Piercing system

Abstract

The present invention relates to a puncture system, which utilizes interventional navigation technology and corresponding puncture instruments to achieve a puncture operation that is easier to operate, more accurate, more effective, safer, has fewer complications, and has no surgical monitoring blind spots.

Description

Technical Field

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

[0012] Among them, interventional diagnosis and treatment with narrow and tortuous interventional pathways, angle requirements, and the need to pass through important tissues and organs, such as transjugular intrahepatic portosystemic shunt (TIPS), are difficult, have high risk factors, and have high technical requirements, and especially require accurate and effective navigation technology.

[0013] 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.

[0014] 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).

[0015] 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.

[0016] 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;

[0017] Contraindications to TIPS include:

[0018] 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.

[0019] 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.

[0020] 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).

[0021] 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).

[0022] Therefore, it has become an urgent problem to solve the monitoring blind spot through puncture navigation technology, monitor and guide the puncture instrument in real time to puncture the portal vein safely and effectively through the hepatic vein to the predetermined position, and reduce complications.

[0023] 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).

[0024] 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; 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; perform portal vein wedge angiography to clarify the anatomical structure of the portal vein and its branches; and puncture the portal vein from the right hepatic vein to the front and bottom.

[0025] 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)).

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.).

[0030] There is an urgent need for a TIPS portal vein puncture system that is suitable for various population sizes and livers with various cirrhotic lesions, has no monitoring blind spots, and reduces surgical complications.

[0031] Therefore, for puncture surgeries, especially those with narrow and tortuous puncture pathways, angle requirements, and those that need to pass through important tissues and organs, such as TIPS portal vein puncture, problems such as high difficulty in operation, poor accuracy, poor safety, prone to complications, and blind spots in surgical monitoring have become issues that need to be urgently addressed. Summary of the invention

[0032] In view of this, an embodiment of the present invention provides a puncture system, which utilizes interventional navigation technology and corresponding puncture instruments to solve one or more of the problems of the above-mentioned existing puncture surgeries, such as high difficulty in operation, poor accuracy, poor safety, prone to complications, and blind spots in surgical monitoring, so as to achieve a puncture surgery that is easier to operate, more accurate and effective, safer, and has fewer complications.

[0033] According to one aspect of the present invention, the present invention provides a puncture system, characterized in that it includes: an interventional navigation system and a puncture instrument; the interventional navigation system includes an electromagnetic positioning module, a navigation processing module and a navigation output module, wherein: the electromagnetic positioning module is connected to an ultrasonic imaging device and a puncture instrument to obtain the position and direction of an ultrasonic image generated by the ultrasonic imaging device and the position and direction of the puncture instrument; the navigation processing module is connected to the ultrasonic imaging device and the electromagnetic positioning module to form a puncture path according to the position and direction of the puncture instrument, and according to the position and direction of the ultrasonic image, the position and direction of the puncture instrument, and the puncture path, the puncture instrument and the puncture path are orthogonally projected onto the ultrasonic image to form a navigation image that fuses the projections of the puncture instrument and the puncture path; the navigation output module is connected to the navigation processing module to output the navigation image according to a set display mode.

[0034] Furthermore, the puncture instrument includes a puncture needle, and the puncture needle includes a sensor mounting portion, and the sensor mounting portion can be mounted with the sensor of the electromagnetic positioning module.

[0035] Furthermore, the sensor mounting portion is a cavity inside the puncture needle or a recessed portion on the body surface of the puncture needle.

[0036] 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.

[0037] Furthermore, the puncture needle comprises a needle head and a needle rod, and the needle head and the needle rod are integrally formed.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] Furthermore, the inner needle rod and the outer needle rod are sealed by welding or bonding.

[0043] Further, at a distal end portion of the needle rod, the inner needle rod extends beyond the outer needle rod.

[0044] 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.

[0045] Furthermore, the auxiliary part is a spring or a sleeve.

[0046] Furthermore, the spring is connected to the needle rod by welding.

[0047] Furthermore, the sleeve is made of polytetrafluoroethylene, and the sleeve is connected to the needle rod by heat shrinking.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] Furthermore, the sensor is a wireless sensor or a wired sensor.

[0053] Furthermore, the material of the puncture needle includes but is not limited to one or more of stainless steel and nickel-titanium alloy.

[0054] Furthermore, the thickness specifications of the puncture needle include but are not limited to: 16G, 17G, 18G, 19G, 20G, and 21G.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] Furthermore, the weakened portion extends to the distal opening of the flexible sleeve.

[0059] 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.

[0060] Furthermore, the weakened portion is a discontinuous score line or indentation.

[0061] Furthermore, the weakened portion is arranged on the inner surface or the outer surface of the weakened portion.

[0062] Furthermore, the inner diameter of the necked portion is 0.05 mm to 1 mm smaller than the outer diameter of the guide tube.

[0063] 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.

[0064] Furthermore, the material of the guide tube includes but is not limited to one or more of stainless steel and nickel-titanium alloy.

[0065] 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.

[0066] Furthermore, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

[0067] 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.

[0068] Furthermore, the connection method of the connecting piece is a threading method, a snap-fit ​​method or a bonding method.

[0069] Furthermore, the navigation image is displayed differently when the puncture instrument and the ultrasonic image are in a coplanar state and when they are not in a coplanar state.

[0070] Furthermore, the navigation image is displayed in a three-dimensional perspective manner.

[0071] Further, when the puncture instrument and the ultrasonic image are in a coplanar state and a non-coplanar state, the projection of the puncture instrument is displayed differently, and / or the projection of the puncture path is displayed differently.

[0072] Furthermore, the display method of the projection of the puncture instrument and / or the projection of the puncture path includes but is not limited to a combination of one or more of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, and static display.

[0073] Furthermore, when the puncture instrument and the ultrasonic image are not in a coplanar state, the display mode of the intersection of the puncture path and the ultrasonic image is different from the display mode of other points on the projection of the puncture path.

[0074] Furthermore, the display mode of the intersection includes but is not limited to a combination of one or more of cross-line display, star display, circle display, various color displays, and dynamic display.

[0075] Furthermore, when the puncture instrument and the ultrasonic image are not in a coplanar state, the projections of the two parts of the puncture path on both sides of the ultrasonic image are displayed in different ways, and / or the projections of the two parts of the puncture instrument on both sides of the ultrasonic image are displayed in different ways.

[0076] Furthermore, the display method of the projection of the two parts of the puncture instrument and / or the projection of the two parts of the puncture path includes but is not limited to a combination of one or more of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, and static display.

[0077] Furthermore, the puncture path is extended in the direction of the puncture instrument to form a straight line.

[0078] Furthermore, the electromagnetic positioning module includes a first sensor and a second sensor, the first sensor is connected to the probe of the ultrasonic imaging device, and the second sensor is connected to the puncture instrument.

[0079] In summary, the puncture system according to the present invention utilizes interventional navigation technology and corresponding puncture instruments to achieve a puncture surgery that is easier to operate, more accurate and effective, safer, has fewer complications, and has no surgical monitoring blind spots, thereby solving the technical problems existing in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] 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:

[0081] Figure 1 is a schematic diagram of a puncture system according to an embodiment of the present invention;

[0082] Figure 2 is a schematic diagram of an electromagnetic positioning module according to an embodiment of the present invention;

[0083] Figure 3 is a schematic diagram of a sensor according to an embodiment of the present invention;

[0084] Figure 4 is a schematic diagram of a sensor according to an embodiment of the present invention;

[0085] Figure 5 is a schematic diagram of an ultrasonic probe provided with a sensor according to an embodiment of the present invention;

[0086] Figure 6 is a schematic diagram of a puncture needle provided with a sensor according to an embodiment of the present invention;

[0087] Figure 7 is a schematic diagram of the fusion to form a navigation image according to an embodiment of the present invention;

[0088] Figure 8 is a schematic diagram of navigation image display when the puncture instrument and the ultrasound image according to the embodiment of the present invention are in a coplanar state;

[0089] Fig. 9 is a schematic diagram of navigation image display when the puncture instrument and the ultrasound image according to the embodiment of the present invention are not in a coplanar state;

[0090] Fig.10 is a schematic diagram of displaying a navigation image when the puncture instrument and the ultrasound image are not in a coplanar state according to another embodiment of the present invention;

[0091] Fig.11 is a schematic diagram of a puncture instrument according to an embodiment of the present invention;

[0092] Fig.12is a schematic diagram of a puncture instrument according to an embodiment of the present invention;

[0093] Fig.13 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0094] Fig.14 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0095] Fig.15 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0096] Fig.16 is a schematic diagram of a puncture needle according to an embodiment of the present invention;

[0097] Fig.17 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0098] Fig.18 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0099] Fig.19 is a schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention;

[0100] Fig. 20 is a schematic diagram of a puncture needle provided with a catheter according to an embodiment of the present invention;

[0101] Fig.21 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention;

[0102] Fig. 22 is a schematic diagram of a guide tube according to an embodiment of the present invention;

[0103] Fig.23 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention;

[0104] Fig.24 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to an embodiment of the present invention;

[0105] Fig.25 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;

[0106] Fig.26 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;

[0107] Fig. 27 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;

[0108] Fig.28 Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention;

[0109] Fig.29 is a schematic diagram of a necked portion of a flexible sleeve according to an embodiment of the present invention;

[0110] Fig.30 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;

[0111] Fig.31 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;

[0112] Fig.32 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

[0113] 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.

[0114] 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.

[0115] 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".

[0116] The present invention provides a puncture system, which utilizes interventional navigation technology and corresponding puncture instruments to solve one or more of the problems of existing puncture surgeries, such as high difficulty in operation, poor accuracy, poor safety, and proneness to complications, thereby achieving a puncture surgery that is easier to operate, more accurate and effective, safer, and has fewer complications.

[0117] Figure 1 Schematic diagram of the puncture system of an embodiment of the present invention. Figure 1 As shown, in the embodiment of the present invention, the puncture system 0 includes an interventional navigation system 1 and a puncture instrument 6 , and the interventional navigation system 1 includes an electromagnetic positioning module 2 , a navigation processing module 3 and a navigation output module 4 .

[0118] The electromagnetic positioning module 2 is connected to the ultrasonic imaging device 5 and the puncture instrument 6 to obtain the position and direction of the ultrasonic image generated by the ultrasonic imaging device 5 and the position and direction of the puncture instrument 6 .

[0119] Interventional instruments are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional instruments may include, but are not limited to, one or more of puncture instruments, radiofrequency instruments, microwave instruments, particle instruments, implant instruments, sheath instruments, tube instruments, biopsy instruments, etc. Interventional instruments may include one or more interventional tools, which may be catheters, guidewires, puncture needles, vascular sheaths, balloons, biopsy needles, etc.

[0120] As needed, the interventional navigation system 1 can be used in conjunction with other interventional instruments.

[0121] The electromagnetic positioning module 2 of the embodiment of the present invention measures the position and direction of an object using electromagnetic induction according to the Biot-Savart law, wherein 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).

[0122] The accuracy of electromagnetic positioning technology can effectively solve the problem of inaccurate interventional navigation caused by the volume effect of ultrasonic imaging equipment.

[0123] Figure 2 Schematic diagram of an electromagnetic positioning module according to an embodiment of the present invention. Figure 2 As shown, the electromagnetic positioning module 2 of the embodiment of the present invention includes a transmitter 21, a sensor 22 and a magnetic field signal processor 23. At present, the widely used products include the POLARIS system of Canada's NDI Company, the VISLAN system of the British RMR Company, and the Stealthstation system of the American Medtronic Company. Among them, the measurement accuracy of the POLARIS system is 0.35mm RMS, which is considered to be the international standard for navigation and positioning systems, and can track 9 passive and 3 active targets at the same time.

[0124] The transmitter 21 includes an electromagnetic transmitting coil to transmit electromagnetic waves and generate an electromagnetic field. The effective positioning range of the electromagnetic field in the embodiment of the present invention may be 300mm×300mm×300mm, 400mm×400mm×400mm, etc.

[0125] The sensor 22 receives the electromagnetic signal emitted by the transmitter 21 through the electromagnetic receiving coil, and converts the electromagnetic signal into an electrical signal. The position and direction of the sensor 22 in the electromagnetic field are tracked and located through the magnetic field signal processor 23 .

[0126] According to clinical requirements, the positioning accuracy of interventional navigation 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 usually be as low as 1.5mm and the positioning speed can be as fast as 12.5ms. Further, in the implementation of the present invention, the electromagnetic positioning module 2 can adjust the positioning accuracy and speed as needed.

[0127] Figure 3 and Figure 4 2 is a schematic diagram of a sensor according to an embodiment of the present invention. The sensor 22 can be designed into various structures and sizes according to application requirements. In the embodiment of the present invention, the size of the sensor 22 can be a minimum outer diameter of 0.56 mm. Figure 3 As shown, the sensor 22 can be designed as a column with a larger diameter, suitable for installation on an ultrasonic probe. Figure 4 As shown, the sensor 22 may also be designed as a wire with a smaller diameter, suitable for installation on interventional instruments, such as puncture instruments, etc.

[0128] The sensor 22 can be wired or wireless, so the connection between the electromagnetic positioning module 2 and the ultrasonic imaging device 5 and the puncture instrument 6 can be wired or wireless, for example, it can be connected by Bluetooth, WIFI, Zigbee, etc.

[0129] Figure 5 FIG. 1 is a schematic diagram of an ultrasonic probe provided with a sensor according to an embodiment of the present invention. Figure 5 As shown, the sensor 221 is detachably mounted on the ultrasonic probe 51, so that the electromagnetic positioning module 2 can track and locate the position and direction of the ultrasonic probe 51. According to the relationship between the ultrasonic probe 51 and the ultrasonic image generated by the ultrasonic imaging device 5, the electromagnetic positioning module 2 can track and locate the position and direction of the ultrasonic image generated by the ultrasonic imaging device 5.

[0130] In the embodiment of the present invention, the puncture instrument 6 may include a puncture needle 61 . Figure 6 Schematic diagram of a puncture needle provided with a sensor according to an embodiment of the present invention. Figure 6 As shown, the sensor 222 is detachably disposed in the needle cavity of the puncture needle 61 .

[0131] In order to adapt to puncture instruments 6 of different lengths, auxiliary connecting pieces of different lengths may be provided to connect the sensor to the puncture instrument 6 .

[0132] The electromagnetic positioning module 2 can track and locate the position and direction of the puncture needle 61 through the sensor 222 disposed on the puncture instrument 6 .

[0133] The magnetic field signal processor 23 collects the electrical signals of the tracking positioning data in real time, calculates the real-time position and direction of the sensor, and transmits the calculation result information to the navigation processing module 3 in real time.

[0134] like Figure 1 As shown, the navigation processing module 3 is connected to the ultrasonic imaging device 5 to obtain an ultrasonic image. Figure 1 As shown, the navigation processing module 3 is connected to the electromagnetic positioning module 2 to obtain the ultrasonic image and the position and direction of the puncture instrument 6.

[0135] In the embodiment of the present invention, the navigation processing module 3 forms a puncture path 64 according to the position and direction of the puncture instrument 6, and orthogonally projects the puncture instrument 6 and the puncture path 64 onto the ultrasound image according to the position and direction of the ultrasound image, the position and direction of the puncture instrument 6, and the puncture path 64, to form a navigation image that fuses the projections of the puncture instrument 6 and the puncture path 64.

[0136] In the embodiment of the present invention, the navigation processing module 3 can be connected to the ultrasonic imaging device 5 via a video image acquisition device to obtain ultrasonic image data. In one embodiment, the connection is via USB 3.0, which can also be PCI or PCIE.

[0137] In the embodiment of the present invention, preferably, the video acquisition device can acquire real-time ultrasound video through a high-definition shielded video cable or wirelessly with the DVI or HDMI interface of the full-digital color Doppler ultrasound diagnostic system, and convert it into a digital signal for transmission to the navigation processing module 3.

[0138] The video acquisition device of the embodiment of the present invention has a standard video interface, such as HDMI or DVI, and can be connected to the standard video interface of the existing ultrasound imaging device through a standard video signal line. Therefore, the interventional navigation system of the embodiment of the present invention is compatible with various ultrasound imaging devices. On the one hand, it can make full use of the existing ultrasound imaging devices, and on the other hand, the volume and weight of the interventional navigation system can be smaller, more flexible, and convenient to use.

[0139] In the embodiment of the present invention, the ultrasonic imaging device 5 may be a black and white ultrasound system, a full digital color Doppler ultrasound diagnostic system, or the like.

[0140] In the embodiment of the present invention, the navigation processing module 3 and the electromagnetic positioning module 2 can be connected via a USB interface using the USB2.0 protocol to obtain the ultrasonic image and the position and direction data of the puncture instrument 6 from the electromagnetic positioning module 2 .

[0141] In the embodiment of the present invention, the navigation processing module 3 can form a puncture path 64 according to the shape, position and direction of the puncture instrument 6 and the needs of interventional diagnosis and treatment. Usually, the puncture path 64 is a straight line extending in the direction of the puncture instrument 6.

[0142] Figure 7 FIG. 1 is a schematic diagram of a navigation image formed by fusing an embodiment of the present invention. Figure 7 As shown, in the embodiment of the present invention, according to the position and direction of the ultrasound image, the position and direction of the puncture instrument 6, and the position and direction of the puncture path 64, the navigation processing module 3 can orthogonally project the puncture instrument 6 and the puncture path 64 onto the ultrasound image, and merge them with the ultrasound image to form a navigation image that integrates the information of the ultrasound image, the puncture instrument, and the puncture path.

[0143] like Figure 1 As shown, in the embodiment of the present invention, the navigation output module 4 is connected to the navigation processing module 3 to obtain navigation image data from the navigation processing module, and outputs it to the display device in a clearer and more intuitive display mode according to the set display mode, so as to provide intervention navigation for medical staff performing intervention.

[0144] The navigation image may be displayed in a two-dimensional or three-dimensional perspective display manner.

[0145] In the embodiment of the present invention, when the puncture instrument 6 and the ultrasound image are in a coplanar state and a non-coplanar state, the navigation image may be displayed differently to provide interventional navigation more clearly and intuitively.

[0146] For example, Figure 8 FIG. 1 is a schematic diagram of the navigation image display when the puncture instrument and the ultrasound image are in the same plane as each other according to an embodiment of the present invention. Figure 8 As shown, in the embodiment of the present invention, when the puncture instrument 6 and the ultrasonic image are in a coplanar state, the projection of the puncture instrument 6 and the projection of the puncture path 64 can be displayed in the form of solid lines.

[0147] Fig. 9 FIG. 1 is a schematic diagram of the navigation image display when the puncture instrument and the ultrasound image are not in the same plane as each other according to an embodiment of the present invention. Fig. 9 As shown, in the embodiment of the present invention, when the puncture instrument 6 and the ultrasonic image are not in a coplanar state, the projection of the puncture instrument 6 and the projection of the puncture path 64 can be displayed in a dotted line manner.

[0148] In an embodiment of the present invention, the display method of the projection of the puncture instrument 6 and / or the projection of the puncture path 64 may include but is not limited to a combination of one or more of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, static display, etc.

[0149] In the embodiment of the present invention, when the puncture instrument 6 and the ultrasound image are not in a coplanar state, the display mode of the puncture path 64 or the intersection of the puncture instrument 6 and the ultrasound image may be different from the display mode of other points on the projection of the puncture path 64. Fig. 9 As shown, the intersection of the puncture path 64 and the ultrasound image is displayed in the form of cross lines.

[0150] In the embodiment of the present invention, the display method of the intersection of the puncture path 64 and the ultrasound image includes but is not limited to one or more combinations of cross-line display, star display, various color displays, dynamic display, etc.

[0151] In an embodiment of the present invention, when the puncture instrument 6 and the ultrasound image are in a non-coplanar state, the projections of the two parts of the puncture path 64 on both sides of the ultrasound image can be displayed in different ways, and / or the projections of the two parts of the puncture instrument 6 on both sides of the ultrasound image can be displayed in different ways.

[0152] Fig.10 FIG. 2 is a schematic diagram of another embodiment of the present invention showing a navigation image when the puncture instrument and the ultrasound image are not in the same plane. Fig.10 As shown, in the embodiment of the present invention, the projections of the two parts of the puncture path 64 on both sides of the ultrasound image can be displayed in the form of a solid line and a dotted line, respectively.

[0153] In an embodiment of the present invention, the display method of the projection of the two parts of the puncture instrument 6 and / or the projection of the two parts of the puncture path 64 may include but is not limited to one or more combinations of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, static display, etc.

[0154] In the embodiment of the present invention, when the puncture instrument 6 and the ultrasound image are not in a coplanar state, navigation can be performed through the intersection of the puncture path 64 and the ultrasound image to adjust the position and direction of the puncture instrument 6. When the intersection coincides with the target point, the puncture path 64 intersects with the target point, thereby realizing interventional navigation when the puncture instrument 6 and the ultrasound image are not in a coplanar state.

[0155] In the embodiment of the present invention, according to the arrangement of the sensor 222 on the puncture needle 61 and the structure of the puncture needle 61 , the shape of the puncture needle 61 , especially the real-time position and direction of the working part of the puncture needle 61 , can be drawn and displayed.

[0156] The embodiment of the present invention can guide and position in real time, and provide feedback on the puncture path and the position direction of the working part of the puncture needle, without being restricted by angles, and has high safety, convenience and reliability in use.

[0157] In the embodiment of the present invention, the navigation processing module 3 and the navigation output module 4 can be implemented by a computer system.

[0158] In an embodiment of the present invention, the interventional ultrasound navigation system may further include a carrier, and the carrier may include an operating console, an electromagnetic positioning module mounting component, a display mounting component, a power control module, a mobile device, and the like.

[0159] In the embodiment of the present invention, the operating table can be used to temporarily place medical consumables or tools and to install, carry and lift a display and an electromagnetic positioning module, and may have a lifting function.

[0160] In the embodiment of the present invention, the electromagnetic positioning module mounting piece can be used to mount and support the electromagnetic positioning module 2, and can be a support arm or an independent bracket capable of hovering.

[0161] In the embodiment of the present invention, the display mounting member may be used to mount a display, and may be a support arm or an independent bracket capable of hovering.

[0162] In the embodiment of the present invention, the power control module may be a power control module that complies with the safety regulations of GB9706.1-2007, and includes a battery, and the battery specification is not less than 14.8V / 15.6Ah.

[0163] In the embodiment of the present invention, the moving device may be a caster with a locking function.

[0164] In order to solve one or more of the above problems of the existing puncture surgery, such as the difficulty of operation, poor accuracy, and poor safety, and realize a puncture surgery that is easier to operate, more accurate, effective, and safer, the puncture instrument of the embodiment of the present invention can be applied to interventional navigation technology to realize a puncture surgery that is easier to operate, more accurate, effective, and safer under interventional navigation.

[0165] Fig.11 Schematic diagram of a puncture instrument according to an embodiment of the present invention. Fig.11 As shown, in the embodiment of the present invention, the puncture instrument 6 may include a puncture needle 61 , and the puncture needle 61 may be provided with a sensor mounting portion 611 , and the sensor mounting portion 611 may be used to mount the sensor 222 .

[0166] In the embodiment of the present invention, the material of the puncture needle 61 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, etc.

[0167] According to the requirements of clinical applications, the thickness specifications of the puncture needle 61 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).

[0168] According to the requirements of clinical applications, the puncture needle 61 can be designed to have various lengths. For example, for transjugular intrahepatic portosystemic shunt, the length specification can be 50 cm to 65 cm.

[0169] like Fig.11 As shown, the puncture needle 61 may include a needle head 612 and a needle rod 613. In the embodiment of the present invention, the needle head 612 and the needle rod 613 may be integrally formed. Fig.11 The needle 612 and the needle rod 613 can also be connected by separate assembly, for example, the needle 612 and the needle rod 613 are connected by welding, threading, etc. Fig.13 shown.

[0170] In the embodiment of the present invention, the needle tip 6121 of the needle head 612 may be in the shape of a triangular pyramid, a quadrangular pyramid or a cone. The height of the cone of the needle tip 6121 may be 1 mm to 4 mm.

[0171] 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 611 may be disposed at the distal end of the puncture needle 61 .

[0172] In the embodiment of the present invention, the sensor mounting portion 611 may be a cavity inside the puncture needle 61, such as Fig.11 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 61. If the sensor is wireless, the cavity may be closed after the sensor is installed.

[0173] In the embodiment of the present invention, the distance from the cavity of the puncture needle 61 to the needle tip of the puncture needle 61 may be 0.10 mm to 30 mm.

[0174] like Fig.11 As shown, the puncture needle 61 may be tubular, one end of the lumen of the puncture needle 61 is open at the proximal end of the puncture needle 61 , 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 611 .

[0175] Fig.12 Schematic diagram of a puncture instrument according to an embodiment of the present invention. Fig.12 As described above, in the embodiment of the present invention, the sensor mounting portion 611 may be a recessed portion on the body surface of the puncture needle 61 .

[0176] Fig.13 Schematic diagram of a puncture needle according to an embodiment of the present invention. Fig.13 As shown, the proximal end of the needle 612 may include a connecting portion 6122, and the outer diameter of the connecting portion 6122 is smaller than the inner diameter of the lumen of the needle shaft 613. When the needle 612 and the needle shaft 613 are connected, the connecting portion 6122 can be inserted into the lumen of the needle shaft 613.

[0177] In order to adapt to the tortuous and narrow puncture path and increase the flexibility and guidance of the puncture needle 61, in the embodiment of the present invention, the needle rod 613 can be set to a variable diameter shape, and the outer diameter of the distal end of the needle rod 613 is smaller than the outer diameter of the proximal end of the needle rod 613. The two outer diameter parts can be gradually transitioned or stepped.

[0178] Fig.14 Schematic diagram of a puncture needle according to an embodiment of the present invention. Fig.14 As shown, the outer diameter of the distal end of the needle rod 613 is smaller than the outer diameter of the proximal end of the needle rod 613, 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 613.

[0179] In order to adapt to the tortuous puncture path and increase the flexibility and guidance of the puncture needle 61, 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.

[0180] Fig.15 Schematic diagram of a puncture needle according to an embodiment of the present invention. Fig.15 As shown, the needle rod 613 may include an inner needle rod 6131 and an outer needle rod 6132, and the outer needle rod 6132 is sleeved outside the inner needle rod 6131. ​​The outer needle rod 6132 and the inner needle rod 6131 may be connected by welding, threading, etc. In addition, in order to prevent body fluid from entering between the inner needle rod 6131 and the outer needle rod 6132, the inner needle rod 6131 and the outer needle rod 6132 need to be sealed, and the sealing method may be welding or bonding.

[0181] 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. Fig.16 Schematic diagram of a puncture needle according to an embodiment of the present invention. Fig.16 As shown, at the distal end portion of the needle rod 613, the inner needle rod 6131 extends beyond the outer needle rod 6132, thereby forming a needle rod design with reduced diameter.

[0182] In order to adapt to the tortuous and narrow puncture path, effectively reduce the friction resistance of the puncture needle 61, and improve the operational stability of the puncture needle 61, 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.

[0183] The spring can effectively reduce the contact area between the outer surface of the puncture needle 61 and the surrounding material, thereby reducing its friction resistance. At the same time, the spring can improve the operational stability of the puncture needle 61 due to its elastic tensile force and the effect of increasing the radial dimension of the puncture needle 61.

[0184] 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.

[0185] 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 61 due to its elastic tensile force and the effect of increasing the radial dimension of the puncture needle 61.

[0186] In the embodiment of the present invention, the sleeve can be sleeved on the needle rod by heat shrinking.

[0187] Fig.17 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Fig.17 As shown, the needle rod 613 may be in a variable diameter shape, the outer diameter of the distal end portion of the needle rod 613 is smaller than the outer diameter of the proximal end portion of the needle rod 613, and the spring 614 is sleeved on the distal end portion of the needle rod 613 with a smaller outer diameter. The spring 614 may be connected to the needle rod 613 by welding.

[0188] In the embodiment of the present invention, the material of the spring 614 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, cobalt-based alloy, and titanium-based alloy.

[0189] In the embodiment of the present invention, the dimensions of the spring 614 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.

[0190] Fig.18 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Fig.18 As shown, in the embodiment of the present invention, the outer needle rod 6132 may include a distal outer needle rod 61321 and a proximal outer needle rod 61322. The distal outer needle rod 61321 is sleeved on the distal end of the inner needle rod 6131, and the proximal outer needle rod 61322 is sleeved on the proximal end of the inner needle rod 6131. ​​The spring 614 may be sleeved on the inner needle rod 6131 between the distal outer needle rod 61321 and the proximal outer needle rod 61322.

[0191] Fig.19 Schematic diagram of a puncture needle provided with a spring according to an embodiment of the present invention. Fig.19 As shown, in one embodiment of the present invention, the inner needle rod 6131 may be in a variable diameter shape, and the outer diameter of the distal end portion of the inner needle rod 6131 is smaller than the outer diameter of the proximal end portion of the inner needle rod 6131. Fig. 9 As shown, the outer needle rod 6132 and the spring 614 are sequentially sleeved on the distal end of the inner needle rod 6131 from the distal end to the proximal end.

[0192] In the embodiment of the present invention, the spring can also be sleeved on Fig.16 In the embodiment of the present invention shown, the inner needle rod 6131 extends beyond the portion of the outer needle rod 6132.

[0193] 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.

[0194] Fig. 20 Schematic diagram of a puncture needle with a catheter according to an embodiment of the present invention. Fig. 20 As shown, in the embodiment of the present invention, the puncture device 6 may include a catheter 62. On the one hand, the catheter 62 can be used to establish a channel to deliver the guide wire; on the other hand, the catheter 62 can protect the outer surface of the puncture needle 61 to prevent thrombus formation and reduce friction resistance when the puncture needle 61 moves.

[0195] like Fig. 20 As shown, the catheter 62 can be sleeved outside the puncture needle 61. The distal end of the catheter 62 can be processed by tip molding. After assembly, the distal end of the catheter 62 is located near the conical bottom surface of the needle tip 6121 of the puncture needle 61. 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 62 can be connected to the proximal end of the puncture needle 61 in a threaded manner through a connector.

[0196] 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.).

[0197] 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.

[0198] 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.

[0199] 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.

[0200] 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.

[0201] 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)).

[0202] 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.

[0203] In the embodiment of the present invention, the puncture instrument 6 may include a catheter instrument 63 . Fig.21 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.21 As shown, the catheter device 63 may include a guide tube 631 and a flexible sleeve 632 to provide guidance for the puncture needle 61. According to clinical needs, the catheter device 63 may be linear or curved, for example, the curved one may be used for transjugular intrahepatic puncture surgery.

[0204] Fig. 22 Schematic 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 631 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 631 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.

[0205] like Fig. 22 As shown, the distal end of the guide tube 631 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.

[0206] like Fig. 22 As shown, according to clinical needs, the distal side of the guide tube 631 can form one or more bends. In one embodiment of the present invention, the distal end of the guide tube 631 is a curved bevel blade, and can be bent 10° to 80°, for example 60°, at a distance of 0.5 cm to 12 cm from the bevel blade tip.

[0207] Fig.23 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 632 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.

[0208] Fig.24 Schematic diagram of the assembly of the guide tube and the flexible sleeve of the embodiment of the present invention. Fig.24 As shown, the flexible sleeve 632 can be sleeved outside the guide tube 631, and its inner diameter can be 0.1 mm to 2 mm larger than the outer diameter of the guide tube 631. The guide tube 631 and the flexible sleeve 632 can move relative to each other, so that the distal end of the guide tube 631 can extend beyond the distal end of the flexible sleeve 632, or the distal end of the flexible sleeve 632 can extend beyond the distal end of the guide tube 631 (such as Fig.24 shown).

[0209] In the embodiment of the present invention, the proximal end of the flexible sleeve 632 can be connected to the proximal end of the guide tube 631 by means of threads, buckles or bonding via the connector 633, and the flexible sleeve 632 and the guide tube 631 can be moved relative to each other via the connector 633. Fig.21 or Fig.24 It is shown that the proximal end of the flexible sleeve 632 and the guide tube 631 are connected in a threaded manner via a connector 633 .

[0210] In the puncture surgery of the embodiment of the present invention, the catheter device 63 including the guide tube 631 and the flexible sleeve 632 first enters the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Fig.25 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.25 As shown, during this process, the flexible sleeve 632 is sleeved outside the guide tube 631, and the distal end of the flexible sleeve 632 extends beyond the distal bevel of the guide tube 631 by 2 to 3 mm to prevent the distal bevel from damaging the tissue it passes through.

[0211] 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 631 and the flexible sleeve 632 can be moved relative to each other, so that the distal end of the guide tube 631 extends beyond the distal end of the flexible sleeve 632, so that the distal end of the guide tube 631 can be against the puncture target point and remain motionless to implement puncture guidance. Fig.26 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.

[0212] In the puncture surgery of the embodiment of the present invention, when the catheter instrument 63 is to be withdrawn through the interventional pathway after implementing the puncture guidance, the guide tube 631 and the flexible sleeve 632 can be moved relative to each other so that the distal end of the flexible sleeve 632 extends beyond the distal bevel blade of the guide tube 631 to prevent the distal bevel blade from damaging the tissue passed through. Fig. 27 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.

[0213] 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.

[0214] To solve this technical problem, further, in an embodiment of the present invention, the distal end of the flexible sleeve 632 can be subjected to a shrinkage molding process to form a shrinkage portion 6321. The shrinkage portion 6321 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 631. Fig.28 Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention.

[0215] Since the inner diameter of the distal end of the narrowed portion of the flexible sleeve 632 is smaller than the outer diameter of the distal end of the guide tube 631, during the process of the catheter instrument 63 passing through the interventional pathway to reach the puncture target, the flexible sleeve 632 will not move proximally relative to the guide tube 631 even if it is affected by the resistance of the tissues and organs it passes through, so that the guide tube 631 will not extend from the distal end of the flexible sleeve 632, thereby damaging the tissues it passes through.

[0216] further, Fig.29 63 is a 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 6321 of the flexible sleeve 632 may be provided with a weakened portion 63211 that is easily damaged, such as Fig.29As shown. The weakened portion 63211 may extend to the distal opening of the flexible sleeve 632. The weakened portion 63211 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 632 to its distal opening. The weakened portion 63211 may be disposed on the inner surface or the outer surface of the constricted portion 6321. When the weakened portion 63211 is disposed on the outer surface of the constricted portion 6321, 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 63211 is disposed on the inner surface of the constricted portion 6321.

[0217] The weakened portion 63211 allows the guide tube 631 to break the weakened portion 6321 and extend out of the distal opening of the flexible sleeve 632 when a force greater than the above resistance is applied to push the guide tube 631 distally relative to the flexible sleeve 632 when the catheter device 63 abuts against the puncture target point. In one embodiment of the present invention, the weakened portion 6321 is a longitudinal indentation with a width of 1 mm.

[0218] Therefore, in the puncture surgery of the embodiment of the present invention, the guide tube 631 and the flexible sleeve 632 first enter the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Fig.30 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.30 As shown, during this process, the flexible sleeve 632 is sleeved outside the guide tube 631, and the constricted portion of the flexible sleeve 632 extends beyond the distal bevel of the guide tube 631 by 2 to 3 mm to prevent the distal bevel from damaging the tissue it passes through.

[0219] In the puncture surgery of the embodiment of the present invention, when the distal end of the catheter device 63 reaches the puncture target point, a force greater than the above resistance can be applied to push the guide tube 631 distally relative to the flexible sleeve 632, so that the guide tube 631 breaks the weakened portion 6321 and extends 2 to 3 mm out of the distal opening of the flexible sleeve 632. In this way, the distal oblique blade of the guide tube 631 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 61. Then, the puncture needle 61 can pass through the catheter device 63 to puncture the puncture target point. Fig.31 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.

[0220] In the embodiment of the present invention, after the puncture of the puncture needle 61 is completed, the guide tube 631 can be pulled back proximally relative to the flexible sleeve 632, so that the distal bevel blade of the guide tube 631 is retracted into the distal opening of the flexible sleeve 632 by 3 to 5 mm. Afterwards, the guide tube 631 and the flexible sleeve 632 are taken out along the original interventional pathway. Since the distal bevel blade of the guide tube 631 has been retracted into the distal opening of the flexible sleeve 632, it will not cause damage to the tissues passed through. In addition, during the withdrawal process of the catheter device 63, the direction of the resistance applied to the flexible sleeve 632 is in the distal direction, which will not cause the flexible sleeve 632 to move proximally relative to the guide tube 631, and will not cause the distal end of the guide tube 631 to extend beyond the distal end of the flexible sleeve 632 and cause damage to the tissues passed through. Fig.32 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.

[0221] 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.

[0222] 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.

[0223] The puncture system of the embodiment of the present invention utilizes interventional navigation technology and corresponding puncture instruments to solve one or more of the problems of the above-mentioned existing puncture surgeries, such as high difficulty in operation, poor accuracy, poor safety, prone to complications, and blind spots in surgical monitoring, thereby achieving a puncture surgery that is easier to operate, more accurate and effective, safer, and has fewer complications.

[0224] In summary, the above embodiments describe the puncture system 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.

[0225] 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.

[0226] 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.

[0227] Those skilled in the art will appreciate that embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may take the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Moreover, the present invention may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0228] The present invention is described with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It should be understood that each process and / or block in the flowchart and / or block diagram, as well as the combination of processes and / or blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 A process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.

[0229] These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 A process or multiple processes and / or boxes Figure 1 A function specified in one or more boxes.

[0230] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing instructions for implementing the process. Figure 1 A process or multiple processes and / or boxes Figure 1 The steps for the functions specified in one or more boxes.

[0231] 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.

[0232] 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 system, characterized in that: include: Interventional navigation system and puncture instrument; the interventional navigation system includes an electromagnetic positioning module, a navigation processing module and a navigation output module, wherein: The electromagnetic positioning module includes a first sensor and a second sensor, the first sensor is connected to the probe of the ultrasonic imaging device, and the second sensor is connected to the puncture instrument; 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; The electromagnetic positioning module is connected to the ultrasonic imaging device and the puncture instrument to obtain the position and direction of the ultrasonic image generated by the ultrasonic imaging device and the position and direction of the puncture instrument; The navigation processing module is connected to the ultrasonic imaging device and the electromagnetic positioning module, forms a puncture path according to the position and direction of the puncture instrument, and orthogonally projects the puncture instrument and the puncture path onto the ultrasonic image according to the position and direction of the ultrasonic image, the position and direction of the puncture instrument, and the puncture path, to form a navigation image that fuses the projections of the puncture instrument and the puncture path; The navigation output module is connected to the navigation processing module and outputs the navigation image according to a set display mode; The puncture path is extended in a straight line along the direction of the puncture instrument.

2. The puncture system according to claim 1, characterized in that: The puncture instrument comprises a puncture needle, and the puncture needle comprises a sensor mounting portion, and the sensor mounting portion can be mounted with the sensor of the electromagnetic positioning module.

3. The puncture system according to claim 2, 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.

4. The puncture system according to claim 2, 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.

5. The puncture system according to claim 2, characterized in that: The puncture needle comprises a needle head and a needle rod, and the needle head and the needle rod are integrally formed.

6. The puncture system according to claim 2, characterized in that: The puncture needle comprises a needle head and a needle rod, and the needle head and the needle rod are connected by welding or threading.

7. The puncture system according to claim 6, 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.

8. The puncture system according to any one of claims 5 to 7, characterized in that: 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.

9. The puncture system according to any one of claims 5 to 7, characterized in that: 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.

10. The puncture system according to claim 9, characterized in that: The inner needle rod and the outer needle rod are sealed by welding or bonding.

11. The puncture system according to claim 9, characterized in that: At a distal end portion of the needle shaft, the inner needle shaft extends beyond the outer needle shaft.

12. The puncture system according to claim 5, 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.

13. The puncture system according to claim 12, characterized in that: The auxiliary part is a spring or a sleeve.

14. The puncture system according to claim 13, characterized in that: The spring is connected to the needle rod by welding.

15. The puncture system according to claim 13, characterized in that: The sleeve is made of polytetrafluoroethylene, and the sleeve is connected to the needle rod by heat shrinking.

16. The puncture system according to claim 13, characterized in that: 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.

17. The puncture system according to claim 13, characterized in that: The outer needle rod comprises a distal outer needle rod and a proximal outer needle rod, wherein the distal outer needle rod is sleeved on the distal end of the inner needle rod, and 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.

18. The puncture system according to claim 13, characterized in that: The outer diameter of the distal part of the inner needle rod is smaller than the outer diameter of the proximal part of the inner needle rod, and the outer needle rod and the spring are sequentially sleeved on the distal part 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 part of the inner needle rod from the distal end to the proximal end.

19. The puncture system according to claim 13, 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.

20. The puncture system according to claim 2, characterized in that: The sensor is a wireless sensor or a wired sensor.

21. The puncture system according to claim 2, characterized in that: The material of the puncture needle includes one or more of stainless steel and nickel-titanium alloy.

22. The puncture system according to claim 2, characterized in that: The thickness specifications of the puncture needle include: 16G, 17G, 18G, 19G, 20G, and 21G.

23. The puncture system according to claim 13, 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.

24. The puncture system 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.

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

26. The puncture system 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.

27. The puncture system 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.

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

29. The puncture system 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.

30. The puncture system 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.

31. The puncture system 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.

32. The puncture system according to claim 31, characterized in that: The connection method of the connecting piece is threading, snap-fitting or bonding.

33. The puncture system according to claim 1, characterized in that: When the puncture instrument and the ultrasonic image are in a coplanar state and a non-coplanar state, the navigation image is displayed in different ways.

34. The puncture system according to claim 1, characterized in that: The navigation image is displayed in a three-dimensional perspective manner.

35. The puncture system according to claim 1, characterized in that: When the puncture instrument and the ultrasonic image are in a coplanar state and a non-coplanar state, the projection of the puncture instrument is displayed differently, and / or the projection of the puncture path is displayed differently.

36. The puncture system according to claim 35, characterized in that: The projection of the puncture instrument and / or the projection of the puncture path may be displayed in a manner that includes one or a combination of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, and static display.

37. The puncture system according to claim 1, characterized in that: When the puncture instrument and the ultrasonic image are not in a coplanar state, the display mode of the intersection of the puncture path and the ultrasonic image is different from the display mode of other points on the projection of the puncture path.

38. The puncture system according to claim 37, characterized in that: The display mode of the intersection includes one or more combinations of cross line display, star display, circle display, various color displays, and dynamic display.

39. The puncture system according to claim 1, characterized in that: When the puncture instrument and the ultrasonic image are not in a coplanar state, the projections of the two parts of the puncture path on both sides of the ultrasonic image are displayed in different ways, and / or the projections of the two parts of the puncture instrument on both sides of the ultrasonic image are displayed in different ways.

40. The puncture system according to claim 39, characterized in that: The projection of the two parts of the puncture instrument and / or the projection of the two parts of the puncture path may be displayed in a manner that includes one or more combinations of wireframe display, surface display, solid line display, dotted line display, various color displays, dynamic display, and static display.

Images