Combined ablation needle and ablation system

By designing a composite ablation needle and combining multiple physical factor ablation methods, the problem of being unable to select multiple treatment methods under the same ablation device in existing technologies has been solved, achieving more flexible and effective tumor treatment.

CN118697450BActive Publication Date: 2025-09-16HYGEA MEDICAL TECH CO LTD
View PDF 2 Cites 0 Cited by

Patent Information

Application Number
CN202410841162.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-06-13
Publication Date
2025-09-16
Estimated Expiration
2044-06-13

AI Technical Summary

Technical Problem

Existing tumor ablation treatment systems cannot select multiple ablation treatment methods under the same ablation device, and cannot perform comprehensive treatment based on the specific conditions of clinical tumor lesions.

Method used

A combined composite ablation needle is designed, comprising a needle assembly and an ablation system. The needle assembly includes a first and a second working part, which can release a variety of physical factors such as pulsed electric field, radio frequency, electrolysis, freezing and thermal energy, and achieve chemical ablation through a medium release cavity and an injection and suction hole, supporting the combination of multiple ablation methods.

Benefits of technology

It enables the selection of two or more ablation treatment modes under the same needle assembly, enhances the treatment effect, and adapts to the needs of different tumor lesions.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN118697450B_ABST
    Figure CN118697450B_ABST
Patent Text Reader

Abstract

The present invention relates to a combined composite ablation needle and ablation system. The present invention provides a direct-push composite ablation needle, including a needle assembly, wherein the needle assembly includes a first working part and a second isolation part, the first working part includes a needle, a first tube connected to the distal side of the needle, and a first tube extension tube connected to the distal side of the first tube, and the first tube extension tube extends into the second isolation part; in one embodiment, the needle and / or the first tube can be conductive to release pulsed electric field energy, radio frequency energy or electrolysis energy; a medium release cavity is provided in the first tube, and the medium release cavity can release freezing energy or thermal energy; the needle assembly also includes an injection and suction hole, which is provided on the first working part or jointly defined by the first working part and the second isolation part, and the injection and suction hole connects the inside and outside of the needle assembly to achieve chemical ablation.
Need to check novelty before this filing date? Find Prior Art

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 field of ablation technology, and in particular to a combined-action composite ablation needle and an ablation system. Background Art

[0003] Tumor ablation techniques generally include chemical ablation and energy-based ablation. Chemical ablation involves injecting chemicals directly into the tumor to inhibit tumor growth. Energy ablation can be categorized by different working principles, including radiofrequency ablation, cryoablation, and pulsed electric field ablation. Currently, treatment systems for chemical ablation and energy ablation methods such as radiofrequency, cryoablation, and pulsed electric field ablation are relatively independent and generally utilize a single-mode physical effect for ablation. Therefore, it is not possible to select two or more ablation treatment methods using the same ablation device based on the clinical tumor lesion. Summary of the Invention

[0004] The present invention provides a combined-action composite ablation needle and ablation system to solve the above-mentioned technical problems.

[0005] According to a first aspect of the present invention, there is provided a combined action composite ablation needle comprising a needle assembly, the needle assembly comprising a first working portion and a second isolating portion, the first working portion comprising a needle, a first tube connected to a distal end of the needle, and a first tube extension tube connected to a distal end of the first tube, the first tube extension tube extending into the second isolating portion;

[0006] In one embodiment, the needle and / or the first tube are capable of conducting electricity to release pulsed electric field energy, radio frequency energy or electrolysis energy; a medium release cavity is provided in the first tube, and the medium release cavity is capable of releasing freezing energy or thermal energy; the needle assembly also includes an injection and suction hole, which is provided on the first working part or jointly defined by the first working part and the second isolation part, and the injection and suction hole connects the inside and outside of the needle assembly to achieve chemical ablation.

[0007] The needle assembly also includes a first medium tube and a second medium tube arranged outside the first medium tube, the proximal end of the second medium tube extends to abut against the distal end of the needle, and the medium release cavity is a cavity structure formed between the proximal end of the second medium tube and the first medium tube.

[0008] In one embodiment, the needle assembly further includes a first medium tube and a second medium tube disposed outside the first medium tube, the proximal end of the second medium tube is a closed end, and the medium release cavity is a cavity structure formed between the closed end and the first medium tube.

[0009] In one embodiment, the needle assembly also includes an injection medium cavity and at least one injection hole connected to the fluid of the injection medium cavity, and the injection medium cavity is jointly defined by the inner wall of the first tube extension tube and the outer wall of the injection inner tube located in the first tube extension tube, by the inner wall of the injection inner tube arranged side by side with the second medium tube, or by the outer wall of the second medium tube and the inner wall of the injection inner tube sleeved on the outside of the second medium tube.

[0010] In one embodiment, when there are multiple injection and suction holes, the diameter of each injection and suction hole gradually increases along the injection direction.

[0011] In one embodiment, at least one of the injection and suction holes is provided on the first tube and penetrates the first tube in a radial direction of the first tube.

[0012] In one embodiment, the second medium tube includes a bent tube arranged at its proximal end, the bent tube extends to abut against the distal end of the needle, and at least one of the injection and suction holes is located at the proximal end of the first tube and closer to the needle.

[0013] In one embodiment, the needle assembly further comprises a second isolation tube, which is located between the second medium tube and the injection and suction inner tube, disposed inside the first tube extension tube, or integrated into the second isolation portion (10).

[0014] The outer wall of the second isolation tube and the inner wall of the injection and suction inner tube jointly define an isolation layer for achieving temperature isolation, or the outer wall of the second isolation tube and the inner wall of the first tube extension tube jointly define an isolation layer for achieving temperature isolation.

[0015] In one embodiment, the needle assembly further comprises an injection medium cavity and at least one injection hole fluidically connected to the injection medium cavity, the injection hole being configured as a proximal side opening between the second isolation portion and the first working portion, and the injection medium cavity being configured as a gap between the second isolation portion and the first working portion.

[0016] In one embodiment, the second isolating portion is connected to a handle assembly, and the handle assembly is capable of moving the second isolating portion along its circumference to change the length of the radial gap between the second isolating portion and the first tube extension tube, as well as the position of the open end of the second isolating portion. The handle assembly is a straight-push handle assembly, a rotary handle assembly, or a sliding-propelled handle assembly.

[0017] According to a second aspect of the present invention, the present invention provides an ablation system, comprising two of the above-mentioned combined-action composite ablation needles; the ablation system further comprises one or more of a medium source, a drug delivery device, and an energy source.

[0018] Compared with the existing technology, 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 lesion, two or more treatment methods can be selected under the same needle assembly to achieve enhanced treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Hereinafter, the present invention will be described in more detail based on embodiments with reference to the accompanying drawings.

[0020] Figure 1 is a cross-sectional view of the needle assembly in Example 1 of the present invention;

[0021] Figure 2 is a cross-sectional view of a needle assembly in Example 2 of the present invention;

[0022] Figure 3a is a cross-sectional view of an optional needle assembly in Example 3 of the present invention;

[0023] Figure 3b is a cross-sectional view of another optional needle assembly in Example 3 of the present invention;

[0024] Figure 3c yes Figure 3a The enlarged view of point I in the middle;

[0025] Figure 3d yes Figure 3b Enlarged view of position II in the middle;

[0026] Figure 3e This is a schematic structural diagram of another optional needle assembly in Example 3 of the present invention;

[0027] Figure 4 is a cross-sectional view of a needle assembly in Example 4 of the present invention;

[0028] Figure 5is a cross-sectional view of a needle assembly in Example 5 of the present invention;

[0029] Figure 6a is a cross-sectional view of a needle assembly in Example 6 of the present invention;

[0030] Figure 6b is a schematic diagram of the shapes of the first dielectric hole and the second dielectric hole in Example 6 of the present invention;

[0031] 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;

[0032] 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;

[0033] 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;

[0034] 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;

[0035] Figure 7a and Figure 7b is a cross-sectional view of a handle assembly in Example 7 of the present invention;

[0036] Figure 8 is an enlarged view of the front end of the handle assembly in Example 7 of the present invention;

[0037] Figure 9 is a schematic structural diagram of the locking of the mobile drive assembly and the first housing in Example 7 of the present invention;

[0038] Figure 10 2 is a schematic structural diagram of the unlocking of the mobile drive assembly and the first housing in Example 7 of the present invention;

[0039] Figure 11 yes Figure 9 A schematic diagram of the three-dimensional structure of the mobile seat shown;

[0040] Figure 12 yes Figure 7b A cross-sectional view of the second housing is shown;

[0041] Figure 13a and Figure 13b is a cross-sectional view of a handle assembly in Example 8 of the present invention;

[0042] Figure 14 is a schematic diagram of the three-dimensional structure of the handle assembly in Example 8 of the present invention;

[0043] Figure 15is a schematic diagram of the internal structure of the handle assembly in Example 8 of the present invention;

[0044] Figure 16 Schematic diagram of the structure of the slider and the scale ring in Example 9 of the present invention;

[0045] Figure 17 yes Figure 16 A schematic diagram of the three-dimensional structure of the slider shown;

[0046] Figure 18 is a schematic diagram of the three-dimensional structure of the slider in Example 9 of the present invention;

[0047] Figure 19a and Figure 19b is a cross-sectional view of a handle assembly in embodiment 10 of the present invention;

[0048] Figure 20 is a top view of the handle assembly in embodiment 10 of the present invention;

[0049] Figure 21a yes Figure 20 A schematic diagram of the three-dimensional structure of the sliding propulsion mechanism shown;

[0050] Figure 21b yes Figure 20 A cross-sectional view of the sliding propulsion mechanism shown;

[0051] Figure 21c yes Figure 21a Schematic diagram of the three-dimensional structure of the double torsion spring shown;

[0052] Figure 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;

[0053] 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;

[0054] Figure 22c is a top view of the handle assembly in embodiment 10 of the present invention, wherein the pushing portion is hidden;

[0055] Figure 23a is a radial cross-sectional view of the handle assembly in embodiment 10 of the present invention;

[0056] Figure 23b is a schematic structural diagram of a double torsion spring in a compressed state in embodiment 10 of the present invention;

[0057] Figure 23c is a schematic structural diagram of a double torsion spring in a natural state in embodiment 10 of the present invention;

[0058] Figure 24 yes Figure 20 The enlarged view of point I in the middle;

[0059] Figure 25 Schematic diagram of the three-dimensional structure of the shielding structure in Example 10 of the present invention

[0060] Figure 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;

[0061] Figure 27 Schematic diagram of a push button in a housing slide groove in a process position in embodiment 10 of the present invention;

[0062] Figure 28 is a schematic diagram of a push button in a terminal position in a housing slide slot in embodiment 10 of the present invention;

[0063] Figure 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;

[0064] Figure 30 is a schematic diagram of a locating groove located on the right side of the housing slide groove in embodiment 10 of the present invention;

[0065] Figure 31 Schematic diagram of the staggered distribution of the positioning grooves on the left and right sides of the casing slide groove in embodiment 10 of the present invention;

[0066] Figure 32 Schematic diagram showing that the positioning grooves are symmetrically distributed on the left and right sides of the casing slide groove in embodiment 10 of the present invention;

[0067] Figure 33 is a cross-sectional view of a needle assembly in Example 12 of the present invention;

[0068] Figure 34 is a cross-sectional view of a needle assembly in Example 13 of the present invention;

[0069] Figure 35 is a cross-sectional view of a needle assembly in Example 14 of the present invention;

[0070] Figure 36 is a cross-sectional view of a needle assembly in Example 15 of the present invention;

[0071] Figure 37 is a cross-sectional view of a needle assembly in Example 16 of the present invention;

[0072] Figure 38 is a cross-sectional view of the needle assembly in Example 17 of the present invention.

[0073] Reference numerals:

[0074] 1. Needle assembly;

[0075] 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;

[0076] 111. Needle coating; 141. Inlet channel;

[0077] 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;

[0078] 161. Second medium cavity; 162. Bent tube; 163. Closed end;

[0079] 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;

[0080] 203, first shell; 2001, treatment area;

[0081] 300, mobile drive assembly;

[0082] 301, pushing member; 302, positioning member; 303, moving seat; 304, elastic member;

[0083] 3001, positioning slot; 3002, receiving slot; 3003, pushing slot; 3004, sliding slot;

[0084] 3031, guide platform; 3021, guide groove; 3032, deformation cavity; 3033, support block;

[0085] 601, needle bar seat; 602, second housing; 6002, cable;

[0086] 6003, insulating end face; 6004, operating hole; 6021, first boss; 6022, mounting groove; 6023, second boss; 6005, second boss end face;

[0087] 53. Knob; 54. Seal; 55. Handle front shell; 56. Slider; 57. Scale ring; 58. Handle back shell; 59. LED light board;

[0088] 531, first sealing groove; 532, limiting groove; 533, sliding groove; 534, rotating part; 535, connecting part;

[0089] 551, wedge-shaped protruding ring; 552, internal thread; 553, locking block;

[0090] 561, pillar; 562, notch structure; 563, sliding sleeve; 564, spiral notch entrance; 565, spiral notch;

[0091] 581, shaft hole; 582, locking groove; 583, connecting hole; 584, second sealing groove; 585, protrusion;

[0092] 41, housing; 411, housing slide; 413, positioning groove; 412, left housing; 416, right housing; 414, pin receiving portion; 415, housing scale line;

[0093] 4131, neck portion; 4132, open portion; 4133, trough body;

[0094] 43. Push button; 431. Pushing portion; 432. Fitting portion; 433. Sleeve; 434. Double torsion spring; 4311. Push button scale line; 4031. Connecting hole; 4032. Cavity structure; 4033. Conical transition portion;

[0095] 4341, inner pin; 4342, torsion spring coil; 4343, outer pin;

[0096] 44, cover; 441, spiral chute; 4411, open end; 4412, closed end. DETAILED DESCRIPTION

[0097] The present invention will be further described below with reference to the accompanying drawings.

[0098] 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.

[0099] The following will describe in detail various embodiments of the various types of composite ablation needles of the present invention. It should be noted that the same reference numerals are used for the same components or assemblies in the various embodiments of the present invention, and the embodiments are not intended to limit the scope of the present invention, and the embodiments can be freely combined.

[0100] Example 1

[0101] like Figure 1As shown, the present invention provides a composite ablation needle, more specifically, a composite ablation needle with multiple physical factors, 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 that can cover one or more of the first working part 15, the first isolation part 17 and the second working part 19.

[0102] 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 .

[0103] The first working portion 15 is configured to function independently 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 region. The second working portion 19 is also configured to function independently 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 region.

[0104] Furthermore, the first working portion 15 and the second working portion 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.

[0105] 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.

[0106] Optionally, a cold medium or a 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 treatment with different physical effects of cryoablation (or thermal ablation) and chemical ablation.

[0107] Optionally, the first working part 15 acts as a 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 acts as a 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.

[0108] Optionally, the first working portion 15 and the second working portion 19 serve as two paired poles, respectively, so that the first working portion 15 and the second working portion 19 jointly release radiofrequency energy, pulsed electric field energy, or electrolytic energy to achieve corresponding energy ablation. For example, one of the first working portion 15 and the second working portion 19 serves as the positive pole and the other serves as the negative pole to form a discharge circuit, thereby releasing radiofrequency energy, that is, the first working portion 15 and the second working portion 19 can jointly release radiofrequency energy to achieve radiofrequency ablation. Alternatively, the first working portion 15 and the second working portion 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 portion 15 and the second working portion 19 can jointly release pulsed electric field energy to achieve pulsed electric field energy ablation. Alternatively, the first working part 15 and the second working part 19 form a cathode and an anode, respectively, and the designated treatment area can serve 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.

[0109] 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 multiple energies.

[0110] 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 .

[0111] 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.

[0112] The needle 11 is used for puncture, so the shape of the needle tip at the front end of the needle 11 can be a triangular prism, a cone, a semicircle, or the like, which is convenient for puncturing the skin, tissue, and treatment area.

[0113] If the needle 11 is too short, it may not reach the designated treatment area. If it is too long, the treatment effect may be affected. Therefore, the length of the needle 11 is generally between 1 mm and 50 mm, or preferably between 5 mm and 50 mm, for example, 10 mm. If the outer diameter of the needle 11 is too small, the rigidity and visualization of the needle 11 may be insufficient, thereby affecting the clinical puncture effect. Conversely, if the outer diameter of the needle 11 is too large, the resistance to puncture may increase, and the treatment trauma to the patient may be increased. 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.

[0114] 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.

[0115] The needle tip 11 may also be coated to prevent tissue adhesion during treatment or corrosion caused by electrolysis on the needle surface. For example, this may be a needle tip coating 111 or an anti-adhesion membrane. The needle tip coating 111 may be made of an insulating material such as polytetrafluoroethylene (PTFE) or titanium nitride, or it may be made of a conductive, heat-resistant, anti-adhesion material.

[0116] The first tube 156 and the first tube extension tube 155 can be constructed separately or integrally formed. 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 between the two, or the diameters therebetween are gradually reduced, that is, the first tube 156 transitions to the first tube extension tube 155 at a certain cone angle.

[0117] The first tube 156 and the first tube extension tube 155 can be made of the same material, for example, a medical metal material (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium, or other metal or alloy material). Alternatively, the first tube 156 and the first tube extension tube 155 can be made of different materials.

[0118] 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, to prevent tissue adhesion during treatment. The coating may be, for example, a coating made of a heat-resistant, anti-adhesive material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesive heat shrink film made of materials such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0119] It is understood that when the first working portion 15 releases RF energy, pulsed electric field energy, or electrolytic energy alone, or in combination with the second working portion 19, the needle 11 and / or first tube 156 of the first working portion 15 can serve as one of the aforementioned electrodes. Therefore, the needle 11 and / or first tube 156 is coated with a conductive coating made of a conductive, heat-resistant, and anti-adhesive material, making the needle 11 and / or first tube 156 conductive. The first and second isolation portions 17 and 10 prevent energy from escaping to non-treatment areas. The thickness of the conductive coating can be 0.01-0.1 mm.

[0120] like Figure 1 As shown, the interior of the first tube 156 defines a 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 can be the same as or greater than the length of the first tube 156. The medium can release energy in the medium release chamber 12, which can be used for cooling during thermal ablation or heat exchange during cold ablation.

[0121] The medium may be, for example, a cold medium (such as liquid nitrogen, high-pressure gas, liquid metal or cooling water), or a hot medium such as liquid (alcohol).

[0122] 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 . Both the first medium tube 14 and the second medium tube 16 extend inside the first working portion 15 , the first isolation portion 17 , and the second working portion 19 .

[0123] The inner wall of first medium tube 14 defines a first medium channel, which can serve as either an inlet or return channel for the medium. The outer wall of first medium tube 14 and the inner wall of second medium tube 16 jointly define a second medium channel 161, which can serve as the other of the inlet and return channels. The inlet and return channels are fluidically connected via medium release cavity 12. Cryoablation and thermal ablation can be achieved through the inlet and return channels.

[0124] 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 return channel. The cold medium or hot medium from the cold source or heat source can be input into 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 return 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.

[0125] 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 disposed 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 disposed adjacent to the first medium pipe 14, and the two are coaxially disposed. It is conceivable that the second medium pipe 16 can also be disposed side by side adjacent to the first medium pipe 14.

[0126] 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.

[0127] In addition, if Figure 1 As 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.

[0128] 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 1As shown, first isolation portion 17 includes a first isolation tube 172 disposed outside first tube extension tube 155 and a first isolation tube extension tube 171 connected to the distal end of first isolation tube 172. First isolation tube extension tube 171 extends into second working portion 19. The outer diameter of first isolation tube extension tube 171 is smaller than the inner diameter of first isolation tube 172, thereby forming a step structure between the first isolation tube 171 and the first isolation tube 172, or a gradually decreasing diameter between the first isolation tube 172, that is, the first isolation tube 172 transitions to the first isolation tube extension tube 171 at a certain taper angle.

[0129] 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 total length of the first isolation tube 172 and the first isolation tube extension tube 171 can be, for example, 5 mm to 200 mm or 5 mm to 60 mm.

[0130] The second working part 19 can form a working electrode pair with the first working part 15, and release corresponding working energy to the tissue between the two working areas, or the second working part 19 and the first working part 15 can release working energy separately through the third circuit. The second working part 19 can adopt a similar structure to 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 .

[0131] The second tube 193 and the second tube extension tube 192 can be constructed separately or integrally formed. 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 between the two, or the diameters therebetween are gradually reduced, that is, the second tube 193 transitions to the second tube extension tube 192 at a certain cone angle.

[0132] The second tube 193 and the second tube extension tube 192 can be made of the same material, for example, a medical metal material (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium, or other metal or alloy material). Alternatively, the second tube 193 and the second tube extension tube 192 can be made of different materials.

[0133] The outer surface of the second tube 193 may also be provided with a coating to prevent tissue adhesion during treatment. For example, the coating may be a second working area coating 191 made of a heat-resistant, anti-adhesive material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesive heat shrink film made of a material such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0134] It can be understood that when the second working portion 19 releases radiofrequency energy, pulsed electric field energy, or electrolytic energy alone, or when the second working portion 19 and the first working portion 15 are combined to release radiofrequency energy, pulsed electric field energy, or electrolytic energy, the second tube 193 of the second working portion 19 can be used as one of the poles described above. Therefore, the coating on the second working portion 19 is a conductive coating made of a conductive, heat-resistant, and anti-adhesive material. The conductive coating can transmit radiofrequency energy, pulsed electric field energy, or electrolytic energy to the designated treatment area, and the first isolation portion 17 and the second isolation portion 10 can prevent energy from flowing out of non-treatment areas. The first tube 156 (or the needle 11 and the first tube 156) defines the length of the first working area, which can be 1 mm to 50 mm, for example, 20 mm. The second tube 193 defines the length of the second working area, which can be 1 mm to 50 mm, for example, 20 mm. The length of the first working area and the length of the second working area can be the same or different.

[0135] The needle assembly 1 further includes an injection and suction inner tube 153 and at least one injection and suction hole 151 , through which chemical ablation can be achieved.

[0136] 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. The outer wall of the injection and suction inner tube 153 and the inner wall of the first working part 15 jointly define the injection and suction medium cavity 154. The injection and suction medium cavity 154 is fluidically connected to the injection and suction hole 151.

[0137] The inner injection and suction 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 inner injection and suction 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 inner injection and suction 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.

[0138] Alternatively, it is also conceivable that the inner injection and suction tube 153 may be a capillary tube arranged side by side with the second medium tube 16 , that is, the inner wall of the inner injection and suction tube 153 defines the injection and suction medium cavity 154 .

[0139] In addition, the second medium pipe 16 may be provided only partially or entirely 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.

[0140] Please continue to see Figure 1One or more of the injection and suction holes 151 can be disposed at the connection between the first tube 156 and the first tube extension tube 155, and can extend radially through the first tube 156. Because the injection and suction holes 151 are located at the axially forward end, they are aligned with the proximal end of the inner injection and suction tube 153. Liquid drawn from the designated treatment area through the injection and suction holes 151 can enter the inner injection and suction tube 153 directly, reducing the liquid's flow path. Furthermore, when multiple injection and suction holes 151 are disposed at the connection between the first tube 156 and the first tube extension tube 155, the injection and suction holes 151 can be equally spaced along the circumference of the first tube 156 (or the injection and suction holes 151 can be arranged at non-equidistant intervals along the circumference of the second tube 193, such as with the distance between the injection and suction holes 151 gradually increasing or decreasing).

[0141] Furthermore, one or more of the injection and suction holes 151 can be positioned on the second tube 193 near the first isolation tube 172, and can 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. Multiple injection and suction holes 151 can also be provided on the second tube 193, and each injection and suction hole 151 can be equally spaced 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, with the distance between each injection and suction hole 151 gradually increasing or decreasing). Furthermore, 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, similarly reducing the liquid flow path. The distance between each injection and suction hole 151 can range from 1 mm to 50 mm.

[0142] Each injection / suction hole 151 is fluidically connected to a designated treatment area and is used to draw liquid from or inject liquid (e.g., a chemical or protein coagulant) into the designated treatment area. Blood, tissue, etc. from the designated treatment area can enter the injection / suction medium channel 154 through the injection / suction hole 151 and be collected from the distal end of the injection / suction medium channel 154. Alternatively, the injection / suction medium channel 154 can deliver desired anesthetics, saline, or therapeutic drugs, etc., to the designated treatment area through the injection / suction hole 151.

[0143] The size (pore diameter, etc.) of each injection and suction hole 151 can gradually increase 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.

[0144] Specifically, the liquid inlet and outlet flow rates Q of the injection and suction holes 151 satisfy the following relationship (1):

[0145] Q=KAV (1)

[0146] Wherein: K is the cross-sectional area correction coefficient of the injection and suction hole 151;

[0147] A is the cross-sectional area of ​​the injection and suction hole 151;

[0148] V is the speed of liquid injection and suction through the injection and suction hole 151;

[0149] It can be determined based on parameters such as the type, pressure, flow coefficient, etc. of the push and aspiration liquid medium used clinically.

[0150] To ensure uniformity in the liquid flow rate between the injection holes 151 closer to the proximal end of the needle assembly 1 and the injection holes 151 closer to the distal end of the needle assembly 1 in the injection direction, the injection 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 hole 151 is set to be the same or substantially the same, and the size of each injection hole 151 is determined by setting the correction coefficient K.

[0151] Furthermore, 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.

[0152] Furthermore, for the injection and suction hole 151 having a circular cross-sectional shape, its cross-sectional area A satisfies the following relational expression (2):

[0153] A=π×R×R (2)

[0154] 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.

[0155] The maximum diameter of each injection and suction hole 151 can be 0.05 mm to 10 mm. The injection and suction holes 151 can be arranged at equal intervals along the injection direction, and each injection and suction hole 151 can have a circular cross-section, an elliptical cross-section, or a long strip cross-section.

[0156] like Figure 1 As shown, the proximal side of the needle assembly 1 comprises, from inside to outside, 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; alternatively, 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 portion 10. In other words, the aforementioned components are coaxially arranged. It is understood that one or more of these components may also be arranged side by side with other components, or partially coaxially.

[0157] The needle assembly 1 further includes a second isolation tube 18 for isolating the cold medium or hot medium from the external temperature. The second isolation tube 18 extends inside the injection and suction inner tube 153, so that the inner wall of the second isolation tube 18 and the outer wall of the injection and suction inner tube 153 jointly define an isolation layer 181.

[0158] 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.

[0159] 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 jointly defined by the inner wall of the second isolation tube 18 and the outer 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.

[0160] Optionally, the second isolating portion 10 is configured to be movable along its axial direction, and the handle assembly can be used to 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 .

[0161] 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.

[0162] Optionally, the second isolation portion 10 is configured to be immovable, for example, 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, thereby forming a step structure between the two. The proximal end of the second isolation 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.

[0163] 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.

[0164] In an optional embodiment, the needle assembly 1 further includes a temperature measuring element 13. The temperature measuring element 13 may be embedded within the needle 11 to measure the temperature of the tissue at the needle 11; or the temperature measuring element 13 may be located within the medium release chamber 12 to measure the temperature of the medium within the medium release chamber 12; or the temperature measuring element 13 may be disposed on the distal side of the needle assembly 1 to measure the reflux temperature in the reflux channel or the temperature of the normal tissue area contacted by the needle assembly 1. The temperature measuring element 13 may be a temperature sensor, such as a thermocouple or a thermistor (NTC, PTC).

[0165] 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.

[0166] In a specific example of a composite ablation needle, the outer diameters of the needle tip 11, the first working portion 15, the second working portion 19, and the first isolating portion 17 are all 3.0 mm. The inner diameter of the second isolating 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 isolating portion 10 can be 3.15 mm.

[0167] The inner diameter of the medium release cavity 12 can be 2.7 mm, the radial dimension of the medium injection and suction channel 154 can be 0.2 mm (i.e., the difference between the outer diameter of the inner injection and suction tube 153 and the inner diameter of the first tube extension tube 155), the wall thickness of the inner injection and suction 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 inner injection and suction tube 153), the wall thickness of the second isolation tube 18 or the second medium tube 16 can both be 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 using the composite ablation needle in experiments, good energy ablation effects were achieved, which were consistent with the expected results.

[0168] Example 2

[0169] 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 the second embodiment does not include a separate second isolation tube 18 .

[0170] like Figure 2As 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.

[0171] 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 component, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0172] The similarities between this embodiment 2 and the above embodiment 1 will not be repeated.

[0173] Example 3

[0174] 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 As shown, please combine Figure 1 The difference between the composite ablation needle for multiple physical factors of 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 cavity 154 in this embodiment 3 are constructed differently. Specifically, the proximal end of the second isolation portion 10 is constructed as an open end, which together with the first working portion 15, the first isolation portion 17, or one of the second working portions 19 defines the injection and suction hole 151. The injection and suction medium cavity 154 is constructed as a gap (radial gap) between the second isolation portion 10 and one or more of the first working portion 15, the first isolation portion 17, and the second working portion 19. The injection and suction medium cavity 154 and the injection and suction hole 151 are in fluid communication to achieve the suction and injection function.

[0175] 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 area of ​​the ablation needle can be adjusted, so that the position where chemical ablation needs to be performed can be adjusted according to actual needs.

[0176] 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 .

[0177] Specifically, the second insulating portion 10 extends to partially cover the second working portion 19 , for example, the second insulating portion 10 extends to cover only a portion of the second tube extension tube 192 , or the second insulating portion 10 extends beyond the second tube extension tube 192 and extends to cover a portion of the second tube 193 .

[0178] 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 channel 154. Or as Figure 3a and Figure 3c As 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. And 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, so 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 the 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.

[0179] Understandably, Figure 3a and Figure 3b The stepped structure shown is not required. Providing a stepped structure allows the outer diameter of the second isolating portion 10 to be consistent with the outer diameter of the second tube 193, resulting in a relatively uniform overall size of the needle assembly 1. If the stepped structure is not provided, the second isolating portion 10 can simply be positioned externally of the second tube extension tube 192 in a sleeve-like manner.

[0180] In this manner, the second isolating portion 10 can move along its axial direction. 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 injection and suction hole 151 is located further 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 injection and suction hole 151 is located closer to the needle 11.

[0181] 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 fluidically connected, thereby serving as the injection and suction medium cavity 154. Figure 3b and Figure 3d As 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. The open end of the second isolation part 10 and the step structure together define the injection hole 151. Therefore, 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 the drug 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 is to provide a step structure 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 portion 10, thereby making the needle assembly 1 have a uniform overall size.

[0182] In this manner, the second isolating portion 10 can move along its axial direction. 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 further 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.

[0183] Specifically, the second isolation 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 isolation portion 17 (the first isolation tube 172 ).

[0184] Similarly, the proximal end of the second isolation portion 10 can be configured as an open end. The open end and the outer wall of the first isolation tube 172 together define the injection and suction hole 151. A radial gap is provided between the second isolation portion 10 and the first isolation tube 172. This radial gap can serve as the injection and suction medium channel 154. It is understood that the second isolation portion 10 should also have a radial gap between it and the second tube extension tube 192, and a radial gap between it and the second tube 193. These radial gaps are in fluid communication, thereby serving as the injection and suction medium channel 154.

[0185] A stepped structure for positioning can be formed between the first isolation tube 172 and the first tube 156. The outer diameter of the second isolation portion 10 is consistent with that of the first isolation tube 172, while the inner diameter of the second isolation portion 10 is larger than the outer diameter of the first tube 156. Therefore, the second isolation portion 10 can be sleeved onto the first tube 156 and aligned with the first isolation tube 172. The proximal end of the second isolation portion 10 extends to a position corresponding to the stepped structure. The open end of the second isolation portion 10 and the stepped structure together define the injection and suction hole 151. A radial gap is defined between the inner wall of the second isolation portion 10 and the outer wall of the first isolation tube 172. The second isolation portion 10 should also have a radial gap with the second tube extension tube 192 and a radial gap with the second tube 193. These radial gaps are fluidically connected, thereby serving as the injection and suction medium channel 154.

[0186] In this manner, the second isolating portion 10 can move along its axial direction. 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 further 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.

[0187] 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.

[0188] Specifically, if Figure 3e As shown, the second isolation part 10 completely covers the second working part 19 and the first isolation part 17, and extends to completely or partially cover the first working part 15 (first tube 156). The proximal end of the second isolation part 10 is an open end, which together with the outer wall of the first tube 156 defines the injection and suction hole 151. There is a radial gap between the inner wall of the second isolation part 10 and the first tube 156, and there is a radial gap between the inner wall of the second isolation part 10 and the first isolation tube 172, a radial gap between the inner wall of the second isolation part 10 and the second tube extension tube 192, and a radial gap between the inner wall of the second isolation part 10 and the second tube 193. The radial gaps are fluid-connected, so that they can serve as the injection and suction medium cavity 154. The second isolation part 10 can be used in the same manner as Figure 3c or Figure 3d In a similar manner, a step structure can be constructed on the first tube 156 , and the second isolation part 10 is aligned with the first tube 156 through the step structure, and the outer diameters of the two are consistent; or the second isolation part 10 can be simply set on the first tube 156 .

[0189] In this manner, the second isolating portion 10 can move along its axial direction. 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 further 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.

[0190] In the various optional embodiments described above, 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 0.01 mm-1 mm, 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).

[0191] 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.

[0192] It is conceivable that in the various optional embodiments described above, 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 .

[0193] like Figure 3e As shown, the outer wall of the second isolation portion 10 can be integrated with the second isolation tube 18 into a single component.

[0194] It is understood that the second medium pipe 16 is disposed inside the first pipe extension pipe 155, and a second isolation pipe 18 can be disposed outside the second medium pipe 16. Since a separate injection / absorption inner pipe 153 is not provided in this embodiment 3, 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 can be integrated into a single component, in which case the outer wall thereof and the inner wall of the first pipe extension pipe 155 jointly define the isolation layer 181.

[0195] 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.

[0196] All components, whether specified or not, in this embodiment 3 may be constructed in the same manner as those described in the aforementioned embodiments 1 or 2. For example, the first working portion 15, the first isolation portion 17, and the second isolation tube 18, which are not described in detail in this embodiment 3, may adopt the same structural forms as the corresponding components in the aforementioned embodiments 1 or 2. Furthermore, those skilled in the art may freely combine embodiment 3 with the aforementioned embodiments 1 and 2.

[0197] Example 4

[0198] The present invention provides a multi-physical factor composite ablation needle, such as Figure 4 As shown, 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 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 embodiment 1 are integrated into one element, which can simultaneously realize 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.

[0199] 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 provided. 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.

[0200] like Figure 4 As shown, the second isolation portion 10 extends to partially cover the second working portion 19 (second tube 193). Its proximal end is open and can be used as an injection orifice 151. Therefore, liquid can enter the chamber defined by the inner wall of the second isolation portion 10 and the outer wall of the second working portion 19 from the proximal end of the second isolation portion 10, or drugs can flow out of the chamber to the designated treatment area. It is understood that the second isolation portion 10 can also extend to completely cover the second working portion 19.

[0201] 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. 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.

[0202] 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. 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.

[0203] The similarities between this embodiment 4 and the above-mentioned embodiment 1 will not be repeated.

[0204] Example 5

[0205] The present invention provides a multi-physical factor composite ablation needle, such as Figure 5 As shown, 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, that is, an inlet channel or a return channel for the medium.

[0206] Furthermore, the difference between this embodiment 5 and the above-mentioned embodiment 1 is that a separate second isolation tube 18 is not provided in this embodiment 5, but the second isolation tube 18 in the above-mentioned 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.

[0207] The similarities between this embodiment 5 and the above-mentioned embodiment 1 will not be repeated.

[0208] Example 6

[0209] 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 further 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 hole 173 is provided in a one-to-one correspondence with the first medium hole 157.

[0210] The first medium hole 157 and the second medium hole 173 are in fluid communication, and both 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 media in the second working part 19, which can realize the cooling function of thermal ablation and the heat exchange function of cold ablation. For example, when the cold medium or hot medium is released from the medium release cavity 12 by the inlet channel 141 of the medium defined by the first medium tube 14 and returned by the second medium cavity 161, the cold medium or 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, thereby more effectively controlling the temperature of various parts located on the distal side of the needle assembly 1, such as the first isolation tube extension tube 171 and the second tube 193.

[0211] Furthermore, the aperture of the first dielectric hole 157 is larger than that of the second dielectric hole 173, which is intended 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. In addition to the radial distance between the first dielectric hole 157 and the second dielectric hole 173, the creepage distance between the first tube extension tube 155 and the second tube 193 also increases the axial length of the inner wall of the first dielectric hole 157 and the second dielectric hole 173, thereby increasing the creepage distance and meeting the high-voltage protection requirements.

[0212] Specifically, the creepage distance between the first extension tube 155 and the second tube 193 is related to the operating 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.

[0213] Table 1 Minimum creepage distances for basic insulation and supplementary insulation (unit: mm)

[0214]

[0215]

[0216] The creepage distance is determined as follows:

[0217] 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 can withstand when the needle assembly 1 is operating at rated voltage and under normal operating conditions.

[0218] Second, determine the pollution level of needle assembly 1. The pollution level is a number that represents the expected microenvironmental pollution characteristics. Pollution Level 1 indicates no pollution or only dry, non-conductive pollution. For example, components or assemblies sealed to isolate dust and moisture within the device are considered Pollution Level 1. Pollution Level 2 indicates only non-conductive pollution, with occasional temporary conductivity expected due to condensation. Pollution Level 3 indicates conductive pollution, or dry, non-conductive pollution that is expected to become conductive due to condensation. Pollution Level 4 indicates persistent conductive pollution, such as pollution caused by conductive dust or rain or snow.

[0219] Therefore, the contamination level of the needle assembly 1 of the present invention can be either contamination level 1 or contamination level 2.

[0220] 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 the 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 examined for its 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, it can be assumed to be material group III. b .

[0221] For example, the needle assembly 1 of the present invention is made of polyimide or polytetrafluoroethylene. The typical CTI value of polyimide is 150, and the typical CTI value of polytetrafluoroethylene is 600.

[0222] Table 2 Comparative tracking index (CTI) correspondence table of material groups

[0223]

[0224] Fourth, based on 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.

[0225] 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 .

[0226] 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 strip (as shown in Figure 6b (3)), rectangle (as shown in Figure 6b (4)) or triangle (as shown in Figure 6bSimilarly, 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.

[0227] like Figure 6c 、 Figure 6d and Figure 6e As shown, please combine Figure 6a The first medium holes 157 are arranged in an equidistant manner in the axial direction of the first tube extension tube 155, that is, the spacing between adjacent first medium holes 157 is equal; similarly, the second medium holes 173 can also be arranged in an equidistant manner in the axial direction of the first isolation tube extension tube 171 (e.g., Figure 6c Chinese (5) Figure 6c Chinese (6) Figure 6c Zhong (7) and Figure 6c Middle (8); Figure 6d Chinese (5) Figure 6d Chinese (6) Figure 6d Zhong (7) and Figure 6d (8) and Figure 6e Chinese (5) Figure 6e Chinese (6) Figure 6e Zhong (7) and Figure 6e (as shown in (8)).

[0228] like Figure 6c and Figure 6d As shown, the first medium hole 157 and the second medium hole 173 can 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 6c Chinese (1) Figure 6c Chinese (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 Chinese (1) Figure 6d Chinese (2) Figure 6d Neutralize (3) Figure 6d (as shown in (4)).

[0229] 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 (e.g., Figure 6e Chinese (1) Figure 6e Chinese (2) Figure 6e Neutralize (3) Figure 6e (4) and Figure 6f Chinese (1) Figure 6f Chinese (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, rectangular, triangular, etc.

[0230] like Figure 6f As shown, 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 Chinese (5) Figure 6f Chinese (6) Figure 6f Chinese (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).

[0231] Preferably, under the premise of ensuring that the second dielectric hole 173 can effectively exchange heat for the first isolation tube extension tube 171 and the second tube 193 sleeved outside the first isolation tube extension tube 171, the aperture of the first dielectric hole 157 is as large as possible compared to the aperture of the second dielectric hole 173 (for example, the aperture of the first dielectric hole 157 is more than 60% larger than the aperture of the second dielectric hole 173). Because under the same conditions, the larger the difference between the aperture of the first dielectric hole 157 and the aperture of the second dielectric 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.

[0232] For each first dielectric hole 157 with a circular (or elliptical) cross-section, its diameter (semi-major axis) is no larger than the outer diameter of the needle 1, and can be, for example, 0.05 mm to 3 mm. The diameter of each second dielectric hole 173 with a circular cross-section can correspondingly be 0.05 mm to 1 mm. For each first dielectric hole 157 with a rectangular (or elongated) cross-section, its length can be longer, for example, up to 40 mm. For each first dielectric hole 157 with a rectangular (or elongated) cross-section, its length can be even longer, for example, up to 15 mm.

[0233] All components specified or not specified in this embodiment 6 may be constructed in the same manner as the components described in one or more of the above-mentioned embodiments 1, 2, 3, 4, and 5. For example, the components of the first working portion 15, the first isolation portion 17, and the second isolation tube 18 that are not described in detail in this embodiment 6 may adopt the configurations of the corresponding components described in one or more of the above-mentioned embodiments 1, 2, 3, 4, or 5. Furthermore, those skilled in the art may freely combine embodiment 6 with one or more of the above-mentioned embodiments 1, 2, 3, 4, and 5.

[0234] Example 7

[0235] The present invention provides a direct-push composite ablation needle, comprising the needle assembly 1 described in one or more of Embodiments 1 through 6 above, and a handle assembly. The distal end of the needle assembly 1 in Embodiments 1 through 6 is connected to the handle assembly. The first working portion 15, first isolating portion 17, second working portion 19, and second isolating portion 10 all extend into the handle assembly. The handle assembly will be described in detail below.

[0236] like Figure 7a 、 Figure 7b 、 Figures 8-12 As shown, the handle assembly of Example 7 of the present invention is a push-type handle assembly, which adjusts the effective length of the first working portion 15 and / or the second working portion 19 by pushing or pulling. The handle assembly includes a first housing 203 and a second housing 602 connected to the rear end of the first housing 203, and the two can be connected by various known means.

[0237] like Figure 8 As shown, the distal end of the needle assembly 1 is disposed within the first housing 203, with the needle 11 of the needle assembly 1 extending from one side of the first housing 203. One end of the second isolation portion 10 is disposed within the first housing 203, with the other end extending 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 can be changed, thereby adjusting the effective use range of the treatment area in the needle assembly 1 as needed.

[0238] Specifically, if Figure 9 、 Figure 10 and Figure 11As shown, the mobile drive assembly 300 is connected to the second isolation part 10, and the mobile drive assembly 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 drive assembly 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.

[0239] 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 part of 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.

[0240] like Figure 7b As shown, a plurality of positioning slots 3001 are provided on the first housing 203 at intervals. For ease of adjustment, the positioning slots 3001 are provided at equal intervals. Figure 9 As shown, the mobile drive assembly 300 includes 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 both sides of the positioning member 302. 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, it can be pushed to move along the axial direction of the second isolation portion 10. The elastic member 304 can be, for example, a thin sheet structure such as a spring, or a spring structure, so that it can undergo elastic deformation under the action of a force and return to its original state when the force disappears.

[0241] The positioning member 302 is configured to be inserted into or separated from one of the positioning slots 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, thereby fixing the second isolation portion 10 in its current position. When the positioning member 302 is disengaged from the positioning slot 3001, the mobile drive assembly 300 is unlocked from the first housing 203, thereby allowing adjustment of the relative position of the second isolation portion 10 and the needle assembly 1.

[0242] like Figure 9 and Figure 10 As shown, a pushing groove 3003 is provided on one side of the pushing member 301 close to the positioning member 302. The pushing groove 3003 extends in a direction away from the positioning member 302. The pushing groove 3003 can be 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. Figure 10 As shown, the cross-section of the pushing groove 3003 can be triangular or trapezoidal. 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 forces the positioning member 302 to move toward the elastic member 304, causing the elastic member 304 to elastically deform until the positioning member 302 disengages from the positioning groove 3001, thereby unlocking the mobile drive assembly 300 from the first housing 203.

[0243] like Figure 9 As shown, when the push member 301 is pushed from the left, since the right inner wall of the pushing groove 3003 is inclined, as it moves further to the left, the right inner wall of the pushing groove 3003 will exert a downward force on the positioning member 302, thereby moving the positioning member 302 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, as shown in FIG. Figure 10 As shown, the first housing 203 is unable to constrain the mobile drive assembly 300, and thus the mobile drive assembly 300 can drive the second isolation portion 10 to move freely. It is understood that when the positioning member 302 moves downward, it can press the elastic member 304 downward, causing the elastic member 304 to elastically deform and generate elastic potential energy.

[0244] When the pusher 301 and the positioning member 302 move together until the positioning member 302 is aligned with the next positioning slot 3001 (e.g., the positioning slot 3001 to the left of the previous positioning slot 3001), the inner wall of the first housing 203 no longer abuts the positioning member 302, and the elastic member 304 can return to its initial state, thereby pushing the positioning member 302 upward, and the positioning member 302 can be inserted into the positioning slot 3001, thereby locking the mobile drive assembly 300 and the first housing 203 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.

[0245] Or as Figure 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 further to the right, the left inner wall of the push groove 3003 will exert a downward force on the positioning member 302, thereby moving the positioning member 302 downward until the positioning member 302 is disengaged from the corresponding positioning groove 3001 (the end of the positioning member 302 is lower than the inner wall of the first housing 203). At this time, 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, it can press the elastic member 304 downward, so that the elastic member 304 undergoes elastic deformation and generates elastic potential energy.

[0246] 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 to the right of the previous positioning groove 3001), the inner wall of the first shell 203 no longer abuts the positioning member 302, and the elastic member 304 can return to its initial state, so that the positioning member 302 is pushed upward by the elastic member 304, and the positioning member 302 can be inserted into the positioning groove 3001, thereby locking the mobile drive assembly 300 and the first shell 203 in the current position, and the length of the treatment area 2001 can be increased accordingly. It can be understood that the length of the treatment area 2001 that is reduced is the distance the positioning member 302 moves.

[0247] Therefore, when adjusting the handle assembly of Example 7 of the present invention, the size of the exposed portion of the first working portion 15 and / or the second working portion 19 can be adjusted by directly pushing the mobile drive assembly 300 toward the front or 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 allow movement; 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, making the operation more reliable and convenient.

[0248] like Figure 11 As shown, please combine Figure 8 The second isolation portion 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. A guide platform 3031 is also provided on the movable seat 303. Please continue to refer to Figure 9 and Figure 10 The pushing member 301 is further provided with a receiving groove 3002 on the side thereof adjacent to the positioning member 302. The receiving groove 3002 extends away from the positioning member 302. The pushing groove 3003 is provided on the bottom wall of the receiving groove 3002. The width of the receiving groove 3002 is greater than the maximum width of the pushing groove 3003. The guide platform 3031 is provided within the receiving groove 3002. The inner wall of the receiving groove 3002 serves to limit the position of the guide platform 3031. When the positioning member 302 is disengaged from its corresponding positioning groove 3001, the pushing member 301 continues to be pushed. The inner wall of the receiving groove 3002 contacts the side wall of the guide platform 3031, thereby driving the movable base 303 to move together.

[0249] like Figure 9 、 Figure 10 and Figure 11As 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 constructed in various suitable shapes.

[0250] like Figure 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. Figure 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 pushing groove 3003, the positioning member 302 can move in a direction perpendicular to the axial direction of the second isolation part 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.

[0251] like Figure 11 As shown, the movable base 303 is further provided with a deformation cavity 3032, in which a support block 3033 is disposed. The support blocks 3033 may be arranged at intervals. The elastic member 304 is disposed on the support block 3033. The deformation cavity 3032 provides 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 groove 3004, the bottom end of the positioning member 302 abuts against the elastic member 304, causing the elastic member 304 to undergo elastic deformation.

[0252] It can be understood that because the guide groove 3021 passes through the positioning member 302, the portions of the positioning member 302 located on either side of the guide groove 3021 are also located on either side of the guide platform 3031. Therefore, the deformation cavities 3032 are correspondingly disposed on either side of the guide platform 3031, and the elastic members 304 are correspondingly disposed in the deformation cavities 3032. As a result, the portions of the positioning member 302 located on either side of the guide groove 3021 can exert force on the two elastic members 304.

[0253] The handle assembly provided by the present invention further comprises a second housing 602, which is connected to a side of the first housing 203 away from the needle 11. Figure 12 As shown, a needle rod seat 601 is further provided in the first shell 203 , and the needle assembly 1 passes through the movable seat 303 and is conductively connected to one side of the needle rod seat 601 .

[0254] like Figure 12As shown, the second housing 602 includes a first boss 6021 extending toward the first housing 203. The first boss 6021 is disposed within the first housing 203. A mounting groove 6022 is provided on the first boss 6021. The needle bar base 601 is disposed within the mounting groove 6022. The end surface of the needle bar base 601 is flush with the end surface of the first boss 6021. The second housing 602 also includes a second boss 6023 extending away from the first housing 203. The cable 6002 passes through the second housing 602 and, after passing through the second boss 6023, is connected to the operating hole 6004 of the needle bar base 601.

[0255] 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.

[0256] The outer surface of the portion of the needle assembly 1 located within the first housing 203 is provided with an insulating coating. More specifically, the insulating coating covers the entire area of ​​the needle assembly 1 from the point where the needle assembly 1 connects to the front end of the first housing 203 to the front region of the operating hole 6004. The end of the needle bar base 601 is also covered with an insulating coating, forming an insulating end surface 6003. An adhesive layer is provided between the insulating coating of the needle assembly 1 and the insulating end surface 6003. For example, adhesive (e.g., glue) can be poured into the chamfered corner of the insulating end surface 6003 for bonding, thereby securing and insulating the needle bar base 601 from the needle assembly 1, thereby achieving external insulation of the front end of the handle assembly. The outer surface of the cable 6002 is covered with an insulating layer. An adhesive layer can also be provided between the cable 6002 and the second boss end surface 6005. For example, adhesive (e.g., glue) can be poured into the chamfered corner of the second boss end surface 6005 for bonding, thereby achieving external insulation of the rear end of the handle assembly.

[0257] Therefore, after the needle assembly 1 and the cable 6002 are respectively connected (welded) on the needle rod seat 601, the needle rod 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.

[0258] 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.

[0259] Example 8

[0260] The present invention provides a rotary composite ablation needle, comprising the needle assembly 1 described in one or more of Embodiments 1 to 6 above, and a handle assembly. The distal end of the needle assembly 1 in 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 via the handle assembly to transmit the corresponding energy.

[0261] The handle assembly will be described in detail below.

[0262] like Figure 13a 、 Figure 13b As shown, the handle assembly of embodiment 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.

[0263] 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. The two can be connected by various known means, for example, the two can be connected by a rotationally fixed manner.

[0264] like Figure 13b and Figure 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. Figure 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. Its distal end abuts the proximal end of the handle front shell 55 to facilitate gripping and applying rotational torque. The connecting portion 535 is configured as a columnar structure, which is sleeved outside the second isolation portion 10 and extends into the handle front shell 55.

[0265] The rotating portion 534 is rotatably connected to the handle front shell 55. Specifically, Figure 14 As shown, the rotating portion 534 is provided with a limiting groove 532 extending along its circumference, and the inner wall of the handle front shell 55 is provided with a wedge-shaped protruding ring 551 extending toward its interior. The wedge-shaped protruding 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.

[0266] The rotating portion 534 is disposed at the proximal end of the handle front shell 55, which can help reduce the radial size of the handle assembly, so that there can be smaller spacing between the various components of the handle assembly, thereby improving the operability of the handle assembly.

[0267] The connecting portion 535 is further provided with a slider 56. Figure 14 and Figure 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.

[0268] The slider 56 is sleeved on the outside of the second isolation part 10, and the slider 56 and the second isolation part 10 can be fixedly connected by bonding or other means, so that when the slider 56 moves, it can drive the second isolation part 10 to move along its axial direction.

[0269] Specifically, if Figure 17 As shown, the slider 56 includes a sliding sleeve 563 and a plurality of struts 561 disposed on either side of the sliding sleeve 563. Each strut 561 extends radially along the sliding sleeve 563. The struts 561 on either side of the sliding sleeve 563 are symmetrically arranged about the sliding sleeve 563, and a notch structure 562 is provided between the struts 561 on the same side of the sliding sleeve 563. The struts 561 on either side of the sliding sleeve 563 extend from the sliding slot 533 on the connecting portion 535.

[0270] like Figure 16 As shown, an internal thread 552 is provided on the inner wall of the handle front shell 55, and a notch structure 562 can cooperate with the internal thread 552. When the rotating portion 534 is subjected to a rotational force, it drives the connecting portion 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 enabling a spiral motion along the thread. The spiral motion of the slider 56 includes rotational motion around the axial direction of the second isolation portion 10 and translational motion along the axial direction of the second isolation portion 10. The translational motion of the slider 56 along the axial direction of the second isolation portion 10 can drive the second isolation portion 10 to move toward the proximal side or distal side of the handle front shell 55.

[0271] 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 arcuate surface, which allows the notch structure 562 to engage with the internal thread 552 more easily.

[0272] Furthermore, a scale ring 57 is also provided on the second isolation portion 10. The scale ring 57 is located in the slot 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.

[0273] The handle front shell 55 and the handle rear shell 58 are installed by rotating. Figure 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 its circumference is provided on the handle rear shell 58. The opening of the locking groove 582 has a protrusion 585 extending toward the interior of the locking groove 582. Both the protrusion 585 and the locking block 553 are provided with an arcuate transition portion. When the handle rear shell 58 is rotated, the arcuate transition portion on the protrusion 585 and the arcuate transition portion on the locking block 553 are tangent to each other under the action of the rotational force, causing the locking groove 582 to slightly deform, allowing the locking block 553 to enter the locking groove 582. When the locking block 553 is fully inserted into 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.

[0274] like Figure 15 As shown, a seal 54 is provided in the second sealing groove 584 of the handle rear shell 58. Under the action of the seal 54, a seal can be achieved between the handle front shell 55 and the handle rear shell 58. Figure 13b and Figure 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 .

[0275] The handle rear housing 58 is also provided with a rear housing shaft hole 581, whose inner diameter is slightly larger than the diameter of the connecting portion 535. A sleeve is provided on the connecting portion 535 to provide a restraining force during rotation of the connecting portion 535 and prevent excessive deformation of the connecting portion 535. The handle rear housing 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 positioned in the connecting hole 583 and adhesively fixed thereto. This secures the needle assembly 1 and the handle assembly, thereby providing puncture force for the needle shaft.

[0276] Furthermore, if Figure 13b As shown, an LED light panel 59 is also provided on the handle rear housing 58. The LED light panel 59 can adopt an existing light panel structure, for example, a light-emitting portion is provided thereon. An opening is provided at a corresponding position on the handle rear housing 58, and the light-emitting portion of the LED light panel 59 can pass through the handle rear housing 58 and display a light signal to indicate the different operating states of the ablation needle.

[0277] like Figure 13bAs shown, after the knob 53, the handle front shell 55 and the handle rear shell 58 are installed, they have uniform external dimensions. The handle assembly formed is a uniform columnar structure and is not provided with 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.

[0278] Example 9

[0279] The present invention provides a rotary composite ablation needle. The handle assembly in this embodiment 9 differs from that in the aforementioned embodiment 8, specifically in the structure of the slider 56. Furthermore, the connection portion 535 of embodiment 8 is omitted in this embodiment 9. In other words, the rotating portion 534 is connected to the slider 56 to drive the slider 56 to rotate. The second isolation portion 10 extends through the slider 56 and is connected to the slider 56.

[0280] Specifically, if Figure 18 As shown, the slider 56 and the scale ring 57 are constructed in an integral manner, 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.

[0281] 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 .

[0282] Example 10

[0283] The present invention provides a sliding-propelled composite ablation needle, comprising the needle assembly 1 described in one or more of Embodiments 1 to 6 above, and a handle assembly. The distal end of the needle assembly 1 in Embodiments 1 to 6 is connected to the handle assembly, wherein the first working portion 15, the first isolating portion 17, the second working portion 19, and the second isolating 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 via the handle assembly to transmit the corresponding energy.

[0284] The handle assembly will be described in detail below.

[0285] like Figure 19a and Figure 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.

[0286] Specifically, if Figure 20 、 Figure 22a and Figure 22b As shown, the handle assembly includes a housing 41, which is constructed in a pistol-shaped structure with its lower portion convenient for the user to hold. The housing 41 can be a split structure, for example, it can be formed by snapping together a left housing 412 and a right housing 416 so that other components can be installed inside it.

[0287] 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.

[0288] Specifically, if Figure 20 As shown, the housing 41 is provided with a housing slide 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 411 to move it. Figure 22c As shown, the casing slide groove 411 can be respectively provided on a portion of the left shell 412 and the right shell 416. When the left shell 412 and the right shell 416 are buckled together, a closed casing slide groove 411 can be formed.

[0289] like Figure 20 As shown, the sliding propulsion mechanism passes through the casing slide groove 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.

[0290] like Figure 21a 、 Figure 21b and Figure 21cAs shown, the sliding propulsion mechanism includes a push button 43, which includes a push portion 431, a mating portion 432, and a sleeve 433. The axial direction of the sleeve 433 corresponds to the direction of movement of the push portion 431. A cavity structure 4032 is provided on the left and right axial sides of the sleeve 433, as well as a connecting hole 4031 connecting the left and right cavity structures 4032 of the sleeve 433. The cavity structures 4032 are connected to the connecting holes 4031 via tapered transition portions 4033. The second insulating portion 10 enters the cavity structure 4032 on one side of the sleeve 433 and exits 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 serves as a guide when connecting to the second insulating portion 10. The cavity structure 4032 is much larger than the connecting hole 4031, thereby reducing weight.

[0291] A mounting hole is provided at the middle position of the sleeve 433, the fitting 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 fitting portion 432, and the pushing portion 431 extends circumferentially along the sleeve 433, so as to facilitate applying force on its upper surface to make it move axially along the sleeve 433.

[0292] The push portion 431, the mating portion 432, and the sleeve 433 may be integrally formed, for example, by machining, metal injection molding, insert injection molding, etc. The mating portion 432 may be a stainless steel or tungsten steel bar with an outer diameter of 0.5 mm to 1.5 mm and a ground or polished surface.

[0293] The push portion 431 is disposed on the exterior of the housing 41, the mating portion 432 is disposed in the housing slot 411, and the sleeve 433 is disposed within the interior of the housing 41. The second isolation portion 10 extends through the sleeve 433 and is fixedly connected thereto. When a forward or backward force is applied to the push portion 431, it drives the mating portion 432 and the sleeve 433, and subsequently drives the second isolation portion 10 forward or backward, thereby changing the relative position of the second isolation portion 10 and the first working portion 15 and / or the second working portion 19.

[0294] like Figure 21a As shown, a double torsion spring 434 is also sleeved on the outer surface of the sleeve 433. Figure 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 that connects the two torsion spring coils 4342 and mates with the mating portion 432. The outer pins 4343 are located on the sides of the torsion spring coils 4342 and engage with slots inside the housing 41 to provide torque.

[0295] 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 0.3 mm-0.8 mm.

[0296] The sliding propulsion mechanism further includes a shield 44, which is located inside the housing 41 and is rotatably connected to the housing 41. The shield 44 is located inside the housing 41, so that it can shield the housing slide 411 from the inside of the housing 41; and the shield 44 can also move with the movement of the pusher 431. For example, the shield 44 is rotatably connected to the housing 41, so that when the pusher 431 moves, the shield 44 can rotate synchronously with the pusher 431, so that a portion of the spiral slide 441 is always aligned with a portion of the housing slide 411 (e.g., Figure 22c As shown in FIG, to ensure the normal movement of the push portion 431. The other parts of the housing slide 411 are blocked by the portion of the shield 44 where the spiral slide 441 is not provided.

[0297] like Figure 25 As shown, the shield 44 is provided with a spiral groove 441, which extends helically along the entire axial direction of the shield 44 and is in communication with the interior of the shield 44. The spiral groove 441 has an open end 4411 at one end and a closed end 4412 at the other end. The spiral groove 441 is a spiral path that extends helically along the entire axial direction of the shield 44 from the open end 4411 to the closed end 4412. The spiral groove 441 is in communication with the interior of the shield 44, so that the mating portion 432 can enter the spiral groove 441 through the open end 4411.

[0298] The width of the spiral groove 441 may be slightly larger than the diameter of the fitting portion 432 to facilitate installation of the fitting portion 432 . The width of the spiral groove 441 may be, for example, 2 mm to 2.5 mm.

[0299] like Figure 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 opened from the open end 4411 of the spiral groove 441 (as shown in FIG. Figure 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). Figure 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, thereby changing the position of the spiral groove 441 accordingly (please refer to Figure 26 、 Figure 27 and Figure 28), so that the movement of the push button 43 will not be hindered. Therefore, when a force is applied to the pushing portion 431 to move the pushing 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 part of the spiral groove 441 is always aligned with the housing groove 411 (please refer to Figure 27 ) to ensure that the movement of the pushing portion 431 will not be hindered.

[0300] The purpose of providing the cover 44 in the casing 41 is that the 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 matter will not fall into the casing slide groove 411 and the casing 41, thereby solving the technical problem that foreign matter in the slide groove is easy to fall into and cause jamming; and the 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.

[0301] 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 Figure 22c ), that is, the position of the housing slide 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 411, the push portion 431 can simultaneously cover the portion where the housing slide 411 and the spiral slide 441 are aligned with each other. Therefore, it can be seen that the cover 44 and the push portion 431 of the push button 43 can jointly play the role of shielding the housing slide 411, thereby avoiding various problems caused by the exposure of the housing slide 411. Figure 26 、 Figure 27 and Figure 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.

[0302] 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 when the push button 43 moves, causing the spiral groove 441 to be exposed. The stroke of the push portion 431 can be 0mm to 60mm.

[0303] A plurality of positioning slots 413 are further provided in the casing slide slot 411 . When the push button 43 moves to a desired position, it can enter the corresponding positioning slot 413 from the casing slide slot 411 , thereby fixing the push button 43 at the current position.

[0304] like Figure 23a As shown, the two outer pins 4343 of the double torsion spring 434 extend from the spiral groove 441 respectively and engage with the slot inside the housing 41, thereby providing torque. Specifically, a pin receiving portion 414 that is recessed away from the shield 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). The pin receiving portion 414 extends along the axial direction of the shield 44. The two outer pins 4343 of the double torsion spring 434 can rest 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. Figure 19a and Figure 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, thereby fixing the pushing portion 431 at the current position.

[0305] Specifically, if Figure 24 As shown, the positioning slot 413 is configured in a trumpet-shaped configuration that opens toward the housing slide slot 411. The positioning slot 413 includes a slot body 4133, a constricted portion 4131, and an open portion 4132. The open portion 4132 communicates with the housing slide slot 411 and is larger than the constricted portion 4131. This allows the mating portion 432 of the push button 43 to be smoothly inserted from the open portion 4132 through the constricted portion 4131 into the slot body 4133. Furthermore, the constricted portion 4131 blocks the mating portion 432 in the slot body 4133, preventing it from falling out of the slot body 4133.

[0306] Preferably, if Figure 29 and Figure 30 As shown, each positioning groove 413 can be respectively arranged on one side (such as the left or 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 Figure 22c shown).

[0307] Please combine Figure 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 Figure 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). Figure 23a As shown), the pin receiving portion 414 applies a preload 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 Figure 23c As shown, 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 slot 413, the inner pin 4341 and the outer pin 4343 of the double torsion spring 434 tend to return from angle α2 to angle α1. Therefore, the inner pin 4341 can automatically push the push button 43 into the corresponding positioning slot 413, thereby securing the push button 43 in the desired positioning slot 413, achieving 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 slot 413, the angle between the outer pin 4343 and the inner pin 4341 becomes α1, i.e., the double torsion spring 434 returns to its natural state. When it is necessary to push the push button 43 again, force can be applied to the push button 43 so that it enters the casing slide groove 411 from the positioning groove 413 through the matching portion 432. The outer pin 4343 of the double torsion spring 434 then rests 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.

[0308] like Figure 29 and Figure 30 As shown, each positioning groove 413 can be respectively arranged on the left or right side of the housing slide groove 411. Figure 31 and Figure 32 As shown, each positioning groove 413 can be respectively arranged on both sides of the housing slide groove 411. Figure 31 As shown in , the scales are staggered on the left and right sides (for example, every 5mm unit is a small scale, every 10mm unit is a large scale); or it can be as shown in Figure 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 slot 413.

[0309] The housing 41 is also provided with housing scale lines 415, which correspond to the positioning grooves 413. Each housing scale line 415 is formed by laser etching, silk screen printing, or injection molding the housing 41. As described above, a scale of 5 mm can be used as a small scale and 10 mm as a large scale, or other suitable methods can be used.

[0310] In addition, if Figure 21aAs shown, a push button scale line 4311 is also provided on the pushing 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 stroke of the push button 43.

[0311] In an optional embodiment, the shielding sleeve 44 is a telescopic sleeve or a telescopic baffle that can be attached to the pusher 431, and the spiral groove 441 can be replaced with an arcuate groove extending along the circumference of the shielding sleeve 44. A portion of the shielding sleeve 44 can be synchronously extended with the movement of the pusher 431, while another portion can be synchronously contracted with the movement of the pusher 431. This ensures that the arcuate groove between the extended and contracted portions of the shielding sleeve 44 is always aligned with a portion of the housing groove 411, ensuring normal movement of the pusher 431. The rest of the housing groove 411 is blocked by the portion of the shielding sleeve 44 that is not provided with the arcuate groove.

[0312] Example 11

[0313] The present invention also provides an ablation system, including 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-propelled composite ablation needle described in Example 10.

[0314] 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 DC power supply, etc.).

[0315] Example 12

[0316] like Figure 33 As shown, the present invention provides a combined action composite ablation needle, more specifically, a composite ablation needle of multiple physical factors, which is different from the composite ablation needle of the above embodiment 1 in that the second working portion 19 and the first isolation portion 17 of the above embodiment 1 are not provided in this embodiment 12. In other words, the combined action composite ablation needle of this embodiment 12 includes a needle assembly 1, and the needle assembly 1 includes a first working portion 15 and a second isolation portion 10. Figure 33 As shown, the distal side of the first working portion 15 extends directly into the second insulating portion 10 .

[0317] 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.

[0318] 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 separately 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).

[0319] Optionally, cold medium or hot medium can be released in the first working part 15, and chemical drugs or protein coagulants can also be input into the designated treatment area in the first working part 15, thereby achieving ablation treatment with different physical effects of cryoenergy ablation (or thermal energy ablation) and chemical ablation.

[0320] Optionally, the first working part 15 acts as a pole, which forms a discharge circuit with another pole outside the 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.

[0321] In addition, the multiple combined composite ablation needles of this embodiment 12 can also work together to jointly release radiofrequency energy, pulsed electric field energy, or electrolytic energy to achieve the corresponding energy ablation. For example, the first working portion 15 of one combined composite ablation needle acts as the positive electrode, and the first working portion 15 of another combined composite ablation needle acts as the negative electrode to form a discharge circuit, thereby releasing radiofrequency energy. That is, the multiple first working portions 15 can work together to release radiofrequency energy to achieve radiofrequency ablation. Alternatively, the multiple first working portions 15 can each form an electrode pair to perform pulsed discharge, thereby releasing pulsed electric field energy to the tissue between them. That is, the multiple first working portions 15 can work together to release pulsed electric field energy to achieve pulsed electric field energy ablation. Alternatively, one first working portion 15 can act as a cathode, and another first working portion 15 can act as an anode. The designated treatment area can serve as an electrolyte. When a DC power supply is connected to each of the first working portions 15, electrolytic energy is released to the tissue between them. That is, the multiple first working portions 15 can work together to release electrolytic energy to achieve electrolytic energy ablation.

[0322] The distal end of the needle assembly 1 of the combined-action composite ablation needle of this embodiment 12 is connected to the 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 multiple energies.

[0323] like Figure 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 . The first tube extension tube 155 extends into the second isolation part 10 .

[0324] 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.

[0325] The needle 11 is used for puncture, so the shape of the needle tip at the front end of the needle 11 can be a triangular prism, a cone, a semicircle, or the like, which is convenient for puncturing the skin, tissue, and treatment area.

[0326] If the needle 11 is too short, it may not reach the designated treatment area. If it is too long, the treatment effect may be affected. 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 visualization of the needle 11 may be insufficient, thereby clinically affecting the puncture. Conversely, if the outer diameter of the needle 11 is too large, the resistance to puncture increases and the treatment trauma to the patient increases. 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.

[0327] 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.

[0328] The needle tip 11 may also be coated to prevent tissue adhesion during treatment or corrosion caused by electrolysis on the needle surface. The coating may be, for example, a needle tip coating 111 or an anti-adhesion membrane. The needle tip coating 111 may be made of an insulating material such as polytetrafluoroethylene (PTFE) or titanium nitride, or it may be made of a conductive, heat-resistant, anti-adhesion material.

[0329] The first tube 156 and the first tube extension tube 155 can be constructed separately or integrally formed. Figure 33As shown, the first tube 156 and the first tube extension tube 155 have the same diameter. 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, forming a step structure between the two. Alternatively, it is 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 taper angle.

[0330] The first tube 156 and the first tube extension tube 155 can be made of the same material, for example, a medical metal material (such as 314 stainless steel or 316 stainless steel, titanium alloy, platinum, iridium, or other metal or alloy material). Alternatively, the first tube 156 and the first tube extension tube 155 can be made of different materials.

[0331] 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, to prevent tissue adhesion during treatment. The coating may be, for example, a coating made of a heat-resistant, anti-adhesive material such as polytetrafluoroethylene (PTFE) or titanium nitride, or an anti-adhesive heat shrink film made of materials such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET).

[0332] 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. Therefore, the coating on the needle 11 and / or the first tube 156 is a conductive coating made of a 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.

[0333] like Figure 33 As shown, the interior of the first tube 156 defines a 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 can be the same as or greater than the length of the first tube 156. The medium can release energy in the medium release chamber 12, which can be used for cooling during thermal ablation or heat exchange during cold ablation.

[0334] The medium may be, for example, a cold medium (such as liquid nitrogen, high-pressure gas, liquid metal or cooling water), or a hot medium such as liquid (alcohol).

[0335] 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 . Both the first medium tube 14 and the second medium tube 16 extend inside the first working portion 15 .

[0336] 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.

[0337] 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 return channel. The cold medium or hot medium from the cold source or heat source can be input into 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 return 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.

[0338] 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 33 As shown, the first medium pipe 14 is disposed 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 disposed adjacent to the first medium pipe 14, and the two are coaxially disposed. It is conceivable that the second medium pipe 16 can also be disposed side by side adjacent to the first medium pipe 14.

[0339] 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.

[0340] 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.

[0341] The needle assembly 1 further includes an injection and suction inner tube 153 and at least one injection and suction hole 151 , through which chemical ablation can be achieved.

[0342] 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 .

[0343] The inner injection and suction 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 inner injection and suction 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 inner injection and suction 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.

[0344] Alternatively, it is also conceivable that the inner injection and suction tube 153 may be a capillary tube arranged side by side with the second medium tube 16 , that is, the inner wall of the inner injection and suction tube 153 defines the injection and suction medium cavity 154 .

[0345] In addition, the second medium pipe 16 may be provided only partially or entirely 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.

[0346] Please continue to see Figure 33 One or more of the injection and suction holes 151 can be positioned closer to the second isolation portion 10 on the first tube 156 and extend radially through the first tube 156. The injection and suction holes 151 at this location are aligned with the proximal end of the inner injection and suction tube 153 (or the inner injection and suction tube 153 slightly extends axially beyond the injection and suction holes 151). Liquid drawn from the designated treatment area through the injection and suction holes 151 can then enter the inner injection and suction tube 153 directly, reducing the liquid's flow path. Furthermore, when multiple injection and suction holes 151 are provided at the junction between the first tube 156 and the first tube extension tube 155, the injection and suction holes 151 can be equally spaced along the circumference of the first tube 156 (or the injection and suction holes 151 can be arranged at non-equidistant intervals along the circumference of the second tube 193, such as with the distance between the injection and suction holes 151 gradually increasing or decreasing).

[0347] Each injection / suction hole 151 is fluidically connected to a designated treatment area and is used to draw liquid from or inject liquid (e.g., a chemical or protein coagulant) into the designated treatment area. Blood, tissue, etc. from the designated treatment area can enter the injection / suction medium channel 154 through the injection / suction hole 151 and be collected from the distal end of the injection / suction medium channel 154. Alternatively, the injection / suction medium channel 154 can deliver desired anesthetics, saline, or therapeutic drugs, etc., to the designated treatment area through the injection / suction hole 151.

[0348] The size (pore diameter, etc.) of each injection and suction hole 151 can gradually increase 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.

[0349] Specifically, the liquid inlet and outlet flow rates Q of the injection and suction holes 151 satisfy the following relationship (1):

[0350] Q=KAV (1)

[0351] Wherein: K is the cross-sectional area correction coefficient of the injection and suction hole 151;

[0352] A is the cross-sectional area of ​​the injection and suction hole 151;

[0353] V is the speed of liquid injection and suction through the injection and suction hole 151;

[0354] It can be determined based on parameters such as the type, pressure, flow coefficient, etc. of the push and aspiration liquid medium used clinically.

[0355] To ensure uniformity in the liquid flow rate between the injection holes 151 closer to the proximal end of the needle assembly 1 and the injection holes 151 closer to the distal end of the needle assembly 1 in the injection direction, the injection 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 hole 151 is set to be the same or substantially the same, and the size of each injection hole 151 is determined by setting the correction coefficient K.

[0356] Furthermore, 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.

[0357] Furthermore, for the injection and suction hole 151 having a circular cross-sectional shape, its cross-sectional area A satisfies the following relational expression (2):

[0358] A=π×R×R (2)

[0359] 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.

[0360] The maximum diameter of each injection and suction hole 151 can be 0.05 mm to 10 mm. The injection and suction holes 151 can be arranged at equal intervals along the injection direction, and each injection and suction hole 151 can have a circular cross-section, an elliptical cross-section, or a long strip cross-section.

[0361] like Figure 33 As shown, the proximal side of the needle assembly 1 comprises, from the inside to the outside, 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 portion 10. In other words, these components are coaxially arranged. It is understood that one or more of these components may also be arranged side by side with other components, or partially coaxially.

[0362] The needle assembly 1 further includes a second isolation tube 18 for isolating the cold medium or hot medium from the external temperature. The second isolation tube 18 extends inside the injection and suction inner tube 153, so that the outer wall of the second isolation tube 18 and the inner wall of the injection and suction inner tube 153 jointly define an isolation layer 181.

[0363] 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.

[0364] 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 jointly defined 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.

[0365] Optionally, the second isolation portion 10 is configured to be movable along its axial direction, and the handle assembly can be used to drive the second isolation portion 10 to move, thereby changing the length of the isolation portion 10 covering the first working portion 15, thereby changing the exposed length of the first working portion 15, and thus changing the effective length of the first working area (the effective length is the length of the treatment area). Figure 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 .

[0366] 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.

[0367] Optionally, the second isolating portion 10 is configured to be immovable, for example, fixedly connected to the first tube extension tube 155. In this immovable embodiment, the outer surface of the second isolating portion 10 may be provided with an insulating coating such as polytetrafluoroethylene (PTFE) or silicone, or an insulating film such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or fluorinated ethylene propylene copolymer (FEP).

[0368] In an optional embodiment, the needle assembly 1 further includes a temperature measuring element 13. The temperature measuring element 13 may be embedded within the needle 11 to measure the temperature of the tissue at the needle 11; or the temperature measuring element 13 may be located within the medium release chamber 12 to measure the temperature of the medium within the medium release chamber 12; or the temperature measuring element 13 may be disposed on the distal side of the needle assembly 1 to measure the reflux temperature in the reflux channel or the temperature of the normal tissue area contacted by the needle assembly 1. The temperature measuring element 13 may be a temperature sensor, such as a thermocouple or a thermistor (NTC, PTC).

[0369] 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.

[0370] All components 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 those skilled in the art can freely combine embodiment 12 with the above embodiments 1 to 6.

[0371] Example 13

[0372] like Figure 34 As shown, the present invention provides a combined action composite ablation needle, more specifically, it is a composite ablation needle of multiple physical factors, please combine Figure 33 The difference between the combined-action composite ablation needle of this 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 this embodiment 13.

[0373] like Figure 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.

[0374] like Figure 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 component, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0375] The similarities between this embodiment 13 and the above-mentioned embodiment 12 will not be repeated.

[0376] Example 14

[0377] like Figure 35As shown, the present invention provides a composite ablation needle with a combined effect, more specifically, it is a composite ablation needle with multiple physical factors, and please combine Figure 33 and Figure 34 The difference between the combined-action composite ablation needle of this embodiment 14 and the combined-action 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.

[0378] Furthermore, a bent tube 162 is provided at the proximal end of the second medium tube 16 . The diameter of the bent tube 162 is smaller than that 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.

[0379] 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 .

[0380] Optionally, a separate injection and suction inner tube 153 may not be provided in this embodiment 14, 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.

[0381] In addition, if Figure 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). Figure 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.

[0382] like Figure 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 component, so that the second isolation part 10 can achieve both length adjustment and temperature isolation.

[0383] Optionally, a separate injection and suction inner tube 153 can also be provided in this embodiment 14, which can 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 the injection and suction medium cavity 154 to realize the injection and suction function.

[0384] The similarities between this embodiment 14 and the above-mentioned embodiment 12 will not be repeated.

[0385] Example 15

[0386] like Figure 36 As shown, the present invention provides a combined-action composite ablation needle, more specifically, it is a composite ablation needle of multiple physical factors. The combined-action composite ablation needle of this embodiment 15 is different from the combined-action 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.

[0387] 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 part of the injection and suction medium cavity 154 to realize the injection and suction function.

[0388] The similarities between this embodiment 15 and the above-mentioned embodiment 14 will not be repeated.

[0389] Example 16

[0390] like Figure 37 As shown, the present invention provides a combined-action composite ablation needle, more specifically, it is a composite ablation needle of multiple physical factors. The combined-action composite ablation needle of this embodiment 16 is different from the combined-action composite 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. Instead, 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.

[0391] For example, the second isolation portion 10 may extend to partially cover the first tube extension tube 155. A radial gap may be provided between the second isolation portion 10 and the first tube extension tube 155, which may serve as the injection and suction medium channel 154. The proximal end of the second isolation portion 10 may also serve as the injection and suction hole 151. Liquid may flow from the proximal end of the second isolation portion 10 into the chamber defined by the inner wall of the second isolation portion 10 and the outer wall of the first tube extension tube 155, or medication may flow from the chamber to a designated treatment area. It is understood that the second isolation portion 10 may also extend to completely cover the first tube extension tube 155.

[0392] The second isolating portion 10 may be formed by Figure 3c or Figure 3d In a similar manner, a step structure can be constructed on the first tube extension tube 155, and the second isolation part 10 is aligned with the first tube extension tube 155 through the step structure, and the outer diameters of the two are consistent; or the second isolation part 10 can be simply set on the first tube extension tube 155.

[0393] In this manner, the second isolating portion 10 can move along its axial direction. The specific movement method has been described in detail in Examples 7, 8, 9, and 10 above. 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 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 hole 151 is further 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 hole 151 is closer to the needle 11.

[0394] 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 can be 0.01 mm-1 mm, for example, it can be the difference between the inner diameter of the second isolation part 10 and the outer diameter of the first tube extension tube 155 .

[0395] 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.

[0396] 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 communicated with the injection and suction medium cavity 154 and may also be used as the injection and suction holes 151 .

[0397] The second medium pipe 16 is disposed inside the first pipe extension pipe 155, and a second isolation pipe 18 can be disposed outside the second medium pipe 16. Since a separate injection / absorption inner pipe 153 is not provided 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 can be integrated into a single component, in which case the outer wall of the second isolation pipe 18 and the inner wall of the first pipe extension pipe 155 jointly define the isolation layer 181.

[0398] 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.

[0399] The similarities between this embodiment 16 and the above-mentioned embodiment 12 will not be repeated.

[0400] All components specified or not specified in this embodiment 16 may be constructed in the same manner as the components described in one or more of the above-mentioned embodiments 12, 13, 14, and 15. For example, the components of the first working section 15 and the second isolation tube 18 not described in detail in this embodiment 16 may adopt the configurations of the corresponding components described in one or more of the above-mentioned embodiments 12, 13, 14, and 15. Furthermore, those skilled in the art may freely combine embodiment 16 with one or more of the above-mentioned embodiments 12, 13, 14, and 15.

[0401] Example 17

[0402] like Figure 38 As shown, the present invention provides a composite ablation needle with combined effects, more specifically, it is a composite ablation needle with multiple physical factors. Figure 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 the separate second medium tube 16 is not provided in this embodiment 17. Figure 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, that is, an inlet channel or a return channel for the medium.

[0403] Furthermore, the difference between this embodiment 17 and the above-mentioned embodiment 12 is that a separate second isolation tube 18 is not provided in this 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.

[0404] The similarities between this embodiment 17 and the above-mentioned embodiment 12 will not be repeated.

[0405] Example 18

[0406] The present invention provides a combined-action composite ablation needle, comprising the needle assembly 1 described in one or more of Examples 12 to 17 above, and a handle assembly, wherein the distal end of the needle assembly 1 in each of Examples 12 to 17 above is connected to the handle assembly. The first working portion 15 and the second isolation portion 10 both extend into the handle assembly.

[0407] The handle assembly can be, for example, the straight-push handle assembly described in Example 7 above, which adjusts the effective length of the first working portion 15 by pushing or pulling; or the handle assembly can be the rotary handle assembly described in Examples 8 and 9 above, which adjusts the effective length of the first working portion 15 by rotating the knob 53 at the proximal end of the handle assembly; or the handle assembly can be the sliding-propelling handle assembly described in Example 10 above, which adjusts the effective length of the first working portion 15 by combining movement and rotation, thereby solving the problem of sticking and improving the aesthetics of the handle assembly. Therefore, no further details will be given.

[0408] In addition, the ablation system of the present invention may include the combined-action composite ablation needles 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 DC power supply, etc.).

[0409] 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 .

[0410] While the present invention has been described with reference to preferred embodiments, various modifications may be made and equivalent components may be substituted without departing from the scope of the present invention. In particular, the various technical features described in the various embodiments may be combined in any manner, provided no structural conflicts exist. The present invention is not limited to the specific embodiments disclosed herein, but encompasses all technical solutions within the scope of the claims.

Claims

1. A combined ablation needle, characterized in that: The needle assembly (1) comprises a first working portion (15) and a second isolation portion (10), wherein the first working portion (15) comprises 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), wherein the first tube extension tube (155) extends into the second isolation portion (10); The needle (11) and / or the first tube (156) are capable of conducting electricity to release pulsed electric field energy, radiofrequency energy or electrolytic energy; a medium release chamber (12) is provided in the first tube (156), and the medium release chamber (12) is capable of releasing freezing energy or thermal energy; the needle assembly (1) further comprises an injection and suction hole (151), the injection and suction hole (151) being defined by the first working portion (15) and the second isolation portion (10), and the injection and suction hole (151) is connected to the inside and outside of the needle assembly (1) to achieve chemical ablation; The needle assembly (1) further comprises an injection medium cavity (154) and at least one injection hole (151) in fluid communication with the injection medium cavity (154), wherein the injection hole (151) is configured as a proximal opening between the second isolation portion (10) and the first working portion (15), and the injection medium cavity (154) is configured as a gap between the second isolation portion (10) and the first working portion (15); The second isolating portion (10) is connected to a handle assembly, and the handle assembly is capable of moving the second isolating portion (10) along its circumference to change the length of the radial gap between the second isolating portion (10) and the first tube extension tube (155), as well as the position of the open end of the second isolating portion (10).

2. The combined action 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 proximal end of the second medium tube (16) extends to abut against the distal end of the needle (11), and the medium release cavity (12) is a cavity structure formed between the proximal end of the second medium tube (16) and the first medium tube (14).

3. The combined action 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), the proximal end of the second medium tube (16) being a closed end (163), and the medium release cavity (12) being a cavity structure formed between the closed end (163) and the first medium tube (14).

4. The combined action composite ablation needle according to claim 2, characterized in that: The second medium tube (16) comprises a bent tube (162) arranged at its proximal end, and the bent tube (162) extends to abut against the distal end of the needle (11).

5. The combined action composite ablation needle according to claim 1, characterized in that: The needle assembly (1) further comprises a second isolation tube (18), the second isolation tube (18) being arranged inside the first tube extension tube (155) or integrated into the second isolation portion (10), The outer wall of the second insulating tube (18) and the inner wall of the first tube extension tube (155) jointly define an insulating layer (181) for achieving temperature isolation.

6. The combined action composite ablation needle according to claim 1, characterized in that: The handle assembly is a straight-push handle assembly, a rotary handle assembly or a sliding-propelled handle assembly.

7. An ablation system comprising two combined-action composite ablation needles according to any one of claims 1 to 6; the ablation system further comprising one or more of a medium source, a drug delivery device, and an energy source.

Citation Information

Patent Citations

  • Ablation needle capable of puncturing

    CN115137467A

  • Electric cooling probe for electric cooling ablation device

    CN209808517U