WO2020177256A1 - 一种实时监测的超声与射频消融二合一导管 - Google Patents

一种实时监测的超声与射频消融二合一导管 Download PDF

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WO2020177256A1
WO2020177256A1 PCT/CN2019/094962 CN2019094962W WO2020177256A1 WO 2020177256 A1 WO2020177256 A1 WO 2020177256A1 CN 2019094962 W CN2019094962 W CN 2019094962W WO 2020177256 A1 WO2020177256 A1 WO 2020177256A1
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ultrasound
ablation
catheter
metal mesh
metal
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PCT/CN2019/094962
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English (en)
French (fr)
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郑良荣
孙泽玮
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浙江大学
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Priority to US16/965,009 priority Critical patent/US20220008124A1/en
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    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0883—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • 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
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00065—Material properties porous
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00148—Coatings on the energy applicator with metal
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • 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
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • 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
    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • 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
    • 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
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation

Definitions

  • the invention belongs to the field of medical equipment, and relates to a two-in-one catheter for ultrasound and radiofrequency ablation that can be monitored in real time, and the application of the catheter in radiofrequency ablation.
  • Radiofrequency ablation technology is widely used in a variety of medical operations, especially radiofrequency ablation for arrhythmia.
  • radiofrequency ablation a certain range of tissue damage needs to be caused to ensure the ablation effect.
  • the ablation catheter and the ultrasound catheter are separated, if you want to clarify the scope of tissue damage through ultrasound, you need to withdraw the ablation catheter and then replace it with an ultrasound catheter. This is not only time-consuming, but also because the ablation electrode diameter It is several millimeters and the tissue damage range is small. After the catheter is exchanged, the ultrasound catheter often cannot find the previous ablation point. Therefore, it is impossible to observe the tissue damage under ultrasound.
  • tissue damage area is found to be insufficient under ultrasound, it must be repeated It is very troublesome to replace the catheter. Therefore, it is very necessary to design a two-in-one ultrasound and radiofrequency ablation catheter. Because it is a two-in-one catheter, it saves time for catheter exchange, and at the same time avoids the difficulty of finding ablation sites after catheter exchange. At the same time, it can Use ultrasound imaging to monitor the ablation effect in real time to ensure that the predetermined range of tissue damage is reached, so as to increase the success rate of the operation and reduce complications.
  • the purpose of the present invention is to provide a two-in-one ultrasound and radiofrequency ablation catheter that can be monitored in real time, which is composed of a tube body, an ultrasound probe, a cold saline perfusion hole, a recording electrode, and an ablation electrode.
  • the ultrasound probe is located in the lumen of the tube body.
  • the ablation electrode is located at the head end of the tube body, the cold saline perfusion hole and the recording electrode are located in the front section of the tube body.
  • the ablation electrode is a metal mesh or metal column, made of material with pores, the diameter of the metal wire used, or metal mesh, metal The diameter of the pore formed by the column is compatible with the commonly used clinical ultrasound wavelength, which is 0.05mm-0.3mm.
  • the frequency of intracavity ultrasound commonly used in clinical practice is 5-15M, so that ultrasound can reach behind the ablation electrode through diffraction for imaging. Therefore, ultrasound can be used to monitor the entire process of ablation.
  • the cold saline perfusion hole is a pore-like structure, and there are 6 holes around the tube body. They are used to infuse cold saline during ablation to prevent the formation of eschar at the contact interface between the catheter and the tissue, thereby reducing impedance.
  • the recording electrode is a pair of ring electrodes made of platinum material, fixed on the surface of the tube body, and used to record the electrocardiogram of the part of the myocardial tissue in contact with the catheter to find the ectopic pacing point of arrhythmia.
  • the ablation electrode is preferably a metal mesh, and the material can be selected from various metals, such as platinum, titanium, copper, iron, stainless steel, etc., preferably platinum or titanium.
  • the application of the present invention has the steps of turning on the ultrasound, performing ablation under ultrasound monitoring, and turning off the radio frequency ablation current when the tissue damage range reaches the predetermined target.
  • the catheter designed in the present invention integrates ultrasound and radio frequency ablation.
  • the ablation electrode is designed as a metal mesh or metal column with pores. The diameter of the pore is compatible with the ultrasound wavelength, so that the ultrasound can reach the rear of the ablation electrode through diffraction for imaging.
  • ultrasound can be used for real-time monitoring without the need to exchange catheters, which saves a lot of time and at the same time avoids the trouble of finding ablation sites after catheter exchange.
  • Radiofrequency ablation under real-time ultrasound monitoring can also help the surgeon accurately reach the predetermined range of tissue damage, improve the success rate of surgery, reduce surgical complications, and greatly help radiofrequency ablation surgery.
  • the invention has reasonable design, simple preparation and convenient operation, and is worthy of popularization.
  • Figure 1 is a schematic diagram of the two-in-one catheter structure of ultrasound and radiofrequency ablation.
  • 1 is the catheter body
  • 2 is the ultrasound probe located in the catheter lumen
  • 3 is the cold saline perfusion hole
  • 4 is the recording electrode
  • 5 is the ablation electrode made of metal mesh or metal post.
  • Figure 2 is an imaging diagram of the ultrasound probe wrapped with a metal mesh. As shown in the figure, the use of metal mesh to wrap the ultrasound probe has no significant effect on the quality of ultrasound images.
  • Figure 3 shows the result of radiofrequency ablation using a metal mesh as an ablation electrode. As shown in the figure, the use of metal mesh for radiofrequency ablation does not affect the ablation effect and can cause tissue damage.
  • Figure 4 is a diagram showing the ablation results of using a metal mesh to wrap the ultrasound probe while using another metal mesh as the ablation electrode. As shown in the figure, using a metal mesh to wrap the ultrasound probe does not affect ultrasound imaging, and you can see the tissue damage after ablation with another metal mesh.
  • FIG. 5 is a specific application diagram of the two-in-one ultrasound and radiofrequency ablation catheter of the present invention.
  • the ultrasound probe (2) emits ultrasound (7)
  • the ultrasonic wave penetrates the ablation electrode (5) to reach the tissue (6), and forms a reflected ultrasonic wave (9) to reach the ultrasound probe for imaging.
  • the ablation electrode (5) conducts radio frequency current (8, dashed arrow) into the tissue (6) to form tissue damage.
  • cold saline is injected through the cold saline perfusion hole 3 to prevent the formation of eschar at the contact interface between the catheter and the tissue, thereby reducing impedance.
  • Example 1 A two-in-one catheter for ultrasound and radiofrequency ablation that can be monitored in real time
  • the two-in-one ultrasound and radiofrequency ablation catheter consists of a tube body 1, an ultrasound probe 2, a cold saline perfusion hole 3, a recording electrode 4 and an ablation electrode 5.
  • the ultrasound probe 2 is located in the lumen of the tube body 1
  • the ablation electrode 5 is located at the head end of the tube body 1
  • the cold saline perfusion hole 3 the recording electrode 4 are located in the front section of the tube body 1
  • the ablation electrode 5 is made of metal mesh or metal column
  • the diameter of the metal wire of the metal mesh and the metal column, or the diameter of the pore formed by the metal mesh and the metal column is suitable for the ultrasonic wavelength.
  • the diameter of the metal wire that constitutes the metal mesh and metal column is designed to be 0.05mm-0.3mm, so that the ultrasound can reach the back of the ablation electrode through diffraction for imaging.
  • the cold saline irrigation hole 3 is a pore-like structure, and there are 6 in total around the tube body. They are used to infuse cold saline during ablation to prevent the formation of eschar at the contact interface between the catheter and the tissue and reduce impedance.
  • the recording electrode 4 is a pair of ring electrodes made of platinum material, fixed on the surface of the tube body 1.
  • the fixing method of the recording electrode 4 and the tube body is the same as the recording electrode on the Johnson & Johnson ablation catheter (NS7TCDL174HS), which is used for recording and The catheter touches the electrocardiogram of part of the myocardial tissue to find the ectopic pacemaker of arrhythmia.
  • the ablation electrode 5 is preferably a metal mesh, and the material can be selected from various metals, such as platinum, titanium, copper, iron, stainless steel, etc., preferably platinum or titanium.
  • Example 2 Imaging after wrapping the ultrasonic probe with metal mesh
  • Fig. 2A is an ultrasound imaging diagram without a copper mesh in front of the ultrasound probe. Arrow 1 in the figure is skin, arrow 2 is blood vessel, and arrow 3 is bone.
  • Figure 2B is the ultrasound imaging diagram after the ultrasound probe is wrapped with a 200-mesh copper mesh (copper wire diameter is about 0.05mm)
  • Figure 2C is the ultrasound imaging after the ultrasound probe is wrapped with a 100-mesh copper mesh (copper wire diameter is about 0.1mm)
  • Figure 2D is an ultrasound imaging diagram of the ultrasound probe after being wrapped with a 30-mesh copper mesh (copper wire diameter is about 0.3mm).
  • arrow 1 is the skin
  • arrow 2 is the blood vessel
  • arrow 3 is the bone. Comparing Figures 2A, 2B, 2C, and 2D, it can be seen that the use of metal mesh to wrap the ultrasound probe has no significant effect on the quality of ultrasound imaging.
  • Example 3 Radiofrequency ablation using metal mesh as ablation electrode
  • FIG. 1 is a photo before radiofrequency ablation
  • Figure 3B is a photo after radiofrequency ablation using a metal mesh as the ablation electrode. It can be seen that tissue damage occurs at the ablation site and the color turns white (arrow 1).
  • Example 4 Using a metal mesh to wrap the ultrasound probe while using another metal mesh as the ablation electrode.
  • the result of ablation using a metal mesh to wrap the ultrasound probe place the pig's heart in the basin, and put normal saline in the basin, before ablation Perform ultrasound imaging.
  • the metal mesh is fixed to the tip of the disposable chopsticks, and the metal mesh is connected to the commercial ablation electrode with alligator forceps.
  • the isolated pig heart is placed in a basin, and physiological saline is placed in the basin.
  • the metal mesh is attached to the surface of the pig's heart.
  • the back electrode is immersed in the physiological saline in the basin, and then radiofrequency ablation is performed.
  • FIG. 4A is an ultrasound image of a pig's heart before radiofrequency ablation, and the arrow 1 is the left ventricle.
  • Figure 4B is an ultrasound image of a pig heart after ablation with an ultrasound probe and a metal mesh as an ablation electrode. It can be seen that tissue damage occurs at the ablation site after ablation (arrow 2).
  • Figure 4C shows ultrasound imaging using an ultrasound probe surrounded by a metal mesh. An ultrasound image of a pig's heart before radiofrequency ablation. Arrow 3 is the left ventricle. It can be seen that the ultrasound probe is surrounded by a metal mesh, which has no significant effect on the quality of ultrasound imaging.
  • Figure 4D is an ultrasound image after using a metal mesh-wrapped ultrasound probe for ultrasound imaging and using metal mesh as an ablation electrode for radiofrequency ablation. It can be seen that using metal mesh for ablation can cause tissue damage, and using metal mesh to wrap the ultrasound probe is not Affect the quality of ultrasound imaging, which can show tissue damage after ablation (arrow 4).
  • Example 5 Using the two-in-one catheter for ultrasound and radiofrequency ablation of the present invention.
  • the specific application method of the present invention is as follows: After finding the ectopic pacemaker through the recording electrode 4, the ultrasonic probe 2 emits ultrasonic waves, and the ultrasonic waves penetrate the ablation electrode 5 to reach the tissue (6) and form a reflective Ultrasound 9 arrives at the ultrasound probe for imaging. At the same time, the ablation electrode 5 conducts the radio frequency current 8 (shown by the dashed arrow) into the tissue (6) to form tissue damage. The tissue damage is monitored in real time through ultrasound images. During ablation, cold saline is injected through the cold saline perfusion hole 3 to prevent the formation of eschar at the contact interface between the catheter and the tissue and reduce impedance.
  • the metal mesh is placed in front of the ultrasound probe, which does not affect ultrasound imaging.
  • the use of metal mesh for radiofrequency ablation does not affect the ablation effect and can cause tissue damage. Therefore, in the present invention, the ultrasound probe is placed inside the catheter, and the metal mesh is used as the ablation electrode at the tip of the catheter, which can achieve the following effects: ultrasound can be imaged through the metal mesh, and the metal mesh can be used as the ablation electrode for radiofrequency ablation, thereby Realize radio frequency ablation under real-time ultrasound monitoring, and accurately reach the predetermined range of tissue damage.
  • Radiofrequency ablation under real-time ultrasound monitoring can also help the surgeon accurately reach the predetermined range of tissue damage, improve the success rate of the operation, and reduce surgical complications. It is of great help to radiofrequency ablation, simple and easy, and worthy of promotion.

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Abstract

本发明提供一种实时监测的超声与射频消融二合一导管，由管身、超声探头冷盐水灌注孔、记录电极和消融电极组成。消融电极为金属网或金属柱，由带有孔隙的材料制成，组成金属网、金属柱的金属丝直径，或金属网、金属柱形成的孔隙直径与临床常用超声波波长相适，使得超声波可通过衍射到达消融电极后方成像。因而，可以用超声监测消融的整个过程。使用本发明可以实现超声实时监测下的消融，从而，确保达到预定的组织损伤范围，同时由于导管是二合一的，在术中不必交换导管，因而节省了大量的时间，同时，使用超声实时监测，可以准确达到预定组织损伤范围，提高手术成功率，减少并发症。本发明设计合理，简便易行，应用价值大，值得推广。

Description

一种实时监测的超声与射频消融二合一导管 技术领域
本发明属于医疗器械领域，涉及一种可以实时监测的超声与射频消融二合一导管，以及使用此导管在射频消融中的应用。
背景技术
射频消融技术广泛运用于多种医疗手术中，尤其是心律失常的射频消融治疗。在进行射频消融时，需要造成一定的组织损伤范围，从而保证消融效果。目前，在进行射频消融时，由于消融导管和超声导管是分开的，如要通过超声明确组织损伤范围时，需要先撤出消融导管，再替换为超声导管，不仅费时，而且由于消融电极直径仅为数个毫米，组织损伤范围小，在交换导管后，超声导管常常无法找到先前的消融点，因而，就无法进行超声下组织损伤情况观察，并且，如果超声下发现组织损伤范围不足，则必须再次更换导管，非常麻烦。因而，设计一种超声与射频消融二合一导管非常必要，由于是二合一导管，因而，省去了交换导管的时间，同时也避免了交换导管后寻找消融位点的困难，同时，可以使用超声显像实时监测消融效果，确保达到预定的组织损伤范围，以提高手术成功率，减少并发症。
发明内容
本发明的目的是提供一种可实时监测的超声与射频消融二合一导管，由管身、超声探头、冷盐水灌注孔、记录电极和消融电极组成，超声探头位于管身的管腔内，消融电极位于管身的头端，冷盐水灌注孔、记录电极位于管身的前段，消融电极为金属网或金属柱，由带有孔隙的材料制成，所用金属丝直径，或金属网、金属柱形成的孔隙直径与临床常用超声波波长相适，为0.05mm-0.3mm。目前临床常用腔内超声频率为5-15M，使得超声波可通过衍射到达消融电极后方成像。因而，可以用超声监测消融的整个过程。冷盐水灌注孔为孔隙状结构，围绕管身一周共有6个，用于消融时灌注冷盐水，防止导管与组织接触界面焦痂形成，从而降低阻抗。记录电极为一对铂金材料制成的环状电极，固定在管身表面，用于记录与导管接触部分心肌组织心电图，从而寻找心律失常的异位起搏点。
消融电极优选为金属网，材料可选择各类金属，如铂金、钛、铜、铁、不锈钢等，优选为铂金或钛。
本发明的应用，其步骤为，打开超声，在超声监测下进行消融，当组织损伤范围到达预定目标时，关闭射频消融电流。
本发明设计的导管，集超声与射频消融为一体，将消融电极设计为金属网或金属柱等 带有孔隙，孔隙直径与超声波波长相适，使得超声波可通过衍射到达消融电极后方成像。使用本发明进行射频消融时，可以用超声波进行实时监测，而不必交换导管，节省了大量时间，同时，也避免了交换导管后寻找消融位点的麻烦。超声实时监测下的射频消融，也可帮助术者准确达到预定组织损伤范围，提高手术成功率，减少手术并发症，对射频消融手术有较大帮助。本发明设计合理，制备简便，操作方便，值得推广。
附图说明
图1为超声与射频消融二合一导管结构示意图。其中1是导管管身，2是位于导管管腔内的超声探头，3是冷盐水灌注孔，4是记录电极，5是由金属网或金属柱做成的消融电极。
图2为用金属网包绕超声探头后成像图。如图所示，使用金属网包绕超声探头对超声图像质量无明显影响。
图3为使用金属网作为消融电极进行射频消融结果图。如图所示，使用金属网进行射频消融不影响消融效果，可造成组织损伤。
图4为使用金属网包绕超声探头，同时用另一个金属网作为消融电极的消融结果图。如图所示，使用金属网包绕超声探头不影响超声成像，可以看到用另一个金属网进行消融后的组织损伤。
图5为使用本发明的超声与射频消融二合一导管的具体应用图，如图所示，使用时，记录电极4记录到异位起搏点后，通过超声探头(2)发出超声波(7)，超声波透过消融电极(5)到达组织(6)中，并形成反射的超声波(9)，到达超声探头成像。同时，消融电极(5)将射频电流(8，虚线箭头)传导到组织(6)中，形成组织损伤。在消融时，通过冷盐水灌注孔3灌注冷盐水，防止导管与组织接触界面焦痂形成，从而降低阻抗。
具体实施方式
下面结合附图和实施例对本发明作进一步的说明。
实施例1：一种可以实时监测的超声与射频消融二合一导管
如图1所示，超声与射频消融二合一导管由管身1、超声探头2、冷盐水灌注孔3、记录电极4和消融电极5组成。超声探头2位于管身1的管腔内，消融电极5位于管身1的头端，冷盐水灌注孔3、记录电极4位于管身1的前段，其中消融电极5由金属网或金属柱制成，金属网、金属柱的金属丝直径，或金属网、金属柱形成的孔隙直径与超声波波长相适，由于临床常用腔内超声频率为5-15M，组成金属网、金属柱的金属丝直径，或金属网、金属柱形成的孔隙直径设计为0.05mm-0.3mm，使得超声波可通过衍射到达消融电极后方成像。冷盐水灌 注孔3为孔隙状结构，围绕管身一周共有6个，用于消融时灌注冷盐水，防止导管与组织接触界面焦痂形成，降低阻抗。记录电极4为一对铂金材料制成的环状电极，固定在管身1表面，记录电极4与管身的固定方式与强生公司的消融导管(NS7TCDL174HS)上的记录电极相同，用于记录与导管接触部分心肌组织心电图，从而寻找心律失常的异位起搏点。
消融电极5优选为金属网，材料可选择各类金属，如铂金、钛、铜、铁、不锈钢等，优选为铂金或钛。
实施例2：用金属网包绕超声探头后成像
用30目铜网(铜丝直径约为0.3mm)、100目铜网(铜丝直径约为0.1mm)、200目铜网(铜丝直径约为0.05mm)、包绕超声探头，随后对发明人手腕处进行超声成像，超声频率为10M Hz。如图2所示，图2A为超声探头前不加铜网时超声成像图，图中箭头1为皮肤，箭头2为血管，箭头3为骨骼。图2B为用200目铜网(铜丝直径约为0.05mm)包绕超声探头后超声成像图，图2C为用100目铜网(铜丝直径约为0.1mm)包绕超声探头后超声成像图，图2D为用30目铜网(铜丝直径约为0.3mm)包绕超声探头后超声成像图，图中箭头1为皮肤，箭头2为血管，箭头3为骨骼。比较图2A、2B、2C、2D可知，使用金属网包绕超声探头对超声成像质量无明显影响。
实施例3：使用金属网作为消融电极进行射频消融
将金属网固定于一次性筷子头端，用鳄鱼钳将金属网与商用消融电极连接。将离体猪心置于盆中，盆中放入生理盐水，将金属网贴靠在猪心表面，背部电极浸泡于盆里生理盐水中，随后进行射频消融。图3A为射频消融前照片，图3B为使用金属网作为消融电极进行射频消融后照片，可见消融部位出现了组织损伤，颜色变白(箭头1)。
实施例4：使用金属网包绕超声探头，同时用另一个金属网作为消融电极的消融结果使用金属网包绕超声探头，将猪心置于盆中，盆中放入生理盐水，在消融前进行超声成像。随后，将金属网固定于一次性筷子头端，用鳄鱼钳将金属网与商用消融电极连接。将离体猪心置于盆中，盆中放入生理盐水，将金属网贴靠在猪心表面，背部电极浸泡于盆里生理盐水中，随后进行射频消融。射频消融后，再次用金属网包绕的超声探头进行超声成像。如图4所示，图4A为直接用超声探头进行成像，射频消融前猪心超声图，箭头1为左心室。图4B为直接用超声探头进行成像，并用金属网作为消融电极进行消融后猪心超声图，可见消融后消融位点出现组织损伤(箭头2)。图4C为使用金属网包绕的超声探头进行超声成像，射频消融前猪心超声图，箭头3为左心室，可见使用金属网包绕超声探头，对超声成像质量无明 显影响。图4D为使用金属网包绕的超声探头进行超声成像，并用金属网作为消融电极进行射频消融后的超声图，可见使用金属网进行消融可造成组织损伤，并且使用金属网包绕超声探头，不影响超声成像质量，可显示消融后组织损伤(箭头4)。
实施例5：使用本发明的超声与射频消融二合一导管。
如图5所示，本发明的具体应用方法如下：通过记录电极4找到异位起搏点后，通过超声探头2发出超声波，超声波透过消融电极5到达组织(6)中，并形成反射的超声波9，到达超声探头成像。同时，消融电极5将射频电流8(虚线箭头所示)传导到组织(6)中，形成组织损伤。通过超声图像实时监控组织损伤情况，在消融时，通过冷盐水灌注孔3灌注冷盐水，防止导管与组织接触界面焦痂形成，降低阻抗。
从上述实施例可见，超声探头前放置金属网，不影响超声成像。同时，使用金属网进行射频消融，也不影响消融效果，可造成组织损伤。因而，本发明设计将超声探头置于导管内部，导管头端使用金属网作为消融电极，可以实现如下效果：超声可以透过金属网进行成像，同时，金属网可作为消融电极进行射频消融，从而实现超声实时监测下的射频消融，准确达到预定的组织损伤范围。使用本发明的二合一导管进行射频消融时，不必交换导管，节省了大量时间，同时，也避免了交换导管后寻找消融位点的麻烦。超声实时监测下的射频消融，也可帮助术者准确达到预定组织损伤范围，提高手术成功率，减少手术并发症，对射频消融手术有较大帮助，简便易行，值得推广。

Claims (5)

  1. 一种实时监测的超声与射频消融二合一导管，其特征在于，由管身(1)、超声探头(2)、冷盐水灌注孔(3)、记录电极(4)和消融电极(5)组成，超声探头(2)位于管身(1)的管腔内，消融电极(5)位于管身(1)的头端，冷盐水灌注孔(3)、记录电极(4)位于管身(1)前段。
  2. 根据权利要求1所述的一种实时监测的超声与射频消融二合一导管，其特征在于，冷盐水灌注孔(3)为孔隙状结构，围绕管身(1)一周共有6个，记录电极(4)为一对铂金材料制成的环状电极，固定在管身(1)表面。
  3. 根据权利要求1所述的一种实时监测的超声与射频消融二合一导管，其特征在于，消融电极(5)由金属网或金属柱制成，金属网、金属柱的金属丝直径，或金属网、金属柱形成的孔隙直径与超声波波长相适。
  4. 根据权利要求2所述的一种实时监测的超声与射频消融二合一导管，其特征在于，金属网、金属柱的金属丝直径，或金属网、金属柱形成的孔隙直径设计为0.05mm-0.3mm。
  5. 根据权利要求1所述的一种实时监测的超声与射频消融二合一导管，其特征在于，消融电极(5)材料选用铂金、钛、铜、铁或不锈钢。
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