Intravascular guide catheter with balloon occlusion and flushing function

Abstract

The application discloses a balloon blocking and flushing function's intravascular guide catheter, including catheter body, balloon blocking section and proximal end connecting assembly, the catheter body has the main inner cavity through in the axial direction, the main inner cavity can be used for the intervention instrument to pass, the distal end of the catheter body is provided with the flushing liquid outlet structure that communicates with the main inner cavity, the balloon blocking section is around and is arranged on the outer wall of the distal end of catheter body, and is located on the proximal end side of the distal end tip of the catheter body, by the main inner cavity of catheter body itself reuse, simultaneously as the intervention instrument passageway and the flushing fluid delivery channel, effectively reduce the overall outer diameter of catheter and simplify the structure, the distal end balloon can reliably block the target blood vessel to block the blood flow, simultaneously, the main inner cavity can obtain the flushing flow that is much better than the built-in flushing cavity of miniature endoscope, effectively flushes and removes the residual blood in the blood vessel, and quickly constructs the bloodless operation visual field.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically an intravascular guiding catheter with balloon occlusion and flushing functions. Background Technology

[0002] In interventional vascular procedures, balloon guiding catheters are a commonly used medical device. They are mainly used to temporarily block blood flow in target blood vessels by inflating the distal balloon, thus providing surgical conditions for endovascular operations. They are widely used in interventional surgeries of cerebrovascular, cardiovascular, and peripheral blood vessels.

[0003] Most of the balloon guiding catheters currently used in clinical practice only have the function of blocking blood flow. The catheter body does not integrate a flushing channel. If it is necessary to flush the blood in the lumen of the blood vessel during the operation, an additional independent guiding catheter or microcatheter needs to be inserted to complete the flushing operation, which increases the number of instruments used during the operation, increases the number of operation steps, and increases the complexity of the operation.

[0004] Although some microvascular endoscopes have their own irrigation chambers, their internal irrigation chambers have a small flow cross-sectional area due to the overall outer diameter of the endoscope (usually 3Fr). The irrigation flow rate that can be achieved is far from meeting the clinical requirement of 20-30 mL / min, which makes it difficult to efficiently remove blood from the blood vessels and obtain a clear intraluminal view. At the same time, the inner lumen size of existing mainstream balloon catheters is too small to allow ultra-micro endoscopic catheters to pass through, which limits the synergistic application of blood flow occlusion and endoscopic visualization diagnosis and treatment. Furthermore, most balloon catheters are only available in a single size, which is difficult to adapt to target blood vessels of different diameters in clinical practice, thus limiting the applicable scenarios. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the present invention aims to provide an intravascular guiding catheter with balloon occlusion and flushing functions.

[0006] The technical solution adopted in this invention is as follows: an intravascular guiding catheter with balloon occlusion and flushing functions, comprising a catheter body, a balloon occlusion segment, and a proximal connection assembly;

[0007] The catheter body has a main inner cavity that extends axially. The main inner cavity can be used for the passage of interventional instruments and for the delivery of flushing fluid. The distal end of the catheter body is provided with a flushing fluid outlet structure that communicates with the main inner cavity.

[0008] The balloon occlusion section is disposed around the distal outer wall of the catheter body and is located on the proximal side of the distal tip of the catheter body. The balloon occlusion section includes a balloon and a balloon inflation / deflation tubing communicating with the interior of the balloon.

[0009] The proximal connection assembly is installed at the proximal end of the catheter body. The proximal connection assembly integrates at least an instrument insertion passage for interventional instruments to penetrate the main lumen, a flushing interface communicating with the main lumen, and a balloon inflation / deflation interface communicating with the balloon inflation / deflation tubing.

[0010] The flushing fluid outlet structure is located on the distal side of the balloon occlusion segment, so that the flushing fluid flows out of the flushing fluid outlet structure through the main lumen and directly acts on the vascular lumen region distal to the balloon occlusion segment.

[0011] In a preferred embodiment, the balloon occlusion segment is positioned 10 mm to 30 mm from the distal tip of the catheter body;

[0012] The inner diameter of the main lumen is not less than 1.0 mm to allow external endoscopic catheters with an outer diameter not greater than 1 mm to pass coaxially.

[0013] In a preferred embodiment, a balloon inflation / deflation line is provided within the interlayer of the catheter body wall. A through hole is provided in the section of the catheter body wall within the balloon coverage area. The distal end of the balloon inflation / deflation line is connected to the interior of the balloon through the through hole, so that the inflation medium enters or exits the balloon through the balloon inflation / deflation line and the through hole.

[0014] The inflation pressure of the balloon is 0.3 atm to 0.5 atm, and the inflated diameter ranges from 3 mm to 10 mm.

[0015] The increase in outer diameter of the catheter body due to the balloon in its folded state is no more than 0.3 mm.

[0016] The axial length of the balloon is 5 mm to 20 mm.

[0017] In a preferred embodiment, the flushing fluid outlet structure is a port opened at the distal tip of the catheter body, or a side hole opened on the side wall of the catheter body and located on the distal side of the balloon occlusion segment.

[0018] The main lumen is connected to the blood vessel lumen distal to the balloon occlusion segment via a flushing fluid outlet structure, and the flushing fluid outlet structure and the balloon inflation / deflation tubing are not connected to each other in the fluid path.

[0019] In a preferred embodiment, the catheter body has multiple outer diameter specifications, including four specifications: 4Fr, 5Fr, 6Fr, and 7Fr.

[0020] The outer diameter of the catheter body of the 4Fr specification is 1.35 mm, and the inner diameter of the main lumen is not less than 1.00 mm;

[0021] The 5Fr specification has an outer diameter of 1.67mm and an inner diameter of not less than 1.35mm;

[0022] The 6Fr specification has an outer diameter of 2.00mm and an inner diameter of not less than 1.67mm;

[0023] The 7Fr specification has an outer diameter of 2.33mm and an inner diameter of not less than 2.00mm.

[0024] In a preferred embodiment, the proximal connection assembly includes a Y-type connector, which is mounted on the proximal end of the catheter body;

[0025] The Y-type connector has a main passage that runs through the axis. A hemostatic valve is provided at the proximal end of the main passage. The hemostatic valve is opened by the instrument when it is inserted to form the instrument insertion passage. A flushing port is also provided at the proximal end of the main passage. Flushing fluid is injected into the main inner cavity through the flushing port.

[0026] The Y-type connector is also provided with a lateral branch, on which a balloon inflation / deflation port is provided. The balloon inflation / deflation port is connected to the balloon inflation / deflation pipeline. The main passage and the lateral branch are independent of each other in the internal fluid path and are not connected to each other.

[0027] In a preferred embodiment, at least one radiopaque marker is fixedly disposed at the distal end of the catheter body near the balloon occlusion segment. The radiopaque marker is made of platinum, tungsten, or barium-polymer composite material and is used for imaging and positioning under DSA or X-ray fluoroscopy.

[0028] In a preferred embodiment, the catheter body is a multi-layer composite tube, including an inner liner, an intermediate braided reinforcement layer, and an outer layer. The inner liner is made of PTFE or FEP, the intermediate braided reinforcement layer is a stainless steel braid or a nickel-titanium alloy braid, and the outer layer is made of polyurethane, nylon, or a fluoropolymer.

[0029] In a preferred embodiment, the flushing interface is a standard Luer connector for use with a medical syringe or a medical flushing pump.

[0030] In a preferred embodiment, the balloon is a semi-compliant balloon or a non-compliant balloon, and the balloon is made of medical-grade polyurethane material.

[0031] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0032] 1. By reusing the main lumen of the catheter body itself, which serves as both the passageway for interventional devices and the channel for delivering flushing fluid, the overall outer diameter of the catheter is effectively reduced and the structure is simplified. The distal balloon can reliably occlude the target blood vessel to block blood flow. At the same time, the main lumen can obtain a flushing flow rate far superior to that of the built-in flushing chamber of the miniature endoscope, effectively flushing away residual blood in the blood vessel, quickly establishing a bloodless surgical field, and fully meeting the clinical needs for visual clarity in endovascular operations.

[0033] 2. By offering a series of products with various outer diameters from 4Fr to 7Fr, each size can be adapted to target blood vessels of different diameters, comprehensively covering various vascular interventional clinical scenarios such as cerebral blood vessels, coronary arteries, and peripheral arteries. This not only solves the clinical problem that a single-size catheter cannot be adapted to blood vessels of different diameters, but also provides operators with the convenience of flexibly selecting the appropriate size according to the patient's vascular conditions.

[0034] 3. The radiopaque markers placed at the distal end of the catheter can be clearly visualized under intraoperative X-ray or DSA fluoroscopy, helping the operator to accurately determine the real-time position of the balloon occlusion segment and the irrigation fluid structure within the target vessel, reducing the operational risks caused by positioning errors. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the overall planar structure of the present invention;

[0036] Figure 2 This is a schematic diagram of the catheter of the present invention placed inside a blood vessel;

[0037] Figure 3 This is a schematic diagram of the internal structure of the device of the present invention penetrating the main cavity;

[0038] Figure 4 This is a schematic diagram of the guiding tube structure with balloon occlusion and flushing functions of the present invention;

[0039] Figure 5 This is a schematic diagram of the distal structure of the catheter (balloon + flushing fluid structure + distal tip) of the present invention;

[0040] Figure 6 This is a schematic diagram of the distal cross-section of the catheter of the present invention (showing the folding of the main lumen and the balloon);

[0041] Figure 7 This is a schematic diagram of the balloon occlusion function (inflated state) of the present invention;

[0042] Figure 8 This is a functional and structural schematic diagram of the flushing channel of the present invention;

[0043] Figure 9This is a schematic diagram of the proximal catheter structure (Y-type connector + irrigation port + filling port) of the present invention;

[0044] Figure 10 This is a schematic diagram of the multi-specification balloon structure adapted to different blood vessel diameters according to the present invention;

[0045] Figure 11 This is a schematic diagram of the structure of the present invention used in conjunction with an endoscopic catheter.

[0046] Marked in the image:

[0047] 100 - Catheter body; 110 - Main lumen;

[0048] 200 - Balloon occlusion segment; 210 - Balloon; 220 - Balloon inflation / deflation tubing;

[0049] 300 - Proximity connection assembly; 310 - Y-type connector;

[0050] 400 - Non-transmissive marking. Detailed Implementation

[0051] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0052] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0053] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0054] Reference Figures 1-11As shown, an endovascular guiding catheter with balloon occlusion and flushing functions includes a catheter body 100, a balloon occlusion section 200, and a proximal connecting assembly 300. The catheter body 100 has a main lumen 110 extending axially, which can accommodate interventional instruments and deliver flushing fluid. The catheter body 100 is a multi-layer composite tube, including an inner liner, a middle braided reinforcement layer, and an outer layer. The inner liner is made of PTFE or FEP, the middle braided reinforcement layer is made of stainless steel or nickel-titanium alloy braid, and the outer layer is made of polyurethane, nylon, or a fluoropolymer. By adopting a multi-layer composite tube structure, the inner liner has a low coefficient of friction, reducing the resistance of interventional instruments and external endoscopic catheters passing through the main lumen 110. The middle braided reinforcement layer can improve the overall pushing performance and torque transmission capacity of the catheter body 100, facilitating the delivery of the catheter to the target blood vessel during the procedure. At the same time, the outer layer material takes into account both flexibility and biocompatibility, reducing mechanical damage to the inner wall of the blood vessel.

[0055] Reference Figures 4 to 10 As shown, the catheter body 100 has multiple outer diameter specifications, including four specifications: 4Fr, 5Fr, 6Fr, and 7Fr. The outer diameter of the 4Fr specification catheter body 100 is 1.35mm, and the inner diameter of the main lumen 110 is not less than 1.00mm. The outer diameter of the 5Fr specification is 1.67mm, and the inner diameter is not less than 1.35mm. The outer diameter of the 6Fr specification is 2.00mm, and the inner diameter is not less than 1.67mm. The outer diameter of the 7Fr specification is 2.33mm, and the inner diameter is not less than 2.00mm. By setting multiple specifications of the catheter body 100 from 4Fr to 7Fr, different specifications can be matched with target blood vessels of different diameters, which can cover multiple clinical interventional surgical scenarios such as cerebral blood vessels, coronary arteries, and peripheral arteries, and solve the problem of poor adaptability of traditional balloon catheters with single specifications.

[0056] Reference Figures 4 to 11 As shown, the distal end of the catheter body 100 is provided with a flushing fluid outlet structure communicating with the main lumen 110. The flushing fluid outlet structure is located on the distal side of the balloon occlusion segment 200, so that the flushing fluid flows out of the flushing fluid outlet structure through the main lumen 110 and directly acts on the vascular lumen region distal to the balloon occlusion segment 200. With the flushing fluid outlet structure arranged on the distal side of the balloon occlusion segment 200, after the balloon blocks the upstream blood flow, the flushing fluid directly enters the distal vascular lumen isolated by the balloon, which can quickly flush the blood in the lumen and create a bloodless surgical field. At the same time, the main lumen 110 is reused as a flushing fluid delivery channel, eliminating the need to add an additional independent flushing chamber and reducing the number of interventional instruments used during the operation.

[0057] Reference Figure 2 , Figure 3 and 7As shown, the balloon occlusion segment 200 is disposed around the distal outer wall of the catheter body 100 and located on the proximal side of the distal tip of the catheter body 100. The balloon occlusion segment 200 includes a balloon 210 and a balloon inflation / deflation tubing 220 communicating with the interior of the balloon 210. The balloon 210 is a semi-compliant or non-compliant balloon and is made of medical polyurethane material. The semi-compliant or non-compliant medical polyurethane balloon 210 has good biocompatibility and excellent pressure resistance. After inflation, it can reliably block the lumen of the target blood vessel to achieve temporary blood flow occlusion.

[0058] Specifically, the catheter body 100 has a through main lumen 110 inside. This main lumen 110 serves two purposes: it acts as a passageway for interventional devices and external endoscopic catheters, and as a flow channel for flushing fluid. By using the larger diameter main lumen 110 as a flushing channel, the flow cross-sectional area is much larger than the small flushing chamber of the micro-endoscope, thus achieving a flushing flow rate of 20-30 mL / min without the need for a separate small flushing chamber. The catheter body 100 has an independently installed balloon inflation / deflation line 220 inside the wall interlayer. This line connects to the distal balloon 210 and the proximal end to the proximal connection component 300. When it is necessary to block blood flow, the inflation medium is introduced through the balloon inflation / deflation interface. The medium reaches the balloon 210 along the balloon inflation / deflation line 220, causing the balloon 210 to inflate and adhere to the inner wall of the target blood vessel, thereby temporarily blocking the upstream blood flow.

[0059] Reference Figure 3 , Figure 4 and Figure 5 As shown, the balloon occlusion section 200 is positioned 10mm to 30mm from the distal tip of the catheter body 100. The inner diameter of the main lumen 110 is not less than 1.0mm to allow coaxial passage of an external endoscopic catheter with an outer diameter not greater than 1mm. A balloon inflation / deflation channel 220 is provided within the interlayer of the catheter body 100 wall. A through-hole is provided in the section of the catheter body 100 wall within the coverage area of ​​the balloon 210. The distal end of the balloon inflation / deflation channel 220 is connected to the interior of the balloon 210 through the through-hole, so that the inflation medium enters or exits the balloon 210 through the balloon inflation / deflation channel 220 and the through-hole. The main lumen 110 is connected through... The flushing fluid outlet structure is connected to the lumen of the blood vessel distal to the balloon occlusion segment 200, and the flushing fluid outlet structure and the balloon inflation / deflation line 220 are not interconnected in the fluid path. The distance between the balloon occlusion segment 200 and the tip of the catheter body 100 is 10-30 mm, which provides operating space for distal flushing and endoscopic imaging. At the same time, the inner diameter of the main lumen 110 meets the requirements for the passage of external endoscopic catheters, realizing the coordinated diagnosis and treatment of blood flow occlusion and endoscopic visualization. Furthermore, the balloon inflation / deflation line 220 is arranged in the interlayer of the tube wall, and the flushing fluid path and the balloon inflation / deflation fluid path are independent and not interconnected, avoiding cross-flow between the filling medium and the flushing medium.

[0060] Reference Figures 6 to 10 As shown, the inflation pressure of balloon 210 is 0.3 atm to 0.5 atm, and the inflated diameter ranges from 3 mm to 10 mm. When folded, the balloon 210 causes an outer diameter increase of no more than 0.3 mm on the outer wall of the catheter body 100. The axial length of balloon 210 is 5 mm to 20 mm. The flushing fluid outlet is either a port located at the distal tip of the catheter body 100 or a side hole located on the side wall of the catheter body 100, distal to the balloon blocking segment 200. The balloon 210 is inflated at a pressure of 0.3 atm to 0.5 atm. With a diameter ranging from m to 0.5 atm, it is suitable for the occlusion pressure requirements of different blood vessels such as cerebral vessels, coronary vessels, and peripheral vessels. The filling diameter is 3-10mm, matching the inner diameter of common clinical blood vessels. The outer diameter increase in the folded state is no more than 0.3mm, ensuring that the overall outer diameter of the catheter is small and reducing the stimulation of blood vessels during catheter delivery. At the same time, the axial length of 5-20mm ensures the contact length between the balloon 210 and the inner wall of the blood vessel, improving the reliability of vascular occlusion and sealing. The flushing fluid outlet structure provides two implementation forms: tip port and side wall side hole, to adapt to the needs of different surgical conditions.

[0061] Specifically, the inner diameter of the main lumen 110 can accommodate an external endoscopic catheter with an outer diameter of no more than 1 mm to coaxially pass through. The endoscopic catheter can pass through the main lumen 110 and deliver the imaging window to the distal end of the balloon occlusion segment 200. Under the conditions of balloon occlusion of blood flow and irrigation to establish a bloodless field of vision, endovascular visualization diagnosis and treatment can be performed. This guiding catheter is available in multiple sizes from 4 to 7 Fr, and with the distal radiopaque marker 400, it is compatible with cerebral blood vessels, coronary arteries, and peripheral blood vessels of different diameters. This device can be used in conjunction with an external endoscopic catheter for synergistic imaging diagnosis and treatment, or it can be used alone as a balloon occlusion catheter without the use of an endoscope. The irrigation function can be opened and closed as needed. After the operation, the balloon 210 is depressurized, the balloon contracts, and the catheter can be withdrawn.

[0062] Reference Figure 1 , Figure 2 and Figure 3 As shown, at least one radiopaque marker 400 is fixedly installed at the distal end of the catheter body 100 near the balloon occlusion segment 200. The radiopaque marker 400 is made of platinum, tungsten or barium-polymer composite material and is used for imaging and positioning under DSA or X-ray fluoroscopy. With the radiopaque marker 400 clearly visible under DSA or X-ray fluoroscopy, the surgeon can determine the position of the catheter body 100 and the balloon occlusion segment 200 inside the blood vessel in real time during the operation, which helps with surgical positioning.

[0063] Reference Figures 1 to 4As shown, the proximal connection component 300 is installed at the proximal end of the catheter body 100. The proximal connection component 300 integrates at least a device insertion passage for interventional devices to pass through the main lumen 110, a flushing interface communicating with the main lumen 110, and a balloon inflation / deflation interface communicating with the balloon inflation / deflation tubing 220. The flushing interface is a standard Luer connector, used to adapt to medical syringes or medical flushing pumps. Through the integrated three-function interface of the proximal connection component 300, one device can simultaneously perform device passage, fluid flushing, and balloon inflation / deflation operations. The flushing interface uses a standard Luer connector, which can be directly connected to existing clinical medical syringes and medical flushing pumps without the need for special adapters.

[0064] Reference Figures 1 to 11 As shown, the proximal connection assembly 300 includes a Y-type connector 310, which is installed at the proximal end of the catheter body 100. The Y-type connector 310 has a main passage that runs through the axial direction. A hemostatic valve is provided at the proximal end of the main passage. The hemostatic valve is opened by the device during insertion to form a device insertion passage. A flushing port is also provided at the proximal end of the main passage. Flushing fluid is injected into the main lumen through the flushing port. The Y-type connector 310 also has a lateral branch with a balloon inflation / deflation port connected to the balloon inflation / deflation tubing 220. The main passage and the lateral branch are independent of each other in terms of internal fluid path and are not interconnected. The Y-type connector 310 allows the installation of a hemostatic valve to maintain the tubing seal during the passage of interventional devices and external endoscopic catheters, preventing blood and flushing fluid from leaking out. At the same time, the fluid of the main passage and the lateral branch is isolated from each other, further ensuring the safety of multi-medium operation of the device.

[0065] Specifically, the proximal Y-connector 310 integrates three independent flow channels: the device insertion channel, the flushing interface, and the balloon inflation / deflation interface. The hemostatic valve ensures the sealing of the tubing during device insertion. The flushing fluid is injected into the main lumen 110 through the flushing interface, and then transported along the main lumen 110 to the distal end of the catheter body 100. It flows out from the flushing fluid outlet structure located on the distal side of the balloon occlusion section 200 and directly enters the distal blood vessel lumen isolated by the balloon 210, flushing the blood in the lumen and creating a bloodless field of view for endoscopic observation. The flushing fluid channel is completely isolated from the balloon inflation / deflation channel, preventing media cross-flow.

[0066] The guiding catheter of this invention has two working modes: a collaborative imaging mode and an independent occlusion mode. In the collaborative imaging mode, the balloon occlusion segment 200 blocks blood flow, and the main lumen 110 is irrigated with flushing fluid to establish a bloodless field of view, which is used for imaging through which an external endoscopic catheter passes. In the independent occlusion mode, the balloon occlusion segment 200 blocks blood flow without the need for an external endoscopic catheter, and the flushing interface can be selectively opened or closed. The specific usage steps are as follows:

[0067] Step S1: Select the corresponding guide catheter according to the diameter of the target blood vessel. 4Fr specification is suitable for small blood vessels with a diameter of 3-5mm, 5Fr specification is suitable for small and medium blood vessels with a diameter of 4-7mm, 6Fr specification is suitable for medium and large blood vessels with a diameter of 6-8mm, and 7Fr specification is suitable for large blood vessels with a diameter of 7-10mm. Insert the selected guide catheter through the vascular puncture sheath. Under DSA or X-ray fluoroscopy, locate the catheter by the radiopaque marker 400. Push the distal end of the catheter body 100 to the proximal end of the predetermined blocking position of the target blood vessel.

[0068] Step S2: Connect the inflation device to the balloon inflation / deflation interface on the lateral branch of the Y-type connector 310, and inject inflation medium into the balloon 210 through the balloon inflation / deflation line 220. The inflation pressure is 0.3 atm to 0.5 atm, so that the balloon 210 is inflated to the predetermined diameter (3 mm to 10 mm). The outer wall of the balloon 210 fits tightly against the inner wall of the target blood vessel, so as to completely block the lumen of the target blood vessel and block the antegrade blood flow in the blood vessel.

[0069] Step S3: Connect a medical syringe or medical flushing pump to the flushing interface at the proximal end of the main access via the Y-type connector 310, and inject flushing fluid such as saline or contrast agent through the main lumen 110. The flushing fluid flows distally along the main lumen 110 and flows out from the port at the distal tip of the catheter body 100 or the side hole on the distal side of the balloon blocking section 200, directly acting on the vascular lumen area distal to the balloon 210. The flushing flow rate is not less than 20 mL / min (preferably 20 mL / min to 30 mL / min), quickly removing residual blood in this area and establishing a bloodless and transparent local field of view distal to the balloon 210.

[0070] Step S4 (executed in collaborative imaging mode): Insert an external ultra-micro endoscopic catheter with an outer diameter of no more than 1 mm through the hemostasis valve at the proximal end of the main access via the Y-type connector 310. Push the endoscopic catheter distally along the main lumen 110 until the distal imaging window of the endoscopic catheter extends beyond the distal tip of the catheter body 100 and is located distal to the balloon occlusion segment 200. At this time, observe the tissue morphology and lesion condition in the distal vascular lumen of the balloon 210 in real time through the imaging window of the endoscopic catheter.

[0071] Step S5 (executed in collaborative imaging mode): Under the condition of continuous flushing to maintain a bloodless field of vision, the endoscopic catheter is used to observe, diagnose and / or treat lesions in the distal vascular lumen of balloon 210, or in independent occlusion mode, under the condition of continuous flushing to maintain a bloodless field of vision, other interventional devices inserted through the main lumen 110 are used to perform vascular operations.

[0072] Step S6: After completing the assessment and treatment, if it is necessary to withdraw the endoscopic catheter, first withdraw it from the main lumen 110, then connect the negative pressure device through the balloon inflation and deflation interface, and extract the inflation medium in the balloon 210 through the balloon inflation and deflation tubing 220, so that the balloon 210 is depressurized and folded back to a low profile state, and the outer wall of the balloon 210 is de-contacted with the inner wall of the blood vessel.

[0073] Step S7: After confirming that the balloon 210 has been completely depressurized, withdraw the catheter body 100 from the blood vessel to complete the surgical procedure.

[0074] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An intravascular guiding catheter with balloon occlusion and flushing functions, characterized in that, Includes the catheter body, balloon occlusion segment, and proximal connection assembly; The catheter body has a main inner cavity that extends axially. The main inner cavity can be used for the passage of interventional instruments and for the delivery of flushing fluid. The distal end of the catheter body is provided with a flushing fluid outlet structure that communicates with the main inner cavity. The balloon occlusion section is disposed around the distal outer wall of the catheter body and is located on the proximal side of the distal tip of the catheter body. The balloon occlusion section includes a balloon and a balloon inflation / deflation tubing communicating with the interior of the balloon. The proximal connection assembly is installed at the proximal end of the catheter body. The proximal connection assembly integrates at least an instrument insertion passage for interventional instruments to penetrate the main lumen, a flushing interface communicating with the main lumen, and a balloon inflation / deflation interface communicating with the balloon inflation / deflation tubing. The flushing fluid outlet structure is located on the distal side of the balloon occlusion segment, so that the flushing fluid flows out of the flushing fluid outlet structure through the main lumen and directly acts on the vascular lumen region distal to the balloon occlusion segment.

2. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The balloon occlusion segment is positioned 10 mm to 30 mm from the distal tip of the catheter body; The inner diameter of the main lumen is not less than 1.0 mm to allow external endoscopic catheters with an outer diameter not greater than 1 mm to pass coaxially.

3. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The catheter body has a balloon inflation / deflation tubing in the interlayer of its tube wall. The tube wall section of the catheter body within the balloon coverage area has a through hole. The distal end of the balloon inflation / deflation tubing is connected to the inside of the balloon through the through hole, so that the inflation medium can enter or exit the balloon through the balloon inflation / deflation tubing and the through hole. The inflation pressure of the balloon is 0.3 atm to 0.5 atm, and the inflated diameter ranges from 3 mm to 10 mm. The increase in outer diameter of the catheter body due to the balloon in its folded state is no more than 0.3 mm. The axial length of the balloon is 5 mm to 20 mm.

4. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The flushing fluid outlet structure is a port opened at the distal tip of the catheter body, or a side hole opened on the side wall of the catheter body and located on the distal side of the balloon occlusion segment; The main lumen is connected to the blood vessel lumen distal to the balloon occlusion segment via a flushing fluid outlet structure, and the flushing fluid outlet structure and the balloon inflation / deflation tubing are not connected to each other in the fluid path.

5. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The catheter body has multiple outer diameter specifications, including four specifications: 4Fr, 5Fr, 6Fr and 7Fr; The outer diameter of the catheter body of the 4Fr specification is 1.35 mm, and the inner diameter of the main lumen is not less than 1.00 mm; The 5Fr specification has an outer diameter of 1.67mm and an inner diameter of not less than 1.35mm; The 6Fr specification has an outer diameter of 2.00mm and an inner diameter of not less than 1.67mm; The 7Fr specification has an outer diameter of 2.33mm and an inner diameter of not less than 2.00mm.

6. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The proximal connection assembly includes a Y-type connector, which is installed at the proximal end of the catheter body; The Y-type connector has a main passage that runs through the axis. A hemostatic valve is provided at the proximal end of the main passage. The hemostatic valve is opened by the instrument when it is inserted to form the instrument insertion passage. A flushing port is also provided at the proximal end of the main passage. Flushing fluid is injected into the main inner cavity through the flushing port. The Y-type connector is also provided with a lateral branch, on which a balloon inflation / deflation port is provided. The balloon inflation / deflation port is connected to the balloon inflation / deflation pipeline. The main passage and the lateral branch are independent of each other in the internal fluid path and are not connected to each other.

7. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: At least one radiopaque marker is fixedly disposed at the distal end of the catheter body near the balloon occlusion segment. The radiopaque marker is made of platinum, tungsten, or barium-polymer composite material and is used for imaging and positioning under DSA or X-ray fluoroscopy.

8. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The catheter body is a multi-layer composite tube, including an inner liner, an intermediate braided reinforcement layer and an outer layer. The inner liner is made of PTFE or FEP, the intermediate braided reinforcement layer is a stainless steel braid or a nickel-titanium alloy braid, and the outer layer is made of polyurethane, nylon or a fluoropolymer.

9. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The flushing interface is a standard Luer connector, used to adapt to medical syringes or medical flushing pumps.

10. The intravascular guiding catheter with balloon occlusion and flushing function according to claim 1, characterized in that: The balloon is a semi-compliant or non-compliant balloon, and the balloon is made of medical-grade polyurethane material.

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