WO2021036143A1 - 经桡动脉或尺动脉进行心脏及血管介入手术的方法及装置 - Google Patents

经桡动脉或尺动脉进行心脏及血管介入手术的方法及装置 Download PDF

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WO2021036143A1
WO2021036143A1 PCT/CN2019/129865 CN2019129865W WO2021036143A1 WO 2021036143 A1 WO2021036143 A1 WO 2021036143A1 CN 2019129865 W CN2019129865 W CN 2019129865W WO 2021036143 A1 WO2021036143 A1 WO 2021036143A1
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catheter
guiding catheter
arterial
port
artery
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PCT/CN2019/129865
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English (en)
French (fr)
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蓝明
孟玉
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蓝明
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • 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
    • A61M5/007—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 for contrast media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0279—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing medical instruments into the body, e.g. endoscope, surgical tools
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body

Definitions

  • the present invention relates to the technical field of heart and blood vessel surgery, in particular to a method and device for heart and blood vessel intervention operations such as endocardial myocardial biopsy via radial artery or ulnar artery.
  • Endocardial myocardial biopsy is a technique for obtaining materials for cardiac examination, and it is a representative cardiac intervention operation.
  • the pathological results of endocardial myocardial biopsy are the gold standard for the diagnosis of non-ischemic cardiomyopathy. It has important clinical significance in the diagnosis of myocarditis, the diagnosis of the cause of unexplained heart failure, and the monitoring of rejection after heart transplantation.
  • Endocardial myocardial biopsy is divided into left ventricular endocardial myocardial biopsy (hereinafter referred to as “left heart biopsy”, which must be completed via arterial route) and right ventricular endocardial myocardial biopsy (hereinafter referred to as “right heart biopsy”, which requires intravenous route) carry out).
  • Right heart biopsy is done by puncturing the catheter through the internal jugular vein, subclavian vein, femoral vein and other venous routes, and entering the myocardial biopsy forceps through the venous catheter. Most of the myocardial tissue is clamped in the ventricular septum.
  • right ventricle wall is thin (usually less than 4mm), complications such as heart perforation are prone to occur during myocardial biopsy, while the left ventricular wall is thicker (about 10mm). Therefore, right heart biopsy is safer than left heart biopsy difference.
  • right heart biopsy can only be taken from the ventricular septum, and the scope of sampling is limited, and most heart diseases involve the left heart. The effectiveness of right heart biopsy is not as good as that of left heart biopsy.
  • some patients undergoing myocardial biopsy require coronary angiography, left ventricle angiography, and heart or arterial vascular system interventions, while coronary angiography, left ventricular angiography, and heart or arterial vascular system interventions can be done through the arterial route.
  • one method of left heart biopsy is through the femoral artery. Due to the large diameter of the femoral artery (about 8mm), the risk of bleeding and complications at the puncture site (such as vagal reflex, arteriovenous fistula, retroperitoneal hematoma, etc.) are higher. . There is also a way to perform left heart biopsy through the radial artery, using the Sheathless guiding catheter technology.
  • the specific operation steps of this technology are: 1. Perform radial artery puncture and insert the arterial sheath, and then insert the instrument through the arterial sheath. Corresponding operations (depending on the specific clinical situation); 2. Withdraw the instruments in the arterial sheath; 3.
  • the guide wire Withdraw the arterial sheath, the guide wire remains in the artery, at this time, the surgeon needs to press the radial artery puncture port to avoid bleeding; 4
  • the assistant assists the surgeon to insert the Sheathless guide catheter with the dilator into the radial artery through the guide wire, and then send it to the ascending aorta via the brachial artery and subclavian artery; 5.
  • Withdraw the dilator from the Sheathless guide catheter Feed the Pigtail catheter into the Sheathless guiding catheter, and the Sheathless guiding catheter and the Pigtail catheter enter the left ventricle at the same time; 6.
  • the Sheathless guiding catheter Withdraw the Pigtail catheter, the Sheathless guiding catheter remains in the left ventricle, and the myocardial biopsy forceps sent through the Sheathless guiding catheter are in the left ventricle.
  • the ventricular septum or free wall clamps the myocardial tissue.
  • the continuous penetration of the Sheathless guide catheter with a length of about 100 cm into the radial artery, as well as the rotation, push and pull of the Sheathless guide catheter during the operation will directly stimulate the radial artery puncture port and continue to stimulate the puncture port. It is easy to cause arterial spasm. Severe arterial spasm can lead to the failure of the operation.
  • the purpose of the present invention is to provide a method and device for cardiac and vascular interventional operations such as endocardial myocardial biopsy through the radial artery or ulnar artery, and use this method to perform cardiac and vascular interventions including myocardial biopsy. And/or multiple interventional operations of blood vessels, only one puncture and catheterization of the radial artery or ulnar artery is required, which avoids the puncture and catheterization of multiple blood vessels, reduces the chance of trauma and complications, and compares with the existing surgical procedures. Compared with the radial artery Sheathless guiding catheter technology, it can reduce the pain caused by repeated stimulation of the puncture port and increase the success rate, safety and effectiveness of the operation.
  • a method for cardiac and vascular interventional surgery via radial artery or ulnar artery including:
  • Step 1 Place the arterial sheath in the punctured arterial vessel, the arterial vessel being the radial artery or the ulnar artery;
  • Step 2 Pass the guiding catheter into the arterial sheath from outside the body and pass it out from the other end, and send it into the left ventricle;
  • Step 3 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue;
  • Step 4 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, and leave a specimen of the myocardial tissue;
  • Step 5 Withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • the method further includes:
  • the angiography catheter After completing the coronary angiography, the angiography catheter is withdrawn from the arterial sheath.
  • the method further includes:
  • the Pigtail catheter was withdrawn from the arterial sheath.
  • the method further includes: disinfecting the puncture site of the radial artery or the ulnar artery, draping and local anesthesia.
  • the method further includes: injecting a developer into the guiding catheter to perform left ventricular angiography.
  • the present invention also provides another method for cardiac and vascular interventional surgery via radial artery or ulnar artery, which includes:
  • Step 1 Pass the guiding catheter into the arterial sheath from outside the body and pass it out from the other end, and then send it to the aortic sinus;
  • Step 2 Inject the contrast agent through the guiding catheter to perform coronary angiography, and/or enter the coronary interventional therapy device through the guiding catheter to perform coronary interventional surgery;
  • Step 3 After completing the coronary angiography and/or the coronary intervention surgery, send the guiding catheter to the left ventricle;
  • Step 4 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of myocardial tissue;
  • Step 5 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, and leave a specimen of the myocardial tissue;
  • Step 6 Withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial blood vessel, and apply pressure to the puncture port.
  • step 6 the method further includes: injecting a developer into the guiding catheter to perform left ventricular angiography.
  • the present invention also provides another method for cardiac and vascular interventional surgery via radial artery or ulnar artery, which is characterized in that it comprises:
  • Step 1 Pass the guiding catheter into the arterial sheath from outside the body and pass it out from the other end, and then send it to the aortic sinus;
  • Step 2 Inject the contrast agent through the guiding catheter to perform peripheral arteriography, and/or enter the peripheral arterial interventional therapy device through the guiding catheter to perform peripheral arterial interventional therapy;
  • Step 3 After completing the peripheral arteriography or the peripheral arterial intervention operation, send the guiding catheter to the left ventricle;
  • Step 4 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of myocardial tissue;
  • Step 5 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, and leave a specimen of the myocardial tissue;
  • Step 6 Withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial blood vessel, and apply pressure to the puncture port.
  • step 6 the method further includes: injecting a developer into the guiding catheter to perform left ventricular angiography.
  • the utility model also provides a device for performing heart and blood vessel interventions through the radial artery or the ulnar artery, which includes an arterial sheath, a guiding catheter, and a myocardial biopsy forceps.
  • the arterial sheath is used to place the radial artery or the puncture after the puncture.
  • the guiding catheter can be passed from the arterial sheath into the arterial blood vessel, wherein the guiding catheter can be sent to the aorta, peripheral artery, aortic sinus, or left ventricle
  • the myocardial biopsy forceps can be sent out from the guiding catheter to the left ventricle, and the myocardial biopsy forceps are used to bite and cut myocardial tissue.
  • the device further includes a Y-shaped hemostatic valve, the Y-shaped hemostatic valve includes three mutually communicating ports, the first port of the Y-shaped hemostatic valve is in linear communication with the second port of the Y-shaped hemostatic valve, The second port of the Y-shaped hemostatic valve is provided with a hemostatic valve body; the first port of the Y-shaped hemostatic valve is communicated with the external port of the guide catheter, and the myocardial biopsy forceps are separated from the Y-shaped hemostatic valve. The second port penetrates the Y-shaped hemostatic valve and the guiding catheter.
  • the device further includes a three-way catheter, a pressure transducer, a pressure monitor, and a developer injection system.
  • the first port of the three-way catheter is in communication with the third port of the Y-shaped hemostatic valve.
  • the second port of the duct is connected with the pressure transducer and the developer injection system, and the pressure transducer is connected with the pressure monitor.
  • a rotary switch is provided on the three-way pipe, and the rotary switch is used to connect or close any two ports of the three-way pipe.
  • the device further includes a contrast catheter, which can be passed from the arterial sheath into the arterial blood vessel and can be delivered to the aorta, peripheral artery, aortic sinus, or left ventricle.
  • a contrast catheter which can be passed from the arterial sheath into the arterial blood vessel and can be delivered to the aorta, peripheral artery, aortic sinus, or left ventricle.
  • the device further includes a three-way catheter, a pressure transducer, a pressure monitor, and a developer injection system.
  • the first port of the three-way catheter is in communication with the external port of the coronary angiography catheter.
  • the second port is connected with the pressure transducer and the developing injection system, and the pressure transducer is connected with the pressure monitor.
  • the device further includes a Pigtail catheter, which can pass through the arterial sheath into the arterial blood vessel and can be delivered to the aorta, peripheral artery, aortic sinus, or left ventricle.
  • a Pigtail catheter which can pass through the arterial sheath into the arterial blood vessel and can be delivered to the aorta, peripheral artery, aortic sinus, or left ventricle.
  • the device further includes a three-way catheter, a pressure transducer, a pressure monitor, and a developer injection system.
  • the first port of the three-way catheter is in communication with the external port of the Pigtail catheter, and the first port of the three-way catheter is in communication with the external port of the Pigtail catheter.
  • the two ports are connected with the pressure transducer and the developing injection system, and the pressure transducer is connected with the pressure monitor.
  • the size ranges of the length, outer diameter, and inner diameter of the arterial sheath are 3-40 cm, 1.40-3.53 mm, and 1.30-3.40 mm, respectively, and the length, outer diameter and inner diameter of the guiding catheter are respectively.
  • the size ranges of the length and outer diameter of the myocardial biopsy forceps are 30 to 140 cm, 1.30 to 3.40 mm, and 1.20 to 3.30 mm.
  • the size ranges of the myocardial biopsy forceps are respectively 31 to 180 cm and 0.10 to 3.30 mm.
  • the difference between the outer diameter of the guiding catheter and the inner diameter of the arterial sheath is greater than or equal to 0.003 mm, and the difference between the outer diameter of the myocardial biopsy forceps and the inner diameter of the guiding catheter is greater than or equal to 0.003 mm.
  • Figure 1 is a schematic diagram of the structure of an arterial sheath in an embodiment of the present invention
  • FIG. 2 is a schematic diagram of the structure of the guiding catheter in the embodiment of the present invention.
  • FIG. 3 is a schematic diagram of the structure of the myocardial biopsy forceps in the embodiment of the present invention.
  • FIG. 4 is a schematic diagram of the structure of the contrast catheter in the embodiment of the present invention.
  • FIG. 5 is a schematic diagram of the structure of the Pigtail catheter in the embodiment of the present invention.
  • FIG. 6 is a schematic diagram of the connection structure during coronary angiography in the embodiment of the present invention.
  • FIG. 7 is a schematic diagram of the connection structure when performing a myocardial biopsy operation in an embodiment of the present invention.
  • the method is a method for performing a cardiac endocardial myocardial biopsy, which includes:
  • Step 1 Place the arterial sheath in the punctured arterial vessel, the arterial vessel is the radial artery or the ulnar artery;
  • Step 2 Pass the guiding catheter into the arterial sheath through the short guide wire and out from the other end of the arterial sheath, and then send it to the left ventricle, withdraw the short guide wire, and leave the guiding catheter in the left ventricle;
  • Step 3 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue; specifically, adjust the position of the myocardial biopsy forceps under fluoroscopy, withdraw the myocardial biopsy forceps about 1.0cm, open the bite and cut Once you feel resistance, quickly close the bite cutter, pull back the myocardial biopsy forceps steadily to separate from the left ventricular wall, and ensure the bite cutter when the myocardial biopsy forceps are withdrawn. In the closed state. Before this step, use heparin saline gauze to wipe the myocardial biopsy forceps.
  • the position of the guiding catheter can be adjusted so that the biopsy forceps can reach different positions to obtain myocardial tissue.
  • the guiding catheter will not continuously stimulate the puncture site, which further reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 4 Remove the myocardial biopsy forceps from the guiding catheter outside the body, and save the myocardial tissue samples; repeat steps 3 and 4 to clamp 4-10 pieces of myocardial tissue in the ventricular septum and left ventricular free wall, respectively.
  • the guiding catheter was flushed with heparin saline and the myocardial biopsy forceps were flushed with heparin saline between biopsy operations.
  • Step 5 Use a short guide wire to withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • left ventricle angiography can also be selectively performed, that is, after the myocardial biopsy is completed, a contrast agent is injected into the guide tube for left ventricular angiography to eliminate complications such as myocardial perforation.
  • This embodiment provides the second embodiment of the method for performing cardiac and vascular interventional surgery via the radial artery or ulnar artery of the present invention.
  • the method performs coronary angiography and endocardial myocardial biopsy in a cardiac interventional operation.
  • Methods include:
  • Step 1 Place the arterial sheath in the punctured arterial vessel, the arterial vessel is the radial artery or the ulnar artery;
  • Step 2 Pass the angiographic catheter from the outside of the body into the arterial sheath through the short guide wire and pass it out from the other end to the aortic sinus, then withdraw the short guide wire; because the diameter of the arterial vessel at the puncture site is small, From the puncture site to the aortic sinus, the diameter of the arterial vessel gradually increases. Therefore, the arterial sheath does not need to be too long.
  • the angiographic catheter passes through the other end of the arterial sheath, the diameter of the arterial vessel has increased. From the arteries there, it can easily penetrate into the aortic sinus.
  • the arterial sheath placed in the arterial blood vessel ensures that the angiographic catheter can stably penetrate to the aortic sinus, so that there will be no continuous stimulation to the puncture site, which reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 3 Adjust the angiography catheter to the left and right coronary artery openings, and inject the contrast agent into the angiography catheter to perform coronary angiography.
  • Step 4 After the coronary angiography is completed, the angiography catheter is withdrawn from the coronary artery opening, and the short guide wire is inserted from the outer end of the angiography catheter and out of the other end in the artery to remove the angiography catheter from the arterial sheath Out, the short guide wire remains in the arterial vessel; during the process of withdrawing the angiographic catheter from the arterial sheath, the puncture site will not be continuously stimulated.
  • Step 5 Pass the guide catheter into the arterial sheath through the short guide wire and pass it out from the other end.
  • the end of the arterial sheath placed in the arterial vessel is passed through, the diameter of the arterial vessel has increased, and the guiding catheter can easily penetrate into the left ventricle from the arterial vessel there.
  • the arterial sheath placed in the arterial blood vessel ensures that the guiding catheter can stably penetrate into the left ventricle, so that it will not produce continuous stimulation to the puncture site, reduce the chance of vasospasm, and increase the success rate of surgery.
  • Step 6 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue; specifically, adjust the position of the myocardial biopsy forceps under fluoroscopy, withdraw the myocardial biopsy forceps about 1.0cm, open the bite and cut Once you feel resistance, quickly close the bite cutter, pull back the myocardial biopsy forceps steadily to separate from the left ventricular wall, and ensure the bite cutter when the myocardial biopsy forceps are withdrawn. In the closed state. Before this step, wipe the myocardial biopsy forceps with heparin saline gauze.
  • the position of the guiding catheter can be adjusted so that the biopsy forceps can reach different positions to obtain myocardial tissue.
  • the guiding catheter will not continuously stimulate the puncture site, which further reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 7 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, and save the myocardial tissue specimen; repeat steps 6 and 7 to clamp 4-10 pieces of myocardial tissue in the ventricular septum and left ventricular free wall, respectively, in the adjacent two
  • the guiding catheter was flushed with heparin saline and the myocardial biopsy forceps were flushed with heparin saline between the two biopsy operations.
  • Step 8 Use a short guide wire to withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • left ventricular angiography can also be selectively performed, that is, after the myocardial biopsy is completed, contrast agent is injected into the guide tube for left ventricular angiography to eliminate complications such as myocardial perforation.
  • This embodiment provides the third embodiment of the method for performing cardiac and vascular interventional surgery via the radial artery or ulnar artery of the present invention.
  • the method performs left ventricular angiography and endocardial myocardial biopsy during a cardiac intervention operation.
  • Methods include:
  • Step 1 Place the arterial sheath in the arterial vessel after puncture, the arterial vessel is the radial artery or the ulnar artery;
  • Step 2 Pass the Pigtail catheter into the arterial sheath from outside the body and pass it out from the other end, and then send it to the left ventricle; the Pigtail catheter can be sent to the left ventricle with the help of a long guide wire or a short guide wire, and the Pigtail catheter can be sent to the left ventricle. After the left ventricle, withdraw the long guide wire or short guide wire; because the diameter of the arterial vessel at the puncture site is small, the diameter of the arterial vessel gradually increases from the puncture site to the aortic sinus.
  • the arterial sheath is not required Too long, when the Pigtail catheter passes through the other end of the arterial sheath, the diameter of the arterial vessel has increased, and the Pigtail catheter can easily penetrate into the left ventricle from the arterial vessel there.
  • the arterial sheath placed in the arterial blood vessel ensures that the Pigtail catheter can stably penetrate the left ventricle, so that there will be no continuous stimulation to the puncture site, which reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 3 Inject the imaging agent into the Pigtail catheter, and perform left ventricular angiography.
  • Step 4 After completing the left ventricular angiography, send the long guide wire through the Pigtail catheter into the left ventricle, withdraw the Pigtail catheter from the arterial sheath while keeping the long guide wire in the left ventricle; withdraw the arterial sheath from the Pigtail catheter During the tube process, there will be no continuous stimulation to the puncture site.
  • Step 5 Pass the guiding catheter into the arterial sheath from outside the body and pass it out from the other end, and send it to the left ventricle; specifically, the guiding catheter is assisted by the long guide wire left in the left ventricle in step 4. Go to the left ventricle, withdraw the long guide wire, and leave the guide catheter in the left ventricle; because the diameter of the arterial vessel at the puncture site is small, the diameter of the arterial vessel gradually increases from the puncture site to the left ventricle. Therefore, The arterial sheath does not need to be too long. When the guiding catheter passes through the end of the arterial sheath placed in the arterial vessel, the diameter of the arterial vessel has increased, and the guiding catheter can be easily pierced from the arterial vessel there. Into the left ventricle. The arterial sheath placed in the arterial blood vessel ensures that the guiding catheter can stably penetrate into the left ventricle, so that it will not produce continuous stimulation to the puncture site, reduce the chance of vasospasm, and increase the success rate of surgery.
  • Step 6 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue; specifically, adjust the position of the myocardial biopsy forceps under fluoroscopy, withdraw the myocardial biopsy forceps about 1.0cm, open the bite and cut Once you feel resistance, quickly close the bite cutter, pull back the myocardial biopsy forceps steadily to separate from the left ventricular wall, and ensure the bite cutter when the myocardial biopsy forceps are withdrawn. In the closed state. Before this step, wipe the myocardial biopsy forceps with heparin saline gauze.
  • the position of the guiding catheter can be adjusted so that the biopsy forceps can reach different positions to obtain myocardial tissue.
  • the guiding catheter will not continuously stimulate the puncture site, which further reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 7 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, and save the myocardial tissue specimen; repeat steps 6 and 7 to clamp 4-10 pieces of myocardial tissue in the ventricular septum and left ventricular free wall, respectively, in the adjacent two
  • the guiding catheter was flushed with heparin saline and the myocardial biopsy forceps were flushed with heparin saline between the two biopsy operations.
  • Step 8 Use a short guide wire to withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • left ventricle angiography can also be selectively performed, that is, after the myocardial biopsy is completed, a contrast agent is injected into the guide tube for left ventricular angiography to eliminate complications such as myocardial perforation.
  • This example provides the fourth embodiment of the method for performing cardiac and vascular interventional surgery via the radial artery or ulnar artery of the present invention.
  • the method performs coronary angiography, left ventricle angiography, and cardiac endocardium in a cardiac intervention operation.
  • Myocardial biopsy surgery the method includes:
  • Step 1 Place the arterial sheath in the arterial vessel after puncture, the arterial vessel is the radial artery or the ulnar artery;
  • Step 2 Pass the angiographic catheter from the outside of the body into the arterial sheath through the short guide wire and pass it out from the other end to the aortic sinus, then withdraw the short guide wire; because the diameter of the arterial vessel at the puncture site is small, From the puncture site to the aortic sinus, the diameter of the arterial vessel gradually increases. Therefore, the arterial sheath does not need to be too long.
  • the angiographic catheter passes through the other end of the arterial sheath, the diameter of the arterial vessel has increased. From the arteries there, it can easily penetrate into the aortic sinus.
  • the arterial sheath placed in the arterial blood vessel ensures that the angiographic catheter can stably penetrate to the aortic sinus, so that there will be no continuous stimulation to the puncture site, which reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 3 Adjust the angiography catheter to the left and right coronary artery openings, and inject the contrast agent into the angiography catheter to perform coronary angiography.
  • Step 4 After the coronary angiography is completed, the angiography catheter is withdrawn from the coronary artery opening, and the short guide wire is inserted from the outer end of the angiography catheter and out of the other end in the artery to remove the angiography catheter from the arterial sheath
  • the short guide wire remains in the arterial blood vessel; during the process of withdrawing the angiographic catheter from the arterial sheath, the puncture site will not be continuously stimulated.
  • Step 5 Pass the Pigtail catheter from outside the body into the arterial sheath through the short guide wire retained in the arterial vessel in step 4 and pass it out from the other end.
  • the Pigtail catheter is sent to the left ventricle with the help of the short guide wire, Withdraw the short guide wire; since the diameter of the arterial vessel at the puncture site is small, the diameter of the arterial vessel gradually increases from the puncture site to the aortic sinus. Therefore, the arterial sheath does not need to be too long.
  • the other end of the sheath is passed through, the diameter of the arterial vessel has increased, and the Pigtail catheter can easily penetrate into the left ventricle from the arterial vessel there.
  • the arterial sheath placed in the arterial blood vessel ensures that the Pigtail catheter can stably penetrate the left ventricle, so that there will be no continuous stimulation to the puncture site, which reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 6 Inject the imaging agent into the Pigtail catheter and perform left ventricular angiography.
  • Step 7 After completing the left ventricular angiography, send the long guide wire through the Pigtail catheter into the left ventricle, withdraw the Pigtail catheter from the arterial sheath while keeping the long guide wire in the left ventricle; withdraw the arterial sheath from the Pigtail catheter During the tube process, there will be no continuous stimulation to the puncture site.
  • Step 8 Pass the guiding catheter into the arterial sheath from outside the body and pass it out from the other end, and send it to the left ventricle; specifically, the guiding catheter is assisted by the long guide wire left in the left ventricle in step 7 Go to the left ventricle, withdraw the long guide wire, and leave the guide catheter in the left ventricle; because the diameter of the arterial vessel at the puncture site is small, the diameter of the arterial vessel gradually increases from the puncture site to the left ventricle. Therefore, The arterial sheath does not need to be too long.
  • the guiding catheter passes through the end of the arterial sheath placed in the arterial vessel, the diameter of the arterial vessel has increased, and the guiding catheter can be easily pierced from the arterial vessel there.
  • the arterial sheath placed in the arterial blood vessel ensures that the guiding catheter can stably penetrate into the left ventricle, so that it will not produce continuous stimulation to the puncture site, reduce the chance of vasospasm, and increase the success rate of surgery.
  • Step 9 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue; specifically, adjust the position of the myocardial biopsy forceps under fluoroscopy, retract the myocardial biopsy forceps about 1.0cm, open the bite and cut Once you feel resistance, quickly close the bite cutter, pull back the myocardial biopsy forceps steadily to separate from the left ventricular wall, and ensure the bite cutter when the myocardial biopsy forceps are withdrawn. In the closed state. Before this step, wipe the myocardial biopsy forceps with heparin saline gauze.
  • the position of the guiding catheter can be adjusted so that the biopsy forceps can reach different positions to obtain myocardial tissue.
  • the guiding catheter will not continuously stimulate the puncture site, which further reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 10 Remove the myocardial biopsy forceps from the guiding catheter to the outside of the body, and save the myocardial tissue specimen; repeat steps 9 and 10 to clamp 4-10 pieces of myocardial tissue in the ventricular septum and left ventricular free wall, respectively.
  • the guiding catheter was flushed with heparin saline and the myocardial biopsy forceps were flushed with heparin saline between the two biopsy operations.
  • Step 10 Use a short guide wire to withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • left ventricular angiography can also be selectively performed, that is, after the myocardial biopsy is completed, a contrast agent is injected into the guide tube to perform left ventricular angiography to eliminate complications such as myocardial perforation.
  • the left ventricular angiography of steps 5 to 7 may be performed first, and then the coronary angiography of steps 2 to 4 may be performed.
  • This example provides a fifth embodiment of the method for performing cardiac and vascular interventional surgery via the radial artery or ulnar artery of the present invention.
  • the method performs coronary interventional surgery and cardiac endocardial myocardial biopsy in a cardiac interventional operation.
  • Surgery the method includes:
  • Step 1 Place the arterial sheath in the arterial vessel after puncture, the arterial vessel is the radial artery or the ulnar artery;
  • Step 2 Pass the guide catheter into the arterial sheath through the short guide wire and pass it out from the other end, to the aortic sinus, and withdraw the short guide wire; because the diameter of the arterial vessel at the puncture site is small, From the puncture site to the aortic sinus, the diameter of the arterial vessel gradually increases. Therefore, the arterial sheath does not need to be too long.
  • the angiography catheter passes through the other end of the arterial sheath, the diameter of the arterial vessel has increased. The catheter can easily penetrate into the aortic sinus from the arterial vessel there.
  • the arterial sheath placed in the arterial blood vessel ensures that the angiographic catheter can stably penetrate to the aortic sinus, so that there will be no continuous stimulation to the puncture site, which reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 3 Inject the contrast agent through the guiding catheter to perform coronary angiography, and/or enter the coronary interventional treatment device through the guiding catheter to perform coronary interventional surgery;
  • Step 4 After the coronary angiography or coronary intervention surgery is completed, the guiding catheter is withdrawn from the coronary artery opening, and the short guide wire is inserted from the outer end of the guiding catheter and out of the other end in the artery. With the assistance of the short guide wire, the guide catheter is sent to the left ventricle, the short guide wire is withdrawn, and the guide catheter is left in the left ventricle.
  • Step 5 Send the myocardial biopsy forceps to the left ventricle through the guiding catheter, bite and cut a part of the myocardial tissue; specifically, adjust the position of the myocardial biopsy forceps under fluoroscopy, withdraw the myocardial biopsy forceps about 1.0 cm, open the bite and cut Once you feel resistance, quickly close the bite cutter, pull back the myocardial biopsy forceps steadily to separate from the left ventricular wall, and ensure the bite cutter when the myocardial biopsy forceps are withdrawn. In the closed state. Before this step, wipe the myocardial biopsy forceps with heparin saline gauze.
  • the position of the guiding catheter can be adjusted so that the biopsy forceps can reach different positions to obtain myocardial tissue.
  • the guiding catheter will not continuously stimulate the puncture site, which further reduces the chance of vasospasm and increases the success rate of the operation.
  • Step 6 Withdraw the myocardial biopsy forceps from the guiding catheter outside the body, leaving a sample of myocardial tissue; repeat steps 5 and 6 to clamp 4-10 pieces of myocardial tissue in the ventricular septum and left ventricular free wall, respectively.
  • the guiding catheter was flushed with heparin saline and the myocardial biopsy forceps were flushed with heparin saline between the two biopsy operations.
  • Step 7 After completing the myocardial biopsy, use the guiding catheter to perform left ventricular angiography to exclude complications such as myocardial perforation.
  • Step 8 Use a short guide wire to withdraw the guiding catheter from the arterial sheath, pull out the arterial sheath in the arterial vessel, and apply pressure to the puncture port.
  • left ventricle angiography can also be selectively performed, that is, after the myocardial biopsy is completed, a contrast agent is injected into the guide tube for left ventricular angiography to eliminate complications such as myocardial perforation.
  • coronary intervention and myocardial biopsy can be completed with one guiding catheter at a time, especially suitable for coronary intervention and endocardial myocardial biopsy , It makes it possible to "one-stop" diagnosis and treatment of heart disease intervention, saves medical expenses, greatly reduces the pain of patients who need to undergo multiple operations, and increases the success rate of operations.
  • the example shown in Figures 1-5 provides the first embodiment of the device for cardiac and vascular interventional surgery via the radial artery or ulnar artery of the present invention.
  • the device includes an arterial sheath 1 connected with a hemostatic valve 11 Catheter 2, myocardial biopsy forceps 3, contrast catheter 4, Pigtail catheter, Y-shaped hemostatic valve 5, pressure transducer 6, pressure monitor 7, three-way catheter 8, contrast agent injection system 9, long guide wire and short guide wire
  • the arterial sheath 1 is used to be placed in the arterial vessel of the radial artery or ulnar artery after puncture.
  • the guiding catheter 2, the contrast catheter 4 and the Pigtail catheter can all pass from the arterial sheath 1 into the arterial blood vessel.
  • the catheter 4 can be delivered to the aortic sinus, the guiding catheter 2 and Pigtail catheter can be delivered to the aorta, peripheral artery, aortic sinus and the left ventricle, respectively, and the myocardial biopsy forceps 3 can be passed from the guiding catheter 2 to the left ventricle.
  • the myocardial biopsy forceps 3 is used to bite and cut the myocardial tissue; the tip of the catheter is bent and angled, and the long guide wire or short guide wire can be placed in it to straighten the tip and reduce the risk of damage to the approach blood vessel.
  • the contrast agent injection The system 9 is only schematic, and does not represent the actual form of the developer injection system 9 itself.
  • the Y-shaped hemostatic valve 5 includes three mutually communicating ports, the first port of the Y-shaped hemostatic valve 5 is in linear communication with the second port of the Y-shaped hemostatic valve 5, and the second port of the Y-shaped hemostatic valve 5 is provided with a hemostatic valve body;
  • the myocardial biopsy forceps 3 includes a bite cutter at the front end and a forceps body 31 at the rear end.
  • the device in this embodiment can be used to perform all the operations in Embodiment 1 to Embodiment 5. Among them, only some of the above components are selectively used in the operations in each embodiment.
  • the specific usage of the parts is as follows:
  • the arterial sheath 1 After performing routine disinfection, draping and local anesthesia on the patient's radial artery puncture site, after puncturing the radial artery, the arterial sheath 1 is inserted into the blood vessel.
  • the guide catheter 2 is sent to the left ventricle through the short guide wire, and the short guide wire is withdrawn, and the guide catheter 2 remains in the left ventricle.
  • the first port of the Y-shaped hemostatic valve 5 communicates with the external port of the guiding catheter 2, and the myocardial biopsy forceps penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5.
  • the first port of the three-way catheter 8 is connected with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 is connected with the pressure transducer 6 and the developer injection system 9.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation; the contrast agent injection system 9 is used to inject a small amount of contrast agent into the left ventricle to confirm that the end hole of the guiding catheter 2 is located in the ventricular cavity and does not reach Live on the ventricular wall.
  • the third port of the three-way duct 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. Surgery for myocardial biopsy.
  • the bite cutter and forceps body 31 of the myocardial biopsy forceps 3 penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5, as shown in Figure 7.
  • the ventricular endocardium is fed, and once resistance is felt, the bite cutter is quickly closed, and the myocardial biopsy forceps 3 are pulled back smoothly to separate them from the left ventricular wall, and the bite cutter is in a closed state when the myocardial biopsy forceps 3 are withdrawn.
  • the jaws of the myocardial biopsy forceps 3 are opened, and the myocardial tissue sample is retained. Repeat the above operation to clamp 4-10 pieces of myocardial tissue from the ventricular septum and the free wall of the left ventricle respectively.
  • a short guide wire was used to withdraw the guiding catheter 2, and then the arterial sheath 1 in the radial artery was removed, and local compression bandage was performed.
  • the arterial sheath 1 After performing routine disinfection, draping and local anesthesia on the patient's radial artery puncture site, after puncturing the radial artery, the arterial sheath 1 is inserted into the blood vessel.
  • the tail end of the contrast catheter 4 is connected to the first port of the three-way catheter 8, the second port of the three-way catheter 8 is connected to the pressure transducer 6 and the developer injection system 9, and the pressure transducer 6 is connected to the pressure monitor 7. It is used to check the blood pressure value during the operation.
  • the contrast agent injection system 9 is used to inject the contrast agent.
  • the third port of the three-way pipe 8 is used for exhaust before the operation. After the exhaust, the rotation on the three-way pipe 8 is adjusted. The switch seals the third port of the three-way catheter 8 so that the first port and the second port are connected, and the coronary angiography operation can be performed, as shown in FIG. 6.
  • the angiography catheter is withdrawn from the coronary artery opening, and the short guide wire is inserted from the outer end of the angiography catheter and out from the other end inside the artery.
  • the angiography catheter 4 is withdrawn, and the short guide wire is indwelled In arteries.
  • the guide catheter 2 is sent to the left ventricle through a short guide wire, the short guide wire is withdrawn, and the guide catheter 2 is left in the left ventricle.
  • the first port of the Y-shaped hemostatic valve 5 communicates with the external port of the guiding catheter 2, and the myocardial biopsy forceps penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5.
  • the first port of the three-way catheter 8 is connected with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 is connected with the pressure transducer 6 and the developer injection system 9.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation; the contrast agent injection system 9 is used to inject a small amount of contrast agent into the left ventricle to confirm that the end hole of the guiding catheter 2 is located in the ventricular cavity and does not reach Live on the ventricular wall.
  • the third port of the three-way duct 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. Surgery for myocardial biopsy.
  • the bite cutter and forceps body 31 of the myocardial biopsy forceps 3 penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5, as shown in Figure 7.
  • the ventricular endocardium is fed, and once resistance is felt, the bite cutter is quickly closed, and the myocardial biopsy forceps 3 are pulled back smoothly to separate them from the left ventricular wall, and the bite cutter is in a closed state when the myocardial biopsy forceps 3 are withdrawn.
  • the arterial sheath 1 After performing routine disinfection, draping and local anesthesia on the patient's radial artery puncture site, after puncturing the radial artery, the arterial sheath 1 is inserted into the blood vessel.
  • the tail end of the Pigtail catheter is connected to the first port of the three-way catheter 8, the second port of the three-way catheter 8 is connected to the pressure transducer 6 and the developer injection system 9, and the pressure transducer 6 is connected to the pressure monitor 7.
  • the developer injection system 9 is used to inject the developer
  • the third port of the three-way pipe 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch on the three-way pipe 8
  • the third port of the three-way catheter 8 is sealed, so that the first port and the second port are connected, and then the left ventricular angiography operation can be performed.
  • the guide catheter 2 is sent to the left ventricle through the long guide wire, and the long guide wire is withdrawn, and the guide catheter 2 remains in the left ventricle.
  • the first port of the Y-shaped hemostatic valve 5 communicates with the external port of the guiding catheter 2, and the myocardial biopsy forceps penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5.
  • the first port of the three-way catheter 8 is connected with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 is connected with the pressure transducer 6 and the developer injection system 9.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation; the contrast agent injection system 9 is used to inject a small amount of contrast agent into the left ventricle to confirm that the end hole of the guiding catheter 2 is located in the ventricular cavity and does not reach Live on the ventricular wall.
  • the third port of the three-way duct 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. Surgery for myocardial biopsy.
  • the bite cutter and forceps body 31 of the myocardial biopsy forceps 3 penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5, as shown in Figure 7.
  • the ventricular endocardium is fed, and once resistance is felt, the bite cutter is quickly closed, and the myocardial biopsy forceps 3 are pulled back smoothly to separate them from the left ventricular wall, and the bite cutter is in a closed state when the myocardial biopsy forceps 3 are withdrawn.
  • Example 4 When performing coronary angiography, left ventricular angiography, and myocardial biopsy operations in Example 4, the procedure for performing the operation using the device in this example is as follows:
  • the arterial sheath 1 After performing routine disinfection, draping and local anesthesia on the patient's radial artery puncture site, after puncturing the radial artery, the arterial sheath 1 is inserted into the blood vessel.
  • the tail end of the contrast catheter 4 is connected to the first port of the three-way catheter 8, the second port of the three-way catheter 8 is connected to the pressure transducer 6 and the developer injection system 9, and the pressure transducer 6 is connected to the pressure monitor 7. It is used to check the blood pressure value during the operation.
  • the contrast agent injection system 9 is used to inject the contrast agent.
  • the third port of the three-way pipe 8 is used for exhaust before the operation. After the exhaust, the rotation on the three-way pipe 8 is adjusted. The switch seals the third port of the three-way catheter 8 so that the first port and the second port are connected, and the coronary angiography operation can be performed, as shown in FIG. 6.
  • the angiography catheter 4 is withdrawn from the coronary artery opening, the short guide wire is inserted from the outer end of the angiography catheter 4 and out from the other end, the angiography catheter 4 is withdrawn from the arterial sheath 1, and the short guide wire The silk remains in the arteries.
  • the Pigtail catheter is inserted into the arterial sheath from outside the body and out from the other end. With the help of the short guide wire, the Pigtail catheter is sent to the left ventricle, and the short guide wire is withdrawn.
  • the tail end of the Pigtail catheter is connected to the first port of the three-way catheter 8, the second port of the three-way catheter 8 is connected to the pressure transducer 6 and the developer injection system 9, and the pressure transducer 6 is connected to the pressure monitor 7.
  • the developer injection system 9 is used to inject the developer
  • the third port of the three-way pipe 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch on the three-way pipe 8
  • the third port of the three-way catheter 8 is sealed, so that the first port and the second port are connected, and then the left ventricular angiography operation can be performed.
  • the long guide wire is sent into the left ventricle through the Pigtail catheter, the Pigtail catheter is withdrawn, the long guide wire is left in the left ventricle, and the guiding catheter 2 is sent to the left ventricle along the long guide wire.
  • the long guide wire is pulled out, and the guide catheter 2 remains in the left ventricle.
  • the first port of the Y-shaped hemostatic valve 5 communicates with the external port of the guiding catheter 2, and the myocardial biopsy forceps penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5.
  • the first port of the three-way catheter 8 is connected with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 is connected with the pressure transducer 6 and the developer injection system 9.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation; the contrast agent injection system 9 is used to inject a small amount of contrast agent into the left ventricle to confirm that the end hole of the guiding catheter 2 is located in the ventricular cavity and does not reach Live on the ventricular wall.
  • the third port of the three-way duct 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. Surgery for myocardial biopsy.
  • the bite cutter and forceps body 31 of the myocardial biopsy forceps 3 penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5, as shown in Figure 7.
  • the ventricular endocardium is fed, and once resistance is felt, the bite cutter is quickly closed, and the myocardial biopsy forceps 3 are pulled back smoothly to separate them from the left ventricular wall, and the bite cutter is in a closed state when the myocardial biopsy forceps 3 are withdrawn.
  • the jaws of the myocardial biopsy forceps 3 are opened, and the myocardial tissue sample is retained. Repeat the above operation to clamp 4-10 pieces of myocardial tissue from the ventricular septum and the free wall of the left ventricle respectively.
  • the device in this embodiment can also be used, which is equivalent to using the same guiding catheter 2 for coronary interventional therapy and myocardial biopsy.
  • the procedure is as follows:
  • the arterial sheath 1 After performing routine disinfection, draping and local anesthesia on the patient's radial artery puncture site, after puncturing the radial artery, the arterial sheath 1 is inserted into the blood vessel.
  • the first port of the Y-shaped hemostatic valve 5 communicates with the extracorporeal port of the guiding catheter 2
  • the first port of the three-way catheter 8 communicates with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 communicates with the pressure.
  • the energy device 6 and the developer injection system 9 are connected.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation; the contrast agent injection system 9 is used to inject a small amount of contrast agent into the coronary artery to determine the position of the coronary artery disease and the guiding catheter 2.
  • the third port of the three-way duct 8 is used for exhaust before surgery. After exhausting, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. For clinical conditions, adjust the guiding catheter to the left or right coronary artery opening, and then inject the contrast agent into the guiding catheter for coronary angiography, or enter the corresponding coronary intervention device through the guiding catheter to complete the coronary intervention surgery.
  • the guiding catheter 2 is withdrawn from the opening of the coronary artery, and the short guide wire is inserted from the outer end of the guiding catheter 2 and out of the other end in the artery.
  • the guiding catheter is sent to the left ventricle, the short guide wire is withdrawn, and the guiding catheter is left in the left ventricle.
  • the first port of the Y-shaped hemostatic valve 5 is in communication with the external port of the guiding catheter 2, and the myocardial biopsy forceps penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5.
  • the first port of the three-way catheter 8 is connected with the third port of the Y-shaped hemostatic valve 5, and the second port of the three-way catheter 8 is connected with the pressure transducer 6 and the developer injection system 9.
  • the pressure transducer 6 and the pressure monitor 7 are used to measure the blood pressure value during the operation;
  • the contrast agent injection system 9 is used to inject a small amount of contrast agent into the left ventricle to confirm that the end hole of the guiding catheter 2 is located in the ventricular cavity and does not reach Live on the ventricular wall.
  • the third port of the three-way duct 8 is used for exhaust before the operation. After the exhaust, adjust the rotary switch set on the three-way duct 8 to close the third port so that the first port and the second port are connected. Surgery for myocardial biopsy.
  • the bite cutter and forceps body 31 of the myocardial biopsy forceps 3 penetrate the Y-shaped hemostatic valve 5 and the guiding catheter 2 from the second port of the Y-shaped hemostatic valve 5, as shown in Figure 7.
  • the ventricular endocardium is fed, and once resistance is felt, the bite cutter is quickly closed, and the myocardial biopsy forceps 3 are pulled back smoothly to separate them from the left ventricular wall, and the bite cutter is in a closed state when the myocardial biopsy forceps 3 are withdrawn.
  • the jaws of the myocardial biopsy forceps 3 are opened, and the myocardial tissue sample is retained. Repeat the above operation to clamp 4-10 pieces of myocardial tissue from the ventricular septum and the free wall of the left ventricle respectively.
  • the arterial sheath does not need to be withdrawn from the blood vessel during the cardiac intervention operation. It will not cause the patient to lose too much blood and reduce the incidence of complications such as hematoma at the puncture site.
  • the guiding catheter 2 and myocardial biopsy forceps 3 are inserted into the arterial sheath for surgery, and will not cause continuous irritation to the puncture site. There is no displacement between the tube 1 and the puncture site, which reduces the probability of corresponding stimulation and vasospasm, and increases the success rate of the operation.
  • the device in this embodiment can be used in sequence. The patient only needs to perform arterial puncture once, without other vascular punctures, which greatly reduces the patient’s pain. , Improve the success rate of surgery.
  • the size combinations of the arterial sheath 1, guiding catheter 2 and myocardial biopsy forceps 3 in this embodiment can be selected according to the specific clinical patient conditions as shown in the following table.
  • the wall thickness of the arterial sheath 1 is less than or equal to 0.40mm, and the wall thickness of the guiding catheter 2 is less than or equal to 0.30mm; the difference between the outer diameter of the guiding catheter 2 and the inner diameter of the arterial sheath 1 is greater than or equal to 0.003mm, that is, a certain amount of The distance between the guiding catheter 2 is used to penetrate the arterial sheath 1; the difference between the outer diameter of the myocardial biopsy forceps 3 and the inner diameter of the guiding catheter 2 is greater than or equal to 0.003mm, ensuring a certain space in the guiding catheter 2 for surgery.
  • the guiding catheter 2, the contrast catheter 4, and the Pigtail catheter may have the shape shown in FIG. 2 or FIG. 4 or other shapes of catheters used in the art.
  • the choice to use the radial artery or the ulnar artery for surgery depends on the patient's vascular condition.
  • the device for transradial or ulnar heart and vascular interventions in this embodiment can also be applied to other heart and vascular interventions, and these are all Those skilled in the art can make it based on their basic skills on the basis of understanding the idea of the present invention, so they will not be listed one by one here.

Abstract

本发明公开了经桡动脉或尺动脉进行心脏及血管介入手术的方法及装置，该方法包括：步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；步骤二、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至所述左心室内；步骤三、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；步骤四、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；步骤五、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。该方法在进行包括心肌活检在内的多个手术时不需要穿刺其它部位血管，无需将动脉鞘管从动脉血管中抽出更换其它鞘管，减少对穿刺部位刺激带来的并发症。

Description

经桡动脉或尺动脉进行心脏及血管介入手术的方法及装置 技术领域
本发明涉及心脏及血管手术技术领域，尤其是一种经桡动脉或尺动脉进行心内膜心肌活检等心脏及血管介入手术的方法及装置。
背景技术
心内膜心肌活检术是进行心脏检查的一种取材技术，是一种有代表性的心脏介入手术。心内膜心肌活检的病理结果是非缺血性心肌病诊断的金标准，在心肌炎的诊断、不明原因心衰的病因诊断、心脏移植术后排异反应的监测等方面有重要的临床意义。
心内膜心肌活检分为左心室心内膜心肌活检(以下简称“左心活检”，须经动脉途径完成)与右心室心内膜心肌活检(以下简称“右心活检”，须经静脉途径完成)。右心活检经颈内静脉、锁骨下静脉、股静脉等静脉途径穿刺置管，经由静脉置管内进入行心肌活检钳，大多在室间隔钳夹心肌组织。因右心室室壁较薄(一般小于4mm)，心肌活检过程中容易发生心脏穿孔等并发症，而左心室室壁较厚(约10mm左右)，因此，右心活检的安全性比左心活检差。其次，右心活检大多只能在室间隔取材，取材范围有限，且心脏疾病大多累及左心，右心活检的有效性不如左心活检。此外，心肌活检的一部分患者需行冠脉造影、左心室造影及心脏或动脉血管系统介入手术等，而冠脉造影、左心室造影及心脏或动脉血管系统介入手术等可经由动脉途径完成，这部分患者如采取右心活检则需要接受动脉、静脉两次穿刺置管，手术操作繁琐，并发症几率增加，患者也会承受较大的痛苦。因此，与右心活检相比，左心活检更加安全、有效、简捷。
目前，左心活检的一种方式是经股动脉途径，由于股动脉直径较大(8mm左右)，出血风险及穿刺部位并发症(如迷走反射、动静脉瘘、腹膜后血肿等)风险较高。还有一种经桡动脉进行左心活检的途径，采用的是Sheathless导引导管技术，该技术的具体操作步骤为：1.进行桡动脉穿刺置入动脉鞘管，经动脉鞘管置入器械完成相应操作(根据具体临床情况而定)；2.撤回动脉鞘管中的器械；3.撤回动脉鞘管，导丝保留在动脉中，这时需要术者用力压迫桡动脉穿刺口以免出血；4.助手协助术者将带有扩张器的Sheathless导引导管经由导丝置入桡动脉，继而经肱动脉、锁骨下动脉送至升主动脉；5.将扩张器从Sheathless导引导管撤出，将Pigtail导管送入Sheathless导引导管，Sheathless导引导管和Pigtail导管同时进入左心室；6.撤回Pigtail导管，Sheathless导引导管保留在左心室内，经Sheathless导引导管送入的心肌活检钳在室间隔或游离壁钳夹心肌组织。在此过程中，长约100cm的Sheathless导引导管持续穿入桡动脉的过程以及术中对Sheathless导引导管转动和推拉，均会直接对桡动脉穿刺口 产生持续刺激，对穿刺口的持续刺激容易造成动脉痉挛，严重动脉痉挛会导致手术的失败，目前已有因Sheathless导引导管对穿刺口的刺激而导致手术失败的案例。此外，在动脉鞘管撤出桡动脉后，需持续压迫穿刺口，容易产生因配合不当造成过多的失血；Sheathless导引导管头端很软，常与其自身扩张器配合不好，在心脏大血管中操作，容易产生大血管损伤等并发症。
发明内容
针对现有技术存在的问题，本发明的目的在于提供一种经桡动脉或尺动脉进行心内膜心肌活检等心脏及血管介入手术的方法及装置，使用该方法进行包括心肌活检在内的心脏和/或血管的多个介入手术时，仅需对桡动脉或尺动脉进行一次穿刺置管，避免了多个部位血管的穿刺置管，减少了创伤和并发症的几率，与现有的经桡动脉Sheathless导引导管技术相比，能够减少对穿刺口的反复刺激给患者带来的痛苦，增加手术的成功率、安全性和有效性。
为实现上述目的，本发明的技术方案如下：
一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，所述动脉血管为桡动脉血管或尺动脉血管；
步骤二、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至所述左心室内；
步骤三、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
步骤四、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
步骤五、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
进一步，在所述步骤二之前，所述方法还包括：
将造影导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
向所述造影导管中注入显影剂，进行冠脉造影；
完成所述冠脉造影后，将所述造影导管从所述动脉鞘管内撤出。
进一步，在所述步骤二之前，所述方法还包括：
将Pigtail导管从体外穿入所述动脉鞘管并从其另一端穿出，送至左心室内；
向所述Pigtail导管中注入显影剂，进行左心室造影；
完成所述左心室造影后，将所述Pigtail导管从所述动脉鞘管内撤出。
进一步，在步骤一之前，所述方法还包括：对所述桡动脉或所述尺动脉的穿刺处进行消毒、铺巾和局部麻醉。
进一步，在步骤五之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
本发明还提供了另一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，包括：
步骤一、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
步骤二、通过所述导引导管注入显影剂，进行冠脉造影，和/或通过所述导引导管进入冠脉介入治疗器械，进行冠脉介入治疗手术；
步骤三、完成所述冠脉造影和/或所述冠脉介入治疗手术后，将所述导引导管送至左心室内；
步骤四、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
步骤五、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
步骤六、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
进一步，在步骤六之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
本发明还提供了另一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，其特征在于，包括：
步骤一、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
步骤二、通过所述导引导管注入显影剂，进行外周动脉造影，和/或通过所述导引导管进入外周动脉介入治疗器械，进行外周动脉介入治疗手术；
步骤三、完成所述外周动脉造影或所述外周动脉介入治疗手术后，将所述导引导管送至左心室内；
步骤四、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
步骤五、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
步骤六、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
进一步，在步骤六之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
本实用新型还提供了一种经桡动脉或尺动脉进行心脏及血管介入手术的装置，包括动脉鞘管、导引导管、心肌活检钳，所述动脉鞘管用于置于穿刺后的桡动脉或尺动脉的动脉血管中，所述导引导管能够从所述动脉鞘管穿出到所述动脉血管中，其中，所述导引导管能够送至主动脉、外周动脉、主动脉窦或左心室，所述心肌活检钳能够从所述导引导管穿出送至所述左心室内，所述心肌活检钳用于咬切心肌组织。
进一步，所述装置还包括Y形止血阀，所述Y形止血阀包括三个互相连通的端口，所述Y形止血阀的第一端口与所述Y形止血阀的第二端口直线连通，所述Y形止血阀的第二端口处设置止血阀体；所述Y形止血阀的第一端口与所述导引导管的体外端口连通，所述心肌活检钳从所述Y形止血阀的第二端口穿入所述Y形止血阀和所述导引导管。
进一步，所述装置还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述Y形止血阀的第三端口连通，所述三通导管的第二端口与所述压力换能器及所述显影剂注射系统连接，所述压力换能器与所述压力监视器连接。
进一步，所述三通导管上设置旋转开关，所述旋转开关用于将述三通导管任意两个端口连通或封闭。
进一步，所述装置还包括造影导管，所述造影导管能够从所述动脉鞘管穿出到所述动脉血管中并能够送至主动脉、外周动脉、主动脉窦或左心室。
进一步，所述装置还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述冠脉造影导管体外端口连通，所述三通导管的第二端口与所述压力换能器及所述显影注射系统连接，所述压力换能器与所述压力监视器连接。
进一步，所述装置还包括Pigtail导管，所述Pigtail导管能够从所述动脉鞘管穿出到所述动脉血管中并能够送至主动脉、外周动脉、主动脉窦或左心室。
进一步，所述装置还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述Pigtail导管体外端口连通，所述三通导管的第二端口与所述压力换能器及所述显影注射系统连接，所述压力换能器与所述压力监视器连接。
进一步，所述动脉鞘管的长度、外径和内径的尺寸范围分别为3～40cm、1.40～3.53mm、1.30～3.40mm，所述导引导管的长度、外径和内径的尺寸范围分别为30～140cm、1.30～3.40mm、1.20～3.30mm，所述心肌活检钳的长度、外径的尺寸范围分别为31～180cm、0.10～3.30mm。
进一步，所述导引导管外径和所述动脉鞘管内径差大于等于0.003mm，所述心肌活检钳外径和所述导引导管内径差大于或等于0.003mm。
附图说明
图1为本发明实施例中动脉鞘管的结构示意图；
图2为本发明实施例中导引导管的结构示意图；
图3为本发明实施例中心肌活检钳的结构示意图；
图4为本发明实施例中造影导管的结构示意图；
图5为本发明实施例中Pigtail导管的结构示意图；
图6为本发明实施例中进行冠脉造影手术时连接的结构示意图；
图7为本发明实施例中进行心肌活检手术时连接的结构示意图；
图中：
1、动脉鞘管；11、止血阀；
2、导引导管；
3、心肌活检钳；31、钳体；32、手柄；
4、造影导管；5、Y形止血阀；6、压力换能器；7、压力监视器；8、三通导管；9、显影剂注射系统。
具体实施方式
为清楚地说明本发明的设计思想，下面结合示例对本发明进行说明。
为了使本领域的技术人员更好地理解本发明的方案，下面结合本发明示例中的附图对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的示例仅仅是本发明的一部分示例，而不是全部的示例。基于本发明的中示例，本领域的普通技术人员在没有做出创造性劳动的前提下，所获得的所有其他实施方式都应当属于本发明保护的范围。
需要注意的是，这里所使用的术语仅是为了描述具体实施方式，而非意图限制根据本申请的示例性实施方式。如在这里所使用的，除非上下文另外明确指出，否则单数形式也意图包括复数形式，此外，还应当理解的是，当在本说明书中使用术语“包含”和/或“包括”时，其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
为了更加清晰的对本发明中的技术方案进行阐述，下面将参考附图并结合实施例来详细说明本发明，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。
实施例1
本实施例提供了本发明的经桡动脉或尺动脉进行心脏及血管介入手术的方法的第一种实施方式，该方法是进行心脏心内膜心肌活检的方法，包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；
在该步骤之前，首先对患者的桡动脉或尺动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉或尺动脉，具体采用桡动脉还是采用尺动脉进行手术根据患者的具体情况确定。
步骤二、通过短导丝将导引导管从体外穿入动脉鞘管并从其另一端穿出，送至左心室内，撤出短导丝，导引导管留置于左心室内；
步骤三、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；具体地，在透视下调整心肌活检钳的位置，回撤心肌活检钳约1.0cm，张开咬切器，重新将心肌活检钳向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳使其脱离左心室壁，在心肌活检钳撤出时保证咬切器处于闭合状态。在该步骤之前，采用肝素盐水纱布擦 拭心肌活检钳。在此过程中，可调整导引导管的位置以便使活检钳达到不同位置取得心肌组织，导引导管也不会对穿刺处进行持续刺激，进一步减少了血管痉挛的几率，增加手术成功率。
步骤四、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；重复步骤三和步骤四可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期用肝素盐水冲洗导引导管及肝素盐水清洗心肌活检钳。待血液涌出导引导管后，用肝素盐水清洗心肌活检钳和肝素盐水冲洗导引导管，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
步骤五、采用短导丝将导引导管从动脉鞘管中撤出，拔出动脉血管内的动脉鞘管，对穿刺口进行加压包扎。
本实施例中，在进行步骤五之前，还可以选择性地进行左心室造影，即完成心肌活检后，向导引导管内注射显影剂进行左心室造影，以除外心肌穿孔等并发症。
本实施例进行心内膜心肌活检手术的方法，在进行经桡动脉或尺动脉的血管穿刺置管后，在手术过程中不需要穿刺其它部位血管，也无需将动脉鞘管从动脉血管中抽出更换其它鞘管或Sheathless导引导管，患者术后无需卧床，更加舒适，可以减少对穿刺部位刺激带来的相关并发症，同时可以降低更换长鞘管导致的动脉痉挛几率、更换鞘管过程中的失血风险和穿刺部位血肿等并发症的几率。
实施例2
本实施例提供了本发明的经桡动脉或尺动脉进行心脏及血管介入手术的方法的第二种实施方式，该方法在一次心脏介入手术中进行冠脉造影和心内膜心肌活检手术，该方法包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；
在该步骤之前，首先对患者的桡动脉或尺动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉或尺动脉，具体采用桡动脉还是采用尺动脉进行手术根据患者的具体情况确定。
步骤二、通过短导丝将造影导管从体外穿入动脉鞘管并从其另一端穿出，送至主动脉窦，撤出短导丝；由于在穿刺处的动脉血管的直径较小，从穿刺处到主动脉窦，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在造影导管从动脉鞘管的另一端穿出时，动脉血管的直径就已增加，造影导管从该处的动脉血管即可很容易地穿入到主动脉窦。置于动脉血管中的动脉鞘管保证造影导管能够稳定地穿至主动脉窦，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤三、调整造影导管分别至左、右冠脉开口，向造影导管中注入显影剂，进行冠脉造影。
步骤四、完成冠脉造影后，造影导管撤出冠脉开口，将短导丝从造影导管体外端穿入并 从其处于动脉血管内的另一端穿出，以便将造影导管从动脉鞘管内撤出，该短导丝保留在动脉血管内；在造影导管撤出动脉鞘管的过程中，也不会对穿刺处产生持续刺激。
步骤五、通过短导丝将导引导管从体外穿入动脉鞘管并从其另一端穿出，在短导丝辅助下，将导引导管送至左心室内，撤出短导丝，导引导管留置于左心室内；由于在穿刺处的动脉血管的直径较小，从穿刺处到左心室，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在导引导管穿出置于动脉血管内的动脉鞘管的一端时，动脉血管的直径就已增加，导引导管从该处的动脉血管即可很容易地穿入到左心室中。置于动脉血管中的动脉鞘管保证导引导管能够稳定地穿至左心室内，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤六、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；具体地，在透视下调整心肌活检钳的位置，回撤心肌活检钳约1.0cm，张开咬切器，重新将心肌活检钳向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳使其脱离左心室壁，在心肌活检钳撤出时保证咬切器处于闭合状态。在该步骤之前，采用肝素盐水纱布擦拭心肌活检钳。在此过程中，可调整导引导管的位置以便使活检钳达到不同位置取得心肌组织，导引导管也不会对穿刺处进行持续刺激，进一步减少了血管痉挛的几率，增加手术成功率。
步骤七、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；重复步骤六和步骤七可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期用肝素盐水冲洗导引导管及肝素盐水清洗心肌活检钳。待血液涌出导引导管后，用肝素盐水清洗心肌活检钳和肝素盐水冲洗导引导管，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
步骤八、采用短导丝将导引导管从动脉鞘管中撤出，拔出动脉血管内的动脉鞘管，对穿刺口进行加压包扎。
本实施例中，在进行步骤八之前，还可以选择性地进行左心室造影，即完成心肌活检后，向导引导管内注射显影剂进行左心室造影，以除外心肌穿孔等并发症。
本实施例进行冠脉造影和心内膜心肌活检手术的方法，在进行经桡动脉或尺动脉的血管穿刺置管后，在手术过程中不需要穿刺其它部位血管，也无需将动脉鞘管从动脉血管中抽出更换其它鞘管或Sheathless导引导管，可以减少对穿刺部位刺激带来的相关并发症，患者术后无需卧床，更加舒适，同时可以降低更换长鞘管导致的动脉痉挛几率、更换鞘管过程中的失血风险和穿刺部位血肿等并发症的几率；并且，能够通过一次手术完成冠脉造影和心肌活检，使心脏病介入的“一站式”诊疗成为可能，大大减轻需要进行多个手术患者的痛苦，增加手术的成功率。
实施例3
本实施例提供了本发明的经桡动脉或尺动脉进行心脏及血管介入手术的方法的第三种实施方式，该方法在一次心脏介入手术中进行左心室造影和心内膜心肌活检手术，该方法包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；
在该步骤之前，首先对患者的桡动脉或尺动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉或尺动脉，具体采用桡动脉还是采用尺动脉进行手术根据患者的具体情况确定。
步骤二、将Pigtail导管从体外穿入动脉鞘管并从其另一端穿出，送至左心室内；Pigtail导管可以通过长导丝或短导丝辅助送至左心室内，将Pigtail导管送至左心室后，撤出长导丝或短导丝；由于在穿刺处的动脉血管的直径较小，从穿刺处到主动脉窦，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在Pigtail导管从动脉鞘管的另一端穿出时，动脉血管的直径就已增加，Pigtail导管从该处的动脉血管即可很容易地穿入到左心室。置于动脉血管中的动脉鞘管保证Pigtail导管能够稳定地穿至左心室，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤三、向Pigtail导管中注入显影剂，进行左心室造影。
步骤四、完成左心室造影后，将长导丝通过Pigtail导管送至左心室内，将Pigtail导管从动脉鞘管内撤出，同时将长导丝保留在左心室内；在Pigtail导管撤出动脉鞘管的过程中，也不会对穿刺处不会产生持续刺激。
步骤五、将导引导管从体外穿入动脉鞘管并从其另一端穿出，送至左心室内；具体地，通过步骤四中留在左心室内的长导丝将导引导管辅助送至左心室内，撤出长导丝，导引导管留置于左心室内；由于在穿刺处的动脉血管的直径较小，从穿刺处到左心室，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在导引导管穿出置于动脉血管内的动脉鞘管的一端时，动脉血管的直径就已增加，导引导管从该处的动脉血管即可很容易地穿入到左心室中。置于动脉血管中的动脉鞘管保证导引导管能够稳定地穿至左心室内，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤六、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；具体地，在透视下调整心肌活检钳的位置，回撤心肌活检钳约1.0cm，张开咬切器，重新将心肌活检钳向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳使其脱离左心室壁，在心肌活检钳撤出时保证咬切器处于闭合状态。在该步骤之前，采用肝素盐水纱布擦拭心肌活检钳。在此过程中，可调整导引导管的位置以便使活检钳达到不同位置取得心肌组织，导引导管也不会对穿刺处进行持续刺激，进一步减少了血管痉挛的几率，增加手术成功率。
步骤七、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；重复步骤六和步骤七 可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期用肝素盐水冲洗导引导管及肝素盐水清洗心肌活检钳。待血液涌出导引导管后，用肝素盐水清洗心肌活检钳和肝素盐水冲洗导引导管，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
步骤八、采用短导丝将导引导管从动脉鞘管中撤出，拔出动脉血管内的动脉鞘管，对穿刺口进行加压包扎。
本实施例中，在进行步骤八之前，还可以选择性地进行左心室造影，即完成心肌活检后，向导引导管内注射显影剂进行左心室造影，以除外心肌穿孔等并发症。
本实施例进行左心室造影和心脏心内膜心肌活检手术的方法，在进行经桡动脉或尺动脉的血管穿刺置管后，在手术过程中不需要穿刺其它部位血管，也无需将动脉鞘管从动脉血管中抽出更换其它鞘管或Sheathless导引导管，可以减少对穿刺部位刺激带来的相关并发症，患者术后无需卧床，更加舒适，同时可以降低更换长鞘管导致的动脉痉挛几率、更换鞘管过程中的失血风险和穿刺部位血肿等并发症的几率；并且，能够通过一次手术完成左心室造影和心肌活检，使心脏病介入的“一站式”诊疗成为可能，大大减轻需要进行多个手术患者的痛苦，增加手术的成功率。
实施例4
本实施例提供了本发明的经桡动脉或尺动脉进行心脏及血管介入手术的方法的第四种实施方式，该方法在一次心脏介入手术中进行冠脉造影、左心室造影和心脏心内膜心肌活检手术，该方法包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；
在该步骤之前，首先对患者的桡动脉或尺动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉或尺动脉，具体采用桡动脉还是采用尺动脉进行手术根据患者的具体情况确定。
步骤二、通过短导丝将造影导管从体外穿入动脉鞘管并从其另一端穿出，送至主动脉窦，撤出短导丝；由于在穿刺处的动脉血管的直径较小，从穿刺处到主动脉窦，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在造影导管从动脉鞘管的另一端穿出时，动脉血管的直径就已增加，造影导管从该处的动脉血管即可很容易地穿入到主动脉窦。置于动脉血管中的动脉鞘管保证造影导管能够稳定地穿至主动脉窦，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤三、调整造影导管分别至左、右冠脉开口，向造影导管中注入显影剂，进行冠脉造影。
步骤四、完成冠脉造影后，造影导管撤出冠脉开口，将短导丝从造影导管体外端穿入并从其处于动脉血管内的另一端穿出，以便将造影导管从动脉鞘管内撤出，该短导丝保留在动 脉血管内；在造影导管撤出动脉鞘管的过程中，也不会对穿刺处产生持续刺激。
步骤五、通过步骤四中保留在动脉血管内的短导丝将Pigtail导管从体外穿入动脉鞘管并从其另一端穿出，在短导丝辅助下将Pigtail导管送至左心室内后，撤出短导丝；由于在穿刺处的动脉血管的直径较小，从穿刺处到主动脉窦，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在Pigtail导管从动脉鞘管的另一端穿出时，动脉血管的直径就已增加，Pigtail导管从该处的动脉血管即可很容易地穿入到左心室。置于动脉血管中的动脉鞘管保证Pigtail导管能够稳定地穿至左心室，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤六、向Pigtail导管中注入显影剂，进行左心室造影。
步骤七、完成左心室造影后，将长导丝通过Pigtail导管送至左心室内，将Pigtail导管从动脉鞘管内撤出，同时将长导丝保留在左心室内；在Pigtail导管撤出动脉鞘管的过程中，也不会对穿刺处不会产生持续刺激。
步骤八、将导引导管从体外穿入动脉鞘管并从其另一端穿出，送至左心室内；具体地，通过步骤七中留在左心室内的长导丝将导引导管辅助送至左心室内，撤出长导丝，导引导管留置于左心室内；由于在穿刺处的动脉血管的直径较小，从穿刺处到左心室，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在导引导管穿出置于动脉血管内的动脉鞘管的一端时，动脉血管的直径就已增加，导引导管从该处的动脉血管即可很容易地穿入到左心室中。置于动脉血管中的动脉鞘管保证导引导管能够稳定地穿至左心室内，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤九、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；具体地，在透视下调整心肌活检钳的位置，回撤心肌活检钳约1.0cm，张开咬切器，重新将心肌活检钳向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳使其脱离左心室壁，在心肌活检钳撤出时保证咬切器处于闭合状态。在该步骤之前，采用肝素盐水纱布擦拭心肌活检钳。在此过程中，可调整导引导管的位置以便使活检钳达到不同位置取得心肌组织，导引导管也不会对穿刺处进行持续刺激，进一步减少了血管痉挛的几率，增加手术成功率。
步骤十、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；重复步骤九和步骤十可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期用肝素盐水冲洗导引导管及肝素盐水清洗心肌活检钳。待血液涌出导引导管后，用肝素盐水清洗心肌活检钳和肝素盐水冲洗导引导管，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
步骤十、采用短导丝将导引导管从动脉鞘管中撤出，拔出动脉血管内的动脉鞘管，对穿 刺口进行加压包扎。
本实施例中，在进行步骤十之前，还可以选择性地进行左心室造影，即完成心肌活检后，向导引导管内注射显影剂进行左心室造影，以除外心肌穿孔等并发症。
本实施例进行冠脉造影、左心室造影和心脏心内膜心肌活检手术的方法，在进行经桡动脉或尺动脉的血管穿刺置管后，在手术过程中不需要穿刺其它部位血管，也无需将动脉鞘管从动脉血管中抽出更换其它鞘管，可以减少对穿刺部位刺激带来的相关并发症，患者术后无需卧床，更加舒适，同时可以降低更换长鞘管导致的动脉痉挛几率、更换鞘管过程中的失血风险和穿刺部位血肿等并发症的几率；并且，能够通过一次手术完成冠脉造影、左心室造影和心肌活检，使心脏病介入的“一站式”诊疗成为可能，大大减轻需要进行多个手术患者的痛苦，增加手术的成功率。
在其他实施方式中，也可以先进行步骤五～七的左心室造影手术，再进行步骤二～四的冠脉造影手术。
实施例5
本实施例提供了本发明的经桡动脉或尺动脉进行心脏及血管介入手术的方法的第五种实施方式，该方法在一次心脏介入手术中进行冠脉介入治疗手术和心脏心内膜心肌活检手术，该方法包括：
步骤一、将动脉鞘管置于穿刺后的动脉血管中，动脉血管为桡动脉血管或尺动脉血管；
在该步骤之前，首先对患者的桡动脉或尺动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉或尺动脉，具体采用桡动脉还是采用尺动脉进行手术根据患者的具体情况确定。
步骤二、通过短导丝将导引导管从体外穿入动脉鞘管并从其另一端穿出，送至主动脉窦，撤出短导丝；由于在穿刺处的动脉血管的直径较小，从穿刺处到主动脉窦，动脉血管的直径是逐渐增加的，因此，动脉鞘管不需要过长，在造影导管从动脉鞘管的另一端穿出时，动脉血管的直径就已增加，造影导管从该处的动脉血管即可很容易地穿入到主动脉窦。置于动脉血管中的动脉鞘管保证造影导管能够稳定地穿至主动脉窦，这样，对穿刺处不会产生持续刺激，减少了血管痉挛的几率，增加手术成功率。
步骤三、通过导引导管注入显影剂，进行冠脉造影，和/或通过导引导管进入冠脉介入治疗器械，进行冠脉介入治疗手术；
步骤四、完成冠脉造影或冠脉介入治疗手术后，将导引导管撤出冠脉开口，将短导丝从导引导管体外端穿入并从其处于动脉血管内的另一端穿出，在短导丝辅助下，将导引导管送至左心室内，撤出短导丝，导引导管留置于左心室内。
步骤五、将心肌活检钳通过导引导管送至左心室内膜，咬切一部分心肌组织；具体地，在透视下调整心肌活检钳的位置，回撤心肌活检钳约1.0cm，张开咬切器，重新将心肌活检 钳向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳使其脱离左心室壁，在心肌活检钳撤出时保证咬切器处于闭合状态。在该步骤之前，采用肝素盐水纱布擦拭心肌活检钳。在此过程中，可调整导引导管的位置以便使活检钳达到不同位置取得心肌组织，导引导管也不会对穿刺处进行持续刺激，进一步减少了血管痉挛的几率，增加手术成功率。
步骤六、将心肌活检钳撤出导引导管至体外，留取心肌组织标本；重复步骤五和步骤六可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期用肝素盐水冲洗导引导管及肝素盐水清洗心肌活检钳。待血液涌出导引导管后，用肝素盐水清洗心肌活检钳和肝素盐水冲洗导引导管，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
步骤七、完成心肌活检后，采用导引导管行左心室造影，以除外心肌穿孔等并发症。
步骤八、采用短导丝将导引导管从动脉鞘管中撤出，拔出动脉血管内的动脉鞘管，对穿刺口进行加压包扎。
本实施例中，在进行步骤八之前，还可以选择性地进行左心室造影，即完成心肌活检后，向导引导管内注射显影剂进行左心室造影，以除外心肌穿孔等并发症。
本实施例进行冠脉造影或冠脉介入治疗手术和心内膜心肌活检手术的方法，在进行经桡动脉或尺动脉的血管穿刺置管后，在手术过程中不需要穿刺其它部位血管，也无需将动脉鞘管从动脉血管中抽出更换其它鞘管，可以减少对穿刺部位刺激带来的相关并发症，患者术后无需卧床，更加舒适，同时可以降低更换长鞘管导致的动脉痉挛几率、更换鞘管过程中的失血风险和穿刺部位血肿等并发症的几率；并且，能够通过一次手术一条导引导管完成冠脉介入治疗和心肌活检，尤其适合冠脉介入治疗与心内膜心肌活检手术，使心脏病介入的“一站式”诊疗成为可能，节省了医疗费用，大大减轻需要进行多个手术患者的痛苦，增加手术的成功率。
实施例6
如图1-5所示的示例提供了本发明经桡动脉或尺动脉进行心脏及血管介入手术的装置的第一种实施方式，该装置包括连接有止血阀11的动脉鞘管1、导引导管2、心肌活检钳3、造影导管4、Pigtail导管、Y形止血阀5、压力换能器6、压力监视器7、三通导管8、显影剂注射系统9、长导丝和短导丝，动脉鞘管1用于置于穿刺后的桡动脉或尺动脉的动脉血管中，导引导管2、造影导管4和Pigtail导管均能够从动脉鞘管1穿出到动脉血管中，其中，造影导管4能够送至主动脉窦，导引导管2和Pigtail导管能够分别送至主动脉、外周动脉、主动脉窦和左心室，心肌活检钳3能够从导引导管2穿出至左心室内，心肌活检钳3用于咬切心肌组织；导管头端弯曲、成角，长导丝或短导丝置入其中可将头端拉直，减少入路血管的损 伤几率，图中，显影剂注射系统9仅是示意性地，不代表显影剂注射系统9本身的真实形态。
Y形止血阀5包括三个互相连通的端口，Y形止血阀5的第一端口与Y形止血阀5的第二端口直线连通，Y形止血阀5的第二端口处设置止血阀体；心肌活检钳3包括位于前端的咬切器和位于后端的钳体31。
采用本实施例中的装置可以进行实施例1～实施例5中的全部手术，其中，每个实施例中手术仅选择性地采用上述某些部件，零部件的具体使用情况如下：
当进行实施例1中的心肌活检手术时，采用本实施例中的装置进行手术的过程如下：
在对患者的桡动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉后，将动脉鞘管1置入到血管中。
通过短导丝将导引导管2送至左心室内，撤出短导丝，导引导管2保留在左心室内。
Y形止血阀5的第一端口与导引导管2的体外端口连通，心肌活检钳从Y形止血阀5的第二端口穿入Y形止血阀5和所述导引导管2。三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向左心室内注射少许造影剂，确定导引导管2端孔位于心室腔而未抵住心室壁。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋转开关将第三端口封闭，使第一端口、第二端口相通，此后再进行心肌活检的手术。
采用肝素盐水纱布擦拭心肌活检钳3后，心肌活检钳3的咬切器和钳体31从Y形止血阀5的第二端口穿入Y形止血阀5和导引导管2，如图7所示，将心肌活检钳3送至左室心内膜，在透视下调整心肌活检钳3的位置，回撤心肌活检钳3约1.0cm，张开咬切器，重新将心肌活检钳3向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳3使其脱离左心室壁，在心肌活检钳3撤出时保证咬切器处于闭合状态。
将心肌活检钳3撤出导引导管2至体外后，将心肌活检钳3钳口打开，并留取其中的心肌组织标本。重复上述操作可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期，旋开Y型阀第二端口处止血阀，见血液“冒出”后，用肝素盐水冲洗导引导管2及肝素盐水清洗心肌活检钳3，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。在手术结束后，旋开Y型阀第二端口处止血阀，见血液“冒出”后，肝素盐水清洗心肌活检钳3和用肝素盐水冲洗导引导管2，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
手术结束后，应用短导丝撤回导引导管2，然后拔除桡动脉内的动脉鞘管1，局部加压包扎。
当进行实施例2中的冠脉造影和心肌活检手术时，采用本实施例中的装置进行手术的过 程如下：
在对患者的桡动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉后，将动脉鞘管1置入到血管中。
通过短导丝将造影导管4从体外穿入动脉鞘管并从另一端穿出，送至主动脉窦，撤出短导丝；
造影导管4尾端与三通导管8的第一端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接，压力换能器6与压力监视器7连接，用于检查手术过程中的血压值，显影剂注射系统9用于注射显影剂，三通导管8的第三端口用于进行手术前的排气，排气后，调节三通导管8上的旋转开关将三通导管8的第三端口密封，使第一端口、第二端口相通，即可进行冠脉造影的手术，如图6所示。
完成冠脉造影后，造影导管撤出冠脉开口，将短导丝从造影导管体外端穿入并从其处于动脉血管内的另一端穿出，将造影导管4一同撤出，短导丝留置于动脉血管内。
通过短导丝将导引导管2送至左心室内，撤回短导丝，导引导管2留置于左心室内。
Y形止血阀5的第一端口与导引导管2的体外端口连通，心肌活检钳从Y形止血阀5的第二端口穿入Y形止血阀5和所述导引导管2。三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向左心室内注射少许造影剂，确定导引导管2端孔位于心室腔而未抵住心室壁。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋转开关将第三端口封闭，使第一端口、第二端口相通，此后再进行心肌活检的手术。
采用肝素盐水纱布擦拭心肌活检钳3后，心肌活检钳3的咬切器和钳体31从Y形止血阀5的第二端口穿入Y形止血阀5和导引导管2，如图7所示，将心肌活检钳3送至左室心内膜，在透视下调整心肌活检钳3的位置，回撤心肌活检钳3约1.0cm，张开咬切器，重新将心肌活检钳3向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳3使其脱离左心室壁，在心肌活检钳3撤出时保证咬切器处于闭合状态。
将心肌活检钳3撤出导引导管2至体外后，将心肌活检钳3钳口打开，并留取其中的心肌组织标本。重复上述操作可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期，旋开Y型阀第二端口处止血阀，见血液“冒出”后，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。用肝素盐水冲洗导引导管2及肝素盐水清洗心肌活检钳3。在手术结束后，旋开Y型阀第二端口处止血阀，见血液“冒出”后，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。肝素盐水清洗心肌活检钳3和用肝素盐水冲洗导引导管2。手术结束后，应用第一导 丝撤回导引导管2，然后拔除桡动脉内的动脉鞘管1，局部加压包扎。
当进行实施例3中的左心室造影和心肌活检手术时，采用本实施例中的装置进行手术的过程如下：
在对患者的桡动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉后，将动脉鞘管1置入到血管中。
通过短导丝将Pigtail导管从体外穿入动脉鞘管并从其另一端穿出，送至左心室，撤出短导丝；
Pigtail导管尾端与三通导管8的第一端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接，压力换能器6与压力监视器7连接，用于检查手术过程中的血压值，显影剂注射系统9用于注射显影剂，三通导管8的第三端口用于进行手术前的排气，排气后，调节三通导管8上的旋转开关将三通导管8的第三端口密封，使第一端口、第二端口相通，即可进行左心室造影的手术。
完成左心室后，将长导丝从Pigtail导管体外端穿入并从另一端穿出，将Pigtail导管撤出，将长导丝保留在左心室中。
通过长导丝将导引导管2送至左心室内，撤回长导丝，导引导管2保留在左心室内。
Y形止血阀5的第一端口与导引导管2的体外端口连通，心肌活检钳从Y形止血阀5的第二端口穿入Y形止血阀5和所述导引导管2。三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向左心室内注射少许造影剂，确定导引导管2端孔位于心室腔而未抵住心室壁。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋转开关将第三端口封闭，使第一端口、第二端口相通，此后再进行心肌活检的手术。
采用肝素盐水纱布擦拭心肌活检钳3后，心肌活检钳3的咬切器和钳体31从Y形止血阀5的第二端口穿入Y形止血阀5和导引导管2，如图7所示，将心肌活检钳3送至左室心内膜，在透视下调整心肌活检钳3的位置，回撤心肌活检钳3约1.0cm，张开咬切器，重新将心肌活检钳3向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳3使其脱离左心室壁，在心肌活检钳3撤出时保证咬切器处于闭合状态。
将心肌活检钳3撤出导引导管2至体外后，将心肌活检钳3钳口打开，并留取其中的心肌组织标本。重复上述操作可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期，旋开Y型阀第二端口处止血阀，见血液“冒出”后，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。用肝素盐水冲洗导引导管2及肝素盐水清洗心肌活检钳3。在手术结束后，旋开Y型阀第二端口处止血阀，见血液“冒 出”后，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。肝素盐水清洗心肌活检钳3和用肝素盐水冲洗导引导管2。手术结束后，应用第一导丝撤回导引导管2，然后拔除桡动脉内的动脉鞘管1，局部加压包扎。
当进行实施例4中的冠脉造影、左心室造影和心肌活检手术时，采用本实施例中的装置进行手术的过程如下：
在对患者的桡动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉后，将动脉鞘管1置入到血管中。
通过短导丝将造影导管4从体外穿入动脉鞘管并从其另一端穿出，送至主动脉窦，撤出短导丝；
造影导管4尾端与三通导管8的第一端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接，压力换能器6与压力监视器7连接，用于检查手术过程中的血压值，显影剂注射系统9用于注射显影剂，三通导管8的第三端口用于进行手术前的排气，排气后，调节三通导管8上的旋转开关将三通导管8的第三端口密封，使第一端口、第二端口相通，即可进行冠脉造影的手术，如图6所示。
完成冠脉造影后，造影导管4撤出冠脉开口，将短导丝从造影导管4体外端穿入并从其另一端穿出，将造影导管4从动脉鞘管1中撤出，短导丝保留在动脉血管内。
通过上述短导丝将Pigtail导管从体外穿入动脉鞘管并从其另一端穿出，在短导丝辅助下，将Pigtail导管送至左心室内，撤出短导丝。
Pigtail导管尾端与三通导管8的第一端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接，压力换能器6与压力监视器7连接，用于检查手术过程中的血压值，显影剂注射系统9用于注射显影剂，三通导管8的第三端口用于进行手术前的排气，排气后，调节三通导管8上的旋转开关将三通导管8的第三端口密封，使第一端口、第二端口相通，即可进行左心室造影的手术。
完成左心室造影后，将长导丝通过Pigtail导管内送至左心室内，撤出Pigtail导管，长导丝留置于左心室内，将导引导管2沿长导丝送至左心室内，撤出长导丝，导引导管2保留在左心室内。
Y形止血阀5的第一端口与导引导管2的体外端口连通，心肌活检钳从Y形止血阀5的第二端口穿入Y形止血阀5和所述导引导管2。三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向左心室内注射少许造影剂，确定导引导管2端孔位于心室腔而未抵住心室壁。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋 转开关将第三端口封闭，使第一端口、第二端口相通，此后再进行心肌活检的手术。
采用肝素盐水纱布擦拭心肌活检钳3后，心肌活检钳3的咬切器和钳体31从Y形止血阀5的第二端口穿入Y形止血阀5和导引导管2，如图7所示，将心肌活检钳3送至左室心内膜，在透视下调整心肌活检钳3的位置，回撤心肌活检钳3约1.0cm，张开咬切器，重新将心肌活检钳3向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳3使其脱离左心室壁，在心肌活检钳3撤出时保证咬切器处于闭合状态。
将心肌活检钳3撤出导引导管2至体外后，将心肌活检钳3钳口打开，并留取其中的心肌组织标本。重复上述操作可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期，旋开Y型阀第二端口处止血阀，见血液“冒出”后，用肝素盐水冲洗导引导管2及肝素盐水清洗心肌活检钳3，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。在手术结束后，旋开Y型阀第二端口处止血阀，见血液“冒出”后，肝素盐水清洗心肌活检钳3和用肝素盐水冲洗导引导管2，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。手术结束后，应用短导丝撤回导引导管2，然后拔除桡动脉内的动脉鞘管1，局部加压包扎。
当进行实施例5中的冠脉造影或冠脉介入治疗和心肌活检手术时，采用本实施中装置也可以进行，即相当于采用同一导引导管2进行冠脉介入治疗手术和心肌活检手术，其手术过程如下：
在对患者的桡动脉穿刺处进行常规消毒、铺巾及局部麻醉后，穿刺桡动脉后，将动脉鞘管1置入到血管中。
通过短导丝将导引导管2从体外穿入动脉鞘管并从其处于动脉血管内的另一端穿出，送至主动脉窦,撤出短导丝；
Y形止血阀5的第一端口与导引导管2的体外端口连通，三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向冠脉内注射少许造影剂，确定冠脉病变及导引导管2位置。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋转开关将第三端口封闭，使第一端口、第二端口相通，根据具体临床情况，调整导引导管至左冠或右冠脉开口，此后可向导引导管中注入显影剂，进行冠脉造影，也可以通过导引导管进入相应冠脉介入治疗器械以完成冠脉介入治疗手术。
完成冠脉介入治疗后，将导引导管2撤出冠脉开口，将短导丝从导引导管2体外端穿入并从其处于动脉血管内的另一端穿出，在短导丝辅助下，将导引导管送至左心室内，撤出短导丝，导引导管留置于左心室内。Y形止血阀5的第一端口与导引导管2的体外端口连通， 心肌活检钳从Y形止血阀5的第二端口穿入Y形止血阀5和所述导引导管2。三通导管8的第一端口与Y形止血阀5的第三端口连通，三通导管8的第二端口与压力换能器6及显影剂注射系统9连接。压力换能器6与压力监视器7，用于测量手术过程中的血压值；显影剂注射系统9用于向左心室内注射少许造影剂，确定导引导管2端孔位于心室腔而未抵住心室壁。
三通导管8的第三端口用于进行手术前的排气，排气后，调节设置在三通导管8上的旋转开关将第三端口封闭，使第一端口、第二端口相通，此后再进行心肌活检的手术。
采用肝素盐水纱布擦拭心肌活检钳3后，心肌活检钳3的咬切器和钳体31从Y形止血阀5的第二端口穿入Y形止血阀5和导引导管2，如图7所示，将心肌活检钳3送至左室心内膜，在透视下调整心肌活检钳3的位置，回撤心肌活检钳3约1.0cm，张开咬切器，重新将心肌活检钳3向左室心内膜送入，一旦感到阻力，快速闭合咬切器，平稳回拽心肌活检钳3使其脱离左心室壁，在心肌活检钳3撤出时保证咬切器处于闭合状态。
将心肌活检钳3撤出导引导管2至体外后，将心肌活检钳3钳口打开，并留取其中的心肌组织标本。重复上述操作可分别于室间隔、左室游离壁钳取心肌组织4～10块，在相邻两次活检操作间期，旋开Y型阀第二端口处止血阀，见血液“冒出”后，用肝素盐水冲洗导引导管2及肝素盐水清洗心肌活检钳3，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。在手术结束后，旋开Y型阀第二端口处止血阀，见血液“冒出”后，肝素盐水清洗心肌活检钳3和用肝素盐水冲洗导引导管2，避免将导引导管中可能存在的血栓、掉落的心肌组织等冲入左心室内，造成外周动脉栓塞。
需要说明的是，上述实施例中所描述的长导丝和短导丝是相对而言的。
本实施例中的经桡动脉或尺动脉进行心脏介入手术的装置，在将桡动脉或尺动脉的动脉血管穿刺后，在心脏介入手术进行的过程中不需要将动脉鞘管从血管中抽出，不会使患者失血过多，降低因穿刺部位血肿等并发症的发生几率，导引导管2和心肌活检钳3穿入到动脉鞘管中进行手术，不会对穿刺处产生持续刺激，动脉鞘管1与穿刺处不发生位移，减少了相应的刺激和血管痉挛的几率，增加手术成功率。此外，在使用本方案的装置进行手术的过程中，无需使用Sheathless导引导管技术中的扩张器，在以往的Sheathless导引导管手术装置中由于扩张器头端尖锐，如操作不当，会增加血管和心脏瓣膜的损伤几率，而在本方案提供的装置中则不会出现该问题。此外当患者需要进行冠脉造影手术、左心室造影手术和心肌活检手术时可采用本实施例中的装置依次进行，患者只需要进行一次动脉穿刺，无需进行其它血管穿刺，大大减轻了患者的痛苦，提高了手术的成功率。
本实施例中的动脉鞘管1、导引导管2和心肌活检钳3尺寸可根据具体临床病人状况选择的尺寸组合情况如下表所示。
Figure PCTCN2019129865-appb-000001
Figure PCTCN2019129865-appb-000002
需要注意的是，动脉鞘管1壁厚小于等于0.40mm，导引导管2壁厚小于等于0.30mm；导引导管2外径和动脉鞘管1内径差大于等于0.003mm，即要留有一定的间隔供导引导管2穿入动脉鞘管1内；心肌活检钳3外径和导引导管2内径差大于或等于0.003mm，保证一定的导引导管2内的空间进行手术。
导引导管2、造影导管4和Pigtail导管在未进行手术之前，其形态可以是图2或图4所示的形态或本领域所用导管的其它形态。
在进行心脏及血管介入手术时，选择采用桡动脉或采用尺动脉进行手术时，具体视患者的血管情况而定。
需要说明的是，除了上述给出的具体实施例之外，本实施例中的经桡动脉或尺动脉心脏及血管介入手术的装置还可以应用于其他的心脏及血管介入手术，而这些都是本领域技术人员在理解本发明思想的基础上基于其基本技能即可做出的，故在此不再一一例举。
最后，可以理解的是，以上实施方式仅仅是为了说明本发明的原理而采用的示例性实施方式，然而本发明并不局限于此。对于本领域普通技术人员而言，在不脱离本发明的原理和实质的情况下，可以做出各种变型和改进，这些变型和改进也视为本发明的保护范围。

Claims (19)

  1. 一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，其特征在于，包括：
    步骤一、将动脉鞘管置于穿刺后的动脉血管中，所述动脉血管为桡动脉血管或尺动脉血管；
    步骤二、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至所述左心室内；
    步骤三、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
    步骤四、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
    步骤五、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
  2. 根据权利要求1所述的方法，其特征在于，在所述步骤二之前，所述方法还包括：
    将造影导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
    向所述造影导管中注入显影剂，进行冠脉造影；
    完成所述冠脉造影后，将所述造影导管从所述动脉鞘管内撤出。
  3. 根据权利要求1或2所述的方法，其特征在于，在所述步骤二之前，所述方法还包括：
    将Pigtail导管从体外穿入所述动脉鞘管并从其另一端穿出，送至左心室内；
    向所述Pigtail导管中注入显影剂，进行左心室造影；
    完成所述左心室造影后，将所述Pigtail导管从所述动脉鞘管内撤出。
  4. 根据权利要求1所述的方法，其特征在于，在步骤一之前，所述方法还包括：对所述桡动脉或所述尺动脉的穿刺处进行消毒、铺巾和局部麻醉。
  5. 根据权利要求1-4任一项所述的方法，其特征在于，在步骤五之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
  6. 一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，其特征在于，包括：
    步骤一、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
    步骤二、通过所述导引导管注入显影剂，进行冠脉造影，和/或通过所述导引导管进入冠脉介入治疗器械，进行冠脉介入治疗手术；
    步骤三、完成所述冠脉造影和/或所述冠脉介入治疗手术后，将所述导引导管送至左心室内；
    步骤四、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
    步骤五、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
    步骤六、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
  7. 根据权利要求6所述的方法，其特征在于，在步骤六之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
  8. 一种经桡动脉或尺动脉进行心脏及血管介入手术的方法，其特征在于，包括：
    步骤一、将所述导引导管从体外穿入所述动脉鞘管并从其另一端穿出，送至主动脉窦；
    步骤二、通过所述导引导管注入显影剂，进行外周动脉造影，和/或通过所述导引导管进入外周动脉介入治疗器械，进行外周动脉介入治疗手术；
    步骤三、完成所述外周动脉造影或所述外周动脉介入治疗手术后，将所述导引导管送至左心室内；
    步骤四、将心肌活检钳通过所述导引导管送至左心室内膜，咬切一部分心肌组织；
    步骤五、将所述心肌活检钳撤出所述导引导管至体外，留取所述心肌组织的标本；
    步骤六、将所述导引导管从所述动脉鞘管中撤出，拔出所述动脉血管内的所述动脉鞘管，对穿刺口进行加压包扎。
  9. 根据权利要求8所述的方法，其特征在于，在步骤六之前，所述方法还包括：向所述导引导管中注入显影剂，进行左心室造影。
  10. 一种经桡动脉或尺动脉进行心脏及血管介入手术的装置，其特征在于，包括动脉鞘管、导引导管、心肌活检钳，所述动脉鞘管用于置于穿刺后的桡动脉或尺动脉的动脉血管中，所述导引导管能够从所述动脉鞘管穿出到所述动脉血管中，其中，所述导引导管能够送至主动脉、外周动脉、主动脉窦或左心室，所述心肌活检钳能够从所述导引导管穿出送至所述左心室内，所述心肌活检钳用于咬切心肌组织。
  11. 根据权利要求10所述的装置，其特征在于，还包括Y形止血阀，所述Y形止血阀包括三个互相连通的端口，所述Y形止血阀的第一端口与所述Y形止血阀的第二端口直线连通，所述Y形止血阀的第二端口处设置止血阀体；所述Y形止血阀的第一端口与所述导引导管的体外端口连通，所述心肌活检钳从所述Y形止血阀的第二端口穿入所述Y形止血阀和所述导引导管。
  12. 根据权利要求11所述的装置，其特征在于，还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述Y形止血阀的第三端口连通，所述三通导管的第二端口与所述压力换能器及所述显影剂注射系统连接，所述压力换能器与所述压力监视器连接。
  13. 根据权利要求12所述的装置，其特征在于，所述三通导管上设置旋转开关，所述旋转开关用于将述三通导管任意两个端口连通或封闭。
  14. 根据权利要求10所述的装置，其特征在于，还包括造影导管，所述造影导管能够从所述动脉鞘管穿出到所述动脉血管中并能够送至主动脉、外周动脉、主动脉窦或左心室。
  15. 根据权利要求14所述的装置，其特征在于，还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述造影导管体外端口连通，所述三通导管的第二端口与所述压力换能器及所述显影注射系统连接，所述压力换能器与所述压力监视器连接。
  16. 根据权利要求10所述的装置，其特征在于，还包括Pigtail导管，所述Pigtail导管能够从所述动脉鞘管穿出到所述动脉血管中并能够送至主动脉、外周动脉、主动脉窦或左心室。
  17. 根据权利要求16所述的装置，其特征在于，还包括三通导管、压力换能器、压力监视器、显影剂注射系统，所述三通导管的第一端口与所述Pigtail导管体外端口连通，所述三通导管的第二端口与所述压力换能器及所述显影注射系统连接，所述压力换能器与所述压力监视器连接。
  18. 根据权利要求10-17任一项所述的装置，其特征在于，所述动脉鞘管的长度、外径和内径的尺寸范围分别为3～40cm、1.40～3.53mm、1.30～3.40mm，所述导引导管的长度、外径和内径的尺寸范围分别为30～140cm、1.30～3.40mm、1.20～3.30mm，所述心肌活检钳的长度、外径的尺寸范围分别为31～180cm、0.10～3.30mm。
  19. 根据权利要求10-18任一项所述的装置，其特征在于，所述导引导管外径和所述动脉鞘管内径差大于等于0.003mm，所述心肌活检钳外径和所述导引导管内径差大于或等于0.003mm。
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