The disclosure relates to a blood pump system, particularly to a blood pump system using a dual-pump aortic circulation structure, belonging to the field of medical device technology.
Cardiac dysfunction, also known as heart failure, is accompanied by clinical symptoms of heart dysfunction. Heart failure is a group of syndromes with various cardiac structural or functional diseases leading to ventricular filling and (or) impaired ejection function, and cardiac output cannot meet the needs of body tissue metabolism, with pulmonary circulation and (or) systemic circulation congestion, and organ or tissue blood perfusion insufficiency as clinical manifestations. Hear failure is mainly manifested as dyspnea, physical activity limitation and body fluid retention. For patients with cardiac dysfunction, cardiac assist devices can be used to improve symptoms. However, current cardiac assist devices generally suffer from problems such as large size and complex surgical implantation into the body.
The technical problem to be solved by the present disclosure is to provide a blood pump system using a dual pump aortic circulation structure.
To achieve the above technical objectives, the present disclosure adopts the following technical solutions:
According to a first aspect of embodiments of the present disclosure, provided is a blood pump system comprising:
Preferably, the heart circulation pump and/or the aortic circulation pump, each is configured to has a Coanda effect tube and a Venturi supersonic nozzle structure,
Preferably, the heart circulation pump comprises:
Preferably, the aortic circulation pump comprises:
Preferably, the first rotating member and the second rotating each comprises:
Preferably, the first mesh stent has one end sleeved on the power transmission section, forms a cylindrical cavity for accommodating the first rotating member.
Preferably, the supporting stent has one end sleeved on the power transmission section, and the other end spread outwardly.
Preferably, the first mesh stent has a middle section forms a cylindrical cavity for accommodating the first rotating member.
Preferably, the supporting stent is laser engraved from a metal tube, so that a first end of the supporting stent is sleeved on the power transmission section, and a second end of the supporting stent is spread outwardly.
Preferably, the power transmission section comprises a cardiac transmission section, an aortic transmission section, and a power cable;
Preferably, the first guiding tube comprises a first acceleration section and a second acceleration section, which are spaced along the length direction of the first guiding tube to increase flow velocity of blood inside the first guiding tube.
Preferably, the first acceleration section comprises a first arc-shaped tube and a second arc-shaped tube with gradually changing diameters, and both the first arc-shaped tube and the second arc-shaped tube are bent towards the axis direction of the first guiding tube to form a Coanda effect area at the connection between the first arc-shaped tube and the second arc-shaped tube;
Preferably, the second acceleration section comprises a third arc-shaped tube and a fourth arc-shaped tube, both of which are bent towards the axis direction of the first guiding tube; the diameter of the third arc-shaped tube decreases, and the diameter of the fourth arc-shaped tube increases to form a Venturi sonic nozzle action area at the connection between the third curved tube and the fourth curved tube.
According to a second aspect of embodiments of the present disclosure, provided is a blood pump system comprising:
Preferably, the heart circulation pump is configured to be delivered and placed in a left ventricle and the aortic circulation pump is delivered and placed in an aorta.
Preferably, the heart circulation pump has a first guiding tube, and the aortic circulation pump has a second guiding tube,
The second guiding tube is similar to the first guiding tube.
Preferably, the heart circulation pump comprises:
Preferably, the aortic circulation pump comprises:
Preferably, the first rotating member and the second rotating each comprises:
According to a third aspect of embodiments of the present disclosure, provided is a blood pump system comprising:
Compared with the existing technology, the blood pump system provided in the embodiments of the present disclosure can accelerate the circulation of blood in the heart and the aorta respectively through the heart circulation pump and the aortic circulation pump, thereby assisting in improving the blood supply function of the heart. Moreover, the rotating blades of the blood pump system are adjustable. When in use, the blood pump system can be easily inserted into the body through a simple interventional surgery in a fully-folded state (with a smaller size at this state), and then opened to a semi-unfolded or fully-unfolded state in the body to increase blood flow and enhance convenience of use.
The technical content of the present disclosure will be described in detail below in combination with the accompanying drawings and specific embodiments.
The heart circulation pump is configured to be delivered and placed in a left ventricle and the aortic circulation pump is delivered and placed in an aorta. The heart circulation pump and the aortic circulation pump, each is configured to has a Coanda effect tube and a Venturi supersonic nozzle structure, the Coanda effect tube accelerates the blood to the Venturi supersonic nozzle structure. It is also applicable that only one of the heart circulation pumps and the aortic circulation pump has a Coanda effect tube and a Venturi supersonic nozzle structure.
As shown in
In addition, in one embodiment of the present disclosure, the outer side of the rotating body 111 is symmetrically provided with two sets of rotating shaft grooves 1111 along the axial direction of the rotating body 111. Each set of rotating shaft grooves includes three individual slots. The angle between each pair of adjacent rotating shaft grooves 1111 is 120 degrees. In other words, each set of rotating blades is situated adjacent to one set of rotating shaft grooves. The outer side of the rotating body 111 features two sets of rotating blades 112, comprising six rotating blades in total, to enhance the suction force generated by the rotation of the first rotating member 11. It can be understood that in one embodiment of the present disclosure, the aforementioned structure is only one specific implementation. In other embodiment, the number of the rotating shaft grooves and the number of the rotating blades can be adaptively adjusted as needed.
A first mesh stent 12 is installed on the outer side of the first rotating member 11, so as to protect the first rotating member 11 from hurting body tissues and improve the safety of using the heart circulation pump 1. The first mesh stent has one end sleeved on the power transmission section, and forms a cylindrical cavity for accommodating the first rotating member. Specifically, as shown in
The first guiding tube 13, is positioned on the outer side of the first mesh stent 12. The first guiding tube 13 has a first blood inlet 131 and a first blood outlet 132. The first blood inlet 131 is located at a distance from the aortic circulation pump 2. In contrast, the first blood outlet 132 is situated close to the aortic circulation pump 2. The first guiding tube 13 directs blood from the heart through the first blood inlet 131, into the tube, and then out of the tube through the first blood outlet 132. Specifically, as shown in
Moreover, in one embodiment of the present disclosure, the second acceleration section 134 is a Venturi supersonic nozzle structure, commonly known as a supersonic nozzle or a critical flow nozzle, mainly used for transmitting flow standards, measuring gas flow rates, and limiting the maximum flow rate of a flow systems. Specifically, the second acceleration section 134 includes a third arc-shaped tube 1341 and a fourth arc-shaped tube 1342. Similarly, the third arc-shaped tube 1341 and the fourth arc-shaped tube 1342 both bend towards the axis of the first guiding tube 13. The diameter of the third curved tube 1341 decreases from large to small, with a reduction-value of φ99 mm to φ0.1 mm, and the diameter of the fourth curved tube 1342 increases from small to large, with an increase-value of φ99 mm to φ0.1 mm, thus forming a Venturi sonic nozzle action area 1340 (indicated by a dotted circle in
As shown in
In addition, it can be understood that, in one embodiment of the present disclosure, the second mesh stent 22 and the supporting stent 23 can be integrated together. In another embodiment, they can also be designed as a two-piece structure, which allows for selection based on actual needs. In another embodiment, the first mesh stent 12 is laser engraved from a metal tube, so that both ends of the first mesh stent 12 are fitted onto the power transmission section 3, and the middle section of the first mesh stent 12 forms a cylindrical cavity for accommodating the first rotating member. And, the supporting stent 22 is formed by laser engraving from a metal tube, so that the first end of the supporting stent 22 is sleeved on the power transmission section 3, and the second end of the supporting stent 22 is spread outwardly in a petal shape.
As shown in
In summary, the blood pump system provided in the present embodiment can accelerate the circulations of blood in the heart and/or the aorta respectively through the heart circulation pump 1 and/or the aortic circulation pump 2, thereby assisting in improving the blood supply of the heart. Moreover, the rotating blades 112 of the blood pump system are adjustable. So, when in use, the blood pump system can be easily inserted into the body through a common interventional surgery in the fully-folded state (with the smallest profile), and then spread to a semi-unfolded or fully-unfolded state to increase blood flow and enhance convenience of use.
A blood pump system provided in the second embodiment includes a heart circulation pump, an aortic circulation pump, a power transmission section, a main device 1A and a plurality of flexible shaft connectors 2A and a flexible shaft 3A. The heart circulation pump, the aortic circulation pump, the power transmission section are connected to the flexible shaft 3A with the flexible shaft connectors 2A and are activated by the main device 1A through the flexible shaft 3A.
As shown in
Specifically, in one embodiment of the present disclosure, the main device 1A is located at the end of the blood pump system, and includes a power motor, a display, and a controller. The power motor is used to provide rotational power to the multiple flexible shafts 3A. The display is used for image display. The controller is used for program control of various sensors, valves, and blades. The monitor has multiple data interfaces that can read data from various sensors, valves, and blades. The above data interfaces include interfaces that comply with USB standards and can be used to output or import data. This controller can run software, which can analyze and calculate the appropriate blood flow rate at the current time based on the information collected through the data interface, and control the speed of blades 5A according to the calculation results. The main device 1A also includes one or more power source interfaces for connecting the flexible shaft 3A, and transmitting the power generated by the motor to the blade 5A through gears or other energy-delivery structures.
In one embodiment of the present disclosure, the blood pump system further comprises an operating handle for connecting the power source interface and data interface of the main device 1A, regulating the operations of the blades 5A and the guiding cover 12A. The material of the operating handle may be composed of ABS, nylon, polycarbonate, carbon fiber, fiberglass, etc.
The flexible shaft 3A is connected to the main equipment 1 through the flexible shaft connector 2A. And there is a flexible shaft connector 2A connected between adjacent two flexible shafts 3A. This flexible shaft connector 2A is used to connect with the main equipment 1A, thereby achieving the conversion between rigid transmission and flexible transmission. The flexible shaft 3A is composed of a single or multiple wires, which are made of stainless steel, carbon steel, titanium alloy, nickel titanium alloy or the like. The flexible shaft 3A is composed of multiple wires, with some metal wires woven together.
The guiding dock 4A is connected to the flexible shaft 3A through the flexible shaft connector 2A, and is equipped with the blades 5A at an end far from the main device 1A. The rotation of the blades 5A can accelerate blood to flow into the guiding dock 4A. Moreover, the guiding cover 12A is fixed on the outer side of the guiding dock 4A. The flow of blood accelerated by the blades 5A into the guiding dock 4A is ejected from the guiding cover 12A according to the design direction. Thus, a vortex is formed within the guiding cover 12A at one end thereof. The guiding cover 12A is used to accommodate the blades 5A to prevent collision between the blades 5A and body tissue, and to provide containment and restraint for blood flow. In addition, the guiding cover 12A may be composed of a thin film of polymer material, which can automatically expand and unfold, or it can expand under compression after the blades 5A rotates and draws in fluid.
The blades 5A can be an integrated structure, a split structure, or composed of a woven metal skeleton with a surface membrane or coating. The material of the blades 5A can be organic or inorganic. The blades 5A can be extended or retracted, with the extended size ranging from 1 mm to 3000 mm, and the retracted size ranging from 1 mm to 1000 mm.
The guiding cover 12A can also be woven from metal wire or laser engraved from metal pipes, with elasticity or self-expansion, allowing for automatic unfolding. The metal materials that make up the guiding cover 12A may be titanium alloy, nickel titanium alloy, stainless steel, carbon fiber or polymer material sheets, or a combination of metal and polymer materials. The guiding cover 12A has protrusions distributed at one end where the blood flow in, which helps to achieve the Coanda Effect. By utilizing the Coanda Effect, when the blades 5A start rotating to suck in blood, the velocity and flow rate of blood flow inside the guiding cover 12A will increase, resulting in an increase in liquid pressure at the center section of the guiding cover 12A. This pathway 1300 A inside the guiding cover 12A allows for faster and more efficient suction of blood flow than in a straight pathway. The overall inside structure of the guiding cover 12A conforms to the Venturi effect (critical flow Venturi nozzle) property. Thus, when blood is drawn in from the inlet and accelerated by the blades 5A, it flows inside the Venturi tube. Due to the continuity equation, the velocity reaches its maximum value at the narrowest areas 1330/1340 of the pathway 1300A, and the static pressure reaches its minimum value. Therefore, the speed of blood increases due to changes in the cross-sectional areas 1330/1340 of the pathway 1300A. The entire blood flow undergoes a narrowing process at the same time, resulting in a pressure difference that ensures a pressure loss of around 5% to 20% between the blood inlet and outlet.
The stent 6A is set at an end of the guiding cover 12A for fixing the guiding cover 12A to the blood vessel wall.
The plurality of metal tubes 7A are spaced around the outer side of the flexible shaft 3. Each transformable tube 8A is provided between adjacent metal tubes 7A. The inner layer of the metal tube 7A is braided with nickel titanium alloy wire, the outer layer is coated with hydrophilic polymer material. The outer layer is in contact with blood, the inner layer accommodates the soft shaft 3A. The soft shaft 3A is connected to the main equipment 1A at one end, and is connected to the blades 5A at the other end. The metal tube 7A is partially located outside the body (the end near the main device 1A), and the other end (the end near the blades 5A) is located inside the body. In addition, each of the transformable tubes 8A provides support to the metal tube 7A, and provides axial support and positioning for the soft shaft 2A through the internally fixed wear-resistant positioning bearing 9A.
The upstream flow velocity sensor 10A is mounted on the guiding cover 12A for detecting the blood flow velocity before acceleration. Similarly, the downstream flow velocity sensor 11A is installed in the central area of the blood pump system (for example, installed on one of the transformable tubes 8A or one of the metal tubes 7A in the central area) to detecting the accelerated blood flow velocity.
The film valve 13A are installed adjacent to the upstream flow velocity sensor 10A to control the outflow of blood that simulates the flow stimulated by heartbeats. This simulation is based on the electrocardiogram signals collected by the main device 1A. Consequently, the blood pump system is able to output blood flow in a pulse-like manner, similar to the output of the human heart. In one embodiment of the present disclosure, each outlet of the guiding cover 12A is equipped with one film valve 13A. The film valve 13A is driven by optokinetic energy, thermal energy, mechanical force, magnetic force, ultrasonic force, or electric force. The film valve 13A can be opened or closed according to the preset frequency and opening angle, or to the collected physiological signals that include electrocardiogram signals, temperature signals, flow velocity signals, or photoelectric signals.
As shown in
Specifically, in one embodiment of the present disclosure, the main device 1B is located at the end of the blood pump system, and includes a power motor, a display, and a controller. The power motor is used to provide rotational power to the multiple flexible shafts 3A. The display is used for image display. The controller is used for program control of various sensors and blades. The monitor has multiple data interfaces that can read data from various sensors, valves, and blades. The above data interfaces include interfaces that comply with USB standards and can be used to output or import data. This controller can run software, which can analyze and calculate the appropriate blood flow rate at the current time based on the information collected through the data interface, and control the speed of blades 6B according to the calculation results. The main device 1B also includes one or more power source interfaces for connecting the cable 3B, and transmitting the power generated by the motor to the blade 6B through gears or other energy-delivery structures.
In one embodiment of the present disclosure, the blood pump system further comprises an operating handle for connecting the power source interface and data interface of the main device 1B, regulating the operations of the blades 5B and the guiding cover 12B. The material of the operating handle may be composed of ABS, nylon, polycarbonate, carbon fiber, fiberglass, etc.
The cable 3B is connected to the main equipment 1 through the cable connector 2B. And there is a cable connector 2B connected between adjacent two cables 3A. This cable connector 2B is used to connect with the main equipment 1A, thereby achieving the conversion between rigid transmission and flexible transmission. The cable 3B is connected to motor 4B of the blades 5B at one end, and the cable 3B is connected to the operating handle at another end.
The guiding dock 5B is connected to the cable 3B through the cable connector 2A, and is equipped with the blades 6B at an end. The rotation of the blades 6B can accelerate blood to flow into the guiding dock 5B. Moreover, the guiding cover 12A is fixed on the outer side of the guiding dock 5B. The flow of blood accelerated by the blades 6B into the guiding dock 5B is ejected from the guiding cover 12B according to the design direction. Thus, a vortex is formed within the guiding cover 12B at one end thereof. The guiding cover 12B is used to accommodate the blades 6B to prevent collision between the blades 6B and body tissue, and to provide containment and restraint for blood flow. In addition, the guiding cover 12B may be composed of a thin film of polymer material, which can automatically expand and unfold, and it can expand under compression after the blades 6B rotates and sucks in fluid.
The blades 6B can be an integrated structure, a split structure, or composed of a braided metal skeleton with a surface membrane or coating. The material of the blades 6B can be organic or inorganic. The blades 6B can be extended or retracted, with the extended size ranging from 1 mm to 3000 mm, and the retracted size ranging from 1 mm to 1000 mm.
The guiding cover 12B can be braided from metal wire or laser engraved from metal pipes, with elasticity or self-expansion, allowing for automatic unfolding. The metal materials that make up the guiding cover 12B may be titanium alloy, nickel titanium alloy, stainless steel, carbon fiber or polymer material sheets, or a combination of metal and polymer materials. The guiding cover 12B has protrusions distributed at one end where the blood flows in, which helps to achieve the Coanda Effect. By utilizing the Coanda Effect, when the blades 6B start rotating to draw in blood, the velocity and flow rate of the blood flow inside the guiding cover 12B will increase, resulting in an increase in liquid pressure at the center of the guiding cover 12B. This pathway 1300B inside the guiding cover 12B allows for faster and more efficient suction of blood flow than in a straight pathway. The overall inside structure of the guiding cover 12B conforms to the Venturi effect (critical flow Venturi nozzle) property. Thus, when blood is drawn in from an inlet and accelerated by the blades 6B, it flows inside the Venturi tube. Due to the continuity equation, the velocity reaches its maximum value at the narrowest areas 1330/1340 of the pathway 1300B, and the static pressure reaches its minimum value. Therefore, the speed of blood increases due to changes in the cross-sectional area of the pathway 1300B. The entire blood flow undergoes a narrowing process at the same time, resulting in a pressure difference that ensures a pressure loss of around 5% to 20% between the blood inlet and outlet.
The stent 7B is set at one end of the guiding cover 12B for fixing the guiding cover 12B to the blood vessel wall.
The plurality of metal tubes 8B are spaced around the outer side of the cable 3B. Each transformable tube 9B is provided between adjacent metal tubes 8B. The inner layer of the metal tube 8B is braided with nickel titanium alloy wire, the outer layer is coated with hydrophilic polymer material. The outer layer is in contact with blood, the inner layer accommodates the cable 3B. The cable 3B is connected to the main equipment 1A at one end, and is connected to the blades 5B at the other end. Some of the metal tubes 8B are located outside the body (near the main device 1A), and the others is located inside the body (near the blades 6B). In addition, each of the transformable tubes 9B provides support to the metal tube 8B, and provides axial support and positioning for the soft shaft 2B through the internally fixed wear-resistant positioning bearing 9B.
The upstream flow velocity sensor 10B is mounted on the guiding cover 12B for detecting the blood flow velocity before acceleration. Similarly, the downstream flow velocity sensor 11B is installed in the central area of the blood pump system (for example, installed on one of the transformable tubes 9B or one of the metal tubes 8B in the central area) to detecting the accelerated blood flow velocity.
The blood pump system provided by the present disclosure has been described in detail above. For general technical personnel in this field, any apparent alteration made on the present disclosure by persons of ordinary skilled in the art without departing from the substantive content of the present disclosure shall constitute an infringement of the patent right of the present disclosure, and the person shall bear corresponding legal liability.
| Number | Date | Country | Kind |
|---|---|---|---|
| 202210316344.8 | Mar 2022 | CN | national |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/CN2023/083515 | Mar 2023 | WO |
| Child | 18893903 | US |