CN117085241A - External pulse type minimally invasive interventional ventricular mechanical auxiliary device - Google Patents
External pulse type minimally invasive interventional ventricular mechanical auxiliary device Download PDFInfo
- Publication number
- CN117085241A CN117085241A CN202311114996.4A CN202311114996A CN117085241A CN 117085241 A CN117085241 A CN 117085241A CN 202311114996 A CN202311114996 A CN 202311114996A CN 117085241 A CN117085241 A CN 117085241A
- Authority
- CN
- China
- Prior art keywords
- catheter
- blood
- connector
- minimally invasive
- diaphragm pump
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 230000002861 ventricular Effects 0.000 title claims abstract description 45
- 210000004369 blood Anatomy 0.000 claims abstract description 61
- 239000008280 blood Substances 0.000 claims abstract description 61
- 230000017531 blood circulation Effects 0.000 claims abstract description 34
- 210000005240 left ventricle Anatomy 0.000 claims abstract description 17
- 210000001105 femoral artery Anatomy 0.000 claims abstract description 15
- 210000000709 aorta Anatomy 0.000 claims abstract description 11
- 210000001765 aortic valve Anatomy 0.000 claims abstract description 6
- 230000033764 rhythmic process Effects 0.000 abstract description 5
- 239000000203 mixture Substances 0.000 abstract 1
- 206010018910 Haemolysis Diseases 0.000 description 11
- 230000008588 hemolysis Effects 0.000 description 11
- 238000005516 engineering process Methods 0.000 description 9
- 239000012528 membrane Substances 0.000 description 8
- 238000000034 method Methods 0.000 description 8
- 208000007536 Thrombosis Diseases 0.000 description 7
- 230000004087 circulation Effects 0.000 description 6
- 238000013461 design Methods 0.000 description 6
- 208000014674 injury Diseases 0.000 description 6
- 206010019280 Heart failures Diseases 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 5
- 230000000747 cardiac effect Effects 0.000 description 5
- 230000006378 damage Effects 0.000 description 5
- 238000002513 implantation Methods 0.000 description 5
- 230000010349 pulsation Effects 0.000 description 5
- 238000005086 pumping Methods 0.000 description 5
- 230000008733 trauma Effects 0.000 description 5
- 230000002792 vascular Effects 0.000 description 5
- 210000000601 blood cell Anatomy 0.000 description 4
- 230000004217 heart function Effects 0.000 description 4
- 206010007556 Cardiac failure acute Diseases 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 3
- 210000001367 artery Anatomy 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 230000008081 blood perfusion Effects 0.000 description 3
- 230000036770 blood supply Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000007789 gas Substances 0.000 description 3
- 238000013146 percutaneous coronary intervention Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 230000035485 pulse pressure Effects 0.000 description 3
- 238000011084 recovery Methods 0.000 description 3
- 230000000472 traumatic effect Effects 0.000 description 3
- 208000032843 Hemorrhage Diseases 0.000 description 2
- 206010067268 Post procedural infection Diseases 0.000 description 2
- 208000035965 Postoperative Complications Diseases 0.000 description 2
- 238000004891 communication Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 230000010412 perfusion Effects 0.000 description 2
- 230000002980 postoperative effect Effects 0.000 description 2
- 238000009256 replacement therapy Methods 0.000 description 2
- 238000009991 scouring Methods 0.000 description 2
- 238000010008 shearing Methods 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 230000002459 sustained effect Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 238000002054 transplantation Methods 0.000 description 2
- 208000009304 Acute Kidney Injury Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 208000033626 Renal failure acute Diseases 0.000 description 1
- 206010039163 Right ventricular failure Diseases 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 208000034158 bleeding Diseases 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 206010007625 cardiogenic shock Diseases 0.000 description 1
- 238000005094 computer simulation Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 210000004798 organs belonging to the digestive system Anatomy 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000000541 pulsatile effect Effects 0.000 description 1
- 230000035939 shock Effects 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 210000000596 ventricular septum Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
- A61M60/117—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body for assisting the heart, e.g. transcutaneous or external ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/247—Positive displacement blood pumps
- A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
- A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/845—Constructional details other than related to driving of extracorporeal blood pumps
Abstract
The invention relates to the technical field of ventricular assist devices, in particular to an external pulse type minimally invasive interventional ventricular mechanical assist device, which comprises a catheter, a connector and a diaphragm pump, wherein the front end of the catheter is a suction tip, a two-way valve is arranged on the catheter, the two ends of the connector are respectively connected with the rear end of the catheter and the diaphragm pump, the catheter is used for entering a heart through a femoral artery, the suction tip is positioned in a left ventricle, the two-way valve is positioned on an aortic valve, the connector and the diaphragm pump are positioned outside the body, the diaphragm pump is used for sucking and reinjecting blood at a set pulse frequency under the control and the driving of a control unit, and when the blood is sucked, the blood in the left ventricle flows into the diaphragm pump through the suction tip, the catheter and the two-way valve which is automatically closed; when the blood is refilled, the blood in the diaphragm pump flows into the aorta through the connector, the catheter and the automatic opening two-way valve; the blood flow in the catheter is greater than 2L/min. The composition accords with the human body electrocardio rhythms, and has good blood compatibility, small wound and large flow.
Description
Technical Field
The invention relates to the technical field of ventricular assist devices, in particular to an external pulse type minimally invasive interventional ventricular mechanical assist device.
Background
Heart failure, where morbidity and mortality rise year by year, is a scarcity of heart donors, which makes short-term and long-term circulatory support urgent for heart failure patients. The international clinical application guidelines apply to the use of intra-aortic balloon counterpulsation pumps (IABPs) to protect patients in high-risk PCI (percutaneous coronary intervention) procedures. In recent years, a part of implantable magnetic suspension technology (such as LVAD) and axial flow pump technology (such as Impella technology of ABIOMED company) appear in international ventricular assist devices, and a part of implantable magnetic suspension technology has good effect in treating acute heart failure. However, implantable devices are relatively traumatic to the patient, and interventional axial flow pump technology, because of the continuous blood flow, results in the occurrence of physiological complications in the patient, and presents blood compatibility issues.
At present, the clinic has three main requirements for an interventional artificial heart: firstly, the longer clinical support time indicates that the product has good blood compatibility; secondly, the product is required to have smaller size and weight; third, better hemodynamics, the blood flow provided per minute can not reach the body's needs. The three points are difficult to balance, the size of the product determines the blood flow, the probability of hemolysis is easily increased for longer clinical support time, and the problem of how to perfectly solve the three problems at the same time becomes the problem to be solved in the interventional artificial heart.
In the prior art, both the im technique and the implanted Left Ventricular Assist Device (LVAD), a folded mechanical pump is delivered to the left ventricle through a catheter that rotates and delivers blood from the left ventricle to the aorta at a sustained flow rate, but the catheter provides a greater blood flow support, but relies on a sustained high-speed mode of operation set by a motor to circulate blood, which is a continuous circulatory blood delivery process, rather than delivering blood according to the pulsatile frequency of the heart. The mechanical pump replaces the left heart to pump blood, and the working modes are different from those of a normal heart, the shearing stress of the ventricular wall and the mechanical mechanics of micro myocardial fibers are also different, the functional influence on the valve is also different (continuous pumping blood can aggravate the insufficiency of the aortic valve), and the load of the heart can be aggravated.
Moreover, the falling off of the wear particles of the medical implant-grade motor brings great risks. In addition, motor operation heating will lead to thrombosis problems, and implanted grade products require bearing seals to reduce thrombosis. In addition to the motor, impeller design affects the performance of blood compatibility, and the impeller design does not simply mimic and replicate rotational speed and mechanism and angle, which involves hydrodynamic design, flow field design. The design of the impeller needs to consider the internal flow field of the product, needs a large number of simulation tests, and needs a large number of core theoretical foundations such as computer simulation and flow field design. The image technology pumps blood directly from the left ventricle through folding the impeller and the micro motor, the rotating speed of the motor can reach 51000 r/min, the high-rotating-speed axial flow pump brings high-speed running of blood flow, and meanwhile, the blood is subjected to relatively large shearing force when flowing through the artificial heart due to the fact that the rotating speed is too high, and blood cells are easily cut up by the impeller, so that hemolysis is caused. While the incidence of hemolysis during the auxiliary period is high in the Impella system, which can be as high as 5% -10% in the first 24 hours, mainly related to the direct destruction of erythrocytes by shear forces generated by high-speed operation of the blood stream. In addition, poor placement of the catheter in the heart chamber may also lead to hemolysis. If hemolysis continues to exist, the risk of acute renal insufficiency will increase.
Furthermore, implantable artificial hearts are relatively traumatic to the patient. Heart failure patients suffer from cardiogenic shock caused by cardiotomy or other reasons and high-risk coronary intervention PCI, and the heart pump is implanted in a minimally invasive intervention mode. In addition, the artificial heart is only a transition device before heart transplantation, but not a replacement therapy device, if a chest opening implantation mode is used, the heart transplantation is carried out at a later stage to open the chest again, so that the wound on a patient is large, and complications such as bleeding, infection, thromboembolism and the like are also encountered.
As for the IABP commonly used in clinic, because the IABP is an internal balloon, the flow provided by pumping blood each time is limited due to the size of the aorta, and the blood flow required by normal operation of the body and viscera of a patient cannot be satisfied.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention aims to provide an external pulse type minimally invasive interventional ventricular mechanical assist device which meets the requirements of human body for cardiac rhythm, good blood compatibility, small trauma and large flow.
In order to solve the technical problems, the invention adopts the following technical scheme:
the invention provides an external pulse type minimally invasive interventional ventricular mechanical auxiliary device, which comprises a catheter, a connector and a diaphragm pump, wherein the front end of the catheter is a suction tip, a two-way valve is arranged on the catheter, the rear end of the catheter is connected with one end of the connector, the other end of the connector is connected with the diaphragm pump, the catheter is used for entering a heart through a femoral artery, the suction tip is positioned in a left ventricle, the two-way valve is positioned on an aortic valve, the connector and the diaphragm pump are positioned outside the body, the diaphragm pump is used for sucking and reinjecting blood at a set pulse frequency under the control and the driving of a control unit, and when the blood is sucked, the blood in the left ventricle flows into the diaphragm pump through the suction tip, the catheter and the two-way valve which is automatically closed, and the connector; when the blood is refilled, the blood in the diaphragm pump flows into the aorta through the connector, the catheter and the automatic opening two-way valve; the blood flow in the catheter is greater than 2L/min.
Preferably, the diameter of the connector is larger than the diameter of the catheter, and one end of the connector connected with the catheter is a tapered end with gradually reduced diameter.
Preferably, the diameter of the catheter is 4.0mm-6.2mm.
Preferably, the diameter of the catheter is 5.6mm.
Preferably, the length of the conduit is 98cm-105cm.
Preferably, the length of the catheter is 100cm.
Preferably, the distance between the bi-directional valve and the suction tip is 70mm-76mm.
Preferably, the distance between the bi-directional valve and the aspiration tip is 72mm.
Preferably, the diameter of the connector is 13mm-16mm.
Preferably, the diameter of the connector is 14mm.
Compared with the prior art, the invention has obvious progress:
the external pulse type minimally invasive interventional ventricular mechanical auxiliary device is characterized in that the interventional part is only provided with the catheter, the connector and the diaphragm pump are external, and no mechanical pump enters the heart lumen, so that more blood flow gaps and larger catheter passages can be released to enable more blood flow to pass through, and more than half of the normal cardiac output of a human body (more than 2L/min) is achieved. The human femoral artery diameter is about 9mm, only the catheter is used for intervention, smooth passing through the femoral artery can be realized through the catheter diameter, meanwhile, all femoral artery channels are not occupied, and blood flowing through the femoral artery is not influenced, so that long-time blood circulation support can be provided. The blood flow is larger, the circulation auxiliary requirement of a patient can be met, the recovery of the heart function is facilitated, and complications caused by poor blood perfusion are reduced.
The external pulse type minimally invasive interventional ventricular mechanical auxiliary device does not adopt an implanted mechanical pump, but drives blood to be pumped into the main artery from the left ventricle by means of the pulse operation of the diaphragm pump driven by external power, so that the damage to blood cells caused by continuous high-speed movement of the implanted mechanical pump is avoided in the working principle, the probability of hemolysis and thrombus generation is greatly reduced, and the device has better blood compatibility. Meanwhile, the pulse pressure difference generated by the pulse technology is more in line with the human body electrocardio rhythm, so that the scouring of blood to blood vessels by long-time high-speed circulation is avoided, the blood vessels and the heart can be protected, and related complications are reduced.
The external pulse type minimally invasive intervention ventricular mechanical auxiliary device provided by the invention has the advantages that the diaphragm pump is arranged outside the body, only the catheter is used for minimally invasive intervention in the ventricle, the breakthrough of' intervention is realized, the support of high blood flow can be provided, the problems of hemolysis and thrombus caused by the mechanical pump positioned in the heart can be reduced, the trauma to a patient can be reduced, the postoperative hospitalization time of the patient can be reduced, and the risk of postoperative infection and complications can be reduced.
Drawings
Fig. 1 is a schematic structural view of an external pulse type minimally invasive ventricular mechanical assist device according to an embodiment of the present invention.
Wherein reference numerals are as follows:
1. catheter tube
2. Connector with a plurality of connectors
3. Diaphragm pump
31. Diaphragm sheet
32. Working room
33. Medium chamber
4. Suction tip
5. Two-way valve
6. Control unit
Detailed Description
The following describes the embodiments of the present invention in further detail with reference to the accompanying drawings. These embodiments are merely illustrative of the present invention and are not intended to be limiting.
In the description of the present invention, it should be noted that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
Furthermore, in the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
As shown in fig. 1, one embodiment of the external pulse type minimally invasive ventricular mechanical assist device of the present invention.
The external pulse type minimally invasive interventional ventricular mechanical assist device of the embodiment comprises a catheter 1, a connector 2 and a diaphragm pump 3. The front end of the catheter 1 is a suction tip 4, a two-way valve 5 is arranged on the catheter 1, the rear end of the catheter 1 is connected with one end of a connector 2, and the other end of the connector 2 is connected with a diaphragm pump 3. The diaphragm pump 3 has a working chamber 32 and a medium chamber 33 separated by a diaphragm 31. The aspiration tip 4, the catheter 1, the connector 2 and the working chamber 32 of the diaphragm pump 3 are in communication with each other in this order. The two-way valve 5 is provided with three valve ports, two valve ports are respectively communicated with the inside of the catheter 1, the third valve port is positioned on the wall of the catheter 1, the two-way valve 5 is automatically closed or opened under the action of the flow direction and the pressure of fluid (blood) in the catheter 1, specifically, when the blood flows from the front end of the catheter 1 to the rear end of the catheter 1, the two-way valve 5 is automatically closed, when the two-way valve 5 is closed, the valve ports positioned on the wall of the catheter 1 are closed, and the other two valve ports are communicated, so that the blood can flow from the suction tip 4 at the front end of the catheter 1 to the connector 2 at the rear end of the catheter 1 and cannot leak from the valve ports on the wall of the catheter 1; when blood flows from the rear end of the catheter 1 to the front end of the catheter 1, the two-way valve 5 is automatically opened, and when the two-way valve 5 is opened, a valve port close to the rear end of the catheter 1 is communicated with a valve port positioned on the wall of the catheter 1, and a valve port close to the front end of the catheter 1 is closed, so that the blood can flow from the rear end of the catheter 1 to the two-way valve 5 and flow out from the valve port of the two-way valve 5 positioned on the wall of the catheter 1. The diaphragm pump 3 and the two-way valve 5 can both be of existing construction.
In this embodiment, the catheter 1 is used to enter the heart of a human body via the femoral artery with the aspiration tip 4 located in the left ventricle, the bi-directional valve 5 located in the aorta on the aortic valve, the connector 2 and the diaphragm pump 3 located outside the body. The catheter 1 may be introduced into the heart by way of a minimally invasive intervention in the femoral artery, in particular from the femoral artery via a vascular sheath and a guidewire. The membrane pump 3 is used to pump and reinject blood at a set pulsation frequency under control and actuation of an external control unit 6. The control unit 6 provides power and an operation panel, embeds flow rate, pulsation rate adjustment and control programs, and simultaneously accesses medium (such as helium) to the medium chamber 33 of the diaphragm pump 3 to provide power to drive the diaphragm 31 to move back and forth, thereby allowing the working chamber 32 to suck and discharge blood. The control unit 6 may be a control driving module of an existing diaphragm pump, which is not described herein.
When the diaphragm pump 3 pumps out blood, that is, when the working chamber 32 of the diaphragm pump 3 sucks in blood, blood in the left ventricle flows into the diaphragm pump 3 through the suction tip 4, the catheter 1, the self-closing bi-directional valve 5, and the connector 2. When the diaphragm pump 3 is refilled with blood, that is, when the working chamber 32 of the diaphragm pump 3 is discharged, the blood in the diaphragm pump 3 flows into the aorta via the connector 2, the catheter 1 and the automatically opened two-way valve 5. Thus, the blood supply process of one heart beat can be completed by one pulse of the diaphragm pump 3, and the blood circulation can be assisted by the diaphragm pump 3 at the set pulse frequency and the simulated rational pulse frequency.
In this embodiment, the blood flow in the catheter 1 is greater than 2L/min. The external pulse type minimally invasive interventional ventricular mechanical auxiliary device is characterized in that the interventional part of the external pulse type minimally invasive interventional ventricular mechanical auxiliary device is only provided with the catheter 1, the connector 2 and the diaphragm pump 3 are external, and no implanted mechanical pump is arranged, and under the condition that the diameter of the catheter 1 is enough, the external control unit 6 drives the diaphragm pump 3 to work in a pulse mode to drive blood to be pumped into the main artery from the left ventricle through the catheter 1 and the connector 2, so that the blood flow of more than 2L/min can be provided, the blood flow is larger, and the normal blood flow requirement of a patient can be ensured. While the normal heart discharge amount of the human body is about 4L/min, IABP in the prior art can increase blood supply of coronary artery and brain through counterpulsation, but the flow is only tens milliliters, when acute heart failure leads to shock, the flow is insufficient to maintain organ perfusion, and the acute kidney function injury can be caused by heart-kidney syndrome, so that the rehabilitation or subsequent treatment of a patient is directly influenced. The external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment can release more blood flowing gaps and larger guide tube 1 passages to enable more blood to pass through as no mechanical pump enters the heart lumen, so that the output of the normal heart of a human body is more than half (more than 2L/min). The external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment only has the intervention of the catheter 1, can smoothly pass through the femoral artery through the diameter of the catheter 1, does not occupy all femoral artery channels and does not influence blood to flow through the femoral artery, so that long-time blood circulation support can be provided. The blood flow is larger, the circulation auxiliary requirement of a patient can be met, the recovery of the heart function is facilitated, and complications caused by poor blood perfusion are reduced.
The external pulse type minimally invasive interventional ventricular mechanical auxiliary device does not adopt an implanted mechanical pump, but drives blood to be pumped into the main artery from the left ventricle by means of the pulse operation of the diaphragm pump 3 driven by external power, so that the damage to blood cells caused by continuous high-speed movement of the implanted mechanical pump is avoided in the working principle, the probability of hemolysis and thrombus generation is greatly reduced, and better blood compatibility is achieved. Meanwhile, the pulse pressure difference generated by the pulse technology is more in line with the human body electrocardio rhythm, so that the scouring of blood to blood vessels by long-time high-speed circulation is avoided, the blood vessels and the heart can be protected, and related complications are reduced. The pulsating blood flow can assist the ventricular septum swing, reduce the incidence of right heart failure, reduce the incidence of valve insufficiency, increase vascular elasticity, improve tissue perfusion, reduce hemorrhage of digestive organs of patients, and enable patients after LVAD operation to benefit more. The pulsation characteristic of the external pulsation type minimally invasive interventional ventricular mechanical auxiliary device simulates a real heart, generates pulsating blood flow, can maintain the pulse pressure difference of about 20mmHg-30mmHg of a patient, generates pulse, is close to the physiological cycle of a normal heart, and is more physiological.
The external pulse type minimally invasive intervention ventricular mechanical auxiliary device of the embodiment externally places the diaphragm pump 3 outside the body, only has the catheter 1 minimally invasive intervention in the ventricle, realizes the breakthrough of 'intervention without implantation', can provide support of high blood flow, reduces the problems of hemolysis and thrombus caused by the mechanical pump positioned in the heart, can further lead the wound caused to a patient to be smaller, reduces the postoperative hospitalization time of the patient, and reduces the risk of postoperative infection and complications. Short term cardiac mechanical circulatory support is commonly used in patients with acute decompensated heart failure for the purpose of assisting the heart failure patient until the patient has recovered sufficient cardiac function or until the heart donor is reached, the assisting support being a transitional device rather than a replacement therapy device, the assisting time being from hours to days, but typically not more than two weeks, the subsequent patient waiting for the cardiac function to recover or transition to the next therapy, so that the prior assisting transitional device should minimize trauma to the patient, facilitating the subsequent recovery and therapy. The external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment is in an 'interventional non-implantation' mode, the problem of large trauma caused by implantation of an implantable artificial heart during open chest implantation can be solved in short-time support, the damage to a patient needing short-time artificial heart support is small, nursing is relatively simple, and the device can be externally connected with a membranous lung if necessary. Due to the minimally invasive advantage of percutaneous intervention, a channel of the auxiliary circulation can be established rapidly. While recent clinical guidelines show that short-term intervention procedures for cardiac circulatory intervention are evolving into a first line. The earlier the intervention time, the better the patient is returned, since percutaneous intervention can place ventricular mechanical assist devices in the ventricles in a short time, and can maintain blood perfusion at the first time that heart failure occurs, thereby directly affecting the patient's near and far returns. Meanwhile, because the operation threshold of the intervention is lower, the cost of the operation type learning time of doctors is reduced, and the medical expense of patients is reduced.
Therefore, compared with the IABP in the prior art, the external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment can provide higher blood flow and is more beneficial to patients.
Compared with the Impella technology in the prior art, the external pulse type minimally invasive interventional ventricular mechanical assist device of the embodiment can provide the same blood flow circulation support, but has better blood compatibility. While the Impella is an interposed axial flow pump, the volume is smaller, and in order to ensure the blood flow, the rotating speed of a mechanical pump must be increased, so that blood cells can be destroyed to cause hemolysis and even thrombus.
Compared with an implanted Left Ventricular Assist Device (LVAD) in the prior art, the external pulse type minimally invasive interventional ventricular mechanical assist device of the present embodiment is less traumatic to a patient in a manner of "intervention is not implanted", can provide higher blood flow, has a lower probability of causing hemolysis, can bring about an effect similar to heart pumping by a pulse technique, and reduces complications of blood vessels or organs caused by continuous blood flow flushing.
In summary, the external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment simultaneously meets the requirements of small trauma, large flow, good blood compatibility and compliance with the human body electrocardio rhythms, and is a ventricular auxiliary device which can be used for replacing the cardiac pumping function and maintaining the blood circulation function in a short period (from several hours to several weeks).
Preferably, in the external pulse type minimally invasive ventricular mechanical assist device of the present embodiment, the diameter D2 of the connector 2 is larger than the diameter D1 of the catheter 1, and one end of the connector 2 connected to the catheter 1 is a tapered end with a gradually decreasing diameter. The smallest diameter of the tapered end of the connector 2 is adapted to the diameter D1 of the catheter 1 to ensure tightness of the connection between the tapered end of the connector 2 and the catheter 1. The diameter D2 of the connector 2 is adapted to the diameter of the interface on the working chamber 32 of the diaphragm pump 3 to ensure tightness of the connection between the connector 2 and the diaphragm pump 3.
In this embodiment, the diameter D1 of the catheter 1 is preferably 4.0mm-6.2mm. Preferably, the diameter D1 of the catheter 1 is 5.6mm.
In this embodiment, the length L1 of the catheter 1 is preferably 98cm-105cm. Preferably, the length L1 of the catheter 1 is 100cm.
In this embodiment, the distance L2 between the two-way valve 5 and the suction tip 4 is preferably 70mm-76mm. Preferably, the distance L2 between the two-way valve 5 and the suction tip 4 is 72mm.
In this embodiment, the diameter D2 of the connector 2 is preferably 13mm-16mm. Preferably, the diameter of the connector 2 is 14mm.
The using method of the external pulse type minimally invasive interventional ventricular mechanical auxiliary device of the embodiment comprises the following steps: the front end of the catheter 1 is sent into the heart from the femoral artery through the vascular sheath and the guide wire, the suction tip 4 is positioned in the left ventricle for drawing blood from the left ventricle, the position of the two-way valve 5 on the catheter 1 is fixed in the aorta on the aortic valve, and the connector 2 connected with the rear end of the catheter 1 is positioned outside the body. After the catheter 1 is introduced into the heart via the femoral artery and fixed in position, the connector 2 is clamped by a clamp, and the connector 2 is blocked to prevent outflow of blood from the heart. The guide wire in the catheter 1 is then withdrawn, the connector 2 is assembled with the interface on the working chamber 32 of the membrane pump 3, the clip is opened, and blood automatically flows into the working chamber 32 of the membrane pump 3. The interface on the medium chamber 33 of the diaphragm pump 2 is connected with the external control unit 6, the control unit 6 is started after being powered on, and the medium gas in the control unit 6 is pumped and inflated according to the set pulsation frequency, so that the pumping of blood in the working chamber 32 of the diaphragm pump 3 is driven, and the pulsating blood circulation effect is achieved. When the control unit 6 fills the medium chamber 33 of the membrane pump 2 with medium gas, the working chamber 32 of the membrane pump 3 discharges blood, which flows into the aorta via the connector 2, the catheter 1 and the automatically opened bi-directional valve 5. When the control unit 6 draws the medium gas out of the medium chamber 33 of the membrane pump 2, the working chamber 32 of the membrane pump 3 draws in blood, the blood in the left ventricle flows into the membrane pump 3 via the suction tip 4, the catheter 1 and the automatically closed bi-directional valve 5, the connector 2, and the closed bi-directional valve 5 is such that no blood leaks into the aorta. The blood supply process of one heart beat can be completed through one pulse (one air suction and air inflation) of the diaphragm pump 3, so that the diaphragm pump 3 works at a set pulse frequency, and the blood circulation is assisted by the simulated rational pulse frequency. When the external pulse type minimally invasive interventional ventricular mechanical auxiliary device is required to be stopped, the control unit 6 is shut down, the catheter 1 is withdrawn from the vascular sheath, and the vascular sheath is taken out.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and substitutions can be made by those skilled in the art without departing from the technical principles of the present invention, and these modifications and substitutions should also be considered as being within the scope of the present invention.
Claims (10)
1. An external pulse type minimally invasive interventional ventricular mechanical auxiliary device is characterized by comprising a catheter (1), a connector (2) and a diaphragm pump (3), wherein the front end of the catheter (1) is a suction tip (4), a two-way valve (5) is arranged on the catheter (1), the rear end of the catheter (1) is connected with one end of the connector (2), the other end of the connector (2) is connected with the diaphragm pump (3), the catheter (1) is used for entering the heart through femoral artery, the suction tip (4) is positioned in the left ventricle, the two-way valve (5) is positioned in the aorta on the aortic valve, the connector (2) and the diaphragm pump (3) are positioned outside the body, and the diaphragm pump (3) is used for sucking and reinjecting blood at a set pulse frequency under the control and driving of a control unit (6), and when blood is sucked, blood in the left ventricle flows into the diaphragm pump (3) through the suction tip (4), the catheter (1) and the two-way valve (5) which is automatically closed; when the blood is refilled, the blood in the diaphragm pump (3) flows into the aorta through the connector (2), the catheter (1) and the automatic opening two-way valve (5); the blood flow in the catheter (1) is greater than 2L/min.
2. The external pulse type minimally invasive ventricular mechanical assist device according to claim 1, characterized in that the diameter of the connector (2) is larger than the diameter of the catheter (1), and the end of the connector (2) connected with the catheter (1) is a tapered end with gradually reduced diameter.
3. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 1, characterized in that the diameter of the catheter (1) is 4.0mm-6.2mm.
4. An external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 3, characterized in that the diameter of the catheter (1) is 5.6mm.
5. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 1, characterized in that the length of the catheter (1) is 98cm-105cm.
6. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 5, characterized in that the length of the catheter (1) is 100cm.
7. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 1, characterized in that the distance between the bi-directional valve (5) and the suction tip (4) is 70-76 mm.
8. The external pulse type minimally invasive ventricular mechanical assistance device according to claim 7, characterized in that the distance between the bi-directional valve (5) and the suction tip (4) is 72mm.
9. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 1, characterized in that the diameter of the connector (2) is 13-16 mm.
10. The external pulse type minimally invasive interventional ventricular mechanical assistance device according to claim 9, characterized in that the diameter of the connector (2) is 14mm.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202311114996.4A CN117085241A (en) | 2023-08-30 | 2023-08-30 | External pulse type minimally invasive interventional ventricular mechanical auxiliary device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202311114996.4A CN117085241A (en) | 2023-08-30 | 2023-08-30 | External pulse type minimally invasive interventional ventricular mechanical auxiliary device |
Publications (1)
Publication Number | Publication Date |
---|---|
CN117085241A true CN117085241A (en) | 2023-11-21 |
Family
ID=88773370
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202311114996.4A Pending CN117085241A (en) | 2023-08-30 | 2023-08-30 | External pulse type minimally invasive interventional ventricular mechanical auxiliary device |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN117085241A (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN117679628A (en) * | 2024-01-29 | 2024-03-12 | 北京航空航天大学 | Pulsation type intervention artificial heart |
-
2023
- 2023-08-30 CN CN202311114996.4A patent/CN117085241A/en active Pending
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN117679628A (en) * | 2024-01-29 | 2024-03-12 | 北京航空航天大学 | Pulsation type intervention artificial heart |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US4080958A (en) | Apparatus for aiding and improving the blood flow in patients | |
CA2367469C (en) | Heart assist system | |
US9504774B2 (en) | Intraatrial ventricular assist device | |
US6428464B1 (en) | Implantable heart assist system | |
CN117085241A (en) | External pulse type minimally invasive interventional ventricular mechanical auxiliary device | |
CN107080871A (en) | Catheter sheath and making assisted circulation of ventriculus cordis device | |
CN114177516A (en) | High-flow two-stage catheter pump for left ventricle assistance and using method thereof | |
Meyns et al. | Miniaturized implantable rotary blood pump in atrial-aortic position supports and unloads the failing heart | |
US20050010077A1 (en) | Low flow atrial-arterial shunt for pump-assisted myocardial revascularization without cardiopulmonary bypass | |
JP2800585B2 (en) | Blood circulation assist device | |
Mihaylov et al. | Mechanical Circulatory Support Systems–A review | |
CN211024414U (en) | ECMO closed pre-charging device | |
JP7233077B2 (en) | blood circulation device | |
Thuaudet | The Medos ventricular assist device system | |
CN219804146U (en) | External magnetic suspension centrifugal ventricular assist device implanted through periphery | |
CN218165800U (en) | Medical ventricular assist device | |
CN110975113B (en) | Counterpulsation pump pipeline of external blood pump aorta counterpulsation circulation auxiliary device | |
CN220159038U (en) | Circulation auxiliary device for providing pulsating blood flow | |
CN117679628A (en) | Pulsation type intervention artificial heart | |
CN116099120A (en) | Combined auxiliary treatment system for heart and kidney | |
Jungschleger et al. | Mechanical circulatory support | |
Akdis et al. | Mechanical blood pumps for cardiac assistance | |
EP4021524A1 (en) | Arrangement for transporting a liquid through a cannula system, corresponding kit and method | |
Konertz | Clinical applications in children of the Medos ventricular assist device | |
De Paulis et al. | In vitro evaluation of left ventricular assistance by cannulation of both femoral arteries |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination |