a pulse ablation electrode delivery device as described above;

[0033] The ablation mechanism is used to provide a pulse group to the electrode assembly, and the electrode assembly is connected to the distal end of the delivery tube assembly.

[0034] Further, the electrode assembly includes at least one electrode, and the electrode is a tubular structure having a cavity inside;

[0035] Driven by the delivery tube assembly, the two opposite ends of the electrode move toward or away from each other until the tubular structure contracts or expands.

[0036] Further, the electrode assembly includes a distal electrode and at least one proximal electrode, the distal electrode and at least one proximal electrode are sequentially arranged from the distal end to the proximal end of the delivery tube assembly, and two adjacent electrodes are relatively fixed;

[0037] The second end of the traction assembly and the distal end of the inner tube are both fixedly connected to the distal end of the distal electrode, at least one intermediate tube is arranged corresponding to the at least one proximal electrode, and the distal end of the intermediate tube is fixedly connected to the distal end of the proximal electrode;

[0038] Under the action of external force, the traction assembly can reciprocate along the axial direction of the delivery tube assembly to drive the relative distal end and proximal end of the same electrode to move toward or away from each other until the electrode contracts or expands.

[0039] Furthermore, there is a gap between the distal end of the inner tube and the second end of the traction assembly; and there is a gap between the distal end of the intermediate tube and the distal end of the proximal electrode.

[0040] Furthermore, the electrode satisfies at least one of the following characteristics:

[0041] The electrode is in a contracted state, and the maximum diameter of the electrode is 1.0 mm-2.8 mm;

[0042] The electrode is in an expanded state, and the maximum diameter of the electrode is 2.0 mm-20 mm.

[0043] Furthermore, when the electrode is in a contracted state, the cross-section of the electrode is cylindrical; when the electrode is in an expanded state, the cross-section of the electrode is elliptical.

[0044] Further, the electrode is a tubular structure woven from metal wires;

[0045] And / or, the electrode is a tubular structure formed by at least two support members circumferentially spaced around the distal end of the delivery tube assembly.

[0046] Further, when the electrode is in a compressed state, the length direction of the support member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the support member passes through the axis of the delivery tube assembly, and the support member satisfies at least one of the following characteristics:

[0047] The thickness of the support member is much smaller than the width of the support member;

[0048] The width of the support member is much smaller than the length of the support member;

[0049] The number of the supporting members is 2-14.

[0050] Implementing the embodiments of the present application has the following beneficial effects:

[0051] The present application realizes the movement of the delivery tube assembly relative to the handle assembly by setting a handle assembly, a rotating assembly and a traction assembly that cooperate with each other, thereby adjusting the distance between the distal end of the electrode assembly and the rotating assembly at the distal end of the delivery tube assembly. Specifically, by adjusting the distance between the distal end of the electrode assembly and the rotating assembly, the ablation area and pressure of the electrode assembly can be adjusted, so that the ablation area close to the lesion can be expanded by rotating the above-mentioned rotating assembly, the ablation effect can be ensured, and the ablation success rate can be improved; at the same time, through the cooperation of the rotating assembly, the traction assembly and the delivery tube assembly, it can also realize the contraction or expansion of the electrode, and realize more accurate conformal treatment of lesions with irregular shapes or positions through diameter adjustment; the delivery system adjusts the electrode size according to the inner diameter of the lesion to avoid insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode. In the lesion site close to important anatomical structures, the electrode diameter is reduced by the delivery system to avoid accidental injury to important tissues; and the operation efficiency is optimized, the complexity and difficulty of the surgical equipment are reduced, thereby further improving the ablation success rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] In order to more clearly illustrate the technical solution of the present application, the following is a brief introduction to the drawings required for use in the embodiments or prior art descriptions. Obviously, the drawings described below are only some embodiments of the present application, and a person of ordinary skill in the art can obtain other drawings based on these drawings without creative work.

[0053] Figure 1 is a structural diagram of the pulse ablation electrode delivery device described in this embodiment;

[0054] Figure 2 This is a structural diagram of the rotating assembly, the adapter assembly and the traction assembly in this embodiment after being connected;

[0055] Figure 3 is a structural diagram of the rotating assembly described in this embodiment;

[0056] Figure 4 is a structural diagram of the adapter assembly described in this embodiment;

[0057] Figure 5 for Figure 4 sectional view of;

[0058] Figure 6 is a cross-sectional view of the delivery pipe assembly described in this embodiment;

[0059] Figure 7 This is a structural diagram of the electrode assembly in the pulse ablation device described in this embodiment in a contracted state;

[0060] Figure 8This is a structural diagram of the electrode assembly in the pulse ablation device described in this embodiment in an expanded state.

[0061] Among them, the reference numerals in the figure correspond to:

[0062] 1-rotating assembly; 2-delivery tube assembly; 3-electrode assembly; 4-traction assembly; 5-adapter assembly; 11-fixed member; 12-rotating member; 13-handle housing; 14-connector assembly; 21-outer tube; 22-middle tube; 23-inner tube; 31-distal electrode; 32-proximal electrode; 51-slider; 52-transmission sleeve; 53-end face; 121-first rotating part; 122-second rotating part; 123-second abutting part; 124-limiting part; 131-slide groove. DETAILED DESCRIPTION

[0063] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0064] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions.

[0065] See attached Figure 1-8The present embodiment provides a pulse ablation electrode delivery device, comprising: a handle assembly, a rotating assembly 1 capable of rotating relative to the handle assembly; a traction assembly 4 arranged in the rotating assembly 1; an adapter assembly 5 arranged in the handle assembly, the adapter assembly 5 is rotatably connected to the rotating assembly 1, the adapter assembly 5 is slidably connected to the handle assembly, the first end of the traction assembly 4 is fixedly connected to the adapter assembly 5, and the adapter assembly 5 is used to convert the rotational motion of the rotating assembly 1 into the linear motion of the traction assembly 4; a delivery tube assembly 2, the first end of the delivery tube assembly 2 can be connected to the distal end of the electrode assembly 3, the second end of the delivery tube assembly 2 is fixedly connected to the rotating assembly 1, the second end of the traction assembly 4 is extended into the delivery tube assembly 2 from the second end of the delivery tube assembly 2, and is connected to the distal end of the electrode assembly 3; under the action of external force, the rotating assembly 1 rotates relative to the handle assembly, and the rotating assembly 1 drives the adapter assembly 5, the traction assembly 4 and the delivery tube assembly 2 to move relative to the handle assembly to adjust the distance between the distal end of the electrode assembly 3 and the rotating assembly 1.

[0066] The pulse ablation electrode delivery device in this embodiment is used to deliver a pulse ablation electrode assembly 3 into a natural cavity of the human body. In some embodiments, the electrode assembly 3 delivered can be an electrode assembly for treating malignant pulmonary nodules. In other embodiments, the electrode assembly 3 delivered can also be other medical devices. For ease of understanding, the pulse ablation electrode delivery device is introduced by taking the example of delivering the electrode assembly 3 to the peripheral bronchus to treat malignant pulmonary nodules. The electrode assembly 3 in this embodiment is configured to transmit pulse energy to the target lesion for irreversible electroporation ablation; the electrode assembly 3 is configured so that at least one electrode contacts the lesion tissue; wherein, when only one electrode contacts the lesion, an energy release loop is formed with the body surface electrode to achieve local irreversible electroporation ablation of small lesions; when at least two adjacent electrodes can contact the lesion, bipolar ablation can be achieved, that is, the pulsed electric field is transmitted through adjacent electrodes of opposite sex; optionally, the electrode assembly 3 is composed of a distal electrode 31 and a proximal electrode 32; the distal electrode 31 and the proximal electrode 32 are arranged axially at intervals along the tube body assembly 2; the exterior of the distal electrode 31 and the proximal electrode 32 is a conductive surface; the distal electrode 31 and / or the proximal electrode 32 can be expanded from a tubular shape to an ellipsoid or a spindle shape to more fully contact the lesion tissue and improve the pulse energy delivery effect.

[0067] When the electrode assembly 3 is delivered through the bronchoscope using a pulse ablation electrode delivery device, the electrode assembly 3 and the delivery tube assembly 2 are inserted into the bronchoscope channel; then, the electrode assembly 3 is guided to the lesion site with the help of positioning technologies such as electromagnetic navigation, and the electrode assembly 3 is delivered into the lesion, and then the electrode assembly 3 is controlled by the pulse ablation electrode delivery device to achieve radial expansion and / or radial bending of the electrode, so that the electrode assembly 3 is fully in contact with the lesion tissue, reducing the loss of the pulse electric field transmission caused by media such as air, mucus, and blood; finally, the relative position of the electrode assembly 3 and the lesion is confirmed by CT imaging and a pulse electric field ablation operation is performed; optionally, if the lesion location is not confirmed before the operation, it can also be delivered in conjunction with a guide sheath, and the adapted guide sheath is pre-pushed to the vicinity of the lesion by electromagnetic navigation, the delivery tube assembly 2 is withdrawn, and the lesion location is further confirmed by a radial ultrasonic probe and tissue biopsy, and then the delivery tube assembly 2 is replaced and inserted to locate the lesion through CT imaging for ablation.

[0068] In this embodiment, the delivery tube assembly 2 has a distal end and a proximal end that are relatively set, the electrode assembly 3 is set at the distal end of the delivery tube assembly 2, and the electrode in the electrode assembly 3 has a distal end and a proximal end that are relatively set. When the delivery tube assembly 2 is in an incomplete state, the proximal end of the electrode is the side close to the proximal end of the delivery tube assembly 2, and the distal end of the electrode is the side away from the proximal end of the delivery tube assembly 2. The delivery tube assembly 2 is used to connect and limit the axial movement of the electrode assembly 3.

[0069] In this embodiment, the pulse ablation electrode delivery device is mainly used for tumor ablation treatment, especially for tumors that are difficult to observe or irregular. The electrode assembly 3 arranged at the distal end of the delivery tube assembly 2 can be extended into the diseased tissue, and the outer surface of the electrode assembly 3 is in contact with the diseased tissue. The movement of the traction assembly 4 drives the movement of the electrode assembly 3 to adjust the diameter of the electrode assembly 3 or the contact area and pressure of the electrode assembly 3 at the lesion, thereby improving the electrode pulse energy transmission efficiency and preventing the electrode assembly 3 from shifting during the ablation process. At the same time, the electrode assembly 3 can also adapt to lesions of different shapes or sizes, so that the electrode assembly 3 in this embodiment, driven by the delivery tube assembly 2 and the traction assembly 4, can perform pulse ablation on tumors that are difficult to observe or irregular, while ensuring the ablation effect.

[0070] Preferably, the pulse formed by the electrode assembly 3 can emit pulses with a width of microns or nanoseconds to the pulmonary diseased tissue, so as to damage the stability of the surface of the diseased tissue cell membrane and cause multiple hydrophilic micropores to appear on the surface of the diseased tissue cells, so as to destroy the homeostasis of the diseased tissue cells and cause the diseased tissue cells to die, thereby achieving the therapeutic effect of pulse ablation of the diseased tissue.

[0071] It is understandable that different diseased tissue cells have different destruction thresholds. By controlling the size of the pulse energy emitted by the electrode assembly, the pulse emitted by the electrode assembly 3 can be accurately directed to the lesion location, and the pulse ablation treatment has tissue cell selectivity. By controlling the size of the pulse energy emitted by the electrode assembly 3 corresponding to the diseased tissue cells, the pulse only performs pulse ablation treatment on the diseased tissue cells without destroying other tissue cells, thereby ensuring the safety of ablation to a certain extent.

[0072] In some possible embodiments, the electrodes in the electrode assembly 3 can be contracted or expanded, that is, the outer diameter of the electrode assembly 3 can be extended and deformed to adapt to lesions of different sizes; the conductor part in the electrode is preferably made of a material with excellent biocompatibility and corrosion resistance, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, platinum, titanium, tungsten, palladium and other materials.

[0073] In other possible embodiments, the electrodes in the electrode assembly 3 cannot be contracted or expanded, and the conductor part of the electrode is preferably made of a material with excellent biocompatibility and corrosion resistance, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, platinum, titanium, tungsten, palladium and other materials.

[0074] In this embodiment, by setting a handle assembly, a rotating assembly 1 and a traction assembly 4 that cooperate with each other, it is possible to drive the delivery tube assembly 2 to move relative to the handle assembly, and then adjust the distance between the distal end of the electrode assembly 3 set at the distal end of the delivery tube assembly 2 and the rotating assembly 1; specifically, by adjusting the distance between the distal end of the electrode assembly 3 and the rotating assembly 1, the contact area and pressure of the electrode assembly 3 can be adjusted, so that the ablation area in contact with the lesion can be expanded by rotating the above-mentioned rotating assembly 1, thereby ensuring the ablation effect and improving the ablation success rate; at the same time, through the cooperation of the rotating assembly 1, the traction assembly 4 and the delivery tube assembly 2, it is also possible to drive the electrode to contract or expand, and achieve more precise conformal treatment of lesions with irregular shapes or positions through diameter adjustment; the delivery system can adjust the electrode size according to the inner diameter of the lesion to avoid insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode. At lesion sites close to important anatomical structures (such as blood vessels and nerves), the delivery system is used to reduce the electrode diameter to avoid accidental injury to important tissues; and to optimize operational efficiency, reduce the complexity of surgical equipment and operational difficulty, thereby increasing the success rate of electrode delivery and surgical safety, and further improving the success rate of ablation.

[0075] In some possible embodiments, the adapter assembly 5 moves between the first extreme position and the second extreme position of the handle assembly; when the adapter assembly 5 moves to the first extreme position, the distance between the distal end of the electrode assembly 3 and the rotating assembly 1 is a first distance; when the adapter assembly 5 moves to the second extreme position, the distance between the distal end of the electrode assembly 3 and the rotating assembly 1 is a second distance, wherein the first distance is greater than the second distance. By controlling the adapter assembly 5 to move between the first extreme position and the second extreme position, it is possible to ensure precise control of the electrode assembly 3 indirectly connected to the adapter assembly 5, and to achieve precise control of the reciprocating distance of the electrode assembly 3 relative to the rotating assembly 1, thereby achieving precise control of the contraction and expansion of the electrode assembly 3 and ensuring the ablation effect.

[0076] See attached Figure 1 One of the outer wall of the adapter assembly 5 and the inner wall of the handle assembly is provided with a slide groove 131, and the other is provided with a slider 51 cooperating with the slide groove 131. By providing the slide groove 131 and the slider 51 cooperating with each other, it can be ensured that the adapter assembly 5 slides relative to the handle shell 13 of the handle assembly, and it can be ensured that the adapter assembly 5 and the handle shell 13 do not rotate, so that the rotating assembly 5 can move relative to the handle shell 13 under the drive of the rotating member 12, thereby driving the electrode assembly 3 to move, and the ablation area close to the lesion can be expanded by rotating the above-mentioned rotating assembly, thereby ensuring the ablation effect and improving the ablation success rate.

[0077] In this embodiment, a slider 51 is provided on the outer wall of the adapter assembly 5 and a slide groove 131 is provided on the inner wall of the handle assembly, or a slider 51 is provided on the outer wall of the adapter assembly 5 and a slide groove 131 is provided on the inner wall of the handle assembly.

[0078] In this embodiment, the slide groove 131 and the slider 51 are both arranged along the length direction of the handle assembly. The number of the slide groove 131 and the slider 51 is not limited as long as the two are arranged correspondingly.

[0079] Preferably, two sliders 51 are arranged at intervals on the outer wall of the adapter assembly 5, and two slide grooves 131 corresponding to the two sliders 51 are arranged on the inner wall of the inner cavity of the handle assembly. By providing the two sliders 51 and the two slide grooves 131, the smoothness of the sliding of the adapter assembly 5 relative to the inner cavity of the handle assembly can be ensured, and the radial rotation of the adapter assembly 5 along the handle assembly can be avoided, ensuring that the force of the rotating assembly 1 acting on the adapter assembly 5 can drive the adapter assembly 5 to slide relative to the handle assembly, thereby ensuring the stability of the overall operation.

[0080] See attached Figure 1The rotating component 1 includes a fixing part 11 and a rotating part 12; the first end of the fixing part 11 is fixedly connected to the second end of the delivery tube component 2, and the second end of the fixing part 11 can rotate relative to the rotating part 12. By arranging the fixing part 11 and the rotating part 12 that cooperate with each other, it can be achieved that during the rotation of the rotating part 12, the electrode component 3 connected to the delivery tube component 2 can be driven to move, thereby ensuring the ablation area of ​​the electrode component 3 in contact with the lesion, ensuring the ablation effect, and improving the ablation success rate.

[0081] In this embodiment, the rotating member 12 can rotate along the first direction under the action of external force to release the lock of the adapter assembly 5, and then the adapter assembly 5 moves from the distal end to the proximal end to release the lock of the traction assembly 4; thereafter, the traction assembly 4 can move from the distal end to the proximal end under the action of external force to release the distal electrode 31 and at least one proximal electrode 32, and the distal electrode 31 and at least one proximal electrode 32 are axially compressed, so that the electrode assembly 3 gradually expands inside the lesion, and when the rotating member 12 rotates through a predetermined angle, the adapter assembly 5 moves along the slide groove 131 and contacts the end of the slide groove 131, so that the adapter assembly 5 stops moving along the slide groove 131; when the rotating member 12 rotates along the second direction under the action of external force, the lock of the adapter assembly 5 is released, and then the adapter assembly 5 moves from the proximal end to the distal end to release the lock of the traction assembly 4; thereafter, the traction assembly 4 moves from the proximal end to the distal end to straighten the electrode assembly 3; the first direction is opposite to the second direction. It is understood that in this embodiment, when the first direction is clockwise, the second direction is counterclockwise, and vice versa. In addition, "external force" refers to the element receiving the force, and the force comes from the user, other elements or mechanisms.

[0082] In this embodiment, when the adapter assembly 5 is in the first extreme position, the first end of the adapter assembly 5 abuts against the end of the slide groove 131, and when the adapter assembly 5 is in the second extreme position, the second end of the adapter assembly 5 abuts against the limiting portion 124 of the rotating member 12.

[0083] In this embodiment, the rotating member 12 has an initial position; the rotating member 12 is configured such that, when in the initial position, the rotating member 12 is used to lock the adapter assembly 5 to move from the proximal end to the distal end, and the adapter assembly 5 is used to lock the traction assembly 4 to move from the proximal end to the distal end; the traction assembly 4 is used to lock the electrode assembly 3, and at this time the electrode assembly 3 is in a straightened state, and the delivery is achieved with a smaller outer diameter; when the rotating member 12 is in the initial position, the adapter assembly 5 is in the second extreme position;

[0084] The rotating member 12 has a terminal position; the rotating member 12 is configured such that, when in the terminal position, the rotating member 12 is used to lock the adapter assembly 5 to move from the distal end to the proximal end, and the adapter assembly 5 is used to lock the traction assembly 4 to move from the distal end to the proximal end; the traction assembly 4 is used to lock the electrode assembly 3, and the electrode assembly 3 is in an expanded state at this time to increase the contact area between the electrode assembly 3 and the lesion; when the rotating member 12 is in the terminal position, the adapter assembly 5 is in the first extreme position.

[0085] In some possible embodiments, a first abutment portion is provided at the second end of the fixing member 11, and a second abutment portion 123 cooperating with the first abutment portion is provided at one end of the rotating member 12 facing the fixing member 11; the first abutment portion and the second abutment portion 123 can abut and cooperate with each other, and by providing the first abutment portion and the second abutment portion 123 cooperating with each other, relative locking of the fixing member 11 and the rotating member 12 is achieved to avoid displacement during ablation, ensure the safety of ablation, and improve the success rate of ablation; at the same time, the first abutment portion and the second abutment portion 123 can cooperate with each other to show when the rotating member 12 rotates one circle, thereby achieving the function of feedback on the number of circles, which is more convenient for operators to operate it.

[0086] In this embodiment, a plurality of through holes are provided on the end surface of the rotating member 12 to facilitate the passage of the wire harness.

[0087] In this embodiment, during the unfolding process of the electrode assembly 3, the shape control of the electrode assembly 3 can be achieved by controlling the rotating member 12 with external force; the second abutment portion 123 of the rotating member 12 abuts against the circle number feedback structure (not shown in the figure) on the fixed portion 11 to produce a sense of frustration, namely the first abutment portion, so that the operator knows that the rotating member 12 is unlocked; at the same time, when the rotating member 12 rotates 360°, the second abutment portion 123 again abuts against the circle number feedback structure on the fixed portion 11 to produce a sense of frustration, reminding the operator that the rotating member 12 has rotated 1 circle; optionally, when the rotating member 12 rotates an integer number of circles, the electrode assembly 3 is unfolded and released; in this process, the traction assembly 4 is connected with the adapter The component 5 moves from the distal end to the proximal end until the slider 51 of the adapter component 5 stops moving against the end of the slide groove 131; the traction component 4 pulls the distal electrode 31 driven by the adapter component 5; when the head end of the distal electrode 31 contacts the inner tube 23, the distal electrode 31 completes the maximum expansion; then, when the head end of the proximal electrode 32 contacts the intermediate tube 202, the proximal electrode 32 completes the maximum expansion; during the straightening process of the electrode component 3, the operation sequence is opposite to that of the expansion process, which will not be described in detail here; optionally, by limiting the number of rotations or direction of the rotating member 12 through the self-locking of the transmission thread, the distal electrode 31 or the proximal electrode 32 can be expanded or straightened separately.

[0088] That is to say, in the pulse ablation electrode delivery device provided in this embodiment, the rotating member 12, the adapter assembly 5 and the traction assembly 4 are in a motion locked state at the initial position, so that the pulse ablation electrode delivery device must be started in a predetermined order so that the pulse ablation electrode delivery device can completely unfold the electrode assembly 3 in a predetermined order, so as to avoid triggering the wrong sequence due to electrode delivery or endoscope blind spots during surgery, resulting in electrode unfolding failure or erroneous unfolding. At the same time, the second abutting portion 123 of the rotating member 12 abuts against the fixed portion 11 to achieve tactile feedback on the number of turns, reminding the operator to know the unlocking number of the rotating member 12, accurately controlling the unfolding state of the electrode assembly 3, improving the unfolding accuracy of the electrode assembly 3, and thus improving the success rate of ablation.

[0089] In some possible embodiments, the first abutting portion is made of elastic material; and / or, the second abutting portion 123 is made of elastic material. The above arrangement can ensure that the first abutting portion and the second abutting portion 123 will switch from the abutting state to the free state only under the action of external force, thereby ensuring the stability of the operation of the pulse ablation electrode delivery device.

[0090] In this embodiment, the first abutting portion and / or the second abutting portion 123 is a protruding structure protruding toward the fixing member 11, and the specific structure of the first abutting portion and the second abutting portion 123 is not limited, as long as the two can abut and cooperate with each other.

[0091] See attached Figure 3 The rotating member 12 includes a first rotating portion 121 and a second rotating portion 122; the first end of the first rotating portion 121 is rotatably connected to the fixed member 11, and the second end of the first rotating portion 121 is fixedly connected to the second rotating portion 122; the adapter assembly 5 is sleeved on the second rotating portion 122, and the second rotating portion 122 is rotatably connected to the adapter assembly 5. The above arrangement can ensure that the rotating member 12 can rotate while also driving the adapter assembly 5 arranged in the handle assembly to rotate, thereby ensuring the stability of the operation of the pulse ablation electrode delivery device.

[0092] In this embodiment, the first rotating portion 121 and the second rotating portion 122 are integrally formed.

[0093] In this embodiment, the outer diameter of the first rotating part 121 is larger than the outer diameter of the second rotating part 122. The second rotating part 122 extends into the inner cavity of the handle shell 13 and is threadedly connected to the adapter assembly 5 arranged in the inner cavity of the handle shell 13; the outer diameter of the second rotating part 122 is provided with an external thread, and the inner diameter of the adapter assembly 5 is provided with an internal thread matching the external thread.

[0094] In this embodiment, the outer diameter of the adapter assembly 5 is smaller than the outer diameter of the first rotating part 121, and the outer diameter of the first rotating part 121 is equal to the outer diameter of the handle shell 13, so that the overall structure is beautiful and the handle shell 13 is prevented from being too large, which increases the manufacturing cost.

[0095] In this embodiment, the length of the thread on the second rotating portion 122 is slightly smaller than the length of the second rotating portion 122 , and the length of the thread on the inner wall of the adapter component 5 is slightly smaller than the length of the adapter component 5 .

[0096] See attached Figure 2 A limiting portion 124 is provided on the first rotating portion 121. When the adapter assembly 5 moves to the first extreme position, the adapter assembly 5 abuts against the limiting portion 124. By providing the limiting portion 124, one side of the adapter assembly 5 can be limited, thereby ensuring the accuracy of the reciprocating movement of the adapter assembly 5, and further ensuring the working accuracy of the electrode assembly 3.

[0097] In this embodiment, a second abutment portion 123 is provided on the side of the first rotating portion 121 facing the fixed member 11, and a limiting portion 124 is provided on the side of the first rotating portion 121 facing the rotating member away from the fixed member 11. The second abutment portion 123 and the limiting portion 124 are provided on opposite sides of the first rotating portion 121.

[0098] In this embodiment, the limiting portion 124 is a limiting step, and the limiting portion 124 is disposed in the sliding groove 131 .

[0099] In this embodiment, the delivery tube assembly 2 is made of a material with a developing function, and the delivery tube assembly 2 can adjust and confirm the electrode position under X-rays, thereby improving the accuracy of delivering the electrode assembly 3 to the lesion.

[0100] In this embodiment, the material of the delivery tube assembly 2 is at least one of polyetheramide, nylon, thermoplastic polyurethane, and polytetrafluoroethylene. The above materials can ensure that the electrode can be delivered in a curved or bifurcated lumen.

[0101] See attached Figure 4 and attached Figure 5 A transmission sleeve 52 or an internal thread that cooperates with the external thread of the second rotating part 122 is provided on the inner cavity side wall of the adapter component 5. A plurality of through holes are provided on the end face 53 of the adapter component 5 facing the conveying pipe component 2 to facilitate the passage of the wiring harness. A mounting notch is provided on the other end face of the adapter component 5. The traction component 4 extends into the interior of the adapter component 5 through the mounting notch and is fixedly connected to the mounting notch. A slider 51 is provided on the outer side wall of the adapter component 5. The slider 51 cooperates with the slide groove 131 to achieve that the adapter component 5 can slide relative to the slide groove 131.

[0102] In this embodiment, the traction assembly 4 includes a pull rod and a pull rod fixing block connected to each other, the pull rod is connected to the installation notch through the pull rod fixing block, and the axis of the pull rod, the axis of the adapter assembly 5 and the axis of the rotating assembly 1 are arranged to coincide.

[0103] In this embodiment, when the rotating member 12 rotates in the first direction under the action of external force, the slider 51 on the adapter assembly 5 slides in the slide groove 131 through the transmission thread, thereby driving the traction assembly 4 to move from the distal end to the proximal end; the traction assembly 4 is indirectly connected to the distal end of the electrode assembly 3, driving the distal end of the electrode assembly 3 to move from the distal end to the proximal end.

[0104] See attached Figure 6 The conveying tube assembly 2 includes an outer tube 21, at least one intermediate tube 22 and an inner tube 23; from the inside to the outside, the traction assembly 4, the inner tube 23, at least one intermediate tube 22 and the outer tube 21 are sequentially arranged, the outer tube 21 is fixedly connected to the intermediate tube 22, the inner tube 23 is slidably connected to the intermediate tube 22, and the traction assembly 4 is slidably connected to the inner tube 23; the first end of the inner tube 23 can be fixedly connected to the distal end of the electrode assembly 3, and the distal end of the outer tube 21 can be fixedly connected to the proximal end of the electrode assembly 3, so that the conveying tube assembly 2 can be driven by the traction assembly, and the traction assembly 4 can reciprocate relative to the inner tube 23 and the outer tube 21, thereby driving the distal end and the proximal end of the same electrode to move toward or away from each other, so as to realize the contraction or expansion of the electrode.

[0105] In this embodiment, the number of the intermediate tubes 22 is not limited, as long as the number of the intermediate tubes 22 is consistent with the number of the proximal electrodes 32 .

[0106] In this embodiment, the conveying tube assembly 2 is used to execute the displacement control of the electrode assembly 3 by the rotating assembly 1, the inner tube 23 can realize displacement movement relative to the intermediate tube 22, the outer tube 21 is used to limit the displacement movement of the proximal part of a proximal electrode 32 close to the proximal end in the electrode assembly 3, the intermediate tube 22 is used to limit the displacement movement of the distal part of the proximal electrode 32, and the inner tube 23 is used to limit the displacement movement of the distal part of the traction assembly 4 and the distal electrode 31.

[0107] In this embodiment, the outer tube 21 preferably adopts a composite reinforced tube structure such as a composite braided tube, a spring tube, etc.; the middle tube 22 and the inner tube 23 preferably adopt a high dielectric strength tube, such as at least one of PTFE, PI, FPM, PEEK, PU, ​​PEBAX or PA.

[0108] See attached Figure 7The handle assembly includes a handle shell 13, an electrode wire and a connector assembly 14; the electrode wire is arranged in the handle shell 13, the first end of the electrode wire is electrically connected to the connector assembly 14, the connector assembly 14 is located at one end of the handle shell 13, and the connector assembly 14 is electrically connected to an ablation mechanism that can provide a pulse group; the second end of the electrode wire is electrically connected to at least two electrodes 31 respectively, and by arranging mutually matching electrode wires and connector assemblies 302, the electrode can be electrically connected to the connector assembly 14 through the electrode wire, and the electrode can reciprocate relative to the proximal end of the delivery tube assembly 2 under the drive of the traction assembly 4, and current can be supplied to the electrode through the connector assembly 14 to achieve ablation of the lesion.

[0109] In this embodiment, there are at least two electrode wires, and the second ends of the at least two electrode wires are electrically connected to at least two electrodes respectively, so that the positive and negative polarities of two adjacent electrodes are opposite, thereby improving the ablation effect.

[0110] In this embodiment, the handle shell 13 is electrically insulated from the electrode assembly 3 and is electrically connected to the ablation mechanism via the connector assembly 14; the connector assembly 14 includes a pulse cable and a pulse connector, a sensor cable and a sensor connector; the pulse cable and the pulse connector are electrically connected to the electrode assembly 3; the sensor cable and the sensor connector are electrically connected to the position detection device; and the pulse connector and the sensor connector are communicatively connected to the ablation mechanism.

[0111] In some possible embodiments, a direction mark and / or an extended length mark is provided on the handle housing 13 or the fixing member 11; wherein the direction mark is used to indicate the number of times the operator rotates the rotating member 12, and is used to indicate that the rotating member 12 is rotated in a first direction, and the distal end of the electrode assembly 3 moves toward the proximal end of the delivery tube assembly 2, or the rotating member 12 is rotated in a second direction, and the distal end of the electrode assembly 3 moves away from the proximal end of the delivery tube assembly 2, and the first direction and the second direction are opposite.

[0112] In this embodiment, the delivery tube assembly 2 is insulated from the electrode assembly 3, and the wire of the electrode assembly 3 is electrically connected to the ablation mechanism via the connector assembly 14; the connector assembly 14 includes a pulse cable W1 and a pulse connector L1; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode assembly 3; the pulse connector L1 is communicatively connected to the ablation system; the pulse cable W1 has an insulation layer, a shielding layer and a wire layer;

[0113] Optionally, the connector assembly 14 includes a pulse cable W1 and a pulse connector L1, a sensor cable W2 and a sensor connector L2; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode assembly 3; the sensor cable W2 and the sensor connector L2 are electrically connected to the sensor assembly (not shown in the figure); the pulse connector L1 and the sensor connector L2 are communicatively connected to the ablation mechanism.

[0114] On the other hand, the present invention also protects a pulse ablation device, including an ablation mechanism, an electrode assembly 3 and the above-mentioned pulse ablation electrode delivery device; the ablation mechanism is used to provide a pulse group to the electrode assembly 3, and the electrode assembly 3 is connected to the distal end of the delivery tube assembly 2. By arranging the pulse ablation electrode delivery device and the ablation mechanism to cooperate with each other, the electrode assembly 3 can be accurately delivered to the interior of the tumor for ablation, thereby reducing postoperative complications and improving the ablation success rate of irreversible electroporation. At the same time, the ablation mechanism can provide pulse ablation energy with a pulse energy size corresponding to the diseased tissue cells of the lungs. The pulse only performs pulse ablation treatment on the diseased tissue cells without destroying other tissue cells, thereby improving the adaptability range of the pulse ablation equipment to a certain extent.

[0115] In this embodiment, the ablation mechanism can provide at least one pulse group for the electrode assembly 3, and the pulse group ensures at least one high-frequency high-voltage sub-pulse and / or one low-frequency low-voltage sub-pulse. The high-frequency high-voltage sub-pulse is a bipolar pulse, and the low-frequency low-voltage sub-pulse is a unipolar pulse or a bipolar pulse; wherein the bipolar pulse includes a positive pulse amplitude and a negative pulse amplitude. By setting a low-frequency high-voltage sub-pulse and / or a low-frequency low-voltage sub-pulse, the coverage range of the pulse group can be improved, thereby increasing the range of ablation that can be performed by the pulse ablation setting.

[0116] In this embodiment, the electrode assembly 3 can move axially or bend radially relative to the delivery tube assembly 2 .

[0117] In some possible embodiments, the electrode assembly 3 includes at least one electrode, and the electrode is a tubular structure with a cavity inside; driven by the delivery tube assembly 2, the opposite ends of the electrode move toward or away from each other until the tubular structure contracts or expands, and by setting the electrode as a contractible or expandable tubular structure, more precise conformal treatment can be achieved through diameter adjustment; the delivery system adjusts the electrode size according to the inner diameter of the lesion, avoiding insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode.

[0118] In this embodiment, regardless of whether the electrode assembly 3 can be contracted or expanded, the number of electrodes in the electrode assembly 3 is not limited, as long as the electrode assembly 3 can perform pulse ablation on the lesion through the electrodes.

[0119] In this embodiment, at least one position detection device is further provided on the electrode assembly 3 . The at least one position detection device is arranged inside the electrode assembly 3 and fixedly arranged on the inner tube 23 .

[0120] In this embodiment, the position detection device includes but is not limited to a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor, which is used for real-time monitoring of the position data and / or electrode morphology data and / or temperature information of the electrode assembly 3; when the position detection device is configured as a positioning sensor, at least one positioning sensor is arranged at the distal end close to the distal electrode 31, which is used to collect the position and direction data of the electrode assembly 3, and based on the above position coordinate information, a three-dimensional model reconstruction of the electrode assembly 3 in space is achieved; the positioning sensor and the electrode assembly 3 are insulated and isolated by high dielectric strength materials such as polyimide and tetrafluoroethylene; the positioning sensor is preferably a 5DOF or 6DOF electromagnetic positioning sensor, which can measure the spatial position coordinates of the electrode assembly 3 in real time, and relay the position and direction data to the ablation system interface for visualization.

[0121] In some possible embodiments, the electrode assembly 3 includes a distal electrode 31 and at least one proximal electrode 32, and the distal electrode 31 and at least one proximal electrode 32 are arranged in sequence from the distal end to the proximal end of the delivery tube assembly, and the two adjacent electrodes are relatively fixed; the second end of the traction assembly 4 and the distal end of the inner tube 23 are both fixedly connected to the distal end of the distal electrode 31, and at least one intermediate tube 22 is correspondingly arranged to at least one proximal electrode 31, and the distal end of the intermediate tube 22 is fixedly connected to the distal end of the proximal electrode 32; under the action of external force, the traction assembly 4 can reciprocate along the axial direction of the delivery tube assembly 2 to drive the relative distal and proximal ends of the same electrode to move toward or away from each other until the electrode contracts or expands. Compared with setting one electrode, setting at least two electrodes at intervals can further improve the ductility of the electrode assembly 3, and at the same time improve the flexibility of the electrode assembly 3, so as to achieve a larger area of ​​electrode and lesion contact, realize the delivery and ablation of lesions at large angles around the lesion, and ensure the ablation effect.

[0122] In some possible embodiments, the positive and negative polarities of two adjacent electrodes are opposite. The above arrangement can ensure that the ablation range is less affected by tissue impedance, and the ablation energy is concentrated around the electrode, thereby increasing the ablation range of the electrode assembly 3 and avoiding the problem that the ablation range of a single electrode is narrow, which makes the ablation effect easily affected by the air in the lungs and causes incomplete ablation. More importantly, the pulse energy range generated by the bipolar electrode is controllable, thereby ensuring that the pulse energy damage range is controllable, thereby achieving the technical effect of less damage to adjacent nerves and blood vessels and fewer postoperative complications.

[0123] In some possible embodiments, there is a gap between the distal end of the inner tube 23 and the second end of the traction assembly 4; there is a gap between the distal end of the intermediate tube 22 and the distal end of the proximal electrode 32. By setting the gap, the proximal electrode 32 and the distal electrode 31 can be easily retracted and expanded, thereby ensuring the stability of the retraction and expansion of the proximal electrode 32 and the distal electrode 31.

[0124] In some possible embodiments, when the electrode assembly 3 is capable of contracting or expanding and the electrode assembly 3 includes an electrode, the second end of the traction assembly 4 and the distal end of the inner tube 23 are both fixedly connected to the distal region of the electrode, and there is a gap between the second end of the traction assembly 4 and the distal end of the inner tube 23, the second end of the traction assembly 4 is closer to the distal end of the electrode assembly 3 than the distal end of the inner tube 23, and the distal end of the outer tube 21 is fixedly connected to the proximal region of the electrode.

[0125] Specifically, along the distal end to the proximal end of the electrode assembly 3, the distal end of the distal electrode 31, the second end of the traction assembly 4, the distal end of the inner tube 23, the proximal end of the distal electrode 31 and the proximal end of the delivery tube assembly 2 are arranged in sequence.

[0126] In some other possible embodiments, see the attached Figure 8 In the case where the electrode assembly 3 can be contracted or expanded and the electrode assembly 3 includes two electrodes, the second end of the traction assembly 4 and the distal end of the inner tube 23 are both fixedly connected to the distal region of the distal electrode 31, and there is a gap between the second end of the traction assembly 4 and the distal end of the inner tube 23, the second end of the traction assembly 4 is closer to the distal end of the electrode assembly 3 than the distal end of the inner tube 23, the distal end of the intermediate tube 22 is fixedly connected to the distal region of the proximal electrode 32, and the distal end of the outer tube 21 is fixedly connected to the proximal region of the proximal electrode 32.

[0127] Specifically, along the distal end to the proximal end of the electrode assembly 3, the distal end of the distal electrode 31, the second end of the traction assembly 4, the distal end of the inner tube 23, the proximal end of the distal electrode 31, the proximal end of the proximal electrode 32, the distal end of the intermediate tube 22, the distal end of the proximal electrode 32 and the proximal end of the delivery tube assembly 2 are arranged in sequence.

[0128] Optionally, when the number of electrodes of the electrode assembly 3 is greater than 2, the number of intermediate tubes 22 is increased according to the number of electrodes on the basis of the outer tube 21, the intermediate tube 22, and the inner tube 23 to achieve more electrode deployment control.

[0129] Specifically, when the electrode assembly 3 is capable of contracting or expanding, and the electrode assembly 3 includes three electrodes, one of which is the distal electrode 31, and the other two are the proximal electrodes 32, the number of the intermediate tubes 22 is consistent with the number of the proximal electrodes 32, that is, the number of the intermediate tubes 22 is two; the second end of the traction assembly 4 and the distal end of the inner tube 23 are both fixedly connected to the distal region of the distal electrode 31, and there is a gap between the second end of the traction assembly 4 and the distal end of the inner tube 23, the second end of the traction assembly 4 is closer to the distal end of the electrode assembly 3 than the distal end of the inner tube 23, the distal end of the first intermediate tube 22 is fixedly connected to the distal region of the first proximal electrode 32, the distal end of the second intermediate tube 22 is fixedly connected to the distal region of the second proximal electrode 32, and the distal end of the outer tube 21 is fixedly connected to the proximal region of the second proximal electrode 32.

[0130] Specifically, along the distal end to the proximal end of the electrode assembly 3, the distal end of the distal electrode 31, the second end of the traction assembly 4, the distal end of the inner tube 23, the proximal end of the distal electrode 31, the proximal end of the first proximal electrode 32, the distal end of the first intermediate tube 22, the distal end of the first proximal electrode 32, the proximal end of the second proximal electrode 32, the distal end of the second intermediate tube 22, the distal end of the second proximal electrode 32 and the proximal end of the delivery tube assembly 2 are arranged in sequence.

[0131] In this embodiment, setting the above gap can prevent the conveying tube assembly 2 from interfering with the contraction or expansion of the electrode. The specific value of the above gap is not limited, and the above gap is matched according to the maximum diameter of the electrode required to be expanded.

[0132] Preferably, the gap is not less than 10%-25% of the length of a single electrode. Such a setting can shorten the length of some tubes in the conveying tube assembly 2, reduce the preparation cost, and prevent the conveying tube assembly 2 from interfering with the contraction or expansion of the electrode.

[0133] In some possible embodiments, the electrode satisfies at least one of the following characteristics: when the electrode is in a contracted state, the maximum diameter of the electrode is 1.0mm-2.8mm; when the electrode is in an expanded state, the maximum diameter of the electrode is 2.0mm-20mm. By setting the relevant dimensions of the electrode within the above range, it can be ensured that the electrode is easy to move in the bronchus, and the contact area between the electrode and the bronchus can be ensured, so that the maximum area of ​​the electrode and the lesion can be attached, and a larger radial ablation range can be achieved, thereby ensuring the ablation effect.

[0134] In the present embodiment, in order to achieve the expected expanded shape of the electrode assembly 3, the electrode assembly 3 is initially a cylindrical structure and / or a tubular structure, etc.; the head end of the distal electrode 31 is preferably arc-shaped or conical, so as to facilitate penetrating into the narrower sections of the bronchus and the inside of the lesion; in order to better fit the peripheral bronchial lesions, increase the effective contact area of ​​the electrode, and achieve a larger radial ablation range, the electrode assembly 3 is an expansion structure, such as a woven mesh structure, a sac structure, a spline structure, etc.; the initial diameter of the distal electrode 31 and the proximal electrode 32 is preferably φ1.0mm to φ2.8mm, and the diameter after expansion is preferably φ2.0mm to φ20mm.

[0135] In this embodiment, the electrode is in a retracted state, and the maximum diameter of the electrode is 1.0mm-1.3mm, 1.0mm-1.5mm, 1.0mm-2.0mm, 1.5mm-2.0mm, 1.0mm-2.8mm, 2.0mm-2.6mm, 2.3mm-2.6mm or 2.5mm-2.8mm, etc.; the electrode is in an expanded state, and the maximum diameter of the electrode 102 is 2.0mm-5mm, 2.0mm-8mm, 2.0mm-20mm, 4mm-7mm, 4mm-10mm, 5mm-10mm, 8mm-10mm, 15mm-20mm, 16mm-20mm or 18mm-20mm, etc.

[0136] In some possible embodiments, when the electrode is in a retracted state, the cross-section of the electrode is cylindrical; when the electrode is in an expanded state, the cross-section of the electrode is elliptical. Such a configuration can ensure that the volume of the electrode is as small as possible during transportation, and the shape is a cylindrical structure that is easy to transport, thereby ensuring the transportation rate; at the same time, when the electrode is in an expanded state, the cross-section of the electrode is elliptical, which can increase the contact area between the electrode and the lesion and ensure the ablation effect.

[0137] In this embodiment, when the electrode is compressed axially, the flexible extension segment expands radially to form an ellipsoidal or spindle-shaped surface; during ablation, the shape of the electrode assembly 3 can be adjusted by changing the axial distance of the extension segment, thereby adapting to the wall adhesion requirements of the lumen during ablation of different lesions, increasing the ablation area, and ensuring the ablation effect.

[0138] In some possible embodiments, the electrode is a tubular structure woven from metal wires; and / or, the electrode is a tubular structure formed by at least two support members circumferentially spaced around the distal end of the delivery tube assembly 2. By weaving the electrode from metal wires, the connection stability of the electrode can be ensured, and when the electrode is rotated at any angle, the maximum contact area with the lesion is guaranteed, thereby further ensuring the ablation effect; at the same time, the adverse effects of increased electrode length or diameter on delivery and abutment are avoided, thereby achieving better delivery effect and conformal ablation; by arranging the electrode by at least two support members at intervals, the ductility of the electrode can be increased on the basis of ensuring the contact area between the electrode and the lesion, thereby increasing the flexibility of the electrode, achieving the ability to flexibly adjust the electrode shape to adapt to the lesion structure, achieving a larger area of ​​electrode and lesion abutment, thereby improving the success rate of pulse ablation; at the same time, the adverse effects of increased electrode length or diameter on delivery and abutment are avoided, thereby achieving better delivery effect and conformal ablation.

[0139] In this embodiment, the electrodes are woven by metal wires in a one-on-one or one-on-two or two-on-two weaving manner; the metal wires are preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals.

[0140] In this embodiment, along the length direction of the support member, the surface slope of the support member gradually changes from small to large, and then gradually changes from large to small, so as to form an arch structure. By setting the support member as an arch structure, it can be ensured that the electrode can bend and deform under the slight action of the delivery tube assembly 2, which increases the sensitivity of the electrode, improves the response speed of the electrode assembly 3, saves ablation time, and improves the user experience.

[0141] In this embodiment, the support member is a simply supported beam. Initially, that is, when the electrode is in a contracted state, the simply supported beam closes to form a micro-arch structure. When the electrode is in an expanded state, the simply supported beam bends along its thickness direction.

[0142] In this embodiment, in order to achieve the expected electrode expansion shape, the simply supported beam is initially an arched structure; in some schemes, the arched structure is achieved by pre-stressing assembly, that is, the electrode is moved toward the proximal end through the conveying tube assembly 2 to maintain the pre-stressed installation, causing the simply supported beam to produce a slight bending deformation; when fully expanded, the electrode is moved toward the proximal end until the ellipsoidal surface is expanded; in other schemes, the arched structure can also be achieved by pre-forming, that is, the simply supported beam is fixed on a shaping tool, and pre-bending and shaping is achieved through high-temperature heat treatment.

[0143] In some possible embodiments, when the electrode is in a compressed state, the length direction of the support member is parallel to the axial direction of the delivery tube assembly 2, and the thickness direction of the support member passes through the axis of the delivery tube assembly 2, and the support member satisfies at least one of the following characteristics: the thickness of the support member is much smaller than the width of the support member; the width of the support member is much smaller than the length of the support member; the number of supports is 2-14. By restricting the support member as above, the ductility of the support member can be guaranteed, thereby increasing the flexibility of the electrode, so as to achieve the ability to flexibly adjust the electrode shape to adapt to the lesion structure, and achieve a larger area of ​​electrode and lesion contact, thereby improving the success rate of pulse ablation.

[0144] Based on the pulse ablation electrode delivery device, an embodiment of the present invention further provides an electrode delivery method for ablation of pulmonary nodules. The electrode delivery method includes:

[0145] Step S10: Imaging examination: Before treatment, obtain the patient's chest CT or MRI imaging data to understand the bronchial anatomical structure, measure the location, size, shape and other information of the nodules;

[0146] Step S20: Image analysis and planning: Use CT or MRI images to analyze the location of the nodules and surrounding tissue structures. Use navigation planning software to perform three-dimensional reconstruction of the lungs and obtain the delivery path of the target lesion;

[0147] Step S30: Electrode delivery guidance: During treatment, the delivery tube assembly 2 and the electrode assembly 3 are slowly pushed along the bronchus to the target lesion by using virtual navigation and / or electromagnetic navigation system for image guidance.

[0148] Step S40 electrode deployment: electrode deployment is completed by the following operations: 1) applying external force to the rotating member 12 to rotate along the first direction, so that the second abutting portion 123 is disengaged from the first abutting portion on the fixed portion 11, so that the rotating member 12 is unlocked; 2) after the rotating member 12 continues to apply external force to rotate a full circle, the second abutting portion 123 again abuts against the first abutting portion on the fixed portion 11 to produce a sense of frustration, reminding the operator that the rotating member 12 has rotated a full circle; at the same time, the traction component 4 is driven by the adapter component 5 to pull the distal electrode 31; 3) when the head end of the distal electrode 31 contacts the inner tube 203, the distal electrode 31 is fully deployed; 4) when the head end of the proximal electrode 32 contacts the intermediate tube 202, the proximal electrode 32 is fully deployed;

[0149] Step S50: straightening the electrode: the electrode straightening is completed by the following operations: 1) applying an external force to the rotating member 12 to rotate along the second direction; 2) the external force moves the adapter assembly 5 from the proximal end to the distal end, driving the traction assembly 4 to push the distal electrode 31 from the proximal end to the distal end; 3) when the external force is continuously applied to push the traction assembly 4 to the initial position, the distal electrode 31 and the proximal electrode 32 return to the initial straightened state;

[0150] Step S60 Pulsed electric field ablation: Confirm that the electrode assembly 3 is in place, test the electric pulse to observe the muscle contraction and ECG synchronization, and after confirming that the electrical impedance of the tissue is within the acceptable range, perform ablation with the best ablation parameters. Perform a CT scan immediately after the ablation operation to confirm that the real-time ablation range completely covers the tumor area.

[0151] Embodiment 1

[0152] See attached Figure 1-8The present embodiment provides a pulse ablation electrode delivery device, comprising: a handle assembly, a rotating assembly 1 capable of rotating relative to the handle assembly; a traction assembly 4 arranged in the rotating assembly 1; an adapter assembly 5 arranged in the handle assembly, the adapter assembly 5 is rotatably connected to the rotating assembly 1, the adapter assembly 5 is slidably connected to the handle assembly, the first end of the traction assembly 4 is fixedly connected to the adapter assembly 5, and the adapter assembly 5 is used to convert the rotational motion of the rotating assembly 1 into the linear motion of the traction assembly 4; a delivery tube assembly 2, the first end of the delivery tube assembly 2 can be connected to the distal end of the electrode assembly 3, the second end of the delivery tube assembly 2 is fixedly connected to the rotating assembly 1, the second end of the traction assembly 4 is extended into the delivery tube assembly 2 from the second end of the delivery tube assembly 2, and is connected to the distal end of the electrode assembly 3; under the action of external force, the rotating assembly 1 rotates relative to the handle assembly, and the rotating assembly 1 drives the adapter assembly 5, the traction assembly 4 and the delivery tube assembly 2 to move relative to the handle assembly to adjust the distance between the distal end of the electrode assembly 3 and the rotating assembly 1.

[0153] The pulse ablation electrode delivery device in this embodiment is used to deliver a pulse ablation electrode assembly 3 into a natural cavity of the human body. In some embodiments, the electrode assembly 3 delivered can be an electrode assembly for treating malignant pulmonary nodules. In other embodiments, the electrode assembly 3 delivered can also be other medical devices. For ease of understanding, the pulse ablation electrode delivery device is introduced by taking the example of delivering the electrode assembly 3 to the peripheral bronchus to treat malignant pulmonary nodules. The electrode assembly 3 in this embodiment is configured to transmit pulse energy to the target lesion for irreversible electroporation ablation; the electrode assembly 3 is configured so that at least one electrode contacts the lesion tissue; wherein, when only one electrode contacts the lesion, an energy release loop is formed with the body surface electrode to achieve local irreversible electroporation ablation of small lesions; when at least two adjacent electrodes can contact the lesion, bipolar ablation can be achieved, that is, the pulsed electric field is transmitted through adjacent electrodes of opposite sex; optionally, the electrode assembly 3 is composed of a distal electrode 31 and a proximal electrode 32; the distal electrode 31 and the proximal electrode 32 are arranged axially at intervals along the tube body assembly 2; the exterior of the distal electrode 31 and the proximal electrode 32 is a conductive surface; the distal electrode 31 and / or the proximal electrode 32 can be expanded from a tubular shape to an ellipsoid or a spindle shape to more fully contact the lesion tissue and improve the pulse energy delivery effect.

[0154] When the electrode assembly 3 is delivered through the bronchoscope using a pulse ablation electrode delivery device, the electrode assembly 3 and the delivery tube assembly 2 are inserted into the bronchoscope channel; then, the electrode assembly 3 is guided to the lesion site with the help of positioning technologies such as electromagnetic navigation, and the electrode assembly 3 is delivered into the lesion, and then the electrode assembly 3 is controlled by the pulse ablation electrode delivery device to achieve radial expansion and / or radial bending of the electrode, so that the electrode assembly 3 is fully in contact with the lesion tissue, reducing the loss of the pulse electric field transmission caused by media such as air, mucus, and blood; finally, the relative position of the electrode assembly 3 and the lesion is confirmed by CT imaging and a pulse electric field ablation operation is performed; optionally, if the lesion location is not confirmed before the operation, it can also be delivered in conjunction with a guide sheath, and the adapted guide sheath is pre-pushed to the vicinity of the lesion by electromagnetic navigation, the delivery tube assembly 2 is withdrawn, and the lesion location is further confirmed by a radial ultrasonic probe and tissue biopsy, and then the delivery tube assembly 2 is replaced and inserted to locate the lesion through CT imaging for ablation.

[0155] In this embodiment, the delivery tube assembly 2 has a distal end and a proximal end that are relatively set, the electrode assembly 3 is set at the distal end of the delivery tube assembly 2, and the electrode in the electrode assembly 3 has a distal end and a proximal end that are relatively set. When the delivery tube assembly 2 is in an incomplete state, the proximal end of the electrode is the side close to the proximal end of the delivery tube assembly 2, and the distal end of the electrode is the side away from the proximal end of the delivery tube assembly 2. The delivery tube assembly 2 is used to connect and limit the axial movement of the electrode assembly 3.

[0156] In this embodiment, the adapter assembly 5 moves between the first extreme position and the second extreme position of the handle assembly; when the adapter assembly 5 moves to the first extreme position, the distance between the distal end of the electrode assembly 3 and the rotating assembly 1 is the first distance; when the adapter assembly 5 moves to the second extreme position, the distance between the distal end of the electrode assembly 3 and the rotating assembly 1 is the second distance, wherein the first distance is greater than the second distance.

[0157] Preferably, two sliders 51 are spaced apart on the outer wall of the adapter assembly 5, and two slide grooves 131 corresponding to the two sliders 51 are provided on the inner wall of the inner cavity of the handle assembly, and the slide grooves 131 and the sliders 51 are both provided along the length direction of the handle assembly.

[0158] See attached Figure 1 The rotating component 1 includes a fixed component 11 and a rotating component 12; the first end of the fixed component 11 is fixedly connected to the second end of the conveying pipe component 2, and the second end of the fixed component 11 can rotate relative to the rotating component 12.

[0159] In this embodiment, the rotating member 12 can rotate along the first direction under the action of external force to release the lock of the adapter assembly 5, and then the adapter assembly 5 moves from the distal end to the proximal end to release the lock of the traction assembly 4; thereafter, the traction assembly 4 can move from the distal end to the proximal end under the action of external force to release the distal electrode 31 and at least one proximal electrode 32, and the distal electrode 31 and at least one proximal electrode 32 are axially compressed, so that the electrode assembly 3 gradually expands inside the lesion, and when the rotating member 12 rotates through a predetermined angle, the adapter assembly 5 moves along the slide groove 131 and contacts the end of the slide groove 131, so that the adapter assembly 5 stops moving along the slide groove 131; when the rotating member 12 rotates along the second direction under the action of external force, the lock of the adapter assembly 5 is released, and then the adapter assembly 5 moves from the proximal end to the distal end to release the lock of the traction assembly 4; thereafter, the traction assembly 4 moves from the proximal end to the distal end to straighten the electrode assembly 3; the first direction is opposite to the second direction. It is understood that in this embodiment, when the first direction is clockwise, the second direction is counterclockwise, and vice versa. In addition, "external force" refers to the element receiving the force, and the force comes from the user, other elements or mechanisms.

[0160] In this embodiment, when the adapter assembly 5 is in the first extreme position, the first end of the adapter assembly 5 abuts against the end of the slide groove 131, and when the adapter assembly 5 is in the second extreme position, the second end of the adapter assembly 5 abuts against the limiting portion 124 of the rotating member 12.

[0161] In this embodiment, the rotating member 12 has an initial position; the rotating member 12 is configured such that, when in the initial position, the rotating member 12 is used to lock the adapter assembly 5 to move from the proximal end to the distal end, and the adapter assembly 5 is used to lock the traction assembly 4 to move from the proximal end to the distal end; the traction assembly 4 is used to lock the electrode assembly 3, and at this time the electrode assembly 3 is in a straightened state, and the delivery is achieved with a smaller outer diameter; when the rotating member 12 is in the initial position, the adapter assembly 5 is in the second extreme position;

[0162] The rotating member 12 has a terminal position; the rotating member 12 is configured such that, when in the terminal position, the rotating member 12 is used to lock the adapter assembly 5 to move from the distal end to the proximal end, and the adapter assembly 5 is used to lock the traction assembly 4 to move from the distal end to the proximal end; the traction assembly 4 is used to lock the electrode assembly 3, and the electrode assembly 3 is in an expanded state at this time to increase the contact area between the electrode assembly 3 and the lesion; when the rotating member 12 is in the terminal position, the adapter assembly 5 is in the first extreme position.

[0163] In this embodiment, a first abutting portion is disposed at the second end of the fixing member 11 , and a second abutting portion 123 cooperating with the first abutting portion is disposed at one end of the rotating member 12 facing the fixing member 11 ; the first abutting portion and the second abutting portion 123 can abut and cooperate with each other.

[0164] In this embodiment, a plurality of through holes are provided on the end surface of the rotating member 12 to facilitate the passage of the wire harness.

[0165] In this embodiment, during the unfolding process of the electrode assembly 3, the shape control of the electrode assembly 3 can be achieved by controlling the rotating member 12 with external force; the second abutment portion 123 of the rotating member 12 abuts against the circle number feedback structure (not shown in the figure) on the fixed portion 11 to produce a sense of frustration, namely the first abutment portion, so that the operator knows that the rotating member 12 is unlocked; at the same time, when the rotating member 12 rotates 360°, the second abutment portion 123 again abuts against the circle number feedback structure on the fixed portion 11 to produce a sense of frustration, reminding the operator that the rotating member 12 has rotated 1 circle; optionally, when the rotating member 12 rotates an integer number of circles, the electrode assembly 3 is unfolded and released; in this process, the traction assembly 4 is connected with the adapter The component 5 moves from the distal end to the proximal end until the slider 51 of the adapter component 5 stops moving against the end of the slide groove 131; the traction component 4 pulls the distal electrode 31 driven by the adapter component 5; when the head end of the distal electrode 31 contacts the inner tube 23, the distal electrode 31 completes the maximum expansion; then, when the head end of the proximal electrode 32 contacts the intermediate tube 202, the proximal electrode 32 completes the maximum expansion; during the straightening process of the electrode component 3, the operation sequence is opposite to that of the expansion process, which will not be described in detail here; optionally, by limiting the number of rotations or direction of the rotating member 12 through the self-locking of the transmission thread, the distal electrode 31 or the proximal electrode 32 can be expanded or straightened separately.

[0166] That is to say, in the pulse ablation electrode delivery device provided in this embodiment, the rotating member 12, the adapter assembly 5 and the traction assembly 4 are in a motion locked state at the initial position, so that the pulse ablation electrode delivery device must be started in a predetermined order so that the pulse ablation electrode delivery device can completely unfold the electrode assembly 3 in a predetermined order, so as to avoid triggering the wrong sequence due to electrode delivery or endoscope blind spots during surgery, resulting in electrode unfolding failure or erroneous unfolding. At the same time, the second abutting portion 123 of the rotating member 12 abuts against the fixed portion 11 to achieve tactile feedback on the number of turns, reminding the operator to know the unlocking number of the rotating member 12, accurately controlling the unfolding state of the electrode assembly 3, improving the unfolding accuracy of the electrode assembly 3, and thus improving the success rate of ablation.

[0167] In this embodiment, the first abutting portion is made of an elastic material; and / or the second abutting portion 123 is made of an elastic material.

[0168] In this embodiment, the first abutting portion and / or the second abutting portion 123 is a protruding structure protruding toward the fixing member 11, and the specific structure of the first abutting portion and the second abutting portion 123 is not limited, as long as the two can abut and cooperate with each other.

[0169] See attached Figure 3The rotating member 12 includes a first rotating portion 121 and a second rotating portion 122; the first end of the first rotating portion 121 is rotatably connected to the fixed member 11, and the second end of the first rotating portion 121 is fixedly connected to the second rotating portion 122; the adapter component 5 is sleeved on the second rotating portion 122, and the second rotating portion 122 is rotatably connected to the adapter component 5.

[0170] In this embodiment, the first rotating portion 121 and the second rotating portion 122 are integrally formed.

[0171] In this embodiment, the outer diameter of the first rotating part 121 is larger than the outer diameter of the second rotating part 122. The second rotating part 122 extends into the inner cavity of the handle shell 13 and is threadedly connected to the adapter assembly 5 arranged in the inner cavity of the handle shell 13; the outer diameter of the second rotating part 122 is provided with an external thread, and the inner diameter of the adapter assembly 5 is provided with an internal thread matching the external thread.

[0172] In this embodiment, the outer diameter of the adapter assembly 5 is smaller than the outer diameter of the first rotating part 121, and the outer diameter of the first rotating part 121 is equal to the outer diameter of the handle shell 13, so that the overall structure is beautiful and the handle shell 13 is prevented from being too large, which increases the manufacturing cost.

[0173] In this embodiment, the length of the thread on the second rotating portion 122 is slightly smaller than the length of the second rotating portion 122 , and the length of the thread on the inner wall of the adapter component 5 is slightly smaller than the length of the adapter component 5 .

[0174] See attached Figure 2 A limiting portion 124 is provided on the first rotating portion 121 , and when the adapter assembly 5 moves to the first limit position, the adapter assembly 5 abuts against the limiting portion 124 .

[0175] In this embodiment, a second abutment portion 123 is provided on the side of the first rotating portion 121 facing the fixed member 11, and a limiting portion 124 is provided on the side of the first rotating portion 121 facing the rotating member away from the fixed member 11. The second abutment portion 123 and the limiting portion 124 are provided on opposite sides of the first rotating portion 121.

[0176] In this embodiment, the limiting portion 124 is a limiting step, and the limiting portion 124 is disposed in the sliding groove 131 .

[0177] In this embodiment, the delivery tube assembly 2 is made of a material with a developing function, and the delivery tube assembly 2 can adjust and confirm the electrode position under X-rays, thereby improving the accuracy of delivering the electrode assembly 3 to the lesion.

[0178] See attached Figure 4 and attached Figure 5A transmission sleeve 52 or an internal thread that cooperates with the external thread of the second rotating part 122 is provided on the inner cavity side wall of the adapter component 5. A plurality of through holes are provided on the end face 53 of the adapter component 5 facing the conveying pipe component 2 to facilitate the passage of the wiring harness. A mounting notch is provided on the other end face of the adapter component 5. The traction component 4 extends into the interior of the adapter component 5 through the mounting notch and is fixedly connected to the mounting notch. A slider 51 is provided on the outer side wall of the adapter component 5. The slider 51 cooperates with the slide groove 131 to achieve that the adapter component 5 can slide relative to the slide groove 131.

[0179] In this embodiment, the traction assembly 4 includes a pull rod and a pull rod fixing block connected to each other, the pull rod is connected to the installation notch through the pull rod fixing block, and the axis of the pull rod, the axis of the adapter assembly 5 and the axis of the rotating assembly 1 are arranged to coincide.

[0180] In this embodiment, when the rotating member 12 rotates in the first direction under the action of external force, the slider 51 on the adapter assembly 5 slides in the slide groove 131 through the transmission thread, thereby driving the traction assembly 4 to move from the distal end to the proximal end; the traction assembly 4 is indirectly connected to the distal end of the electrode assembly 3, driving the distal end of the electrode assembly 3 to move from the distal end to the proximal end.

[0181] See attached Figure 6 The conveying pipe assembly 2 includes an outer pipe 21, at least one intermediate pipe 22 and an inner pipe 23; from the inside to the outside, the traction assembly 4, the inner pipe 23, at least one intermediate pipe 22 and the outer pipe 21 are sequentially arranged, the outer pipe 21 is fixedly connected to the intermediate pipe 22, the inner pipe 23 is slidably connected to the intermediate pipe 22, and the traction assembly 4 is slidably connected to the inner pipe 23; the first end of the inner pipe 23 can be fixedly connected to the distal end of the electrode assembly 3, and the distal end of the outer pipe 21 can be fixedly connected to the proximal end of the electrode assembly 3.

[0182] In this embodiment, the conveying tube assembly 2 is used to execute the displacement control of the electrode assembly 3 by the rotating assembly 1, the inner tube 23 can realize displacement movement relative to the intermediate tube 22, the outer tube 21 is used to limit the displacement movement of the proximal part of a proximal electrode 32 close to the proximal end in the electrode assembly 3, the intermediate tube 22 is used to limit the displacement movement of the distal part of the proximal electrode 32, and the inner tube 23 is used to limit the displacement movement of the distal part of the traction assembly 4 and the distal electrode 31.

[0183] In this embodiment, the outer tube 21 preferably adopts a composite reinforced tube structure such as a composite braided tube, a spring tube, etc.; the middle tube 22 and the inner tube 23 preferably adopt a high dielectric strength tube, such as at least one of PTFE, PI, FPM, PEEK, PU, ​​PEBAX or PA.

[0184] See attached Figure 7The handle assembly includes a handle shell 13, an electrode wire and a connector assembly 14; the electrode wire is arranged in the handle shell 13, the first end of the electrode wire is electrically connected to the connector assembly 14, the connector assembly 14 is located at one end of the handle shell 13, and the connector assembly 14 is electrically connected to an ablation mechanism capable of providing a pulse group; the second end of the electrode wire is electrically connected to at least two electrodes 31 respectively.

[0185] In this embodiment, there are at least two electrode wires, and the second ends of the at least two electrode wires are electrically connected to at least two electrodes respectively, so that the positive and negative polarities of two adjacent electrodes are opposite, thereby improving the ablation effect.

[0186] In this embodiment, the handle shell 13 is electrically insulated from the electrode assembly 3 and is electrically connected to the ablation mechanism via the connector assembly 14; the connector assembly 14 includes a pulse cable and a pulse connector, a sensor cable and a sensor connector; the pulse cable and the pulse connector are electrically connected to the electrode assembly 3; the sensor cable and the sensor connector are electrically connected to the position detection device; and the pulse connector and the sensor connector are communicatively connected to the ablation mechanism.

[0187] In this embodiment, a direction mark and / or an extended length mark is provided on the handle housing 13 or the fixing member 11; wherein the direction mark is used to indicate the number of times the operator rotates the above-mentioned rotating member 12, and is used to indicate that the rotating member 12 is rotated in a first direction, and the distal end of the electrode assembly 3 moves toward the proximal end of the conveying tube assembly 2, or the rotating member 12 is rotated in a second direction, and the distal end of the electrode assembly 3 moves away from the proximal end of the conveying tube assembly 2, and the first direction and the second direction are opposite.

[0188] In this embodiment, the delivery tube assembly 2 is insulated from the electrode assembly 3, and the wire of the electrode assembly 3 is electrically connected to the ablation mechanism via the connector assembly 14; the connector assembly 14 includes a pulse cable W1 and a pulse connector L1; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode assembly 3; the pulse connector L1 is communicatively connected to the ablation system; the pulse cable W1 has an insulation layer, a shielding layer and a wire layer;

[0189] Optionally, the connector assembly 14 includes a pulse cable W1 and a pulse connector L1, a sensor cable W2 and a sensor connector L2; the pulse cable W1 and the pulse connector L1 are electrically connected to the electrode assembly 3; the sensor cable W2 and the sensor connector L2 are electrically connected to the sensor assembly (not shown in the figure); the pulse connector L1 and the sensor connector L2 are communicatively connected to the ablation mechanism.

[0190] On the other hand, the present invention also protects a pulse ablation device, including an ablation mechanism, an electrode assembly 3 and the above-mentioned pulse ablation electrode delivery device; the ablation mechanism is used to provide a pulse group to the electrode assembly 3, and the electrode assembly 3 is connected to the distal end of the delivery tube assembly 2.

[0191] In this embodiment, the ablation mechanism can provide at least one pulse group for the electrode assembly 3, and the pulse group ensures at least one high-frequency high-voltage sub-pulse and / or one low-frequency low-voltage sub-pulse, the high-frequency high-voltage sub-pulse is a bipolar pulse, and the low-frequency low-voltage sub-pulse is a unipolar pulse or a bipolar pulse; wherein the bipolar pulse includes a positive pulse amplitude and a negative pulse amplitude.

[0192] In some possible embodiments, the electrode assembly 3 can move axially or bend radially relative to the conveying tube assembly 2, and the electrode assembly 3 includes at least one electrode, which is a tubular structure with a cavity inside; driven by the conveying tube assembly 2, the opposite ends of the electrode move toward or away from each other until the tubular structure contracts or expands.

[0193] See attached Figure 8 The electrode assembly 3 includes a distal electrode 31 and at least one proximal electrode 32, which are arranged in sequence from the distal end to the proximal end of the delivery tube assembly, and the two adjacent electrodes are relatively fixed; the second end of the traction assembly 4 and the distal end of the inner tube 23 are fixedly connected to the distal end of the distal electrode 31, at least one intermediate tube 22 is correspondingly arranged to at least one proximal electrode 31, and the distal end of the intermediate tube 22 is fixedly connected to the distal end of the proximal electrode 32; under the action of external force, the traction assembly 4 can reciprocate along the axial direction of the delivery tube assembly 2 to drive the relative distal and proximal ends of the same electrode to move toward or away from each other until the electrodes are contracted or expanded.

[0194] In this embodiment, there is a gap between the distal end of the inner tube 23 and the second end of the pulling assembly 4 ; there is a gap between the distal end of the middle tube 22 and the distal end of the proximal electrode 32 .

[0195] In this embodiment, when the electrode assembly 3 is capable of contracting or expanding and the electrode assembly 3 includes two electrodes, the second end of the traction assembly 4 and the distal end of the inner tube 23 are fixedly connected to the distal region of the distal electrode 31, and there is a gap between the second end of the traction assembly 4 and the distal end of the inner tube 23, the second end of the traction assembly 4 is closer to the distal end of the electrode assembly 3 than the distal end of the inner tube 23, the distal end of the intermediate tube 22 is fixedly connected to the distal region of the proximal electrode 32, and the distal end of the outer tube 21 is fixedly connected to the proximal region of the proximal electrode 32.

[0196] In this embodiment, the second end of the traction assembly 4 is closer to the distal end of the electrode assembly 3 than the distal end of the inner tube 23. Along the distal end to the proximal end of the electrode assembly 3, the distal end of the distal electrode 31, the second end of the traction assembly 4, the distal end of the inner tube 23, the proximal end of the distal electrode 31, the proximal end of the proximal electrode 32, the distal end of the intermediate tube 22, the distal end of the proximal electrode 32 and the proximal end of the transport tube assembly 2 are arranged in sequence.

[0197] In this embodiment, setting the above gap can prevent the conveying tube assembly 2 from interfering with the contraction or expansion of the electrode. The specific value of the above gap is not limited, and the above gap is matched according to the maximum diameter of the electrode required to be expanded.

[0198] Preferably, the gap is not less than 10%-25% of the length of a single electrode. Such a setting can shorten the length of some tubes in the conveying tube assembly 2, reduce the preparation cost, and prevent the conveying tube assembly 2 from interfering with the contraction or expansion of the electrode.

[0199] In this embodiment, the electrode satisfies at least one of the following characteristics: when the electrode is in a contracted state, the maximum diameter of the electrode is 1.0 mm-2.8 mm; when the electrode is in an expanded state, the maximum diameter of the electrode is 2.0 mm-20 mm.

[0200] In the present embodiment, in order to achieve the expected expanded shape of the electrode assembly 3, the electrode assembly 3 is initially a cylindrical structure and / or a tubular structure, etc.; the head end of the distal electrode 31 is preferably arc-shaped or conical, so as to facilitate penetrating into the narrower sections of the bronchus and the inside of the lesion; in order to better fit the peripheral bronchial lesions, increase the effective contact area of ​​the electrode, and achieve a larger radial ablation range, the electrode assembly 3 is an expansion structure, such as a woven mesh structure, a sac structure, a spline structure, etc.; the initial diameter of the distal electrode 31 and the proximal electrode 32 is preferably φ1.0mm to φ2.8mm, and the diameter after expansion is preferably φ2.0mm to φ20mm.

[0201] In this embodiment, when the electrode is in a contracted state, the cross-section of the electrode is cylindrical; when the electrode is in an expanded state, the cross-section of the electrode is elliptical.

[0202] In this embodiment, the electrode is a tubular structure woven from metal wires; and / or, the electrode is a tubular structure formed by at least two support members circumferentially spaced around the distal end of the delivery tube assembly 2 .

[0203] In this embodiment, the electrodes are woven by metal wires in a one-on-one or one-on-two or two-on-two weaving manner; the metal wires are preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals.

[0204] In this embodiment, along the length direction of the support member, the surface slope of the support member gradually increases from small to large, and then gradually decreases from large to small, so as to form an arch structure.

[0205] In this embodiment, the support member is a simply supported beam. Initially, that is, when the electrode is in a contracted state, the simply supported beam closes to form a micro-arch structure. When the electrode is in an expanded state, the simply supported beam bends along its thickness direction.

[0206] In this embodiment, in order to achieve the expected electrode expansion shape, the simply supported beam is initially an arched structure; in some schemes, the arched structure is achieved by pre-stressing assembly, that is, the electrode is moved toward the proximal end through the conveying tube assembly 2 to maintain the pre-stressed installation, causing the simply supported beam to produce a slight bending deformation; when fully expanded, the electrode is moved toward the proximal end until the ellipsoidal surface is expanded; in other schemes, the arched structure can also be achieved by pre-forming, that is, the simply supported beam is fixed on a shaping tool, and pre-bending and shaping is achieved through high-temperature heat treatment.

[0207] In this embodiment, when the electrode is in a compressed state, the length direction of the support member is parallel to the axial direction of the conveying tube assembly 2, the thickness direction of the support member passes through the axis of the conveying tube assembly 2, and the support member satisfies at least one of the following characteristics: the thickness of the support member is much smaller than the width of the support member; the width of the support member is much smaller than the length of the support member; the number of the support members is 2-14.

[0208] The embodiments of the present application have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

[0209] In the absence of conflict, the above embodiments and features in the embodiments can be combined with each other.

[0210] The above disclosure is only a preferred embodiment of the present application, and certainly cannot be used to limit the scope of rights of the present application. Therefore, equivalent changes made according to the claims of the present application are still within the scope covered by the present application.

Claims

1. A pulse ablation electrode delivery device, characterized in that: include: Handle assembly, A rotating assembly (1) capable of rotating relative to the handle assembly; A traction assembly (4) disposed in the rotating assembly (1); an adapter assembly (5) disposed in the handle assembly, the adapter assembly (5) being rotationally connected to the rotating assembly (1), the adapter assembly (5) being slidably connected to the handle assembly, the first end of the traction assembly (4) being fixedly connected to the adapter assembly (5), the adapter assembly (5) being used for converting the rotational motion of the rotating assembly (1) into the linear motion of the traction assembly (4); A delivery tube assembly (2), wherein the first end of the delivery tube assembly (2) is connectable to the distal end of the electrode assembly (3), the second end of the delivery tube assembly (2) is fixedly connected to the rotating assembly (1), and the second end of the traction assembly (4) extends from the second end of the delivery tube assembly (2) into the delivery tube assembly (2) and is connected to the distal end of the electrode assembly (3); Under the action of external force, the rotating assembly (1) rotates relative to the handle assembly, and the rotating assembly (1) drives the adapter assembly (5), the traction assembly (4) and the delivery tube assembly (2) to move relative to the handle assembly, thereby adjusting the distance between the distal end of the electrode assembly (3) and the rotating assembly (1).

2. The pulse ablation electrode delivery device according to claim 1, characterized in that: The adapter assembly (5) moves between a first extreme position and a second extreme position of the handle assembly; When the adapter assembly (5) moves to the first extreme position, the distance between the distal end of the electrode assembly (3) and the rotating assembly (1) is a first distance; When the adapter assembly (5) moves to the second extreme position, the distance between the distal end of the electrode assembly (3) and the rotating assembly (1) is a second distance, wherein the first distance is greater than the second distance.

3. The pulse ablation electrode delivery device according to claim 1, characterized in that: One of the outer wall of the adapter assembly (5) and the inner wall of the handle assembly is provided with a slide groove (131), and the other is provided with a sliding block (51) matched with the slide groove (131).

4. The pulse ablation electrode delivery device according to claim 1, characterized in that: The rotating assembly (1) comprises a fixed component (11) and a rotating component (12); The first end of the fixing member (11) is fixedly connected to the second end of the conveying pipe assembly (2), and the second end of the fixing member (11) is capable of rotating relative to the rotating member (12).

5. The pulse ablation electrode delivery device according to claim 4, characterized in that: The second end of the fixing member (11) is provided with a first abutment portion, and the end of the rotating member (12) facing the fixing member (11) is provided with a second abutment portion (123) that cooperates with the first abutment portion; The first abutting portion and the second abutting portion (123) are capable of abutting and fitting with each other.

6. The pulse ablation electrode delivery device according to claim 5, characterized in that: The first abutting portion is made of elastic material; And / or, the material of the second abutting portion (123) is elastic material.

7. The pulse ablation electrode delivery device according to claim 4, characterized in that: The rotating member (12) comprises a first rotating portion (121) and a second rotating portion (122); The first end of the first rotating part (121) is rotatably connected to the fixing member (11), and the second end of the first rotating part (121) is fixedly connected to the second rotating part (122); The adapter component (5) is sleeved on the second rotating part (122), and the second rotating part (122) is rotatably connected to the adapter component (5).

8. The pulse ablation electrode delivery device according to claim 7, characterized in that: A limiting portion (124) is provided on the first rotating portion (121), and when the adapter component (5) moves to the first limit position, the adapter component (5) abuts against the limiting portion (124).

9. The pulse ablation electrode delivery device according to any one of claims 1 to 8, characterized in that: The delivery pipe assembly (2) comprises an outer pipe (21), at least one intermediate pipe (22) and an inner pipe (23); From inside to outside, the traction component (4), the inner tube (23), the at least one intermediate tube (22) and the outer tube (21) are sequentially sleeved, the outer tube (21) is fixedly connected to the intermediate tube (22), the inner tube (23) is slidably connected to the intermediate tube (22), and the traction component (4) is slidably connected to the inner tube (23); The first end of the inner tube (23) can be fixedly connected to the distal end of the electrode assembly (3), and the distal end of the outer tube (21) can be fixedly connected to the proximal end of the electrode assembly (3).

10. The pulse ablation electrode delivery device according to any one of claims 1 to 8, characterized in that: The handle assembly comprises a handle housing (13), an electrode wire and a connector assembly (14); The electrode wire is arranged in the handle housing (13), the first end of the electrode wire is electrically connected to the connector assembly (14), the connector assembly (14) is located at one end of the handle housing (13), and the connector assembly (14) is electrically connected to an ablation mechanism capable of providing a pulse group; The second ends of the electrode wires are electrically connected to at least two electrodes (31) respectively.

11. A pulse ablation device, characterized in that: It comprises an ablation mechanism, an electrode assembly (3) and a pulse ablation electrode delivery device as claimed in any one of claims 1 to 10; The ablation mechanism is used to provide a pulse group to the electrode assembly (3), and the electrode assembly (3) is connected to the distal end of the delivery tube assembly (2).

12. The pulse ablation device according to claim 11, characterized in that: The electrode assembly (3) comprises at least one electrode, and the electrode is a tubular structure having a cavity inside; Driven by the delivery tube assembly (2), the two opposite ends of the electrode move towards or away from each other until the tubular structure contracts or expands.

13. The pulse ablation device according to claim 12, characterized in that: The electrode assembly (3) comprises a distal electrode (31) and at least one proximal electrode (32), wherein the distal electrode (31) and the at least one proximal electrode (32) are arranged in sequence from the distal end to the proximal end of the delivery tube assembly, and two adjacent electrodes are relatively fixed; The second end of the traction assembly (4) and the distal end of the inner tube (23) are both fixedly connected to the distal end of the distal electrode (31); at least one intermediate tube (22) is arranged corresponding to the at least one proximal electrode (31); and the distal end of the intermediate tube (22) is fixedly connected to the distal end of the proximal electrode (32); Under the action of external force, the traction assembly (4) can reciprocate along the axial direction of the delivery tube assembly (2) to drive the relative distal end and proximal end of the same electrode to move towards or away from each other until the electrode contracts or expands.

14. The pulse ablation device according to claim 13, characterized in that: There is a gap between the distal end of the inner tube (23) and the second end of the traction assembly (4); there is a gap between the distal end of the intermediate tube (22) and the distal end of the proximal electrode (32).

15. The pulse ablation device according to claim 12, characterized in that: The electrode satisfies at least one of the following characteristics: The electrode is in a contracted state, and the maximum diameter of the electrode is 1.0 mm-2.8 mm; The electrode is in an expanded state, and the maximum diameter of the electrode is 2.0 mm-20 mm.

16. The pulse ablation device according to claim 15, characterized in that: When the electrode is in a contracted state, the cross section of the electrode is cylindrical; when the electrode is in an expanded state, the cross section of the electrode is elliptical.

17. The pulse ablation device according to claim 12, characterized in that: The electrode is a tubular structure woven from metal wires; And / or, the electrode is a tubular structure formed by at least two support members circumferentially spaced around the distal end of the delivery tube assembly (2).

18. The pulse ablation device according to claim 17, characterized in that: When the electrode is in a compressed state, the length direction of the support member is parallel to the axial direction of the delivery tube assembly (2), the thickness direction of the support member passes through the axis of the delivery tube assembly (2), and the support member meets at least one of the following characteristics: The thickness of the support member is much smaller than the width of the support member; The width of the support member is much smaller than the length of the support member; The number of the supporting members is 2-14.

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