WO2023006075A1 - 穿刺器械 - Google Patents

穿刺器械 Download PDF

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Publication number
WO2023006075A1
WO2023006075A1 PCT/CN2022/108990 CN2022108990W WO2023006075A1 WO 2023006075 A1 WO2023006075 A1 WO 2023006075A1 CN 2022108990 W CN2022108990 W CN 2022108990W WO 2023006075 A1 WO2023006075 A1 WO 2023006075A1
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WO
WIPO (PCT)
Prior art keywords
needle
puncture
guide tube
puncture device
needle bar
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PCT/CN2022/108990
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English (en)
French (fr)
Inventor
胡猛
郭栋
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北京迈迪斯医疗技术有限公司
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Priority to EP22848679.1A priority Critical patent/EP4378412A1/en
Publication of WO2023006075A1 publication Critical patent/WO2023006075A1/zh

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    • 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
    • A61B17/3403—Needle locating or guiding means
    • 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
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • 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
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
    • 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
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2063—Acoustic tracking systems, e.g. using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2065—Tracking using image or pattern recognition

Definitions

  • the invention relates to the technical field of medical devices, in particular to a puncture device.
  • Interventional Radiology is a marginal subject that developed rapidly in the late 1970s. Under the guidance of medical imaging equipment, it is based on imaging diagnostics and clinical diagnostics, combined with the principles of clinical therapeutics, and uses catheters, guide wires and other equipment to diagnose and treat various diseases. That is: under the guidance of imaging medicine (X-ray, ultrasound, CT, MRI), through the percutaneous puncture or through the original orifice of the human body, a special catheter or instrument is inserted into the lesion for diagnostic imaging and treatment. Or tissue collection, cytology, bacteriology and biochemical examination.
  • imaging medicine X-ray, ultrasound, CT, MRI
  • Interventional radiology provides new drug delivery routes and surgical methods for modern medical diagnosis and treatment. Compared with traditional routes of drug administration and surgical methods, it is more direct, effective, simpler and minimally invasive. Interventional radiology has opened up a new way of treatment, and it is simple, safe, less traumatic, less complications, quick effect, minimally invasive; strong repeatability; accurate positioning; high curative effect, quick effect; low incidence of complications; The connection and application of multiple technologies is simple and easy.
  • interventional radiology can be divided into interventional diagnostics and interventional therapy; according to technology, it can be divided into: vascular interventional radiology (drug infusion; embolization technology; formed stent; filter technology, etc.) and non-vascular interventional radiology (puncture biopsy ; drainage technology; foreign body removal; cavity stent, etc.); according to the scope of clinical application, it can be divided into tumor interventional radiology, non-tumor interventional radiology, neurological interventional radiology, etc.
  • vascular interventional radiology drug infusion; embolization technology; formed stent; filter technology, etc.
  • non-vascular interventional radiology puncture biopsy ; drainage technology; foreign body removal; cavity stent, etc.
  • the medical imaging equipment used in interventional radiology mainly includes X-ray, ultrasound, CT, MRI guidance, etc.
  • X-ray and CT are radioactive, while MRI needs to cooperate with non-ferromagnetic equipment and environmental applications.
  • MRI needs to cooperate with non-ferromagnetic equipment and environmental applications.
  • intraoperative interventional guidance multiple, long-term imaging is required.
  • the radioactivity of X-rays and CT is harmful to patients and medical staff. Inconvenience and difficulties have hindered the clinical application of interventional radiology.
  • Ultrasound has the characteristics of real-time imaging and no radiation, and has been widely used in interventional radiology.
  • the non-intuitive two-dimensionality of ultrasound imaging, the coplanarity of the ultrasound imaging plane and the interventional tool, etc. easily lead to difficulties and mistakes in the positioning and guidance of the interventional tool, which in turn causes puncture errors, trauma, complications, etc.
  • Medical personnel who are required to perform interventional diagnosis and treatment need to have a lot of training, skilled technology and rich experience.
  • Ultrasonic interventional navigation can display the movement of interventional tools in the tissue in real time, providing a basis for interventional path selection, and is an important means of interventional radiology.
  • conventional ultrasound-guided interventions rely heavily on the operator's skills, experience, and performance of ultrasound equipment, and there may be problems such as more intervention times and longer operation times, which will lead to an increase in the incidence of complications.
  • an electromagnetic positioning technology which uses electromagnetic induction to measure the position and direction of an object according to the Biot-Savart law, in which the magnetic field signal transmitter generates a signal field by emitting a magnetic field signal, and the magnetic signal
  • the receiving sensor receives the magnetic field signal, transmits the signal to the magnetic field signal controller, and obtains the space vector information (space coordinates and direction) of the object.
  • Interventional instruments can be navigated through electromagnetic positioning technology, and its accuracy can effectively solve the problem of inaccurate interventional navigation caused by the volume effect of ultrasonic imaging equipment.
  • Interventional radiology has a wide range of clinical applications, and can be applied to vascular diseases (such as vascular stenosis, portal hypertension, etc.), heart diseases (mitral valve stenosis, coronary artery stenosis, etc.), tumors (tumor feeding artery infusion chemotherapy, embolization for malignant tumors, etc.) etc.), non-vascular diseases (digestive tract, urinary tract, biliary tract, airway, nasolacrimal duct stenosis, etc.), needle biopsy, etc.
  • vascular diseases such as vascular stenosis, portal hypertension, etc.
  • heart diseases mitral valve stenosis, coronary artery stenosis, etc.
  • tumors tumor feeding artery infusion chemotherapy, embolization for malignant tumors, etc.
  • non-vascular diseases digestive tract, urinary tract, biliary tract, airway, nasolacrimal duct stenosis, etc.
  • needle biopsy
  • TIPS transjugular intrahepatic portosystemic shunt
  • Transjugular intrahepatic portosystemic shunt stems from the fact that the portal vein is often punctured during transjugular cholangiography and liver biopsy. It was developed by the famous interventional radiologist Rosch J and his colleagues. Establishing a shunt in the hepatic parenchyma between the hepatic vein and the portal vein can significantly reduce the portal vein resistance structurally in a minimally invasive way, which is one of the key measures to reduce the portal vein pressure in patients with liver cirrhosis.
  • TIPS The first metal stent TIPS with real clinical significance was implemented in January 1988.
  • TIPS has been widely used in the treatment of esophageal and gastric variceal bleeding caused by liver cirrhosis and portal hypertension, intractable pleural effusion, Budd-Chiari syndrome (BCS) and sinusoidal obstruction syndrome, etc.
  • BCS Budd-Chiari syndrome
  • SCS Budd-Chiari syndrome
  • sinusoidal obstruction syndrome etc.
  • the steps of the TIPS technique operation procedure are as follows: 1) anesthesia; 2) portal vein imaging; 3) internal jugular vein puncture; 4) hepatic vein cannulation; 5) portal vein puncture; 6) portal cavity establishment; 7) balloon catheter dilatation and endoluminal stent implantation; 8) postoperative PPG measurement and optimal threshold; 9) embolization of portosystemic collateral vessels.
  • TIPS The indications for TIPS include: 1) acute esophageal variceal bleeding; 2) gastric variceal bleeding; 3) prevention of esophageal variceal bleeding; 4) prevention of gastric variceal bleeding; 5) refractory or recurrent ascites due to cirrhosis; Pleural effusion and hepatorenal syndrome; 6) BCS; 7) sinusoidal obstruction syndrome; 8) portal hypertension combined with portal vein thrombosis;
  • Absolute contraindications (1) congestive heart failure or severe valvular heart failure; (2) uncontrolled systemic infection or inflammation; (3) Child-Pugh score > 13 or end-stage liver disease score > 18 (4) Severe pulmonary hypertension; (5) Severe renal insufficiency (except hepatic renal insufficiency); (6) Rapidly progressive liver failure; (7) Diffuse malignant tumor of the liver; (8) Contrast medium allergy.
  • the complications related to the technique mainly include biliary tract bleeding and injury, intraperitoneal hemorrhage, hepatic artery injury, biliary peritonitis, skin radiation burns, and hematoma at the puncture site (Dariushina SR, Haskal ZJ , Midia M, et al. Quality improvement guidelines for transjugular intrahepatic portosystemic shunts. J Vasc Interv Radiol 2016; 27(1):1-7.).
  • the general process of portal vein puncture through the hepatic vein is as follows: the operator estimates the puncture angle by observing the imaging data before the operation; the patient completes local anesthesia in the catheterization room or operating room; firstly, the right internal jugular vein is punctured; , the catheter was sent from the right internal jugular vein, through the right atrium and inferior vena cava, to the right internal hepatic vein; portal vein wedge angiography was performed to clarify the anatomical structure of the portal vein and its branches; the portal vein was punctured from the right hepatic vein forward and downward.
  • RUPS-100 puncture assembly consists of outer sheath, dilator, plastic guide tube, metal guide tube, plastic cannula and puncture needle (Chu Jianguo, The development status and standardization of transjugular intrahepatic portosystemic shunt technology in China, Zhonghua Intervention Electronic Journal of Radiology, 2013, 1(2)).
  • the design of the puncture component is designed according to the body shape and vascular network characteristics of European and American races, and it is not completely suitable for Asians and Chinese patients with liver atrophy who mainly change from hepatitis B to cirrhosis.
  • the hit rate of portal vein branch puncture using this puncture assembly is low, not only the patient suffers more, but also the doctor and the patient need to suffer from a larger dose of X-ray irradiation. What's more serious, this will also make the operator perforate the liver capsule and stray into the main extrahepatic portal vein, causing serious complications such as abdominal hemorrhage.
  • the operator before performing puncture into the intrahepatic portal vein branch, the operator must carefully study the results of portal vein angiography, and according to the portal vein position, shape and the relationship between the hepatic vein and the portal vein branch shown in the above portal vein contrast, usually each individual The anatomical relationship between the hepatic vein and the portal vein is very different, and the RUPS-100 should be manually adjusted in vitro (in most cases, the bending angle of the puncture needle needs to be increased); as for whether the bending angle of the metal guide tube is appropriate, and whether the inner diameter is flat , can only rely on the experience of the operator.
  • the judgment of the position of the puncture needle and the positional relationship between the puncture needle and various parts of the subject's body also depends on the experience of the operator.
  • puncture navigation technology it has become an urgent problem to solve monitoring blind spots, real-time monitoring and guidance of puncture instruments to safely and effectively puncture through the hepatic vein to the predetermined position of portal vein, and reduce complications. Furthermore, there is an urgent need for a puncture instrument that can be applied to interventional navigation technology, so as to achieve easier operation, more accurate and effective, and safer puncture surgery under interventional navigation.
  • an embodiment of the present invention provides a puncture device to solve one or more of the above-mentioned problems of the existing puncture surgery such as difficult operation, poor accuracy, and poor safety, so as to achieve easier operation, more accurate and effective, and more efficient operation. Safe piercing procedure.
  • the present invention provides a puncture device, comprising: a puncture needle, the puncture needle includes a sensor installation part, and the sensor installation part is capable of installing an electromagnetic sensor.
  • the sensor installation part is a cavity inside the puncture needle or a concave part on the body surface of the puncture needle.
  • the puncture needle is tubular, one end of the lumen of the puncture needle opens at the proximal end of the puncture needle, the other end of the lumen is closed at the distal end of the puncture needle, and the lumen forms The sensor mounting part.
  • the puncture needle includes a needle head and a needle shaft, and the needle head and the needle shaft are integrally formed.
  • the puncture needle includes a needle head and a needle shaft, and the needle head and the needle shaft are connected by welding or threading.
  • the proximal end of the needle includes a connection part
  • the needle shaft is tubular, and when the needle is connected to the needle shaft, the connection part is inserted into the lumen of the needle shaft.
  • the outer diameter of the distal portion of the needle shaft is smaller than the outer diameter of the proximal portion of the needle shaft.
  • the needle bar includes an inner needle bar and an outer needle bar, the outer needle bar is sheathed outside the inner needle bar, and the outer needle bar is connected to the inner needle bar by welding.
  • the sealing process between the inner needle bar and the outer needle bar is welding or bonding.
  • the inner needle shaft extends beyond the outer needle shaft.
  • the puncture needle includes an auxiliary part sleeved on the needle shaft, and the coefficient of friction of the auxiliary part is smaller than that of the needle shaft.
  • auxiliary part is a spring or a sleeve.
  • the spring is connected to the needle bar by welding.
  • the material of the sleeve is polytetrafluoroethylene, and the sleeve is connected with the needle rod by heat shrinkage.
  • the outer diameter of the distal portion of the needle shaft is smaller than the outer diameter of the proximal portion of the needle shaft, and the spring or the sleeve is sleeved on the distal portion of the needle shaft.
  • the outer needle bar includes a distal outer needle bar and a proximal outer needle bar, the distal outer needle bar is sleeved on the distal end of the inner needle bar, and the proximal outer needle bar is sleeved on the The proximal end of the inner needle bar, the spring or the sleeve is sleeved outside the inner needle bar between the distal outer needle bar and the proximal outer needle bar.
  • the outer diameter of the distal part of the inner needle bar is smaller than the outer diameter of the proximal part of the inner needle bar, and the outer needle bar and the spring are sequentially sleeved on the inner needle bar from the distal end to the proximal end.
  • the distal end portion of the inner needle bar, or the outer needle bar and the sleeve are sleeved on the distal end portion of the inner needle bar sequentially from the distal end to the proximal end.
  • the inner needle bar extends beyond the outer needle bar, and the spring or the sleeve is sleeved on the inner needle bar and extends beyond the outer needle bar part.
  • the electromagnetic sensor is a wireless sensor or a wired sensor.
  • the material of the puncture needle includes but not limited to one or more of stainless steel and nickel-titanium alloy.
  • the thickness specification of the puncture needle includes but not limited to: 16G, 17G, 18G, 19G, 20G, 21G.
  • the material of the spring includes but not limited to one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy.
  • the puncture device includes an interventional catheter device
  • the interventional catheter device includes: a guide tube; a flexible sleeve, the flexible sleeve is set outside the guide tube; the flexible sleeve and the guide tube can move relatively, so that The distal end of the flexible sheath extends beyond the distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sheath.
  • the distal end of the flexible sleeve is provided with a constricted part, the inner diameter of the constricted part is smaller than the outer diameter of the guide tube, and the constricted part is provided with a weakened part that is easy to break, when the intervention catheter Displacement of the guide tube relative to the flexible sheath as the instrument abuts the puncture target breaks the weakened portion such that the guide tube extends beyond the distal end of the flexible sheath.
  • the weakened portion extends to the distal opening of the flexible sheath.
  • the weakened portion extends to the distal opening of the flexible sheath in a linear or helical manner along the longitudinal direction of the flexible sheath.
  • the weakened portion is intermittent scoring lines or indentations.
  • the weakened portion is disposed on the inner surface or the outer surface of the weakened portion.
  • the inner diameter of the constricted part is 0.05mm-1mm smaller than the outer diameter of the guide tube.
  • the material of the flexible sleeve includes but not limited to one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyetheramide elastomer, high-density polyethylene kind.
  • the material of the guide tube includes but not limited to one or more of stainless steel and nickel-titanium alloy.
  • the thickness specification of the guide tube includes but not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm-57cm.
  • the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.
  • the interventional catheter device includes a connecting piece through which the proximal end of the guide tube is connected to the proximal end of the flexible sheath, and the guiding tube and the flexible sheath can be connected through the connecting piece relatively mobile.
  • connection method of the connector is a threaded method, a buckle method or an adhesive method.
  • the puncture instrument of the present invention the puncture operation that is easier to operate, more accurate, effective and safer can be realized under the interventional navigation technology, thereby solving the technical problems existing in the prior art.
  • Fig. 1 is the schematic diagram of the puncture instrument of the embodiment of the present invention.
  • Fig. 2 is the schematic diagram of the puncture instrument of the embodiment of the present invention.
  • Fig. 3 is the schematic diagram of the puncture needle of the embodiment of the present invention.
  • Fig. 4 is the schematic diagram of the puncture needle of the embodiment of the present invention.
  • FIG. 5 is a schematic diagram of a puncture needle according to an embodiment of the present invention.
  • FIG. 6 is a schematic diagram of a puncture needle according to an embodiment of the present invention.
  • Fig. 7 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • Fig. 8 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • Fig. 9 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of a puncture needle provided with a catheter according to an embodiment of the present invention.
  • Fig. 11 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention
  • Fig. 12 is a schematic diagram of a guide tube according to an embodiment of the present invention.
  • Fig. 13 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention.
  • Fig. 14 is a schematic diagram of assembly of a guide tube and a flexible sleeve according to an embodiment of the present invention
  • Fig. 15 is a schematic diagram of the state of the guide tube and the flexible sleeve in the process of reaching the puncture target through the interventional approach according to the embodiment of the present invention
  • Fig. 16 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention
  • Fig. 17 is a schematic diagram of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the exit process through the interventional approach after the implementation of puncture guidance;
  • Fig. 18 is a schematic diagram of a flexible sleeve formed with a distal constriction according to an embodiment of the present invention.
  • Fig. 19 is a schematic diagram of the shrinkage part of the flexible sleeve of the embodiment of the present invention.
  • Fig. 20 is a schematic diagram of the state of the guide tube and the flexible sleeve in the process of reaching the puncture target through the interventional approach according to the embodiment of the present invention
  • Fig. 21 is a schematic diagram of the state of the guide tube and the flexible sleeve when performing puncture guidance according to the embodiment of the present invention.
  • Fig. 22 is a schematic diagram of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance;
  • interventional navigation technology such as electromagnetic navigation technology
  • Electromagnetic navigation equipment can use electromagnetic induction to measure the position and direction of objects according to the Biot-Savart law, in which the magnetic field signal transmitter generates a signal field by emitting a magnetic field signal, and the magnetic signal receiving sensor receives the magnetic field Signal, transmit the signal to the magnetic field signal controller to obtain the object space vector information (space coordinates and direction).
  • the widely used electromagnetic navigation products include POLARIS system of Canadian NDI company, VISLAN system of British RMR company, STEALTHSTATION system of American MEDTRONIC company, etc.
  • the measurement accuracy of POLARIS system is 0.35mm.
  • RMS is considered the international standard for navigation and positioning systems, capable of tracking 9 passive and 3 active surgical instruments simultaneously.
  • the transmitter of electromagnetic navigation equipment usually includes electromagnetic transmitting coils to emit electromagnetic waves and generate electromagnetic fields.
  • the effective positioning range of electromagnetic fields can be 300mm ⁇ 300mm ⁇ 300mm, 400mm ⁇ 400mm ⁇ 400mm, etc.
  • the sensor of the electromagnetic navigation equipment can receive the electromagnetic signal through the electromagnetic receiving coil, and convert the electromagnetic signal into an electrical signal, so as to track and locate the position of the sensor in the electromagnetic field.
  • the positioning accuracy of navigation is usually required to reach 5mm, and the positioning speed reaches 30ms.
  • the precision of electromagnetic positioning may be at least 1.5, and the positioning speed may be as fast as 12.5 ms.
  • the senor can be designed into various structures and sizes.
  • the sensor can be linear, and its size can be: the minimum outer diameter is 0.56 mm, as shown in FIG. 1 .
  • the sensor can be wired or wireless. Therefore, the connection between the electromagnetic device and the puncture instrument can be wired or wireless.
  • the wireless connection can be Bluetooth, WIFI, Zigbee, etc.
  • An embodiment of the present invention provides a puncture device applicable to interventional navigation technology.
  • the puncture device can be provided with the above-mentioned sensor. Through the sensor, combined with an ultrasonic imaging device, the puncture device can be positioned and navigated during the puncture operation.
  • Fig. 1 is a schematic diagram of a puncture device according to an embodiment of the present invention.
  • the puncture device 1 may include a puncture needle 11 , and the puncture needle 11 may be provided with a sensor installation part 111 , and the sensor installation part 111 may be used for installing the sensor 2 .
  • the material of the puncture needle 11 may be one or more including but not limited to stainless steel, nickel-titanium alloy and the like.
  • the thickness specifications of the puncture needle 11 may include but not limited to: 16G, 17G, 18G, 19G, 20G, 21G, etc.
  • G is the abbreviation of GAUGE, which is a length measurement about diameter originated in North America unit).
  • the puncture needle 11 can be designed in various lengths, for example, for transjugular intrahepatic portosystemic shunt, its length specification can be 50cm-65cm.
  • the puncture needle 11 may include a needle head 112 and a needle shaft 113 .
  • the needle head 112 and the needle bar 113 can be integrally formed, as shown in FIG. 1 .
  • the needle head 112 and the needle bar 113 can also be assembled and connected separately, for example, the needle head 112 and the needle bar 113 are connected by means of welding or threading, as shown in FIG. 3 .
  • the tip 1121 of the needle 112 may be in the shape of a triangular pyramid, a quadrangular pyramid or a cone.
  • the height of the taper of the needle tip 1121 may be 1mm ⁇ 4mm.
  • the sensor installation part 111 may be disposed at the distal end of the puncture needle 11 .
  • the sensor mounting part 111 may be a cavity inside the puncture needle 11, as shown in FIG. 1 . If the sensor is wired, the lumen may be provided with an opening for the passage of the wire, eg the lumen opens at the proximal end of the puncture needle 11 . If the sensor is wireless, the cavity can be closed after the sensor is mounted.
  • the distance from the cavity of the puncture needle 11 to the tip of the puncture needle 11 may be 0.10mm-30mm.
  • the puncture needle 11 can be tubular, one end of the lumen of the puncture needle 11 opens at the proximal end of the puncture needle 11, the other end of the lumen is closed at the far end of the puncture needle, and the lumen forms a sensor mounting portion 111 .
  • Fig. 2 is a schematic diagram of a puncture device according to an embodiment of the present invention.
  • the sensor installation part 111 may be a concave part of the body surface of the puncture needle 11 .
  • Fig. 3 is a schematic diagram of a puncture needle according to an embodiment of the present invention.
  • the proximal end of the needle 112 may include a connecting portion 1122 , the outer diameter of the connecting portion 1122 is smaller than the inner diameter of the lumen of the needle shaft 113 .
  • the connecting part 1122 can be inserted into the lumen of the needle shaft 113 .
  • the needle bar 113 can be set in a shape with a reduced diameter, and the outer diameter of the distal part of the needle bar 113 is smaller than that of the needle bar 113.
  • Fig. 4 is a schematic diagram of a puncture needle according to an embodiment of the present invention.
  • the outer diameter of the distal portion of the needle shaft 113 is smaller than the outer diameter of the proximal portion of the needle shaft 113 , and there is a step transition between the two outer diameter portions.
  • the above-mentioned reduced and reduced-diameter shape can effectively increase the flexibility and guideability of the needle bar 113 .
  • the needle bar may also be configured to include an inner needle bar and an outer needle bar.
  • Fig. 5 is a schematic diagram of a puncture needle according to an embodiment of the present invention.
  • the needle bar 113 may include an inner needle bar 1131 and an outer needle bar 1132 , and the outer needle bar 1132 is sheathed outside the inner needle bar 1131 .
  • the outer needle bar 1132 and the inner needle bar 1131 can be connected by means of welding or threading.
  • sealing treatment is required between the inner needle bar 1131 and the outer needle bar 1132, and the sealing treatment method may be welding or bonding.
  • FIG. 6 is a schematic diagram of a puncture needle according to an embodiment of the present invention. As shown in FIG. 6 , at the distal portion of the needle bar 113 , the inner needle bar 1131 extends beyond the outer needle bar 1132 , thereby forming a reduced-diameter needle bar design.
  • the puncture needle can also be configured to include an auxiliary part, which can be a spring or a sleeve. Tube.
  • the spring can effectively reduce the contact area between the outer surface of the puncture needle 11 and surrounding substances, thereby reducing its frictional resistance. At the same time, the spring can improve the operational stability of the puncture needle 11 due to its elastic stretching force and the effect of increasing the radial dimension of the puncture needle 11 .
  • the spring can be sleeved on the needle bar, and can be connected with the needle bar by welding.
  • the two ends of the spring can be welded to the needle bar respectively.
  • the sleeve can be selected from a material with a small friction coefficient to reduce frictional resistance, such as polytetrafluoroethylene (PTFE) material.
  • PTFE polytetrafluoroethylene
  • the coefficient of friction of polytetrafluoroethylene (PTFE) is very low, and the coefficient of friction of polytetrafluoroethylene on steel is often quoted as 0.04.
  • the sleeve can also improve the operational stability of the puncture needle 11 due to its elastic stretching force and the effect of increasing the radial dimension of the puncture needle 11 .
  • the sleeve can be sheathed on the needle shaft in a heat-shrinking manner.
  • Fig. 7 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • the needle bar 113 can be in the shape of variable diameter. the distal portion of the diameter.
  • the spring 114 can be connected with the needle bar 113 by welding.
  • the material of the spring 114 may be one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy, but not limited to.
  • the size of the spring 114 may be: the diameter of the spring wire is 0.08-0.3 mm, the middle diameter of the spring is 0.5 mm-2.0 mm, and the free length of the spring is 30 mm-200 mm.
  • Fig. 8 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • the outer needle bar 1132 may include a distal outer needle bar 11321 and a proximal outer needle bar 11322.
  • the distal outer needle bar 11321 is sleeved on the far end of the inner needle bar 1131
  • the proximal outer needle bar 11322 is sleeved on the proximal end of the inner needle bar 1131
  • the spring 114 can be connected between the distal outer needle bar 11321 and the proximal outer needle bar 11322, sleeved on the inner needle bar 1131.
  • Fig. 9 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention.
  • the inner needle bar 1131 can be in a shape of variable diameter, and the outer diameter of the distal end portion of the inner needle bar 1131 is smaller than the outer diameter of the proximal end portion of the inner needle bar 1131 .
  • the outer needle bar 1132 and the spring 114 are sheathed on the distal part of the inner needle bar 1131 sequentially from the distal end to the proximal end.
  • the spring can also be sleeved on the part of the inner needle bar 1131 extending beyond the outer needle bar 1132 in the embodiment of the present invention shown in FIG. 6 .
  • the assembly relationship between the sleeve and the needle bar may be the same as the assembly relationship between the spring and the needle bar, as described above.
  • Fig. 10 is a schematic diagram of a puncture needle provided with a catheter according to an embodiment of the present invention.
  • the puncture device 1 may include a catheter 12 .
  • the catheter 12 can be used to establish a channel to deliver the guide wire; on the other hand, the catheter 12 can protect the outer surface of the puncture needle 11 to prevent thrombus formation and reduce frictional resistance when the puncture needle 11 moves.
  • the catheter 12 can be sheathed outside the puncture needle 11 .
  • the distal end of the catheter 12 can be tip-shaped. After the assembly is completed, the distal end of the catheter 12 is on the proximal side of the conical bottom surface of the needle tip 1121 of the puncture needle 11.
  • the distance between the two can be 0-1 mm, forming an interference or transition fit, preferably transition fit.
  • the proximal end of the catheter 12 can be threadedly connected to the proximal end of the puncture needle 11 through a connecting piece.
  • catheter technology is widely used in interventional radiology.
  • catheter devices were mostly used to establish channels for interventional surgical devices, and most of them did not have the function of bending and guiding at specific positions (Li Yanhao. Practical Clinical Interventional Diagnosis Diagnosis [M]. Beijing: Science Press, 2012.).
  • the catheter devices clinically used in human blood vessels and organs need to be bent at a certain angle at a specific position after entering the human body, and guide the interventional surgical devices such as puncture needles and guide wires after bending.
  • the RUPS-100 puncture assembly plastic catheter device and metal catheter device produced by COOK in the United States have a specific position bending guide structure to realize the corresponding guiding function.
  • the distal end of the catheter device During the intervention process, sometimes in order to achieve guidance for the intervention, it is necessary for the distal end of the catheter device to abut against the intervention target, so that the intervention device passes through the catheter device, extends out of the distal end of the catheter device, and is accurately positioned at the intervention target. Intervene.
  • a flexible sleeve can be provided on the outside of the catheter, and the flexible sleeve extends beyond the distal end of the catheter so that the distal end of the catheter Covered by a flexible sleeve to prevent it from injuring surrounding tissue.
  • the puncture device 1 may include a catheter device 13 .
  • Fig. 11 is a schematic diagram of the assembly of the interventional catheter device and the puncture needle according to the embodiment of the present invention.
  • the catheter device 13 may include a guide tube 131 and a flexible sleeve 132 to provide guidance for the puncture needle 11 .
  • the catheter device 13 can be straight or curved, for example, the curved one can be used for transjugular intrahepatic puncture.
  • Fig. 12 is a schematic diagram of a guide tube according to an embodiment of the present invention.
  • the material of the guide tube 131 may be one or more of materials including but not limited to stainless steel, nickel-titanium alloy, and the like.
  • the thickness specifications of the guide tube 131 may include but are not limited to: 13G, 14G, 15G, 16G, etc. It is 42cm ⁇ 57cm.
  • the distal end of the guide tube 131 can be beveled, which can be used for puncturing, or for piercing into the intervention target so as to abut against the intervention target.
  • one or more bends can be formed on the distal side of the guide tube 131 .
  • the distal end of the guide tube 131 is a curved oblique blade, which can be bent by 10° to 80°, for example, 60°, at a distance of 0.5 cm to 12 cm from the tip of the oblique blade.
  • Figure 13 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention.
  • the material of the flexible sleeve 132 may include but not limited to polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12 (PA12), block One or more of polyetheramide elastomer (Pebax), high-density polyethylene (HDPE), etc.
  • PTFE polytetrafluoroethylene
  • FEP fluorinated ethylene propylene copolymer
  • TPU thermoplastic polyurethane elastomer
  • PA12 nylon 12
  • Pebax polyetheramide elastomer
  • HDPE high-density polyethylene
  • Fig. 14 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to the embodiment of the present invention.
  • the flexible sleeve 132 can be sleeved on the outside of the guide tube 131 , and its inner diameter can be 0.1 mm to 2 mm larger than the outer diameter of the guide tube 131 .
  • the guide tube 131 and the flexible sheath 132 can move relative to each other, so that the distal end of the guide tube 131 can extend beyond the distal end of the flexible sheath 132, or the distal end of the flexible sheath 132 can extend beyond the distal end of the guide tube 131 (as shown in Figure 14 shown).
  • the proximal end of the flexible sleeve 132 can be connected with the proximal end of the guide tube 131 through the connecting piece 133 in a threaded, buckled or adhesive manner, and the flexible sleeve 132 can be opposite to the guiding tube 132 through the connecting piece 133 move.
  • the flexible sheath 132 and the proximal end of the guide tube 131 are threadedly connected through the connecting piece 133 .
  • Fig. 15 is a schematic diagram of the state of the guide tube and the flexible sleeve in the process of reaching the puncture target through the interventional approach according to the embodiment of the present invention.
  • the flexible sleeve 132 is sleeved outside the guide tube 131, and the distal end of the flexible sleeve 132 extends beyond the distal bevel of the guide tube 131 by 2 to 3 mm to prevent the distal bevel Injury to the tissue it passes through.
  • Fig. 16 is a schematic view of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.
  • Fig. 17 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.
  • the distal end of the flexible sleeve 132 can be necked and formed to form a necked part 1321, and the necked part 1321 can be tapered. After molding, the necked part The inner diameter may be smaller than the outer diameter of the guide tube 131 by 0.05mm ⁇ 1mm.
  • Fig. 18 is a schematic diagram of a flexible sheath formed with a distal constriction according to an embodiment of the present invention.
  • the inner diameter of the distal end of the flexible sheath 132 is smaller than the outer diameter of the distal end of the guide tube 131, when the catheter instrument 13 reaches the puncture target through the interventional approach, even if the flexible sheath 132 is affected by the passing tissue, Due to the resistance of the organ, the guide tube 131 will not move proximally relative to the guide tube 131, so that the guide tube 131 will not protrude from the distal end of the flexible sheath 132, thereby injuring the passing tissue.
  • Fig. 19 is a schematic diagram of the necking part of the flexible sleeve according to the embodiment of the present invention.
  • a weakened portion 13211 that is easy to break can be provided on the constricted portion 1321 of the flexible sleeve 132 , as shown in FIG. 19 .
  • the weakened portion 13211 can extend to the distal opening of the flexible sheath 132 .
  • the weakened portion 13211 may be an intermittent score line or indentation, and may extend in a linear or helical manner along the longitudinal direction of the flexible sheath 132 to its distal opening.
  • the weakened portion 13211 can be disposed on the inner surface or the outer surface of the constricted portion 1321 .
  • the weakened part 13211 When the weakened part 13211 is disposed on the outer surface of the constricted part 1321, a depression may be formed on the outer surface, which will stimulate the blood vessel wall and affect the blood flow, thereby increasing the possibility of thrombus formation. Therefore, preferably, the weakened portion 13211 is disposed on the inner surface of the constricted portion 1321 .
  • the weakened portion 13211 makes it possible for the guide tube 131 to destroy the weakened portion 1321 and stretch out the flexible portion 1321 when a force greater than the above-mentioned resistance is applied and the guide tube 131 is pushed distally relative to the flexible sheath 132 when the catheter instrument 13 abuts against the puncture target.
  • the distal end of the sleeve 132 is open.
  • the weakened portion 1321 is a longitudinal indentation with a width of 1 mm.
  • Fig. 20 is a schematic diagram of the state of the guide tube and the flexible sheath in the process of reaching the puncture target through the interventional approach according to the embodiment of the present invention;
  • the constricted portion of the flexible sheath 132 extends 2-3 mm beyond the distal beveled edge of the guide tube 131 to prevent the distal beveled edge from injuring the passing tissue.
  • a force greater than the above-mentioned resistance can be applied to push the guide tube 131 distally relative to the flexible sleeve 132, so that the guide tube 131 is damaged and weakened.
  • Part 1321 protrudes from the distal opening of the flexible sheath 132 by 2 to 3 mm.
  • Needle 11 provides a puncture guiding guide. Then the puncture needle 11 can be passed through the catheter instrument 13 to puncture the puncture target.
  • Fig. 21 is a schematic view of the state of the guide tube and the flexible sleeve implementing puncture guidance according to the embodiment of the present invention.
  • the guide tube 131 can be pulled back proximally relative to the flexible sheath 132, so that the distal inclined edge of the guide tube 131 can retract into the distal opening of the flexible sheath 132 3 ⁇ 5mm. Afterwards, the guide tube 131 and the flexible sheath 132 are taken out along the original intervention approach. Since the distal inclined edge of the guide tube 131 has retracted into the distal opening of the flexible sheath 132, no damage will be caused to the passing tissue.
  • Fig. 22 is a schematic view of the state of the guide tube and the flexible sleeve in the embodiment of the present invention during the withdrawal process through the interventional approach after the implementation of puncture guidance.
  • the interventional catheter device of the embodiment of the present invention can not only prevent damage to the surrounding tissue it passes through, but also keep it at the intervention target point in the blood vessel or tissue during the intervention process, and build a stable and reliable guiding structure for the operator to guide Puncture or insert interventional devices.
  • the interventional catheter device has a simple structure and process, low cost, good operability, high efficiency and safety, and can meet the operator's requirements for precise guidance during curved puncture.
  • the puncture instrument of the embodiment of the present invention can realize easier operation, more accurate and effective, and safer puncture operation under the interventional navigation technology, thereby solving the technical problems existing in the prior art.
  • the above-mentioned embodiment has described the puncture device in detail.
  • the present invention includes but is not limited to the above-mentioned implementation, and any content that is transformed on the basis of the above-mentioned embodiment falls within the scope of protection of the present invention.
  • Those skilled in the art can draw inferences based on the content of the foregoing embodiments.

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Abstract

本发明涉及一种穿刺器械，可应用于电磁结合超声导航的穿刺手术，实现安全、精确、高效、易于操作的穿刺手术。

Description

穿刺器械 技术领域
本发明涉及医疗器械技术领域，具体而言，涉及一种穿刺器械。
背景技术
以下对本发明的相关背景技术进行说明，但这些说明并不一定构成本发明的现有技术。
介入放射学(Interventional Radiology)是二十世纪七十年代后期迅速发展起来的一门边缘性学科。它是在医学影像设备的引导下，以影像诊断学和临床诊断学为基础，结合临床治疗学原理，利用导管、导丝等器材对各种疾病进行诊断及治疗的一系列技术。即：在影像医学(X线、超声、CT、MRI)的引导下，通过经皮穿刺途径或通过人体原有孔道，将特制的导管或器械插至病变部位进行诊断性造影和治疗的学科，或组织采集，进行细胞学细菌学及生化检查。
介入放射学为现代医学诊疗提供了新的给药途径和手术方法。与传统的给药途径和手术方法相比较，具有更直接有效、更简便微创。介入放射学开拓了新的治疗途径，且简便、安全、创伤小、合并症少、见效快，具有微创性；可重复性强；定位准确；疗效高、见效快；并发症发生率低；多种技术的联系应用简便易行。
介入放射学按目的可分为介入诊断学和介入治疗学；按技术可分为：血管性介入放射学(药物灌注；栓塞技术；成形支架；滤器技术等)和非血管放射介入学(穿刺活检；引流技术；异物取除；腔道支架等)；按临床应用范围可分为肿瘤介入放射学、非肿瘤介入放射学、神经介入放射学等等。
介入放射学所应用的医学影像设备主要包括X线、超声、CT、MRI引导等，其中，X线和CT具有放放射性，而MRI则需要配合非铁磁性设备和环境 应用。对于术中介入引导而言，需要多次，长时间的成像，X线和CT所具有的放射性对于患者和医护人员的危害，MRI对于配套设备和环境的非铁磁性要求，都对介入诊治造成了不便和困难，妨碍了介入放射学的临床应用。
超声具有实时成像、无放射性等特点，在介入放射学中得到了较广泛的应用。但是，超声成像的非直观二维性、超声成像平面与介入工具的共面等问题，易造成对介入工具的定位、引导的困难与失误，进而引起穿刺误差、创伤、并发症等状况发生，要求执行介入诊治的医护人员需要具备大量的训练、熟练的技术和丰富的经验。
超声介入导航可以实时显示介入工具在组织内的运动情况，为介入路径选择提供依据，是介入放射学的重要手段。但是，常规超声引导介入严重依赖操作者的技术、经验和超声仪器性能，可能存在介入次数较多和操作用时较长等问题，进而导致并发症发生率增加。
由于超声成像的特点，在介入过程中为了对介入器械进行实时成像导航，需要保持靶点、介入器械和超声成像平面处于同一平面。由于组织密度小，在受压的情况下容易发生位移/变形，需要随时根据情况重新调整超声探头的角度和按压的力度，往往相应的介入器械的位置也会发生变化，就需要同时调整超声探头和介入器械重新成像导航，难度非常大，对于医生的要求非常高。
由于超声的容积效应，超声设备对于介入器械的成像并不能反映其真实位置及大小，从而影响导航的准确性。
目前已有电磁定位技术，其根据比奥-萨伐戈尔定律(Biot-Savart)，利用电磁感应对物体的位置和方向进行测量，其中磁场信号发射器通过发射磁场信号产生信号场，磁信号接收传感器接收磁场信号，将信号传输到磁场信号控制器，获得物体空间矢量信息(空间坐标及方向)。
通过电磁定位技术可对介入器械进行导航，其精度可以有效解决由于超声成像设备的容积效应所造成的介入导航不准确的问题。
介入放射学的临床应用广泛，可应用于血管性疾病(如血管狭窄、门静脉高压等)、心脏疾病(二尖瓣狭窄、冠状动脉狭窄等)、肿瘤(肿瘤供血动脉灌注化疗、栓塞治疗恶性肿瘤等)、非血管性疾病(消化道，泌尿道、胆道、气道、鼻泪管狭窄等)、穿刺活检等。
其中，对于介入途径长、曲折、经过重要组织器官的介入诊疗，例如经颈静脉肝内门体分流术(transjugular intrahepatic portosystemic shunt，TIPS)，难度大、危险系数高、技术要求高，尤其需要准确有效的导航技术。
经颈静脉肝内门体分流术源于经颈静脉胆道造影术和肝穿活检术过程中经常刺中门静脉的事实，由著名介入放射学家Rosch J和他的同事开发研究而成，通过在肝静脉与门静脉之间的肝实质内建立分流道，以微创的方式从结构上显著降低门静脉阻力，是降低肝硬化患者门静脉压力的关键措施之一。
从1988年1月份施行了第一例真正具有临床意义的金属支架TIPS，通过不断的改进，目前TIPS已广泛地用于治疗肝硬化门静脉高压所致食管胃静脉曲张破裂出血、顽固性胸腹水、布加综合征(BCS)及肝窦阻塞综合征等(De Franchis,R.and V.I.F.Baveno,Expanding consensus in portal hypertension:Report of the Baveno VI Consensus Workshop:Stratifying risk and individualizing care for portal hypertension.J Hepartol,2015.63(3):p.743-52)(中国医师协会介入医师分会.中国门静脉高压经颈静脉肝内门体分流术临床实践指南[J].中华肝脏病杂志，2018,27(8)：582-593)。
TIPS技术操作流程步骤如下：1)麻醉；2)门静脉显像；3)颈内静脉穿刺；4)肝静脉插管；5)门静脉穿刺；6)门腔通道建立；7)球囊导管扩张术及腔内支架植入术；8)术后PPG的测量和最佳阈值；9)门体侧枝血管的栓塞。
TIPS的适应症包括：1)急性食管静脉曲张出血；2)胃静脉曲张出血；3)预防食管静脉曲张出血；4)预防胃静脉曲张出血；5)肝硬化顽固性或复发性腹水；肝性胸水和肝肾综合征；6)BCS；7)肝窦阻塞综合征；8)门静脉高 压合并门静脉血栓；
TIPS的禁忌症包括：
1.绝对禁忌证：(1)充血性心力衰竭或重度瓣膜性心功能不全；(2)难以控制的全身感染或炎症；(3)Child-Pugh评分>13分或者终末期肝病评分>18分；(4)重度肺动脉高压；(5)严重肾功能不全(肝源性肾功能不全除外)；(6)快速进展的肝衰竭；(7)肝脏弥漫性恶性肿瘤；(8)对比剂过敏。
2.相对禁忌证：(1)先天性肝内胆管囊状扩张(Caroli病)、胆道阻塞性扩张；(2)多囊性肝病；(3)门静脉海绵样变；(4)中度肺动脉高压；(5)重度或顽固性HE；(6)胆红素>51.3μmol/L(胆汁淤积性肝硬化除外)；(7)重度凝血病。
TIPS目前主要的技术难度在三块：1)在X射线监控下，门静脉穿刺成功率低；2)术后门腔分流通道再狭窄；3)术后肝性脑病(HE)发生率高。
目前随着PTFE覆膜支架(PerarnauJM,Le GougeA,NicolasC,et al.Covered vs.uncovered stents for transjugular intrahepatic portosystemic shunt:a randomized controlledtrial[J].J Hepatol,2014,60(5):962-968.DOI:10.1016/j.jhep.2014.01.015.)和专用ePTFE覆膜支架(Charon.JP，Alaeddin FH，Pimpalwar SA，et a1.Results of aretrospective muhicenter trial of the Viatorr expanded Polyetrafluoroethylene covered stent--graft for transjugular intrahepatic portosystemic shunt creation[J].JVIR，2004，15：1219.1230.)的使用，受试者分流道狭窄率明显降低。TIPS术后HE发病率为18％～45％，选择门静脉左支位置的建立分流通道回顾性临床研究发现能一定程度减少HE发病率(朱清亮，邓明明，唐世孝，等.支架位置不同对TIPS术后肝性脑病发生率的影响.当代医学，2016，22(4)：92－93.)，选择直径较小的支架和支架内限流的临床研究发现一定程度减少HE发病率以及大部分HE发病患者改善症状(Riggio,O.等,J Hepatol,2010,53(2):p.267-72)(中国医师协会介入医师分会.中国门静脉高压经颈静脉肝内门体分流术临床实践指南[J].中华肝脏病杂志，2018,27(8)： 582-593)。
在TIPS中经肝静脉穿刺门静脉的过程中，与技术相关的并发症主要包括胆道出血及损伤、腹腔出血、肝动脉损伤、胆汁性腹膜炎、皮肤放射性灼伤及穿刺部位血肿等(Dariushina SR,Haskal ZJ,Midia M,et al.Quality improvement guidelines for transjugular intrahepatic portosystemic shunts.J Vasc Interv Radiol 2016；27(1):1-7.)。虽然这些并发症随着TIPS技术推广和操作者经验的积累，发生率可进一步降低，但经肝静脉穿刺门静脉仍是TIPS手术中最大的技术难点，是TIPS成败的关键步骤，是容易产生严重并发症的操作环节(中国医师协会介入医师分会。中国门静脉高压经颈静脉肝内门体分流术临床实践指南[J].中华肝脏病杂志，2018,27(8)：582-593)。
经肝静脉穿刺门静脉的一般流程为：操作者术前通过观察影像学资料，预估穿刺角度；患者在导管室或手术室中完成局部麻醉；首先穿刺右侧颈内静脉；通过X线透视辅助，将导管从右侧颈内静脉、经右心房和下腔静脉，送至右肝内静脉；进行门静脉楔形造影以明确门静脉及其分支解剖结构；从右肝静脉向前下方穿刺门静脉。
这被认为是目前TIPS手术中最安全的穿刺途径(Siramolpiwat,S.,World J Gastroenterol,2014.20(45):p.16996-7010)。目前TIPS术中穿刺肝内门静脉分支的器械主要为美国库克生产的RUPS-100，其他同类型器材基本上消失。RUPS-100穿刺组件由外鞘、扩张器、塑料导向管、金属导向管、塑料套管与穿刺针组成(褚建国,我国经颈静脉肝内门体分流技术的发展现状及其规范化,中华介入放射学电子杂志,2013,1(2))。
然而该穿刺组件设计是按照欧美国家人种的体型、血管网络特点设计的，并不完全适合亚裔体型和中国主要由乙型肝炎病变转为肝硬化的肝萎缩的患者。在实践中，采用该穿刺组件进行门静脉分支穿刺的命中率较低，不仅患者多受痛苦，医生和患者也需要遭受更大剂量的X线照射。更严重的是，这也会使得手术实施者穿出肝包膜误入肝外门静脉主干而造成腹腔大出血等严重并 发症。
因而，通常手术实施者在实施向肝内门静脉分支穿刺前，必须仔细研读门静脉造影的结果，并根据上述门静脉造影所显示的门静脉位置、形态及肝静脉与门静脉分支的前后关系，通常每个个体之间肝静脉和门静脉解剖关系差异大，在体外对RUPS-100进行徒手手工调整(大多数情况需要加大该穿刺针的弯曲角度)；至于金属导向管弯曲的角度是否合适，内径是否弯扁，只能依赖于手术实施者的经验。
由于依靠医生肉眼进行手术，对于术中穿刺针所在的位置以及穿刺针与受试者身体各个部位之间的位置关系的判断同样依赖于手术实施者的经验。
此外，由于受试者在手术中的体位和呼吸运动会产生肝脏位移而造成位置偏差，因此即使是有经验的实施者通常也需要进行多次穿刺(大约5～8次，甚至10～15次)才能成功；穿刺次数越多，产生的并发症机会越多，这也是术后再狭窄和急性血栓形成的原因(李彦豪.实用临床介入诊疗学图解[M].北京:科学出版社,2012.)。
因此，通过穿刺导航技术，解决监视盲区，实时监视引导穿刺器械安全有效经肝静脉穿刺到门静脉预定位置，减少并发症，已经成为急需解决的问题。进而，亟需一种可应用于介入导航技术的穿刺器械，以在介入导航下实现更易于操作、更准确有效、更安全的穿刺手术。
发明内容
有鉴于此，本发明实施例提供一种穿刺器械，以解决上述现有穿刺手术的操作难度大、准确性差、安全性差等问题中的一个或多个，实现更易于操作、更准确有效、更安全的穿刺手术。
根据本发明的一个方面，本发明提供了一种穿刺器械，包括：穿刺针，所述穿刺针包括传感器安装部，所述传感器安装部能够安装电磁传感器。
进一步，所述传感器安装部为所述穿刺针的内部的腔或所述穿刺针的体表 的凹部。
进一步，所述穿刺针为管状，所述穿刺针的管腔的一端开口于所述穿刺针的近端，所述管腔的另一端封闭于所述穿刺针的远端，所述管腔形成所述传感器安装部。
进一步，所述穿刺针包括针头和针杆，所述针头和针杆一体成形。
进一步，所述穿刺针包括针头和针杆，所述针头和针杆通过焊接方式或螺纹方式连接。
进一步，所述针头的近端包括连接部，所述针杆为管状，所述针头与所述针杆连接时，所述连接部插入所述针杆的管腔中。
进一步，所述针杆的远端部分的外径小于所述针杆的近端部分的外径。
进一步，所述针杆包括内针杆和外针杆，所述外针杆套设于所述内针杆外，所述外针杆与所述内针杆通过焊接方式连接。
进一步，所述内针杆和所述外针杆之间密封处理，所述密封处理的方式为焊接或粘接。
进一步，在所述针杆的远端部分，所述内针杆延伸超出所述外针杆。
进一步，所述穿刺针包括辅助部分，所述辅助部分套设在所述针杆外，所述辅助部分的摩擦系数小于所述针杆。
进一步，所述辅助部分为弹簧或套管。
进一步，所述弹簧与所述针杆通过焊接方式连接。
进一步，所述套管的材料为聚四氟乙烯，所述套管与所述针杆通过热缩方式连接。
进一步，所述针杆的远端部分的外径小于所述针杆的近端部分的外径，所述弹簧或所述套管套设在所述针杆的远端部分。
进一步，所述外针杆包括远端外针杆和近端外针杆，所述远端外针杆套设在所述内针杆的远端，所述近端外针杆套设在所述内针杆的近端，所述弹簧或所述套管在所述远端外针杆和所述近端外针杆之间套设于所述内针杆外。
进一步，所述内针杆的远端部分的外径小于所述内针杆的近端部分的外径，所述外针杆和所述弹簧从远端向近端、依次套设于所述内针杆的远端部分，或者，所述外针杆和所述套管从远端向近端、依次套设于所述内针杆的远端部分。
进一步，所述在所述针杆的远端部分，所述内针杆延伸超出所述外针杆，所述弹簧或所述套管套设于所述内针杆延伸超出所述外针杆的部分。
进一步，所述电磁传感器是无线传感器或有线传感器。
进一步，所述穿刺针的材料包括但不限于不锈钢、镍钛合金中的一种或多种。
进一步，所述穿刺针的粗度规格包括但不限于：16G、17G、18G、19G、20G、21G。
进一步，所述弹簧的材料包括但不限于不锈钢、镍钛合金、钴基合金、钛基合金中的一种或多种。
进一步，所述穿刺器械包括介入导管器械，所述介入导管器械包括：导向管；柔性套，所述柔性套套设于所述导向管外；所述柔性套与所述导向管能够相对移动，使得所述柔性套的远端延伸超出所述导向管的远端、或者所述导向管的远端延伸超出所述柔性套的远端。
进一步，所述柔性套的远端设有缩口部分，所述缩口部分的内径小于所述导向管的外径，并且所述缩口部分设有易于破损的弱化部分，当所述介入导管器械抵靠到穿刺靶点时，使所述导向管相对所述柔性套向远端移动能够破坏所述弱化部分，从而所述导向管延伸超出所述柔性套的远端。
进一步，所述弱化部分延伸至所述柔性套的远端开口。
进一步，所述弱化部分沿所述柔性套的纵向、以直线方式或螺旋方式延伸至所述柔性套的远端开口。
进一步，所述弱化部分是断续的刻线或压痕。
进一步，所述弱化部分设置于所述弱化部分的内表面或外表面。
进一步，所述缩口部分的内径比所述导向管的外径小0.05mm～1mm。
进一步，所述柔性套的材料包括但不限于聚四氟乙烯、氟化乙烯丙烯共聚物、热塑性聚氨酯弹性体、尼龙12、嵌段聚醚酰胺弹性体、高密度聚乙烯中的一种或多种。
进一步，所述导向管的材料包括但不限于不锈钢、镍钛合金中的一种或多种。
进一步，所述导向管的粗度规格包括但不限于：13G、14G、15G、16G，所述导向管的长度为42cm～57cm。
进一步，所述柔性套的内径比所述导向管的外径大0.1mm～2mm。
进一步，所述介入导管器械包括连接件，所述导向管的近端通过所述连接件与所述柔性套的近端连接，并且通过所述连接件能够使所述导向管和所述柔性套相对移动。
进一步，所述连接件的连接方式为螺纹方式、卡扣方式或粘接方式。
综上，根据本发明的穿刺器械，可以在介入导航技术下实现更易于操作、更准确有效、更安全的穿刺手术，从而解决了现有技术中存在的技术问题。
附图说明
通过以下参照附图提供的具体实施方式部分，本发明的特征和优点将变得更加容易理解，在附图中：
图1是本发明实施例的穿刺器械的示意图；
图2是本发明实施例的穿刺器械的示意图；
图3是本发明实施例的穿刺针的示意图；
图4是本发明实施例的穿刺针的示意图；
图5是本发明实施例的穿刺针的示意图；
图6是本发明实施例的穿刺针的示意图；
图7是本发明实施例的设有弹簧的穿刺针的示意图；
图8是本发明实施例的设有弹簧的穿刺针的示意图；
图9是本发明实施例的设有弹簧的穿刺针的示意图；
图10是本发明实施例的设有导管的穿刺针的示意图；
图11是本发明实施例的介入导管器械和穿刺针的装配示意图；
图12是本发明实施例的导向管的示意图；
图13是本发明实施例的柔性套的示意图；
图14是本发明实施例的导向管和柔性套的装配示意图；
图15是本发明实施例的导向管和柔性套在经过介入途径到达穿刺靶点过程中的状态示意图；
图16是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图；
图17是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图；
图18是本发明实施例的远端缩口成型的柔性套的示意图；
图19是本发明实施例的柔性套的缩口部分的示意图；
图20是本发明实施例的导向管和柔性套在经过介入途径到达穿刺靶点过程中的状态示意图；
图21是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图；
图22是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图；
具体实施方式
下面参照附图对本发明的示例性实施方式进行详细描述。对示例性实施方式的描述仅仅是出于示范目的，而绝不是对本发明及其应用或用法的限制。
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一 步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本发明中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本发明中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。在本发明中所述的“远端”、“远侧”是指远离操作者的一侧；相应的，“近端”、“近侧”是与“远端”、“远侧”相对的一侧。
为了解决穿刺手术的操作难度大、准确性差、安全性差等问题，实现更易于操作、更准确有效、更安全的穿刺手术，可利用介入导航技术，例如电磁导航技术。
电磁导航设备可根据比奥-萨伐戈尔定律(Biot-Savart)，利用电磁感应对物体的位置和方向进行测量，其中磁场信号发射器通过发射磁场信号产生信号场，磁信号接收传感器接收磁场信号，将信号传输到磁场信号控制器，获得物体空间矢量信息(空间坐标及方向)。
目前，应用较广泛的电磁导航产品有加拿大NDI公司的POLARIS系统，英国RMR公司的VISLAN系统，美国MEDTRONIC公司STEALTHSTATION系统等；其中，POLARIS系统的测量精度为0.35mm。RMS被认为是导航定位系统的国际标准，能同时跟踪9个被动和3个主动的手术器械。
电磁导航设备的发射器通常包括电磁发射线圈，以发射电磁波，产生电磁场，电磁场的有效定位范围可以是300mm×300mm×300mm、400mm×400mm×400mm等。
电磁导航设备的传感器可通过电磁接收线圈接收电磁信号，并将电磁信号并转化成电信号，以跟踪定位处于电磁场中的传感器的位置。
根据临床要求，通常需要导航的定位精度达到5mm，定位速度达到30ms。本发明实施例中，通常电磁定位的精度可为最小为1.5，定位速度可为最快为12.5ms。
根据应用需要，传感器可设计成各种结构和尺寸，本发明实施例中传感器可以为线状的，其尺寸可为：最小外径0.56mm，如图1所示。
传感器可以是有线的，也可以是无线的，因而，电磁设备和穿刺器械之间的连接可以是有线的，也可以是无线的，例如，无线连接方式可以是蓝牙、WIFI、Zigbee等。
本发明实施例提供一种可应用于介入导航技术的穿刺器械，该穿刺器械可设有上述传感器，通过该传感器，结合超声成像设备，可在穿刺手术中对该穿刺器械进行定位导航。
图1是本发明实施例的穿刺器械的示意图。如图1所示，本发明实施例中，穿刺器械1可包括穿刺针11，穿刺针11可设有传感器安装部111，传感器安装部111可用于安装传感器2。
本发明实施例中，穿刺针11的材料可以为包括但不限于不锈钢、镍钛合金等中的一种或多种。
根据临床应用的要求，穿刺针11的粗度规格可以包括但不限于：16G、17G、18G、19G、20G、21G等(G为GAUGE的缩写，是起源于北美的一种关于直径的长度计量单位)。
根据临床应用的要求，穿刺针11可设计为各种长度，例如，对于经颈静脉肝内门体分流术，其长度规格可以为50cm～65cm。
如图1所示，穿刺针11可穿刺针包括针头112和针杆113。本发明实施例中，针头112和针杆113可一体成型，如图1所示。针头112和针杆113也可分体装配连接，例如，针头112和针杆113通过焊接、螺纹等方式连接，如图3所示。
本发明实施例中，针头112的针尖1121可以是三棱锥形、四棱锥形或圆锥形。针尖1121的锥形的高度可以为1mm～4mm。
由于穿刺手术导航通常需要定位穿刺针的远端，本发明实施例中，传感器安装部111可设于穿刺针11的远端。
本发明实施例中，传感器安装部111可以是穿刺针11的内部的腔，如图1所示。如果传感器是有线的，所述腔可以设有开口，以用于所述线的通过，例如，所述腔开口于穿刺针11的近端。如果传感器是无线的，传感器安装后所述腔可以被封闭。
本发明实施例中，穿刺针11的腔至穿刺针11的针尖的距离可以为0.10mm～30mm。
如图1所示，穿刺针11可为管状，穿刺针11的管腔的一端开口于穿刺针11的近端，管腔的另一端封闭于穿刺针的远端，管腔形成传感器安装部111。
图2是本发明实施例的穿刺器械的示意图。如图2所述，本发明实施例中，传感器安装部111可以是穿刺针11的体表的凹部。
图3是本发明实施例的穿刺针的示意图。如图3所示，针头112的近端可包括连接部1122，连接部1122的外径小于针杆113的管腔的内径。针头112和针杆113连接时，连接部1122可插入针杆113的管腔中。
为了适应曲折狭长的穿刺途径，增加穿刺针11的灵活性、导向性，本发明实施例中，针杆113可设置为变径的形状，针杆113的远端部分的外径小于针杆113的近端部分的外径。两种外径部分之间可以渐变过渡，也可以阶梯式过渡。
图4是本发明实施例的穿刺针的示意图。如图4所示，针杆113的远端部分的外径小于针杆113的近端部分的外径，两种外径部分之间以阶梯式过渡。上述减缩的变径形状的可有效地增加针杆113的灵活性和导向性。
为了适应曲折的穿刺途径，增加穿刺针11的灵活性、导向性，本发明实施例中，针杆也可设置为包括内针杆和外针杆。
图5是本发明实施例的穿刺针的示意图。如图5所示，针杆113可包括内针杆1131和外针杆1132，外针杆1132套设于内针杆1131外。外针杆1132与内针杆1131可通过焊接、螺纹等方式连接。并且，为了防止体液进入内针杆1131和外针杆1132之间，内针杆1131和外针杆1132之间需要进行密封处理， 密封处理方式可以是焊接或粘接。
本发明实施例中，减缩变径的针杆设计与内外针杆的针杆设计可以相结合。图6是本发明实施例的穿刺针的示意图。如图6所示，在针杆113的远端部分，内针杆1131延伸超出外针杆1132，从而形成减缩变径的针杆设计。
为了适应曲折狭长的穿刺途径，有效减少穿刺针11的摩擦阻力、改善穿刺针11的操作稳定性，本发明实施例中，穿刺针也可设置为包括辅助部分，该辅助部分可以是弹簧或套管。
弹簧可有效减少穿刺针11外表面与周围物质的接触面积，从而减少其摩擦阻力。同时，弹簧由于其弹性拉伸力和增加穿刺针11的径向尺寸的作用，可以提高穿刺针11的操作稳定性。
弹簧可套设于针杆，其可通过焊接方式与针杆连接。例如，弹簧的两端可分别与针杆焊接。
套管可选择摩擦系数小的材料，以减少摩擦阻力，例如聚四氟乙烯(PTFE)材料。聚四氟乙烯(PTFE)的摩擦系数非常低，一般聚四氟乙烯对钢的摩擦系数常引用为0.04。同时，套管由于其弹性拉伸力和增加穿刺针11的径向尺寸的作用，也可以提高穿刺针11的操作稳定性。
本发明实施例中，套管可以通过热缩的方式套设于针杆。
图7是本发明实施例的设有弹簧的穿刺针的示意图。如图7所示，针杆113可为变径的形状，针杆113的远端部分的外径小于针杆113的近端部分的外径，弹簧114套设在针杆113的较小外径的远端部分。弹簧114可与针杆113通过焊接方式连接。
本发明实施例中，弹簧114的材料可以为包括但不限于不锈钢、镍钛合金、钴基合金、钛基合金中的一种或多种。
本发明实施例中，弹簧114的尺寸可以为：弹簧丝直径0.08～0.3mm、弹簧中径0.5mm～2.0mm、弹簧自由长度30mm～200mm。
图8是本发明实施例的设有弹簧的穿刺针的示意图。如图8所示，本发明 实施例中，外针杆1132可包括远端外针杆11321和近端外针杆11322。远端外针杆11321套设于内针杆1131的远端，近端外针杆11322套设于内针杆1131的近端，弹簧114可在远端外针杆11321和近端外针杆11322之间、套设于内针杆1131。
图9是本发明实施例的设有弹簧的穿刺针的示意图。如图9所示，本发明一实施例中，内针杆1131可为变径的形状，内针杆1131的远端部分的外径小于内针杆1131的近端部分的外径。如图9所示，外针杆1132和弹簧114从远端向近端、依次套设于内针杆1131的远端部分。
本发明实施例中，弹簧也可套设于图6所示的本发明的实施例中内针杆1131延伸超出外针杆1132的部分。
套管和针杆之间的装配关系可以与弹簧与针杆之间的装配关系相同，如上所述。
图10是本发明实施例的设有导管的穿刺针的示意图。如图10所示，本发明实施例中，穿刺器械1可包括导管12。一方面，导管12可用于建立通道以输送导丝；另一方面，导管12可保护穿刺针11外表面，以防止形成血栓和减少穿刺针11运动时候的摩擦阻力。
如图10所示，导管12可套设于穿刺针11外。导管12的远端可尖端成型加工，装配完成后导管12的远端处于穿刺针11的针尖1121的锥形底面的近侧，二者之间的距离可为0～1mm，成过盈或过渡配合，优选为过渡配合。导管12的近端可通过连接件与穿刺针11的近端以螺纹方式连接。
介入放射学中广泛应用了导管技术。以往的导管器械多用于建立介入手术器械的通道，绝大部分不具备特定位置弯曲导向功能(李彦豪.实用临床介入诊疗学图解[M].北京:科学出版社,2012.)。
目前，临床上用于人体血管内与器官内的导管器械，有些需要在进入人体后于特定的位置弯曲一定的角度，并在弯曲后对穿刺针、导丝等介入手术器械 进行导向引导。如美国COOK生产的RUPS-100穿刺组件的塑料导管器械、金属导管器械，其具有特定位置弯曲导向结构，以实现相应的导向功能。
在介入过程中，有时为了实现对于介入的导向，需要导管器械的远端抵靠在介入靶点处，使得介入器械穿过导管器械、伸出导管器械的远端，而准确地在介入靶点进行介入。
为了防止导管器械的远端在经过介入途径到达介入靶点的过程中对于所经过的组织造成伤害，导管的外部可设有柔性套，该柔性套延伸超过导管的远端，使得导管的远端被柔性套所包覆，以防止其伤害周围的组织。
在介入手术中，特别是介入途径长且曲折的介入手术，需要介入器械通过导管器械在血管内弯曲一定的角度再进行血管或组织介入。当套设在导管外的柔性套的远端抵靠在介入靶点处时，由于柔性套的柔性，介入过程中无法使其保持在介入靶点处，往往导致介入过程中发生跳针穿不上的失误或介入方向发生变动等误差，给手术操作者造成非常大的操作的难度，目前只能依靠手术从业术者通过体外的导管扶持或人体特定部位按压，大大增加术者操作难度，限制了手术应用。
例如，经颈静脉肝内穿刺手术中，使导管器械能在肝静脉壁上保持在穿刺靶点处就是此手术穿刺成功的关键(李彦豪.实用临床介入诊疗学图解[M].北京:科学出版社,2012.)。而目前的穿刺组件无法有效解决该问题(褚建国,我国经颈静脉肝内门体分流技术的发展现状及其规范化,中华介入放射学电子杂志,2013,1(2))。
因而，亟需一种既能防止伤害所经的周围组织、又能在介入过程中保持在介入靶点处的导管器械，以防止在介入过程中发生跳针穿刺不上的失误或介入方向发生变动的误差。
本发明实施例中，穿刺器械1可包括导管器械13。图11是本发明实施例的介入导管器械和穿刺针的装配示意图。本发明实施例中，如图11所示，导管器械13可包括导向管131和柔性套132，以为穿刺针11提供导向引导。根 据临床需求，导管器械13可以是直线状的，也可以是弯曲状的，例如弯曲状的可用于经颈静脉肝内穿刺手术。
图12是本发明实施例的导向管的示意图。本发明实施例中，导向管131的材料可以是包括但不限于不锈钢、镍钛合金等中的一种或多种。根据临床需要，导向管131的粗度规格可以包括但不限于：13G、14G、15G、16G等(G为GAUGE的缩写，是起源于北美的一种关于直径的长度计量单位)；长度规格可以为42cm～57cm。
如图12所示，导向管131的远端可为斜刃型，可用于进行穿刺，也可用于刺入介入靶点从而抵靠住介入靶点。
如图12所示，根据临床需要，导向管131的远侧可形成一处或多处弯曲。本发明一实施例中，导向管131的远端为弯曲的斜刃型，距离斜刃尖端0.5cm～12cm处可弯曲10°～80°，例如弯曲60°。
图13是本发明实施例的柔性套的示意图。本发明实施例中，柔性套132的材料可以包括但不限于聚四氟乙烯(PTFE)、氟化乙烯丙烯共聚物(FEP)、热塑性聚氨酯弹性体(TPU)、尼龙12(PA12)、嵌段聚醚酰胺弹性体(Pebax)、高密度聚乙烯(HDPE)等中的一种或多种。
图14是本发明实施例的导向管和柔性套的装配示意图。本发明实施例中，如图14所示，柔性套132可套设于导向管131外，其内径可比导向管131的外径大0.1mm～2mm。导向管131和柔性套132可相对移动，从而使得，导向管131的远端可延伸超出柔性套132的远端，或者柔性套132的远端可延伸超出导向管131的远端(如图14所示)。
本发明实施例中，柔性套132的近端可通过连接件133与导向管131的近端以螺纹、卡扣或粘接方式连接，并且可通过连接件133使柔性套132与导向管132相对移动。如图11或图14示出了柔性套132和导向管131的近端通过连接件133以螺纹方式连接。
本发明实施例的穿刺手术中，包括导向管131和柔性套132的导管器械13 先经皮或经器官腔道等介入途径进入体内到达穿刺靶点。图15是本发明实施例的导向管和柔性套在经过介入途径到达穿刺靶点过程中的状态示意图。如图15所示，在此过程中，柔性套132套设于导向管管131外，柔性套132的远端延伸超出导向管131的远端斜刃2～3mm，以防止该远端斜刃伤害所经过的组织。
本发明实施例的穿刺手术中，当导管器械1的远端到达穿刺靶点后，可让导向管131和柔性套132相对移动，使得导向管131的远端延伸超出柔性套132的远端，从而导向管131的远端可抵靠住穿刺靶点不动，以实施穿刺引导。图16是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图。
本发明实施例的穿刺手术中，当导管器械13在实施穿刺引导之后要经过介入途径退出时，可让导向管131和柔性套132相对移动，使得柔性套132的远端延伸超出导向管131的远端斜刃，以防止该远端斜刃伤害所经过的组织。图17是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图。
在介入诊疗中，导管器械的远端在经过介入途径到达介入靶点的过程中，特别是介入途径长且曲折的介入手术，会受到所经过的组织、器官的阻力作用，由于柔性套的柔性，常会导致柔性套相对于导向管向近端移动，使得导向管的远端延伸超出柔性套的远端，从而伤害到所经过的周围组织。
为解决该技术问题，进一步地，本发明实施例中，柔性套132的远端可进行缩口成型加工，形成缩口部分1321，缩口部分1321可以为锥形，成型后该缩口部分的内径可比导向管131的外径小0.05mm～1mm。图18是本发明实施例的远端缩口成型的柔性套的示意图。
由于柔性套132的缩口部分成型的远端的内径小于导向管131的远端的外径，在导管器械13经过介入途径到达穿刺靶点的过程中，柔性套132即使受到所经过的组织、器官的阻力作用，也不会相对于导向管131向近端移动，使得导向管131不会从柔性套132的远端伸出，从而伤害所经过的组织。
进一步，图19是本发明实施例的柔性套的缩口部分的示意图。本发明实施例中，柔性套132的缩口部分1321上可设有易于破损的弱化部分13211，如图19所示。弱化部分13211可延伸至柔性套132的远端开口。弱化部分13211可以是断续的刻线或压痕，可沿柔性套132的纵向以直线方式或螺旋方式延伸至其远端开口。弱化部分13211可设置于缩口部分1321的内表面或外表面。当弱化部分13211设置于缩口部分1321的外表面时，可在外表面上形成凹陷，会对血管壁产生刺激，也会对血流产生影响，从而增加形成血栓的可能性。因而，优选地，弱化部分13211设置于缩口部分1321的内表面。
弱化部分13211使得当导管器械13抵靠到穿刺靶点时，施加大于上述阻力的作用力、相对于柔性套132向远端推进导向管131时，导向管131可破坏弱化部分1321而伸出柔性套132的远端开口。本发明一实施例中，弱化部分1321为1mm宽的纵向压痕。
从而，本发明实施例的穿刺手术中，导向管131和柔性套132先经皮或经器官腔道等介入途径进入体内到达穿刺靶点。图20是本发明实施例的导向管和柔性套在经过介入途径到达穿刺靶点过程中的状态示意图；如图20所示，在此过程中，柔性套132套设于导向管管131外，柔性套132的缩口部分延伸超出导向管131的远端斜刃2～3mm，以防止该远端斜刃伤害所经过的组织。
本发明实施例的穿刺手术中，当导管器械13的远端到达穿刺靶点后，可施加大于上述阻力的作用力、相对于柔性套132向远端推进导向管131，使得导向管131破坏弱化部分1321而伸出柔性套132的远端开口2～3mm，如此，导向管131的远端斜刃可刺入穿刺靶点，使其在穿刺过程中可始终保持在穿刺靶点处，以为穿刺针11提供穿刺引导导向。接着就可将穿刺针11穿过导管器械13对穿刺靶点进行穿刺。图21是本发明实施例的导向管和柔性套实施穿刺引导时的状态示意图。
本发明实施例中，当穿刺针11的穿刺完成后，可相对于柔性套132向近端拉回导向管131，使导向管131的远端斜刃缩进柔性套132的远端开口之内 3～5mm。之后，沿原介入途径取出导向管131和柔性套132。由于导向管131的远端斜刃已缩进柔性套132的远端开口之内，不会对所经的组织形成伤害。并且在导管器械13退出过程中，柔性套132所受的阻力作用的方向是向远端方向，不会导致柔性套132相对于导向管131向近端移动，也就不会使导向管131的远端延伸出柔性套132的远端而对所经的组织造成伤害。图22是本发明实施例的导向管和柔性套在实施穿刺引导之后经过介入途径退出过程中的状态示意图。
本发明实施例的介入导管器械，既能防止伤害所经的周围组织，又能在介入过程中保持在血管内或组织内的介入靶点处，给术者搭建稳定可靠的导向结构，以引导穿刺或置入介入器械。介入导管器械的结构和工艺简单，成本低廉，操作性好，高效安全，能满足术者对弯曲穿刺时精准导向的要求。
本发明实施例的穿刺器械，可以在介入导航技术下实现更易于操作、更准确有效、更安全的穿刺手术，从而解决了现有技术中存在的技术问题。
综上，上述实施例对穿刺器械进行了详细说明，当然，本发明包括但不同限于上述实施，任何在上述实施例的基础上进行变换的内容，均属于本发明所保护的范围。本领域技术人员可以根据上述实施例的内容举一反三。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。
虽然参照示例性实施方式对本发明进行了描述，但是应当理解，本发明并不局限于文中详细描述和示出的具体实施方式，在不偏离权利要求书所限定的范围的情况下，本领域技术人员可以对所述示例性实施方式做出各种改变，所有的这种改变均落入本发明的保护范围。
尽管已描述了本发明的优选实施例，但本领域内的技术人员一旦得知了基本创造性概念，则可对这些实施例作出另外的变更和修改。所以，所附权利要求意欲解释为包括优选实施例以及落入本发明范围的所有变更和修改。
显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (35)

  1. 一种穿刺器械，其特征在于，包括：
    穿刺针，所述穿刺针包括传感器安装部，所述传感器安装部能够安装电磁传感器。
  2. 根据权利要求1所述的穿刺器械，其特征在于，所述传感器安装部为所述穿刺针的内部的腔或所述穿刺针的体表的凹部。
  3. 根据权利要求1-2中任一项所述的穿刺器械，其特征在于，所述穿刺针为管状，所述穿刺针的管腔的一端开口于所述穿刺针的近端，所述管腔的另一端封闭于所述穿刺针的远端，所述管腔形成所述传感器安装部。
  4. 根据权利要求1-3中任一项所述的穿刺器械，其特征在于，所述穿刺针包括针头和针杆，所述针头和针杆一体成形。
  5. 根据权利要求1-3中任一项所述的穿刺器械，其特征在于，所述穿刺针包括针头和针杆，所述针头和针杆通过焊接方式或螺纹方式连接。
  6. 根据权利要求5所述的穿刺器械，其特征在于，所述针头的近端包括连接部，所述针杆为管状，所述针头与所述针杆连接时，所述连接部插入所述针杆的管腔中。
  7. 根据权利要求1-6中任一项所述的穿刺器械，其特征在于，所述针杆的远端部分的外径小于所述针杆的近端部分的外径。
  8. 根据权利要求1-7中任一项所述的穿刺器械，其特征在于，所述针杆包括内针杆和外针杆，所述外针杆套设于所述内针杆外，所述外针杆与所述内针杆通过焊接方式连接。
  9. 根据权利要求8所述的穿刺器械，其特征在于，所述内针杆和所述外针杆之间密封处理，所述密封处理的方式为焊接或粘接。
  10. 根据权利要求8-9中任一项所述的穿刺器械，其特征在于，在所述针杆的远端部分，所述内针杆延伸超出所述外针杆。
  11. 根据权利要求1-10中任一项所述的穿刺器械，其特征在于，所述穿刺针包括辅助部分，所述辅助部分套设在所述针杆外，所述辅助部分的摩擦系数小于所述针杆。
  12. 根据权利要求11所述的穿刺器械，其特征在于，所述辅助部分为弹簧或套管。
  13. 根据权利要求12所述的穿刺器械，其特征在于，所述弹簧与所述针杆通过焊接方式连接。
  14. 根据权利要求12所述的穿刺器械，其特征在于，所述套管的材料为聚四氟乙烯，所述套管与所述针杆通过热缩方式连接。
  15. 根据权利要求12-14中任一项所述的穿刺器械，其特征在于，所述针杆的远端部分的外径小于所述针杆的近端部分的外径，所述弹簧或所述套管套设在所述针杆的远端部分。
  16. 根据权利要求12-14中任一项所述的穿刺器械，其特征在于，所述外针杆包括远端外针杆和近端外针杆，所述远端外针杆套设在所述内针杆的远端，所述近端外针杆套设在所述内针杆的近端，所述弹簧或所述套管在所述远端外针杆和所述近端外针杆之间套设于所述内针杆外。
  17. 根据权利要求12-14中任一项所述的穿刺器械，其特征在于，所述内针杆的远端部分的外径小于所述内针杆的近端部分的外径，所述 外针杆和所述弹簧从远端向近端、依次套设于所述内针杆的远端部分，或者，所述外针杆和所述套管从远端向近端、依次套设于所述内针杆的远端部分。
  18. 根据权利要求12-14中任一项所述的穿刺器械，其特征在于，所述在所述针杆的远端部分，所述内针杆延伸超出所述外针杆，所述弹簧或所述套管套设于所述内针杆延伸超出所述外针杆的部分。
  19. 根据权利要求1-18中任一项所述的穿刺器械，其特征在于，所述电磁传感器是无线传感器或有线传感器。
  20. 根据权利要求1-19中任一项所述的穿刺器械，其特征在于，所述穿刺针的材料包括但不限于不锈钢、镍钛合金中的一种或多种。
  21. 根据权利要求1-20中任一项所述的穿刺器械，其特征在于，所述穿刺针的粗度规格包括但不限于：16G、17G、18G、19G、20G、21G。
  22. 根据权利要求12-21中任一项所述的穿刺器械，其特征在于，所述弹簧的材料包括但不限于不锈钢、镍钛合金、钴基合金、钛基合金中的一种或多种。
  23. 根据权利要求1-22中任一项所述的穿刺器械，其特征在于，所述穿刺器械包括介入导管器械，所述介入导管器械包括：
    导向管；
    柔性套，所述柔性套套设于所述导向管外；
    所述柔性套与所述导向管能够相对移动，使得所述柔性套的远端延伸超出所述导向管的远端、或者所述导向管的远端延伸超出所述柔性套的远端。
  24. 根据权利要求23所述的穿刺器械，其特征在于，所述柔性套的远端 设有缩口部分，所述缩口部分的内径小于所述导向管的外径，并且所述缩口部分设有易于破损的弱化部分，当所述介入导管器械抵靠到穿刺靶点时，使所述导向管相对所述柔性套向远端移动能够破坏所述弱化部分，从而所述导向管延伸超出所述柔性套的远端。
  25. 根据权利要求24所述的穿刺器械，其特征在于，所述弱化部分延伸至所述柔性套的远端开口。
  26. 根据权利要求24-25中任一项所述的穿刺器械，其特征在于，所述弱化部分沿所述柔性套的纵向、以直线方式或螺旋方式延伸至所述柔性套的远端开口。
  27. 根据权利要求24-26中任一项所述的穿刺器械，其特征在于，所述弱化部分是断续的刻线或压痕。
  28. 根据权利要求24-27中任一项所述的穿刺器械，其特征在于，所述弱化部分设置于所述弱化部分的内表面或外表面。
  29. 根据权利要求24-28中任一项所述的穿刺器械，其特征在于，所述缩口部分的内径比所述导向管的外径小0.05mm～1mm。
  30. 根据权利要求23-29中任一项所述的穿刺器械，其特征在于，所述柔性套的材料包括但不限于聚四氟乙烯、氟化乙烯丙烯共聚物、热塑性聚氨酯弹性体、尼龙12、嵌段聚醚酰胺弹性体、高密度聚乙烯中的一种或多种。
  31. 根据权利要求23-30中任一项所述的穿刺器械，其特征在于，所述导向管的材料包括但不限于不锈钢、镍钛合金中的一种或多种。
  32. 根据权利要求23-31中任一项所述的穿刺器械，其特征在于，所述导向管的粗度规格包括但不限于：13G、14G、15G、16G，所述导 向管的长度为42cm～57cm。
  33. 根据权利要求23-32中任一项所述的穿刺器械，其特征在于，所述柔性套的内径比所述导向管的外径大0.1mm～2mm。
  34. 根据权利要求23-33中任一项所述的穿刺器械，其特征在于，所述介入导管器械包括连接件，所述导向管的近端通过所述连接件与所述柔性套的近端连接，并且通过所述连接件能够使所述导向管和所述柔性套相对移动。
  35. 根据权利要求34所述的穿刺器械，其特征在于，所述连接件的连接方式为螺纹方式、卡扣方式或粘接方式。
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