Ablation needle assembly and ablation system

Abstract

The invention provides an ablation needle assembly and an ablation system. The ablation needle assembly comprises a hollow outer sleeve and an ablation needle, the outer sleeve is movably arranged outside an electrode needle body of the ablation needle in a sleeving mode and is detachably and rotatably connected with an ablation handle, so that after ablation operation is completed, the ablation needle and the outer sleeve can be detached, the outer sleeve is still left in tissue, a channel is provided for other operations such as biopsy, and the ablation needle assembly is simple in structure and convenient to use. Repeated puncture is avoided, damage to tissue is reduced, and biopsy operation can be more convenient and efficient. Furthermore, the ablation handle is rotationally connected with the outer sleeve, so that the ablation handle can drive the electrode needle main body to rotate relative to the outer sleeve when rotating relative to the outer sleeve, that is, the outer sleeve and the electrode needle main body are not of an integrated structure, and when the ablation needle needs to be rotated, the outer sleeve can be kept not rotating, so that damage to tissues is reduced; and the rotation resistance is small. Therefore, the ablation needle assembly and the ablation system are particularly suitable for radiofrequency ablation treatment of hypertrophic cardiomyopathy.

Description

[0001] This application is a divisional application with application number 201810971599.1, application date August 24, 2018, and invention name “Ablation needle assembly and ablation system”. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to an ablation needle assembly and an ablation system. Background Art

[0003] In the prior art, for the diagnosis of tumors in the liver, kidneys, soft tissues, etc., a biopsy needle can be used to puncture the lesion site and obtain a small amount of tissue from the lesion site for pathological analysis. For the treatment of such lesions, a radiofrequency ablation needle or a microwave ablation needle can be inserted into the lesion, and the radiofrequency energy or microwave energy can be used to cause the local tissue of the lesion to generate high temperature, causing coagulative necrosis of the lesion tissue to achieve the treatment purpose.

[0004] Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant cardiovascular disease with an incidence of about 1:500 in the general population and a mortality rate of about 1.4%-2.2%. The natural history of HCM varies greatly. Some patients have no obvious clinical symptoms, but it can also cause chest tightness, chest pain, dyspnea, repeated syncope, atrial fibrillation, ventricular tachycardia, heart failure, etc. It is the most common cause of sudden death in young people and athletes. The main manifestation of HCM is hypertrophy of one or more segments of the left ventricle (LV), and the general diagnostic standard is a thickness greater than or equal to 15mm. When the systolic anterior motion (SAM) of the anterior leaflet of the mitral valve is close to the ventricular septum, causing stenosis or even obstruction of the left ventricular outflow tract (LVOT), that is, when the LVOT pressure gradient is too large, it is called obstructive hypertrophic cardiomyopathy (HOCM), which accounts for about 70% of HCM patients. In 2014, the European Society of Cardiology (ESC) published the HCM diagnosis and management guidelines (2014ESC Guidelines on diagnosis and management of hypertrophiccardiomyopathy), which pointed out that the treatment strategy for HOCM is to expand the LVOT to reduce the pressure gradient and alleviate its obstruction. The main methods include drug therapy, surgical septal myectomy, and alcohol septal ablation. Drug treatment is relatively simple and easy, and patients do not have the pain of surgery, but some patients do not respond well to drug treatment or cannot tolerate it; ventricular septal rotator cleft surgery, also known as modified Morrow surgery, is a surgical procedure to remove hypertrophic myocardium through thoracotomy. The resection site is mainly the anterior part of the ventricular septum and is concentrated on the left ventricular surface. After resection, the thickness of the ventricular septum can be reduced by 50%, and the LVOT is significantly reduced after surgery. However, the modified Morrow surgery has certain risks, and the patient's postoperative recovery is also painful; ventricular septal alcohol ablation is an interventional treatment method, which mainly uses percutaneous transluminal coronary angioplasty technology to send a balloon into the septal branch to be eliminated, and slowly inject alcohol into the septal branch to produce chemical occlusion, thereby causing ischemia, necrosis, thinning, decreased contractility of the hypertrophic ventricular septum myocardium, and reducing LVOT. Although this method avoids the pain of surgery, in clinical applications, alcohol may cause myocardial infarction through the branch blood vessels, and there is still a certain risk. Therefore, a less invasive, safer and more effective treatment method is needed for HCM.In addition, in order to understand the extent of hypertrophic myocardial lesions and the effect of ablation treatment of HCM, biopsy before and / or after ablation is extremely necessary.

[0005] As mentioned above, radiofrequency ablation needles or microwave ablation needles are minimally invasive interventional treatment devices, and are currently mainly used to treat tumors in the liver, kidneys, soft tissues, etc., and most existing ablation needles are integrated. If other operations such as biopsy are required before and / or after ablation, multiple punctures are required, which is difficult and increases tissue damage. In addition, if the ablation needle needs to be rotated during the ablation operation, the part of the ablation needle inserted into the tissue is directly covered by the tissue, which is not only difficult to rotate, but also causes damage to the tissue. Summary of the invention

[0006] The present invention provides an ablation needle assembly with less damage to tissues and an ablation system, which are particularly suitable for radiofrequency ablation of hypertrophic cardiomyopathy.

[0007] The ablation needle assembly includes a hollow outer sleeve and an ablation needle movably installed in the outer sleeve; the ablation needle includes an electrode needle body and an ablation handle connected to the proximal end of the electrode needle body; the outer sleeve is at least partially insulated; the proximal end of the outer sleeve is detachably and rotatably connected to the ablation handle, and the distal end of the electrode needle body extends out of the outer sleeve; the ablation handle rotates relative to the outer sleeve to drive the electrode needle body to rotate relative to the outer sleeve.

[0008] Wherein, it also includes a biopsy needle, and the biopsy needle and the ablation needle are alternately installed in the outer sleeve.

[0009] Among them, the ablation handle includes a driving assembly and a connecting piece rotatably connected to the driving assembly, and the outer sleeve and the connecting piece are detachably connected; the driving assembly drives the outer sleeve to move relative to the electrode needle body along the extension direction of the electrode needle body to adjust the length of the distal end of the electrode needle body extending out of the outer sleeve.

[0010] Among them, the driving assembly includes a sliding member and an adjusting member connected to the sliding member, the connecting member is coaxially arranged and rotationally connected to the sliding member, and the adjusting member controls the sliding member to move along its axial direction to drive the outer sleeve connected to the connecting member to move relative to the electrode needle body to adjust the length of the distal end of the electrode needle body extending out of the outer sleeve.

[0011] Among them, the ablation handle includes a shell, and the drive assembly is accommodated in the shell; a control groove is opened on the shell along the axial direction of the sliding member, and one end of the adjustment member extends out of the shell from the control groove; the sliding member is controlled to move along its axial direction by moving the adjustment member to the position of the control groove.

[0012] Wherein, at least one side of the control groove is provided with a scale mark.

[0013] Among them, an elastic member is provided between the adjusting member and the sliding member, and the extending direction of the elastic member is toward the control groove; the inner wall of the outer shell is provided with a plurality of snap positions corresponding to the scale marks, and the adjusting member is provided with at least one protrusion; when the elastic member is naturally stretched, the elastic member pushes the protrusion to snap into the snap position.

[0014] The inner surface of the shell is provided with a first guide member arranged along the axial direction of the sliding member, and the surface of the sliding member is provided with a second guide member adapted to the first guide member, and the sliding member moves along its axial direction through the cooperation between the second guide member and the first guide member.

[0015] Wherein, a groove is provided at the distal ring of the sliding member, and a clamping ring is provided at the proximal end of the connecting member, and the clamping ring is clamped into the groove to make the sliding member and the connecting member rotationally connected.

[0016] It also includes a puncture needle core, which is alternately installed in the outer sleeve with the ablation needle or the biopsy needle and is detachably connected to the outer sleeve, and the distal end of the puncture needle core extends out of the outer sleeve.

[0017] Wherein, the outer surface of the outer sleeve is provided with scale markings.

[0018] Wherein, the distal end of the outer sleeve has a first guide portion, and the first guide portion is visualized under a medical imaging device.

[0019] Wherein, the distal end of the electrode needle body has a second guide portion, and the second guide portion is visualized under a medical imaging device.

[0020] Wherein, a cooling channel is provided in the electrode needle body.

[0021] The ablation system includes the ablation needle assembly and an energy generating device electrically connected to the electrode needle body of the ablation needle.

[0022] Wherein, the energy generating device is a radio frequency generator or a microwave generator.

[0023] Wherein, the ablation system further comprises a cooling device connected to the proximal end of the electrode needle body.

[0024] Compared with the prior art, the ablation needle assembly and ablation system of the present invention have at least the following beneficial effects:

[0025] The ablation needle assembly includes the outer sleeve and the ablation needle. The outer sleeve is movably mounted outside the electrode needle body of the ablation needle and is detachably and rotatably connected to the ablation handle, so that after the ablation operation is completed, the ablation needle can be disassembled from the outer sleeve, and the outer sleeve is still left in the tissue, providing a channel for other operations such as biopsy, avoiding repeated punctures, reducing damage to tissues, and making the biopsy operation more convenient and efficient. Furthermore, in the present invention, the ablation handle is rotatably connected to the outer sleeve, so that when the ablation handle rotates relative to the outer sleeve, it can drive the electrode needle body to rotate relative to the outer sleeve, that is, the outer sleeve and the electrode needle body are not an integrated structure. When the ablation needle needs to be rotated, the outer sleeve can be kept from rotating, thereby reducing damage to the tissue, and the rotation resistance is small. Therefore, the ablation needle assembly and ablation system of the present invention are particularly suitable for radiofrequency ablation treatment of HCM. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the structural features and effects of the present invention, it is described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0027] Figure 1 is a schematic structural diagram of an ablation needle assembly according to an embodiment of the present invention;

[0028] Figure 2 is a schematic structural diagram of an ablation needle and an outer sleeve after being assembled according to an embodiment of the present invention;

[0029] Figure 3 yes Figure 2 A front view of the ablation needle and the outer sleeve after being assembled;

[0030] Figure 4 It is a schematic diagram of the outer sleeve structure of an embodiment of the present invention;

[0031] Figure 5 It is a schematic diagram of the outer sleeve structure of an embodiment of the present invention;

[0032] Figure 6 is an enlarged schematic diagram of the distal end of an electrode needle body according to an embodiment of the present invention;

[0033] Figure 7 yes Figure 6 A schematic cross-sectional view of the electrode needle body at position AA;

[0034] Figure 8 is a schematic diagram of the main structure of an electrode needle according to an embodiment of the present invention;

[0035] Fig. 9 yes Figure 2 The schematic cross-sectional view of the ablation needle and the outer sleeve after being assembled;

[0036] Fig.10is a schematic diagram of the process of adjusting the length of the distal end of the ablation needle extending out of the outer sleeve after the ablation needle and the outer sleeve are assembled;

[0037] Fig.11 is a schematic structural diagram of a driving assembly of the ablation needle according to an embodiment of the present invention;

[0038] Fig.12 Schematic diagram of the disassembly of the biopsy needle and the outer sleeve according to an embodiment of the present invention;

[0039] Fig.13 yes Fig.12 The schematic diagram of the biopsy needle and outer sleeve combination shown;

[0040] Fig.14 Schematic diagram of the disassembly of the puncture needle core and the outer sleeve in an embodiment of the present invention;

[0041] Fig.15 yes Fig.14 A schematic diagram of the combination of the puncture needle core and the outer sleeve shown;

[0042] Figures 16a to 16c is a schematic diagram of the use process of the ablation needle assembly according to one embodiment of the present invention;

[0043] Figures 17a to 17e is a schematic diagram of the use process of an ablation needle assembly according to another embodiment of the present invention;

[0044] Fig.18 Schematic diagram of the structure of the ablation system according to an embodiment of the present invention. DETAILED DESCRIPTION

[0045] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention, wherein the accompanying drawings are only for illustrative purposes and are only schematic diagrams and cannot be understood as limiting the present invention.

[0046] In order to more clearly describe the structure of the ablation needle assembly and the ablation system, the terms "proximal end" and "distal end" are defined here as commonly used terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, and the "proximal end" refers to the end close to the operator during the surgical operation.

[0047] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those commonly understood by those skilled in the art. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0048] Please also read Figures 1 to 3The present invention provides an ablation needle assembly 100 for performing an ablation operation. The ablation needle assembly 100 includes an outer sleeve 30 and an ablation needle 10. The ablation needle 10 includes an electrode needle body 11 and an ablation handle 12 connected to the proximal end of the electrode needle body 11. The outer sleeve 30 is movably sleeved outside the electrode needle body 11 and is detachably and rotatably connected to the ablation handle 12. In the present invention, the outer sleeve 30 is at least partially insulated. In other words, the outer sleeve 30 can be fully insulated or partially insulated. The distal end of the electrode needle body 11 extends out of the outer sleeve 30. When the outer sleeve 30 is fully insulated, the portion of the electrode needle body 11 extending out of the outer sleeve 30 performs the ablation operation; when the outer sleeve 30 is partially insulated, the portion of the electrode needle body 11 extending out of the outer sleeve 30 and the non-insulated portion of the outer sleeve 30 perform the ablation operation. Specifically, when the electrode needle body 11 is electrically connected to the radio frequency generator, the electrode needle body 11 transmits high-frequency current to cause the charged positive and negative ions in the diseased tissue around the distal end of the electrode needle body 11 to oscillate at a high speed. The high-speed oscillating ions generate a large amount of heat due to friction, which increases the temperature in the diseased tissue, and eventually causes the protein in the diseased cells to denature, the water inside and outside the cells to lose water, and the diseased tissue to develop coagulative necrosis, thereby achieving radiofrequency ablation; when the electrode needle body 11 is electrically connected to the microwave generator, a microwave field is formed at the distal end of the electrode needle body 11, and the dipole molecules such as water molecules in the diseased tissue generate heat due to friction and violent collision under the action of the microwave field, which increases the temperature in the diseased tissue, and eventually causes the protein in the diseased cells to denature, the water inside and outside the cells to lose water, and the diseased tissue to develop coagulative necrosis, thereby achieving microwave ablation. Furthermore, the outer sleeve 30 is detachably connected to the ablation handle 12, so that after the ablation operation is completed, the ablation needle 10 can be disassembled from the outer sleeve 30, and the outer sleeve 30 is still left in the tissue to provide a channel for other operations, avoiding repeated punctures, reducing damage to the tissue, and making the ablation and other operations more convenient and efficient. Furthermore, the ablation handle 12 can rotate relative to the outer sleeve 30 to drive the electrode needle body 11 to rotate relative to the outer sleeve 30, that is, the outer sleeve 30 and the electrode needle body 11 of the ablation needle 10 are not an integrated structure. When the ablation needle 10 needs to be rotated, the outer sleeve 30 can be kept from rotating, thereby reducing damage to the tissue, and the resistance to rotation is small.

[0049] The outer sleeve 30 is at least partially insulated, and preferably, the outer sleeve 30 is completely insulated. Figure 4As shown, the outer sleeve 30 is at least partially insulated, which means that the first tube body 30a of the outer sleeve 30 near the proximal end is an insulating structure, and the second tube body 30b of the outer sleeve 30 near the distal end can be a non-insulating structure, so that the non-insulating part of the outer sleeve 30 can also transmit high-frequency current or microwaves to increase the ablation area. The outer sleeve 30 can be at least partially made of insulating material, or the outer sleeve 30 can be made entirely of non-insulating material, and then the outer surface of the outer sleeve 30 is at least partially covered with an insulating coating. When performing an ablation operation, the part of the outer sleeve 30 covered with the insulating layer serves as an insulating tube of the ablation needle 10. In order to improve the support of the outer sleeve 30 and facilitate puncturing human tissue. Preferably, the outer sleeve 30 is made of metal material, and the outer surface of the tube body is coated with an insulating coating. The metal material includes but is not limited to 304 stainless steel, 321 stainless steel or 631 stainless steel tube, and the insulating coating includes but is not limited to PTFE coating, titanium nitride coating, parylene coating, etc. The metal material used to make the outer sleeve 30 should have sufficient hardness to penetrate human tissue and have excellent biocompatibility. The insulating coating should have reliable insulation, excellent biocompatibility and a small friction coefficient, and the insulating coating should be tightly combined with the outer surface of the outer sleeve 30, and the insulating coating should not fall off easily. For example, 304 stainless steel tube with PTFE coating, 321 stainless steel tube with titanium nitride coating, or 631 stainless steel tube with parylene coating can be selected. Considering the insulation reliability and process feasibility, the thickness of various insulating coatings should be ≥3μm. It is understandable that in other embodiments, the outer sleeve 30 can also be made entirely of insulating materials, such as plastic tubes that can meet the hardness requirements such as PEEK, PI or PA, and ceramic tubes such as high-aluminum porcelain, talc porcelain or boron nitride.

[0050] The distal end of the outer sleeve 30 may be straight or be a beveled tip. Preferably, the distal end of the outer sleeve 30 is a tip, so that each position of the outer sleeve 30 can be easily inserted into the tissue, and the contact area between the tissue around each position of the outer sleeve 30 and the electrode needle body 11 is different, so that the required ablation area is determined according to the anatomical structure of the tissue to be treated, and directional and positioning ablation is achieved by adjusting the insertion direction of the outer sleeve 30.

[0051] Furthermore, the outer sleeve 30 is provided with a scale mark 31 to indicate the depth of the outer sleeve 30 inserted into the tissue, and the scale mark 31 includes a series of scale values, and the scale values ​​gradually increase from the distal end to the proximal end. When the outer sleeve 30 is inserted into the tissue, the depth of the outer sleeve 30 inserted into the tissue can be known by observing the scale values ​​on the outer sleeve 30, thereby knowing the approximate position of the outer sleeve 30 inserted into the tissue. Figure 5As shown, the distal end of the outer tube 30 has a first guide portion 34 that can be developed under a medical imaging device. The length of the first guide portion 34 needs to be ≥5mm to ensure the accuracy of the position guidance. The first guide portion 34 can help the doctor determine whether the distal end of the outer tube 30 is moving along the desired puncture path and whether it is close to the predetermined ablation position. Specifically, the first guide portion 34 can be a part of the structure added to the distal end of the outer tube 30, or the distal end of the outer tube 30 is processed in a certain manner. Since ultrasound imaging is less harmful to the human body than other imaging modes (such as X-ray fluoroscopy) and is more economical, it is preferred to process the surface of the tube body near the distal end of the outer tube 30 into an uneven rough surface to form the first guide portion 34 to meet the needs of ultrasound imaging. For example, the surface of the second tube body 30b near the distal end of the outer tube 30 can be roughened by sandblasting or drilling to form the first guide portion 34. In addition, in the present invention, the surface roughness of the first guide portion 34 should not be too high, and while achieving the needs of ultrasound imaging, it will not affect the advancement of the outer tube 30 in the tissue.

[0052] The electrode needle body 11 of the ablation needle 10 can be made of biocompatible metals with excellent conductive properties such as stainless steel. Since an at least partially insulated outer sleeve 30 is provided, the surface of the electrode needle body 11 of the ablation needle 10 does not need to be coated with insulating materials, which simplifies the manufacturing process of the electrode needle body 11 of the ablation needle 10, and the outer sleeve 30 can provide support and protection for the electrode needle body 11 of the ablation needle 10, thereby allowing the diameter of the electrode needle body 11 to be reduced. For example, the diameter of the electrode needle body 11 can be selected from 20G to 16G, which helps to further reduce tissue damage on the one hand, and on the other hand, if the structure of the tissue to be ablated, such as the ventricular septum, is relatively flat, the smaller the diameter of the electrode needle body 11, the more suitable it is for ablation of flat tissues, and when ablating the hypertrophic myocardium in the ventricular septum, it can prevent the occurrence of problems such as pneumothorax and pericardial effusion, and reduce bleeding. Therefore, the ablation needle assembly of this embodiment is particularly suitable for ablation treatment of HCM.

[0053] The electrode needle body 11 of the ablation needle 10 is electrically connected to an energy generator, wherein the energy generator may be a microwave generator or a radio frequency generator. When the outer sleeve 30 is completely insulated, microwave energy or radio frequency energy is transmitted to the tissue through the portion of the electrode needle body 11 of the ablation needle 10 that is exposed from the outer sleeve 30 to perform an ablation operation. Preferably, the distal end of the electrode needle body 11 of the ablation needle 10 is in the shape of a sharp triangular pyramid or needle, which facilitates puncture after the electrode needle body 11 of the ablation needle 10 is combined with the outer sleeve 30. Of course, the distal end of the electrode needle body 11 of the ablation needle 10 may also be set to other shapes, such as a spherical shape, an umbrella shape, etc.

[0054] For further information, please also refer to Figures 1 to 3 and Figure 6 to Figure 7 The portion of the electrode needle body 11 of the ablation needle 10 that contacts the tissue will transmit radio frequency energy or microwave energy to cause high temperature in the tissue, resulting in coagulative necrosis of the tissue to achieve the treatment purpose. However, excessive local temperature will affect normal tissue that does not require ablation. Therefore, a cooling channel 16 is provided in the electrode needle body 11 of the ablation needle 10. The cooling channel 16 is used to transport a gaseous or liquid cooling medium (such as cooling water) to cool the high-temperature portion to control the temperature during the ablation operation.

[0055] Furthermore, if Figure 8 As shown, the distal end of the electrode needle body 11 has a second guide portion 17 that can be developed under a medical imaging device. The length of the second guide portion 17 needs to be ≥5mm. The second guide portion 17 can be developed under a medical imaging device to help doctors determine whether the distal end of the electrode needle body 11 has reached or is in a predetermined ablation position. Specifically, the second guide portion 17 can be a part of the structure added to the distal end of the electrode needle body 11, or the distal end of the electrode needle body 11 is processed to a certain extent. Preferably, the surface of the distal end of the electrode needle body 11 is processed into an uneven rough surface to form the second guide portion 17 to meet the needs of ultrasonic imaging. For example, the surface of the distal end of the electrode needle body 11 can be sandblasted or punched. In addition, in the present invention, the surface roughness of the second guide portion 17 should not be too high. While meeting the needs of ultrasonic imaging, it will not affect the advancement of the electrode needle body 11 in the tissue. Therefore, the ablation needle assembly of this embodiment is particularly suitable for ablation treatment under ultrasound guidance. The operator can insert the distal end of the ablation needle assembly into the patient's body through puncture under ultrasound guidance, and ablate the diseased tissue through the part of the ablation needle 10 exposed from the outer sleeve 30.

[0056] Please also see Figure 2 , Fig. 9 and Fig.11, the ablation handle 12 includes a driving assembly 120 and a connecting piece 121 rotatably connected to the driving assembly 120, and the proximal end of the outer sleeve 30 is detachably connected to the connecting piece 121. In other words, the outer sleeve 30 is connected to the driving assembly 120 through the connecting piece 121, and the outer sleeve 30 is driven by the driving assembly 120 to move relative to the electrode needle body 11 along the extension direction of the electrode needle body 11, so as to adjust the length of the distal end of the electrode needle body 11 of the ablation needle 10 extending out of the outer sleeve 30 according to the actual ablation range requirements. In this embodiment, the proximal end of the outer sleeve 30 is provided with an external thread, and the distal end of the connecting piece 121 is provided with an internal thread matched with the external thread of the outer sleeve 30, and the detachable connection between the outer sleeve 30 and the connecting piece 121 is achieved by the cooperation of the external thread and the internal thread. Furthermore, in some embodiments of the present invention, a gripping portion 33 is provided at the distal end of the outer sleeve 30 where the outer thread is provided, so as to facilitate rotation relative to the ablation needle 10 or disassembly and assembly with the ablation needle 10. In this embodiment, a plurality of protrusions are provided on the outer wall of the outer sleeve 30 to form the gripping portion 33.

[0057] See also Fig. 9, the driving assembly 120 includes a sliding member 122 arranged in the axial direction and an adjusting member 123 connected to the sliding member 122. The connecting member 121 is coaxially arranged and rotationally connected with the sliding member 122, so that the connecting member 121 can rotate relative to the sliding member 122 with its axis as the axis center, so that the outer sleeve 30 connected to the connecting member 121 can rotate relative to the sliding member 122, and the electrode needle body 11 is connected to the ablation handle 12, so that the outer sleeve 30 can rotate relative to the electrode needle body 11. Therefore, when it is necessary to rotate and adjust the ablation needle 10 or the biopsy needle 20, the position of the outer sleeve 30 can be kept unchanged, and only the ablation needle 10 or the biopsy needle 20 installed in the outer sleeve 30 can be rotated, which can not only reduce the friction or damage to the tissue, but also has a small resistance to rotation, and is easy to operate. In this embodiment, the distal ring of the sliding member 122 is provided with a slot 1221, and the proximal end of the connecting member 121 is provided with a collar 1211 adapted to the slot 1221, and the collar 1211 is just inserted into the slot 1221, so that the connecting member 121 can rotate around the axial direction, but cannot move along the axial direction, so as to realize the rotational connection between the connecting member 121 and the sliding member 122. In addition, during the ablation process, when it is necessary to straighten the wires and cooling pipelines outside the ablation handle 12 to prevent the wires and cooling pipelines from excessive bending, twisting and winding, and to facilitate viewing of the scale values ​​on the ablation handle 12, when the operator needs to rotate the ablation handle 12 or / and the ablation needle 10, the operator can hold the connecting member 121 with his hand to keep the outer sleeve 30 from rotating, and rotate the ablation handle 12 of the ablation needle 10, so as to drive the electrode needle body 11 to rotate through the ablation handle 12, thereby reducing the friction damage to the tissue when the outer sleeve 30 rotates, and the resistance to rotation is small.

[0058] The sliding member 122 is provided with a through hole extending axially therethrough, and the proximal end of the electrode needle body 11 of the ablation needle 10 passes through the through hole, thereby ensuring the coaxiality of the outer sleeve 30 and the ablation needle 10. The proximal end of the electrode needle body 11 of the ablation needle 10 is fixedly connected to the ablation handle 12 by bonding, clamping, pinning, etc., which are common in the art.

[0059] The axial direction of the connecting member 121 and the sliding member 122 is the same as the extension direction of the electrode needle body 11 of the ablation needle. The adjusting member 123 controls the sliding member 122 to move along its axial direction, so as to drive the outer sleeve 30 connected to the connecting member 121 to move relative to the electrode needle body 11, so as to adjust the length of the distal end of the electrode needle body 11 extending out of the outer sleeve 30, so as to adjust the length of the distal end of the electrode needle body 11 extending out of the outer sleeve 30 according to the anatomical structure of the lesion and the actual ablation area. In this embodiment, the adjusting member 123 is arranged on the sliding member 122, and the extension direction is perpendicular to the extension direction of the sliding member 122. By pushing the adjusting member 123 to move along the axial direction, the sliding member 122 is driven to move along the axial direction. The distal end of the sliding member 122 is inserted into the proximal end of the outer sleeve 30, so that the sliding member 122 is coaxial with the outer sleeve 30. When the sliding member 122 is moved along the axial direction, the outer sleeve 30 is driven to move along the axial direction. In this embodiment, the distal end of the sliding member 122 is tapered, and the inner wall of the proximal end of the outer sleeve 30 is set to a cone corresponding to the sliding member 122, so that the distal end of the sliding member 122 can be easily inserted into the outer sleeve 30 and can achieve axial positioning, and can also facilitate the assembly of the clamping ring 1211 and the clamping groove 1221.

[0060] The ablation handle 12 of the ablation needle 10 includes a housing 124, and the drive assembly 120 is accommodated in the housing 124. In this embodiment, the housing 124 includes a first housing and a second housing that are arranged opposite to each other, and the two are fixedly connected together by means of snaps, bonding, etc., so as to facilitate the assembly of the drive assembly 120 in the housing 124. A control groove 1222 is provided on the housing 124 along the axial direction of the sliding member 122. The control groove 1222 can be directly provided on the first housing or the second housing, or a groove can be provided on each of the first housing and the second housing and then buckled together to form the control groove 1222. The end of the adjusting member 123 that is away from the sliding member 122 extends out of the housing 124 from the control groove 122; by moving the adjusting member 123 in the position of the control groove 1222, the movement of the sliding member 122 along its axial direction can be controlled.

[0061] Furthermore, a scale mark 1225 is provided on one or both sides of the control slot 1222. After the adjustment member 123 is actuated to a certain position of the control slot 1222, the scale value corresponding to the adjustment member 123 can be observed to know the length of the ablation needle 10 exposed from the outer sleeve 30. When the outer sleeve 30 is completely insulated, the length of the ablation needle 10 exposed from the outer sleeve 30 is the effective ablation length of the ablation needle 10 that can perform ablation. Fig.10As shown, when the adjusting member 123 is actuated to be at the nearest end of the control slot 1222, the scale value corresponding to the adjusting member 123 is the largest, and the length of the ablation needle 10 exposed from the outer sleeve 30 is the longest, and its length is Lmax; when the adjusting member 123 is actuated to be at the farthest end of the control slot 1222, the scale value corresponding to the adjusting member 123 is the smallest, and the length of the ablation needle 10 exposed from the outer sleeve 30 is the shortest, and its length is Lmin. According to the anatomical structure differences of different tissues, the adjustable range of the effective ablation length of the ablation needle 10 is also different. For example, when applied to ablation treatment of HCM, the adjustable range of the effective ablation length of the ablation needle 10 is 5mm to 35mm.

[0062] Please also read Figures 9 to 11 The inner surface of the housing 124 is provided with a first guide member (not shown) arranged along the axial direction of the sliding member 122, and the surface of the sliding member 122 is provided with a second guide member 1223 that cooperates with the first guide member, and the sliding member 122 can move smoothly along its axial direction through the cooperation between the second guide member 1223 and the first guide member. Specifically, the first guide member can be Fig.10 The groove shown in the figure, the second guide member 1223 can be a convex rib provided on the sliding member 122 and adapted to the groove; the first guide member can also be set as a convex rib, and the second guide member 1223 can be a groove provided on the sliding member 122 and adapted to the convex rib.

[0063] An elastic member 125 is further provided between the adjusting member 123 and the sliding member 122, and the extending direction of the elastic member 125 is toward the control slot 1222. A plurality of latching positions 1226 are provided on the inner wall of the housing 124 at positions corresponding to the scale marks 1225 on one side or both sides of the control slot 1222. At least one protrusion 1231 is provided on the adjusting member 123. The elastic member 125 may be, but is not limited to, a spring, a spring sheet, or an elastic washer. In the natural state, the elastic member 125 pushes the protrusion 1231 of the adjusting member 123 to snap into the snap position 1226 to realize the positioning of the adjusting member 123 and the sliding member 122. The operator manually presses the adjusting member 123 downward, and the elastic member 125 contracts under pressure, and the protrusion 1231 of the adjusting member 123 is separated and released from the snap position 1226. At this time, pushing and pulling the adjusting member 123 axially can drive the sliding member 122 and the outer sleeve 30 to move axially, thereby adjusting the length of the ablation needle 10 exposed from the outer sleeve 30, that is, the effective ablation length; when the adjusting member 123 reaches a certain scale position to obtain the desired effective ablation length, the operator releases the adjusting member 123, and the elastic member 125 resets itself elastically, pushing the protrusion 1231 of the adjusting member 123 to snap into the corresponding snap position 1226, so that the adjusting member 123 and the sliding member 122 can be positioned at this position and remain motionless.

[0064] See also Fig.12 , Fig.13 and Figures 16a to 16c In the present invention, the ablation needle assembly 100 further includes a biopsy needle 20, and the ablation needle 10 and the biopsy needle 20 are alternately inserted into the outer sleeve 30. Furthermore, the biopsy needle 20 can be detachably and rotatably connected to the outer sleeve 30. Specifically, the biopsy needle 20 includes a biopsy needle body 21 and a biopsy handle 22 connected to the proximal end of the biopsy needle body 21; after the ablation needle 10 is separated from the outer sleeve 30, the biopsy needle body 21 of the biopsy needle 20 is inserted into the outer sleeve 30, and the outer sleeve 30 and the biopsy handle 22 of the biopsy needle 20 are detachably and rotatably connected. In other words, the ablation needle 10 and the outer sleeve 30 can be detachably connected, and the biopsy needle 20 can also be detachably connected to the outer sleeve 30. After the ablation needle 10 and the outer sleeve 30 are separated, the biopsy needle 20 can be connected to the outer sleeve 30. Therefore, after the ablation operation is completed, the connection between the ablation needle 10 and the outer sleeve 30 is released, and the outer sleeve 30 is left in the tissue to provide a channel for the biopsy operation, so that the biopsy needle 20 can quickly reach the desired biopsy position, avoiding repeated punctures and reducing damage to the tissue; or, in some surgical procedures, after the biopsy operation is completed first, the connection between the biopsy needle 20 and the outer sleeve 30 can be released, and the outer sleeve 30 can be left in the tissue to provide a channel for the ablation operation, so that the ablation needle 10 can quickly reach the desired ablation position. In addition, since the outer sleeve 30 and the biopsy needle body 21 of the biopsy needle 20 are detachably and rotatably connected, during the biopsy operation, if the biopsy needle 20 needs to be rotated, the outer sleeve 30 can be kept stationary, thereby reducing damage to the tissue, and the resistance to rotation is small.

[0065] Please combine Fig.14 , Fig.15 and Figures 17a to 17eFurthermore, in some embodiments of the present invention, the ablation needle assembly 100 further includes a puncture needle core 40, the diameter of which is greater than the diameter of the ablation needle 10 or the biopsy needle 20, and the diameter range of the puncture needle core 40 is preferably 19G to 16G. And the puncture needle core 40 is preferably made of a harder material, such as stainless steel. The puncture needle core 40 and the ablation needle 10 or the biopsy needle 20 are alternately installed in the outer sleeve 30 and are detachably connected to the outer sleeve 30, and the distal end of the puncture needle core 40 extends out of the outer sleeve 30. In this embodiment, the distal end of the puncture needle core 40 is in the shape of a sharp needle or a triangular pyramid, and a connector 41 with an internal thread can be fixed at the proximal end, and the internal thread of the connector 41 is compatible with the external thread at the proximal end of the outer sleeve 30. After the puncture needle core 40 is added, the puncture needle core 40 can be combined with the outer sleeve 30 to puncture the tissue before ablation or biopsy, and then the connection between the puncture needle core 40 and the outer sleeve 30 is released, the puncture needle core 40 is withdrawn, and the ablation needle 10 or the biopsy needle 20 is inserted into the outer sleeve 30. The puncture needle core 40 with a larger diameter and harder material can provide better support for the outer sleeve 30, so the combination of the puncture needle core 40 and the outer sleeve 30 is more convenient for puncture, and can prevent the ablation needle 10 or the biopsy needle 20 from being damaged when the ablation needle 10 or the biopsy needle 20 is directly used for puncture.

[0066] For further information, please also refer to Figure 6 and Fig.18 The present invention also provides an ablation system, comprising the ablation needle assembly 100 and an energy generating device 110. In some embodiments of the present invention, the ablation system 200 further comprises a medical imaging device 120 and / or a cold source supply device 130. The energy generating device 110 is electrically connected to the ablation needle 10, and the energy generating device 110 may be, but is not limited to, a radio frequency generator or a microwave generator. The cold source supply device 130 is connected to the cooling channel 16 through a cooling pipeline 160, and provides a gaseous or liquid cooling medium into the cooling channel 16. The medical imaging device 120 is used to display the distal position of the outer sleeve 30 and the ablation needle 10 in real time, and can be selected from at least one of ultrasound, CT, nuclear magnetic resonance, and X-ray fluoroscopy, preferably ultrasound.

[0067] The ablation needle assembly 100 and ablation system of the present invention can be used, but not limited to, in the treatment of HCM, as well as the treatment and biopsy of kidney, liver or soft tissue tumors.

[0068] like Figures 16a to 16c As shown, this embodiment takes the treatment of HCM as an example to illustrate the use process of the ablation needle assembly 100:

[0069] Step 1: First, the ablation needle 10 is inserted into the outer sleeve 30, and the outer sleeve 30 is connected to the ablation handle 12 of the ablation needle 10 through the connecting piece 121 to obtain the following Figure 2 The ablation needle assembly shown. The adjusting member 123 is actuated to drive the driving assembly 120 and the outer sleeve 30 to move axially relative to the ablation needle 10, and the outer sleeve 30 is used as an insulating tube of the ablation needle 10 to obtain the desired length of the ablation needle 10 exposed from the outer sleeve 30, that is, the effective ablation length.

[0070] Step 2: If Fig.16a As shown, under the guidance of an ultrasonic device, the outer sleeve 30 and the ablation needle 10 are inserted through the apex of the heart through the epicardium into the ventricular septum through the ribs, and the radiofrequency generator is turned on. The hypertrophic ventricular septal myocardium is subjected to radiofrequency ablation by the portion of the ablation needle 10 that is exposed from the outer sleeve 30, thereby destroying the activity of the ventricular septal myocardium in the corresponding part, causing myocardial necrosis, atrophy, and thinning, thereby widening the left ventricular outflow tract and relieving obstruction. The use of the ablation needle assembly 100 to treat HCM not only avoids the risks and pain of surgical thoracotomy and extracorporeal circulation, but also avoids the risk of chemical alcohol ablation being ineffective or alcohol spillage causing large-area myocardial infarction. It is simple and easy to perform, causes minimal trauma to the patient, has low surgical risks, and has significant efficacy.

[0071] Step 3: If Fig.16b and Fig.16c As shown, when both ablation and biopsy are required, the connection between the outer sleeve 30 and the connector 121 is released after ablation is completed, the ablation needle 10 is withdrawn and the outer sleeve 30 is left, and then the biopsy needle 20 is inserted into the outer sleeve 30 to extract tissue samples for biopsy. The outer sleeve 30 provides a channel for the biopsy operation, which can avoid repeated punctures, reduce damage to tissues, and enable the biopsy needle 20 to quickly reach the desired biopsy position.

[0072] It is understandable that, in some cases, before performing ablation, the outer sleeve 30 and the biopsy needle 20 can be combined to perform puncture and biopsy, and then the biopsy needle 20 can be withdrawn while the outer sleeve 30 is retained. The adjustment member 123 is then actuated to allow the drive assembly 120 to reach and position at the desired scale position, and finally the ablation needle 10 is inserted into the outer sleeve 30. The connection between the outer sleeve 30 and the connecting member 121 is established by rotating the connecting member 121. The ablation needle 10 performs ablation with the desired effective ablation length, which can also avoid repeated punctures and reduce damage to tissues.

[0073] like Figures 17a to 17eAs shown, in some embodiments of the present invention, after the ablation needle assembly 100 is added with a puncture needle core 40, the puncture needle core 40 can be combined with the outer sleeve 30 for puncture before ablation or biopsy, and then the connection between the puncture needle core and the outer sleeve 30 is released, the puncture needle core 40 is withdrawn, and the outer sleeve 30 is left in the patient's body. Then, the ablation needle 10 or the biopsy needle 20 is inserted into the outer sleeve 30 to perform ablation or biopsy operations to increase the puncture strength and prevent the ablation needle 10 or the biopsy needle 20 from being damaged during the puncture process.

[0074] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An ablation needle assembly, characterized in that: It includes a hollow outer sleeve and an ablation needle; The ablation needle comprises an electrode needle and an ablation handle connected to the proximal end of the electrode needle; The electrode needle is movably installed in the outer sleeve, and the distal end of the electrode needle extends out of the outer sleeve; The ablation handle comprises a driving assembly and a connecting piece connected to the driving assembly, and the outer sleeve is connected to the connecting piece; The driving assembly drives the outer sleeve to move relative to the electrode needle along the extension direction of the electrode needle to adjust the length of the distal end of the electrode needle extending out of the outer sleeve.

2. The ablation needle assembly according to claim 1, characterized in that: The length of the ablation needle exposed from the outer sleeve is the effective ablation length of the ablation needle capable of performing ablation; the adjustable range of the effective ablation length is 5 mm to 35 mm.

3. The ablation needle assembly according to claim 1, characterized in that: A cooling channel is arranged inside the electrode needle of the ablation needle.

4. The ablation needle assembly according to claim 1, characterized in that: It also includes a biopsy needle or a puncture needle core, and the biopsy needle or the puncture needle core and the ablation needle are alternately installed in the outer sleeve.

5. The ablation needle assembly according to claim 1, wherein: The driving assembly includes a sliding member and an adjusting member connected to the sliding member, the connecting member is coaxially connected to the sliding member, and the adjusting member controls the sliding member to move along its axial direction to drive the outer sleeve connected to the connecting member to move relative to the electrode needle body.

6. The ablation needle assembly according to claim 5, characterized in that: The ablation handle includes a shell, and the drive assembly is accommodated in the shell; a control groove is opened on the shell along the axial direction of the sliding member, and one end of the adjustment member extends out of the shell from the control groove; the sliding member is controlled to move along its axial direction by moving the adjustment member to the position of the control groove.

7. The ablation needle assembly according to claim 6, characterized in that: The ablation handle housing is provided with scale markings.

8. The ablation needle assembly according to claim 1, characterized in that: The distal end of the outer sleeve and / or the distal end of the electrode needle has a guide portion, and the guide portion is visualized under a medical imaging device.

9. An ablation system, characterized in that: It comprises the ablation needle assembly as claimed in any one of claims 1 to 8 and an energy generating device electrically connected to the electrode needle of the ablation needle.

10. An ablation needle, wherein a cooling channel is provided in the ablation needle. It is characterized in that The distal end of the ablation needle is in the shape of a sharp triangular pyramid, a needle, a sphere or an umbrella.

11. The ablation needle according to claim 10, characterized in that: The ablation needle comprises an electrode needle, the distal end of which has a guide portion that can be visualized under a medical imaging device, and the length of the guide portion needs to be ≥5 mm.

12. The ablation needle according to claim 10, characterized in that: The ablation needle comprises an electrode needle, and the diameter of the electrode needle ranges from 20G to 16G.

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