Ablation needle assembly and ablation system

Abstract

The invention provides an ablation needle assembly and an ablation system. The ablation needle comprises an electrode needle main body and an ablation handle connected with the near end of the electrode needle main body, the electrode needle main body is movably arranged in the outer sleeve in a penetrating manner, and a limiting part is arranged on the outer sleeve to limit the ablation direction of the ablation needle. The far end face of the outer sleeve is connected with a conductive section which extends towards the side away from the outer sleeve in the axial direction of the outer sleeve, and the limiting part is one or more insulating layers which are arranged in the axial direction of the conductive section and partially cover the conductive section. Or the limiting part is one or a plurality of insulating strips which are axially connected to part of the far-end end face of the outer sleeve along the outer sleeve, the plurality of insulating strips are arranged at intervals around the axis of the outer sleeve, and a hollow part is formed on the far side of the part, which is not connected with the insulating strips, of the far-end end face of the outer sleeve. When the ablation needle assembly is applied to ablation treatment of HCM, the ablation direction of the ablation needle can be kept away from the thickness direction of the ventricular septum, and therefore the situation that the ablation needle ablates in the thickness direction of the ventricular septum and penetrates through the endocardium is avoided.

Description

[0001] This application is a divisional application of the parent application with the application number 201811292574.5 and the title "Ablation needle assembly and ablation system", and the parent application was filed on October 31, 2018. TECHNICAL FIELD

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

[0003] In the prior art, for the diagnosis of tumors in liver, kidney, soft tissue and other parts, a biopsy needle can be used to puncture to the lesion site and obtain a small amount of tissue at the lesion site, and then pathological analysis is performed. For the treatment of such lesion sites, a radiofrequency ablation needle or a microwave ablation needle can be inserted into the lesion, and radiofrequency energy or microwave energy is used to cause the local tissue of the lesion to generate high temperature, so that the tissue of the lesion is coagulation necrosis, thereby achieving 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 main manifestation of HCM is the hypertrophy of one or more segments of the left ventricle (LV), and the general diagnostic criterion is that the thickness is greater than or equal to 15 mm. When the anterior leaflet of the mitral valve moves forward during systole and adheres to the interventricular septum, causing left ventricular outflow tract (LVOT) stenosis or even obstruction, i.e. LVOT pressure difference is too large, it is called hypertrophic obstructive cardiomyopathy (HOCM). HOCM accounts for about 70% of HCM patients. At present, the treatment strategy for HCM is to expand the LVOT to reduce the pressure difference and alleviate the obstruction. The main methods are drug treatment, surgical septal myectomy (Surgical septal myectomy), and septal alcohol ablation (Alcohol Septal Ablation). Drug treatment is relatively simple and easy to implement, and patients do not have the pain of surgery, but some patients do not respond well to drug treatment or are intolerant to it. Surgical septal myectomy, i.e. modified Morrow operation, is to remove the hypertrophic myocardium by surgical thoracotomy. The main removal site is the anterior part of the interventricular septum and the left ventricular surface. The thickness of the interventricular septum can be reduced by 50% after removal, and the LVOT is significantly reduced after surgery. However, the modified Morrow operation has certain risks, and the postoperative recovery of patients is also painful. Septal alcohol ablation is an interventional treatment method. It 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 cause chemical occlusion, so that the hypertrophic interventricular septum myocardium becomes ischemic, necrotic, thinned, and the contraction force decreases, reducing the LVOT. Although this method avoids the pain of surgery, there is still a certain risk in clinical application, as alcohol may cause myocardial infarction through the branch vessels. Therefore, a less invasive and safer and more effective treatment method is needed for HCM. In addition, in order to know the extent of the hypertrophic myocardium and the effect of HCM after ablation, biopsy before and / or after ablation is extremely necessary.

[0005] As mentioned earlier, radiofrequency ablation needles or microwave ablation needles are currently mainly used for the treatment of tumors in the liver, kidney, soft tissue, etc. as a minimally invasive interventional treatment instrument, and most of the existing ablation needles are one-piece. On the one hand, if biopsy and other operations are needed before and / or after ablation, multiple punctures are required, which is difficult and increases the damage to the myocardial tissue. On the other hand, if the ablation needle is broken during the operation, it is difficult to remove the broken needle from the body, which may cause serious consequences. Figure 1As shown, due to the relatively large volume of the tumor, existing radiofrequency ablation needles or microwave ablation needles, after being inserted into the tumor tissue 1, aim to increase the contact area between the ablation needle and the tumor tissue 1, so that a large, spherical or near-spherical ablation area 2 can be uniformly formed during ablation, but the ablation direction is not adjustable. However, as... Figure 2 As shown, due to the relatively flat structure of the ventricular septum 3, the aforementioned existing radiofrequency ablation needles or microwave ablation needles are not suitable for treating HCM. They are prone to ablation and penetration into the endocardium 4 in the thickness direction of the ventricular septum 3, damaging the conduction bundle and causing arrhythmia. Summary of the Invention

[0006] This invention provides an ablation needle assembly and ablation system that cause less tissue damage and allow for adjustment of the ablation direction, and is particularly suitable for the ablation treatment of HCM.

[0007] The ablation needle assembly includes a hollow, insulating outer tube and an ablation needle; the ablation needle includes an electrode needle body and an ablation handle connected to the proximal end of the electrode needle body, the electrode needle body is movably inserted into the outer tube, the proximal end of the outer tube is detachably and rotatably connected to the ablation handle, and a limiting part is provided on the electrode needle body or the outer tube to limit the ablation direction of the ablation needle.

[0008] In this invention, the ablation needle assembly includes an outer cannula and an ablation needle. The outer cannula is movably fitted over the electrode needle body of the ablation needle and is detachably and rotatably connected to the ablation handle of the ablation needle. After the ablation operation is completed, the outer cannula can be separated from the ablation needle, leaving the outer cannula inside the tissue to provide a channel for other operations such as biopsy, avoiding repeated punctures, reducing tissue damage, and making biopsy operations more convenient and efficient. Furthermore, in this invention, a limiting part for adjusting the ablation direction is provided on the electrode needle body or the outer cannula. By rotating the ablation needle relative to the outer cannula, the ablation direction of the ablation needle can be adjusted by means of the limiting part, so that the ablation direction of the ablation needle avoids the thickness direction of the interventricular septum, thereby preventing the ablation needle from penetrating into the endocardium in the thickness direction of the interventricular septum. Therefore, the ablation needle assembly and ablation system are particularly suitable for the ablation treatment of HCM. Attached Figure Description

[0009] To more clearly illustrate the structural features and effects of the present invention, a detailed description is provided below in conjunction with the accompanying drawings and specific embodiments.

[0010] Figure 1 This is a schematic diagram of existing ablation needles used to ablate tumors; Figure 2 This is a schematic diagram of ablation of the ventricular septum using existing ablation needles; Figure 3This is a schematic diagram of the structure of the ablation needle assembly of the present invention after the ablation needle and the outer tube are separated; Figure 4 yes Figure 3 The diagram shows the structure of the ablation needle and outer sheath after assembly. Figure 5 yes Figure 3 The front view shown is of the ablation needle and outer cannula assembled together. Figure 6 yes Figure 3 A three-dimensional exploded view of the ablation needle assembly shown; Figure 7a This is a schematic diagram of the structure of the distal end of the ablation needle for HCM ablation treatment according to an embodiment of the present invention; Figure 7b In one embodiment of the present invention, the distal end of the ablation needle is used for HCM ablation treatment along... Figure 7a A cross-sectional view along the KK direction; Figure 7c In another embodiment of the invention, the distal end of the ablation needle is used for HCM ablation treatment along... Figure 7a A cross-sectional view along the KK direction; Figure 8a This is a schematic diagram of the distal end of an ablation needle according to an embodiment of the present invention; Figure 8b This invention relates to an embodiment of an ablation needle used for the ablation treatment of HCM. Figure 8a Schematic diagram of the cross section in the GG direction; Figure 8c Another embodiment of the ablation needle of the present invention is used for ablation treatment of HCM. Figure 8a Schematic diagram of the cross section in the GG direction; Figure 9a This is a schematic diagram of the distal end of an ablation needle according to an embodiment of the present invention; Figure 9b This invention relates to an embodiment of an ablation needle used for the ablation treatment of HCM. Figure 9a A schematic diagram of the cross-section along the HH direction; Figure 9c Another embodiment of the ablation needle of the present invention is used for ablation treatment of HCM. Figure 9a A schematic diagram of the cross-section along the HH direction; Figure 10 This is a schematic diagram of the outer tube structure according to an embodiment of the present invention; Figure 11 This is a schematic diagram of the structure of the electrode needle body according to an embodiment of the present invention; Figure 12 yes Figure 5 A schematic cross-sectional view of the ablation needle assembly along the BB position; Figure 13This is a three-dimensional structural schematic diagram of the base shaft according to an embodiment of the present invention; Figure 14 This is a cross-sectional schematic diagram of a connector according to an embodiment of the present invention; Figure 15 yes Figure 5 A schematic cross-sectional view of the ablation needle assembly along the CC position; Figure 16 yes Figure 6 An exploded three-dimensional view of the ablation needle handle after the outer shell has been removed. Figure 17 yes Figure 16 A three-dimensional structural diagram of the slider at one angle; Figure 18 yes Figure 16 A three-dimensional structural diagram of the slider from another angle; Figure 19 yes Figure 16 A three-dimensional structural diagram of the slider from another angle; Figure 20 yes Figure 16 A three-dimensional structural diagram of the slider from another angle; Figure 21 This is an enlarged schematic diagram of the control groove on the outer shell of the ablation needle assembly in this invention; Figure 22 This is a magnified perspective view of the electrode needle body according to an embodiment of the present invention; Figure 23 yes Figure 22 The diagram shows a cross-sectional view of the electrode needle body along position AA. Figure 24 This is a schematic cross-sectional view of the ablation needle in this invention, excluding the outer shell, along the axial direction. Figure 25 This is a three-dimensional structural diagram of the piston component inside the ablation handle in this invention, taken from one direction. Figure 26 This is a three-dimensional structural diagram of the piston component inside the ablation handle in this invention from another direction; Figure 27 This is a three-dimensional structural diagram of the inner and outer sleeves of the ablation handle in one direction of the present invention; Figure 28 This is a three-dimensional structural diagram of the inner and outer sleeves of the ablation handle in this invention from another direction; Figure 29 and Figure 30 This is a schematic diagram illustrating the process of adjusting the length of the distal end of the electrode needle extending beyond the outer sleeve after the ablation needle and outer sleeve are assembled in this invention. Figure 31 This is a schematic diagram of the combination of the biopsy needle and the outer cannula according to an embodiment of the present invention; Figure 32 This is a schematic diagram showing the disassembly of the puncture needle core and the outer sheath in an embodiment of the present invention; Figure 33 yes Figure 32 The diagram shows the combination of the puncture needle core and the outer cannula; Figure 34 This is a schematic block diagram of the ablation system according to an embodiment of the present invention; Figures 35a to 35c This is a schematic diagram illustrating the usage process of an ablation needle assembly according to an embodiment of the present invention; Figures 36a to 36e This is a schematic diagram illustrating the usage process of the ablation needle assembly according to another embodiment of the present invention. Detailed Implementation

[0011] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. The accompanying drawings are for illustrative purposes only and are schematic diagrams, and should not be construed as limiting the present invention.

[0012] To more clearly describe the structure of the ablation needle assembly and ablation system, the terms "proximal" and "distal" are used here as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the procedure, and "proximal" refers to the end closest to the operator during the procedure.

[0013] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by those skilled in the art. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention.

[0014] Please refer to the following: Figures 3 to 6This invention provides an ablation needle assembly 100 for performing ablation operations. The ablation needle assembly 100 includes a hollow and insulated outer tube 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 electrode needle body 11 can be electrically connected to an energy generating device such as a radio frequency generator or a microwave generator to 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 a high-frequency current, causing the charged positive and negative ions in the lesion tissue surrounding the distal end of the electrode needle body 11 to oscillate at high speed. The high-speed oscillating ions generate a large amount of heat due to friction, which raises the temperature inside the lesion tissue, ultimately causing protein denaturation in the lesion cells, loss of water inside and outside the cells, and coagulative necrosis of the lesion tissue, 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. Under the action of the microwave field, water molecules and other dipole molecules in the lesion tissue generate heat due to motion friction and violent collisions, raising the temperature inside the lesion tissue, ultimately causing protein denaturation in the lesion cells, loss of water inside and outside the cells, and coagulative necrosis of the lesion tissue, thereby achieving microwave ablation.

[0015] The electrode needle body 11 is movably inserted into the outer sheath 30, allowing the distal end of the electrode needle body 11 to extend beyond the outer sheath 30 and adjusting the length of the distal end extending beyond the outer sheath 30. The proximal end of the outer sheath 30 is detachably connected to the ablation handle 12, such as through a threaded connection or snap-fit ​​connection. This allows for easy separation of the ablation needle 10 from the outer sheath 30 after the ablation operation, leaving the outer sheath 30 within the tissue to provide a channel for other procedures (such as biopsy), avoiding repeated punctures, reducing tissue damage, and making ablation and other procedures more convenient and efficient, thus simplifying the surgical process. Furthermore, the outer sheath 30 is rotatably connected to the ablation handle 12. During ablation, if the electrode needle body 11 and the outer sheath 30 need to rotate relative to each other, the outer sheath 30 can be kept stationary while the ablation handle 12 is rotated to drive the electrode needle body 11 to rotate, or the electrode needle body 11 can be kept stationary while the outer sheath 30 is rotated. It is worth noting that in this invention, the electrode needle body 11 or the outer sheath 30 is provided with a limiting part to limit the ablation direction of the ablation needle 10, so that the ablation direction of the ablation needle 10 avoids the thickness direction of the interventricular septum, thereby preventing the ablation needle 10 from penetrating into the endocardium in the thickness direction of the interventricular septum and preventing damage to the conduction bundle, thus making it suitable for ablation treatment of HCM. Furthermore, by rotating the electrode needle body 11 and the outer sheath 30 relative to each other, the ablation direction of the ablation needle 10 can also be adjusted by means of the limiting part, so as to perform more complete and thorough ablation of the hypertrophic part of the interventricular septum from different directions while avoiding the thickness direction of the interventricular septum.

[0016] In this invention, the outer sheath 30 is insulated and serves as an insulating tube for the electrode needle body 11 during ablation. The portion of the electrode needle body 11 extending beyond the outer sheath 30 performs the ablation operation, and the length of the electrode needle body 11 extending beyond the outer sheath 30 is the effective ablation length. The outer sheath 30 can be made entirely of insulating materials, such as plastic tubes like PEEK, PI, or PA that meet hardness requirements, or ceramic tubes like high-alumina ceramic, talc ceramic, or boron nitride. Alternatively, the outer sheath 30 can be made entirely of non-insulating materials, with an insulating coating covering its outer surface. To improve the support of the outer sheath 30 and facilitate insertion into human tissue, preferably, the outer sheath 30 is made of a metallic material, with an insulating coating applied to its outer surface. The metallic material includes, but is not limited to, 304 stainless steel, 321 stainless steel, or 631 stainless steel, and the insulating coating includes, but is not limited to, PTFE coating, titanium nitride coating, and pyrene coating. The metal material used to fabricate the outer tube 30 should possess sufficient hardness to penetrate human tissue, while also exhibiting excellent biocompatibility. The insulating coating must possess reliable insulation, excellent biocompatibility, and a low coefficient of friction. Furthermore, the insulating coating must be tightly bonded to the outer surface of the outer tube 30, and the coating should not easily detach. For example, 304 stainless steel tubes with a PTFE coating, 304 stainless steel tubes with a pyrene coating, 321 stainless steel tubes with a titanium nitride coating, or 631 stainless steel tubes with a pyrene coating can be selected. Considering insulation reliability and process feasibility, the thickness of all insulating coatings should be ≥3μm.

[0017] In some embodiments of the present invention, the distal end of the outer sleeve 30 can be straight or obliquely pointed. Preferably, the distal end of the outer sleeve 30 is pointed, so that the various positions of the outer sleeve 30 can be easily inserted into the tissue.

[0018] Please see Figures 7a-7cIn some embodiments of the present invention, one or more axially extending insulating strips 119 are provided on the outer peripheral surface of the distal end of the electrode needle body 11 as the limiting part for defining and adjusting the ablation direction. The insulating strips 119 can be a strip-shaped insulating coating obtained by coating an insulating material such as PTFE, titanium nitride, or pyrene onto a portion of the outer peripheral surface of the distal end of the electrode needle body 11. The insulating strips 119 partially cover the outer peripheral surface of the distal end of the electrode needle body 11 along the axial direction. The portion of the distal end of the electrode needle body 11 that is not covered by the insulating strips 119, extending out of the outer sleeve 30, can conduct high-frequency current or microwaves into the lesion tissue to perform ablation, thereby extending the ablation direction of the ablation needle 10 from the portion of the distal end of the electrode needle body 11 that is not covered by the insulating strips 119 outward from the electrode needle body 11. By rotating the ablation handle 12 to rotate the electrode needle body 11, the portion of the electrode needle body 11 that is not covered by the insulating strips 119 can be directed toward the location in the tissue that needs to be ablated, thereby enabling directional and localized ablation according to the anatomical structure of the tissue to be treated. If the lesion to be treated is located within the interventricular septum, by using the limiting part on the electrode needle body 11 and rotating the ablation handle 12 to rotate the electrode needle body 11, the portion of the electrode needle body 11 not covered by the insulating strip 119 can be prevented from being placed in the thickness direction of the interventricular septum 3. This allows the ablation direction of the ablation needle 10 to avoid the thickness direction of the interventricular septum 3, thereby preventing the ablation needle 10 from penetrating into the endocardium in the thickness direction of the interventricular septum 3. Therefore, this ablation needle assembly 100 is particularly suitable for ablation treatment of HCM.

[0019] like Figure 7a and Figure 7bAs shown, the insulating strip 119 can be a single strip, which covers part of the outer circumferential surface of the electrode needle body 11 along the axial direction. Preferably, the arc length of the insulating strip 119 in the circumferential direction of the electrode needle body 11 is greater than 1 / 2 of the circumference of the electrode needle body 11, so that the ablation area 2 formed when the part of the electrode needle body 11 not covered by the insulating strip 119 is ablated is relatively flat. In this way, when ablation is performed in the interventricular septum 3, the ablation area 2 can be relatively far away from the endocardium 4. Preferably, the part of the electrode needle body 11 not covered by the insulating strip 119 is oriented in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, that is, the ablation direction is perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by the outward conduction of high-frequency current or microwave ablation in the part of the electrode needle body 11 not covered by the insulating strip 119 is basically extended in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, thereby avoiding ablation penetration into the endocardium 4. Furthermore, in order to completely and thoroughly ablate the thickened portion within the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the ablation handle 12 can be rotated to drive the electrode needle body 11 to rotate, and the ablation direction of the ablation needle 10 can be adjusted with the help of the insulating strip 119, so as to ablate the thickened portion within the interventricular septum 3 from different directions.

[0020] like Figure 7cAs shown, when there are multiple insulating strips 119, these multiple insulating strips 119 are spaced apart circumferentially along the electrode needle body 11 and cover part of the outer peripheral surface of the distal end of the electrode needle body 11 axially. The part of the electrode needle body 11 not covered by the insulating strips 119, that is, the part between two adjacent insulating strips 119, conducts high-frequency current or microwaves to perform ablation. In this embodiment, there are two insulating strips 119, which are arranged opposite each other. Preferably, the arc length of each insulating strip 119 in the circumferential direction of the electrode needle body 11 is not less than 1 / 4 of the circumference of the electrode needle body 11, so that the ablation area 2 formed when the part of the electrode needle body 11 not covered by the insulating strips 119 is ablated is relatively flat, so that when ablation is performed in the interventricular septum 3, the ablation area 2 can be relatively far away from the endocardium 4. Furthermore, when performing HCM ablation treatment using the ablation needle 10, the portion of the electrode needle body 11 not covered by the insulating band 119 is oriented in a direction perpendicular or nearly perpendicular to the thickness of the interventricular septum 3, so that the ablation direction is perpendicular or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by the outward conduction of high-frequency current or microwaves from the portion of the electrode needle body 11 not covered by the insulating band 119 extends substantially in a direction perpendicular or nearly perpendicular to the thickness of the interventricular septum 3, thereby preventing ablation penetration into the endocardium 4. In order to completely and thoroughly ablate the thickened portion of the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the ablation handle 12 can be rotated to rotate the electrode needle body 11, and the ablation direction of the ablation needle 10 can be adjusted with the help of the insulating band 119, so as to ablate the thickened portion within the interventricular septum 3 from different directions.

[0021] Furthermore, a first imaging layer (not shown) may be provided on the surface of the insulating tape 119. This first imaging layer is developed under a medical imaging device, allowing the position of the insulating tape 119 to be determined from the developed image. This enables the electrode needle body 11 to be rotated as needed, ensuring that the portion of the electrode needle body 11 not covered by the insulating tape 119 faces the appropriate direction. Preferably, the surface of the insulating tape 119 is treated to be an uneven, rough surface to form the first imaging layer, adapting to the requirements of ultrasound imaging. For example, the surface of the insulating tape 119 can be sandblasted. Moreover, in this invention, the surface roughness of the first imaging layer should not be too high, so as to achieve the requirements of ultrasound imaging without affecting the advancement of the electrode needle body 11 in the tissue.

[0022] Please see Figures 8a-8cIn some embodiments of the present invention, one or more elongated insulating strips 32 extending distally along the axial direction of the outer sleeve 30 are connected to a portion of the distal end face of the outer sleeve 30, and the cross-section of the insulating strip 32 is an arc shape with the same curvature as the outer sleeve 30. In this embodiment, the insulating strip 32 serves as the limiting part, and a hollow portion 321 is formed on the distal side of the portion of the outer sleeve 30 where the insulating strip 32 is not connected. The insulating strip 32 partially obstructs the distal end of the electrode needle body 11 extending distally from the outer sleeve 30. The portion of the distal end of the electrode needle body 11 not obstructed by the insulating strip 32 conducts high-frequency current or microwaves into the lesion tissue through the hollow portion 321 to perform ablation, thereby extending the ablation direction of the ablation needle 10 from the portion of the distal end of the electrode needle body 11 not obstructed by the insulating strip 32 outward from the electrode needle body 11. By rotating the outer sleeve 30, the portion of the hollow part 321 and the distal end of the electrode needle body 11 not covered by the insulating strip 32 can be directed towards the area within the tissue to be ablated. This allows for targeted and precise ablation based on the anatomical structure of the tissue to be treated. If the lesion to be treated is located within the interventricular septum, the limiting portion on the outer sleeve 30, by rotating the outer sleeve 30, prevents the portion of the hollow part 321 and the distal end of the electrode needle body 11 not covered by the insulating strip 32 from being positioned in the thickness direction of the interventricular septum. This ensures that the ablation direction of the ablation needle 10 avoids the thickness direction of the interventricular septum 3, thereby preventing the ablation needle 10 from penetrating into the endocardium 4 in the thickness direction of the interventricular septum 3. Therefore, this ablation needle assembly 100 is particularly suitable for ablation treatment of HCM. It is understood that the insulating strip 32 can be integrally formed with the outer sleeve 30, and the distal end of the hollow part 32 can be closed or open.

[0023] like Figure 8a and Figure 8bAs shown, the insulating strip 32 can be a single strip, which partially blocks the distal end of the electrode needle body 11 extending out of the outer sleeve 30 along its axial direction. A hollow portion 321 is formed between the two sides of the single insulating strip. Preferably, the arc length of the single insulating strip 32 in the circumferential direction of the outer sleeve 30 is greater than 1 / 2 of the circumference of the outer sleeve 30, so that the ablation area 2 formed when the part of the electrode needle body 11 not blocked by the insulating strip 32 is ablated through the hollow portion 321 is relatively flat. In this way, when ablation is performed in the interventricular septum 3, the ablation area 2 can be further away from the endocardium 4. Preferably, the portion of the perforated part 321 and the part of the electrode needle body 11 not covered by the insulating strip 32 is oriented in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. That is, the ablation direction is perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by the high-frequency current or microwave ablation performed by the part of the electrode needle body 11 not covered by the insulating strip 321 through the perforated part 321 extends substantially in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, thereby avoiding ablation penetration into the endocardium 4. In order to completely and thoroughly ablate the thickened part of the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the outer sheath 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating strip 32 to ablate the thickened part of the interventricular septum 3 from different directions.

[0024] like Figure 8c As shown, when there are multiple insulating strips 32, these multiple insulating strips 32 are spaced apart around the axis of the outer sleeve 30 and partially cover the distal end of the electrode needle body 11 along the axial direction, forming a hollow portion 321 between adjacent insulating strips 32. In this embodiment, there are two insulating strips 32, which are arranged opposite each other. Preferably, the arc length of each insulating strip 32 in the circumferential direction of the outer sleeve 30 is not less than 1 / 4 of the circumference of the outer sleeve 30, so that the ablation area 2 formed when the part of the electrode needle body 11 not covered by the insulating strips 32 is ablated through the hollow portion 321 is relatively flat. In this way, when ablation is performed in the interventricular septum 3, the ablation area 2 can be relatively far away from the endocardium. Preferably, the portion of the perforated part 321 and the part of the electrode needle body 11 not covered by the insulating strip 32 is oriented in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. That is, the ablation direction is perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by the high-frequency current or microwave ablation performed by the part of the electrode needle body 11 not covered by the insulating strip 321 through the perforated part 321 extends substantially in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, thereby avoiding ablation penetration into the endocardium 4. In order to completely and thoroughly ablate the thickened part of the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the outer sheath 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating strip 32 to ablate the thickened part of the interventricular septum 3 from different directions.

[0025] Furthermore, the surface of the insulating strip 32 has a second imaging layer (not shown). This second imaging layer is developed under a medical imaging device, allowing the position of the insulating strip 32 to be determined from the developed image. This enables the outer sheath 30 to be rotated as needed, so that the portion of the electrode needle body 11 not obscured by the insulating strip 32 passes through the perforation 321 and faces the appropriate direction. Preferably, the surface of the insulating strip 32 is treated to form a rough, uneven surface to meet the requirements of ultrasound imaging; for example, the surface of the insulating strip 32 can be sandblasted. Moreover, in this invention, the surface roughness of the second imaging layer should not be too high, so as to achieve the requirements of ultrasound imaging without affecting the advancement of the outer sheath 30 in the tissue.

[0026] Please see Figures 9a-9c In other embodiments of the present invention, a conductive segment 33 extending axially away from the outer sleeve 30 is connected to the distal end face of the outer sleeve 30. One or more elongated insulating layers 331 extending axially along the conductive segment 33 serve as the limiting portion. The insulating layer 331 partially covers the outer surface of the conductive segment 33 along its axial direction, and partially covers the distal end of the electrode needle body 11 extending from the distal end of the outer sleeve 30. The portion of the distal end of the electrode needle body 11 not covered by the insulating layer 331 can conduct high-frequency current or microwaves into the lesion tissue through the portion of the conductive segment 33 not covered by the insulating layer 331 to perform ablation. Thus, the ablation direction of the ablation needle 10 extends outward from the portion of the conductive segment 33 not covered by the insulating layer 331. By rotating the outer sleeve 30, the portion of the electrode needle body 11 not covered by the insulating layer 331 can be directed towards the area within the tissue to be ablated, thereby enabling directional and localized ablation based on the anatomical structure of the tissue to be treated. If the lesion to be treated is located within the interventricular septum, the restriction portion, by rotating the outer sleeve 30, can prevent the portion of the electrode needle body 11 not covered by the insulating layer 331 from being positioned in the thickness direction of the interventricular septum 3. This ensures that the ablation direction of the ablation needle 10 avoids the thickness direction of the interventricular septum 3, thus preventing the ablation needle 10 from penetrating into the endocardium 4 in the thickness direction of the interventricular septum 3. Therefore, this ablation needle assembly 100 is particularly suitable for ablation treatment of HCM.

[0027] like Figure 9a and Figure 9bAs shown, the insulating layer 331 can be a single layer, which axially covers the distal end of the electrode needle body 11. The cross-section of the insulating layer 331 is arc-shaped. Preferably, the arc length of the single insulating layer 331 in the circumferential direction of the conductive segment 33 is greater than 1 / 2 of the circumference of the conductive segment 33, so that the ablation area 2 formed when the distal end of the electrode needle body 11 not covered by the insulating layer 331 is ablated is relatively flat. In this way, when ablation is performed in the interventricular septum 3, the ablation area 2 can be relatively far away from the endocardium. Preferably, the portion of the distal end of the electrode needle body 11 not covered by the insulating layer 331 is oriented in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, that is, the ablation direction is perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by the conduction of high-frequency current or microwave through the portion of the conductive segment 33 not covered by the insulating layer 331 extends substantially in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, thereby avoiding ablation penetration into the endocardium 4. In order to completely and thoroughly ablate the thickened portion of the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the outer sheath 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating layer 331 to ablate the thickened portion of the interventricular septum 3 from different directions.

[0028] like Figure 9cAs shown, when there are multiple insulating layers 331, these multiple insulating layers 331 are spaced apart along the circumference of the conductive section 33, i.e., the circumference of the outer sleeve 30, and partially cover the distal end of the electrode needle body 11 along the axial direction. The portion of the distal end of the electrode needle body 11 extending out of the outer sleeve 30 that is not covered by the insulating layer 331 conducts high-frequency current or microwaves through the portion of the conductive section 33 that is not covered by the insulating layer 331, i.e., the portion between two adjacent insulating layers 331, to perform ablation. In this embodiment, there are two insulating layers 331, which are arranged opposite each other. The cross-section of the insulating layer 331 is arc-shaped. Preferably, the arc length of each insulating layer 331 in the circumferential direction of the conductive section 33 is not less than 1 / 4 of the circumference of the conductive section, so that the ablation area 2 formed when the portion of the electrode needle body 11 not covered by the insulating layer 331 is ablated is relatively flat. In this way, when ablation is performed in the interventricular septum 3, the ablation area 2 can be relatively far away from the endocardium. Preferably, the portion of the electrode needle body 11 not covered by the insulating layer 331 is oriented in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, meaning the ablation direction is perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3. The ablation area 2 formed by conducting high-frequency current or microwaves through the portion of the conductive section 33 not covered by the insulating layer 331 extends substantially in a direction perpendicular to or nearly perpendicular to the thickness of the interventricular septum 3, thereby preventing ablation penetration into the endocardium 4. In order to completely and thoroughly ablate the thickened portion of the interventricular septum 3, while avoiding the thickness direction of the interventricular septum 3, the outer sheath 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating layer 331 to ablate the thickened portion of the interventricular septum 3 from different directions.

[0029] Furthermore, the surface of the insulating layer 331 has a third imaging layer (not shown). This third imaging layer is developed under a medical imaging device, allowing the position of the insulating layer 331 to be determined from the developed image. This enables the outer sheath 30 to be rotated as needed, ensuring that the portion of the electrode needle body 11 not covered by the insulating layer 331 faces the appropriate direction. Preferably, the surface of the insulating layer 331 is treated to form a rough, uneven surface to meet the requirements of ultrasound imaging. For example, the surface of the insulating layer 331 can be sandblasted. Moreover, in this invention, the surface roughness of the third imaging layer should not be too high, so as to achieve the requirements of ultrasound imaging without affecting the advancement of the outer sheath 30 in the tissue.

[0030] Please see Figure 10The outer tube 30 is provided with scale markings 31 to indicate the depth of insertion into the tissue. The scale markings 31 include a series of scale values, which gradually increase from the distal end to the proximal end. When the outer tube 30 is inserted into the tissue, the depth of insertion can be determined by observing the scale values, thus revealing the approximate location of the outer tube 30 within the tissue. Furthermore, the distal end of the outer tube 30 has a first guide portion 34 that can be visualized under medical imaging. The length of the first guide portion 34 must be ≥5mm to ensure accurate positioning. The first guide portion 34 helps the doctor determine whether the distal end of the outer tube 30 is traveling along the desired puncture path and whether it is approaching the predetermined ablation location. Specifically, the first guide portion 34 can be an additional structure added to the distal end of the outer tube 30, or it can be obtained by processing the distal end of the outer tube 30. Since ultrasound imaging is less harmful to the human body and more economical than other imaging modes (such as X-ray fluoroscopy), it is preferable to roughen the surface of the outer tube 30 near the distal end to form the first guide portion 34, which meets the requirements of ultrasound imaging. For example, the surface of the outer tube 30 near the distal end can be roughened by sandblasting or drilling to form the first guide portion 34. Furthermore, in this invention, the surface roughness of the first guide portion 34 should not be too high, so as to meet the requirements of ultrasound imaging without affecting the advancement of the outer tube 30 in the tissue.

[0031] The electrode needle body 11 of the ablation needle 10 can be made of biocompatible metals with excellent conductivity, such as stainless steel. Due to the inclusion of an insulating outer sheath 30, the surface of the electrode needle body 11 of the ablation needle 10 does not need to be coated with insulating material, simplifying the manufacturing process. Furthermore, the outer sheath 30 provides support and protection for the electrode needle body 11, allowing for a smaller diameter, such as 20G to 16G. This helps to further reduce tissue damage. Additionally, if the tissue to be ablated, such as the interventricular septum, has a relatively flat structure, a smaller diameter electrode needle body 11 is more suitable for ablating flat tissues. Moreover, when ablating hypertrophic myocardium within the interventricular septum, it can prevent 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.

[0032] Please see Figure 11 The distal end of the electrode needle body 11 of the ablation needle 10 can be in the shape of a sharp triangular pyramid or needle, which is conducive to puncture after the electrode needle body 11 of the ablation needle 10 is combined with the outer sheath 30. Of course, the distal end of the electrode needle body 11 of the ablation needle 10 can also be set into other shapes, such as spherical or umbrella-shaped.

[0033] The distal end of the electrode needle body 11 has a second guide portion 13 that can be visualized under a medical imaging device. The length of the second guide portion 13 must be ≥5mm. The second guide portion 13 can be visualized under a medical imaging device to help doctors determine whether the distal end of the electrode needle body 11 has reached or is at the predetermined ablation position. Specifically, the second guide portion 13 can be a structure added to the distal end of the electrode needle body 11, or it can be obtained by processing the distal end of the electrode needle body 11. 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 13, to meet the requirements of ultrasound imaging. For example, the surface of the distal end of the electrode needle body 11 can be sandblasted or perforated. Furthermore, in this invention, the surface roughness of the second guide portion 13 should not be too high, so as to meet the requirements of ultrasound imaging without affecting the advancement of the electrode needle body 11 in the tissue. Therefore, the ablation needle assembly of this embodiment is particularly suitable for ultrasound-guided ablation treatment. Under ultrasound guidance, the operator can insert the distal end of the ablation needle assembly into the patient's body through puncture, and perform ablation on the lesion tissue through the part of the ablation needle 10 extending out of the outer cannula 30.

[0034] Please see Figure 6 and Figure 12In this invention, the ablation handle 12 includes a housing 121, a connector 122 connected to the distal end of the housing 121, and a drive unit 123 disposed within the housing 121 and movable along the axial direction of the housing 121. The axial direction of the housing 121 is the same as the axial direction of the electrode needle body 11. The outer sleeve 30 is detachably connected to the connector 122, and the proximal end of the electrode needle body 11 is fixed to the drive unit 123. After the ablation needle assembly 100 is inserted into the lesion site in the patient's body, the electrode needle body 11 is driven to move axially relative to the outer sheath 30 by the drive unit 123. This allows for real-time adjustment of the length of the distal end of the electrode needle body 11 extending beyond the outer sheath 30 within the body, adapting to the ablation needs of different lesion sites or different patients. This eliminates the need to remove the ablation needle assembly 100 from the patient's body to adjust the effective ablation length and then puncture again, greatly improving surgical efficiency and reducing damage to human tissue. Furthermore, since most of the axial length of the electrode needle body 11 is contained within the outer sheath 30 rather than being directly covered by human tissue, the resistance encountered when adjusting the length of the distal end of the electrode needle body 11 extending beyond the outer sheath 30 within the body is smaller, making adjustment easier. The outer sheath 30 is detachably connected to the connector 122. This means that the outer sheath 30 is connected to the connector 122 via a detachable connection such as a threaded connection or a snap-fit ​​connection. This allows the ablation needle 10 to be easily separated from the outer sheath 30 after the ablation operation, leaving the outer sheath 30 within the tissue to provide a channel for other operations. This avoids repeated punctures, reduces tissue damage, and makes other operations, such as biopsies, more convenient and efficient. Furthermore, the outer sheath 30 is rotatably connected to the connector 122, meaning that after the outer sheath 30 is connected to the connector 122, it can rotate about the axis of the connector 122.

[0035] Please see Figure 6 and Figures 12 to 14 In one embodiment of the present invention, the outer shell 121 includes a first outer shell 121a and a second outer shell 121b disposed opposite to each other, and the two can be joined together by means of snap-fit, adhesive, screw fixing or other methods. Both the first outer shell 121a and the second outer shell 121b are provided with a retaining plate 1212.

[0036] The connector 122 includes a base shaft 122a and a retaining ring 122b rotatably connected to the base shaft 122a. The proximal end of the base shaft 122a is fixedly connected to the outer casing 121. The base shaft 122a is arranged along the axial direction of the electrode needle body 11, allowing the electrode needle body 11 to pass through the axis of the base shaft 122a and extend into the outer casing 121.

[0037] Specifically, please refer to Figure 10The base shaft 122a has a first retaining groove 1221 around its proximal end. The proximal end of the base shaft 122a extends into the outer shell 121, and retaining plates 1212 on the first outer shell 121a and the second outer shell 121b engage with and engage in the first retaining groove 1221. In this embodiment, the bottom wall of the first retaining groove 1221 has a rectangular outline, and the inner surface of the retaining plate 1212, which engages in the first retaining groove 1221, abuts against the bottom wall of the first retaining groove 1221, thereby fixing the base shaft 122a to the outer shell 121 and preventing the base shaft 122a from rotating relative to the outer shell 121. Furthermore, in this embodiment, the outer shell 121 is obtained by the engagement and connection of the first outer shell 121a and the second outer shell 121b, which facilitates the engagement of the retaining plate 1212 into the first retaining groove 1221 to achieve the fixation of the base shaft 122a to the outer shell 121. Furthermore, a second slot 1222 is provided at the distal end of the first slot 1221, and the proximal end of the retaining ring 122b is inserted into the second slot 1222. Specifically, the bottom wall of the second slot 1222 has a circular outline. After the proximal end of the retaining ring 122b is inserted into the second slot 1222, it can rotate around the axial direction of the base shaft 122a, but cannot move along the axial direction, that is, the retaining ring 122b can rotate in place.

[0038] The outer sleeve 30 is detachably connected to the retaining ring 122b. In this embodiment, the proximal end of the outer sleeve 30 is provided with an external thread, and the retaining ring 122b is provided with an internal thread adapted to the external thread. The proximal end of the outer sleeve 30 is threadedly connected to the retaining ring 122b. It is understood that in other embodiments of the present invention, the proximal end of the outer sleeve 30 and the retaining ring 122b can also be connected by other detachable methods such as snap fasteners. Further, as... Figure 6 As shown, the outer sleeve 30 has a gripping portion 39 on the distal side of the portion with external threads, which facilitates rotation relative to the ablation needle 10 or detachment from the ablation needle 10. In this embodiment, multiple protrusions are provided on the outer wall of the outer sleeve 30 to form the gripping portion 39.

[0039] In some embodiments of the present invention, during the ablation process, if it is necessary to rotate the electrode needle body 11 to adjust the ablation direction, or to straighten the wires and cooling pipes outside the ablation handle 12 to prevent excessive bending, twisting, or tangling of the wires and cooling pipes, and to facilitate viewing the scale values ​​on the ablation handle 12, the operator can hold the retaining ring 122b to keep the outer tube 30 stationary, and rotate the ablation handle 12 of the ablation needle 10 to drive the electrode needle body 11 to rotate via the ablation handle 12. In other embodiments of the present invention, during the ablation process, if it is necessary to rotate the outer tube 30 to adjust the ablation direction, the ablation handle 12 and the electrode needle body 11 can be kept stationary, and the operator can drive the outer tube 30 to rotate by rotating the retaining ring 122b on the connector 122.

[0040] Furthermore, the distal end of the base shaft 122a has a frustum-shaped structure to facilitate the insertion of the retaining ring 122b into the second retaining groove 1222. Additionally, the distal portion of the base shaft 122a passes through the outer sleeve 30 to support the distal end of the outer sleeve 30, thereby making the connection between the outer sleeve 30 and the connector 122 more stable.

[0041] Please refer to the following: Figure 15 and Figure 16 , Figures 17 to 20 The driving unit 123 includes a slider 1231 and an adjusting member 1232 connected to the slider 1231. The proximal end of the electrode needle body 11 is fixed to the slider 1231. The slider 1231 is housed within the outer casing 121, and the adjusting member 1232 controls the slider 1231 to move axially along the outer casing 121, thereby moving the electrode needle body 11 relative to the outer sleeve 30.

[0042] Please see Figure 6 In this embodiment, the sliding member 1231 includes a cylindrical first part 1231a and a block-shaped second part 1231b connected to the first part 1231a. The central axis of the first part 1231a is coaxial with the central axis of the second part 1231b. The first part 1231a has a first cavity 12311, and the second part 1231b has a first central hole 12312. The electrode needle body 11 passes through the first central hole 12312 and is either cut off or partially extended into the first cavity 12311. Furthermore, the proximal end of the electrode needle body 11 is fixed to the inner wall of the first central hole 12312 to achieve the fixation of the electrode needle body 11 and the sliding member 1231. In this embodiment, the electrode needle body 11 and the sliding member 1231 are fixed by injecting glue into the first central hole 12312 and allowing the glue to cure. Furthermore, the inner surface of the outer casing 121 is provided with a first guide member 1213 arranged along the extending direction of the electrode needle body 11, and the surface of the sliding member 1231 is provided with a second guide member 12313 adapted to the first guide member 1213. The cooperation between the second guide member 12313 and the first guide member 1213 ensures that the sliding member 1231 moves axially along the electrode needle body 11. The movement of the sliding member 1231 drives the electrode needle body 11 to move relative to the outer sleeve 30, thereby adjusting the length of the distal end of the electrode needle body 11 extending out of the outer sleeve 30. In this embodiment, the first guide member 1213 is a groove, and the second guide member 12313 is a protrusion. The protrusion is embedded in the groove and moves along the groove. It can be understood that in other embodiments of the present invention, the first guide member 1213 may also be a protrusion, and the second guide member 12313 may be a groove.

[0043] Please see Figure 15 , Figure 21 Figure 6In this embodiment, the adjusting member 1232 includes a button 12321 and a connecting portion 12322, and a control groove 1211 is formed on the outer shell 121 along the axial direction. In this embodiment, the first outer shell 121a and the second outer shell 121b are respectively provided with grooves at the positions where they are engaged. The groove on the first outer shell 121a and the groove on the second outer shell 121b are engaged to form the control groove 1211. It can be understood that in other embodiments of the present invention, the control groove 1211 may also be formed only on the first outer shell 121a or the second outer shell 121b. One end of the connecting part 12322 is connected to the second part 1231b of the sliding member 1231, and the other end extends out of the outer shell 121 from the control groove 1211 and is connected to the button 12321. Pushing the button 12321 along the control groove 1211 can control the sliding member 1231 to move axially along the outer shell 121, thereby driving the electrode needle body 11, which is fixed to the sliding member 1231, to move relative to 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. After the ablation needle assembly 100 is punctured into the lesion site in the patient's body, the length of the distal end of the electrode needle body 11 extending out of the outer sleeve 30 can be conveniently adjusted in real time inside the body by actuating the button 12321, that is, the effective ablation length can be adjusted to adapt to the ablation needs of different lesion sites or different patients. In this embodiment, the connecting part 12322 includes a limiting body 12322a and a column 12322b. One end of the column 12322b is fixedly connected to the limiting body 12322a, and the other end is connected to the second part 1231b of the slider 1231. The limiting body 12322a is connected to the button 12321. The column 12322b is arranged in a direction perpendicular to the axial direction of the slider 1231 and is capable of moving along its own axial direction.

[0044] In this embodiment, two columns 12322b are arranged in parallel, and each column 12322b has an annular groove at one end away from the limiting body 12322a. An E-type retaining ring 12324 is detachably held within the annular groove. The second portion 1231b of the sliding member 1231 has a first plane 12314 and a second plane 12315 opposite to the first plane 12314. The second portion 1231b has two openings 12316 penetrating from the first plane 12314 to the second plane 12315. The ends of the two columns 12322b facing away from the limiting body 12322a extend from the side of the first plane 12314 into one of the openings 12316, and the E-type retaining ring 12324 is located on one side of the second plane 12315. Further, in this embodiment, an elastic body 1322 is provided between the limiting body 12322a and the sliding member 1231. The elastic body 1322 may be, but is not limited to, a spring, a sheet, or an elastic washer. In this embodiment, the elastic body 1322 is a spring, which is wound around the periphery of the column 12323b and located between the limiting body 12322a and the first plane 12314. It is understood that in some embodiments of the present invention, the column 12323b may not be provided, and the two ends of the elastic body 1322 may be directly fixed to the limiting body 12322a and the sliding member 1231 respectively to connect the limiting body 12322a and the sliding member 1231. The inner wall of the outer shell 121 has a plurality of spaced slots 1214 on at least one side of the control groove 1211, and the limiting body 12322a has at least one locking position 123221. When the elastic body 1322 naturally elongates, it pushes against the limiting body 12322a to cause the locking position 123221 to engage in the locking groove 1214. Simultaneously, the limiting body 12322a drives the column 12322b to move axially along the column 12322b until the E-type retaining ring 12324 abuts against the second plane 12315. At this point, the adjusting member 1232 cannot be moved, thus keeping the sliding member 1231 stationary and preventing changes in the length of the electrode needle body 11 extending beyond the outer sleeve 30.When it is necessary to change the length of the electrode needle body 11 extending out of the outer sleeve 30, the operator manually presses down the button 12321. The limiting body 12322a and the column 12322b move down, and the elastic body 1322 contracts under pressure. The locking position 123221 on the limiting body 12322a separates and disengages from the slot 1214. At this time, pushing and pulling the button 12321 along the axial direction can drive the sliding member 1231 and the electrode needle body 11 to move along the axial direction, thereby adjusting the length of the electrode needle body 11 extending out of the outer sleeve 30, i.e., the effective ablation length. When the button 12321 reaches a certain position and obtains the desired effective ablation length, the operator releases the button 12321. The elastic body 1322 elastically resets itself and pushes the locking position 123221 on the limiting body 12322a into the slot 1214, so that the adjusting member 1232 and the sliding member 1231 are positioned at that position and remain stationary.

[0045] Please refer to the previous document. Figure 21 and Figure 29 The outer surface of the outer casing 121 is provided with multiple scale markings 1215, each of which corresponds one-to-one with a plurality of slots 1214. After the actuating adjustment member 1232 is moved to a certain position in the control slot 1211, the scale value corresponding to the adjustment member 1232 can be observed to determine the length of the distal end of the electrode needle body 11 extending beyond the outer sleeve 30. Since the outer sleeve 30 is insulated, the length of the distal end of the electrode needle body 11 extending beyond the outer sleeve 30 is the effective ablation length that the ablation needle 10 can perform ablation. Figure 30 and Figure 22 As shown, when the actuation adjustment member 1232 is at the farthest end of the control groove 1211, the scale value corresponding to the adjustment member 1232 is the largest, and the length of the distal end of the electrode needle body 11 extending out of the outer sheath 30 is the longest, which is Lmax. When the actuation adjustment member 1232 is at the nearth end of the control groove 1211, the scale value corresponding to the adjustment member 1232 is the smallest, and the length of the distal end of the electrode needle body 11 extending out of the outer sheath 30 is the shortest, which is Lmin. Depending on the anatomical differences of different tissues, the adjustable range of the effective ablation length of the electrode needle body 11 is also different. For example, when applied to the ablation treatment of HCM, the adjustable range of the effective ablation length of the electrode needle body 11 is 5mm to 35mm.

[0046] Please see Figure 23 , Figure 24 and Figure 16The portion of the electrode needle body 11 of the ablation needle 10 that contacts the tissue transmits radiofrequency or microwave energy, causing the tissue to reach high temperatures, resulting in coagulative necrosis and achieving the therapeutic purpose. However, excessively high local temperatures can affect normal tissue that does not require ablation. Therefore, except for the solid tip portion, the electrode needle body 11 of the ablation needle 10 is a hollow inner cavity 111. A cooling channel 113, spaced from and coaxial with the inner wall of the inner cavity 111, is provided within the inner cavity 111. The inner cavity 111 and the cooling channel 113 are used to deliver gaseous or liquid cooling media (such as cooling water) for cooling to control the temperature during the ablation operation. In this invention, a thermocouple 112 is also installed within the inner cavity 111 to measure the temperature of the tissue surrounding the electrode needle body 11 in real time. In this embodiment, the thermocouple 112 is installed within the cooling channel 113 and spaced from the inner wall of the cooling channel 113. The ablation handle 12 has an inlet 114 and an outlet 115 at its proximal end. The inlet 114 is connected to the proximal end of the capillary tube 113. The first gap between the cooling channel 113 and the inner wall of the inner cavity 111 is connected to the outlet 115. The cooling medium flows through the inlet 114 into the capillary tube 113, and flows from the distal end of the capillary tube 113 to the first gap, and then flows out through the outlet 115, thereby forming a circulation of cooling water to achieve cooling of the electrode needle body 11 and its surrounding tissues.

[0047] Specifically, please refer to Figures 22 to 26 and Figure 16The ablation handle 12 further includes a piston 1233 disposed within the outer casing 121, the piston 1233 being coaxially arranged with the sliding member 1231. The distal end of the piston 1233 is sealed and fixed to the proximal end of the sliding member 1231, and a water storage cavity C1 is formed between the sliding member 1231 and the piston 1233. The outlet 115 and the first gap between the capillary tube 113 and the inner wall of the inner cavity 111 communicate with the water storage cavity C1. The cooling medium flows into the water storage cavity C1 through the first gap between the capillary tube 113 and the inner wall of the inner cavity 111, and then flows out through the outlet 115. In this embodiment, the piston 1233 is basically cylindrical, with the diameter of its distal end being smaller than the diameter of its proximal end, and its distal end is fitted into the proximal end of the first cavity 12311 of the sliding member 1231. The distal end of the piston 1233 and the inner wall of the first cavity 12311 are sealed and fixed with waterproof adhesive. Furthermore, a second gap exists between the distal end face 12331 of the piston member 1233 and the bottom wall of the first cavity 12311, and this second gap constitutes the water outlet storage cavity C1. Further, a second cavity 12332 extends distally from the proximal end of the piston member 1233. A second central hole 12333 is provided on the bottom wall of the second cavity 12332, and the second central hole 12333 is coaxial with the first central hole 12312 of the sliding member 1231. The proximal end of the cooling channel 113 passes through the second central hole 12333 and then stops, or extends into the second cavity 12332 and then stops, and the proximal end of the cooling channel 113 is fixed to the inner wall of the second central hole 12333.

[0048] Further, please refer to Figure 24 , Figure 27 and Figure 28 , Figure 6The ablation handle 12 further includes a sleeve 1234 disposed within and fixed to the housing 121, the sleeve 1234 being coaxially arranged with the piston 1233. The distal end of the sleeve 1234 is sleeved over the proximal end of the piston 1233 and is movably and sealingly connected to the piston 1233. Furthermore, a water inlet storage cavity C2 is formed between the piston 1233 and the sleeve 1234. The inlet 114 and the cooling channel 113 communicate with the water inlet storage cavity C2. The cooling medium enters the water inlet storage cavity C2 through the inlet 114 and then enters the cooling channel 113. Specifically, the sleeve 1234 is also substantially cylindrical, including a third cavity 12341 extending from the distal end to the proximal end. The proximal end of the piston 1233 is fitted into the third cavity 12341 of the sleeve 1234 and is sealed to the inner wall of the third cavity 12341 and movably connected. When the adjusting member 1232 drives the sliding member 1231 to slide axially, the sliding member 1231 drives the piston 1233 to move, and the proximal end of the piston 1233 moves axially within the third cavity 12341 without disengaging from the third cavity 12341. Furthermore, the second cavity 12332 and the third cavity 12341 communicate to form the water inlet storage cavity C2. The inlet 114 and the outlet 115 are provided on the bottom wall 12342 of the third cavity 12341, and the bottom wall 12342 also has a third central hole 123421, through which the thermocouple 112 passes. When the adjusting member 1232 moves the sliding member 1231, the sliding member 1231 moves the piston member 1233 relative to the sleeve member 1234, making the space of the water inlet storage chamber C2 variable. Furthermore, the sliding member 1231 moves the piston member 1233 within the sleeve member 1234, and the piston member 1233 and the sleeve member 1234 always share a portion of the axial space, which helps to reduce the axial length of the ablation handle 12.

[0049] In this embodiment, a number of sealing rings 12337 are sleeved on the outer wall of the proximal end of the piston 1233. The sealing rings 12337 seal the gap between the proximal end of the piston 1233 and the sleeve 1234, preventing the cooling medium in the water inlet storage chamber C2 from flowing out from the gap between the sleeve 1234 and the piston 1233.

[0050] Further, please refer to Figure 16The ablation handle 12 also includes an end cap 124 detachably connected to the proximal end of the housing 121 for sealing the proximal end of the housing 121. The end cap 124 has spaced-apart inlet pipe holes, outlet pipe holes, and wire harness holes. The inlet pipe holes allow the inlet pipe 116 connected to the inlet 114 to pass through; the outlet pipe holes allow the outlet pipe 117 connected to the outlet 115 to pass through; and the wire harness holes allow the wire harness 118, formed by wires electrically connected to the thermocouple 112 and wires electrically connected to the electrode needle body 11, to pass through.

[0051] Furthermore, please also refer to Figure 24 and Figure 24 The water inlet storage chamber C2 is provided with a water outlet adapter 1235. The distal end of the water outlet adapter 1235 passes through the piston member 1233 and communicates with the water outlet storage chamber C1. The proximal end of the water outlet adapter 1235 is connected to the outlet 115 and is connected to the water outlet pipe 117. In this embodiment, the water outlet adapter 1235 includes a spiral section 1235a that can extend and retract along the axial direction of the sleeve member 1234. When the actuator adjustment member 1232 drives the sliding member 1231 and the piston member 1233 to move axially, the spiral section 1235a of the water outlet adapter 1235 will stretch or contract with the piston member 1233 in the water inlet storage chamber C2 without affecting the axial movement of the piston member 1233. This also avoids the water outlet pipe 117 from frequently entering and exiting the outer shell 121, thereby avoiding friction and damage to the water outlet pipe 117.

[0052] Figure 31 The arrows in the diagram indicate the flow path of the cooling medium. Specifically, the cooling medium enters the water inlet storage chamber C2 from the water inlet pipe 116 via the inlet 114, then flows from the water inlet storage chamber C2 to the cooling channel 113, and then flows out from the first gap between the cooling channel 113 and the inner wall of the inner cavity 111 of the electrode needle body 11 to the water outlet storage chamber C1, flows through the water outlet adapter 1235 to the outlet 115, and finally flows out through the water outlet pipe 117, thus realizing the cooling circulation of the cooling medium within the electrode needle body 11.

[0053] Please see Figure 32In some embodiments of the present invention, the ablation needle assembly 100 further includes a biopsy needle 20, which is alternately fitted inside the outer sheath 30 with the ablation needle 10. Specifically, the biopsy needle 20 includes a biopsy needle body and a biopsy handle connected to the proximal end of the biopsy needle body. After the ablation needle 10 is separated from the outer sheath 30, the biopsy needle body of the biopsy needle 20 is inserted into the outer sheath 30 and extends along the outer sheath 30 to the biopsy position to perform a biopsy operation. Further, the biopsy handle of the biopsy needle 20 can also be detachably connected to the outer sheath 30, so that after the ablation needle 10 is separated from the outer sheath 30, the biopsy needle 20 can be connected to the outer sheath 30. Therefore, after the ablation operation is completed, the connection between the ablation needle 10 and the outer cannula 30 is released, leaving the outer cannula 30 inside the tissue to provide a channel for the biopsy operation. This allows the biopsy needle 20 to quickly reach the desired biopsy location, avoiding repeated punctures and reducing tissue damage. Alternatively, in some surgical procedures, after the biopsy operation is completed, the connection between the biopsy needle 20 and the outer cannula 30 can be released, leaving the outer cannula 30 inside the tissue to provide a channel for the ablation operation. This allows the ablation needle 10 to quickly reach the desired ablation location, similarly avoiding repeated punctures and reducing tissue damage.

[0054] Please combine Figure 33 and Figure 6 Furthermore, in some embodiments of the present invention, the ablation needle assembly 100 further includes a puncture needle core 40, the diameter of which is larger 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. The puncture needle core 40 is preferably made of a relatively hard material, such as stainless steel. The puncture needle core 40 is alternately inserted into the outer sheath 30 and detachably connected to the outer sheath 30, alternating with the ablation needle 10 or the biopsy needle 20, with the distal end of the puncture needle core 40 extending out of the outer sheath 30. In this embodiment, the distal end of the puncture needle core 40 is a sharp needle-like or triangular pyramidal shape, and a connector 41 with internal threads can be fixed to the proximal end, the internal thread of which is adapted to the external thread of the proximal end of the outer sheath 30. With the addition of the puncture needle core 40, the puncture needle core 40 can be combined with the outer cannula 30 to puncture tissue before ablation or biopsy. Afterwards, the connection between the puncture needle core 40 and the outer cannula 30 is released, the puncture needle core 40 is withdrawn, and then the ablation needle 10 or biopsy needle 20 is inserted into the outer cannula 30. The larger diameter and harder puncture needle core 40 can provide better support for the outer cannula 30. Therefore, the combination of the puncture needle core 40 and the outer cannula 30 facilitates puncture and can prevent damage to the ablation needle 10 or biopsy needle 20 when puncturing directly.

[0055] Further, please refer to Figure 24 , Figure 34 andFigure 6 The present invention also provides an ablation system, including the ablation needle assembly 100 and an energy generating device 110. The energy generating device 110 is electrically connected to the electrode needle body 11 via the wire bundle 118 to perform ablation operations. In some embodiments of the present invention, the ablation system 200 further includes a medical imaging device 120 and / or a cooling 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 cooling device 130 is connected to the ablation needle assembly 100 via an inlet pipe 116 and an outlet pipe 117 to provide a gaseous or liquid cooling medium circulating within the electrode needle body 11. The medical imaging device 120 is used to display the distal position of the outer sheath 30 and the electrode needle body 11 in real time, and can be selected from at least one of ultrasound, CT, MRI, and X-ray fluoroscopy, preferably ultrasound.

[0056] The ablation needle assembly 100 and ablation system 200 of the present invention can be used, but are not limited to, in the treatment of HCM, as well as in the treatment and biopsy of kidney, liver or soft tissue tumors.

[0057] like Figures 35a to 35c and Figure 4 As shown, this embodiment uses the treatment of HCM as an example to illustrate the usage process of the ablation needle assembly 100: Step 1: First, insert the ablation needle 10 into the outer tube 30, and connect the outer tube 30 to the ablation handle 12 via the connector 122, resulting in the following... Figure 35a The ablation needle assembly is shown. An actuation adjustment member 1232 drives the sliding member 1231 and the electrode needle body 11 to move axially relative to the outer sleeve 30, obtaining a desired length for the distal end of the electrode needle body 11 to extend beyond the outer sleeve 30, thus obtaining an initial effective ablation length; and by relatively rotating the electrode needle body 11 and the outer sleeve 30, the direction corresponding to the limiting part (insulating tape, insulating strip, or insulating layer) is adjusted to initially adjust the ablation direction so that the ablation direction avoids the thickness direction of the interventricular septum.

[0058] Step 2: As Figure 35b As shown, under the guidance of an ultrasound device, the outer sheath 30 and the electrode needle body 11 are inserted into the interventricular septum through the apex of the heart via the intercostal space and the epicardium. The radiofrequency generator is turned on, and the portion of the electrode needle body 11 extending out of the outer sheath 30 and not corresponding to the restricted portion is used to perform radiofrequency ablation on the hypertrophic interventricular septal myocardium.

[0059] During ablation, if the effective ablation length needs to be adjusted, the button 12321 is moved axially to actuate the adjusting member 1232 and the sliding member 1231, causing the electrode needle body 11 to move relative to the outer sheath 30 in real time within the body to adjust to the required effective ablation length. If the ablation direction needs to be adjusted, the electrode needle body 11 or the outer sheath 30 is rotated, and the desired ablation direction is obtained by using the limiting part to avoid the thickness direction of the interventricular septum, thus preventing ablation penetration into the endocardium. In this embodiment, it is preferable to place the limiting part in the thickness direction of the interventricular septum.

[0060] Radiofrequency ablation can destroy the activity of the interventricular septum myocardium in the corresponding area, causing myocardial necrosis, atrophy, and thinning, thereby widening the left ventricular outflow tract and relieving the obstruction. Using this ablation needle assembly 10 to treat hemorrhage (HCM) avoids the risks and pain of open-chest surgery and cardiopulmonary bypass, as well as the risks of ineffective chemical alcohol ablation or alcohol spillage causing large-area myocardial infarction. It is simple and easy to perform, with minimal trauma to the patient, low surgical risk, and significant efficacy. Furthermore, the effective ablation length can be adjusted in real time within the body, greatly improving surgical efficiency and reducing damage to human tissues. Simultaneously, the limiting part prevents ablation from penetrating into the endocardium, preventing damage to the conduction bundle.

[0061] Step 3: As Figure 35c and Figure 8a As shown, after ablation is performed, the connection between the outer cannula 30 and the connector 122 is disconnected, the ablation needle 10 is withdrawn while the outer cannula 30 remains in place, and then the biopsy needle 20 is inserted into the outer cannula 30 to extract tissue samples for biopsy. The outer cannula 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 location.

[0062] It is understood that, in some cases, such as in this invention, the limiting part is Figure 9a or Figures 36a to 36e As shown, the electrode needle body 11 is located outside the outer sheath 30. Under normal circumstances, the needle tip will not extend beyond the distal end of the limiting part. In order to facilitate puncture, the outer sheath 30 and the biopsy needle 20 can be combined for puncture and biopsy before performing ablation. Then, the biopsy needle 20 can be withdrawn while the outer sheath 30 is left in place. Finally, the ablation needle 10 is inserted into the outer sheath 30, and the connection between the outer sheath 30 and the ablation needle 10 is established through the connector 122. This can also avoid repeated punctures and reduce damage to the tissue.

[0063] like ​As shown, in some embodiments of the present invention, after the ablation needle assembly 100 is equipped with a puncture needle core 40, the puncture needle core 40 and the outer cannula 30 can be combined for puncture before ablation or biopsy. Afterwards, the connection between the puncture needle core 40 and the outer cannula 30 is released, the puncture needle core 40 is withdrawn, the outer cannula 30 is left in the patient's body, and then the ablation needle 10 or biopsy needle 20 is inserted into the outer cannula 30 to perform ablation or biopsy operations, so as to increase the puncture intensity and prevent damage to the ablation needle 10 or biopsy needle 20 during the puncture process.

[0064] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. An ablation needle assembly, comprising: The ablation needle comprises an electrode needle body and an ablation handle connected with the proximal end of the electrode needle body, the electrode needle body is movably arranged in the hollow and insulated outer sleeve, and a limiting part is arranged on the outer sleeve to limit the ablation direction of the ablation needle. The distal end surface of the outer sleeve is connected with a conductive section extending to the side away from the outer sleeve along the axial direction of the outer sleeve, and the limiting part is one or a plurality of insulating layers partially covering the conductive section along the axial direction of the conductive section. The insulating layers are a plurality of insulating layers, and the plurality of insulating layers are arranged at intervals along the circumference of the conductive section, the distal end of the electrode needle body protruding out of the distal end of the outer sleeve is partially covered by the insulating layers, the part of the distal end of the electrode needle body not covered by the insulating layers performs ablation, and the ablation direction of the ablation needle expands outward from the part of the distal end of the electrode needle body not covered by the insulating layers.

2. The ablation needle assembly of claim 1, wherein, The insulating layer is one insulating layer, and the one insulating layer partially covers the distal end of the electrode needle body protruding out of the outer sleeve along the axial direction; the cross section of the insulating layer is arc-shaped, and the arc length of the one insulating layer along the circumference of the conductive section is greater than 1 / 2 of the circumference of the conductive section. The distal end of the outer sleeve is a beveled tip.

3. The ablation needle assembly of claim 1, wherein, The proximal end of the outer sleeve is detachably and rotatably connected with the ablation handle.

4. The ablation needle assembly of claim 1, wherein, The ablation handle comprises a shell, a connecting piece fixed with the distal end of the shell, and a driving part moving along the axial direction of the shell; the outer sleeve is detachably and rotatably connected with the connecting piece, the proximal end of the electrode needle body is fixed with the driving part, and the driving part drives the electrode needle body to move relative to the outer sleeve to adjust the length of the distal end of the electrode needle body protruding out of the outer sleeve in real time.

5. The ablation needle assembly of claim 4, wherein, The driving part comprises a sliding piece and an adjusting piece connected with the sliding piece, the proximal end of the electrode needle body is fixed with the sliding piece, the sliding piece is accommodated in the shell, and the adjusting piece controls the movement of the sliding piece in the shell to drive the electrode needle body to move along the axial direction relative to the outer sleeve.

6. The ablation needle assembly of claim 5, wherein, The ablation needle comprises an electrode needle body and an ablation handle connected with the proximal end of the electrode needle body, the electrode needle body is movably arranged in the hollow and insulated outer sleeve, and a limiting part is arranged on the outer sleeve to limit the ablation direction of the ablation needle.

7. An ablation needle assembly, comprising: The limiting part is one or a plurality of insulating strips connected with the distal end surface of the outer sleeve along the axial direction of the outer sleeve, and the plurality of insulating strips are arranged at intervals around the axis of the outer sleeve; the distal side of the part of the distal end surface of the outer sleeve not connected with the insulating strips forms a hollow part. The insulating strips extend to the side away from the outer sleeve, the distal end of the electrode needle body protruding out of the distal end of the outer sleeve is partially covered by the insulating strips, the part of the distal end of the electrode needle body not covered by the insulating strips performs ablation, and the ablation direction of the ablation needle expands outward from the part of the distal end of the electrode needle body not covered by the insulating strips. The insulating strips are one insulating strip partially covering the distal end of the electrode needle body protruding out of the outer sleeve along the axial direction, and the two side surfaces of the one insulating strip form the hollow part; the arc length of the one insulating strip along the circumference of the outer sleeve is greater than 1 / 2 of the circumference of the outer sleeve.

8. The ablation needle assembly of claim 7, wherein, ​ 9. The ablation needle assembly of claim 7, wherein, ​ Or the insulation strip is a plurality of, a plurality of insulation strip around the axis of the sleeve is set apart and along the axial part of the electrode needle body distal end, the adjacent two insulation strip between the hollow part.

10. The ablation needle assembly of claim 7, wherein, The insulation strip is made into an integral structure with the outer sleeve.

11. The ablation needle assembly of claim 7, wherein, The distal end of the hollow part is open.

12. An ablation system, characterized by, The energy generating device is electrically connected with the electrode needle body of the ablation needle assembly.

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