CN117298445A - Double-ventricle full artificial heart device - Google Patents
Double-ventricle full artificial heart device Download PDFInfo
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- CN117298445A CN117298445A CN202311296116.XA CN202311296116A CN117298445A CN 117298445 A CN117298445 A CN 117298445A CN 202311296116 A CN202311296116 A CN 202311296116A CN 117298445 A CN117298445 A CN 117298445A
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- heart
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- 210000002216 heart Anatomy 0.000 title claims abstract description 49
- 230000002861 ventricular Effects 0.000 claims abstract description 54
- 210000001174 endocardium Anatomy 0.000 claims abstract description 10
- 238000006243 chemical reaction Methods 0.000 claims description 4
- 206010019280 Heart failures Diseases 0.000 abstract description 21
- 230000006870 function Effects 0.000 abstract description 6
- 210000005240 left ventricle Anatomy 0.000 abstract description 6
- 210000005241 right ventricle Anatomy 0.000 abstract description 6
- 238000002054 transplantation Methods 0.000 abstract description 6
- 230000000004 hemodynamic effect Effects 0.000 abstract description 4
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 208000024891 symptom Diseases 0.000 abstract description 2
- 239000008280 blood Substances 0.000 description 8
- 210000004369 blood Anatomy 0.000 description 8
- 230000017531 blood circulation Effects 0.000 description 8
- 230000000747 cardiac effect Effects 0.000 description 5
- 239000012528 membrane Substances 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 208000024172 Cardiovascular disease Diseases 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 3
- 230000008081 blood perfusion Effects 0.000 description 3
- 210000003709 heart valve Anatomy 0.000 description 3
- 230000010349 pulsation Effects 0.000 description 3
- 230000002159 abnormal effect Effects 0.000 description 2
- 210000000709 aorta Anatomy 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 201000002064 aortic valve insufficiency Diseases 0.000 description 2
- 230000008602 contraction Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000010412 perfusion Effects 0.000 description 2
- 230000000737 periodic effect Effects 0.000 description 2
- 230000001360 synchronised effect Effects 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 206010002915 Aortic valve incompetence Diseases 0.000 description 1
- 208000002330 Congenital Heart Defects Diseases 0.000 description 1
- 206010058314 Dysplasia Diseases 0.000 description 1
- 206010067171 Regurgitation Diseases 0.000 description 1
- 206010039163 Right ventricular failure Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 238000005299 abrasion Methods 0.000 description 1
- 208000019269 advanced heart failure Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000001174 ascending effect Effects 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 230000036996 cardiovascular health Effects 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000005794 circulatory dysfunction Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000002360 explosive Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000002107 myocardial effect Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 210000001147 pulmonary artery Anatomy 0.000 description 1
- 230000004088 pulmonary circulation Effects 0.000 description 1
- 230000000541 pulsatile effect Effects 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 230000008054 signal transmission Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
- 201000002282 venous insufficiency Diseases 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
- A61M60/20—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
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
- A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
-
- 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
- A61M60/40—Details relating to driving
- A61M60/424—Details relating to driving for positive displacement blood pumps
- A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
-
- 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
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/871—Energy supply devices; Converters therefor
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
Abstract
The invention belongs to the technical field of medical appliances, and particularly relates to a double-ventricle full artificial heart device. The double-ventricle total artificial heart device comprises an artificial heart body and is characterized in that: the artificial heart body comprises a ventricular housing, an endocardium is arranged in the ventricular housing, a ventricular inlet and a ventricular outlet are arranged on the ventricular housing, an inlet one-way valve is arranged at the ventricular inlet, an outlet one-way valve is arranged at the ventricular outlet, a driving inlet and a driving outlet are arranged on the endocardium, and the driving inlet and the driving outlet are connected with a pulse air pressure driver. The beneficial effects of the invention are as follows: can completely replace the whole functions of the left ventricle and the right ventricle of the original heart, radically improve refractory heart failure symptoms, meet the hemodynamic characteristics of human bodies, and solve the problem of insufficient heart transplantation donors of patients with end-stage heart failure.
Description
Field of the art
The invention belongs to the technical field of medical appliances, and particularly relates to a double-ventricle full artificial heart device.
(II) background art
With the increasing degree of global population aging, the incidence of cardiovascular diseases is in an ascending stage, and the final course of cardiovascular diseases is heart failure, which is totally called heart failure, and refers to a syndrome mainly caused by circulatory dysfunction due to myocardial cell relaxation and/or contraction dysfunction, caused by insufficient cardiac ejection amount to maintain the metabolic needs of various organ tissues, characterized by clinically reduced cardiac ejection amount, reduced blood perfusion of organ tissues and venous stasis of pulmonary circulation and/or body circulation under the condition of proper venous return. According to the data of 2023 white paper of heart failure industry, the prevalence rate of heart failure patients in China is increased by 44% in 2000 to 2015, and about 50 ten thousand new heart failure patients exist each year, wherein about 5% of patients can progress to refractory end-stage heart failure. The heart-moving vegetation is considered as the optimal and effective treatment scheme aiming at refractory end-stage heart failure patients in the existing market. According to the Chinese cardiovascular health and disease report 2020, the number of patients suffering from cardiovascular diseases in China is about 3.3 hundred million, and the number of patients suffering from heart failure is about 890 ten thousand. According to the data of the heart transplantation registration system in China, 72 medical institutions in China have heart transplantation qualification by 2022, but due to the extreme shortage of donors, a huge gap exists between the number of heart transplantation operations per year and the number of refractory heart failure patients, and only a small part of heart failure patients are expected to receive heart transplantation operations.
In the case of an extremely deficient heart donor, the mechanical circulatory support device is a device which can replace part of the heart function, can provide effective help for patients with end-stage heart failure and brings new living hopes for patients with end-stage heart failure. The basic principle is to assist or replace a failed heart to complete the blood circulation of a human body so as to enable the heart to meet the hemodynamics of the human body.
Mechanical circulatory support devices include fully artificial heart and ventricular assist systems. At present, no fully artificial heart is clinically used in China, and heart auxiliary devices are mostly adopted in clinical application of domestic medical institutions for treating heart failure, and are also called ventricular auxiliary devices. However, due to the different structures of the left and right heart chambers, current ventricular assist devices are often used only for left ventricular assist. Further clinical research and validation is needed as to whether other adverse effects on the patient will result from use in right ventricular assist applications.
Left ventricular assist devices have two main directions, interventional and implantable. The interventional type heart valve has small interventional volume and small operation wound, but the same output flow is smaller, and is suitable for treating patients in the middle period before heart failure, but adverse reactions such as aortic insufficiency, aortic regurgitation and the like can be caused. Axial pumps and centrifugal pumps, among others, also have some similar drawbacks: 1. right ventricular assist cannot be achieved; 2. the blood flow is provided in a rotating mode, and the impeller rotating at a high speed can damage the blood, so that thrombus is easy to cause and the risk of stroke is increased; 3. only continuous blood flow, which is different from physiological pulsation of a normal heart, cannot meet normal blood flow dynamics, and can cause abnormal pulse and influence blood perfusion of each organ; 4. the pump body cannot be ensured to have no blood residue, so that the risk of thrombosis is increased; 5. long-term continuous left ventricular blood flow output can not balance the left ventricle and the right ventricle, so that the risk of right heart failure is increased; 6. once the pump is stopped by failure, the blood stagnates for too long in the pump, and accidents are very easy to happen when the pump is started again.
The patent application 202310096170.3 entitled pressure driven heart assist device discloses the following: when the heart contracts, the pressure sac is depressurized, so that a low-pressure area is generated between the aortic valve and the unidirectional valve, and the left ventricular afterload is reduced; during diastole, the pressure in the pressure sac is increased, so that a high pressure area is generated between the aortic valve and the unidirectional valve, thereby generating a second pressure wave, and coronary perfusion and peripheral perfusion are increased. The basic principle is that a set of devices similar to a secondary diaphragm pump is added on the output side of a ventricle to simulate the function similar to the expansion and contraction of the aorta. If the working frequency of the diaphragm pump is not matched with the self-pulsation period of the heart, the auxiliary ejection function of the expected design cannot be realized, but instead, the afterload of the ventricle is increased due to the fact that a one-way valve is added between the ventricle and an artery, so that more serious consequences are caused; even though the heart state is monitored by the electrocardio and the pressure sensor, the signal transmission and the regulation have hysteresis, and the frequency of the heart cannot be completely consistent with the frequency of the heart under the prior art.
(III) summary of the invention
The invention provides a double-ventricle full artificial heart device for overcoming the defects in the prior art.
The invention is realized by the following technical scheme:
the utility model provides a bi-ventricular total artificial heart device, includes artificial heart body, characterized by: the artificial heart body comprises a ventricular housing, an endocardium is arranged in the ventricular housing, a ventricular inlet and a ventricular outlet are arranged on the ventricular housing, an inlet one-way valve is arranged at the ventricular inlet, an outlet one-way valve is arranged at the ventricular outlet, a driving inlet and a driving outlet are arranged on the endocardium, and the driving inlet and the driving outlet are connected with a pulse air pressure driver.
The driving inlet and outlet are connected with the pulse air pressure driver through a driving pipeline.
The driving pipeline is composed of an inner driving pipeline connected with the driving inlet and outlet and an outer driving pipeline connected with the pulse pneumatic driver, and a conversion joint is connected between the inner driving pipeline and the outer driving pipeline.
The pulse pneumatic driver is provided with a filter screen, and a cover plate is arranged outside the filter screen.
And a battery is arranged in the pulse pneumatic driver.
The beneficial effects of the invention are as follows: can completely replace the whole functions of the left ventricle and the right ventricle of the original heart, radically improve refractory heart failure symptoms, meet the hemodynamic characteristics of human bodies, and solve the problem of insufficient heart transplantation donors of patients with end-stage heart failure.
(IV) description of the drawings
The invention is further described below with reference to the accompanying drawings.
FIG. 1 is a schematic diagram of an explosive structure of the present invention;
FIG. 2 is a schematic diagram of the ventricular diastole structure of the present invention;
FIG. 3 is a schematic view of the ventricular systole structure of the present invention;
in the figure, an artificial heart body 1, a ventricular shell 2, an endocardium 3, a ventricular inlet 4, a ventricular outlet 5, an inlet 6 one-way valve 7, an outlet one-way valve 8, a driving inlet and outlet 9, a pulse pneumatic driver 10, a driving pipeline 11, an inner driving pipeline 12, an outer driving pipeline 13, a switching joint 14, a filter screen 15 and a battery 16.
(fifth) detailed description of the invention
The drawings illustrate one embodiment of the invention. This embodiment includes artificial heart body 1, and artificial heart body 1 includes ventricular shell 2, is equipped with endocardium 3 in the ventricular shell 2, is equipped with ventricular entry 4 and ventricular export 5 on the ventricular shell 2, and ventricular entry 4 is equipped with entry one-way valve 6, and ventricular export 5 is equipped with export one-way valve 7, and endocardium 3 is equipped with drive access & exit 8, and pulse pneumatic driver 9 is connected to drive access & exit 8. The driving inlet and outlet 8 is connected with the pulse air pressure driver 9 through a driving pipeline 10. The driving pipeline 10 is composed of an inner driving pipeline 11 connected with the driving inlet and outlet 8 and an outer driving pipeline 12 connected with the pulse pneumatic driver 9, and a conversion joint 13 is connected between the inner driving pipeline 11 and the outer driving pipeline 12. The pulse air pressure driver 9 is provided with a filter screen 14, and a cover plate 15 is arranged outside the filter screen 14. A battery 16 is installed in the pulse pneumatic driver 9.
By adopting the double-ventricle total artificial heart device, the ventricular housing 2 has certain strength, can keep the special shape of the simulated ventricle to form a closed cavity, the ventricular membrane 3 is soft and smooth, the ventricular membrane 3 is fixed on the inner wall of the ventricular housing 2, the cavity of the ventricular housing 2 is divided into two independent chambers M and N, wherein the chamber M formed between the ventricular housing 2 and the ventricular membrane 3 is used for storing blood during ventricular filling and backflow, and the independent chamber N in the ventricular membrane 3 on the other side is connected with the inner driving pipeline 11 through the driving inlet and outlet 8 and then connected to the pulse pneumatic driver 9 through the outer driving pipeline 12 by the conversion connector 13. When the pulse air pressure driver 9 supplies the periodic pulse air pressure, the chamber N formed by the endocardium 3 expands and contracts with the air pressure fluctuation, and the volume of the chamber M on the other side changes together. In the diastole stage, negative pressure is formed in the chamber N, the volume of the chamber N is reduced, blood flows into the chamber M through the inlet one-way valve 6 under the action of blood pressure, and the volume of the chamber M is increased; during the systolic phase, the volume of the chamber N gradually increases with the increase of the driving pressure, forcing the volume of the chamber M to decrease, so that the blood filled in the chamber M flows out of the ventricle through the outlet one-way valve 6. The ventricular inlet 4 is connected to the native atrium and the ventricular outlet 5 is connected to the corresponding aorta or pulmonary artery. The inlet one-way valve 6 and the outlet one-way valve 7 can function as a native heart valve, ensuring blood flow and preventing regurgitation. The volume of the chamber M is 50-80ml, and the chamber M can be in an optimal state of partial filling and complete ejection by adjusting the frequency of periodical pulse air pressure, so that the chamber M can not only provide enough cardiac output, but also adapt to different requirements of a human body on cardiac blood supply during exercise or rest, thereby achieving ideal hemodynamic characteristics. The pulse air pressure driver 9 consists of a main pump, a standby pump, a battery 16, a control system, a display interface and the like, wherein the battery 16 can provide energy for the pump, is convenient for a patient to go out temporarily, and can also be directly powered by an external power supply. The pump body can provide periodical pulse air pressure, and the periodical pulse air pressure is respectively transmitted to the left ventricle and the right ventricle of the in-vivo implantation part through the two driving pipelines 10, so that the two ventricles can realize synchronous diastole and systole and coordinate work.
According to the invention, the artificial ventricle is adopted to replace the original ventricle, and the implanted part of the artificial ventricle is driven to relax and contract by periodical pulsating air pressure, so that the blood pumping function of the artificial heart is completed. The invention adopts a pneumatic mode as a driving source, but the driving fluid is not limited to gas, and can be liquid or other mediums. The capacity of the artificial ventricle can be optimized according to the actual demand, and the selection can be adjusted within the range of 50-80 ml. The material used for the implantation part of the invention is a biocompatible material. The pulsed pneumatic drive 9 employs a plunger pump system, but is not limited to various other systems that can provide periodic drive.
The invention completely replaces the ventricular part of the primary heart failure, uses the artificial ventricle to replace, can be understood as a half-heart transplanting state, and can meet the clinical treatment requirements of patients with heart failure at the end stage of heart failure and the left and right ventricles at the same time. The replaced artificial ventricle can completely realize the diastole and the systole of the original ventricle, provide the blood output meeting the human blood flow dynamics and provide the stable cardiac output. The device has the advantages of no rotary moving part, simple principle, no abrasion of the implanted part and no damage to blood to form thrombus. Imitate the pulsation of the original heart, provide pulsatile output, and are suitable for the blood perfusion of each organ. The left ventricle and the right ventricle can work cooperatively and are closest to the working state of the original heart, the self-pulsation of the original heart is not needed, and the situation that the pulsation of the original heart is not coordinated or cannot be synchronized is avoided. The method has wide range of patient indications, is not limited to patients with advanced heart failure, and can be also suitable for patients with abnormal heart valves, congenital heart diseases, heart dysplasia and the like.
Claims (5)
1. The double-ventricle total artificial heart device comprises an artificial heart body (1), and is characterized in that: the artificial heart body (1) comprises a ventricular housing (2), an endocardium (3) is arranged in the ventricular housing (2), a ventricular inlet (4) and a ventricular outlet (5) are arranged on the ventricular housing (2), the ventricular inlet (4) is provided with an inlet one-way valve (6), the ventricular outlet (5) is provided with an outlet one-way valve (7), the endocardium (3) is provided with a driving inlet and outlet (8), and the driving inlet and outlet (8) is connected with a pulse air pressure driver (9).
2. The bi-ventricular total artificial heart device of claim 1, wherein: the driving inlet and outlet (8) is connected with the pulse pneumatic driver (9) through a driving pipeline (10).
3. The bi-ventricular total artificial heart device of claim 2, wherein: the driving pipeline (10) is composed of an inner driving pipeline (11) connected with the driving inlet and outlet (8) and an outer driving pipeline (12) connected with the pulse pneumatic driver (9), and a conversion joint (13) is connected between the inner driving pipeline (11) and the outer driving pipeline (12).
4. The bi-ventricular total artificial heart device of claim 1, wherein: a filter screen (14) is arranged on the pulse pneumatic driver (9), and a cover plate (15) is arranged outside the filter screen (14).
5. The bi-ventricular total artificial heart device of claim 1, wherein: a battery (16) is arranged in the pulse pneumatic driver (9).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311296116.XA CN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311296116.XA CN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117298445A true CN117298445A (en) | 2023-12-29 |
Family
ID=89284550
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311296116.XA Pending CN117298445A (en) | 2023-10-09 | 2023-10-09 | Double-ventricle full artificial heart device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117298445A (en) |
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2023
- 2023-10-09 CN CN202311296116.XA patent/CN117298445A/en active Pending
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