Visual duplex balloon thrombus aspiration device in blood vessel cavity and working method of visual duplex balloon thrombus aspiration device

Abstract

The invention relates to a blood vessel intracavity visual duplex balloon thrombus aspiration device and a working method thereof. The intravascular visual duplex balloon thrombus aspiration device comprises an aspiration tube main body, and a thrombus aspiration channel, a balloon filling channel and a perfusion channel which are arranged in the aspiration tube main body, the front portion of the suction tube body is provided with a notch section, the notch section is provided with a sacculus filling channel and a front sacculus communicated with the sacculus filling channel, and the middle of the suction tube body is provided with a rear sacculus communicated with the sacculus filling channel. The rear part of the suction tube main body is provided with a balloon filling outer port which is communicated with the balloon filling channel and is used for inputting filling fluid; the intravascular visual duplex balloon thrombus aspiration device can reduce blood loss of a patient and effectively prevent thrombus escape from causing secondary embolism at the downstream of the blood flow.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an intravascular visualization dual balloon thrombus aspiration device and its working method. Background Art

[0003] Thrombi are distributed systemically in the human body. According to the anatomical classification of the affected vascular system, they can be divided into two major pathological types: venous thrombosis (VT) and arterial thrombosis (AT).

[0004] Venous thrombosis has anatomical location specificity and mainly invades the deep venous system of the lower extremities and its distal branches. Its annual incidence is about 1.6‰, and it shows a centripetal extension along the blood vessel axis biologically, which can involve the iliac vein and secondary involvement of the inferior vena cava. When the thrombus undergoes mechanical detachment, it can induce fatal pulmonary embolism (PE). If the hemodynamic homeostasis of the lower extremity veins is not restored in time through thrombus removal and vascular recanalization techniques, post-thrombotic syndrome (PTS) will occur. Epidemiological research data show that about 60% of acute-phase patients develop decompensation of venous valve function and disturbed reflux hemodynamics due to thrombus-mediated aseptic inflammatory reactions, leading to chronic venous hypertension. Its pathological manifestations include progressive tissue edema, subcutaneous fibrosis, and trophic skin ulcers, seriously affecting the quality of life of patients and becoming an important burden on the public health system.

[0005] Arterial thrombosis has the characteristic of multi-organ invasion, and its pathological process is more acute and destructive than that of the venous system. Intracranial arterial thrombosis can lead to acute ischemic stroke (AIS), causing irreversible neurological deficits or even death; coronary artery thrombosis, as the core pathological mechanism of acute coronary syndrome (ACS), can trigger myocardial cell necrosis and sudden cardiac death; mesenteric artery thrombosis can cause acute intestinal ischemia necrosis (AMI); renal artery thrombosis can induce renal infarction and renal insufficiency; acute embolism of the lower extremity arteries can cause acute ischemia of skeletal muscle and soft tissues. If the vascular occlusion cannot be relieved within the 6-8-hour treatment time window, it will progress to irreversible tissue necrosis and ischemic gangrene, and emergency amputation may be required in severe cases to prevent sepsis.

[0006] Based on the obstructive effect of thrombotic diseases on the microcirculation system, timely relief of mechanical obstruction and reconstruction of tissue perfusion have important clinical value. Current treatment strategies can be divided into two major systems: endovascular interventional therapy and open surgery, according to vascular anatomical characteristics and lesion stages. Adjuvant drug therapy includes antiplatelet aggregation and anticoagulant therapy, aiming to inhibit thrombus expansion and prevent embolism events.

[0007] As the core intervention method for thrombotic diseases, the main techniques of endovascular interventional therapy include mechanical thrombectomy, aspiration thrombectomy, mechanical thrombus fragmentation, balloon-assisted thrombectomy, and catheter-directed thrombolysis. In clinical practice, technical combinations are often applied according to the characteristics of the lesions. The standard operation process of endovascular interventional therapy includes: (1) establishment of vascular puncture access; (2) insertion of vascular sheath and protection device; (3) under image guidance, through instrument delivery systems such as guide wires, catheters, balloons, and stents, the thrombectomy device is accurately positioned at the thrombus obstruction site to perform comprehensive interventions including thrombus removal, fragmentation, and drug dissolution to restore physiological blood flow in the blood vessels.

[0008] Mechanical thrombectomy achieves thrombus clearance through the synergistic effect of a thrombectomy catheter and a blood flow reconstruction stent. Its technical advantages include: (1) high recanalization efficiency: the mechanical interlocking of the stent mesh structure and the thrombus combined with negative pressure aspiration can effectively treat large vessel occlusion lesions, especially suitable for cardiogenic embolism or high-load thrombus; (2) anatomical adaptability: the thrombectomy stent can adapt to the vascular bifurcation structure (such as the bifurcation of the middle cerebral artery) through morphological reconstruction, and the double-stent technique (Parallel / Series Configuration) can improve the capture efficiency of complex thrombi; (3) vascular protection: combined with a balloon guiding catheter, it can reduce the risk of distal embolism and maintain the integrity of the vascular structure.

[0009] Aspiration thrombectomy achieves thrombus removal based on the principle of fluid mechanics. It is simple to operate and widely used. Its technical characteristics include: (1) minimally invasive advantage: direct aspiration with a large-caliber catheter reduces mechanical damage to the vascular endothelium; (2) time-effect advantage: rapid reperfusion can be achieved for proximal large vessel occlusion (such as the end of the internal carotid artery); (3) synergistic effect: it can form a composite technique with stent thrombectomy to improve the overall efficacy.

[0010] However, the current techniques still have significant limitations, including but not limited to the following aspects: (1)Risk of mechanical injury. During operations such as repeated pushing, rotation, and aspiration of the catheter within the blood vessel, there is a continuous mechanical friction effect with the vessel wall. For patients with abnormal vascular anatomical structures, atherosclerotic plaque involvement in the vessel wall, or vascular tortuosity, the mechanical force of the catheter may cause endothelial denudation of the blood vessel, plaque rupture, and even the formation of a vascular dissection. At small blood vessel branches or bifurcations, blind operation of the catheter tip may trigger vasospasm, further aggravating tissue ischemic injury. In addition, if the negative pressure generated by aspiration is not properly adjusted, it may cause local collapse of the blood vessel lumen, hinder the passage of subsequent instruments, and increase the difficulty and risk of surgical operation.

[0011] (2)Incompleteness of thrombus removal. Relying solely on the physical contact between the catheter outer diameter and the thrombus to achieve thrombus aspiration is often difficult to completely remove the thrombus at one time in cases of a large thrombus burden, tight adhesion between the thrombus and the vessel wall, or hard thrombus texture (such as old thrombus rich in fibrous components). Residual thrombus fragments may become a new source of emboli, triggering distal vascular embolism events, leading to re-ischemia after reperfusion injury, seriously affecting the functional recovery of tissues and organs, and increasing the risk of poor prognosis for patients.

[0012] (3)Intraoperative blood loss and hemodynamic disorders. During the thrombus aspiration process, continuous negative pressure aspiration easily leads to the aspiration of blood mixed with thrombus into the catheter, resulting in a certain degree of intraoperative blood loss. For patients with relatively insufficient blood volume or poor compensatory ability, it may induce hemodynamic instability states such as hypotension and arrhythmia, further aggravating the ischemic and hypoxic injury of systemic organs, and even endangering life. Repeated aspiration operations may also cause vasospasm and blood stasis, disturbing the local hemodynamic environment and being unfavorable for the full recovery of blood flow and the establishment of collateral circulation.

[0013] (4)Limitations of equipment and technology. There are a variety of thrombus aspiration catheters commonly used in clinical practice at present, but there is no single catheter that can be applicable to all vascular sites and thrombus types. Performance indicators such as the flexibility, passageability, and aspiration efficiency of the catheter vary among different brands and models, and there is a lack of a unified evaluation standard. In the face of complex vascular lesions (such as severe vascular calcification, acute vascular occlusion combined with dissection, etc.), the existing catheter designs may not be able to meet the requirements of precise and efficient thrombus removal. In addition, the thrombus aspiration technique highly depends on the experience and skills of the operator, has a relatively steep learning curve, and there may be significant differences in the treatment effects among different operators, affecting the wide promotion and standardized application of this technique.

[0014] In view of the defects existing in the above technical solutions, the future research and development focus is mainly concentrated in the following directions: (1)Research and development of intelligent visualization catheter. By integrating advanced imaging technologies (such as intravascular ultrasound, optical coherence tomography, etc.) into the aspiration thrombectomy catheter, real-time visual monitoring of the intravascular structure, thrombus morphology and distribution, and vascular wall injury during the operation can be achieved. The operator can accurately locate the thrombus under direct vision, optimize the contact angle and aspiration force between the catheter and the thrombus, effectively reducing the risk of mechanical injury and the probability of thrombus escape. The intelligent catheter can also automatically adjust the aspiration mode and negative pressure intensity according to the real-time feedback of hemodynamic parameters (such as blood flow velocity, pressure gradient, etc.), improving the thrombus removal efficiency and reducing the incidence of intraoperative blood loss and vasospasm.

[0015] (2)Integration of multimodal composite technology. Combine the aspiration thrombectomy technology with other intravascular treatment methods such as drug thrombolysis, mechanical thrombectomy, and angioplasty to build a multimodal composite treatment platform. Through the complementary advantages of different technologies, individualized and precise treatment of various complex thrombus lesions can be achieved.

[0016] (3)Application of biomaterials and coating technologies. Develop new biocompatible materials for manufacturing aspiration thrombectomy catheters, reducing the surface roughness and friction coefficient of the catheter, and decreasing the adhesion force between the catheter and the vascular wall, thereby reducing the risk of vascular endothelial injury.

[0017] (4)Artificial intelligence-assisted treatment decision-making system. With the help of artificial intelligence algorithms, deep learning and analysis are carried out on a large amount of vascular intervention treatment case data to build a database containing multi-dimensional information such as patient basic information, vascular lesion characteristics, thrombus type and burden, surgical operation process parameters, and postoperative outcomes. In clinical practice, by inputting the patient's real-time examination and test data and angiography image materials, the artificial intelligence-assisted system can quickly generate personalized aspiration thrombectomy treatment plans, including key decision-making suggestions such as catheter selection, aspiration strategy, and combined treatment timing, providing strong technical support for clinicians, improving the scientificity and precision of treatment, and reducing the incidence of complications caused by insufficient experience or decision-making errors.

[0018] Based on the comprehensive evaluation of the inventor's many years of clinical vascular intervention practice experience, among many existing technical routes, the technical path of intravascular visualization shows significant clinical significance and high operability. In view of this, the present invention intends to develop an aspiration catheter system integrated with real-time intravascular imaging function, aiming to improve the surgical accuracy, optimize the clinical efficacy evaluation, reduce the surgical risk, and enhance the overall surgical efficiency. Summary of the Invention

[0020] The technical problem to be solved by the present invention is to provide an intravascular visualization dual-balloon thrombus aspiration device, which can reduce the blood loss of patients, effectively prevent secondary embolism in the downstream blood flow caused by thrombus escape, and monitor the intravascular structure and thrombus aspiration status in real time, so as to perform targeted, precise and efficient intravascular thrombus aspiration operations.

[0021] In order to solve the above technical problems, the technical solution adopted by the present invention is: An intravascular visualization dual-balloon thrombus aspiration device, characterized in that it includes a suction tube main body, a thrombus aspiration channel, a balloon inflation channel, a perfusion channel and a guide wire rapid exchange channel arranged in the suction tube main body; A notch section is provided at the front part of the suction tube main body, a balloon inflation channel and a front balloon communicating with the balloon inflation channel are provided on the notch section, a rear balloon communicating with the balloon inflation channel is provided in the middle of the suction tube main body, and a balloon inflation outer port for inputting inflation fluid is provided at the rear part of the suction tube main body and communicating with the balloon inflation channel; A thrombus aspiration inlet communicating with the thrombus aspiration channel is provided at the intersection position of the suction tube main body and the notch section, and a thrombus aspiration outer port for connecting a negative pressure device is provided at the rear part of the suction tube main body and communicating with the thrombus aspiration channel; Side holes of the perfusion channel communicating with the perfusion channel are provided on the tube wall of the suction tube main body between the thrombus aspiration inlet and the rear balloon, and a side hole perfusion channel outer port for perfusing transparent liquid is provided at the rear part of the suction tube main body and communicating with the perfusion channel. After the front balloon and the rear balloon are inflated with fluid, they bulge and abut against the inner wall of the blood vessel to form an operation interface in the blood vessel between the front balloon and the rear balloon to prevent blood from entering.

[0022] Further, the above-mentioned notch section is formed by cutting off a section at the upper part of the front end of the tube body of the suction tube main body to form a depression relatively lower than both sides.

[0023] Further, the front end of the above-mentioned balloon inflation channel extends to the position of the front balloon and communicates with the front balloon through the front balloon inflation channel inlet on the tube wall of the suction tube main body, and the rear balloon communicates with the rear balloon through the rear balloon inflation channel inlet on the tube wall of the suction tube main body.

[0024] Further, a rapid exchange end is provided at the front end of the above-mentioned notch section, and the rapid exchange end is a tapered tube body with a guide wire rapid exchange channel in the center.

[0025] Further, the above-mentioned front balloon is sleeved on the middle part of the notch section with a tubular impermeable film material, and the two end heads of the front balloon are hermetically bonded and fixed to the wall surface of the notch section; the rear balloon is sleeved on the main body of the suction pipe with a tubular impermeable film material, and the two end heads of the rear balloon are hermetically bonded and fixed to the pipe wall surface of the main body of the suction pipe.

[0026] Further, a camera cable and a micro camera connected to the end of the camera cable are arranged inside the main body of the suction pipe, and the micro camera is installed beside the thrombus extraction inlet.

[0027] Further, a camera cable support sheath, a cable protection layer and a WIFI signal transmitting device are successively arranged beside the rear part of the main body of the suction pipe, and the camera cable passes through the camera cable support sheath and the cable protection layer in sequence and is connected to the WIFI signal transmitting device.

[0028] Further, a front end X-ray impermeable metal marker ring is arranged around the surface of the quick exchange end of the main body of the suction system, a middle X-ray impermeable metal marker ring is arranged around the surface of the main body of the suction system at the opening of the thrombus extraction channel, and a rear end X-ray impermeable metal marker ring is arranged around the surface of the main body of the suction system behind the rear balloon.

[0029] The working method of the intravascular visualization double-balloon thrombus aspiration device of the present invention is characterized in that: It is delivered to the working position of the vascular thrombus through the cooperation of a micro-guide wire and a catheter. According to the in-place micro-guide wire, the main body of the suction pipe is guided to the working position. Normal saline or contrast agent is injected into the balloon inflation outer port. The fluid enters the front balloon or the rear balloon through the balloon inflation channel, the front balloon inflation channel inlet and the rear balloon inflation channel inlet; after the front balloon and the rear balloon are filled with fluid and expand and abut against the inner wall of the blood vessel, an operation interface that prevents blood from entering is formed between the front balloon and the rear balloon in the blood vessel; start the negative pressure device to work, and under the action of the negative pressure device, aspirate the thrombus on the inner wall of the blood vessel through the thrombus extraction inlet; when the thrombus extraction at the operation interface is completed, aspirate the normal saline or contrast agent through the balloon inflation outer port, narrow the balloon, and push or retract the main body of the suction pipe to the next working interface, and repeat the aspiration operation.

[0030] The technical advantages of the present invention compared with the existing aspiration catheter device are as follows: 1. The double-compliance balloon can effectively block the blood flow at the working interface, minimize blood loss during the operation, enable the surgical operation to be carried out calmly without worrying about the damage caused by blood loss to the patient, and effectively improve the safety of the operation and the probability of vascular recanalization.

[0031] 2. Through the built-in imaging device, accurate assessment can be made on intraoperative complications such as vascular loss and thrombus residue until the vascular obstruction state is completely relieved, eliminating the blindness and randomness of the operation without intravascular cavity monitoring.

[0032] 3. It can more effectively break the static friction force between the thrombus and the blood vessel wall, making the thrombus easier to be aspirated; the pulsatile aspiration will cause pulsatile fluctuations in the blood pressure around the thrombus and the pressure at the distal end of the aspiration catheter. This change in pressure difference can increase the instability of the thrombus and promote the loosening of the thrombus. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic cross-sectional structure diagram of the balloon in the contracted state of the present invention; Figure 2 、 3 is Figure 1 a partial view of; Figures 4 - 11 is Figure 2 a cross-sectional view taken along a1-a8 of; Figures 12 - 15 is Figure 3 a cross-sectional view taken along a9-a12 of; Figure 16 is Figure 2 a schematic diagram of the balloon in the inflated (filled) state in; Figure 17 is Figure 16 a cross-sectional view taken along a3 of; Figure 18 is Figure 16 a cross-sectional view taken along a7 of; Figure 19 is a partial external top view of the present invention; Figure 20 is a partial external front view of the present invention; Figure 21 is a schematic diagram of threading a guide wire through the present invention; Figure 22 is Figure 2 a schematic structural diagram of another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0035] To describe in detail the technical content, achieved objectives and effects of the present invention, the following is described in conjunction with the embodiments and with reference to the accompanying drawings.

[0036] The intravascular visual dual-balloon thrombus aspiration device of the present invention includes a suction pipe main body 21, a thrombus aspiration channel 7, a balloon inflation channel 10 and a perfusion channel 12 arranged in the suction pipe main body; The device is a catheter-type instrument with a diameter of 3-4 mm and a length of 1-1.5 m. Its material can be transparent or opaque polymer materials, etc. The cross-section of the thrombus aspiration channel 7 can be 1.5×2.5 mm or 2.5×3.5 mm.

[0037] A notch section 22 is provided at the front of the aspiration tube body 21. The notch section 22 is formed by cutting off a section from the upper part of the front end of the tube body of the aspiration tube body 21 to form a depression relatively lower than both sides.

[0038] The present invention provides the notch section 22 so that the length of the contact between the guide wire and the aspiration tube is the end (only the quick exchange end 2 contacts), because the guide wire only needs to pass through the relatively short guiding channel at the head end, does not contact the entire length of the aspiration catheter body, and does not pass through the inner cavity of the aspiration channel, which can reduce the guiding resistance.

[0039] A balloon inflation channel 10 and a front balloon 4 communicating with the balloon inflation channel are provided on the notch section. A rear balloon 9 communicating with the balloon inflation channel 10 is provided in the middle of the aspiration tube body 21. The front balloon 4 can be made of materials such as a tubular waterproof film and sleeved on the middle of the notch section 22, and both ends of the front balloon 4 are hermetically bonded and fixed to the wall surface of the notch section 22; the rear balloon 9 is made of materials such as a tubular waterproof film and sleeved on the aspiration tube body 21, and both ends of the rear balloon 9 are hermetically bonded and fixed to the tube wall surface of the aspiration tube body 21.

[0040] The front end of the balloon inflation channel 10 extends to the position of the front balloon 4 and communicates with the front balloon 4 through the front balloon inflation channel inlet 11 on the wall of the aspiration tube body 21. The rear balloon 9 communicates with the rear balloon 9 through the rear balloon inflation channel inlet 14 on the wall of the aspiration tube body 21.

[0041] A balloon inflation outer port 19 for inputting inflation fluid is provided at the rear of the aspiration tube body 21 and communicates with the balloon inflation channel 10. When injecting fluid (saline or contrast agent) into the balloon inflation outer port 19, the fluid enters the front balloon 4 or the rear balloon 9 through the balloon inflation channel 10, the front balloon inflation channel inlet 11, and the rear balloon inflation channel inlet 14; after the front balloon 4 and the rear balloon 9 are inflated with fluid, they abut against the inner wall of the blood vessel to form an operation interface in the blood vessel between the front balloon 4 and the rear balloon 9 to prevent blood from entering.

[0042] After the thrombus aspiration at the operation interface is completed, the saline or contrast agent can be aspirated through the balloon inflation outer port 19 to narrow the balloon, and the aspiration tube body 21 can be pushed or retracted to the next working interface to repeat the aspiration operation. This balloon is a compliant balloon (its inflation diameter can change with the fluid pressure).

[0043] At the junction position of the aspiration tube main body 21 and the notch section 22, there is an aspiration plug inlet 23 communicating with the aspiration plug channel 7. At the rear of the aspiration tube main body 21, there is a thrombus aspiration outer port 20 for connecting a negative pressure device and communicating with the aspiration plug channel 7. Under the action of the negative pressure device, thrombus on the inner wall of the blood vessel is aspirated through the aspiration plug inlet 23.

[0044] On the tube wall of the aspiration tube main body 21, between the aspiration plug inlet 23 and the rear balloon 9, there is a perfusion channel side hole 13 communicating with the perfusion channel 12. The perfusion channel side hole 13 can have multiple small holes or strip-shaped slot holes. The perfusion channel side hole 13 spans a length of about 3.0 cm. At the rear of the aspiration tube main body 21, there is a side hole perfusion channel outer port 18 for perfusing transparent liquid and communicating with the perfusion channel 12. By injecting transparent liquid (such as heparin saline, etc.) into the side hole perfusion channel outer port 18, the transparent liquid enters the blood vessel lumen of the working interface blocked by the double balloons via the perfusion channel 12 and the perfusion channel side hole 13, forming an in / out closed-loop circulation with the aspiration plug channel 7, balancing the damage caused by negative pressure aspiration to the inner wall of the blood vessel and improving the thrombus aspiration efficiency. Since the transparent liquid is continuously or intermittently input into the blood vessel lumen of the working interface and discharged through the aspiration plug channel 7, the situation in the blood vessel lumen of the working interface can be clearly seen by the camera installed on the aspiration tube main body 21.

[0045] At the front end of the notch section 22, there is a rapid exchange end 2. The rapid exchange end 2 is a tapered tube body with a guide wire rapid exchange channel 1 in the center. The rapid exchange end 2 being tapered can quickly guide the whole into the predetermined working area of the blood vessel; the outer diameter of the rapid exchange end 2 is 1.0 mm and the length is 5.0 mm. The guide wire rapid exchange channel 1 (diameter = 0.5 mm) can introduce instruments into the blood vessel through a 0.018-inch micro guide wire. The rapid exchange end 2 is not combined with the aspiration catheter main body (i.e., there is a notch section 22 between the two), which can effectively reduce the diameter of the catheter main body to meet the need for thrombus aspiration in small-caliber blood vessels and also reduce the manufacturing difficulty.

[0046] In the notch section 22, between the rapid exchange end 2 and the front balloon 4 is the rapid exchange support rod 3, about 5.0 mm long. Between the front balloon 4 and the aspiration plug inlet 23 on the aspiration tube main body 21 is the balloon support rod 5. The length of the balloon support rod 5 is about 20 mm. The balloon support rod 5 gradually widens and is connected to the aspiration tube main body 21, and the connection part is the same width as the aspiration tube main body 21.

[0047] To facilitate the observation of thrombus removal, a camera cable 8 (with a diameter of about 0.4 mm) and a micro camera 6 (with a diameter of about 0.6 mm) connected to the end of the camera cable 8 are inserted into the main body 21 of the aspiration tube. The micro camera 6 is installed beside the thrombus extraction inlet 23. On the side beside the rear part of the main body 21 of the aspiration tube, there are successively arranged a camera cable support sheath 15, a cable protection layer 16, and a WIFI signal transmitting device 17. The camera cable 8 passes through the camera cable support sheath 15 (with a diameter of 1.5 mm) and the cable protection layer 16 (with a diameter of 1.2 mm) in sequence and is connected to the WIFI signal transmitting device 17. Through the wireless (WiFi) signal transmitting device module 17 at the tail end, the image in the blood vessel cavity can be transmitted to the external image receiving and displaying device in real time (which is a prior art and will not be elaborated here). Doctors can then perform adaptive operations based on the images displayed on the display device.

[0048] Another embodiment: On the surface of the quick-exchange end 2 of the main body 21 of the aspiration system, there is a front X-ray-impermeable metal marking ring 24 arranged in a circular shape. On the surface of the main body 21 of the aspiration system at the opening of the thrombus extraction channel 7, there is a middle X-ray-impermeable metal marking ring 25 arranged in a circular shape. On the surface of the main body 21 of the aspiration system behind the rear balloon 9, there is a rear X-ray-impermeable metal marking ring 26 arranged in a circular shape, so as to facilitate the marking and positioning of the catheter position during thrombus extraction under X-ray guidance.

[0049] The key technical points of the present invention are as follows: 1. The micro camera device, which is the core component of the present invention, can overcome the weakness that all thrombus cleaning devices in clinical practice cannot monitor the operation interface in real time. It can accurately extract thrombus, judge the thrombus extraction effect in real time, and avoid thrombus residue and damage to the blood vessel inner wall.

[0050] 2. The dual-balloon design can effectively prevent blood from entering the operation interface and reduce the blood loss of patients caused by the operation. The balloon is set as a compliant balloon, which can closely fit the inner wall of blood vessels with various diameters at a lower pressure to block blood flow under low-pressure conditions without damaging the blood vessel inner wall. A similar single-balloon design for blocking blood flow can only block the blood flow at one end of the blood vessel. After the thrombus blocks the blood vessel, there are often collateral blood vessels at the distal end of the blocked segment that bypass the blocked segment from the proximal end of the blockage and perfuse into the blood vessel in the reverse direction from the distal end. Although the proximal single-balloon design can reduce but cannot completely block the blood flow perfusion at the operation interface, a large amount of blood loss will still occur during the aspiration process. The dual-balloon design of the present application has stronger control ability compared with the single-balloon design. The front and rear blockages seal the entire operation interface into an independent space, with accurate positioning, eliminating the interference of blood flow perfusion, and allowing for precise thrombus extraction operations with ease.

[0051] 3. The design of the micro-camera device + double-lumen balloon can prevent residual thrombus and tissue debris from shedding and escaping, causing secondary embolism downstream of the blood flow. Without balloon occlusion of the blood flow, when the conventional aspiration catheter partially opens the blood vessel or suddenly withdraws the thrombus to open the blood flow at the end, small thrombi or tissue debris that are not completely aspirated into the catheter can be carried to the distal end of the blood flow direction with the restoration of blood flow, causing secondary embolism. On the contrary, due to the occlusion of the balloon in this application, when the blood vessel is partially or completely opened, the remaining thrombus or tissue debris will still remain in place. The camera device can clearly monitor the condition of the residual thrombus in the blood vessel lumen, and can perform targeted re-aspiration to ensure that there is no residue of small thrombi or tissue debris, and prevent the escape of small thrombi and tissue debris after the restoration of blood flow from causing secondary embolism in the distal end.

[0052] 4. The coaxial perfusion channel and the parallel multi-side hole design can continuously perfuse heparinized normal saline during the operation to promote the shedding of thrombus; and form a closed-loop structure with the aspiration channel to prevent excessive negative pressure from damaging the inner wall of the blood vessel; the multi-side hole (i.e., the side hole 13 of the perfusion channel) design can also continuously introduce carbon dioxide gas during the operation to improve the visualization of the working interface; or alternately introduce carbon dioxide - heparinized normal saline to improve the thrombus aspiration efficiency.

[0053] 5. The head end is provided with a rapid exchange end, which can quickly introduce the aspiration catheter into the working area. The rapid exchange end is not juxtaposed with the main body of the aspiration catheter, which can effectively reduce the diameter of the aspiration catheter, facilitate the aspiration catheter to enter blood vessels with a smaller diameter, and at the same time reduce the manufacturing difficulty.

[0054] The technical advantages of the present invention compared with the existing aspiration catheter devices are as follows: 1. The double-lumen balloon design can ensure that the thrombus aspiration operation is accurately carried out in segments and reduce blood loss. The double-compliance balloon can effectively block the blood flow at the working interface, minimize blood loss during the operation, and enable the surgical operation to be carried out calmly in the double-balloon closed area without worrying about the damage caused by blood loss to the patient; after the segmented operation is successful, the catheter is advanced into the next segment to fill the balloon, and the thrombus aspiration operation is carried out again. Repeating in this way can effectively improve the safety of the operation and the probability of blood vessel recanalization.

[0055] 2. The built-in micro-camera device provides real-time images of the blood vessel lumen and adjusts the treatment plan. In clinical practice, the acquisition and transmission of real-time image data in the blood vessel lumen play a very important guiding role in judging the thrombus morphology to evaluate the thrombus aspiration effect and adjusting the diagnosis and treatment plan accordingly.

[0056] There are two commonly used methods for directly performing high-resolution imaging of intravascular structures in clinical practice: Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT). The clinical application scopes of the two methods overlap and intersect, and their respective characteristics are not the same: (1) Intravascular Ultrasound (IVUS) can image local blood vessels. However, its principle lies in the secondary processing of ultrasonic echo information. Therefore, the image is a reconstructed grayscale image rather than the real image of the blood vessel lumen. Additionally, its resolution is relatively low, showing large granularity in real-time images, and it cannot clearly distinguish the situation of residual thrombus in the blood vessel. The axial resolution of IVUS is 100 - 150 microns, and the radial resolution is 150 - 300 microns (at 40 MHz) or 40 - 60 microns (at 60 MHz). This limits its ability to perform detailed evaluations of conditions such as arterial dissection and tissue protrusion. At the same time, the use of IVUS requires first withdrawing the aspiration catheter and then introducing IVUS, resulting in complicated operations, potentially prolonging the surgical time due to the need for an imaging catheter, and increasing costs.

[0057] (2) Optical Coherence Tomography (OCT) The resolution of OCT can reach the micron level (usually 10 - 20 microns), much higher than that of traditional ultrasound imaging (usually 100 - 150 microns). This enables OCT to clearly display the fine structure of tissues and has real-time imaging capabilities. However, its weaknesses are also prominent: 1. Limited penetration depth: Compared with ultrasound imaging, the penetration depth of OCT is relatively shallow, usually only able to penetrate a tissue depth of a few millimeters (for example, about 1 - 3 millimeters in biological tissues). This limits its application in deep tissue imaging. For large-diameter blood vessels such as the femoral vein, it is difficult to perform panoramic imaging, and a lot of information about the blood vessels and vessel walls will be missed. 2. Sensitive to scattering media: OCT imaging relies on the reflection and scattering of light. Therefore, the imaging quality will decline in highly scattering media (such as blood or certain tissue types). Thus, its application in thrombus lesions is severely restricted. 3. Inconvenient operation. Similar to IVUS, OCT imaging also requires the aspiration catheter to be withdrawn from the body before imaging, so the aspiration operation and imaging cannot be carried out continuously. 4. Require contrast agents. During the OCT imaging process, a contrast agent needs to be injected to clear the blood in the vascular lumen so that the infrared light wave at the catheter tip can perform imaging. After the thrombus blocks the blood vessel, the contrast agent cannot flow forward, and it will form a turbulent flow with the mixture of residual thrombus, tissue debris, and blood, thereby directly reducing the imaging quality and making it difficult to judge the patency of the blood vessel and the presence of residual thrombus. 5. Weaknesses of reconstructed images. Although OCT has a relatively high resolution, it still belongs to grayscale / pseudo-color images reconstructed based on energy and is not the real image inside the blood vessel, which also limits the accurate judgment of the nature of the lesion site.

[0058] The above two methods are complicated in operation and require the use of dedicated imaging and aspiration catheters, thus resulting in high costs. Currently, for the convenience of operation and to understand the thrombus aspiration status in real time, clinical thrombus aspiration operations usually need to be carried out under the guidance of X-rays. However, soft tissues such as blood vessel thrombi are not visible under X-rays, and only the results of preoperative angiography are relied on to indirectly judge the scope and degree of thrombus obstruction, etc. During the blood vessel aspiration process, only whether the negative pressure aspiration is reduced and whether a large amount of blood is drawn out through the catheter are relied on to judge whether the thrombus is aspirated; the postoperative angiography can only briefly judge the patency of the blood vessel and cannot accurately evaluate whether there is residual thrombus and damage to the blood vessel inner wall; therefore, if the above two blood vessel imaging and conventional thrombus extraction operations are used, there is a certain degree of blindness and randomness, and the accuracy is insufficient. After the built-in camera device of this application, it can accurately evaluate intraoperative complications such as blood vessel damage and residual thrombus until the blood vessel obstruction state is completely relieved, eliminating the blindness and randomness of the operation without intravascular monitoring.

[0059] The double-balloon design in the device of the present invention can ensure that the clarity, breadth, and depth of the image quality can meet the treatment requirements. After the double balloons are inflated, it can be seen that the working interface is isolated from the upstream and downstream ranges of the blood vessel. Through the suction operation of the suction channel and the perfusion channel, the blood in the isolated section is emptied, and normal saline is injected. The imaging device can clearly perform real-time imaging of the condition inside the blood vessel lumen. Therefore, integrating the imaging device into the suction system of the present application is highly feasible both theoretically and practically.

[0060] 3. The built-in imaging device + double-lumen balloon design can effectively prevent thrombus escape from causing secondary embolism in the downstream blood flow. In conventional thrombus aspiration operations, the opening of the blood vessel is random and uncontrollable. In the case of extracting the main thrombus or most of the thrombus, with the partial or complete restoration of blood flow, the residual thrombus and (or) tissue fragments that are not completely extracted will escape from the original occlusion site into the downstream blood flow, causing secondary embolism. However, the double-balloon design of the present invention can ensure that all thrombus aspiration operations are completed under precise control. After most or the main thrombus is aspirated out of the body, the imaging device can be used to clarify the residual condition of the thrombus and tissue fragments in the double-balloon blocking area, and subsequent operations can be carried out calmly until all thrombus and (or) fragments are completely cleared.

[0061] 4. Coaxial perfusion channel and multi-side hole design. This design can continuously perfuse heparinized normal saline during the operation, enabling the perfusion-aspiration state to continue without worrying about excessive blood loss. (1) The continuous circular flow can effectively promote the dissolution and loosening of thrombus, making it easier to enter and exit the aspiration catheter. At the same time, (2) the double balloons control the working interface to be in a closed and stable state. By adjusting the perfusion rate and perfusion closure state, the suction negative pressure can be made to fluctuate in a pulsed and periodic manner. This changing negative pressure will generate repeated impact loads on the thrombus and the surrounding blood vessels. Compared with a stable negative pressure, the impact load can more effectively break the static friction between the thrombus and the blood vessel wall, making the thrombus easier to be aspirated out. At the same time, the pulsed aspiration will cause pulsed fluctuations in the blood pressure around the thrombus and the pressure at the distal end of the aspiration catheter. This change in the pressure difference can increase the instability of the thrombus and prompt the thrombus to loosen.

[0062] The physical properties of thrombus determine that pulsed aspiration is a very efficient thrombus extraction strategy: (1) Viscoelastic properties of thrombus: Thrombus is a heterogeneous viscoelastic solid with viscoelastic recovery hysteresis and long-term deformability. Under the action of pulsed negative pressure, the deformation of thrombus lags behind the change of stress, and maintaining it in a stretched equilibrium state for a long time will cause certain deformation of the thrombus and it cannot fully recover. Under the influence of the structural changes accumulated by multiple pulses and the impact load brought by the rise of the last pulse, the thrombus will move slightly, so that the frictional force it receives changes from static friction to smaller dynamic friction, making it easier to be extracted; (2) Heterogeneity of thrombus: From a pathological perspective, thrombus can be divided into three types: red thrombus (mainly composed of red blood cells and fibrin, containing a small amount of platelets and white blood cells), white thrombus (mainly composed of platelets and a small amount of fibrin), and mixed thrombus (composed of platelets, red blood cells, fibrin and white blood cells). Clinically, most thrombi are mixed thrombi, with complex components and uneven internal structures. Under the repeated impact force generated by pulsed aspiration, the weak parts inside the thrombus are more likely to break or loosen, thereby reducing the stability of the whole thrombus, which is beneficial for aspiration.

[0063] 5. Rapid exchange wire channel. Conventional aspiration catheters or other types of thrombectomy devices need to go through multiple complex interventional operation steps to reach the working position; the specific operation procedure is as follows: Introduce a guiding catheter through the puncture tract, insert a guide wire into the guiding catheter, and the two cooperate to send the guide wire to the working position, then pull out the guiding catheter, and use coaxial technology to introduce the extraction device and / or catheter through this guide wire into the working position in the blood vessel, and then pull out the guide wire to perform thrombus extraction operation; in clinical work, often due to a large number of solid thrombi blocking the device and / or catheter, the whole catheter and / or device have to be pulled out of the body, cleaned thoroughly and then repeat the above complex operation again, introduce the cleaned catheter and device into the working position, and perform extraction operation. This process often needs to be repeated, consuming time and effort and having low efficiency.

[0064] The rapid exchange channel 1 of the guide wire of the present invention can effectively overcome the disadvantages of low efficiency of the above-mentioned complex operations: after the micro-guide wire (0.018 inch) is first delivered to the working position with the cooperation of the catheter, the main body of the suction tube of the present invention can be directly introduced into the working position according to the already in-place micro-guide wire. Since the guide wire only needs to pass through the short guiding channel at the head end, it does not contact the entire length of the suction catheter main body, nor does it pass through the inner cavity of the suction channel. Therefore, once the main body of the suction tube is in place, the micro-guide wire can be retained in place without being withdrawn from the body and the thrombus aspiration operation can be carried out; afterwards, once catheter obstruction or other operations that require the device to be withdrawn from the body for treatment occur, after the cleaning operation is completed, the catheter device of the present invention can be directly introduced into the previously established working position through the micro-guide wire retained in place and through the rapid exchange channel 1 of the guide wire to carry out the thrombus aspiration operation, greatly simplifying the steps and process of reinserting the main body of the suction tube, saving time and effort, and significantly improving the surgical efficiency.

[0065] In addition, a mechanical grasping device can be introduced into the suction channel to perform precise cleaning and grasping operations on solid mural thrombi under real-time monitoring, improve the probability of thrombus clearance and blood vessel recanalization, and effectively cope with the thrombus load limitation of conventional suction catheters.

[0066] The above are only embodiments of the present invention, and do not limit the patent scope of the present invention accordingly. Any equivalent transformation made by using the description and drawings of the present invention, or directly or indirectly applied in related technical fields, shall be similarly included in the patent protection scope of the present invention.

Claims

1. A dual-balloon thrombus aspiration device for intravascular visualization, characterized in that: It includes a suction tube main body (21), a thrombus aspiration channel (7), a balloon inflation channel (10), and an irrigation channel (12) provided inside the suction tube main body; A notch section (22) is provided at the front of the suction tube main body (21). A balloon inflation channel (10) and a front balloon (4) communicating with the balloon inflation channel are provided on the notch section. A rear balloon (9) communicating with the balloon inflation channel (10) is provided in the middle of the suction tube main body (21). A balloon inflation outer port (19) for inputting inflation fluid and communicating with the balloon inflation channel (10) is provided at the rear of the suction tube main body (21); A thrombus aspiration inlet (23) communicating with the thrombus aspiration channel (7) is provided at the junction position of the suction tube main body (21) and the notch section (22). A thrombus aspiration outer port (20) for connecting a negative pressure device and communicating with the thrombus aspiration channel (7) is provided at the rear of the suction tube main body (21); An irrigation channel side hole (13) communicating with the irrigation channel (12) is provided on the tube wall of the suction tube main body (21) between the thrombus aspiration inlet (23) and the rear balloon (9). A side hole irrigation channel outer port for irrigating a transparent liquid and communicating with the irrigation channel (12) is provided at the rear of the suction tube main body (21). After the front balloon (4) and the rear balloon (9) are inflated with fluid, they bulge and abut against the inner wall of the blood vessel to form an operation interface that prevents blood from entering between the front balloon (4) and the rear balloon (9) in the blood vessel.

2. The intravascular visualization dual balloon thrombus aspiration device according to claim 1, characterized in that: The notch section (22) is formed by cutting off a section at the upper part of the front end of the tube body of the suction tube main body (21) to form a depression relatively lower than both sides.

3. The intravascular visualization dual balloon thrombus aspiration device according to claim 1 or 2, characterized in that: The front end of the balloon inflation channel (10) extends to the position of the front balloon (4) and communicates with the front balloon (4) through a front balloon inflation channel inlet (11) on the tube wall of the suction tube main body (21). The rear balloon (9) communicates with the rear balloon (9) through a rear balloon inflation channel inlet (14) on the tube wall of the suction tube main body (21).

4. The intravascular visualization dual balloon thrombus aspiration device according to claim 3, wherein: A rapid exchange end (2) is provided at the front end of the notch section (22). The rapid exchange end (2) is a tapered tube body with a guide wire rapid exchange channel (1) in the center.

5. The intravascular visualization dual balloon thrombus aspiration device according to claim 1 or 2, characterized in that: The front balloon (4) is sleeved on the middle part of the notch section (22) with a tubular waterproof film material, and both ends of the front balloon (4) are hermetically bonded and fixed to the wall surface of the notch section (22); the rear balloon (9) is sleeved on the suction tube main body (21) with a tubular waterproof film material, and both ends of the rear balloon (9) are hermetically bonded and fixed to the tube wall surface of the suction tube main body (21).

6. The intravascular visualization dual-balloon thrombus aspiration device according to claim 1, wherein: A camera cable (8) and a micro camera (6) connected to the end of the camera cable (8) are inserted into the suction tube main body (21). The micro camera (6) is installed beside the thrombus aspiration inlet (23).

7. The intravascular visualization dual balloon thrombus aspiration device according to claim 6, wherein: A camera cable support sheath (15), a cable protective layer (16), and a WIFI signal transmitting device (17) are sequentially arranged beside the rear part of the suction pipe body (21). The camera cable (8) sequentially passes through the camera cable support sheath (15) and the cable protective layer (16) and is connected to the WIFI signal transmitting device (17).

8. The intravascular visualization dual balloon thrombus aspiration device according to claim 4, characterized in that: In the notch section (22), the rapid exchange support rod (3) is located between the rapid exchange end (2) and the front balloon (4), and the balloon support rod (5) is located between the front balloon (4) and the thrombus extraction inlet (23) on the suction pipe body (21).

9. The intravascular visualization dual balloon thrombus aspiration device according to claim 1, characterized in that: A front X-ray opaque metal marker ring (24) is circumferentially arranged on the surface of the rapid exchange end (2) of the suction system body (21). A middle X-ray opaque metal marker ring (25) is circumferentially arranged on the surface of the suction system body (21) at the opening of the thrombus extraction channel (7). A rear X-ray opaque metal marker ring (26) is circumferentially arranged on the surface of the suction system body (21) behind the rear balloon (9) to facilitate the marking and positioning of the catheter position during thrombus extraction under X-ray guidance.

10. A working method of an intravascular visual double-balloon thrombus aspiration device according to any one of claims 1-9, characterized in that: It is delivered to the working position of the vascular thrombus through the cooperation of a micro-guide wire and a catheter. According to the in-place micro-guide wire, the suction pipe body is guided to the working position. Normal saline or contrast agent is injected into the balloon inflation outer port (19). The fluid enters the front balloon (4) or the rear balloon (9) through the balloon inflation channel (10), the front balloon inflation channel inlet (11), and the rear balloon inflation channel inlet (14). After the front balloon (4) and the rear balloon (9) are inflated with fluid, they abut against the inner wall of the blood vessel, and an operation interface that prevents blood from entering is formed between the front balloon (4) and the rear balloon (9) in the blood vessel; Start the negative pressure device to work. Under the action of the negative pressure device, the thrombus on the inner wall of the blood vessel is aspirated through the thrombus extraction inlet (23); When the thrombus extraction at the operation interface is completed, the normal saline or contrast agent is aspirated through the balloon inflation outer port (19), the balloon is narrowed, and the suction pipe body (21) is pushed or retracted to the next working interface, and the aspiration operation is repeated.

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