WO2020038216A1 - Ablation needle assembly and ablation system - Google Patents

Ablation needle assembly and ablation system Download PDF

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Publication number
WO2020038216A1
WO2020038216A1 PCT/CN2019/099087 CN2019099087W WO2020038216A1 WO 2020038216 A1 WO2020038216 A1 WO 2020038216A1 CN 2019099087 W CN2019099087 W CN 2019099087W WO 2020038216 A1 WO2020038216 A1 WO 2020038216A1
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WIPO (PCT)
Prior art keywords
ablation
outer sleeve
needle
ablation needle
electrode
Prior art date
Application number
PCT/CN2019/099087
Other languages
French (fr)
Chinese (zh)
Inventor
张庭超
刘丽文
李阳
彭波波
丘信炯
Original Assignee
杭州诺诚医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Priority claimed from CN201810971599.1A external-priority patent/CN109833091A/en
Application filed by 杭州诺诚医疗器械有限公司 filed Critical 杭州诺诚医疗器械有限公司
Publication of WO2020038216A1 publication Critical patent/WO2020038216A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • 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
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves

Definitions

  • the invention relates to the technical field of medical instruments, and in particular to an ablation needle assembly and an ablation system.
  • a biopsy needle can be used to puncture the lesion, and a small amount of tissue at a part of the lesion can be obtained, and then pathological analysis can be performed.
  • radiofrequency or microwave ablation needles can be used to insert the lesion, and radiofrequency energy or microwave energy can cause high temperature in the local tissue of the lesion, so that the lesion tissue can be coagulated and necrotic.
  • HCM Hypertrophic cardiomyopathy
  • HOCM obstructive hypertrophic cardiomyopathy
  • the methods of obstruction include drug therapy, Surgical Septalmyectomy, and Alcohol Septal Ablation.
  • Drug therapy is relatively simple and easy. Patients do not have the pain of surgery, but some patients have poor or intolerable drug therapy.
  • Ventricular septal resection which is a modified Morrow surgery, removes hypertrophic myocardium through surgical thoracotomy and removes the site. It is mainly the front of the ventricular septum and is concentrated on the left ventricle. The thickness of the ventricular septum can be reduced by 50% after resection, and the postoperative LVOT is significantly reduced, but the modified Morrow surgery has certain risks, and the patient's postoperative recovery is also painful; Alcohol ablation is an interventional method.
  • radiofrequency ablation needles or microwave ablation needles as a minimally invasive interventional treatment device, are currently mainly used to treat tumors in the liver, kidney, soft tissue and other parts, and most of the existing ablation needles are integrated. Other operations such as biopsy are required before and / or after ablation, and multiple punctures are required, which is difficult to puncture and aggravates tissue damage.
  • the ablation needle needs to be rotated during the ablation operation, the part of the ablation needle inserted into the tissue is directly covered by the tissue, which is not only difficult to rotate, but also causes damage to the tissue.
  • the invention provides an ablation needle assembly with less damage to the tissue and an ablation system, and is particularly suitable for radiofrequency ablation of hypertrophic cardiomyopathy.
  • the ablation needle assembly includes a hollow outer sleeve and an ablation needle that is movably inserted in the outer sleeve;
  • the ablation needle includes an electrode needle body and an ablation handle connected to the proximal end of the electrode needle body;
  • the outer sleeve At least partially insulated;
  • the proximal end of the outer sleeve and the ablation handle are detachably and rotatably connected, and the distal end of the electrode needle body extends out of the outer sleeve;
  • the ablation handle rotates relative to the outer sleeve to drive
  • the electrode needle body rotates relative to the outer sleeve.
  • the method further includes a biopsy needle, and the biopsy needle and the ablation needle are alternately worn in the outer sleeve.
  • the ablation handle includes a driving component and a connecting member rotatably connected with the driving component, and the outer casing is detachably connected with the connecting component; the driving component drives the outer casing along the electrode needle.
  • the extension direction of the main body is moved relative to the electrode needle main body to adjust the length of the distal end of the electrode needle main body protruding from the outer sleeve.
  • the driving assembly includes a sliding member and an adjusting member connected to the sliding member.
  • the connecting member is coaxially disposed with the sliding member and is rotationally connected.
  • the adjusting member controls the sliding member to move in the axial direction thereof.
  • the ablation handle includes a housing, and the driving component is housed in the housing; a control groove is provided on the housing along the axial direction of the slider, and one end of the adjustment member protrudes from the control groove.
  • the housing controlling the sliding member to move along its axial direction by moving the adjusting member at the position of the control slot.
  • a scale mark is provided on at least one side of the control slot.
  • an elastic member is provided between the adjusting member and the sliding member, and the extending direction of the elastic member faces the control slot; the inner wall of the housing is provided with a plurality of card positions corresponding to the scale mark. At least one protrusion is provided on the adjusting member; when the elastic member is naturally extended, the elastic member pushes the protrusion to snap into the locking position.
  • the inner surface of the housing is provided with a first guide member disposed along the axial direction of the slider, and the surface of the slide member is provided with a second guide member adapted to the first guide member. The cooperation of the second guide with the first guide causes the slider to move along its axial direction.
  • the distal end ring of the sliding member is provided with a clamping slot
  • the proximal end of the connecting member is provided with a clamping ring
  • the clamping ring is inserted into the clamping slot to rotate the sliding member and the connecting member. connection.
  • a puncture needle core which is alternately inserted into the outer sleeve and the ablation needle or the biopsy needle and is detachably connected to the outer sleeve, and the distal end of the puncture core Extend the outer sleeve.
  • the outer surface of the outer sleeve is provided with a scale mark.
  • the distal end of the outer sleeve has a first guide portion, and the first guide portion is developed under a medical imaging device.
  • the distal end of the electrode needle body has a second guide portion, and the second guide portion is developed under a medical imaging device.
  • the electrode needle main body is provided with a cooling channel therein.
  • the ablation system includes the ablation needle assembly and an energy generating device electrically connected to an electrode needle body of the ablation needle.
  • the energy generating device is a radio frequency generator or a microwave generator.
  • the ablation system further includes a cooling device in communication with the proximal end of the electrode needle body.
  • the ablation needle assembly and the ablation system of the present invention have at least the following beneficial effects:
  • the ablation needle assembly includes the outer sleeve and an ablation needle, and the outer sleeve is movably sleeved outside the electrode needle body of the ablation needle and is detachably and rotationally connected with the ablation handle, that is, after the ablation operation is completed, Disassembling the ablation needle from the outer cannula, leaving the outer cannula in the tissue, providing channels for other operations such as biopsy, avoiding repeated puncture, reducing tissue damage, and making the biopsy operation more convenient and efficient .
  • the ablation handle is rotatably connected with the outer sleeve, so that when the ablation handle is rotated relative to the outer sleeve, the electrode needle body can be driven to rotate relative to the outer sleeve, that is, the outer sleeve and the electrode needle body are not an integrated structure and need to be rotated.
  • the outer cannula can be kept from rotating, thereby reducing tissue damage and less resistance to rotation. Therefore, the ablation needle assembly and the ablation system of the present invention are particularly suitable for radiofrequency ablation treatment of HCM.
  • FIG. 1 is a schematic structural diagram of an ablation needle assembly according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural diagram of an ablation needle and an outer sleeve after assembly according to an embodiment of the present invention
  • FIG. 3 is a front view of the ablation needle and the outer cannula assembled in FIG. 2;
  • FIG. 4 is a schematic structural diagram of an outer sleeve according to an embodiment of the present invention.
  • FIG. 5 is a schematic structural diagram of an outer sleeve according to an embodiment of the present invention.
  • FIG. 6 is an enlarged schematic view of a distal end of an electrode needle body according to an embodiment of the present invention.
  • FIG. 7 is a schematic cross-sectional view of the electrode needle body A-A position shown in FIG. 6;
  • FIG. 8 is a schematic structural diagram of an electrode needle main body according to an embodiment of the present invention.
  • FIG. 9 is a schematic cross-sectional view of the ablation needle and the outer sleeve shown in FIG. 2 after assembly;
  • FIG. 10 is a schematic diagram of a process of adjusting the length of the distal end of the ablation needle protruding from the outer sleeve after the ablation needle is assembled with the outer sleeve;
  • FIG. 11 is a schematic structural diagram of a driving assembly of the ablation needle according to an embodiment of the present invention.
  • FIG. 12 is a schematic exploded view of a biopsy needle and an outer cannula according to an embodiment of the present invention
  • FIG. 13 is a schematic diagram of a combination of the biopsy needle and the outer cannula shown in FIG. 12;
  • FIG. 14 is a schematic exploded view of the puncture needle core and the outer sleeve according to the embodiment of the present invention.
  • FIG. 15 is a schematic diagram of the combination of the puncture needle core and the outer sleeve shown in FIG. 14;
  • 16a to 16c are schematic diagrams of a process of using an ablation needle assembly according to an embodiment of the present invention.
  • 17a to 17e are schematic diagrams of a process of using an ablation needle assembly according to another embodiment of the present invention.
  • FIG. 18 is a schematic structural diagram of an ablation system according to an embodiment of the present invention.
  • proximal and distal are defined herein as common terms in the field of interventional medicine. Specifically, the “distal end” indicates the end far from the operator during the surgical operation, and the “proximal end” indicates the end near 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 an outer cannula 30 and an ablation needle 10.
  • the ablation needle 10 includes an electrode needle body 11 and an ablation handle 12 connected to a proximal end of the electrode needle body 11.
  • the outer sleeve 30 is movably sleeved outside the electrode needle main body 11 and is detachably and rotationally connected with the ablation handle 12.
  • the outer casing 30 is at least partially insulated. In other words, the outer casing 30 may be fully insulated or partially insulated.
  • the distal end of the electrode needle body 11 protrudes from the outer casing 30.
  • the part of the electrode needle main body 11 protruding from the outer casing 30 performs an ablation operation; when the outer casing When the tube 30 is partially insulated, an ablation operation is performed on a portion of the electrode needle body 11 protruding from the outer tube 30 and a non-insulated portion of the outer tube 30.
  • the electrode needle main body 11 when the electrode needle main body 11 is electrically connected to a radio frequency generator, the electrode needle main body 11 transmits a high-frequency current so that charged positive and negative ions in the diseased tissue around the distal end of the electrode needle main body 11 undergo high-speed oscillating motion.
  • the ions generate a large amount of heat due to friction, which causes the temperature in the diseased tissue to rise, eventually denature protein in the diseased cells, loss of water inside and outside the cell, and coagulation necrosis of 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 main body 11.
  • the dipole molecules such as water molecules in the diseased tissue are heated by friction and severe collision under the action of the microwave field, which causes 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 the coagulated necrosis of the diseased tissue occurs, thereby achieving microwave ablation.
  • the outer sleeve 30 and the ablation handle 12 are detachably connected, so that after the ablation operation is completed, the ablation needle 10 can be detached from the outer sleeve 30, and the outer sleeve 30 remains in the tissue.
  • Other operations provide channels to avoid repeated puncture, reduce tissue damage, and make the ablation and other operations more convenient and efficient.
  • the ablation handle 12 can be rotated relative to the outer sleeve 30 to drive the electrode needle body 11 to rotate relative to the outer sleeve 30, that is, the outer sleeve 30 and the electrode needle body 11 of the ablation needle 10 are not With the integrated structure, when the ablation needle 10 needs to be rotated, the outer cannula 30 can be kept from rotating, thereby reducing tissue damage, and the resistance to rotation is small.
  • the outer sleeve 30 is at least partially insulated.
  • the outer sleeve 30 is entirely insulated.
  • the outer tube 30 is at least partially insulated, which means that the first tube body 30 a near the proximal end of the outer tube 30 is an insulating structure, and the second tube body 30 b near the distal end of the outer tube 30 may be It is a non-insulating structure, so that the non-insulating part of the outer sleeve 30 can also transmit high-frequency current or microwaves to increase the ablation area.
  • the outer sleeve 30 may be made at least partially of an insulating material, or the outer sleeve 30 may be made entirely of a non-insulating material, and then the outer surface of the outer sleeve 30 is at least partially covered with an insulating coating, and an ablation operation is performed. At this time, a part of the outer tube 30 covering the insulating layer serves as an insulating tube of the ablation needle 10.
  • the outer tube 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 tube.
  • the insulating coating includes but Not limited to PTFE coating, titanium nitride coating, parylene coating, etc.
  • the metal material used to make the outer sleeve 30 should have sufficient hardness to penetrate human tissues, and at the same time, it must have excellent biocompatibility.
  • the insulating coating must have reliable insulation, excellent biocompatibility, and relatively Small friction coefficient, and requires close bonding 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, 321 stainless steel tube with titanium nitride coating, Or 631 stainless steel pipe with Parylene coating. Considering the insulation reliability and process feasibility, the thickness of various insulation coatings should be ⁇ 3 ⁇ m.
  • the outer casing 30 can also be made entirely of insulating materials, such as PEEK, PI, or PA, which can meet the hardness requirements of plastic tubes, such as high alumina porcelain, talc porcelain, or nitride Boron and other ceramic tubes.
  • the distal end of the outer sleeve 30 may be straight or a beveled tip.
  • the distal end of the outer cannula 30 is a tip, so that various positions of the outer cannula 30 can be easily inserted into the tissue, and the contact areas of the tissues surrounding the respective positions of the outer cannula 30 and the electrode needle body 11 are different, so that According to the anatomical structure of the tissue to be treated, a desired ablation region is determined, and orientation and positioning ablation are achieved by adjusting the insertion direction of the outer sleeve 30.
  • 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 distal end of the outer sleeve 30 has a first guide portion 34 capable of developing under a medical imaging device, and 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 can help a doctor determine whether the distal end of the outer cannula 30 is traveling along a desired puncture path and whether it is approaching a 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 a certain treatment on the distal end of the outer sleeve 30.
  • the surface of the tube body near the distal end of the outer sleeve 30 be processed into an uneven rough surface to form a first surface.
  • the guide portion 34 is adapted to the requirements of ultrasonic development.
  • the surface of the second tube body 30b of the outer sleeve 30 near the distal end may be subjected to a surface roughening treatment such as sandblasting or punching to form the first guide portion 34.
  • the surface roughness of the first guide portion 34 should not be too high, and while fulfilling the requirements of ultrasonic development, it will not affect the advancement of the outer sleeve 30 in the tissue.
  • the electrode needle main body 11 of the ablation needle 10 may be made of a biocompatible metal with excellent conductivity such as stainless steel. Since an outer sleeve 30 is provided that is at least partially insulated, the surface of the electrode needle body 11 of the ablation needle 10 does not need to be coated with an insulating material, which simplifies the manufacturing process of the electrode needle body 11 of the ablation needle 10, and the outer tube 30 can be an ablation needle.
  • the electrode needle body 11 of 10 provides support and protection, thereby allowing the diameter of the electrode needle body 11 to be reduced.
  • the diameter of the electrode needle body 11 can be selected from 20G to 16G, which helps to further reduce tissue damage, and
  • the structure of the tissue to be ablated such as the ventricular septum
  • the electrode needle body 11 of the ablation needle 10 is electrically connected to an energy generating device, wherein the energy generating device may be a microwave generator or a radio frequency generator.
  • the energy generating device may be a microwave generator or a radio frequency generator.
  • microwave energy or radio frequency energy is transmitted to the tissue by the electrode needle body 11 of the ablation needle 10 exposing the outer cannula 30 to perform ablation operation.
  • the distal end of the electrode needle main body 11 of the ablation needle 10 has a sharp triangular pyramid shape or a needle shape, which is advantageous for performing puncture after the electrode needle main body 11 of the ablation needle 10 is combined with the outer sleeve 30, of course, the electrodes of the needle 10 are ablated.
  • the distal end of the needle body 11 can also be set in other shapes, such as a spherical shape, an umbrella shape, and the like.
  • the part of the electrode needle main body 11 of the ablation needle 10 that contacts the tissue will transmit radio frequency energy or microwave energy to cause the tissue to generate high temperature, which causes the tissue to be coagulated and necrotic.
  • the electrode needle body 11 of the ablation needle 10 is provided with a cooling channel 16 which is used to transport gaseous or liquid cooling.
  • the medium (such as cooling water) cools the high-temperature part to control the temperature during the ablation operation.
  • the distal end of the electrode needle body 11 has a second guide portion 17 capable of developing under a medical imaging device.
  • the length of the second guide portion 17 needs to be ⁇ 5 mm. It can be developed under a medical imaging device to help a doctor determine whether the distal end of the electrode needle body 11 has reached or is at a predetermined ablation position.
  • the second guide portion 17 may be a part of a structure added to the distal end of the electrode needle main body 11, or may be obtained by performing a certain treatment on the distal end of the electrode needle main body 11.
  • the surface of the distal end of the electrode needle main body 11 is processed into an uneven rough surface to form a second guide portion 17 to meet the needs of ultrasonic development.
  • the surface of the distal end of the electrode needle main body 11 may be sandblasted or Punching and other processing.
  • the surface roughness of the second guide portion 17 should not be too high, and it will not affect the advancement of the electrode needle main body 11 in the tissue while fulfilling the requirements of ultrasonic development. Therefore, the ablation needle assembly of this embodiment is particularly suitable for ultrasound-guided ablation treatment. Under ultrasound guidance, an operator can insert the distal end of the ablation needle assembly into the patient through puncture, and the ablation needle 10 exposes the outer sheath. The portion of the tube 30 performs an ablation operation on the diseased tissue.
  • the ablation handle 12 includes a driving assembly 120 and a connecting member 121 rotatably connected to the driving assembly 120.
  • the proximal end of the outer sleeve 30 and the connecting member 121 Removable connection.
  • the outer casing 30 is connected to the driving assembly 120 through the connecting member 121, and the outer casing 30 is driven by the driving assembly 120 to oppose the electrode needle main body 11 along the extending direction of the electrode needle main body 11.
  • a proximal end of the outer sleeve 30 is provided with an external thread
  • a distal end of the connecting member 121 is provided with an internal thread adapted to the external thread of the outer sleeve 30.
  • the cooperation of the internal thread realizes the detachable connection of the outer casing 30 and the connecting member 121.
  • the outer tube 30 is provided with a holding portion 33 toward a distal side of the outer tube 30 to facilitate rotation with the ablation needle 10 or with the ablation needle. 10 Disassembly.
  • a plurality of protrusions are provided on the outer wall of the outer casing 30 to form the holding portion 33.
  • the driving assembly 120 includes a sliding member 122 and an adjusting member 123 connected to the sliding member 122 along the axial direction.
  • the connecting member 121 is coaxially disposed with the sliding member 122 and is rotatably connected, that is, the connecting member 121 can rotate relative to the sliding member 122 with its axis as an axis, so that the outer casing 30 connected to the connecting member 121 can be opposite to
  • the slider 122 rotates, and the electrode needle main body 11 is connected to the ablation handle 12, that is, the outer sleeve 30 can rotate relative to the electrode needle main body 11.
  • the position of the outer cannula 30 can be maintained, and only the ablation needle 10 or the biopsy needle 20 worn in the outer cannula 30 can be rotated, which can not only reduce the damage to the tissue. Friction or damage, and less resistance to rotation, easy to operate.
  • the distal end ring of the sliding member 122 is provided with a clamping groove 1221, and the proximal end of the connecting member 121 is provided with a retaining ring 1211 adapted to the retaining groove 1221, and the retaining ring 1211 is exactly stuck.
  • the connecting member 121 can rotate around the axial direction, but cannot move in the axial direction, so that the connecting member 121 and the sliding member 122 are rotationally connected.
  • the operator needs to rotate During the ablation handle 12 or / and the ablation needle 10, the operator can hold the connecting piece 121 with his hand to keep the outer sleeve 30 from rotating, and rotate the ablation handle 12 of the ablation needle 10 to drive the electrode through the ablation handle 12.
  • the needle body 11 rotates, thereby reducing the friction damage to the tissue when the outer sleeve 30 rotates, and the resistance to rotation is small.
  • the sliding member 122 is provided with a through hole penetrating in the axial direction, and the proximal end of the electrode needle body 11 of the ablation needle 10 passes through the through hole, thereby ensuring the coaxiality of the outer sleeve 30 and the ablation needle 10.
  • the proximal end of the electrode needle body 11 of the ablation needle 10 and the ablation handle 12 are fixedly connected by means of bonding, snapping, pinning and the like commonly used in the art.
  • the axial direction of the connecting member 121 and the sliding member 122 is the same as the extending direction of the electrode needle body 11 of the ablation needle, and the adjusting member 123 controls the sliding member 122 to move along the axial direction to drive the sliding member 122 along with the axial direction.
  • the outer sleeve 30 connected by the connecting member 121 is moved relative to the electrode needle main body 11 to adjust the length of the distal end of the electrode needle main body 11 protruding from the outer sleeve 30, so that it can be based on the anatomical structure of the diseased part and As needed for the actual ablation area, the length of the distal end of the electrode needle body 11 protruding from the outer sleeve 30 is adjusted.
  • the adjusting member 123 is disposed on the sliding member 122, and the extending direction is perpendicular to the extending direction of the sliding member 122.
  • the sliding member 122 is driven Move in the axial direction.
  • the distal end of the sliding member 122 is inserted into the proximal end of the outer casing 30, so that the sliding member 122 is coaxial with the outer casing 30.
  • the outer casing is driven. 30 moves in the axial direction.
  • the distal end of the sliding member 122 is tapered, and the inner wall of the proximal end of the outer sleeve 30 is set to a tapered shape corresponding to the sliding member 122, so that the distal end of the sliding member 122 is tapered.
  • the end can be easily inserted into the outer sleeve 30 and can achieve axial positioning, and can also facilitate the assembly of the clip 1211 and the clip groove 1221.
  • the ablation handle 12 of the ablation needle 10 includes a housing 124, and the driving assembly 120 is received in the housing 124.
  • the casing 124 includes a first casing and a second casing opposite to each other, and the two are fixedly connected together by means of snapping, bonding, etc., so as to facilitate the assembly of the driving assembly 120 to the casing 124.
  • a control slot 1222 is defined in the casing 124 along the axial direction of the sliding member 122.
  • the control groove 1222 may be directly opened on the first shell or the second shell, or a groove may be formed on each of the first shell and the second shell and then fastened together to form the control groove 1222.
  • An end of the adjusting member 123 facing away from the sliding member 122 protrudes from the housing 124 from the control slot 1222; by moving the position of the adjusting member 123 in the control slot 1222, the sliding member 122 is controlled along Its axial movement.
  • a scale mark 1225 is provided on one or both sides of the control slot 1222.
  • the scale corresponding to the adjusting member 123 is the largest, and the length of the ablation needle 10 exposed to the outer sleeve 30 is the longest, and the length is Lmax ;
  • the scale value corresponding to the adjusting member 123 is the smallest, and the length of the ablation needle 10 exposing the outer sleeve 30 is the shortest, and its length is Lmin.
  • the adjustable range of the effective ablation length of the ablation needle 10 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 ablation needle 10 is 5 mm to 35 mm.
  • the inner surface of the casing 124 is provided with a first guide (not shown in the figure) disposed along the axial direction of the sliding member 122.
  • the surface of the sliding member 122 is provided with The second guide 1223 cooperates with the first guide, and the sliding member 122 moves along the axial direction smoothly through the cooperation of the second guide 1223 and the first guide.
  • the first guide member may be a groove shown in FIG. 10, and the second guide member 1223 may be a convex rib provided on the sliding member 122 to fit the groove; the first guide member may also be provided It is a convex rib, and the second guide 1223 may be a groove provided on the sliding member 122 and adapted to the convex rib.
  • An elastic member 125 is further provided between the adjusting member 123 and the sliding member 122, and an extending direction of the elastic member 125 faces the control groove 1222.
  • the inner wall of the casing 124 is provided with a plurality of latching positions 1226 at positions corresponding to the scale marks 1225 on one or both sides of the control slot 1222.
  • the adjusting member 123 is provided with at least one protrusion 1231.
  • the elastic member 125 may be, but is not limited to, a spring, a spring sheet, or an elastic washer. In a natural state, the elastic member 125 pushes the protrusion 1231 of the adjusting member 123 and snaps into the locking position 1226 to realize the positioning of the adjusting member 123 and the sliding member 122.
  • the operator manually presses the adjusting member 123 downward, and the elasticity The piece 125 is compressed and contracted, and the protrusion 1231 of the adjustment piece 123 is separated from the latch 1226. At this time, the adjustment piece 123 can be pushed and pulled in the axial direction to drive the slider 122 and the outer sleeve 30 to move axially, thereby adjusting the ablation needle.
  • the adjustment member 123 reaches a certain scale position to obtain the desired effective ablation length
  • the operator releases the adjustment member 123
  • the elastic member 125 resets due to its own elasticity, and ejects
  • the protrusions 1231 of the adjusting member 123 are snapped into the corresponding locking positions 1226, so that the adjusting member 123 and the sliding member 122 can be positioned at this position and remain stationary.
  • the ablation needle assembly 100 further includes a biopsy needle 20.
  • the ablation needle 10 and the biopsy needle 20 are alternately worn on the outer sleeve.
  • the biopsy needle 20 can be detachably and rotationally connected with the outer sleeve 30.
  • the biopsy needle 20 includes a biopsy needle body 21 and a biopsy handle 22 connected to the proximal end of the biopsy needle body 21; after the ablation needle 10 is separated from the outer sleeve 30, the biopsy of the biopsy needle 20
  • the needle body 21 is inserted into the outer sleeve 30, and the outer sleeve 30 and the biopsy handle 22 of the biopsy needle 20 are detachably and rotatably connected.
  • the ablation needle 10 and the outer sleeve 30 can be detachably connected, and the biopsy needle 20 can also be detachably connected to the outer sleeve 30 to connect the ablation needle 10 and the outer sleeve 30.
  • the biopsy needle 20 can be connected to the outer sleeve 30. Therefore, after the ablation operation is completed, the connection between the ablation needle 10 and the outer cannula 30 is released, and the outer cannula 30 is left in the tissue, providing a channel for the biopsy operation, so that the biopsy needle 20 quickly reaches the desired biopsy position, avoiding repetition Puncture to reduce damage to the tissue; or, in some surgical procedures, after completing the biopsy operation, the biopsy needle 20 is disconnected from the outer sleeve 30, 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.
  • the outer sleeve 30 and the biopsy needle main body 21 of the biopsy needle 20 are detachably and rotatably connected, if the biopsy needle 20 needs to be rotated during a biopsy operation, the outer sleeve 30 can be held still. Therefore, the damage to the tissue is reduced, and the resistance to rotation is small.
  • the ablation needle assembly 100 further includes a puncture needle core 40, and the diameter of the puncture needle core 40 is larger than that of the ablation needle 10 or
  • the diameter of the biopsy needle 20 and the diameter of the puncture needle core 40 are preferably 19G to 16G.
  • the puncture needle core 40 is preferably made of a harder material, such as stainless steel.
  • the puncture needle core 40 and the ablation needle 10 or the biopsy needle 20 are alternately inserted into 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 Mentioned outer 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 can be fixed with a connector 41 having an internal thread, and the internal thread of the connector 41 and the proximal end of the outer sleeve 30 External threads fit.
  • the puncture needle 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 needle core 40 and the outer sleeve 30 is released, and the puncture needle core 40 is withdrawn.
  • the ablation needle 10 or the biopsy needle 20 is then inserted into the outer cannula 30.
  • the larger diameter and harder puncture needle core 40 can provide better support for the outer cannula 30, so the combination of the puncture needle core 40 and the outer cannula 30 is more convenient for puncture, and can prevent the direct use of the ablation needle 10 or the biopsy needle When the puncture is performed, 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 ablation system 200 further includes a medical imaging device 120 and / or a cold source supply device 130.
  • the energy generating device 110 is electrically connected to the ablation needle 10, and the energy generating device 110 may be, but is not limited to, a radio frequency generator or a microwave generator.
  • the cold source supply device 130 communicates with the cooling channel 16 through a cooling pipe 160 and provides a gaseous or liquid cooling medium into the cooling channel 16.
  • the medical imaging device 120 is used to display the distal positions of the outer cannula 30 and the ablation needle 10 in real time, and may be selected from at least one of ultrasound, CT, nuclear magnetic resonance, and X-ray fluoroscopy, and preferably ultrasound.
  • the ablation needle assembly 100 and the ablation system 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 describe the use process of the ablation needle assembly 100:
  • First step First, the ablation needle 10 is inserted into the outer sleeve 30, and the outer sleeve 30 is connected to the ablation handle 12 of the ablation needle 10 through the connecting member 121 to obtain the ablation needle assembly shown in FIG. 2.
  • the adjustment member 123 is actuated to drive the driving assembly 120 and the outer cannula 30 to move relative to the ablation needle 10 in the axial direction, and the outer cannula 30 serves as the insulating tube of the ablation needle 10 to obtain the desired length of the ablation needle 10 to expose the outer cannula 30. Effective ablation length.
  • Step 2 As shown in FIG. 16a, under the guidance of the ultrasound device, the outer cannula 30 and the ablation needle 10 are punctured through the apex of the ribs from the epicardium into the compartment wall.
  • the radio frequency generator is turned on and exposed by the ablation needle 10.
  • Part of the outer sleeve 30 performs radiofrequency ablation of the hypertrophic ventricular septal myocardium, destroying the activity of the ventricular septal myocardium at the corresponding site, shrinking and thinning the myocardial necrosis, thereby widening the left ventricular outflow tract and removing obstruction.
  • the application of the ablation needle assembly 10 to treat HCM not only avoids the risks and pain of surgical thoracotomy and extracorporeal circulation, but also does not have the risk of large-scale myocardial infarction caused by ineffective alcohol ablation or alcohol spillage. It is extremely small, the risk of surgery is small, and the effect is significant.
  • Step 3 As shown in FIG. 16b and FIG. 16c, when an ablation operation is needed and a biopsy operation is required, after performing the ablation, the outer tube 30 is disconnected from the connecting member 121, the ablation needle 10 is withdrawn and the outer sheath is left. The tube 30 is then passed through the biopsy needle 20 into the outer cannula 30 to extract a tissue sample for biopsy.
  • the outer cannula 30 provides a channel for biopsy operation, can avoid repeated puncture, reduces tissue damage, and enables the biopsy needle 20 to reach the desired biopsy position quickly.
  • the outer cannula 30 and the biopsy needle 20 are combined for puncture and biopsy, and then the biopsy needle 20 is withdrawn and the outer cannula 30 is left, and then the adjustment member 123 is actuated
  • the driving assembly 120 is reached and positioned at a desired scale position.
  • the ablation needle 10 is inserted into the outer sleeve 30, and the connection between the outer sleeve 30 and the connection member 121 is established by rotating the connecting member 121.
  • the ablation needle 10 is at a desired effective ablation length. Performing ablation can also avoid repeated puncture and reduce tissue damage.
  • the puncture needle core 40 and the outer sleeve 30 can be combined before the ablation or the biopsy.
  • the puncture needle core 40 is withdrawn, 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 cannula 30 for ablation or biopsy In order to increase the puncture intensity and prevent the ablation needle 10 or the biopsy needle 20 from being damaged during the puncture process.

Abstract

Provided are an ablation needle assembly (100) and an ablation system. The ablation needle assembly (100) comprises a hollow outer sleeve (30) and an ablation needle (10), wherein the outer sleeve (30) is movably sheathed outside an electrode needle main body (11) of the ablation needle (10) and is detachably and rotatably connected to an ablation handle (12), such that after an ablation operation is completed, the ablation needle (10) can be detached from the outer sleeve (30), and the outer sleeve (30) still remains in a tissue to provide a channel for other operations, such as a biopsy, thereby avoiding repeated puncturing, reducing damage to the tissue and achieving a more convenient and high-efficiency biopsy operation. Furthermore, the ablation handle (12) is rotatably connected to the outer sleeve (30), such that when rotating relative to the outer sleeve (30), the ablation handle (12) can drive the electrode needle main body (11) to rotate relative to the outer sleeve (30), i.e. the outer sleeve (30) and the electrode needle main body (11) are not of an integrated structure, and when the ablation needle (10) needs to be rotated, the outer sleeve (30) can remain static, thereby reducing damage to the tissue and having a relatively small rotation resistance. Therefore, the ablation needle assembly (100) and the ablation system are particularly applicable to radiofrequency ablation treatment of hypertrophic cardiomyopathy.

Description

消融针组件及消融***Ablation needle assembly and ablation system
相关申请的交叉引用Cross-reference to related applications
本发明要求于2018年8月24日提交至中国国家知识产权局、申请号为201810971599.1及201821371321.2、发明名称为“消融针组件及消融***”的中国专利申请的优先权，上述专利申请的全部内容以引入的方式并入本文本中。The present invention claims priority from Chinese patent applications filed on August 24, 2018 with the State Intellectual Property Office of China, with application numbers 201810971599.1 and 201821371321.2, and the invention name is "Ablation Needle Assembly and Ablation System". Incorporated into this text by way of introduction.
技术领域Technical field
本发明涉及医疗器械技术领域，尤其涉及一种消融针组件以及一种消融***。The invention relates to the technical field of medical instruments, and in particular to an ablation needle assembly and an ablation system.
背景技术Background technique
现有技术中，对于肝脏、肾脏、软组织等部位的肿瘤诊断，可以通过活检针穿刺至病变位置，并获取部分病变位置的少量组织，再进行病理学分析。对于这类病变部位的治疗，则可以通过射频消融针或者微波消融针***病灶，通过射频能量或微波能量导致病灶局部组织产生高温，使得病灶组织凝固性坏死而达到治疗目的。In the prior art, for tumor diagnosis of liver, kidney, soft tissue and other parts, a biopsy needle can be used to puncture the lesion, and a small amount of tissue at a part of the lesion can be obtained, and then pathological analysis can be performed. For the treatment of such lesions, radiofrequency or microwave ablation needles can be used to insert the lesion, and radiofrequency energy or microwave energy can cause high temperature in the local tissue of the lesion, so that the lesion tissue can be coagulated and necrotic.
肥厚型心肌病(Hypertrophic cardiomyopathy，简称：HCM)，是一种常见的常染色体显性遗传心血管疾病，在普通人群中的发病率约1：500，病死率约1.4％-2.2％。HCM自然病史差异大，部分患者无明显临床症状，但也可导致胸闷、胸痛、呼吸困难、反复晕厥、房颤、室速、心力衰竭等，是年轻人和运动员猝死的最常见原因。HCM的主要表现为左心室(Left Ventricle,LV)一个或多个节段肥厚，一般诊断标准为厚度大于等于15mm。当出现二尖瓣前叶收缩期前向运动(Systolic Anterior Motion,SAM)贴靠室间隔，造成左室流出道(Left Ventricular Outflow Tract,LVOT)狭窄甚至梗阻，即LVOT压差过大时，便称为梗阻性肥厚型心肌病(Hypertrophic Obstructive Cardiomyopathy,HOCM)，HOCM约占HCM患者的70％。2014年，欧洲心脏学会(European Society of Cardiology,ESC)公布的HCM诊断和管理指南(2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy)中指出，对HOCM的治疗策略是扩大LVOT以降低压差并减轻其梗阻，方法主要有药物治疗、室间隔旋切术(Surgical septalmyectomy)、室间隔酒精消融术(Alcohol Septal Ablation)。药物治疗相对来说简单易行，患者没有手术的痛苦，但部分患者药物治疗效果不佳或不耐受；室间隔旋切术，即改良Morrow术是通过外科手术开胸切除肥厚心肌，切除部位主要为室间隔前部并集中在左室面，切除后室间隔厚度可以降低50％，术后LVOT明显降低，但改良Morrow术存在一定的风险，而且患者的术后恢复也比较痛苦；室间隔酒精消融术是一种介入治疗手段， 其主要是应用经皮腔内冠状动脉成形术技术，将球囊送入拟消除的间隔支内，对间隔支缓慢注入酒精使其产生化学性闭塞，从而使肥厚室间隔心肌缺血、坏死、变薄、收缩力下降，降低LVOT，此种方法虽然避免了手术的痛苦，但在临床应用中，酒精通过支血管可能造成心肌梗死，仍然存在一定的风险。因此，针对HCM需要有一种创伤小且更加安全、有效的治疗方式。此外，为了获知肥厚心肌的病变程度以及HCM经消融治疗后的效果，在消融前和\或消融后进行活检是极其必要的。Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant genetic cardiovascular disease with an incidence of about 1: 500 in the general population and a mortality rate of about 1.4% -2.2%. The natural history of HCM varies widely, and some patients have no obvious clinical symptoms, but can also cause chest tightness, chest pain, dyspnea, repeated syncope, atrial fibrillation, ventricular tachycardia, heart failure, etc., which are the most common causes of sudden death in young people and athletes. The main manifestation of HCM is left ventricular (Left Ventricle, LV) hypertrophy in one or more segments, and the general diagnostic standard is 15 mm or more in thickness. When the systolic anterior motion (SAM) of the anterior mitral systole appears against the ventricular septum, the left ventricular outflow tract (LVOT) is narrowed or even obstructed, that is, when the LVOT pressure difference is too large, It is called obstructive hypertrophic cardiomyopathy (Hypertrophic Obstructive Cardiomyopathy, HOCM), HOCM accounts for about 70% of patients with HCM. In 2014, the European Society of Cardiology (ESC) published HCM diagnostic and management guidelines (2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy) pointed out that the treatment strategy for HOCM is to expand LVOT to reduce blood pressure and reduce pressure. The methods of obstruction include drug therapy, Surgical Septalmyectomy, and Alcohol Septal Ablation. Drug therapy is relatively simple and easy. Patients do not have the pain of surgery, but some patients have poor or intolerable drug therapy. Ventricular septal resection, which is a modified Morrow surgery, removes hypertrophic myocardium through surgical thoracotomy and removes the site. It is mainly the front of the ventricular septum and is concentrated on the left ventricle. The thickness of the ventricular septum can be reduced by 50% after resection, and the postoperative LVOT is significantly reduced, but the modified Morrow surgery has certain risks, and the patient's postoperative recovery is also painful; Alcohol ablation is an interventional method. It mainly uses percutaneous coronary angioplasty to send the balloon into the septum branch to be eliminated, and slowly injects alcohol into the septum branch to cause chemical occlusion. The 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 blood vessels, and there is still a certain risk. . Therefore, there is a need for a safer and more effective treatment for HCM. In addition, in order to know the extent of myocardial hypertrophy and the effect of HCM after ablation treatment, it is extremely necessary to perform a biopsy before and / or after ablation.
如前所述，射频消融针或微波消融针作为一种微创介入治疗器械，目前主要被应用于治疗肝脏、肾脏、软组织等部位的肿瘤，并且现有的消融针大多是一体式的，若消融前和\或消融后还需要进行活检等其它操作，则需要进行多次穿刺，穿刺难度大，加剧了对组织的损伤。另外，若需在消融操作过程中旋转消融针时，由于消融针***组织的部分直接被组织包覆，不仅不易旋转，亦会对组织造成损伤。As mentioned earlier, radiofrequency ablation needles or microwave ablation needles, as a minimally invasive interventional treatment device, are currently mainly used to treat tumors in the liver, kidney, soft tissue and other parts, and most of the existing ablation needles are integrated. Other operations such as biopsy are required before and / or after ablation, and multiple punctures are required, which is difficult to puncture and aggravates tissue damage. In addition, if the ablation needle needs to be rotated during the ablation operation, the part of the ablation needle inserted into the tissue is directly covered by the tissue, which is not only difficult to rotate, but also causes damage to the tissue.
发明内容Summary of the Invention
本发明提供一种对组织的损伤较小的消融针组件以及一种消融***，尤其适用于肥厚型心肌病的射频消融。The invention provides an ablation needle assembly with less damage to the tissue and an ablation system, and is particularly suitable for radiofrequency ablation of hypertrophic cardiomyopathy.
所述消融针组件包括中空的外套管以及活动穿装在所述外套管中的消融针；所述消融针包括电极针主体及与所述电极针主体近端连接的消融手柄；所述外套管至少部分绝缘；所述外套管近端与所述消融手柄之间可拆卸并旋转连接，所述电极针主体的远端伸出所述外套管；所述消融手柄相对所述外套管旋转以带动所述电极针主体相对所述外套管旋转。The ablation needle assembly includes a hollow outer sleeve and an ablation needle that is movably inserted in the outer sleeve; the ablation needle includes an electrode needle body and an ablation handle connected to the proximal end of the electrode needle body; the outer sleeve At least partially insulated; the proximal end of the outer sleeve and the ablation handle are detachably and rotatably connected, and the distal end of the electrode needle body extends out of the outer sleeve; the ablation handle rotates relative to the outer sleeve to drive The electrode needle body rotates relative to the outer sleeve.
其中，还包括活检针，所述活检针与所述消融针更替地穿装在所述外套管内。The method further includes a biopsy needle, and the biopsy needle and the ablation needle are alternately worn in the outer sleeve.
其中，所述消融手柄包括驱动组件及与所述驱动组件旋转连接的连接件，所述外套管与所述连接件之间可拆卸连接；所述驱动组件驱动所述外套管沿所述电极针主体的延伸方向相对所述电极针主体移动，以调节所述电极针主体的远端伸出所述外套管的长度。Wherein, the ablation handle includes a driving component and a connecting member rotatably connected with the driving component, and the outer casing is detachably connected with the connecting component; the driving component drives the outer casing along the electrode needle. The extension direction of the main body is moved relative to the electrode needle main body to adjust the length of the distal end of the electrode needle main body protruding from the outer sleeve.
其中，所述驱动组件包括滑动件及与所述滑动件连接的调节件，所述连接件与所述滑动件同轴设置并旋转连接，所述调节件控制所述滑动件沿其轴向移动，以带动与所述连接件连接的所述外套管相对所述电极针主体移动，以调节所述电极针主体的远端伸出所述外套管的长度。Wherein, the driving assembly includes a sliding member and an adjusting member connected to the sliding member. The connecting member is coaxially disposed with the sliding member and is rotationally connected. The adjusting member controls the sliding member to move in the axial direction thereof. To drive the outer sleeve connected to the connecting member to move relative to the electrode needle body, so as to adjust the length of the distal end of the electrode needle body protruding from the outer sleeve.
其中，所述消融手柄包括外壳，所述驱动组件收容于所述外壳内；所述外壳上沿所述滑动件的轴向开设有控制槽，所述调节件的一端从所述控制槽伸出所述外壳；通过移动所述调节件在所述控制槽的位置控制所述滑动件沿其轴向移动。Wherein, the ablation handle includes a housing, and the driving component is housed in the housing; a control groove is provided on the housing along the axial direction of the slider, and one end of the adjustment member protrudes from the control groove. The housing; controlling the sliding member to move along its axial direction by moving the adjusting member at the position of the control slot.
其中，所述控制槽的至少一侧设有刻度标识。A scale mark is provided on at least one side of the control slot.
其中，所述调节件与所述滑动件之间设有弹性件，所述弹性件的延伸方向 朝向所述控制槽；所述外壳的内壁设有与所述刻度标识相对应的多个卡位，所述调节件上设有至少一个凸起；所述弹性件自然伸长时，所述弹性件顶推所述凸起卡入所述卡位中。Wherein, an elastic member is provided between the adjusting member and the sliding member, and the extending direction of the elastic member faces the control slot; the inner wall of the housing is provided with a plurality of card positions corresponding to the scale mark. At least one protrusion is provided on the adjusting member; when the elastic member is naturally extended, the elastic member pushes the protrusion to snap into the locking position.
其中，所述外壳的内表面设有沿所述滑动件轴向设置的第一导向件，所述滑动件的表面设有与所述第一导向件适配的第二导向件，通过所述第二导向件与所述第一导向件的配合使得所述滑动件沿其轴向移动。The inner surface of the housing is provided with a first guide member disposed along the axial direction of the slider, and the surface of the slide member is provided with a second guide member adapted to the first guide member. The cooperation of the second guide with the first guide causes the slider to move along its axial direction.
其中，所述滑动件的远端环设有卡槽，所述连接件的近端设有卡圈，所述卡圈卡入所述卡槽内以使所述滑动件与所述连接件旋转连接。Wherein, the distal end ring of the sliding member is provided with a clamping slot, and the proximal end of the connecting member is provided with a clamping ring, and the clamping ring is inserted into the clamping slot to rotate the sliding member and the connecting member. connection.
其中，还包括穿刺针芯，所述穿刺针芯与所述消融针或所述活检针更替地穿装在所述外套管内并与所述外套管可拆卸连接，所述穿刺针芯的远端伸出所述外套管。Wherein, it also includes a puncture needle core, which is alternately inserted into the outer sleeve and the ablation needle or the biopsy needle and is detachably connected to the outer sleeve, and the distal end of the puncture core Extend the outer sleeve.
其中，所述外套管的外表面设有刻度标识。The outer surface of the outer sleeve is provided with a scale mark.
其中，所述外套管的远端具有第一引导部，所述第一引导部在医学影像装置下显影。The distal end of the outer sleeve has a first guide portion, and the first guide portion is developed under a medical imaging device.
其中，所述电极针主体的远端具有第二引导部，所述第二引导部在医学影像装置下显影。The distal end of the electrode needle body has a second guide portion, and the second guide portion is developed under a medical imaging device.
其中，所述电极针主体内设有冷却通道。Wherein, the electrode needle main body is provided with a cooling channel therein.
所述消融***包括所述消融针组件以及与所述消融针的电极针主体之间电性连接的能量发生装置。The ablation system includes the ablation needle assembly and an energy generating device electrically connected to an electrode needle body of the ablation needle.
其中，所述能量发生装置为射频发生器或微波发生器。Wherein, the energy generating device is a radio frequency generator or a microwave generator.
其中，所述消融***还包括与所述电极针主体的近端相连通的冷却装置。The ablation system further includes a cooling device in communication with the proximal end of the electrode needle body.
本发明的消融针组件及消融***与现有技术相比，至少具有以下有益效果：Compared with the prior art, the ablation needle assembly and the ablation system of the present invention have at least the following beneficial effects:
所述消融针组件包括所述外套管以及消融针，所述外套管活动套设于所述消融针的电极针主体外并与消融手柄可拆卸并旋转连接，即使得在完成消融操作后，能够将消融针与所述外套管拆开，将外套管仍然留在组织内，为其它操作如活检提供通道，避免了重复穿刺，减小了对组织的损伤，并能够使得活检操作更加的方便高效。进一步的，本发明中，所述消融手柄与外套管旋转连接，从而使得消融手柄相对外套管旋转时能够带动电极针主体相对外套管旋转，即外套管与电极针主体并非一体式结构，需要旋转消融针时，可以保持外套管不转，从而减小对组织的损伤，而且旋转的阻力较小。因此，本发明的消融针组件及消融***尤其适用于HCM的射频消融治疗。The ablation needle assembly includes the outer sleeve and an ablation needle, and the outer sleeve is movably sleeved outside the electrode needle body of the ablation needle and is detachably and rotationally connected with the ablation handle, that is, after the ablation operation is completed, Disassembling the ablation needle from the outer cannula, leaving the outer cannula in the tissue, providing channels for other operations such as biopsy, avoiding repeated puncture, reducing tissue damage, and making the biopsy operation more convenient and efficient . Further, in the present invention, the ablation handle is rotatably connected with the outer sleeve, so that when the ablation handle is rotated relative to the outer sleeve, the electrode needle body can be driven to rotate relative to the outer sleeve, that is, the outer sleeve and the electrode needle body are not an integrated structure and need to be rotated. When the ablation needle is used, the outer cannula can be kept from rotating, thereby reducing tissue damage and less resistance to rotation. Therefore, the ablation needle assembly and the ablation system of the present invention are particularly suitable for radiofrequency ablation treatment of HCM.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为更清楚地阐述本发明的构造特征和功效，下面结合附图与具体实施例来对其进行详细说明。In order to clarify the structural features and effects of the present invention more clearly, it will be described in detail below with reference to the accompanying drawings and specific embodiments.
图1是本发明实施例的消融针组件的结构示意图；1 is a schematic structural diagram of an ablation needle assembly according to an embodiment of the present invention;
图2是本发明实施例的消融针与外套管装配后的结构示意图；FIG. 2 is a schematic structural diagram of an ablation needle and an outer sleeve after assembly according to an embodiment of the present invention; FIG.
图3是图2所述消融针与外套管装配后的主视图；3 is a front view of the ablation needle and the outer cannula assembled in FIG. 2;
图4是本发明一实施例的外套管结构示意图；4 is a schematic structural diagram of an outer sleeve according to an embodiment of the present invention;
图5是本发明一实施例的外套管结构示意图；5 is a schematic structural diagram of an outer sleeve according to an embodiment of the present invention;
图6是本发明一实施例的电极针主体的远端的放大示意图；6 is an enlarged schematic view of a distal end of an electrode needle body according to an embodiment of the present invention;
图7是图6所述电极针主体A-A位置的截面示意图；7 is a schematic cross-sectional view of the electrode needle body A-A position shown in FIG. 6;
图8是本发明一实施例的电极针主体结构示意图；8 is a schematic structural diagram of an electrode needle main body according to an embodiment of the present invention;
图9是图2所示消融针与外套管装配后的截面示意图；9 is a schematic cross-sectional view of the ablation needle and the outer sleeve shown in FIG. 2 after assembly;
图10是所述消融针与外套管装配后调整所述消融针远端伸出外套管长度的过程示意图；10 is a schematic diagram of a process of adjusting the length of the distal end of the ablation needle protruding from the outer sleeve after the ablation needle is assembled with the outer sleeve;
图11是本发明实施例的所述消融针的驱动组件结构示意图；11 is a schematic structural diagram of a driving assembly of the ablation needle according to an embodiment of the present invention;
图12是本发明实施例的活检针与外套管的拆分示意图；12 is a schematic exploded view of a biopsy needle and an outer cannula according to an embodiment of the present invention;
图13是图12所示的活检针与外套管组合示意图；13 is a schematic diagram of a combination of the biopsy needle and the outer cannula shown in FIG. 12;
图14是本发明实施例的所述穿刺针芯与外套管的拆分示意图；14 is a schematic exploded view of the puncture needle core and the outer sleeve according to the embodiment of the present invention;
图15是图14所示穿刺针芯与外套管的组合示意图；15 is a schematic diagram of the combination of the puncture needle core and the outer sleeve shown in FIG. 14;
图16a至图16c是本发明一实施例的消融针组件的使用过程示意图；16a to 16c are schematic diagrams of a process of using an ablation needle assembly according to an embodiment of the present invention;
图17a至图17e是本发明另一实施例的消融针组件的使用过程示意图；17a to 17e are schematic diagrams of a process of using an ablation needle assembly according to another embodiment of the present invention;
图18是本发明实施例的消融***的结构示意图。FIG. 18 is a schematic structural diagram of an ablation system according to an embodiment of the present invention.
具体实施方式detailed description
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行描述。其中，附图仅用于示例性说明，表示的仅是示意图，不能理解为对本专利的限制。The technical solutions in the embodiments of the present invention will be described below with reference to the drawings in the embodiments of the present invention. Among them, the drawings are only for illustrative description, and are shown only as schematic diagrams, which should not be construed as limiting the patent.
为了更加清楚地描述消融针组件及消融***的结构，此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。In order to more clearly describe the structure of the ablation needle assembly and the ablation system, the terms "proximal" and "distal" are defined herein as common terms in the field of interventional medicine. Specifically, the "distal end" indicates the end far from the operator during the surgical operation, and the "proximal end" indicates the end near the operator during the surgical operation.
除非另有定义，本发明所使用的所有的技术和科学术语与本领域技术人员通常理解的含义相同。本发明在说明书中所使用的术语只是为了描述具体实施例的目的，不是旨在限制本发明。Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the present invention.
请一并参阅图1至图3，本发明提供一种消融针组件100，用于进行消融操作。所述消融针组件100包括外套管30以及消融针10。所述消融针10包括电极针主体11及与所述电极针主体11近端连接的消融手柄12。所述外套管30活动套设于所述电极针主体11外并与所述消融手柄12可拆卸并旋转连接。本发明中，所述外套管30至少部分绝缘。换句话说，所述外套管30可以全部绝缘或者部分绝缘。所述电极针主体11的远端伸出所述外套管30，当所述外套管30全部绝缘时，所述电极针主体11伸出所述外套管30的部分执行消融操作；当所述外套管30部分绝缘时，所述电极针主体11伸出所述外套管30的部分以及所述外套管30非绝缘的部分执行消融操作。具体的，所述电极针主体11电性连接射频发生器 时，电极针主体11传递高频电流使得电极针主体11远端周围的病变组织中带电荷的正负离子发生高速振荡运动，高速振荡的离子因摩擦产生大量的热量，使病变组织内温度升高，最终使得病变细胞内的蛋白质变性，细胞内外水分丧失，病变组织出现凝固性坏死，从而实现射频消融；所述电极针主体11电性连接微波发生器时，电极针主体11远端形成微波场，病变组织内的水分子等偶极分子在微波场的作用下因运动摩擦、剧烈碰撞而产热使得病变组织内温度升高，最终使得病变细胞内的蛋白质变性，细胞内外水分丧失，病变组织出现凝固性坏死，从而实现微波消融。并且，所述外套管30与所述消融手柄12可拆卸连接，从而使得在完成消融操作后，能够将消融针10与所述外套管30拆开，将外套管30仍然留在组织内，为其它操作提供通道，避免了重复穿刺，减小了对组织的损伤，并能够使得所述消融及其它操作更加的方便高效。进一步的，所述消融手柄12能够相对所述外套管30旋转以带动所述电极针主体11相对所述外套管30旋转，即所述外套管30与所述消融针10的电极针主体11并非一体式结构，需要旋转消融针10时，可以保持外套管30不转，从而减小对组织的损伤，而且旋转的阻力较小。Please refer to FIG. 1 to FIG. 3 together. The present invention provides an ablation needle assembly 100 for performing an ablation operation. The ablation needle assembly 100 includes an outer cannula 30 and an ablation needle 10. The ablation needle 10 includes an electrode needle body 11 and an ablation handle 12 connected to a proximal end of the electrode needle body 11. The outer sleeve 30 is movably sleeved outside the electrode needle main body 11 and is detachably and rotationally connected with the ablation handle 12. In the present invention, the outer casing 30 is at least partially insulated. In other words, the outer casing 30 may be fully insulated or partially insulated. The distal end of the electrode needle body 11 protrudes from the outer casing 30. When the outer casing 30 is fully insulated, the part of the electrode needle main body 11 protruding from the outer casing 30 performs an ablation operation; when the outer casing When the tube 30 is partially insulated, an ablation operation is performed on a portion of the electrode needle body 11 protruding from the outer tube 30 and a non-insulated portion of the outer tube 30. Specifically, when the electrode needle main body 11 is electrically connected to a radio frequency generator, the electrode needle main body 11 transmits a high-frequency current so that charged positive and negative ions in the diseased tissue around the distal end of the electrode needle main body 11 undergo high-speed oscillating motion. The ions generate a large amount of heat due to friction, which causes the temperature in the diseased tissue to rise, eventually denature protein in the diseased cells, loss of water inside and outside the cell, and coagulation necrosis of 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 main body 11. The dipole molecules such as water molecules in the diseased tissue are heated by friction and severe collision under the action of the microwave field, which causes 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 the coagulated necrosis of the diseased tissue occurs, thereby achieving microwave ablation. In addition, the outer sleeve 30 and the ablation handle 12 are detachably connected, so that after the ablation operation is completed, the ablation needle 10 can be detached from the outer sleeve 30, and the outer sleeve 30 remains in the tissue. Other operations provide channels to avoid repeated puncture, reduce tissue damage, and make the ablation and other operations more convenient and efficient. Further, the ablation handle 12 can be rotated relative to the outer sleeve 30 to drive the electrode needle body 11 to rotate relative to the outer sleeve 30, that is, the outer sleeve 30 and the electrode needle body 11 of the ablation needle 10 are not With the integrated structure, when the ablation needle 10 needs to be rotated, the outer cannula 30 can be kept from rotating, thereby reducing tissue damage, and the resistance to rotation is small.
所述外套管30至少部分绝缘，优选的，所述外套管30全部绝缘。如图4所示，所述外套管30至少部分绝缘是指所述外套管30靠近近端的第一管体30a为绝缘结构，所述外套管30的靠近远端的第二管体30b可以为非绝缘结构，从而所述外套管30的非绝缘的部分也可以传递高频电流或微波，增大消融区域。所述外套管30可以至少部分为绝缘材料制成，或者所述外套管30可以全部由非绝缘材料制成，然后在所述外套管30的外表面至少部分覆盖绝缘涂层，在执行消融操作时，所述外套管30覆盖绝缘层的部分作为消融针10的绝缘管。为了提高外套管30的支撑性，且便于刺入人体组织。优选地，所述外套管30由金属材料制成，管体的外表面涂覆绝缘涂层，所述金属材料包括但不限于304不锈钢、321不锈钢或631不锈钢管，所述绝缘涂层包括但不限于PTFE涂层、氮化钛涂层、派瑞林涂层等。制作所述外套管30的金属材料应具备足够的硬度以刺入人体组织，同时需要具有优良的生物相容性，所述绝缘涂层需具有可靠的绝缘性、优良的生物相容性及较小的摩擦系数，并且要求绝缘涂层与外套管30的管体外表面之间紧密结合，绝缘涂层不易脱落，例如可以选择304不锈钢管加PTFE涂层、321不锈钢管加氮化钛涂层、或631不锈钢管加派瑞林涂层等。考虑到绝缘可靠性及工艺可行性，各种绝缘涂层的厚度均应≥3μm。可以理解的是，在其他实施例中，所述外套管30也可以完全由绝缘材料制作，比如PEEK、PI或者PA等能够满足硬度要求的塑料管，再比如高铝瓷、滑石瓷或氮化硼等陶瓷管。The outer sleeve 30 is at least partially insulated. Preferably, the outer sleeve 30 is entirely insulated. As shown in FIG. 4, the outer tube 30 is at least partially insulated, which means that the first tube body 30 a near the proximal end of the outer tube 30 is an insulating structure, and the second tube body 30 b near the distal end of the outer tube 30 may be It is a non-insulating structure, so that the non-insulating part of the outer sleeve 30 can also transmit high-frequency current or microwaves to increase the ablation area. The outer sleeve 30 may be made at least partially of an insulating material, or the outer sleeve 30 may be made entirely of a non-insulating material, and then the outer surface of the outer sleeve 30 is at least partially covered with an insulating coating, and an ablation operation is performed. At this time, a part of the outer tube 30 covering the insulating layer serves as an insulating tube of the ablation needle 10. In order to improve the supportability of the outer sleeve 30 and facilitate penetration into human tissues. Preferably, the outer tube 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 tube. The insulating coating includes but Not limited to PTFE coating, titanium nitride coating, parylene coating, etc. The metal material used to make the outer sleeve 30 should have sufficient hardness to penetrate human tissues, and at the same time, it must have excellent biocompatibility. The insulating coating must have reliable insulation, excellent biocompatibility, and relatively Small friction coefficient, and requires close bonding 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, 321 stainless steel tube with titanium nitride coating, Or 631 stainless steel pipe with Parylene coating. Considering the insulation reliability and process feasibility, the thickness of various insulation coatings should be ≥3μm. It can be understood that, in other embodiments, the outer casing 30 can also be made entirely of insulating materials, such as PEEK, PI, or PA, which can meet the hardness requirements of plastic tubes, such as high alumina porcelain, talc porcelain, or nitride Boron and other ceramic tubes.
外套管30的远端可以是平直的，也可以是斜切的尖端。优选的，外套管30的远端为尖端，使得外套管30的各个位置能够较容易地***组织内，并使得围绕所述外套管30各个位置的组织与电极针主体11的接触面积不同，从而根据待治疗组织的解剖结构，确定需要的消融区域，并通过调整所述外套管30的***方向实现定向、定位消融。The distal end of the outer sleeve 30 may be straight or a beveled tip. Preferably, the distal end of the outer cannula 30 is a tip, so that various positions of the outer cannula 30 can be easily inserted into the tissue, and the contact areas of the tissues surrounding the respective positions of the outer cannula 30 and the electrode needle body 11 are different, so that According to the anatomical structure of the tissue to be treated, a desired ablation region is determined, and orientation and positioning ablation are achieved by adjusting the insertion direction of the outer sleeve 30.
进一步的，外套管30上设有刻度标识31以指示外套管30***组织的深度，所述刻度标识31包括一系列刻度值，且刻度值自远端向近端逐渐增大。当外套管30***组织内时，通过观察外套管30上的刻度值能够获知外套管30***组织的深度，从而获知所述外套管30***组织中的大致位置。进一步地，如图5所示，所述外套管30远端具有能够在医学影像装置下显影的第一引导部34，该第一引导部34的长度需≥5mm，以保证位置引导的准确性，第一引导部34可帮助医生判断外套管30远端是否沿着期望的穿刺路径行进及是否接近预定的消融位置。具体的，所述第一引导部34可以为在所述外套管30远端增加的一部分结构，或者将所述外套管30的远端进行一定处理得到。由于超声显影相较其他显影模式(如X光透视)对人体的损害较小，也比较经济，优选将所述外套管30靠近远端的管体表面处理成凹凸不平的粗糙面以形成第一引导部34，适应超声显影的需求。比如可以对外套管30靠近远端的第二管体30b的表面做喷砂或打孔等表面粗糙化处理形成第一引导部34。并且，本发明中，所述第一引导部34的表面粗糙度不应过高，在实现超声显影需求的同时，并不会影响所述外套管30在组织中的推进。Further, 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. When the outer cannula 30 is inserted into the tissue, the depth of the outer cannula 30 inserted into the tissue can be known by observing the scale value on the outer cannula 30, so as to know the approximate position of the outer cannula 30 inserted into the tissue. Further, as shown in FIG. 5, the distal end of the outer sleeve 30 has a first guide portion 34 capable of developing under a medical imaging device, and 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 can help a doctor determine whether the distal end of the outer cannula 30 is traveling along a desired puncture path and whether it is approaching a predetermined ablation position. Specifically, 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 a certain treatment on the distal end of the outer sleeve 30. Because ultrasonic imaging has less damage to the human body and is more economical than other development modes (such as X-ray fluoroscopy), it is preferred that the surface of the tube body near the distal end of the outer sleeve 30 be processed into an uneven rough surface to form a first surface. The guide portion 34 is adapted to the requirements of ultrasonic development. For example, the surface of the second tube body 30b of the outer sleeve 30 near the distal end may be subjected to a surface roughening treatment such as sandblasting or punching to form the first guide portion 34. Moreover, in the present invention, the surface roughness of the first guide portion 34 should not be too high, and while fulfilling the requirements of ultrasonic development, it will not affect the advancement of the outer sleeve 30 in the tissue.
所述消融针10的电极针主体11可选用不锈钢等具有优良导电性能的生物相容性金属来制作。由于设置了至少部分绝缘的外套管30，该消融针10的电极针主体11表面不必再涂覆绝缘材料，简化了消融针10的电极针主体11的制作工艺，且外套管30可以为消融针10的电极针主体11提供支撑与保护，从而允许减小电极针主体11的直径，例如所述电极针主体11的直径可选择20G～16G，一方面有助于进一步减小组织损伤，另一方面若待消融组织如室间隔的结构较为扁平，电极针主体11的直径越小，越适于对扁平的组织进行消融，并且在消融室间隔内的肥厚心肌时能够防止气胸、心包积液等问题的发生，减少出血。由此，本实施例的消融针组件尤其适用于HCM的消融治疗术。The electrode needle main body 11 of the ablation needle 10 may be made of a biocompatible metal with excellent conductivity such as stainless steel. Since an outer sleeve 30 is provided that is at least partially insulated, the surface of the electrode needle body 11 of the ablation needle 10 does not need to be coated with an insulating material, which simplifies the manufacturing process of the electrode needle body 11 of the ablation needle 10, and the outer tube 30 can be an ablation needle. The electrode needle body 11 of 10 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 helps to further reduce tissue damage, and On the other hand, if the structure of the tissue to be ablated, such as the ventricular septum, is relatively flat, the smaller the diameter of the electrode needle body 11 is, the more suitable it is to ablate the flat tissue, and it can prevent pneumothorax and pericardial effusion when ablating the thick myocardium in the ventricular septum Problems occur and reduce bleeding. Therefore, the ablation needle assembly of this embodiment is particularly suitable for the ablation therapy of HCM.
所述消融针10的电极针主体11电性连接能量发生装置，其中，所述能量发生装置可以为微波发生器或者射频发生器。在外套管30全部绝缘的情况下，通过消融针10的电极针主体11露出外套管30的部分对组织传递出微波能量或者射频能量，以进行消融操作。优选地，所述消融针10的电极针主体11的远端呈尖锐的三棱锥状或针状，利于消融针10的电极针主体11与外套管30组合后实施穿刺，当然消融针10的电极针主体11的远端也可以设置成其他形状，比如球状、伞状等。The electrode needle body 11 of the ablation needle 10 is electrically connected to an energy generating device, wherein the energy generating device may be a microwave generator or a radio frequency generator. In the case where the outer cannula 30 is completely insulated, microwave energy or radio frequency energy is transmitted to the tissue by the electrode needle body 11 of the ablation needle 10 exposing the outer cannula 30 to perform ablation operation. Preferably, the distal end of the electrode needle main body 11 of the ablation needle 10 has a sharp triangular pyramid shape or a needle shape, which is advantageous for performing puncture after the electrode needle main body 11 of the ablation needle 10 is combined with the outer sleeve 30, of course, the electrodes of the needle 10 are ablated. The distal end of the needle body 11 can also be set in other shapes, such as a spherical shape, an umbrella shape, and the like.
进一步的，请一并参阅图1至图3及图6至图7，消融针10的电极针主体11接触组织的部分会传递射频能量或微波能量导致组织产生高温，使得组织凝固性坏死而达到治疗目的，但局部温度过高会影响不需要进行消融操作的正常组织，因此所述消融针10的电极针主体11内设有冷却通道16，所述冷却通道16用于输送气态或液态的冷却介质(如冷却水)对高温部位进行降温，以控制消融操作时的温度。Further, please refer to FIG. 1 to FIG. 3 and FIG. 6 to FIG. 7 together. The part of the electrode needle main body 11 of the ablation needle 10 that contacts the tissue will transmit radio frequency energy or microwave energy to cause the tissue to generate high temperature, which causes the tissue to be coagulated and necrotic. For the purpose of treatment, but the local temperature is too high, it will affect the normal tissues that do not need to perform the ablation operation. Therefore, the electrode needle body 11 of the ablation needle 10 is provided with a cooling channel 16 which is used to transport gaseous or liquid cooling. The medium (such as cooling water) cools the high-temperature part to control the temperature during the ablation operation.
进一步地，如图8所示，所述电极针主体11的远端具有能够在医学影像装 置下显影的第二引导部17，该第二引导部17的长度需≥5mm，第二引导部17能够在医学影像装置下显影，帮助医生判断电极针主体11远端是否到达或处于预定的消融位置。具体的，所述第二引导部17可以为在所述电极针主体11的远端增加的一部分结构，或者将所述电极针主体11的远端进行一定处理得到。优选的，将所述电极针主体11远端的表面处理成凹凸不平的粗糙面以形成第二引导部17，适应超声显影的需求，比如可以对电极针主体11远端的表面做喷砂或打孔等处理。并且，本发明中，所述第二引导部17的表面粗糙度不应过高，在实现超声显影需求的同时，并不会影响所述电极针主体11在组织中的推进。由此，本实施例的消融针组件尤其适用于超声引导下的消融术治疗，操作者可在超声引导下，经穿刺，将消融针组件的远端送入患者体内，由消融针10露出外套管30的部分对病变组织进行消融操作。Further, as shown in FIG. 8, the distal end of the electrode needle body 11 has a second guide portion 17 capable of developing under a medical imaging device. The length of the second guide portion 17 needs to be ≧ 5 mm. It can be developed under a medical imaging device to help a doctor determine whether the distal end of the electrode needle body 11 has reached or is at a predetermined ablation position. Specifically, the second guide portion 17 may be a part of a structure added to the distal end of the electrode needle main body 11, or may be obtained by performing a certain treatment on the distal end of the electrode needle main body 11. Preferably, the surface of the distal end of the electrode needle main body 11 is processed into an uneven rough surface to form a second guide portion 17 to meet the needs of ultrasonic development. For example, the surface of the distal end of the electrode needle main body 11 may be sandblasted or Punching and other processing. In addition, in the present invention, the surface roughness of the second guide portion 17 should not be too high, and it will not affect the advancement of the electrode needle main body 11 in the tissue while fulfilling the requirements of ultrasonic development. Therefore, the ablation needle assembly of this embodiment is particularly suitable for ultrasound-guided ablation treatment. Under ultrasound guidance, an operator can insert the distal end of the ablation needle assembly into the patient through puncture, and the ablation needle 10 exposes the outer sheath. The portion of the tube 30 performs an ablation operation on the diseased tissue.
请同时参阅图2、图9与图11，所述消融手柄12包括驱动组件120及与所述驱动组件120旋转连接的连接件121，所述外套管30近端与所述连接件121之间可拆卸连接。换句话说，所述外套管30通过所述连接件121与驱动组件120连接，通过所述驱动组件120驱动所述外套管30沿所述电极针主体11的延伸方向相对所述电极针主体11移动，以根据实际的消融范围需求调节所述消融针10的电极针主体11的远端伸出所述外套管30的长度。本实施例中，外套管30的近端设有外螺纹，所述连接件121的远端设有与所述外套管30的外螺纹相适配的内螺纹，通过所述外螺纹与所述内螺纹的配合实现外套管30与连接件121的可拆卸连接。进一步的，本发明一些实施例中，所述外套管30设有外螺纹的位置朝向其远端一侧设有握持部33，以便于相对所述消融针10进行旋转或者与所述消融针10的拆装。本实施例中，在所述外套管30的外壁设置多圈凸起，以形成所述握持部33。Please refer to FIG. 2, FIG. 9 and FIG. 11 at the same time. The ablation handle 12 includes a driving assembly 120 and a connecting member 121 rotatably connected to the driving assembly 120. The proximal end of the outer sleeve 30 and the connecting member 121 Removable connection. In other words, the outer casing 30 is connected to the driving assembly 120 through the connecting member 121, and the outer casing 30 is driven by the driving assembly 120 to oppose the electrode needle main body 11 along the extending direction of the electrode needle main body 11. Move to adjust the length of the distal end of the electrode needle body 11 of the ablation needle 10 protruding from the outer sleeve 30 according to the actual ablation range requirement. In this embodiment, a proximal end of the outer sleeve 30 is provided with an external thread, and a distal end of the connecting member 121 is provided with an internal thread adapted to the external thread of the outer sleeve 30. The cooperation of the internal thread realizes the detachable connection of the outer casing 30 and the connecting member 121. Further, in some embodiments of the present invention, the outer tube 30 is provided with a holding portion 33 toward a distal side of the outer tube 30 to facilitate rotation with the ablation needle 10 or with the ablation needle. 10 Disassembly. In this embodiment, a plurality of protrusions are provided on the outer wall of the outer casing 30 to form the holding portion 33.
请参阅图9，所述驱动组件120包括沿轴向设置的滑动件122及与所述滑动件122连接的调节件123。所述连接件121与所述滑动件122同轴设置并旋转连接，即使得连接件121能够相对滑动件122以其轴线为轴心进行旋转，从而使得与连接件121连接的外套管30能够相对滑动件122进行旋转，而电极针主体11与消融手柄12进行连接，即使得所述外套管30能够相对电极针主体11进行旋转。由此，当需要旋转调整消融针10或者活检针20时，可以保持外套管30位置不变，仅旋转穿装在外套管30中的消融针10或者活检针20，不仅可以减小对组织的摩擦或损伤，而且旋转的阻力较小，易于操作。本实施例中，所述滑动件122的远端环设有卡槽1221，所述连接件121的近端设有与所述卡槽1221适配的卡圈1211，所述卡圈1211恰好卡入所述卡槽1221内，从而连接件121能够绕轴向旋转，但不能沿轴向移动，实现所述连接件121与所述滑动件122旋转连接。并且，当在消融过程中，需要理顺消融手柄12外部的导线与冷却管路，防止导线与冷却管路过度弯折、扭转缠绕，并方便查看消融手柄12上的刻度值，操作者需要旋转消融手柄12或/和消融针10时，操作者可以用手握住连接件121保持外套管30不转，转动所述消融针10的消 融手柄12，以通过所述消融手柄12带动所述电极针主体11旋转，从而减小外套管30旋转时对组织的摩擦损伤，而且旋转的阻力较小。Referring to FIG. 9, the driving assembly 120 includes a sliding member 122 and an adjusting member 123 connected to the sliding member 122 along the axial direction. The connecting member 121 is coaxially disposed with the sliding member 122 and is rotatably connected, that is, the connecting member 121 can rotate relative to the sliding member 122 with its axis as an axis, so that the outer casing 30 connected to the connecting member 121 can be opposite to The slider 122 rotates, and the electrode needle main body 11 is connected to the ablation handle 12, that is, the outer sleeve 30 can rotate relative to the electrode needle main body 11. Therefore, when the ablation needle 10 or the biopsy needle 20 needs to be rotated and adjusted, the position of the outer cannula 30 can be maintained, and only the ablation needle 10 or the biopsy needle 20 worn in the outer cannula 30 can be rotated, which can not only reduce the damage to the tissue. Friction or damage, and less resistance to rotation, easy to operate. In this embodiment, the distal end ring of the sliding member 122 is provided with a clamping groove 1221, and the proximal end of the connecting member 121 is provided with a retaining ring 1211 adapted to the retaining groove 1221, and the retaining ring 1211 is exactly stuck. Into the slot 1221, so that the connecting member 121 can rotate around the axial direction, but cannot move in the axial direction, so that the connecting member 121 and the sliding member 122 are rotationally connected. In addition, during the ablation process, it is necessary to straighten out the wires and cooling pipes outside the ablation handle 12 to prevent the wires and cooling pipes from being excessively bent and twisted, and to conveniently view the scale value on the ablation handle 12, the operator needs to rotate During the ablation handle 12 or / and the ablation needle 10, the operator can hold the connecting piece 121 with his hand to keep the outer sleeve 30 from rotating, and rotate the ablation handle 12 of the ablation needle 10 to drive the electrode through the ablation handle 12. The needle body 11 rotates, thereby reducing the friction damage to the tissue when the outer sleeve 30 rotates, and the resistance to rotation is small.
所述滑动件122中设有沿轴向贯穿的通孔，所述消融针10的电极针主体11近端穿过所述通孔，保证了外套管30与消融针10的同轴。所述消融针10的电极针主体11近端与消融手柄12之间通过本领域常见的粘结、卡接、销接等方式进行固定连接。The sliding member 122 is provided with a through hole penetrating in the axial direction, and the proximal end of the electrode needle body 11 of the ablation needle 10 passes through the through hole, thereby ensuring the coaxiality of the outer sleeve 30 and the ablation needle 10. The proximal end of the electrode needle body 11 of the ablation needle 10 and the ablation handle 12 are fixedly connected by means of bonding, snapping, pinning and the like commonly used in the art.
所述连接件121与所述滑动件122的轴向与所述消融针的电极针主体11的延伸方向相同，所述调节件123控制所述滑动件122沿其轴向移动，以带动与所述连接件121连接的所述外套管30相对所述电极针主体11移动，以调节所述电极针主体11的远端伸出所述外套管30的长度，从而能够根据病变部位的解剖结构及实际的消融面积的需要，调整电极针主体11的远端伸出外套管30的长度。本实施例中，所述调节件123设于滑动件122上，且延伸方向与所述滑动件122的延伸方向垂直，通过推动所述调节件123沿轴向移动，以带动所述滑动件122沿轴向移动。所述滑动件122的远端***所述外套管30的近端内，使得所述滑动件122与所述外套管30同轴，沿轴向移动所述滑动件122时，带动所述外套管30沿轴向移动。本实施例中，所述滑动件122的远端为锥形，所述外套管30的近端的内壁设为与所述滑动件122相对应的锥形，从而使得所述滑动件122的远端能够容易地***外套管30内并能实现轴向定位，还能够方便卡圈1211与卡槽1221的装配。The axial direction of the connecting member 121 and the sliding member 122 is the same as the extending direction of the electrode needle body 11 of the ablation needle, and the adjusting member 123 controls the sliding member 122 to move along the axial direction to drive the sliding member 122 along with the axial direction. The outer sleeve 30 connected by the connecting member 121 is moved relative to the electrode needle main body 11 to adjust the length of the distal end of the electrode needle main body 11 protruding from the outer sleeve 30, so that it can be based on the anatomical structure of the diseased part and As needed for the actual ablation area, the length of the distal end of the electrode needle body 11 protruding from the outer sleeve 30 is adjusted. In this embodiment, the adjusting member 123 is disposed on the sliding member 122, and the extending direction is perpendicular to the extending direction of the sliding member 122. By pushing the adjusting member 123 to move in the axial direction, the sliding member 122 is driven Move in the axial direction. The distal end of the sliding member 122 is inserted into the proximal end of the outer casing 30, so that the sliding member 122 is coaxial with the outer casing 30. When the sliding member 122 is moved in the axial direction, the outer casing is driven. 30 moves in the axial direction. In this embodiment, the distal end of the sliding member 122 is tapered, and the inner wall of the proximal end of the outer sleeve 30 is set to a tapered shape corresponding to the sliding member 122, so that the distal end of the sliding member 122 is tapered. The end can be easily inserted into the outer sleeve 30 and can achieve axial positioning, and can also facilitate the assembly of the clip 1211 and the clip groove 1221.
所述消融针10的消融手柄12包括外壳124，所述驱动组件120收容于所述外壳124内。本实施例中，所述外壳124包括相对设置的第一外壳和第二外壳，二者之间通过卡扣、粘结等方式固定连接在一起，从而方便将所述驱动组件120装配于外壳124中。所述外壳124上沿所述滑动件122的轴向开设有控制槽1222。控制槽1222可以直接在第一外壳或第二外壳上开设，也可以在第一外壳和第二外壳上各开一个槽然后扣合在一起形成控制槽1222。所述调节件123背离所述滑动件122的一端从所述控制槽1222伸出所述外壳124；通过移动所述调节件123在所述控制槽1222的位置，以控制所述滑动件122沿其轴向的移动。The ablation handle 12 of the ablation needle 10 includes a housing 124, and the driving assembly 120 is received in the housing 124. In this embodiment, the casing 124 includes a first casing and a second casing opposite to each other, and the two are fixedly connected together by means of snapping, bonding, etc., so as to facilitate the assembly of the driving assembly 120 to the casing 124. in. A control slot 1222 is defined in the casing 124 along the axial direction of the sliding member 122. The control groove 1222 may be directly opened on the first shell or the second shell, or a groove may be formed on each of the first shell and the second shell and then fastened together to form the control groove 1222. An end of the adjusting member 123 facing away from the sliding member 122 protrudes from the housing 124 from the control slot 1222; by moving the position of the adjusting member 123 in the control slot 1222, the sliding member 122 is controlled along Its axial movement.
进一步地，所述控制槽1222一侧或两侧设置有刻度标识1225。作动调节件123至控制槽1222的某一位置后观测调节件123所对应的刻度值能够获知所述消融针10露出所述外套管30的长度，在外套管30全部绝缘的情况下，消融针10露出所述外套管30的长度即消融针10能够执行消融的有效消融长度。如图10所示，作动调节件123使其处于控制槽1222最近端时，调节件123对应的刻度值最大，所述消融针10露出所述外套管30的长度最长，其长度为Lmax；作动调节件123使其处于控制槽1222最远端时，调节件123对应的刻度值最小，所述消融针10露出所述外套管30的长度最短，其长度为Lmin。根据不同组织的解剖结构差异，消融针10的有效消融长度的可调范围也是不同的，例如，在应用于HCM的消融治疗时，消融针10的有效消融长度的可 调范围为5mm～35mm。Further, a scale mark 1225 is provided on one or both sides of the control slot 1222. After operating the adjusting member 123 to a certain position of the control groove 1222 and observing the scale value corresponding to the adjusting member 123, it is possible to know the length of the ablation needle 10 exposing the outer casing 30. When the outer casing 30 is fully insulated, ablation The length of the needle 10 exposed to the outer cannula 30 is the effective ablation length at which the ablation needle 10 can perform ablation. As shown in FIG. 10, when the adjusting member 123 is actuated to the closest end of the control groove 1222, the scale corresponding to the adjusting member 123 is the largest, and the length of the ablation needle 10 exposed to the outer sleeve 30 is the longest, and the length is Lmax ; When the adjusting member 123 is actuated so that it is at the farthest end of the control groove 1222, the scale value corresponding to the adjusting member 123 is the smallest, and the length of the ablation needle 10 exposing the outer sleeve 30 is the shortest, and its length is Lmin. The adjustable range of the effective ablation length of the ablation needle 10 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 ablation needle 10 is 5 mm to 35 mm.
请一并参阅图9至图11，所述外壳124的内表面设有沿所述滑动件122轴向设置的第一导向件(图中未示出)，所述滑动件122的表面设有与所述第一导向件相配合的第二导向件1223，通过所述第二导向件1223与所述第一导向件的配合以使所述滑动件122顺畅地沿其轴向移动。具体地，第一导向件可以是图10中所示的凹槽，第二导向件1223可以为设置于滑动件122上与所述凹槽适配的凸肋；也可以将第一导向件设置成凸肋，而第二导向件1223可以为设置于滑动件122上与凸肋适配的凹槽。Please refer to FIG. 9 to FIG. 11 together. The inner surface of the casing 124 is provided with a first guide (not shown in the figure) disposed along the axial direction of the sliding member 122. The surface of the sliding member 122 is provided with The second guide 1223 cooperates with the first guide, and the sliding member 122 moves along the axial direction smoothly through the cooperation of the second guide 1223 and the first guide. Specifically, the first guide member may be a groove shown in FIG. 10, and the second guide member 1223 may be a convex rib provided on the sliding member 122 to fit the groove; the first guide member may also be provided It is a convex rib, and the second guide 1223 may be a groove provided on the sliding member 122 and adapted to the convex rib.
所述调节件123与所述滑动件122之间还设有弹性件125，所述弹性件125的延伸方向朝向所述控制槽1222。所述外壳124的内壁与所述控制槽1222一侧或两侧的刻度标识1225相对应的位置设有多个卡位1226。所述调节件123上设有至少一个凸起1231。所述弹性件125可以但不限于为弹簧、弹片或弹性垫圈等。自然状态下，弹性件125推顶所述调节件123的凸起1231卡入所述卡位1226中实现调节件123及滑动件122的定位，操作者手动向下按压调节件123，所述弹性件125受压收缩，调节件123的凸起1231从卡位1226中分离解脱出来，此时沿轴向推拉调节件123便可以带动滑动件122及外套管30沿轴向移动，从而调节消融针10露出外套管30的长度，即有效消融长度；当调节件123到达某一刻度位置获得期望的有效消融长度后，操作者松开调节件123，所述弹性件125由于自身弹性复位，推顶调节件123的凸起1231卡入相应的卡位1226中，使得调节件123及滑动件122能够定位在该位置保持不动。An elastic member 125 is further provided between the adjusting member 123 and the sliding member 122, and an extending direction of the elastic member 125 faces the control groove 1222. The inner wall of the casing 124 is provided with a plurality of latching positions 1226 at positions corresponding to the scale marks 1225 on one or both sides of the control slot 1222. The adjusting member 123 is provided with at least one protrusion 1231. The elastic member 125 may be, but is not limited to, a spring, a spring sheet, or an elastic washer. In a natural state, the elastic member 125 pushes the protrusion 1231 of the adjusting member 123 and snaps into the locking position 1226 to realize the positioning of the adjusting member 123 and the sliding member 122. The operator manually presses the adjusting member 123 downward, and the elasticity The piece 125 is compressed and contracted, and the protrusion 1231 of the adjustment piece 123 is separated from the latch 1226. At this time, the adjustment piece 123 can be pushed and pulled in the axial direction to drive the slider 122 and the outer sleeve 30 to move axially, thereby adjusting the ablation needle. 10 reveals the length of the outer sleeve 30, that is, the effective ablation length; when the adjustment member 123 reaches a certain scale position to obtain the desired effective ablation length, the operator releases the adjustment member 123, and the elastic member 125 resets due to its own elasticity, and ejects The protrusions 1231 of the adjusting member 123 are snapped into the corresponding locking positions 1226, so that the adjusting member 123 and the sliding member 122 can be positioned at this position and remain stationary.
请参阅图12、图13及图16a至图16c，本发明中，所述消融针组件100还包括活检针20，所述消融针10与所述活检针20更替地穿装在所述外套管30内，进一步地，所述活检针20可以与所述外套管30进行可拆卸并旋转连接。具体的，所述活检针20包括活检针主体21及与所述活检针主体21近端连接的活检手柄22；所述消融针10与所述外套管30分离后，所述活检针20的活检针主体21穿装入所述外套管30中，且所述外套管30与所述活检针20的活检手柄22可拆卸并旋转连接。换句话说，所述消融针10与所述外套管30能够可拆卸连接，所述活检针20也可以与所述外套管30进行可拆卸连接，将所述消融针10与所述外套管30拆分后，可以将所述活检针20与所述外套管30连接。因此，在完成消融操作后，解除消融针10与所述外套管30的连接，将外套管30留在组织内，为活检操作提供通道，使得活检针20快速到达期望的活检位置，避免了重复穿刺，减小对组织的损伤；或者，在有些手术过程中，可以在先完成活检操作后，解除活检针20与外套管30的连接，将外套管30留在组织内，为消融操作提供通道，使得消融针10快速到达期望的消融位置。并且，由于所述外套管30与所述活检针20的活检针主体21可拆卸并旋转连接，从而使得在活检操作中，若需要旋转所述活检针20，可以保持所述外套管30不动，从而减小对组织的损伤，而且旋转的阻力较小。Please refer to FIG. 12, FIG. 13, and FIGS. 16 a to 16 c. In the present invention, the ablation needle assembly 100 further includes a biopsy needle 20. The ablation needle 10 and the biopsy needle 20 are alternately worn on the outer sleeve. Within 30, further, the biopsy needle 20 can be detachably and rotationally connected with the outer sleeve 30. Specifically, the biopsy needle 20 includes a biopsy needle body 21 and a biopsy handle 22 connected to the proximal end of the biopsy needle body 21; after the ablation needle 10 is separated from the outer sleeve 30, the biopsy of the biopsy needle 20 The needle body 21 is inserted into the outer sleeve 30, and the outer sleeve 30 and the biopsy handle 22 of the biopsy needle 20 are detachably and rotatably connected. In other words, the ablation needle 10 and the outer sleeve 30 can be detachably connected, and the biopsy needle 20 can also be detachably connected to the outer sleeve 30 to connect the ablation needle 10 and the outer sleeve 30. After disassembly, the biopsy needle 20 can be connected to the outer sleeve 30. Therefore, after the ablation operation is completed, the connection between the ablation needle 10 and the outer cannula 30 is released, and the outer cannula 30 is left in the tissue, providing a channel for the biopsy operation, so that the biopsy needle 20 quickly reaches the desired biopsy position, avoiding repetition Puncture to reduce damage to the tissue; or, in some surgical procedures, after completing the biopsy operation, the biopsy needle 20 is disconnected from the outer sleeve 30, 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. In addition, since the outer sleeve 30 and the biopsy needle main body 21 of the biopsy needle 20 are detachably and rotatably connected, if the biopsy needle 20 needs to be rotated during a biopsy operation, the outer sleeve 30 can be held still. Therefore, the damage to the tissue is reduced, and the resistance to rotation is small.
请结合图14、图15及图17a至图17e，进一步的，本发明一些实施例中，所述消融针组件100还包括穿刺针芯40，穿刺针芯40的直径大于所述消融针10或活检针20的直径，穿刺针芯40的直径范围优选为19G～16G。且穿刺针芯40优选为较硬质的材料制成，如：不锈钢。所述穿刺针芯40与所述消融针10或活检针20更替地穿装在所述外套管30内并与所述外套管30可拆卸连接，所述穿刺针芯40的远端伸出所述外套管30。本实施例中，所述穿刺针芯40的远端呈尖锐的针状或三棱锥状，近端可以固定一具有内螺纹的接头41，所述接头41的内螺纹与外套管30近端的外螺纹相适配。增加了穿刺针芯40后，可在消融前或活检前将穿刺针芯40与外套管30组合对组织进行穿刺，之后解除穿刺针芯40与外套管30的连接，撤出穿刺针芯40，再向外套管30内穿入消融针10或活检针20。直径较大、较硬质的穿刺针芯40可以为外套管30提供较好的支撑性，因此穿刺针芯40与外套管30的组合更便于穿刺，并且可以防止直接利用消融针10或活检针20进行穿刺时，消融针10或活检针20受到损伤。Please refer to FIG. 14, FIG. 15, and FIGS. 17 a to 17 e. Further, in some embodiments of the present invention, the ablation needle assembly 100 further includes a puncture needle core 40, and the diameter of the puncture needle core 40 is larger than that of the ablation needle 10 or The diameter of the biopsy needle 20 and the diameter of the puncture needle core 40 are preferably 19G to 16G. The puncture needle core 40 is preferably made of a harder material, such as stainless steel. The puncture needle core 40 and the ablation needle 10 or the biopsy needle 20 are alternately inserted into 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 Mentioned outer tube 30. In this embodiment, the distal end of the puncture needle core 40 has a sharp needle shape or a triangular pyramid shape, and a proximal end can be fixed with a connector 41 having an internal thread, and the internal thread of the connector 41 and the proximal end of the outer sleeve 30 External threads fit. After the puncture needle core 40 is added, the puncture needle 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 needle core 40 and the outer sleeve 30 is released, and the puncture needle core 40 is withdrawn. The ablation needle 10 or the biopsy needle 20 is then inserted into the outer cannula 30. The larger diameter and harder puncture needle core 40 can provide better support for the outer cannula 30, so the combination of the puncture needle core 40 and the outer cannula 30 is more convenient for puncture, and can prevent the direct use of the ablation needle 10 or the biopsy needle When the puncture is performed, the ablation needle 10 or the biopsy needle 20 is damaged.
进一步的，请一并参阅图6及图18，本发明还提供一种消融***，包括所述消融针组件100及能量发生装置110。本发明一些实施例中，所述消融***200还包括医学影像装置120和/或冷源供给装置130。其中，所述能量发生装置110电性连接所述消融针10，所述能量发生装置110可以但不限于为射频发生器或微波发生器。所述冷源供给装置130通过冷却管路160与所述冷却通道16连通，向所述冷却通道16内提供气态或液态冷却介质。所述医学影像装置120用于实时显示所述外套管30及消融针10的远端位置，可选自超声、CT、核磁、X光透视中的至少一种，优选超声。Further, referring to FIG. 6 and FIG. 18 together, the present invention also provides an ablation system including the ablation needle assembly 100 and the energy generating device 110. In some embodiments of the present invention, the ablation system 200 further includes a medical imaging device 120 and / or a cold source supply device 130. The energy generating device 110 is electrically connected to the ablation needle 10, and the energy generating device 110 may be, but is not limited to, a radio frequency generator or a microwave generator. The cold source supply device 130 communicates with the cooling channel 16 through a cooling pipe 160 and provides a gaseous or liquid cooling medium into the cooling channel 16. The medical imaging device 120 is used to display the distal positions of the outer cannula 30 and the ablation needle 10 in real time, and may be selected from at least one of ultrasound, CT, nuclear magnetic resonance, and X-ray fluoroscopy, and preferably ultrasound.
本发明的所述消融针组件100及消融***能够但不限于应用在HCM的治疗，以及肾脏、肝脏或软组织肿瘤的治疗以及活检。The ablation needle assembly 100 and the ablation system 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.
如图16a至图16c所示，本实施例以治疗HCM为例，说明所述消融针组件100的使用过程：As shown in FIG. 16a to FIG. 16c, this embodiment takes the treatment of HCM as an example to describe the use process of the ablation needle assembly 100:
第一步：首先将消融针10穿装在外套管30内，通过连接件121将外套管30与消融针10的消融手柄12连接，得到如图2所示的消融针组件。作动调节件123以带动所述驱动组件120及外套管30相对消融针10沿轴向移动，以外套管30作为消融针10的绝缘管，获得期望的消融针10露出外套管30的长度即有效消融长度。First step: First, the ablation needle 10 is inserted into the outer sleeve 30, and the outer sleeve 30 is connected to the ablation handle 12 of the ablation needle 10 through the connecting member 121 to obtain the ablation needle assembly shown in FIG. 2. The adjustment member 123 is actuated to drive the driving assembly 120 and the outer cannula 30 to move relative to the ablation needle 10 in the axial direction, and the outer cannula 30 serves as the insulating tube of the ablation needle 10 to obtain the desired length of the ablation needle 10 to expose the outer cannula 30. Effective ablation length.
第二步：如图16a所示，在超声装置的引导下将外套管30与消融针10经肋骨间经心尖穿刺由心外膜进入室间隔壁内，开启射频发生器，由消融针10露出外套管30的部分对肥厚的室间隔心肌进行射频消融，破坏相应部位室间隔心肌的活性，使心肌坏死萎缩、变薄，从而使左室流出道增宽，解除梗阻。应用该消融针组件10治疗HCM，既避免了外科旋切手术开胸和体外循环的风险和痛苦，也没有化学酒精消融无效或酒精外溢造成大面积心梗的风险，简单易行，对患者创伤极其微小，手术风险小，且疗效显著。Step 2: As shown in FIG. 16a, under the guidance of the ultrasound device, the outer cannula 30 and the ablation needle 10 are punctured through the apex of the ribs from the epicardium into the compartment wall. The radio frequency generator is turned on and exposed by the ablation needle 10. Part of the outer sleeve 30 performs radiofrequency ablation of the hypertrophic ventricular septal myocardium, destroying the activity of the ventricular septal myocardium at the corresponding site, shrinking and thinning the myocardial necrosis, thereby widening the left ventricular outflow tract and removing obstruction. The application of the ablation needle assembly 10 to treat HCM not only avoids the risks and pain of surgical thoracotomy and extracorporeal circulation, but also does not have the risk of large-scale myocardial infarction caused by ineffective alcohol ablation or alcohol spillage. It is extremely small, the risk of surgery is small, and the effect is significant.
第三步：如图16b及图16c所示，在需要进行消融操作，又需要进行活检操作时，在执行完消融后解除外套管30与连接件121的连接，撤出消融针10而留置外套管30，然后活检针20穿入外套管30提取组织样本用于活检。所述外套管30为活检操作提供了通道，能够避免重复穿刺，减小了对组织的损伤，并能够使得活检针20快速到达期望的活检位置。Step 3: As shown in FIG. 16b and FIG. 16c, when an ablation operation is needed and a biopsy operation is required, after performing the ablation, the outer tube 30 is disconnected from the connecting member 121, the ablation needle 10 is withdrawn and the outer sheath is left. The tube 30 is then passed through the biopsy needle 20 into the outer cannula 30 to extract a tissue sample for biopsy. The outer cannula 30 provides a channel for biopsy operation, can avoid repeated puncture, reduces tissue damage, and enables the biopsy needle 20 to reach the desired biopsy position quickly.
可以理解的是，在某些情况下，亦可以在执行消融前先将外套管30与活检针20组合进行穿刺、活检，然后撤出活检针20而留置外套管30，接着作动调节件123使驱动组件120到达并定位在期望的刻度位置，最后将消融针10穿入外套管30，通过旋转连接件121建立起外套管30与连接件121的连接，消融针10以期望的有效消融长度执行消融，同样能够避免重复穿刺，减小对组织的损伤。It can be understood that, in some cases, before performing the ablation, the outer cannula 30 and the biopsy needle 20 are combined for puncture and biopsy, and then the biopsy needle 20 is withdrawn and the outer cannula 30 is left, and then the adjustment member 123 is actuated The driving assembly 120 is reached and positioned at a desired scale position. Finally, the ablation needle 10 is inserted into the outer sleeve 30, and the connection between the outer sleeve 30 and the connection member 121 is established by rotating the connecting member 121. The ablation needle 10 is at a desired effective ablation length. Performing ablation can also avoid repeated puncture and reduce tissue damage.
如图17a至图17e所示，在本发明的一些实施例中，所述消融针组件100增加了穿刺针芯40后，可在消融前或活检前将穿刺针芯40与外套管30组合进行穿刺，之后解除穿刺针芯与外套管30的连接，撤出穿刺针芯40，留置外套管30在患者体内，再向外套管30内穿入消融针10或活检针20，进行消融或活检操作，以增加穿刺强度，并防止穿刺过程损伤消融针10或者活检针20。As shown in FIG. 17a to FIG. 17e, in some embodiments of the present invention, after the puncture needle core 40 is added to the ablation needle assembly 100, the puncture needle core 40 and the outer sleeve 30 can be combined before the ablation or the biopsy. After the puncture, the connection between the puncture needle core and the outer sleeve 30 is removed, the puncture needle core 40 is withdrawn, 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 cannula 30 for ablation or biopsy In order to increase the puncture intensity and prevent the ablation needle 10 or the biopsy needle 20 from being damaged during the puncture process.
以上所述为本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本发明的保护范围。The above is a preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principles of the present invention, several improvements and retouches can be made. It is the protection scope of the present invention.

Claims (17)

  1. 一种消融针组件，其特征在于，包括中空的外套管以及消融针；所述消融针包括电极针主体及与所述电极针主体近端连接的消融手柄；所述外套管至少部分绝缘；所述电极针主体活动穿装在所述外套管内，所述外套管近端与所述消融手柄之间可拆卸并旋转连接，所述电极针主体的远端伸出所述外套管；所述消融手柄相对所述外套管旋转以带动所述电极针主体相对所述外套管旋转。An ablation needle assembly is characterized in that it comprises a hollow outer sleeve and an ablation needle; the ablation needle comprises an electrode needle body and an ablation handle connected to the proximal end of the electrode needle body; the outer sleeve is at least partially insulated; The electrode needle main body is movably installed in the outer sleeve, the proximal end of the outer sleeve and the ablation handle are detachably and rotatably connected, and the distal end of the electrode needle main body protrudes from the outer sleeve; the ablation; The handle is rotated relative to the outer sleeve to drive the electrode needle body to rotate relative to the outer sleeve.
  2. 如权利要求1所述的消融针组件，其特征在于，还包括活检针，所述活检针与所述消融针更替地穿装在所述外套管内。The ablation needle assembly according to claim 1, further comprising a biopsy needle, wherein the biopsy needle and the ablation needle are alternately worn in the outer sleeve.
  3. 如权利要求1所述的消融针组件，其特征在于，所述消融手柄包括驱动组件及与所述驱动组件旋转连接的连接件，所述外套管与所述连接件之间可拆卸连接；所述驱动组件驱动所述外套管沿所述电极针主体的延伸方向相对所述电极针主体移动，以调节所述电极针主体的远端伸出所述外套管的长度。The ablation needle assembly according to claim 1, wherein the ablation handle comprises a driving assembly and a connection member rotatably connected to the driving assembly, and the outer sleeve and the connection member are detachably connected; The driving component drives the outer sleeve to move relative to the electrode needle body along the extension direction of the electrode needle body to adjust the length of the distal end of the electrode needle body protruding from the outer sleeve.
  4. 如权利要求3所述的消融针组件，其特征在于，所述驱动组件包括滑动件及与所述滑动件连接的调节件，所述连接件与所述滑动件同轴设置并旋转连接，所述调节件控制所述滑动件沿其轴向移动，以带动与所述连接件连接的所述外套管相对所述电极针主体移动。The ablation needle assembly according to claim 3, wherein the driving assembly comprises a sliding member and an adjusting member connected to the sliding member, and the connecting member is coaxially disposed with the sliding member and is rotationally connected. The adjusting member controls the sliding member to move along its axial direction to drive the outer sleeve tube connected to the connecting member to move relative to the electrode needle body.
  5. 如权利要求4所述的消融针组件，其特征在于，所述消融手柄包括外壳，所述驱动组件收容于所述外壳内；所述外壳上沿所述滑动件的轴向开设有控制槽，所述调节件的一端从所述控制槽伸出所述外壳；通过移动所述调节件在所述控制槽的位置控制所述滑动件沿其轴向移动。The ablation needle assembly according to claim 4, wherein the ablation handle includes a housing, and the driving component is housed in the housing; the housing is provided with a control slot along the axial direction of the slider, One end of the adjusting member protrudes from the housing through the control groove; and the sliding member is controlled to move in the axial direction by moving the adjusting member at the position of the control groove.
  6. 如权利要求5所述的消融针组件，其特征在于，所述控制槽的至少一侧设有刻度标识。The ablation needle assembly according to claim 5, wherein a scale mark is provided on at least one side of the control groove.
  7. 如权利要求6所述的消融针组件，其特征在于，所述调节件与所述滑动件之间设有弹性件，所述弹性件的延伸方向朝向所述控制槽；所述外壳的内壁设有与所述刻度标识相对应的多个卡位，所述调节件上设有至少一个凸起；所述弹性件自然伸长时，所述弹性件顶推所述凸起卡入所述卡位中。The ablation needle assembly according to claim 6, wherein an elastic member is provided between the adjusting member and the sliding member, and an extending direction of the elastic member faces the control groove; an inner wall of the housing is provided There are a plurality of card positions corresponding to the scale marks, and at least one protrusion is provided on the adjusting member; when the elastic member naturally extends, the elastic member pushes the protrusion to engage the card In the bit.
  8. 如权利要求5所述的消融针组件，其特征在于，所述外壳的内表面设有沿所述滑动件轴向设置的第一导向件，所述滑动件的表面设有与所述第一导向件适配的第二导向件，通过所述第二导向件与所述第一导向件的配合使得所述滑动件沿其轴向移动。The ablation needle assembly according to claim 5, wherein the inner surface of the housing is provided with a first guide provided along the axial direction of the slider, and the surface of the slide is provided with the first guide The second guide member adapted to the guide member causes the sliding member to move along its axial direction through cooperation between the second guide member and the first guide member.
  9. 如权利要求4所述的消融针组件，其特征在于，所述滑动件的远端环设有卡槽，所述连接件的近端设有卡圈，所述卡圈卡入所述卡槽内以使所述滑动件与所述连接件旋转连接。The ablation needle assembly according to claim 4, wherein a distal end ring of the sliding member is provided with a clamping slot, a proximal end of the connecting member is provided with a clamping ring, and the clamping ring is clicked into the clamping slot. Inside so that the sliding member and the connecting member are rotationally connected.
  10. 如权利要求1或2所述的消融针组件，其特征在于，还包括穿刺针芯，所述穿刺针芯与所述消融针或所述活检针更替地穿装在所述外套管内并与所述外套管可拆卸连接，所述穿刺针芯的远端伸出所述外套管。The ablation needle assembly according to claim 1 or 2, further comprising a puncture needle core, the puncture needle core and the ablation needle or the biopsy needle are alternately inserted into the outer sleeve and communicated with the outer sleeve. The outer sleeve is detachably connected, and the distal end of the puncture needle core extends out of the outer sleeve.
  11. 如权利要求1所述的消融针组件，其特征在于，所述外套管的外表面设有刻度标识。The ablation needle assembly according to claim 1, wherein a scale mark is provided on an outer surface of the outer sleeve.
  12. 如权利要求1所述的消融针组件，其特征在于，所述外套管的远端具有第一引导部，所述第一引导部在医学影像装置下显影。The ablation needle assembly according to claim 1, wherein a distal end of the outer sleeve has a first guide portion, and the first guide portion is developed under a medical imaging device.
  13. 如权利要求1或12所述的消融针组件，其特征在于，所述电极针主体的远端具有第二引导部，所述第二引导部在医学影像装置下显影。The ablation needle assembly according to claim 1 or 12, wherein a distal end of the electrode needle body has a second guide portion, and the second guide portion is developed under a medical imaging device.
  14. 如权利要求1所述的消融针组件，其特征在于，所述电极针主体内设有冷却通道。The ablation needle assembly according to claim 1, wherein a cooling channel is provided in the electrode needle body.
  15. 一种消融***，其特征在于，包括如权利要求1至14任一项所述的消融针组件以及与所述消融针的电极针主体之间电性连接的能量发生装置。An ablation system, comprising an ablation needle assembly according to any one of claims 1 to 14 and an energy generating device electrically connected to an electrode needle body of the ablation needle.
  16. 如权利要求15所述的消融***，其特征在于，所述能量发生装置为射频发生器或微波发生器。The ablation system according to claim 15, wherein the energy generating device is a radio frequency generator or a microwave generator.
  17. 如权利要求15所述的消融***，其特征在于，还包括与所述电极针主体的近端相连通的冷却装置。The ablation system according to claim 15, further comprising a cooling device in communication with the proximal end of the electrode needle body.
PCT/CN2019/099087 2018-08-24 2019-08-02 Ablation needle assembly and ablation system WO2020038216A1 (en)

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