Interventional pulsatile left ventricular assist system and method

Abstract

The application provides an interventional pulsatile left ventricular assist system and method, which comprises a drainage tube, a perfusion tube, a magnetic suspension pump head, a main machine and a systemic tube line, one end of the drainage tube is arranged to a left ventricle through a femoral artery on one side for draining blood in the left ventricle, the other end is connected to an inlet of the magnetic suspension pump head through a first systemic tube line, one end of the perfusion tube is arranged to a preset position of a femoral artery on the other side for perfusing blood, the other end is connected to an outlet of the magnetic suspension pump head through a second systemic tube line, the magnetic suspension pump head is connected to the main machine, the main machine monitors a heart state signal, and according to the heart state signal, the magnetic suspension pump head is driven by a magnetic field to output pulsatile blood. The application can reconstruct a reasonable physiological blood flow mode in an engineering way, rather than simply increasing the flow, and is suitable for short-term assist demand of severe patients.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an interventional pulsating left ventricular assist system and method. Background Technology

[0002] Short-term ventricular assist systems are core equipment for critical cardiovascular care, but current technologies struggle to balance safety, effectiveness, and practicality. Existing product defects: Products for atrial septal puncture: The procedure is difficult and can easily cause arrhythmia and bleeding; the physiological compatibility with adaxial perfusion is poor. Interventional vascular pumps (such as Impella): Catheterization causes significant damage to blood vessels, carries a high risk of distal embolism, has been recalled multiple times due to safety issues, and provides laminar flow perfusion; IABP: High safety but flow rate ≤1L / min, which cannot meet the needs of critically ill patients, and it has no active pulsatile perfusion function; Implantable blood pumps offer excellent flow rates but involve complex surgery. Once implanted, they cannot be removed, requiring patients to carry the controller and battery long-term (which is inconvenient). They also pose a risk of damaging the right ventricle and typically provide laminar flow. Limitations of ECMO AA mode: It provides general circulation support rather than left ventricular support. Its core drawback is adventitious perfusion, poor physiological compatibility, large system size, complex operation, and reliance on DSA guidance, which increases the risk of radiation. Summary of the Invention

[0003] To address the problems existing in the prior art, the present invention provides an interventional pulsating left ventricular assist system and method.

[0004] This invention provides an interventional pulsating left ventricular assist system, comprising a drainage tube, an infusion tube, a magnetically levitated pump head, a main unit, and systemic circulation tubing, wherein: One end of the drainage tube is routed to the left ventricle via the femoral artery on one side for draining blood from the left ventricle; the other end is connected to the inlet of the magnetic levitation pump head via a first circulation tube. One end of the infusion tube is positioned at a predetermined location on the other side of the femoral artery for infusing blood; the other end is connected to the outlet of the magnetic levitation pump head via a second circulation tube. The magnetic levitation pump head is connected to the host computer, which monitors heart status signals and drives the magnetic levitation pump head to output pulsatile blood through a magnetic field based on the heart status signals.

[0005] According to the present invention, an interventional pulsatile left ventricular assist system is provided, the system further comprising a cardiac status signal acquisition device, including an ECG acquisition module and an aortic pressure acquisition module.

[0006] According to the present invention, an interventional pulsating left ventricular assist system is provided, wherein a first pressure sensor and a first flow sensor are provided on the first systemic circulation line.

[0007] According to the present invention, an interventional pulsating left ventricular assist system is provided, wherein a second pressure sensor is provided on the second systemic circulation line.

[0008] According to the present invention, an interventional pulsating left ventricular assist system is provided, wherein the drainage tube is a single-lumen interventional catheter, the front end of the catheter is provided with a three-dimensional spiral pigtail positioning structure, the inner wall is coated with an anticoagulant coating, and multiple drainage holes are evenly distributed.

[0009] According to the present invention, an interventional pulsating left ventricular assist system is provided, wherein the perfusion catheter is a single-lumen interventional catheter, including an in vivo segment and an external segment, and the inner wall is coated with an anticoagulant coating.

[0010] According to the present invention, an interventional pulsating left ventricular assist system is provided, wherein the magnetic levitation pump head is a passive disposable magnetic levitation pump head, and the inlet and outlet are provided with pagoda-shaped interfaces, which are engaged and fixed with the pump head seat of the V host by a snap-fit.

[0011] According to the present invention, an interventional pulsatile left ventricular assist system is provided in which the host computer prioritizes the use of ECG mode during pulsatile blood control, and automatically switches to aortic pressure mode when the ECG signal is interrupted, so as to continuously drive the magnetic levitation pump head to output pulsatile blood.

[0012] According to the present invention, an interventional pulsating left ventricular assist system is provided in which both the drainage tube and the perfusion tube are positioned by portable ultrasound navigation.

[0013] The present invention also provides an interventional pulsatile ventricular assist method, applied to the above-mentioned interventional pulsatile left ventricular assist system, the method comprising: The drainage tube is inserted through one femoral artery and then through the aortic valve into the left ventricle. The perfusion tube is inserted through the other femoral artery and positioned at the preset location. Connect the drainage tube and the infusion tube to the inlet and outlet of the magnetic levitation pump head through the corresponding first circulation pipe and second circulation pipe, and then snap the magnetic levitation pump head into the main unit for fixed connection. The host is started, and the heart status signal is collected through the heart status signal acquisition module. Based on the heart status signal, the magnetic levitation pump head is driven by a magnetic field to output pulsatile blood. When the ECG signal is interrupted, it automatically switches to aortic pressure mode to maintain continuous pulsatile perfusion.

[0014] This invention provides an interventional pulsatile left ventricular assist system and method. One end of a drainage tube is placed into the left ventricle via one femoral artery, and the other end is connected to the inlet of a magnetic levitation pump head via a systemic circulation tube. One end of an infusion tube is placed at a preset position on the other femoral artery, and the other end is connected to the outlet of the magnetic levitation pump head via a second systemic circulation tube. The magnetic levitation pump head is connected to a host computer, which monitors cardiac status signals and drives the magnetic levitation pump head to output pulsatile blood through a magnetic field based on the cardiac status signals. This achieves the reconstruction of a reasonable physiological blood flow pattern in an engineering manner, rather than simply increasing the flow rate, thus adapting to the short-term auxiliary needs of critically ill patients. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of the structure of the interventional pulsating left ventricular assist system provided by the present invention.

[0017] Figure 2 This is a top view of the pig tail tube provided by the present invention.

[0018] Figure 3 This is a side view of the pig tail tube provided by the present invention.

[0019] Figure 4 This is a perspective view of the pig tail tube provided by the present invention.

[0020] Figure 5 This is a schematic flowchart of the interventional pulsatile left ventricular assist method provided by the present invention. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0022] Figure 1 A schematic diagram of an interventional pulsating left ventricular assist system provided by the present invention is shown below. Figure 1 The system includes a drainage tube, an infusion tube, a magnetic levitation pump head, a main unit, and a circulation pipeline, wherein: One end of the drainage tube is routed to the left ventricle via the femoral artery on one side to drain blood from the left ventricle; the other end is connected to the inlet of the magnetic levitation pump head via a first-body circulation tube. One end of the perfusion tube is positioned at a predetermined location on the other side of the femoral artery for perfusion of blood; the other end is connected to the outlet of the magnetic levitation pump head via a second circulation tube. The magnetic levitation pump head is connected to the main unit, which monitors the heart status signal and drives the magnetic levitation pump head to output pulsatile blood based on the heart status signal through a magnetic field.

[0023] It should be noted that, under real-time ultrasound guidance, one end of the drainage tube was inserted through a guidewire inserted into the femoral artery on one side and advanced retrogradely along the aorta to confirm entry into the left ventricle via the aortic valve. The other end of the drainage tube was connected to the inlet of the magnetic levitation pump head via a corresponding systemic circulation tube. This drainage tube is a single-lumen interventional catheter with an outer diameter of approximately 5.67 mm, a length of 90 cm, and an inner diameter of approximately 5.07 mm (cross-sectional area approximately 20.2 mm²). 2 The catheter tip is equipped with a three-dimensional spiral pig tail positioning structure (see...). Figures 2-4 These are top, side, and oblique views, respectively, to prevent negative pressure at the drainage port from adhering to the ventricular wall. The inner wall is coated with an anticoagulant coating, with multiple drainage holes evenly distributed. A portable ultrasound-guided intervention is used via the unilateral femoral artery, entering the left ventricle through the aortic valve for drainage, eliminating the need for DSA radiation. The catheter can be visualized and positioned under ultrasound guidance.

[0024] One end of the infusion cannula is inserted through a guidewire inserted into the femoral artery on the other side, positioned at a predetermined location in the femoral artery, and then naturally positioned to the iliac artery after being advanced to its total length. The infusion cannula consists of an internal segment and an external segment, with an anticoagulant coating on the inner wall. The outer diameter of the infusion cannula is approximately 5.67 mm, the total length is 40 cm (30 cm internal segment), and the inner diameter is approximately 5.07 mm (cross-sectional area approximately 20.2 mm²). 2 ).

[0025] In this invention, the magnetic levitation pump head uses sterile disposable consumables, has a built-in permanent magnet, and features pagoda-shaped interfaces at the inlet and outlet; it is snapped into the main pump head seat of the host unit. The magnetic levitation pump head connects to the VAD host, which monitors cardiac status signals and drives the magnetic levitation pump head to output pulsatile blood through a magnetic field based on these signals, achieving a high flow rate of 3-5 L / min in conjunction with the tubing; the internal flow channel is optimized through fluid dynamics finite element simulation, eliminating blood flow disturbances and dead zones, and exhibiting excellent blood compatibility.

[0026] In this invention, the main unit's structural design integrates an ECG acquisition module and an aortic pressure acquisition module, and also includes a built-in centrifugal pump module, a pump head speed control module, and a portable power supply unit. The two acquisition modules operate independently, automatically switching when the signal is interrupted. The centrifugal pump module and pump head speed control module adjust the pump head speed (1000-5000 rpm), outputting a pulsatile blood flow of 50-120 beats / minute (precisely synchronized with the heart's contraction and relaxation cycle). Furthermore, when the heart rate is higher than 120 beats per minute, to ensure the centrifugal pump keeps up with the heart rate, the pulsation frequency is set to 2:1 or 3:1, meaning one pulsatile blood flow is output for every two heartbeats, or one pulsatile blood flow for every three heartbeats, thus maintaining operation at high heart rates. The aortic pressure acquisition module has a sampling accuracy of 5 mmHg. The main unit also features a constant current mode and a fixed-frequency pulsation mode. The main unit measures 30cm × 24cm × 18cm, weighs 8kg, and supports both AC power and lithium battery dual power supply modes (battery life ≥ 2 hours).

[0027] During the pulsatile blood control process, the host prioritizes the ECG mode. When the ECG signal is interrupted, it automatically switches to the aortic pressure mode to continuously drive the magnetic levitation pump head to output pulsatile blood.

[0028] In this invention, a first pressure sensor and a first flow sensor are installed on the first infusion line. A second pressure sensor is installed on the second infusion line. These sensors can monitor the status signals of infusion and drainage in real time, such as pressure and flow information, providing real-time reference values ​​and decision-making basis for the auxiliary system.

[0029] The specific application scenarios of the interventional pulsed left ventricular assist system of the present invention are as follows: 1) Preoperative preparation: Select the appropriate specification components (standard 17F dual tube), connect the ECG electrodes and pressure sensor, and prepare the portable ultrasound device; 2) Interventional procedures: (1) Left ventricular guidewire intervention: Under real-time ultrasound guidance, the guidewire is inserted through the femoral artery on one side and advanced retrogradely along the aorta to confirm entry into the left ventricle through the aortic valve; (2) The drainage tube is inserted into the guidewire and enters the aorta through the femoral artery. Under ultrasound guidance, it enters the left ventricle through the aortic valve; (3) Iliac artery guidewire intervention: The guidewire is inserted through the femoral artery on the other side and enters the iliac artery; (4) Irrigation cannula intervention: The guidewire is inserted through the femoral artery on the other side and advanced to the external segment with a 10cm margin. It is naturally positioned to the iliac artery. There is no DSA radiation throughout the entire process. 3) System connection: Connect the circulation pipeline to the pump head pagoda head, lock the pump head into the main unit, and turn on the power self-test (default ECG mode). 4) Pulsating Operation: The main unit collects ECG / aortic pressure signals and drives the pump head to output pulses with the heart cycle (high speed and high flow during systole, low speed and low flow during diastole), with a flow rate of 3-5 L / min. It optimizes coronary arteries and microcirculation by reconstructing physiological blood flow patterns, and automatically switches modes when the signal is interrupted. 5) Postoperative withdrawal: After the machine is stopped, the tube is removed directly, and the pump head is disposed of as medical waste.

[0030] The interventional pulsatile left ventricular assist system provided by this invention involves a drainage tube with one end inserted into the left ventricle via the femoral artery on one side, and the other end connected to the inlet of a magnetic levitation pump head via a systemic circulation conduit. One end of an infusion tube is positioned at a predetermined location on the other femoral artery, and the other end is connected to the outlet of the magnetic levitation pump head via a second systemic circulation conduit. The magnetic levitation pump head is connected to a main unit, which monitors cardiac status signals and drives the magnetic levitation pump head to output pulsatile blood via a magnetic field based on these signals. This achieves the reconstruction of a reasonable physiological blood flow pattern through engineering, rather than simply increasing flow rate, thus meeting the short-term auxiliary needs of critically ill patients.

[0031] The high flow rate of 3-5 L / min achieved by this invention, combined with active pulsatile output, is unmatched by existing similar adaxial perfusion products. Its core advantage lies in reconstructing a rational physiological blood flow pattern through engineering, rather than simply increasing the flow rate: ① It reduces the risk of structural cardiac complications and minimizes mechanical damage to the ventricular wall and vascular endothelium; ② It improves coronary perfusion and microcirculation, providing more adequate oxygen and nutrient delivery to the myocardium and peripheral organs; ③ It enhances patient tolerance and long-term safety, reducing adverse events such as hemolysis and thrombosis, and is particularly suitable for the short-term support needs of critically ill patients.

[0032] The entire drainage tube implantation process relies on portable ultrasound navigation, eliminating the need for DSA radiation. This protects both patients and medical staff, lowers the equipment threshold for primary hospitals, and is suitable for emergency rescue and a wide range of clinical scenarios.

[0033] It eliminates the need for atrial septal puncture and implantable pump placement, making the procedure nearly as complex as IABP; the dual-tube independent intervention simplifies the operation, and real-time ultrasound visualization ensures precise implantation and enhanced safety.

[0034] Compared to ECMO, it is more precise, portable, radiation-free and physiologically compatible; compared to interventional vascular pumps, it has lower safety risks; compared to implantable blood pumps, it is more flexible (short-term application, no irreversible damage); compared to IABP, it increases flow by 3-5 times and has active pulsation function.

[0035] The interventional pulsating left ventricular assist method provided by the present invention is described below. The interventional pulsating left ventricular assist method described below can be referred to in correspondence with the interventional pulsating left ventricular assist system described above.

[0036] Figure 5This diagram illustrates a flow chart of an interventional pulsating left ventricular assist method provided by the present invention. (See attached diagram.) Figure 5 This method, applied to the aforementioned interventional pulsating left ventricular assist system, includes the following steps: Step 51: Insert the drainage tube through one femoral artery and into the left ventricle through the aortic valve, and insert the perfusion tube through the other femoral artery and position it at the preset location.

[0037] Step 52: Connect the drainage tube and the infusion tube to the inlet and outlet of the magnetic levitation pump head through the corresponding first circulation pipe and second circulation pipe, and fix the magnetic levitation pump head to the main unit.

[0038] Step 53: Start the host, collect heart status signals through the heart status signal acquisition module, and drive the magnetic levitation pump head to output pulsatile blood based on the heart status signals through the magnetic field.

[0039] Step 54: When the ECG signal is interrupted, automatically switch to aortic pressure mode to maintain continuous pulsatile perfusion.

[0040] Since the method in this embodiment of the invention is based on the same principle as the system in the above embodiment, more detailed explanations will not be repeated here.

[0041] The interventional pulsatile left ventricular assist method provided by this invention involves placing one end of a drainage tube into the left ventricle via one femoral artery, and the other end connecting to the inlet of a magnetic levitation pump head via a systemic circulation tube; placing one end of an infusion tube at a preset position on the other femoral artery, and the other end connecting to the outlet of the magnetic levitation pump head via a second systemic circulation tube; connecting the magnetic levitation pump head to a host computer, which monitors cardiac status signals and drives the magnetic levitation pump head to output pulsatile blood based on the cardiac status signals, thereby achieving the reconstruction of a reasonable physiological blood flow pattern through engineering, rather than simply increasing the flow rate, and adapting to the short-term assistive needs of critically ill patients.

[0042] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An interventional pulsating left ventricular assist system, characterized in that, Includes drainage tubes, infusion tubes, magnetic levitation pump heads, main unit, and circulation tubing, among which: One end of the drainage tube is routed to the left ventricle via the femoral artery on one side for draining blood from the left ventricle; the other end is connected to the inlet of the magnetic levitation pump head via a first circulation tube. One end of the infusion tube is positioned at a predetermined location on the other side of the femoral artery for infusing blood; the other end is connected to the outlet of the magnetic levitation pump head via a second circulation tube. The magnetic levitation pump head is connected to the host computer, which monitors heart status signals and drives the magnetic levitation pump head to output pulsatile blood through a magnetic field based on the heart status signals.

2. The interventional pulsating left ventricular assist system according to claim 1, characterized in that, The system also includes a cardiac status signal acquisition device, comprising an ECG acquisition module and an aortic pressure acquisition module.

3. The interventional pulsating left ventricular assist system according to claim 1 or 2, characterized in that, A first pressure sensor and a first flow sensor are installed on the first body circulation pipeline.

4. The interventional pulsating left ventricular assist system according to claim 3, characterized in that, A second pressure sensor is installed on the second body circulation pipeline.

5. The interventional pulsating left ventricular assist system according to claim 1 or 4, characterized in that, The drainage tube is a single-lumen interventional catheter with a three-dimensional spiral pigtail positioning structure at the front end, an anticoagulant coating on the inner wall, and multiple drainage holes evenly distributed.

6. The interventional pulsating left ventricular assist system according to claim 5, characterized in that, The infusion tube is a single-lumen interventional catheter, comprising an in vivo segment and an external segment, with its inner wall coated with an anticoagulant coating.

7. The interventional pulsating left ventricular assist system according to claim 6, characterized in that, The magnetic levitation pump head is a passive, disposable magnetic levitation pump head with pagoda-shaped interfaces at the inlet and outlet, which are engaged and fixed to the pump head seat of the V host by snap-fit.

8. The interventional pulsating left ventricular assist system according to claim 7, characterized in that, During the pulsatile blood control process, the host computer prioritizes the ECG mode and automatically switches to the aortic pressure mode when the ECG signal is interrupted, continuously driving the magnetic levitation pump head to output pulsatile blood.

9. The interventional pulsating left ventricular assist system according to any one of claims 1-8, characterized in that, Both the drainage tube and the infusion tube are positioned for intervention using portable ultrasound navigation.

10. An interventional pulsatile ventricular assist method, characterized in that, An interventional pulsating ventricular assist method applied to the interventional pulsating left ventricular assist system according to any one of claims 1-9, the method comprising: The drainage tube is inserted through one femoral artery and then through the aortic valve into the left ventricle. The perfusion tube is inserted through the other femoral artery and positioned at the preset location. Connect the drainage tube and the infusion tube to the inlet and outlet of the magnetic levitation pump head through the corresponding first circulation pipe and second circulation pipe, and then snap the magnetic levitation pump head into the main unit for fixed connection. The host is started, and the heart status signal is collected through the heart status signal acquisition module. Based on the heart status signal, the magnetic levitation pump head is driven by a magnetic field to output pulsatile blood. When the ECG signal is interrupted, it automatically switches to aortic pressure mode to maintain continuous pulsatile perfusion.

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