WO2020088139A1 - Ensemble aiguille d'ablation et système d'ablation - Google Patents

Ensemble aiguille d'ablation et système d'ablation Download PDF

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Publication number
WO2020088139A1
WO2020088139A1 PCT/CN2019/106745 CN2019106745W WO2020088139A1 WO 2020088139 A1 WO2020088139 A1 WO 2020088139A1 CN 2019106745 W CN2019106745 W CN 2019106745W WO 2020088139 A1 WO2020088139 A1 WO 2020088139A1
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WIPO (PCT)
Prior art keywords
ablation
outer sleeve
distal end
electrode needle
needle body
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PCT/CN2019/106745
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English (en)
Chinese (zh)
Inventor
彭波波
张庭超
丘信炯
李阳
刘丽文
胡芮
Original Assignee
杭州诺诚医疗器械有限公司
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Publication of WO2020088139A1 publication Critical patent/WO2020088139A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1487—Trocar-like, i.e. devices producing an enlarged transcutaneous opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle

Definitions

  • the invention relates to the technical field of medical equipment, in particular to an ablation needle assembly and an ablation system.
  • biopsy needles can be used to puncture to the location of the lesion, and a small amount of tissue at the location of the lesion can be obtained for pathological analysis.
  • the radiofrequency ablation needle or microwave ablation needle can be inserted into the lesion, and the local tissue of the lesion is generated high temperature by radio frequency energy or microwave energy, so that the tissue of the lesion is coagulated and necrotic for the purpose of treatment.
  • Hypertrophic cardiomyopathy 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 left ventricular (Left Ventricle, LV) one or more segments of hypertrophy, the general diagnostic criteria is a thickness greater than or equal to 15mm.
  • the left ventricular outflow tract narrows or even obstructs, that is, when the LVOT pressure difference is too large, it is called obstructive hypertrophic myocardium Disease (Hypertrophic Obstructive Cardiomyopathy, HOCM), HOCM accounts for about 70% of HCM patients.
  • HOCM obstructive hypertrophic myocardium Disease
  • the main methods include drug therapy, ventricular septal surgery (Surgical septalmyectomy), and septal alcohol ablation (Alcohol Septal Ablation).
  • ventricular septal rotation that is, modified Morrow surgery is a surgical operation to open the chest to remove the hypertrophic myocardium and remove the site It is mainly anterior of the ventricular septum and concentrated on the left ventricular surface. The thickness of the interventricular septum can be reduced by 50% after resection.
  • Alcohol ablation is an interventional treatment method, which mainly uses percutaneous transluminal coronary angioplasty technique to send the balloon into the septal branch to be eliminated, and slowly inject alcohol into the septal branch to cause chemical occlusion, thereby Hypertrophic ventricular septal myocardial ischemia, necrosis, thinning, decreased contractility, and reduced LVOT. Although this method avoids the pain of surgery, in clinical applications, alcohol may cause myocardial infarction through branch vessels, and there are still certain risks. . Therefore, there is a need for a less invasive, safer and more effective treatment for HCM. In addition, in order to know the degree of hypertrophic myocardial lesions and the effect of HCM after ablation treatment, it is extremely necessary to perform a biopsy before and / or after ablation.
  • radiofrequency ablation needles or microwave ablation needles are used as a minimally invasive interventional treatment device. They are currently mainly used to treat tumors in the liver, kidneys, and soft tissues. Most of the existing ablation needles are integrated. On the other hand, if biopsy and other operations need to be performed before and / or after ablation, multiple punctures are required. The puncture is difficult and exacerbates the damage to myocardial tissue; on the other hand, as shown in Figure 1, due to the tumor The volume is relatively large.
  • the existing radiofrequency ablation needle or microwave ablation needle is inserted into the tumor tissue 1, it is desirable to increase the contact area of the ablation needle and the tumor tissue 1 to uniformly form a large area, spherical or nearly spherical ablation when performing ablation Area 2, the ablation direction is not adjustable.
  • the aforementioned conventional radiofrequency ablation needle or microwave ablation needle is not suitable for the treatment of HCM, and it is easy to ablate and penetrate to the heart in the thickness direction of the interventricular septum 3 Endometrium 4, damage the conduction beam, causing arrhythmia.
  • the invention provides an ablation needle assembly and an ablation system with less tissue damage and capable of adjusting the ablation direction, and is especially suitable for ablation treatment of HCM.
  • the ablation needle assembly includes a hollow insulated outer sleeve 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 mounted on the outer sleeve In the tube, the proximal end of the outer sleeve and the ablation handle are detachably and rotatably connected, and a restriction part is provided on the electrode needle body or the outer sleeve to limit the ablation direction of the ablation needle.
  • the ablation needle assembly includes the outer sleeve and the ablation needle, the outer sleeve is movably sleeved on the electrode needle body of the ablation needle, and is detachably and rotationally connected to the ablation handle of the ablation needle After the ablation operation is completed, the outer sleeve and the ablation needle can be disassembled, leaving the outer sleeve in the tissue, providing a channel for other operations such as biopsy, avoiding repeated punctures, reducing damage to the tissue, and enabling The biopsy operation is more convenient and efficient.
  • a restriction portion for adjusting the ablation direction is provided on the electrode needle main body or the overtube, and the ablation needle and the overtube can be relatively rotated by using the restriction portion to adjust the ablation needle ablation Direction, so that the ablation direction of the ablation needle avoids the thickness direction of the interventricular septum, thereby preventing the ablation needle from ablating and penetrating into the endocardium in the thickness direction of the interventricular septum, therefore, the ablation needle assembly and ablation system are particularly suitable for Ablation treatment of HCM.
  • Figure 1 is a schematic diagram of an existing ablation needle for ablating tumors
  • Figure 2 is a schematic diagram of ablation of the ventricular septum of the heart using an existing ablation needle
  • FIG. 3 is a schematic structural view of the ablation needle assembly of the present invention after the ablation needle and the outer sleeve are split;
  • FIG. 4 is a schematic diagram of the structure of the ablation needle and the outer sleeve shown in FIG. 3 after assembly;
  • FIG. 5 is a front view of the ablation needle shown in FIG. 3 after being assembled with the outer sleeve;
  • FIG. 6 is a three-dimensional exploded schematic view of the ablation needle assembly shown in FIG. 3;
  • FIG. 7a is a schematic structural view of HCM ablation treatment at the distal end of an ablation needle according to an embodiment of the present invention
  • FIG. 7b is a schematic cross-sectional view taken along the K-K direction in FIG. 7a when the distal end of the ablation needle of the present invention is subjected to HCM ablation treatment;
  • FIG. 7c is a schematic cross-sectional view taken along the K-K direction in FIG. 7a when the distal end of the ablation needle of another embodiment of the present invention is subjected to HCM ablation treatment;
  • FIG. 8a is a schematic structural diagram of the distal end of an ablation needle according to an embodiment of the present invention.
  • FIG. 8b is a schematic cross-sectional view taken along the G-G direction in FIG. 8a when an ablation needle according to an embodiment of the present invention is used for ablation treatment of HCM;
  • FIG. 8c is a schematic cross-sectional view taken along the G-G direction in FIG. 8a when an ablation needle of another embodiment of the present invention is used for ablation treatment of HCM;
  • 9a is a schematic structural diagram of the distal end of an ablation needle according to an embodiment of the present invention.
  • FIG. 9b is a schematic cross-sectional view taken along the H-H direction in FIG. 9a when an ablation needle according to an embodiment of the present invention is used for ablation treatment of HCM;
  • FIG. 9c is a schematic cross-sectional view taken along the direction H-H in FIG. 9a when an ablation needle according to another embodiment of the present invention is used for ablation treatment of HCM;
  • FIG. 10 is a schematic structural view of an outer sleeve of an embodiment of the present invention.
  • FIG. 11 is a schematic structural view of an electrode needle body according to an embodiment of the invention.
  • FIG. 12 is a schematic cross-sectional view of the ablation needle assembly shown in FIG. 5 along the B-B position;
  • FIG. 13 is a three-dimensional schematic view of the base shaft of an embodiment of the present invention.
  • FIG. 14 is a schematic cross-sectional view of a connector according to an embodiment of the invention.
  • FIG. 15 is a schematic cross-sectional view of the ablation needle assembly shown in FIG. 5 along the C-C position;
  • FIG. 16 is an exploded perspective view of the ablation handle of the ablation needle shown in FIG. 6 after removing the housing;
  • FIG. 17 is a schematic perspective structural view of the slider in FIG. 16 at an angle
  • FIG. 18 is a schematic perspective structural view of the slider in FIG. 16 at another angle;
  • FIG. 19 is a schematic perspective structural view of the slider in FIG. 16 at another angle;
  • FIG. 20 is a schematic perspective structural view of the slider in FIG. 16 at another angle
  • 21 is an enlarged schematic view of the control groove of the housing of the ablation needle assembly of the present invention.
  • FIG. 22 is an enlarged schematic perspective view of an electrode needle body according to an embodiment of the invention.
  • FIG. 23 is a schematic cross-sectional view of the electrode needle body shown in FIG. 22 along the A-A position;
  • 24 is a schematic cross-sectional view along the axial direction of other structures of the ablation needle of the present invention except the housing;
  • FIG. 25 is a schematic perspective structural view of one direction of the piston member in the ablation handle of the present invention.
  • FIG. 26 is a schematic perspective structural view of another direction of the piston in the ablation handle of the present invention.
  • FIG. 27 is a three-dimensional schematic structural view of the inner and outer sleeves of the ablation handle in the present invention in one direction;
  • FIG. 28 is a schematic perspective structural view of another direction of the inner and outer sleeves of the ablation handle of the present invention.
  • 29 and 30 are schematic diagrams of the process of adjusting the length of the distal end of the electrode needle body extending out of the outer sleeve after the ablation needle and the outer sleeve are assembled in the present invention
  • FIG. 31 is a schematic structural view of the combination of a biopsy needle and an outer sleeve according to an embodiment of the present invention.
  • 32 is a schematic diagram of the splitting of the puncture needle core and the outer sleeve of the embodiment of the present invention.
  • FIG. 33 is a schematic diagram of the combination of the puncture needle core and the outer sleeve shown in FIG. 32;
  • 35a to 35c are schematic views of the use process of the ablation needle assembly according to an embodiment of the invention.
  • 36a to 36e are schematic diagrams of the use process of the ablation needle assembly according to another embodiment of the present invention.
  • proximal and distal are defined herein as commonly used in the field of interventional medicine. Specifically, “distal” means the end far away from the operator during the surgical operation, and “proximal” means the end close to the operator during the surgical operation.
  • the present invention provides an ablation needle assembly 100 for performing an ablation operation.
  • the ablation needle assembly 100 includes a hollow and insulated 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 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 an 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 so that the charged positive and negative ions in the diseased tissue around the distal end of the electrode needle body 11 oscillate at high speed.
  • the ions generate a lot of heat due to friction, which raises the temperature in the diseased tissue, eventually denatures the protein in the diseased cell, loses water inside and outside the cell, and causes coagulative necrosis in the diseased tissue, thereby achieving radiofrequency ablation;
  • the electrode needle body 11 is electrically When a microwave generator is connected, a microwave field is formed at the distal end of the electrode needle body 11, and dipole molecules such as water molecules in the diseased tissue generate heat due to motion friction and violent collision under the action of the microwave field, causing the temperature in the diseased tissue to rise.
  • the protein in the diseased cell is denatured, the water inside and outside the cell is lost, and coagulative necrosis of the diseased tissue appears, thereby achieving microwave ablation.
  • the electrode needle body 11 is movably mounted in the outer sleeve 30, that is, the distal end of the electrode needle body 11 can extend out of the outer sleeve 30 and the distal end of the electrode needle body 11 can be adjusted to extend The length of the outer sleeve 30.
  • the proximal end of the outer sleeve 30 is detachably connected to the ablation handle 12, for example, the outer sleeve 30 is connected to the ablation handle 12 through a detachable connection such as a threaded connection or a snap connection, so that after the ablation operation is completed,
  • the ablation needle 10 can be easily disassembled from the outer sleeve 30, leaving the outer sleeve 30 in the tissue, providing a channel for other operations (such as biopsy), avoiding repeated punctures, reducing damage to the tissue, and enabling Ablation and other operations are more convenient and efficient, simplifying the surgical procedure.
  • the outer sleeve 30 is rotatably connected to the ablation handle 12.
  • the outer sleeve 30 can be kept stationary and the ablation handle 12 can be rotated to drive The electrode needle body 11 rotates, or the outer body 30 can be rotated while keeping the electrode needle body 11 stationary.
  • the electrode needle body 11 or the outer sleeve 30 is provided with a restricting portion to limit the ablation direction of the ablation needle 10 so that the ablation direction of the ablation needle 10 avoids the chamber
  • the thickness direction of the interval so as to prevent the ablation needle 10 from ablating and penetrating into the endocardium in the thickness direction of the interventricular septum to prevent damage to the conduction beam, and is suitable for ablation treatment of HCM.
  • the ablation direction of the ablation needle 10 can also be adjusted by the restricting portion so as to avoid the interventricular septum from different directions while avoiding the thickness direction of the interventricular septum The hypertrophic site is completely and thoroughly ablated.
  • the outer sleeve 30 is insulated and serves as an insulating tube for the electrode needle body 11 during ablation, so that the portion of the electrode needle body 11 extending out of the outer sleeve 30 performs an ablation operation, and the length of the electrode needle body 11 extending out of the outer sleeve 30 is Effective ablation length.
  • the outer sleeve 30 can be made entirely of insulating materials, such as PEEK, PI, or PA plastic pipes that can meet the hardness requirements, such as high-alumina porcelain, talc porcelain, or boron nitride ceramic pipes; the outer sleeve 30 can also be All are made of non-insulating material, and then the outer surface of the outer sleeve 30 is covered with an insulating coating.
  • the outer sleeve 30 is made of a 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
  • the insulating coating includes but is not limited to PTFE coating, titanium nitride coating, parylene coating, and the like.
  • the metal material for manufacturing the outer sleeve 30 should have sufficient hardness to penetrate into human tissues, and at the same time need to have excellent biocompatibility, the insulating coating must have reliable insulation, excellent biocompatibility and comparative Low coefficient of friction, and requires an intimate bond between the insulating coating and the outer surface of the outer tube 30, the insulating coating is not easy to fall off, for example, you can choose 304 stainless steel tube with PTFE coating, 304 stainless steel tube with parylene coating, 321 stainless steel tube with titanium nitride coating, or 631 stainless steel tube with parylene coating, etc. Considering the insulation reliability and process feasibility, the thickness of various insulation coatings should be ⁇ 3 ⁇ m.
  • the distal end of the outer sleeve 30 may be straight or may be a beveled tip.
  • the distal end of the outer sleeve 30 is a tip, so that various positions of the outer sleeve 30 can be easily inserted into the tissue.
  • the outer peripheral surface of the distal end of the electrode needle body 11 is provided with one or several axially extending insulating bands 119 as a method for defining and adjusting the ablation direction The restriction part.
  • the insulating tape 119 may be a long insulating coating formed by applying an insulating material such as PTFE, titanium nitride, parylene, etc. on the outer peripheral surface of the distal portion of the electrode needle body 11.
  • the insulating tape 119 partially covers the outer circumferential surface of the distal end of the electrode needle body 11 in the axial direction, and the portion of the distal end of the electrode needle body 11 that protrudes from the outer sleeve 30 that is not covered by the insulating tape 119 can be directed toward the diseased tissue
  • the high-frequency current or microwave is conducted internally to perform ablation, so that the ablation direction of the ablation needle 10 extends from the portion of the distal end of the electrode needle body 11 not covered with the insulating tape 119 to the outside of the electrode needle body 11.
  • the portion of the electrode needle body 11 that is not covered by the insulating tape 119 can be directed to the position in the tissue that needs to be ablated, so that it can be oriented according to the anatomy of the tissue to be treated 3. Position ablation.
  • the electrode needle body 11 can be rotated by rotating the ablation handle 12 through the restriction portion on the electrode needle body 11 by rotating the ablation handle 12, so that the electrode needle body 11 can be avoided from the insulating tape
  • the portion covered by 119 is placed in the thickness direction of the interventricular septum 3, so 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 ablating and penetrating in the thickness direction of the interventricular septum 3 to Endocardium, therefore, the ablation needle assembly 100 is particularly suitable for ablation treatment of HCM.
  • the one insulating tape 119 covers a part of the outer circumferential surface of the electrode needle body 11 in the axial direction.
  • the one insulating tape 119 is located on the electrode needle body
  • the arc length in the 11th circumferential direction is greater than 1/2 of the circumference of the electrode needle body 11, so that the ablation area 2 formed when performing ablation on the portion of the electrode needle body 11 not covered by the insulating tape 119 is relatively flat, so that in the room When ablation is performed within interval 3, ablation zone 2 can be farther away from endocardium 4.
  • the portion of the electrode needle body 11 that is not covered by the insulating tape 119 is oriented perpendicular or close to the direction perpendicular to the thickness of the interventricular septum 3, and even if the ablation direction is perpendicular or close to the direction perpendicular to the thickness of the intercompartmental septum 3, the electrode needle main body 11
  • the portion not covered by the insulating tape 119 conducts high-frequency current outward or microwaves to perform ablation.
  • the ablation area 2 is basically extended in a direction perpendicular to or close to the thickness of the interventricular septum 3, which can prevent the ablation from penetrating into the heart ⁇ 4.
  • the ablation handle 12 can be rotated to drive the electrode needle body 11 to rotate and adjusted by the insulating tape 119
  • the ablation direction of the ablation needle 10 is to ablate the hypertrophy site in the interventricular septum 3 from different directions.
  • the plurality of insulating tapes 119 are spaced along the circumferential direction of the electrode needle body 11 and axially cover a part of the outer peripheral surface of the distal end of the electrode needle body 11,
  • the portion of the electrode needle main body 11 that is not covered by the insulating tape 119, that is, the portion between the two adjacent insulating tapes 119 conducts high-frequency current or microwave to perform ablation.
  • the arc length of each insulating tape 119 in the circumferential direction of the electrode needle body 11 is not less than that of the electrode needle body 11 1/4, so that the ablation area 2 formed when performing ablation on the portion of the electrode needle body 11 that is not covered by the insulating tape 119 is relatively flat, so that when ablation is performed in the interventricular septum 3, the ablation area 2 can be farther away from the endocardium 4.
  • the portion of the electrode needle body 11 that is not covered by the insulating tape 119 is oriented to be perpendicular to or close to the direction perpendicular to the thickness of the interventricular septum 3, so that the ablation direction is perpendicular to or close to perpendicular to the chamber
  • the portion of the electrode needle main body 11 that is not covered by the insulating tape 119 conducts high-frequency current or microwave ablation region 2 formed by performing ablation basically extending in a direction perpendicular to or close to the thickness of the interventricular interval 3, Thereby, it is possible to prevent the ablation from penetrating to the endocardium 4.
  • the ablation handle 12 can be rotated to drive the electrode needle body 11 to rotate and the ablation needle 10 can be adjusted by means of the insulating tape 119
  • the ablation direction is to ablate the hypertrophic site in the interventricular septum 3 from different directions.
  • a first developing layer (not shown) may be provided on the surface of the insulating belt 119, the first developing layer is developed under a medical imaging device, so that the corresponding position of the insulating belt 119 can be known from the developed image,
  • the electrode needle main body 11 is rotated according to actual requirements, so that the portion of the electrode needle main body 11 not covered by the insulating tape 119 faces a proper direction.
  • the surface of the insulating tape 119 is processed into an uneven rough surface to form the first developing layer to meet the needs of ultrasonic development.
  • the surface of the insulating tape 119 may be sandblasted or the like.
  • the surface roughness of the first development layer should not be too high, while achieving the ultrasound development requirements, it will not affect the advancement of the electrode needle body 11 in the tissue.
  • a portion of the distal end surface of the outer sleeve 30 is connected with one or several elongated insulations extending to the distal end along the axial direction of the outer sleeve 30.
  • the insulating strip 32 has an arc shape with the same curvature as the outer sleeve 30.
  • the insulating strip 32 is used as the restricting portion, and the distal end of the outer sleeve 30 A hollow portion 321 is formed on the far side of the end surface where the insulating strip 32 is not connected.
  • the insulating strip 32 partially shields the distal end of the electrode needle body 11 extending beyond the distal end of the outer sleeve 30, and the portion of the distal end of the electrode needle body 11 that is not blocked by the insulating strip 32 passes through the hollow portion 321 toward the lesion High-frequency current or microwave is conducted in the tissue to perform ablation, so that the ablation direction of the ablation needle 10 extends from the portion of the distal end of the electrode needle body 11 that is not blocked by the insulating strip 32 to the outside of the electrode needle body 11.
  • the hollow portion 321 and the portion of the distal end of the electrode needle body 11 that is not covered by the insulating strip 32 can be directed to the position in the tissue that needs to be ablated, so that it can be oriented according to the anatomy of the tissue to be treated 3. Position ablation.
  • the ablation needle assembly 100 is particularly suitable for ablation treatment of HCM.
  • the insulating strip 32 may be formed into an integral structure with the outer sleeve 30, and the distal end of the hollow portion 32 may be closed or open.
  • the one insulating strip 32 partially shields the distal end of the electrode needle body 11 extending out of the outer sleeve 30 along the axial direction, between the two side surfaces of the one insulating strip
  • the hollow part 321 is formed.
  • the arc length of the one insulating strip 32 in the circumferential direction of the outer sleeve 30 is greater than 1/2 of the circumferential length of the outer sleeve 30, so that the portion of the electrode needle body 11 that is not blocked by the insulating strip 32 performs ablation through the hollow portion 321
  • the formed ablation zone 2 is relatively flat, so that when ablation is performed within the interventricular septum 3, the ablation zone 2 can be farther away from the endocardium 4.
  • the hollowed portion 321 and the portion of the electrode needle body 11 not covered by the insulating strip 32 are oriented in a direction perpendicular to or close to the thickness of the interventricular septum 3, even if the ablation direction is perpendicular to or close to the thickness of the interventricular septum 3 Direction, the portion of the electrode needle body 11 that is not blocked by the insulating strip 32 conducts high-frequency current or microwave outward through the hollow portion 321 to perform ablation.
  • the ablation region 2 is basically in a direction perpendicular to or close to perpendicular to the thickness of the interventricular septum 3 Expansion, so that ablation can be prevented from penetrating to the endocardium 4.
  • the outer sleeve 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by the insulating strip 32 to The hypertrophic part of the interventricular septum 3 was ablated from different directions.
  • the plurality of insulating strips 32 are spaced around the axis of the outer sleeve 30 and partially shield the distal end of the electrode needle body 11 along the axial direction, and two adjacent insulating strips
  • the hollow 321 is formed between 32.
  • 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 circumferential length of the outer sleeve 30.
  • the portion of the electrode needle body 11 that is not covered by the insulating strip 32 is relatively flat when the ablation area 2 is formed through the hollow portion 321 to perform ablation, so that when the ablation is performed within the interventricular septum 3, the ablation area 2 can be more distant Endometrium.
  • the hollowed portion 321 and the portion of the electrode needle body 11 not covered by the insulating strip 32 are oriented in a direction perpendicular to or close to the thickness of the interventricular septum 3, even if the ablation direction is perpendicular to or close to the thickness of the interventricular septum 3 Direction, the portion of the electrode needle body 11 that is not blocked by the insulating strip 32 conducts high-frequency current or microwave outward through the hollow portion 321 to perform ablation.
  • the ablation region 2 is basically in a direction perpendicular to or close to perpendicular to the thickness of the interventricular septum 3 Expansion, so that ablation can be prevented from penetrating to the endocardium 4.
  • the outer sleeve 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by the insulating strip 32 to The hypertrophic part of the interventricular septum 3 was ablated from different directions.
  • the surface of the insulating strip 32 has a second developing layer (not shown), and the second developing layer is developed under a medical imaging device, so that the corresponding position of the insulating strip 32 can be known from the developed image to Rotate the outer sleeve 30 according to actual needs, so that the portion of the distal end of the electrode needle body 11 that is not covered by the insulating strip 32 passes through the hollow portion 321 to face a proper direction.
  • the surface of the insulating strip 32 is processed into an uneven rough surface to form the second developing layer, to meet the needs of ultrasonic development, for example, the surface of the insulating strip 32 may be treated by sandblasting or the like.
  • the surface roughness of the second development layer should not be too high, while achieving the ultrasound development requirements, it will not affect the advancement of the outer sleeve 30 in the tissue.
  • the distal end surface of the outer sleeve 30 is connected with a conductive segment 33 extending along the axial direction of the outer sleeve 30 away from the outer sleeve 30.
  • One or several long insulating layers 331 extending in the axial direction of the conductive segment 33 are provided on the conductive segment 33 as the restricting portion.
  • the insulating layer 331 partially covers the outer surface of the conductive segment 33 in the axial direction, and the insulating layer 331 partially covers the distal end of the electrode needle body 11 extending out of the distal end of the outer sleeve 30, the electrode needle body 11
  • the portion of the distal end that is not covered by the insulating layer 331 can conduct high-frequency current or microwave into the diseased tissue through the portion of the conductive segment 33 that is not covered by the insulating layer 331 to perform ablation, so that the ablation direction of the ablation needle 10 is from the conductive
  • the portion of the segment 33 that is not covered by the insulating layer 331 extends out of the conductive segment 33.
  • the portion of the distal end of the electrode needle body 11 that is not covered by the insulating layer 331 can be directed to a position in the tissue that needs to be ablated, so that orientation and positioning ablation can be performed according to the anatomy of the tissue to be treated.
  • the ablation needle assembly 100 is particularly Suitable for ablation treatment of HCM.
  • the one insulating layer 331 may cover a portion of the distal end of the electrode needle body 11 in the axial direction.
  • the cross section of the insulating layer 331 is arc-shaped.
  • the arc length of the one insulating layer 331 in the circumferential direction of the conductive section 33 is greater than 1/2 of the circumferential length of the conductive section 33, so that the distal end of the electrode needle body 11 is not.
  • the portion covered by the insulating layer 331 is relatively flat when ablation is performed, so that when ablation is performed within the interventricular septum 3, the ablation region 2 can be farther away from the endocardium.
  • the portion of the distal end of the electrode needle body 11 that is not covered by the insulating layer 331 is oriented perpendicular or close to the direction perpendicular to the thickness of the interventricular septum 3, even if the ablation direction is perpendicular or close to the direction perpendicular to the thickness of the interventricular septum 3, the electrode The portion of the distal end of the needle body 11 that is not covered by the insulating layer 331 conducts a high-frequency current or microwave outward through the portion of the conductive segment 33 that is not covered with the insulating layer 331.
  • the ablation region 2 formed by performing ablation is substantially perpendicular to or nearly perpendicular to the interventricular septum 3
  • the thickness expands in the direction so that ablation can be prevented from penetrating to the endocardium 4.
  • the outer tube 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating layer 331 to The hypertrophic part of the interventricular septum 3 was ablated from different directions.
  • the plurality of insulating layers 331 are arranged along the circumferential direction of the conductive segment 33, that is, the circumferential direction of the outer sleeve 30, and partially cover the electrode needle body 11 in the axial direction
  • the distal end of the electrode needle body 11 extending out of the outer sleeve 30 is not covered by the insulating layer 331 through the portion of the conductive segment 33 that is not covered by the insulating layer 331, that is, the portion between the two adjacent insulating layers 331 Conduct high-frequency currents or microwaves to perform ablation.
  • the cross section of the insulating layer 331 is arc-shaped.
  • the arc length of each insulating layer 331 in the circumferential direction of the conductive section 33 is not less than the conductive 1/4 of the circumference of the segment, so that the ablation area 2 formed when performing ablation on the portion of the electrode needle body 11 not covered by the insulating layer 331 is relatively flat, so that when ablation is performed within the interventricular septum 3, the ablation area 2 can be relatively Keep away from the endocardium.
  • the portion of the electrode needle body 11 that is not covered by the insulating layer 331 is oriented to be perpendicular to or close to the direction perpendicular to the thickness of the interventricular septum 3, even if the ablation direction is perpendicular to or close to the direction perpendicular to the thickness of the interventricular septum 3, the electrode needle main body 11
  • the portion of the distal end that is not covered by the insulating layer 331 conducts a high-frequency current or microwave through the portion of the conductive segment 33 that is not covered by the insulating layer 331 to perform ablation.
  • the ablation area 2 is substantially perpendicular to or close to perpendicular to the inter-ventricular septum 3 thickness Expand in the direction of, so that ablation can be prevented from penetrating to the endocardium 4.
  • the outer tube 30 can be rotated and the ablation direction of the ablation needle 10 can be adjusted by means of the insulating layer 331 to The hypertrophic part of the interventricular septum 3 was ablated from different directions.
  • the surface of the insulating layer 331 has a third developing layer (not shown), and the third developing layer is developed under a medical imaging device, so that the corresponding position of the insulating layer 331 can be known from the developed image to Rotate the outer sleeve 30 according to actual needs, so that the portion of the electrode needle body 11 not covered by the insulating layer 331 faces a proper direction.
  • the surface of the insulating layer 331 is processed into an uneven rough surface to form the second developing layer, to meet the needs of ultrasonic development, for example, the surface of the insulating layer 331 can be treated by sandblasting and the like.
  • the surface roughness of the third developing layer should not be too high, while achieving the requirement of ultrasonic imaging, it will not affect the advancement of the outer sleeve 30 in the tissue.
  • a scale mark 31 is provided on the outer sleeve 30 to indicate the depth of insertion of the outer sleeve 30 into the tissue.
  • the scale mark 31 includes a series of scale values, and the scale values gradually increase from the distal end to the proximal end.
  • the depth of the outer sleeve 30 inserted into the tissue can be known by observing the scale value on the outer sleeve 30, so as to know the approximate position of the outer sleeve 30 inserted into the tissue.
  • the distal end of the outer sleeve 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 ⁇ 5 mm to ensure the accuracy of position guidance.
  • the first guide portion 34 It can help the doctor to judge whether the distal end of the overtube 30 is following the desired puncture path and is approaching the predetermined ablation position.
  • the first guide portion 34 may be a part of the structure added at the distal end of the outer sleeve 30, or may be obtained by performing certain processing on the distal end of the outer sleeve 30. Compared with other imaging modes (such as X-ray fluoroscopy), ultrasound imaging causes less damage to the human body and is more economical. It is preferable to treat the surface of the outer tube 30 near the distal end into an uneven rough surface to form the first
  • the guide portion 34 is adapted to the needs of ultrasound imaging.
  • the surface of the outer sleeve 30 near the distal end may be roughened by sandblasting or perforation to form the first guide portion 34.
  • the surface roughness of the first guide portion 34 should not be too high, while achieving the need for ultrasound imaging, it will not affect the advancement of the outer sleeve 30 in the tissue.
  • the electrode needle body 11 of the ablation needle 10 can be made of biocompatible metal with excellent electrical conductivity such as stainless steel. Since the insulating 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 material, which simplifies the manufacturing process of the electrode needle body 11 of the ablation needle 10, and the outer sleeve 30 can be the ablation needle 10
  • the electrode needle body 11 provides support and protection, 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 on the one hand helps to further reduce tissue damage, on the other hand
  • the structure of the tissue to be ablated, such as the interventricular septum, is relatively flat.
  • the ablation needle assembly of this embodiment is particularly suitable for the ablation therapy of HCM.
  • the distal end of the electrode needle body 11 of the ablation needle 10 may have a sharp triangular pyramid shape or a needle shape, which is conducive to the combination of the electrode needle body 11 of the ablation needle 10 and the outer sleeve 30 to puncture, of course
  • the distal end of the electrode needle body 11 of the ablation needle 10 may also be provided in other shapes, such as a spherical shape, an umbrella shape, or the like.
  • the distal end of the electrode needle body 11 has a second guide 13 that can be developed under a medical imaging device.
  • the length of the second guide 13 needs to be ⁇ 5 mm.
  • the second guide 13 can be developed under a medical imaging device to help The doctor determines whether the distal end of the electrode needle body 11 has reached or is at a predetermined ablation position.
  • the second guide portion 13 may be a part of the structure added at the distal end of the electrode needle body 11 or obtained by performing certain processing on the distal end of the electrode needle body 11.
  • 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 needs of ultrasonic imaging, for example, the surface of the distal end of the electrode needle body 11 may be sandblasted or Punching and other processing.
  • the surface roughness of the second guide portion 13 should not be too high, while achieving the need for ultrasound imaging, it will not affect the advancement of the electrode needle body 11 in the tissue.
  • the ablation needle assembly of this embodiment is particularly suitable for ultrasound-guided ablation treatment. Under ultrasound guidance, the operator can puncture the distal end of the ablation needle assembly into the patient's body and extend from the ablation needle 10 The portion of the outer sleeve 30 performs an ablation operation on the diseased tissue.
  • the ablation handle 12 includes a housing 121, a connecting member 122 connected to the distal end of the housing 121, and is disposed in the housing 121 and can move axially along the housing 121. ⁇ ⁇ ⁇ 123.
  • 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 driving part 123.
  • the electrode part body 11 is driven to move axially relative to the outer sleeve 30 by the driving part 123, so that the distal end of the electrode needle body 11 can be adjusted to extend out of the outer sleeve in real time in the body
  • the length of the tube 30 is adapted to the ablation needs of different lesions or different patients, without having to withdraw the ablation needle assembly 100 from the patient's body to adjust the effective ablation length and puncture again, which greatly improves the surgical efficiency and reduces the damage to human tissue
  • most of the axial length of the electrode needle body 11 is accommodated in the outer sleeve 30, rather than being directly covered by human tissue, when the length of the distal end of the electrode needle body 11 extends beyond the outer sleeve 30 in vivo
  • the resistance is smaller and easier to adjust.
  • the outer sleeve 30 is detachably connected to the connecting piece 122, which means that the outer sleeve 30 is connected to the connecting piece 122 by a detachable connection method such as screw connection, snap connection, etc., so that the ablation operation is completed Afterwards, the ablation needle 10 and the outer sleeve 30 can be easily disassembled, leaving the outer sleeve 30 in the tissue, providing a channel for other operations, avoiding repeated punctures, reducing damage to the tissue, and enabling other operations Such as biopsy is more convenient and efficient.
  • a detachable connection method such as screw connection, snap connection, etc.
  • the outer sleeve 30 is rotatably connected to the connecting member 122, that is, after the outer sleeve 30 is connected to the connecting member 122, it can rotate about the axis of the connecting member 122 as an axis.
  • the housing 121 includes a first housing 121a and a second housing 121b, which can be fixed by snapping, bonding, or screwing Connect together in equal ways.
  • the first housing 121a and the second housing 121b are provided with a card board 1212.
  • the connecting member 122 includes a base shaft 122a and a collar 122b rotatably connected to the base shaft 122a.
  • the proximal end of the base shaft 122a is fixedly connected to the housing 121.
  • the base shaft 122a is disposed along the axial direction of the electrode needle body 11, and the electrode needle body 11 extends through the axis of the base shaft 122a into the housing 121.
  • the proximal ring of the base shaft 122a is provided with a first clamping groove 1221, the proximal end of the base shaft 122a extends into the housing 121, and the first housing 121a and the second The card board 1212 on the housing 121b snaps into the first card slot 1221.
  • the bottom wall of the first clamping slot 1221 has a rectangular outline, and the inner surface of the clamping board 1212 that is caught in the first clamping slot 1221 abuts the bottom wall of the first clamping slot 1221, thereby making the base
  • the shaft 122 a is fixed to the housing 121 and the base shaft 122 a cannot rotate relative to the housing 121.
  • the housing 121 is obtained by connecting the first housing 121a and the second housing 121b in a mating manner, which facilitates the clamping of the card board 1212 into the first card slot 1221 to achieve the fixation of the base shaft 122a and the housing 121 . Further, the distal end of the first clamping slot 1221 is provided with a second clamping slot 1222, and the proximal end of the clamping ring 122b is snapped into the second clamping slot 1222.
  • the outline of the bottom wall of the second clamping groove 1222 is circular, and the proximal end of the collar 122b can be rotated around the axial direction of the base shaft 122a after being snapped into the second clamping groove 1222, However, it cannot move in the axial direction, that is, the collar 122b can rotate in situ.
  • the outer sleeve 30 is detachably connected to the collar 122b.
  • the proximal end of the outer sleeve 30 is provided with an external thread
  • the collar 122b is provided with an internal thread adapted to the external thread
  • the proximal end of the outer sleeve 30 is threaded with the collar 122b connection.
  • the proximal end of the outer sleeve 30 and the collar 122b may also be connected by other detachable methods such as snaps. Further, as shown in FIG.
  • a portion of the outer sleeve 30 provided with external threads is provided with a grip portion 39 toward the distal end side thereof, so as to facilitate rotation relative to the ablation needle 10 or to interact with the ablation needle 10 Disassembly.
  • multiple rings of protrusions are provided on the outer wall of the outer sleeve 30 to form the grip portion 39.
  • the operator can hold the collar 122b by hand to keep the outer sleeve 30 from rotating, and rotate the ablation handle 12 of the ablation needle 10 to pass the ablation
  • the handle 12 drives the electrode needle body 11 to rotate.
  • the ablation handle 12 and the electrode needle body 11 can be kept stationary, and the operator rotates the collar on the connecting member 122 122b to drive the outer sleeve 30 to rotate.
  • the distal end of the base shaft 122a is a truncated cone structure, so that the clamping ring 122b is inserted into the second clamping groove 1222. Moreover, the distal end portion of the base shaft 122a is inserted into the outer sleeve 30 to support the distal end of the outer sleeve 30, so that the connection between the outer sleeve 30 and the connecting member 122 is more stable .
  • the driving part 123 includes a sliding member 1231 and an adjusting member 1232 connected to the sliding member 1231.
  • the proximal end of the electrode needle body 11 is fixed to the slider 1231.
  • the sliding member 1231 is accommodated in the housing 121, and the adjusting member 1232 controls the sliding member 1231 to move along the axial direction of the housing 121 to drive the electrode needle body 11 to move relative to the outer sleeve 30.
  • the slider 1231 includes a cylindrical first portion 1231a and a square second portion 1231b connected to the first portion 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, the first part 1231b is provided with a first central hole 12312, and the electrode needle body 11 passes through the first central hole 12312 ends or partially extends into the first cavity 12311.
  • the proximal end of the electrode needle body 11 is fixed to the inner wall of the first central hole 12312, so that the electrode needle body 11 and the slider 1231 are fixed.
  • the electrode needle body 11 and the slider 1231 are fixed. Further, the inner surface of the housing 121 is provided with a first guide 1213 provided along the extending direction of the electrode needle body 11, and the surface of the slider 1231 is provided with a second guide 12313 adapted to the first guide 1213. The cooperation of the guide 12313 and the first guide 1213 ensures that the slider 1231 moves along the axial direction of the electrode needle body 11. The movement of the slider 1231 drives the electrode needle body 11 to move relative to the outer sleeve 30 to adjust the distal extension of the electrode needle body 11 The length of the outer sleeve 30.
  • the first guide member 1213 is a slide groove
  • the second guide member 12313 is a protrusion.
  • the protrusion is embedded in the slide groove and moves along the slide groove. It can be understood that, in other embodiments of the present invention, the first guide 1213 may also be a protrusion, and the second guide 12313 may be a chute.
  • the adjusting member 1232 includes a key 12321 and a connecting portion 12322, and a control slot 1211 is opened on the housing 121 in the axial direction.
  • the first housing 121a and the second housing 121b are respectively provided with grooves at positions where the two are engaged, and the grooves on the first housing 121a and the second housing 121b are engaged
  • the control groove 1211 is formed. It can be understood that, in other implementations of the present invention, the control groove 1211 may also be formed only on the first housing 121a or the second housing 121b.
  • One end of the connecting portion 12322 is connected to the second portion 1231b of the slider 1231, and the other end extends from the control slot 1211 to the housing 121 and connects to the key 12321, pushing the key 12321 along the control
  • the movement of the groove 1211 can control the sliding member 1231 to move along the axial direction of the housing 121, thereby driving the electrode needle body 11 fixed with the sliding member 1231 to move relative to the outer sleeve 30 to adjust the distal end of the electrode needle body 11 to extend out of the outer sleeve The length of 30.
  • the length of the outer sleeve 30 extending from the distal end of the electrode needle body 11 can be conveniently adjusted in real time by actuating the key 12321, that is, the effective ablation length can be adjusted to Adapt to the ablation needs of different lesions or different patients.
  • the connecting portion 12322 includes a limiter 12322a and a post 12322b.
  • the post 12322b is fixedly connected to the limiter 12322a at one end and connected to the second part 1231b of the slider 1231 at the other end.
  • the body 12322a is connected to the key 12321.
  • the upright 12322b is arranged along the axial direction perpendicular to the sliding member 1231 and can move along its own axial direction.
  • the two uprights 12322b are arranged in parallel, and each end of the uprights 12322b away from the limiting body 12322a is provided with an annular groove in which the E-shaped snap ring 12324 can be detachably held.
  • the second part 1231b of the sliding member 1231 is provided with a first plane 12314 and a second plane 12315 opposite to the first plane 12314, and the second part 1231b is provided with a penetration from the first plane 12314 to Two openings 12316 of the second plane 12315, ends of the two uprights 12322b facing away from the limiting body 12322a extend into the openings 12316 from the first plane 12314 side, and the E-shaped snap ring 12324 is located on the side of the second plane 12315.
  • an elastic body 1322 is provided between the limiting body 12322a and the sliding member 1231.
  • the elastic body 1322 may be, but not limited to, a spring, an elastic piece, an elastic washer, or the like.
  • the elastic body 1322 is a spring, and the spring is wound around the periphery of the upright 12323b and is located between the limiting body 12322a and the first plane 12314. It can be understood that in some embodiments of the present invention, the post 12323b may not be provided, and the two ends of the elastic body 1322 are directly fixed to the limiting body 12322a and the sliding member 1231 to connect the limiting position.
  • the inner wall of the housing 121 is provided with a plurality of spaced locking grooves 1214 on at least one side of the control groove 1211, and at least one locking position 123221 is provided on the limiting body 12322a.
  • the elastic body 1322 stretch naturally, the elastic body 1322 pushes the limiting body 12322a so that the locking position 12321 is locked into the locking slot 1214, and at the same time, the limiting body 12322a drives the The post 12322b moves along the axial direction of the post 12322b until the E-shaped snap ring 12324 abuts the second plane 12315. At this time, the adjusting member 1232 cannot be moved, that is, the sliding member 1231 remains stationary, and the length of the electrode needle body 11 protruding from the outer sleeve 30 is prevented from changing.
  • the operator manually presses the key 12321 downward, the limiter 12322a and the post 12322b move down, the elastic body 1322 is compressed and contracted, and the limiter 12322a
  • the locking position 123221 is separated and released from the locking slot 1214.
  • pushing and pulling the key 12321 in the axial direction can drive the slider 1231 and the electrode needle body 11 to move in the axial direction, thereby adjusting the length of the electrode needle body 11 extending out of the outer sleeve 30.
  • the effective ablation length when the key 12321 reaches a certain position to obtain the desired effective ablation length, the operator releases the key 12321, the elastic body 1322 elastically resets itself, and pushes the locking position 123221 on the limiting body 12322a into the position In the card slot 1214, the adjusting member 1232 and the sliding member 1231 are positioned at this position and remain stationary.
  • the outer surface of the housing 121 is provided with a plurality of scale marks 1215, and the plurality of scale marks 1215 correspond to the plurality of clamping slots 1214 one-to-one.
  • observing the scale value corresponding to the adjusting member 1232 can know 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 electrode The length of the distal end of the needle body 11 extending beyond the outer sleeve 30 is the effective ablation length of the ablation needle 10 capable of performing ablation. As shown in FIGS.
  • the adjustable range of the effective ablation length of the electrode needle body 11 is also different according to the anatomical structure of different tissues. 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 5 mm ⁇ 35mm.
  • the part of the electrode needle body 11 of the ablation needle 10 contacting the tissue will transmit radio frequency energy or microwave energy to cause high temperature of the tissue, causing tissue coagulation necrosis to achieve the treatment purpose, but the local temperature is too high It will affect the normal tissue that does not need to be ablated, so the electrode needle body 11 of the ablation needle 10 is a hollow inner cavity 111 except for the needle tip part, and the inner cavity 111 is provided with an inner wall of the inner cavity 111 Spaced and coaxial cooling channels 113, the inner cavity 111 and the cooling channels 113 are used to transport gaseous or liquid cooling medium (such as cooling water) for cooling to control the temperature during the ablation operation.
  • gaseous or liquid cooling medium such as cooling water
  • the inner cavity 111 is also provided with a thermocouple 112 to measure the temperature of the tissue around the electrode needle body 11 in real time.
  • the thermocouple 112 penetrates the cooling channel 113 and is spaced from the inner wall of the cooling channel 113.
  • the proximal end of the ablation handle 12 is provided with an inflow port 114 and an outflow port 115.
  • the inflow port 114 communicates with the proximal end of the cooling channel 113.
  • the first gap between the cooling channel 113 and the inner wall of the inner cavity 111 is The outlet 115 communicates, and the cooling medium flows into the cooling channel 113 through the inlet 114, and flows from the distal end of the cooling channel 113 to the first gap, and then flows out through the outlet 115, thereby forming a circulation of cooling water.
  • the temperature of the electrode needle main body 11 and surrounding tissues is reduced.
  • the ablation handle 12 further includes a piston 1233 disposed in the housing 121, and the piston 1233 is disposed coaxially with the sliding member 1231.
  • the distal end of the piston member 1233 and the proximal end of the sliding member 1231 are sealed and fixed, and a water outlet storage chamber C1 is formed between the sliding member 1231 and the piston member 1233, and the first between the outlet 115 and the cooling channel 113 and the inner wall of the inner chamber 111
  • the gap communicates with the outlet water storage cavity C1, and the cooling medium flows into the outlet water storage cavity C1 through the first gap between the cooling channel 113 and the inner wall of the inner cavity 111, and then flows out through the outlet 115.
  • the piston 1233 is basically a cylindrical structure, the diameter of the distal end is smaller than the diameter of the proximal end, and the distal end is fitted into the proximal end of the first cavity 12311 of the sliding member 1231.
  • the glue seals and fixes the distal end of the piston 1233 and the inner wall of the first cavity 12311.
  • a second cavity 12332 extends from the proximal end of the piston member 1233 to the distal end.
  • 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 slider 1231.
  • the proximal end of the cooling channel 113 passes through the second central hole 12333 to be blocked or extends into the second cavity 12332 and then ends, and the proximal end of the cooling channel 113 is fixed to the inner wall of the second central hole 12333.
  • the ablation handle 12 further includes a sleeve member 1234 disposed in the housing 121 and fixed to the housing 121, the sleeve member 1234 It is coaxial with the piston 1233.
  • the distal end of the sleeve member 1234 is sleeved outside the proximal end of the piston member 1233 and is movably and sealingly connected with the piston member 1233.
  • an inlet water storage chamber C2 is formed between the piston member 1233 and the sleeve member 1234, the inflow port 114 and the cooling channel 113 communicate with the inlet water storage chamber C2, and the cooling medium passes through the inlet port 114 Enter the inlet water storage chamber C2, and then enter the cooling channel 113.
  • the sleeve member 1234 is also substantially cylindrical, and includes a third cavity 12341 extending from the distal end to the proximal end. The proximal end of the piston member 1233 is fitted into the third cavity 12341 of the sleeve member 1234 and sealed with the inner wall of the third cavity 12341 and movably connected.
  • the sliding member 1231 drives the piston member 1233 to move, and the proximal end of the piston member 1233 moves in the axial direction in the third cavity 12341 and does not escape from the first Three chamber 12341.
  • the second cavity 12332 communicates with the third cavity 12341 to form the inlet water storage cavity C2.
  • the inflow port 114 and the outflow port 115 are provided on the bottom wall 12342 of the third cavity 12341, and the center of the bottom wall 12342 is further provided with a third central hole 123421.
  • the thermocouple 112 is The three central holes 123421 pass through.
  • the sliding member 1231 When the sliding member 1231 is driven by the adjusting member 1232, the sliding member 1231 moves the piston member 1233 relative to the sleeve member 1234, so that the space of the inlet water storage chamber C2 is variable. In addition, the sliding member 1231 drives the piston member 1233 to move within the sleeve member 1234.
  • the piston member 1233 and the sleeve member 1234 always share a part of the axial space, which helps reduce the axial length of the ablation handle 12.
  • a plurality of sealing rings 12337 are sleeved on the outer wall of the proximal end of the piston member 1233, and the sealing ring 12337 seals the gap between the proximal end of the piston member 1233 and the sleeve member 1234 to avoid The cooling medium in the inlet water storage chamber C2 flows out from the gap between the sleeve member 1234 and the piston member 1233.
  • the ablation handle 12 further 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 cover 124 is provided with spaced-apart water inlet pipeline perforation holes, water outlet pipeline perforation holes, and wire harness penetration holes.
  • the water inlet pipe perforating hole can allow the water inlet pipe 116 connected to the inlet 114 to pass through
  • the water outlet pipe perforating hole can allow the water outlet pipe 117 connected to the outlet 115 to pass through
  • the through hole can allow the wire bundle 118 formed by the wire electrically connected to the thermocouple 112 and the wire electrically connected to the electrode needle body 11 to pass through.
  • an outlet adapter tube 1235 is provided in the inlet water storage cavity C2, and the distal end of the outlet adapter tube 1235 passes through the piston member 1233 and the outlet water storage cavity C1 Connected, the proximal end of the outlet adapter pipe 1235 is connected to the outflow port 115, and is connected to the outlet pipe 117.
  • the outlet adapter pipe 1235 includes a spiral section 1235a that can expand and contract in the axial direction of the sleeve member 1234.
  • the spiral section 1235a of the outlet adapter 1235 will follow the piston member 1233 to expand or contract in the inlet water storage chamber C2 without affecting the piston
  • the axial movement of the piece 1233 can also avoid pulling the water outlet pipe 117 frequently into and out of the housing 121, thereby avoiding friction and damage to the water outlet pipe 117.
  • the arrow in FIG. 24 illustrates the flow path of the cooling medium.
  • the cooling medium enters the inlet water storage chamber C2 from the inlet pipe 116 through the inlet 114, and then flows from the inlet water storage chamber C2 to the cooling channel 113, and then from the cooling channel 113 and the electrode needle body 11
  • the first gap between the inner walls of the chamber 111 flows out into the outlet water storage chamber C1, flows out through the outlet adapter 1235 to the outlet 115, and finally flows out through the outlet pipe 117, thereby realizing the cooling cycle of the cooling medium in the electrode needle body 11.
  • the ablation needle assembly 100 further includes a biopsy needle 20, and the ablation needle 10 and the biopsy needle 20 are alternately worn in the outer sleeve 30.
  • 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 overtube 30, the biopsy needle body of the biopsy needle 20 is inserted into the overtube 30 and extends into the biopsy position along the overtube 30 for biopsy operation . Further, the biopsy handle of the biopsy needle 20 can also be detachably connected to the outer sleeve 30.
  • the biopsy needle 20 and the outer sleeve 30 can be separated Tube 30 is connected. Therefore, after the ablation operation is completed, the connection between the ablation needle 10 and the outer sleeve 30 is released, leaving the outer sleeve 30 in the tissue to provide a channel for the biopsy operation, so that the biopsy needle 20 quickly reaches the desired biopsy position, avoiding duplication Puncture to reduce damage to the tissue; or, in some surgical procedures, the biopsy needle 20 and the outer sleeve 30 can be disconnected after the biopsy operation is completed, leaving the outer sleeve 30 in the tissue to provide a channel for the ablation operation , So that the ablation needle 10 quickly reaches the desired ablation position, can also avoid repeated puncture, and reduce damage to the tissue.
  • the ablation needle assembly 100 further includes a puncture needle core 40, the diameter of the puncture needle core 40 is greater than the diameter of the ablation needle 10 or biopsy needle 20,
  • the diameter range of the puncture needle core 40 is preferably 19G to 16G.
  • the puncture needle core 40 is preferably made of a hard material, such as stainless steel.
  • the puncture needle core 40 and the ablation needle 10 or biopsy needle 20 are alternately installed in the outer sleeve 30 and detachably connected to the outer sleeve 30, and the distal end of the puncture needle core 40 extends out of the Narration tube 30.
  • the distal end of the puncture needle core 40 has a sharp needle shape or a triangular pyramid shape, and a proximal end may be fixed with a joint 41 having an internal thread, the internal thread of the joint 41 and the proximal end of the outer sleeve 30 The external thread fits.
  • the puncture core 40 and the outer sleeve 30 can be combined to puncture the tissue before ablation or biopsy, and then the connection between the puncture core 40 and the outer sleeve 30 is released, and the puncture needle core 40 is withdrawn. Then, the ablation needle 10 or the biopsy needle 20 is inserted into the outer sleeve 30.
  • the larger diameter and harder puncture core 40 can provide better support for the outer sleeve 30, so the combination of the puncture core 40 and the outer sleeve 30 is more convenient for puncture, and can prevent the direct use of the ablation needle 10 or biopsy needle When performing the puncture, the ablation needle 10 or the biopsy needle 20 is damaged.
  • the present invention also provides an ablation system, including the ablation needle assembly 100 and the energy generating device 110.
  • the energy generating device 110 is electrically connected to the electrode needle body 11 through the wire harness 118 to perform an ablation operation.
  • 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 not limited to, a radio frequency generator or a microwave generator.
  • the cooling device 130 is connected to the ablation needle assembly 100 through a water inlet pipe 116 and a water outlet pipe 117 to provide a gaseous or liquid cooling medium for circulation in the electrode needle body 11.
  • the medical imaging device 120 is used to display the distal positions of the outer sleeve 30 and the electrode needle body 11 in real time, and may be selected from at least one of ultrasound, CT, nuclear magnetic, and X-ray fluoroscopy, preferably ultrasound.
  • the ablation needle assembly 100 and the ablation system 200 of the present invention can be applied to but not limited to the treatment of HCM, and the treatment and biopsy of kidney, liver, or soft tissue tumors.
  • this embodiment takes the treatment of HCM as an example to illustrate the use process of the ablation needle assembly 100:
  • the first step First, the ablation needle 10 is put into the outer sleeve 30, and the outer sleeve 30 is connected to the ablation handle 12 through the connecting member 122 to obtain the ablation needle assembly shown in FIG. 4. Actuating the adjusting member 1232 to drive the sliding member 1231 and the electrode needle body 11 to move axially relative to the outer sleeve 30 to obtain a desired length of the electrode needle body 11 extending beyond the outer sleeve 30, that is, to obtain preliminary effective ablation Length; and by relatively rotating the electrode needle body 11 and the outer sleeve 30, adjusting the direction corresponding to the restriction (insulating tape, insulating strip or insulating layer) to initially adjust the ablation direction so that the ablation direction avoids the thickness of the interventricular septum direction.
  • the restriction insulating tape, insulating strip or insulating layer
  • Step 2 As shown in FIG. 35a, under the guidance of the ultrasound device, the outer sleeve 30 and the electrode needle body 11 are punctured from the ribs through the apex to enter the interventricular septum from the epicardium, and the radio frequency generator is turned on, and the electrode needle body 11 The portion of the outer cannula 30 that does not correspond to the restriction portion is subjected to radiofrequency ablation of the hypertrophic septal myocardium.
  • the key 12321 is moved in the axial direction to actuate the adjustment member 1232 and the sliding member 1231, which drives the electrode needle body 11 to move relative to the outer sleeve 30 in real time in the body to adjust to the
  • the effective ablation length is needed; if the ablation direction needs to be adjusted, the desired ablation direction can be obtained by rotating the electrode needle body 11 or the outer sleeve 30 and avoiding the ablation penetration on the basis of avoiding the thickness direction of the interventricular septum with the help of the restriction To the endocardium.
  • Radiofrequency ablation can destroy the activity of the ventricular septal myocardium at the corresponding site, atrophy and thinning myocardial necrosis, thereby widening the left ventricular outflow tract and removing the obstruction.
  • the application of the ablation needle assembly 10 for the treatment of HCM not only avoids the risk and pain of surgical rotation and thoracotomy and extracorporeal circulation, but also does not have the risk of chemical alcohol ablation or alcohol overflow caused by a large area of myocardial infarction. It is extremely small, with a small surgical risk and a significant effect; and it can adjust the effective ablation length in real time in the body, greatly improving the surgical efficiency and reducing the damage to human tissue.
  • the restricting portion can prevent the ablation from penetrating into the endocardium and prevent damage to the conduction beam.
  • Step 3 As shown in FIGS. 35b and 35c, after the ablation is performed, the connection between the outer sleeve 30 and the connector 122 is released, 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 for extraction Tissue samples are used for biopsy.
  • the outer sleeve 30 provides a channel for the biopsy operation, can avoid repeated punctures, reduces damage to the tissue, and enables the biopsy needle 20 to quickly reach the desired biopsy position.
  • the restricting portion is located outside the outer sleeve 30 as shown in FIG. 8a or 9a, then the needle tip of the electrode needle body 11 is generally The distal end of the restricting portion will not be extended underneath.
  • the outer sleeve 30 and the biopsy needle 20 may be combined for puncture and biopsy before performing ablation, and then the biopsy needle 20 is withdrawn and the outer sleeve 30 is left.
  • the ablation needle 10 is inserted into the outer sleeve 30, and the connection between the outer sleeve 30 and the ablation needle 10 is established through the connection member 122, which can also avoid repeated puncture and reduce damage to the tissue.
  • the puncture needle core 40 and the outer sleeve 30 may be combined before ablation or biopsy.
  • the connection between the puncture core 40 and the outer sleeve 30 is released, the puncture core 40 is removed, the outer sleeve 30 is left in the patient, and then the ablation needle 10 or the biopsy needle 20 is inserted into the outer sleeve 30 for ablation or biopsy Operation to increase the puncture strength and prevent damage to the ablation needle 10 or biopsy needle 20 during the puncture process.

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Abstract

L'invention concerne un ensemble aiguille d'ablation (100) et un système d'ablation (200). L'ensemble aiguille d'ablation (100) comprend un manchon externe creux (30) et une aiguille d'ablation (10). Le manchon externe (30) est gainé de façon mobile à l'extérieur d'un corps principal d'aiguille d'électrode (11) de l'aiguille d'ablation (10), et est relié de façon détachable et rotative à une poignée d'ablation (12). Après achèvement d'une opération d'ablation, l'aiguille d'ablation (10) peut être détachée du manchon externe (30), et le manchon externe (30) demeure dans un tissu afin de fournir un canal pour effectuer d'autres opérations telles qu'une biopsie, évitant ainsi une perforation répétée, et réduisant les dommages causés au tissu. Une partie de limitation est disposée sur le corps principal d'aiguille d'électrode (11) ou le manchon externe (30), de façon à limiter une direction d'ablation de l'aiguille d'ablation. L'ensemble aiguille d'ablation (100) et le système d'ablation (200) de la présente invention sont particulièrement appropriés pour une thérapie d'ablation par radiofréquence de HCM.
PCT/CN2019/106745 2017-11-28 2019-09-19 Ensemble aiguille d'ablation et système d'ablation WO2020088139A1 (fr)

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CN201711213683 2017-11-28
CN201811292574.5A CN109350233A (zh) 2017-11-28 2018-10-31 消融针组件及消融系统
CN201821788426.8 2018-10-31
CN201811292574.5 2018-10-31
CN201821788426.8U CN210301203U (zh) 2017-11-28 2018-10-31 消融针组件及消融系统

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CN210301203U (zh) 2020-04-14
CN210301204U (zh) 2020-04-14
CN209826963U (zh) 2019-12-24
WO2020088140A1 (fr) 2020-05-07
CN109350234A (zh) 2019-02-19
CN109350233A (zh) 2019-02-19
CN109833091A (zh) 2019-06-04
WO2020052302A1 (fr) 2020-03-19

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