Radio-frequency cutting biopsy needle and method for using same

Abstract

The present invention provides a radio-frequency cutting biopsy needle and a method for using same. The radio-frequency cutting biopsy needle comprises an outer cannula, an inner cannula, an air return assembly, a radio-frequency cutting device, and a driving mechanism. A sampling slot is formed in a side wall of the outer cannula. An ablation end of the radio-frequency cutting device is arranged at a distal end of the inner cannula, and the distal end of the inner cannula is inserted into the outer cannula. An airflow channel communicated with the sampling slot is formed between the inner cannula and the outer cannula for allowing the inner cannula to move linearly relative to the outer cannula. A proximal end of the inner cannula is configured to be able to be connected to a negative-pressure device. One end of the air return assembly is movably sleeved on the outer side of the outer cannula, and the other end of the air return assembly is sleeved at the proximal end of the inner cannula. The driving mechanism is transmittingly connected to the inner cannula, so that under the action of the negative-pressure device, the biopsy needle generates a negative pressure by means of the sampling slot to adsorb tissue, thereby ensuring the tissue adsorption and fixation effect. By moving the air return assembly, the sampling slot is communicated with the external environment, facilitating the removal of cut tissue, and improving the surgical effect.

Description

A radiofrequency biopsy needle and a method for using the biopsy needle. Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a radiofrequency biopsy needle and a method of using the biopsy needle. Background Technology

[0002] The vacuum-assisted breast biopsy system is a minimally invasive medical device used in breast surgery and is applied in clinical practice. The system consists of a control system, a breast biopsy excision device, and a vacuum negative pressure system. The breast biopsy excision device comprises an outer casing, a puncture blade, a cutting blade tube, an outer tube, a sampling slot, a sample collector, and a vacuum catheter kit. It primarily utilizes a vacuum-assisted device to draw lesion tissue into the sampling slot through negative pressure. The cutting blade tube rapidly rotates to cut the lesion tissue drawn into the sampling slot, and after removal, negative pressure draws the lesion tissue back into the sample collector. The doctor can then collect a sample from the sample collector for pathological biopsy. Pathological analysis of the lesion tissue sample determines whether the breast lesion is benign or malignant. The entire procedure requires only a single incision in the breast. Simultaneously, the vacuum-assisted breast biopsy system can also be used for the minimally invasive removal of benign tumors.

[0003] When a vacuum-assisted breast biopsy system is in operation, a vacuum-assisted device is used to generate negative pressure suction at the sampling slot to adsorb the tissue from the patient's lesion into the sampling slot. Existing vacuum-assisted biopsy systems usually set the sampling slot to be connected to the external gas so that the vacuum-assisted device can remove the cut tissue in time. However, the negative pressure at the sampling slot cannot be adjusted, which means that the outer tube cannot be used to extract enough lesion tissue at once, and the initial fixation of the outer tube cannot be achieved.

[0004] Therefore, the present invention aims to provide a radiofrequency biopsy needle and a method for using the biopsy needle to solve the above problems. Summary of the Invention

[0005] The purpose of this invention is to provide a radiofrequency biopsy needle and a method for using the biopsy needle. By moving the return gas assembly relative to the outer blade tube, the negative pressure at the sampling slot is adjusted, thereby achieving the adsorption and fixation of the sampling slot and the adsorption and removal of lesion tissue. The design is ingenious, the structure is simple, and the operation is convenient.

[0006] The technical solution provided by this invention is as follows:

[0007] A radiofrequency biopsy needle includes an outer blade tube, an inner blade tube, a gas return assembly, a radiofrequency cutting device, and a drive mechanism. A sampling groove is provided on the side wall of the outer blade tube, and the ablation end of the radiofrequency cutting device is located at the distal end of the inner blade tube.

[0008] The distal end of the inner knife tube is inserted into the outer knife tube. An airflow channel communicating with the sampling slot is provided between the inner knife tube and the outer knife tube to allow the inner knife tube to move linearly relative to the outer knife tube. The proximal end of the inner knife tube is configured to be connected to a negative pressure device.

[0009] One end of the air return assembly is movably sleeved on the outside of the outer blade tube, and the other end of the air return assembly is sleeved on the proximal end of the inner blade tube. The drive mechanism is connected to the inner blade tube in a driving connection.

[0010] The return air assembly has an initial position relative to the outer blade tube. When the return air assembly is in the initial position, the airflow channel is not connected to the external environment. After the driving mechanism drives the inner blade tube to move a preset distance to the far end, the driving mechanism drives the inner blade tube and the return air assembly to move, so that the return air assembly moves away from the initial position, thereby connecting the airflow channel to the external environment.

[0011] In some embodiments, the return air assembly includes a sealed canister, one end of which is movably fitted onto the outside of the outer blade tube, and the other end of which is sealed to the proximal end of the inner blade tube. An airflow gap suitable for communication with the external environment is provided at the connection between the sealed canister and the outer blade tube, and the airflow channel is connected to the interior of the sealed canister.

[0012] The outer blade tube is fitted with a first sealing element, which is located inside the sealing can. When the sealing can is in the initial position, the first sealing element is located at the airflow gap, so that the airflow channel is not connected to the external environment.

[0013] In some embodiments, the outer blade tube is provided with a fixing seat and is located on the side of the sealed can near the sampling groove. The gas return assembly also includes an elastic element disposed between the fixing seat and the fixing seat, and the elastic element is in a compressed state so that the sealed can is in the initial position.

[0014] In some embodiments, the return gas assembly further includes a second seal located at the end of the sealing can away from the mounting base, so as to provide a hermetically sealed connection between the sealing can and the inner knife tube.

[0015] In some embodiments, when the gas return assembly moves from the initial position toward a direction closer to the outer blade tube, the ablation end of the radio frequency cutting device is located within the sampling slot.

[0016] In some embodiments, the radio frequency cutting device includes an electrode and an insulating blade head disposed at the distal end of the inner blade tube. The insulating blade head is cylindrical and communicates with the inner blade tube. The electrode is disposed at the end of the insulating blade head away from the inner blade tube to form the ablation end, and the electrode is connected to a radio frequency generating device.

[0017] The insulating blade has several through holes on its side wall so that the airflow channel can be connected to the sampling slot through the through holes.

[0018] In some embodiments, the insulating blade includes a first part and a second part connected in sequence, wherein the end of the second part away from the first part is connected to the inner blade tube.

[0019] The outer diameter of the first part is larger than the outer diameter of the second part, and it is in clearance fit with the outer knife tube.

[0020] In some embodiments, the insulating blade tip has a mounting groove on the side away from the inner blade tube that mates with the electrode, so that the electrode can be mounted in the mounting groove.

[0021] Both the insulated blade and the inner blade tube have cable channels for connecting the electrode to the radio frequency generator via wires.

[0022] In some embodiments, a first step is provided on the inner wall of the distal end of the inner blade tube, and a second step is provided on the outer wall of the proximal end of the insulating blade head to cooperate with the first step, so as to install the insulating blade head on the distal end of the inner blade tube.

[0023] The cable channel of the insulating blade head passes through the side wall of the insulating blade head, and the cable channel of the inner blade tube passes through the side wall of the inner blade tube.

[0024] In some embodiments, the device further includes a housing and a puncture knife, the puncture knife being fixedly connected to the distal end of the outer blade tube, the housing being disposed at the end of the outer blade tube away from the puncture knife, and the drive mechanism being mounted inside the housing.

[0025] In some embodiments, the distal end of the outer blade tube and the return air assembly are both installed inside the housing, and the housing is provided with a vent hole that communicates with the external environment.

[0026] The driving mechanism includes a motor and a slider. The slider is fixed to the outside of the inner blade tube. The output end of the motor is connected to the slider for driving the slider and the inner blade tube to move.

[0027] In some embodiments, the sealing container includes a sleeve, a limiting portion, and a protrusion. The protrusion is disposed on the outer side wall of one end of the sleeve, the limiting portion is disposed at the end of the sleeve away from the protrusion, and the elastic element is sleeved on the outer side of the sleeve and located between the protrusion and the fixing seat.

[0028] The limiting part is arranged axially along the opening at one end of the sleeve, and the end of the limiting part away from the sleeve is inclined toward the direction close to the outer knife tube and is spaced apart from the outer knife tube.

[0029] A method of using a biopsy needle, wherein the biopsy needle is a radiofrequency ablation biopsy needle as described in any of the above claims, includes the following steps:

[0030] The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot;

[0031] The external blade enters the lesion tissue;

[0032] The drive mechanism moves the inner blade tube toward the proximal end until the return gas assembly is in the initial position;

[0033] The negative pressure device is activated to adsorb the lesion tissue into the sampling tank;

[0034] Start the radio frequency cutting device;

[0035] The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot to perform adsorption sampling.

[0036] The external blade is removed from the human body.

[0037] The radiofrequency biopsy needle and its usage method provided by this invention have the following beneficial effects:

[0038] 1. The present invention provides a radiofrequency biopsy needle and a method for using the biopsy needle. By movably fitting one end of the gas return assembly to the outside of the outer blade tube and fitting the other end of the gas return assembly to the proximal end of the inner blade tube, the gas return assembly is fitted to the proximal end of the outer blade tube and the outside of the inner blade tube. When the gas return assembly is in its initial position, it can act as a seal, allowing the negative pressure generated by the negative pressure device to be transmitted to the patient's lesion through the inner blade tube and the sampling slot. This allows the sampling slot to fully absorb tissue. Under the action of the driving mechanism, the gas return assembly can move from its initial position, connecting the airflow channel with the external environment. This allows the negative pressure of the negative pressure device to be transmitted to the lesion, adsorbing and removing the cut tissue from the sampling slot. Therefore, it is possible to freely switch between adsorbing and fixing tissue and adsorbing and removing tissue in the sampling slot, thus improving the effectiveness of the biopsy needle.

[0039] 2. The present invention provides a radiofrequency biopsy needle and a method for using the biopsy needle. When the gas return assembly moves from the initial position toward the direction close to the outer blade tube, the ablation end of the radiofrequency cutting device is already located in the sampling groove. This allows the driving mechanism to move the inner blade tube while the gas return assembly is still in the initial position. The negative pressure generated by the negative pressure device can firmly adsorb the tissue into the inner blade tube, making it easier for the gas return assembly to adsorb the tissue into the inner blade tube after it moves away from the initial position.

[0040] 3. The present invention provides a radiofrequency biopsy needle and a method for using the biopsy needle. The radiofrequency biopsy device includes an insulated blade head of an electrode, and the cable connected to the electrode is passed through a cable channel located in the side wall of the insulated blade head and the inner blade tube, ensuring patient safety during the operation.

[0041] 4. The present invention provides a radiofrequency biopsy needle and a method for using the biopsy needle, wherein the first part of the insulating blade head is fitted with the outer blade tube with a gap, which ensures that the insulating blade head can move relative to the outer blade tube while reducing the possibility of tissue entering between the insulating blade head and the outer blade tube.

[0042] 5. The present invention provides a radiofrequency biopsy needle and a method for using the biopsy needle. The radiofrequency cutting device cuts the lesion tissue by energizing the electrodes. The cutting method is changed from the original mechanical cutting to electro-radiofrequency cutting. Electro-radiofrequency cutting does not have the phenomena of chipping, nicks, or reduced sharpness. It has a wider practical cutting range and higher cutting efficiency. Moreover, the electrodes can play the role of cutting and stopping bleeding at the same time, reducing the possibility of bleeding during the operation. Attached Figure Description

[0043] The preferred embodiments will now be described in a clear and easy-to-understand manner, with reference to the accompanying drawings, to further explain the above-mentioned characteristics, technical features, advantages, and implementation methods of this solution.

[0044] Figure 1 is a schematic diagram of an embodiment of a radiofrequency biopsy needle provided by the present invention;

[0045] Figure 2 is a schematic diagram of the internal structure of an embodiment of a radiofrequency biopsy needle provided by the present invention;

[0046] Figure 3 is a cross-sectional view of an embodiment of a radiofrequency biopsy needle provided by the present invention;

[0047] Figure 4 is a partially enlarged schematic diagram of a radiofrequency biopsy needle provided by the present invention, as shown in Figure 3.

[0048] Figure 5 is a schematic diagram of an embodiment of the inner blade of a radiofrequency biopsy needle provided by the present invention;

[0049] Figure 6 is a schematic diagram of the structure of an embodiment of an insulating blade tip for radiofrequency biopsy needles provided by the present invention;

[0050] Figure 7 is a schematic diagram of another embodiment of the radiofrequency biopsy needle provided by the present invention;

[0051] Figure 8 is a cross-sectional view of another embodiment of a radiofrequency biopsy needle provided by the present invention.

[0052] Reference numerals: Outer blade 1, Sampling slot 11, Puncture knife 12, First seal 13, Fixing base 14, Airflow channel 15, Inner blade 2, First step 21, Cable channel 22, Air return assembly 3, Sealing tank 31, Sleeve 311, Limiting part 312, Protrusion 313, Elastic element 32, Second seal 33, Radio frequency cutting device 4, Electrode 41, Insulated blade 42, First part 421, Second part 422, Second step 423, Drive mechanism 5, Motor 51, Slider 52, Outer sleeve 53, Inner sleeve 54, Transmission gear 55, Housing 6, First outer shell 61, Second outer shell 62, Cover 63. Detailed Implementation

[0053] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0054] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0055] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0056] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0057] In one embodiment, a radiofrequency biopsy needle is described, which drives the return gas assembly 3 to move via a drive mechanism 5, thereby enabling the airflow channel 15 to be connected to or disconnected from the external environment. When the airflow channel 15 is connected to the external environment, the negative pressure generated by the negative pressure device enables the sampling slot 11 to fully absorb the lesion tissue and adhere and fix it to the lesion tissue. When the airflow channel 15 is disconnected from the external environment, the negative pressure generated by the negative pressure device enables the cut tissue to be adsorbed into the inner blade tube 2 and discharged outward through the inner blade tube 2.

[0058] Specifically, referring to Figures 1 to 5 in the specification, a radiofrequency biopsy needle includes an outer blade tube 1, an inner blade tube 2, a gas return assembly 3, a radiofrequency cutting device 4, and a drive mechanism 5. The ablation end of the radiofrequency cutting device 4 is located at the distal end of the inner blade tube 2. When operating the biopsy needle, the end of the biopsy needle furthest from the operator is designated as the distal end, and the end closest to the operator is designated as the proximal end. The outer blade tube 1 is sleeved on the outside of the distal end of the inner blade tube 2, and the proximal end of the inner blade tube 2 is located outside the outer blade tube 1. An airflow channel 15 is provided between the outer blade tube 1 and the inner blade tube 2, and the airflow channel 15 is connected to a sampling slot 11, allowing gas from the external environment to communicate with the sampling slot 11 through the airflow channel 15. Correspondingly, the proximal end of the inner blade tube 2 is configured to connect with an external negative pressure device, so that the negative pressure generated by the negative pressure device is transmitted through the inner blade tube 2 to the sampling slot 11 of the outer blade tube 1. When the airflow channel 15 is not connected to the external environment, the negative pressure can only generate suction on the lesion tissue and cannot drive the lesion tissue to move inside the inner blade tube 2. When the airflow channel 15 is connected to the outside, the negative pressure can not only generate suction on the lesion tissue, but also drive the lesion tissue to be discharged through the inner blade tube 2.

[0059] Accordingly, one end of the air return assembly 3 is movably sleeved on the outside of the outer blade tube 1, and the other end of the air return assembly 3 is sleeved on the proximal end of the inner blade tube 2, so that the air return assembly 3 covers the parts of the outer blade tube 1 and the inner blade tube 2 that are in contact with the external environment. Correspondingly, the air return assembly 3 has an initial position relative to the outer blade tube 1, and its position relative to the initial position can be adjusted when the air return assembly 3 moves relative to the outer blade tube 1. When the air return assembly 3 is in the initial position, it can block the airflow channel 15, preventing the airflow channel 15 from connecting with the external environment. At this time, the suction force generated by the negative pressure device can fully adsorb the lesion tissue into the sampling slot 11 and fix it to the lesion tissue. Correspondingly, when the return air assembly 3 is in the initial position, the drive mechanism 5 can only drive the inner blade tube 2 to move a preset distance towards the far end. After the drive mechanism continues to run, it can drive the inner blade tube 2 and the return air assembly 3 to move, so that the return air assembly 3 is away from the initial position. This ensures that the return air assembly 3 does not block the airflow channel 15, allowing the airflow channel 15 to communicate with the external environment. The airflow channel 15 is also connected to the sampling slot 11. In addition to generating negative pressure, the negative pressure device can also drive the cut lesion tissue to be discharged through the inner blade tube 2.

[0060] In one embodiment, referring to Figures 2 and 3 of the specification drawings, this embodiment further describes a radiofrequency biopsy needle. The radiofrequency biopsy needle also includes a housing 6 and a puncture blade 12. The puncture blade 12 is disposed at the distal end of the outer blade tube 1, and the housing 6 is disposed at the end of the outer blade tube 1 away from the puncture blade 12. A drive mechanism 5 is installed within the housing 6.

[0061] Furthermore, the distal end of the inner blade tube 2 and the gas return assembly 3 are both installed inside the housing 6, making the radiofrequency biopsy needle a single unit with a simpler and more compact structure. This eliminates the need for an additional power handle, reducing the difficulty of use. Additionally, a vent is provided on the housing 6 to connect the airflow channel 15 to the outside environment. Correspondingly, the drive mechanism 5 includes a motor 51 and a slider 52, with the slider 52 positioned outside the inner blade tube 2, and the output of the motor 51 connected to the slider 52. It is understood that the motor 51 drives the slider 52 to move, which in turn moves the inner blade tube 2. After the inner blade tube 2 has moved a preset distance, i.e., after the slider 52 has moved a preset distance, the slider 52 contacts the gas return assembly 3, causing the gas return assembly 3 and the inner blade tube 2 to continue moving forward.

[0062] In practical production applications, motor 51 can be set as a linear motor, and slider 52 is fixedly connected to the output end of the linear motor. The linear motor directly pushes slider 52 to move. Motor 51 can also be set as a rotary motor. The output end of the rotary motor is provided with an external thread, and slider 52 is provided with a threaded hole that matches the output end. The slider 52 is driven to move through the lead screw. These are not described in detail here, but are all within the protection scope of this invention.

[0063] In one embodiment, referring to Figures 7 and 8 of the specification drawings, this embodiment provides another specific structure of the housing 6. The housing 6 includes a first outer shell 61, a second outer shell 62, and a cover 63. The distal end of the inner blade tube 2 and the return air assembly 3 are both installed inside the first outer shell 61, and the second outer shell 62 is located below the first outer shell 61. The cover 63 covers the outside of the first outer shell 61 and is connected and fixed to the second outer shell 62. Correspondingly, the drive mechanism 5 includes a motor 51, an outer sleeve 53, and an inner sleeve 54. Both the outer sleeve 53 and the inner sleeve 54 are located inside the first outer shell 61. The inner sleeve 54 is movably sleeved outside the inner blade tube 2 and located on the side of the return air assembly 3 away from the puncture knife 12. The outer sleeve 53 is rotatably sleeved inside the inner sleeve 54. In addition, an external thread is provided on the outer side of the inner sleeve 54, and an internal thread that mates with the external thread is provided on the inner wall of the outer sleeve 53, so that when the outer sleeve 53 rotates, it drives the inner sleeve 54 to move along the extension direction of the inner knife tube 2.

[0064] Furthermore, a transmission gear 55 is provided on the outer sleeve 53, and the motor 51 is located inside the second housing 62 and is connected to the transmission gear 55 for transmission. The transmission gear 55 is driven to rotate, which in turn drives the outer sleeve 53 to rotate, thereby causing the inner sleeve 54 to move relative to the extension direction of the inner blade tube 2. In addition, the movement direction of the inner sleeve 54 can be controlled by controlling the rotation direction of the transmission gear 55. Correspondingly, a through hole connected to the outside is provided on the first housing 61, thereby realizing the forward or backward movement of the return air assembly 3, thereby realizing the opening or closing of the airflow channel 15.

[0065] In one embodiment, this embodiment further describes the return air assembly 3, which includes a sealed canister 31. One end of the sealed canister 31 is movably fitted onto the outside of the outer blade tube 1, and the other end of the sealed canister 31 is sealed to the proximal end of the inner blade tube 2. An airflow gap is provided at the connection between the sealed canister 31 and the outer blade tube 1, the airflow gap being connected to the external environment and adapted to be connected to the interior of the sealed canister 31. Correspondingly, the airflow channel 15 is connected to the interior of the sealed canister 31. A first sealing element 13 is fitted onto the outside of the outer blade tube 1, and the first sealing element 13 is located inside the sealed canister 31. When the sealed canister 31 is in its initial position, the first sealing element 13 is located at the airflow gap, and the inner wall of the sealed canister 31 abuts against the first sealing element 13, causing the first sealing element 13 to block the airflow gap, thereby preventing the airflow channel 15 from communicating with the external environment.

[0066] It is understandable that when the sealing container 31 separates from the initial position, the sealing container 31 separates from the first sealing element 13, so that the airflow gap is connected to the interior of the sealing container 31, and the airflow channel 15 is connected to the interior of the sealing container 31, thereby making the external environment and the airflow gap and the airflow channel 15 interconnected, so that the lesion tissue can be adsorbed into the inner catheter by negative pressure.

[0067] Furthermore, a fixing seat 14 is provided on the outer blade tube 1, and the fixing seat 14 is located on the side of the sealing can 31 near the sampling groove 11. The return air assembly 3 also includes an elastic element 32, which is located between the fixing seat 14 and the sealing can 31 and is in a compressed state. The restoring force generated by the elastic element 32 in the compressed state can move the sealing can 31 away from the puncture knife 12 to the initial position, thereby causing the sealing can 31 to contact and squeeze with the first sealing element 13, so that the airflow channel 15 is not connected to the external environment.

[0068] Furthermore, the return air assembly 3 also includes a second seal 33, which is disposed at the end of the sealing canister 31 away from the fixed base 14, so that the end of the sealing canister 31 away from the fixed base 14 is in a sealed connection with the inner knife tube 2. It can be understood that by providing the second seal 33, the end of the sealing canister 31 away from the fixed base 14 is in a sealed connection with the inner knife tube 2. Under the action of the drive mechanism 5, the sealing canister 31 moves, causing the end of the sealing canister 31 near the fixed base 14 to abut or separate from the first seal 13, thereby achieving the connection or disconnection between the airflow channel 15 and the external environment.

[0069] Correspondingly, the sealing container 31 includes a sleeve 311, a limiting part 312, and a protrusion 313. The sleeve 311 is located at the end of the fixing seat 14 away from the piercing knife 12, and one end of the sleeve 311 is fitted onto the outer side of the proximal end of the outer knife tube 1. The protrusion 313 is located on the outer wall of one end of the sleeve 311, and the limiting part 312 is located at the end of the sleeve 311 away from the protrusion 313. When the sealing container 31 is fitted onto the outer side of the outer knife tube 1, the end of the sealing container 31 with the limiting part 312 is fitted onto the outer side of the proximal end of the outer knife tube 1, and the end of the sealing container 31 with the protrusion 313 is fitted onto the outer side of the inner knife tube 2. The second sealing element 33 is located at the end of the sleeve 311 away from the fixing seat 14 and is fixedly connected to the inner wall of the sleeve 311. Correspondingly, the second sealing element 33 is annularly sleeved on the outside of the inner knife tube 2, and the inner ring of the second sealing element 33 is slidably connected to the inner knife tube 2 so that the second sealing element 33 is sealed to the inner knife tube 2.

[0070] In one embodiment, referring to Figures 2 to 6 of the specification drawings, this embodiment further describes the radio frequency cutting device 4. The radio frequency cutting device 4 includes an electrode 41 and an insulating blade 42. The electrode 41 is disposed at one end of the insulating blade 42, and the end of the insulating blade 42 away from the electrode 41 is connected to the distal end of the inner blade tube 2 to form the ablation end of the radio frequency cutting device 4. Furthermore, the insulating blade 42 is cylindrical, and the electrode 41 is connected to a radio frequency generating device in the external environment to energize the electrode 41 and thereby cut the tissue located in the sampling groove 11. Correspondingly, several through holes are formed on the side wall of the insulating blade 42 to allow the airflow channel 15 to communicate with the interior of the insulating blade 42 through the through holes, and thus with the sampling groove 11.

[0071] It should be noted that the radiofrequency cutting device 4 has a wider cutting range and better cutting efficiency, and avoids the phenomena such as blade chipping and nicks that occur in traditional cutting methods. Moreover, the electrode 41 can stop bleeding in the lesion tissue during the cutting process, effectively reducing the probability of bleeding and lowering surgical risks. In addition, when the gas return assembly is in the initial position, the insulated blade 42 and the electrode 41 are both located inside the inner blade tube 2 and on the side of the sampling groove 11 away from the puncture knife 12.

[0072] Preferably, the insulated blade 42 is made of ceramic material, and the electrode 41 is made of tungsten-rhenium alloy. Furthermore, preferably, the inner blade tube 2, the outer blade tube 1, the electrode 41, and the outer surface of the piercing blade 12 are all coated with an insulating layer.

[0073] The insulating blade 42 includes a first part 421 and a second part 422 connected in sequence, with one end of the second part 422 away from the first part 421 connected to the inner blade tube 2;

[0074] The outer diameter of the first part 421 is larger than that of the second part 422, and it is in clearance fit with the outer blade tube 1. By having the first part 421 in clearance fit with the inner blade tube 2, the end of the insulating blade 42 away from the inner blade tube 2 is tightly fitted, thereby reducing the possibility of cut tissue debris entering between the insulating blade 42 and the inner blade tube 2, and ensuring the stability and reliability of the biopsy needle during operation.

[0075] Furthermore, the insulating blade head 42 is provided with a mounting groove on the side away from the inner blade tube 2 to cooperate with the electrode 41, so as to install the electrode 41 in the mounting groove. Both the insulating blade head 42 and the inner blade tube 2 are provided with cable channels 22 for the electrode 41 to be connected to the radio frequency generator through wires.

[0076] A first step 21 is provided on the inner wall of the distal end of the inner blade tube 2, and a second step 423 is provided on the outer wall of the proximal end of the insulating blade head 42 to cooperate with the first step 21, so as to install the insulating blade head 42 at the distal end of the inner blade tube 2. Correspondingly, the cable channel 22 of the insulating blade head 42 is provided through the side wall of the insulating blade head 42, and the cable channel 22 of the inner blade tube 2 is provided through the side wall of the inner blade tube 2.

[0077] By providing a cable channel for placing the wire within the insulating blade head 42 and the inner blade tube 2, the wire can be protected, reducing the possibility of wear and damage during use.

[0078] In addition, as a preferred embodiment, this embodiment further describes a radiofrequency cutting biopsy needle, wherein when the gas return assembly 3 moves from the initial position toward the direction close to the outer blade tube 1, the ablation end of the radiofrequency cutting device 4 is already located in the sampling groove 11, that is, when the driving mechanism 5 pushes the inner blade tube 2 to move a distance less than a preset distance, the ablation end has already extended into the sampling groove 11 of the outer blade tube 1. Understandably, when the sealed container 31 is in its initial position, the negative pressure device is activated to adsorb the lesion tissue into the sampling slot 11 through negative pressure. The drive mechanism 5 initially only moves the inner blade tube 2. As the inner blade tube 2 moves, the distance between the inner blade tube 2 and the sampling slot 11 gradually decreases, so that the ablation end is located at the sampling slot 11, thereby making the lesion tissue firmly adsorbed in the distal end of the inner blade tube 2. At this time, the gas return component 3 is still in its initial position and has not been driven by the drive mechanism 5. When the inner blade tube 2 continues to move, causing the gas return component 3 to leave the initial position, the airflow channel 15 is connected to the external environment, so that the negative pressure gradually sucks out the lesion tissue.

[0079] In one embodiment, this embodiment provides a method for using a biopsy needle, wherein the biopsy needle is a radiofrequency cutting biopsy needle provided in any of the above embodiments, comprising the following steps:

[0080] The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot;

[0081] The external blade enters the lesion tissue;

[0082] The drive mechanism moves the inner blade tube toward the proximal end until the return gas assembly is in the initial position;

[0083] The negative pressure device is activated to adsorb the lesion tissue into the sampling tank;

[0084] Start the radio frequency cutting device;

[0085] The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot to perform adsorption sampling.

[0086] The external blade is removed from the human body.

[0087] Specifically, the inner blade tube 2 is first moved distally by the drive mechanism 5, so that the radiofrequency cutting device 4 (insulated blade 42 and electrode 41) is located at the sampling slot 11 and completely overlaps with the sampling slot 11. Then, the outer blade tube 1 is inserted into the lesion tissue and punctured into the patient's body by the puncture knife 12. By placing the radiofrequency cutting device 4 at the sampling slot 11, the pain of inserting the puncture knife 12 and the outer blade tube 1 into the patient's body can be reduced. After the outer blade tube 1 and the puncture knife 12 are inserted into the lesion tissue, the drive mechanism 5 drives the inner blade tube 2 to move distally until the return air assembly 3 moves to the initial position, so that the airflow channel 15 is not connected to the external environment. At this time, the negative pressure device is activated to generate negative pressure. The negative pressure is directly transmitted to the sampling slot 11 of the outer blade tube 1 through the inner blade tube 2, which can fully adsorb the lesion tissue into the sampling slot 11. The connection strength between the outer blade tube 1 and the lesion tissue is high. Once the sampling slot 11 is in place, the radiofrequency cutting device 4 is activated, electrically connecting electrode 41 to the radiofrequency generator, thus energizing electrode 41. After electrode 41 is energized, the drive mechanism 5 pushes the inner blade tube 2 to move distally within the outer blade tube 1. The inner blade tube 2 moves towards the sampling slot 11. After the inner blade tube 2 has moved a certain distance, the drive mechanism 5 moves the inner blade tube 2 and the return gas assembly 3, causing the return gas assembly 3 to move away from its initial position. At this time, the airflow channel 15 is connected to the external environment, allowing the negative pressure generated by the negative pressure device to connect with the external environment. As the inner blade tube 2 continues to move, the radiofrequency cutting device 4 performs adsorption sampling at the sampling slot 11, meaning that electrode 41 continuously cuts the lesion tissue. The cut lesion tissue is discharged outward through the inner blade tube 2 under the action of the negative pressure device. After sampling is completed, the outer blade tube 1 and the puncture knife 12 are removed from the lesion tissue of the human body.

[0088] It should be noted that the above embodiments can be freely combined as needed. The above description is only a preferred embodiment of the present invention. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A radiofrequency biopsy needle, characterized in that, It includes an outer blade tube, an inner blade tube, a gas return assembly, a radio frequency cutting device, and a drive mechanism. A sampling groove is provided on the side wall of the outer blade tube, and the ablation end of the radio frequency cutting device is located at the distal end of the inner blade tube. The distal end of the inner knife tube is inserted into the outer knife tube. An airflow channel communicating with the sampling slot is provided between the inner knife tube and the outer knife tube to allow the inner knife tube to move linearly relative to the outer knife tube. The proximal end of the inner knife tube is configured to be connected to a negative pressure device. One end of the air return assembly is movably sleeved on the outside of the outer blade tube, and the other end of the air return assembly is sleeved on the proximal end of the inner blade tube. The drive mechanism is connected to the inner blade tube in a driving connection. The return air assembly has an initial position relative to the outer blade tube. When the return air assembly is in the initial position, the airflow channel is not connected to the external environment. After the driving mechanism drives the inner blade tube to move a preset distance to the far end, the driving mechanism drives the inner blade tube and the return air assembly to move, so that the return air assembly moves away from the initial position, thereby connecting the airflow channel to the external environment.

2. The radiofrequency biopsy needle according to claim 1, characterized in that, The return air assembly includes a sealed canister, one end of which is movably fitted onto the outside of the outer blade tube, and the other end of which is sealed to the proximal end of the inner blade tube. An airflow gap is provided at the connection between the sealed canister and the outer blade tube to communicate with the external environment, and the airflow channel is connected to the interior of the sealed canister. The outer blade tube is fitted with a first sealing element, which is located inside the sealing can. When the sealing can is in the initial position, the first sealing element is located at the airflow gap, so that the airflow channel is not connected to the external environment.

3. The radiofrequency biopsy needle according to claim 2, characterized in that, The outer blade tube is provided with a fixed seat, which is located on the side of the sealed can near the sampling groove. The gas return assembly also includes an elastic element disposed between the fixed seat and the sealed can, and the elastic element is in a compressed state so that the sealed can is in the initial position.

4. The radiofrequency biopsy needle according to claim 3, characterized in that, The return gas assembly further includes a second seal, which is located at the end of the sealing can away from the fixed base, so that the end of the sealing can away from the fixed base is in a sealed connection with the inner knife tube.

5. A radiofrequency biopsy needle according to any one of claims 1-4, characterized in that, When the gas return assembly moves from the initial position toward the direction close to the outer blade tube, the ablation end of the radio frequency cutting device is located in the sampling slot.

6. The radiofrequency biopsy needle according to claim 5, characterized in that, The radio frequency cutting device includes an electrode and an insulating blade head disposed at the distal end of the inner blade tube. The insulating blade head is cylindrical and communicates with the inner blade tube. The electrode is disposed at the end of the insulating blade head away from the inner blade tube to form the ablation end, and the electrode is connected to the radio frequency generating device. The insulating blade has several through holes on its side wall so that the airflow channel can be connected to the sampling slot through the through holes.

7. The radiofrequency biopsy needle according to claim 6, characterized in that, The insulated blade head includes a first part and a second part connected in sequence, and the end of the second part away from the first part is connected to the inner blade tube; The outer diameter of the first part is larger than the outer diameter of the second part, and it is in clearance fit with the outer knife tube.

8. The radiofrequency biopsy needle according to claim 7, characterized in that, The insulating blade tip has a mounting groove on the side away from the inner blade tube that mates with the electrode, so that the electrode can be installed in the mounting groove; Both the insulated blade and the inner blade tube have cable channels for connecting the electrode to the radio frequency generator via wires.

9. The radiofrequency biopsy needle according to claim 8, characterized in that, A first step is provided on the inner wall at the distal end of the inner knife tube, and a second step is provided on the outer wall at the proximal end of the insulating knife head to cooperate with the first step, so as to install the insulating knife head at the distal end of the inner knife tube. The cable channel of the insulating blade head passes through the side wall of the insulating blade head, and the cable channel of the inner blade tube passes through the side wall of the inner blade tube.

10. The radiofrequency biopsy needle according to claim 9, characterized in that, It also includes a housing and a puncture knife, the puncture knife being fixedly connected to the distal end of the outer knife tube, the housing being disposed at the end of the outer knife tube away from the puncture knife, and the drive mechanism being installed inside the housing.

11. The radiofrequency biopsy needle according to claim 10, characterized in that, The distal end of the inner blade tube and the return air assembly are both installed inside the housing, and the housing is provided with a vent hole that communicates with the external environment. The driving mechanism includes a motor and a slider. The slider is disposed on the outside of the inner blade tube. The output end of the motor is connected to the slider for driving the slider and the inner blade tube to move.

12. The radiofrequency biopsy needle according to claim 4, characterized in that, The sealed container includes a sleeve, a limiting part, and a protrusion. The protrusion is disposed on the outer side wall of one end of the sleeve, the limiting part is disposed at the end of the sleeve away from the protrusion, and the elastic element is sleeved on the outside of the sleeve and located between the protrusion and the fixed seat. The limiting part is arranged axially along the opening at one end of the sleeve, and the end of the limiting part away from the sleeve is inclined toward the direction close to the outer knife tube and is spaced apart from the outer knife tube.

13. A method of using a biopsy needle, characterized in that, The biopsy needle is a radiofrequency ablation biopsy needle according to any one of claims 1-12, comprising the following steps: The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot; The external blade enters the lesion tissue; The drive mechanism moves the inner blade tube toward the proximal end until the return gas assembly is in the initial position; The negative pressure device is activated to adsorb the lesion tissue into the sampling tank; Start the radio frequency cutting device; The drive mechanism pushes the inner blade tube toward the distal end until the radio frequency cutting device is located at the sampling slot to perform adsorption sampling. The external blade is removed from the human body.

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