Direct push composite ablation needle and ablation system

Abstract

The present invention relates to a direct-push composite ablation needle and an ablation system. The present invention provides a direct-push composite ablation needle, comprising a needle assembly and a direct-push handle assembly. The needle assembly comprises a first working part, a second working part and a first isolation part. The first isolation part separates the first working part and the second working part. The outside of the first working part and / or the second working part is covered with a second isolation part. The second isolation part is connected to the direct-push handle assembly. The direct-push handle assembly can move the second isolation part relative to the first working part or the second working part to change the effective length of the first working part and / or the second working part.

Description

[0001] The present invention is a divisional application of Chinese patent CN202410764451.6, whose application date is June 13, 2024 and whose name is “Multiple physical factor composite ablation needle and ablation system”. Technical Field

[0002] The present invention relates to the technical field of ablation, and in particular to a direct-push composite ablation needle and an ablation system. Background Art

[0003] Tumor ablation techniques generally include chemical ablation and energy-based ablation. Chemical ablation is the direct injection of chemical drugs into the tumor to inhibit tumor growth. Energy ablation can be divided into radiofrequency ablation, cryoablation and pulsed electric field ablation according to different working principles. Currently, the treatment systems that use chemical ablation and radiofrequency, cryoablation and pulse energy ablation are relatively independent of each other, and generally use a single mode of physical effect for ablation treatment. Therefore, it is impossible to select two or more ablation treatment methods under the same ablation device according to the clinical tumor lesions. Summary of the invention

[0004] The present invention provides a direct-push composite ablation needle and an ablation system, which are used to solve the above-mentioned technical problems.

[0005] According to a first aspect of the present invention, the present invention provides a direct-push composite ablation needle, comprising a needle assembly and a direct-push handle assembly, wherein the needle assembly comprises a first working portion, a second working portion and a first isolation portion, wherein the first isolation portion separates the first working portion from the second working portion;

[0006] The outside of the first working part and / or the second working part is covered with a second isolation part, and the second isolation part is connected to the direct-push handle assembly. The direct-push handle assembly can move the second isolation part relative to the first working part or the second working part to change the effective length of the first working part and / or the second working part.

[0007] In one embodiment, the first working part includes a needle and a first tube connected to the distal end of the needle, the needle and / or the first tube are provided with a coating, and the needle and / or the first tube can release radio frequency energy, pulsed electric field energy or electrolytic energy alone;

[0008] The second working part comprises a second tube, a coating is disposed on the second tube, and the second tube is capable of independently releasing radio frequency energy, pulsed electric field energy or electrolytic energy;

[0009] The needle and / or the first tube can also release radiofrequency energy, pulsed electric field energy or electrolytic energy to the second tube combination.

[0010] In one embodiment, the needle assembly further includes a first medium tube and a second medium tube disposed outside the first medium tube, wherein the first medium tube and the second medium tube both extend inside the first working portion, the first isolation portion, and the second working portion;

[0011] The inner wall of the first medium tube defines a first medium cavity, the outer wall of the first medium tube and the inner wall of the second medium tube jointly define a second medium cavity, and the first working part and the second working part can release freezing energy or thermal energy individually or in combination through the first medium cavity and the second medium cavity.

[0012] In one embodiment, the needle assembly further comprises an injection and suction inner tube and at least one injection and suction hole, wherein the injection and suction inner tube extends inside the first working portion, the first isolation portion and the second working portion, and the outer wall of the injection and suction inner tube and the inner wall of the first working portion jointly define an injection and suction medium cavity, and the injection and suction medium cavity is fluidically connected to the injection and suction hole;

[0013] One of the first working part, the first isolation part and the second working part can achieve chemical ablation alone through the injection hole; or multiple of the first working part, the first isolation part and the second working part can achieve chemical ablation in combination through the injection hole.

[0014] In one embodiment, the needle assembly also includes a second isolation tube for temperature isolation, and the second isolation tube is a separate layer located between the second medium tube and the injection and suction inner tube, or the second isolation tube is constructed in the second isolation part so that the second isolation part can achieve temperature isolation.

[0015] In one embodiment, the handle assembly includes a first shell, one end of the second isolation portion is disposed in the first shell, and the other end of the second isolation portion extends from one side of the first shell and covers one or both of the first working portion and the second working portion;

[0016] The second isolation part is connected to a mobile driving assembly, and the mobile driving assembly is configured to unlock the first shell when it is pushed, thereby driving the second isolation part to move axially along the second isolation part to change the effective length of the first working part and / or the second working part; when the mobile driving assembly is not pushed, it is locked with the first shell, thereby fixing the second isolation part at its current position.

[0017] In one embodiment, the mobile driving assembly includes a pushing member, a positioning member, a moving seat and an elastic member, the pushing member and the elastic member are respectively arranged on both sides of the positioning member, and the second isolation portion is fixedly connected to the moving seat;

[0018] A portion of the pushing member is located outside the first shell and is movably connected to the first shell. By applying force on the pushing member, it can be pushed to move along the axial direction of the second isolation portion.

[0019] In one embodiment, a plurality of positioning grooves are arranged at intervals on the first housing, a pushing groove is arranged on a side of the pushing member close to the positioning member, the pushing groove is configured as a wedge-shaped groove, and an inner wall of the wedge-shaped groove is an inner wall inclined relative to the positioning member;

[0020] When the positioning member is aligned with the positioning groove, the elastic member pushes the positioning member to move upward to be inserted into the positioning groove, thereby locking the mobile drive assembly with the first shell; when the pushing member is pushed and moves along the axial direction of the second isolation portion, the inner wall of the pushing groove prompts the positioning member to move toward the direction close to the elastic member and causes the elastic member to undergo elastic deformation until the positioning member disengages from the positioning groove and the mobile drive assembly is unlocked with the first shell.

[0021] In one embodiment, a deformation cavity is provided on the movable seat, a support block is provided in the deformation cavity, the elastic member is provided on the support block, and the deformation cavity provides a space for elastic deformation of the elastic member.

[0022] In one embodiment, the handle assembly further includes a second shell, the second shell is connected to the first shell, a needle bar seat is further provided in the first shell, and the needle assembly penetrates the movable seat and is conductively connected to one side of the needle bar seat.

[0023] According to a second aspect of the present invention, the present invention provides an ablation system, comprising the above-mentioned direct-push composite ablation needle, and further comprising one or more of a medium source, a drug delivery device, and an energy source.

[0024] Compared with the prior art, the advantage of the present invention is that the first working part and the second working part can act alone or in combination, and can achieve one or more of chemical ablation, cryoablation, thermal ablation, pulsed electric field ablation or electrolytic ablation. Therefore, according to the condition of the clinical tumor lesions, two or more treatment methods can be selected under the same needle assembly to achieve enhanced therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Hereinafter, the present invention will be described in more detail based on embodiments and with reference to the accompanying drawings.

[0026] Figure 1 is a cross-sectional view of the needle assembly in Example 1 of the present invention;

[0027] Figure 2 is a cross-sectional view of a needle assembly in Example 2 of the present invention;

[0028] Figure 3a is a cross-sectional view of an optional needle assembly in Example 3 of the present invention;

[0029] Figure 3b is a cross-sectional view of another optional needle assembly in Example 3 of the present invention;

[0030] Figure 3c yes Figure 3a The enlarged view of point I in the middle;

[0031] Figure 3d yes Figure 3b The enlarged view of II in the middle;

[0032] Figure 3e is a schematic structural diagram of another optional needle assembly in Example 3 of the present invention;

[0033] Figure 4 is a cross-sectional view of a needle assembly in Example 4 of the present invention;

[0034] Figure 5 is a cross-sectional view of a needle assembly in Example 5 of the present invention;

[0035] Figure 6a is a cross-sectional view of a needle assembly in Example 6 of the present invention;

[0036] Figure 6b is a schematic diagram of the shapes of the first medium hole and the second medium hole in Example 6 of the present invention;

[0037] Figure 6c is an optional cross-sectional schematic diagram of the first medium hole and the second medium hole in Example 6 of the present invention;

[0038] Figure 6d is an optional cross-sectional schematic diagram of the first medium hole and the second medium hole in Example 6 of the present invention;

[0039] Figure 6e is an optional cross-sectional schematic diagram of the first medium hole and the second medium hole in Example 6 of the present invention;

[0040] Figure 6f is an optional cross-sectional schematic diagram of the first medium hole and the second medium hole in Example 6 of the present invention;

[0041] Figure 7a and Figure 7b is a cross-sectional view of a handle assembly in Example 7 of the present invention;

[0042] Figure 8 is an enlarged view of the front end of the handle assembly in Example 7 of the present invention;

[0043] Fig. 9 is a schematic diagram of the structure in which the mobile drive assembly is locked with the first housing in Embodiment 7 of the present invention;

[0044] Fig.10 is a structural schematic diagram of unlocking the mobile drive assembly and the first housing in Embodiment 7 of the present invention;

[0045] Fig.11 yes Fig. 9 A schematic diagram of the three-dimensional structure of the mobile seat shown;

[0046] Fig.12 yes Figure 7b A cross-sectional view of the second housing shown;

[0047] Fig.13a and Fig.13b is a cross-sectional view of a handle assembly in Example 8 of the present invention;

[0048] Fig.14 is a schematic diagram of the three-dimensional structure of the handle assembly in Example 8 of the present invention;

[0049] Fig.15 is a schematic diagram of the internal structure of the handle assembly in Example 8 of the present invention;

[0050] Fig.16 is a schematic structural diagram of a slider and a scale ring in Embodiment 9 of the present invention;

[0051] Fig.17 yes Fig.16 A schematic diagram of the three-dimensional structure of the slider shown;

[0052] Fig.18 is a schematic diagram of the three-dimensional structure of a slider in Embodiment 9 of the present invention;

[0053] Fig.19a and Fig.19b is a cross-sectional view of a handle assembly in embodiment 10 of the present invention;

[0054] Fig. 20 is a top view of a handle assembly in embodiment 10 of the present invention;

[0055] Fig.21a yes Fig. 20 A schematic diagram of the three-dimensional structure of the sliding propulsion mechanism shown;

[0056] Figure 21b yes Fig. 20 A cross-sectional view of the sliding propulsion mechanism shown;

[0057] Fig.21c yes Fig.21a A schematic diagram of the three-dimensional structure of the double torsion spring shown;

[0058] Fig.22a is a schematic diagram of the internal structure of the handle assembly in embodiment 10 of the present invention, wherein the right housing is hidden;

[0059] Figure 22b is a schematic diagram of the internal structure of the handle assembly in embodiment 10 of the present invention, wherein the left housing is hidden;

[0060] Fig.22c is a top view of the handle assembly in embodiment 10 of the present invention, wherein the pushing portion is hidden;

[0061] Fig.23a is a radial cross-sectional view of a handle assembly in embodiment 10 of the present invention;

[0062] Figure 23b is a schematic structural diagram of a double torsion spring in a compressed state in Embodiment 10 of the present invention;

[0063] Fig.23c is a schematic structural diagram of a double torsion spring in a natural state in Embodiment 10 of the present invention;

[0064] Fig.24 yes Fig. 20 The enlarged view of point I in the middle;

[0065] Fig.25 is a schematic diagram of the three-dimensional structure of the shielding structure in Example 10 of the present invention

[0066] Fig.26 is a schematic diagram of a push button in an initial position in a housing slide slot in Embodiment 10 of the present invention;

[0067] Fig. 27 is a schematic diagram of a push button in a process position in a housing slide slot in Embodiment 10 of the present invention;

[0068] Fig.28 is a schematic diagram of a push button in a housing slide slot at a terminal position in Embodiment 10 of the present invention;

[0069] Fig.29 is a schematic diagram of a locating groove located on the left side of the casing slide groove in Embodiment 10 of the present invention;

[0070] Fig.30 is a schematic diagram of a locating groove located on the right side of the casing slide groove in Embodiment 10 of the present invention;

[0071] Fig.31 is a schematic diagram of the positioning grooves in Example 10 of the present invention being alternately distributed on the left and right sides of the casing slide groove;

[0072] Fig.32 is a schematic diagram of the symmetrical distribution of the positioning grooves on the left and right sides of the casing slide groove in Embodiment 10 of the present invention;

[0073] Fig.33 is a cross-sectional view of a needle assembly in Example 12 of the present invention;

[0074] Fig.34 is a cross-sectional view of a needle assembly in Example 13 of the present invention;

[0075] Fig.35 is a cross-sectional view of a needle assembly in Example 14 of the present invention;

[0076] Fig.36 is a cross-sectional view of a needle assembly in Example 15 of the present invention;

[0077] Fig.37 is a cross-sectional view of a needle assembly in Example 16 of the present invention;

[0078] Fig.38 is a cross-sectional view of the needle assembly in Example 17 of the present invention.

[0079] Reference numerals:

[0080] 1. Needle assembly;

[0081] 11. needle; 12. medium release chamber; 13. temperature measuring element; 14. first medium tube; 15. first working part; 16. second medium tube; 17. first isolation part; 18. second isolation tube; 19. second working part; 10. second isolation part;

[0082] 111. needle coating; 141. inlet channel;

[0083] 151, injection and suction hole; 153, injection and suction inner tube; 154, injection and suction medium cavity; 155, first tube extension tube; 156, first tube; 157, first medium hole;

[0084] 161. Second medium cavity; 162. Bend tube; 163. Closed end;

[0085] 171, first isolation tube extension tube; 172, first isolation tube; 173, second medium hole; 181, isolation layer; 191, second working area coating; 192, second tube extension tube; 193, second tube;

[0086] 203, first shell; 2001, treatment area;

[0087] 300, mobile drive assembly;

[0088] 301, pushing member; 302, positioning member; 303, moving seat; 304, elastic member;

[0089] 3001, positioning slot; 3002, receiving slot; 3003, pushing slot; 3004, sliding slot;

[0090] 3031, guide platform; 3021, guide groove; 3032, deformation cavity; 3033, support block;

[0091] 601, needle bar seat; 602, second housing; 6002, cable;

[0092] 6003, insulating end face; 6004, operating hole; 6021, first boss; 6022, mounting groove; 6023, second boss; 6005, second boss end face;

[0093] 53. Knob; 54. Seal; 55. Handle front shell; 56. Slider; 57. Scale ring; 58. Handle back shell; 59. LED light board;

[0094] 531, first sealing groove; 532, limiting groove; 533, sliding groove; 534, rotating part; 535, connecting part;

[0095] 551, wedge-shaped convex ring; 552, internal thread; 553, locking block;

[0096] 561, pillar; 562, notch structure; 563, sleeve; 564, spiral notch entrance; 565, spiral notch;

[0097] 581, shaft hole; 582, locking groove; 583, connecting hole; 584, second sealing groove; 585, raised portion;

[0098] 41, housing; 411, housing slide groove; 413, positioning groove; 412, left housing; 416, right housing; 414, pin receiving portion; 415, housing scale line;

[0099] 4131, neck portion; 4132, open portion; 4133, trough body;

[0100] 43. push button; 431. push part; 432. matching part; 433. sleeve; 434. double torsion spring; 4311. push button scale line; 4031. connecting hole; 4032. cavity structure; 4033. conical transition part;

[0101] 4341, inner pin; 4342, torsion spring coil; 4343, outer pin;

[0102] 44, cover; 441, spiral slide; 4411, open end; 4412, closed end. DETAILED DESCRIPTION

[0103] The present invention will be further described below in conjunction with the accompanying drawings.

[0104] The present invention provides a composite ablation needle, a composite ablation needle with multiple physical factors, a composite ablation needle with improved safety, a direct-push composite ablation needle, a rotary composite ablation needle, a sliding-propulsion composite ablation needle, a combined-action composite ablation needle and an ablation system. The various types of composite ablation needles provided by the present invention can realize the simultaneous output of two or more energies for combined treatment, and can also realize the sequential output of two or more energies for sequential treatment.

[0105] The various embodiments of the above-mentioned various types of composite ablation needles of the present invention will be described in detail below. It should be noted that the same components or assemblies in the various embodiments of the present invention use the same reference numerals, and the embodiments are not intended to limit the scope of the present invention, and the embodiments can be freely combined.

[0106] Example 1

[0107] like Figure 1 As shown, the present invention provides a composite ablation needle, more specifically, a multiple physical factor composite ablation needle, which includes a needle assembly 1, the needle assembly 1 includes a first working part 15, a second working part 19, a first isolation part 17 arranged between the first working part 15 and the second working part 19, and a second isolation part 10 capable of covering one or more of the first working part 15, the first isolation part 17 and the second working part 19.

[0108] The distal end of the first working portion 15 passes through the first isolating portion 17 and the second working portion 19 and extends into the second isolating portion 10 . The distal end of the first isolating portion 17 passes through the second working portion 19 and extends into the second isolating portion 10 . The second working portion 19 extends into the second isolating portion 10 .

[0109] The first working part 15 is configured to act alone to achieve one or more of chemical ablation, cryoablation, thermal ablation, pulsed electric field ablation, radiofrequency ablation or electrolytic ablation in its corresponding first working area. The second working part 19 can also act alone to achieve one or more of chemical ablation, cryoablation, thermal ablation, pulsed electric field ablation, radiofrequency ablation or electrolytic ablation in its corresponding second working area.

[0110] Furthermore, the first working part 15 and the second working part 19 may also work together to achieve one or more of chemical ablation, cryoablation, thermal ablation, pulsed electric field ablation, radiofrequency ablation or electrolytic ablation in their corresponding first working areas.

[0111] For example, optionally, a cold medium (such as liquid nitrogen) or a hot medium (such as alcohol vapor) can be released in the first working part 15 (or the second working part 19), so that the first working part 15 (or the second working part 19) can individually release the freezing energy carried by the cold medium or the thermal energy carried by the hot medium to achieve cryoablation or thermal ablation.

[0112] Optionally, cold medium or hot medium can be released from the first working part 15 (or the second working part 19), and chemical drugs or protein coagulants can also be input into the designated treatment area from the first working part 15 (or the second working part 19), thereby achieving ablation therapy with different physical effects of cryoablation (or thermal ablation) and chemical ablation.

[0113] Optionally, the first working part 15 serves as one pole, and forms a discharge circuit with the electrode plate outside the composite ablation needle as another pole (which can be attached to human skin), so that the first working part 15 can release radio frequency energy, pulsed electric field energy or electrolysis energy alone to achieve corresponding energy ablation; or the second working part 19 serves as one pole, and forms a discharge circuit with the electrode plate outside the composite ablation needle as another pole (which can be attached to human skin), so that the second working part 19 can release radio frequency energy, pulsed electric field energy or electrolysis energy alone to achieve corresponding energy ablation.

[0114] Optionally, the first working part 15 and the second working part 19 are respectively used as two paired poles, so that the first working part 15 and the second working part 19 jointly release radio frequency energy, pulsed electric field energy or electrolytic energy to achieve corresponding energy ablation. For example, one of the first working part 15 and the second working part 19 is used as the positive pole, and the other is used as the negative pole to form a discharge circuit, thereby releasing radio frequency energy, that is, the first working part 15 and the second working part 19 can work together to release radio frequency energy to achieve radio frequency ablation. Or optionally, the first working part 15 and the second working part 19 respectively form an electrode pair for pulse discharge, thereby releasing pulsed electric field energy to the tissue between the two, that is, the first working part 15 and the second working part 19 can work together to release pulsed electric field energy to achieve pulsed electric field energy ablation. Or optionally, the first working part 15 and the second working part 19 form a cathode and an anode respectively, and the designated treatment area can be used as an electrolyte. When a DC power supply is connected to the first working part 15 and the second working part 19 respectively, electrolytic energy can be released to the tissue between the two, that is, the first working part 15 and the second working part 19 can work together to release electrolytic energy to achieve electrolytic energy ablation.

[0115] The distal end of the needle assembly 1 of the composite ablation needle is connected to an energy source through various known ports. By adjusting the energy source, pulse, radio frequency and electrolysis energy are output to the needle assembly 1, so that the same needle assembly 1 can carry a variety of energies.

[0116] like Figure 1 As shown, the first working part 15 includes a needle 11 , a first tube 156 connected to the distal end of the needle 11 , and a first tube extension tube 155 connected to the distal end of the first tube 156 . The first tube extension tube 155 passes through the first isolation part 17 and extends into the second working part 19 .

[0117] The needle 11 and the first tube 156 can be constructed separately and connected by bonding or welding. Alternatively, the needle 11 and the first tube 156 can be integrally formed, and the needle 11 and the first tube 156 together constitute the first working area.

[0118] The needle 11 is used for puncture, so the shape of the needle tip at the front end side of the needle 11 can be a triangular shape, a cone shape, a semicircular shape, etc., which is convenient for puncturing the skin, tissue and treatment area.

[0119] If the length of the needle 11 is too short, it may not reach the designated treatment area. If it is too long, it will affect the treatment effect. Therefore, the length of the needle 11 is generally between 1 mm and 50 mm, or preferably between 5 mm and 50 mm, such as 10 mm. If the outer diameter of the needle 11 is too small, the rigidity and development of the needle 11 may be insufficient, thus affecting the clinical puncture effect. On the contrary, if the outer diameter of the needle 11 is too large, the resistance to puncture will increase, and the treatment trauma of the patient will increase. Therefore, the outer diameter of the needle 11 is between 0.5 mm and 5 mm, or preferably between 0.5 mm and 4 mm. For example, the outer diameter of the needle 11 can be 0.95 mm, 1.7 mm, 2.0 mm, 2.6 mm, 3 mm, etc.

[0120] The needle 11 can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials); or it can be made of plastic materials, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK) or PI (polyimide); or it can also be made of materials such as zirconium oxide ceramics.

[0121] The needle 11 may also be covered with a coating to prevent tissue adhesion during treatment or corrosion caused by electrolysis on the needle surface. For example, it may be a needle coating 111 or an anti-adhesion membrane. The needle coating 111 may be made of insulating materials such as polytetrafluoroethylene (PTFE) or titanium nitride, or the needle coating 111 may be made of a conductive, temperature-resistant, anti-adhesion material.

[0122] The first tube 156 and the first tube extension tube 155 can be constructed separately or integrally. Figure 1 As shown, the outer diameter of the first tube extension tube 155 is smaller than the inner diameter of the first tube 156, so a step structure is formed therebetween, or the diameters therebetween gradually decrease, that is, the first tube 156 transitions to the first tube extension tube 155 at a certain taper angle.

[0123] The first tube 156 and the first tube extension tube 155 can be made of the same material, for example, both can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials). Alternatively, the first tube 156 and the first tube extension tube 155 can also be made of different materials.

[0124] The outer surface of the first tube 156 may also be provided with a coating, which may be an extension of the needle coating 111, for preventing tissue adhesion during treatment. The coating may be, for example, a coating made of a temperature-resistant anti-adhesion material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesion heat shrink film made of a material such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0125] It can be understood that when the first working part 15 releases radio frequency energy, pulsed electric field energy or electrolytic energy alone, or when it releases radio frequency energy, pulsed electric field energy or electrolytic energy in combination with the second working part 19, the needle 11 and / or the first tube 156 of the first working part 15 can be used as one of the poles described above, so the coating on the needle 11 and / or the first tube 156 is a conductive coating made of a conductive, temperature-resistant and anti-adhesive material, so that the needle 11 and / or the first tube 156 can be conductive, and the second isolation part 10 can prevent the energy from flowing out of the non-treatment area. The thickness of the conductive coating can be 0.01-0.1 mm.

[0126] like Figure 1 As shown, the interior of the first tube 156 defines the medium release chamber 12, or the first tube 156 and the first tube extension tube 155 jointly define the medium release chamber 12. That is, the length of the medium release chamber 12 may be the same as the length of the first tube 156, or may be greater than the length of the first tube 156. The medium may release energy in the medium release chamber 12, which may be used as cooling for thermal ablation or heat exchange for cold ablation.

[0127] The medium may be, for example, a cold medium (such as liquid nitrogen, high-pressure gas, liquid metal or cooling water, etc.), or a hot medium such as liquid (alcohol), etc.

[0128] Specifically, the needle assembly 1 further includes a first medium tube 14 and a second medium tube 16 disposed outside the first medium tube 14 . The first medium tube 14 and the second medium tube 16 both extend inside the first working portion 15 , the first isolating portion 17 and the second working portion 19 .

[0129] The inner wall of the first medium tube 14 defines a first medium cavity, which can be used as one of the medium inflow channel and the medium return channel. The outer wall of the first medium tube 14 and the inner wall of the second medium tube 16 jointly define a second medium cavity 161, which can be used as the other of the medium inflow channel and the medium return channel. The medium inflow channel and the medium return channel are fluidically connected through the medium release cavity 12. Cryoablation and thermal ablation can be achieved through the inflow channel and the return channel.

[0130] For example, the inner wall of the first medium tube 14 defines the medium inlet channel 141, and the second medium cavity 161 serves as the medium reflux channel. The cold medium or hot medium from the cold source or the heat source can be input to the distal side of the needle assembly 1 through the handle assembly, flow into the medium release cavity 12 from the distal side of the first medium tube 14, and return from the second medium cavity 161 between the first medium tube 14 and the second medium tube 16; or the inner wall of the first medium tube 14 defines the medium reflux channel, and the second medium cavity 161 serves as the medium inlet channel. The cold medium (or hot medium) can also flow into the medium release cavity 12 from the second medium cavity 161 between the first medium tube 14 and the second medium tube 16, and then return from the first medium tube 14.

[0131] Therefore, the first medium pipe 14 and the second medium pipe 16 can form an inflow and return flow channel for the cold medium or the hot medium. Figure 1 As shown, the first medium pipe 14 is arranged at the innermost side of the first pipe extension pipe 155 and extends into the medium release chamber 12. The second medium pipe 16 is arranged adjacent to the first medium pipe 14, and the two are arranged coaxially. It is conceivable that the second medium pipe 16 can also be arranged side by side adjacent to the first medium pipe 14.

[0132] The first medium tube 14 and the second medium tube 16 can be circular, oblate or rectangular tubular structures, and both can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials); or can be made of plastic materials, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK) or PI (polyimide); or can also be made of materials such as zirconium oxide ceramics.

[0133] In addition, if Figure 1As shown, the proximal end of the second medium tube 16 extends to a certain distance from the distal end of the needle 11, thereby forming a cavity structure between the first tube 156 and the distal end of the needle 11, which is the medium release cavity 12. It can be understood that the medium release cavity 12 can be a cylindrical or conical cavity.

[0134] The first isolation portion 17 is used to insulate and / or isolate the energy between the first working portion 15 and the second working portion 19. The first isolation portion 17 may have a structure similar to that of the first working portion 15. Specifically, Figure 1 As shown, the first isolation part 17 includes a first isolation tube 172 disposed outside the first tube extension tube 155 and a first isolation tube extension tube 171 connected to the distal end of the first isolation tube 172, and the first isolation tube extension tube 171 extends into the second working part 19. The outer diameter of the first isolation tube extension tube 171 is smaller than the inner diameter of the first isolation tube 172, so a step structure is formed between the two, or the diameters between the two are gradually reduced, that is, the first isolation tube 172 transitions to the first isolation tube extension tube 171 at a certain cone angle.

[0135] The first isolation tube 172 and the first isolation tube extension tube 171 can be made of medical insulating materials, and can be made of the same material or different materials. The sum of the lengths of the first isolation tube 172 and the first isolation tube extension tube 171 can be, for example, 5mm-200mm or 5mm-60mm.

[0136] The second working part 19 can form a working electrode pair with the first working part 15 to release corresponding working energy to the tissue between the two working areas, or the second working part 19 can release working energy separately with the first working part 15 through the third circuit. The second working part 19 can adopt a structure similar to that of the first working part 15. Specifically, Figure 1 As shown, the second working portion 19 includes a second tube 193 disposed outside the first isolation tube extension tube 171 and a second tube extension tube 192 connected to the proximal end of the second tube 193 , and the second tube extension tube 192 extends into the second isolation portion 10 .

[0137] The second tube 193 and the second tube extension tube 192 can be constructed separately or integrally. Figure 1 As shown, the outer diameter of the second tube extension tube 192 is smaller than the inner diameter of the second tube 193, so a step structure is formed therebetween, or the diameters therebetween taper, that is, the second tube 193 transitions to the second tube extension tube 192 at a certain taper angle.

[0138] The second tube 193 and the second tube extension tube 192 can be made of the same material, for example, both can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials). Alternatively, the second tube 193 and the second tube extension tube 192 can also be made of different materials.

[0139] A coating may also be provided on the outer surface of the second tube 193 to prevent tissue adhesion during treatment. The coating may be, for example, a second working area coating 191 made of a temperature-resistant anti-adhesion material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesion heat shrink film made of a material such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0140] It can be understood that when the second working part 19 releases radio frequency energy, pulsed electric field energy or electrolytic energy alone, or when the second working part 19 and the first working part 15 release radio frequency energy, pulsed electric field energy or electrolytic energy in combination, the second tube 193 of the second working part 19 can be used as one of the poles described above, so the coating on the second working part 19 is a conductive coating made of conductive, heat-resistant and anti-adhesive material, which can transfer radio frequency energy, pulsed electric field energy or electrolytic energy to the designated treatment area, and the first isolation part 17 and the second isolation part 10 can prevent the energy from flowing out of the non-treatment area. The first tube 156 (or the needle 11 and the first tube 156) defines the length of the first working area, and its length can be 1mm-50mm, for example, it can be 20mm. The second tube 193 defines the length of the second working area, and its length can be 1mm-50mm, for example, it can be 20mm. The length of the first working area can be the same as or different from the length of the second working area.

[0141] The needle assembly 1 further comprises an injection and suction inner tube 153 and at least one injection and suction hole 151 , through which chemical ablation can be achieved.

[0142] The injection and suction inner tube 153 extends inside the first working part 15, the first isolation part 17 and the second working part 19, and the outer wall of the injection and suction inner tube 153 and the inner wall of the first working part 15 jointly define an injection and suction medium cavity 154, and the injection and suction medium cavity 154 is fluidically connected to the injection and suction hole 151.

[0143] The injection and suction inner tube 153 is located between the first tube extension tube 155 and the second medium tube 16, and extends through the first isolation tube 172, the first isolation tube extension tube 171, the second tube 193 and the second tube extension tube 192. Therefore, the outer wall of the injection and suction inner tube 153 and the inner wall of the first tube extension tube 155 jointly define the injection and suction medium cavity 154. The difference between the outer diameter of the injection and suction inner tube 153 and the inner diameter of the first tube extension tube 155 is 0.01mm-1mm, that is, the gap of the injection and suction medium cavity 154 is 0.01mm-1mm.

[0144] Alternatively, it is also conceivable that the injection and suction inner tube 153 can be a capillary tube arranged side by side with the second medium tube 16, that is, the inner wall of the injection and suction inner tube 153 defines the injection and suction medium cavity 154.

[0145] In addition, the second medium pipe 16 may be only partially or entirely disposed inside the injection and suction inner pipe 153. Alternatively, the second medium pipe 16 may be integrated with the injection and suction inner pipe 153 into one component.

[0146] Please continue to see Figure 1 , one or more of the injection and suction holes 151 can be arranged at the connection between the first tube 156 and the first tube extension tube 155, and penetrate the first tube 156 in the radial direction of the first tube 156. Since the injection and suction holes 151 here are located at the front end in the axial direction, the injection and suction holes 151 here are aligned with the proximal end of the injection and suction inner tube 153, so that the liquid in the designated treatment area sucked through the injection and suction holes 151 here can directly enter the injection and suction inner tube 153, reducing the flow path of the liquid. In addition, when a plurality of injection and suction holes 151 are arranged at the connection between the first tube 156 and the first tube extension tube 155, each injection and suction hole 151 can be arranged at equal intervals along the circumference of the first tube 156 (or each injection and suction hole 151 can be arranged in a non-equidistant manner along the circumference of the second tube 193, for example, the distance between each injection and suction hole 151 gradually increases or decreases, etc.).

[0147] Further, one or more of the injection and suction holes 151 can be arranged at a position on the second tube 193 close to the first isolation tube 172, and sequentially penetrate the first isolation tube 172 (or the second tube 193) and the first tube extension tube 155 along the radial direction of the first tube 156. There can also be multiple injection and suction holes 151 on the second tube 193, and each injection and suction hole 151 can be arranged at equal intervals along the circumference of the second tube 193 (or each injection and suction hole 151 can be arranged in a non-equidistant manner along the circumference of the second tube 193, for example, the distance between each injection and suction hole 151 gradually increases or decreases, etc.). And the injection and suction holes 151 located at the connection between the first tube 156 and the first tube extension tube 155 and the injection and suction holes 151 on the second tube 193 can be located on the same radial cross section, which can also reduce the flow path of the liquid. The distance between each injection and suction hole 151 can be 1mm-50mm.

[0148] Each injection and suction hole 151 is in fluid communication with a designated treatment area, and is used to absorb liquid from the designated treatment area or inject liquid into the designated treatment area (the liquid may be, for example, a chemical drug or a protein coagulant, etc.). Blood, tissue, etc. from the designated treatment area may enter the injection and suction medium cavity 154 through the injection and suction holes 151, and be collected from the distal end of the injection and suction medium cavity 154. Alternatively, the injection and suction medium cavity 154 may inject the required anesthetic drugs, physiological saline, or therapeutic drugs, etc., into the designated treatment area through the injection and suction holes 151.

[0149] The size (aperture, etc.) of each injection and suction hole 151 can be gradually increased along the injection direction, so that the liquid in the injection and suction medium cavity 154 can more easily reach the injection and suction hole 151 closer to the front end.

[0150] Specifically, the liquid inlet and outlet flow rate Q of the injection and suction hole 151 satisfies the following relationship (1):

[0151] Q=KAV (1)

[0152] Wherein: K is the cross-sectional area correction coefficient of the injection and suction hole 151;

[0153] A is the cross-sectional area of ​​the injection and suction hole 151;

[0154] V is the speed of liquid injection through the injection and suction hole 151;

[0155] It can be determined based on parameters such as the type, pressure, flow coefficient, etc. of the pushing and aspiration liquid medium used clinically.

[0156] In order to ensure the uniformity of the liquid flow rate of the injection and suction holes 151 closer to the proximal side of the needle assembly 1 and the injection and suction holes 151 closer to the distal side of the needle assembly 1 in the injection direction, the injection and suction holes 151 can be set to have different sizes (for example, different cross-sectional areas). Therefore, according to the above relationship (1), the liquid flow rate Q of each injection and suction hole 151 is set to be the same or substantially the same, and the size of each injection and suction hole 151 is determined by setting the correction coefficient K.

[0157] Further, K is related to the ratio of the cross-sectional area of ​​the injection and suction hole 151 to the cross-sectional area of ​​the injection and suction medium cavity 154. For example, K may be 0-1.

[0158] Furthermore, for the injection and suction hole 151 with a circular cross-sectional shape, its cross-sectional area A satisfies the following relational expression (2):

[0159] A=π×R×R (2)

[0160] Wherein, π is pi, and R is the radius of the injection and suction hole 151. Therefore, the radius of the injection and suction hole 151 can be determined according to the cross-sectional area A of the injection and suction hole 151.

[0161] The maximum diameter of each injection and suction hole 151 may be 0.05 mm to 10 mm. Each injection and suction hole 151 may be arranged at equal intervals along the injection direction, and each injection and suction hole 151 may have a circular cross section, an elliptical cross section, or a long strip cross section.

[0162] like Figure 1 As shown, the proximal side of the needle assembly 1 is sequentially provided from the inside to the outside with the first medium tube 14, the second medium tube 16, the injection and suction inner tube 153, the first tube extension tube 155 and the first isolation tube 172, or the first medium tube 14, the second medium tube 16, the injection and suction inner tube 153, the first tube extension tube 155, the first isolation tube 172 and the second tube 193, or the first medium tube 14, the second medium tube 16, the injection and suction inner tube 153, the first tube extension tube 155, the first isolation tube 172, the second tube extension tube 192 and the second isolation part 10, that is, the above-mentioned components are coaxially arranged. It can be understood that one or more of the components can also be arranged side by side with other components, or partially coaxially arranged.

[0163] The needle assembly 1 further comprises a second isolating tube 18 for isolating the cold medium or the hot medium from the external temperature. The second isolating tube 18 extends inside the injection and suction inner tube 153 so that the outer wall of the second isolating tube 18 and the inner wall of the injection and suction inner tube 153 jointly define an isolating layer 181 .

[0164] The second isolation tube 18 can be made of metal materials such as 314 stainless steel, 316 stainless steel, titanium alloy (TC) or copper (Cu), or can be made of plastic materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), PI (polyimide) or glass fiber.

[0165] The second isolation tube 18 can be a separate layer, which can be located between the second medium tube 16 and the injection and suction inner tube 153. The isolation layer 181 defined jointly by the outer wall of the second isolation tube 18 and the inner wall of the injection and suction inner tube 153 can be an air interlayer, a vacuum interlayer, etc., or it can be filled with a low thermal conductivity plastic material to achieve temperature isolation.

[0166] Optionally, the second isolating portion 10 is configured to be movable along its axial direction, and the handle assembly can drive the second isolating portion 10 to move, thereby changing the length of the second isolating portion 10 covering the first working portion 15, the first isolating portion 17, and the second working portion 19, so as to change the exposed length of the first working portion 15, the first isolating portion 17, and the second working portion 19, thereby changing the effective length of the first working area and / or the second working area (the effective length is the length of the treatment area). Figure 1 As shown, the second insulating portion 10 covers the second tube extension tube 192 of the second working portion 19 .

[0167] In this movable embodiment, the second isolation portion 10 can be made of metal materials such as 314 stainless steel, 316 stainless steel, titanium alloy (TC) or copper (Cu), or can be made of plastic materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), PI (polyimide) or glass fiber.

[0168] Optionally, the second isolating portion 10 is configured to be immovable, for example, it is fixedly connected to the second working portion 19. As described above, the outer diameter of the second tube extension tube 192 is smaller than the inner diameter of the second tube 193, so a step structure is formed between the two. The proximal end of the second isolating portion 10 can abut against the step structure between the second tube extension tube 192 and the second tube 193, thereby ensuring that the needle assembly 1 has a uniform outer diameter.

[0169] In this immovable embodiment, an insulating coating such as polytetrafluoroethylene (PTFE) or silicone may be provided on the outer surface of the second isolation portion 10, or an insulating film such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or fluorinated ethylene propylene copolymer (FEP) may be provided.

[0170] In an optional embodiment, the needle assembly 1 further includes a temperature measuring element 13, which can be embedded in the needle 11 to measure the temperature of the tissue at the needle 11; or the temperature measuring element 13 can be located in the medium release chamber 12 to measure the temperature of the medium in the medium release chamber 12; or the temperature measuring element 13 can also be arranged on the distal side of the needle assembly 1 to measure the reflux temperature in the reflux channel, or measure the temperature of the normal tissue area contacted by the needle assembly 1. The temperature measuring element 13 can be a temperature sensor, such as a temperature measuring thermocouple or a thermistor (NTC, PTC), etc.

[0171] It is understandable that the temperature measuring element 13 may not be provided in the needle assembly 1, but the temperature of the tissue at the needle 11 may be obtained by other temperature measuring methods.

[0172] In a specific example of the composite ablation needle, the outer diameters of the needle head 11, the first working portion 15, the second working portion 19, and the first isolation portion 17 are all 3.0 mm. The inner diameter of the second isolation portion 10 is slightly larger than the outer diameter of the first working portion 15, for example, 3.05 mm; the outer diameter of the second isolation portion 10 can be 3.15 mm.

[0173] The inner diameter of the medium release cavity 12 can be 2.7 mm, the radial dimension of the injection medium channel 154 can be 0.2 mm (i.e., the difference between the outer diameter of the injection inner tube 153 and the inner diameter of the first tube extension tube 155), the wall thickness of the injection inner tube 153 can be 0.1 mm, the radial dimension of the isolation layer 181 can be 0.1 mm (i.e., the difference between the inner diameter of the second isolation tube 18 and the outer diameter of the injection inner tube 153), the wall thickness of the second isolation tube 18 or the second medium tube 16 is 0.1 mm, the outer diameter of the first medium tube 14 can be 0.9 mm, and its inner diameter can be 0.7 mm, i.e., the diameter of the first medium channel is 0.7 mm, and the gap of the second medium channel 161 can be 0.4 mm. When the above-mentioned composite ablation needle is used for experiments, a better energy ablation effect is obtained, which is consistent with the expected results.

[0174] Example 2

[0175] like Figure 2 As shown, the present invention provides a composite ablation needle, please combine Figure 1 The difference between the composite ablation needle of the second embodiment and the composite ablation needle of the first embodiment is that a separate second isolation tube 18 is not provided in the second embodiment.

[0176] like Figure 2 As shown, since a separate second isolation tube 18 is not provided, the injection and suction medium cavity 154 can be used as a temperature isolation structure, which can be an air interlayer, or the injection and suction inner tube 153 forming the injection and suction medium cavity 154 can be made of a low thermal conductivity plastic insulation material.

[0177] like Figure 2 As shown, in this embodiment 2, the second isolation tube 18 described in the above embodiment 1 can be integrated with the second isolation part 10, that is, forming the same element, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0178] The similarities between this embodiment 2 and the above-mentioned embodiment 1 will not be repeated again.

[0179] Example 3

[0180] The present invention provides a composite ablation needle with multiple physical factors, which is a composite ablation needle with adjustable ablation area, such as Figure 3a , Figure 3b , Figure 3c , Figure 3d and Figure 3e Please combine Figure 1The difference between the composite ablation needle of multiple physical factors in this embodiment 3 and the composite ablation needle of the above-mentioned embodiment 1 is that the injection and suction holes 151 and the injection and suction medium channels 154 in this embodiment 3 are constructed differently. Specifically, the proximal end of the second isolation part 10 is constructed as an open end, which defines the injection and suction hole 151 together with the first working part 15, the first isolation part 17 or one of the second working parts 19, and the injection and suction medium channels 154 are constructed as a gap (radial gap) between the second isolation part 10 and one or more of the first working part 15, the first isolation part 17 and the second working part 19, and the injection and suction medium channels 154 and the injection and suction holes 151 are in communication to realize the suction and injection function.

[0181] The advantage of adopting this method is that the second isolation part 10 can move along its axial direction, so the length of the gap between it and one or more of the first working part 15, the first isolation part 17 or the second working part 19 can be adjusted, and the position of the proximal end of the second isolation part 10 on the first working part 15, the first isolation part 17 or the second working part 19 is adjustable; in other words, the length of the injection and suction medium cavity 154 is adjustable, and the position of the injection and suction hole 151 is adjustable, that is, the ablation zone of the ablation needle can be adjusted, so that the position where chemical ablation is required can be adjusted according to actual needs.

[0182] In an optional embodiment, the open end of the second isolation portion 10 and the outer wall of the second working portion 19 jointly define the injection and suction hole 151 , and the gap between the second isolation portion 10 and the second working portion 19 serves as the injection and suction medium cavity 154 .

[0183] Specifically, the second isolating portion 10 extends to partially cover the second working portion 19 , for example, the second isolating portion 10 extends to cover only a portion of the second tube extension tube 192 or the second isolating portion 10 extends beyond the second tube extension tube 192 and extends to cover a portion of the second tube 193 .

[0184] When the second isolating portion 10 only covers the second tube extension tube 192, the proximal end of the second isolating portion 10 can be configured as an open end, and the open end and the outer wall of the second tube extension tube 192 together define the injection and suction hole 151, and there is a gap (radial gap) between the second isolating portion 10 and the second tube extension tube 192, and the radial gap can be used as the injection and suction medium cavity 154. Figure 3a and Figure 3cAs shown, the second isolating portion 10 completely covers the second tube extension tube 192. Since the outer diameter of the second tube extension tube 192 is smaller than the inner diameter of the second tube 193, a step structure is formed between the two. In addition, the outer diameter of the second isolating portion 10 is consistent with the outer diameter of the second tube 193, and the inner diameter of the second isolating portion 10 is larger than the outer diameter of the second tube extension tube 192. Therefore, the second isolating portion 10 can be sleeved on the second tube extension tube 192 and aligned with the second tube 193. The proximal end of the second isolating portion 10 can extend to a position corresponding to the step structure, and the open end of the second isolating portion 10 and the step structure together define the injection and suction hole 151 (as shown in FIG. Figure 3b As shown), liquid can enter the radial gap between the inner wall of the second isolation part 10 and the outer wall of the second tube extension tube 192 from the proximal end of the second isolation part 10, or drugs etc. can flow out from the radial gap to the designated treatment area.

[0185] Understandably, Figure 3a and Figure 3b The step structure shown is not necessary. The step structure can make the outer diameter of the second isolating portion 10 consistent with the outer diameter of the second tube 193, so that the needle assembly 1 has a relatively uniform size in overall appearance. When the step structure is not provided, the second isolating portion 10 can be located outside the second tube extension tube 192 in a sleeve-type manner.

[0186] In this way, the second isolating portion 10 can move along its axial direction, and the specific movement method will be described in detail in the following embodiments 7, 8, 9 and 10. When the second isolating portion 10 moves along its axial direction, the length of the radial gap between it and the second tube extension tube 192 can be changed, and the position of the open end of the second isolating portion 10 can be changed, that is, the position of the injection and suction hole 151 can be changed. For example, when the second isolating portion 10 moves along its axial direction away from the needle 11, the length of the radial gap between it and the second tube extension tube 192 decreases, and the position of the injection and suction hole 151 is farther away from the needle 11; when the second isolating portion 10 moves along its axial direction toward the needle 11, the length of the radial gap between it and the second tube extension tube 192 increases, and the position of the injection and suction hole 151 is closer to the needle 11.

[0187] When the second isolating portion 10 extends beyond the second tube extension tube 192 and extends to cover the second tube 193, similarly, the proximal end of the second isolating portion 10 can be configured as an open end, and the open end and the outer wall of the second tube 193 together define the injection and suction hole 151, and there is a radial gap between the second isolating portion 10 and the second tube 193 and between the second isolating portion 10 and the second tube extension tube 192, and the radial gaps are fluid-connected, so that they can serve as the injection and suction medium cavity 154. Figure 3b and Figure 3dAs shown, the second isolation part 10 can completely cover the second tube 193. For example, the proximal end of the second isolation part 10 can extend to the step structure for positioning formed between the second tube 193 and the first isolation tube 172. Then the open end of the second isolation part 10 and the step structure together define the injection hole 151, so that the liquid can enter the radial gap between the inner wall of the second isolation part 10 and the outer wall of the second tube 193 from the proximal end of the second isolation part 10, and flow into the radial gap between the second isolation part 10 and the second tube extension tube 192, or drugs can flow out from the radial gap to the designated treatment area. In addition, it can also be used Figure 3a The structural form shown in the figure, that is, a step structure is provided on the second tube 193, so that the outer diameter of the second tube 193 is the same as the outer diameter of the second isolation part 10, so that the needle assembly 1 has a uniform overall size.

[0188] In this way, the second isolating portion 10 can move along its axial direction, and the specific movement method will be described in detail in the following embodiments 7, 8, 9 and 10. When the second isolating portion 10 moves along its axial direction, the length of the radial gap between it and the second tube 193 can be changed, and the position of the open end of the second isolating portion 10 can be changed, that is, the position of the injection and suction hole 151 can be changed. For example, when the second isolating portion 10 moves along its axial direction away from the needle 11, the length of the radial gap between it and the second tube 193 decreases, and the position of the injection and suction hole 151 is farther away from the needle 11; when the second isolating portion 10 moves along its axial direction toward the needle 11, the length of the radial gap between it and the second tube 193 increases, and the position of the injection and suction hole 151 is closer to the needle 11. In an optional embodiment, the open end of the second isolation portion 10 and the first isolation portion 17 jointly define an injection and suction hole 151, and the radial gap between the second isolation portion 10 and the first isolation portion 17 and the radial gap between the second isolation portion 10 and the second working portion 19 serve as an injection and suction medium cavity 154.

[0189] Specifically, the second isolating portion 10 completely covers the second working portion 19 (the second tube extension tube 192 and the second tube 193 ), and extends to completely or partially cover the first isolating portion 17 (the first isolating tube 172 ).

[0190] Similarly, the proximal end of the second isolation part 10 can be configured as an open end, and the open end and the outer wall of the first isolation tube 172 together define the injection and suction hole 151, and there is a radial gap between the second isolation part 10 and the first isolation tube 172, and the radial gap can be used as the injection and suction medium channel 154. It can be understood that the second isolation part 10 should also have a radial gap with the second tube extension tube 192, and a radial gap with the second tube 193, and each radial gap is fluid-connected, so that it can be used as the injection and suction medium channel 154.

[0191] The first isolation tube 172 may form a step structure for positioning with the first tube 156, and the outer diameter of the second isolation part 10 is consistent with the outer diameter of the first isolation tube 172, and the inner diameter of the second isolation part 10 is larger than the outer diameter of the first tube 156, so the second isolation part 10 can be sleeved on the first tube 156 and aligned with the first isolation tube 172. The proximal end of the second isolation part 10 extends to a position corresponding to the step structure, and the open end of the second isolation part 10 and the step structure together define the injection and suction hole 151, and there is a radial gap between the inner wall of the second isolation part 10 and the outer wall of the first isolation tube 172, and the second isolation part 10 should also have a radial gap with the second tube extension tube 192, and a radial gap with the second tube 193, and each radial gap is fluid-connected, so that it can be used as an injection and suction medium cavity 154.

[0192] In this manner, the second isolating portion 10 can move along its axial direction, and the specific movement method will be described in detail in the following embodiments 7, 8, 9 and 10. When the second isolating portion 10 moves along its axial direction, the length of the radial gap between it and the first isolating tube 172 can be changed, and the position of the open end of the second isolating portion 10 can be changed, that is, the position of the injection and suction hole 151 can be changed. For example, when the second isolating portion 10 moves along its axial direction away from the needle 11, the length of the radial gap between it and the first isolating tube 172 decreases, and the position of the injection and suction hole 151 is farther away from the needle 11; when the second isolating portion 10 moves along its axial direction toward the needle 11, the length of the radial gap between it and the first isolating tube 172 increases, and the position of the injection and suction hole 151 is closer to the needle 11.

[0193] In an optional embodiment, the open end of the second isolation portion 10 and the first working portion 15 jointly define an injection and suction hole 151, and the radial gap between the second isolation portion 10 and the first working portion 15, the radial gap between the second isolation portion 10 and the first isolation portion 17, and the radial gap between the second isolation portion 10 and the second working portion 19 serve as an injection and suction medium cavity 154.

[0194] Specifically, Figure 3eAs shown, the second isolating portion 10 completely covers the second working portion 19 and the first isolating portion 17, and extends to completely or partially cover the first working portion 15 (first tube 156). The proximal end of the second isolating portion 10 is an open end, and it and the outer wall of the first tube 156 together define the injection and suction hole 151. There is a radial gap between the inner wall of the second isolating portion 10 and the first tube 156, and there is a radial gap between the inner wall of the second isolating portion 10 and the first isolating tube 172, there is a radial gap between the inner wall of the second isolating portion 10 and the second tube extension tube 192, and there is a radial gap between the inner wall of the second isolating portion 10 and the second tube 193. The radial gaps are fluid-connected, so that they can be used as injection and suction medium channels 154. The second isolating portion 10 can be used in the same manner as Figure 3c or Figure 3d In a similar manner, a step structure may be constructed on the first tube 156 , and the second isolating portion 10 may be aligned with the first tube 156 through the step structure, with the outer diameters of the two being consistent; or the second isolating portion 10 may be simply sleeved on the first tube 156 .

[0195] In this way, the second isolating portion 10 can move along its axial direction, and the specific movement method will be described in detail in the following embodiments 7, 8, 9 and 10. When the second isolating portion 10 moves along its axial direction, the length of the radial gap between it and the first tube 156 can be changed, and the position of the open end of the second isolating portion 10 can be changed, that is, the position of the injection and suction hole 151 can be changed. For example, when the second isolating portion 10 moves along its axial direction away from the needle 11, the length of the radial gap between it and the first tube 156 decreases, and the position of the injection and suction hole 151 is farther away from the needle 11; when the second isolating portion 10 moves along its axial direction toward the needle 11, the length of the radial gap between it and the first tube 156 increases, and the position of the injection and suction hole 151 is closer to the needle 11.

[0196] In the above-mentioned various optional embodiments, the size of the injection and suction hole 151 defined jointly by the open end of the second isolation part 10 and the first working part 15, the first isolation part 17 or the second working part 19 can be 0.01mm-1mm, for example, it can be the difference between the inner diameter of the second isolation part 10 and the outer diameter of the second tube extension tube 192 (or the second tube 193, the first isolation tube 172, the first tube 156).

[0197] It can be understood that the width of the injection and suction medium cavity 154 (ie, the radial dimension) can also be 0.01 mm-1 mm.

[0198] It is conceivable that in the above-mentioned various optional embodiments, a plurality of radial openings may be provided at intervals in the circumferential direction of the second isolating portion 10 , which are connected to the injection and suction medium cavity 154 and may also be used as the injection and suction holes 151 .

[0199] like Figure 3eAs shown, the outer wall of the second isolation portion 10 can be integrated with the second isolation tube 18 into a single component.

[0200] It can be understood that the second medium tube 16 is arranged inside the first tube extension tube 155, and the second isolation tube 18 can be arranged outside the second medium tube 16. Since a separate injection and suction inner tube 153 is not arranged in this embodiment 3, the outer wall of the second isolation tube 18 and the inner wall of the first tube extension tube 155 jointly define the isolation layer 181. Alternatively, the second medium tube 16 and the second isolation tube 18 are integrated into the same component, and the outer wall thereof and the inner wall of the first tube extension tube 155 jointly define the isolation layer 181.

[0201] The isolation layer 181 may also be an air interlayer, a vacuum interlayer, etc., or may be filled with a plastic material with low thermal conductivity to achieve temperature isolation.

[0202] All components specified or not specified in this embodiment 3 can be constructed in the same manner as the components described in the above embodiment 1 or embodiment 2. For example, the components of the first working part 15, the first isolation part 17, and the second isolation tube 18 that are not described in detail in this embodiment 3 can adopt the structural form of the corresponding components in the above embodiment 1 or embodiment 2. Moreover, those skilled in the art can freely combine embodiment 3 with the above embodiment 1 and embodiment 2.

[0203] Example 4

[0204] The present invention provides a multi-physical factor composite ablation needle, such as Figure 4 Please combine Figure 1 The difference between the multiple physical factor composite ablation needle of this embodiment 4 and the composite ablation needle of the above-mentioned embodiment 1 is that a separate second isolation tube 18 is not provided in this embodiment 4, but the second isolation tube 18 and the first isolation part 17 in the above-mentioned embodiment 1 are integrated into one element, so that the insulation isolation and temperature isolation structure between the first tube 156, the first tube extension tube 155 and the second tube 193, the second tube extension tube 192 can be realized at the same time.

[0205] In addition, in this embodiment 4, no separate injection and suction hole 151, injection and suction inner tube 153 and injection and suction medium cavity 154 are set. Instead, the proximal side opening between the second isolation part 10 and the first working part 15, the first isolation part 17 or the second working part 19 is constructed as the injection and suction hole 151, and the gap between the second isolation part 10 and them is used as the injection and suction medium cavity 154 to realize the suction and injection function.

[0206] like Figure 4As shown, the second isolation part 10 extends to partially cover the second working part 19 (second tube 193), and its proximal end is an open end, which can be used as an injection hole 151, so that liquid can enter the chamber defined by the inner wall of the second isolation part 10 and the outer wall of the second working part 19 from the proximal end of the second isolation part 10, or drugs can flow out of the chamber to the designated treatment area. It can be understood that the second isolation part 10 can also extend to completely cover the second working part 19.

[0207] Alternatively, the second isolation portion 10 completely covers the second working portion 19 and extends to completely or partially cover the first isolation portion 17 (first isolation tube 172). Then the inner wall of the second isolation portion 10 and the outer wall of the second working portion 19 as well as the inner wall of the second isolation portion 10 and the outer wall of the second working portion 19 jointly define a chamber, and liquid can also enter the chamber from the open proximal end of the second isolation portion 10, or drugs and the like can flow out of the chamber to a designated treatment area.

[0208] Alternatively, the second isolation portion 10 completely covers the second working portion 19 and the first isolation portion 17, and extends to completely or partially cover the first working portion 15 (first tube 156), then the inner wall of the second isolation portion 10 and the outer wall of the second working portion 19, the inner wall of the second isolation portion 10 and the outer wall of the second working portion 19, and the inner wall of the second isolation portion 10 and the outer wall of the first working portion 15 jointly define a chamber, and liquid can also enter the chamber from the open proximal end of the second isolation portion 10, or drugs, etc. can flow out of the chamber to the designated treatment area.

[0209] The similarities between this embodiment 4 and the above-mentioned embodiment 1 will not be repeated again.

[0210] Example 5

[0211] The present invention provides a multi-physical factor composite ablation needle, such as Figure 5 Please combine Figure 1 The difference between the multiple physical factor composite ablation needle of the present embodiment 5 and the composite ablation needle of the above-mentioned embodiment 1 is that the present embodiment 5 does not provide a separate second medium tube 16. Figure 5 As shown, the inner wall of the first tube 156 and the outer wall of the first medium tube 14 and the inner wall of the first tube extension tube 155 and the outer wall of the first medium tube 14 jointly define a second medium cavity 161, ie, an inlet channel or a return channel of the medium.

[0212] Furthermore, the difference between the present embodiment 5 and the above-mentioned embodiment 1 is that a separate second isolation tube 18 is not provided in the present embodiment 5, but the second isolation tube 18 in the above-mentioned embodiment 1 can be integrated with the second isolation part 10 to form the same element, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0213] The similarities between this embodiment 5 and the above-mentioned embodiment 1 will not be repeated again.

[0214] Example 6

[0215] The present invention provides a composite ablation needle with improved safety, such as Figure 6a As shown, the difference between the composite ablation needle with improved safety of this embodiment 6 and the composite ablation needle of the above-mentioned embodiment 1 and the multiple physical factor composite ablation needle of embodiment 5 is that at least one first medium hole 157 is also provided on the first tube extension tube 155, and at least one second medium hole 173 is provided on the first isolation tube extension tube 171, and the second medium holes 173 are provided one-to-one with the first medium holes 157.

[0216] The first medium hole 157 and the second medium hole 173 are in fluid communication, and the two are in fluid communication with the second medium cavity 161. The important role of the first medium hole 157 and the second medium hole 173 is to realize the release and heat exchange of the cold and hot medium of the second working part 19, and to realize the cooling function of thermal ablation and the heat exchange function of cold ablation. For example, when the cold medium or the hot medium is released in the medium release cavity 12 by the inlet channel 141 of the medium limited by the first medium tube 14 and returned by the second medium cavity 161, the cold medium or the hot medium can exchange heat with the first isolation tube extension tube 171 and the second tube 193 sleeved on the outside of the first isolation tube extension tube 171 through the second medium hole 173 and the first medium hole 157, so that the temperature of each part located on the distal side of the needle assembly 1, such as the first isolation tube extension tube 171, the second tube 193, etc. can be more effectively controlled.

[0217] Furthermore, the aperture of the first dielectric hole 157 is larger than the aperture of the second dielectric hole 173, the purpose of which is to increase the air gap and creepage distance between the two electrodes (i.e., the first tube extension tube 155 and the second tube 193), thereby improving electrical safety. Figure 3a As shown, the electrical clearance between the first tube extension tube 155 and the second tube 193 is the radial distance (shortest spatial distance) between the first tube extension tube 155 and the second tube 193. The creepage distance between the first tube extension tube 155 and the second tube 193 is increased by the axial length of the inner wall of the first medium hole 157 and the second medium hole 173 in addition to the radial distance between the first medium hole 157 and the second medium hole 173, thereby increasing the creepage distance and meeting the requirements of high voltage protection.

[0218] Specifically, the creepage distance between the first extension tube 155 and the second tube 193 is related to the working voltage frequency, environment (pollution level) and material medium of the needle assembly 1. For example, the creepage distance can be determined according to the corresponding relationship shown in Table 1 based on the voltage.

[0219] Table 1 Minimum creepage distances for basic insulation and supplementary insulation (unit: mm)

[0220]

[0221]

[0222] The creepage distance is determined as follows:

[0223] First, determine the operating voltage of the needle assembly 1. The operating voltage of the needle assembly 1 is the highest voltage that the considered part of the needle assembly 1 is subjected to when the needle assembly 1 is operated at the rated voltage and under normal operating conditions.

[0224] Second, determine the pollution level of the needle assembly 1. The pollution level is a number that represents the expected micro-environment pollution characteristics. Among them, pollution level 1 means no pollution or only dry, non-conductive pollution. For example, inside the equipment, components or assemblies that are sealed to isolate dust and moisture are pollution level 1; pollution level 2 means only non-conductive pollution occurs, but it is expected that temporary conductivity will occasionally be caused by condensation; pollution level 3 means conductive pollution occurs, or dry non-conductive pollution occurs, which is expected to become conductive due to condensation; pollution level 4 means persistent conductive pollution, such as pollution caused by conductive dust or rain and snow.

[0225] Therefore, the contamination level of the needle assembly 1 of the present invention may be contamination level 1 or contamination level 2.

[0226] Third, determine the Comparative Tracking Index (CTI) of the material of needle assembly 1 and determine the material group according to Table 2. CTI is a unit of measure for tracking and dielectric strength of insulating materials and is used as a benchmark for different materials. CTI is determined by a special test in which a voltage pulse is applied to a sample of insulating material and the sample is then checked for discharge resistance and breakdown behavior. The higher the CTI value, the more resistant the material is to this type of failure. If the material group is unknown, assume that the material group is III b .

[0227] For example, the material of the needle assembly 1 of the present invention is polyimide or polytetrafluoroethylene. The typical CTI value of polyimide is 150, and the typical CTI value of polytetrafluoroethylene is 600.

[0228] Table 2 Comparative Tracking Index (CTI) Correspondence Table of Material Groups

[0229]

[0230] Fourth, according to the determined working voltage, pollution level, and material group, the minimum creepage distance for basic insulation and additional insulation can be determined from Table 1.

[0231] After the creepage distance is determined, the first dielectric hole 157 and the second dielectric hole 173 of corresponding sizes can be set according to the creepage distance, and the aperture of the first dielectric hole 157 can be ensured to be larger than the aperture of the second dielectric hole 173 .

[0232] like Figure 6b As shown, the cross-sectional shape of the first medium hole 157 can be circular (eg Figure 6b (1)), elliptical (as shown in Figure 6b (2)), long strips (such as Figure 6b (3)), rectangle (as shown in Figure 6b (4)) or a triangle (as shown in Figure 6b Similarly, the cross-sectional shape of the second medium hole 173 can be one or more of a circle, an ellipse, a strip, a rectangle or a triangle.

[0233] like Figure 6c , Figure 6d and Figure 6e Please combine Figure 6a The first medium holes 157 are arranged at equal intervals in the axial direction of the first tube extension tube 155, that is, the intervals between adjacent first medium holes 157 are equal; similarly, the second medium holes 173 can also be arranged at equal intervals in the axial direction of the first isolation tube extension tube 171 (such as Figure 6c Medium (5) Figure 6c Middle (6) Figure 6c Zhong (7) and Figure 6c Middle (8); Figure 6d Medium (5) Figure 6d Middle (6) Figure 6d Zhong (7) and Figure 6d (8) and Figure 6e Medium (5) Figure 6e Middle (6) Figure 6e Zhong (7) and Figure 6e as shown in (8)).

[0234] like Figure 6c and Figure 6d As shown, the first medium hole 157 and the second medium hole 173 may have the same cross-sectional shape. Figure 6c As shown, each first medium hole 157 has a circular cross section, and each second medium hole 173 has a circular cross section (as shown in FIG. Figure 6cMiddle (1) Figure 6c Middle (2) Figure 6c Neutralize (3) Figure 6c As shown in (4)). Figure 6d As shown, each first medium hole 157 has an elliptical cross section, and each second medium hole 173 has an elliptical cross section (as shown in FIG. Figure 6d Middle (1) Figure 6d Middle (2) Figure 6d Neutralize (3) Figure 6d as shown in (4)).

[0235] like Figure 6e and Figure 6f As shown, the first medium hole 157 and the second medium hole 173 may also have different cross-sectional shapes. For example, the first medium hole 157 has a circular cross-section, and the second medium hole 173 has an elliptical cross-section (eg, Figure 6e Middle (1) Figure 6e Middle (2) Figure 6e Neutralize (3) Figure 6e (4) and Figure 6f Middle (1) Figure 6f Middle (2) Figure 6f Neutralize (3) Figure 6f Alternatively, the first medium hole 157 and the second medium hole 173 may be two different shapes such as circular, elliptical, long strip, rectangular, triangular, etc.

[0236] like Figure 6f Please combine Figure 6a The first medium holes 157 are arranged in a non-equidistant manner in the axial direction of the first tube extension tube 155. Figure 6f Medium (5) Figure 6f Middle (6) Figure 6f Medium (7) Figure 6f As shown in (8), the spacing between adjacent first medium holes 157 gradually increases (or gradually decreases); similarly, the second medium holes 173 can also be arranged in a non-equidistant manner in the axial direction of the first isolation tube extension tube 171, for example, the spacing between adjacent second medium holes 173 gradually increases (or gradually decreases).

[0237] Preferably, under the premise of ensuring that the second medium hole 173 can effectively exchange heat for the first isolation tube extension tube 171 and the second tube 193 sleeved on the outside of the first isolation tube extension tube 171, the aperture of the first medium hole 157 is as large as possible compared with the aperture of the second medium hole 173 (for example, the aperture of the first medium hole 157 is more than 60% larger than the aperture of the second medium hole 173), because under the same conditions, the larger the difference between the aperture of the first medium hole 157 and the aperture of the second medium hole 173, the larger the creepage distance between the two electrodes (i.e., the first tube extension tube 155 and the second tube 193), which helps to improve electrical safety.

[0238] For each first medium hole 157 with a circular (or elliptical) cross section, its diameter (long semi-axis) is not greater than the outer diameter of the needle 1, for example, it can be 0.05mm-3mm; the diameter of each second medium hole 173 with a circular cross section can be 0.05mm-1mm accordingly. For each first medium hole 157 with a rectangular cross section (or a long strip cross section), its length can be longer, for example, it can reach 40mm; for each first medium hole 157 with a rectangular cross section (or a long strip cross section), its length can be longer, for example, it can reach 15mm.

[0239] All components specified or not specified in this embodiment 6 can be constructed in the same manner as the components described in one or more of the above embodiments 1, 2, 3, 4 and 5. For example, the components of the first working part 15, the first isolation part 17 and the second isolation tube 18 that are not described in detail in this embodiment 6 can adopt the structural form of the corresponding components described in one or more of the above embodiments 1, 2, 3, 4 or 5. Moreover, those skilled in the art can freely combine embodiment 6 with one or more of the above embodiments 1, 2, 3, 4 and 5.

[0240] Example 7

[0241] The present invention provides a direct-push composite ablation needle, which includes the needle assembly 1 described in one or more of the above-mentioned embodiments 1 to 6, and also includes a handle assembly, and the distal end of the needle assembly 1 in the above-mentioned embodiments 1 to 6 is connected to the handle assembly. The first working portion 15, the first isolation portion 17, the second working portion 19 and the second isolation portion 10 all extend into the handle assembly. The handle assembly will be described in detail below.

[0242] like Figure 7a , Figure 7b , Figure 8-Figure 12As shown, the handle assembly of embodiment 7 of the present invention is a direct push handle assembly, which adjusts the effective length of the first working part 15 and / or the second working part 19 by pushing or pulling. The handle assembly includes a first shell 203 and a second shell 602 connected to the rear end of the first shell 203, and the two can be connected by various known means.

[0243] like Figure 8 As shown, the distal end of the needle assembly 1 is disposed in the first housing 203, and the needle 11 of the needle assembly 1 extends from one side of the first housing 203. One end of the second isolation portion 10 is disposed in the first housing 203, and the other end of the second isolation portion 10 extends from one side of the first housing 203. The second isolation portion 10 covers one or more of the first working portion 15, the first isolation portion 17, and the second working portion 19 of the needle assembly 1. By moving the second isolation portion 10, the effective lengths of the first working portion 15 and the second working portion 19 are changed, so that the effective use range of the treatment area in the needle assembly 1 can be adjusted as needed.

[0244] Specifically, Fig. 9 , Fig.10 and Fig.11 As shown, the mobile driving component 300 is connected to the second isolation part 10, and the mobile driving component 300 is constructed so that when it is pushed, it is unlocked from the first shell 203, thereby driving the second isolation part 10 to move along the axial direction of the second isolation part 10 to change the length of the treatment area 2001; when the mobile driving component 300 is not pushed, it is locked with the first shell 203, thereby fixing the second isolation part 10 at the current position, thereby ensuring that the treatment area 2001 is fixed to the current adjusted size.

[0245] Since the first working part 15, the first isolating part 17 and the second working part 19 of the needle assembly 1 are all relatively fixed to the first shell 203, when the second isolating part 10 is driven to move along its axial direction by the mobile driving assembly 300, that is, the second isolating part 10 moves relative to the first working part 15, the first isolating part 17 and the second working part 19, the first working part 15 and / or the second working part 19 outside the first shell 203 is more or less covered by the second isolating part 10, thereby adjusting the ablation range.

[0246] like Figure 7b As shown, a plurality of positioning grooves 3001 are arranged at intervals on the first housing 203. For the convenience of adjustment, the positioning grooves 3001 are arranged at equal intervals. Fig. 9As shown, the mobile driving assembly 300 includes a pusher 301, a positioning member 302, a moving seat 303 and an elastic member 304. The pusher 301 and the elastic member 304 are respectively arranged on both sides of the positioning member 302, and a part of the pusher 301 is located outside the first shell 203 and is movably connected to the first shell 203. By applying a force on the pusher 301, it can be pushed to move along the axial direction of the second isolation part 10. The elastic member 304 can be, for example, a thin sheet structure such as a spring sheet, or a spring structure, so that it can be elastically deformed under the action of force and return to its original state when the force disappears.

[0247] The positioning member 302 is configured to be inserted into one of the positioning slots 3001 or to be separated from the positioning slot 3001. When the positioning member 302 is inserted into the positioning slot 3001, the mobile drive assembly 300 is locked with the first housing 203, so that the second isolation portion 10 can be fixed at the current position. When the positioning member 302 is disengaged from the positioning slot 3001, the mobile drive assembly 300 is unlocked with the first housing 203, so that the relative position of the second isolation portion 10 and the needle assembly 1 can be adjusted.

[0248] like Fig. 9 and Fig.10 As shown, a push groove 3003 is provided on one side of the push member 301 close to the positioning member 302. The push groove 3003 extends in a direction away from the positioning member 302. The push groove 3003 can be configured as a wedge-shaped groove, and the inner wall of the wedge-shaped groove is an inner wall inclined relative to the positioning member. Fig.10 As shown, the cross section of the push groove 3003 can be a triangle or a trapezoid. When the push member 301 is pushed and moves along the axial direction of the second isolation portion 10, the inner wall of the push groove 3003 forces the positioning member 302 to move toward the elastic member 304 and causes the elastic member 304 to undergo elastic deformation until the positioning member 302 is disengaged from the positioning groove 3001, thereby unlocking the mobile drive assembly 300 from the first housing 203.

[0249] like Fig. 9 As shown in FIG. 1 , when the push member 301 is pushed from the left side, since the right inner wall of the push slot 3003 is inclined, as it moves further to the left, the right inner wall of the push slot 3003 will exert a downward force on the positioning member 302, thereby causing the positioning member 302 to move downward until the positioning member 302 is separated from the corresponding positioning slot 3001 (the end of the positioning member 302 is lower than the inner wall of the first shell 203, as shown in FIG. 1 ). Fig.10 As shown in FIG. 2 , the first housing 203 cannot constrain the mobile drive assembly 300, so the mobile drive assembly 300 can drive the second isolation portion 10 to move freely. It can be understood that when the positioning member 302 moves downward, the elastic member 304 can be pressed downward, so that the elastic member 304 undergoes elastic deformation and generates elastic potential energy.

[0250] When the push member 301 and the positioning member 302 move together until the positioning member 302 is aligned with the next positioning groove 3001 (for example, the positioning groove 3001 on the left side of the previous positioning groove 3001), since the inner wall of the first shell 203 no longer abuts against the positioning member 302, the elastic member 304 can be restored to its initial state, thereby pushing the positioning member 302 to move upward, and the positioning member 302 can be inserted into the positioning groove 3001, so that the mobile driving assembly 300 and the first shell 203 are locked in the current position, and the length of the treatment area 2001 can be reduced accordingly. It can be understood that the reduced length of the treatment area 2001 is the distance the positioning member 302 moves.

[0251] Or Fig. 9 As shown, when the push member 301 is pushed to the right, since the left inner wall of the push groove 3003 is inclined, as it moves to the right, the left inner wall of the push groove 3003 will exert a downward force on the positioning member 302, so that the positioning member 302 moves downward until the positioning member 302 is separated from the corresponding positioning groove 3001 (the end of the positioning member 302 is lower than the inner wall of the first shell 203), then the first shell 203 cannot constrain the mobile drive assembly 300, so the mobile drive assembly 300 can drive the second isolation part 10 to move freely. It can be understood that when the positioning member 302 moves downward, it can press the elastic member 304 downward, so that the elastic member 304 undergoes elastic deformation and generates elastic potential energy.

[0252] When the pusher 301 and the positioning member 302 move together until the positioning member 302 is aligned with the next positioning groove 3001 (the positioning groove 3001 on the right side of the previous positioning groove 3001), since the inner wall of the first shell 203 no longer abuts against the positioning member 302, the elastic member 304 can be restored to its initial state, so that the positioning member 302 is pushed by the elastic member 304 and moves upward, and the positioning member 302 can be inserted into the positioning groove 3001, so that the mobile drive assembly 300 and the first shell 203 are locked in the current position, and the length of the treatment area 2001 can be increased accordingly. It can be understood that the reduced length of the treatment area 2001 is the distance the positioning member 302 moves.

[0253] Therefore, when adjusting the handle assembly of Example 7 of the present invention, the size of the exposed portion on the first working part 15 and / or the second working part 19 can be adjusted by directly pushing the mobile drive assembly 300 toward the front end or the rear end, thereby achieving the purpose of adjustment. When the mobile drive assembly 300 is pushed, it automatically unlocks from the first housing 203 to move; when adjusting to the next position, the positioning member 302 automatically pops out and inserts into the next positioning slot 3001, thereby locking the mobile drive assembly 300 with the first housing 203. Therefore, the adjustment process does not require unlocking methods such as pressing and rotating, and the operation is more reliable and convenient.

[0254] like Fig.11 Please combine Figure 8 The second isolation part 10 is fixedly connected to the movable seat 303 on the side away from the needle 11. The needle assembly 1 passes through the movable seat 303. The movable seat 303 can move relative to the needle assembly 1. The movable seat 303 is also provided with a guide platform 3031. Please continue to refer to Fig. 9 and Fig.10 The side of the pusher 301 close to the positioning member 302 is also provided with a receiving groove 3002, the receiving groove 3002 extends in a direction away from the positioning member 302, the pushing groove 3003 is provided on the bottom wall of the receiving groove 3002, and the width of the receiving groove 3002 is greater than the maximum width of the pushing groove 3003. The guide platform 3031 is provided in the receiving groove 3002, so the inner wall of the receiving groove 3002 can limit the guide platform 3031, when the positioning member 302 is disengaged from the corresponding positioning groove 3001, the pushing member 301 is continuously pushed, and the inner wall of the receiving groove 3002 contacts the side wall of the guide platform 3031, thereby driving the moving seat 303 to move together.

[0255] like Fig. 9 , Fig.10 and Fig.11 As shown, one end of the positioning member 302 close to the pushing member 301 (i.e., the top of the positioning member 302) is set as an arc end, so as to facilitate the inclined inner wall of the pushing groove 3003 to apply force to it. The pushing member 301 can be a button, which can be configured in various suitable shapes.

[0256] like Fig.11 As shown, the guide platform 3031 is provided with a slide groove 3004 extending in an axial direction perpendicular to the second isolation portion 10, and the positioning member 302 is provided with a guide groove 3021, which is arranged opposite to the slide groove 3004. Fig.11 As shown, the guide groove 3021 and the slide groove 3004 are perpendicular to each other, and the positioning member 302 can move along the slide groove 3004. Under the action of the inner wall of the push groove 3003, the positioning member 302 can move in a direction perpendicular to the axial direction of the second isolation portion 10. When the positioning member 302 moves to the point where its top end is flush with the top end of the slide groove 3004, the positioning member 302 can be disengaged from the guide groove 3021.

[0257] like Fig.11As shown, the movable seat 303 is further provided with a deformation cavity 3032, in which a support block 3033 is provided, and the support block 3033 can be arranged at intervals, and the elastic member 304 is arranged on the support block 3033, and the deformation cavity 3032 can provide a space for elastic deformation of the elastic member 304. When the positioning member 302 moves until its top end is flush with the top end of the slide slot 3004, the lower end of the positioning member 302 abuts against the elastic member 304 and causes the elastic member 304 to undergo elastic deformation.

[0258] It can be understood that, since the guide groove 3021 passes through the positioning member 302, the parts of the positioning member 302 located on both sides of the guide groove 3021 are also located on both sides of the guide platform 3031. Therefore, the deformation cavity 3032 is correspondingly arranged on both sides of the guide platform 3031, and the elastic member 304 is correspondingly arranged in the deformation cavity 3032, so that the parts of the positioning member 302 located on both sides of the guide groove 3021 can respectively apply force to the two elastic members 304.

[0259] The handle assembly provided by the present invention further comprises a second housing 602, and the second housing 602 is connected to a side of the first housing 203 away from the needle 11. Fig.12 As shown, a needle bar seat 601 is also provided in the first shell 203 , and the needle assembly 1 penetrates the movable seat 303 and is conductively connected to one side of the needle bar seat 601 .

[0260] like Fig.12 As shown, the second housing 602 includes a first boss 6021 extending in a direction close to the first housing 203, the first boss 6021 is arranged inside the first housing 203, a mounting groove 6022 is arranged on the first boss 6021, the needle bar seat 601 is arranged in the mounting groove 6022, and the end surface of the needle bar seat 601 is flush with the end surface of the first boss 6021. The second housing 602 also includes a second boss 6023 extending in a direction away from the first housing 203, the cable 6002 penetrates into the second housing 602, and is connected to the operation hole 6004 of the needle bar seat 601 after passing through the second boss 6023.

[0261] The distal end of the needle assembly 1 is arranged in the operating hole 6004 of the needle rod seat 601, and the cable 6002 enters from the rear end hole of the needle rod seat 601, and its front end is located in the operating hole 6004. The end of the needle assembly 1 and the front end of the cable 6002 are welded or crimped in the operating hole 6004 to make the two conductively connected, thereby realizing electrical conduction between the needle assembly 1 and the cable 6002.

[0262] The outer side of the needle assembly 1 located in the first housing 203 is provided with an insulating coating. More specifically, the needle assembly 1 from the front end of the needle assembly 1 and the first housing 203 to the front area of ​​the operation hole 6004 is covered with an insulating coating, and the end of the needle bar seat 601 is also covered with an insulating coating, that is, an insulating end face 6003 is formed. An adhesive layer is provided between the insulating coating of the needle assembly 1 and the insulating end face 6003. For example, an adhesive (such as glue) can be poured from the chamfered position of the insulating end face 6003 for filling and bonding, so that the needle bar seat 601 and the needle assembly 1 are fixed and insulated, thereby achieving external insulation of the front end of the handle assembly. The outer side of the cable 6002 is covered with an insulating layer, and an adhesive layer can also be provided between it and the second boss end face 6005. For example, an adhesive (such as glue) can be poured from the chamfered position of the second boss end face 6005 for filling and bonding, thereby achieving external insulation of the rear end of the handle assembly.

[0263] Therefore, after the needle assembly 1 and the cable 6002 are respectively connected (welded) on the needle bar seat 601, the needle bar seat 601 is placed in the mounting groove 6022 of the first boss 6021, and the insulating end face 6003 and the second boss end face 6005 are sealed with glue, so that the conductive part in the handle assembly is completely isolated from the outside.

[0264] Through the above operations, the connection position between the cable 6002 and the needle assembly 1 is insulated from the outside, and the conductive area of ​​the entire handle assembly only exists in the treatment area 2001 mentioned above, thereby eliminating the conductive risk in the handle assembly area and providing better protection for the operator.

[0265] Example 8

[0266] The present invention provides a rotary composite ablation needle, which includes the needle assembly 1 described in one or more of the above embodiments 1 to 6, and also includes a handle assembly, wherein the distal end of the needle assembly 1 in the above embodiments 1 to 6 is connected to the handle assembly, wherein the first working portion 15, the first isolation portion 17, the second working portion 19, and the second isolation portion 10 all extend into the handle assembly. The first tube extension tube 155 of the first working portion 15 and the second tube extension tube 192 of the second working portion 19 can be connected to an energy source through the handle assembly, thereby transmitting corresponding energy.

[0267] The handle assembly will be described in detail below.

[0268] like Fig.13a , Fig.13b As shown, the handle assembly of Example 8 of the present invention is a rotary handle assembly, that is, the effective length of the first working part 15 and / or the second working part 19 is adjusted by rotating the knob 53 at the proximal end of the handle assembly.

[0269] Specifically, the handle assembly includes a handle front shell 55 and a handle rear shell 58 connected to the distal end of the handle front shell 55, and the two can be connected by various known means, for example, the two can be connected by a rotationally fixed manner.

[0270] like Fig.13b and Fig.14 As shown, a knob 53 is provided on the proximal side of the handle front shell 55, and the knob 53 can rotate relative to the handle front shell 55. Fig.14 As shown, the knob 53 includes a rotating portion 534 and a connecting portion 535. The rotating portion 534 is configured as a generally conical structure with a diameter gradually decreasing in the direction toward the needle assembly 1, and its distal end abuts against the proximal end of the handle front shell 55 to facilitate gripping and applying a rotational torque. The connecting portion 535 is configured as a columnar structure, and its sleeve is arranged outside the second isolation portion 10 and extends into the handle front shell 55.

[0271] The rotating portion 534 is rotatably connected to the handle front shell 55. Specifically, Fig.14 As shown, the rotating portion 534 is provided with a limiting groove 532 extending along its circumferential direction, and the inner wall of the handle front shell 55 is provided with a wedge-shaped convex ring 551 extending toward its interior, and the wedge-shaped convex ring 551 is arranged in the limiting groove 532, thereby limiting the axial movement of the knob 53 along the handle front shell 55, so that the rotating portion 534 can only rotate around its axial direction.

[0272] The rotating portion 534 is disposed at the proximal end of the handle front shell 55, which can help reduce the radial dimension of the handle assembly, so that there can be a smaller spacing between the various components of the handle assembly, thereby improving the operability of the handle assembly.

[0273] The connecting portion 535 is also provided with a slider 56. Fig.14 and Fig.16 As shown, the connecting portion 535 is provided with a sliding groove 533 extending along its axial direction. The sliding groove 533 penetrates the connecting portion 535 in the radial direction. The end of the slider 56 can extend from the sliding groove 533. The sliding groove 533 can act as a guide groove to guide the slider 56 to move therein.

[0274] The slider 56 is sleeved on the outer side of the second isolating portion 10 , and the slider 56 and the second isolating portion 10 can be fixedly connected by bonding or other means, so that when the slider 56 moves, it can drive the second isolating portion 10 to move along its axial direction.

[0275] Specifically, if Fig.17As shown, the slider 56 includes a sliding sleeve 563 and a plurality of pillars 561 arranged on both sides of the sliding sleeve 563. Each pillar 561 extends in the radial direction of the sliding sleeve 563. The pillars 561 on both sides of the sliding sleeve 563 are symmetrically arranged about the sliding sleeve 563, and a notch structure 562 is arranged between the pillars 561 on the same side of the sliding sleeve 563. The pillars 561 on both sides of the sliding sleeve 563 extend from the sliding groove 533 on the connecting portion 535.

[0276] like Fig.16 As shown, an internal thread 552 is provided on the inner wall of the handle front shell 55, and the notch structure 562 can cooperate with the internal thread 552. When the rotating part 534 is subjected to the rotational force, it drives the connecting part 535 to rotate, so that the notch structure 562 of the slider 56 cooperates with the internal thread 552 on the handle front shell 55, thereby performing a spiral motion along the thread. The spiral motion of the slider 56 includes a rotational motion around the axial direction of the second isolation part 10 and a translational motion along the axial direction of the second isolation part 10, wherein the translational motion of the slider 56 along the axial direction of the second isolation part 10 can drive the second isolation part 10 to move toward the proximal side or the distal side of the handle front shell 55.

[0277] In order to improve the smoothness of the movement of the slider 56 , a side of the pillar 561 close to the notch structure 562 has an arc surface, which can make it easier for the notch structure 562 to engage with the internal thread 552 .

[0278] Furthermore, a scale ring 57 is also sleeved on the second isolation portion 10. The scale ring 57 is located in the notch structure 562 and is provided with an identification layer or identification portion of a special color. When the slider 56 performs a spiral motion, the scale ring 57 can be driven to translate to indicate the moving position of the slider 56, thereby realizing the displacement display of the slider 56.

[0279] The handle front shell 55 and the handle rear shell 58 are installed by rotating. Fig.15As shown, a locking block 553 is provided at the distal end of the handle front shell 55, and a locking groove 582 extending along the circumference thereof is provided on the handle rear shell 58. The opening of the locking groove 582 has a protrusion 585 extending toward the inside of the locking groove 582, and arc-shaped transition portions are provided on the protrusion 585 and the locking block 553. When the handle rear shell 58 is rotated, the arc-shaped transition portion on the protrusion 585 is tangent to the arc-shaped transition portion on the locking block 553 under the action of the rotation force, so that the locking groove 582 is slightly deformed, so that the locking block 553 can enter the locking groove 582. When the locking block 553 completely enters the locking groove 582, the protrusion 585 and the locking block 553 no longer interfere with each other, and the normal state is restored. At this time, the protrusion 585 can fix the locking block 553 in the locking groove 582, so that relative rotation and movement cannot occur between the handle front shell 55 and the handle rear shell 58, thereby fixing the handle front shell 55 and the handle rear shell 58 in connection.

[0280] like Fig.15 As shown, a seal 54 is provided in the second seal groove 584 of the handle rear shell 58, and under the action of the seal 54, a seal can be achieved between the handle front shell 55 and the handle rear shell 58. Fig.13b and Fig.14 As shown, a first sealing groove 531 is provided on the proximal side of the rotating portion 534 , in which a sealing member 54 is provided. Under the action of the sealing member 54 , sealing is achieved between the knob 53 and the handle front shell 55 .

[0281] The handle rear shell 58 is also provided with a rear shell shaft hole 581, whose inner diameter is slightly larger than the diameter of the connecting portion 535. The sleeve is provided on the connecting portion 535 to provide a restraining force for the connecting portion 535 during rotation to prevent excessive deformation of the connecting portion 535. The handle rear shell 58 is also provided with a connecting hole 583. The distal ends of the first working portion 15, the first isolating portion 17 and the second working portion 19 of the needle assembly 1 can be provided in the connecting hole 583 and bonded thereto, so that the needle assembly 1 and the handle assembly can be fixed to each other, thereby providing a puncture force for the needle rod.

[0282] Furthermore, if Fig.13b As shown, an LED light board 59 is also provided on the handle rear shell 58. The LED light board 59 can adopt an existing light board structure, for example, a light-emitting portion is provided thereon. An opening is provided at a relative position on the handle rear shell 58, and the light-emitting portion of the LED light board 59 can pass through the handle rear shell 58 and display a light signal to the outside to indicate different working states of the ablation needle.

[0283] like Fig.13bAs shown, after the knob 53, the handle front shell 55 and the handle rear shell 58 are installed, they have uniform external dimensions, and the handle assembly formed is a uniform columnar structure without protrusions such as buttons, thereby ensuring the sealing performance of the handle assembly and allowing the conductive parts inside the handle assembly to be better insulated from the operator, thereby improving safety of use.

[0284] Example 9

[0285] The present invention provides a rotary composite ablation needle. The handle assembly in the rotary composite ablation needle of this embodiment 9 is different from the handle assembly in the above-mentioned embodiment 8, and the specific difference lies in the different structure of the slider 56. In addition, the connecting portion 535 in the embodiment 8 is omitted in this embodiment 9, that is, the rotating portion 534 is connected to the slider 56 to drive the slider 56 to rotate. The second isolation portion 10 passes through the slider 56 and is connected to the slider 56.

[0286] Specifically, Fig.18 As shown, the slider 56 and the scale ring 57 are constructed integrally, and a spiral groove entrance 564 and a spiral groove 565 connected to the spiral groove entrance 564 are provided on the slider 56. The spiral groove 565 extends spirally along the axial direction of the slider 56, and the angle of rotation of the spiral groove 565 in the circumferential direction of the slider 56 is between 180 degrees and 360 degrees, that is, one end of the spiral groove 565 is an open end formed by the spiral groove entrance 564, so that the internal thread 552 on the handle front shell 55 can be screwed into or out of the spiral groove 565 from the spiral groove entrance 564, and the other end is a closed end to ensure that the slider 56 can realize spiral motion along the internal thread 552.

[0287] The internal thread 552 on the handle front shell 55 can be screwed into the spiral groove 565 from the spiral groove entrance 564 , so that the spiral groove 565 is matched with the internal thread 552 .

[0288] Example 10

[0289] The present invention provides a sliding-propelled composite ablation needle, which includes the needle assembly 1 described in one or more of the above-mentioned embodiments 1 to 6, and also includes a handle assembly, wherein the distal end of the needle assembly 1 in the above-mentioned embodiments 1 to 6 is connected to the handle assembly, wherein the first working portion 15, the first isolation portion 17, the second working portion 19, and the second isolation portion 10 all extend into the handle assembly. The first tube extension tube 155 of the first working portion 15 and the second tube extension tube 192 of the second working portion 19 can be connected to an energy source through the handle assembly, thereby transmitting corresponding energy.

[0290] The handle assembly will be described in detail below.

[0291] like Fig.19a and Fig.19b As shown, the handle assembly of embodiment 10 of the present invention is a sliding push-type handle assembly, which adjusts the effective length of the first working part 15 and / or the second working part 19 by combining the two motion modes of movement and rotation, solves the problem of sticking, and improves the aesthetics of the handle assembly.

[0292] Specifically, if Fig. 20 , Fig.22a and Figure 22b As shown, the handle assembly includes a housing 41, which is constructed as a pistol-shaped structure, and its lower part is convenient for the user to hold. The housing 41 can be a split structure, for example, it can be formed by buckling a left housing 412 and a right housing 416, so that other components can be installed inside it.

[0293] The housing 41 is provided with a sliding propulsion mechanism, and the second isolating portion 10 is connected to the sliding propulsion mechanism. The sliding propulsion mechanism can push the second isolating portion 10 to move along its axial direction to change the length of the first working portion 15 and / or the second working portion 19 covered by the second isolating portion 10 .

[0294] Specifically, if Fig. 20 As shown, the housing 41 is provided with a housing slide groove 411, which can be located, for example, at the middle position of the upper side of the housing 41, so that the operator's thumb can control the sliding propulsion mechanism in the housing slide groove 411 to move it. Fig.22c As shown, the casing slide groove 411 can be respectively provided on a portion of the left casing 412 and the right casing 416 , and when the left casing 412 and the right casing 416 are buckled together, a closed casing slide groove 411 can be formed.

[0295] like Fig. 20 As shown, the sliding propulsion mechanism passes through the casing slide slot 411 and is connected to the second isolation portion 10 in the casing 41 , so the second isolation portion 10 can be driven to move by pushing the sliding propulsion mechanism.

[0296] like Fig.21a , Figure 21b and Fig.21cAs shown, the sliding push mechanism includes a push button 43, which includes a pushing portion 431, a matching portion 432 and a sleeve 433. The axial direction of the sleeve 433 is the moving direction of the pushing portion 431. The sleeve 433 is provided with a cavity structure 4032 on the left and right sides of the axial direction, and a connecting hole 4031 connecting the cavity structures 4032 on the left and right sides of the sleeve 433. The cavity structures 4032 are connected to the connecting holes 4031 through the tapered transition portions 4033. The second isolation portion 10 penetrates from the cavity structure 4032 on one side of the sleeve 433 and passes out from the cavity structure 4032 on the other side of the sleeve 433 through the connecting hole 4031, thereby connecting to the sleeve 433. The tapered transition portion 4033 can play a guiding role when connecting the second isolation portion 10. The size of the cavity structure 4032 is much larger than the size of the connecting hole 4031, so it can also play a role in reducing weight.

[0297] A mounting hole is provided at the middle position of the sleeve 433, the matching portion 432 is provided in the mounting hole and extends radially along the sleeve 433, the pushing portion 431 is connected to the end of the matching portion 432, and the pushing portion 431 extends circumferentially along the sleeve 433, so as to apply force on its upper surface to make it move axially along the sleeve 433.

[0298] The pusher 431, the mating part 432 and the sleeve 433 may be integrally formed, for example, by machining or metal material injection molding, insert injection molding, etc. The mating part 432 may be a stainless steel or tungsten steel bar with an outer diameter of 0.5 mm-1.5 mm and a ground or polished surface.

[0299] The push portion 431 is disposed outside the housing 41, the matching portion 432 is disposed in the housing slide groove 411, the sleeve 433 is disposed inside the housing 41, and the second isolation portion 10 passes through the sleeve 433 and is fixedly connected to the sleeve 433. When the push portion 431 is subjected to a forward or backward force, it drives the matching portion 432 and the sleeve 433, and then drives the second isolation portion 10 to move forward or backward, so as to change the relative position of the second isolation portion 10 and the first working portion 15 and / or the second working portion 19.

[0300] like Fig.21a As shown, a double torsion spring 434 is also sleeved on the outer surface of the sleeve 433. Fig.21c As shown, the double torsion spring 434 includes a torsion spring coil 4342, an inner pin 4341 and an outer pin 4343. The inner pin 4341 is a U-shaped structure, which can connect the two torsion spring coils 4342 on one hand; on the other hand, the inner pin 4341 can be matched with the matching portion 432. The outer pin 4343 is respectively located at the side of the torsion spring coil 4342, and the outer pin 4343 is engaged with the slot inside the housing 41, so as to provide torque.

[0301] The double torsion spring 434 can be made of medical stainless steel, and the diameter of the stainless steel wire forming the torsion spring coil 4342 is 0.3mm-0.8mm.

[0302] The sliding propulsion mechanism further includes a shielding sleeve 44, which is located inside the housing 41 and is rotatably connected to the housing 41. The shielding sleeve 44 is located inside the housing 41, so it can shield the housing slide groove 411 from the inside of the housing 41; and the shielding sleeve 44 can also move with the movement of the pusher 431. For example, the shielding sleeve 44 is rotatably connected to the housing 41, so that when the pusher 431 moves, the shielding sleeve 44 can rotate synchronously with the pusher 431, so that a part of the spiral slide groove 441 is always aligned with a part of the housing slide groove 411 (such as Fig.22c ), to ensure the normal movement of the push portion 431. The other parts of the housing slide groove 411 are blocked by the part of the cover 44 where the spiral slide groove 441 is not provided.

[0303] like Fig.25 As shown, the shielding sleeve 44 is provided with a spiral groove 441, which extends spirally along the entire axial direction of the shielding sleeve 44, and the spiral groove 441 is connected with the interior of the shielding sleeve 44. One end of the spiral groove 441 is an open end 4411, and the other end is a closed end 4412. The spiral groove 441 is a spiral slideway that extends spirally along the entire axial direction of the shielding sleeve 44 from the open end 4411 to the closed end 4412, and the spiral groove 441 is connected with the interior of the shielding sleeve 44, so that the matching portion 432 can enter the spiral groove 441 through the open end 4411.

[0304] The width of the spiral groove 441 may be slightly larger than the diameter of the matching portion 432 to facilitate installation of the matching portion 432 . The width of the spiral groove 441 may be, for example, 2 mm-2.5 mm.

[0305] like Fig.22a and Figure 22b As shown, the sleeve 433 of the push button 43 and the double torsion spring 434 on the sleeve 433 are both located in the cover 44, and the matching portion 432 of the push button 43 can be moved from the open end 4411 (such as Fig.25 That is, the mating portion 432 of the push button 43 passes through the housing slot 411 of the housing 41 and is located in the spiral slot 441 (as shown in FIG. Fig.22c Therefore, when a force is applied to the push portion 431 to move the push button 43, the matching portion 432 can move along the spiral groove 441 and cause the cover 44 to rotate accordingly, so that the position of the spiral groove 441 changes accordingly (please refer to Fig.26 , Fig. 27 and Fig.28), so that the movement of the push button 43 will not be hindered. Therefore, when a force is applied to the push portion 431 to move the push portion 431, the matching portion 432 can move along the spiral groove 441 and cause the cover 44 to rotate accordingly, so that the position of the spiral groove 441 changes accordingly, so that a portion of the spiral groove 441 is always aligned with the housing groove 411 (please refer to Fig. 27 ) to ensure that the movement of the pushing portion 431 will not be hindered.

[0306] The purpose of providing the shielding cover 44 in the casing 41 is that the shielding cover 44 can block the casing slide groove 411 from the inside of the casing 41 and will not affect the movement of the push button 43 in the casing slide groove 411, so that foreign objects will not fall into the casing slide groove 411 and the casing 41, thereby solving the technical problem that foreign objects in the slide groove are easy to fall into and cause jamming; and the shielding cover 44 blocks the casing slide groove 411, so that the internal structure of the casing 41 will not be exposed to the outside, thereby solving the problem of leakage of the internal structure of the handle assembly and improving the aesthetics of the handle assembly.

[0307] Because the cover 44 is located inside the housing 41, the housing 41 can block the spiral groove 441 of the cover 44, and the cover 44 will block the housing groove 411. It should be noted that when the push button 43 stays at a certain position on the housing groove 411, a part of the spiral groove 441 is aligned with the position of the housing groove 411 (such as Fig.22c ), that is, the position of the housing slide groove 411 is not blocked by the cover 44, so as to ensure that the push button 43 can move normally. However, since the push portion 431 of the push button 43 is arranged outside the housing slide groove 411, the push portion 431 can simultaneously cover the portion where the housing slide groove 411 and the spiral slide groove 441 are aligned with each other. Therefore, it can be known that the cover 44 and the push portion 431 of the push button 43 can jointly play the role of shielding the housing slide groove 411, thereby avoiding various problems caused by the exposure of the housing slide groove 411. Fig.26 , Fig. 27 and Fig.28 As shown, the push button 43 is respectively shown in the initial position, process position and terminal position during the movement of the housing slide groove 411. It can be seen that the cover 44 (and the push portion 431 of the push button 43) effectively covers the housing slide groove 411, avoiding the problem of the internal structure of the ablation needle being exposed.

[0308] Furthermore, the pitch of the spiral groove 441 should be less than or equal to the maximum stroke of the push button 43 to avoid the problem that the push portion 431 cannot cover the spiral groove 441 and exposes the spiral groove 441 when the push button 43 moves. The stroke of the push portion 431 can be 0 mm to 60 mm.

[0309] A plurality of positioning grooves 413 are also provided in the casing slide groove 411. When the push button 43 moves to a desired position, it can enter the corresponding positioning groove 413 from the casing slide groove 411, so that the push button 43 is fixed at the current position.

[0310] like Fig.23a As shown, the two outer pins 4343 of the double torsion spring 434 extend out from the spiral groove 441 respectively, and engage with the slot inside the housing 41, so as to provide torque. Specifically, a pin receiving portion 414 that is recessed in a direction away from the shielding sleeve 44 is provided on the inner wall of the housing 41 (for example, on the inner wall of the left housing 412 and / or the right housing 416), and the pin receiving portion 414 extends along the axial direction of the shielding sleeve 44. The two outer pins 4343 of the double torsion spring 434 can abut against the side wall of the pin receiving portion 414, so that the pin receiving portion 414 can apply a pre-tightening force to the double torsion spring 434. Fig.19a and Fig.24 As shown, a plurality of positioning grooves 413 are further provided in the casing slide groove 411. When the pushing portion 431 moves to a desired position, it can enter the corresponding positioning groove 413 from the casing slide groove 411, so that the pushing portion 431 is fixed at the current position.

[0311] Specifically, Fig.24 As shown, the positioning groove 413 is configured in a trumpet shape that opens toward the housing slide groove 411. The positioning groove 413 includes a groove body 4133, a constricted neck portion 4131, and an open portion 4132, wherein the open portion 4132 is connected to the housing slide groove 411, and its size is larger than that of the constricted neck portion 4131, so that the matching portion 432 of the push button 43 can be smoothly pushed into the groove body 4133 from the open portion 4132 through the constricted neck portion 4131; and the constricted neck portion 4131 can block the matching portion 432 in the groove body 4133 to prevent it from falling out of the groove body 4133.

[0312] Preferably, if Fig.29 and Fig.30 As shown, each positioning groove 413 can be respectively arranged on one side (such as the left side or the right side) of the housing slide groove 411, and the direction of the opening of the positioning groove 413 is opposite to the direction of the opening of the inner pin 4341 (such as Fig.22c shown).

[0313] Please combine Fig.21c In the natural state, the angle between the outer pin 4343 and the inner pin 4341 of the double torsion spring 434 is α1 (as Fig.23c After the double torsion spring 434 is installed, its outer pin 4343 abuts against the side wall of the pin receiving portion 414 (as shown in FIG. Fig.23a As shown), the pin receiving portion 414 applies a preload force to the double torsion spring 434, so that the angle between the outer pin 4343 and the inner pin 4341 becomes α2 (as shown). Figure 23b As shown), and α2 is less than α1, that is, the double torsion spring 434 is in a compressed state. Figure 23b and Fig.23c As shown, the angles α1 and α2 refer to the angles between the line connecting the end of the outer pin 4343 and the center of the sleeve 433 and the line connecting the center of the push portion 431 and the center of the sleeve 433 (i.e., the axial direction of the mating portion 432). When the push button 43 moves to the vicinity of the desired positioning groove 413, the inner pin 4341 and the outer pin 4343 of the double torsion spring 434 have a tendency to recover from the angle α2 to the angle α1, so the inner pin 4341 can automatically push the push button 43 into the corresponding positioning groove 413, thereby fixing the push button 43 in the desired positioning groove 413, so as to achieve the semi-automatic locking effect of the sliding push mechanism. It can be understood that when the push button 43 is pushed into the corresponding positioning groove 413, the angle between the outer pin 4343 and the inner pin 4341 becomes α1, that is, the double torsion spring 434 returns to the natural state. When it is necessary to push the push button 43 again, force can be applied to the push button 43 to make it enter the casing slide groove 411 from the positioning groove 413 via the matching portion 432. The outer pin 4343 of the double torsion spring 434 then abuts against the side wall of the pin receiving portion 414, so that the double torsion spring 434 is in a compressed state again. When the push button 43 is pushed into the next positioning groove 413, the above process can be repeated.

[0314] like Fig.29 and Fig.30 As shown, each positioning groove 413 can be respectively arranged on the left side or the right side of the housing slide groove 411. Fig.31 and Fig.32 As shown, each positioning groove 413 can be respectively arranged on both sides of the housing slide groove 411. Among them, the positioning groove 413 can be as follows Fig.31 As shown in , the scales are staggered on the left and right sides according to the size scale (for example, every 5mm unit is a small scale, and every 10mm unit is a large scale); or it can also be as shown in Fig.32 As shown in , they are symmetrically distributed on both sides of the center line of the housing 41. In this optional embodiment, the double torsion spring 434 may not be provided, and the push button 43 can be manually controlled to be clamped into the corresponding positioning groove 413.

[0315] The housing 41 is also provided with housing scale lines 415, which correspond to the positioning grooves 413. The housing scale lines 415 are formed by laser etching, silk screen printing or injection molding with the housing 41. As described above, a method of a small scale of 5 mm and a large scale of 10 mm can be adopted, or other suitable methods can be adopted.

[0316] In addition, if Fig.21aAs shown, a push button scale line 4311 is also provided on the push portion 431 of the push button 43. When the push button 43 is located in a certain positioning groove 413, the push button scale line 4311 thereon can be aligned with the scale corresponding to the positioning groove 413, thereby indicating the travel of the push button 43.

[0317] In an optional embodiment, the shielding sleeve 44 is a telescopic sleeve or a telescopic baffle, which can be attached to the push part 431, and the spiral slide groove 441 can be replaced by an arc groove extending along the circumference of the shielding sleeve 44. A part of the shielding sleeve 44 can be synchronously extended following the movement of the push part 431, and the other part can be synchronously contracted following the movement of the push part 431, so that the arc groove between the extended part and the contracted part of the shielding sleeve 44 is always aligned with a part of the housing slide groove 411 to ensure the normal movement of the push part 431, and the other part of the housing slide groove 411 is blocked by the part of the shielding sleeve 44 where the arc groove is not provided.

[0318] Embodiment 11

[0319] The present invention also provides an ablation system, comprising one or more of the composite ablation needle described in Example 1, the composite ablation needle described in Example 2, the multiple physical factor composite ablation needle described in Example 3, the multiple physical factor composite ablation needle described in Example 4, the multiple physical factor composite ablation needle described in Example 5, the composite ablation needle with improved safety described in Example 6, the direct-push composite ablation needle described in Example 7, the rotary composite ablation needle described in Example 8, the rotary composite ablation needle described in Example 9, and the sliding-propulsion composite ablation needle described in Example 10.

[0320] In addition, the ablation system of the present invention also includes one or more of a medium source (such as a cold source, a heat source, etc.), a drug delivery device, and an energy source (such as a radio frequency energy source, a pulsed electric field energy source, and a direct current power source, etc.).

[0321] Example 12

[0322] like Fig.33 As shown, the present invention provides a combined ablation needle, more specifically, a multiple physical factor combined ablation needle, which is different from the combined ablation needle of the above embodiment 1 in that the second working part 19 and the first isolation part 17 of the above embodiment 1 are not provided in the present embodiment 12. In other words, the combined ablation needle of the present embodiment 12 includes a needle assembly 1, and the needle assembly 1 includes a first working part 15 and a second isolation part 10. Fig.33 As shown, the distal side of the first working portion 15 extends directly into the second insulating portion 10 .

[0323] The first working portion 15 is configured to act independently to achieve one or more of chemical ablation, cryoablation, thermal ablation, pulsed electric field ablation, radiofrequency ablation or electrolytic energy ablation in its corresponding first working area.

[0324] For example, optionally, a cold medium (such as liquid nitrogen) or a hot medium (such as alcohol vapor) can be released in the first working part 15, so that the first working part 15 can individually release the freezing energy carried by the cold medium or the thermal energy carried by the hot medium to achieve freezing energy ablation or thermal energy ablation (thermal energy ablation only refers to ablation using thermal energy carried by a hot medium such as alcohol, and does not include radiofrequency ablation and microwave ablation).

[0325] Optionally, cold medium or hot medium can be released from the first working part 15, and chemical drugs or protein coagulants can also be input into the designated treatment area from the first working part 15, thereby achieving ablation therapy with different physical effects of cryoenergy ablation (or thermal energy ablation) and chemical ablation.

[0326] Optionally, the first working part 15 acts as a pole, which forms a discharge circuit with another pole outside the combined composite ablation needle (which can be attached to human skin), so that the first working part 15 can independently release pulsed electric field energy, radio frequency energy or electrolysis energy to achieve corresponding energy ablation.

[0327] In addition, the multiple combined composite ablation needles of this embodiment 12 can also work together to jointly release radio frequency energy, pulsed electric field energy or electrolytic energy to achieve corresponding energy ablation. For example, the first working part 15 of one combined composite ablation needle acts as the positive electrode, and the first working part 15 of another combined composite ablation needle acts as the negative electrode to form a discharge circuit, thereby releasing radio frequency energy, that is, multiple first working parts 15 can work together to release radio frequency energy to achieve radio frequency ablation. Or optionally, multiple first working parts 15 respectively form electrode pairs for pulse discharge, thereby releasing pulsed electric field energy to the tissue between the two, that is, multiple first working parts 15 can work together to release pulsed electric field energy to achieve pulsed electric field energy ablation. Or optionally, one first working part 15 forms a cathode, and another first working part 15 forms an anode, and the designated treatment area can be used as an electrolyte. When a DC power supply is connected to the first working part 15, electrolytic energy is released to the tissue between the two, that is, multiple first working parts 15 can work together to release electrolytic energy to achieve electrolytic energy ablation.

[0328] The distal end of the needle assembly 1 of the combined-action composite ablation needle of this embodiment 12 is connected to an energy source through various known ports. By adjusting the energy source, it can output pulse, radio frequency and electrolysis energy to the needle assembly 1, so that the same needle assembly 1 can carry a variety of energies.

[0329] like Fig.33 As shown, the first working part 15 includes a needle 11 , a first tube 156 connected to the distal end of the needle 11 , and a first tube extension tube 155 connected to the distal end of the first tube 156 , and the first tube extension tube 155 extends into the second isolation part 10 .

[0330] The needle 11 and the first tube 156 can be constructed separately and connected by bonding or welding. Alternatively, the needle 11 and the first tube 156 can be integrally formed, and the needle 11 and the first tube 156 together constitute the first working area.

[0331] The needle 11 is used for puncture, so the shape of the needle tip at the front end side of the needle 11 can be a triangular shape, a cone shape, a semicircular shape, etc., which is convenient for puncturing the skin, tissue and treatment area.

[0332] If the length of the needle 11 is too short, it may not reach the designated treatment area. If it is too long, it will affect the treatment effect. Therefore, the length of the needle 11 is generally between 1 mm and 50 mm or between 5 mm and 50 mm, for example, 10 mm. If the outer diameter of the needle 11 is too small, the rigidity and development of the needle 11 may be insufficient, which will affect the puncture clinically. On the contrary, if the outer diameter of the needle 11 is too large, the resistance to puncture will increase and increase the treatment trauma of the patient. Therefore, the outer diameter of the needle 11 is between 0.5 mm and 5 mm or preferably between 0.5 mm and 4 mm. For example, the outer diameter of the needle 11 can be 0.92 mm, 1.7 mm, 2.0 mm, 2.6 mm, or 3 mm.

[0333] The needle 11 can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials); or it can be made of plastic materials, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK) or PI (polyimide); or it can also be made of materials such as zirconium oxide ceramics.

[0334] The surface of the needle 11 may also be covered with a coating to prevent tissue adhesion during treatment or corrosion caused by electrolysis of the needle surface. The coating may be, for example, a needle coating 111 or an anti-adhesion membrane. The needle coating 111 may be made of, for example, an insulating material such as polytetrafluoroethylene (PTFE) or titanium nitride, or may be made of a conductive, temperature-resistant, anti-adhesion material.

[0335] The first tube 156 and the first tube extension tube 155 can be constructed separately or integrally. Fig.33As shown, the diameter of the first tube 156 is the same as that of the first tube extension tube 155. Alternatively, it is conceivable that the inner diameter of the first tube extension tube 155 is set to be smaller than the inner diameter of the first tube 156, so that a step structure is formed between the two. Alternatively, it is also conceivable that the inner diameter of the first tube 156 is set to gradually decrease toward the first tube extension tube 155, that is, the first tube 156 transitions to the first tube extension tube 155 at a certain cone angle.

[0336] The first tube 156 and the first tube extension tube 155 can be made of the same material, for example, both can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials). Alternatively, the first tube 156 and the first tube extension tube 155 can also be made of different materials.

[0337] The outer surface of the first tube 156 may also be provided with a coating, which may be an extension of the needle coating 111, for preventing tissue adhesion during treatment. The coating may be, for example, a coating made of a temperature-resistant anti-adhesion material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesion heat shrink film made of a material such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0338] It can be understood that when the first working part 15 releases radio frequency energy, pulsed electric field energy or electrolytic energy alone, or when radio frequency energy, pulsed electric field energy or electrolytic energy are released in combination, the needle 11 and / or the first tube 156 of the first working part 15 can be used as one of the poles described above, so the coating on the needle 11 and / or the first tube 156 is a conductive coating made of conductive, heat-resistant and anti-adhesive material, so that the needle 11 and / or the first tube 156 can be conductive, and the second isolation part 10 can prevent the energy from flowing out of the non-treatment area.

[0339] like Fig.33 As shown, the interior of the first tube 156 defines the medium release chamber 12, or the first tube 156 and the first tube extension tube 155 jointly define the medium release chamber 12. That is, the length of the medium release chamber 12 may be the same as the length of the first tube 156, or may be greater than the length of the first tube 156. The medium may release energy in the medium release chamber 12, which may be used as cooling for thermal ablation or heat exchange for cold ablation.

[0340] The medium may be, for example, a cold medium (such as liquid nitrogen, high-pressure gas, liquid metal or cooling water, etc.), or a hot medium such as liquid (alcohol), etc.

[0341] Specifically, the needle assembly 1 further includes a first medium tube 14 and a second medium tube 16 disposed outside the first medium tube 14 . The first medium tube 14 and the second medium tube 16 both extend inside the first working portion 15 , the first isolating portion 17 and the second working portion 19 .

[0342] Among them, the inner wall of the first medium tube 14 defines a first medium cavity, which can serve as one of the medium inlet channel and the medium return channel. The outer wall of the first medium tube 14 and the inner wall of the second medium tube 16 jointly define the other of the medium inlet channel and the medium return channel. The medium inlet channel and the medium return channel are fluidically connected through the medium release cavity 12.

[0343] For example, the inner wall of the first medium tube 14 defines the medium inlet channel 141, and the second medium cavity 161 serves as the medium reflux channel. The cold medium or hot medium from the cold source or the heat source can be input to the distal side of the needle assembly 1 through the handle assembly, flow into the medium release cavity 12 from the distal side of the first medium tube 14, and return from between the first medium tube 14 and the second medium tube 16; or the inner wall of the first medium tube 14 defines the medium reflux channel, and the second medium cavity 161 serves as the medium inlet channel. The cold medium (or hot medium) can also flow into the medium release cavity 12 from between the first medium tube 14 and the second medium tube 16, and then return from the first medium tube 14.

[0344] Therefore, the first medium pipe 14 and the second medium pipe 16 can form an inflow and return flow channel for the cold medium or the hot medium. Fig.33 As shown, the first medium pipe 14 is arranged at the innermost side of the first pipe extension pipe 155 and extends into the medium release chamber 12. The second medium pipe 16 is arranged adjacent to the first medium pipe 14, and the two are arranged coaxially. It is conceivable that the second medium pipe 16 can also be arranged side by side adjacent to the first medium pipe 14.

[0345] The first medium tube 14 and the second medium tube 16 can be circular, oblate or rectangular tubular structures, and both can be made of medical metal materials (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium and other metals or alloy materials); or can be made of plastic materials, such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK) or PI (polyimide); or can also be made of materials such as zirconium oxide ceramics.

[0346] The first tube 156 (or the needle 11 and the first tube 156 ) defines the length of the first working area, which may be 1 mm-60 mm or 1 mm-50 mm, for example, 20 mm.

[0347] The needle assembly 1 further comprises an injection and suction inner tube 153 and at least one injection and suction hole 151 , through which chemical ablation can be achieved.

[0348] The injection and suction inner tube 153 extends inside the first working part 15 and the second isolation part 10 , and the outer wall of the injection and suction inner tube 153 and the inner wall of the first working part 15 jointly define an injection and suction medium cavity 154 , and the injection and suction medium cavity 154 is fluidically connected to the injection and suction hole 151 .

[0349] The injection and suction inner tube 153 is located in the first tube extension tube 155 and extends into the second isolation part 10. Therefore, the outer wall of the injection and suction inner tube 153 and the inner wall of the first tube extension tube 155 jointly define the injection and suction medium cavity 154. The difference between the outer diameter of the injection and suction inner tube 153 and the inner diameter of the first tube extension tube 155 is 0.01mm-1mm, that is, the gap of the injection and suction medium cavity 154 is 0.01mm-1mm.

[0350] Alternatively, it is also conceivable that the injection and suction inner tube 153 can be a capillary tube arranged side by side with the second medium tube 16, that is, the inner wall of the injection and suction inner tube 153 defines the injection and suction medium cavity 154.

[0351] In addition, the second medium pipe 16 may be only partially or entirely disposed inside the injection and suction inner pipe 153. Alternatively, the second medium pipe 16 may be integrated with the injection and suction inner pipe 153 into one component.

[0352] Please continue to see Fig.33 , one or more of the injection and suction holes 151 can be arranged at a position where the first tube 156 is closer to the second isolation part 10, and penetrate the first tube 156 in the radial direction of the first tube 156. The injection and suction holes 151 at this location are aligned with the proximal end of the injection and suction inner tube 153 (or the injection and suction inner tube 153 slightly crosses the injection and suction holes 151 in the axial direction), so that the liquid in the designated treatment area sucked through the injection and suction holes 151 here can directly enter the injection and suction inner tube 153, reducing the flow path of the liquid. In addition, when a plurality of injection and suction holes 151 are arranged at the connection between the first tube 156 and the first tube extension tube 155, each injection and suction hole 151 can be arranged at equal intervals along the circumference of the first tube 156 (or each injection and suction hole 151 can be arranged in a non-equidistant manner along the circumference of the second tube 193, for example, the distance between each injection and suction hole 151 gradually increases or decreases, etc.).

[0353] Each injection and suction hole 151 is in fluid communication with a designated treatment area, and is used to absorb liquid from the designated treatment area or inject liquid into the designated treatment area (the liquid may be, for example, a chemical drug or a protein coagulant, etc.). Blood, tissue, etc. from the designated treatment area may enter the injection and suction medium cavity 154 through the injection and suction holes 151, and be collected from the distal end of the injection and suction medium cavity 154. Alternatively, the injection and suction medium cavity 154 may inject the required anesthetic drugs, physiological saline, or therapeutic drugs, etc., into the designated treatment area through the injection and suction holes 151.

[0354] The size (aperture, etc.) of each injection and suction hole 151 can be gradually increased along the injection direction, so that the liquid in the injection and suction medium cavity 154 can more easily reach the injection and suction hole 151 closer to the front end.

[0355] Specifically, the liquid inlet and outlet flow rate Q of the injection and suction hole 151 satisfies the following relationship (1):

[0356] Q=KAV (1)

[0357] Wherein: K is the cross-sectional area correction coefficient of the injection and suction hole 151;

[0358] A is the cross-sectional area of ​​the injection and suction hole 151;

[0359] V is the speed of liquid injection through the injection and suction hole 151;

[0360] It can be determined based on parameters such as the type, pressure, flow coefficient, etc. of the pushing and aspiration liquid medium used clinically.

[0361] In order to ensure the uniformity of the liquid flow rate of the injection and suction holes 151 closer to the proximal side of the needle assembly 1 and the injection and suction holes 151 closer to the distal side of the needle assembly 1 in the injection direction, the injection and suction holes 151 can be set to have different sizes (for example, different cross-sectional areas). Therefore, according to the above relationship (1), the liquid flow rate Q of each injection and suction hole 151 is set to be the same or substantially the same, and the size of each injection and suction hole 151 is determined by setting the correction coefficient K.

[0362] Further, K is related to the ratio of the cross-sectional area of ​​the injection and suction hole 151 to the cross-sectional area of ​​the injection and suction medium cavity 154. For example, K may be 0-1.

[0363] Furthermore, for the injection and suction hole 151 with a circular cross-sectional shape, its cross-sectional area A satisfies the following relational expression (2):

[0364] A=π×R×R (2)

[0365] Wherein, π is pi, and R is the radius of the injection and suction hole 151. Therefore, the radius of the injection and suction hole 151 can be determined according to the cross-sectional area A of the injection and suction hole 151.

[0366] The maximum diameter of each injection and suction hole 151 may be 0.05 mm to 10 mm. Each injection and suction hole 151 may be arranged at equal intervals along the injection direction, and each injection and suction hole 151 may have a circular cross section, an elliptical cross section, or a long strip cross section.

[0367] like Fig.33As shown, the proximal side of the needle assembly 1 is sequentially provided from the inside to the outside with the first medium tube 14, the second medium tube 16, the injection and suction inner tube 153, the first tube extension tube 155 and the second isolation part 10, that is, the above components are coaxially arranged. It can be understood that one or more of the components can also be arranged side by side with other components, or partially coaxially arranged.

[0368] The needle assembly 1 further comprises a second isolating tube 18 for isolating the cold medium or the hot medium from the external temperature. The second isolating tube 18 extends inside the injection and suction inner tube 153 so that the outer wall of the second isolating tube 18 and the inner wall of the injection and suction inner tube 153 jointly define an isolating layer 181 .

[0369] The second isolation tube 18 can be made of metal materials such as 314 stainless steel, 316 stainless steel, titanium alloy (TC) or copper (Cu), or can be made of plastic materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), PI (polyimide) or glass fiber.

[0370] The second isolation tube 18 can be a separate layer, which can be located between the second medium tube 16 and the injection and suction inner tube 153. The isolation layer 181 defined jointly by the outer wall of the second isolation tube 18 and the inner wall of the injection and suction inner tube 153 can be an air interlayer, a vacuum interlayer, etc., or it can be filled with a low thermal conductivity plastic material to achieve temperature isolation.

[0371] Optionally, the second isolation portion 10 is configured to be movable along its axial direction, and the handle assembly can drive the second isolation portion 10 to move, thereby changing the length of the second isolation portion 10 covering the first working portion 15, so as to change the exposed length of the first working portion 15, thereby changing the effective length of the first working area (the effective length is the length of the treatment area). Fig.33 As shown, the second insulating portion 10 covers the first tube extension tube 155 and does not cover the injection and suction hole 151 .

[0372] In this movable embodiment, the second isolation portion 10 can be made of metal materials such as 314 stainless steel, 316 stainless steel, titanium alloy (TC) or copper (Cu), or can be made of plastic materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), PI (polyimide) or glass fiber.

[0373] Optionally, the second isolating portion 10 is configured to be immovable, for example, it is fixedly connected to the first tube extension tube 155. In such an immovable embodiment, an insulating coating such as polytetrafluoroethylene (PTFE) or silicone may be provided on the outer surface of the second isolating portion 10, or an insulating film such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or fluorinated ethylene propylene copolymer (FEP) may be provided.

[0374] In an optional embodiment, the needle assembly 1 further includes a temperature measuring element 13, which can be embedded in the needle 11 to measure the temperature of the tissue at the needle 11; or the temperature measuring element 13 can be located in the medium release chamber 12 to measure the temperature of the medium in the medium release chamber 12; or the temperature measuring element 13 can also be arranged on the distal side of the needle assembly 1 to measure the reflux temperature in the reflux channel, or measure the temperature of the normal tissue area contacted by the needle assembly 1. The temperature measuring element 13 can be a temperature sensor, such as a temperature measuring thermocouple or a thermistor (NTC, PTC), etc.

[0375] It is understandable that the temperature measuring element 13 may not be provided in the needle assembly 1, but the temperature of the tissue at the needle 11 may be obtained by other temperature measuring methods.

[0376] Each component specified or not specified in this embodiment 12 can be constructed in the same manner as the components described in the above embodiments 1 to 6, and a person skilled in the art can freely combine embodiment 12 with the above embodiments 1 to 6.

[0377] Embodiment 13

[0378] like Fig.34 As shown, the present invention provides a combined ablation needle, more specifically, it is a composite ablation needle of multiple physical factors, please combine Fig.33 The difference between the combined-action composite ablation needle of the present embodiment 13 and the combined-action composite ablation needle of the above-mentioned embodiment 12 is that a separate second isolation tube 18 is not provided in the present embodiment 13.

[0379] like Fig.34 As shown, since a separate second isolation tube 18 is not provided, the injection and suction medium cavity 154 can be used as a temperature isolation structure, which can be an air interlayer, or the injection and suction inner tube 153 forming the injection and suction medium cavity 154 can be made of a low thermal conductivity plastic insulation material.

[0380] like Fig.34 As shown, the second isolation tube 18 described in the above embodiment 12 can be integrated with the second isolation part 10, that is, form the same element, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0381] The similarities between this embodiment 13 and the above-mentioned embodiment 12 will not be repeated.

[0382] Embodiment 14

[0383] like Fig.35As shown, the present invention provides a combined ablation needle, more specifically, it is a composite ablation needle of multiple physical factors, and please combine Fig.33 and Fig.34 The difference between the combined composite ablation needle of this embodiment 14 and the combined composite ablation needle of the above-mentioned embodiment 12 is that the proximal end of the second medium tube 16 extends to abut against the distal end of the needle 11, so the proximal end of the second medium tube 16 is closed by the distal end of the needle 11, and a cavity structure is formed between the proximal end of the second medium tube 16 and the first medium tube 14, and the cavity structure is the medium release cavity 12.

[0384] Furthermore, a bent tube 162 is provided at the proximal end of the second medium tube 16 , and the diameter of the bent tube 162 is smaller than the diameter of the second medium tube 16 , so that the space between the outer wall of the bent tube 162 and the inner wall of the first tube 156 is increased.

[0385] It can be understood that, due to the provision of the bent tube 162 , the medium release cavity 12 presents a substantially conical cavity with a diameter decreasing toward the needle 11 .

[0386] Optionally, in this embodiment 14, a separate injection and suction inner tube 153 may not be provided, but the space between the outer wall of the second medium tube 16 and the inner wall of the first tube 156 (and the first tube extension tube 155) and the space between the outer wall of the bent tube 162 and the inner wall of the first tube 156 (i.e., the enlarged part of the space mentioned above) may be used as the injection and suction medium cavity 154 to realize the injection and suction function.

[0387] In addition, if Fig.35 As shown, the injection and suction hole 151 in this embodiment 14 is located at the proximal end of the first tube 156 closer to the needle 11, and is connected to the space where the bent tube 162 is located (i.e., the injection and suction medium cavity 154). Fig.35 As shown, a separate second isolation tube 18 is not provided in this embodiment 14, so the injection and suction medium cavity 154 can be used as a temperature isolation structure, which can be an air interlayer, or the injection and suction inner tube 153 forming the injection and suction medium cavity 154 can be made of a low thermal conductivity plastic insulation material.

[0388] like Fig.34 As shown, in this embodiment 14, the second isolation tube 18 described in the above embodiment 12 can be integrated with the second isolation part 10 to form the same element, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0389] Optionally, a separate injection and suction inner tube 153 may also be provided in this embodiment 14, which may be sleeved on the outside of the second medium tube 16. The space formed between the inner wall of the injection and suction inner tube 153 and the outer wall of the second medium tube 16 serves as an injection and suction medium cavity 154 to realize the injection and suction function.

[0390] The similarities between this embodiment 14 and the above-mentioned embodiment 12 will not be repeated again.

[0391] Embodiment 15

[0392] like Fig.36 As shown, the present invention provides a combined composite ablation needle, more specifically, it is a composite ablation needle of multiple physical factors, the combined composite ablation needle of this embodiment 15 is different from the combined composite ablation needle of the above-mentioned embodiment 14 in that the proximal end of the second medium tube 16 is a closed end 163, and a cavity structure is formed between the closed end 163 and the first medium tube 14, and the cavity structure is the medium release cavity 12; there is a certain distance between the closed end 163 and the distal end of the needle 11, so that the space between the closed end 163 and the distal end of the needle 11 serves as a part of the injection and suction medium cavity 154 to realize the suction function.

[0393] In addition, the injection and suction inner tube 153 can be integrated with the second medium tube 16, that is, to form the same element, and the space between the outer wall of the second medium tube 16 and the inner wall of the first tube 156 (and the first tube extension tube 155) serves as a part of the injection and suction medium cavity 154 to realize the injection and suction function.

[0394] The similarities between this embodiment 15 and the above-mentioned embodiment 14 will not be repeated again.

[0395] Example 16

[0396] like Fig.37 As shown, the present invention provides a combined ablation needle, more specifically, it is a composite ablation needle of multiple physical factors, the combined ablation needle of this embodiment 16 is different from the combined ablation needle of the above-mentioned embodiment 12 in that, in this embodiment 16, no separate injection and suction hole 151, injection and suction inner tube 153 and injection and suction medium cavity 154 are provided, but the proximal side opening between the second isolation part 10 and the first working part 15 is constructed as the injection and suction hole 151, and the gap between the second isolation part 10 and the first working part 15 is used as the injection and suction medium cavity 154 to realize the suction function.

[0397] For example, the second isolation part 10 extends to partially cover the first tube extension tube 155, and there is a radial gap between the first tube extension tube 155 and the first tube extension tube 155, which can be used as the injection and suction medium channel 154, and the proximal end of the second isolation part 10 can be used as the injection and suction hole 151, so that the liquid can enter the chamber defined by the inner wall of the second isolation part 10 and the outer wall of the first tube extension tube 155 from the proximal end of the second isolation part 10, or the medicine can flow out of the chamber to the designated treatment area. It can be understood that the second isolation part 10 can also extend to completely cover the first tube extension tube 155.

[0398] The second isolating portion 10 may be formed by Figure 3c or Figure 3d In a similar manner, a step structure may be constructed on the first tube extension tube 155 , and the second isolation portion 10 may be aligned with the first tube extension tube 155 through the step structure, with the outer diameters of the two being consistent; or the second isolation portion 10 may be simply sleeved on the first tube extension tube 155 .

[0399] In this manner, the second isolating portion 10 can move along its axial direction, and the specific movement method has been described in detail in the above embodiments 7, 8, 9 and 10. When the second isolating portion 10 moves along its axial direction, the length of the radial gap between it and the first tube extension tube 155 can be changed, and the position of the open end of the second isolating portion 10 can be changed, that is, the position of the injection and suction hole 151 can be changed. For example, when the second isolating portion 10 moves along its axial direction away from the needle 11, the length of the radial gap between it and the first tube extension tube 155 decreases, and the position of the injection and suction hole 151 is farther away from the needle 11; when the second isolating portion 10 moves along its axial direction toward the needle 11, the length of the radial gap between it and the first tube extension tube 155 increases, and the position of the injection and suction hole 151 is closer to the needle 11.

[0400] The size of the injection and suction hole 151 defined by the open end of the second isolation part 10 and the first working part 15 may be 0.01 mm-1 mm, for example, it may be the difference between the inner diameter of the second isolation part 10 and the outer diameter of the first tube extension tube 155 .

[0401] It can be understood that the width of the injection and suction medium cavity 154 (ie, the radial dimension) can also be 0.01 mm-1 mm.

[0402] It is conceivable that a plurality of radial openings may be provided at intervals in the circumferential direction of the second isolating portion 10 , which are connected to the injection and suction medium cavity 154 and may also be used as the injection and suction holes 151 .

[0403] The second medium pipe 16 is arranged inside the first pipe extension pipe 155, and a second isolation pipe 18 can be arranged outside the second medium pipe 16. Since a separate injection and suction inner pipe 153 is not arranged in this embodiment 16, the outer wall of the second isolation pipe 18 and the inner wall of the first pipe extension pipe 155 jointly define an isolation layer 181. Alternatively, the second medium pipe 16 and the second isolation pipe 18 are integrated into the same component, and the outer wall thereof and the inner wall of the first pipe extension pipe 155 jointly define an isolation layer 181.

[0404] The isolation layer 181 may also be an air interlayer, a vacuum interlayer, etc., or may be filled with a plastic material with low thermal conductivity to achieve temperature isolation.

[0405] The similarities between this embodiment 16 and the above-mentioned embodiment 12 will not be repeated again.

[0406] All components specified or not specified in this embodiment 16 can be constructed in the same manner as the components described in one or more of the above embodiments 12, 13, 14 and 15. For example, all components of the first working part 15 and the second isolation tube 18 that are not described in detail in this embodiment 16 can adopt the structural form of the corresponding components described in one or more of the above embodiments 12, 13, 14 and 15. Moreover, those skilled in the art can freely combine embodiment 16 with one or more of the above embodiments 12, 13, 14 and 15.

[0407] Embodiment 17

[0408] like Fig.38 As shown, the present invention provides a combined ablation needle, more specifically, a multiple physical factor composite ablation needle. Fig.33 The difference between the combined action composite ablation needle of this embodiment 17 and the combined action composite ablation needle of the above embodiment 12 is that a separate second medium tube 16 is not provided in this embodiment 17. Fig.38 As shown, the inner wall of the first tube 156 and the outer wall of the first medium tube 14 and the inner wall of the first tube extension tube 155 and the outer wall of the first medium tube 14 jointly define a second medium cavity 161, ie, an inlet channel or a return channel of the medium.

[0409] Furthermore, the difference between the present embodiment 17 and the above-mentioned embodiment 12 is that a separate second isolation tube 18 is not provided in the present embodiment 17, but the second isolation tube 18 in the above-mentioned embodiment 12 can be integrated with the second isolation part 10, that is, forming the same element, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0410] The similarities between this embodiment 17 and the above-mentioned embodiment 12 will not be repeated again.

[0411] Embodiment 18

[0412] The present invention provides a combined-action composite ablation needle, comprising the needle assembly 1 described in one or more of the above-mentioned embodiments 12 to 17, and also comprising a handle assembly, wherein the distal end of the needle assembly 1 in each of the above-mentioned embodiments 12 to 17 is connected to the handle assembly. The first working portion 15 and the second isolation portion 10 both extend into the handle assembly.

[0413] The handle assembly can be, for example, the straight-push handle assembly described in the above embodiment 7, which adjusts the effective length of the first working part 15 by pushing or pulling; or the handle assembly can be the rotary handle assembly described in the above embodiments 8 and 9, which adjusts the effective length of the first working part 15 by rotating the knob 53 at the proximal end of the handle assembly; or the handle assembly can be the sliding push handle assembly described in the above embodiment 10, which adjusts the effective length of the first working part 15 by combining the two motion modes of movement and rotation, and can solve the problem of stagnation and improve the aesthetics of the handle assembly. Therefore, it will not be described in detail.

[0414] In addition, the ablation system of the present invention may include the combined-acting composite ablation needle described in the above-mentioned Examples 12 to 17, and the handle assembly described in Examples 7 to 10, and may also include one or more of a medium source (such as a cold source, a heat source, etc.), a drug delivery device, and an energy source (such as a radio frequency energy source, a pulsed electric field energy source, and a direct current power supply, etc.).

[0415] It should be noted that the “proximal end” and “proximal side” mentioned herein refer to the end or side close to the needle tip of the needle 11 , and the “distal end” and “distal side” refer to the end or side away from the needle tip of the needle 11 .

[0416] Although the present invention has been described with reference to preferred embodiments, various modifications may be made thereto and parts thereof may be replaced by equivalents without departing from the scope of the present invention. In particular, the various technical features mentioned in the various embodiments may be combined in any manner as long as there are no structural conflicts. The present invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A direct-push composite ablation needle, characterized in that: The invention comprises a needle assembly (1) and a straight-push handle assembly, wherein the needle assembly (1) comprises a first working portion (15), a second working portion (19) and a first isolating portion (17), wherein the first isolating portion (17) separates the first working portion (15) from the second working portion (19); The first working part (15) and / or the second working part (19) is / are covered with a second isolating part (10) on the outside, the second isolating part (10) being connected to the direct-push handle assembly, and the direct-push handle assembly is capable of moving the second isolating part (10) relative to the first working part (15) or the second working part (19) to change the effective length of the first working part (15) and / or the second working part (19); The handle assembly comprises a first shell (203), one end of the second isolation portion (10) is arranged in the first shell (203), and the other end of the second isolation portion (10) extends from one side of the first shell (203) and covers one or both of the first working portion (15) and the second working portion (19); The second isolation portion (10) is connected to a mobile drive assembly (300), and the mobile drive assembly (300) is configured to unlock the first housing (203) when it is pushed, thereby driving the second isolation portion (10) to move along the axial direction of the second isolation portion (10) to change the effective length of the first working portion (15) and / or the second working portion (19); when the mobile drive assembly (300) is not pushed, it is locked with the first housing (203), thereby fixing the second isolation portion (10) at a current position; The mobile driving assembly (300) comprises a pushing member (301), a positioning member (302), a moving seat (303) and an elastic member (304); the pushing member (301) and the elastic member (304) are respectively arranged on two sides of the positioning member (302); and the second isolation portion (10) is fixedly connected to the moving seat (303); A portion of the pushing member (301) is located outside the first shell (203) and is movably connected to the first shell (203); by applying a force on the pushing member (301), the pushing member (301) can be pushed to move along the axial direction of the second isolation portion (10); The movable seat (303) is provided with a deformation cavity (3032), a support block (3033) is provided in the deformation cavity (3032), the elastic member (304) is provided on the support block (3033), and the deformation cavity (3032) provides a space for elastic deformation of the elastic member (304).

2. The direct-push composite ablation needle according to claim 1, characterized in that: The first working part (15) comprises a needle (11) and a first tube (156) connected to the distal end of the needle (11), the needle (11) and / or the first tube (156) being provided with a coating, and the needle (11) and / or the first tube (156) being capable of independently releasing radio frequency energy, pulsed electric field energy or electrolytic energy; The second working part (19) comprises a second tube (193), a coating is provided on the second tube (193), and the second tube (193) is capable of independently releasing radio frequency energy, pulse electric field energy or electrolytic energy; The needle (11) and / or the first tube (156) can also release radio frequency energy, pulsed electric field energy or electrolytic energy to the second tube (193) in combination.

3. The direct-push composite ablation needle according to claim 1, characterized in that: The needle assembly (1) further comprises a first medium tube (14) and a second medium tube (16) arranged outside the first medium tube (14), wherein the first medium tube (14) and the second medium tube (16) both extend inside the first working portion (15), the first isolating portion (17) and the second working portion (19); The inner wall of the first medium tube (14) defines a first medium cavity, the outer wall of the first medium tube (14) and the inner wall of the second medium tube (16) jointly define a second medium cavity (161), and the first working part (15) and the second working part (19) are capable of releasing freezing energy or thermal energy individually or in combination through the first medium cavity and the second medium cavity (161).

4. The direct-push composite ablation needle according to claim 3, characterized in that: The needle assembly (1) further comprises an injection and suction inner tube (153) and at least one injection and suction hole (151), wherein the injection and suction inner tube (153) extends inside the first working portion (15), the first isolation portion (17) and the second working portion (19), and the outer wall of the injection and suction inner tube (153) and the inner wall of the first working portion (15) jointly define an injection and suction medium cavity (154), and the injection and suction medium cavity (154) and the injection and suction hole (151) are in fluid communication; One of the first working part (15), the first isolating part (17) and the second working part (19) can achieve chemical ablation individually through the injection and suction hole (151); or multiple of the first working part (15), the first isolating part (17) and the second working part (19) can achieve chemical ablation in combination through the injection and suction hole (151).

5. The direct-push composite ablation needle according to claim 4, characterized in that: The needle assembly (1) further comprises a second isolation tube (18) for temperature isolation, wherein the second isolation tube (18) is a separate layer located between the second medium tube (16) and the injection / absorption inner tube (153), or the second isolation tube (18) is constructed in the second isolation part (10) so that the second isolation part (10) can achieve temperature isolation.

6. The direct-push composite ablation needle according to claim 1, characterized in that: A plurality of positioning grooves (3001) are arranged at intervals on the first shell (203); a pushing groove (3003) is arranged on a side of the pushing member (301) close to the positioning member (302); the pushing groove (3003) is constructed as a wedge-shaped groove, and the inner wall of the wedge-shaped groove is an inner wall inclined relative to the positioning member (302); When the positioning member (302) is aligned with the positioning groove (3001), the elastic member (304) pushes the positioning member (302) to move upwards to be inserted into the positioning groove (3001), thereby locking the mobile drive assembly (300) with the first shell (203); when the pushing member (301) is pushed and moves along the axial direction of the second isolation portion (10), the inner wall of the pushing groove (3003) prompts the positioning member (302) to move in a direction close to the elastic member (304) and causes the elastic member (304) to undergo elastic deformation until the positioning member (302) is disengaged from the positioning groove (3001), thereby unlocking the mobile drive assembly (300) with the first shell (203).

7. The direct-push composite ablation needle according to claim 1, characterized in that: The handle assembly further comprises a second shell (602), wherein the second shell (602) is connected to the first shell (203), wherein a needle bar seat (601) is further provided in the first shell (203), and the needle assembly (1) is conductively connected to one side of the needle bar seat (601) after passing through the movable seat (303).

8. An ablation system, characterized in that: The direct-push composite ablation needle comprises any one of claims 1 to 7, and further comprises one or more of a medium source, a drug delivery device, and an energy source.

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