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WO2024046356A1 - Aiguille d'ablation, dispositif d'ablation et système d'ablation - Google Patents

Aiguille d'ablation, dispositif d'ablation et système d'ablation Download PDF

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Publication number
WO2024046356A1
WO2024046356A1 PCT/CN2023/115743 CN2023115743W WO2024046356A1 WO 2024046356 A1 WO2024046356 A1 WO 2024046356A1 CN 2023115743 W CN2023115743 W CN 2023115743W WO 2024046356 A1 WO2024046356 A1 WO 2024046356A1
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Prior art keywords
ablation
needle
perfusion
area
adjustable
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Legal status (The legal status 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 status listed.)
Ceased
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PCT/CN2023/115743
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English (en)
Chinese (zh)
Inventor
齐泽龙
丘信炯
张庭超
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Hangzhou Nuoqin Medical Instrument Co Ltd
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Hangzhou Nuoqin Medical Instrument Co Ltd
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Publication of WO2024046356A1 publication Critical patent/WO2024046356A1/fr
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Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A61B2090/3762—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the present disclosure relates generally to the field of medical device technology, and more specifically to ablation needles, ablation devices, and ablation systems.
  • Hypertrophic Cardiomyopathy is a common autosomal dominant cardiovascular disease, with an incidence rate of approximately 1:500 in the general population and a mortality rate of approximately 1.4% to 2.2%.
  • the main manifestation of HCM is hypertrophy of one or more segments of the left ventricle (Left Ventricle, LV).
  • the general diagnostic standard is that the thickness is greater than or equal to 15 mm. Its treatment methods mainly include drug therapy, ventricular septal resection, ventricular septal ablation, etc.
  • Ventricular septal ablation technology can use an ablation needle to puncture the ventricular septal tissue and ablate the ventricular septal tissue to release ablation energy to the hypertrophic myocardial tissue of the ventricular septum to destroy the cell activity of the tissue there and make the myocardium of the ventricular septum hypertrophic.
  • the tissue becomes thinner and contractility decreases, thereby reducing left ventricular outflow tract obstruction.
  • the ablation energy will cause the temperature of the myocardial tissue to increase. It is often necessary to infuse liquid into the ablation area through several perfusion holes provided on the ablation needle to avoid excessive temperature rise in the ablation area, which may lead to tissue carbonization. At the same time, it can also diffuse ablation. energy to expand the ablation range.
  • the current technology cannot control the flow rate of the perfusion liquid within a reasonable range to ensure ventricular septal ablation. The process does not cause tissue carbonization and at the same time improves ablation efficiency.
  • the present disclosure relates to an ablation needle, including a needle body having an inner cavity, the needle body being provided with at least one ablation segment and at least two perfusion holes communicating with the inner cavity; the ablation segment includes at least one ablation hole.
  • An electrode configured to release energy to tissue and ablate the tissue to form an ablation area;
  • the perfusion hole is configured to transport perfusion liquid from the inner cavity to the tissue around the needle body to form an perfusion area; taking the plane where the axial and radial directions of the needle body are located as a standard plane, the area S1 is the The projected area of the ablation area on the standard surface, area S2 is the projected area of the perfusion area on the standard surface, where 0.3 ⁇ S1/S2 ⁇ 1.
  • the perfusion holes are evenly distributed in the axial and circumferential directions of the needle body.
  • the length of the ablation segment is adjustable.
  • At least one perfusion hole is provided at both ends of the ablation electrode in the axial direction, so that the ablation area is within the perfusion area.
  • the projection of the perfusion area on the standard plane is an ellipse or an ellipse-like shape, with a short axis radius ranging from 1.41 mm to 69.1 mm, and a major axis radius ranging from 2.5 mm to 15 mm.
  • the projection of the ablation area on the standard plane is an ellipse or an ellipse-like shape, with a short axis radius ranging from 1 mm to 69.1 mm, and a long axis radius ranging from 1 mm to 12 mm.
  • the ratio of the area S1 to the area S2 is 0.5 ⁇ S1/S2 ⁇ 0.85.
  • the ratio of the area S1 to the area S2 is 0.6 ⁇ S1/S2 ⁇ 0.75.
  • the present disclosure relates to an ablation device including an ablation needle of the present disclosure.
  • the ablation device further includes a catheter connected to the ablation needle, and the wall thickness of the catheter is no less than 0.5 mm.
  • the present disclosure relates to a myocardial ablation system that includes an energy generating device, a pump, and the myocardial ablation device of the present disclosure, the energy generating device being electrically connected to the ablation needle and configured to deliver ablation energy to the ablation electrode.
  • the pump is in fluid communication with the ablation needle and is configured to deliver the perfusion liquid to the perfusion hole.
  • the myocardial ablation system further includes a delivery component, the delivery component includes an adjustable bend sheath and an adjustable bend catheter movably threaded within the adjustable bend sheath; and the ablation The needle can be movably inserted into the adjustable bending catheter.
  • the perfusion fluid is a mixture of 0.9% NaCl solution at room temperature, 0.9% NaCl solution at 5°C, 5% glucose solution, heparinized 0.9% NaCl solution, 0.9% NaCl solution and contrast medium any of the solutions.
  • the energy generating device is electrically connected to the pump, and after the pump sets the perfusion parameters, the pump delivers the perfusion parameters to the energy generating device, and the energy generating device The generating device generates reference ablation parameters based on comparison between the perfusion parameters and reference data.
  • the ablation segment releases energy to the tissue to form an ablation area, and the perfusion hole infuses liquid into the tissue to form the perfusion area, thereby preventing the tissue from heating up too quickly and causing carbonization.
  • the ratio between the projected area S1 of the ablation area on the standard plane and the projected area S2 of the perfusion area on the standard plane is between 0.3 and 1, which can not only ensure the safety of the ventricular septal ablation process, but also ensure the ablation efficiency. .
  • Figure 1 is a schematic structural diagram of an ablation needle provided by an embodiment of the present disclosure
  • Figure 2 is a schematic diagram of Figure 1 from another perspective
  • Figure 3 is a schematic cross-sectional view of Figure 2;
  • Figure 4 is a schematic diagram of the projection of the perfusion area and ablation area on the standard surface during ablation;
  • Figure 5 is a schematic diagram of the perfusion area and the ablation area on the YZ plane during ablation
  • Figure 6 is a schematic diagram of the temperature rise in perfusion ablation
  • Figure 7 is a schematic cross-sectional view at B-B in Figure 2;
  • Figure 8 is a schematic cross-sectional view taken at B-B in Figure 2 in an embodiment of the present disclosure
  • Figure 9 is a schematic diagram of an ablation device provided in an embodiment of the present disclosure.
  • Figure 10 is a schematic structural diagram of the adjustable bending sheath in a natural state according to an embodiment of the present disclosure
  • Figure 11 is a schematic structural diagram of the adjustable bending sheath tube in the straightening transition state
  • Figure 12 is a structural diagram of the adjustable bending sheath tube in a straightened state
  • Figure 13 is a schematic structural diagram of the adjustable bending sheath located in the aorta
  • Figure 14 is a schematic structural diagram from another perspective at M-M in Figure 13;
  • Figure 15 is a schematic structural diagram of another embodiment of the adjustable bending sheath.
  • Figure 16 is a schematic diagram of Figure 15 from another perspective
  • Figure 17 is a schematic structural diagram of the adjustable bending catheter and the adjustable bending sheath
  • Figure 18 is a schematic structural diagram of the distal end of the adjustable bending catheter crossing the aortic valve
  • Figure 19 is a schematic structural diagram from another perspective at N-N in Figure 18;
  • Figure 20 is a schematic structural diagram of the distal end of the adjustable bending catheter
  • Figure 21 is a schematic structural diagram of the distal end of the adjustable bend catheter contacting the interventricular septum
  • Figure 22 is a schematic structural diagram of the ablation needle puncturing the endocardium through the aorta to ablate the ventricular septal tissue;
  • Figure 23 is a schematic structural diagram of the distal opening point selection of the adjustable bend catheter
  • Figure 24 is a schematic structural diagram of a myocardial ablation system provided in an embodiment of the present disclosure.
  • Figure 25 is a schematic structural diagram of the ablation needle puncturing the endocardium through another path to ablate the ventricular septal tissue;
  • Figure 26 is a schematic structural diagram of the ablation needle puncturing the endocardium through another path to ablate the ventricular septal tissue;
  • Figure 27 is a schematic diagram of another ablation device provided in an embodiment of the present disclosure.
  • Figure 28 is a schematic structural diagram of the ablation needle puncturing the epicardium through the apex of the heart to ablate the ventricular septal tissue.
  • proximal end refers to the end closer to the operator, while “distal end” refers to the end farther away from the operator.
  • Axial refers to the direction parallel to the line connecting the distal center and proximal center of the medical device
  • radial refers to the direction along the diameter or radius, where “radial” and “axial” are perpendicular to each other
  • centircumferential is Refers to the circumferential direction around the central axis.
  • the present disclosure provides an ablation needle 13.
  • the ablation method of the ablation needle 13 can be radiofrequency ablation, microwave ablation, alcohol ablation, etc.
  • the ablation needle 13 in the present disclosure includes a needle body 132 with an inner cavity 132b.
  • the needle body 132 is provided with at least one ablation segment 134 and at least two perfusion sections connected to the inner cavity 132b.
  • the ablation section 134 includes at least one ablation electrode configured to release ablation energy to the tissue and ablate the tissue to form an ablation area;
  • the perfusion hole is configured to deliver perfusion liquid from the inner cavity to the
  • the tissue around the needle body 132 forms a perfusion area; taking the plane where the axial and radial directions of the needle body 132 lie is the standard plane, the area S1 is the projected area of the ablation area on the standard plane, the area S2 is the projected area of the perfusion area on the standard surface, where 0.3 ⁇ S1/S2 ⁇ 1.
  • the ablation energy in this disclosure may include, but is not limited to: radio frequency energy, ultrasound energy, microwave energy, etc.
  • the ablation area range of the ablation needle 13 has a clear relationship with the output power and output time of radio frequency energy. In a stable state, the range of the ablation area is proportional to the output power and output time of radio frequency energy. In theory, , through higher output power and longer output time, the size of the ablation area can be increased. That is to say, when the length of the ablation segment 134 is determined, the size of the ablation area can be roughly determined by setting the output power and output time.
  • the tissue in contact with the ablation segment 134 will be burned and scabbed, and the burned and scabbed tissue will adhere to the surface of the ablation segment 134, forming a
  • the electrically insulating condensation accompanied by a sudden increase in electrical impedance, prevents further current flow into the tissue and further heating, thereby greatly reducing the extent of the ablation zone and resulting in poor ablation results. Therefore, in order to prevent this phenomenon, improve the ablation efficiency, and expand the ablation area, the temperature of the contact surface between the ablation section 134 and the tissue can be reduced to reduce the risk of tissue scabbing.
  • the electrolyte solution 33 can be a mixed solution of cold physiological saline + developer. Through X-ray imaging, the operator can visually observe the diffusion of the electrolyte solution 33 mixed with the developer in the myocardial tissue. , thereby regulating the ablation time and perfusion flow rate and flow rate in real time, so as to achieve the purpose of accurately controlling the size of the ablation area.
  • the electrolyte solution 33 may be used including, but not limited to, room temperature. 0.9% NaCl solution, 0.9% NaCl solution at 5°C, 5% glucose solution, mixed solution of heparinized 0.9% NaCl solution, 0.9% NaCl solution and contrast agent. At the same time, it should be considered to better reduce the risk of radiofrequency discharge. For the temperature at the contact interface between the ablation section 134 and the myocardial tissue, a 0.9% NaCl solution of about 5°C can be used to reduce the temperature more effectively.
  • the electrolyte solution 33 perfused through the perfusion hole 132a can cool the ablation segment 134 to a certain extent, reduce the temperature between the ablation segment 134 and the tissue contact interface, and avoid excessive temperature rise of the myocardial tissue around the ablation segment 134.
  • the risk of tissue burning, scabbing, and carbonization will occur quickly, resulting in a relatively gentle temperature rise of the myocardial tissue around the ablation segment 134; on the other hand, since the electrolyte solution 33 will diffuse after being perfused into the myocardial tissue, the diffused electrolyte
  • the solution 33 will serve as a good transmission medium for radio frequency current, transmitting the radio frequency current to farther parts of the myocardial tissue. Through this principle, the purpose of increasing the ablation area can also be achieved.
  • the axial direction of the needle body 132 is the X direction
  • the radial direction of the needle body 132 is the Y direction
  • the axial direction (X direction) and the radial direction (Y direction) of the needle body are The plane is defined as the standard plane.
  • the Z direction is perpendicular to the standard plane.
  • the present disclosure also provides a myocardial ablation system, including an energy generating device, a pump, and the above-mentioned myocardial ablation device.
  • the energy generating device is electrically connected to the ablation needle and configured to deliver ablation energy to the ablation electrode.
  • a pump is in fluid communication with the ablation needle and is configured to deliver irrigation fluid to the irrigation hole.
  • the energy generating device is electrically connected to the pump. After the pump sets the perfusion parameters, the pump delivers the perfusion parameters to the energy generating device.
  • the energy generating device generates reference ablation parameters based on comparison between the perfusion parameters and the reference data.
  • the total amount of perfusion liquid from the pump 32 will be equal to the total amount of perfusion liquid flowing through all the perfusion holes 132a on the ablation needle 13, so the ablation
  • the perfusion area of the needle 13 is determined by the distribution length of the perfusion holes 132a axially provided on the ablation needle 13 and the perfusion flow rate v.
  • the axial distribution length of the perfusion holes 132a is the two furthest distances in the axial direction. The distance between the far irrigation holes 132a.
  • the perfusion flow rate ranges from 0.1 to 5.0 mL/min, and the length of the portion of the ablation needle 13 with the perfusion hole ranges from 5 to 20 mm.
  • the shape perfused through the ablation needle 13 can be approximated as an ellipsoid. According to the volume calculation formula of the ellipsoid:
  • V is the volume of the ellipsoid
  • a, b, and c are respectively 1/2 of the length of the three axes of the ellipsoid (that is, a, b, and c correspond to the Y direction, Z direction, and X direction respectively).
  • v is the perfusion flow rate, and the value range is 0.1mL/min to 5.0mL/min;
  • t is the ablation duration, ranging from 1min to 10min;
  • c' is the major axis radius of the perfusion area
  • c is the major axis radius of the ablation range (half the length of the ablation segment)
  • c' is 1 to 1.5 times of c
  • the value range of 2c is 5 to 20mm
  • the value range of 2c' is 5 to 30mm. From formula 2, we can know that the volume V of the perfusion area is positively related to the perfusion flow rate v and perfusion duration (ablation time) t. From formula 3, we can know that the short-axis diameter 2a' is inversely proportional to the long-axis radius c', so the volume V is the minimum value.
  • the corresponding short axis diameter 2a' is the minimum value; when the volume V is the maximum value and the long axis radius c' is the minimum value, the corresponding short axis diameter 2a' is at this time. is the maximum value.
  • the minimum value of 2a’ can be calculated, that is, the short-axis diameter 2a’ value of the minimum perfusion area is 2.52mm.
  • the maximum value of 2a’ can be calculated, that is, the short-axis diameter 2a’ value of the maximum perfusion area is: 138.2mm.
  • the short axis diameter 2a' of the perfusion area ranges from 2.52mm to 138.2mm. It should be noted that since the short axis diameter 2a' and the long axis diameter 2c' of the perfusion area have different values in different situations, it can be seen from the above value range that 2a' may be larger than 2c', here for the convenience of understanding , define the axis of the perfusion area in the Y direction as the short axis, and the axis in the X direction as the long axis.
  • Perfusion is the enhancement of the ablation area. This enhancement specifically refers to the enhancement on the short axis, because for the long axis, the perfusion holes 132a are evenly distributed on the ablation section 134 along the axial direction, and the length of the ablation section 134 is the long axis diameter of the ablation range. while the perfusion direction is in the radial direction, and Non-axial.
  • the ablation area should be surrounded by the perfusion area (as shown in Figures 4 to 5).
  • the projected area of the ablation area on the standard surface is S1
  • the projected area of the perfusion area on the standard surface is S2.
  • S2 should be greater than or Equal to S1, generally speaking, 0.3 ⁇ S1/S2 ⁇ 1.
  • the figure shows the myocardial tissue temperature rise curve under different S1/S2 ratios.
  • the abscissa in the figure is the ablation time (t/s), and the ordinate is the temperature of the ablated tissue (T/°C).
  • the process of heating the tissue temperature from body temperature T0 to a predetermined temperature T1 is a temperature rise process. After the tissue temperature undergoes the temperature rise process, it needs to be maintained for a period of time before the ablation can be completed. That is to say, the ablation process includes the temperature rise process and the maintenance process.
  • the time required for the ablation process is the ablation time t
  • the time required for the temperature rise process is the temperature rise time ta
  • the ablation time t is generally a preset value.
  • the temperature rise time ta and the maintenance time tb are inversely proportional, that is, the larger ta, the smaller tb, and the smaller ta, the larger tb.
  • the temperature rise time t1 is small, so there is a greater probability of tissue carbonization; when the S1/S2 ratio is 0.3, the temperature rise time t6 is large, so it is less likely to occur.
  • the tissue is carbonized, but due to the longer temperature rise time t6, the maintenance time tb is shorter, so the ablation efficiency is lower.
  • the S1/S2 ratio is 0.7 and 0.6, the corresponding temperature rise times are t3 and t4. At this time, tissue carbonization is not easy to occur, and the ablation efficiency is also relatively good, so it can achieve both efficiency and avoid tissue temperature rise. Carbonization occurs too quickly.
  • the area S1 is related to the ablation energy, and the ablation energy range is between 1 and 100W.
  • the operator can view the ablation area under the imaging system.
  • the ablation area can be increased by increasing the ablation energy, and the ablation area can be reduced by decreasing the ablation energy. area.
  • the operator can compare the reference data and select corresponding ablation parameters such as output power and output time, which can also adjust the size of the area S1. In some embodiments, you can refer to the data in Tables 1 to 4.
  • S2 when determining 2c to be 5mm, 2c' to be 7.5mm, t to be 3min, and v to be 0.5mL/min, S2 can be obtained according to the above formula. is 230.19mm 2 , then when the output power (i.e., ablation power) is 4W, S1 is 119.15mm 2 , so S1/S2 is equal to 51.76%. At this time, the ablation efficiency is medium, but the probability of tissue carbonization is low, and the ablation effect is good.
  • radiofrequency ablation is selected.
  • the ablation needle 13 includes a needle body 132, and an ablation segment 134 is at least partially disposed on the needle body 132.
  • the ablation segment 134 is electrically conductive and configured to conduct radiofrequency ablation energy.
  • the ablation needle 13 is connected to the energy generating device 20.
  • the energy generating device 20 is an existing technology and will not be described again here.
  • the needle body 132 is provided with at least one perfusion hole 132a, and the perfusion hole 132a is in communication with the interior of the needle body 132.
  • the ablation needle 13 can puncture the endocardium or epicardial tissue under the puncture of the needle tip 131, so that the distal end of the ablation needle 13 including the needle tip 131, the perfusion hole 132a, and the ablation section 134 enters the hypertrophic area of the ventricular septum, and passes through the ablation section 134
  • the energy is released to destroy the cell activity of the hypertrophic myocardial tissue, causing the hypertrophic myocardial tissue of the interventricular septum to become thinner and reduce the contractility, thereby reducing the phenomenon of left ventricular outflow tract obstruction; at the same time, under the perfusion of the electrolyte solution 33 in the perfusion hole 132a, the solution passes through the electrolyte solution 33 in the perfusion hole 132a. Diffusion within the myocardial tissue brings the radiofrequency energy to the myocardial tissue farther away from the ablation section 134, thereby achieving the purpose of expanding the ablation range.
  • the needle tip 131 of the ablation needle 13 is a closed and sharp tip structure, and its shape includes but is not limited to cone, triangular pyramid, quadrangular pyramid, single bevel edge, etc.
  • the shape of the needle tip 131 can provide a sufficiently sharp tip 131 for the ablation needle 13
  • the structure allows it to pierce the endocardial tissue with a small puncture force, thereby smoothly entering the ventricular septal myocardial tissue.
  • the needle tip 131 is fixed to the distal end of the needle body 132 through connection methods including but not limited to bonding, laser welding, welding, etc.
  • the needle body 132 is a long, hollow tubular structure with a completely penetrating lumen 132b inside.
  • the pump 32 injects the electrolyte solution 33 into the inner cavity 132b of the needle body 132, and the electrolyte solution 33 flows out from the perfusion hole 132a through the inner cavity 132b of the needle body 132.
  • the needle body 132 may have a circular structure in cross-section.
  • the cross-section of the needle body 132 may also be an elliptical structure.
  • the outer wall of the needle body 132 should be smooth and have no obvious protrusions or edges to prevent it from scratching the vascular intima and other tissues when entering the target position of the human body.
  • the needle body 132 can be made of a metal material with good electrical conductivity, so that it can achieve the purpose of releasing radio frequency energy through the excellent electrical conductivity of the needle body 132 itself.
  • the above-mentioned ablation Segment 134 should be part of needle body 132.
  • the needle body 132 may be made of metal pipes including, but not limited to, stainless steel pipes, nickel-titanium alloys, and the like.
  • the ablation needle 13 when using a transcatheter route for ablation, the ablation needle 13 needs to reach the target position of the interventricular septum through a complex and tortuous peripheral vascular path, and in order to ensure a good puncture angle, the ablation needle 13 The distal part of the needle 13 will pass through the adjustable bending sheath 110, The bending catheter 120 has a long path to bend, and may cause scratches and friction. Therefore, in addition to the excellent conductivity, the good mechanical and mechanical properties of the needle body 132 should also be considered; the ablation needle 13 can Made of highly biocompatible metal tubing.
  • nickel-titanium alloy has excellent biocompatibility, high strength, good shapeability, and can exhibit superelastic mechanical properties after heat treatment
  • needles made of nickel-titanium alloy 132 can maintain good resilience without plastic deformation after passing through complex and tortuous blood vessel paths and repeated bending. This allows the system to pass through the blood vessels more smoothly and reach the target location without causing any problems.
  • the plastic deformation of the needle body 132 increases the resistance to passage.
  • the needle body 132 can also be made of polymer material. In this case, the ablation segment 134 should be used as an independent component with good electrical conductivity fixed on the needle body 132 .
  • the needle body 132 When the needle body 132 is made of a polymer material, the polymer material used should have excellent strength, hardness, high elastic modulus and good bending resistance, and should be able to withstand repeated bending without fracture or plasticity. Deformation. On the other hand, in order to ensure that the needle 132 has excellent pushing performance during the forward and backward movement along the central axis of the adjustable bending catheter 120, the material should have a low surface friction coefficient, which can reduce the friction of the ablation needle 13 during the adjustable bending. The pushing resistance inside the lumen of the catheter 120, and at the same time, in order to ensure the insulation of the needle body 132, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance. To sum up, the needle body 132 can be made of polymer materials such as polypropylene PP, high-density polyethylene HDPE, and polytetrafluoroethylene PTFE.
  • At least one ablation segment 134 is provided at the distal end of the ablation needle 13 .
  • the ablation segment 134 can be electrically connected to the energy generating device 20 , thereby releasing energy into the tissue through the ablation segment 134 .
  • the ablation section 134 should exist as a part of the needle body 132 .
  • an insulating layer 133 should be attached to the outer surface of the needle body 132, and the exposed area at the distal end of the needle body 132 that is not covered with insulating material serves as an ablation section 134 for releasing radiofrequency energy.
  • the insulating layer 133 may be a layer of polymer material coated on the needle body 132 through heat shrinkage, may be directly placed on the outside of the needle body 132, or may be attached to the outside of the needle body 132 through a coating process.
  • the outer surface of the insulating layer 133 should have a low friction coefficient and a high insulation resistance. The low friction coefficient can give the ablation needle 13 good lubricity and pushing performance, and the high insulation resistance can make the insulating layer 133 operate at a high temperature. Under the action of high frequency radio frequency current, it still maintains excellent dielectric insulation without being broken down.
  • the insulating material may be PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), etc. .
  • the insulating layer 133 can be made of PEEK (polyetheretherketone), PI (polyimide) or other materials.
  • Parylene may be used as the insulating material.
  • the ablation section 134 should be an independent component with good electrical conductivity fixed on the outside of the needle body 132 .
  • the ablation segment 134 should be one or more ring-shaped metal electrodes, which are fixed on the distal end of the needle body 132 by methods including but not limited to bonding, welding, crimping, welding, etc. And achieve electrical conduction with the external energy generating device through wires.
  • Ring-shaped metal electrodes can be made of radio-opaque metal materials such as platinum-iridium alloy, cobalt-chromium alloy, and tantalum. In this way, while having excellent conductive properties, it can also develop under radiation, which can help the surgeon. Confirm the role of the location of ablation segment 134.
  • the effective length 2c of the ablation segment 134 refers to the length exposed outside the insulating layer 133 and capable of contacting the tissue to be treated.
  • the effective length 2c of the ablation segment 134 is 5 mm to 15 mm.
  • the length of the ablation segment 134 is fixed, that is, the relative position between the needle body 132 and the insulating layer 133 is fixed.
  • the effective length of the ablation segment 134 in the same set of ablation needles 13 is a certain fixed value. value, a plurality of ablation needles 13 of different models and specifications can be designed by setting ablation segments 134 of different effective lengths to meet the use needs of different patients with different tissue shapes and sizes.
  • the relative position between the needle body 132 and the insulating layer 133 can be adjusted to achieve different exposed lengths of the needle body 132, thereby achieving the purpose of adjusting different effective lengths of the ablation segment 134.
  • an insulating sleeve is provided around the needle body 132, and the insulating sleeve is used as the above-mentioned insulating layer 133.
  • the insulating sleeve and the needle body 132 can slide relative to each other, and the effective length 2C of the ablation section 134 can be controlled by controlling the relative movement between the needle 132 and the insulating layer 133. It is known that an ablation section 134 that is too short will make the ablation area too small.
  • the ablation needle 13 is provided with an ablation operating handle (not shown in the figure).
  • the ablation operating handle is provided with a pushing structure.
  • the pushing structure is connected to the insulating sleeve and can drive the insulating sleeve relative to the needle body.
  • a locking structure is also provided on the ablation operating handle, and the locking structure is connected to the needle body 132 and is configured as Lock Stop and fix the needle body 132.
  • the endocardial tissue and the ventricular septal myocardial tissue can be punctured together while the needle body 132 and the insulating sleeve remain relatively fixed, that is, the effective length of the ablation segment 134 remains unchanged.
  • the needle body 132 when it is necessary to adjust the effective length of the ablation section 134, the needle body 132 can be locked by the locking structure of the ablation operating handle, so that it remains fixed in the direction along the central axis of the adjustable bending catheter 120, and then the ablation can be performed by pushing
  • the push structure in which the operating handle is fixedly connected to the insulating sleeve enables the insulating sleeve to move forward and backward relative to the central axis of the needle body 132, thereby controlling the elongation or shortening of the ablation segment 134 exposed outside the insulating sleeve.
  • the effective length of ablation segment 134 is thereby changed.
  • the locking structure is connected to the insulating sleeve and is configured to lock and fix the insulating sleeve.
  • the pushing structure is connected to the needle body 132 and can drive the needle body 132 to slide relative to the insulating sleeve.
  • the endocardial tissue is punctured and inserted into the ventricular septal myocardial tissue.
  • the locking structure is controlled so that the insulating sleeve remains fixed in the direction of the central axis of the needle body 132, and then the push structure is pushed to enable the needle body 132 to achieve relative movement back and forth along the direction of the central axis of the insulating sleeve, thereby achieving The purpose of controlling the elongation or shortening of the ablation section 134 exposed outside the insulating sleeve, thereby changing the effective length of the ablation section 134.
  • the ablation needle 13 is provided with at least one or more perfusion holes 132a, which are evenly distributed in the axial and circumferential directions of the needle body 132.
  • the shape of the filling hole 132a may be circular, elliptical, or other shapes.
  • the pouring hole 132a is formed using laser cutting.
  • the structure of the ablation needle 13 using ablation methods such as microwave ablation is basically the same as the structure of the ablation needle 13 using radiofrequency ablation, and will not be described again here.
  • the output capacity of the perfusion pump 32 should at least meet 0.1 to 5.0 mL/min. Since during the perfusion ablation process, the pump needs to continuously supply liquid to the ablation needle 13 through the conduit 34, the conduit 34 needs to have a certain size to avoid being affected by the expected flow rate when the ablation needle 13 with a small hole diameter and a small inner diameter outputs the expected flow rate.
  • the pipe wall is too thin and deforms or breaks. Taking 5.0mL/min as an example, when the wall thickness is less than 0.5mm, the conduit 34 is prone to deformation and rupture. Therefore, when the wall thickness of the conduit 34 is not less than 0.5mm, the conduit 34 will not deform or rupture.
  • the conduit 34 wall thickness is no less than 0.65 mm. In certain embodiments, the conduit 34 wall thickness is no less than 1 mm.
  • the conduit 34 can also be composed of two different sizes of hose, such as a first conduit section with an outer diameter of 2.5mm and an inner diameter of 1.2mm (unilateral wall thickness 0.65mm), and a first conduit section with an outer diameter of 4.0mm and an inner diameter of 0.8mm (unilateral wall thickness 0.65mm).
  • Wall thickness 1.6mm It consists of a second conduit segment, as long as the wall thickness is not less than 0.5mm.
  • the present disclosure provides an ablation device, which includes the ablation needle of the present disclosure.
  • the ablation device 10 includes a delivery tube assembly and an ablation needle 13.
  • the delivery tube assembly includes an adjustable bend sheath 110 and is movably threaded through the adjustable sheath 110.
  • the ablation needle 13 can be movably inserted into the adjustable and curved catheter 120 in the curved sheath 110 , and the distal end of the ablation needle 13 can extend out of the adjustable and curved catheter 120 . end.
  • the ablation device includes an ablation needle 42, which can puncture the epicardium through the apex to ablate the ventricular septal tissue without the need for a delivery component.
  • the ablation device also includes an outer cannula 41 and an ablation handle 40 .
  • the outer sleeve 41 is movably sleeved outside the ablation needle 42 and is detachably and rotatably connected to the ablation handle 40 .
  • the outer sleeve 41 is at least partially insulated. In other words, the outer sleeve 41 may be fully insulated or partially insulated.
  • the distal end of the ablation needle 42 extends out of the outer sleeve 41.
  • the ablation needle 42 When the outer sleeve 41 is completely insulated, the ablation needle 42 extends out of the outer sleeve 41 to perform an ablation operation; when the outer sleeve 41 When partially insulated, the ablation needle 42 extends out of the outer cannula 41 and performs ablation on the non-insulated portion of the outer cannula 41 .
  • Adjustment 10 uses the above adjustable sheath 110 that enters the left ventricle through the aorta as an example.
  • the structure of the adjustable sheath 110 can be referred to the corresponding Make adaptive adjustments to the path.
  • the adjustable bending sheath 110 includes an adjustable bending sheath 110 and an adjustment member (not marked in the figure).
  • the adjustable bending sheath 110 is a prefabricated pipe fitting with a certain degree of rigidity and flexibility.
  • the bending sheath 110 applies force to adjust the shape of the adjustable bending sheath 110. After the force of the adjusting member is eliminated, the adjustable bending sheath 110 can gradually return to its natural state.
  • the adjustable bending sheath 110 has a hollow inner cavity.
  • the adjustable bend sheath 110 includes a first tube section 111 , a second tube section 112 and a third tube section 113 that are connected in sequence from the proximal end to the distal end.
  • the first pipe section 111 , the second pipe section 112 and the third pipe section 113 are all located on the same plane, and the second pipe section 112 first extends in a direction away from the first pipe section, and then moves closer to the third pipe section.
  • One tube section 111 extends in the direction of the first tube section 111
  • the third tube section 113 extends in the direction close to the first tube section 111, so that the first tube section 111 matches the shape of the descending aorta of the human body, and the second tube section 112 matches the shape of the aortic arch of the human body.
  • the third tube section 113 is adapted to the shape of the ascending aorta of the human body, and the distal end of the third tube section 113 is close to the middle part of the aortic valve of the human body. Therefore, the adjustable The curved sheath tube 110 has a predetermined shape in a natural state, which matches the shape of the human aorta, making it easier to cross the aortic valve from the aorta and enter the left ventricle to treat myocardial tissue.
  • the adjustable bending sheath 110 is in a natural state.
  • the adjusting member is connected to the adjustable bending sheath 110 and is configured to adjust the shape of the adjustable bending sheath 110.
  • the adjustable bending sheath 110 can be placed in a straightened state (as shown in Figure 12) and a natural state. (as shown in Figure 10).
  • the above-mentioned straightening state refers to the state in which the shape of the above-mentioned adjustable bending sheath is approximated to a straight line by the above-mentioned adjusting member, and the shape of the adjustable bending sheath is made by operating the adjusting member to apply an external force opposite to the direction C to the adjustable bending sheath.
  • the adjustable bending sheath 110 is first adjusted from the natural state to the straightening state. As the adjustable bending sheath 110 deepens, the self-straightening state gradually changes to the natural state, and finally returns to the natural state. , and then the distal end of the adjustable bending sheath 110 can be adjusted by operating the adjusting member, and at this time, the adjustable bending sheath 110 is in the bending state (as shown in Figure 10).
  • the distal end of the third tube section 113 of the above-mentioned adjustable bending sheath 110 is provided with an anchoring ring, and the above-mentioned anchoring ring is connected to the distal end of the pulling wire built into the above-mentioned adjustable bending sheath 110, The proximal end of the pulling wire is connected to the adjusting member. Therefore, the above-mentioned adjusting member can adjust the bending degree of the above-mentioned third pipe section 113 by pushing and pulling the above-mentioned pulling wire. When the above-mentioned third pipe section 113 is bent to a certain extent away from the above-mentioned first pipe section 111, the adjustment can be continued.
  • the above-mentioned third pipe section 113 can be affected.
  • the second pipe section 112 is gradually straightened, and finally the first pipe section 111, the second pipe section 112, and the third pipe section 113 are adjusted to a straight line or an approximately straight line state. Therefore, by operating the above adjusting member
  • the above-mentioned adjustable bending sheath tube 110 can be brought into a straightening state. Since the adjustable bending sheath 110 is straightened by operating the adjustment member, the third tube section 113 of the adjustable bending sheath 110 during this operation will be partially bent in the straightened state, but this part will not be bent. Influence the adjustable bending sheath 110 to enter the relevant blood vessel path as a whole.
  • the operator can also insert a dilator into the adjustable curved sheath tube 110 and straighten the adjustable curved sheath tube 110 through the dilator, so that the first tube section 111 and the third tube section 111 can be straightened.
  • the second tube section 112 and the above-mentioned third tube section 113 are adjusted to a straight or nearly straight state, and then as the adjustable bending sheath tube 110 goes deeper, the dilator is gradually withdrawn, causing its self-aligning state to gradually change to a natural state, and Finally, the natural state is restored, and then the distal end of the adjustable bending sheath 110 can be adjusted by operating the adjusting member. At this time, the adjustable bending sheath 110 is in the bending state.
  • a guidewire can also be inserted into the dilator and then withdrawn along with the dilator during the removal of the dilator.
  • the adjustable bending sheath 110 in the natural state conforms to the shape of the aorta, wherein the first tube section 111 is similar to or the same shape as the descending aorta, and the second tube section 112 is similar to or the same shape as the aortic arch.
  • the shape of the third tube section 113 is similar to that of the ascending aorta, so that when the adjustable sheath 110 is inserted into the aorta and returned to its natural state, the distal portion of the third tube section 113 will be close to the aortic valve.
  • the direction of the distal opening of the third tube section 113 can be adjusted by operating the adjustment member.
  • the adjustable bending sheath 110 is in the adjustment state. bending state.
  • the adjustable bending sheath 110 is a straight line or an approximately straight line in its natural state, and the operator applies external force through the handle to adjust the degree of bending of the distal end of the adjustable bending sheath 110.
  • the handle state needs to be maintained after the sheath 110 becomes the target shape; and in this embodiment, the adjustable and bendable sheath 110 has a predetermined shape in a natural state, that is, the above-mentioned third pipe section 113, second pipe section 112 and first
  • the pipe sections 111 are located on the same spatial plane.
  • the second pipe section 112 first extends in a direction away from the first pipe section 111 and then extends in the direction of the first pipe section 111.
  • the third pipe section 113 extends in the direction of the first pipe section 111.
  • the operator applies external force through the adjustment member or inserts a dilator into the adjustable curved sheath 110 to adjust the adjustable curved sheath 110 to a straight line or an approximately straight line.
  • aortic arch In the process of descending the aorta, aortic arch and reaching the ascending aorta, gradually reduce the straightening external force exerted by the adjusting member on the adjustable sheath 110 or withdraw the dilator, so that the first tube section 111 of the adjustable sheath 110 , the second tube section 112 and the third tube section 113 gradually return to their natural state.
  • the distal end of the third tube section 113 reaches the ascending aorta and its opening points toward the aorta.
  • the second tube segment 112 is located in the aortic arch, and the first tube segment 111 is located in the descending aorta, and the operator does not need to apply any external force to the adjusting member, thus improving the surgical efficiency and preventing the operator from pulling the adjusting member for a long time. , reduce the possibility of misoperation.
  • the direction of the distal opening of the third tube section 113 can be adjusted by operating the adjustment member. At this time, the adjustable sheath 110 is in the bending state.
  • the shape of the third tube section 113 in the natural state can ensure that the distal end of the third tube section 113 moves in two directions, close to the interventricular septum or away from the interventricular septum, thereby facilitating the subsequent selection of different puncture sites and providing a suitable location for puncture.
  • the adjustable catheter 120 and ablation needle 13 in the adjustable sheath 110 provide different treatment positions.
  • the proximal end of the adjustable bending sheath 110 is connected to the first handle 114, and the adjustable bending catheter
  • the proximal end of 120 is connected to the second handle 124, and the first handle 114 and the second handle 124 can respectively adjust the bending degree of the distal end of the adjustable bending sheath 110 and the adjustable bending catheter 120.
  • the adjustment member can be used to control the circumferential rotation of the adjustable bending sheath 110 to control the swing of the third tube section 113 to control the direction of the distal opening of the third tube section 113 .
  • the third tube section 113 will swing toward the Anterior side of the aortic arch (that is, the side of the aortic arch close to the chest).
  • the adjustable bending sheath 110 when controlled to rotate in the counterclockwise direction, the third tube section 113 will swing toward the posterior side of the aortic arch (that is, the side of the aortic arch close to the back).
  • the first tube section 111 is linear in its natural state.
  • the proximal portion of the first tube segment 111 is straight and the distal portion is curved.
  • the curved portion of the third pipe section 113 may adopt a regular or irregular curve shape. In some embodiments, the curved portion of the third pipe section 113 is configured in a circular arc shape.
  • the second tube section 112 in its natural state, is curved with a middle portion arched relative to both ends.
  • the second pipe section 112 may adopt a regular or irregular curve shape to make the connection transition between the first pipe section 111 and the third pipe section 113 smooth.
  • the second tube section 112 is arc-shaped.
  • the third tube section 113 in the natural state, is curved, and the curvature of the proximal portion of the third tube section 113 is smaller than the curvature of the distal portion of the third tube section 113 , that is, the distal portion of the third tube section 113
  • the degree of curvature is greater than that of the proximal part.
  • the distal end of the third tube section 113 is located close to the middle part of the aortic valve and biased towards the descending aorta, that is, the distal end of the third tube section 113 The end is far away from the interventricular septum, thereby increasing the distance from the distal end of the third tube section 113 to the interventricular septum, thereby increasing the range of points for the adjustable-bend sheath 110 and the adjustable-bend catheter 120 .
  • the curvatures of the first pipe section 111 , the second pipe section 112 and the third pipe section 113 are different, and the curvature of the second pipe section 112 is greater than the curvature of the first pipe section 111 , the third pipe section 113 , and the third pipe section 111 has a curvature greater than that of the third pipe section 111 .
  • the curvature of section 113 is greater than the curvature of first pipe section 111 .
  • the curvature of the second tube section 112 may remain unchanged, or may be configured such that the curvature of the second tube section 112 first increases and then decreases, or gradually increases from the proximal end to the distal end.
  • the second tube section 112 When the curvature of the second tube section 112 first increases and then decreases, the second tube section 112 partially conflicts with the aortic arch and the friction area is small.
  • the force provided by the blood vessel wall to the second tube section 112 can assist the adjustable bending sheath 110 to maintain position.
  • the second tube section 112 When the curvature of the third tube section 112 gradually increases, the second tube section 112 partially conflicts with the aortic arch and the friction area is large, which can increase the force provided for positioning the second tube section 112 .
  • the first tube section 111 and the second tube section 112 of the adjustable bending sheath 110 are located on the first plane 91
  • the third tube section 113 is located on the second plane 92 that is angled with the first plane 91 .
  • the adjustable sheath 110 The third pipe section 113 , the second pipe section 112 and the first pipe section 111 are also correspondingly arranged in a three-dimensional spatial structure.
  • the second pipe section 112 and the first pipe section 111 are located in the same plane 91
  • the third pipe section 113 is located in the same plane. 91 forms a certain angle in the plane 92.
  • the bending direction C of the third tube section 113 should be bent in the direction of the side of the aortic arch close to the human chest, that is, the bending in the Anterior direction.
  • the adjustable bending sheath 110 can be made to better fit the shape of the aortic arch. .
  • the angle between the first plane 91 and the second plane 92 is a, where 10° ⁇ a ⁇ 45°.
  • a can be 15°, 20°, 25°, 30°, 35°, or 40°.
  • the ablation device can perform endocardial puncture and post-ablation of the interventricular septum through the inferior vena cava-right atrium-right ventricle or inferior vena cava-right atrium-atrial septum-left atrium-left ventricle. , then the structure of the adjustable bending sheath 110 is adapted with reference to this embodiment.
  • adjustable sheath 110 that enters the left ventricle through the aorta as an example to illustrate the structure of the adjustable catheter 120.
  • the structure of the adjustable catheter 120 is as follows: This embodiment makes adaptive adjustments.
  • the adjustable bending catheter 120 has at least a main body section 121, a shaping section 122 and a bending section 123 from the proximal end to the distal end.
  • the shape of the main body section 121 is the same as that of the first tube section 111 of the adjustable bending sheath 110.
  • the shape is adapted to the shape of the shaping section 121 and the shape of the second pipe section 112 and the third pipe section 113 of the adjustable bending sheath 110, so as to achieve the structural form of the adjustable bending catheter 120 and the adjustable bending sheath 110. better adaptability.
  • the adjustable-bend catheter 120 is disposed in the hollow inner cavity of the adjustable-bend sheath 110 and can realize relative movement with the adjustable-bend sheath 110 along the central axis direction.
  • the distal portion of the shaping section 121 extends away from the direction of the interventricular septum, and the bending section 123 extends towards the direction of the interventricular septum.
  • the adjustable-bend catheter 120 when the adjustable-bend sheath 110 is located in the aorta and is in a natural state, the adjustable-bend catheter 120 is transported through the lumen of the adjustable-bend sheath 110, and the bending section 123 will move from the adjustable-bend sheath 110 to the aorta.
  • the third tube section 113 of the sheath 110 extends from the distal opening, crosses the aortic valve, and reaches the position of the LVOT (left ventricular outflow tract). At this time, the adjustable catheter 120 is in a natural state (not adjusted). .
  • the adjustable bending conduit 120 is connected to a bending handle.
  • the circumferential swing of the bending section 123 of the adjustable bending conduit 120 can be controlled.
  • the bending section 123 will exhibit a slight swing in the counterclockwise direction and an angle toward the dorsal direction of the aortic arch (posterior direction). Swing; when the bending handle is controlled to rotate in the counterclockwise direction, the bending section 123 will exhibit a slight swing in the clockwise direction and an angular swing toward the aortic arch toward the chest direction (Anterior direction).
  • the bending direction D of the bending section 123 can be toward the outside of the aortic arch, that is, towards the interventricular septum.
  • the bending section 123 can be made to move outside the aortic arch 42. The bending is performed to ensure that the distal end of the bending section 123 always faces the side of the interventricular septum, so that the ablation needle 13 has the correct needle exit angle and direction when puncturing.
  • the distal end of the bending section 123 When the bending section 123 is bent to a suitable angle in the D direction, the distal end of the bending section 123 will be in contact with the left ventricular side wall of the interventricular septum, thereby preparing for subsequent needle removal.
  • the distal part of the shaping section 121 extends away from the direction of the interventricular septum, and the bending section 123 extends towards the direction of the interventricular septum, that is, the shape of the distal end part of the adjustable bending catheter 120 is set in a manner to first move away from and then approach the interventricular septum.
  • the needle exit angle of the bending section 123 can be increased by first moving away from and then approaching the interventricular septum.
  • the present disclosure provides an ablation system 1, which includes the ablation device 10 of the present disclosure; and also includes an energy generating device 20.
  • the energy generating device 20 is electrically connected to the ablation device 10 and is configured to provide energy for the ablation device 10.
  • the ablation device 10 includes a delivery component and an ablation needle 13; the ablation needle 13 is movably inserted into the delivery component; the delivery component is configured to intervene in the heart via a catheter route. After the ablation needle 13 passes through the delivery component, it passes through the heart. The intima enters the myocardial tissue, and then the energy generating device 20 provides energy to the ablation needle 13 to ablate the myocardial tissue.
  • the ablation system 1 further includes a perfusion device 30 configured to provide a liquid for the ablation device 10 , where the liquid is the above-mentioned electrolyte solution 33 .
  • the ablation needle 13 is provided with a perfusion hole 132a, and the electrolyte solution can be used to cool the myocardial tissue to prevent the myocardial tissue from rising in temperature too quickly and to expand the ablation range.
  • the present disclosure provides a myocardial ablation method, which method includes the following steps:
  • the ablation needle 13 is extended from the distal opening of the adjustable bend catheter 120 and penetrated into the myocardial tissue to deliver ablation energy for ablation.
  • the myocardial tissue is the interventricular septum.
  • the path used for myocardial ablation may be one of path a, path b, and path c;
  • Path a reaches the left ventricle via the femoral artery and aortic arch;
  • Path b via the inferior vena cava, right atrium, and to the right ventricle;
  • Path c via the inferior vena cava, right atrium, interatrial septum and left atrium to the left ventricle.
  • the adjustable sheath 110 of the adjustable sheath 110 is straightened through the first handle 114 or the dilator and inserted into the aorta, and gradually decreases as the depth of the adjustable sheath 110 increases.
  • the external force applied by the first handle 114 to the adjustable curved sheath 110 or the dilator is gradually withdrawn.
  • the third tube section 113 of the adjustable curved sheath 110 reaches the target position, that is, the ascending aorta
  • the first handle 114 is removed from the dilator.
  • External force on the adjustable bending sheath 110 or withdrawal of the dilator causes the adjustable bending sheath 110 to return to its natural state.
  • the adjustable-bend catheter 120 is extended from the distal opening of the third tube section 113 of the adjustable-bend sheath 110, and the shape of the adjustable-bend catheter 120 is adjusted so that the distal opening of the adjustable-bend catheter 120 contacts the interventricular septum.
  • a developing component is provided on the third tube section 113 of the adjustable bending sheath 110 or the ablation needle 13, for example, a developing ring made of metal or a developing material is applied, and under the guidance of ultrasound imaging/CT, the transfemoral Arterial puncture is guided by a guidewire (not shown in the figure), and the adjustable sheath 110 is sent through the aortic arch to a position on the side of the aortic valve close to the aortic arch, as shown in Figure 13 .
  • the position of the adjustable bending sheath 110 is correct.
  • the guide wire is withdrawn, and the adjustable bending catheter 120 is The inner lumen of the adjustable curved sheath 110 is delivered to the side of the aortic valve near the upper side of the aortic arch, and is crossed over the aortic valve without damaging the aortic valve under ultrasound/CT guidance, as shown in Figure 18 .
  • the distal end of the adjustable bending catheter 120 can be well placed against the desired puncture of the interventricular septum. at the ablation point.
  • control handle 14 Operate the control handle 14 to control the ablation needle 13 to extend along the central axis of the adjustable sheath tube 110 to pierce the interventricular septum and reach the hypertrophic myocardial tissue of the interventricular septum, and the ultrasound image and the double scale mark on the control handle 14 Under judgment, control the angle and depth of its penetration, as shown in Figure 22.
  • the perfusion device 30 After completing the above steps, first start the perfusion device 30 and set the perfusion flow rate so that the electrolyte solution 33 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and is perfused outside the tissue for a period of time, and then the ablation energy generating device 20 is turned on.
  • the hypertrophic myocardial tissue is ablated through the ablation section 134 of the ablation needle 13, and the size of the ablation range is determined by ultrasound and/or contrast imaging.
  • the ablation can be controlled by adjusting the length of the ablation section 134 according to the actual size of the ablation area. purpose of the area.
  • the energy output of the energy generating device 20 is stopped, the infusion of the electrolyte solution 33 is stopped, the ablation needle 13 is returned to the adjustable bending catheter 120, and the bending section 123 of the adjustable bending catheter 120 is adjusted.
  • the distal end is out of contact with the interventricular septum, and then the adjustable bending catheter 120 is operated to select the next point.
  • the distal end of the adjustable bending catheter 120 will swing in an arc from point E to point F, as shown in Figure 23 As shown in the figure, within the appropriate range, select 1, 2, 3, 4 or even more puncture sites.
  • multiple continuous ablation zones will be left on the hypertrophic ventricular septum.
  • multiple ablation zones can be connected together to form a long continuous ablation range, and all puncture points will be punctured and
  • the ablation needle 13, the adjustable bending catheter 120, and the adjustable bending sheath 110 are sequentially withdrawn, and the blood vessel suturing and puncture point skin suturing are completed.
  • route b is selected, under ultrasound/CT guidance, the femoral vein is punctured, guided by a guidewire (not shown), and the adjustable adjustable sheath 110 is passed through the inferior vena cava, the right atrium and into the right ventricle. position, through angiography, determine whether the adjustable and bendable sheath 110 is placed correctly.
  • the adjustable and bendable sheath 110 reaches the target position, withdraw the guide wire and move the adjustable and bendable catheter 120 along the adjustable bend.
  • the lumen of sheath 110 is delivered to the right ventricle. Control the bending direction and the bending angle of the bending section 123 of the adjustable sheath 110 and the adjustable catheter 120 so that the distal end of the adjustable catheter 120 can be well placed against the interventricular septum as desired. puncture ablation site.
  • control handle 14 control the ablation needle 13 to extend along the central axis direction of the adjustable adjustable sheath 110, pierce the interventricular septum, reach the hypertrophic myocardial tissue of the interventricular septum, and mark the ultrasound image and the control handle 14 Under the double judgment of the logo, control the angle and depth of its penetration, as shown in Figure 25.
  • the perfusion device 30 After completing the above steps, first start the perfusion device 30 and set the perfusion flow rate so that the electrolyte solution 33 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and is perfused outside the tissue for a period of time, and then the ablation energy generating device xx is turned on.
  • the hypertrophic myocardial tissue is ablated through the ablation section 134 of the ablation needle 13 .
  • the size of the ablation range is determined by ultrasound and/or contrast imaging, and the length of the ablation section 134 can be adjusted by controlling the handle 14 according to the actual size of the ablation area, thereby achieving the purpose of controlling the ablation area.
  • the energy output of the energy generating device is stopped, the infusion of the electrolyte solution 33 is stopped, and the ablation needle 13 is returned to the adjustable and bendable catheter 120 .
  • Adjust the bending section 123 of the adjustable bending catheter 120 so that its distal end is out of contact with the interventricular septum, and then operate the adjustable bending catheter 120 to select the next point.
  • the distal end of the adjustable bending catheter 120 will present a Swing in an arc from point E to point F (as shown in Figure 23), and select 1, 2, 3, 4 or even more puncture sites within a suitable range.
  • multiple continuous ablation zones will be left on the hypertrophic ventricular septum.
  • multiple ablation zones can be connected together to form a long continuous ablation range.
  • the ablation needle 13 After all puncture points have been punctured and ablated, the ablation needle 13, the adjustable catheter 120, and the adjustable sheath 110 are sequentially withdrawn, and blood vessel suturing and puncture point skin suturing are completed.
  • route c is selected, under ultrasound/CT guidance, the femoral vein is punctured, guided by a guidewire (not shown), and the adjustable adjustable sheath 110 is passed through the inferior vena cava, the right atrium and through the interatrial septum. to the left atrium, and determine whether the adjustable and bendable sheath 110 is correctly placed through angiography.
  • the adjustable and bendable sheath 110 reaches the target position, withdraw the guide wire and insert the adjustable and bendable sheath 110 into the target position.
  • 120 is transported along the inner lumen of the adjustable adjustable sheath 110 to the side of the left atrium near the upper side of the mitral valve, and crosses the mitral valve without damaging the mitral valve under ultrasound/CT guidance.
  • control handle 14 control the ablation needle 13 to extend along the central axis of the adjustable and bendable catheter 120, pierce the interventricular septum, reach the hypertrophic myocardial tissue of the interventricular septum, and mark the scale on the ultrasound image and control handle 14 Under the double judgment, control the angle and depth of its penetration, as shown in Figure 26.
  • the perfusion device 30 After completing the above steps, first start the perfusion device 30 and set the perfusion flow rate so that the electrolyte solution 33 reaches the position of the perfusion hole 132a through the inner cavity 132b of the ablation needle 13 and is perfused outside the tissue for a period of time, and then the ablation energy generating device xx is turned on.
  • the hypertrophic myocardial tissue is ablated through the ablation segment 134 at the distal end of the ablation needle 13 .
  • the size of the ablation range is determined by ultrasound and/or contrast imaging, and the ablation area can be controlled by adjusting the length of the ablation section 134 according to the actual size of the ablation area.
  • the energy output of the energy generating device is stopped, the infusion of the electrolyte solution 33 is stopped, and the ablation needle 13 is returned to the adjustable and bendable catheter 120 .
  • multiple continuous ablation zones will be left on the hypertrophic ventricular septum.
  • multiple ablation zones can be connected together to form a long continuous ablation range.
  • the ablation needle 13 After all puncture points have been punctured and ablated, the ablation needle 13, the adjustable catheter 120, and the adjustable sheath 110 are sequentially withdrawn, and blood vessel suturing and puncture point skin suturing are completed.
  • references in the specification to "one embodiment,” “an embodiment,” “exemplary embodiments,” “certain embodiments,” etc. mean that the described embodiment may include specific features, structures or characteristics, but Not every embodiment may include this particular feature, structure or characteristic. Furthermore, such phrases are not necessarily referring to the same embodiment. Furthermore, where a particular feature, structure or characteristic is described in connection with an embodiment, it is within the knowledge of a person skilled in the art to implement such feature, structure or characteristic in conjunction with other embodiments, explicitly or not explicitly described.
  • spatially relative terms may be used in this disclosure for convenience of explanation, such as, “below,” “below,” “under,” “above,” “above,” etc., to describe the relative position of one element or feature with respect to other elements or features.
  • Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation illustrated in the figures.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used in this disclosure interpreted accordingly.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Gynecology & Obstetrics (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)

Abstract

Sont divulgués une aiguille d'ablation, un dispositif d'ablation et un système d'ablation. L'aiguille d'ablation comprend un corps d'aiguille doté d'une cavité interne. Le corps d'aiguille est pourvu d'au moins une section d'ablation et d'au moins deux trous de perfusion communiquant avec la cavité interne. La section d'ablation comprend au moins une électrode d'ablation. L'électrode d'ablation est conçue pour libérer de l'énergie vers le tissu et effectuer l'ablation du tissu pour former une région d'ablation. Les trous de perfusion sont conçus pour acheminer un liquide de perfusion de la cavité interne au tissu autour du corps d'aiguille pour former une région de perfusion. Avec le plan où la direction axiale et la direction radiale du corps d'aiguille sont situées en tant que plan de référence, une zone S1 est une zone de projection de la région d'ablation sur le plan de référence et une zone S2 est la zone de projection de la région de perfusion sur le plan de référence, où 0,3 ≤ S1/S2 ≤ 1.
PCT/CN2023/115743 2022-08-31 2023-08-30 Aiguille d'ablation, dispositif d'ablation et système d'ablation Ceased WO2024046356A1 (fr)

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CN119632652A (zh) * 2023-09-15 2025-03-18 杭州诺沁医疗器械有限公司 一种消融针、消融装置及消融系统

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US20050222558A1 (en) * 1999-07-14 2005-10-06 Cardiofocus, Inc. Methods of cardiac ablation employing a deflectable sheath catheter
CN201356648Y (zh) * 2009-03-04 2009-12-09 微创医疗器械(上海)有限公司 盐水灌注射频消融导管
CN108024803A (zh) * 2015-04-10 2018-05-11 安吉戴尼克公司 使用热控电极进行不可逆电穿孔的系统和方法
CN109350233A (zh) * 2017-11-28 2019-02-19 杭州诺诚医疗器械有限公司 消融针组件及消融系统
CN111374799A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种单窗导引的瓣膜缩环系统
CN112353488A (zh) * 2020-11-12 2021-02-12 绍兴梅奥心磁医疗科技有限公司 一种可伸缩环形盐水灌注射频消融装置
CN114652429A (zh) * 2021-12-31 2022-06-24 杭州诺沁医疗器械有限公司 经导管心肌消融装置及经导管心肌消融系统

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050222558A1 (en) * 1999-07-14 2005-10-06 Cardiofocus, Inc. Methods of cardiac ablation employing a deflectable sheath catheter
CN201356648Y (zh) * 2009-03-04 2009-12-09 微创医疗器械(上海)有限公司 盐水灌注射频消融导管
CN108024803A (zh) * 2015-04-10 2018-05-11 安吉戴尼克公司 使用热控电极进行不可逆电穿孔的系统和方法
CN109350233A (zh) * 2017-11-28 2019-02-19 杭州诺诚医疗器械有限公司 消融针组件及消融系统
CN111374799A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种单窗导引的瓣膜缩环系统
CN112353488A (zh) * 2020-11-12 2021-02-12 绍兴梅奥心磁医疗科技有限公司 一种可伸缩环形盐水灌注射频消融装置
CN114652429A (zh) * 2021-12-31 2022-06-24 杭州诺沁医疗器械有限公司 经导管心肌消融装置及经导管心肌消融系统

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