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CN-122006082-A - Vena cava occlusion type ventricular assist system

CN122006082ACN 122006082 ACN122006082 ACN 122006082ACN-122006082-A

Abstract

The invention discloses a vena cava occlusion type ventricular assist system, which comprises a balloon catheter device and a control processor. The balloon catheter device comprises a six-cavity catheter, and the six-cavity catheter is provided with a first balloon and a second balloon. The six-cavity catheter is provided with a first pressure cavity, a second pressure cavity, a third pressure cavity, a transfusion cavity, a gas transmission cavity and a heart monitoring cavity which are not communicated with each other. The first pressure lumen proximal port is disposed proximate the first balloon distal end as a first pressure port. The second pressure chamber proximal port is disposed proximate the first balloon proximal end as a second pressure port. The third pressure lumen proximal port is at the six lumen catheter proximal end as a third pressure port. The infusion lumen proximal port is located within the first balloon as an infusion port. The proximal port of the gas delivery lumen is located within the second balloon as a gas delivery port. The heart monitoring cavity proximal port is disposed as a monitoring port near the second balloon distal end. The invention solves the problems that the occlusion and evacuation time is fixed and the treatment termination time cannot be reasonably controlled.

Inventors

  • LIU GUANGMAO
  • HU SHENGSHOU
  • HE ZHIPENG

Assignees

  • 中国医学科学院阜外医院深圳医院(深圳市孙逸仙心血管医院)

Dates

Publication Date
20260512
Application Date
20260319

Claims (10)

  1. 1. A vena cava occlusion type ventricular assist system is characterized by comprising a balloon catheter device and a control processor connected with the balloon catheter device, wherein the balloon catheter device comprises a six-cavity catheter, a first balloon is arranged in the middle of the six-cavity catheter and used for blocking an upper vena cava at a position 1 cm-2 cm away from the junction of the upper vena cava and a right atrium, a second balloon is arranged at a position, close to the proximal end, of the six-cavity catheter and used for being placed in a pulmonary artery, the six-cavity catheter is provided with a first pressure cavity, a second pressure cavity, a third pressure cavity, an infusion cavity and a heart monitoring cavity which are not communicated with each other, the proximal end of the first pressure cavity is used as a first pressure measuring port and is arranged close to the distal end of the first balloon, the proximal end is used for monitoring the vena cava pressure by means of the first pressure sensor, the proximal end of the second pressure cavity is used as a second balloon and is used for monitoring the right atrium pressure by means of the second pressure sensor, the proximal end of the second balloon is arranged at the position, the proximal end of the third pressure cavity is used as a second pressure measuring port, the proximal end of the third pressure measuring port is used for being placed in a pulmonary artery, the balloon is used for being placed in the inflation port, the proximal end is used for monitoring the infusion cavity, the proximal end is used for the infusion cavity is used as a third pressure measuring balloon, the proximal end is used for the infusion cavity, and the infusion cavity is placed in the distal end.
  2. 2. The vena cava occlusion ventricular assist system of claim 1, wherein the first pressure chamber, the second pressure chamber, the third pressure chamber, the infusion chamber, the gas delivery chamber, and the heart monitoring chamber distal port are distal to the six-chamber catheter, the six-chamber catheter distal end having an injection molding head mounted thereto, the conduit being connected to the injection molding head.
  3. 3. The vena cava occlusion ventricular assist system of claim 2 wherein the conduit comprises a first pressure tube, a second pressure tube, a third pressure tube, a fluid delivery tube, a gas delivery tube, and a heart monitor tube, the first pressure tube, the second pressure tube, the third pressure tube, the fluid delivery tube, the gas delivery tube, and the heart monitor tube being in communication with the first pressure chamber, the second pressure chamber, the third pressure chamber, the fluid delivery chamber, the gas delivery chamber, the heart monitor chamber, respectively, via the injection head, wherein the thermistor cable exits via the heart monitor chamber, the heart monitor tube, into which saline is injected.
  4. 4. The vena cava occlusion ventricular assist system of claim 1, wherein the first pressure port, the second pressure port, and the third pressure port are between 0.8mm and 1.2mm in diameter.
  5. 5. The vena cava occlusion ventricular assist system of claim 1 wherein a seal is made between the first balloon and the six lumen catheter surface such that fluid within the first balloon does not leak, and wherein a seal is made between the second balloon and the six lumen catheter surface such that gas within the second balloon does not leak.
  6. 6. The vena cava occlusion ventricular assist system of claim 1, wherein the monitor port diameter is between 0.5mm and 1.0mm, and the thermistor is provided with a packaging cover.
  7. 7. The vena cava occlusion ventricular assist system of claim 1, wherein the control processor comprises a housing, a processing module, a gas driving module, an electric signal acquisition module, a blood pressure signal acquisition module, and a timing module are disposed in the housing, a liquid driving module is disposed outside the housing, the processing module is electrically connected with the gas driving module, the electric signal acquisition module, the blood pressure signal acquisition module, the liquid driving module, and the timing module, wherein the gas delivery pipe is connected with the gas driving module through a gas delivery extension pipe, the gas delivery pipe is connected with the liquid driving module through a gas delivery extension pipe, the electric signal acquisition module is connected with a cable led out from the balloon catheter device by the thermistor, and the blood pressure signal acquisition module is connected with pressure measuring chips of the first blood pressure sensor, the second blood pressure sensor, and the third blood pressure sensor.
  8. 8. The vena cava occlusion ventricular assist system of any one of claims 1 to 7, wherein during the first balloon occlusion of the superior vena cava, a right atrial pressure decrease rate and a superior vena cava pressure increase rate are calculated for the first 120 seconds after the occlusion of the superior vena cava based on the superior vena cava pressure monitored by the first blood pressure sensor and the right atrial pressure monitored by the second blood pressure sensor, wherein the occlusion period is set to 3 minutes if the right atrial pressure decrease rate is equal to or greater than 0.05mmHg/s and the superior vena cava pressure increase rate is equal to or less than 0.03mmHg/s, the occlusion period is set to 4 minutes to 5 minutes if the right atrial pressure decrease rate is equal to or less than 0.02mmHg/s, and the occlusion period is set to 6 minutes if the right atrial pressure decrease rate is equal to or less than 0.02 mmHg/s; the method comprises the steps of judging whether the superior vena cava pressure is less than or equal to 30mmHg or not in the occlusion process, immediately stopping the occlusion if the superior vena cava pressure is not met, monitoring the ascending rate of the superior vena cava pressure, immediately stopping the occlusion if the ascending rate of the superior vena cava pressure is more than 0.08mmHg/s, starting the emptying, and otherwise, maintaining the occlusion state until the occlusion duration is over, and starting the emptying.
  9. 9. The vena cava occlusion ventricular assist system of claim 8, wherein initiating evacuation comprises initiating the first blood pressure sensor to monitor superior vena cava pressure and the second blood pressure sensor to monitor right atrial pressure in a state where the first balloon remains partially inflated but not fully collapsed, calculating a pressure gradient between the superior vena cava and the right atrium to determine an evacuation period, wherein evacuation is stopped immediately if the pressure gradient falls to 3mmHg-5mmHg, maintaining the current inflation of the first balloon, determining a rate of pressure gradient decrease if the pressure gradient does not fall to 3mmHg-5mmHg, stopping evacuation after 60 seconds of evacuation if the rate of pressure gradient decrease is <0.01mmHg/s, otherwise stopping evacuation 5 seconds in advance; wherein the pressure gradient is continuously monitored during the evacuation process.
  10. 10. The vena cava occlusion ventricular assist system of claim 9, further comprising employing dual index control for treatment termination: if not, continuing the occlusion period, updating monitoring data through the first blood pressure sensor and the second blood pressure sensor every 1 occlusion period is completed, if so, calculating the accumulated pressure gradient stability of the continuous 3 occlusion periods and judging whether the accumulated pressure gradient stability is less than or equal to 15%, if not, continuing the occlusion period, if so, detecting whether the right atrium pressure at the end of the occlusion period in the continuous 2 occlusion periods is less than or equal to 8mmHg and the pressure gradient is less than or equal to 5mmHg, if so, terminating the treatment, otherwise, judging whether the right atrium pressure drop rate of the continuous 5 occlusion periods is less than 0.01mmHg/s, if so, terminating the treatment, otherwise, prolonging the treatment for 2 occlusion periods, and then repeatedly executing; After stopping the treatment, the first balloon is firstly changed into 30% filling degree and maintained for 30 minutes, and if the fluctuation of the right atrium pressure and the pressure gradient is detected to be less than or equal to 2mmHg, the first balloon is completely emptied.

Description

Vena cava occlusion type ventricular assist system Technical Field The invention relates to a vena cava occlusion type ventricular assist system, and belongs to the technical field of ventricular assist devices. Background Patients with Acute Decompensated Heart Failure (ADHF) experience symptoms such as elevated cardiac filling pressure, and congestion in the systemic and pulmonary circulation due to impaired cardiac function, manifested as dyspnea, edema in the lower extremities, and the degree of congestion is a critical factor in predicting short-term and long-term prognosis-sustained congestion is still present in about 60% -80% of patients discharged, and the readmission rate and mortality of such patients are significantly increased. Current treatments for ADHF are aimed at relieving congestion, mainly by means of drug therapy and adjuvant therapy with devices. In the medical treatment, diuretics (such as furosemide) and vasodilators are basic schemes, but have the problems of slow onset of action (usually several hours to several days), failure of standard resistance of part of patients due to the diuretics, and the like, and the damage of renal function may be aggravated after long-term use. During auxiliary treatment of the apparatus, technologies such as blood ultrafiltration and intra-aortic balloon counterpulsation are generally adopted, but the limitations are that the blood ultrafiltration needs extracorporeal circulation, the operation is complex and the problem of hypotension can be caused, and the intra-aortic balloon counterpulsation is mainly used for improving myocardial perfusion, but has very limited direct effect on reducing the filling pressure of the heart. With respect to the need for "rapid reduction of cardiac filling pressure", vena cava occlusion technology is becoming of increasing interest. The Superior Vena Cava (SVC) bears about 1/3 of the venous return blood volume, and theoretically, by occluding SVC, cardiac preload can be reduced, lowering right atrial and pulmonary circulatory pressure. Existing SVC occlusion related devices (e.g., PRECARDIA early systems) use a fixed occlusion-evacuation cycle (e.g., 5 minute occlusion, 30 second evacuation), while capable of reducing filling pressure to some extent, suffer from significant drawbacks: The method can not adapt to individual differences, and has obvious hemodynamic response difference on SVC occlusion of different patients, for example, the SVC pressure is excessively increased (> 30 mmHg) due to fixed time length for people with sensitive occlusion, the risk of vascular injury and cerebral congestion is increased, and the right atrium pressure RAP can not be effectively reduced due to insufficient time length for people with slow occlusion response, so that the treatment effect is affected. The treatment termination judgment is inaccurate, the existing system depends on a single duration threshold (such as 24 hours) to determine the termination time, and the lack of assessment of 'hemodynamic stability' is easy to cause premature termination (insufficient treatment) or excessive treatment (increased complication risk). Disclosure of Invention In order to solve the problems in the prior art, the invention provides a vena cava occlusion type ventricular assist system. The invention adopts the following technical scheme: A vena cava occlusion type ventricular assist system comprises a balloon catheter device and a control processor connected with the balloon catheter device, wherein the balloon catheter device comprises a six-cavity catheter, a first balloon is arranged in the middle of the six-cavity catheter and used for blocking an upper vena cava at a position 1 cm-2 cm away from the junction of the upper vena cava and a right atrium, a second balloon is arranged at a position, close to the proximal end of the six-cavity catheter, used for being placed in a pulmonary artery, the six-cavity catheter is provided with a first pressure cavity, a second pressure cavity, a third pressure cavity, an infusion cavity and a heart monitoring cavity which are not communicated with each other, the proximal end of the first pressure cavity is used as a first pressure measuring port and is arranged close to the distal end of the first balloon, the first balloon is used for monitoring the vena pressure of the upper cavity, the proximal end of the second balloon is used as a second pressure measuring port and is arranged close to the proximal end of the first balloon, the second balloon is used for monitoring the right pressure, the proximal end of the second balloon is used as a second pressure measuring port, the proximal end of the third pressure measuring port is used as a third balloon, the proximal end is used for being placed in a pulmonary artery, the second pressure measuring port is used as a pressure measuring port, the proximal end of the second balloon is used for being placed in the infusion cavity, the infusion cavity