WO2021031616A1 - Triple micro-catheter device and method for transthoracic and epicardial intramyocardial injection under ultrasound guidance - Google Patents

Triple micro-catheter device and method for transthoracic and epicardial intramyocardial injection under ultrasound guidance Download PDF

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WO2021031616A1
WO2021031616A1 PCT/CN2020/088743 CN2020088743W WO2021031616A1 WO 2021031616 A1 WO2021031616 A1 WO 2021031616A1 CN 2020088743 W CN2020088743 W CN 2020088743W WO 2021031616 A1 WO2021031616 A1 WO 2021031616A1
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catheter
micro
microcatheter
puncture
needle core
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PCT/CN2020/088743
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French (fr)
Chinese (zh)
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曹丰
陶博
刘峻松
李苏雷
邱雅
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中国人民解放军总医院
曹丰
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Publication of WO2021031616A1 publication Critical patent/WO2021031616A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287Accessories for bringing the needle into the body; Automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3297Needles arranged coaxially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M2005/3201Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart

Definitions

  • This application relates to the technology of intramyocardial injection of drugs, in particular to a triple microcatheter device and method for transthoracic transepicardial intramyocardial injection under ultrasound guidance.
  • Cardiovascular diseases account for about 25% of all human deaths.
  • Various cardiovascular diseases can cause heart failure, such as myocardial infarction, valvular disease, cardiomyopathy, hypertension, etc.
  • the incidence of adult heart failure is 1-2% in European and American countries, and 0.9-1.3% in my country, showing an upward trend.
  • For patients with heart failure even if the primary cause is corrected, most of the cardiomyocytes are in a terminally differentiated state, and the cells lack self-regeneration ability. Once necrosis, it is difficult to regenerate. Therefore, the deterioration of heart function is difficult to reverse, and the mortality rate is high. Constantly consume medical resources.
  • treatment methods for heart failure also include cardiac resynchronization therapy, left ventricular assist devices, heart transplantation, etc., but all have their own limitations.
  • cardiac resynchronization therapy e.g., left ventricular assist devices, heart transplantation, etc.
  • heart transplantation e.g., left ventricular assist devices
  • the long-term prognosis of patients with heart failure is not optimistic.
  • the 5-year survival rate after the first onset of heart failure is less than 50%, which is equivalent to that of malignant tumors.
  • the electrophysiological system mapping further increases the difficulty and cost of the operation, which affects practical applications.
  • the injection route of thoracotomy via epicardial intramyocardial injection although the local blood concentration of the damaged myocardium is high, the trauma of thoracotomy is large, the risk of anesthesia is high, the structure of the pericardium is directly destroyed, the postoperative scar adhesion further reduces the intervention effect, and clinical application is difficult , More used for patients who originally planned thoracotomy. Therefore, exploring a way and method that is less traumatic, can accurately locate the local myocardial tissue that needs intervention, and has high drug delivery efficiency has strong scientific research and clinical application value.
  • the current spatial resolution of high-resolution ultrasound is close to that of magnetic resonance imaging.
  • the high-quality images make the clinical application of ultrasound-guided puncture more and more widely used in many diseases such as liver tumors and thyroid nodules.
  • the heart is a continuously beating organ, and ultrasound has the characteristics of high time resolution, ultrasound has unique advantages in the field of cardiac imaging.
  • bevel puncture needle (18G or 22G) to puncture myocardial tissue, as long as it does not directly damage the blood vessels and penetrate the ventricular wall, only a small amount of local myocardium permeates Blood, animal vital signs are stable.
  • Coronary arteries and veins are distributed in the epicardium. Once injured during puncture, acute pericardial tamponade may be life-threatening. In addition, the heart continues to beat, which has a great influence on the precise control of the puncture injection and drug delivery position. When the puncture needle is completely fixed, with the heart contraction and relaxation movement, it may cause secondary injury, and the injection drug location will also change.
  • the conventionally used puncture needle is a bevel puncture needle with a matching needle core inside. The needle body shows strong echo under ultrasound.
  • a thick puncture needle such as an 18G puncture needle with an outer diameter of 1.2mm, is more conducive to penetrating superficial hard tissues, and Establish a stable channel in the surrounding bony tissues such as the chest wall, but the risk of damaging deep tissues, especially important tissues, is higher. For example, when transthoracic epicardial puncture of the myocardium, the risk of damaging the epicardial blood vessels is even greater High, the direct damage to the local myocardial tissue is also greater.
  • this application aims to propose a microcatheter device that can perform intramyocardial injection through the thorax and epicardium under ultrasound guidance, which can directly administer and inject the myocardium.
  • This application also aims to propose a method for injecting the myocardium through the thoracic epicardium under ultrasound guidance.
  • This application proposes a triple microcatheter device for intramyocardial injection through the thorax and epicardium under ultrasound guidance, which includes: a thick puncture needle, a micro catheter, and a fine needle core;
  • the thick puncture needle is formed into a tube body, the first end of which is a tip with a bevel, which is used to puncture the chest wall;
  • the microcatheter is a flexible tube body, the first end of which is a tip with a bevel, which is used to penetrate the subject's myocardium;
  • the thin needle core is formed as a solid, and its first end is a tip with a bevel;
  • the length of the micro catheter and the fine needle core is greater than the length of the thick puncture needle
  • the micro catheter is inserted into the thick puncture needle, and the gap between the micro catheter and the thick puncture needle is airtight;
  • the fine needle core is inserted into the microcatheter, and the space between the fine needle core and the microcatheter is airtight; when the drug is injected, the fine needle core is withdrawn from the microcatheter, and the second end of the microcatheter Connect with drug injection device.
  • a marker is formed on the first end of the microcatheter, and the marker has a strong echo under ultrasound.
  • the bevel of the first end of the thick puncture needle, the bevel of the first end of the microcatheter, and the bevel of the first end of the thin needle core are aligned to form a flat bevel.
  • the first end of the micro catheter and the first end of the fine needle core extend from the first end of the thick puncture needle together.
  • the microcatheter includes a plurality of markers distributed along its length, wherein at least one marker is located at the first end of the microcatheter.
  • a scale is formed on the outside of the thick puncture needle; a scale is formed on the outside of the micro catheter.
  • the second end of the thick puncture needle is formed with an end seat; the second end of the micro catheter is formed with an end seat; the second end of the fine needle core is formed with an end seat; the end of the micro catheter A recess is formed on the second side of the seat; a protruding head is formed on the first side of the end seat of the fine needle core; the protruding head is detachably snapped into the recess, so that the micro catheter and the fine needle
  • the core is formed as one body.
  • This application proposes an ultrasound-guided transthoracic transepicardial intramyocardial injection method, which uses the aforementioned triple microcatheter device for injection;
  • the fine needle core is inserted into the catheter, and the micro catheter is inserted into the thick puncture needle.
  • the first ends of the thick puncture needle, micro catheter, and fine needle core are aligned, perform chest wall puncture;
  • the microcatheter is first withdrawn into the thick puncture needle. Ultrasound observes that there is no pericardial effusion and the blood circulation is stable. Then together with the thick puncture needle, the chest wall is withdrawn and the skin opening is closed.
  • the depth of the first end of the microcatheter into the myocardium is 1-5 cm;
  • the drug is injected.
  • the angle between the line connecting the epicardial puncture point and the short axis centerline of the left ventricle and the inserted microcatheter and the fine needle core is 120°-150°.
  • the ultrasound-guided transthoracic epicardial intramyocardial injection of the triple microcatheter device and method for ultrasound-guided transthoracic epicardial intramyocardial injection of the present application only needs to be in the chest wall of the experimental animal or subject each time Puncture 2-3 holes (each hole is about 1mm in diameter), and the drug can be injected into the myocardium through the epicardium through the thoracic epicardium through the microcatheter under ultrasound guidance, and it can overcome the influence of heartbeat on the positioning of the puncture needle. Drug administration can avoid secondary damage to the myocardium. It has the advantages of high local drug concentration, precise and controllable injection location, less trauma, fewer complications, and multiple drug administration at different time points.
  • the triple microcatheter device and method can be used for non-thoracic minimally invasive intramyocardial injection and administration in scientific research and clinical practice, providing a convenient, safe and efficient intramyocardial administration method, and has strong clinical transformation value.
  • FIG. 1 is a schematic cross-sectional structure diagram of each component of the triple microcatheter device of this application;
  • Figure 2 is a schematic diagram of the triple microcatheter device of the application during chest wall puncture
  • Fig. 3 is a schematic diagram of the triple microcatheter device of the application during myocardial puncture
  • Figure 4 is a schematic diagram of the triple microcatheter device of the application during drug injection
  • Figure 5 is a schematic diagram of ultrasound-guided transthoracic epicardial injection of drugs into pig myocardium
  • Figure 6 is a schematic diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium during and after injection;
  • Figure 7 is a comparison diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium before and after drug injection;
  • Figure 8 is an image of the puncture site after the animal operation.
  • This application proposes a triple microcatheter device for intramyocardial injection through the thorax and epicardium under ultrasound guidance, which includes a thick puncture needle 10, a microcatheter 20, and a fine needle core 30.
  • the thick puncture needle 10 is formed as a tube body, and the first end of the thick puncture needle 10 is a tip 11 formed with a bevel for puncturing the chest wall.
  • the microcatheter 20 is a flexible tube body, the first end of which is a tip 21 formed with a bevel, for piercing into the myocardium of the subject.
  • the thin needle core 30 is formed as a solid, and its first end is a tip with a bevel, which is used to insert the microcatheter 20 to provide rigidity for the microcatheter 20 during the puncture process.
  • the length of the micro catheter 20 and the fine needle core 30 is greater than the length of the thick puncture needle 10.
  • the micro catheter 20 is inserted into the thick puncture needle 10, and the micro catheter 20 and the thick puncture needle 10 are formed to be airtight.
  • the outer surface of the micro catheter 20 is in close contact with the inner surface of the thick puncture needle 10 to achieve air tightness. It can also be achieved by providing a sealing means between the microcatheter 20 and the coarse puncture needle 10, such as a sealing ring or a puncturable sealing film.
  • a scale may be formed on the surface of the micro catheter 20 to facilitate the determination of the penetration depth of the micro catheter.
  • a scale is formed on the outer surface of the thick puncture needle 10 to facilitate the determination of the puncture depth of the thick catheter.
  • the fine needle core 30 is inserted into the microcatheter 20, and the space between the fine needle core 30 and the microcatheter 20 is formed to be airtight, for example, the outer surface of the fine needle core 30 is tightly connected to the inner surface of the microcatheter 20
  • the airtightness of contact can also be achieved by providing a sealing means, such as a sealing ring or gasket, between the fine needle core 30 and the micro catheter 20; when the drug is injected, the fine needle core 30 is withdrawn from the micro catheter 20 , The second end of the micro catheter 20 is connected with the drug injection device.
  • a marker 24 is formed at the first end of the microcatheter 20.
  • the marker 24 has a strong echo under ultrasound, such as a metal marker or other material with strong echo under ultrasound, so that it can be clearly observed in the ultrasound image.
  • the marker may be a plurality of marking points distributed along the microcatheter 20, at least one of which is located near the first end of the microcatheter 20.
  • the bevel of the first end 11 of the thick puncture needle 10 when puncturing the chest wall, the bevel of the first end 21 of the microcatheter 20, and the bevel of the first end 31 of the thin needle core 30 are aligned to form a flat bevel. , As shown in Figure 2, it is convenient to puncture the chest wall.
  • the first end 21 of the micro catheter 20 and the first end 31 of the fine needle core 30 extend from the first end 11 of the thick puncture needle 10 together, as shown in FIG. 3.
  • the second end of the coarse puncture needle 10 is formed with an end seat 12, which is convenient to hold for corresponding operations on the coarse puncture needle.
  • the second end of the micro-catheter 20 is formed with an end seat 22, which is convenient to hold and operate the micro-catheter.
  • the second end of the thin needle core 30 is formed with an end seat 32, which is convenient to hold and operate the thin needle core.
  • a recess 23 is formed on the second side of the end seat 22 of the micro catheter 20; a convex head is formed on the first side of the end seat 32 of the fine needle core 30; the convex head is detachably snapped into the recess 23 so that the micro The catheter 20 is formed integrally with the thin needle core 30.
  • This application proposes an ultrasound-guided transthoracic transepicardial intramyocardial injection method, in which the aforementioned triple microcatheter device performs injection.
  • the short-axis view of the left ventricle of the heart is displayed through the ultrasound diagnostic apparatus, and the anterior wall and the anterior wall of the left ventricle are selected as the drug delivery area.
  • the puncture needle is punctured under the condition that ultrasound is completely visible, and the needle is inserted at the upper edge of the next rib.
  • the path avoids the anterior interventricular groove directly opposite the ventricular septum to prevent damage to the anterior descending vessel. Control the puncture needle to avoid the needle parallel to the contraction direction of the myocardium on the short axis, reduce the risk of penetrating the ventricular wall, and the longer intramyocardial needle path is beneficial to increase the drug delivery space.
  • Premature ventricular beats may occur in ECG monitoring when the fine needle core and micro catheter are just punctured into the myocardium, which can be used as an auxiliary judgment.
  • the microcatheter is gradually withdrawn, and a single needle track can be intermittently injected at multiple points during the withdrawal.
  • the microcatheter is first withdrawn into the thick puncture needle, and the ultrasound observation is that there is no pericardial effusion and the blood circulation is stable, and then the thoracic cavity is withdrawn together, and the skin opening is closed. Under ultrasound guidance, re-select the chest wall needle insertion position and needle path, and the same patient can choose two or more puncture paths for drug delivery.
  • Apparatus and equipment preparation mainly including high-resolution ultrasound diagnostic apparatus, cardiac ultrasound probe, probe puncture frame, triple microcatheter device of this application, and 2ml syringe.
  • the thick puncture needle, the fine needle core, and the metal mark at the tip of the microcatheter are all strongly echoed under ultrasound to facilitate positioning under ultrasound guidance.
  • the thick puncture needle carries a micro catheter and a fine needle core to keep the tip level, punctures the chest wall, with a sense of breakthrough, and fixes it before puncturing the pericardium and myocardium.
  • a single needle track can be intermittently injected into multiple points during the withdrawal process.
  • the microcatheter is first withdrawn into the thick puncture needle, and the ultrasound observation is that there is no pericardial effusion and the blood circulation is stable, and then the thoracic cavity is withdrawn together, and the skin opening is closed. Under ultrasound guidance, re-select the chest wall needle insertion position and needle path, and the same patient can choose two or more puncture paths for drug delivery. After the injection and administration, only a small amount of needles were left in the puncture part, as shown in Figure 8.
  • a thick puncture needle to guide through the chest wall of hard and surrounding bony structures, and carry a micro catheter along the preset guide wire with a fine needle core to puncture the myocardium, which directly reduces the risk of local myocardial injury and epicardial vascular injury.
  • the microcatheter has low friction in the lumen of the thick puncture needle and is easy to enter and exit.
  • the inner diameter of the thick puncture needle is equal to the outer diameter of the microcatheter, which can avoid the occurrence of pneumothorax.
  • the micro-catheter enters the myocardial tissue and exits the fine needle core.
  • the micro-catheter can move with the myocardial tissue to a certain extent, overcome the influence of the heartbeat on the drug delivery system, and reduce the secondary damage of the myocardium.
  • the tail end of the micro-catheter can be directly administered after suction by negative pressure, and the operation is smooth, saving operation time and improving operation safety.
  • the heart structure and function can be dynamically observed in real time, complications can be found in the first time, catheterization and drainage are convenient, and safety guarantee is improved.

Abstract

A triple micro-catheter device, for transthoracic and epicardial intramyocardial injection under ultrasound guidance. The triple micro-catheter device comprises: a thick puncture needle (10), a micro-catheter (20), and a thin needle core (30). In a puncture process, the thin needle core (30) is inserted into the micro-catheter (20), and air tightness is formed between the thin needle core (30) and the micro-catheter (20); when a medicine is injected, the thin needle core (30) is withdrawn from the micro-catheter (20), and a second end of the micro-catheter (20) is connected to a medicine injection device. According to the device and the method thereof, two to three holes only need to be punctured in the chest wall of an experimental animal or a subject each time, the medicine can be injected into the myocardium via the thoracic epicardium by means of the micro-catheter (20) under the ultrasonic guidance, and the influence of heart beat on puncture needle positioning can be overcome; accurate administration is achieved, secondary myocardial injury is avoided, and the advantages of being high in local administration concentration, accurate and controllable in injection position, small in trauma, few in complications, capable of achieving administration for many times at different time points and the like are achieved. A convenient, safe and efficient intramyocardial administration mode is provided, and a high clinical translational value is achieved.

Description

一种用于超声引导下经胸经心外膜心肌内注射的三联微导管装置和方法A triple microcatheter device and method for transthoracic transepicardial intramyocardial injection under ultrasound guidance 技术领域Technical field
本申请涉及心肌内注射药物的技术,尤其涉及超声引导下经胸经心外膜心肌内注射的三联微导管装置和方法。This application relates to the technology of intramyocardial injection of drugs, in particular to a triple microcatheter device and method for transthoracic transepicardial intramyocardial injection under ultrasound guidance.
背景技术Background technique
心血管疾病约占人类全部死因的25%,多种心血管疾病均可导致心力衰竭,如心肌梗死,心脏瓣膜病、心肌病、高血压病等。成年人心力衰竭的发生率在欧美国家是1-2%,在我国是0.9-1.3%,呈上升趋势。对于心衰患者,即使纠正原发病因,由于绝大多数的心肌细胞都处于终末分化状态,细胞缺乏自我再生能力,一旦坏死就很难再生,所以心功能恶化很难逆转,死亡率居高不下,且大量消耗医疗资源。目前除药物治疗改善左室重构外,心衰的治疗方法还包括心脏再同步化治疗、左室辅助装置、心脏移植等,但均具有各自局限性。当前,心衰患者远期预后不容乐观,心衰首次发病后5年生存率小于50%,与恶性肿瘤相当。Cardiovascular diseases account for about 25% of all human deaths. Various cardiovascular diseases can cause heart failure, such as myocardial infarction, valvular disease, cardiomyopathy, hypertension, etc. The incidence of adult heart failure is 1-2% in European and American countries, and 0.9-1.3% in my country, showing an upward trend. For patients with heart failure, even if the primary cause is corrected, most of the cardiomyocytes are in a terminally differentiated state, and the cells lack self-regeneration ability. Once necrosis, it is difficult to regenerate. Therefore, the deterioration of heart function is difficult to reverse, and the mortality rate is high. Constantly consume medical resources. At present, in addition to drug therapy to improve left ventricular remodeling, treatment methods for heart failure also include cardiac resynchronization therapy, left ventricular assist devices, heart transplantation, etc., but all have their own limitations. At present, the long-term prognosis of patients with heart failure is not optimistic. The 5-year survival rate after the first onset of heart failure is less than 50%, which is equivalent to that of malignant tumors.
近年来,以干细胞和细胞因子等为代表的生物治疗为心衰患者带来了希望,该治疗方法有直接修复受损心肌的潜力,具有巨大的社会应用价值。在科研相关的动物实验和临床实验中,目前主要有经外周静脉、经冠状动脉,通过导管经心内膜和开胸经心外膜心肌内注射给药等途径。其中经外周静脉和冠状动脉途径,药物经过血液循环进入局部心肌,使得受损心肌局部血药浓度低,效果差。通过导管经心内膜给药需要特殊手术器械,花费大,且导管穿刺针在立体的心腔内很难精确定位,通过电生理系统标测进一步增加了手术难度和费用,影响实际应用。而开胸经心外膜心肌内注射途径,虽然受损心肌局部血药浓度高,但开胸创伤大、麻醉风险高,直接破坏心包结构,术后瘢痕黏连进一步降低干预效果,临床应用困难,更多用于原本就计划开胸手术的患者。因此,探索一种创伤小、针对需要干预的局部心肌组织能准确定位,给药效率高的途径和方法具有很强的科研和临床应用价值。In recent years, biological treatments represented by stem cells and cytokines have brought hope to patients with heart failure. This treatment has the potential to directly repair damaged myocardium and has great social application value. In scientific research-related animal experiments and clinical experiments, there are currently mainly routes of administration via peripheral veins, via coronary arteries, via catheters via endocardium and via thoracotomy via epicardial intramyocardial injection. Among them, the drugs enter the local myocardium through the blood circulation through the peripheral veins and coronary arteries, making the local blood drug concentration of the damaged myocardium low and the effect is poor. Transendocardial drug delivery through a catheter requires special surgical equipment, which is expensive, and the catheter puncture needle is difficult to accurately locate in a three-dimensional heart cavity. The electrophysiological system mapping further increases the difficulty and cost of the operation, which affects practical applications. However, the injection route of thoracotomy via epicardial intramyocardial injection, although the local blood concentration of the damaged myocardium is high, the trauma of thoracotomy is large, the risk of anesthesia is high, the structure of the pericardium is directly destroyed, the postoperative scar adhesion further reduces the intervention effect, and clinical application is difficult , More used for patients who originally planned thoracotomy. Therefore, exploring a way and method that is less traumatic, can accurately locate the local myocardial tissue that needs intervention, and has high drug delivery efficiency has strong scientific research and clinical application value.
高分辨率超声目前的空间分辨率已接近磁共振成像,高质量的图像让超声导引下穿刺临床应用日益增多,在肝脏肿瘤、甲状腺结节等多种疾病中广泛开展。由于心脏是一个持续跳动的器官,而超声具有 高时间分辨率特点,因此在心脏影像领域超声具有独到优势。我们在前期的动物实验中发现,开胸或者利用高分辨率超声引导临床常用的斜面式穿刺针(18G或22G)穿刺心肌组织,只要不直接损伤血管和穿透室壁,局部心肌仅少量渗血,动物生命体征平稳。The current spatial resolution of high-resolution ultrasound is close to that of magnetic resonance imaging. The high-quality images make the clinical application of ultrasound-guided puncture more and more widely used in many diseases such as liver tumors and thyroid nodules. Since the heart is a continuously beating organ, and ultrasound has the characteristics of high time resolution, ultrasound has unique advantages in the field of cardiac imaging. We have found in previous animal experiments that if thoracotomy or high-resolution ultrasound is used to guide the clinically commonly used bevel puncture needle (18G or 22G) to puncture myocardial tissue, as long as it does not directly damage the blood vessels and penetrate the ventricular wall, only a small amount of local myocardium permeates Blood, animal vital signs are stable.
心外膜分布有冠状动脉和静脉,穿刺过程中一旦损伤,有可能引起急性心包填塞危及生命。且心脏持续跳动,对穿刺注射给药位置的精确控制存在很大影响,当穿刺针完全固定,随着心脏收缩舒张运动,可能引起二次损伤,注射给药位置也会发生改变。常规使用的穿刺针为内带配套针芯的斜面式穿刺针,针体在超声下呈强回声,粗穿刺针,如18G穿刺针外径1.2mm,更利于穿透浅表质硬组织,以及在周围多骨性结构的组织中建立一条稳定的通道如胸壁,但损伤深部组织,尤其是重要组织的风险更高,如经胸经心外膜穿刺心肌时,损伤心外膜血管的风险更高,对局部心肌组织的直接损伤也更大。Coronary arteries and veins are distributed in the epicardium. Once injured during puncture, acute pericardial tamponade may be life-threatening. In addition, the heart continues to beat, which has a great influence on the precise control of the puncture injection and drug delivery position. When the puncture needle is completely fixed, with the heart contraction and relaxation movement, it may cause secondary injury, and the injection drug location will also change. The conventionally used puncture needle is a bevel puncture needle with a matching needle core inside. The needle body shows strong echo under ultrasound. A thick puncture needle, such as an 18G puncture needle with an outer diameter of 1.2mm, is more conducive to penetrating superficial hard tissues, and Establish a stable channel in the surrounding bony tissues such as the chest wall, but the risk of damaging deep tissues, especially important tissues, is higher. For example, when transthoracic epicardial puncture of the myocardium, the risk of damaging the epicardial blood vessels is even greater High, the direct damage to the local myocardial tissue is also greater.
发明的公开Disclosure of invention
鉴于上述问题,本申请旨在提出一种可以在超声引导下经胸经心外膜进行心肌内注射的微导管装置,其可以直接对心肌进行给药注射。本申请还旨在提出一种在超声引导下经胸经心外膜对心肌进行注射的方法。In view of the above-mentioned problems, this application aims to propose a microcatheter device that can perform intramyocardial injection through the thorax and epicardium under ultrasound guidance, which can directly administer and inject the myocardium. This application also aims to propose a method for injecting the myocardium through the thoracic epicardium under ultrasound guidance.
本申请提出一种三联微导管装置,用于超声引导下经胸经心外膜进行心肌内注射,其包括:粗穿刺针、微导管、细针芯;This application proposes a triple microcatheter device for intramyocardial injection through the thorax and epicardium under ultrasound guidance, which includes: a thick puncture needle, a micro catheter, and a fine needle core;
粗穿刺针形成为管体,其第一端为形成有斜面的尖端,用于穿刺胸壁;The thick puncture needle is formed into a tube body, the first end of which is a tip with a bevel, which is used to puncture the chest wall;
微导管为具有柔韧性的管体,其第一端为形成有斜面的尖端,用于刺入受试者的心肌内;The microcatheter is a flexible tube body, the first end of which is a tip with a bevel, which is used to penetrate the subject's myocardium;
细针芯形成为实心的,其第一端为形成有斜面的尖端;The thin needle core is formed as a solid, and its first end is a tip with a bevel;
微导管和细针芯的长度大于粗穿刺针的长度;The length of the micro catheter and the fine needle core is greater than the length of the thick puncture needle;
微导管插入于粗穿刺针中,微导管与粗穿刺针之间形成为气密的;The micro catheter is inserted into the thick puncture needle, and the gap between the micro catheter and the thick puncture needle is airtight;
在穿刺过程中,细针芯插入于微导管中,且细针芯与微导管之间形成为气密的;在注射药物时,细针芯自微导管中撤出,微导管的第二端与药物注射装置连接。During the puncture process, the fine needle core is inserted into the microcatheter, and the space between the fine needle core and the microcatheter is airtight; when the drug is injected, the fine needle core is withdrawn from the microcatheter, and the second end of the microcatheter Connect with drug injection device.
优选地,所述微导管的第一端形成有标记物,该标记物在超声下具有强回声。Preferably, a marker is formed on the first end of the microcatheter, and the marker has a strong echo under ultrasound.
优选地,穿刺过程中,在穿刺胸壁时,所述粗穿刺针的第一端的斜面、微导管的第一端的斜面、细针芯的第一端的斜面对齐,构成一 个平整的斜面。Preferably, during the puncture process, when puncturing the chest wall, the bevel of the first end of the thick puncture needle, the bevel of the first end of the microcatheter, and the bevel of the first end of the thin needle core are aligned to form a flat bevel.
优选地,在心肌穿刺时,所述微导管的第一端和细针芯的第一端一起自所述粗穿刺针的第一端延伸出。Preferably, during myocardial puncture, the first end of the micro catheter and the first end of the fine needle core extend from the first end of the thick puncture needle together.
优选地,所述微导管包括沿其长度分布的多个标记物,其中至少一个标记物位于所述微导管的第一端。Preferably, the microcatheter includes a plurality of markers distributed along its length, wherein at least one marker is located at the first end of the microcatheter.
优选地,所述粗穿刺针外侧形成有刻度;所述微导管外侧形成有刻度。Preferably, a scale is formed on the outside of the thick puncture needle; a scale is formed on the outside of the micro catheter.
优选地,所述粗穿刺针的第二端形成有端座;所述微导管的第二端形成有端座;所述细针芯的第二端形成有端座;所述微导管的端座的第二侧形成有凹穴;所述细针芯的端座的第一侧形成有凸头;所述凸头可拆卸地卡入所述凹穴中,使得所述微导管与细针芯形成为一体。Preferably, the second end of the thick puncture needle is formed with an end seat; the second end of the micro catheter is formed with an end seat; the second end of the fine needle core is formed with an end seat; the end of the micro catheter A recess is formed on the second side of the seat; a protruding head is formed on the first side of the end seat of the fine needle core; the protruding head is detachably snapped into the recess, so that the micro catheter and the fine needle The core is formed as one body.
本申请提出一种超声引导下经胸经心外膜心肌内注射的方法,其利用前述的三联微导管装置进行注射;This application proposes an ultrasound-guided transthoracic transepicardial intramyocardial injection method, which uses the aforementioned triple microcatheter device for injection;
细针芯微插入导管中,微导管插入粗穿刺针中,在粗穿刺针、微导管、细针芯的第一端对齐的情况下,进行胸壁穿刺;The fine needle core is inserted into the catheter, and the micro catheter is inserted into the thick puncture needle. When the first ends of the thick puncture needle, micro catheter, and fine needle core are aligned, perform chest wall puncture;
在胸壁穿刺完成后,将微导管、细针芯一起延伸超出粗穿刺针的第一端,选择适当的心外膜穿刺点,以预定角度刺入左心室的心肌的预定深度,完成心肌穿刺;After the chest wall puncture is completed, extend the micro-catheter and the fine needle core together beyond the first end of the thick puncture needle, select an appropriate epicardial puncture point, and puncture the left ventricle to a predetermined depth at a predetermined angle to complete the myocardial puncture;
撤去细针芯,将微导管的第二端与药物注射装置连接,将药物经由微导管而提供到心肌中;Remove the fine needle core, connect the second end of the micro catheter to the drug injection device, and deliver the drug to the myocardium through the micro catheter;
给药完成后微导管先回撤入粗穿刺针,超声观察无心包积液且血液循环稳定,再连同粗穿刺针一起共同撤出胸壁,封闭皮口。After the administration is completed, the microcatheter is first withdrawn into the thick puncture needle. Ultrasound observes that there is no pericardial effusion and the blood circulation is stable. Then together with the thick puncture needle, the chest wall is withdrawn and the skin opening is closed.
优选地,微导管的第一端进入心肌内的深度为1-5cm;Preferably, the depth of the first end of the microcatheter into the myocardium is 1-5 cm;
当微导管的第一端位于心内膜和心外膜中的心肌层,且在心脏舒张期与心内膜层的距离D1、与心外膜层的距离D2均大于2mm时进行药物注射。When the first end of the microcatheter is located in the myocardium in the endocardium and the epicardium, and the distance D1 from the endocardium layer and the distance D2 from the epicardium layer during diastole are both greater than 2mm, the drug is injected.
优选地,心外膜穿刺点与左心室短轴中心线的连线与插在一起的微导管与细针芯之间的夹角为120°-150°。Preferably, the angle between the line connecting the epicardial puncture point and the short axis centerline of the left ventricle and the inserted microcatheter and the fine needle core is 120°-150°.
本申请的超声引导下经胸经心外膜心肌内注射给药的超声引导下经胸经心外膜心肌内注射的三联微导管装置和方法,每次只需在实验动物或受试者胸壁上穿刺2-3个孔(每孔直径约1mm),即可在超声引导下将药物通过微导管经胸经心外膜注入到心肌内,且可克服心脏跳动对穿刺针定位的影响,精确给药,避免心肌二次损伤,具有局部给药浓度高、注射位置精确可控、创伤小、并发症少、可不同时间点多次给药等优点。该三联微导管装置和方法可用于科研及临床中不开胸 微创心肌内注射给药,提供了一种便捷、安全、高效的心肌内给药方式,具有较强的临床转化价值。The ultrasound-guided transthoracic epicardial intramyocardial injection of the triple microcatheter device and method for ultrasound-guided transthoracic epicardial intramyocardial injection of the present application only needs to be in the chest wall of the experimental animal or subject each time Puncture 2-3 holes (each hole is about 1mm in diameter), and the drug can be injected into the myocardium through the epicardium through the thoracic epicardium through the microcatheter under ultrasound guidance, and it can overcome the influence of heartbeat on the positioning of the puncture needle. Drug administration can avoid secondary damage to the myocardium. It has the advantages of high local drug concentration, precise and controllable injection location, less trauma, fewer complications, and multiple drug administration at different time points. The triple microcatheter device and method can be used for non-thoracic minimally invasive intramyocardial injection and administration in scientific research and clinical practice, providing a convenient, safe and efficient intramyocardial administration method, and has strong clinical transformation value.
附图的简要说明Brief description of the drawings
图1为本申请的三联微导管装置的各组成部分的剖面结构示意图;FIG. 1 is a schematic cross-sectional structure diagram of each component of the triple microcatheter device of this application;
图2为本申请的三联微导管装置进行胸壁穿刺时的示意图;Figure 2 is a schematic diagram of the triple microcatheter device of the application during chest wall puncture;
图3为本申请的三联微导管装置进行心肌穿刺时的示意图;Fig. 3 is a schematic diagram of the triple microcatheter device of the application during myocardial puncture;
图4为本申请的三联微导管装置进行药物注射时的示意图;Figure 4 is a schematic diagram of the triple microcatheter device of the application during drug injection;
图5为超声引导下经胸经心外膜给猪心肌注射药物的示意图;Figure 5 is a schematic diagram of ultrasound-guided transthoracic epicardial injection of drugs into pig myocardium;
图6为超声引导下经胸经心外膜给猪心肌注射药物注射过程中和注射后的示意图;Figure 6 is a schematic diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium during and after injection;
图7为超声引导下经胸经心外膜给猪心肌注射药物注射前后的对照图;Figure 7 is a comparison diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium before and after drug injection;
图8为动物术后穿刺部位图像。Figure 8 is an image of the puncture site after the animal operation.
实现本发明的最佳方式The best way to implement the invention
下面,结合附图对本申请的用于超声引导下经胸经心外膜心肌内注射的三联微导管装置和方法进行详细说明。Hereinafter, the triple microcatheter device and method for transthoracic epicardial intramyocardial injection under ultrasound guidance of the present application will be described in detail with reference to the accompanying drawings.
本申请提出一种三联微导管装置,用于超声引导下经胸经心外膜进行心肌内注射,其包括:粗穿刺针10、微导管20、细针芯30。This application proposes a triple microcatheter device for intramyocardial injection through the thorax and epicardium under ultrasound guidance, which includes a thick puncture needle 10, a microcatheter 20, and a fine needle core 30.
粗穿刺针10形成为管体,其第一端为形成有斜面的尖端11,用于穿刺胸壁。The thick puncture needle 10 is formed as a tube body, and the first end of the thick puncture needle 10 is a tip 11 formed with a bevel for puncturing the chest wall.
微导管20为具有柔韧性的管体,其第一端为形成有斜面的尖端21,用于刺入受试者的心肌内。The microcatheter 20 is a flexible tube body, the first end of which is a tip 21 formed with a bevel, for piercing into the myocardium of the subject.
细针芯30形成为实心的,其第一端为形成有斜面的尖端,其用于插入微导管20中,在穿刺过程中为微导管20提供刚性。The thin needle core 30 is formed as a solid, and its first end is a tip with a bevel, which is used to insert the microcatheter 20 to provide rigidity for the microcatheter 20 during the puncture process.
微导管20和细针芯30的长度大于粗穿刺针10的长度。The length of the micro catheter 20 and the fine needle core 30 is greater than the length of the thick puncture needle 10.
微导管20插入于粗穿刺针10中,微导管20与粗穿刺针10之间形成为气密的,例如通过微导管20的外表面与粗穿刺针10的内表面紧密接触而实现气密,也可以通过在微导管20和粗穿刺针10之间设置密封手段,例如密封圈或可穿刺的密封膜来实现。The micro catheter 20 is inserted into the thick puncture needle 10, and the micro catheter 20 and the thick puncture needle 10 are formed to be airtight. For example, the outer surface of the micro catheter 20 is in close contact with the inner surface of the thick puncture needle 10 to achieve air tightness. It can also be achieved by providing a sealing means between the microcatheter 20 and the coarse puncture needle 10, such as a sealing ring or a puncturable sealing film.
微导管20表面可形成有刻度,以方便确定微导管刺入的深度。A scale may be formed on the surface of the micro catheter 20 to facilitate the determination of the penetration depth of the micro catheter.
粗穿刺针10外表面形成有刻度,以方便确定粗导管的穿刺深度。A scale is formed on the outer surface of the thick puncture needle 10 to facilitate the determination of the puncture depth of the thick catheter.
在穿刺过程中,细针芯30插入于微导管20中,且细针芯30与微导管20之间形成为气密的,例如通过细针芯30的外表面与微导管20 的内表面紧密接触而实现气密,也可以通过在细针芯30与微导管20之间设置密封手段,例如密封圈或密封垫等来实现;在注射药物时,细针芯30自微导管20中撤出,微导管20的第二端与药物注射装置连接。During the puncture process, the fine needle core 30 is inserted into the microcatheter 20, and the space between the fine needle core 30 and the microcatheter 20 is formed to be airtight, for example, the outer surface of the fine needle core 30 is tightly connected to the inner surface of the microcatheter 20 The airtightness of contact can also be achieved by providing a sealing means, such as a sealing ring or gasket, between the fine needle core 30 and the micro catheter 20; when the drug is injected, the fine needle core 30 is withdrawn from the micro catheter 20 , The second end of the micro catheter 20 is connected with the drug injection device.
微导管20的第一端形成有标记物24,该标记物24在超声下具有强回声,例如金属标记物或是在超声下具有强回声的其他物质,以便于在超声图像中可以清楚地观察到微导管20的第一端所处的位置,尤其是在心肌外膜的穿刺点的位置和在心肌中所处的位置,以方便判断穿刺点是否合适、注射点是否合适。标记物可以是沿微导管20分布的多个标记点,其中至少一个设置微导管20的第一端的附近。A marker 24 is formed at the first end of the microcatheter 20. The marker 24 has a strong echo under ultrasound, such as a metal marker or other material with strong echo under ultrasound, so that it can be clearly observed in the ultrasound image. To the position of the first end of the microcatheter 20, especially the position of the puncture point of the epimyocardium and the position in the myocardium, to facilitate the judgment of whether the puncture point is appropriate and the injection point is appropriate. The marker may be a plurality of marking points distributed along the microcatheter 20, at least one of which is located near the first end of the microcatheter 20.
穿刺过程中,在穿刺胸壁时,粗穿刺针10的第一端11的斜面、微导管20的第一端21的斜面、细针芯30的第一端31的斜面对齐,构成一个平整的斜面,如图2所示,便于穿刺胸壁。During the puncture process, when puncturing the chest wall, the bevel of the first end 11 of the thick puncture needle 10, the bevel of the first end 21 of the microcatheter 20, and the bevel of the first end 31 of the thin needle core 30 are aligned to form a flat bevel. , As shown in Figure 2, it is convenient to puncture the chest wall.
在心肌穿刺时,微导管20的第一端21和细针芯30的第一端31一起自粗穿刺针10的第一端11延伸出,如图3所示。During myocardial puncture, the first end 21 of the micro catheter 20 and the first end 31 of the fine needle core 30 extend from the first end 11 of the thick puncture needle 10 together, as shown in FIG. 3.
粗穿刺针10的第二端形成有端座12,便于握持以对粗穿刺针进行相应操作。The second end of the coarse puncture needle 10 is formed with an end seat 12, which is convenient to hold for corresponding operations on the coarse puncture needle.
微导管20的第二端形成有端座22,便于握持以对微导管进行操作。The second end of the micro-catheter 20 is formed with an end seat 22, which is convenient to hold and operate the micro-catheter.
细针芯30的第二端形成有端座32,便于握持以对细针芯进行操作。The second end of the thin needle core 30 is formed with an end seat 32, which is convenient to hold and operate the thin needle core.
微导管20的端座22的第二侧形成有凹穴23;细针芯30的端座32的第一侧形成有凸头;凸头可拆卸地卡入凹穴23中,使得所述微导管20与细针芯30形成为一体。A recess 23 is formed on the second side of the end seat 22 of the micro catheter 20; a convex head is formed on the first side of the end seat 32 of the fine needle core 30; the convex head is detachably snapped into the recess 23 so that the micro The catheter 20 is formed integrally with the thin needle core 30.
本申请提出一种超声引导下经胸经心外膜心肌内注射的方法,其前述的三联微导管装置进行注射。This application proposes an ultrasound-guided transthoracic transepicardial intramyocardial injection method, in which the aforementioned triple microcatheter device performs injection.
具体使用步骤如下:The specific steps are as follows:
(1)通过超声诊断仪显示心脏左心室短轴切面,选择左室前壁和前侧壁为给药区域,穿刺针在超声完全可视情况下进行穿刺,在下一肋骨上缘进针,穿刺路径避开室间隔正对的前室间沟,以防损伤前降支血管。控制穿刺针避免平行于心肌在短轴上的收缩方向进针,降低穿透室壁的风险,且较长的心肌内针道利于增加给药空间。(1) The short-axis view of the left ventricle of the heart is displayed through the ultrasound diagnostic apparatus, and the anterior wall and the anterior wall of the left ventricle are selected as the drug delivery area. The puncture needle is punctured under the condition that ultrasound is completely visible, and the needle is inserted at the upper edge of the next rib. The path avoids the anterior interventricular groove directly opposite the ventricular septum to prevent damage to the anterior descending vessel. Control the puncture needle to avoid the needle parallel to the contraction direction of the myocardium on the short axis, reduce the risk of penetrating the ventricular wall, and the longer intramyocardial needle path is beneficial to increase the drug delivery space.
(2)先应用超声探头配套的穿刺架固定粗穿刺针,穿入微导管和细针芯,三者在穿刺前形成一个整体。粗穿刺针携带微导管和细针芯保持尖端平齐,穿刺胸壁,有突破感,在穿刺心包及心肌前固定,如图2。(2) First, use the puncture frame provided with the ultrasound probe to fix the thick puncture needle, penetrate the micro catheter and the fine needle core, and the three form a whole before puncture. The thick puncture needle carries the micro catheter and the fine needle core to keep the tip level, punctures the chest wall with a sense of breakthrough, and fixes it before puncturing the pericardium and myocardium, as shown in Figure 2.
(3)利用超声自带的引导线确定进一步穿刺心肌的针道位置,进 一步推送微导管和细针芯,因无需交换步骤,避免和减少气胸的发生。细针芯和微导管刚刚穿刺入心肌时心电监护会有室性早搏发生,可作为辅助判断。以细针芯携带微导管穿刺进入心肌内1-5cm,以微导管表面的刻度标记判断进针深度,以舒张期微导管尖端的金属标记位置确定给药位置,距离心内膜和心外膜保持2mm以上安全距离,观察无异常则退出细针芯。微导管随心肌跳动,尾端可直接连接注射器负压回抽后给药,避免心肌二次损伤,如图3和图4所示。(3)Using the guide line that comes with ultrasound to determine the position of the needle path for further puncturing the myocardium, and further pushing the micro catheter and fine needle core, because there is no need to exchange steps, avoid and reduce the occurrence of pneumothorax. Premature ventricular beats may occur in ECG monitoring when the fine needle core and micro catheter are just punctured into the myocardium, which can be used as an auxiliary judgment. Use a fine needle core to carry the microcatheter into the myocardium for 1-5cm, use the scale mark on the surface of the microcatheter to determine the depth of the needle, and determine the drug delivery position with the metal mark on the tip of the microcatheter during diastole, which is away from the endocardium and epicardium Keep a safe distance above 2mm, and exit the fine needle core if there is no abnormality observed. The micro-catheter beats with the myocardium, and the tail end can be directly connected to the syringe after the negative pressure is drawn back to avoid secondary damage to the myocardium, as shown in Figure 3 and Figure 4.
(4)逐渐回撤微导管,回撤过程中单个针道可以间断进行多点注射。给药完成后微导管先撤入粗穿刺针,超声观察无心包积液且血液循环稳定,再共同撤出胸腔,封闭皮口。在超声引导下重新选择胸壁进针位置和针道,同一患者可以选择两个或更多穿刺道进行给药。(4) The microcatheter is gradually withdrawn, and a single needle track can be intermittently injected at multiple points during the withdrawal. After the administration is completed, the microcatheter is first withdrawn into the thick puncture needle, and the ultrasound observation is that there is no pericardial effusion and the blood circulation is stable, and then the thoracic cavity is withdrawn together, and the skin opening is closed. Under ultrasound guidance, re-select the chest wall needle insertion position and needle path, and the same patient can choose two or more puncture paths for drug delivery.
(5)穿刺心肌给药结束后常规观察心电及心包1小时,维持心电稳定,必要时置管引流,提高安全保障。(5) Routinely observe the ECG and pericardium for 1 hour after myocardial puncture and administration to maintain the stability of the ECG, and place a tube for drainage if necessary to improve safety.
实施例Example
1.仪器和器械准备,主要包括高分辨率超声诊断仪、心脏超声探头、探头穿刺架、本申请的三联微导管装置、2ml注射器。其中粗穿刺针、细针芯、微导管尖端的金属标记在超声下均呈强回声,以便于超声引导下定位。1. Apparatus and equipment preparation, mainly including high-resolution ultrasound diagnostic apparatus, cardiac ultrasound probe, probe puncture frame, triple microcatheter device of this application, and 2ml syringe. Among them, the thick puncture needle, the fine needle core, and the metal mark at the tip of the microcatheter are all strongly echoed under ultrasound to facilitate positioning under ultrasound guidance.
2.动物麻醉、脱毛后取仰卧位,调整超声探头位置,选择左心室短轴前壁和前侧壁为给药区域,于下一肋骨上缘进针,穿刺路径避开室间隔正对的前室间沟,以防损伤前降支。控制穿刺针避免平行于心肌在短轴上的收缩方向进针,降低穿透室壁的风险,且较长的心肌内针道利于增加给药空间。在针尖于超声完全可视情况下选择注射给药部位。对于心梗小型猪,选择心梗节段以上的缺血区域进行精确注射给药,如图6和图7所示。2. After the animal is anesthetized and depilated, take the supine position, adjust the position of the ultrasound probe, select the left ventricle short axis anterior wall and anterior wall as the drug delivery area, and insert the needle at the upper edge of the next rib, avoiding the puncture path directly opposite the ventricular septum Interventricular groove to prevent damage to the anterior descending branch. Control the puncture needle to avoid the needle parallel to the contraction direction of the myocardium on the short axis, reduce the risk of penetrating the ventricular wall, and the longer intramyocardial needle path is beneficial to increase the drug delivery space. Select the injection site under the condition that the needle tip is completely visible on the ultrasound. For myocardial infarction minipigs, the ischemic area above the myocardial infarction segment is selected for precise injection, as shown in Figure 6 and Figure 7.
3.先应用超声探头配套的穿刺架固定粗穿刺针,穿入微导管和细针芯,三者在穿刺前形成一个整体,如图2所示。粗穿刺针携带微导管和细针芯保持尖端平齐,穿刺胸壁,有突破感,在穿刺心包及心肌前固定。3. First, use the puncture frame that is matched with the ultrasound probe to fix the thick puncture needle, penetrate the micro catheter and the fine needle core, and the three form a whole before puncture, as shown in Figure 2. The thick puncture needle carries a micro catheter and a fine needle core to keep the tip level, punctures the chest wall, with a sense of breakthrough, and fixes it before puncturing the pericardium and myocardium.
4.利用超声自带的引导线确定进一步穿刺心肌的针道位置,进一步推送微导管和细针芯,无需交换,避免和减少气胸的发生。细针芯和微导管刚刚穿刺入心肌时心电监护会有室性早搏发生,可作为辅助判断。以细针芯携带微导管穿刺进入心肌内1-5cm,以微导管表面的刻度标记判断进针深度,以舒张期微导管尖端的金属标记位置确定给药位置,距离心内膜和心外膜保持2mm以上安全距离,观察无异常则退出细针芯。微导管随心肌跳动,尾端可直接连接注射器负压回抽后 给药,避免心肌二次损伤,如图3和图4所示。4. Use the guide wire that comes with ultrasound to determine the position of the needle path for further puncturing the myocardium, and further push the microcatheter and fine needle core without exchange, avoiding and reducing the occurrence of pneumothorax. Premature ventricular beats may occur in ECG monitoring when the fine needle core and micro catheter are just punctured into the myocardium, which can be used as an auxiliary judgment. Use a fine needle core to carry the microcatheter into the myocardium for 1-5cm, use the scale mark on the surface of the microcatheter to determine the depth of the needle, and determine the drug delivery position with the metal mark on the tip of the microcatheter during diastole, which is away from the endocardium and epicardium Keep a safe distance above 2mm, and exit the fine needle core if there is no abnormality observed. The microcatheter beats with the myocardium, and the tail end can be directly connected to the syringe for negative pressure retraction to avoid secondary damage to the myocardium, as shown in Figure 3 and Figure 4.
5.逐渐回撤微导管,回撤过程中单个针道可以间断进行多点注射。给药完成后微导管先撤入粗穿刺针,超声观察无心包积液且血液循环稳定,再共同撤出胸腔,封闭皮口。在超声引导下重新选择胸壁进针位置和针道,同一患者可以选择两个或更多穿刺道进行给药。注射给药结束后,穿刺局部仅遗留少量针眼,如图8所示。5. Gradually withdraw the microcatheter, a single needle track can be intermittently injected into multiple points during the withdrawal process. After the administration is completed, the microcatheter is first withdrawn into the thick puncture needle, and the ultrasound observation is that there is no pericardial effusion and the blood circulation is stable, and then the thoracic cavity is withdrawn together, and the skin opening is closed. Under ultrasound guidance, re-select the chest wall needle insertion position and needle path, and the same patient can choose two or more puncture paths for drug delivery. After the injection and administration, only a small amount of needles were left in the puncture part, as shown in Figure 8.
6.整个穿刺操作过程中及术后1小时对受试者行心电、血压、血氧饱和度监测,当心电图发现频发室性早搏时即暂停穿刺,动态观察心律情况,减少发生室颤可能。当发生室颤或血流动力学不稳定时,停止穿刺,迅速明确病因。如为室颤,立即行非同步电除颤,不成功可静脉注射利多卡因并再次电除颤,直至恢复窦性心律。如出现心包积液,则通过超声监测积液动态变化。若积液较少且血流动力学稳定,则继续观察;若积液迅速增加或血流动力学不稳定,则通过超声明确积液最多的部位,并在超声引导下行心包穿刺置管术,术后持续引流,直至积液减少为少量且对血流动力学无影响。6. During the whole puncture operation and 1 hour after the operation, monitor the subject's ECG, blood pressure, and oxygen saturation. When frequent ventricular premature beats are found on the ECG, the puncture will be suspended to observe the heart rhythm dynamically to reduce the occurrence of ventricular fibrillation may. When ventricular fibrillation or hemodynamic instability occurs, stop the puncture and quickly identify the cause. If it is ventricular fibrillation, immediately perform asynchronous electrical defibrillation, if unsuccessful, intravenous injection of lidocaine and electrical defibrillation again until sinus rhythm is restored. If pericardial effusion occurs, the dynamic changes of the effusion are monitored by ultrasound. If the effusion is small and the hemodynamics is stable, continue to observe; if the effusion increases rapidly or the hemodynamics is unstable, the area with the most effusion is identified by ultrasound, and the pericardiocentesis is guided by ultrasound. Drainage was continued after the operation until the effusion was reduced to a small amount and had no effect on hemodynamics.
工业实用性Industrial applicability
本申请的用于超声引导下经胸经心外膜心肌内注射的三联微导管装置和方法具有如下优势:The triple microcatheter device and method used for transthoracic transepicardial intramyocardial injection under ultrasound guidance of the present application have the following advantages:
1.以粗穿刺针引导穿透质硬且周围多骨性结构的胸壁,沿预设的导引线以细针芯携带微导管穿刺心肌,直接减少局部心肌损伤和心外膜血管损伤风险。微导管在粗穿刺针内腔中摩擦小,进出容易,同时粗穿刺针内径等于微导管外径,可避免气胸发生。微导管进入心肌组织,退出细针芯,微导管可随心肌组织有一定活动幅度,克服了心脏跳动对给药系统的影响,减少心肌二次损伤。微导管尾端可负压吸引后直接给药,操作流畅,节约手术时间,提高操作安全性。1. Use a thick puncture needle to guide through the chest wall of hard and surrounding bony structures, and carry a micro catheter along the preset guide wire with a fine needle core to puncture the myocardium, which directly reduces the risk of local myocardial injury and epicardial vascular injury. The microcatheter has low friction in the lumen of the thick puncture needle and is easy to enter and exit. At the same time, the inner diameter of the thick puncture needle is equal to the outer diameter of the microcatheter, which can avoid the occurrence of pneumothorax. The micro-catheter enters the myocardial tissue and exits the fine needle core. The micro-catheter can move with the myocardial tissue to a certain extent, overcome the influence of the heartbeat on the drug delivery system, and reduce the secondary damage of the myocardium. The tail end of the micro-catheter can be directly administered after suction by negative pressure, and the operation is smooth, saving operation time and improving operation safety.
2.不开胸,高分辨率超声指引下微创穿刺技术,微导管尖端有金属标记,超声下可以精确定位,操作安全可行,给药明确。2. No thoracotomy, minimally invasive puncture technology under the guidance of high-resolution ultrasound, the tip of the microcatheter has a metal mark, which can be accurately positioned under ultrasound, the operation is safe and feasible, and the drug delivery is clear.
3.能够做到单针道不同深度给药,不同角度多针道多个部位给药,微创条件下不同时间点多次注射,从而实现心肌内不同节段、不同深度多点注射的目标,提高给药效率。3. Able to achieve single needle injection at different depths, multiple needle paths at different angles, multiple injections at different time points under minimally invasive conditions, so as to achieve the goal of multiple injections at different segments and different depths in the myocardium , Improve drug delivery efficiency.
4.可实时动态观察心脏结构和功能,第一时间发现并发症,置管引流便捷,提高安全保障。4. The heart structure and function can be dynamically observed in real time, complications can be found in the first time, catheterization and drainage are convenient, and safety guarantee is improved.
5.可直接应用于科研实践,如大动物心梗/心衰模型干预研究,操作安全可行。临床转化方面,更适合常规手术风险高的心衰患者的治疗,大幅度降低手术风险,使心梗后心衰的早期干预成为可能,从 而改善预后,具有良好的科研应用价值和临床转化价值。5. It can be directly applied to scientific research practice, such as large animal myocardial infarction/heart failure model intervention research, and the operation is safe and feasible. In terms of clinical transformation, it is more suitable for the treatment of heart failure patients with high risk of conventional surgery, greatly reducing the risk of surgery, and enabling early intervention of heart failure after myocardial infarction, thereby improving the prognosis, and having good scientific research application value and clinical transformation value.

Claims (10)

  1. 一种三联微导管装置,用于超声引导下经胸经心外膜进行心肌内注射,其特征在于包括:粗穿刺针、微导管、细针芯;A triple microcatheter device used for intramyocardial injection through the thoracic epicardium under ultrasound guidance, which is characterized by comprising: a thick puncture needle, a micro catheter, and a fine needle core;
    粗穿刺针形成为管体,其第一端为形成有斜面的尖端,用于穿刺胸壁;微导管为具有柔韧性的管体,其第一端为形成有斜面的尖端,用于刺入受试者的心肌内;The thick puncture needle is formed as a tube, the first end of which is a beveled tip for puncturing the chest wall; the microcatheter is a flexible tube, and its first end is a beveled tip for piercing In the examinee’s myocardium;
    细针芯形成为实心的,其第一端为形成有斜面的尖端;The thin needle core is formed as a solid, and its first end is a tip with a bevel;
    微导管和细针芯的长度大于粗穿刺针的长度;The length of the micro catheter and the fine needle core is greater than the length of the thick puncture needle;
    微导管插入于粗穿刺针中,微导管与粗穿刺针之间形成为气密的;在穿刺过程中,细针芯插入于微导管中,且细针芯与微导管之间形成为气密的;在注射药物时,细针芯自微导管中撤出,微导管的第二端与药物注射装置连接。The micro catheter is inserted into the thick puncture needle, the micro catheter and the thick puncture needle are airtight; during the puncture process, the fine needle core is inserted into the micro catheter, and the thin needle core and the micro catheter are airtight. When injecting drugs, the fine needle core is withdrawn from the micro catheter, and the second end of the micro catheter is connected to the drug injection device.
  2. 如权利要求1所述的三联微导管装置,其特征在于:The triple microcatheter device of claim 1, wherein:
    所述微导管的第一端形成有标记物,该标记物在超声下具有强回声。The first end of the micro-catheter is formed with a marker, and the marker has a strong echo under ultrasound.
  3. 如权利要求1所述的三联微导管装置,其特征在于:The triple microcatheter device of claim 1, wherein:
    穿刺过程中,在穿刺胸壁时,所述粗穿刺针的第一端的斜面、微导管的第一端的斜面、细针芯的第一端的斜面对齐,构成一个平整的斜面。During the puncture process, when puncturing the chest wall, the bevel of the first end of the thick puncture needle, the bevel of the first end of the microcatheter, and the bevel of the first end of the thin needle core are aligned to form a flat bevel.
  4. 如权利要求1所述的三联微导管装置,其特征在于:The triple microcatheter device of claim 1, wherein:
    在心肌穿刺时,所述微导管的第一端和细针芯的第一端一起自所述粗穿刺针的第一端延伸出。During myocardial puncture, the first end of the micro catheter and the first end of the fine needle core extend from the first end of the thick puncture needle together.
  5. 如权利要求1所述的三联微导管装置,其特征在于:The triple microcatheter device of claim 1, wherein:
    所述微导管包括沿其长度分布的多个标记物,其中至少一个标记物位于所述微导管的第一端。The microcatheter includes a plurality of markers distributed along its length, wherein at least one marker is located at the first end of the microcatheter.
  6. 如权利要求1所述的三联微导管装置,其特征在于:The triple microcatheter device of claim 1, wherein:
    所述粗穿刺针外侧形成有刻度;所述微导管外侧形成有刻度。A scale is formed on the outside of the thick puncture needle; a scale is formed on the outside of the micro catheter.
  7. 如权利要求6所述的三联微导管装置,其特征在于:The triple microcatheter device according to claim 6, wherein:
    所述粗穿刺针的第二端形成有端座;所述微导管的第二端形成有端座;所述细针芯的第二端形成有端座;The second end of the thick puncture needle is formed with an end seat; the second end of the micro catheter is formed with an end seat; the second end of the thin needle core is formed with an end seat;
    所述微导管的端座的第二侧形成有凹穴;所述细针芯的端座的第一侧形成有凸头;所述凸头可拆卸地卡入所述凹穴中,使得所述微导管与细针芯形成为一体。The second side of the end seat of the micro-catheter is formed with a recess; the first side of the end seat of the fine needle core is formed with a convex head; the convex head is detachably snapped into the recess, so that the The micro catheter and the fine needle core are formed as one body.
  8. 一种超声引导下经胸经心外膜心肌内注射的方法,其利用权利要求1-7中任一项所述的三联微导管装置进行注射;A method for transthoracic transepicardial intramyocardial injection under ultrasound guidance, which uses the triple microcatheter device of any one of claims 1-7 for injection;
    细针芯微插入导管中,微导管插入粗穿刺针中,在粗穿刺针、微导管、 细针芯的第一端对齐的情况下,进行胸壁穿刺;The fine needle core is inserted into the catheter, the micro catheter is inserted into the thick puncture needle, and the chest wall puncture is performed when the first ends of the thick puncture needle, micro catheter, and fine needle core are aligned;
    在胸壁穿刺完成后,将微导管、细针芯一起延伸超出粗穿刺针的第一端,选择适当的心外膜穿刺点,以预定角度刺入左心室的心肌的预定深度,完成心肌穿刺;After the chest wall puncture is completed, extend the micro-catheter and the fine needle core together beyond the first end of the thick puncture needle, select an appropriate epicardial puncture point, and puncture the left ventricle to a predetermined depth at a predetermined angle to complete the myocardial puncture;
    撤去细针芯,将微导管的第二端与药物注射装置连接,将药物经由微导管而提供到心肌中;Remove the fine needle core, connect the second end of the micro catheter to the drug injection device, and deliver the drug to the myocardium through the micro catheter;
    给药完成后微导管先回撤入粗穿刺针,超声观察无心包积液且血液循环稳定,再连同粗穿刺针一起共同撤出胸壁,封闭皮口。After the administration is completed, the microcatheter is first withdrawn into the thick puncture needle. Ultrasound observes that there is no pericardial effusion and the blood circulation is stable. Then together with the thick puncture needle, the chest wall is withdrawn and the skin opening is closed.
  9. 如权利要求8所述的方法,其特征在于:The method of claim 8, wherein:
    微导管的第一端进入心肌内的深度为1-5cm;The depth of the first end of the microcatheter into the myocardium is 1-5 cm;
    当微导管的第一端位于心内膜和心外膜中的心肌层,且在心脏舒张期与心内膜层的距离D1、与心外膜层的距离D2均大于2mm时进行药物注射。When the first end of the microcatheter is located in the myocardium in the endocardium and the epicardium, and the distance D1 from the endocardium layer and the distance D2 from the epicardium layer during diastole are both greater than 2mm, the drug is injected.
  10. 如权利要求8所述的方法,其特征在于:The method of claim 8, wherein:
    心外膜穿刺点与左心室短轴中心线的连线与插在一起的微导管与细针芯之间的夹角为120°-150°。The angle between the line connecting the epicardial puncture point and the short axis centerline of the left ventricle and the inserted microcatheter and the fine needle core is 120°-150°.
PCT/CN2020/088743 2019-08-20 2020-05-06 Triple micro-catheter device and method for transthoracic and epicardial intramyocardial injection under ultrasound guidance WO2021031616A1 (en)

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