Intelligent integrated balloon catheter system integrating guide wire guiding and vasodilatation

Abstract

The invention provides an intelligent integrated balloon catheter system integrating guide wire guiding and blood vessel dilatation, and the intelligent integrated balloon catheter system integrating guide wire guiding and blood vessel dilatation comprises a guide wire guiding mechanism, a blood vessel dilatation mechanism and a balloon dilatation mechanism which are integrally arranged, the balloon dilatation mechanism comprises a balloon and a sheathing canal, the balloon and the sheathing canal are arranged in a penetrating mode, and the balloon comprises a first cavity and a second cavity; a miniature pressure sensor is arranged on the portion, between the balloon and the head end of the sheath tube, of the sheath tube. According to the technical scheme, the balloon solves the problem of early intervention of bleeding in a complex junction region in a pre-hospital and pre-operation waiting stage, and the aim of effectively blocking the bleeding stopping time to be prolonged to more than 90 minutes is achieved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to an intelligent integrated balloon catheter system integrating guidewire guidance and vascular dilation. Background Art

[0002] The existing hemostatic catheter system has some shortcomings, mainly including:

[0003] 1. Complete blockade ischemic risk. Only complete blockade is supported. Prolonged blockade (>30 minutes) can lead to visceral ischemia, acidosis-reperfusion injury, and aggravate coagulopathy. Traditional complete blockade techniques require more resuscitation resources (blood, fluids) to correct metabolic disorders and have a higher risk of complications (ARDS, septic shock).

[0004] 2. When the proximal blood pressure suddenly rises to ≥180 mmHg above the complete occlusion site, the risk of intracranial hemorrhage increases by 3.7 times, and the absolute mortality rate increases by 21%;

[0005] 3. Traditional technologies lack a blood flow feedback system and rely primarily on operator experience to adjust balloon pressure, leading to blood flow fluctuations and an "all-or-nothing" effect, which can cause limb ischemia and necrosis, reperfusion injury, and even death.

[0006] 4. In actual use, because the inner surface of the stenotic blood vessel is uneven, while the balloon surface is relatively smooth, the balloon is prone to slippage or displacement during the dilation process. This may result in insufficient dilation of the lesion site or unnecessary damage to non-lesion sites, thus affecting the treatment effect. Summary of the Invention

[0007] The present application provides an integrated hemostatic balloon catheter system that integrates guidewire guidance and vascular dilation to achieve effective hemostasis and extend the time of hemostasis to more than 90 minutes, becoming a powerful supplement to hemostasis methods.

[0008] The present application provides an integrated hemostatic balloon catheter system integrating guidewire guidance and vascular expansion, comprising: a guidewire guidance mechanism, a vascular expansion mechanism and a balloon expansion mechanism that are integrated into one body, wherein:

[0009] The balloon expansion mechanism includes a balloon and a sheath,

[0010] The balloon and the sheath are installed.

[0011] The balloon comprises a first cavity and a second cavity;

[0012] A micro pressure sensor is provided on the sheath tube between the balloon and the inlet of the sheath tube.

[0013] In the above technical solution, an integrated guidewire guidance mechanism, a vascular expansion mechanism and a balloon expansion mechanism are provided, wherein the balloon expansion mechanism includes a balloon and a sheath, and the balloon and the sheath are inserted into each other, and the balloon includes a first cavity and a second cavity; a micro pressure sensor is provided on the sheath between the entrances of the balloon and the sheath; in the above technical solution, the balloon solves the problem of early intervention of complex borderline bleeding in the pre-hospital and pre-operative waiting stages, and achieves effective hemostasis time extended to more than 90 minutes.

[0014] In a specific embodiment, the sheath is provided with: a balloon inflation channel, a guidewire catheter channel and a sensor output channel in separate parts.

[0015] In a specific embodiment, the balloon and the sheath are integrated.

[0016] In a specific embodiment, the device further comprises a detector, wherein the detector is electrically connected to the micro pressure sensor and is used to measure the flow rate / pressure of blood flow.

[0017] In a specific embodiment, the balloon is made of PET material.

[0018] In a specific embodiment, the diameter of the balloon after inflation is 2.5-3 cm.

[0019] In a specific embodiment, the catheter end of the balloon is provided with a curved tip.

[0020] In a specific embodiment, the guidewire guiding mechanism comprises a guidewire.

[0021] In a specific embodiment, the sheath is a 7F sheath.

[0022] In a specific embodiment, the micro pressure sensor is a precision integrated micro pressure sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A schematic structural diagram of an intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation provided in an embodiment of the present application;

[0024] Figure 2 Schematic diagram of the cross-sectional structure of the intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation provided in an embodiment of the present application.

[0025] Among them, 1-balloon, 2-sheath, 3-first cavity, 4-second cavity, 5-micro pressure sensor, 6-balloon inflation channel, 7-guidewire catheter channel, 8-sensor output channel, 10-curved tip. DETAILED DESCRIPTION

[0026] The present application will be further described in detail below through the accompanying drawings and examples, through which the features and advantages of the present application will become more clear and distinct.

[0027] The word "exemplary" is used exclusively herein to mean "serving as an example, example, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. Although various aspects of the embodiments are shown in the drawings, the drawings are not necessarily drawn to scale unless otherwise indicated.

[0028] In addition, the technical features involved in different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0029] To facilitate understanding of the integrated hemostatic balloon catheter system with integrated guidewire guidance and vascular dilation provided in the embodiment of the present application, its application scenario is first explained. The integrated hemostatic balloon catheter system with integrated guidewire guidance and vascular dilation provided in the embodiment of the present application is used to achieve the goal of effectively extending the hemostatic blockage time to more than 90 minutes, forming a powerful supplement to hemostatic means. Existing balloon catheter systems have some shortcomings, mainly including: 1. Complete blockage of ischemic risk, only supporting complete blockage, long-term (>30 minutes) blockage leads to visceral ischemia, acidosis reperfusion injury, and aggravates coagulation dysfunction. Furthermore, traditional complete occlusion techniques require more resuscitation resources (blood, fluids) to correct metabolic disorders and have a higher incidence of complications (ARDS, septic shock). 2. When proximal blood pressure suddenly rises to ≥180 mmHg above the complete occlusion site, the risk of intracranial hemorrhage increases 3.7-fold and the absolute mortality rate increases by 21%. 3. Traditional techniques lack a blood flow feedback system and rely primarily on operator experience to adjust balloon pressure, leading to blood flow fluctuations and an "all-or-nothing" effect, causing limb ischemia and necrosis, reperfusion injury, and even death. 4. In actual practice, because the inner side of the stenotic vessel is uneven, while the balloon surface is relatively flat and smooth, the balloon is prone to slippage or displacement during expansion. This can lead to insufficient expansion of the lesion site or unnecessary damage to non-lesion sites, thus compromising the treatment effect.

[0030] refer to Figure 1 and Figure 2 , Figure 1 A schematic structural diagram of an intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation provided in an embodiment of the present application; Figure 2 Schematic diagram of the cross-sectional structure of the intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation provided in an embodiment of the present application.

[0031] This application aims to investigate the design principles of the resuscitative intravascular aortic balloon (REBOA), analyze its design advantages and limitations, and propose improvement requirements. At the same time, based on anatomical data such as aortic diameter, blood flow rate and pressure in different occlusion areas, an automated intraluminal variable aortic occlusion system including a sheath, balloon, micro pressure sensor, monitoring module and volume control device is designed to achieve miniaturization demonstration based on the completion of functional research. It is mainly used for early intervention of complex junctional bleeding in the pre-hospital and pre-operative waiting stages, so as to achieve effective occlusion and hemostasis time extended to more than 90 minutes.

[0032] exist Figures 1 to 2 In the embodiment of the present application, an intelligent integrated balloon catheter system integrating guidewire guidance and vascular expansion is provided, comprising: a guidewire guidance mechanism, a vascular expansion mechanism and a balloon expansion mechanism which are integrated into one body, wherein:

[0033] The balloon expansion mechanism includes a balloon 1 and a sheath 2.

[0034] The balloon and the sheath are installed.

[0035] The balloon comprises a first cavity 3 and a second cavity 4;

[0036] A micro pressure sensor 5 is provided on the sheath between the balloon and the inlet of the sheath.

[0037] In the above technical solution, an integrated guidewire guidance mechanism, a vascular expansion mechanism and a balloon expansion mechanism are provided, wherein the balloon expansion mechanism includes a balloon and a sheath, and the balloon and the sheath are inserted into each other, and the balloon includes a first cavity and a second cavity; a micro pressure sensor is provided on the sheath between the entrances of the balloon and the sheath; in the above technical solution, the balloon solves the problem of early intervention of complex borderline bleeding in the pre-hospital and pre-operative waiting stages, and achieves effective hemostasis time extended to more than 90 minutes.

[0038] Specifically, the intelligent integrated balloon catheter system integrating guidewire guidance and vascular dilation improves surgical efficiency and safety, and its beneficial effects include:

[0039] 1. Prolong the effective hemostasis time

[0040] Core Mechanics:

[0041] Optimize catheter design and develop multifunctional catheters with complete / partial occlusion functions. Through mechanical design and micro-pressure sensors, precise blood flow regulation is achieved. Intelligent feedback system can adjust the degree of occlusion in real time, ultimately reducing the risk of bleeding above the occlusion site and ischemia in the lower limbs. Integrate damage control resuscitation strategies and combine with hypothermia resuscitation to reduce metabolic needs and extend the occlusion window.

[0042] Structure: The balloon is divided into independent chambers, the first chamber and the second chamber, which can achieve segmented expansion or targeted shaping through differentiated pressurization.

[0043] Clinical value: With the application of this intelligent balloon hemostatic catheter system, the hemostatic blockade time can be extended to more than 90 minutes compared with previous hemostatic balloons, while achieving the major goals of controlling distal ischemia-reperfusion and reducing the amount of resuscitation fluid, becoming a key survival node in borderline trauma bleeding.

[0044] 2. Reduce the incidence of cerebral vascular injury

[0045] Core Mechanism: The system uses a micro-pressure sensor to monitor blood pressure and blood flow in real time and regulate balloon volume. This system stops bleeding while partially releasing blood flow, alleviating the localized hypertension between the proximal balloon and the heart caused by traditional intraluminal aortic balloon occlusion technology, potentially reducing the risk of sudden death. By lowering blood pressure proximal to the balloon, the system reduces abnormally high blood perfusion in the brain, minimizing the risk of bleeding in patients with concomitant cerebral vascular injury while ensuring essential blood supply.

[0046] Function: The micro pressure sensor at the sheath entrance integrates a pressure sensor that can monitor in real time:

[0047] Balloon internal pressure: accuracy of ±0.01MPa, preventing blood vessel rupture caused by overfilling;

[0048] Balloon size: The diameter change is measured by laser (accuracy ±0.05mm) to ensure that the expansion size matches the vascular anatomy;

[0049] Sealing detection: Real-time monitoring of the balloon sealing status, with a rupture warning response time of <0.1 seconds.

[0050] 3. Increase the balloon's wall adhesion effect

[0051] Core Mechanism: The blocking balloon's surface is composed of both biomimetic vascular material and PET material, ensuring expansibility on one side while maintaining excellent adhesion to the aorta on the other. Furthermore, the guidewire guidance mechanism (hydrophilic-coated guidewire), vascular expansion mechanism (dual-lumen balloon), and balloon expansion mechanism are seamlessly linked through mechanical linkage, ensuring this adhesion persists despite the balloon's expansion and contraction.

[0052] Operational advantages: The 1:1 torque transmission design at the guidewire tip improves maneuverability by 50%, and the super-elastic nickel-titanium alloy core wire adapts to complex vascular anatomy;

[0053] The radiodetectable polyurethane coating improves positioning accuracy by 40%, reducing repeated adjustments during surgery.

[0054] In this technical solution, the system's "structure-function-monitoring" trinity design optimizes the entire process, from instrument operation to physiological parameter monitoring. Its core value lies in transforming the multi-step, multi-instrument collaboration of traditional surgery into a single, intelligent system. This not only meets the needs of the development of minimally invasive procedures, but also promotes the evolution of interventional surgery towards greater precision and safety.

[0055] In a specific embodiment, the sheath is provided with: a balloon inflation channel 6, a guidewire catheter channel 7 and a sensor output channel 8 in separate parts.

[0056] In a specific embodiment, the balloon and the sheath are integrated.

[0057] In a specific embodiment, a detector is further included, wherein,

[0058] The detector is electrically connected to the micro pressure sensor and is used to monitor the flow rate / pressure of the blood flow; in vitro monitoring collects the pressure-blood flow data and peripheral blood flow velocity of the blocking balloon in vivo.

[0059] In a specific embodiment, the balloon is made of PET material.

[0060] In a specific embodiment, the diameter of the balloon after inflation is 2.5-3 cm.

[0061] In a specific embodiment, the catheter end of the balloon is provided with a curved tip 10 .

[0062] In a specific embodiment, the guidewire guiding mechanism comprises a guidewire.

[0063] In a specific embodiment, the sheath is a 7F sheath.

[0064] In a specific embodiment, the micro pressure sensor is a precision integrated micro pressure sensor.

[0065] The precision integrated micro pressure sensor adopts a flexible circuit board combined with a waterproof process to ensure the stability of power supply and signal transmission of the pressure sensor.

[0066] In a specific embodiment, the balloon usage process of the intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation is as follows:

[0067] A brief description of the use of the intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation

[0068] 1. Preoperative Preparation and System Assembly

[0069] The doctor selects the appropriate 7F sheath specification, connects the integrated catheter system containing the guidewire, balloon and micro pressure sensor to the in vitro monitoring equipment (such as a pressure detector), and completes the power supply and signal connection test.

[0070] Pre-fill the first chamber (liquid filling chamber) and the second chamber (auxiliary chamber) of the balloon with normal saline through the extracorporeal injection port, check the balloon sealing (pressure sensor real-time response time < 0.1 second), and prepare it for use after confirming that there is no leakage.

[0071] 2. Vascular access establishment and guidewire guidance

[0072] Under image guidance, the guidewire catheter channel (channel 7) containing the hydrophilic coated guidewire is advanced along the vascular pathway to the target lesion site (such as a bleeding point in a complex junctional area).

[0073] The guidewire tip adopts a 1:1 torque transmission design with a super-elastic nickel-titanium alloy core wire to adapt to tortuous vascular anatomy. It is precisely positioned through a radiographically detectable polyurethane coating, reducing the number of intraoperative adjustments.

[0074] 3. Balloon positioning and segmental expansion

[0075] The sheath is advanced to the distal end of the guidewire, allowing the balloon (2.5-3 cm in diameter) to cross the bleeding area. The curved tip at the end of the balloon helps adhere to the vessel wall.

[0076] Contrast agent is injected into the first chamber through the balloon inflation channel (channel 6), and differential pressure is achieved using a dual-chamber design:

[0077] First chamber: high-pressure expansion to block proximal blood flow (pressure sensor monitors internal pressure in real time, accuracy ±0.01MPa);

[0078] Second chamber: Low pressure maintains blood perfusion in the distal part (laser diameter measurement accuracy ±0.05mm, matching the blood vessel diameter).

[0079] The synergistic effect of the two cavities improves the uniformity of balloon expansion by 40%, increases the stent positioning accuracy by 35%, and significantly reduces the elastic retraction rate.

[0080] 4. Real-time monitoring and dynamic control during surgery

[0081] A precision integrated miniature pressure sensor at the sheath entrance continuously monitors:

[0082] Changes in balloon pressure and blood vessel wall pressure;

[0083] Peripheral blood flow velocity (data is transmitted to an external monitor via sensor output channel 8).

[0084] If an abnormal increase in proximal blood pressure is detected (such as >180 mmHg), the system automatically adjusts the balloon volume to release part of the blood flow to avoid cerebral hyperperfusion injury.

[0085] 5. Postoperative evacuation and prevention of complications

[0086] After hemostasis is completed, the liquid in the balloon is slowly withdrawn through the inflation channel, and the pressure sensor data is observed to confirm that there is no blood return to avoid sudden deflation of the balloon causing blood vessel collapse.

[0087] When withdrawing the catheter, the guidewire and sheath are retracted synchronously, and the biomimetic adhesion properties of the PET material balloon are used to reduce vascular endothelial damage and lower the risk of thrombosis.

[0088] 6. Data Recording and Postoperative Analysis

[0089] The in vitro monitoring device automatically records the pressure-blood flow curve and balloon sealing status, generates a surgical report, and provides a reference for subsequent treatment.

[0090] The system realizes intelligent operation of the entire process of "guidewire guidance-vascular dilation-balloon occlusion" through an integrated design. While extending the hemostasis time (>90 minutes), it reduces the risk of cardiovascular and cerebrovascular complications by 40%, significantly improving the safety and efficiency of interventional surgery.

[0091] In a specific embodiment, the detection process of the intelligent integrated balloon catheter system with integrated guidewire guidance and vascular dilation is as follows:

[0092] 1. In vitro system initialization and calibration

[0093] The sheath tube containing the precision integrated micro pressure sensor is electrically connected to an in vitro detector, and the detector establishes a signal path through the sensor output channel (channel 8).

[0094] Start the detector, perform zero point calibration on the sensor (accuracy ±0.005MPa), and verify the synchronization between the laser diameter measurement module (accuracy ±0.05mm) and the pressure monitoring module.

[0095] Inject physiological saline into the balloon inflation channel (channel 6) to test the balloon sealing performance and confirm that the sensor response time to pressure changes is less than 0.1 second.

[0096] 2. Real-time pressure and blood flow monitoring during surgery

[0097] Balloon pressure monitoring:

[0098] When the balloon is expanded, the sensor collects the pressure data of the first and second cavities in real time (accuracy ±0.01MPa), and the detector dynamically displays the pressure curve.

[0099] If the pressure exceeds the preset threshold (such as 0.3MPa), the detector triggers an audible and visual alarm, prompting the doctor to adjust the inflation rate.

[0100] Vascular wall pressure and blood flow velocity monitoring:

[0101] The blood flow velocity proximal to the balloon is calculated (error < 5%) through a sensor integrated algorithm combined with pressure gradient changes.

[0102] The detector automatically calculates hemodynamic parameters (such as mean arterial pressure and shear stress) and generates real-time trend graphs to assist in determining the effect of vascular obstruction.

[0103] 3. Dynamic detection of balloon size and sealing

[0104] Dimension monitoring:

[0105] The laser diameter measurement module reflects the light signal from the inner wall of the sheath to measure the change in balloon diameter in real time (accuracy ±0.05mm) and compare it with the target blood vessel diameter (preoperative imaging data).

[0106] If the balloon diameter deviation is greater than 0.1mm, the detector will prompt the doctor to fine-tune the inflation pressure to ensure adherence to the wall.

[0107] Leakage detection:

[0108] The sensor continuously monitors the stress distribution on the balloon surface. If a sudden drop in local pressure (>0.05MPa / s) is detected, it is determined to be a risk of rupture. The detector immediately locks the inflation channel and issues an alarm.

[0109] 4. Data Recording and Postoperative Analysis

[0110] The detector automatically stores the entire pressure-blood flow data, balloon size change curve and alarm records, and generates an encrypted surgical log.

[0111] After surgery, data can be replayed using dedicated software to analyze hemostasis efficiency (such as occlusion time and blood perfusion in the ischemic area) and complication risks (such as duration of hypertension and vascular elastic retraction rate).

[0112] The system uses the synergistic effect of micro pressure sensors and detectors to achieve full-dimensional monitoring of balloon internal pressure, blood vessel wall pressure, blood flow velocity and size, shortening the intraoperative decision response time to within 0.1 seconds, significantly improving surgical safety and accuracy.

[0113] Those skilled in the art will appreciate that the present application may be implemented as a system, method, or computer program product.

[0114] Therefore, the present disclosure may be implemented in the following forms: entirely in hardware, entirely in software (including firmware, resident software, microcode, etc.), or in a combination of hardware and software, generally referred to herein as a "circuit," "module," or "system." Furthermore, in some embodiments, the present disclosure may be implemented in the form of a computer program product embodied in one or more computer-readable media, wherein the computer-readable media contains computer-readable program code.

[0115] Any combination of one or more computer-readable media may be used. A computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media include: an electrical connection having one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof. In this document, a computer-readable storage medium may be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device.

[0116] Although the embodiments of the present application have been shown and described above, it should be understood that the above embodiments are exemplary and should not be construed as limiting the present application. Persons skilled in the art may make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present application. Various substitutions and improvements may be made to the present application on this basis, all of which fall within the scope of protection of the present application.

Claims

1. An intelligent integrated balloon catheter system integrating guidewire guidance and vascular dilation, characterized in that: include: The guidewire guiding mechanism, blood vessel dilation mechanism and balloon dilation mechanism are integrated and arranged in an integrated manner, wherein: The balloon expansion mechanism includes a balloon and a sheath, The balloon and the sheath are installed. The balloon comprises a first cavity and a second cavity; A micro pressure sensor is provided on the sheath tube between the balloon and the inlet of the sheath tube.

2. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 1, characterized in that: The sheath is provided with a balloon inflation channel, a guidewire catheter channel and a sensor output channel in separate parts.

3. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 2, characterized in that: The balloon and the sheath are integrated.

4. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 3, characterized in that: The device further comprises a detector, wherein the detector is electrically connected to the micro pressure sensor and is used to monitor the flow rate / pressure of the blood flow.

5. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 4, characterized in that: The balloon is made of PET material.

6. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 5, characterized in that: The diameter of the balloon after inflation is 2.5-3 cm.

7. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 6, characterized in that: The catheter end of the balloon is provided with a curved tip.

8. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 7, characterized in that: The guidewire guiding mechanism includes a guidewire.

9. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 8, characterized in that: The sheath is a 7F sheath.

10. The intelligent integrated balloon catheter system for integrated guidewire guidance and vascular dilation according to claim 9, characterized in that: The micro pressure sensor is a precision integrated micro pressure sensor.

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