Puncture instruments

Abstract

The present invention relates to a puncture instrument which can be applied to puncture surgery combining electromagnetic and ultrasonic navigation to achieve safe, accurate, efficient and easy-to-operate puncture surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a puncture device. Background Art

[0002] The following is a description of the background technologies related to the present invention, but these descriptions do not necessarily constitute the prior art of the present invention.

[0003] Interventional Radiology is a marginal discipline that has developed rapidly in the late 1970s. It is a series of technologies that use catheters, guidewires and other equipment to diagnose and treat various diseases under the guidance of medical imaging equipment, based on imaging diagnosis and clinical diagnosis, combined with the principles of clinical therapy. That is: under the guidance of medical imaging (X-ray, ultrasound, CT, MRI), special catheters or instruments are inserted into the lesion site through percutaneous puncture or through the original channels of the human body for diagnostic imaging and treatment, or tissue collection for cytological, bacteriological and biochemical examinations.

[0004] Interventional radiology provides new drug administration routes and surgical methods for modern medical diagnosis and treatment. Compared with traditional drug administration routes and surgical methods, it is more direct, effective, simpler and minimally invasive. Interventional radiology has opened up new treatment routes that are simple, safe, less invasive, less complication, and quick to take effect. It is minimally invasive, highly repeatable, accurately positioned, highly effective, and quick to take effect. The incidence of complications is low, and the combination of multiple technologies is simple and easy to apply.

[0005] Interventional radiology can be divided into interventional diagnosis and interventional therapy according to its purpose; according to its technology, it can be divided into vascular interventional radiology (drug infusion; embolization technology; formed stents; filter technology, etc.) and non-vascular interventional radiology (puncture biopsy; drainage technology; foreign body removal; cavity stents, etc.); according to its clinical application scope, it can be divided into tumor interventional radiology, non-tumor interventional radiology, neuro-interventional radiology, etc.

[0006] The medical imaging equipment used in interventional radiology mainly includes X-ray, ultrasound, CT, MRI guidance, etc. Among them, X-ray and CT have radioactivity, while MRI needs to be used with non-ferromagnetic equipment and environment. For intraoperative intervention guidance, multiple and long-term imaging is required. The radioactivity of X-ray and CT is harmful to patients and medical staff, and MRI requires non-ferromagnetic equipment and environment. All these have caused inconvenience and difficulties in interventional diagnosis and treatment, hindering the clinical application of interventional radiology.

[0007] Ultrasound has the characteristics of real-time imaging and no radioactivity, and has been widely used in interventional radiology. However, the non-intuitive two-dimensional nature of ultrasound imaging and the coplanarity of the ultrasound imaging plane and the interventional tool can easily lead to difficulties and errors in the positioning and guidance of the interventional tool, which in turn causes puncture errors, trauma, complications, etc., requiring medical staff who perform interventional diagnosis and treatment to have extensive training, skilled techniques, and rich experience.

[0008] Ultrasound interventional navigation can display the movement of interventional tools in tissues in real time, providing a basis for interventional path selection, and is an important means of interventional radiology. However, conventional ultrasound-guided interventions rely heavily on the operator's skills, experience, and ultrasound instrument performance, and may result in more interventions and longer operation times, which in turn increase the incidence of complications.

[0009] Due to the characteristics of ultrasound imaging, in order to perform real-time imaging navigation of interventional instruments during the intervention process, it is necessary to keep the target, interventional instruments and ultrasound imaging plane in the same plane. Due to the low density of tissue, it is easy to shift / deform under pressure, and the angle of the ultrasound probe and the pressure must be readjusted at any time according to the situation. Often the position of the corresponding interventional instrument will also change, so it is necessary to adjust the ultrasound probe and interventional instruments at the same time for re-imaging navigation, which is very difficult and requires very high standards from doctors.

[0010] Due to the volume effect of ultrasound, the imaging of interventional instruments by ultrasound equipment cannot reflect their actual position and size, thus affecting the accuracy of navigation.

[0011] At present, there is electromagnetic positioning technology, which uses electromagnetic induction to measure the position and direction of an object based on the Biot-Savart law. 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 and transmits the signal to the magnetic field signal controller to obtain the object's spatial vector information (spatial coordinates and direction).

[0012] 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.

[0013] 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 blood supply artery perfusion chemotherapy, embolization treatment of malignant tumors, etc.), non-vascular diseases (digestive tract, urinary tract, bile duct, airway, nasolacrimal duct stenosis, etc.), puncture biopsy, etc.

[0014] Among them, interventional diagnosis and treatment with long and tortuous interventional pathways passing through important tissues and organs, such as transjugular intrahepatic portosystemic shunt (TIPS), are difficult, risky, and technically demanding, and particularly require accurate and effective navigation technology.

[0015] The transjugular intrahepatic portosystemic shunt originated from the fact that the portal vein is often punctured during transjugular cholangiography and liver biopsy. It was developed and researched by the famous interventional radiologist Rosch J and his colleagues. It significantly reduces the portal vein resistance structurally in a minimally invasive manner by establishing a shunt in the liver parenchyma between the hepatic vein and the portal vein. It is one of the key measures to reduce portal vein pressure in patients with cirrhosis.

[0016] Since the first truly clinically significant metal stent TIPS was implemented in January 1988, through continuous improvement, TIPS has been widely used to treat esophageal and gastric varicose bleeding caused by portal hypertension in cirrhosis, refractory pleural effusion, Budd-Chiari syndrome (BCS) and hepatic sinusoidal obstruction syndrome (De Franchis, R. and VIF 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) (Chinese Medical Association Interventional Physicians Branch. Clinical Practice Guidelines for Transjugular Intrahepatic Portosystemic Shunt for Portal Hypertension in China [J]. Chinese Journal of Hepatology, 2018, 27(8): 582-593).

[0017] The steps of TIPS technique operation 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 channel establishment; 7) balloon catheter dilatation and intraluminal stent implantation; 8) postoperative PPG measurement and optimal threshold; 9) embolization of portal-systemic collateral vessels.

[0018] 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 in cirrhotic patients; hepatic hydrothorax and hepatorenal syndrome; 6) BCS; 7) hepatic sinusoidal obstruction syndrome; 8) portal hypertension combined with portal vein thrombosis;

[0019] Contraindications to TIPS include:

[0020] 1. Absolute contraindications: (1) congestive heart failure or severe valvular heart failure; (2) difficult to control 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) allergy to contrast agents.

[0021] 2. Relative contraindications: (1) congenital cystic dilatation of the intrahepatic bile duct (Caroli disease) and obstructive dilatation of the biliary tract; (2) polycystic liver disease; (3) cavernous transformation of the portal vein; (4) moderate pulmonary hypertension; (5) severe or refractory HE; (6) bilirubin >51.3 μmol / L (except for cholestatic cirrhosis); (7) severe coagulopathy.

[0022] The main technical difficulties of TIPS are currently threefold: 1) low success rate of portal vein puncture under X-ray monitoring; 2) restenosis of the portal-cavity shunt channel after surgery; and 3) high incidence of postoperative hepatic encephalopathy (HE).

[0023] Currently, with the use of PTFE coated stents (Perarnau JM, Le Gouge A, Nicolas C, et al. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: arandomized controlled trial [J]. J Hepatol, 2014, 60 (5): 962-968. DOI: 10.1016 / j.jhep.2014.01.015.) and dedicated ePTFE coated stents (Charon. JP, Alaeddin FH, Pimpalwar SA, et al. Results of aretrospective muhicenter trial of the Viatorr expanded Polyetrafluoroethylene covered stent--graft for transjugular intrahepatic portosystemic shunt creation [J]. J VIR, 2004, 15: 1219.1230.), the shunt stenosis rate of subjects has been significantly reduced. The incidence of HE after TIPS surgery is 18% to 45%. Retrospective clinical studies have shown that selecting the location of the left branch of the portal vein to establish a shunt channel can reduce the incidence of HE to a certain extent (Zhu Qingliang, Deng Mingming, Tang Shixiao, et al. The influence of different stent positions on the incidence of hepatic encephalopathy after TIPS surgery. Contemporary Medicine, 2016, 22(4): 92-93.). Clinical studies have shown that selecting a smaller diameter stent and limiting flow within the stent can reduce the incidence of HE to a certain extent and improve symptoms in most patients with HE (Riggio, O. et al., J Hepatol, 2010, 53(2): p. 267-72) (Interventional Physicians Branch of the Chinese Medical Doctor Association. Clinical Practice Guidelines for Transjugular Intrahepatic Portosystemic Shunt for Portal Hypertension in China [J]. Chinese Journal of Hepatology, 2018, 27(8): 582-593).

[0024] During the process of puncturing the portal vein through the hepatic vein in TIPS, technical complications mainly include biliary bleeding and injury, abdominal bleeding, hepatic artery injury, bile 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.). Although the incidence of these complications can be further reduced with the promotion of TIPS technology and the accumulation of operator experience, puncturing the portal vein through the hepatic vein is still the biggest technical difficulty in TIPS surgery, the key step for the success of TIPS, and the operation link that is prone to serious complications (Interventional Physicians Branch of the Chinese Medical Doctor Association. Clinical Practice Guidelines for Transjugular Intrahepatic Portosystemic Shunt for Portal Hypertension in China [J]. Chinese Journal of Hepatology, 2018, 27(8): 582-593).

[0025] The general procedure for puncturing the portal vein via 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; first puncture the right internal jugular vein; with the assistance of X-ray fluoroscopy, the catheter is 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 is performed to clarify the anatomical structure of the portal vein and its branches; and the portal vein is punctured from the right hepatic vein to the front and bottom.

[0026] This is considered to be the safest puncture route in TIPS surgery (Siramolpiwat, S., World J Gastroenterol, 2014.20(45): p.16996-7010). Currently, the instrument used to puncture the intrahepatic portal vein branches during TIPS surgery is mainly the RUPS-100 produced by Cook in the United States, and other similar instruments have basically disappeared. The RUPS-100 puncture component consists of an outer sheath, a dilator, a plastic guide tube, a metal guide tube, a plastic cannula and a puncture needle (Chu Jianguo, The current status and standardization of transjugular intrahepatic portosystemic shunt technology in my country, Chinese Journal of Interventional Radiology Electronics, 2013, 1(2)).

[0027] However, the design of the puncture component is based on the body shape and vascular network characteristics of European and American people, and is not completely suitable for Asian body shapes and Chinese patients with liver atrophy mainly caused by hepatitis B lesions turning into cirrhosis. In practice, the hit rate of using this puncture component for portal vein branch puncture is low, not only the patient suffers more, but the doctor and the patient also need to be exposed to a larger dose of X-rays. More seriously, this may also cause the operator to pierce the liver capsule and mistakenly enter the extrahepatic portal vein trunk, causing severe complications such as massive abdominal bleeding.

[0028] Therefore, before puncturing the intrahepatic portal vein branches, the surgeon must carefully study the results of portal venography and, based on the location and morphology of the portal vein as well as the anterior-posterior relationship between the hepatic vein and the portal vein branches shown in the portal venography, manually adjust the RUPS-100 in vitro (in most cases, the bending angle of the puncture needle needs to be increased). Whether the bending angle of the metal guide tube is appropriate and whether the inner diameter is flat can only depend on the surgeon's experience.

[0029] Since the operation is performed with the naked eye of the doctor, the position of the puncture needle during the operation and the positional relationship between the puncture needle and various parts of the subject's body also depend on the experience of the surgeon.

[0030] In addition, because the subject's body position and respiratory movement during the operation can cause liver displacement and positional deviation, even experienced operators usually need to perform multiple punctures (about 5 to 8 times, or even 10 to 15 times) to succeed; the more punctures, the more chances of complications, which is also the cause of postoperative restenosis and acute thrombosis (Li Yanhao. Practical Clinical Interventional Diagnosis and Treatment Illustrated [M]. Beijing: Science Press, 2012.).

[0031] Therefore, it has become an urgent problem to solve the monitoring blind spot through puncture navigation technology, monitor and guide the puncture instrument to puncture the portal vein safely and effectively through the hepatic vein to the predetermined position of the portal vein in real time, and reduce complications. Furthermore, there is an urgent need for a puncture instrument that can be applied to interventional navigation technology to achieve a puncture operation that is easier to operate, more accurate, effective, and safer under interventional navigation. Summary of the invention

[0032] In view of this, an embodiment of the present invention provides a puncture instrument to solve one or more of the problems of the above-mentioned existing puncture surgery, such as high operating difficulty, poor accuracy, and poor safety, to achieve a puncture surgery that is easier to operate, more accurate, effective, and safer.

[0033] According to one aspect of the present invention, the present invention provides a puncture instrument, comprising: a puncture needle, wherein the puncture needle comprises a sensor mounting portion, and the sensor mounting portion can be equipped with an electromagnetic sensor.

[0034] Furthermore, the sensor mounting portion is a cavity inside the puncture needle or a recessed portion on the body surface of the puncture needle.

[0035] Furthermore, the puncture needle is tubular, one end of the lumen of the puncture needle opens at the proximal end of the puncture needle, and the other end of the lumen is closed at the distal end of the puncture needle, and the lumen forms the sensor mounting portion.

[0036] Furthermore, the puncture needle comprises a needle head and a needle rod, and the needle head and the needle rod are integrally formed.

[0037] Furthermore, the puncture needle includes a needle head and a needle rod, and the needle head and the needle rod are connected by welding or threading.

[0038] Furthermore, the proximal end of the needle head includes a connecting portion, the needle rod is tubular, and when the needle head is connected to the needle rod, the connecting portion is inserted into the lumen of the needle rod.

[0039] Further, the outer diameter of the distal end portion of the needle rod is smaller than the outer diameter of the proximal end portion of the needle rod.

[0040] Furthermore, the needle rod comprises an inner needle rod and an outer needle rod, the outer needle rod is sleeved outside the inner needle rod, and the outer needle rod is connected to the inner needle rod by welding.

[0041] Furthermore, the inner needle rod and the outer needle rod are sealed by welding or bonding.

[0042] Further, at a distal end portion of the needle rod, the inner needle rod extends beyond the outer needle rod.

[0043] Furthermore, the puncture needle includes an auxiliary part, which is sleeved outside the needle rod, and the friction coefficient of the auxiliary part is smaller than that of the needle rod.

[0044] Furthermore, the auxiliary part is a spring or a sleeve.

[0045] Furthermore, the spring is connected to the needle rod by welding.

[0046] Furthermore, the sleeve is made of polytetrafluoroethylene, and the sleeve is connected to the needle rod by heat shrinking.

[0047] Furthermore, the outer diameter of the distal end portion of the needle rod is smaller than the outer diameter of the proximal end portion of the needle rod, and the spring or the sleeve is sleeved on the distal end portion of the needle rod.

[0048] Furthermore, the outer needle rod includes a distal outer needle rod and a proximal outer needle rod, the distal outer needle rod is sleeved on the distal end of the inner needle rod, the proximal outer needle rod is sleeved on the proximal end of the inner needle rod, and the spring or the sleeve is sleeved outside the inner needle rod between the distal outer needle rod and the proximal outer needle rod.

[0049] Furthermore, the outer diameter of the distal portion of the inner needle rod is smaller than the outer diameter of the proximal portion of the inner needle rod, and the outer needle rod and the spring are sequentially sleeved on the distal portion of the inner needle rod from the distal end to the proximal end, or the outer needle rod and the sleeve are sequentially sleeved on the distal portion of the inner needle rod from the distal end to the proximal end.

[0050] Furthermore, at the distal end portion of the needle rod, the inner needle rod extends beyond the outer needle rod, and the spring or the sleeve is sleeved on the portion of the inner needle rod extending beyond the outer needle rod.

[0051] Furthermore, the electromagnetic sensor is a wireless sensor or a wired sensor.

[0052] Furthermore, the material of the puncture needle includes but is not limited to one or more of stainless steel and nickel-titanium alloy.

[0053] Furthermore, the thickness specifications of the puncture needle include but are not limited to: 16G, 17G, 18G, 19G, 20G, and 21G.

[0054] Furthermore, the material of the spring includes but is not limited to one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy.

[0055] Furthermore, the puncture instrument includes an interventional catheter instrument, which includes: a guide tube; a flexible sleeve, which is arranged outside the guide tube; the flexible sleeve and the guide tube can move relative to each other, so that the distal end of the flexible sleeve 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 sleeve.

[0056] Furthermore, a constricted portion is provided at the distal end of the flexible sleeve, the inner diameter of the constricted portion is smaller than the outer diameter of the guide tube, and the constricted portion is provided with a weakened portion that is easily damaged. When the interventional catheter instrument abuts against the puncture target point, the weakened portion can be destroyed by moving the guide tube distally relative to the flexible sleeve, so that the guide tube extends beyond the distal end of the flexible sleeve.

[0057] Furthermore, the weakened portion extends to the distal opening of the flexible sleeve.

[0058] Further, the weakened portion extends along the longitudinal direction of the flexible sleeve in a straight line or a spiral manner to the distal end opening of the flexible sleeve.

[0059] Furthermore, the weakened portion is a discontinuous score line or indentation.

[0060] Furthermore, the weakened portion is arranged on the inner surface or the outer surface of the weakened portion.

[0061] Furthermore, the inner diameter of the necked portion is 0.05 mm to 1 mm smaller than the outer diameter of the guide tube.

[0062] Furthermore, the material of the flexible sleeve includes but is not limited to one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, and high-density polyethylene.

[0063] Furthermore, the material of the guide tube includes but is not limited to one or more of stainless steel and nickel-titanium alloy.

[0064] Furthermore, the thickness specifications of the guide tube include but are not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm to 57cm.

[0065] Furthermore, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

[0066] Furthermore, the interventional catheter instrument includes a connector, through which the proximal end of the guide tube is connected to the proximal end of the flexible sleeve, and through which the guide tube and the flexible sleeve can move relative to each other.

[0067] Furthermore, the connection method of the connecting piece is a threading method, a snap-fit ​​method or a bonding method.

[0068] In summary, the puncture instrument according to the present invention can realize a puncture operation that is easier to operate, more accurate, effective, and safer under interventional navigation technology, thereby solving the technical problems existing in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] The features and advantages of the present invention will become more easily understood through the following detailed description provided with reference to the accompanying drawings, in which:

[0070] Figure 1 is a schematic diagram of a puncture instrument according to an embodiment of the present invention;

[0071] Figure 2 is a schematic diagram of a puncture device according to an embodiment of the present invention;

[0072] Figure 3 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0073] Figure 4 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0074] Figure 5 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0075] Figure 6 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0076] Figure 7 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0077] Figure 8 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0078] Fig. 9 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0079] Fig.10 is a schematic diagram of a puncture needle provided with a catheter according to an embodiment of the present invention;

[0080] 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;

[0081] Fig.12 is a schematic diagram of a guide tube according to an embodiment of the present invention;

[0082] Fig.13 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention;

[0083] Fig.14 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to an embodiment of the present invention;

[0084] Fig.15 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the puncture target point through the interventional approach;

[0085] Fig.16 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when performing puncture guidance;

[0086] Fig.17 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of withdrawing through the interventional pathway after the puncture guidance is implemented;

[0087] Fig.18 Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention;

[0088] Fig.19 is a schematic diagram of a necked portion of a flexible sleeve according to an embodiment of the present invention;

[0089] Fig. 20is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the puncture target point through the interventional approach;

[0090] Fig.21 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when performing puncture guidance;

[0091] Fig. 22 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of withdrawing through the interventional pathway after the puncture guidance is implemented; DETAILED DESCRIPTION

[0092] The following is a detailed description of exemplary embodiments of the present invention with reference to the accompanying drawings. The description of the exemplary embodiments is only for illustrative purposes and is in no way intended to limit the present invention and its application or usage.

[0093] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0094] As used in the present invention, the singular forms "a", "an", and "the" include plural objects unless the context clearly indicates otherwise. As used in the present invention, the term "or" is generally used in a sense including "and / or", unless the context clearly indicates otherwise. The "distal end" and "distal side" mentioned in the present invention refer to the side away from the operator; correspondingly, the "proximal end" and "proximal side" are the side opposite to the "distal end" and "distal side".

[0095] In order to solve the problems of difficult operation, poor accuracy and poor safety of puncture surgery and to achieve easier, more accurate, effective and safer puncture surgery, interventional navigation technology, such as electromagnetic navigation technology, can be used.

[0096] Electromagnetic navigation equipment can measure the position and direction of an object using electromagnetic induction according to the Biot-Savart law. 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 and transmits the signal to the magnetic field signal controller to obtain the object's spatial vector information (spatial coordinates and direction).

[0097] At present, the most widely used electromagnetic navigation products include the POLARIS system of Canada's NDI, the VISLAN system of the UK's RMR, and the STEALTHSTATION system of the US's MEDTRONIC. Among them, the measurement accuracy of the POLARIS system is 0.35mm. RMS is considered the international standard for navigation and positioning systems and can track 9 passive and 3 active surgical instruments at the same time.

[0098] The transmitter of the electromagnetic navigation equipment usually includes an electromagnetic transmitting coil to emit electromagnetic waves and generate an electromagnetic field. The effective positioning range of the electromagnetic field can be 300mm×300mm×300mm, 400mm×400mm×400mm, etc.

[0099] The sensor of the electromagnetic navigation device can receive the electromagnetic signal through the electromagnetic receiving coil and convert the electromagnetic signal into an electrical signal to track and locate the position of the sensor in the electromagnetic field.

[0100] According to clinical requirements, the navigation positioning accuracy is usually required to reach 5mm and the positioning speed is usually required to reach 30ms. In the embodiment of the present invention, the electromagnetic positioning accuracy can be as low as 1.5 and the positioning speed can be as fast as 12.5ms.

[0101] According to application requirements, the sensor can be designed into various structures and sizes. In the embodiment of the present invention, the sensor can be linear, and its size can be: the minimum outer diameter is 0.56mm, such as Figure 1 shown.

[0102] The sensor may be wired or wireless, and thus the connection between the electromagnetic device and the puncture instrument may be wired or wireless. For example, the wireless connection may be Bluetooth, WIFI, Zigbee, and the like.

[0103] An embodiment of the present invention provides a puncture instrument applicable to interventional navigation technology. The puncture instrument may be provided with the above-mentioned sensor. Through the sensor, combined with ultrasonic imaging equipment, the puncture instrument can be positioned and navigated during the puncture operation.

[0104] Figure 1 Schematic diagram of a puncture instrument according to an embodiment of the present invention. Figure 1 As shown, in the embodiment of the present invention, the puncture instrument 1 may include a puncture needle 11 , and the puncture needle 11 may be provided with a sensor mounting portion 111 , and the sensor mounting portion 111 may be used to mount the sensor 2 .

[0105] In the embodiment of the present invention, the material of the puncture needle 11 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, and the like.

[0106] According to the requirements of clinical application, the thickness specifications of the puncture needle 11 may include but are not limited to: 16G, 17G, 18G, 19G, 20G, 21G, etc. (G is the abbreviation of GAUGE, which is a length measurement unit for diameter originating in North America).

[0107] According to the requirements of clinical application, the puncture needle 11 can be designed to have various lengths. For example, for transjugular intrahepatic portosystemic shunt, the length specification can be 50 cm to 65 cm.

[0108] like Figure 1 As shown, the puncture needle 11 may include a needle head 112 and a needle rod 113. In the embodiment of the present invention, the needle head 112 and the needle rod 113 may be integrally formed. Figure 1 The needle 112 and the needle rod 113 can also be connected by separate assembly, for example, the needle 112 and the needle rod 113 are connected by welding, threading, etc. Figure 3 shown.

[0109] In the embodiment of the present invention, the needle tip 1121 of the needle head 112 may be in the shape of a triangular pyramid, a quadrangular pyramid or a cone. The height of the cone of the needle tip 1121 may be 1 mm to 4 mm.

[0110] Since puncture surgery navigation usually requires positioning the distal end of the puncture needle, in the embodiment of the present invention, the sensor mounting portion 111 may be disposed at the distal end of the puncture needle 11 .

[0111] In the embodiment of the present invention, the sensor mounting portion 111 may be a cavity inside the puncture needle 11, such as Figure 1 If the sensor is wired, the cavity may be provided with an opening for the passage of the wire, for example, the cavity opens at the proximal end of the puncture needle 11. If the sensor is wireless, the cavity may be closed after the sensor is installed.

[0112] In the embodiment of the present invention, the distance from the cavity of the puncture needle 11 to the needle tip of the puncture needle 11 may be 0.10 mm to 30 mm.

[0113] like Figure 1 As shown, the puncture needle 11 may be tubular, one end of the lumen of the puncture needle 11 is open at the proximal end of the puncture needle 11 , and the other end of the lumen is closed at the distal end of the puncture needle, and the lumen forms a sensor mounting portion 111 .

[0114] Figure 2 Schematic diagram of a puncture instrument according to an embodiment of the present invention. Figure 2 As described above, in the embodiment of the present invention, the sensor mounting portion 111 may be a recessed portion on the body surface of the puncture needle 11 .

[0115] Figure 3 Schematic diagram of a puncture needle according to an embodiment of the present invention. Figure 3As shown, the proximal end of the needle 112 may include a connecting portion 1122, the outer diameter of which is smaller than the inner diameter of the lumen of the needle shaft 113. When the needle 112 and the needle shaft 113 are connected, the connecting portion 1122 may be inserted into the lumen of the needle shaft 113.

[0116] In order to adapt to the tortuous and narrow puncture path and increase the flexibility and guidance of the puncture needle 11, in the embodiment of the present invention, the needle rod 113 can be set to a variable diameter shape, and the outer diameter of the distal end of the needle rod 113 is smaller than the outer diameter of the proximal end of the needle rod 113. The two outer diameter parts can be gradually transitioned or stepped.

[0117] Figure 4 Schematic diagram of a puncture needle according to an embodiment of the present invention. Figure 4 As shown, the outer diameter of the distal end of the needle rod 113 is smaller than the outer diameter of the proximal end of the needle rod 113, and the two outer diameters transition in a stepped manner. The reduced diameter shape can effectively increase the flexibility and guidance of the needle rod 113.

[0118] In order to adapt to the tortuous puncture path and increase the flexibility and guidance of the puncture needle 11, in the embodiment of the present invention, the needle rod can also be configured to include an inner needle rod and an outer needle rod.

[0119] Figure 5 Schematic diagram of a puncture needle according to an embodiment of the present invention. Figure 5 As shown, the needle rod 113 may include an inner needle rod 1131 and an outer needle rod 1132, and the outer needle rod 1132 is sleeved outside the inner needle rod 1131. The outer needle rod 1132 and the inner needle rod 1131 may be connected by welding, threading, etc. In addition, in order to prevent body fluids from entering between the inner needle rod 1131 and the outer needle rod 1132, the inner needle rod 1131 and the outer needle rod 1132 need to be sealed, and the sealing method may be welding or bonding.

[0120] In the embodiment of the present invention, the needle bar design with reduced diameter and the needle bar design with inner and outer needle bars can be combined. Figure 6 Schematic diagram of a puncture needle according to an embodiment of the present invention. Figure 6 As shown, at the distal end portion of the needle rod 113, the inner needle rod 1131 extends beyond the outer needle rod 1132, thereby forming a needle rod design with reduced diameter.

[0121] In order to adapt to the tortuous and narrow puncture path, effectively reduce the friction resistance of the puncture needle 11, and improve the operational stability of the puncture needle 11, in the embodiment of the present invention, the puncture needle can also be configured to include an auxiliary part, which can be a spring or a sleeve.

[0122] The spring can effectively reduce the contact area between the outer surface of the puncture needle 11 and the surrounding material, thereby reducing its friction resistance. At the same time, the spring can improve the operational stability of the puncture needle 11 due to its elastic tensile force and the effect of increasing the radial dimension of the puncture needle 11.

[0123] The spring can be sleeved on the needle bar, and can be connected to the needle bar by welding. For example, the two ends of the spring can be welded to the needle bar respectively.

[0124] The sleeve can be made of a material with a small friction coefficient to reduce friction resistance, such as polytetrafluoroethylene (PTFE). The friction coefficient of polytetrafluoroethylene (PTFE) is very low, and the friction coefficient of polytetrafluoroethylene to steel is generally quoted as 0.04. At the same time, the sleeve can also improve the operational stability of the puncture needle 11 due to its elastic tensile force and the effect of increasing the radial dimension of the puncture needle 11.

[0125] In the embodiment of the present invention, the sleeve can be sleeved on the needle rod by heat shrinking.

[0126] Figure 7 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Figure 7 As shown, the needle rod 113 may be in a variable diameter shape, the outer diameter of the distal end of the needle rod 113 is smaller than the outer diameter of the proximal end of the needle rod 113, and the spring 114 is sleeved on the distal end of the needle rod 113 with a smaller outer diameter. The spring 114 may be connected to the needle rod 113 by welding.

[0127] In the embodiment of the present invention, the material of the spring 114 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy.

[0128] In the embodiment of the present invention, the dimensions of the spring 114 may be: spring wire diameter 0.08-0.3 mm, spring middle diameter 0.5 mm-2.0 mm, and spring free length 30 mm-200 mm.

[0129] Figure 8 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Figure 8 As shown, in the embodiment of the present invention, the outer needle rod 1132 may include a distal outer needle rod 11321 and a proximal outer needle rod 11322. The distal outer needle rod 11321 is sleeved on the distal end of the inner needle rod 1131, and the proximal outer needle rod 11322 is sleeved on the proximal end of the inner needle rod 1131. The spring 114 may be sleeved on the inner needle rod 1131 between the distal outer needle rod 11321 and the proximal outer needle rod 11322.

[0130] Fig. 9 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Fig. 9As shown, in one embodiment of the present invention, the inner needle rod 1131 may be in a variable diameter shape, and the outer diameter of the distal end portion of the inner needle rod 1131 is smaller than the outer diameter of the proximal end portion of the inner needle rod 1131. Fig. 9 As shown, the outer needle rod 1132 and the spring 114 are sequentially sleeved on the distal end of the inner needle rod 1131 from the distal end to the proximal end.

[0131] In the embodiment of the present invention, the spring can also be sleeved on Figure 6 In the embodiment of the present invention shown, the inner needle rod 1131 extends beyond the portion of the outer needle rod 1132.

[0132] The assembly relationship between the sleeve and the needle bar can be the same as the assembly relationship between the spring and the needle bar, as described above.

[0133] Fig.10 Schematic diagram of a puncture needle with a catheter according to an embodiment of the present invention. Fig.10 As shown, in the embodiment of the present invention, the puncture device 1 may include a catheter 12. On the one hand, 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 friction resistance when the puncture needle 11 moves.

[0134] like Fig.10 As shown, the catheter 12 can be sleeved outside the puncture needle 11. The distal end of the catheter 12 can be processed by tip molding. After assembly, the distal end of the catheter 12 is located near the conical bottom surface of the needle tip 1121 of the puncture needle 11. The distance between the two can be 0-1mm, forming an interference fit or transition fit, preferably a transition fit. The proximal end of the catheter 12 can be connected to the proximal end of the puncture needle 11 in a threaded manner through a connector.

[0135] Catheter technology is widely used in interventional radiology. In the past, catheter instruments were mostly used to establish channels for interventional surgical instruments, and most of them did not have the function of bending and guiding at specific locations (Li Yanhao. Practical Clinical Interventional Diagnosis and Treatment Illustrated [M]. Beijing: Science Press, 2012.).

[0136] At present, some catheter devices used clinically 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 interventional surgical instruments such as puncture needles and guide wires after bending. For example, the plastic catheter device and metal catheter device of the RUPS-100 puncture assembly produced by COOK in the United States have a bending guide structure at a specific position to achieve the corresponding guiding function.

[0137] During the intervention process, in order to guide the intervention, the distal end of the catheter device is sometimes required to rest 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 accurately intervenes at the intervention target.

[0138] In order to prevent the distal end of the catheter instrument from causing damage to the tissue it passes through during the process of passing through the interventional pathway to reach the interventional target, a flexible sleeve may be provided on the outside of the catheter. The flexible sleeve extends beyond the distal end of the catheter so that the distal end of the catheter is covered by the flexible sleeve to prevent it from damaging surrounding tissue.

[0139] In interventional surgery, especially interventional surgery with a long and tortuous interventional pathway, the interventional device needs to be bent at a certain angle in the blood vessel through the catheter device before performing blood vessel or tissue intervention. When the distal end of the flexible sleeve mounted outside the catheter is against the intervention target, due to the flexibility of the flexible sleeve, it cannot be kept at the intervention target during the intervention process, which often leads to errors such as needle skipping and failure to insert the needle or changes in the intervention direction during the intervention process, causing great difficulty for the operator. At present, the operator can only rely on the support of the catheter outside the body or pressing on specific parts of the human body, which greatly increases the difficulty of the operator's operation and limits the application of surgery.

[0140] For example, in transjugular intrahepatic puncture surgery, the key to successful puncture is to keep the catheter instrument at the puncture target point on the wall of the hepatic vein (Li Yanhao. Practical Clinical Interventional Diagnosis and Treatment Illustrated [M]. Beijing: Science Press, 2012.). However, the current puncture components cannot effectively solve this problem (Chu Jianguo, The current status and standardization of transjugular intrahepatic portosystemic shunt technology in my country, Chinese Journal of Interventional Radiology Electronics, 2013, 1(2)).

[0141] Therefore, there is an urgent need for a catheter device that can prevent damage to surrounding tissues and remain at the intervention target during the intervention process, so as to prevent errors such as needle skipping and failure to puncture or changes in the intervention direction during the intervention process.

[0142] In the embodiment of the present invention, the puncture instrument 1 may include a catheter instrument 13 . Fig.11 FIG. 1 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.11 As shown, the catheter device 13 may include a guide tube 131 and a flexible sleeve 132 to provide guidance for the puncture needle 11. According to clinical needs, the catheter device 13 may be linear or curved, for example, the curved one may be used for transjugular intrahepatic puncture surgery.

[0143] Fig.12Schematic diagram of the guide tube of the embodiment of the present invention. In the embodiment of the present invention, the material of the guide tube 131 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, etc. According to clinical needs, the thickness specifications of the guide tube 131 may include but are not limited to: 13G, 14G, 15G, 16G, etc. (G is the abbreviation of GAUGE, which is a length measurement unit for diameter originating in North America); the length specification may be 42cm to 57cm.

[0144] like Fig.12 As shown, the distal end of the guide tube 131 may be of an oblique blade type, which can be used for puncture, and can also be used to penetrate into the intervention target site and abut against the intervention target site.

[0145] like Fig.12 As shown, according to clinical needs, the distal side of the guide tube 131 can form one or more bends. In one embodiment of the present invention, the distal end of the guide tube 131 is a curved bevel blade, and can be bent 10° to 80°, for example 60°, at 0.5 cm to 12 cm from the bevel blade tip.

[0146] Fig.13 is a schematic diagram of a flexible sleeve of an embodiment of the present invention. In the embodiment of the present invention, the material of the flexible sleeve 132 may include but is not limited to one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12 (PA12), segmented polyetheramide elastomer (Pebax), high-density polyethylene (HDPE), etc.

[0147] Fig.14 Schematic diagram of the assembly of the guide tube and the flexible sleeve of the embodiment of the present invention. Fig.14 As shown, the flexible sleeve 132 can be sleeved outside 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 sleeve 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 sleeve 132, or the distal end of the flexible sleeve 132 can extend beyond the distal end of the guide tube 131 (such as Fig.14 shown).

[0148] In the embodiment of the present invention, the proximal end of the flexible sleeve 132 can be connected to the proximal end of the guide tube 131 by means of threads, buckles or bonding via the connector 133, and the flexible sleeve 132 and the guide tube 131 can be moved relative to each other via the connector 133. Fig.11 or Fig.14 It is shown that the proximal end of the flexible sleeve 132 and the guide tube 131 are connected in a threaded manner via a connector 133 .

[0149] In the puncture surgery of the embodiment of the present invention, the catheter device 13 including the guide tube 131 and the flexible sleeve 132 first enters the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Fig.15 Schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the puncture target through the interventional approach. Fig.15 As shown, during this process, 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 from damaging the tissue it passes through.

[0150] In the puncture surgery of the embodiment of the present invention, when the distal end of the catheter device 1 reaches the puncture target point, the guide tube 131 and the flexible sleeve 132 can be moved relative to each other, so that the distal end of the guide tube 131 extends beyond the distal end of the flexible sleeve 132, so that the distal end of the guide tube 131 can be against the puncture target point and remain motionless to implement puncture guidance. Fig.16 It is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when implementing puncture guidance.

[0151] In the puncture surgery of the embodiment of the present invention, when the catheter instrument 13 is to be withdrawn through the interventional pathway after implementing the puncture guidance, the guide tube 131 and the flexible sleeve 132 can be moved relative to each other so that the distal end of the flexible sleeve 132 extends beyond the distal bevel blade of the guide tube 131 to prevent the distal bevel blade from damaging the tissue passed through. Fig.17 It is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention during the withdrawal process through the interventional pathway after the puncture guidance is implemented.

[0152] In interventional diagnosis and treatment, the distal end of the catheter instrument will be subject to resistance from the tissues and organs it passes through as it passes through the interventional pathway to reach the interventional target, especially in interventional surgeries with long and tortuous pathways. Due to the flexibility of the flexible sheath, the flexible sheath often moves proximally relative to the guide tube, causing the distal end of the guide tube to extend beyond the distal end of the flexible sheath, thereby damaging the surrounding tissues it passes through.

[0153] To solve this technical problem, further, in an embodiment of the present invention, the distal end of the flexible sleeve 132 can be subjected to a shrinkage molding process to form a shrinkage portion 1321. The shrinkage portion 1321 can be conical. After molding, the inner diameter of the shrinkage portion can be 0.05 mm to 1 mm smaller than the outer diameter of the guide tube 131. Fig.18 Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention.

[0154] Since the inner diameter of the distal end of the narrowed portion of the flexible sleeve 132 is smaller than the outer diameter of the distal end of the guide tube 131, during the process of the catheter instrument 13 passing through the interventional pathway to reach the puncture target, the flexible sleeve 132 will not move proximally relative to the guide tube 131 even if it is affected by the resistance of the tissues and organs it passes through, so that the guide tube 131 will not extend from the distal end of the flexible sleeve 132, thereby damaging the tissues it passes through.

[0155] further, Fig.19 Schematic diagram of the necking portion of the flexible sleeve of the embodiment of the present invention. In the embodiment of the present invention, the necking portion 1321 of the flexible sleeve 132 may be provided with a weakened portion 13211 that is easily damaged, such as Fig.19 As shown. The weakened portion 13211 may extend to the distal opening of the flexible sleeve 132. The weakened portion 13211 may be a discontinuous score line or indentation, and may extend in a straight line or spirally along the longitudinal direction of the flexible sleeve 132 to its distal opening. The weakened portion 13211 may be disposed on the inner surface or the outer surface of the constricted portion 1321. When the weakened portion 13211 is disposed on the outer surface of the constricted portion 1321, a depression may be formed on the outer surface, which may 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.

[0156] The weakened portion 13211 allows the guide tube 131 to break the weakened portion 1321 and extend out of the distal opening of the flexible sleeve 132 when a force greater than the above resistance is applied to push the guide tube 131 distally relative to the flexible sleeve 132 when the catheter device 13 abuts against the puncture target site. In one embodiment of the present invention, the weakened portion 1321 is a longitudinal indentation with a width of 1 mm.

[0157] Therefore, in the puncture surgery of the embodiment of the present invention, the guide tube 131 and the flexible sleeve 132 first enter the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Fig. 20 Schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the puncture target through the interventional approach; Fig. 20 As shown, during this process, the flexible sleeve 132 is sleeved outside the guide tube 131, and the constricted portion 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 from damaging the tissue it passes through.

[0158] In the puncture surgery of the embodiment of the present invention, when the distal end of the catheter device 13 reaches the puncture target point, a force greater than the above resistance can be applied to push the guide tube 131 distally relative to the flexible sleeve 132, so that the guide tube 131 destroys the weakened portion 1321 and extends 2 to 3 mm out of the distal opening of the flexible sleeve 132. In this way, the distal oblique blade of the guide tube 131 can penetrate the puncture target point, so that it can always remain at the puncture target point during the puncture process to provide a puncture guide for the puncture needle 11. Then, the puncture needle 11 can pass through the catheter device 13 to puncture the puncture target point. Fig.21 It is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when implementing puncture guidance.

[0159] In the embodiment of the present invention, after the puncture of the puncture needle 11 is completed, the guide tube 131 can be pulled back proximally relative to the flexible sleeve 132, so that the distal bevel blade of the guide tube 131 is retracted into the distal opening of the flexible sleeve 132 by 3 to 5 mm. Afterwards, the guide tube 131 and the flexible sleeve 132 are taken out along the original interventional pathway. Since the distal bevel blade of the guide tube 131 has been retracted into the distal opening of the flexible sleeve 132, it will not cause damage to the tissues passed through. In addition, during the withdrawal process of the catheter instrument 13, the direction of the resistance applied to the flexible sleeve 132 is in the distal direction, which will not cause the flexible sleeve 132 to move proximally relative to the guide tube 131, and will not cause the distal end of the guide tube 131 to extend beyond the distal end of the flexible sleeve 132 and cause damage to the tissues passed through. Fig. 22 It is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention during the withdrawal process through the interventional pathway after the puncture guidance is implemented.

[0160] The interventional catheter device of the embodiment of the present invention can not only prevent damage to the surrounding tissues it passes through, but also maintain the intervention target point in the blood vessel or tissue during the intervention process, and provide the operator with a stable and reliable guide structure to guide puncture or insertion of interventional devices. The structure and process of the interventional catheter device are simple, low cost, good operability, high efficiency and safety, and can meet the operator's requirements for precise guidance during curved puncture.

[0161] The puncture instrument of the embodiment of the present invention can realize a puncture operation that is easier to operate, more accurate, effective, and safer under interventional navigation technology, thereby solving the technical problems existing in the prior art.

[0162] In summary, the above embodiments describe the puncture instrument in detail. Of course, the present invention includes but is not limited to the above embodiments. Any changes made on the basis of the above embodiments fall within the scope of protection of the present invention. Those skilled in the art can draw inferences based on the above embodiments.

[0163] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

[0164] Although the present invention has been described with reference to exemplary embodiments, it should be understood that the present invention is not limited to the specific embodiments described and illustrated in detail herein, and that those skilled in the art may make various changes to the exemplary embodiments without departing from the scope defined by the claims, and all such changes shall fall within the scope of protection of the present invention.

[0165] Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0166] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A puncture instrument, characterized in that: include: A puncture needle, the puncture needle comprising a sensor mounting portion, the sensor mounting portion being capable of mounting an electromagnetic sensor, the puncture needle comprising a needle head and a needle rod; The outer diameter of the distal end portion of the needle shaft is smaller than the outer diameter of the proximal end portion of the needle shaft; The needle rod comprises an inner needle rod and an outer needle rod, the outer needle rod is sleeved outside the inner needle rod, and the outer needle rod is connected to the inner needle rod by welding; The puncture instrument comprises an interventional catheter instrument, and the interventional catheter instrument comprises: Guide tube; A flexible sleeve, the flexible sleeve being arranged outside the guide tube; The flexible sleeve and the guide tube are relatively movable, so that the distal end of the flexible sleeve 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 sleeve; The distal end of the flexible sleeve is provided with a constricted portion, the inner diameter of the constricted portion is smaller than the outer diameter of the guide tube, and the constricted portion is provided with a weakened portion that is easily damaged. When the interventional catheter device abuts against the puncture target point, the guide tube is moved distally relative to the flexible sleeve to destroy the weakened portion, so that the guide tube extends beyond the distal end of the flexible sleeve; The weakened portion extends to the distal opening of the flexible sleeve; the weakened portion is a discontinuous score line or indentation.

2. The puncture instrument according to claim 1, characterized in that: The sensor mounting portion is a cavity inside the puncture needle or a recessed portion on the body surface of the puncture needle.

3. The puncture instrument according to claim 1, characterized in that: The puncture needle is tubular, one end of the lumen of the puncture needle opens at the proximal end of the puncture needle, and the other end of the lumen is closed at the distal end of the puncture needle, and the lumen forms the sensor mounting portion.

4. The puncture instrument according to claim 1, characterized in that: The needle head and the needle rod are integrally formed.

5. The puncture instrument according to claim 1, characterized in that: The needle head and the needle rod are connected by welding or threading.

6. The puncture instrument according to claim 5, characterized in that: The proximal end of the needle head comprises a connecting portion, and the needle rod is tubular. When the needle head is connected to the needle rod, the connecting portion is inserted into the lumen of the needle rod.

7. The puncture instrument according to claim 1, characterized in that: The inner needle rod and the outer needle rod are sealed by welding or bonding.

8. The puncture instrument according to claim 1, characterized in that: At a distal end portion of the needle shaft, the inner needle shaft extends beyond the outer needle shaft.

9. The puncture instrument according to any one of claims 1 to 8, characterized in that: The puncture needle comprises an auxiliary part, the auxiliary part is sleeved outside the needle rod, and the friction coefficient of the auxiliary part is smaller than that of the needle rod.

10. The puncture instrument according to claim 9, characterized in that: The auxiliary part is a spring or a sleeve.

11. The puncture instrument according to claim 10, characterized in that: The spring is connected to the needle rod by welding.

12. The puncture instrument according to claim 10, characterized in that: The sleeve is made of polytetrafluoroethylene, and the sleeve is connected to the needle rod by heat shrinking.

13. The puncture instrument according to claim 10, characterized in that: The spring or the sleeve is sleeved on the distal end portion of the needle rod.

14. The puncture instrument according to claim 10, characterized in that: The outer needle rod comprises a distal outer needle rod and a proximal outer needle rod, the distal outer needle rod is sleeved on the distal end of the inner needle rod, the proximal outer needle rod is sleeved on the proximal end of the inner needle rod, and the spring or the sleeve is sleeved outside the inner needle rod between the distal outer needle rod and the proximal outer needle rod.

15. The puncture instrument according to claim 10, characterized in that: The outer diameter of the distal portion of the inner needle rod is smaller than the outer diameter of the proximal portion of the inner needle rod, and the outer needle rod and the spring are sequentially sleeved on the distal portion of the inner needle rod from the distal end to the proximal end, or the outer needle rod and the sleeve are sequentially sleeved on the distal portion of the inner needle rod from the distal end to the proximal end.

16. The puncture instrument according to claim 10, characterized in that: At the distal end portion of the needle rod, the inner needle rod extends beyond the outer needle rod, and the spring or the sleeve is sleeved on the portion of the inner needle rod extending beyond the outer needle rod.

17. The puncture instrument according to claim 1, characterized in that: The electromagnetic sensor is a wireless sensor or a wired sensor.

18. The puncture instrument according to claim 1, characterized in that: The material of the puncture needle includes one or more of stainless steel and nickel-titanium alloy.

19. The puncture instrument according to claim 1, characterized in that: The thickness specifications of the puncture needle include: 16G, 17G, 18G, 19G, 20G, and 21G.

20. The puncture instrument according to claim 10, characterized in that: The material of the spring includes one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy.

21. The puncture instrument according to claim 1, characterized in that: The weakened portion extends along the longitudinal direction of the flexible sleeve in a straight line or a spiral manner to the distal end opening of the flexible sleeve.

22. The puncture instrument according to claim 1, characterized in that: The weakened portion is arranged on the inner surface or the outer surface of the weakened portion.

23. The puncture instrument according to claim 1, characterized in that: The inner diameter of the necked portion is 0.05 mm to 1 mm smaller than the outer diameter of the guide tube.

24. The puncture instrument according to claim 1, characterized in that: The material of the flexible sleeve includes one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, and high-density polyethylene.

25. The puncture instrument according to claim 1, characterized in that: The material of the guide tube includes one or more of stainless steel and nickel-titanium alloy.

26. The puncture instrument according to claim 1, characterized in that: The thickness specifications of the guide tube include: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm to 57cm.

27. The puncture instrument according to claim 1, characterized in that: The inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

28. The puncture instrument according to claim 1, characterized in that: The interventional catheter instrument comprises a connecting piece, through which the proximal end of the guide tube is connected to the proximal end of the flexible sleeve, and through which the guide tube and the flexible sleeve can be relatively moved.

29. The puncture instrument according to claim 28, characterized in that: The connection method of the connecting piece is threading, snap-fitting or bonding.

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