A dual balloon catheter for intravascular visualization and thrombus aspiration

Abstract

The utility model relates to a kind of vascular endoluminal visualization double balloon thrombus suction device including suction pipe main body, the suction pipe main body inside the suction channel, balloon filling channel and perfusion channel are equipped;The front of the suction pipe main body is equipped with gap section, balloon filling channel and the front balloon that is penetrated with balloon filling channel are equipped on the gap section, the middle of the suction pipe main body is equipped with the rear balloon that is penetrated with balloon filling channel, the rear of the suction pipe main body is equipped with the balloon filling outer port for input filling fluid that is communicated with balloon filling channel;The vascular endoluminal visualization double balloon thrombus suction device can reduce patient blood loss, and effectively prevent thrombus escape from causing blood flow downstream secondary embolism.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to an intravascular visualization dual-balloon thrombus aspiration device. Background Technology

[0002] Thrombosis has a systemic distribution in the human body. Based on the anatomical classification of the vascular system involved, it can be divided into two major pathological types: venous thrombus (VT) and arterial thrombus (AT).

[0003] Venous thrombosis is anatomically specific, primarily affecting the deep venous system of the lower extremities and its distal branches. Its annual incidence is approximately 1.6‰, exhibiting a centripetal extension along the vessel axis. It can involve the iliac veins and subsequently the inferior vena cava. When the thrombus is mechanically severed, it can induce fatal pulmonary embolism (PE). If lower extremity venous hemodynamic homeostasis is not restored promptly through thrombectomy and recanalization techniques, post-thrombotic syndrome (PTS) will develop. Epidemiological studies indicate that approximately 60% of acute-phase patients experience venous valve decompensation and hemodynamic disturbances due to thrombus-mediated aseptic inflammatory responses, leading to chronic venous hypertension. Pathological manifestations include progressive tissue edema, subcutaneous fibrosis, and trophic skin ulcers, severely impacting patients' quality of life and becoming a significant burden on public health systems.

[0004] Arterial thrombosis is characterized by its multi-organ invasiveness, and its pathological progression is more rapid and destructive than that of the venous system. Intracranial arterial thrombosis can lead to 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 lead to acute ischemic necrosis of the intestine (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 is not relieved within the 6-8 hour treatment window, it will progress to irreversible tissue necrosis and ischemic gangrene. Severe cases require emergency amputation to prevent sepsis.

[0005] Given the obstructive effect of thrombotic diseases on the microcirculation system, timely relief of mechanical obstruction and restoration of tissue perfusion are of significant clinical value. Current treatment strategies, based on vascular anatomy and disease stage, can be divided into two main systems: endovascular interventional therapy and open surgery. Adjunctive drug therapy includes antiplatelet aggregation and anticoagulation therapy, aiming to inhibit thrombus extension and prevent embolic events.

[0006] Endovascular interventional therapy, as a core intervention for thrombotic diseases, mainly includes mechanical thrombectomy, aspiration thrombectomy, mechanical thrombus fragmentation, balloon-assisted thrombectomy, and catheter-directed thrombolysis. In clinical practice, these techniques are often combined according to the characteristics of the lesion. The standard operating procedure for endovascular interventional therapy includes: (1) establishing a vascular puncture approach; (2) placing a vascular sheath and protective device; (3) under image guidance, using a device delivery system such as guidewires, catheters, balloons, and stents, accurately positioning the thrombectomy device at the thrombus obstruction site, and implementing comprehensive intervention including thrombus removal, fragmentation, and drug dissolution to restore physiological blood flow in the blood vessel.

[0007] Mechanical thrombectomy achieves thrombus removal through the synergistic effect of thrombectomy catheter and blood flow reconstruction stent. Its technical advantages include: (1) High recanalization efficiency: The mechanical interlocking of the stent mesh structure with the thrombus, combined with negative pressure aspiration, can effectively treat large vessel occlusion lesions, especially suitable for cardiogenic embolism or high-burden thrombus; (2) Anatomical adaptability: The thrombectomy stent can adapt to the bifurcation structure of the blood vessel (such as the bifurcation of the middle cerebral artery) through morphological reconstruction, and the dual stent technology (Parallel / Series Configuration) can improve the capture efficiency of complex thrombi; (3) Vascular protection: The combination of balloon guiding catheter can reduce the risk of distal embolism and maintain the integrity of the vascular structure.

[0008] Thrombectomy is based on the principle of fluid dynamics to remove thrombi. It is simple to operate and has the widest application. Its technical characteristics include: (1) Minimally invasive advantage: direct aspiration with a large-diameter catheter reduces mechanical damage to the vascular endothelium; (2) Time advantage: rapid reperfusion can be achieved for occlusion of proximal large vessels (such as the end of the internal carotid artery); (3) Synergistic effect: it can be combined with stent thrombectomy to form a composite technology to improve the overall efficacy.

[0009] However, current technology still has significant limitations, including but not limited to the following aspects:

[0010] (1) Risk of mechanical injury. During repeated pushing, rotating, and aspiration operations within the blood vessel, the catheter experiences continuous mechanical friction against the vessel wall. In patients with abnormal vascular anatomy, atherosclerotic plaques affecting the vessel wall, or tortuous vessels, the mechanical force of the catheter may lead to endothelial abrasion, plaque rupture, or even vascular dissection. Blind manipulation of the catheter tip at small vessel branches or bifurcation points may induce vasospasm, further aggravating tissue ischemia and injury. In addition, improper adjustment of the negative pressure generated by aspiration may cause local vascular collapse, obstructing the passage of subsequent instruments and increasing the difficulty and risk of the surgical procedure.

[0011] (2) Incomplete thrombus removal. Relying solely on the physical contact between the catheter's outer diameter and the thrombus for thrombus aspiration is often insufficient for completely removing thrombi in cases with a large thrombus burden, tight adhesion to the vessel wall, or hard thrombi (such as old thrombi 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, severely affecting the recovery of tissue and organ function, and increasing the risk of poor patient prognosis.

[0012] (3) Intraoperative blood loss and hemodynamic disturbances. During thrombectomy, continuous negative pressure aspiration can easily lead to blood and thrombus mixing and being drawn into the catheter, causing a certain degree of intraoperative blood loss. For patients with relatively insufficient blood volume or poor compensatory capacity, this may induce hemodynamic instability such as hypotension and arrhythmia, further aggravating ischemic and hypoxic damage to systemic organs, and even endangering life. Repeated aspiration operations may also cause vasospasm and blood stasis, disrupting the local hemodynamic environment and hindering the full recovery of blood flow and the establishment of collateral circulation.

[0013] (4) Limitations of equipment and technology. Currently, there are many types of catheters used in clinical practice for thrombectomy, but no single catheter is suitable for all vascular sites and thrombus types. The performance indicators of catheters, such as flexibility, permeability, and aspiration efficiency, vary among different brands and models, and there is a lack of unified evaluation standards. When facing complex vascular lesions (such as severe vascular calcification, acute vascular occlusion with dissection, etc.), the design of existing catheters may not meet the needs of precise and efficient thrombectomy. In addition, thrombectomy techniques are highly dependent on the operator's experience and skills, with a steep learning curve. The treatment effects of different operators may vary greatly, affecting the widespread promotion and standardized application of this technology.

[0014] To address the shortcomings of the aforementioned technical solutions, future research and development will primarily focus on the following areas:

[0015] (1) Development of intelligent visualization catheters. Integrating advanced imaging technologies (such as intravascular ultrasound and optical coherence tomography) into thrombectomy catheters enables real-time visualization monitoring of intravascular structure, thrombus morphology and distribution, and vessel wall damage during surgery. Operators can accurately locate thrombi under direct vision, optimize the contact angle between the catheter and the thrombus, and adjust the suction force, effectively reducing the risk of mechanical damage and the probability of thrombus escape. The intelligent catheter can also automatically adjust the suction mode and negative pressure intensity based on real-time feedback hemodynamic parameters (such as blood flow velocity and pressure gradient), improving thrombus removal efficiency and reducing intraoperative blood loss and vasospasm.

[0016] (2) Integration of multimodal composite technologies. By organically combining thrombolysis with other endovascular treatments such as drug thrombolysis, mechanical thrombectomy, and angioplasty, a multimodal composite treatment platform can be constructed. Through the complementary advantages of different technologies, individualized and precise treatment of various complex thrombotic lesions can be achieved.

[0017] (3) Application of biomaterials and coating technology. Develop new biocompatible materials for manufacturing aspiration catheters, reduce the surface roughness and friction coefficient of the catheter, reduce the adhesion between the catheter and the blood vessel wall, and thus reduce the risk of vascular endothelial injury.

[0018] (4) Artificial Intelligence-Assisted Treatment Decision-Making System. Using artificial intelligence algorithms, a large amount of data from interventional vascular treatment cases is deeply learned and analyzed to construct a database containing multi-dimensional information such as patient basic information, vascular lesion characteristics, thrombus type and burden, surgical procedure parameters, and postoperative outcomes. In clinical practice, by inputting real-time patient examination and laboratory data and angiography images, the artificial intelligence-assisted system can quickly generate personalized aspiration and thrombectomy treatment plans, including key decision-making suggestions such as catheter selection, aspiration strategy, and timing of combined treatments. This provides strong technical support for clinicians, improves the scientific rigor and precision of treatment, and reduces the incidence of complications caused by insufficient experience or decision-making errors.

[0019] Based on the inventor's extensive clinical experience in interventional vascular procedures, among numerous existing technologies, endovascular visualization demonstrates significant clinical value and high operability. Therefore, this invention aims to develop an endovascular visualization dual-balloon thrombus aspiration device to improve surgical precision, reduce surgical risks, and enhance overall surgical efficiency. Summary of the Invention

[0020] The technical problem to be solved by this utility model is to provide an intravascular visual dual-balloon thrombus aspiration device, which can reduce patient blood loss and effectively prevent thrombus escape and secondary embolism downstream of the blood flow.

[0021] To solve the above-mentioned technical problems, the technical solution adopted by this utility model is as follows:

[0022] An intravascular visualization dual-balloon thrombus aspiration device, characterized in that it includes an aspiration tube body, a thrombus aspiration channel, a balloon inflation channel, an infusion channel, and a guidewire rapid exchange channel disposed within the aspiration tube body;

[0023] The front part of the suction tube body is provided with a notch section, the notch section is provided with a balloon inflation channel and a front balloon that communicates with the balloon inflation channel, the middle part of the suction tube body is provided with a rear balloon that communicates with the balloon inflation channel, and the rear part of the suction tube body is provided with a balloon inflation port for inputting inflation fluid that communicates with the balloon inflation channel.

[0024] The junction of the suction tube body and the notch section has a thrombus inlet that communicates with the thrombus aspiration channel, and the rear of the suction tube body has a thrombus aspiration port that communicates with the thrombus aspiration channel for connecting to a negative pressure device.

[0025] The suction tube body has a side hole for perfusion channel located between the embolization inlet and the rear balloon, which communicates with the perfusion channel. The rear of the suction tube body has a side hole for perfusion channel external port for perfusing transparent liquid, which communicates with the perfusion channel. After the front balloon and the rear balloon are filled with fluid, they swell and abut against the inner wall of the blood vessel, so as to form an operating interface that prevents blood from entering the blood vessel between the front balloon and the rear balloon.

[0026] Furthermore, the aforementioned notch section is formed by cutting off a section from the upper part of the front end of the suction tube body to create a recess that is relatively lower than the sides.

[0027] Furthermore, the front end of the aforementioned balloon inflation channel extends to the position of the front balloon, and is connected to the front balloon through the front balloon inflation channel inlet located on the main wall of the suction tube. The rear balloon is connected to the rear balloon through the rear balloon inflation channel inlet located on the main wall of the suction tube.

[0028] Furthermore, the front end of the aforementioned notch section is provided with a quick-exchange end, which is a tapered tube with a guide wire quick-exchange channel at its center.

[0029] Furthermore, the aforementioned anterior balloon is fitted onto the middle of the notch section using a tubular, waterproof membrane material, and both ends of the anterior balloon are sealed and bonded to the wall of the notch section; the posterior balloon is fitted onto the suction tube body using a tubular, waterproof membrane material, and both ends of the posterior balloon are sealed and bonded to the tube wall of the suction tube body.

[0030] Furthermore, a camera cable and a miniature camera connected to the end of the camera cable are threaded through the main body of the suction tube, and the miniature camera is installed on the side of the suction inlet.

[0031] Furthermore, a camera cable support sheath, a cable protection layer, and a WIFI signal transmitter are sequentially provided on the rear side of the aforementioned suction tube body. The camera cable passes through the camera cable support sheath and the cable protection layer in sequence and is connected to the WIFI signal transmitter.

[0032] Furthermore, the surface of the rapid exchange end of the aforementioned suction system body is surrounded by a front-end X-ray-proof metal marking ring, the surface of the suction system body at the opening of the thrombectomy channel is surrounded by a middle X-ray-proof metal marking ring, and the surface of the suction system body on the rear side of the rear balloon is surrounded by a rear-end X-ray-proof metal marking ring.

[0033] The working method of this utility model's intravascular visual dual-balloon thrombus aspiration device.

[0034] With the aid of a catheter, a microguidewire is delivered to the location of the thrombus in the blood vessel. Based on the positioned microguidewire, the aspiration cannula is guided to the working position. Saline or contrast agent is injected into the balloon inflation port. Fluid flows through the balloon inflation channel, the inlet of the front balloon inflation channel, and the inlet of the rear balloon inflation channel into the anterior or posterior balloon. After the anterior and posterior balloons are inflated, they swell and press against the inner wall of the blood vessel, forming an interface within the blood vessel between the anterior and posterior balloons to prevent blood from entering. The negative pressure device is activated, and under the action of the negative pressure device, the thrombus is aspirated from the inner wall of the blood vessel through the aspiration inlet. After the aspiration at the working interface is completed, saline or contrast agent is withdrawn through the balloon inflation port, the balloon is narrowed, and the aspiration cannula is pushed or retracted to the next working interface, repeating the aspiration operation.

[0035] The technical advantages of this invention compared to existing suction catheter devices are as follows:

[0036] 1. Dual compliant balloons can effectively block blood flow at the working interface, minimizing intraoperative blood loss. This allows for a smooth surgical procedure without worrying about the harm caused to the patient by blood loss, effectively improving the safety of the surgery and the chance of vascular recanalization.

[0037] 2. The built-in camera device can accurately assess complications that occur during the operation, such as vascular loss and residual thrombus, until the vascular obstruction is completely relieved, eliminating the blindness and arbitrariness of operation without endovascular monitoring.

[0038] 3. It can more effectively destroy the static friction between the thrombus and the blood vessel wall, making the thrombus easier to remove; the pulsed aspiration will cause the blood pressure around the thrombus and the pressure at the distal end of the aspiration catheter to produce pulse fluctuations. This pressure difference change can increase the instability of the thrombus and promote the loosening of the thrombus. Attached Figure Description

[0039] Figure 1 This is a schematic cross-sectional view of the balloon in its contracted state according to this utility model.

[0040] Figure 2 , 3 yes Figure 1 A partial view;

[0041] Figures 4-15 yes Figure 2 Cross-sectional view of a1-a12;

[0042] Figure 16 yes Figure 2 A schematic diagram of the balloon's inflated (full) state;

[0043] Figure 17 yes Figure 16 A cross-sectional view of a3;

[0044] Figure 18 yes Figure 16 A cross-sectional view of a7;

[0045] Figure 19 This is a partial top view of the present invention;

[0046] Figure 20 This is a partial front view of the appearance of this utility model;

[0047] Figure 21 This is a schematic diagram of the guide wire insertion method of this utility model;

[0048] Figure 22 yes Figure 2 A schematic diagram of another embodiment. Detailed Implementation

[0049] To explain in detail the technical content, objectives, and effects of this utility model, the following description is provided in conjunction with the embodiments and accompanying drawings.

[0050] This utility model of an intravascular visualization dual-balloon thrombus aspiration device includes an aspiration tube body 21, a thrombus aspiration channel 7, a balloon inflation channel 10, and an infusion channel 12 located within the aspiration tube body;

[0051] 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 material, etc. The cross-section of the thrombectomy channel 7 can be 1.5×2.5 mm or 2.5×3.5 mm.

[0052] The front part of the suction tube body 21 is provided with a notch section 22, which is formed by cutting off a section at the upper part of the front end of the suction tube body 21 to form a recess that is relatively lower than the sides.

[0053] The notch section 22 of this invention allows the guidewire to contact the length of the suction tube (only the quick exchange end 2) because the guidewire only needs to pass through the shorter guide channel at the tip and does not contact the entire length of the suction catheter body, nor does it pass through the inner cavity of the suction channel, which can reduce the resistance of the guide.

[0054] The notch section is provided with a balloon inflation channel 10 and a front balloon 4 that communicates with the balloon inflation channel. The middle part of the suction tube body 21 is provided with a rear balloon 9 that communicates with the balloon inflation channel 10. The front balloon 4 can be made of tubular waterproof membrane or other materials and is placed on the middle part of the notch section 22. The two ends of the front balloon 4 are sealed and bonded to the wall of the notch section 22. The rear balloon 9 is made of tubular waterproof membrane or other materials and is placed on the suction tube body 21. The two ends of the rear balloon 9 are sealed and bonded to the tube wall of the suction tube body 21.

[0055] The front end of the balloon inflation channel 10 extends to the position of the front balloon 4 and is connected to the front balloon 4 through the front balloon inflation channel inlet 11 located on the wall of the suction tube body 21. The rear balloon 9 is connected to the rear balloon 9 through the rear balloon inflation channel inlet 14 located on the wall of the suction tube body 21.

[0056] The rear of the suction tube body 21 is provided with a balloon inflation port 19 for introducing inflation fluid, which communicates with the balloon inflation channel 10. When fluid (physiological saline or contrast agent) is injected into the balloon inflation port 19, the fluid enters the anterior balloon 4 or the posterior 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 anterior balloon 4 and the posterior balloon 9 are inflated with fluid, they swell and abut against the inner wall of the blood vessel, so as to form an operating interface between the anterior balloon 4 and the posterior balloon 9 in the blood vessel to prevent blood from entering.

[0057] After the thrombectomy is completed at the operating interface, saline or contrast agent can be withdrawn through the balloon inflation port 19. The balloon is then narrowed, and the aspiration tube body 21 is 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 fluid pressure).

[0058] At the junction of the suction tube body 21 and the notch section 22, there is a thrombus inlet 23 that communicates with the thrombus aspiration channel 7. The rear part of the suction tube body 21 is provided with a thrombus aspiration external port 20 that communicates with the thrombus aspiration channel 7 for connecting a negative pressure device. Under the action of the negative pressure device (which provides stable negative pressure or pulsed negative pressure), thrombi on the inner wall of the blood vessel are aspirated through the thrombus aspiration inlet 23.

[0059] The suction tube body 21 has a perfusion channel side hole 13 on its wall between the thrombectomy inlet 23 and the rear balloon 9, which communicates with the perfusion channel 12. The perfusion channel side hole 13 may have multiple small holes or strip-shaped slots. The perfusion channel side hole 13 spans a length of about 3.0 cm. The rear of the suction tube body 21 has a side hole perfusion channel outer port 18 for perfusing transparent liquid, which communicates with the perfusion channel 12. By injecting transparent liquid (such as heparinized saline) into the side hole perfusion channel outer port 18, the transparent liquid enters the working interface blood vessel lumen of the double balloon occlusion through the perfusion channel 12 and the perfusion channel side hole 13, forming an inlet / outlet closed loop with the thrombectomy channel 7. This balances the damage to the blood vessel wall caused by negative pressure suction and improves the efficiency of thrombectomy. Because transparent liquid is continuously or intermittently introduced into the working interface blood vessel lumen and discharged through the thrombectomy channel 7, the camera installed on the suction tube body 21 can clearly see the situation in the working interface blood vessel lumen.

[0060] A quick exchange end 2 is provided at the front end of the notch section 22. The quick exchange end 2 is a tapered tube with a guidewire quick exchange channel 1 in the center. The tapered shape of the quick exchange end 2 can quickly guide the whole device into the predetermined working area of ​​the blood vessel. The outer diameter of the quick exchange end 2 is 1.0 mm and the length is 5.0 mm. The guidewire quick exchange channel 1 (diameter = 0.5 mm) can introduce the device into the blood vessel through a 0.018 inch micro guidewire. The quick exchange end 2 is not combined with the aspiration catheter body (i.e. there is a notch section 22 between the two), which can effectively reduce the diameter of the catheter body to meet the needs of thrombectomy of small-diameter blood vessels, and also reduce the manufacturing difficulty.

[0061] In the notch section 22, the quick exchange support rod 3, about 5.0 mm long, is located between the quick exchange end 2 and the front balloon 4. The balloon support rod 5, about 20 mm long, is located between the front balloon 4 and the suction tube body 21 and the suction plug inlet 23. The balloon support rod 5 gradually widens and connects to the suction tube body 21. The connection part is the same width as the suction tube body 21.

[0062] To facilitate observation of the thrombectomy process, a camera cable 8 (approximately 0.4 mm in diameter) and a miniature camera 6 (approximately 0.6 mm in diameter) connected to the end of the suction tube 8 are threaded inside the suction tube body 21. The miniature camera 6 is installed beside the thrombectomy inlet 23. A camera cable support sheath 15, a cable protection layer 16, and a WIFI signal transmitter 17 are sequentially arranged on the rear side of the suction tube body 21. The camera cable 8 passes through the camera cable support sheath 15 (1.5 mm in diameter) and the cable protection layer 16 (1.2 mm in diameter) in sequence and is connected to the WIFI signal transmitter 17. The image inside the blood vessel can be transmitted in real time to an external image receiving and display device (existing technology, not described in detail here) through the wireless (WiFi) signal transmitter module 17 connected to the tail end. Doctors can then perform adaptive operations based on the images displayed on the display device.

[0063] Another embodiment: A front-end opaque metal marking ring 24 is provided around the surface of the quick exchange end 2 of the aspiration system body 21, a middle opaque metal marking ring 25 is provided around the surface of the aspiration system body 21 at the opening of the thrombectomy channel 7, and a rear-end opaque metal marking ring 26 is provided around the surface of the aspiration system body 21 behind the rear balloon 9, so as to facilitate marking and positioning the catheter position during thrombectomy under X-ray guidance.

[0064] The key technical points of this utility model are:

[0065] 1. The miniature camera device, the core component of this invention, overcomes the weakness of all clinical thrombus removal devices that cannot monitor the operating interface in real time. It can accurately extract thrombi, judge the thrombus removal effect in real time, and avoid thrombus residue and damage to the inner wall of blood vessels.

[0066] 2. The dual-balloon design effectively prevents blood from entering the operating interface, reducing blood loss during surgery. The balloon is designed as a compliant balloon, allowing it to closely conform to the inner wall of blood vessels of various diameters at low pressure, thus blocking blood flow without damaging the vessel wall. Similar single-balloon designs can only block blood flow at one end of the vessel. After a thrombus obstructs a blood vessel, collateral vessels often flow from the proximal end of the obstruction, bypassing the obstruction and perfusing into the vessel from the distal end. While proximal single-balloon designs can reduce but not completely block blood flow to the operating interface, significant blood loss still occurs during aspiration. The dual-balloon design of this application offers superior control compared to the single-balloon design. The anterior and posterior sealing creates an independent space for the entire operating interface, ensuring precise positioning and eliminating interference from blood flow perfusion, allowing for accurate and efficient thrombectomy.

[0067] 3. The miniature camera device combined with the dual balloon design prevents residual thrombi and tissue fragments from escaping and causing secondary embolism downstream. Without balloon-blocked blood flow, conventional aspiration catheters may not completely aspirate small thrombi or tissue fragments that were not fully aspirated during the moment when blood flow is partially opened or when thrombi are suddenly removed to restore blood flow. These fragments can be carried downstream as blood flow resumes, causing secondary embolism. In contrast, due to the balloon blocking function of this application, residual thrombi or tissue fragments remain in place after partial or complete opening of the blood vessel. The camera device can clearly monitor the residual thrombus status within the blood vessel lumen and can perform targeted re-aspiration to ensure no small thrombi or tissue fragments remain, preventing the escape of small thrombi and tissue fragments after blood flow is restored and causing secondary embolism downstream.

[0068] 4. The coaxial perfusion channel and parallel multi-side hole design allow for continuous perfusion of heparinized saline to promote thrombus detachment during the procedure; and form a closed-loop structure with the aspiration channel to prevent excessive negative pressure from damaging the vascular wall; the multi-side hole design (i.e., the side hole 13 of the perfusion channel) can also continuously introduce carbon dioxide gas during the procedure to improve the visibility of the working interface; or alternately introduce carbon dioxide-heparinized saline to improve the efficiency of thrombectomy.

[0069] 5. The head end is equipped with a quick-exchange end, which can quickly introduce the suction tube into the working area. The quick-exchange end is not parallel to the main body of the suction tube, which can effectively reduce the diameter of the suction tube, making it easier for the suction tube to enter blood vessels with smaller diameters, while also reducing manufacturing difficulty.

[0070] The technical advantages of this invention compared to existing suction catheter devices are as follows:

[0071] 1. The dual-balloon design ensures precise segmented thrombectomy and minimizes blood loss. The dual compliant balloons effectively block blood flow at the working interface, minimizing intraoperative blood loss. This allows the procedure to be performed comfortably within the double-balloon-sealed area without concern for potential harm to the patient from blood loss. After successful segmented thrombectomy, the catheter is advanced to the next segment to inflate the balloon, and the thrombectomy is repeated. This process effectively improves surgical safety and the chance of vascular recanalization.

[0072] 2. The built-in miniature camera provides real-time intravascular imaging and adjusts the treatment plan accordingly. In clinical practice, the acquisition and transmission of real-time intravascular imaging data is of great guiding importance for determining thrombus morphology, evaluating the effectiveness of thrombectomy, and adjusting the treatment plan in a timely manner.

[0073] In clinical practice, two commonly used methods for direct high-resolution imaging of intravascular structures are intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The clinical applications of these two methods overlap and intersect, and their characteristics differ:

[0074] (1) Intravascular Ultrasound (IVUS) can image local blood vessels, but its principle lies in the secondary processing of ultrasound echo information. Therefore, the image is a reconstructed grayscale image, not a true image of the blood vessel lumen. In addition, its resolution is low, and the real-time image shows large granularity, which cannot clearly distinguish the residual thrombus in the blood vessel. The axial resolution of IVUS is 100-150 micrometers, and the radial resolution is 150-300 micrometers (at 40 MHz) or 40-60 micrometers (at 60 MHz). This limits its ability to conduct detailed assessments of conditions such as arterial dissection and tissue protrusion. At the same time, the use of IVUS requires the removal of the aspiration catheter before the IVUS is introduced, which makes the operation complicated and may prolong the operation time and increase the cost due to the need for an imaging catheter.

[0075] (2) Optical Coherence Tomography (OCT) OCT has a resolution that can reach the micrometer level (usually 10-20 micrometers), which is much higher than that of traditional ultrasound imaging (usually 100-150 micrometers). This allows 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, OCT has a shallower penetration depth, usually only penetrating a few millimeters of tissue depth (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 vessel and its wall will be missed. ② Sensitive to scattering media: OCT imaging depends on the reflection and scattering of light, so the imaging quality will decrease in highly scattering media (such as blood or certain tissue types). Therefore, its application in thrombotic lesions is greatly limited. ③ Inconvenient operation. Similar to IVUS, OCT imaging also requires the aspiration catheter to be removed from the body before imaging, so it cannot be performed continuously with the aspiration operation. ④ Contrast agent required. During OCT imaging, a contrast agent needs to be injected to clear the blood from the vessel lumen so that the infrared light from the catheter tip can be used for imaging. When a thrombus blocks a vessel, the contrast agent cannot flow forward and will form turbulence with the mixture of residual thrombus, tissue debris, and blood, thus significantly reducing image quality and making it difficult to determine vessel patency and the extent of residual thrombus. ⑤ Weaknesses in reconstructed images. Although OCT has high resolution, it is still an energy-based reconstruction of grayscale / pseudo-color images, not a true image of the blood vessel, which limits the accurate determination of the nature of the lesion.

[0076] The two methods described above are complex and require specialized imaging and aspiration catheters, resulting in high costs. Currently, to facilitate operation and monitor thrombus aspiration status in real time, clinical thrombus aspiration is routinely performed under X-ray guidance. However, soft tissues such as vascular thrombi are not visible under X-ray, and the extent and degree of thrombus obstruction are indirectly determined solely by preoperative angiography results. During vascular aspiration, the removal of thrombi is determined solely by whether negative pressure is reduced and whether a large amount of blood is drawn through the catheter; follow-up angiography can only provide a rough assessment of vascular patency and cannot accurately evaluate whether there is residual thrombus or damage to the vascular wall. Therefore, using the aforementioned two methods of vascular imaging and routine thrombus aspiration is somewhat arbitrary and lacks precision. This application, with its built-in imaging device, can accurately assess intraoperative complications such as vascular loss and residual thrombus until the vascular obstruction is completely relieved, eliminating the arbitrariness and uncertainty of operations without endovascular monitoring.

[0077] The dual-balloon design in this device ensures that the clarity, breadth, and depth of the images meet treatment requirements. After inflation, the working interface is isolated from the upstream and downstream areas of the blood vessel. Through aspiration and perfusion channels, the blood in the isolated segment is emptied, and saline solution is injected. The imaging device can then clearly image the intravascular lumen in real time. Therefore, integrating the imaging device into the aspiration system of this application is highly feasible both theoretically and practically.

[0078] 3. The built-in camera device and dual balloon design effectively prevent thrombus escape and secondary embolism downstream. In conventional thrombectomy, the opening of blood vessels is random and uncontrollable. Even after the main or most thrombus is removed, as blood flow partially or completely recovers, residual thrombi and / or tissue fragments that were not completely removed can escape from the original blockage site and enter the downstream blood flow, causing secondary embolism. The dual balloon design of this invention ensures that all thrombus aspiration operations are completed under precise control. After most or the main thrombus has been removed from the body, the camera device clearly shows the residual thrombus and tissue fragments in the dual balloon blockage area, allowing for subsequent operations to be carried out calmly until all thrombi and / or fragments are completely cleared.

[0079] 4. Coaxial perfusion channel and multi-side hole design. This design allows for continuous perfusion of heparinized saline during the operation, so that the perfusion-aspiration state can continue without worrying about excessive blood loss. (1) Continuous circulation can effectively promote the dissolution and loosening of thrombi, making them easier to enter and exit the aspiration catheter. At the same time, (2) the double balloon controls the working interface to be in a closed and stable state. By adjusting the perfusion rate and the perfusion closure state, the aspiration negative pressure can be made to fluctuate in a pulse-like periodic manner. This changing negative pressure will generate repeated impact loads on the thrombus and surrounding blood vessels. Compared with stable negative pressure, the impact load can more effectively destroy the static friction between the thrombus and the blood vessel wall, making the thrombus easier to be aspirated. At the same time, the pulse aspiration will cause the blood pressure around the thrombus and the pressure at the distal end of the aspiration catheter to fluctuate in a pulse. This pressure difference change can increase the instability of the thrombus and promote the loosening of the thrombus.

[0080] The physical properties of thrombi determine that pulse aspiration is a very efficient thrombus removal strategy: (1) Viscoelastic properties of thrombi: Thrombi are heterogeneous viscoelastic solids with viscoelastic recovery hysteresis and long-term deformation. Under the action of pulse negative pressure, the deformation of thrombi lags behind the change of stress, and the long-term maintenance of the tensile equilibrium state will cause the thrombi to undergo certain deformation and 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 friction force it experiences changes from static friction to a smaller dynamic friction, making it easier to be extracted; (2) the heterogeneity of the thrombus: from a pathological perspective, thrombi can be divided into three types: red thrombi (mainly composed of red blood cells and fibrin, containing a small amount of platelets and white blood cells), white thrombi (mainly composed of platelets and a small amount of fibrin), and mixed thrombi (composed of platelets, red blood cells, fibrin and white blood cells); clinically, most thrombi are mixed thrombi, with complex components and uneven internal structure. 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 entire thrombus and facilitating aspiration.

[0081] 5. Rapid guidewire exchange: Conventional aspiration catheters or other types of thrombectomy devices require multiple complex interventional procedures to reach the working position. The specific procedure involves: introducing a guide tube through the puncture channel, inserting a guidewire into the guide tube, and using both to advance the guidewire to the working position. The guide tube is then removed, and the aspiration device and / or catheter are introduced through the guidewire using a coaxial technique to the working position within the blood vessel. The guidewire is then removed again before thrombectomy can be performed. However, in clinical practice, due to numerous firmly lodged thrombi obstructing the device and / or catheter, it is often necessary to remove the entire catheter and / or device from the body, thoroughly clean it, and repeat the complex procedure to reintroduce the cleaned catheter and device to the working position for aspiration. This process is frequently repeated, time-consuming, labor-intensive, and inefficient.

[0082] The rapid guidewire exchange channel 1 of this invention effectively overcomes the shortcomings of the aforementioned complex and inefficient operation: after the microguidewire (0.018 inch) is first delivered to the working position with the assistance of the catheter, the main body of the aspiration tube can be directly introduced into the working position based on the already positioned microguidewire. Because the guidewire only needs to pass through the short guide channel at its tip and does not contact the entire length of the aspiration catheter body or pass through the inner cavity of the aspiration channel, once the aspiration tube body is in place, the microguidewire can remain in place without being withdrawn from the body for embolization. Subsequently, if catheter blockage or other operations require the device to be removed from the body for treatment occur, after the cleaning operation is completed, the microguidewire remaining in place can be directly passed through the rapid guidewire exchange channel 1 to introduce the catheter device of this invention into the previously predetermined working position for embolization, greatly simplifying the steps and process of re-inserting the aspiration tube body, saving time and effort, and significantly improving surgical efficiency.

[0083] In addition, a mechanical gripping device can be introduced into the aspiration channel to perform precise cleaning and gripping operations on solid mural thrombi under real-time monitoring, thereby improving the chances of thrombus removal and vascular recanalization and effectively addressing the thrombus load limitations of conventional aspiration catheters.

[0084] The above description is merely an embodiment of this utility model and does not limit the patent scope of this utility model. Any equivalent modifications made based on the content of this utility model specification and drawings, or direct or indirect applications in related technical fields, are similarly included within the patent protection scope of this utility model.

Claims

1. An intravascular visualization dual-balloon thrombus aspiration device, characterized in that: It includes a suction tube body (21), a thrombus aspiration channel (7) located in the suction tube body, a balloon inflation channel (10) and an infusion channel (12). The front part of the suction tube body (21) is provided with a notch section (22), the notch section is provided with a balloon inflation channel (10) and a front balloon (4) that communicates with the balloon inflation channel, the middle part of the suction tube body (21) is provided with a rear balloon (9) that communicates with the balloon inflation channel (10), and the rear part of the suction tube body (21) is provided with a balloon inflation port (19) for inputting inflation fluid that communicates with the balloon inflation channel (10). The junction of the suction tube body (21) and the notch section (22) has a thrombus inlet (23) that communicates with the thrombus aspiration channel (7), and the rear of the suction tube body (21) is provided with a thrombus aspiration port (20) that communicates with the thrombus aspiration channel (7) for connecting a negative pressure device. The suction tube body (21) has a side hole (13) for perfusion channel that communicates with the perfusion channel (12) between the embolization inlet (23) and the rear balloon (9). The rear of the suction tube body (21) has a side hole for perfusion channel that communicates with the perfusion channel (12) for perfusing transparent liquid. After the front balloon (4) and the rear balloon (9) are filled with fluid, they swell and abut against the inner wall of the blood vessel to form an operating interface that prevents blood from entering the blood vessel between the front balloon (4) and the rear balloon (9).

2. The intravascular visualization dual-balloon thrombus aspiration device according to claim 1, characterized in that: The notch (22) is formed by cutting off a section at the upper part of the front end of the suction tube body (21) to create a recess that is relatively lower than the 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 is connected to the front balloon (4) through the front balloon inflation channel inlet (11) located on the wall of the suction tube body (21). The rear balloon (9) is connected to the rear balloon (9) through the rear balloon inflation channel inlet (14) located on the wall of the suction tube body (21).

4. The intravascular visualization dual-balloon thrombus aspiration device according to claim 3, characterized in that: The front end of the notch section (22) is provided with a fast exchange end (2), which is a tapered tube with a guide wire fast 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 made of tubular impermeable membrane material and is placed on the middle of the notch section (22), and the two ends of the front balloon (4) are sealed and bonded to the wall of the notch section (22); the rear balloon (9) is made of tubular impermeable membrane material and is placed on the suction tube body (21), and the two ends of the rear balloon (9) are sealed and bonded to the tube wall of the suction tube body (21).

6. The intravascular visualization dual-balloon thrombus aspiration device according to claim 1, characterized in that: The suction tube body (21) is equipped with a camera cable (8) and a miniature camera (6) connected to the end of the camera cable (8). The miniature camera (6) is installed on the side of the suction inlet (23).

7. The intravascular visualization dual-balloon thrombus aspiration device according to claim 6, characterized in that: The rear side of the suction tube body (21) is provided with a camera cable support sheath (15), a cable protection layer (16) and a WIFI signal transmitter (17). The camera cable (8) passes through the camera cable support sheath (15) and the cable protection layer (16) in sequence and is connected to the WIFI signal transmitter (17).

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

9. The intravascular visualization dual-balloon thrombus aspiration device according to claim 1, characterized in that: The negative pressure device provides stable negative pressure or pulsed negative pressure.

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

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