WO2021031617A1 - 一种用于超声引导下经胸经心外膜心肌内注射的三联穿刺针装置和方法 - Google Patents

一种用于超声引导下经胸经心外膜心肌内注射的三联穿刺针装置和方法 Download PDF

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WO2021031617A1
WO2021031617A1 PCT/CN2020/088744 CN2020088744W WO2021031617A1 WO 2021031617 A1 WO2021031617 A1 WO 2021031617A1 CN 2020088744 W CN2020088744 W CN 2020088744W WO 2021031617 A1 WO2021031617 A1 WO 2021031617A1
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puncture needle
fine
tube body
puncture
core
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PCT/CN2020/088744
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English (en)
French (fr)
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曹丰
刘丽文
李苏雷
刘峻松
陶博
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中国人民解放军总医院
曹丰
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Publication of WO2021031617A1 publication Critical patent/WO2021031617A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3297—Needles arranged coaxially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M2005/3201—Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart

Definitions

  • This application relates to the technology of intramyocardial injection of drugs, in particular to a triple puncture needle 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.
  • a puncture needle (18G, 1.2mm outer diameter) through the epicardium to puncture myocardial tissue under the condition of open chest and direct vision, as long as it does not directly damage the blood vessels and penetrate the wall, only a small amount of local myocardium permeates Blood, animal vital signs were stable during and after operation, without obvious complications.
  • the conventionally used puncture needle is a bevel type puncture needle with a matching needle core inside.
  • the needle body shows strong echo under ultrasound, and can complete puncture of various organs and tissues under ultrasound guidance.
  • Thick puncture needles such as the 18G puncture needle with an outer diameter of 1.2mm, are more conducive to penetrating the superficial hard tissues and establishing a stable channel in the surrounding bony structures, such as the chest wall. The echo is also stronger under ultrasound.
  • Fine puncture needles such as 22G or 25G puncture needles, have outer diameters of 0.7mm and 0.5mm, respectively.
  • the needle body is soft and difficult to penetrate the chest wall.
  • the echo under ultrasound is relatively weak, but it greatly reduces the risk of damaging coronary blood vessels and local myocardium. Especially when multiple punctures.
  • this application aims to propose a puncture needle 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.
  • the triple puncture needle device of the present application is used for intramyocardial injection through the thoracic epicardium under ultrasound guidance, and includes: a thick puncture needle, a fine puncture needle, a fine puncture needle core, and an extension tube;
  • the thick puncture needle includes a first tube body, the first end of the first tube body is a tip including a bevel, and the second end is a base; the thick puncture needle is used to puncture the chest wall;
  • the fine puncture needle includes a second tube body, the first end of the second tube body is a tip including a bevel, and the second end is a base; the length of the fine puncture needle is greater than that of the thick puncture needle; the thin puncture needle is used to puncture the myocardium, Provide drugs to the heart muscle;
  • the core of the fine puncture needle is solid, the first end is a tip including a bevel, and the second end is a base;
  • the first end of the extension hose includes an end seat, and the second end of the extension hose is used to connect the device;
  • the second tube body of the thin puncture needle can be inserted into the first tube body of the thick puncture needle in a retractable manner
  • the core of the fine puncture needle is inserted into the second tube body
  • the fine puncture needle core is withdrawn from the second tube body; the end seat of the extension hose is combined with the base of the second tube body, so that the second tube body is in communication with the extension hose.
  • the first end of the first tube body, the first end of the second tube body, and the first end of the thin puncture needle core are aligned to form a flat slope; when puncturing the myocardium, The first end of the second tube body is aligned with the first end of the thin puncture needle core and extends from the first end of the first tube body.
  • the second tube body of the thin puncture needle when the second tube body of the thin puncture needle is inserted into the first tube body of the thick puncture needle, the second tube body and the first tube body are airtight;
  • the space between the core of the fine puncture needle and the second tube body is airtight.
  • a scale is provided on the outside of the first tube body to confirm the depth of the thick puncture needle
  • a scale is provided on the outside of the second tube body to confirm the depth of the fine puncture needle.
  • annular mark is provided on the outside of the second tube body, and when the annular mark is aligned with the second end of the first tube body, the first end of the second tube body is aligned with the first end of the first tube body;
  • a recess is formed on the second end of the base of the second tube body; a protrusion is formed on the first end of the base of the fine puncture needle core; the protrusion can be inserted into the recess to realize the The first end is aligned with the first end of the fine puncture needle core.
  • the tip of the first end of the second tube body is used to penetrate the short-axis front wall and the front side wall of the left ventricle, or penetrate the lower and back wall of the left ventricle.
  • the depth of the first end of the fine puncture needle 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 center line of the left ventricle and the thin puncture needle is 120°-150°.
  • the ultrasound-guided transthoracic epicardial intramyocardial injection method of the present application uses the aforementioned triple puncture needle device for injection;
  • the thin puncture needle core is inserted into the thin puncture needle, and the first ends of the thick puncture needle, the thin puncture needle, and the thin puncture needle core are aligned, perform chest wall puncture;
  • the fine puncture needle 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 angle between the line connecting the epicardial puncture point and the short axis centerline of the left ventricle and the thin puncture needle is 120°-150°;
  • the depth of the first end of the fine puncture needle into the myocardium is 1-5 cm;
  • the drug is injected .
  • the ultrasound-guided puncture needle device and method of the present application can be used for transthoracic epicardial intramyocardial injection. It only needs to puncture 2-3 holes (each hole about 1mm in diameter) in the chest wall of the subject each time. Under the guidance of ultrasound, the drug is injected into the myocardium through the thoracic epicardium through a puncture needle. It has the advantages of high local drug concentration, precise and controllable injection location, less trauma, fewer complications, and multiple administrations at different time points. .
  • the device and method provide a convenient, safe, and efficient way of intramyocardial administration, and can also be used for injection administration of other deep tissues, reducing damage to important deep tissues, and has strong clinical transformation value.
  • Figure 1 is a schematic cross-sectional structure diagram of each component of the triple puncture needle device of this application.
  • Figure 2 is a schematic diagram of the triple puncture needle of this application when performing chest wall puncture
  • Figure 3 is a schematic diagram of the triple puncture needle of the application when performing myocardial puncture
  • Figure 4 is a schematic diagram of the triple puncture needle of the application for drug injection
  • Figure 5 is a schematic diagram of the combination of an ultrasonic diagnostic apparatus, an ultrasonic probe and a corresponding puncture frame and a puncture needle;
  • Figure 6 is a schematic diagram of the needle tip distribution in the myocardium (blue area);
  • Figure 7 is a schematic diagram of the angle ⁇ between the fine puncture needle, the epicardial puncture point and the short axis center of the left ventricle;
  • Figure 8 is a schematic diagram of the intramyocardial injection point, D1 is the distance between the needle tip and the endocardial layer, and D2 is the distance between the needle tip and the epicardial layer;
  • Figure 9 is a schematic diagram of ultrasound-guided transthoracic epicardial injection of drugs into pig myocardium
  • Figure 10 is a schematic diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium during and after injection;
  • Figure 11 is a comparison diagram of ultrasound-guided transthoracic epicardial injection into pig myocardium before and after drug injection;
  • Figure 12 is an image of the puncture site after the animal operation.
  • the triple puncture needle device of the present application is used for intramyocardial injection through the thoracic epicardium under ultrasound guidance, and includes: a thick puncture needle, a fine puncture needle, a fine puncture needle core, and an extension tube;
  • the thick puncture needle includes a first tube body 10, the first end 12 of the first tube body is a tip, and the second end is a base 11; the thick puncture needle is used to puncture the chest wall.
  • the fine puncture needle includes a second tube body 20, the first end 22 of the second tube body is a tip, and the second end is a base 21; the length of the fine puncture needle is greater than the length of the thick puncture needle; the thin puncture needle is used to penetrate the myocardium, Provide medicine to the heart muscle.
  • the fine puncture needle core 30 is solid, the first end 32 is a tip, and the second end 31 is a base.
  • the first end of the extension hose 40 includes an end seat 41, and the second end of the extension hose 40 is used to connect a device, such as a syringe.
  • a joint 42 connected to the nipple of the syringe can be provided at the second end of the extension hose 40.
  • the second tube body 20 of the thin puncture needle is removably inserted into the first tube body 10 of the thick puncture needle.
  • the fine puncture needle core 30 is inserted into the second tube body 20.
  • the fine puncture needle core 30 is withdrawn from the second tube body 20; the end seat 41 of the extension tube 40 is combined with the base 21 of the second tube body, so that the second tube body 20 and the extension soft The tube 40 communicates.
  • the end seat 41 is tightly coupled in the cavity 23 at the second end of the base 21 so that the extension hose 40 communicates with the second tube body 20.
  • the first end 12 of the first tube body 10, the first end 22 of the second tube body 20, and the first end 21 of the fine puncture needle core 30 are aligned to form a flat inclined surface, such as 2; when puncturing the myocardium, the first end 22 of the second tube body 20 and the first end 32 of the fine puncture needle core 30 are aligned and extend from the first end 12 of the first tube body 10, as shown in Figure 3 Shown.
  • the second tube body 20 of the thin puncture needle When the second tube body 20 of the thin puncture needle is inserted into the first tube body 10 of the thick puncture needle, the second tube body 20 and the first tube body 10 are airtight; the airtightness can pass through the second tube body 20
  • the close contact with the first tube body 10 can be achieved, and it can also be achieved by providing a sealing ring between the second tube body 20 and the first tube body 10.
  • the fine puncture needle core 30 when the fine puncture needle core 30 is inserted into the second tube body 20, the fine puncture needle core 30 and the second tube body 20 are airtight; the airtightness can pass through the second tube body 20 and the fine puncture
  • the tight contact between the needle cores 30 can also be achieved by providing a sealing ring between the second tube body 20 and the fine puncture needle core 30.
  • a scale is provided on the outer side of the first tube body 10 to confirm the penetration depth of the coarse puncture needle.
  • a scale is provided on the outside of the second tube body 20 to confirm the needle depth of the fine puncture needle.
  • An annular mark is provided on the outside of the second tube body 20, and when the annular mark is aligned with the second end of the first tube body, the first end of the second tube body is aligned with the first end of the first tube body.
  • a recess is formed on the second end of the base 21 of the second tube body 20; a protrusion is formed on the first end of the base 31 of the fine puncture needle core 30; the protrusion can be inserted into the recess to realize the first end
  • the first end of the second tube is aligned with the first end of the needle core of the fine puncture needle.
  • the tip of the first end 22 of the second tube body 20 is used to pierce the left ventricle short axis anterior wall and the anterior side wall, or pierce the lower and posterior wall of the left ventricle.
  • the depth of the first end of the fine puncture needle into the myocardium is 1-5 cm; when the first end of the fine puncture needle is located in the myocardium in the endocardium and epicardium, and the distance from the endocardium in diastole When D1, the distance D2 from the epicardial layer is greater than 2mm, 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 thin puncture needle is 120°-150°.
  • the ultrasound-guided transthoracic epicardial intramyocardial injection method of the present application uses the aforementioned triple puncture needle device for injection;
  • the thin puncture needle core is inserted into the thin puncture needle, and the first end of the thick puncture needle, the thin puncture needle, and the thin puncture needle core are aligned, perform chest wall puncture;
  • the fine puncture needle 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 thick puncture needle is a tubular needle with a scale on the surface.
  • the tip or tip of the needle is inclined, and the inner diameter is the same as the outer diameter of the fine puncture needle. That is, the thickness of the tube wall is increased on the basis of the conventional puncture needle. It can also be designed according to the needs of other puncture parts. And many other specifications.
  • the length of the thick puncture needle can penetrate shallow hard tissues, such as the chest wall.
  • the needle tip or tip of the fine puncture needle and the fine puncture needle core is beveled, and the tip and the thick puncture needle tip form a common slope to facilitate puncture; the length is the same, the outer diameter of the needle core is roughly equal to the inner diameter of the fine puncture needle; through the needle The protrusion of the end of the core is interlocked with the groove of the end interface of the fine puncture needle to keep the direction of the fine puncture needle and the needle core consistent.
  • the position is marked with a straight line and marked with a scale, which is convenient for grasping the relative position of the coarse/fine puncture needle and the actual needle penetration depth during the puncture operation.
  • the fine puncture needle is longer than the thick puncture needle, which can meet the requirements of intramyocardial injection. It can also be designed into different length specifications according to application requirements. After the fine puncture needle is in place, withdraw the needle core. The tail end of the fine puncture needle is designed with an interface for easy connection of the extension hose.
  • One end of the extension tube is connected with a fine puncture needle, and the other end is connected with a syringe for administration.
  • the hand When injecting, the hand only fixes one end of the extension tube connected to the syringe, so that the fine puncture needle has a certain range of movement with the deep tissue, reducing secondary damage.
  • Figures 1-4 show the case where the thick puncture needle, the fine puncture needle, and the fine puncture needle core are an inclined plane when aligned, the application is not limited to this type of needle tip form, as long as the three are assembled, it is good for puncture , Any kind of tip can be used.
  • the specific usage method is as follows:
  • the chest wall puncture needle is completed under the guidance of conventional ultrasound, and the needle is inserted at the upper edge of the next rib, avoiding intercostal blood vessels and nerves.
  • the short-axis view of the left ventricle of the heart is displayed through the ultrasound diagnostic apparatus, the probe is adjusted, the epicardial puncture point is determined through the puncture guide line that comes with the instrument, the needle depth is determined according to the treatment needs, and the needle tip is completely visible under ultrasound. Administration site.
  • the triple puncture needle forms a whole before puncture, keeping the tip level ( Figure 2), puncturing the chest wall with a sense of breakthrough, and fixing it before puncturing the pericardium and myocardium.
  • Premature ventricular beats may occur in ECG monitoring when the fine puncture needle just penetrates into the myocardium, which can be used as an auxiliary judgment.
  • the ultrasound diagnostic apparatus Display the short-axis view of the left ventricle of the heart through the ultrasound diagnostic apparatus, and control the puncture needle to avoid the needle parallel to the contraction direction of the myocardium on the short axis, and reduce the risk of penetrating the ventricular wall.
  • the location where the puncture needle enters the epicardium is the epicardial puncture point, and the location where the puncture needle enters the myocardium and the drug is administered is the intramyocardial injection point.
  • the included puncture guide line can be used to calculate the angle ⁇ between the puncture needle and the epicardial puncture point and the short axis center of the left ventricle. Adjust the size of ⁇ by changing the position of the ultrasound probe and selecting puncture guide lines of different angles.
  • the needle when 120° ⁇ 150°, the needle can be punctured (Figure 7). At this time, the puncture can ensure that the puncture needle travels a long distance in the myocardium and minimize the risk of penetrating the ventricular wall.
  • Premature ventricular beats may occur in ECG monitoring when the fine needle is just punctured into the myocardium, which can be used as an auxiliary judgment.
  • the fine puncture needle 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.
  • ventricular fibrillation or hemodynamic instability 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 it is unsuccessful, intravenously inject lidocaine and epinephrine and perform electrical defibrillation again until the 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.
  • Equipment and equipment preparation mainly including high-resolution ultrasound diagnostic apparatus, cardiac ultrasound probe, probe puncture rack, triple puncture needle, 2ml syringe.
  • the needle cores of the thick puncture needle, the thin puncture needle, and the fine puncture needle are all strongly echoed under ultrasound to facilitate positioning under ultrasound guidance.
  • the puncture injection area can be reselected under ultrasound guidance.
  • the same experimental animal or subject can choose 2-3 puncture points for puncture, so as to achieve the goal of multi-point injection at different segments and different depths in the myocardium .
  • the fine puncture needle has little friction in the inner cavity of the thick puncture needle, and it is easy to enter and exit.
  • the thick puncture needle and the fine puncture needle are airtight, which can avoid the occurrence of pneumothorax.
  • the fine puncture needle enters the deep tissue, the needle core is removed, and the syringe is connected through the extension tube. The fine puncture needle 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 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.

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Abstract

一种三联穿刺针装置，在超声引导下经胸经心外膜进行心肌内注射，包括：粗穿刺针、细穿刺针、细穿刺针针芯（30）、延长软管（40）；细穿刺针插入粗穿刺针中；细穿刺针针芯（30）插入细穿刺针中；注射时，细穿刺针针芯（30）被从细穿刺针撤出；延长软管（40）的端座（41）结合在细穿刺针的底座（21）上，使得细穿刺针与延长软管（40）连通。通过本装置，只需每次在受试者胸壁上穿刺2-3个孔，即可在超声引导下将药物通过穿刺针经胸经心外膜注入到心肌内，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。同时，最大限度减少穿刺针本身对心肌组织的直接损伤以及损伤心外膜血管的风险，并在一定程度上克服心脏持续跳动的问题，精确给药，避免心肌二次损伤。

Description

一种用于超声引导下经胸经心外膜心肌内注射的三联穿刺针装置和方法 技术领域
本申请涉及心肌内注射药物的技术，尤其涉及一种超声引导下经胸经心外膜心肌内注射的三联穿刺针装置和方法。
背景技术
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。
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。
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，开胸直视情况下经心外膜使用穿刺针(18G，外径1.2mm)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，术中及术后动物生命体征平稳，无明显并发症。亦有小样本临床研究证明，针对肥厚梗阻型心肌病患者，在超声引导下经心尖穿刺室间隔行射频消融，术后心包填塞发生率很低，且必要时可以便捷的置管引流，保障患者安全，提示经心外膜心肌穿刺的临床可行性。
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。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，在超声指引下可完成多种脏器组织的穿刺。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，在超声下回声也更强，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。细穿刺针，如22G或25G穿刺针，外径分别是0.7mm和0.5mm，针体偏软，不易穿透胸壁，超声下回声相对弱，但大幅降低损伤冠脉血管和局部心肌的风险，尤其是多次穿刺时。
发明的公开
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穿刺针装置，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。
本申请的三联穿刺针装置，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、细穿刺针、细穿刺针针芯、延长软管；
粗穿刺针包括第一管体，第一管体的第一端为包括斜面的尖端，第二端为底座；粗穿刺针用于穿刺胸壁；
细穿刺针包括第二管体，第二管体的第一端为包括斜面的尖端，第二端为底座；细穿刺针的长度大于粗穿刺针的长度；细穿刺针用于刺入心肌，向心肌提供药物；
细穿刺针针芯为实心的，第一端为包括斜面的尖端，第二端为底座；
延长软管的第一端包括端座，延长软管的第二端用于连接装置；
细穿刺针的第二管体可撤出地插入于粗穿刺针的第一管体中；
在穿刺过程中，细穿刺针针芯插入于第二管体中；
在注射过程中，细穿刺针针芯被从第二管体中撤出；延长软管的端座结合在第二管体的底座上，使得第二管体与延长软管连通。
优选地，穿刺过程中，穿刺胸壁时，第一管体的第一端、第二管体的第一端、细穿刺针针芯的第一端对齐，形成一个平整的斜面；穿刺心肌时，第二管体的第一端和细穿刺针针芯的第一端对齐且自第一管体的第一端延伸出。
优选地，细穿刺针的第二管体插入于粗穿刺针的第一管体中时，第二管体与第一管体之间为气密的；
细穿刺针针芯插入于第二管体中时，细穿刺针针芯与第二管体之间为气密的。
优选地，在第一管体外侧设置有刻度，以便确认粗穿刺针的进针深度；
在第二管体外侧设置有刻度，以便确认细穿刺针的进针深度。
优选地，在第二管体外侧设置有环形标记，当环形标记与第一管体的第二端对齐时，第二管体的第一端与第一管体的第一端对齐；
在第二管体的底座的第二端上形成有凹口；在细穿刺针针芯的底座的第一端上形成有凸起；凸起可卡入于凹口内，实现第二管体的第一端与细穿刺针针芯的的第一端的对齐。
优选地，所述第二管体的第一端的尖端用于刺入左心室短轴前壁和前侧壁，或者刺入左心室下后壁。
优选地，细穿刺针的第一端进入心肌内的深度为1-5cm；
当细穿刺针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。
优选地，心外膜穿刺点与左心室短轴中心线的连线与细穿刺针之间的夹角为120°-150°。
本申请的超声引导下经胸经心外膜心肌内注射的方法，其利用上述的三联穿刺针装置进行注射；
在细穿刺针插入粗穿刺针，细穿刺针针芯插入细穿刺针，其粗穿刺针、细穿刺针、细穿刺针针芯的第一端对齐的情况下，进行胸壁穿刺；
在胸壁穿刺完成后，将细穿刺针、细穿刺针针芯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；
撤去细穿刺针针芯，将延长软管连接到细穿刺针的第二端，使得药物经由延长软管、细穿刺针而进入心肌；
重新将细穿刺针针芯插入细穿刺针，将残留在细穿刺针中的药物推送到心肌中；
给药完成后细穿刺针先回撤入粗穿刺针，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。
优选地，心外膜穿刺点与左心室短轴中心线的连线与细穿刺针之间的夹角为120°-150°；
细穿刺针的第一端进入心肌内的深度为1-5cm；
当细穿刺针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。
本申请的超声引导下穿刺针装置和方法，可用于经胸经心外膜心肌内注射，只需每次在受试者胸壁上穿刺2-3个孔(每孔直径约1mm)，即可在超声引导下将药物通过穿刺针经胸经心外膜注入到心肌内，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。在有效完成注射给药的同时，最大限度减少穿刺针本身对心肌组织的直接损伤以及损伤心外膜血管的风险，并在一定程度上克服心脏持续跳动的问题，精确给药，避免心肌二次损伤。该装置和方法提供了一种便捷、安全、高效的心肌内给药方式，亦可用于其他深部组织注射给药，减少深部重要组织损伤，且具有很强的临床转化价值。
附图的简要说明
图1为本申请的三联穿刺针装置的各组成部分的剖面结构示意图；
图2为本申请的三联穿刺针进行胸壁穿刺时的示意图；
图3为本申请的三联穿刺针进行心肌穿刺时的示意图；
图4为本申请的三联穿刺针进行药物注射时的示意图；
图5为超声诊断仪、超声探头及相应的穿刺架和穿刺针的结合示意图；
图6为心肌内针尖分布示意图(蓝色区域)；
图7为细穿刺针和心外膜穿刺点与左心室短轴中心连线的夹角α示意图；
图8为心肌内注射点示意图，D1为针尖与心内膜层的距离，D2为针尖与心外膜层的距离；
图9为超声引导下经胸经心外膜给猪心肌注射药物的示意图；
图10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；
图11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；
图12为动物术后穿刺部位图像。
实现本发明的最佳方式
下面，结合附图对本申请进行详细说明。
本申请的三联穿刺针装置，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、细穿刺针、细穿刺针针芯、延长软管；
粗穿刺针包括第一管体10，第一管体的第一端12为尖端，第二端为底座11；粗穿刺针用于穿刺胸壁。
细穿刺针包括第二管体20，第二管体的第一端22为尖端，第二端为底座21；细穿刺针的长度大于粗穿刺针的长度；细穿刺针用于刺入心肌，向心肌提供药物。
细穿刺针针芯30为实心的，第一端32为尖端，第二端31为底座。
延长软管40的第一端包括端座41，延长软管40的第二端用于连接装置，例如注射器。与注射器连接时，可以在延长软管40第二端设置于注射器的乳头相连接的接头42。
细穿刺针的第二管体20可撤出地插入于粗穿刺针的第一管体10中。
在穿刺过程中，细穿刺针针芯30插入于第二管体20中。
在注射过程中，细穿刺针针芯30被从第二管体20中撤出；延长软管40的端座41结合在第二管体的底座21上，使得第二管体20与延长软管40连通。具体地，端座41紧密地耦合在底座21第二端的凹穴23中，使得延长软管40与第二管体20连通。
穿刺过程中，穿刺胸壁时，第一管体10的第一端12、第二管体20的第一端22、细穿刺针针芯30的第一端21对齐，形成一个平整的斜面，如图2所示；穿刺心肌时，第二管体20的第一端22和细穿刺针针芯30的第一端32对齐且自第一管体10的第一端12延伸出，如图3所示。
细穿刺针的第二管体20插入于粗穿刺针的第一管体10中时，第二管体20与第一管体10之间为气密的；气密可以通过第二管体20 与第一管体10之间紧密接触而实现，也可以通过在第二管体20与第一管体10之间设置密封圈来实现。
同理，细穿刺针针芯30插入于第二管体20中时，细穿刺针针芯30与第二管体20之间为气密的；气密可以通过第二管体20与细穿刺针针芯30之间紧密接触而实现，也可以通过在第二管体20与细穿刺针针芯30之间设置密封圈来实现。
在第一管体10外侧设置有刻度，以便确认粗穿刺针的进针深度。
在第二管体20外侧设置有刻度，以便确认细穿刺针的进针深度。
在第二管体20外侧设置有环形标记，当环形标记与第一管体的第二端对齐时，第二管体的第一端与第一管体的第一端对齐。
在第二管体20的底座21的第二端上形成有凹口；在细穿刺针针芯30的底座31的第一端上形成有凸起；凸起可卡入于凹口内，实现第二管体的第一端与细穿刺针针芯的的第一端的对齐。
第二管体20的第一端22的尖端用于刺入左心室短轴前壁和前侧壁，或者刺入左心室下后壁。
细穿刺针的第一端进入心肌内的深度为1-5cm；当细穿刺针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。
心外膜穿刺点与左心室短轴中心线的连线与细穿刺针之间的夹角为120°-150°。
本申请的超声引导下经胸经心外膜心肌内注射的方法，其利用上述的三联穿刺针装置进行注射；
在细穿刺针插入粗穿刺针，细穿刺针针芯插入细穿刺针，其中粗穿刺针、细穿刺针、细穿刺针针芯的第一端对齐的情况下，进行胸壁穿刺；
在胸壁穿刺完成后，将细穿刺针、细穿刺针针芯延伸超出粗穿刺针的第一端，选择适当的穿刺点，以预定角度刺入左心室的心肌的预定深度，完成心肌穿刺；
撤去细穿刺针针芯，将延长软管连接到细穿刺针的第二端，使得药物经由延长软管、细穿刺针而进入心肌；
重新将细穿刺针针芯插入细穿刺针，将残留在细穿刺针中的药物推送到心肌中；
给药完成后细穿刺针先回撤入粗穿刺针，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。
粗穿刺针，为管式针，表面有刻度，针尖或尖端呈斜面式，内径与细穿刺针外径相同，即在常规穿刺针的基础上增加管壁厚度，也可 以根据其他穿刺部位需要设计等多种规格。粗穿刺针的长度以能穿透浅部质硬组织即可，如胸壁。
细穿刺针以及细穿刺针针芯的针尖或尖端均呈斜面式，在尖端与粗穿刺针针尖形成一个共同的斜面，便于穿刺；长度一致，针芯外径大致等于细穿刺针内径；通过针芯尾端的突起与细穿刺针尾端接口的凹槽相扣保持细穿刺针和针芯方向一致。保持粗、细穿刺针的针尖平齐，在细穿刺针体部与粗穿刺针长度一致的位置设置环形标记，长出粗穿刺针的部分，在细穿刺针尾端凹槽对应的针体中线位置设置直线标记，并标记刻度，便于把握粗/细穿刺针在穿刺操作时的相对位置和实际进针深度。细穿刺针较粗穿刺针更长，能满足心肌内注射的要求，也可根据应用需求设计成不同长度规格。细穿刺针到位后，退出针芯。细穿刺针尾端设计有接口，便于连接延长软管。
延长软管一端连接细穿刺针，另一端连接注射器给药。注射时手仅固定延长软管连接注射器的一端，使细穿刺针有一定随深部组织活动的幅度，减少二次损伤。
虽然图1-4中所给出的是对齐时，粗穿刺针、细穿刺针、细穿刺针芯为一个斜面的情况，但本申请不限于该种针尖形式，只要三者组装后是利于穿刺，任何形式的尖端均可。
具体使用方法如下：
(1)胸壁穿刺进针在常规超声指引下完成，在下一肋骨上缘进针，避开肋间血管和神经。先应用超声探头配套的穿刺架锁定穿刺针(如图5)，切面选择左室短轴心尖水平或室中水平，位置主要位于左心室短轴前壁和前侧壁(如图6)，也可选择下后壁，穿刺路径避开室间隔正对的前室间沟，以避免直接损伤前降支。通过超声诊断仪显示心脏左心室短轴切面，调整探头，通过仪器自带的穿刺引导线确定心外膜穿刺点，根据治疗需要决定进针深度，在针尖于超声下完全可视情况下选择注射给药部位。
(2)三联穿刺针在穿刺前形成一个整体，保持尖端平齐(如图2)，穿刺胸壁，有突破感，在穿刺心包及心肌前固定。利用超声自带的引导线确定进一步穿刺心肌的针道位置。进一步推送细穿刺针和针芯，以刻度标记判断进针深度。细穿刺针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。选定注射位置后(如图3)，撤出细穿刺针针芯，连接延长软管(如图4)，注射时手仅固定延长软管连接注射器的一端，使细穿刺针有一定随心脏等深部组织活动的幅度，减少二次损伤。逐渐回撤细穿刺针，回撤过程中间断注射给药，可完成单针道的多点给药。给药完成后细穿刺针先回撤入粗穿刺针，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。
(3)通过超声诊断仪显示心脏左心室短轴切面，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。穿刺针进入心外膜的位置为心外膜穿刺点，进入心肌内并给药的位置为心肌内注射点。具体角度，可以通过仪器自带的穿刺引导线计算穿刺针和心外膜穿刺点与左心室短轴中心连线的夹角α，通过改变超声探头位置和选择不同角度的穿刺引导线调整α大小，考虑室壁厚度因素，当120°≤α≤150°时可以穿刺进针(如图7)。此时穿刺能够保证穿刺针在心肌内走行距离长，最大程度降低穿透心室壁的风险。
(4)进一步推送细穿刺针和针芯，以刻度标记判断进针深度。推送细穿刺针进入心肌内1-5cm。细针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。选择注射位置，超声引导下保证针尖与心室的内膜和外膜距离均超过2mm，以室壁相对薄的舒张期为准，增加安全性，避免穿透室壁(如图8)。此时能够保证注射的药物会存留在心室肌内，而不会流入到心室腔或心包腔内，减少药物丢失和心包积液的发生。当心脏收缩时，室壁进一步增厚，最大限度保障动物安全。
(5)撤出细穿刺针针芯，连接延长软管，注射时手仅固定延长软管连接注射器的一端，使细穿刺针有一定随深部组织活动的幅度，减少二次损伤。逐渐回撤细穿刺针，回撤过程中间断注射给药，可完成单针道的多点给药。
(6)给药完成后细穿刺针先回撤入粗穿刺针，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。
(7)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针道进行给药。
(8)穿刺心肌给药结束后常规观察心电及心包1小时，必要时置管引流，提高安全保障，穿刺过程及术后如有室颤等恶性心律失常，必要时暂中断操作，及时电除颤，稳定后可以继续操作。在整个穿刺操作过程中及术后1小时对实验动物或受试者行气管插管及呼吸机支持、心电血压监护、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及肾上腺素并再次电除颤，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。
实施例
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、三联穿刺针、2ml注射器。其中粗穿刺针、细穿刺针、细穿刺针针芯在超声下均呈强回声，以便于超声引导下定位。
2.动物麻醉、脱毛后取仰卧位，调整超声探头位置，选择左心室短轴中间段或心尖段切面，根据科研或临床需求确定拟干预给药心肌节段和位置，于下一肋骨上缘将安装在一起的粗穿刺针、细穿刺针、细穿刺针针芯异同刺入(如图9)，进行胸壁穿刺；完成胸壁穿刺后，推出细穿刺针和细穿刺针针芯。
3.改变超声探头位置和选择不同角度的穿刺引导线，考虑室壁厚度且需确保心肌内注射点位于左心室短轴前壁或前侧壁心肌内，当细穿刺针和心外膜穿刺点与左心室短轴中心连线的夹角α满足120°≤α≤150°时可以进行心肌穿刺。
4.细穿刺进针后，监测心电图变化，当出现室性早搏时提示针尖到达心外膜层，此时密切观察超声图像，根据治疗需要决定进针深度，在针尖于超声下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10和图11)。
5.当细穿刺针尖位于心内膜和心外膜中的心肌层，且在心脏舒张期时与心内膜层的距离D1、心外膜层的距离D2均大于2mm，确定为注射点。
6.退出细穿刺针芯并在细穿刺针底座上连接延长软管，细穿刺针固定不动，于延长软管尾端连上2ml注射器，利用三通和另一注射器抽负压排气，缓慢注射药物，在细穿刺针回撤过程中间断注射给药，可完成单针道的多点给药的目的。
7.给药完成后取下注射器，将细穿刺针针芯重新插入细穿刺针，推送残留在细穿刺针的药物进入拟干预心肌局部，然后共同撤出胸腔，局部封闭，避免气胸。采用同样的方法，在超声引导下可以重新选择穿刺注射区域，同一实验动物或受试者可以选择2-3个穿刺点进行穿刺，从而实现心肌内不同节段、不同深度进行多点注射的目标。注射给药结束后，穿刺局部仅遗留少量针眼(如图12)。
8.在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。
工业实用性
本申请具有如下优点：
(1)以粗穿刺针引导穿透胸壁，克服常规细针针体偏软的缺陷，再以一体化的细针和针芯穿刺心肌，直接减少局部心肌损伤和心外膜血管损伤风险。细穿刺针在粗穿刺针内腔中摩擦小，进出容易，同时粗穿刺针与细穿刺针之间气密，可避免气胸发生。细穿刺针进入深部组织，取掉针芯，通过延长软管连接注射器，细穿刺针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。
(2)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)不开胸，高分辨率超声指引下微创穿刺技术，操作完全可视，定位准确，给药明确。
(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。
(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。

Claims (10)

  1. 一种三联穿刺针装置，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、细穿刺针、细穿刺针针芯、延长软管；
    粗穿刺针包括第一管体，第一管体的第一端为包括斜面的尖端，第二端为底座；粗穿刺针用于穿刺胸壁；
    细穿刺针包括第二管体，第二管体的第一端为包括斜面的尖端，第二端为底座；细穿刺针的长度大于粗穿刺针的长度；细穿刺针用于刺入心肌，向心肌提供药物；
    细穿刺针针芯为实心的，第一端为包括斜面的尖端，第二端为底座；
    延长软管的第一端包括端座，延长软管的第二端用于连接装置；
    细穿刺针的第二管体可撤出地插入于粗穿刺针的第一管体中；
    在穿刺过程中，细穿刺针针芯插入于第二管体中；
    在注射过程中，细穿刺针针芯被从第二管体中撤出；延长软管的端座结合在第二管体的底座上，使得第二管体与延长软管连通。
  2. 如权利要求1所述的三联穿刺针装置，其特征在于：
    穿刺过程中，穿刺胸壁时，第一管体的第一端、第二管体的第一端、细穿刺针针芯的第一端对齐，形成一个平整的斜面；穿刺心肌时，第二管体的第一端和细穿刺针针芯的第一端对齐且自第一管体的第一端延伸出。
  3. 如权利要求1所述的三联穿刺针装置，其特征在于：
    细穿刺针的第二管体插入于粗穿刺针的第一管体中时，第二管体与第一管体之间为气密的；
    细穿刺针针芯插入于第二管体中时，细穿刺针针芯与第二管体之间为气密的。
  4. 如权利要求1所述的三联穿刺针装置，其特征在于：
    在第一管体外侧设置有刻度，以便确认粗穿刺针的进针深度；
    在第二管体外侧设置有刻度，以便确认细穿刺针的进针深度。
  5. 如权利要求1所述的三联穿刺针装置，其特征在于：
    在第二管体外侧设置有环形标记，当环形标记与第一管体的第二端对齐时，第二管体的第一端与第一管体的第一端对齐；
    在第二管体的底座的第二端上形成有凹口；在细穿刺针针芯的底座的第一端上形成有凸起；凸起可卡入于凹口内，实现第二管体的第一端与细穿刺针针芯的的第一端的对齐。
  6. 如权利要求1所述的三联穿刺针装置，其特征在于：
    所述第二管体的第一端的尖端用于刺入左心室短轴前壁和前侧壁，或者刺入左心室下后壁。
  7. 如权利要求1所述的三联穿刺针装置，其特征在于：
    细穿刺针的第一端进入心肌内的深度为1-5cm；
    当细穿刺针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。
  8. 如权利要求1所述的三联穿刺针装置，其特征在于：
    心外膜穿刺点与左心室短轴中心线的连线与细穿刺针之间的夹角为120°-150°。
  9. 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1-9中任一项所述的三联穿刺针装置进行注射；
    在细穿刺针插入粗穿刺针，细穿刺针针芯插入细穿刺针，在粗穿刺针、细穿刺针、细穿刺针针芯的第一端对齐的情况下，进行胸壁穿刺；
    在胸壁穿刺完成后，将细穿刺针、细穿刺针针芯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；
    撤去细穿刺针针芯，将延长软管连接到细穿刺针的第二端，使得药物经由延长软管、细穿刺针而进入心肌；
    重新将细穿刺针针芯插入细穿刺针，将残留在细穿刺针中的药物推送到心肌中；
    给药完成后细穿刺针先回撤入粗穿刺针，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。
  10. 如权利要求10所述的超声引导下经胸经心外膜心肌内注射的方法，其特征在于：
    心外膜穿刺点与左心室短轴中心线的连线与细穿刺针之间的夹角为120°-150°；
    细穿刺针的第一端进入心肌内的深度为1-5cm；
    当细穿刺针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。
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