Device for assisting a heart in case of functional failure

Abstract

A device for assisting cardiac function during cardiac failure is provided, comprising a drive assembly and a working assembly. The drive assembly includes a motor housing, a motor housed within the motor housing, and an active component driven by the motor. The working assembly includes a catheter, a drive shaft passing through the catheter, a driven component connected to a proximal end of the drive shaft, a coupler connected to a proximal end and a distal end of the catheter, and a pump head. The coupler is detachably connected to the motor housing, and the driven component is coupled to the active component. The pump head includes a pump housing and an impeller housed within the pump housing. The working assembly further includes a sensor, a first PCB disposed within the coupler and connected to the sensor, and a first connector disposed on the coupler and connected to the first PCB. The drive assembly further includes a second PCB disposed within the motor housing and a second connector disposed on the motor housing and connected to the second PCB. The first connector and the second connector are detachably connected.

Description

[Technical Field]

[0001] This invention relates to a device for assisting the heart in the event of functional failure. [Background Technology]

[0002] Heart disease is a health problem with a high mortality rate, and doctors are increasingly using mechanical circulatory support systems to treat heart failure. Treatment of acute heart failure requires a device that can quickly provide support to patients, and doctors are looking for a rapid, minimally invasive approach to treatment.

[0003] Mechanical circulatory support (MCS) systems and ventricular assist devices (VADs) are increasingly accepted in the treatment of acute heart failure. For example, they are used to stabilize patients following cardiogenic shock in the treatment of acute myocardial infarction (MI) or compensated heart failure, or to provide support during high-risk percutaneous coronary intervention (PCI). One example of an MCS system is a rotary blood pump placed percutaneously via catheter.

[0004] In conventional methods, a blood pump is inserted into the body and connected to the cardiovascular system (e.g., connecting the left ventricle and the ascending aorta) to assist the heart's pumping function. Other known applications include pumping venous blood from the right ventricle into the pulmonary artery to support the right side of the heart. Typically, acute circulatory support devices are used to reduce the load on the myocardium for a period of time, to stabilize patients before heart transplantation, or for continuous support.

[0005] The duct pump requires real-time monitoring of various parameters, including pump head speed, flow rate, and flushing fluid pressure. Typically, this data needs to be transmitted to a PCB located within the motor, but the motor and coupler are detachably connected, making data transmission difficult. [Summary of the Invention]

[0006] The purpose of this invention is to provide a device for assisting the heart in the event of cardiac failure, which can at least solve one of the above-mentioned problems.

[0007] The objective of this invention is achieved through the following technical solution:

[0008] A device for assisting cardiac function during heart failure includes a drive assembly and a working assembly. The drive assembly includes a motor housing, a motor housed within the motor housing, and an active component driven by the motor. The working assembly includes a catheter, a drive shaft passing through the catheter, a driven component connected to the proximal end of the drive shaft, a coupler connected to the proximal and distal ends of the catheter, and a pump head. The coupler is detachably connected to the motor housing, and the driven component is coupled to the active component to transmit rotational power from the motor to the drive shaft. The pump head includes a pump housing and an impeller housed within the pump housing. The working assembly also includes a sensor, a first PCB housed within the coupler and connected to the sensor, and a first connector housed on the coupler and connected to the first PCB. The drive assembly also includes a second PCB housed within the motor housing, and a second connector housed on the motor housing and connected to the second PCB; the first connector and the second connector are detachably connected.

[0009] The coupler and motor housing each house a first PCB and a second PCB, respectively. This not only reduces wiring and simplifies the circuitry, making the internal structure of the device more compact and organized, but also reduces the computational burden on the second PCB, allowing the reusable drive components to maintain optimal performance after multiple uses. The connection between the first and second connectors enables communication between the first and second PCBs, allowing them to work together to transmit detection data. [Attached Image Description]

[0010] Figure 1 This is a perspective view of the device according to an embodiment of the present invention;

[0011] Figure 2 This is a schematic diagram of the transmission mechanism according to the first embodiment of the present invention;

[0012] Figure 3 This is a schematic diagram of the transmission mechanism according to the second embodiment of the present invention;

[0013] Figure 4 This is a schematic diagram of the transmission mechanism according to the third embodiment of the present invention;

[0014] Figure 5 This is a schematic diagram of the transmission mechanism according to the fourth embodiment of the present invention;

[0015] Figure 6 This is a schematic diagram of the transmission mechanism according to the fifth embodiment of the present invention;

[0016] Figure 7 This is a schematic diagram of the transmission mechanism according to the sixth embodiment of the present invention;

[0017] Figure 8 for Figure 7 Cross-sectional view;

[0018] Figure 9 for Figure 1A three-dimensional schematic diagram of the coupler and protective cover in an assembled state;

[0019] Figure 10 A three-dimensional schematic diagram showing the coupler and protective cover in a disassembled state;

[0020] Figure 11 for Figure 9 A perspective view of the first form of the protective cover;

[0021] Figure 12 for Figure 9 A perspective view of the second form of the central protective cover;

[0022] Figure 13 for Figure 9 A three-dimensional view of the third form of the protective cover. [Specific Implementation Examples]

[0023] As used in this invention, the terms "proximal," "rear," "far," and "front" are relative to the clinician operating the device. The terms "proximal" and "rear" refer to portions relatively close to the clinician, while "far" and "front" refer to portions relatively far from the clinician. For example, the drive assembly is located at the proximal and rear ends, while the working assembly is located at the distal and front ends. As another example, the proximal end of a component / assembly refers to the end relatively close to the drive assembly, while the distal end refers to the end relatively close to the working assembly.

[0024] It is important to understand that terms like "near," "far," "behind," and "in front" are definitions used for ease of description. However, devices can be used in many directions and positions, so these terms expressing relative positional relationships are not limited or absolute.

[0025] The device 100 of this embodiment can at least partially assist the heart's pumping function, thereby at least partially reducing the burden on the heart. In an illustrative scenario, the device 100 can be used as a left ventricular assist device, and its working part (specifically, the pump head below) can be inserted into the left ventricle. When the pump head is in operation, it can pump blood from the left ventricle into the ascending aorta.

[0026] It is worth noting that the above-mentioned use as a left ventricular assist device is only one feasible application scenario for the device 100. In other feasible and not explicitly excluded scenarios, the device 100 can also be used as a right ventricular assist device, in which the pump head can be inserted into the right ventricle, and when the pump head is in operation, it pumps blood from the vein into the right ventricle.

[0027] The following description primarily focuses on the scenario where the device 100 is used as a left ventricular assist device. However, as can be seen from the above description, the scope of protection of the embodiments of the present invention is not limited thereto.

[0028] like Figure 1and Figure 2 As shown, the device 100 includes a drive assembly 10 and a working assembly 30. The drive assembly 10 provides power to the working assembly 30 to drive the working assembly 30 to perform the blood pumping function. The drive assembly 10 includes a motor housing 12, a motor 14 housed within the motor housing 12, and a drive member 99 driven by the motor 14. The device 100 also includes a control module electrically or communicatively connected to the motor 14, which will be described in detail later. The working assembly 30 includes a conduit 32, a drive shaft (not shown) passing through the conduit 32, a follower connected to the proximal end of the drive shaft, a coupler 39 connected to the proximal end and the distal end of the conduit, and a pump head 36, respectively. The coupler 39 is detachably connected to the motor housing 12, and the connection method includes plug-in, interference fit, snap-fit ​​connection, nut locking connection, etc.

[0029] The pump head 36 can be delivered to a desired location in the heart (e.g., the left ventricle) via the conduit 32 to pump blood, including a pump housing 363 connected to the distal end of the conduit 32 and having an inlet 361 and an outlet 362, an impeller (not shown) housed in the pump housing 363, the impeller being connected to the distal end of a drive shaft to be driven to rotate by the drive shaft to draw blood from the inlet 361 into the pump housing 363 and out from the outlet 362.

[0030] The drive assembly 10 also includes a drive member 99 driven by the motor shaft 16 of the motor 14. The working assembly 30 includes a driven member 89 coupled to the drive member 99 to be driven to rotate about a rotation axis. A connecting shaft 44 is provided between the driven member 89 and the drive shaft, the driven member 89 drives the connecting shaft 44, and the drive shaft is connected to the connecting shaft 44. Thus, the rotation of the motor 14 is transmitted to the impeller sequentially via the drive member 99, the driven member 89, the connecting shaft 44, and the drive shaft.

[0031] The driving element 99 and the driven element 89 can employ a magnetic coupling method as provided in CN103120810B or CN101820933B, meaning both the driving element 99 and the driven element 89 are magnets. Alternatively, the driving element 99 and the driven element 89 can also employ an eddy current coupling transmission method as provided in CN216061675U or CN114452527A, meaning one of them is a magnetic force providing element, and the other is a conductor. The magnetic force providing element is a magnet that is itself magnetic, such as a permanent magnet or a hard magnet. Alternatively, the magnetic force providing element can also be an electromagnetic element that can generate magnetism when energized, such as a coil. The conductor can be a metal, such as copper, aluminum, or an alloy containing copper or aluminum, which have good conductivity.

[0032] In the embodiment where the drive member 99 and the driven member 89 employ an eddy current coupling transmission method, after the motor shaft 16 rotates, driving the drive member 99 to rotate, the conductor cuts magnetic lines of force in the magnetic field generated by the magnetic force providing element, thereby generating eddy currents in the conductor. These eddy currents then generate a reverse induced magnetic field on the conductor. This induced magnetic field magnetically couples with the magnetic field generated by the magnetic force providing element, thus achieving coupling between the driven member 89 and the drive member 99 and driving it to rotate around the rotation axis. The rotation of the driven member 89 drives the connecting shaft 44 and the drive shaft to rotate, ultimately driving the impeller to rotate.

[0033] Based on the working principle of eddy current couplings, this structure, when transmitting rotational power, does not significantly reduce the rotational speed of the working side (drive shaft or impeller) if the impeller rotation is obstructed, compared to magnetic coupling power transmission. Therefore, the transmission method of eddy current couplings possesses a certain clutch function, protecting ventricular tissue without significantly reducing pumped blood flow, thus greatly reducing the risk of thrombosis due to decreased blood flow and device intervention.

[0034] The speed difference between the driving component 99 and the driven component 89 is precisely the reason for their coupling. Therefore, once the resistance hindering the impeller rotation disappears, as long as the motor 14 is still operating normally, the driven component 89 will automatically resume rotation without needing to stop and restart the motor 14. This results in better continuity of ventricular assist for the subjects, and this continuity does not rely on complex monitoring and control methods, leading to higher clinical stability.

[0035] A gap 79 is formed between the driving member 99 and the driven member 89, enabling non-contact power transmission through magnetic coupling between them. This facilitates sealing of the fluid and prevents liquid from entering the motor 14. The liquid is a flushing fluid that needs to be at least partially introduced into the human body during the operation of the device 100. This flushing fluid can be, for example, physiological saline, glucose solution, anticoagulant, or any combination thereof.

[0036] The device 100 also includes a flushing system, which includes a flushing pump (not shown) connected to the coupler 39 via a flushing conduit. The proximal end of the conduit 32 is connected to and in fluid communication with the coupler 39. After the flushing pump injects flushing fluid into the coupler 39 through the flushing conduit, the flushing fluid enters the conduit 32, flows forward within the conduit 32, and enters the human body. During this process, the flushing fluid flushes rotating components such as drive shafts and bearings, achieving cooling and lubrication.

[0037] To constrain the magnetic lines of force of the driving member 99 in the direction toward the driven member 89, a first magnetic constraint member 71 is provided on the side of the driving member 99 away from the driven member 89. The first magnetic constraint member 71 is made of a magnetically conductive material, and may include, for example, a solid back iron, a parallel flux silicon steel sheet back iron, a vertical flux silicon steel sheet back iron, etc. The first magnetic constraint member 71 moves synchronously with the driving member 99.

[0038] Similarly, to constrain the magnetic lines of force of the driven member 89 towards the driving member 99, a second magnetic constraint member 72 is provided on the side of the driven member 89 away from the driving member 99. The second magnetic constraint member 72 is made of a magnetically conductive material, as described above, and will not be repeated here. The second magnetic constraint member 72 moves synchronously with the driven member 89. The first and second magnetic constraint members 71 and 72 cooperate to constrain the magnetic lines of force between the driving member 99 and the driven member 89, thereby maximizing the magnetic force between them and improving transmission efficiency.

[0039] The above describes the principle of eddy current coupling transmission between the driving component 99 and the driven component 89. The specific transmission structures are described below through different embodiments. The principles of these transmission structures are the same and will not be repeated.

[0040] Please see Figure 2 The diagram shows a portion of the transmission mechanism according to the first embodiment of the present invention.

[0041] In this embodiment, the distal end face of the driving member 99 and the proximal end face of the driven member 89 are opposite each other, forming an end-face coupling. The gap 79 formed between the end faces of the driving member 99 and the driven member 89 is less than or equal to 5 mm.

[0042] The driving component 99 includes a main body 993 and a connecting portion 995 connected to the side of the main body 993 away from the driven component 89. The main body 993 is disc-shaped, and the connecting portion 995 is tubular or hollow cylindrical. The motor shaft 16 is inserted into the connecting portion 995 to drive the driving component 99. The driven component 89 is annular, and a connecting shaft 44 is inserted into the central hole of the annular driven component 89 and connected to the driven component 89. The proximal end face of the connecting shaft 44 is flush with the proximal end face of the driven component 89.

[0043] The first magnetic constraint member 71 constrains the magnetic lines of force of the driving member 99 to the far side of the first magnetic constraint member 71, preventing the magnetic lines of force of the driving member 99 from spreading away from the driven member 89. The first magnetic constraint member 71 is ring-shaped and sleeved on the connecting part 995, and the first magnetic constraint member 71 abuts against the near end face of the main body 993.

[0044] The first magnetic constraint member 71 moves synchronously with the driving member 99. One method is that the outer surfaces of the connecting portion 995 between the first magnetic constraint member 71 and the driving member 99 are tightly fitted to achieve synchronous movement. Another method is that the proximal faces of the first magnetic constraint member 71 and the driving member 99 are connected in some way, such as by adhesion, to achieve synchronous movement.

[0045] Similarly, the magnetic field lines of the follower 89 are constrained to the near side of the second magnetic constraint member 72. The synchronous movement of the second magnetic constraint member 72 and the follower 89 is achieved in the same way as described above, and will not be repeated here.

[0046] Please see Figure 3 The diagram shows a portion of the transmission mechanism according to a second embodiment of the present invention.

[0047] Known embodiments, such as US7393181B2, provide a foldable blood pump. The foldability is manifested in the pump housing and impeller folding during intervention and unfolding after the intervention is complete. The advantages are that it can reduce the size of the intervention, thereby reducing infection and complications and minimizing patient discomfort, while also achieving optimal hydraulic performance during pump operation.

[0048] The pump head (specifically the impeller) of a collapsible blood pump is typically driven by an externally located motor via a long, flexible shaft. During operation, the rotating shaft inevitably rubs against the inner wall of the catheter housing it, generating heat. This heat exacerbates wear on the shaft and catheter, reducing the lifespan of these components. The same problem exists in other rotating parts throughout the drivetrain, such as bearings.

[0049] Therefore, known embodiments, such as US8591393B2, provide a solution for cooling and / or lubricating the aforementioned long drive link during the operation of the foldable blood pump. The general process involves an external fluid supply source flushing fluid into the catheter, which lubricates the rotating flexible shaft and bearings, reducing frictional heat generation and promptly cooling the generated heat.

[0050] However, the introduction of a cooling / lubricating fluid brings another problem – sealing – that must be addressed. Essentially, it is undesirable for flushing fluid to enter the motor, as this could damage it. Therefore, how to transmit the motor's rotational power to the impeller via a flexible shaft while preventing flushing fluid from entering the motor has always been a pressing problem in this field.

[0051] This embodiment and Figure 2The difference in the first embodiment shown is that a liquid isolation wall 75 is provided in the gap 79 between the driving member 99 and the driven member 89 to seal the flushing fluid and prevent it from entering the motor 14. In addition, the liquid isolation wall 75 defines the flow direction of the flushing fluid, so that the flushing fluid can only flow to the distal end, namely the working component 30, thereby lubricating and cooling the rotating parts.

[0052] A liquid isolation layer (not shown) is provided around the driven member 89 to isolate it from the flushing fluid, preventing the flushing fluid from contacting and corroding the driven member 89 during operation. Specifically, in embodiments where the driven member 89 is a magnetic force providing element, the liquid isolation layer prevents the magnet or coil from being corroded by the liquid, thus preventing magnetic force weakening and extending the lifespan of the driven member 89 in providing magnetic force as much as possible. In embodiments where the driven member 89 is a conductor, the liquid isolation layer prevents the conductor from being corroded, thus preventing a decrease in conductivity and ensuring the stability of the driven member 89's performance in generating eddy currents and thus an induced magnetic field.

[0053] In some embodiments, the liquid barrier layer can be a waterproof coating, such as a titanium plating. A liquid barrier layer constructed with a waterproof coating offers advantages such as thinness, light weight, ease of forming, and high bonding strength, which will beneficially improve coupling efficiency, assembly, manufacturing costs, and service life. In other embodiments, the liquid barrier layer can be a mechanical structure, such as a resin encapsulation, that encapsulates or covers the follower 89, forming a housing cavity therein. Similar to the waterproof coating embodiments, the housing cavity can reliably protect the follower 89 from erosion by rinsing fluids.

[0054] Please see Figure 4 The diagram shows a portion of the transmission mechanism according to a third embodiment of the present invention.

[0055] This embodiment and Figure 2 The difference in the first embodiment shown is that the inner and outer circumferential surfaces of the driving member 993 and the driven member 893 achieve eddy current transmission and are configured for radial coupling. The driving member 993 and the driven member 893 at least partially overlap in the circumferential direction of the rotation axis and are spaced apart in the radial direction of the rotation axis with a gap 79. Alternatively, the driving member 993 includes a channel 73 in which the driven member 893 is disposed. The driving member 993 and the driven member 893 are continuous annular in the circumferential direction, or the driving member 993 and the driven member 893 include multiple annular segments spaced apart in the circumferential direction. It should be noted that the driving member 993 and the driven member 893 at least partially overlap in the circumferential direction, but it is not strictly required that the driving member 993 and the driven member 893 be annular or annular segments; other annular shapes are also acceptable.

[0056] A motor shaft 16 is connected to a first bracket 51. The first bracket 51 includes a first hollow portion 52, a driving member 993 disposed on the outer wall of the first hollow portion 52, and a first magnetic constraint member 713 disposed radially outward of the driving member 993. The first bracket 51 also includes a mounting portion 53 connected to the first hollow portion 52, the mounting portion 53 having a mounting hole for mounting the motor shaft 16. The first bracket 51 is driven to rotate by the motor shaft 16, thereby causing the driving member 993 to rotate. The first bracket 51 also includes a limiting portion 54 connected to the first hollow portion 52, the limiting portion 54 extending radially outward from the distal end of the first hollow portion 52, the extending direction of the limiting portion 54 being perpendicular to the extending direction of the first hollow portion 52. The driving member 993 simultaneously abuts against both the first hollow portion 52 and the limiting portion 54. Preferably, the first hollow portion 52, the mounting portion 53, and the limiting portion 54 of the first bracket 51 are integrally formed. The limiting part 54 is flush with the outer peripheral surface of the driving member 993, and the first magnetic constraint member 713 is in contact with the outer peripheral surface of the driving member 993 and the limiting part 54, thereby constraining the magnetic lines of force of the driving member 993 to the radial inner side of the first magnetic constraint member 713.

[0057] Of course, it is understandable that the first magnetic constraint member 713 may only be in contact with the outer peripheral surface of the driving member 993. The driven member 893 has a through hole, and the connecting shaft 44 is inserted into the through hole and connected to the driven member 893, so that the rotation of the driven member 893 drives the rotation of the connecting shaft 44. The proximal end face of the connecting shaft 44 is flush with the proximal end face of the driven member 893.

[0058] The working assembly 30 includes a second magnetic constraint member 723 disposed between the connecting shaft 44 and the driven member 893. The second magnetic constraint member 723 connects the driven member 893 and the connecting shaft 44 and is sleeved on the outer peripheral surface of the connecting shaft 44. The driven member 893 is sleeved on the outer peripheral surface of the second magnetic constraint member 723. The second magnetic constraint member 723 constrains the magnetic lines of force of the driven member 893 to the radially outer side of the second magnetic constraint member 723. The axial length of the second magnetic constraint member 723 is the same as the axial length of the driven member 893, and the second magnetic constraint member 723 and the driven member 893 are aligned axially.

[0059] Therefore, the rotation of the motor shaft 16 drives the first bracket 51 to rotate, the first bracket 51 drives the drive member 993 to rotate, the rotation of the drive member 993 drives the driven member 893 to rotate via eddy current transmission, the rotation of the driven member 893 drives the connecting shaft 44 to rotate, thereby driving the impeller to rotate via the drive shaft. The first magnetic constraint member 713 and the second magnetic constraint member 723 cooperate to constrain the magnetic lines of force between them.

[0060] In an alternative embodiment, the second magnetic constraint 723 is integrally formed with the connecting shaft 44. Alternatively, the connecting shaft 44 itself is made of a magnetically conductive material, and the connecting shaft 44 itself is constructed as the second magnetic constraint 723, thus eliminating the need for a separate second magnetic constraint 723 and simplifying the structure.

[0061] In this embodiment, the drive member 993 forms a channel, and the follower member 893 extends at least partially into the channel. In some other alternative embodiments, the follower member 893 includes a channel, and the drive member 993 is disposed in the channel.

[0062] In this embodiment, the motor shaft 16 is connected to the first bracket 51, and the drive member 993 is also connected to the first bracket 51. In an alternative embodiment, the first bracket 51 itself is configured as the drive member. In some other alternative embodiments, the connecting shaft 44 is connected to a second bracket, the second bracket including a second hollow portion, and a follower 893 is disposed on the outer wall of the second hollow portion, the second hollow portion being configured as a second magnetic constraint member. Alternatively, the follower 893 is disposed on the inner wall of the second hollow portion, and the second magnetic constraint member is disposed radially inside the follower 893.

[0063] Similar to the second embodiment, this embodiment also includes a liquid isolation wall 75 in the gap 79, which will not be described in detail here.

[0064] Please see Figure 5 The diagram shows a portion of the transmission mechanism according to a fourth embodiment of the present invention.

[0065] As mentioned above, based on the transmission principle of eddy current couplings, the speeds of the driving and driven components are not synchronized. In short, there must be a speed difference between the motor shaft 16 and the drive shaft or impeller. If there were no speed difference between the motor shaft and the drive shaft, the control module could indirectly control the speed of the drive shaft or impeller by directly detecting and controlling the speed of the motor shaft, thus keeping the impeller speed within a reasonable range.

[0066] In this invention, the coupling method between the driving component and the driven component determines that there must be a speed difference between the motor shaft 16 and the driving shaft (the rotational speed of the driving shaft is lower than that of the motor shaft 16). Therefore, it is essential for the control module to know the rotational speed of the driving shaft in a timely manner. To this end, the device 100 includes a rotational speed detection component that is communicatively connected to the control module for detecting the rotational speed of the driving shaft.

[0067] When the control module determines, based on the signal provided by the speed detection component, that the drive shaft speed is lower than the target speed, it controls the motor 14 to increase its speed, thereby increasing the drive shaft speed and adjusting it to near the target speed. It should be noted that when the drive shaft speed fluctuates within 10% of the target speed, preferably 5%, and more preferably within 1%, the control module determines that the drive shaft speed is near the target speed.

[0068] When the control module determines that the speed of the drive shaft is near the target speed based on the signal provided by the speed detection component, it controls the motor 14 to maintain the current speed, thereby keeping the speed of the drive shaft near the target speed.

[0069] The device 100 also includes an alarm unit electrically or communicatively connected to the control module. When the control module determines, based on signals provided by the speed detection component, that the drive shaft speed is lower than the target speed, but the motor 14 speed is higher than the set value, it controls the alarm unit to operate. That is, when the motor 14 speed is higher than the set value, theoretically, the drive shaft speed should not be lower than the target speed. In this case, if the drive shaft speed is detected to be lower than the target speed, it indicates a problem in the transmission link from the motor 14 to the drive shaft, such as rotational resistance in the impeller or drive shaft, causing the impeller or drive shaft to stall relative to the motor shaft 16. At this time, the alarm unit issues an alarm signal, allowing the operator (e.g., a doctor) to be promptly informed of the situation and take appropriate measures, thereby improving safety. The alarm unit can be, for example, an audible alarm, a flashing light alarm, or a combination of both.

[0070] The control module includes a first control unit (corresponding to the second PCB below) housed in the motor housing and a second control unit integrated into the rinsing system. The first control unit is electrically or communicatively connected to the speed detection component. The second control unit can provide a converted level signal to the motor 14 and can also provide reverse electrical isolation to the motor 14.

[0071] The first control unit functions to control the rotational speed of motor 14. For example, it controls the rotational speed of motor 14 based on received signals. These signals include at least a rotational speed electrical signal, which the first control unit then converts into rotational speed information for judgment and speed control. The first control unit also functions to control the motor (flushing pump motor) in the flushing system, thereby controlling the injection flow rate of the flushing fluid.

[0072] The functions of the second control unit include: First, providing a suitable voltage to the motor 14 to achieve voltage conversion, such as converting a high level to a low level or vice versa, before supplying it to the motor 14. Second, providing electrical isolation to comply with electrical and electronic regulations based on safety requirements. For example, if there are other high-voltage scenarios on the intervention side, such as a defibrillator transmitting voltage in the reverse direction to the motor 14 via a conductive flexible shaft, it may cause the device 100 to malfunction or be damaged; therefore, electrical isolation is necessary.

[0073] The following focuses on describing the differences between this embodiment and the third embodiment.

[0074] Please see Figure 5To detect the rotational speed of the drive shaft, the speed detection component includes a synchronizer 202 that rotates synchronously with the drive shaft and a sensor 204 that detects the rotational speed of the synchronizer 202. The sensor 204 is electrically or communicatively connected to the control module. The sensor 204 detects the rotational speed of the drive shaft and transmits the detected speed information to the control module. The control module determines whether the rotational speed of the drive shaft meets the requirements and whether it is necessary to adjust the rotational speed of the motor 14 to adjust the rotational speed of the drive component 994, ultimately controlling the rotational speed of the drive shaft within the required range. The specific control logic is as described above and will not be repeated here.

[0075] In one embodiment, the synchronizer 202 is a magnetic force providing element, and the sensor 204 is a coil. Based on the principle of electromagnetic induction, a current is generated in the coil as the magnetic force providing element rotates synchronously with the drive shaft. Furthermore, the magnitude of the current in the coil changes when the magnetic force providing element rotates at different speeds. The coil is electrically or communicatively connected to the control module. By calculating the changes in the coil's current, the control module can determine the rotational speed of the magnetic force providing element, thereby determining the rotational speed of the drive shaft.

[0076] In other embodiments, the rotation speed detection component can be implemented using principles such as gratings, light reflection, and stroboscopes. Any scheme that adopts the same or similar scheme as this embodiment is covered within the protection scope of this invention.

[0077] In another embodiment, synchronizer 202 is a magnetic force providing element, and sensor 204 is a Hall sensor. When the magnetic force providing element rotates at different speeds, the Hall sensor will emit different pulse signals. The control module can obtain the drive shaft speed by detecting the changes in the pulse signals emitted by the Hall sensor and by calculation.

[0078] Synchronizer 202 is mounted on connecting shaft 44, which is made of non-magnetic materials such as stainless steel, ceramic, polymer materials, or combinations thereof. Therefore, connecting shaft 44 itself does not affect the magnetic field of synchronizer 202, allowing sensor 204 to more accurately detect the rotational speed of synchronizer 202. Synchronizer 202 is exposed to a flushing fluid environment during use. To prevent corrosion from the flushing fluid, synchronizer 202 is encased in a housing 206, thus protecting it. Housing 206 is made of insulating material to prevent interaction between synchronizer 202 and any potential current.

[0079] In some embodiments, the housing 206 includes a first portion 208 and a second portion 210, which are manufactured separately and mate to form a space for receiving the synchronizer 202. This facilitates assembly. In other embodiments, the synchronizer 202 may be integrally injection molded with the housing 206.

[0080] Synchronizer 202 is encapsulated in housing 206, which is circumferentially fixed to connecting shaft 44. When connecting shaft 44 rotates, synchronizer 202 rotates synchronously. When synchronizer 202 rotates at different speeds, sensor 204 generates a signal change, thereby detecting the speed of drive shaft.

[0081] During operation, the synchronizer 202, sensor 204, and control module are in a dynamic adjustment process. That is, after the control module adjusts the rotational speed of the connecting shaft 44 as described above, the synchronizer 202 and sensor 204 will again feed back the rotational speed of the connecting shaft 44 to the control module, which will then determine whether further adjustment is needed. This process repeats to ensure that the impeller operates in a relatively stable state.

[0082] Please see Figure 6 The diagram shows a portion of the transmission mechanism according to a fifth embodiment of the present invention.

[0083] In this embodiment, the follower 895 is a magnetic force providing element, specifically a magnetic ring, and a second magnetic force constraint 725 is provided between the magnetic ring and the connecting shaft 44. The second magnetic force constraint 725 is an annular back iron, sleeved on the connecting shaft 44. The follower 895 is sleeved on the second magnetic force constraint 725, and the two ends of the second magnetic force constraint 725 are flush with the two ends of the follower 895.

[0084] To prevent the flushing fluid from corroding the driven member 895, the connecting shaft 44 is provided with a first end cap 231 and a second end cap 232 located at both ends of the driven member 895. The first end cap 231 and the second end cap 232 provide an axial seal for the driven member 895. The outer diameter of the first end cap 231 and the second end cap 232 is larger than the outer diameter of the driven member 895. In other words, the first end cap 231 and the second end cap 232 extend radially beyond the driven member 895. A protective layer 234 is provided radially outside the driven member 895. The protective layer 234 is connected to the first end cap 231 and the second end cap 232 and encloses the driven member 895 therein. The protective layer 234 provides a radial seal for the driven member 895.

[0085] The protective layer 234 is a hollow cylindrical shape and connects to the portion of the first end cap 231 and the second end cap 232 that extends radially beyond the driven member 895. Thus, the protective layer 234, together with the first end cap 231 and the second end cap 232, forms a receiving cavity for accommodating the driven member 895. Preferably, the first end cap 231 and the second end cap 232 have stepped surfaces, and the protective layer 234 mates with these stepped surfaces, with the outer surface of the protective layer 234 not extending beyond the radial outer surface of the first end cap 231 and the second end cap 232. More preferably, the outer surface of the protective layer 234 is flush with the radial outer surface of the first end cap 231 and the second end cap 232. Therefore, the first end cap 231, the second end cap 232, the protective layer 234, and the connecting shaft 44 cooperate to completely enclose the driven member 895, thereby preventing the flushing fluid from corroding the driven member 895.

[0086] Due to factors such as processing, assembly, and inconsistent material uniformity, the center of mass of the connecting shaft 44 may, and is highly likely, shift off-axis. During high-speed operation of the connecting shaft 44, this can cause vibration, which can lead to problems such as hindering the stable maintenance of the gap 79. To reduce vibration, the first end cap 231 and / or the second end cap 232 include a connected body and a balancing part (not shown). The balancing part balances the first end cap 231 and / or the second end cap 232 on the connecting shaft 44, thereby reducing vibration.

[0087] In one embodiment, the balancing portion is an opening extending from one end face of the main body to the other, with the extension length of the opening being less than the thickness of the end cap. That is, the balancing portion reduces the weight of the main body, thereby achieving balancing and reducing vibration. To achieve better balancing, the first end cap 231 and / or the second end cap 232 are preferably made of a relatively dense metal or ceramic material, resulting in a more significant weight-reduction and balancing effect. The thickness of the first end cap 231 and / or the second end cap 232 is greater than the minimum thickness that can be machined from the metal material, but not more than 20 times the minimum thickness that can be machined from the material. The main objective of this design is to achieve the desired dynamic balance through weight-reduction balancing using metal or ceramic end caps while rapidly reducing the thickness of the end caps to meet both dynamic optimization and structural miniaturization requirements.

[0088] In another embodiment, the main body and the balancing part are stacked, and the balancing part includes an opening or a weight block. That is, the balancing part adds weight to the main body. At the same time, the balancing part itself can be weighted or unweighted, thereby achieving a greater degree of balancing of the connecting shaft 44 by the first end cap 231 and / or the second end cap 232. To provide rotational support for the connecting shaft 44, a first bearing 235 and a second bearing 236 are respectively provided at the distal and proximal ends of the connecting shaft 44.

[0089] For ease of description, the part that can be inserted into the subject's body is referred to as the interventional part (including part of the catheter, drive shaft, pump head 36, protective head, etc.). To facilitate the insertion of the interventional part into the subject's body, the device 100 also includes a guide channel 237 that runs through the working assembly. In use, the guidewire, which serves as a guide, is first inserted into the subject's body through the vascular system. Then, a medical professional holds the interventional part and inserts the proximal end of the guidewire into the distal end of the guide channel 237 until the guidewire passes through the entire working assembly and exits from the proximal end. Subsequently, the pump head 36 is delivered to the left ventricle along the guide path established by the guidewire in the subject's vascular system. After the tip of the pump head 36 is inserted into the left ventricle, the guidewire is withdrawn, the working assembly connects to the drive assembly, and the motor 14 is activated, allowing the device to operate.

[0090] The guide channel 237 includes an end-side outlet 238 located proximally at the end of the liquid isolation wall 75. The end-side outlet 238 forms part of the guide channel 237. Therefore, the end-side outlet 238 needs to be re-openable or re-sealed. Specifically, the end-side outlet 238 has a re-sealing seal 240. The seal 240 has two states: a sealed state and an open state. When sealed, the seal 240 closes the end-side outlet 238, preventing flushing fluid from flowing out of the end-side outlet 238 and corroding the motor. When open, the end-side outlet 238 is open, allowing the guidewire to pass through and the interventional portion to be inserted into the subject's body. When guidewire insertion is required, the seal 240 is opened, allowing the guidewire to pass through the end-side opening, ensuring the pump head 36 enters the subject's body. After the intervention of the pump head 36 is completed, the guidewire is withdrawn, and the seal 240 is sealed.

[0091] In one embodiment, the seal 240 includes a flexible sealing plug 241 that is axially movable in an end-side outlet 238. The outer wall of the flexible sealing plug 241 and / or the inner wall of the end-side outlet 238 are inclined so that the flexible sealing plug 241 is squeezed to switch to a sealed state when it moves axially in a first direction, and radially expands to switch to an open state when it moves in a second direction opposite to the first direction.

[0092] The seal 240 also includes a rigid operating part 242 connected to the flexible sealing plug 241. The rigidity of the operating part 242 is greater than that of the flexible sealing plug 241. The operating part is located away from the end outlet 238 relative to the flexible sealing plug 241. The operating part 242 is used to provide a handle for axially moving the flexible sealing plug 241.

[0093] Figure 7 and Figure 8 A partial structure of the working component provided in the sixth embodiment of the present invention is shown. The differences between this embodiment and the previous embodiments are described in detail below, as well as the improvements of this embodiment based on embodiment five.

[0094] exist Figure 6 In the fifth embodiment shown, a reusable seal 240 is provided in the end-side outlet 238. In this embodiment, a cap 60 is provided at the proximal end of the liquid isolation wall 75, and the cap 60 is detachably connected to the proximal end of the liquid isolation wall 75. The function of the cap 60 is the same as that of the seal 240. Specifically, when guidewire insertion is required, the cap 60 is removed from the liquid isolation wall 75; when the guidewire insertion is completed and the drive assembly and working assembly need to be connected for ventricular assist operation, the cap 60 is installed on the liquid isolation wall 75 to prevent leakage of the flushing fluid.

[0095] Please combine Figure 7 , Figure 8 The working component 30 also includes a sensor for collecting operating status information of the working component 30, a first PCB 61 disposed within the coupler 39 and connected to the sensor, and a first connector 62 disposed on the coupler 39 and connected to the first PCB 61. The drive component also includes a second PCB (not shown) disposed within the motor housing 24, and a second connector disposed on the motor housing 24 and connected to the second PCB. The first connector 62 is detachably connected to the second connector.

[0096] The first PCB 61 is connected to the sensor and receives the sensor signal. After processing the signal by noise reduction and amplification, it is transmitted to the second PCB, thereby realizing the transmission of detection information. The data transmitted to the second PCB can be processed, further transmitted to the control module for processing, or processed separately in the second PCB and the control module. Simultaneously, this data (including blood flow and flushing fluid pressure, as described below) can be displayed on a screen connected to the control module. If this data exceeds a set threshold, the control module can control the alarm unit to operate, such as triggering an audible / visual alarm. The connection between the sensor and the first PCB 61 can be wired or wireless.

[0097] The sensor includes a pressure sensor 66 disposed within the flushing chamber 65, and may further include a flow sensor disposed on the conduit and located near the impeller. Those skilled in the art will appreciate that the sensor can also be any other sensor required during the operation of the working component 30, and any solution employing the same or similar methods as this embodiment is covered within the scope of protection of this invention.

[0098] The first connector 62 and the second connector are paired male and female connectors. After they are connected, the first PCB 61 and the second PCB achieve communication connection. The first connector 62 is located on the near end face of the coupler 39, and the second connector is located on the far end face of the motor housing 24. The first connector 62 and the second connector are plugged into each other, and their mating relationship is synchronized with the mating relationship between the coupler 39 and the motor housing. That is, when the coupler 39 is connected to the motor housing 24, the first connector 62 and the second connector are connected simultaneously. When the coupler 39 is separated from the motor housing 24, the first connector 62 and the second connector are separated simultaneously, requiring no additional operation of the first connector 62 and the second connector, making the operation simpler.

[0099] The proximal end face of the coupler 39 and / or the distal end face of the motor housing 24 are provided with at least a flexible element (not shown) located outside the first connector 62. The flexible element is at least partially compressed and deformed when the coupler 39 and the motor housing 24 are connected. The flexible element not only provides a seal for the first connector 62 and / or the second connector to prevent the connector from coming into contact with liquid and short-circuiting, but also reduces the vibration transmitted from the drive assembly 10 to the working assembly 30.

[0100] The first PCB 61 and the second PCB are respectively located in the coupler 39 and the motor housing 24. This not only reduces wiring and simplifies the circuit, making the internal structure of the coupler 39 more compact, but also reduces the computational burden of the second PCB, allowing the reusable drive component 10 to maintain a better condition after multiple uses.

[0101] The first PCB61 and / or the second PCB are equipped with storage units for storing calibration datasets obtained after training. These datasets are embedded into the storage units of the PCBs during product manufacturing. Upon subsequent unpacking and power-on, the datasets can be retrieved to calibrate the sensors, thereby improving the precision of device control.

[0102] The signal detected by the sensor may contain significant noise. A noise reduction module is provided on the first PCB 61 to denoise the original detection signal before providing it to the second PCB. Preferably, the first PCB 61 also includes a signal amplifier to amplify the denoised signal before providing it to the second PCB.

[0103] The first connector 62 is fixed by a positioning element (not shown) disposed on the coupler 39 and approximately perpendicular to the rotation axis of the driven member, and is electrically connected to the first PCB 61 through the positioning element. The positioning element not only serves to fix the connector but also to provide electrical connection. More preferably, the positioning element is a third PCB, which is connected to the first PCB 61 via FPCB 63. By using the third PCB to fix the first connector 62, no additional fixing components are required, allowing for a more compact structure of the working assembly 30.

[0104] The third PCB is connected to the first PCB 61 via FPCB 63. Thus, the working component 30 includes two PCBs and one FPCB 63, which greatly simplifies the circuit structure of the working component 30. Secondly, by using FPCB 63 to connect the two PCBs, the space in the coupler 39 can be fully utilized, making the structure of the working component 30 more compact.

[0105] like Figure 8 As shown, at least a portion of the extended plane of the first PCB 61 is angled relative to the rotation axis of the follower. Simply put, the first PCB 61 is inclined relative to the rotation axis of the follower. Therefore, for the same length, the inclined first PCB 61 reduces its axial length. In other words, with a fixed axial length, the inclined first PCB 61 has a larger surface area, allowing for the placement of more electronic components. Furthermore, the inclined first PCB 61 also reduces the length and bending degree of the FPCB 63, protecting the FPCB 63.

[0106] In another embodiment, at least a portion of the extended plane of the first PCB 61 is substantially parallel to the rotation axis of the follower and close to the inner wall of the coupler 39. Since the first connector 62 is located on the edge of the coupler 39 near the end, and the first PCB 61 is positioned close to the inner wall of the coupler 39, the degree of bending of the FPCB 63 can be reduced to a greater extent.

[0107] The working assembly 30 also includes a flushing bracket 67 disposed within the coupler 39 and located at the distal end of the connecting shaft, with a first PCB 61 disposed on the flushing bracket 67. The flushing bracket 67 includes an axially spaced first support portion 68 and a second support portion 69, the tops of which are coplanar. Preferably, they are coplanar on a plane angled to the rotation axis of the follower 895, and the bottom surface of the first PCB 61 abuts against the tops of the first support portion 68 and the second support portion 69. The first PCB 61 can also be fixedly connected to the first support portion 68 and / or the second support portion 69 by fasteners 70 (e.g., threaded fasteners).

[0108] The flushing bracket 67 defines a flushing chamber 65 that houses the distal end of the connecting shaft. The proximal end of the conduit is connected to the flushing bracket 67 and communicates with the flushing chamber 65. The coupler 39 is provided with a flushing connector 76, the inner end of which communicates with the flushing chamber 65, and the outer end of which communicates with flushing fluid through the flushing conduit. Thus, the flushing pump can pump flushing fluid into the flushing chamber 65 through the flushing connector 76, and the flushing fluid can flow forward through the conduit.

[0109] The flushing connector 76 and the first PCB 61 are located on the same side of the connecting shaft. The first PCB 61 has a through hole 77, through which the flushing connector 76 passes. The flushing connector 76 is positioned by the through hole 77 on the first PCB 61, or in other words, the first PCB 61 is positioned by the flushing connector 76. Moreover, compared to the flushing connector 76 and the first PCB 61 being arranged side by side, using the through hole 77 of the first PCB 61 in conjunction with the flushing connector 76 allows for a more compact structure of the working component 30, which is beneficial for miniaturization.

[0110] The coupler 39 has a through slot in its wall. A light source is mounted on the first PCB 61, and the light source is connected to a light guide strip, which passes through the slot. The light source indicates whether the sensor calibration is complete and emits different colors of light depending on the calibration process. For example, during calibration, the light source emits a flashing red light. After calibration is complete, it emits a continuous green light.

[0111] Because the first connector 62 is located on the proximal end face of the coupler 39 and is exposed, it is easily contaminated by liquids or other foreign matter. For example, in one scenario, during venting, the perfusion fluid flowing from the proximal end of the working assembly 30 may wet the first connector 62. Or, in another scenario, clinically, the working assembly 30 is placed on a blood-stained workbench, and the first connector 62 may become soaked with blood.

[0112] To avoid the above problems, such as Figure 9 and Figure 10 As shown, the coupler 39 has a detachable protective cover 78 that covers the first connector 62 when connected to the coupler 39 to prevent the first connector 62 from contacting the liquid. The protective cover 78 has a through-hole 80, and the proximal portion of the liquid isolation wall 75 extends beyond the coupler 39 and through the through-hole 80. A sealing ring 81 is provided between the through-hole 80 and the liquid isolation wall 75. Figure 12 (As shown). During venting, the perfusion fluid is discharged from the proximal end of the liquid isolation wall 75, and the sealing ring 81 prevents the perfusion fluid from contacting the first connector 62. Of course, the sealing ring 81 can also prevent blood from contacting the first connector 62 in the second scenario described above.

[0113] In the connected state, the protective cover 78 is fitted onto the liquid isolation wall 75 through the second through hole 80 and the sealing ring 81, thereby covering the first connector 62. That is to say, in the connected state, the protective cover 78 is connected to the coupler 39, and the protective cover 78 is not removed until the unpacking and venting are completed and the working component 30 needs to be connected to the drive component.

[0114] Before the device can operate, the sensor needs to be powered on for zero-point drift correction. In this embodiment, the protective cover 78 can be used to power the sensor. Specifically, the protective cover 78 is equipped with a power supply (not shown), which is electrically connected to the sensor's triggerable ground. Figure 8 and Figure 11 As shown, the protective cover 78 is provided with a fourth PCB 82 connected to the power supply and a third connector 83 connected to the fourth PCB 82. The third connector 83 is detachably connected to the first connector 62. Thus, the power supply and the fourth PCB 82 supply power to the first PCB 61 through the third connector 83 and the first connector 62.

[0115] As mentioned earlier, the second connector is detachably connected to the first connector 62. That is, both the second and third connectors 83 are detachably connected to the first connector 62. Therefore, the second and third connectors 83 have identical structures, which reduces molding costs, thereby lowering the overall cost of the device and alleviating the burden on patients.

[0116] The protective cover 78 includes a cover body 84, the distal end of which is recessed towards the proximal end to form a receiving space 85. The distal edge of the cover body 84 matches the shape of the proximal edge of the coupler 39 for connection, thereby allowing the protective cover 78 to be detachably connected to the coupler 39. A through hole 80 is located at the center of the protective cover 78, resulting in a more regular structure. The fourth PCB 82 is received in the receiving space 85, thus protecting the fourth PCB 82. To reduce the volume of the protective cover 78, the fourth PCB 82 is positioned perpendicular to the centerline of the through hole 80. A third connector 83 is fixed to the distal end face of the fourth PCB 82.

[0117] Please see Figure 11 In the first embodiment, one side of the fourth PCB 82 is fitted against the inner wall of the cover 84, while the opposite side is spaced a certain distance from the edge of the through hole 80. The fourth PCB 82 is disposed within the open receiving space 85 formed by the cover 84. That is, the fourth PCB 82 is visible from the far end of the protective cover 78, eliminating the need for additional components to enclose it, resulting in a simpler structure. Due to its simpler structure, more space can be provided for the power supply to the fourth PCB 82, allowing for a larger power supply and ensuring sufficient power for sensor drift correction. In this embodiment, the power supply is axially positioned between the fourth PCB 82 and the through hole 80. Those skilled in the art will understand that the power supply can be installed as needed, and any scheme using the same or similar methods as this embodiment is covered within the scope of protection of this invention.

[0118] In order to better connect the protective cover 78 with the working component 30, the protective cover 78 also includes an insertion part 86 extending axially from the distal end face of the cover body 84. The insertion part 86 is inserted and engaged with the working component 30 to achieve better positioning.

[0119] Please see Figure 12 In the second form, with Figure 11The difference in the illustrated embodiment is that the protective cover 78 also includes an end cap 87 that mates with the cover body 84. The end cap 87 and the cover body 84 mate to form a closed receiving space to house the fourth PCB 82, with the third connector 83 exposed on the distal end face of the end cap 87. This arrangement provides better protection for the fourth PCB 82.

[0120] Please see Figure 13 In the third form, with Figure 11 The difference in the illustrated embodiment is that the fourth PCB 82 extends further, its edge fits against the inner wall of the cover 84, and the fourth PCB 82 and the protective cover 78 form a closed receiving space, in which the electrical components mounted on the fourth PCB 82 are housed. This arrangement results in a neat structure and better protection of the electrical components; furthermore, it eliminates the need for additional components (e.g., Figure 12 The end cap 87) protects the component, thus providing sufficient space to install the power supply for the fourth PCB 82.

[0121] The power supply in the protective cover 78 is a DC power source, specifically a battery, or more specifically, a button cell battery. The sensor drift correction is only required before the working component 30 is put into actual use. To prevent unintended power depletion between the manufacturing process and actual use, a controller is provided between the power supply and the fourth PCB 82, operable to electrically connect or disconnect the power supply from the fourth PCB 82. Thus, when the protective cover 78 is connected, the power supply and the fourth PCB 82 are disconnected, preventing unintended power consumption. Before using the working component 30, connecting the power supply to the fourth PCB 82 via the controller ensures sufficient power for drift correction.

[0122] The controller can be an insulating sheet 88 inserted between the power supply and the fourth PCB 82, and the insulating sheet 88 is configured to be operably removable. That is, with the protective cover 78 connected, the insulating sheet 88 is inserted between the power supply and the fourth PCB 82 to prevent undesirable power consumption. When venting is complete, removing the insulating sheet 88 connects the power supply to the fourth PCB 82, allowing drift correction of the sensors in the working assembly 30. Those skilled in the art will recognize that the controller can also be a switch; any solution using the same or similar methods as this embodiment is covered within the scope of this invention.

[0123] In its packaged state, the protective cover 78 can be housed within a packaging box, which includes two at least partially separable storage sections. An insulating sheet 88 protrudes from the outer end of the protective cover 78 and is connected to one of the storage sections. Upon unpacking, as the packaging box is opened, the insulating sheet 88 moves synchronously with the storage sections, and is simultaneously pulled out, eliminating the need for additional removal of the insulating sheet 88. Furthermore, because the insulating sheet 88 is relatively thin and light, if it were not linked to a storage section of the packaging box, the operator might forget to remove it during operation, resulting in the sensor being used without drift correction. This embodiment connects the insulating sheet 88 to the storage section of the packaging box, automatically removing it when the box is opened, thus avoiding the need to forget to remove the insulating sheet 88.

[0124] The detailed descriptions listed above are merely specific illustrations of feasible embodiments of the present invention and are not intended to limit the scope of protection of the present invention. All equivalent embodiments or modifications made without departing from the spirit of the present invention should be included within the scope of protection of the present invention.

Claims

1. A device for assisting the heart in the event of cardiac failure, comprising: Driver components and working components; The drive assembly includes: a motor housing, a motor housed within the motor housing, and an active component driven by the motor; The working components include: a catheter, a drive shaft passing through the catheter, a follower connected to the proximal end of the drive shaft, a coupler connected to the proximal end and the distal end of the catheter, and a pump head; The coupler is detachably connected to the motor housing; The driven member is coupled to the driving member to transmit the rotational power of the motor to the drive shaft; The pump head includes: a pump housing having an inlet and an outlet, and an impeller housed in the pump housing; the impeller is connected to the distal end of the drive shaft to be driven to rotate and draw blood from the inlet into the pump housing and discharge it from the outlet; The working component further includes: a flushing bracket disposed within the coupler, the flushing bracket including a flushing chamber, a sensor located within the flushing chamber, a first PCB disposed within the coupler and connected to the sensor, and a first connector disposed on the coupler and connected to the first PCB; The drive assembly further includes: a second PCB disposed inside the motor housing, and a second connector disposed on the motor housing and connected to the second PCB; The first connector and the second connector are detachably connected.

2. The apparatus of claim 1, wherein at least a portion of the extended plane of the first PCB is angled to the rotation axis of the follower; or, at least a portion of the extended plane of the first PCB is substantially parallel to the rotation axis of the follower and close to the inner wall of the coupler.

3. The device as described in claim 1, wherein the wall of the coupler is provided with a through slot, the first PCB is provided with a light source, the light source is connected to a light guide strip, and the light guide strip passes through the slot.

4. The apparatus of claim 1, wherein the working component further comprises: A connecting shaft rotatably disposed within the coupler; The flushing bracket is located at the distal end of the connecting shaft; The driven member is mounted on the connecting shaft, the proximal end of the drive shaft is connected to the distal end of the connecting shaft, and the first PCB is mounted on the rinsing bracket.

5. The apparatus of claim 4, wherein the flushing chamber houses the distal end of the connecting shaft within it, the proximal end of the conduit is connected to the flushing support and communicates with the flushing chamber; the coupler is provided with a flushing connector, the inner end of which communicates with the flushing chamber and the outer end of which communicates with the flushing fluid; the sensor includes a pressure sensor disposed within the flushing chamber.

6. The apparatus of claim 5, wherein the flushing connector and the first PCB are located on the same side of the connecting shaft, the first PCB is provided with a through hole, and the flushing connector passes through the through hole.

7. The apparatus of claim 1, wherein the sensor further comprises a flow sensor disposed on the duct and located near the impeller.

8. The device as claimed in claim 1, wherein the first connector is disposed on the proximal end face of the coupler, and the second connector is disposed on the distal end face of the motor housing; the first connector and the second connector are plugged into each other, and the engagement relationship between the two is synchronized with the engagement between the coupler and the motor housing.

9. The apparatus of claim 8, wherein the first connector is fixed by a positioning member disposed on the coupler and substantially perpendicular to the rotation axis of the driven member, and an electrical connection to the first PCB is achieved through the positioning member.

10. The apparatus of claim 9, wherein the positioning element is a third PCB, and the third PCB is connected to the first PCB via an FPCB.

11. The apparatus of claim 8, wherein the proximal end face of the coupler and / or the distal end face of the motor housing are provided with at least a flexible member located outside the first connector, the flexible member being at least partially compressed and deformed when the coupler and the motor housing are in a connected state.

12. The apparatus of claim 1, further comprising a protective cap detachably connected to the coupler, the protective cap covering the first connector when connected to the coupler to prevent the first connector from contacting liquid.

13. The apparatus of claim 12, wherein the protective cover has a through hole, the working component further includes a liquid isolation wall forming a liquid isolation chamber for isolating the flushing fluid from contact with the motor, a portion of the liquid isolation wall extending beyond the coupler, the extended portion passing through the through hole, and a sealing ring being provided between the through hole and the liquid isolation wall.

14. The device of claim 13, wherein the protective cover is provided with a power source, and the power source is electrically connected to the sensor in a triggerable manner.

15. The apparatus of claim 14, wherein the protective cover further comprises a fourth PCB that can be powered by the power supply and a third connector connected to the fourth PCB, the third connector being detachably connected to the first connector; and a controller is provided between the power supply and the fourth PCB, operable to electrically connect or disconnect the power supply from the fourth PCB.

16. The apparatus of claim 15, wherein the controller is an insulating sheet inserted between the power supply and the fourth PCB, the insulating sheet being configured to be operably removable.

17. The device of claim 16, wherein the protective cover may be housed in a package comprising two at least partially separable storage portions, the insulating sheet protruding from the outer end of the protective cover and connected to one of the storage portions.

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