WO2014019274A1 - 一种单支点磁动力离心式血泵 - Google Patents
一种单支点磁动力离心式血泵 Download PDFInfo
- Publication number
- WO2014019274A1 WO2014019274A1 PCT/CN2012/081203 CN2012081203W WO2014019274A1 WO 2014019274 A1 WO2014019274 A1 WO 2014019274A1 CN 2012081203 W CN2012081203 W CN 2012081203W WO 2014019274 A1 WO2014019274 A1 WO 2014019274A1
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- WO
- WIPO (PCT)
- Prior art keywords
- blood pump
- magnetic steel
- centrifugal blood
- groove
- impeller
- Prior art date
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Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04D—NON-POSITIVE-DISPLACEMENT PUMPS
- F04D29/00—Details, component parts, or accessories
- F04D29/04—Shafts or bearings, or assemblies thereof
- F04D29/046—Bearings
- F04D29/047—Bearings hydrostatic; hydrodynamic
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- 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
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
-
- 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
-
- 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
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- 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
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor 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
- A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
- A61M60/818—Bearings
- A61M60/824—Hydrodynamic or fluid film bearings
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04D—NON-POSITIVE-DISPLACEMENT PUMPS
- F04D13/00—Pumping installations or systems
- F04D13/02—Units comprising pumps and their driving means
- F04D13/06—Units comprising pumps and their driving means the pump being electrically driven
- F04D13/0606—Canned motor 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
- A61M60/10—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
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
Definitions
- the present invention relates to the field of medical device technology, and more particularly to a single-point magnetic powered centrifugal blood pump.
- Cardiovascular and cerebrovascular diseases have long been the leading cause of human death in developed countries, accounting for 46% of deaths. US statistics show that the number of heart surgeries per year is about 350,000. At present, the number of open-heart surgery in the country is about 100,000 per year. With the rapid development of the economy and the continuous improvement of medical standards, the number of domestic cardiac surgery is bound to increase. According to statistics, some patients (0.6-2%) have severe heart function damage after cardiac surgery, and they cannot maintain the minimum body requirements even with drug support. This part of the patient had to use the auxiliary circulation device to temporarily support the heart function, maintain life, and wait for the heart function to recover. Some of these patients also need to use long-term circulation aids to replace heart function.
- the blood pump also known as the heart pump
- the blood pump is the core of the cardiac assisted circulation device. In recent years, it has been the focus of assisted circulation research in developed countries and has made some progress.
- the earliest first-generation blood pump was a pulse pump developed in the same way as the heart. This type of blood pump uses a pneumatic or electric squeeze pump chamber to beat the blood through the change of the pump chamber volume.
- the second generation of continuous flow impeller blood pumps was launched in the early 1980s.
- the blades of such blood pumps are mounted on the blood pump rotor by mechanical bearings. The rotor drives the blades to rotate to push the blood forward or backward along the radial or axial spiral. .
- the third-generation blood pump is characterized by suspension technology, so all blood pumps developed using magnetic levitation and/or liquid suspension technology are called third-generation blood pumps.
- the third generation of blood pumps generally have two systems for suspension and drive:
- the suspension system suspends the impeller, the impeller is directly permanent magnetized or a permanent magnet is embedded in the shaped impeller.
- the stator or pump casing of the blood pump is built with a permanent magnet or an electromagnetic coil, and the impeller is suspended in the middle of the pump casing by the interaction of the magnetized impeller with the axial and radial magnetic field between the stator or the pump casing; the drive system drives the impeller to rotate.
- Another set of electromagnetic coils is built into the stator or the pump casing, and a magnetic force is generated by the change of the current of the electromagnetic coil to push the magnetized impeller to rotate.
- the third generation of blood pumps has three stages of development:
- the first stage is the indirect drive of the impeller stage by the outer motor of the suspension and drive system separation.
- the suspension technology of the blood pump is relatively simple.
- the suspension system is separated from the drive system.
- the blood pump uses an external motor drive technology.
- the impeller is driven by a separate external motor.
- the outer motor is connected to the magnetized outer impeller through a mechanical bearing.
- the outer impeller passes the magnetic force.
- Driving another suspended magnetized inner impeller to rotate; the inner impeller is the primary drive portion whose rotation drives blood flow.
- the second stage is the direct drive of the impeller stage by the suspension and drive system separation motor.
- the blood pump motor directly drives the impeller suspension technology.
- the suspension system is also separated from the drive system, but the motor cancels the outer leaf
- the wheel directly uses the suspension impeller as the rotor of the motor.
- the motor directly drives the suspended impeller to rotate the blood to promote blood flow.
- the pump still requires an additional magnetic suspension system to suspend the blood pump impeller.
- the third stage is the fusion phase of the suspension and drive system, that is, the suspension of the blood pump is combined with the drive system.
- the blood pump design combines the suspension and the electromagnetic coil of the drive system to form the stator, and uses one stator to function as the drive and suspension impeller. Therefore, the design of the pump is more concise, and it represents the blood pump as Ventr Assist.
- the third-generation blood pumps are mostly designed as centrifugal pumps, and a few are axial-flow pumps.
- HeartWare pump The impeller of the pump suspends the pump blade by magnetic suspension and liquid suspension technology.
- the total stator of the pump is composed of two independent coils.
- VentrAssist pump The pump is in contact with the blood with a pyrolytic carbon coating, which can reduce the incidence of thrombosis, but the pump has a long inflow path, so it still needs to be after the implantation.
- rectus abdominis rectus sheath or pouches made after pump placement (4)
- No VaCO rVAD pump a special flow into the system, the pump and the pump body parallel to the inflow conduit design, a flat formed outer Like.
- Thrombosis is formed by the accumulation and deposition of platelets, which are commonly found in stagnant areas that are less subject to blood flow and low-velocity areas that are in contact with blood.
- Hemolysis refers to the high speed or high pressure generated by turbulent motion or mechanical movement that destroys red blood cells in the blood, causing hemoglobin to disperse into the plasma, mainly caused by irregular flow and high shear stress in the turbulent motion zone.
- Hemolysis and thrombosis are extremely harmful to patients.
- thrombosis and hemolysis caused by cardiac assisted circulation devices can cause physiological disturbances in patients, which can lead to complications during and after surgery, and even endanger the lives of patients, especially It has a greater impact on patients who require long-term assisted circulation support. It can be seen that reducing the occurrence of thrombus and hemolysis in the heart pump is an urgent problem to be solved in the development of the auxiliary circulation system.
- the third generation blood pump is suspended in the blood pump body due to the application of magnetic levitation technology. Without friction and extrusion, the hemolysis is significantly reduced, the incidence of thrombus is significantly reduced, and there is no bearing wear. The problem is that the durability of the blood pump is improved, and it is more suitable for long-term circulation assistance.
- the structure of the third-generation blood pump is still relatively complicated, and the contact surface with the blood is large, and it is easy to generate a blood stagnant area and cause a blood clot.
- the blood pump is a disposable product, which should be simple in structure and low in cost; for infants and newborns, the pre-charge of the blood pump should also be minimized.
- blood pumps with simpler structure, effective reduction of thrombus rate, small pre-charge, low flow rate and low cost have not been reported.
- the object of the present invention is to provide a single-point magnetic powered centrifugal blood pump in view of the deficiencies in the prior art.
- the utility model relates to a single-point magnetic power centrifugal blood pump, which is provided with a pump body and a driving device.
- the pump body comprises a top cover, a base, an impeller and an outer magnetic steel, and the base is provided with at least three layers of bosses, the top end
- the boss is provided with a groove, the groove is disposed in the groove, and the center of the bottom of the base is provided with an insertion hole;
- the impeller is provided with a blade and an annular connection, and the inner ring of the annular connection is provided a connecting rod, the connecting rod is collected at the center, the bottom portion forms a circular arc-shaped central groove, and the central groove cooperates with the ball in the groove of the boss to form a single-point bearing;
- the outer magnetic steel is disposed at
- the driving device comprises a transmission shaft and a driving motor provided with a motor rotor, wherein the transmission shaft is sleeved on the rotor of the
- the outer magnetic steel is a rectangular parallelepiped or a cylinder
- the inner magnetic steel is a rectangular parallelepiped or a cylinder
- the base is provided with three layers of bosses
- the balls are spherical or hemispherical;
- the balls are made of ceramic
- the blade is a straight blade or curved backward in the direction of blood flow
- the number of the blades is four or six;
- the pump motor is externally provided with a pump body mounting device, and the pump body mounting device is a concave platform.
- the single-point bearing is used as the rotating shaft.
- the contact area between the ball bearing and the blood is very small, which reduces the contact surface between the rotating shaft and the blood, thereby reducing the blood retention zone and effectively reducing the incidence of thrombus;
- the outer magnetic steel and the blood flow channel are in the same cavity.
- the blood pump of the invention has the advantages of simple structure and low pre-charge, and is suitable for assisting circulation after pediatric congenital heart disease surgery, and can also be used for extracorporeal circulation during surgery;
- the ball is spherical or hemispherical, which makes the single-point bearing structure more stable;
- the base is provided with a boss, which can effectively reduce the pre-charge
- the base is provided with an insertion hole to facilitate the placement of the transmission shaft
- the shape of the impeller is that the front end is bent backward in the direction of blood flow, conforming to the direction of blood flow, can effectively reduce the shearing force on red blood cells in the blood, and reduce the incidence of hemolysis;
- Figure 1 is an assembly view of a single-point magnetic powered centrifugal blood pump of the present invention.
- Figure 2 is a view showing the assembly of the single-point magnetic power centrifugal blood pump body of the present invention.
- Figure 3 is a plan view of Figure 2.
- FIG. 4 is a second-class axis view of the single-point magnetic power centrifugal blood pump impeller of the present invention.
- Figure 5 is a bottom view of Figure 4.
- Figure 6 is a second axis view of the single-point magnetic power centrifugal blood pump driving device of the present invention.
- Figure 7 is a second axial view of another impeller of a single-point magnetic powered centrifugal blood pump of the present invention.
- Figure 8 is a second axis view of another driving device of the single-point magnetic power centrifugal blood pump of the present invention.
- Impeller 301 Blade
- FIG. 1 is an assembly diagram of a single-point magnetic centrifugal blood pump of the present invention.
- the single-point magnetic power centrifugal blood pump is provided with a pump body and a driving device, and the pump body comprises a top cover 1, a base 2, an impeller 3 and an outer magnetic steel 305, and the driving device comprises a driving motor 4, Drive shaft 5 and inner magnet 501.
- FIG. 2 is a view showing the assembly of the single-point magnetic centrifugal blood pump body of the present invention.
- the top cover 1 is provided with an inlet 101, an outlet 102, an upper wall 103 and an outer wall 104.
- the outer wall 104 is cylindrical, and the bottom end is provided with internal threads (not shown); the upper wall 103 is tapered and disposed at the top end of the outer wall 104; the inlet 101 is located at the center of the top end of the upper wall 103.
- the outlet 102 is at a right angle to the inlet 101, as shown in Figure 3 ( Figure 3 is a top view of Figure 2 It can be seen that the outlet 102 is placed on the surface of the outer wall 104 in the tangential direction of the outflow channel.
- the base 2 includes a first boss 201, a second boss 202, and a third boss 203.
- the first boss top portion 2011 of the first boss 201 is tapered, and a groove 204 is disposed at the center.
- the groove 204 is disposed with a ball 205, and the ball 205 is hemispherical.
- the first boss main body 2012 of the first boss 201 is a hollow cylinder; the second boss 202 is also a hollow cylinder, and the outer wall thereof is provided with an external thread (not shown), and the second boss 202
- the top end is connected to the first boss 201, the bottom end is connected to the top end of the third boss 203, and the diameter of the second boss 202 is larger than the diameter of the first boss body 2012; the third boss 203 is also a hollow cylinder.
- the diameter of the body is larger than the diameter of the second boss 202 and larger than the diameter of the outer wall 104.
- the hollow interior of the first boss body 2012, the second boss 202 and the third boss 203 form an insertion hole 206, that is, The bottom of the base 2 is provided with an insertion hole 206.
- FIG. 4 is a second-class axis view of the single-point magnetic power centrifugal blood pump impeller of the present invention.
- the impeller 3 is provided with an annular connection 302.
- the annular connection 302 is an annular ring, and the inner ring is provided with three connecting rods 303.
- the three connecting rods 303 are assembled at the center of the impeller 3 to form a joint portion.
- the joint portion 306 is an annular ring, the central bottom of which is a central groove 304, and the central groove 304 has a circular arc shape.
- the lower end of the annular connection 302 is provided with four blades 301, and the four blades 301 are discharged in an array, and are connected by an annular connection 302 as a whole to form a half-disc flow passage, and the front end of the blade 3 flows along the blood.
- the direction is bent backwards.
- An outer magnetic steel 305 is disposed inside the rear end of the vane 301, and the outer magnetic steel 305 is a sheet-like structure. Referring to FIG. 5, FIG. 5 is a bottom view of FIG. 4, wherein the outer magnetic steel top surface 3051 is rectangular, that is, the outer magnetic steel 305 is a rectangular parallelepiped.
- the driving device includes a driving motor 4 and a transmission shaft 5 .
- the driving motor 4 is externally provided with a pump body mounting device 6 .
- the pump body mounting device 6 is a concave table and has an inner diameter.
- the outer diameter of the third boss 203 of the base 2 is equal; the upper end of the drive motor 4 is the motor rotor 401.
- FIG. 6 is a second axis view of the single-point magnetic power centrifugal blood pump driving device of the present invention.
- the drive shaft 5 is jacketed on the motor rotor 401.
- the inner magnet 501 is placed in the drive shaft 5.
- the inner magnet 501 is a circular sheet-shaped magnetic steel, which is the same as the outer magnet 305.
- the internal thread (not shown) at the bottom end of the outer wall 104 cooperates with the external thread (not shown) of the second boss 202.
- the top cover 1 and the base 2 form an internal cavity, and the impeller 3 is located in the internal cavity and is mounted on the first boss 201.
- the 205 is matched to form a single fulcrum bearing; the central axis of the impeller 3 coincides with the central axis of the first boss 201, and the rear end of each blade 301 is spaced apart from the first boss 201 by the same distance, and the first convex
- the tangential direction of the table 201 is parallel; the outer magnetic steel top surface 3051 of the outer magnet 305 is parallel to the central axis of the first boss 201, and is perpendicular to the radial direction of the first boss 201, and the foot is located outside.
- the center of the top surface 3051 of the magnetic steel; the inner magnetic steel 501 and the outer magnetic steel 305 have the same number and are placed facing each other, and the adjacent magnetic poles are staggered.
- the transmission shaft 5 is inserted into the insertion hole 206 of the base 2, and the diameter of the transmission shaft 5 is smaller than the diameter of the insertion hole 206.
- the pump body mounting device 6 is engaged with the third boss 203 to fix the entire pump body.
- FIG. 7 is another second-stage measurement of the impeller of the single-point magnetic centrifugal blood pump of the present invention.
- the impeller 3 is provided with six blades 301, and the blades 301 are straight blades.
- the single-point magnetic power centrifugal blood pump of this embodiment is basically the same as that of the first embodiment, except that: FIG. 8 is a second-class driving device of the single-point magnetic centrifugal blood pump of the present invention.
- the inner magnetic steel 501 is a circular piece of magnetic steel.
- the outer magnetic steel top surface 3051 of the outer magnetic steel 305 (not shown) is circular, that is, the outer magnetic steel 305 is a sheet-shaped cylinder.
- the circular arc-shaped central groove 304 cooperates with the hemispherical ball 205 in the groove 204 of the base 2 to form a single-point bearing, and the hemispherical ball 205 axially supports the impeller 3 and is radially fixed.
- the action of the impeller 3, the single-point bearing has a simple structure, can effectively reduce the contact area with blood, thereby reducing the blood retention zone, and significantly reducing the incidence of thrombus;
- the ball 205 is designed to be hemispherical, allowing the base 2 and the impeller 3 to pass
- the overall structure of the single-point bearing is more stable; the ball 205 can be made of a material that is not easy to wear, such as ceramics;
- the outer magnetic steel 305 is placed in the blade 301, and the inner magnetic steel 501 is placed in the drive shaft 5 as a driving magnetic steel, which solves the magnetic steel placement when the driving magnetic steel and the blood flow channel are in the same cavity.
- the problem is that the structure of the single-point magnetic power centrifugal blood pump of the present invention is simpler; the outer magnetic steel 305 and the inner magnetic steel 501 are disposed in the same direction, and the adjacent magnetic poles are staggered to prevent the synchronization from being lost during rotation;
- the outer magnetic steel 305 has a thickness of l-2 mm, and the shape thereof is preferably a rectangular parallelepiped;
- the inner magnetic steel 501 has a thickness of l-2 mm, and the shape thereof is preferably a rectangular parallelepiped;
- the number of the blades 301 of the impeller 3 is generally designed to be an even number, but not limited to four or six; the rear end of the blade 301 is 5-10 mm from the central axis of the impeller 3, and the length of the blade 301 is ⁇ 30 mm; The width of the gap between the rear end of the blade 301 and the first boss 201 is 0.5 mm; the shape of the blade 301 is preferably that the front end is bent backward in the blood flow direction, which can effectively reduce red blood cells in the blood. Shear force to prevent hemolysis.
- the shape of the central groove 304 is preferably hemispherical; the number of the bosses of the base 2 is at least three, but not limited to three, the design of the boss can effectively reduce the pre-charge;
- the outer wall 104 and the second boss 201 are not limited to the screw connection, and any connection manner may be used, such as adhesive glue sealing; the outer wall 104 has an outer diameter of 40-60 mm; the pump body mounting device 6 has a bump pin. Its function is to fix the pump body and prevent the pump body from rotating with the drive shaft 5, so the part can be omitted.
- the working principle of the single-point magnetic power centrifugal blood pump of the invention is as follows: the rotor 401 of the motor rotates to drive the transmission shaft 5 to rotate, and the inner magnetic steel 501 placed inside the transmission shaft 5 follows the rotation, thereby driving the outer magnetic steel 305 to rotate.
- the outer magnetic steel 305 inside the blade 301 drives the impeller to rotate, and the blood enters into the cavity formed by the top cover 1 and the base from the inlet 101, and flows down from the gap between the connecting rods 303 of the impeller 3, under the centrifugal action of the impeller 3. , pumped out from the outlet 102.
- the single-point magnetic centrifugal blood pump has the advantages of low pre-charge, and the pre-charge can reach 23 ml, which can effectively reduce the incidence of thrombus and hemolysis, and has the advantages of simple and stable structure, convenient installation and low cost.
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Abstract
一种单支点磁动力离心式血泵,设有泵体和驱动装置,所述的泵体包括顶盖(1)、底座(2)、叶轮(3)和外磁钢(305),所述的底座(2)设有至少三层凸台(201,202,203),顶端的凸台(201)设有凹槽(204),凹槽(204)内安放滚珠(205),底座(2)的底部中央设有***孔(206);所述的叶轮(3)设有叶片(301)和环状连接(302),环状连接(302)的内圈设有连接杆(303),连接杆(303)于中央汇集,汇集处底部形成圆弧形的中央凹槽(304),中央凹槽(304)与凸台(201)的凹槽(204)内的滚珠(205)配合构成单支点轴承;所述的外磁钢(305)设于叶片(301)内部;所述的驱动装置包括传动轴(5)和设有电机转子(401)的驱动电机(4),传动轴(5)套于电机转子(401)上,并***在***孔(206)中,传动轴(5)的内部设有内磁钢(501)。该血泵预冲量少,可有效降低血栓和溶血的发生率,结构简单稳固、安装方便、成本低。
Description
一种单支点磁动力离心式血泵
技术领域
本发明涉及医疗器械技术领域, 具体地说, 是一种单支点磁动力离心式血泵。
背景技术
心脑血管疾病在发达国家早已位居人类死亡原因的首位, 约占 46%的死亡率, 美国 统计资料显示每年心脏手术数量约为 35万例。 目前国内每年心内直视手术数量约为 10 万台, 随着经济的高速发展和医疗水平的不断提高, 国内心脏外科手术数量必将有一个 不断增加的过程。 根据统计资料显示, 心脏手术以后有部分病人 (0.6-2%) 因心功能受 损严重, 即使在药物支持下仍不能维持机体最低要求。 这部分病人不得不采用辅助循环 设备暂时支持心脏功能, 维持生命, 等待心功能恢复。 其中部分患者还需要使用长期循 环辅助设备替代心脏功能。此外, 治疗慢性不可逆心功能衰竭的最有效方法是心脏移植, 但供体心脏的不足限制心脏移植疗法在临床的普遍应用, 基因工程、 细胞工程等新疗法 在可见的将来尚不能大范围开展。 因此, 心室辅助技术在很多时候也成为了唯一的选择。
血泵 (又名心脏泵) 是心脏辅助循环装置的核心, 近年来, 一直是发达国家辅助循 环研究的重点, 并取得了一定的进展。
最早的第一代血泵是仿照心脏研制的搏动泵, 此类血泵采用气动或电动挤压泵腔, 通过泵腔容积的改变搏出血液。第二代连续流叶轮血泵兴起于上世纪 80年代早期, 此类 血泵的叶片通过机械轴承安装在血泵转子上, 转子带动叶片旋转从而推动血液沿径向或 轴向螺旋线前向运动。 第三代血泵以悬浮技术为特点, 因此凡采用磁悬浮和 /或液悬浮 技术研发的血泵都称为第三代血泵。
第三代血泵一般具有悬浮和驱动两个***: 悬浮***使叶轮悬浮, 叶轮直接永磁化 或在塑形的叶轮内嵌入永磁体。 血泵的定子或泵壳内置入永磁或电磁线圈, 通过磁化的 叶轮与定子或泵壳之间轴向及径向磁场相互作用, 使叶轮悬浮于泵壳中间; 驱动***驱 动叶轮旋转。 在定子或泵壳内置入另一组电磁线圈, 通过电磁线圈电流的变化产生磁力 推动磁化的叶轮旋转。
第三代血泵有三个发展阶段: 第一个阶段是悬浮和驱动***分离的外马达间接驱动 叶轮阶段。 血泵的悬浮技术较为简单, 悬浮***与驱动***分离, 血泵采用外马达驱动 技术, 叶轮是由一个独立的外马达来驱动; 外马达通过机械轴承旋转连接磁化的外叶轮, 外叶轮通过磁力驱动另一个悬浮的磁化内叶轮旋转; 内叶轮是主要的驱动部分, 它的旋 转可推动血液流动。 第二个阶段是悬浮和驱动***分离的马达直接驱动叶轮阶段, 采用 血泵马达直接驱动叶轮悬浮技术。 悬浮***与驱动***也是分离的, 但马达取消了外叶
轮, 将悬浮叶轮直接作为马达的转子, 马达直接通过磁力的变化驱动悬浮的叶轮转动来 推动血液流动。 泵仍需要另外一个独立的磁悬浮***来悬浮血泵叶轮。 第三阶段是悬浮 与驱动***融合阶段, 即血泵的悬浮与驱动***融合起来, 血泵设计将悬浮与驱动*** 的电磁线圈融合组成定子, 用一个定子来兼做驱动与悬浮叶轮的功能, 因此泵的设计更 加简洁, 其代表血泵为 Ventr Assist。
第三代血泵多数设计成离心泵, 少数为轴流泵, 有代表性的第三代血泵有数种, 例 如: ( 1 ) Berlin Heart Incor泵: 是由 Berlin Heart公司研发的磁悬浮轴流泵, 血泵由钛合 金制成, 泵体内唯一运动的叶轮设计成阿基米德螺旋, 叶轮通过轴向及径向磁力悬浮于 泵壳内, 通过电磁场的变化, 驱动悬浮的叶轮轴向旋转, 从而推动血液向前流动; (2) HeartWare泵: 泵的叶轮通过磁悬浮与液悬浮技术使泵叶悬浮, 泵的总定子由 2个相互 独立的线圈组合而成,在运转时 2个线圈可以同时工作,也可以单独工作; (3 ) VentrAssist 泵: 泵与血液接触的部位均有热解碳涂层, 可减少血栓发生率, 但该泵流入道较长, 因 此, 植入后仍需在后腹直肌鞘或腹直肌后制作小囊袋放置泵体; (4) NoVaCOrVAD泵: 具 有特殊的流入***, 该泵的流入管道与泵体平行设计, 外形成扁平形状。
血栓是由血小板的聚集和沉积形成的, 血泵中一般发于较少受血流冲刷的滞塞区和 与血液接触面的低速区。 溶血是指湍流运动或机械运动产生的高速或高压破坏了血液内 的红细胞, 致使血红蛋白分散到血浆中, 主要由不规则的流动和湍流运动区内高剪切应 力引起。 溶血和血栓现象对病人的危害巨大, 在临床应用中, 心脏辅助循环装置引起的 血栓和溶血会导致患者生理紊乱, 进而引发患者在术中和术后的并发症, 甚至危及患者 生命, 尤其是对于需要长期辅助循环支持的患者的影响更大。 可见, 减少心脏泵的血栓 和溶血的发生是辅助循环***研发中亟待解决的问题。
第三代血泵相比于第一和第二代血泵, 由于应用磁悬浮技术, 叶轮悬浮于血泵体内, 没有摩擦和挤压, 溶血明显减少, 血栓的发生率显著降低, 同时无轴承磨损问题, 提高 了血泵使用的耐久性, 更适合于长期的循环辅助。
而目前的第三代血泵的结构还较为复杂, 与血液接触面大, 容易产生血液的滞留区, 引发血栓。 此外, 血泵属于一次性用品, 应结构简单, 成本低廉; 针对婴儿及新生儿患 者, 还应当尽量减少血泵的预充量。 而目前关于结构更为简单、 可有效降低血栓发生率、 预充量小、 低流量、 成本低的血泵还未见报道。
发明内容
本发明的目的是针对现有技术中的不足, 提供一种单支点磁动力离心式血泵。
为实现上述目的, 本发明采取的技术方案是:
一种单支点磁动力离心式血泵, 设有泵体和驱动装置, 所述的泵体包括顶盖、 底座、 叶轮和外磁钢, 所述的底座设有至少三层凸台, 顶端的凸台设有凹槽, 所述的凹槽内安 放滚珠, 所述底座的底部中央设有***孔; 所述的叶轮设有叶片和环状连接, 所述的环 状连接的内圈设有连接杆, 所述的连接杆于中央汇集, 底部形成圆弧形的中央凹槽, 所 述的中央凹槽与凸台凹槽内的滚珠配合构成单支点轴承; 所述的外磁钢设于叶片内部; 所述的驱动装置包括传动轴和设有电机转子的驱动电机,所述的传动轴套于电机转子上, 并***在底座的***孔中, 传动轴的内部设有内磁钢, 所述的内磁钢与外磁钢数量相同 正对安放, 相邻磁极交错排列;
所述的外磁钢为长方体或圆柱体;
所述的内磁钢为长方体或圆柱体;
所述的底座设有三层凸台;
所述的滚珠为球形或半球形;
所述的滚珠由陶瓷制成;
所述的叶片为直叶片或沿血液流动方向向后弯曲;
所述的叶片的数量为四片或六片;
所述的驱动电机外部设有泵体安放装置, 所述的泵体安放装置为一凹台。
本发明优点在于:
1、 采用单支点轴承作为转动轴, 该滚珠轴承与血液接触面积十分之小, 减少了转动 轴与血液的接触面, 进而减少了血液滞留区, 能有效降低血栓发生率;
2、 所述的外磁钢与血液流道处于同一腔体中, 通过将外磁钢置于叶片内、 将内磁钢 置于传动轴内, 解决了共同腔体的磁钢摆放问题, 同时令本发明的血泵结构简单, 具备 低预充量的优点, 适用于小儿先心病手术后辅助循环, 同时也可在手术中体外循环使用;
3、 所述的滚珠是球形或半球形, 令单支点轴承结构更稳固;
4、 所述的底座设有凸台, 能够有效减少预充量;
5、 所述的底座设有***孔, 方便传动轴的安放;
6、 所述的叶轮的形状为前端沿血液流动方向向后弯曲, 顺应血液流动方向, 能有效 减少对血液中红细胞的剪切力, 减少溶血的发生几率;
7、 体积小, 便于外科植入, 同时可显著降低成本。
附图说明
附图 1是本发明的单支点磁动力离心式血泵装配图。
附图 2是本发明的单支点磁动力离心式血泵泵体装配图。
附图 3是图 2的俯视图。
附图 4是本发明单支点磁动力离心式血泵叶轮二等测轴视图。
附图 5是图 4的仰视图。
附图 6是本发明单支点磁动力离心式血泵驱动装置二等测轴视图。
附图 7是本发明单支点磁动力离心式血泵另一种叶轮二等测轴视图。
附图 8是本发明单支点磁动力离心式血泵另一种驱动装置二等测轴视图
具体实施方式
下面结合附图对本发明提供的具体实施方式作详细说明。
附图中涉及的附图标记和组成部分如下所示:
1.顶盖 101.入口
102.出口 103.上壁
104.外壁 2.底座
201.第一凸台 2011.第一凸台顶部
2012.第一凸台主体 202.第二凸台
203.第三凸台 204.凹槽
205.滚珠 206.***孔
3.叶轮 301.叶片
302.环状连接 303.连接杆
304.中央凹槽 305.外磁钢
3051.外磁钢顶面 306.接合部
4.驱动电机 401.电机转子
5.传动轴 501.内磁钢
6.泵体安放装置
实施例 1
请参照图 1, 图 1是本发明的单支点磁动力离心式血泵装配图。所述的单支点磁动力 离心式血泵设有泵体和驱动装置, 所述的泵体包括顶盖 1、底座 2、 叶轮 3和外磁钢 305, 所述的驱动装置包括驱动电机 4、 传动轴 5和内磁钢 501。
请参照图 2, 图 2是本发明的单支点磁动力离心式血泵泵体装配图。 所述的顶盖 1 设有入口 101、 出口 102、 上壁 103和外壁 104。 所述的外壁 104为圆柱形, 底端设有内 螺纹(未图示); 所述的上壁 103为锥形, 设于外壁 104的顶端; 所述的入口 101位于上 壁 103顶端的中心位置; 所述的出口 102与入口 101呈直角, 从图 3 (图 3是图 2的俯视
图) 可见, 所述的出口 102沿流出道切线方向置于外壁 104表面。
再请参照图 2, 所述的底座 2包括第一凸台 201、 第二凸台 202和第三凸台 203。 所 述的第一凸台 201的第一凸台顶部 2011为锥形, 中心处设有凹槽 204, 所述的凹槽 204 内安放有滚珠 205,所述的滚珠 205为半球形,所述的第一凸台 201的第一凸台主体 2012 为中空圆柱体; 所述的第二凸台 202也为中空圆柱体, 其外壁设有外螺纹(未图示), 第 二凸台 202的顶端与第一凸台 201相连,底端与第三凸台 203的顶端相连,第二凸台 202 的直径大于第一凸台主体 2012的直径; 所述的第三凸台 203也为中空圆柱体, 其直径大 于第二凸台 202直径, 同时大于外壁 104的直径; 所述的第一凸台主体 2012、 第二凸台 202和第三凸台 203的中空的内部形成***孔 206, 即底座 2的底部设有***孔 206。
请参照图 4, 图 4是本发明单支点磁动力离心式血泵叶轮二等测轴视图。所述的叶轮 3设有环状连接 302, 所述的环状连接 302为环形圈, 其内圈设有三支连接杆 303, 所述 的三支连接杆 303于叶轮 3的中央汇集形成接合部 306,所述的接合部 306为环形圈,其 中心底部为中央凹槽 304,所述的中央凹槽 304为圆弧形。所述的环状连接 302的下端设 有四个叶片 301, 所述的四个叶片 301阵列排放, 由环状连接 302连接为一个整体, 形成 半碟形流道, 叶片 3的前端沿血液流动方向向后弯曲。 所述的叶片 301的后端内部设有 外磁钢 305, 所述的外磁钢 305为片状结构。 请参照图 5, 图 5是图 4的仰视图, 所述的 外磁钢顶面 3051为长方形, 即所述的外磁钢 305为长方体。
再请参照图 1, 所述的驱动装置包括驱动电机 4和传动轴 5, 所述的驱动电机 4外部 设有泵体安放装置 6, 所述的泵体安放装置 6为一凹台, 其内径与底座 2的第三凸台 203 的外径相等; 所述的驱动电机 4的上端为电机转子 401。 请参照图 6, 图 6是本发明单支 点磁动力离心式血泵驱动装置二等测轴视图。 所述的传动轴 5外套在电机转子 401上, 传动轴 5内安放内磁钢 501,所述的内磁钢 501为圆形片状磁钢,与外磁钢 305数量相同。
请参照图 1, 当本发明的单支点磁动力离心式血泵装配完成时,所述的外壁 104底端 的内螺纹 (未图示) 与第二凸台 202的外螺纹 (未图示) 配合, 令顶盖 1和底座 2形成 内部腔体, 所述的叶轮 3位于该内部腔体中, 并装配于第一凸台 201之上, 所述的中央 凹槽 304与凹槽 204内的滚珠 205相配合, 构成单支点轴承; 所述的叶轮 3的中心轴线 与第一凸台 201的中心轴线重合,各个叶片 301的后端与第一凸台 201间隔相同的距离, 并且与第一凸台 201的切线方向平行;所述的外磁钢 305的外磁钢顶面 3051与第一凸台 201的中心轴线相平行, 并与第一凸台 201的径向垂直, 而垂足位于外磁钢顶面 3051的 中心; 所述的内磁钢 501与外磁钢 305数量相同并正对安放, 相邻磁极交错排列。 所述 的传动轴 5***在底座 2的***孔 206中, 传动轴 5的直径小于***孔 206的直径, 所
述的泵体安装装置 6卡住第三凸台 203, 将整个泵体固定住。
实施例 2
本实施例的单支点磁动力离心式血泵与实施例 1基本相同, 不同之处仅在于: 请参 照图 7, 图 7是本发明单支点磁动力离心式血泵另一种叶轮二等测轴视图, 所述的叶轮 3 设有六个叶片 301, 所述的叶片 301为直叶片。
实施例 3
本实施例的单支点磁动力离心式血泵与实施例 1基本相同, 不同之处仅在于: 请参 照图 8, 图 8是本发明单支点磁动力离心式血泵另一种驱动装置二等测轴视图,所述的内 磁钢 501为圆体片状磁钢。 对应的, 所述的外磁钢 305 (未图示) 的外磁钢顶面 3051为 圆形, 即所述的外磁钢 305为片状圆柱体。
针对上述实施例 1-3, 需要说明的是:
所述的圆弧形的中央凹槽 304与底座 2的凹槽 204中的半球形滚珠 205相配合, 构 成单支点轴承, 所述的半球形滚珠 205起到轴向支撑叶轮 3和径向固定叶轮 3的作用, 该单支点轴承结构简单, 能有效减少与血液接触面积, 进而减少血液滞留区, 显著降低 血栓发生率; 所述的滚珠 205设计成半球形, 可令底座 2和叶轮 3通过单支点轴承构成 的整体结构更稳固; 所述的滚珠 205可采用不易磨损材料制成, 如陶瓷;
所述的外磁钢 305置于叶片 301内, 所述的内磁钢 501置于传动轴 5内作为驱动磁 钢, 解决了驱动磁钢与血液流道处于同一腔体时的磁钢摆放问题, 同时令本发明单支点 磁动力离心式血泵的结构更加简单;所述的外磁钢 305和内磁钢 501数量相同正对安放, 相邻磁极交错排列, 可防止转动时失同步; 所述的外磁钢 305的厚度为 l-2mm, 其形状 优选为长方体; 所述的内磁钢 501的厚度为 l-2mm, 其形状优选为长方体;
所述的叶轮 3的叶片 301的数量通常设计为偶数个,但不仅限于四或六个; 叶片 301 的后端距离叶轮 3中心轴线的距离为 5-10mm, 叶片 301 的长度 <30mm; 装配完成时, 所述的叶片 301的后端与第一凸台 201之间的间隙宽度为 0.5mm; 所述的叶片 301的形 状优选为前端沿血液流动方向向后弯曲, 可有效减少对血液中红细胞的剪切力, 防止溶 血。
所述的中央凹槽 304的形状优选为半球形;所述的底座 2的凸台的数量至少为三个, 但不仅限于三个, 该凸台的设计能够有效减少预充量; 所述的外壁 104和第二凸台 201 之间不仅限于螺纹连接, 任何连接方式均可, 如粘性胶封闭; 所述的外壁 104的外径为 40-60mm; 所述的泵体安放装置 6 凹凸带销, 其作用是固定泵体, 防止泵体随驱动轴 5 旋转, 因此该部件是可以省略的。
本发明的单支点磁动力离心式血泵的工作原理是: 电机转子 401转动,带动传动轴 5 转动, 置于传动轴 5内部的内磁钢 501跟随转动, 进而驱动外磁钢 305转动, 置于叶片 301内部的外磁钢 305带动叶轮转动,血液由入口 101进入到顶盖 1和底座形成的腔体中, 由叶轮 3的连接杆 303之间的空隙处流下, 在叶轮 3的离心作用下, 从出口 102泵出。 该单支点磁动力离心式血泵具备低预充量的优点, 预充量可达到 23ml以内, 可有效降低 血栓和溶血的发生率, 同时结构简单稳固, 安装方便, 成本低。
Claims
1. 一种单支点磁动力离心式血泵, 设有泵体和驱动装置, 其特征在于,
所述的泵体包括顶盖、 底座、 叶轮和外磁钢, 所述的底座设有至少三层凸台, 顶端 的凸台设有凹槽, 所述的凹槽内安放滚珠, 所述底座的底部中央设有***孔; 所述的叶 轮设有叶片和环状连接, 所述的环状连接的内圈设有连接杆, 所述的连接杆于中央汇集, 底部形成圆弧形的中央凹槽,所述的中央凹槽与凸台凹槽内的滚珠配合构成单支点轴承; 所述的外磁钢设于叶片内部;
所述的驱动装置包括传动轴和设有电机转子的驱动电机, 所述的传动轴套于电机转 子上, 并***在底座的***孔中, 传动轴的内部设有内磁钢, 所述的内磁钢与外磁钢数 量相同正对安放, 相邻磁极交错排列。
2. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的外磁钢为 长方体或圆柱体。
3. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的内磁钢为 长方体或圆柱体。
4. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的底座设有 三层凸台。
5. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的滚珠为球 形或半球形。
6. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的滚珠由陶 瓷制成。
7. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的叶片为直 叶片或沿血液流动方向向后弯曲。
8. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的叶片的数 量为四片或六片。
9. 根据权利要求 1所述的单支点磁动力离心式血泵 其特征在于, 所述的驱动电机 外部设有泵体安放装置, 所述的泵体安放装置为一凹台。
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