Trans-apex right ventricle balloon catheter

Abstract

The invention provides a transapical right ventricular balloon catheter which comprises a transapical imbedding catheter, a pulmonary artery pressure measuring opening is formed in the head end of the transapical imbedding catheter, a right ventricular balloon is arranged behind the pulmonary artery pressure measuring opening, and a right ventricular pressure measuring opening is adjacently formed in front of the right ventricular balloon; the ventriculus dexter is placed into a ventriculus dexter through a ventriculus dexter part and enters a pulmonary artery through a ventriculus dexter outflow tract and a pulmonary artery valve; during use, the right ventricular sac and the right ventricular pressure measuring port are located in the right ventricle, the pulmonary artery pressure measuring port is located in the pulmonary artery, and on the premise of VA-ECMO assistance, liquid is injected into the right ventricular sac to occupy the inner cavity of the right ventricle, so that the output quantity of the right ventricle is adjusted, and the pulmonary artery blood flow and the pulmonary artery pressure are reduced; the traditional Chinese medicine composition is matched with VA-ECMO to effectively regulate the heart function, is applied to lung transplantation, reduces the occurrence rate of primary transplantation lung function loss (PGD), strives for gradual recovery time for left ventricular atrophy patients, and improves the survival rate of the left ventricular atrophy lung transplantation patients.

Description

Technical Field

[0001] The invention relates to the field of medical devices, in particular to a transapical right ventricular balloon catheter. Background Art

[0002] Lung transplantation is the only effective treatment for patients with end-stage lung disease. The first transplanted lung is very prone to PGD, with an incidence of about 40%. The reason is that when the first lung transplant is completed and the second pulmonary artery is blocked, all cardiac blood flow must flow through the first pulmonary blood vessels that have just been opened, which creates a huge capacity burden on the first lung. At the same time, the first lung has just ended its ischemic state and restored blood supply, and is facing ischemia-reperfusion injury. Under this double blow, water, plasma, and even blood cells in the first pulmonary blood vessels can easily leak into the alveoli through the damaged alveolar microvessels, causing pulmonary edema and leading to primary transplant lung function loss (PGD).

[0003] Once PGD occurs, the function of the transplanted lung will recover very slowly. Lung water will enter the alveoli of the other donor lung, and the infection rate will increase significantly. It often takes 1-2 weeks to gradually recover, and may even lead to death.

[0004] There is an urgent need for a medical product in clinical practice that can be used in conjunction with VA-ECMO to fully reduce the blood flow to the first lung during single-lung ventilation, lower pulmonary artery pressure, and reduce the chance of PGD.

[0005] At the same time, pulmonary artery pressure increases significantly in lung transplant patients, accompanied by severe right ventricular hypertrophy and left ventricular disuse atrophy. After the completion of bilateral lung transplantation, the pulmonary blood vessels are unobstructed, and the hypertrophic right ventricle pumps out the full blood flow into the pulmonary blood vessels and into the left ventricle. The atrophic left heart is unable to withstand the increased preload, which often leads to left heart failure and pulmonary edema. Even with VA-ECMO assistance and the addition of an aortic counterpulsation balloon, the effect is extremely limited.

[0006] After lung transplantation, these patients urgently need a medical product that can be used in conjunction with VA-ECMO to fully reduce right ventricular output, avoid left heart failure, and allow the left ventricular function to gradually return to normal after training. Summary of the invention

[0007] In view of the above-mentioned defects of the prior art, the present invention provides a transapical right ventricular balloon catheter, including a transapical insertion catheter.

[0008] A pulmonary artery pressure measuring port is arranged at the tip of the transapical catheter, a pulmonary artery pressure measuring cavity is arranged in the transapical catheter, and a pulmonary artery pressure measuring tube is arranged at the tail end of the pulmonary artery pressure measuring cavity connected with the transapical catheter.

[0009] The right ventricular sac is arranged around the back of the pulmonary artery pressure measuring port through the transapical catheter, a right ventricular sac filling cavity is arranged in the transapical catheter, the head end of the right ventricular sac filling cavity is connected to the right ventricular sac, and the tail end is connected to the transapical catheter and a right ventricular sac injection tube is arranged.

[0010] A right ventricular pressure measuring port is arranged adjacent to the front of the right ventricular intrasac in the transapical catheter, a right ventricular pressure measuring cavity is arranged in the transapical catheter, the head end of the right ventricular pressure measuring cavity is connected to the right ventricular pressure measuring port, and the tail end is connected to the transapical catheter and arranged with a right ventricular pressure measuring tube.

[0011] The head end of the transapical catheter is provided with a temperature probe for measuring pulmonary artery blood flow in cooperation with the thermodilution method. A wire electrically connected to the temperature probe is buried in the transapical catheter, and a signal interface is provided at the tail end of the wire exiting the transapical catheter.

[0012] The transapical right ventricular balloon catheter also includes an intraesophageal catheter, the head end of which is provided with an ultrasonic probe for measuring parameters of the heart and large blood vessel arteries using Doppler technology, a wire is buried in the intraesophageal catheter, and a signal interface is provided at the tail end of the wire exiting the intraesophageal catheter.

[0013] The inner and outer surfaces of the transapical catheter and the outer surface of the right ventricular sac are coated with an anticoagulant coating.

[0014] The length of the right ventricular sac when deflated is 4-6 cm, and it is spherical when filled, with a maximum volume of less than 80 ml.

[0015] The distance between the right ventricular pressure measuring port and the tip of the transapical catheter is 5-10 cm.

[0016] The transapical right ventricular balloon catheter is used as follows:

[0017] S1: Preparation: right ventricular sac inspection, sheath, right ventricular sac filling chamber, pulmonary artery pressure measuring chamber and right ventricular pressure measuring chamber venting.

[0018] S2: Puncture: Prefabricate a purse string suture at the apex of the heart corresponding to the right ventricle, puncture, insert a guide wire, insert the sheath into the right ventricle under the guidance of the guide wire, and tighten the purse string to temporarily fix it.

[0019] S3: Transapical catheter insertion: The pulmonary artery pressure tube and the right ventricular pressure tube are connected to the pressure measuring equipment respectively, and the transapical catheter is inserted through the inner lumen of the sheath. The pressure values ​​and waveforms of the pulmonary artery pressure measuring port and the right ventricular pressure measuring port are observed in real time. When the right ventricular intracardiac sac has completely entered the right ventricle, the sheath is pulled out and the purse pack is tightened again to temporarily fix it.

[0020] S4: Locate the right ventricular sac: Under the premise of VA-ECMO assistance, fill the right ventricular sac with 5-10 ml of liquid, slowly withdraw the catheter through the apex, so that the right ventricular sac is close to the wall of the right ventricle, and stop withdrawing immediately.

[0021] S5: Flow monitoring: temperature probe and flow calibration equipment, calibrate pulmonary blood flow by thermal dilution method, and continuously monitor pulmonary blood flow according to changes in pulmonary artery pressure; or place the ultrasound probe on the intraesophageal catheter into the esophagus at the corresponding heart position, and measure pulmonary blood flow or cardiac function by Doppler technology.

[0022] S6: Pulmonary artery flow regulation: Under the above monitoring, small amounts of fluid are injected into the right ventricular sac in batches to reduce the right ventricular output, while increasing the VA-ECMO flow to adjust the pulmonary artery pressure or pulmonary blood flow to the expected value.

[0023] S7: Recovery: After the patient's condition stabilizes, slowly drain the fluid in the right ventricular endocardium in small amounts in batches, reduce the VA-ECMO flow rate, and finally remove the transapical catheter.

[0024] The tail ends of the pulmonary artery pressure measuring tube, the right ventricular sac injection tube and the right ventricular pressure measuring tube are all connected with elastic valve filling ports.

[0025] The right ventricular sac injection tube is connected to a safety pressure relief valve, and a threshold of the safety pressure relief valve is less than the pressure of the maximum volume of the right ventricular sac.

[0026] Beneficial effects of the present invention:

[0027] 1. The present invention is used in conjunction with VA-ECMO when pulmonary hypertension occurs during lung transplantation surgery; it is a minimally invasive operation at the apex of the heart that is visible to the naked eye, which is convenient and reliable;

[0028] 2. After positioning is completed, the right ventricular intraventricular sac is located in the right ventricle. By filling the right ventricular intraventricular sac with an appropriate amount of liquid, occupying the right ventricular space and reducing the blood output through the right ventricle, the pulmonary artery pressure and pulmonary blood flow can be effectively reduced, and the volume load of the left ventricle can be effectively reduced; at the same time, the pressure of the right atrium great vein in front of the right ventricle is increased, which can effectively increase the VA-ECMO flow and ensure the stability of systemic circulation.

[0029] 3. Cooperate with the thermodilution method or ultrasound monitoring to quantify the VA-ECMO and left heart blood flow values, changing the previous situation where only the VA-ECMO flow but not the left heart flow was known, making the circulation control clearer and more definite.

[0030] 4. By increasing the VA-ECMO flow and decreasing the pulmonary blood flow, the single-donor lung breathing period during lung transplantation can be effectively reduced. The single-donor lung bears the volume load during the full cardiac flow period, effectively avoiding the occurrence of PGD in the first-side lung transplantation.

[0031] 5. After transplantation surgery for pulmonary hypertension caused by pulmonary vascular occlusion, the VA-ECMO flow can be effectively increased, the left ventricular blood flow can be reduced, and the atrophic left ventricular failure can be avoided; then the VA-ECMO flow can be gradually reduced, and the left ventricular flow can be increased, so that the left ventricle can gradually return to normal after exercise, winning recovery time for the left ventricle. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a structural diagram of the first embodiment of the present invention;

[0033] Figure 2 This is a structural diagram of a second embodiment of the present invention;

[0034] Figure 3 This is a schematic diagram of the heart structure;

[0035] Figure 4 The diagram is a schematic diagram of the transapical catheter placement of the present invention; wherein the left diagram is a schematic diagram of the transapical sheath tube establishing the placement channel; the right diagram is a schematic diagram of the transapical catheter placement through the sheath tube;

[0036] Figure 5 It is a schematic diagram of adjusting the position of the transapical catheter of the present invention; the left figure is a schematic diagram of removing the sheath and retaining the transapical catheter; the right figure is a schematic diagram of the right ventricular sac being filled with liquid and then retreating to closely adhere to the right ventricular wall;

[0037] Figure 6 Schematic diagram of the present invention in use; the left diagram is a diagram showing the relationship between the present invention and the heart structure when in use; the right diagram is a diagram showing the present invention in cooperation with VA-ECMO when in use;

[0038] Figure 7 This is a schematic diagram of measuring blood flow using the thermodilution method according to the first embodiment of the present invention.

[0039] In the figure,

[0040] 1. Transapical catheter; 11. Pulmonary artery pressure measuring port; 12. Right ventricular sac; 13. Right ventricular pressure measuring port; 14. Temperature probe; 15. Esophageal catheter; 16. Ultrasound probe;

[0041] 2. Heart; 21. Central veins (including jugular vein, superior vena cava and inferior vena cava); 22. Right atrium; 23. Right ventricle; 24. Pulmonary artery; 25. Pulmonary vein; 26. Left atrium; 27. Left ventricle; 28. Aorta;

[0042] 31. ECMO host; 32. ECMO venous catheter; 33. ECMO arterial catheter; DETAILED DESCRIPTION

[0043] In order to make the technical solution of the present invention better understood by the technical personnel in the field, and to make the above-mentioned features, purposes and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with the embodiments. The embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0044] like Figure 1 and Figure 2 As shown, the transapical right ventricular balloon catheter comprises a transapical insertion catheter 1. The transapical right ventricular balloon catheter is a multi-lumen pipeline, the front section of the multi-lumen pipeline is integrated into one, forming the transapical insertion catheter 1, and the multi-lumen pipeline is branched at the rear section of the transapical insertion catheter 1 to form an operation pipeline that is sequentially connected to the corresponding cavities, and is used to monitor the pressure of the corresponding cavities or inject liquid into the corresponding balloon.

[0045] The outer diameter of the transapical catheter 1 is circular, and a pulmonary artery pressure measuring port 11 is arranged at the head end, a pulmonary artery pressure measuring cavity is arranged inside the transapical catheter 1, and a pulmonary artery pressure measuring tube is arranged at the tail end of the pulmonary artery pressure measuring cavity, which is connected to the apical catheter 1 and is connected to the pulmonary artery pressure measuring tube. The corresponding pressure monitoring pipeline is filled with liquid (heparinized saline), marked to zero, and the pressure monitoring device is connected through the pulmonary artery pressure measuring tube, so that the pressure of the pulmonary artery pressure measuring port 11 can be monitored. By monitoring the pressure of the pulmonary artery pressure measuring port 11, the position of the head end of the transapical catheter 1 can be well judged, and after being placed in the heart 2, the rear transapical catheter 1 can be smoothly guided to move forward in the heart 2 cavity.

[0046] Specifically, the pulmonary artery pressure measuring port 11 is set at 0-20mm away from the front end of the transapical catheter 1. The closer the pulmonary artery pressure measuring port 11 is to the front end of the transapical catheter 1, the better, which can more accurately represent the tip position of the pulmonary artery pressure measuring port 11. Through pressure monitoring, according to the pressure level and waveform characteristics, the specific location of the pulmonary artery pressure measuring port 11 in the cardiovascular system can be determined, thereby guiding the forward or backward operation of the transapical catheter 1 and helping to determine the specific location of the front end of the transapical catheter 1 in the heart cavity.

[0047] The transapical catheter 1 is provided with a right ventricular sac 12 around the rear of the pulmonary artery pressure measuring port 11, and a right ventricular sac filling cavity is provided in the transapical catheter 1. The head end of the right ventricular sac filling cavity is connected to the right ventricular sac 12, and the tail end is connected to the transapical catheter 1 and provided with a right ventricular sac injection tube. The right ventricular sac 12 is optimally 5-10 cm away from the pulmonary artery pressure measuring port 11, and this length is greater than the length of about 2 cm of the outflow tract of the right ventricle 23, ensuring that when the right ventricular sac 12 is located in the right ventricle 23, the pulmonary artery pressure measuring port 11 can enter the pulmonary artery 24.

[0048] The right ventricular sac 12 is completely annularly attached to the outer wall of the transapical catheter 1 when it is not inflated and completely deflated. It is avoided that the wall of the right ventricular sac 12 is not inflated and completely deflated, and the wall of the right ventricular sac 12 is ruptured when the sheath is inserted. When in use, the right ventricular sac 12 needs to be filled with an appropriate amount of liquid, preferably physiological saline, sodium lactate Ringer's solution, sodium acetate Ringer's solution, etc. The right ventricular sac 12 is spherical after being filled, and is located near the apical cavity of the right ventricle, reducing the resistance to blood flow and avoiding complete blockage of the blood flow channel.

[0049] The maximum volume of the right ventricular sac 12 is less than 80ml. In specific implementation, the right ventricular sac 12 is located in the right ventricle 23 of the patient, the normal value of the diastolic volume of the right ventricle 23 is 130-150ml, and the maximum volume of the right ventricular sac 12 is selected to be less than 80ml. According to the specific conditions of different patients, when used, the right ventricular sac 12 should be filled with appropriate amounts of liquid of different volumes under vital sign monitoring to occupy a certain degree of space in the inner cavity of the right ventricle 23, but it must be smaller than the diastolic volume of the inner cavity of the right ventricle 23 to avoid complete blockage of the inner cavity of the right ventricle 23 and complete obstruction of the transcardiac blood flow path.

[0050] The length of the right ventricular intracavitary sac 12 is less than 6 cm, which is smaller than the 7-11 cm length of the inner cavity of the right ventricle 23 of an adult, ensuring that the right ventricular intracavitary sac 12 can be completely contained in the cavity of the right ventricle 23 .

[0051] The right ventricular sac 12 should be made of medical materials such as silicone with soft material and excellent elasticity to ensure that the sac wall is smooth and thin; after injecting an appropriate amount of liquid, when the right ventricle 23 contracts, the ventricular inner wall may be squeezed to the outer wall of the right ventricular sac 12, the pressure in the sac cavity is small, and the texture is soft, which can reduce friction damage to the inner wall of the right ventricle 23.

[0052] The transapical catheter 1 is provided with a right ventricular pressure measuring port 13 adjacent to the front of the right ventricular intramural sac 12, and a right ventricular pressure measuring cavity is provided in the transapical catheter 1. The head end of the right ventricular pressure measuring cavity is connected to the right ventricular pressure measuring port 13, and the tail end is connected to the transapical catheter 1 and provided with a right ventricular pressure measuring tube. The corresponding pressure monitoring line is filled with liquid (heparinized saline), marked as zero, and the pressure monitoring device is connected through the right ventricular pressure measuring tube, so that the pressure of the right ventricular pressure measuring port 13 can be monitored. According to the pressure level and waveform characteristics, the specific position of the right ventricular pressure measuring port 13 in the heart chamber can be determined, and the right ventricular sac 12 can be finally determined to be located in the right ventricle 23 cavity by coordinating the forward or backward operation of the transapical catheter 1.

[0053] Specifically, the right ventricular pressure measuring port 13 is adjacently arranged in front of the right ventricular sac 12. The length of the right ventricular sac 12 is less than 6 cm. The adult model is longer and the child model is shorter. It is suitable for the average length of the right ventricle 23 of the corresponding age and is smaller than the length of the right ventricle 23. Taking adults as an example, the inner cavity length of the right ventricle 23 of a normal adult is 7-11 cm. The length of the right ventricular sac 12 is less than 6 cm. The optimal length is 4.5-5.5 cm, which ensures that the right ventricular sac 12 can be positioned in the right ventricle 23 cavity.

[0054] like Figure 1 As shown, the head end of the transapical catheter 1 is provided with a temperature probe 14 for measuring the pulmonary artery blood flow in cooperation with the thermodilution method, and a wire electrically connected to the temperature probe 14 is buried in the transapical catheter 1, and a signal interface is provided at the tail end of the wire through the transapical catheter 1. 10-15 ml of ice water is injected through the right ventricular pressure measuring port 13, and the ice water mixes with the blood in the jugular vein or the right atrium, which will reduce the temperature of the mixed blood, and the temperature change is sensed by the temperature probe 14, and the blood flow is measured by connecting the temperature flow calculation device through the signal interface.

[0055] Specific as Figure 7 As shown:

[0056] The calculation formula is:

[0057] Among them, Q is the required flow, which is also the cardiac output under the current environment;

[0058] T b The patient's blood temperature can be determined by observing the temperature measured by the flow sensor (16) before the ice water is injected;

[0059] T i is the injection temperature, i.e. the temperature of the ice-water mixture 0°C;

[0060] V i The volume of the injection solution is generally within 10 ml;

[0061] K is the correction coefficient, a constant value, and there will be certain compensation differences depending on the equipment;

[0062] ∫Δ b T X d t It is the area under the thermodilution curve, which can be directly calculated by the device. This is a known method and has been widely used in PICOO clinically, so it will not be described here.

[0063] like Figure 2As shown, the transapical right ventricular balloon catheter also includes an intraesophageal catheter 15, the head end of which is provided with an ultrasonic probe 16 for measuring parameters of the heart and large blood vessels through Doppler technology, and a wire is buried in the intraesophageal catheter 15, and a signal interface is provided at the tail end of the wire out of the intraesophageal catheter 15. After the ultrasonic probe 16 arranged on the intraesophageal catheter 15 is placed in the esophagus at a position corresponding to the rear of the heart, the flow through the pulmonary artery is monitored from the rear of the heart through the ultrasonic Doppler technology, and after adjusting the position, other large blood vessel blood flow data can also be monitored, such as left and right cardiac output, myocardial wall activity state, etc.

[0064] The intraesophageal catheter 15 can be set as a stomach tube, and the ultrasound probe 16 is adjusted to a position close to the back of the heart, so that the ultrasound probe 16 can detect various sections of the heart and obtain various clinical cardiac dynamics data, including pulmonary artery flow, cardiac output per stroke, etc. There are TEE devices in clinical practice, and the technology is the same as this, so I will not repeat them.

[0065] Furthermore, the inner and outer surfaces of the transapical catheter 1 and the outer surface of the right ventricular sac 12 are coated with an anticoagulant coating, which can prevent blood from clotting and forming thrombi on the inner and outer surfaces of the lumen of the transapical catheter 1 and the outer surface of the right ventricular sac 12, thereby avoiding the risk of potential thrombi forming and falling off and blocking the pulmonary artery branches.

[0066] Furthermore, the right ventricular sac 12 has a length of 4-6 cm when deflated, preferably 5 cm. The total length of the right ventricle 23 is about 7-11 cm, and the length of the right ventricular sac 12 is less than this length, so that when the right ventricular sac 12 is close to the inner wall of the right ventricle 23 and is located in the right ventricle 23, it is ensured that the right ventricular pressure measuring port 13 is also located in the right ventricular cavity and will not enter the pulmonary artery 24. The right ventricular sac 12 is spherical after being filled, and the maximum volume is less than 80 ml, which is less than the diastolic volume of the right ventricle 23 of a normal adult of 130-150 ml, ensuring that the right ventricular sac 12 will not block the blood inlet (tricuspid valve orifice) and bleeding outlet (pulmonary valve) of the right ventricle 23 after the liquid is injected.

[0067] When in use, the right ventricular sac 12 is located in the cavity near the apex of the right ventricle 23, close to the inner wall of the right ventricle 23, forming a space occupied by the inner cavity of the right ventricle 23, so that the maximum volume of the right ventricle 23 at the end of diastole does not change. Due to the space occupied, the blood stock in the cavity of the right ventricle 23 at the end of diastole is reduced. At the same time, the volume of the right ventricle 23 at the end of contraction is passively increased, which reduces the blood flow output by the right ventricle 23 with each beat, thereby reducing the output of the right ventricle 23, thereby reducing the blood flow in the pulmonary artery 24, reducing the pressure of the pulmonary artery 24, and ultimately reducing the work done by the left ventricle 27.

[0068] Furthermore, the distance between the right ventricular pressure measuring port 13 and the tip of the transapical catheter 1 is 5-10 cm, with 8 cm being optimal. The diastolic inner cavity length of the right ventricle 23 is about 9 cm, minus the length of the right ventricular sac 12, which is about 5 cm, and the length difference is about 4 cm. This difference is smaller than the distance between the right ventricular pressure measuring port 13 and the tip of the transapical catheter 1, ensuring that after the right ventricular sac 12 is correctly positioned, the right ventricular pressure measuring port 13 can enter the pulmonary artery 24 through the pulmonary artery 24 valve.

[0069] like Figure 3 As shown, it is a schematic diagram of the basic structure of the heart: the heart chambers include the right atrium 22, the right ventricle 23, the left atrium 26 and the left ventricle 27; the valves include the tricuspid valve located at the connecting part between the right atrium 22 and the right ventricle 23, the pulmonary valve located at the outlet of the right ventricle 23, the mitral valve at the connecting part between the left atrium 26 and the left ventricle 27, and the aortic valve at the outlet of the left ventricle 27.

[0070] The blood circulation path is: systemic capillaries → systemic small veins → systemic large veins (including jugular vein, femoral vein, axillary vein, etc.) → central vein 21 (superior vena cava, inferior vena cava) → right atrium 22 → tricuspid valve → right ventricle 23 → pulmonary valve → pulmonary artery 24 → pulmonary arterioles → pulmonary capillaries → pulmonary capillaries → pulmonary venules → pulmonary veins 25 → left atrium 26 → mitral valve → left ventricle 27 → aortic valve → aorta 28 (thoracic aorta, abdominal aorta) → systemic large arteries (including femoral artery, carotid artery, brachial artery, etc.) → systemic arterioles → systemic capillaries → systemic capillaries.

[0071] The characteristics of the pressure in each chamber of the heart (related to this patent) are as follows: the pressure of the right ventricle 23 rises rapidly during the systolic period and drops rapidly during the diastolic period. The descending branch has an obvious notch, and the significant feature is that the diastolic pressure is significantly lower than the systolic pressure; the systolic pressure is normally 20-30 mmHg, and the diastolic pressure is 0-5 mmHg. Even in patients with pulmonary hypertension, the diastolic pressure of the right ventricle 23 generally does not exceed 15 mmHg. The pressure of the pulmonary artery 24 has a significant peak value, and the descending branch has an obvious notch. The systolic pressure of the pulmonary artery 24 is similar to the systolic pressure of the right ventricle 23, but the diastolic pressure of the pulmonary artery 24 is significantly greater than the diastolic pressure of the right ventricle 23, and the pressure difference is more than 10 mmHg.

[0072] The puncture and catheterization site of the present invention is the apex of the heart, which is located at the end of the heart rhythm conduction system and the coronary artery system that supplies blood to the myocardium. The puncture risk is minimal and it is the first choice for minimally invasive heart surgery, such as transapical valve replacement and valve prolapse fixation, both of which use the apex of the heart as the puncture operation site.

[0073] The transapical right ventricular balloon catheter is used in double lung transplantation. The main indication is that the pulmonary hypertension before the operation is acceptable, but after one side of the pulmonary artery is blocked during the operation, the uncontrollable pulmonary hypertension occurs. This situation is more common in double lung transplantation. At present, the methods used to reduce pulmonary hypertension after this condition occurs include cardiotonic, NO inhalation, and adding central VA-ECMO, but the effect is extremely limited.

[0074] The transapical right ventricular balloon catheter needs to establish VA-ECMO assistance before use, and the use method is as follows:

[0075] S1: Preparation: Check the right ventricular sac 12, and exhaust the sheath, right ventricular sac filling chamber, pulmonary artery pressure measuring chamber and right ventricular pressure measuring chamber. At this time, it is necessary to equip the puncture needle, guide wire and guide sheath, which are all common puncture accessories in clinical practice. The puncture needle is used to puncture the apex of the heart. The guide wire is a soft head with a curved spring guide wire structure, which can ensure that the inner wall of the heart cavity will not be damaged when the guide wire is inserted into the heart cavity, ensuring safety. The sheath is a tubular structure with a one-way membrane valve at the tail. The transapical catheter 1 can be inserted through the sheath, but blood will not flow out through the tail, serving as a pathway for the transapical catheter 1 to be inserted into the right ventricle 23 and the pulmonary artery 24.

[0076] S2: Puncture: Pre-make a purse string at the apex of the right ventricle 23, and puncture the puncture needle in the pre-made purse string area at the apex of the right ventricle 23 to enter the right ventricle 23. The inner cavity of the puncture needle is larger than the outer diameter of the guide wire. When the puncture needle is connected to the syringe and blood is drawn back smoothly, insert the guide wire through the puncture needle, and slowly insert the guide wire into the pulmonary artery when the right ventricle 23 and pulmonary artery 24 are visible to the naked eye. Pull out the puncture needle, and insert the sheath into the right ventricle 23 under the guidance of the guide wire, and tighten the purse string to temporarily fix it.

[0077] S3: Insertion of transapical catheter 1: The pulmonary artery pressure gauge and the right ventricular pressure gauge are connected to the pressure measuring equipment respectively, and the transapical catheter 1 is inserted through the inner cavity of the sheath tube, and the pressure values ​​and waveforms of the pulmonary artery pressure gauge port 11 and the right ventricular pressure gauge port 13 are observed in real time. When the right ventricular intraventricular sac 12 completely enters the right ventricle 23, the sheath tube is pulled out, and the purse string knot is tightened again to fix it. To ensure that the right ventricular intraventricular sac 12 completely enters the right ventricle 23, a scale can be pre-made on the apical catheter 1 behind the right ventricular sac 12, and the insertion depth can be greater than the wall thickness of the right ventricle 23.

[0078] S4: Positioning the right ventricular sac 12: Under the premise of VA-ECMO assistance, fill the right ventricular sac 12 with 5-10 ml of liquid, slowly withdraw the catheter 1 through the apex, so that the right ventricular sac 12 is close to the inner wall of the right ventricle 23, and stop withdrawing immediately. After the right ventricular sac 12 is filled with liquid, its volume becomes larger, and when it withdraws close to the inner wall of the apex of the right ventricle 23, it will produce obvious resistance, and then stop withdrawing. Of course, when withdrawing, you should always pay attention to the prefabricated scale on the apex catheter 1 behind the right ventricular sac 12 to avoid pulling out the right ventricular sac 12 by mistake.

[0079] S5: Flow monitoring: The temperature probe 14 and the flow calibration device calibrate the pulmonary blood flow by the thermal dilution method, and continuously monitor the pulmonary blood flow according to the change of pulmonary artery pressure. When calibrating the pulmonary blood flow, 5-10 ml of ice water is the best choice, which has a temperature of zero and is easy to obtain.

[0080] Alternatively, the ultrasound probe 16 on the intraesophageal catheter 15 is placed into the esophagus at a position corresponding to the heart, and the pulmonary blood flow or cardiac function is measured by Doppler technology.

[0081] S6: Pulmonary artery flow regulation: Under the above monitoring, a small amount of fluid is injected into the right ventricular sac 12 in multiple times to reduce the right ventricular 23 output, while increasing the VA-ECMO flow to adjust the pulmonary artery pressure or pulmonary blood flow to the expected value.

[0082] like Figure 6 As shown in the figure on the right, after establishing extracorporeal circulation, the blood circulation path is two parallel pathways:

[0083] ① Venous system → right atrium 22 → right ventricle 23 → pulmonary artery 24 → lung → left atrium 26 → left ventricle 27 → arterial system → venous system.

[0084] ② Venous system → right atrium 22 → ECMO venous catheter 32 → ECMO host 31 → ECMO arterial catheter 33 → arterial system → venous system.

[0085] The two share the function of oxygenating venous blood and pumping it into the arteries. The two work together to ensure blood supply to various organs and tissues in the body. When the right ventricular bladder 12 is filled with fluid, the output of the right ventricle 23 is reduced, and the blood flow through the heart and lungs is reduced. The VA-ECMO flow is increased in time to ensure blood supply to various organs and tissues in the body.

[0086] S7: Recovery: After the patient's condition stabilizes, slowly and gradually drain the fluid in the right ventricular endocardium 12 in small amounts, while reducing the VA-ECMO flow rate, and finally remove the transapical catheter 1.

[0087] Depending on the patient's condition, there are two situations in which the transapical catheter 1 can be removed:

[0088] ① If the left heart function is good and PGD does not occur after the double lung is opened (based on whether visible lung water occurs), the fluid in the right ventricular sac 12 can be evacuated in batches before closing the chest, and finally the apical catheter 1 can be removed. After the catheter is removed, observe whether there is bleeding at the puncture site, and if necessary, suture the puncture site with one stitch to close it.

[0089] ② For patients who have already developed PGD or left heart atrophy, it is necessary to continue to retain the apical catheter 1. When closing the chest, a certain degree of relaxation is reserved for the apical catheter 1, so as not to affect the beating of heart 2. The tail of the apical catheter 1 is led out through the precordial area through the intercostal space of the chest wall, the lead-out incision is treated aseptically, and the dressing is covered to continuously monitor relevant data such as pulmonary artery pressure and right ventricular pressure.

[0090] In PGD patients, when the transplanted lung function recovers and the pulmonary edema disappears, the liquid in the right ventricular sac 12 can be evacuated in batches and the apical catheter 1 can be removed. After the catheter is removed, the bleeding at the puncture point needs to be observed. Generally, the prefabricated purse-string suture will close the apical puncture point and no treatment is required. If the bleeding at the puncture point is obvious, a small incision in the precordial area can be made if necessary, and the puncture point can be closed with sutures under direct vision. This is also a routine operation in cardiothoracic surgery and will not be described in detail here.

[0091] In patients with left heart atrophy, the apical catheter 1 needs to be retained for a longer time, and the liquid in the right ventricular sac 12 is extracted in small amounts in batches (5-10 ml each time, maintained for 1-3 days each time, depending on the condition), and the VA-ECMO speed is slightly reduced accordingly, and the VA-ECMO flow is reduced to slowly increase the preload of the left ventricle 27. Repeat this operation within 1-2 months, through multiple adaptive exercises, the atrophic heart is functionally exercised, and the left ventricular myocardial wall thickness gradually returns to normal. When the liquid in the right ventricular sac 12 is basically emptied and the function of the left ventricle 27 is basically restored, the apical catheter 1 can be removed.

[0092] After the apical catheter 1 is removed, the VA-ECMO flow rate can be reduced according to the patient's condition until the VA-ECMO is removed and the treatment is terminated.

[0093] like Figure 4-7 As shown, detailed explanation is given in combination with specific operations. Figure 1 The embodiment can be completed under TEE monitoring of the cardiac chamber; Figure 2 In the embodiment, the ultrasound probe 16 of the esophageal catheter 15 can be placed into the esophagus at the back of the heart to monitor the heart cavity:

[0094] Figure 4The left figure shows a schematic diagram of the sheath being inserted into the right ventricle 23 and the guide wire being pulled out. The apex-placed catheter 1 has not yet entered the heart cavity and has no pressure characteristics. At this time, the pre-buried purse-string suture is wrapped around the outer ring of the sheath, tightening the puncture hole and temporarily fixing it closed on the outer wall of the sheath. The specific puncture process is: slightly fix the apex, and the puncture needle penetrates the right ventricle; insert the guide wire through the inner cavity of the puncture needle, pull out the puncture needle, and inject the sheath into the right ventricle under the guidance of the guide wire; finally, pull out the guide wire and fix the sheath.

[0095] Figure 4 As shown in the right figure, the apical catheter 1 is inserted into the corresponding depth of the right ventricle 23 through the lumen of the sheath tube, and the pulmonary artery pressure measuring port 11 at the tip of the apical catheter 1 enters the pulmonary artery 24 through the valve of the pulmonary artery 24, while the right ventricular sac 12 enters the right ventricle 23, and the right ventricle pressure measuring port 13 is located in the right ventricle 23. At this time, the pulmonary artery pressure measuring port 11 shows the pressure waveform and characteristics of the pulmonary artery 24, and the right ventricle pressure measuring port 13 shows the pressure waveform and characteristics of the right ventricle 23.

[0096] Figure 5 As shown in the left figure, the sheath is pulled out, the prefabricated purse-string front line is further tightened, and the puncture port is closed. At this time, the pulmonary artery pressure measuring port 11 is still in the pulmonary artery 24, which is manifested as the pressure waveform and characteristics of the pulmonary artery 24; at the same time, the right ventricular pressure measuring port 13 is still in the right ventricle 23, which is manifested as the pressure waveform and characteristics of the right ventricle 23.

[0097] like Figure 5 As shown in the right figure, a small amount of liquid is filled into the right ventricular sac 12, and the right ventricular sac 12 expands. At this time, the apex catheter 1 is withdrawn until the sac wall of the right ventricular sac 12 is attached to the apex inner wall of the right ventricle 23. This operation can be completed under ultrasound observation of the right heart cavity.

[0098] like Figure 6 As shown in the left figure, the right ventricular bladder 12 is filled with appropriate liquid (combined with VA-ECMO speed adjustment), so that the stroke volume of the right ventricle 23 decreases, and the output of the right ventricle 23 decreases. The flow entering the pulmonary artery 24 decreases, and the pulmonary artery pressure systolic pressure and diastolic pressure measured by the pulmonary artery pressure measuring port 11 both decrease; while the right ventricular pressure measuring port 13 is in the right ventricle 23, the right ventricular 23 systolic pressure does not decrease, and even slightly increases, but in the diastolic period, due to the right ventricular bladder 12 occupying the space, the pumping action caused by the relaxation of the right ventricle 23 is reduced, resulting in an increase in the right ventricular 23 diastolic pressure.

[0099] like Figure 6 The right figure shows the application state diagram after the right ventricular bladder 12 is filled with liquid. At this time, the heart pump function and the VA-ECMO pump function work in parallel to oxygenate the venous blood and pump it into the artery to supply blood to various organs and tissues.

[0100] Furthermore, the tail ends of the pulmonary artery pressure measuring tube, the right ventricular bladder injection tube and the right ventricular pressure measuring tube are all connected to a spring valve filling port. After filling with liquid, the filling port can be closed to ensure that the volume of the right ventricular bladder 12 is stable and easy to operate. When the volume needs to be reduced, the reverse operation can be performed.

[0101] Furthermore, the right ventricular sac injection tube is connected to a safety relief valve, and the threshold of the safety relief valve is less than the pressure of the maximum volume of the right ventricular sac 12. The threshold of the safety relief valve is set according to the material, length, wall thickness of the right ventricular sac 12 of the specific product and the thickness of the transapical catheter 1. By limiting the pressure of the right ventricular sac 12, it is ensured that the internal volume of the right ventricular sac 12 does not exceed the maximum volume set by the product, and the maximum volume is less than 80ml, preferably set to 70ml.

[0102] The above embodiments are merely illustrative of the principles and effects of this patent application, and are not intended to limit this patent application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of this patent application. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the relevant technical field without departing from the spirit and technical ideas disclosed in this patent application should still be covered by the claims of this patent application.

Claims

1. A transapical right ventricular balloon catheter, including a transapical insertion catheter (1); A pulmonary artery pressure measuring port (11) is arranged at the head end of the transapical catheter (1), a pulmonary artery pressure measuring cavity is arranged inside the transapical catheter (1), and a pulmonary artery pressure measuring tube is arranged at the tail end of the pulmonary artery pressure measuring cavity and connected to the transapical catheter (1); A right ventricular sac (12) is arranged around the back of the pulmonary artery pressure measuring port (11) of the transapical catheter (1), a right ventricular sac filling cavity is arranged in the transapical catheter (1), the head end of the right ventricular sac filling cavity is connected to the right ventricular sac (12), and the tail end of the transapical catheter (1) is connected to a right ventricular sac injection tube; A right ventricular pressure measuring port (13) is arranged adjacent to the front of the right ventricular intracavitary sac (12) of the transapical catheter (1), a right ventricular pressure measuring cavity is arranged in the transapical catheter (1), the head end of the right ventricular pressure measuring cavity is connected to the right ventricular pressure measuring port (13), and the tail end of the transapical catheter (1) is connected to a right ventricular pressure measuring tube.

2. The transapical right ventricular balloon catheter according to claim 1, characterized in that: The head end of the transapical catheter (1) is provided with a temperature probe (14) for measuring pulmonary artery blood flow in cooperation with the thermodilution method, a wire electrically connected to the temperature probe (14) is buried in the transapical catheter (1), and a signal interface is provided at the tail end of the wire exiting the transapical catheter (1).

3. The transapical right ventricular balloon catheter according to claim 1, characterized in that: It also includes an intraesophageal catheter (15), the head end of which is provided with an ultrasonic probe (16) for measuring parameters of the heart and large blood vessel arteries using Doppler technology, a wire is buried in the intraesophageal catheter (15), and a signal interface is provided at the tail end of the wire that exits the intraesophageal catheter (15).

4. The transapical right ventricular balloon according to claim 1, characterized in that: The inner and outer surfaces of the transapical catheter (1) and the outer surface of the right ventricular sac (12) are coated with an anticoagulant coating.

5. The transapical right ventricular balloon catheter according to claim 1, characterized in that: The right ventricular sac (12) has a length of 4-6 cm when deflated and a spherical shape when filled, with a maximum volume of less than 80 ml.

6. The transapical right ventricular balloon catheter according to claim 1, characterized in that: The right ventricular pressure measuring port (13) is 5-10 cm away from the tip of the transapical catheter (1).

7. The transapical right ventricular balloon catheter according to claims 1-6, characterized in that: Here’s how to use it: S1: Preparation: right ventricular sac (12) inspection, sheath, right ventricular sac filling chamber, pulmonary artery pressure chamber and right ventricular pressure chamber exhaust; S2: Puncture: prefabricate a purse string suture at the apex of the heart corresponding to the right ventricle (23), puncture, insert a guide wire, insert the sheath into the right ventricle (23) under the guidance of the guide wire, and tighten the purse string for temporary fixation; S3: Insertion of the transapical catheter (1): The pulmonary artery pressure measuring tube and the right ventricular pressure measuring tube are connected to the pressure measuring equipment respectively, and the transapical catheter (1) is inserted through the inner cavity of the sheath tube, and the pressure values ​​and waveforms of the pulmonary artery pressure measuring port (11) and the right ventricular pressure measuring port (13) are observed in real time. When the right ventricular intracardiac sac (12) has completely entered the right ventricle (23), the sheath tube is pulled out, and the purse string knot is tightened again to fix it; S4: Positioning the right ventricular sac (12): Under the assisted condition of VA-ECMO, fill the right ventricular sac (12) with 5-10 ml of liquid, slowly withdraw the catheter (1) through the apex of the heart, make the right ventricular sac (12) close to the inner wall of the right ventricle (23), and stop withdrawing immediately; S5: Flow monitoring: The temperature probe (14) and the flow calibration device calibrate the pulmonary blood flow by the thermodilution method, and continuously monitor the pulmonary blood flow according to the changes in the pulmonary artery pressure; or the ultrasound probe (16) on the esophageal catheter (15) is placed into the esophagus at the position corresponding to the heart, and the pulmonary blood flow or heart function is measured by Doppler technology; S6: Pulmonary artery flow regulation: Under the above monitoring, a small amount of fluid is injected into the right ventricular sac (12) in batches to reduce the right ventricular (23) output, while increasing the VA-ECMO flow to adjust the pulmonary artery pressure or pulmonary blood flow to the expected value; S7: Recovery: After the patient's condition stabilizes, slowly drain the fluid in the right ventricular sac (12) in small amounts in batches, reduce the VA-ECMO flow rate, and finally remove the transapical catheter (1).

8. The transapical right ventricular balloon catheter according to claim 1 is characterized in that: The tail ends of the pulmonary artery pressure measuring tube, the right ventricular sac injection tube and the right ventricular pressure measuring tube are all connected with elastic valve filling ports.

9. The transapical right ventricular balloon catheter according to claim 8 is characterized in that: The right ventricular sac injection tube is connected to a safety pressure relief valve, and the threshold of the safety pressure relief valve is less than the pressure of the maximum volume of the right ventricular sac (12).

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