Device for assisting a heart in case of functional failure

Abstract

The application discloses a device for assisting heart when functional failure occurs, comprising a driving assembly and a working assembly detachably connected with the driving assembly. The driving assembly comprises a motor and a driving magnet driven by the motor. The working assembly comprises a connecting shaft, a passive magnet arranged at the proximal end of the connecting shaft and coupled with the driving magnet, a driving shaft connected to the distal end of the connecting shaft and a pump. The pump is used for pumping blood to the desired position of the heart. The pump comprises a pump shell with an inlet end and an outlet end and an impeller accommodated in the pump shell. The impeller is connected to the distal end of the driving shaft and is driven to rotate to suck blood into the pump shell from the inlet end and discharge the blood from the outlet end. The driving magnet and the passive magnet have synchronous rotation in a first matching state and a second matching state in which the rotation speed of the passive magnet is lower than that of the driving magnet. Before the rotation speed of the motor is reduced to a certain threshold value, the driving magnet and the passive magnet can only be switched from the first matching state to the second matching state.

Description

Technical Field

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

[0002] Heart failure is a life-threatening condition with a one-year mortality rate of approximately 75% once it progresses to an advanced stage. Given the limited availability of heart donors for advanced heart failure, ventricular assist devices (VADs) have become a viable treatment or alternative between transplantation and successful treatment. However, adverse events associated with current technology still limit the use of VADs in critically ill patients.

[0003] Existing ventricular assist devices suffer from problems such as low transmission efficiency, and continuously improving the safety of ventricular assist devices has always been a technical problem that those skilled in the art are committed to improving. Summary of the Invention

[0004] The purpose of this invention is to provide a device for assisting the heart in the event of functional failure, which can significantly improve the performance of the device.

[0005] The objective of this invention is achieved through the following technical solution:

[0006] An apparatus for assisting cardiac function during heart failure includes: a drive assembly and a working assembly detachably connected to the drive assembly. The drive assembly includes a motor and an active magnet driven by the motor. The working assembly includes: a connecting shaft, a passive magnet disposed at a proximal end of the connecting shaft and coupled to the active magnet, a drive shaft connected to a distal end of the connecting shaft, and a pump. The pump is used to pump blood to a desired location on the heart. The pump includes: a pump housing having an inlet end and an outlet end, and an impeller housed within the pump housing. The impeller is connected to the distal end of the drive shaft and is driven to rotate to draw blood from the inlet end into the pump housing and discharge it from the outlet end.

[0007] The active magnet and the passive magnet have a first engagement state in which they rotate synchronously, and a second engagement state in which the passive magnet rotates at a lower speed than the active magnet. The active magnet and the passive magnet can only switch from the first engagement state to the second engagement state before the motor speed decreases to a specific threshold.

[0008] When the resistance of the working component is less than or equal to the rated torque between the active and passive magnets, the passive and active magnets are in the first engagement state. When the resistance of the working component is greater than the rated torque between the active and passive magnets, the passive magnet is in the second engagement state.

[0009] Compared with the prior art, the present invention has the following beneficial effects: the device of the present invention can significantly improve the performance of the device and enhance its safety. Attached Figure Description

[0010] Figure 1 and Figure 2 These are three-dimensional schematic diagrams of the device provided by the present invention from different angles;

[0011] Figure 3 yes Figure 1 A three-dimensional schematic diagram of the device showing the drive components and working components separated;

[0012] Figure 4 yes Figure 1 A cross-sectional view of the device shown along the axial direction;

[0013] Figure 5 yes Figure 1 A partial three-dimensional exploded view of the device shown;

[0014] Figure 6 yes Figure 1 The diagram shows a cross-sectional view of the device along a plane perpendicular to the axial direction.

[0015] Figure 7 yes Figure 1 A cross-sectional view of a portion of the drive assembly of the device shown along the axial direction.

[0016] Figure 8 yes Figure 1 A cross-sectional view of a portion of the working components of the device shown along the axial direction on another plane;

[0017] Figure 9 and Figure 10 yes Figure 1 A partial sectional view of the proximal end of the working component of the device shown. Figure 9 In the middle, the seal closes the end face opening near the end; in Figure 10 In the middle, the sealing element connects the first guide channel to the outside.

[0018] Figure 11 A schematic diagram of the locking mechanism provided in another embodiment of the present invention is shown;

[0019] Figure 12 and 13 A schematic diagram of the locking mechanism provided in another embodiment of the present invention is shown;

[0020] Figure 14 A schematic diagram of the locking mechanism provided in another embodiment of the present invention is shown. Detailed Implementation

[0021] The present invention will now be described in detail with reference to the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present invention, and any structural, methodological, or functional modifications made by those skilled in the art based on these embodiments are included within the scope of protection of the present invention.

[0022] As used in this invention, the terms "proximal," "posterior," "distal," and "anterior" are relative to the clinician operating the device (hereinafter referred to as the device) used to assist the heart in the event of cardiac failure. The terms "proximal" and "posterior" refer to portions relatively close to the clinician, while "distal" and "anterior" refer to portions relatively far from the clinician. For example, the drive assembly may be located at the proximal and posterior ends, while the working assembly may be located at the distal and anterior ends; further, the proximal end of a component / assembly may refer to the end relatively close to the drive assembly, while the distal end may refer to the end relatively close to the working assembly.

[0023] The device of this invention defines "axial direction" or "axial extension direction" by the extension direction of the motor shaft or connecting shaft and drive shaft. The drive shaft is a flexible shaft, and the axial direction of the drive shaft refers to the axial direction when the drive shaft is adjusted to extend in a straight line. The terms "inner" and "outer" used in this invention are relative to the center line of axial extension; the direction relative to the center line is "inner," and the direction relative to the direction away from the center line is "outer."

[0024] It is important to understand that terms such as "near," "far," "back," "front," "inner," and "outer" are definitions used for ease of description. However, the device can be used in many directions and positions; therefore, these terms expressing relative positional relationships are not limited or absolute. For example, the above definitions of directions are merely for the convenience of illustrating the technical solution of this invention and do not limit the orientation of the auxiliary device of this invention in scenarios that may lead to its inversion or change of position, including but not limited to product testing, transportation, and manufacturing. In this invention, if the above definitions are otherwise explicitly specified and limited, they shall be followed.

[0025] In this invention, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, a movable connection, or an integral part; they can be a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0026] Please see Figures 1 to 3The device 100 of this embodiment can partially replace the heart's pumping function, thereby at least partially reducing the burden on the heart. The term "replacement" can indicate that the heart has experienced some degree of functional failure or decline, but still retains a certain pumping function, although this function is weak and insufficient to maintain the cardiac output required for normal survival.

[0027] In one illustrative scenario, the device 100 can be used as a left ventricular assist, and its working part (specifically the pump mentioned below) can be inserted into the left ventricle. When the pump is running, it can pump blood from the left ventricle into the ascending aorta.

[0028] It is worth noting that the above example of the device 100 being used as a left ventricular assist is only one feasible application scenario for the device 100. In other feasible and not definitively excluded scenarios, the device 100 can also be used as a right ventricular assist, with the working part being inserted into the right ventricle, and the pump pumping blood from the vein into the right and left ventricles when it is running.

[0029] Alternatively, the device 100 can also be used to pump blood from the vena cava and / or right atrium into the right ventricle, from the vena cava and / or right atrium into the pulmonary artery and / or from the renal vein into the vena cava, and can also be configured to be placed in the subclavian vein or jugular vein at the junction of the vein and lymphatic duct, and to increase the flow of lymphatic fluid from the lymphatic vessels to the vein.

[0030] The following description will primarily focus on the use of this device 100 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.

[0031] The device 100 includes a drive assembly 10 and a working assembly 30. The drive assembly 10 includes a motor housing 12 and a motor 14 housed within the motor housing 12 and having a motor shaft 16. The working assembly 30 includes a conduit 32, a drive shaft 34 passing through the conduit 32, and a pump 36 driven by the drive shaft 34. The drive assembly 10 provides power to the working assembly 30 to drive the working assembly 30 to perform the blood pumping function, that is, the pump is used to pump blood to the desired location in the heart.

[0032] When the device 100 is in use, the pump 36 and a portion of the catheter 32 (specifically the tip portion of the catheter 32) are inserted into and held in the subject's body. It is desirable that the size of the pump 36 and the catheter 32 be as small as possible. Therefore, the axial projected area of ​​the pump 36 and the catheter 32 is smaller than the axial projected area of ​​other components of the working assembly 30, and also smaller than the axial projected area of ​​the drive assembly 10.

[0033] Therefore, the smaller pump 36 and catheter 32 can be inserted into the human body through a smaller interventional size, reducing the pain caused to the subject during the interventional process and reducing complications caused by excessive interventional size.

[0034] Other parts of the working assembly 30 can have relatively large dimensions to meet the needs of the structural design. The relatively large size of the drive assembly 10 can meet the needs of the structural design and provide sufficient power to the drive shaft 34 and the pump 36 to meet their power requirements.

[0035] The drive assembly 10 is detachably connected to the working assembly 30. Thus, when preparing to insert the pump 36 and the tip of the catheter 32 into the subject's body, the drive assembly 10 can be detached from the working assembly 30, avoiding the large and heavy drive assembly 10 from affecting the operation of inserting the pump 36 and the tip of the catheter 32 into the subject's body, making the operation easier.

[0036] Please pay close attention. Figure 4 and Figure 5 The drive component 10 drives the working component 30 via magnetic coupling, specifically:

[0037] The drive assembly 10 includes a connector, and the working assembly 30 includes a coupler. The connector includes a motor end bushing 20 connected to the motor housing 12 and an active magnet 22 housed inside the motor end bushing 20 and connected to the motor shaft 16. The coupler includes an intervention end bushing 40 located near the working assembly 30 and a passive magnet 42 housed inside the intervention end bushing 40 and connected to the proximal end of the drive shaft 34.

[0038] The drive assembly 10 includes a motor shaft 16 and an active magnet 22 connected to the motor shaft 16. The drive assembly 30 includes a passive magnet 42, a connecting shaft 44 on which the passive magnet 42 is mounted, a drive shaft 34 connected to the distal end of the connecting shaft 44, and a pump 36 connected to the distal end of the drive shaft 34.

[0039] like Figures 1 to 3 As shown, a protective head 38 is provided at the distal end of the pump 36. This protective head is configured to be flexible, thus avoiding damage to the subject's tissues. The protective head 38 can be made of any material exhibiting macroscopic flexibility. Specifically, the protective head 38 is a flexible protrusion (pigtail or tipmember) with a rounded or coiled end. This flexible end is supported on the ventricular wall in a non-invasive or non-damaging manner, separating the pump 36's suction inlet from the ventricular wall. This prevents the pump 36's suction inlet from adhering to the ventricular wall due to the reaction force of the fluid (blood) during operation, ensuring the effective suction area.

[0040] When the device 100 is in operation, the distal end of the drive shaft 34 is inserted into the subject's body along with the conduit 32. The drive shaft 34 is a flexible shaft that can be deformed to the naked eye. The passive magnet 42 is installed at the proximal end of the connecting shaft 44. The connecting shaft 44 is a rigid shaft that cannot be deformed to the naked eye, which makes the installation of the active magnet more stable.

[0041] When the device 100 is working, the motor shaft 16 drives the active magnet 22 to rotate. The passive magnet 42 is magnetically coupled to the active magnet 22. The passive magnet 42 is driven to rotate by the active magnet 22. The rotation of the passive magnet 42 sequentially drives the connecting shaft 44 and the drive shaft 34 to rotate. The rotation of the drive shaft 34 drives the pump 36 to realize the blood pumping function.

[0042] The active magnet 22 and the passive magnet 42 have a first engagement state of synchronous rotation and a second engagement state in which the rotational speed of the passive magnet 42 is lower than that of the active magnet 22. In the first engagement state, as the motor 14 starts and its speed increases from zero to the set speed, the rotational speed of the passive magnet 42 increases synchronously with the rotational speed of the motor 14. After the motor 14 reaches the set speed, the rotational speed of the passive magnet 42 remains essentially at the set speed. That is to say, in the first engagement state, the rotational speed of the passive magnet 42 initially increases dynamically with the rotational speed of the motor 14. After reaching a specific value, it essentially maintains that specific value. However, regardless of whether the rotational speed of the passive magnet 42 increases dynamically or remains at a specific static value, the rotational speed of the passive magnet 42 is essentially the same as that of the active magnet 22, thereby maximizing the transmission efficiency.

[0043] The first working state is the state in which the device 100 is in normal use. However, during use, especially when the working component 30 is inserted into the human body and during operation, the device 100 may encounter resistance. Normally, the resistance encountered by the working component 30 originates from the contact between its constituent parts and adjacent parts. For example, the contact between the drive shaft 34 and the catheter 32, the contact between the impeller and the pump housing 363 (especially the support 3631), and so on. In some particularly undesirable scenarios, the aforementioned resistance may also include the contact between the working component 30 and human tissue. For example, damage to the membrane 3632 or the catheter 32 may cause contact between the impeller and the ventricular wall, or between the drive shaft 34 and the vascular wall. In this case, if the passive magnet 42 continues to rotate at a high speed, the high-speed rotation of the impeller driven by the passive magnet 42 may exacerbate wear between components or cause damage to human tissue.

[0044] Therefore, when the aforementioned event occurs, the active magnet 22 and the passive magnet 42 will automatically switch to a second engagement state. In the second engagement state, the rotational speed of the passive magnet 42 is lower than that of the active magnet 22, which can reduce or even avoid wear caused by high-speed friction between components, and / or prevent the device 100 from causing damage to human tissue.

[0045] If the resistance encountered by the working component 30 is less than the rated torque between the active magnet 22 and the passive magnet 42 (that is, the maximum torque that the active magnet 22 and the passive magnet 42 can transmit due to magnetic coupling), the passive magnet 42 and the active magnet 22 are in a first-coupling state of synchronous rotation. In other words, when the resistance is small, it is most likely due to normal friction of related components, such as friction between the drive shaft 43 and the inner wall of the conduit 32, the rotational friction of the bearing supporting the connecting shaft 44, the bearing supporting the impeller, etc., and is unlikely to be caused by contact between the drive shaft 43 and / or the impeller and human tissue due to exposure. At this time, the active magnet 22 and the passive magnet 42 are in the first-coupling state, maintaining normal blood pumping operation.

[0046] When the resistance of the working component 30 exceeds the rated torque between the active magnet 22 and the passive magnet 42, the active magnet 22 and the passive magnet 42 switch from the first engagement state to the second engagement state and remain in the second engagement state. That is, when encountering significant resistance, it is highly likely that at least one of the following events will occur: jamming between the drive shaft 43 and the inner wall of the conduit 32, jamming of the bearing supporting the connecting shaft 44, or jamming of the bearing supporting the impeller; and / or, contact between the rotating components such as the drive shaft 43 and / or the impeller and human tissue. At this time, switching to the second engagement state reduces the rotational speed of the passive magnet 42, which can quickly reduce the rotational speed of the impeller, thereby preventing accelerated wear of components and damage to human tissue by the drive shaft 43 and / or the impeller.

[0047] After the active magnet 22 and the passive magnet 42 switch from the first engagement state to the second engagement state, the rotational speed of the passive magnet 42 does not increase with the decrease or disappearance of resistance, but decreases to a specific value and then remains essentially at that specific value. Preferably, the specific value is at least 50% lower than the rated rotational speed of the active magnet 22 driven by the motor 14. The rated rotational speed of the active magnet 22 is the rotational speed at which the motor 14 drives it to rotate at its rated power.

[0048] It is worth noting that the above values ​​include all lower and upper values ​​that increase by any one unit from the lower limit to the upper limit, provided that there is at least a two-unit interval between any lower value and any higher value.

[0049] For example, a specific value is at least 50% lower than the rated rotational speed of the active magnet 22 due to being driven by the motor 14, preferably 5% to 45°, more preferably 10% to 40%, further preferably 15% to 35%, and even more preferably 20% to 30%, for the purpose of illustrating values ​​such as 6%, 8%, 12%, 16%, 18%, 22%, 24%, 28%, 32%, 36%, 39%, 41%, 43%, 46%, 49%, etc., which are not explicitly listed above.

[0050] As mentioned above, the example ranges with 5% increments do not preclude increases with appropriate increments such as 1%, 2%, 3%, 4%, 6%, 7%, 8%, 9%, 10%, etc. These are merely examples intended to be explicit, and it can be assumed that all possible combinations of values ​​listed between the minimum and maximum values ​​are explicitly described in this specification in a similar manner.

[0051] Unless otherwise stated, all ranges include the endpoints and all numbers between them. The terms "approximately" or "about" used with ranges apply to both endpoints of the range. Thus, "approximately 20 to 30" is intended to cover "approximately 20 to approximately 30," including at least the specified endpoints.

[0052] Other limitations on numerical ranges mentioned in this article can be found in the above description and will not be repeated here.

[0053] After the active magnet 22 and the passive magnet 42 switch to the second engagement state, the passive magnet 42 remains at a specific value, and the impeller rotates at this lower specific value. This rotation speed will not cause increased wear of components or abrasion of human tissue. At the same time, the impeller also maintains a certain rotation and blood pumping function, which can prevent the blood flow from slowing down due to the impeller stopping work. This minimizes the risk of blood clots forming on the outer wall of the parts of the working component 30 that are inserted into the human body, such as the pump and the catheter 32, and minimizes the harm to the human body caused by the pump stopping, thereby improving the safety of the device 100.

[0054] In this embodiment, the active magnet 22 and the passive magnet 42 can only switch from the first engagement state to the second engagement state before the rotational speed of the motor 14 decreases to a specific threshold. That is, the rotational speed of the passive magnet 42 cannot increase before the rotational speed of the motor 14 decreases to the specific threshold, thus preventing accidents.

[0055] Furthermore, when the active magnet 22 and the passive magnet 42 are in the second engagement state, they can only switch to the first engagement state when the speed of the motor 14 decreases to below a certain threshold. When the speed of the motor 14 decreases to below the certain threshold, the passive magnet 42 rotates synchronously with the active magnet 22 again, restoring the original normal working state.

[0056] The specific threshold is less than the rotational speed of motor 14 required by device 100 to achieve a specific blood flow rate. For example, if device 100 actually or expects to provide a blood flow rate of 5 L / min, the rotational speed supporting this flow rate is 20,000 to 30,000 rpm. The specific threshold can be 5,000 rpm, or any value below 5,000 rpm, including 0.

[0057] In one scenario, when the speed of motor 14 decreases to approximately the same level as the speed of passive magnet 42 (with the speed difference fluctuating within 20%), active magnet 22 and passive magnet 42 can switch from the second engagement state to the first engagement state. At this time, the speeds of motor 14 and passive magnet 42 are roughly equal, and active magnet 22 and passive magnet 42 can couple again. Active magnet 22 drives passive magnet 42 to rotate synchronously and gradually increase its speed to the rated operating state. In this case, the restart of passive magnet 42 (impeller) can be achieved without waiting for motor 14 to shut down and restart.

[0058] In another scenario, the rotational speed of motor 14 drops to zero, and the rotational speed of passive magnet 42 also drops to zero. At this point, passive magnet 42 recouples with active magnet 22, restarting motor 14. Active magnet 22 can then drive passive magnet 42 to rotate synchronously, and the two switch to the first engagement state. In this case, the restart process of motor 14 serves as a reminder to the user of device 100 to rule out unexpected situations, thus enhancing safety.

[0059] It should be noted that after motor 14 restarts, the active magnet 22 and passive magnet 42 return to the first engagement state. During the gradual increase in speed of the passive magnet 42 (impeller), if the working component 30 encounters significant resistance again, the active magnet 22 and passive magnet 42 will switch from the first engagement state to the second engagement state. Similarly, before the speed of motor 14 decreases to a specific threshold, the active magnet 22 and passive magnet 42 can only switch from the first engagement state to the second engagement state, which will not be elaborated further.

[0060] As previously described, the drive assembly 10 is detachably connected to the working assembly 30. The drive assembly 10 includes a connector, and the working assembly 30 includes a coupler. For ease of description, the combination of the connector and the coupler is referred to as the connection assembly. The connection assembly is configured such that, when the corresponding connector and coupler are not connected, the motor end bushing 20 is separated from the intervention end bushing 40; and, when the corresponding connector and coupler are connected, the motor end bushing 20 and the intervention end bushing 40 are connected, and the active magnet 22 and the passive magnet 42 at least partially overlap along the axial projection of the drive shaft 34, and the active magnet 22 and the passive magnet 42 are spaced apart along the axial direction.

[0061] Since the active magnet 22 and the passive magnet 42 at least partially overlap along the axial projection of the drive shaft 34, the active magnet 22 can drive the passive magnet 42 more efficiently, improving transmission efficiency. Furthermore, the axial spacing between the active magnet 22 and the passive magnet 42 allows for non-contact power transmission through magnetic coupling between the two magnets, which is beneficial for sealing the fluid and preventing liquid from entering the motor.

[0062] The liquid referred to above is the purge fluid that needs to be injected into the human body during the operation of device 100. The purge fluid is a physiological fluid that can partially maintain the human body's functions, such as physiological saline, glucose solution, anticoagulant, or any combination of the above.

[0063] The connection component is further configured such that the magnetic coupling force between the active magnet 22 and the passive magnet 42 when the corresponding connector and coupler are not connected is less than the magnetic coupling force between the active magnet 22 and the passive magnet 42 when the corresponding connector and coupler are connected.

[0064] Therefore, when the connector and coupler are not connected, the drive assembly 10 and the working assembly 30 are also not connected. The magnetic coupling force between the active magnet 22 and the passive magnet 42 is small, and the drive assembly 10 is insufficient to drive the working assembly 30, thus avoiding misoperation. When the connector and coupler are connected, the drive assembly 10 and the working assembly 30 are connected. The magnetic coupling force between the active magnet 22 and the passive magnet 42 is large enough, and the drive assembly 10 can smoothly drive the working assembly 30.

[0065] Preferably, when the connector and coupler are not connected, the magnetic coupling force between the active magnet 22 and the passive magnet 42 is configured to be insufficient to transmit the rotational power of the motor 14 to the drive shaft 34; or, the magnetic coupling force is insufficient to overcome the rotational resistance of the drive shaft 34; or, the magnetic coupling force is 0. Therefore, when the connector and coupler are not connected, the drive assembly 10 cannot drive the working assembly 30, avoiding misoperation.

[0066] Preferably, when the connector and coupler are not connected, the active magnet 22 and the passive magnet 42 have at least a zero axial projection overlap. That is, when the connector and coupler are not connected, the active magnet 22 and the passive magnet 42 are completely misaligned, the drive component 10 is far from the working component 30, and the conduit 32 and pump 36 of the working component 30 can be easily delivered into the subject's body; and the active magnet 22 cannot drive the passive magnet 42, and the drive component 10 cannot drive the working component 30, thus avoiding misoperation.

[0067] In some embodiments, the active magnet 22 and the passive magnet 42 have approximately the same cross-sectional shape perpendicular to the axial direction. For example, the active magnet 22 and the passive magnet 42 can be cylindrical or conical. In this way, the cross-sectional shape of both the active magnet 22 and the passive magnet 42 is circular.

[0068] Essentially, having identical shapes for the surfaces (i.e., magnetized surfaces) of the two magnets facing each other is advantageous for achieving better magnetic coupling. Therefore, in some embodiments, the overall shapes of the active magnet 22 and the passive magnet 42 may differ, but it is feasible for their magnetized surfaces to be identical. For example, one magnet may be cylindrical and the other conical.

[0069] Furthermore, the axial alignment of the two magnets affects the coupling efficiency, as well as the axial positional stability of the magnets during transmission after coupling and the potential vibrations that may occur. Therefore, it is desirable for the two magnets to be perfectly aligned axially.

[0070] Taking into account factors such as magnet manufacturing precision and assembly tolerances, it is acceptable for the two magnets to be within a predetermined range in the axial direction. For example, along the axial direction, the offset of the projection of the center of mass of the passive magnet 42 relative to the center of mass of the active magnet 22 does not exceed 20%, or the overlap of the projections of the active magnet 22 and the passive magnet 42 along the axial direction is greater than or equal to 80%; more preferably, the active magnet 22 and the passive magnet 42 are perfectly aligned along the axial direction.

[0071] Taking a cylindrical or conical magnet as an example, the center of mass of the magnet can be its center. The offset between the centers of mass of the two magnets can be a radial offset relative to the axis of the connecting shaft. The total offset can then be the ratio of the difference between their offsets to the offset of any one magnet. As shown above, magnetic coupling and power transmission can be achieved when the offset is less than 20%. Furthermore, the offset can be less than 15%, 10%, 5%, or even 1%. When the offset is 0, the two magnets are perfectly aligned axially.

[0072] The coincidence degree of the axial projections of two magnets can be defined as the ratio of the area of ​​the overlapping axial projections of the two magnets to the area of ​​the axial projection of any one magnet. Similarly, this coincidence degree is greater than or equal to 80%, and further, greater than 85%, 90%, 95%, or even 100%.

[0073] Therefore, when the connector and coupler are connected, the active magnet 22 can drive the passive magnet 42 more efficiently, resulting in higher transmission efficiency. The drive component 10 can drive the working component 30 more efficiently, enabling the working component 30 to better perform its function of providing auxiliary blood pumping for the subject's heart.

[0074] Preferably, the active magnet 22 and the passive magnet 42 are continuous annular magnets along the circumferential direction, or the active magnet 22 and the passive magnet 42 include a plurality of magnets spaced apart along the circumferential direction.

[0075] When the device 100 is working, the motor shaft 16 rotates to drive the active magnet 22 to rotate, and the active magnet 22 rotates to drive the passive magnet 42 to rotate. The active magnet 22 and the passive magnet 42 are annular magnets, or include multiple magnets arranged at intervals along the circumference. The active magnet 22 and the passive magnet 42 remain annular during rotation. Thus, the rotational power of the motor 14 can be continuously and stably transmitted to the working component 30, and the working component 30 can stably and reliably realize the blood pumping function.

[0076] A passive magnet 42 is externally provided with a passive magnet protection component 46. This protection component 46 protects the passive magnet 42 from mechanical or chemical damage and, more importantly, directs the magnetic force of the passive magnet 42, constrains its magnetic field range, and prevents undesirable diffusion of the magnetic force, thus ensuring the reliable operation of the passive magnet 42. Specifically, the passive magnet protection component 46 includes a first protective layer that at least partially covers the outer surface of the passive magnet 42. The first protective layer is configured to at least isolate the passive magnet 42 from contact with a liquid. This liquid is the purge fluid mentioned above. The first protective layer's isolation of the liquid from the passive magnet 42 prevents liquid corrosion of the passive magnet 42, avoids liquid erosion leading to magnetic weakening, and extends the lifespan of the magnet 42 in providing magnetic force as much as possible.

[0077] In one embodiment of the invention, the first protective layer may be a waterproof coating. The waterproof coating can be thin and effectively prevent liquid from contacting the passive magnet 42. The first protective layer constructed with the waterproof coating has advantages such as thinness, light weight, ease of forming, and high bonding strength, which will beneficially promote coupling efficiency, assembly, manufacturing costs, and service life.

[0078] For example, the thinness reduces the space required for the rear end face of the passive magnet 42, thereby shortening the axial distance between the passive magnet 42 and the active magnet. This is extremely beneficial for the coupling efficiency between the two magnets and for ensuring the transmission of rotational power.

[0079] The thinness and light weight also reduce the size and weight of the magnet, which is beneficial for reducing the weight of the working components and making it highly adaptable to assembly space. Meanwhile, the waterproof coating can be achieved using existing mature methods such as spraying, vapor deposition, and PVD, which have lower requirements for manufacturing processes and can reduce manufacturing costs accordingly. High bonding strength significantly improves the anti-peeling performance of the waterproof coating, continuously providing waterproof protection for the magnet 42 and extending its lifespan.

[0080] In another embodiment of the present invention, the first protective layer may be a mechanical structure that wraps around or covers the passive magnet 42, forming a first receiving cavity in which the passive magnet 42 is housed. Similar to the above-described waterproof coating embodiment, the first receiving cavity can reliably protect the passive magnet 42 and reliably isolate it from liquid corrosion.

[0081] See Figure 4 and Figure 5 As shown, the passive magnet 42 is located at the near end of the connecting shaft 44. Specifically, the connecting shaft 44 has a variable diameter structure, with a larger diameter at its near end, forming a mounting portion 441, on which the passive magnet 42 is fitted.

[0082] The first protective layer includes a first proximal end protector 451 covering the proximal end face of the passive magnet 42, a first distal end protector 452 sleeved on the connecting shaft 44 and covering the distal end face of the passive magnet 42, and a first circumferential end protector 453 connected between the first proximal end protector 451 and the first distal end protector 452 and covering the circumferential surface of the passive magnet 42. The first proximal end protector 451, the first distal end protector 452, the first circumferential end protector 453, and the connecting shaft 44 together define the first receiving cavity.

[0083] The first proximal end protector 451 is in the form of a thin plate or sheet, and is fitted to the proximal end face of the passive magnet 41 and connected to the proximal end of the connecting shaft 44. This connection is preferably a fixed connection. Optionally, the first proximal end protector 451 is integrally constructed with the connecting shaft 44. That is, the first proximal end protector 451 is formed by extending radially outward from the proximal end of the connecting shaft 44.

[0084] The first proximal protective element 451 of this structure can fix and limit the passive magnet 42. Specifically, based on the coupling principle of the active and passive magnets 22 and 42, the two magnets tend to move towards each other under the action of magnetic force. Therefore, by using the method of fixing the first proximal protective element 451 to the proximal end of the connecting shaft 44, the first proximal protective element 451 can stop or restrict the passive magnet 42 from moving to the proximal end, thus maintaining the fixed position of the passive magnet 42.

[0085] Similarly, the first distal protective element 452 is in the form of a thin ring or sheet, and is sleeved on the outside of the connecting shaft 44. In this way, the proximal and distal protective elements 451 and 452 can clamp the passive magnet 42 axially from the front and rear, keeping the position of the passive magnet 42 fixed.

[0086] As described above, the connecting shaft 44 adopts a variable diameter structure, thus forming a step at the distal end of the mounting portion 441. The first distal protective member 452 can abut against the step, which can limit the first distal protective member 452 and ensure its axial position is fixed.

[0087] The shape of the first peripheral protective component 453 is adapted to the outer peripheral surface of the passive magnet 42. For example, it is in the form of a hollow cylinder, a conical thin plate or a thin sheet, and is attached to the outer peripheral surface of the passive magnet 42. The front and rear ends are connected to the near and far protective components 451 and 452, respectively.

[0088] Sealing treatment is provided at the connection between the first peripheral protective member 453 and the near and far protective members 451 and 452, as well as at the connection between the near and far protective members 451 and 452 and the connecting shaft 44, to prevent liquid leakage at the joints.

[0089] Whether the first protective layer is configured as a waterproof coating or as a first protective layer for receiving a cavity, preferably, the first protective layer is non-magnetic and configured to rotate together with the passive magnet 42. That is, the first protective layer and the passive magnet 42 are fixedly disposed and remain relatively stationary.

[0090] The non-magnetic first protective layer can prevent the passive magnet 42 from attracting impurities and affecting its normal operation. Furthermore, it can also directionally constrain the magnetic force of the passive magnet 42, preventing undesirable diffusion of its magnetic force. This improves magnetic coupling force and efficiency, and prevents the passive magnet 42 from magnetizing other components of the working assembly 30, thus avoiding unnecessary problems. For example, it prevents other components of the working assembly 30 from being magnetized and attracting impurities, which could affect the normal operation of the working assembly 30.

[0091] The passive magnet protection assembly 46 also includes a second protective layer disposed within the intervention end bushing 40 and physically spaced from the passive magnet 42; the second protective layer is configured not to rotate with the passive magnet 42.

[0092] Specifically, the second protective layer is radially disposed around the passive magnet 42 and fixed to the inner cavity of the insertion bushing 40, with the second protective layer spaced apart from the passive magnet 42. Since the passive magnet 42 is rotatable while the second protective layer is fixed, during the rotation of the magnetic passive magnet 42, the second protective layer, being fixed relative to it, undergoes relative movement. If the second protective layer is made of a conductive material, eddy currents may be generated within it.

[0093] Therefore, configuring the second protective layer as non-conductive can prevent the generation of eddy currents within it, ensuring that the equipment casing is not electrified and avoiding the risk of electric shock. Furthermore, configuring the second protective layer as non-magnetic allows for the directional confinement of magnetic forces, as described above and will not be repeated here.

[0094] To further constrain the magnetic force of the passive magnet 42 toward the active magnet 22, a first magnetic constraint member is provided within the insertion end bushing 40. The first magnetic constraint member is generally disc-shaped, mounted on the connecting shaft 44, and located at the distal end of the passive magnet 42. In other words, the first magnetic constraint member is located at the distal end of the connecting shaft 44, and the passive magnet 42 is fixed to the proximal end face of the first magnetic constraint member. The first magnetic constraint member is magnetically conductive. The first magnetic constraint member can constrain the magnetic field lines of the passive magnet 42 to the proximal end face of the first magnetic constraint member, preventing the magnetic force of the passive magnet 42 from spreading forward, i.e., away from the active magnet 22.

[0095] Similarly, an active magnet protection component 24 is also provided outside the active magnet 22. On the one hand, the active magnet 22 can protect it from mechanical or chemical damage. On the other hand, it can provide orientation for the magnetic force of the active magnet 22, constrain its magnetic field range, prevent the magnetic force from spreading undesirably, and enable the active magnet 22 to work reliably.

[0096] Specifically, the active magnet protection assembly 24 includes a third protective layer that at least partially covers the outer surface of the active magnet 22. The third protective layer may be a mechanical structure that encloses or covers the active magnet 22, forming a second receiving cavity that houses the active magnet 22 therein. The second receiving cavity can reliably protect the active magnet 22.

[0097] See Figure 4 and Figure 5 As shown, the active magnet 22 is located at the far end of the motor shaft 16. Specifically, a magnet fixing block 26 is formed or mounted on the motor shaft 16, and the active magnet 22 is sleeved on the magnet fixing block 26.

[0098] The third protective layer includes a second distal protective member 251 covering the distal end face of the active magnet 22, a second proximal protective member 252 sleeved on the magnet fixing block 26 and covering the proximal end face of the active magnet 22, and a second circumferential protective member 253 connected between the second distal protective member 251 and the second proximal protective member 252 and covering the circumferential surface of the active magnet 22. The second distal protective member 251, the second proximal protective member 252, the second circumferential protective member 253, and the magnet fixing block 26 together define the second receiving cavity.

[0099] The second distal protective member 251 is in the form of a thin plate or sheet, and is attached to the distal end face of the active magnet 22 and connected to the distal end of the magnet fixing block 26. This connection is preferably a fixed connection. Optionally, the second distal protective member 251 is integrally constructed with the magnet fixing block 26. That is, the second distal protective member 251 is formed by extending radially outward from the distal end of the magnet fixing block 26.

[0100] The second distal protective element 251 of this structure can fix and limit the active magnet 22. Specifically, based on the coupling principle of the active and passive magnets, the two magnets tend to move towards each other under the action of magnetic force. Therefore, by fixing the second distal protective element 251 to the distal end of the connecting shaft 44, the second distal protective element 251 stops or restricts the tendency of the active magnet 22 to move to the distal end, thus maintaining the fixed position of the active magnet 22.

[0101] Similarly, the second proximal protective member 252 is in the form of a thin ring or sheet, and is fitted over the magnet fixing block 26. In this way, the distal and proximal protective members 251 and 252 can respectively clamp the active magnet 22 axially from the front and rear, keeping the position of the active magnet 22 fixed.

[0102] The shape of the second peripheral protective component 253 is adapted to the outer peripheral surface of the active magnet 22. For example, it is in the form of a hollow cylinder, a conical thin plate or a thin sheet, and is attached to the outer peripheral surface of the active magnet 22. The front and rear ends are connected to the far and near end protective components 251 and 252, respectively.

[0103] Sealing treatment is provided at the connection between the second peripheral protective member 253 and the far and near end protective members 251 and 252, as well as at the connection between the far and near end protective members 251 and 252 and the magnet fixing block 26, to prevent liquid leakage at the joints.

[0104] The third protective layer is non-magnetic and is configured to rotate together with the active magnet 22. That is, the third protective layer and the active magnet 22 are fixedly set and remain relatively stationary.

[0105] The non-magnetic third protective layer can prevent the active magnet 22 from attracting impurities and affecting its normal operation. Furthermore, it can also directionally constrain the magnetic force of the active magnet 22, preventing undesirable diffusion of its magnetic force. This improves magnetic coupling force and efficiency, and prevents the active magnet 22 from magnetizing other components of the drive assembly 10, thus avoiding unnecessary problems. For example, it prevents other components of the drive assembly 10 from being magnetized and attracting impurities, which could affect the normal operation of the drive assembly 10.

[0106] The active magnet protection assembly 24 also includes a fourth protective layer disposed within the motor end bushing 20 and physically spaced from the active magnet 22; the fourth protective layer is configured not to rotate with the active magnet 22.

[0107] Specifically, the fourth protective layer is radially disposed around the active magnet 22 and fixed within the inner cavity of the insertion bushing 40, with the fourth protective layer spaced apart from the active magnet 22. Since the active magnet 22 is rotatable while the fourth protective layer is fixed, during the rotation of the magnetized active magnet 22, the fourth protective layer, being fixed relative to it, undergoes relative motion. If the fourth protective layer is made of a conductive material, eddy currents may be generated within it.

[0108] Therefore, configuring the fourth protective layer as non-conductive can prevent the generation of eddy currents within it, ensuring that the equipment casing is not electrified and avoiding the risk of electric shock. Furthermore, configuring the fourth protective layer as non-magnetic allows for the directional confinement of magnetic forces, as described above and will not be repeated here.

[0109] To further constrain the magnetic force of the active magnet 22 towards the passive magnet 42, a second magnetic constraint member is provided within the motor end bushing 20. This second magnetic constraint member is generally disc-shaped and is mounted on the motor shaft 16 or the magnet fixing member 26, located near the active magnet 22. In other words, the second magnetic constraint member is located near the motor shaft 16 or the magnet fixing member 26, and the active magnet 22 is fixed to the distal end face of the second magnetic constraint member. The second magnetic constraint member is magnetically conductive. This second magnetic constraint member constrains the magnetic lines of force of the active magnet 22 to the distal end face of the second magnetic constraint member, preventing the magnetic force of the active magnet 22 from diffusing backward, i.e., away from the active magnet 22.

[0110] In another embodiment of the invention, the front end face of the active magnet 22 is exposed. For example, the second distal protection member 251 can be omitted, and the distal end face of the motor end bushing 20 can be used to limit the radial portion of the outer surface of the active magnet 22; or the active magnet 22 can be directly fixed to the magnet fixing member 26 or the motor shaft 16 to prevent the active magnet 22 from moving axially upward.

[0111] Since the active magnet 22 is located on the drive assembly 10, and the drive assembly 10 is located outside the subject body when the device 100 is working, the front end of the active magnet 22 is exposed without any additional parts, which makes the structure of the drive assembly 10 more compact; and it can also make the distance between the active magnet 22 and the passive magnet 42 closer, improving the transmission efficiency.

[0112] As previously described, the drive assembly 10 is detachably connected to the working assembly 30. Specifically, the motor end bushing 20 is detachably connected to the intervention end bushing 40, thereby enabling the detachable connection between the drive assembly 10 and the working assembly 30.

[0113] To enable a detachable connection between the motor end bushing 20 and the intervention end bushing 40, the motor end bushing 20 and the intervention end bushing 40 are plugged into each other, one of which is configured as a plug and the other of which includes a slot for receiving the plug; the bushing configured as a plug is defined as an insertion bushing and the bushing defining the slot is defined as a receiving bushing; the device 100 also includes a locking mechanism for engaging and fixing the insertion bushing and the receiving bushing.

[0114] The locking mechanism includes a joint formed in one of the outer wall of the insert bushing and the inner wall of the receiving bushing, and a locking member operable to be inserted into the joint. When the locking member is inserted into the joint, locking is achieved, and the insert bushing and the receiving bushing are fixed relative to each other; when the locking member is disengaged from the joint, the insert bushing and the receiving bushing can be disengaged.

[0115] Please pay close attention. Figure 6 , Figure 6 The first locking mechanism provided by a specific embodiment of the present invention is shown.

[0116] The joint is a locking groove 48 formed by recessing from the outer surface of the insert bushing. An opening is provided through the side wall of the receiving bushing. The locking member is configured as a radially movable pin 50. The pin 50 can be inserted into or removed from the locking groove 48 through the opening, thereby achieving locking or unlocking.

[0117] Pin 50 is disposed inside support sleeve 52, which is sleeved on the outside of receiving bushing and fixedly disposed relative to receiving bushing. Specifically, support sleeve 52 is provided with radially extending guide groove 54, which is recessed outward from the inner wall of support sleeve 52. Pin 50 slides in guide groove 54 to lock or unlock.

[0118] The pin 50 has a locked state in which it is inserted into the locking groove 48 to fix the motor end bushing 20 and the intervention end bushing 40 in a fixed engagement, and an unlocked state in which it is removed from the locking groove 48 to release the fixed engagement between the motor end bushing 20 and the intervention end bushing 40; a first elastic member 56 is biased between the pin 50 and the support sleeve 52, and the first elastic member 56 applies a restoring force to the pin 50 so that the pin 50 has a tendency to maintain the locked state or move toward the locked state.

[0119] Specifically, a first elastic element 56 is provided between the side of the pin 50 away from the locking groove 48 and the closed end of the guide groove 54. The first elastic element 56 applies a radially inward force to the pin 50, thereby making the pin 50 tend to maintain the locked state or move toward the locked state.

[0120] To ensure more reliable installation of the first elastic element 56, the pin 50 has an inwardly recessed elastic element receiving groove 58 on the side opposite to the locking groove 48, and the first elastic element 56 is partially received within the elastic element receiving groove 58. Under the constraint of the elastic element receiving groove 58, the first elastic element 56 can more stably recover its deformation, giving the pin 50 a tendency to maintain the locked state or move toward the locked state.

[0121] To ensure the strength of the pin 50, the pin 50 includes an outer section 60 and an inner section 62 connected together. The width (diameter) of the outer section 60 is greater than the width of the inner section 62. An elastic element receiving groove 58 is provided in the wider outer section 60. The elastic element receiving groove 58 is formed by recessing inward from the end of the outer section 60 away from the locking groove 48.

[0122] The locking mechanism also includes a rotatable unlocking actuator disposed outside the receiving bushing. The unlocking actuator includes an annular body 64 rotatably fitted onto the receiving bushing. The unlocking actuator includes a contour member 66 that engages with the pin 50. The contour member 66 is connected to the annular body 64 and protrudes radially outward from the annular body 64. The contour member 66 is configured to apply a force to the pin 50 opposite to the reset direction of the first elastic member 56 when the annular body 64 of the unlocking actuator rotates in a first direction, and to remove the force applied to the pin 50 when the annular body 64 of the unlocking actuator rotates in a second direction opposite to the first direction.

[0123] As previously described, pin 50 includes an inner section 62 and an outer section 60 of unequal width. A corner is formed at the connection between the inner section 62 and the outer section 60 on the outer surface of pin 50. When the annular body 64 of the unlocking actuator moves along a first direction (e.g., ... Figure 6 When the contouring component 66 rotates in the clockwise direction (as shown in the diagram), it abuts against the corner, applying a radially outward force to the pin 50, causing the pin 50 to disengage from the locking groove 48, allowing the insert bushing to disengage from the receiving bushing. When the annular body 64 of the unlocking actuator rotates in the second direction (as shown in the diagram), Figure 6 When rotated (in the counterclockwise direction as shown), the contouring component 66 moves away from the pin 50, and the pin 50 is inserted into the locking groove 48 under the action of the first elastic element 56, and the insertion bushing is fixed relative to the receiving bushing.

[0124] When the unlocking actuator rotates along the first direction to the first dead point position, pin 50 is in the unlocked state; when the unlocking actuator rotates along the second direction to the second dead point position, pin 50 is in the locked state. That is, during the rotation of the unlocking actuator along the first direction, pin 50 moves radially outward to gradually unlock. When the unlocking actuator rotates along the first direction to the first dead point position, pin 50 is completely disengaged from the lock groove 48, and unlocking is successful.

[0125] During the rotation of the unlocking actuator in the second direction, the pin 50 moves radially inward under the action of the first elastic member 56 and gradually locks. When the unlocking actuator rotates to the second dead point position in the second direction, the contouring member 66 completely releases the pin 50, and the pin 50 is inserted into the lock groove 48 to a certain depth, thus achieving locking.

[0126] A second elastic element 70 is provided between the unlocking actuator and the support sleeve 52. The second elastic element 70 applies a restoring force to the unlocking actuator, which makes it tend to maintain the second dead point position or move toward the second dead point position.

[0127] As previously described, the reset force applied by the first elastic element 56 to the pin 50 tends to keep the pin 50 in the locked state or move towards the locked state, while the reset force applied by the second elastic element 70 to the unlocking actuator tends to keep the conforming component 66 in the state of keeping the pin 50 in the locked state or move towards the state of keeping the pin 50 in the locked state. The first elastic element 56 and the second elastic element 70 work together. Only by overcoming the combined action of the second elastic element 70 and the first elastic element 56 can the insert bushing be separated from the receiving bushing, thus maintaining a reliable lock of the pin 50 on the insert bushing and the receiving bushing and preventing accidents from happening during the operation of the device 100.

[0128] At the same time, after the external force is removed, locking is achieved through the combined action of the two elastic elements.

[0129] The support sleeve 52 is provided with a track opening 72 that is generally arc-shaped in the circumferential direction. The unlocking actuator includes a locking protrusion 74 that extends into the track opening 72. The locking protrusion 74 is connected to the annular body portion 64 and protrudes radially out of the annular body portion 64.

[0130] The locking protrusion 74 has a first stop surface 76 pointing in a first direction and a second stop surface 78 pointing in a second direction. A second elastic member 70 is disposed between the first stop surface 76 and the inner wall of the track opening 72 along the first direction. When the second elastic member 70 is compressed, the locking protrusion 74 has a tendency to maintain the second stop surface 78 abutting against the inner wall of the track opening 72 along the second direction, or to move towards the second direction and abut against the inner wall, thereby causing the contour member 66 of the unlocking actuator to maintain the locked state by reducing the overhead 50. The unlocking state of the unlocking actuator corresponds to the locking protrusion 74 pushing the second elastic member 70 to be further compressed, causing the first stop surface 76 to rotate within the track opening 72 in the direction towards the inner wall in the first direction.

[0131] Therefore, in the locked state, under the action of the second elastic member 70, the contouring member 66 moves away from the pin 50, and the contouring member 66 cannot push the pin 50. Meanwhile, the pin 50, under the action of the first elastic member 56, remains inserted into the locking groove 48. When unlocking is required, overcoming the force of the second elastic member 70, the operating lever protrusion 74 rotates in the first direction, causing the annular main body 64 to rotate. The rotation of the annular main body 64 causes the contouring member 66 to rotate, and the rotation of the contouring member 66 pushes the pin 50 to move radially outward against the force of the first elastic member 56, thus unlocking the insert bushing and the receiving bushing.

[0132] The unlocking actuator is connected to an operating member 80 located outside the support sleeve 52. The operating member 80 is configured to receive external force to drive the unlocking actuator to rotate in a first direction. Specifically, the operating member 80 is fixedly connected to the locking protrusion 74. The operating member 80 drives the locking protrusion 74 to rotate, which in turn drives the annular main body 64 and the contouring component 66 to rotate, thereby achieving unlocking.

[0133] The operating component 80 includes an annular portion 82, which is sleeved on the outside of the support sleeve 52. A portion of the inner wall of the annular portion 82 connects to the retaining protrusion 74; another portion of the inner wall of the annular portion 82 at least covers the portion of the track opening 72 in the support sleeve 52 where the second elastic element 70 is installed. In other words, the annular portion 82, the retaining protrusion 74, and the support sleeve 52 form a relatively enclosed space to accommodate the second elastic element 70, ensuring reliable operation of the second elastic element 70.

[0134] As previously described, the contouring component 66 extends radially outward relative to the annular main body 64. To allow space for the movement of the contouring component 66, a recessed groove 84 is formed by the outward indentation of the inner wall of the support sleeve 52. The circumferential extension length of the recessed groove 84 is approximately equal to the length of the circumferential movement trajectory of the unlocking actuator during the process from locking to unlocking.

[0135] In this embodiment, there are two pins 50 and two locking slots 48. Each pin 50 corresponds to one locking slot 48, meaning one pin 50 corresponds to one locking slot 48. The two pins 50 are spaced 180 degrees apart in the circumferential direction, allowing for relatively balanced locking of the insertion bushing and the receiving bushing. Corresponding to the number of pins 50, there are also two first elastic members 56 and two contouring members 66, each corresponding to one pin 50.

[0136] Although there are two pins 50, there is only one locking protrusion 74 and one operating element 80. That is, one operating element 80 and one locking protrusion 74 can operate two pins 50 at the same time, which not only makes locking reliable, but also makes operation convenient.

[0137] Those skilled in the art will realize that the number of pins 50, locking grooves 48, first elastic elements 56, and contouring components 66 can be more than two, which will not be elaborated further. Any scheme that adopts the same or similar scheme as this embodiment is covered within the protection scope of this invention.

[0138] The operation of this locking mechanism is described below. For ease of description, the first direction will be referred to as the clockwise direction, and the second direction as the counterclockwise direction. However, this is merely for convenience and does not constitute a limitation on the invention.

[0139] From the unlocked state to the locked state, the restoring force of the first elastic element 56 pushes the pin 50 to move radially inward and insert into the lock groove 48. The restoring force of the second elastic element 70 pushes the locking protrusion 74 to rotate counterclockwise until the second stop surface 78 abuts against the inner wall of the track opening 72 in the counterclockwise direction. The counterclockwise rotation of the locking protrusion 74 causes the annular main body 64 and the contoured component 66 to move away from the pin 50. Under the action of the first elastic element 56, the pin 50 is inserted into the lock groove 48 and remains in the locked state.

[0140] It should be noted that the first elastic element 56 and the second elastic element 70 are compressed and store energy, while also having a tendency to reset. Therefore, the reset actions of the first elastic element 56 and the second elastic element 70 can occur simultaneously.

[0141] From the locked state to the unlocked state, the operator pushes the operating component 80 to rotate clockwise. The clockwise rotation of the operating component 80 causes the locking protrusion 74 to rotate clockwise against the force of the second elastic element 70. The clockwise rotation of the locking protrusion 74 causes the annular main body 64 and the contouring component 66 to rotate clockwise. When the contouring component 66 rotates clockwise to abut against the corner of the pin 50, the contouring component 66 pushes the pin 50 to move radially outward against the force of the first elastic element 56, thereby unlocking the device.

[0142] It is worth noting that, in cases such as Figure 6 In the illustrated embodiment, the intervention end bushing 40 is configured as an insertion bushing, the motor end bushing 20 is configured as a receiving bushing, and the front end of the motor housing 12 is configured as a support sleeve 52.

[0143] However, based on the above description, it can be understood that the configuration of the insertion bushing and the receiving bushing can be substantially the opposite of the example described above. That is, the insertion end bushing 40 is configured as a receiving bushing, the motor end bushing 20 is configured as an insertion bushing, and the support sleeve 52 is an additional component that conforms to the description of the above embodiment.

[0144] As a surgical instrument, the device 100 of the present invention needs to have a sufficiently compact structure, and the dimensions of each component need to be sufficiently precise and small. When the insert bushing and the receiver bushing are inserted and fitted together, because the dimensions of the insert bushing and the receiver bushing are sufficiently precise, the space between them is small, resulting in greater assembly resistance and making the assembly operation difficult.

[0145] To facilitate assembly while maintaining dimensional precision, a drag-reducing structure is incorporated between the insert bushing and the receiving bushing. This structure is positioned to reduce the insertion resistance caused by gas compression during the insertion of the insert bushing into the receiving bushing.

[0146] Please pay close attention. Figure 7 In one embodiment of the present invention, a gap is formed between the support sleeve 52 and the receiving bushing; the drag reduction structure includes a pressure relief hole 86 penetrating the side wall of the receiving bushing, and the pressure relief hole 86 communicates with the external space through the gap between the support sleeve 52 and the receiving bushing. Thus, during the insertion of the insert bushing into the receiving bushing, the gas between the insert bushing and the receiving bushing can be discharged to the external space through the pressure relief hole 86, reducing or even avoiding the resistance formed by gas compression on the insert bushing.

[0147] In another embodiment of the invention, the drag-reducing structure includes a pressure relief groove formed on the inner wall of the receiving bushing and / or the outer wall of the insert bushing, the pressure relief groove communicating with the external space. The pressure relief groove can store a portion of air, reducing air resistance; furthermore, the communication with the external space allows air to be discharged into the external space, reducing or even eliminating the resistance to the insert bushing caused by gas compression.

[0148] In this embodiment, the pressure relief groove extends along the insertion direction of the insert bushing. This extension can be a straight line extension or a curved extension, such as a spiral extension. The distal end of the pressure relief groove connects to the proximal end of the inner wall of the receiving bushing and / or the distal end of the outer wall of the insert bushing, thereby achieving communication with the external space.

[0149] In one specific embodiment, the pressure relief groove is formed only on the inner wall of the receiving bushing. During insertion of the insert bushing, the pressure relief groove and the outer wall of the insert bushing define a channel communicating with the external space, thereby achieving pressure relief. Similarly, in another specific embodiment, the pressure relief groove may also be formed only on the outer wall of the insert bushing. Alternatively, the pressure relief groove may be formed on both the inner wall of the receiving bushing and the outer wall of the insert bushing.

[0150] In another embodiment of the invention, the drag-reducing structure includes a space formed between the insert bushing and the receiving bushing when they are in the engaged position. This space is used to temporarily store compressed air during the insertion of the insert bushing into the receiving bushing, indirectly achieving the purpose of depressurization, thereby reducing the resistance to the insert bushing caused by the compression of gas.

[0151] Preferably, the space includes a groove formed in the insert bushing that opens toward the end. The groove allows space between the insert bushing and the receiving bushing, while the gap between the outer wall of the insert bushing and the inner wall of the receiving bushing remains sufficiently small. This sufficiently small gap not only makes the structure compact but also allows the insert bushing and the receiving bushing to slide and engage without relative wobbling, ensuring the normal operation of the device 100.

[0152] The above describes different drag reduction structures designed by the applicant. Of course, those skilled in the art will realize that the drag reduction structure can be a combination of two or more of the above drag reduction structures. All schemes using the same or similar embodiments as described herein are covered within the protection scope of this invention.

[0153] As previously described, the transmission link of the working component 30 includes a passive magnet 42, a connecting shaft 44 on which the passive magnet 42 is mounted, a drive shaft 34 connected to the distal end of the connecting shaft 44, and a pump 36 connected to the distal end of the drive shaft 34. When the device 100 is working, the motor shaft 16 drives the active magnet 22 to rotate, the passive magnet 42 is magnetically coupled to the active magnet 22, and the passive magnet 42 is driven to rotate by the active magnet 22. The rotation of the passive magnet 42 sequentially drives the connecting shaft 44 and the drive shaft 34 to rotate, and the rotation of the drive shaft 34 drives the pump 36 to realize the blood pumping function.

[0154] Please pay close attention. Figure 8 and Figure 9 In this embodiment, the intervention end bushing 40 is provided with a first axial channel 101, and the connecting shaft 44 is rotatably disposed in the first axial channel 101. At least one bearing 90 is provided outside the connecting shaft 44, and a damping element 92 is provided between the outer ring of the bearing 90 and the inner wall of the first axial channel 101. The damping element 92 can not only reduce vibration, but also provide a certain amount of movement buffer space, so that the passive magnet 42 and the active magnet 22 are aligned as much as possible, thereby improving transmission efficiency.

[0155] Specifically, as described above, there is a case of axial misalignment between the active and passive magnets 22 and 42. When the axial misalignment of the two magnets exceeds a predetermined degree, the passive magnet 42 will vibrate radially.

[0156] By providing a damping element 92 between the bearing 90 and the first axial channel 101, and configuring the damping element 92 to be flexible, the flexible damping element 92 can be deformed by the connecting shaft 44, thereby providing radial deformation space for the vibration of the passive magnet 42. The deformation of the damping element 92 by compression will simultaneously store energy, thereby providing a resetting effect on the connecting shaft 44 to center its axial direction, so that the two magnets are restored to alignment.

[0157] Furthermore, the damping element 92 is generally annular and fits around the outer circumference of the bearing 90. It is noteworthy that the damping element 92 can be circumferentially continuous or circumferentially discontinuous, i.e., it comprises multiple arc-shaped damping units. Through the annular structural design of the damping element 92, the damping element 92 can reset the vibration of the passive magnet 42 along 360° of the circumference.

[0158] As described above, the tip of the pump and catheter is inserted anteriorly into the subject's vascular system. It is known that the vascular system is tortuous, especially containing bends with angles potentially less than 30°.

[0159] Because the drive shaft 34 passes through the catheter 32, both the catheter 32 and the drive shaft 34 will conform to the bending of the vascular system during delivery through such a tortuous vascular system. However, due to the difference in flexibility between the drive shaft 34 and the catheter 32, and because the drive shaft 34 is located inside the catheter 32, the drive shaft 34 will move axially within the catheter 32 during delivery through bends.

[0160] Therefore, to accommodate the axial movement of the drive shaft 34, the drive shaft 34 and the connecting shaft 44 are slidably fitted along the axial direction. Furthermore, since the connecting shaft 44 needs to transmit rotation to the drive shaft 34, the drive shaft 34 and the connecting shaft 44 are circumferentially fixed.

[0161] Specifically: a connecting portion 94 is provided or formed at the proximal end of the drive shaft 34, and the cross-section of the connecting portion 94 is of any shape other than circular; a mating channel adapted to the connecting portion 94 is formed at the distal end of the connecting shaft 44, and the connecting portion 94 is axially slidably inserted into the mating channel.

[0162] The cross-section of the connecting part 94 is any shape that is not circular, such as square or elliptical, and is constructed as a flat shaft to prevent rotation in the circumference, ensuring that the drive shaft 34 and the connecting shaft 44 are circumferentially fixed, so that the drive shaft 34 rotates synchronously with the connecting shaft 44.

[0163] The connecting part 94 can be integrally constructed with the drive shaft 34, forming part of the structure of the drive shaft 34. Specifically, it can be obtained by processing the rear end of the drive shaft 34 through a non-circular process.

[0164] Alternatively, the connecting part 94 may be a component additionally provided at the rear end of the drive shaft 34 and have a cross-sectional shape conforming to the description above.

[0165] It should be noted that although the drive shaft 34 and the connecting shaft 44 are axially slidable, there is no need to worry about them disengaging, because the distal end of the drive shaft 34 is connected to the pump 36. Thus, the distal end of the drive shaft 34 is defined in the axial direction by the pump 36. In other words, the mating channel and the pump 36 respectively define the proximal and distal positions of the drive shaft 34 in the axial direction. Therefore, the drive shaft 34 will not disengage due to sliding mating with the connecting shaft 44.

[0166] As previously described, the working component 30 includes a conduit 32, a drive shaft 34 passing through the conduit 32, and a pump 36 driven by the drive shaft 34.

[0167] The drive shaft 34 is inserted into the conduit 32. The conduit 32 prevents the drive shaft 34 from contacting the outside world. On the one hand, this ensures the normal operation of the drive shaft 34. On the other hand, it prevents the drive shaft 34 from directly contacting the subject during operation and causing harm to the subject.

[0168] Pump 36, which can pump blood to the desired location of the heart via conduit 32, includes a pump housing 363 connected to the distal end of conduit 32 and having an inlet end 361 and an outlet end 362, and an impeller (not shown) housed in the pump housing. The impeller is driven to rotate by drive shaft 34 to draw blood from the inlet end 361 into the pump housing 363 and discharge it from the outlet end 362.

[0169] like Figures 1 to 3 As shown, in this embodiment, the pump housing 363 includes a metal lattice support 3631 made of nickel-titanium alloy and an elastic membrane 3632 covering the support 3631. The metal lattice of the support 3631 has a mesh design. The membrane 3632 covers a portion of the support 3631, and the mesh of the portion of the support 3631 not covered by the membrane 3632 forms the inlet end 361. The rear end of the membrane 3632 covers the distal end of the conduit 32, and the outlet end 362 is an opening formed at the rear end of the membrane 3632.

[0170] Furthermore, the impeller includes a hub connected to the far end of the drive shaft 34 and blades supported on the outer wall of the hub. The blades can be helical and can be one or more, such as two.

[0171] The distal end of the drive shaft 34 is connected to the hub, and a proximal bearing chamber (not shown) connects the distal end of the guide tube 32 to the proximal end of the bracket 3631. That is, the bracket 3631 is connected to the guide tube 32 through the proximal bearing chamber. The drive shaft 34 passes through a proximal bearing located in the proximal bearing chamber.

[0172] A distal bearing chamber 37 is provided between the distal end of the support 3631 and the protective head 38. That is, the protective head 38 is connected to the support 3631 through the distal bearing chamber. The distal end of the hub 12 is inserted into the distal bearing located in the distal bearing chamber 37. The impeller 9 is limited by the near and distal bearings, so that the impeller can be better held in the pump casing 363 and the pump clearance between the impeller and the pump casing 363 is stably maintained.

[0173] In this embodiment, pump 36 is a collapsible pump with a compressed state and an extended state. Specifically, pump housing 363 and impeller are configured such that: in the interventional configuration, pump 36 is in a compressed state so that pump 36 delivers blood into the subject's vascular system with a smaller first outer diameter; and in the operational configuration, pump 36 is in an extended state so that pump 36 pumps blood at a desired location with a second radial dimension greater than the first radial dimension.

[0174] In this field, the size and hydrodynamic performance of pump 363 are two conflicting parameters. In short, to reduce patient discomfort and facilitate intervention, a small size of pump 363 is desirable. However, to provide stronger assistive functions for the patient, a high flow rate is desired, which generally requires a larger pump 363 size.

[0175] By designing a collapsible pump 363, the pump 363 has a small collapsible size and a large unfolded size, in order to meet the needs of both reducing patient discomfort and facilitating intervention / delivery during the intervention process, as well as providing a large flow rate.

[0176] As described above, the design of the multi-mesh, especially the diamond-shaped mesh, of the pump housing 3631 can achieve better folding and unfolding, while taking advantage of the memory properties of nickel-titanium alloy.

[0177] The impeller includes a hub connected to the distal end of the drive shaft 34 and blades supported on the outer wall of the hub. The blades are configured to: wrap around the outer wall of the hub and at least partially contact the inner wall of the pump housing when the pump 36 is in the intervention configuration, and extend radially outward from the hub and spaced from the inner wall of the pump 36 when the pump 36 is in the operating configuration.

[0178] The blades are made of a flexible material that stores energy when folded. Once the external constraints are removed, the stored energy is released, causing the blades to unfold.

[0179] Pump 36 is folded by external constraints, and self-unfolds after the constraints are removed. In this embodiment, "compressed state" refers to the state in which pump 36 is radially constrained, that is, pump 36 is radially compressed and folded to its minimum radial dimension under external pressure. "Unfolded state" refers to the state in which pump 36 is not radially constrained, that is, the support 3631 and impeller are radially unfolded to their maximum radial dimension. The aforementioned external constraints are applied by a folded sheath (not shown) that is slidably fitted outside the guide tube 32. When the folded sheath moves forward outside the guide tube 32, pump 36 can be completely housed within it, achieving forced folding of pump 36. When the folded sheath moves backward, the radial constraints on pump 36 disappear, and pump 36 self-unfolds.

[0180] As described above, the retraction of pump 36 is achieved by the radial constraint force applied by the folded sheath. Since the impeller contained in pump 36 is housed within pump casing 363, the retraction process of pump 36 is essentially as follows: the folded sheath applies a radial constraint force to pump casing 363, and when pump casing 363 is radially compressed, it applies a radial constraint force to the impeller.

[0181] In other words, the pump casing 363 is folded directly by the folding sheath, while the impeller is folded directly by the pump casing 363. As mentioned above, the impeller is elastic. Therefore, although it is in a folded state, the energy stored in the folding of the impeller makes it always tend to expand radially, thus the impeller will contact the inner wall of the pump casing 363 and exert a reaction force on the pump casing 363.

[0182] After the constraints of the folded sheath are removed, the pump casing 363, under its own memory characteristics, supports the unfolding of the elastic diaphragm, and the impeller unfolds itself under the released energy storage. In the unfolded state, the outer diameter of the impeller is smaller than the inner diameter of the pump casing 363.

[0183] In this way, a gap is maintained between the radially outer end of the impeller (that is, the blade tip) and the inner wall of the pump casing 363 (specifically, the inner wall of the support 3631), and this gap is called the pump clearance. The existence of the pump clearance allows the impeller to rotate without obstruction and without hitting the wall.

[0184] Furthermore, from a fluid dynamics perspective, it is desirable for the pump clearance to be small and maintained. In this embodiment, the outer diameter of the impeller is slightly smaller than the inner diameter of the support 3631, so that the pump clearance is as small as possible while ensuring that the impeller does not hit the wall during rotation. The main means of maintaining the pump clearance is through the support strength provided by the support 3631, which can resist the back pressure of the fluid (blood) without deformation, thereby maintaining the shape stability of the pump casing 363, and thus the pump clearance is also stably maintained.

[0185] The following describes the folding and unfolding process of pump 36 when this device 100 is used as a left ventricular assist device:

[0186] During the insertion of pump 36 into the left ventricle, pump 36 is in a radially constrained state (compressed state) due to the externally applied radial constraint force. After insertion into the left ventricle and removal of the radial constraint force, stent 3631 expands autonomously by utilizing its own memory characteristics and the blades of the impeller through the release of stored energy, so pump 36 automatically presents its unconstrained shape (expanded state).

[0187] Conversely, when the device 100 needs to be removed from the subject's body after completing its work, the pump 36 is folded up using the folding sheath. After the pump 36 is completely removed from the subject's body, the constraint of the folding sheath on the pump 36 is removed, allowing the pump 36 to return to its natural state of minimum stress, that is, the unfolded state.

[0188] When the device 100 is in operation, heat is generated between relatively rotating components, such as between the connecting shaft 44 and the interventional end bushing 40, and between the drive shaft 34 and the catheter 32. The accumulation of heat will accelerate the wear of these components and reduce their service life. Therefore, it is necessary to take measures for thermal management.

[0189] In view of this, the device 100 also includes a filling channel that substantially runs through the entire working assembly 30. Specifically, the filling channel runs through the drive link from the passive magnet 42 to the pump 36. When the device 100 is in operation, fluid, which is the Purge liquid described above, can be injected into the filling channel to lubricate and cool the drive link.

[0190] For details, please refer to the following: Figure 9 and Figure 10 The proximal inlet 96 of the infusion channel is a cavity located at the proximal end of the interventional end bushing 40 and housing the passive magnet 42 therein. Preferably, the cavity not only houses the passive magnet 42, but also houses the passive magnet protection assembly 46 therein.

[0191] The passive magnet 42 is the starting point of the transmission link in the working assembly 30, and the proximal inlet 96 of the injection channel is configured as a cavity that houses the passive magnet 42. Fluid can be injected into the cavity to lubricate and cool the passive magnet 42. Therefore, the injection channel lubricates and cools the transmission link from the starting point of the transmission link in the working assembly 30, ensuring the effective operation of the working assembly 30.

[0192] As described above, the injection channel extends from the proximal end of the coupler to the distal end of the pump 36. It should be noted that this structural design facilitates venting operations. Specific details are as follows:

[0193] As is known, when purging fluid into a subject, it is important to avoid the introduction of gases that could cause fatal harm into the subject beforehand or during the process. Therefore, before the working component of this device 100 is inserted into the subject's body, the air inside the working component must be expelled with perfusion fluid, so that the working component is pre-filled with perfusion fluid.

[0194] In known perfusion implementations, the perfusion fluid interface is located between the two ends of the working component, typically closer to the proximal end of the working component, i.e., the proximal end of the coupler. Thus, the working component is divided into a proximal section and a distal section, located on either side of the perfusion fluid interface. Therefore, venting operations must be performed on both the proximal and distal sections separately.

[0195] In other words, in the existing known embodiments, the venting operation needs to be performed twice. Specifically:

[0196] First, connect a perfusion fluid source (which can be a syringe) to the perfusion fluid inlet (located on the coupler housing). The syringe contains perfusion fluid, and by pushing the syringe, the perfusion fluid is injected into the working component through the perfusion fluid inlet.

[0197] Because the injection fluid interface is located near the proximal end of the coupler, the length of the distal section is much greater than that of the proximal section; in addition, the distal section mainly consists of structures such as the conduit 32, drive shaft 34, and pump 36. Therefore, the flow resistance of the liquid in the distal section is much greater than that in the proximal section.

[0198] Therefore, the injection fluid first enters the proximal segment to purge the air from the proximal segment. The purging of air from the proximal segment can be verified by the injection fluid flowing out from the end face of the proximal segment, which is the first guide channel of the seal 118 described below.

[0199] Subsequently, the proximal section is sealed, that is, the first guide channel of the seal 118 is sealed (the specific sealing method is described below). Liquid is then injected into the working assembly using a syringe. Because the proximal section is sealed, the injection fluid can only flow towards the distal section, purging the air from the distal section. The purging of air from the distal section can be verified by the injection fluid flowing out from the end of the distal section, namely the front end of the conduit 32 and / or the distal end of the impeller hub.

[0200] Therefore, in existing known embodiments, the gas at the proximal end is first discharged by the perfusion fluid, and then the gas at the distal end is discharged.

[0201] In contrast, the starting point of the infusion channel in this embodiment of the invention is the cavity housing the passive magnet 42, which is located at the proximal end of the entire working assembly. Thus, the infusion fluid enters from the proximal end of the entire infusion channel, and the flow path of the infusion fluid can only be towards the distal end of the working assembly. Therefore, the working assembly can be emptied with only one operation, greatly simplifying the emptying process.

[0202] The interventional end bushing 40 is provided with an infusion input channel 98 communicating with the cavity. The outer end of the infusion input channel 98 extends through a connecting assembly and is used to communicate with an infusion fluid source. The outer end extending through the connecting assembly facilitates communication with the infusion fluid source, providing fluid to the infusion channel.

[0203] The extension direction of the injection input channel 98 is set at an angle to the axial direction, so that the outer end of the injection input channel 98 is far away from the near end of the working component 30, avoiding affecting the installation of the working component 30 and the drive component 10, and making injection more convenient. The structural design is very reasonable.

[0204] As previously described, the connecting shaft 44 is connected to the passive magnet 42. Specifically, as mentioned above, the passive magnet 42 is sleeved on the mounting portion near the proximal end of the connecting shaft 44. The connecting shaft 44 is mounted on the coupler; specifically, the connecting shaft 44 is mounted on the interventional end bushing 40, which has a first axial channel 101. The connecting shaft 44 is rotatably disposed within the first axial channel 101. The connecting shaft 44 has an axially extending hollow cavity, which can also be referred to as a second axial channel 102.

[0205] The infusion channel in the coupler portion includes: a second axial channel 102 formed in the connecting shaft 44, and a first gap formed between the connecting shaft 44 and the first axial channel 101; the second axial channel 102 and the first gap communicate with the cavity.

[0206] Thus, after the fluid is input from the injection input channel 98, it first flows through the cavity housing the passive magnet 42, and then passes through the bearing and the first gap in sequence.

[0207] As described above, the connecting portion 94 of the drive shaft 34 is inserted into the mating channel of the connecting shaft 44. The connecting portion 94 has a hollow structure, thereby connecting the connecting shaft 44 and the internal axial channel of the drive shaft 34. The mating channel is a part of the second axial channel 102. Specifically, the mating channel is the distal portion of the second axial channel 102, and the mating channel communicates with the proximal portion of the second axial channel 102. The radial widths of the two are different, forming a step, which facilitates axial limiting of the proximal end of the connecting portion 94.

[0208] Therefore, at the far end of the connecting shaft 44, the fluid flows through the mating channel to cool and lubricate the interior of the far end of the connecting shaft 44 and the connection part 94 near the drive shaft 34. The installation structure of the connecting shaft 44 and the drive shaft 34 is used to cool and lubricate both, and the flow channel is kept unobstructed. The structural design is very reasonable.

[0209] As previously described, the working assembly 30 includes a conduit 32, through which a drive shaft 34 passes. The infusion channel also includes a second gap formed between the drive shaft 34 and the shaft cavity of the conduit 32. Thus, after the fluid flows through the passive magnet 42 and the connecting shaft 44, it flows through the second gap, cooling and lubricating the outer surface of the drive shaft 34.

[0210] like Figure 8 As shown, in some embodiments, the coupler further includes a positioning sleeve 108 connected to the distal end of the interventional end bushing 40; the proximal end of the catheter 32 is housed within the positioning sleeve 108, and the proximal end of the drive shaft 34 protrudes from the positioning sleeve 108 and is connected to the connecting shaft 44. Specifically, the positioning sleeve 108 includes a connected proximal portion and a distal portion. The end of the proximal portion is connected to the interventional end bushing 40. The proximal portion is recessed from its proximal end face in a direction toward the distal end to form a receiving space 110. The distal portion forms a catheter receiving cavity for housing the catheter 32. The proximal end of the catheter 32 is housed in the catheter receiving cavity, and the proximal end of the drive shaft 34 extends out of the catheter receiving cavity and passes through the receiving space 110 to connect to the connecting shaft 44.

[0211] The radial width of the accommodating space 110 is greater than the width of the conduit receiving cavity. Therefore, a relatively large amount of fluid can be transferred and stored in the accommodating space 110, so that after the liquid flows out from the first gap and the axial channel of the connecting shaft 44, it enters the conduit 32 and the second gap after being transferred and buffered by the larger accommodating space 110, thus avoiding liquid pressure buildup.

[0212] Furthermore, a relatively large accommodating space 110 is formed in the proximal portion of the positioning sleeve 108, which facilitates the assembly of the positioning sleeve 108 with the interventional end bushing 40 and the housing 112 (described below). Specifically, a radial lug structure 1081 is formed at the proximal end of the positioning sleeve 108, and a radial stop 1121 is provided on the proximal inner wall of the housing 112. When the housing 112 is engaged with the interventional end bushing 40, the lug structure 1081 of the positioning sleeve 108 is clamped between the distal end of the interventional end bushing 40 and the stop 1121, thereby fixing the positioning sleeve 108.

[0213] The positioning sleeve 108 is centrally located in the housing 112 to straighten the axial position of the conduit 32, aligning the conduit 32 with the center of the connecting shaft 44, and preventing the drive shaft 34 extending from the proximal opening of the conduit 32 from bending.

[0214] As described above, the positioning sleeve 108 is fixed in position by means of the cooperation between the lug structure 1081 and the stop 1121. The lug structure 1081 abuts against the inner wall of the housing 112, ensuring that the positioning sleeve 108 is centered within the housing 112, with its central channel aligned with the axial channel of the connecting shaft 44. Specifically, the lug structure 1081 is made of a flexible material, is annular, and its outer diameter is slightly larger than or equal to the inner diameter of the housing 112. This ensures that the proximal end of the drive shaft 34 engages with the connecting shaft 44 in a partially or slightly bent manner.

[0215] The second gap is connected to the first gap via the positioning sleeve 108. Specifically, the second gap is connected to the first gap via the accommodating space 110 of the positioning sleeve 108. More specifically, the outlet end (far end) of the first gap is connected to the accommodating space 110, and the inlet end (proximal end) of the second gap is connected to the accommodating space 110. Therefore, after the fluid flows out of the first gap, it flows into the second gap through the accommodating space 110 of the positioning sleeve 108, thereby cooling and lubricating the outer surface of the drive shaft 34.

[0216] The coupler also includes a housing 112 connected to the distal end of the intervention bushing 40 and housing the positioning sleeve 108 therein. The housing 112 is configured such that when the coupler and the connector are in the connected state, the outer surface of the coupler is flush with the outer surface of the connector. This not only avoids scratches that may be caused by uneven outer surfaces, but also results in a neat and aesthetically pleasing appearance.

[0217] Furthermore, the distal opening of the outer casing 112 is provided with a retaining sleeve 114 for the conduit 32 to pass through. For the same purpose as described above, the proximal end of the retaining sleeve 114 is opposite to or connected to the distal end of the positioning sleeve 108, with their central channels aligned. The distal end of the retaining sleeve 114 extends a certain length and has a strength greater than that of the conduit 32, which can support and prevent bending of the conduit 32, and further play a fixing role, providing a strong support transition for the conduit 32 at the outlet of the casing 112, and preventing the conduit 32 from breaking at this outlet due to strong and / or frequent bending.

[0218] The drive shaft 34 is axially continuous; that is, the entire drive shaft 34, including the connecting portion 94 located proximal to the drive shaft 34 and mating with the connecting shaft 44, has an axially extending hollow cavity forming a third axial channel 103, which communicates with the second axial channel 102. The perfusion channel in the portion of the catheter 32 and the drive shaft 34 also includes the third axial channel 103 formed within the drive shaft 34. Fluid flowing through the second axial channel 102 of the connecting shaft 44 enters the third axial channel 103 of the drive shaft 34 via the hollow connecting portion 94 and ultimately flows out at the distal end of the drive shaft 34 into the subject's body, providing physiological support.

[0219] The drive shaft 34 is constructed with a multi-layered braided structure, and its sidewalls are liquid-permeable. That is, the fluid flowing through the second gap and the third axial channel 103 can not only achieve equilibrium by permeating through the sidewalls of the drive shaft 34, but also provide comprehensive cooling and lubrication for the entire drive shaft 34.

[0220] In essence, in the existing known perfusion schemes described above, since the purging fluid enters in the middle of the perfusion channel, in some cases, the perfusion fluid interface may be located distal to the proximal end of the drive shaft. In this case, it is difficult for the purging fluid to enter from the proximal opening of the drive shaft. Therefore, if the purging fluid is to enter the interior of the drive shaft, the drive shaft must be constructed with liquid-permeable sidewalls.

[0221] In contrast, the proximal end of the infusion channel in this embodiment of the invention is a cavity for accommodating the passive magnet 42, and the incoming Purge fluid will sequentially enter the drive shaft 34 through the cavity and the connecting shaft 44.

[0222] In other words, even if the drive shaft 34 in this embodiment of the invention is not constructed with permeable sidewalls, the purging fluid can still enter the interior of the drive shaft 34. This provides more flexible options for the drive shaft 34 of the present invention and is of great benefit to the manufacturing process of the drive shaft 34.

[0223] Furthermore, the injection channel in the pump 36 includes a fourth axial channel formed in the hub and communicating with the third axial channel 103. Thus, fluid flowing through the third axial channel 103 can flow into and out of the fourth axial channel.

[0224] The distal outlet of the infusion channel includes the distal opening of the conduit 32, and further includes the distal opening of the hub. That is, fluid flowing through the second gap flows out through the distal opening of the conduit 32; fluid flowing through the fourth axial channel flows out through the distal opening of the hub.

[0225] Thus, it can be seen that the infusion channel of the working component 30 runs through the transmission link from the passive magnet 42 to the pump 36. The infusion channel first flows through the cavity that houses the passive magnet 42, cooling and lubricating the passive magnet 42. Subsequently, the infusion channel splits into two paths. One path flows sequentially through the second axial channel 102 inside the connecting shaft 44, the third axial channel 103 inside the drive shaft 34, and the fourth axial channel inside the hub of the pump 36, and flows out from the distal opening of the hub. The other path flows sequentially through the first gap between the intervention end bushing 40 and the outer wall of the connecting shaft 44, the bearing 92, the accommodating space 110 of the positioning sleeve 108, and the second gap between the conduit 32 and the outer wall of the drive shaft 34, and flows out from the distal opening of the conduit 32. The Purge fluid diverted in this path can lubricate and cool various components such as the bearing 92, the connecting shaft 44, and the drive shaft 34.

[0226] The entire infusion channel is rationally designed, ensuring smooth fluid flow. Its multi-branch, divertable design increases the infusion volume of purging fluid. Furthermore, the purging fluid naturally lubricates and cools the rotating components as it flows through them, preventing heat buildup, especially on the drive shaft 34. Additionally, thanks to the drive shaft 34's special structural design—which allows fluid permeability and / or serves as the proximal starting point of the infusion channel—purging fluid can enter the drive shaft 34, providing comprehensive cooling and lubrication.

[0227] As previously described, the distal portions of the pump 36, conduit 32, and drive shaft 34 need to be inserted into the subject's body before the device 100 operates. For ease of description, the portion that can be inserted into the subject's body will be referred to as the entry component.

[0228] To facilitate the insertion of the access component into the subject's body, the device 100 also includes a guide channel penetrating the pump 36, drive shaft 34, and coupler. In use, a guidewire, acting as a guide, is first inserted into the subject's body through the vascular system. Then, the user (typically a healthcare professional) holds the distal end of the access component of the device 100 and inserts the proximal end of the guidewire into the distal end of the guide channel until the guidewire passes through the entire working component 30, with its proximal end exiting from the proximal end of the coupler (specifically, the first guide channel of the seal 118 described below, or the bypass outlet 120 of the interventional end bushing 40). Subsequently, the pump 36, in a compressed state, is delivered along the guide path established by the guidewire in the subject's vascular system to the desired location (e.g., the left ventricle). Once the proximal end of the pump 36 has been delivered to the desired location, the guidewire is withdrawn, the constraint on the pump 36 is released to allow it to unfold, the working component 30 is connected to the drive component 10, the motor is activated, and the device is ready for operation.

[0229] As mentioned above, the hub of pump 36 has a fourth axial channel, drive shaft 34 has a third axial channel 103, and connecting shaft 44 has a second axial channel 102. The fourth axial channel, third axial channel 103, and second axial channel 102 are sequentially connected to form a first guide channel.

[0230] In fact, the protective head 38 is a hollow structure that connects to the fourth axial channel of the wheel hub. Therefore, the internal channel of the protective head 38 forms part of the first guide channel.

[0231] Please pay close attention. Figure 4 , Figure 9 and Figure 10The guiding channel also includes an end face outlet 116 located on the proximal end face of the interventional end bushing 40, and the distal end outlet of the hub is connected to the end face outlet 116 through the first guiding channel. That is, the working component 30 has an axially extending first guiding channel that can guide the guide wire through the end face outlet 116, thereby delivering the entry component into the subject's body.

[0232] As described above, since the device 100 needs to be infused with purge fluid during operation, the end-face outlet 116 formed on the proximal end face of the interventional end bushing 40 constitutes the proximal starting cavity of the infusion channel. Therefore, the end-face outlet 116 needs to be designed to be repeatedly openable or resealed.

[0233] Specifically, a seal 118 with a resealable first guide channel is provided in the end-face outlet 116. The seal 118 has two states—a closed sealed state and an open state. When the seal 118 is in the first state, the first guide channel is sealed, and the first guide channel is in a closed sealed state. When the working assembly 30 is operating, the seal 118 closes the end-face opening to prevent fluid in the infusion channel from flowing out of the end-face outlet 116 and to prevent purge fluid from corroding the motor 14. When the seal 118 is in the second state, the first guide channel is open, and the first guide channel is in a connected state to allow the guide wire to pass through, thereby delivering the infusion assembly into the subject's body.

[0234] Thus, when it is necessary to insert the guidewire, the seal 118 can be opened to allow the guidewire to pass through the first guide channel, ensuring that the pump 36 enters the subject's body. After the intervention of the pump 36 is completed, the guidewire is withdrawn, and the seal 118 can be sealed to prevent the pump 36 from leaking purge fluid during operation.

[0235] In one embodiment of the invention, the seal 118 is a flexible sealing plug that can move axially within the end face outlet 116. The outer wall of the flexible sealing plug and / or the inner wall of the end face outlet 116 are designed to be inclined so that the flexible sealing plug is squeezed and switches to a first state when moving axially in a first direction, and expands radially and switches to a second state when moving in a second direction opposite to the first direction.

[0236] like Figure 9 and Figure 10 As shown, in this embodiment, the first direction can be a direction toward the inner side of the interventional end bushing 40, and the second direction is a direction away from or toward the outer side of the interventional end bushing 40. More specifically, the first direction can be as follows: Figure 9 and Figure 10 The direction to the right as shown in the diagram, the second direction is as follows: Figure 9 and Figure 10 The direction shown is to the left.

[0237] As described above, the passive magnet 42 housed within the cavity is fitted onto the mounting portion 441, which has a larger diameter. To avoid obstructing the inward movement of the flexible sealing plug, the proximal end of the mounting portion 441 is recessed inward to form a relief groove 4411, which is used to house the inner end of the flexible sealing plug.

[0238] The proximal end of the central channel 102 of the connecting shaft 44 connects to the clearance groove 4411. Furthermore, the inner end of the flexible sealing plug is approximately conical, and the inner wall of the end-face outlet 116 is also approximately conical in shape. Thus, the conical flexible sealing plug and the end-face outlet 116 have a guiding function, smoothly guiding the purging fluid from the cavity into the central channel 102.

[0239] In another embodiment of the invention, the seal 118 may be a bladder structure similar to a hemostatic valve, the bladder structure being made of an elastic material and having an inner cavity and a channel similar to the first guiding channel described above. The bladder structure is in communication with a fluid filling medium source or an elastic material, and has an inflated state and a collapsed state.

[0240] The first state is the aforementioned inflated state, corresponding to the state when the bladder structure is filled with fluid medium or elastic material. The channel is occupied by the inflated sidewalls of the bladder structure, achieving a seal. The second state is the aforementioned collapsed state, corresponding to the state after at least part of the fluid medium in the bladder structure has been released. The channel is exposed, achieving an open state.

[0241] In this preferred embodiment, the guide channel includes a bypass outlet 120 located on the side of the intervention end bushing 40. As mentioned above, the working component 30 has a passive magnet 42 and a cavity for accommodating the passive magnet 42 at its proximal end. With the bypass outlet 120 provided, the guidewire can pass through the bypass outlet 120 instead of having to pass through the end face outlet 116. The end face outlet 116 can be omitted, thus eliminating the need for the seal 118, thereby shortening the distance between the passive magnet 42 and the active magnet 22 and improving transmission efficiency.

[0242] Specifically, the interventional end bushing 40 is provided with a first bypass channel 121, which connects the bypass outlet 120 with the axial channel of the internal receiving connecting shaft 44 of the interventional end bushing 40. That is, the first bypass channel 121 extends from the bypass outlet 120 to the first axial channel 101 that receives the interventional end bushing 40.

[0243] The side wall of the connecting shaft 44 is provided with a second bypass channel 122, which communicates with the internal channel of the connecting shaft 44. That is, the second bypass channel 122 extends from the opening in the side wall of the connecting shaft 44 to the second axial channel 102 of the connecting shaft 44. The second bypass channel 122 may optionally communicate with the first bypass channel 121.

[0244] Specifically, the second bypass channel 122 is located on the connecting shaft 44, and the connecting shaft 44 is rotatable and engages with the intervention end bushing 40. Therefore, the two interfaces of the second bypass channel 122 and the first bypass channel 121, which are close to each other, have two states: relative and staggered.

[0245] When the two ports are aligned, the guide wire can easily pass through; when the two ports are misaligned, the guide wire cannot exit from the bypass outlet 120. When it is necessary to exit the guide wire through this bypass, if the two ports are misaligned, the rotary pump 36 can be manually adjusted, specifically the rotatable impeller, to sequentially drive the drive shaft 34 and the connecting shaft 44 to rotate. Until the two ports are aligned, the guide wire can exit through the second bypass channel 122, the first bypass channel 121, and the bypass outlet 120.

[0246] Preferably, the working assembly 30 further includes a guidewire bypass cannula 124. When the second bypass channel 122 and the first bypass channel 121 are in communication, the guidewire bypass cannula 124 can be inserted sequentially through the two bypass channels, and the inner end of the guidewire bypass cannula 124 is connected to the second axial channel 102 of the drive shaft 34. The guidewire bypass cannula 124 makes guidewire insertion more convenient.

[0247] Since the bypass outlet 120 is connected to the first axial channel 101 that constitutes the infusion channel through the first bypass channel 121, in order to prevent the Purge fluid flowing through the first axial channel 101 from being ejected during the operation of the pump 36, a sealing plug (not shown) may be optionally provided in the bypass outlet 120 to seal the infusion channel and prevent the Purge fluid from being ejected through the bypass outlet 120.

[0248] The optional configuration of the sealing plug is such that, when the device 100 is in the guidewire insertion state where the guidewire needs to pass through the bypass outlet 120, the sealing plug is configured to be removed from the bypass outlet 120, which can be done manually. In this way, the bypass guide channel of the guidewire is opened, and the bypass insertion operation of the guidewire can be performed.

[0249] Correspondingly, in any working state other than the guidewire insertion state, the sealing plug is inserted into the bypass outlet 120. These other working states mainly include: the state where the pump 36 is turned on after the guidewire insertion operation is completed (at this time, Purge fluid needs to be injected into the infusion channel), the state where the guidewire is inserted from the end face, etc.

[0250] As previously described, the working assembly 30 is provided with an end face outlet 116 and a bypass outlet 120. The guide channel is configured such that an operable guide wire exits from either the end face outlet 116 or the bypass outlet 120. Exiting from the end face outlet 116 allows for smoother guidance; while exiting from the bypass outlet 120 avoids the influence of the seal 118 on the passive magnet 42 and the injection channel.

[0251] Optionally, when the guidewire exits through the end face outlet 116, the bypass outlet 120 is sealed. When the guidewire exits through the bypass outlet 120, the end face outlet 116 is sealed. The purpose of this design is primarily to maintain the unobstructed target guidance path of the guidewire while preventing the guidewire from entering a non-target guidance path, thus ensuring efficient guidewire insertion.

[0252] As described above, when the guidewire needs to exit through the end face outlet 116, the guidewire's insertion path is relatively straight. In this case, it is neither necessary nor possible to insert the guidewire bypass cannula 124 into the first and second bypass channels 121 and 122.

[0253] Conversely, based on the above description, when it is necessary to pass the guidewire through the bypass outlet 120, the guidewire bypass cannula 124 is used to force the guidewire to change direction, from its original straight path to a proximal bend. Thus, when the guidewire bypass cannula 124 is inserted, the path of the guidewire through the end face outlet 116 is blocked, forcing the guidewire to pass through the bypass.

[0254] like Figure 9 As shown, the inner end face of the guidewire bypass cannula 124 is wedge-shaped. The angle between this wedge-shaped surface and the axial direction of the guidewire bypass cannula 124 is the same as the inclination of the first or second bypass channels 121 and 122, for example, 45°. Thus, after the guidewire bypass cannula 124 is inserted, its inner end face is approximately vertical, so as to achieve a face-to-face fit with the proximal end face of the drive shaft 32.

[0255] This avoids the occurrence of undesirable events such as the guidewire passing through a gap at the end face joint of the guidewire bypass cannula 124 and the drive shaft 32, which would allow the guidewire to pass through the gap into other spaces besides the guidewire bypass cannula 124, and ensures that the guidewire can only pass through the bypass outlet 120.

[0256] The channel through which the guidewire exits from the bypass outlet 120 is referred to as the second guide channel. In this embodiment, the guidewire can be selectively passed through either the first guide channel or the second guide channel, providing more options for the guidewire insertion operation and offering users flexible guidewire configuration.

[0257] It is understood that the first guide channel and the second guide channel have overlapping portions. Specifically, the distal ends of the first guide channel and the second guide channel overlap, while the proximal ends are separate, and they are respectively connected to the end face outlet 116 and the bypass outlet 120.

[0258] Of course, the device 100 may also only be provided with end face outlet 116 or bypass outlet 120, which will not be described in detail. Any scheme that adopts the same or similar scheme as this embodiment is covered within the protection scope of this invention.

[0259] The following describes the usage process of the apparatus 100 in this embodiment.

[0260] In this embodiment, the drive assembly 10 and the working assembly 30 of the device 100 are detachably connected via a locking mechanism between the insertion bushing and the receiving bushing. When the device 100 is needed, before intervention in the subject's body, the locking mechanism is operated to separate the drive assembly 10 from the working assembly 30; a guidewire is inserted into the subject's body, and the entry assembly (pump 36 in a folded state) is delivered to the desired location in the subject's body through the cooperation of the guidewire with the first or second guide channel; the guidewire is removed, and the first or second guide channel (i.e., the end face opening and bypass outlet) is sealed; fluid is infused into the working assembly 30 through the perfusion channel; subsequently, the drive assembly 10 and the working assembly 30 are connected via the locking mechanism, and the radial constraint of the pump on the pump 36 is removed, allowing it to unfold. Starting the motor 14 of the drive assembly 10 enables the drive assembly 10 to drive the pump 36 of the working assembly 30 into a working configuration, thereby achieving the function of assisting the heart's pumping function.

[0261] Please participate Figure 11 In another embodiment of the invention, a second locking mechanism is provided to lock and unlock the insert bushing and the receiving bushing. Specifically, the outer surface of the insert bushing 199 is recessed inward to form a locking groove 193L; the inner wall of the receiving bushing 197 has a generally annular receiving groove 191; the locking member is configured as a generally annular spring coil 195 formed on the inner wall of the receiving bushing 197, which is confined within the receiving groove 191. The depth of the receiving groove 191 is less than the diameter of the spring coil 195. Preferably, the spring coil 195 is a helical spring, and the projection of the spring coil 195 onto the radial plane is elliptical. The depth of the receiving groove 191 is less than the width of the major axis of the spring coil 195.

[0262] Thus, the spring ring 195 protrudes from the inner surface of the receiving bushing 197. The spring ring 195 has a radially recoverable deformation. When the locking groove 193L is opposite to the receiving groove 191, the spring ring 195 can be simultaneously engaged in the locking groove 193L and the receiving groove 191 to achieve locking.

[0263] The depth to which the spring coil 195 sinks into the receiving groove 191 when the insert bushing 199 engages with the receiving bushing 197 is greater than the depth to which the insert bushing 199 sinks into the receiving groove 191 when it is not engaged with the receiving bushing 197. In other words, when the insert bushing 199 engages with the receiving bushing 197, the reaction force of the insert bushing 199 on the spring coil 195 causes the spring coil 195 to sink further into the receiving groove 191, ensuring reliable locking. The recoverable deformation of the spring coil 195 does not exceed 20%, further does not exceed 15%, and even further does not exceed 10%. This makes the locking and unlocking operations more reliable.

[0264] The insertion bushing 199 is also provided with a clearance groove 193U spaced apart from the locking groove 193L. The depth of the clearance groove 193U is greater than the depth of the locking groove 193L, and the width of the clearance groove 193U is greater than the width of the locking groove 193L. The clearance groove 193U is farther away from the receiving bushing 197 relative to the locking groove 193L. The distance between the bottom of the locking groove 193L and the bottom of the receiving groove 191 is less than the major axis width of the spring coil 195. The distance between the bottom of the clearance groove 193U and the bottom of the receiving groove 191 is greater than or equal to the major axis width of the spring coil 195.

[0265] An clearance groove 193U is provided on the insert bushing 199 to make the unlocking operation easier. From Figure 11 Figures a to d illustrate the locking and unlocking process. In Figure a, the insert bushing 199 is inserted into the receiving bushing 197. During insertion, when the locking groove 193L is aligned with the receiving groove 191, the spring coil 195 located in the receiving groove 191 engages with the locking groove 193L, locking the insert bushing 199 and the receiving bushing 197. At this time, the tilt direction of the spring coil 195 is the same as the insertion direction of the insert bushing 199. That is, during the insertion of the insert bushing 199, the spring coil 195 is pushed by the insert bushing 199, causing deformation in the insertion direction and engaging with the locking groove 193L, thus achieving locking. After locking, since the deformation direction of the spring coil 195 is the same as the insertion direction, the pull-out direction of the insert bushing 199 is opposite to the deformation direction of the spring coil 195. A self-locking mechanism is formed between the spring coil 195 and the locking groove 193L, preventing the insert bushing 199 from being pulled out directly.

[0266] When unlocking is required, insert bushing 199 is further inserted into receiving bushing 197 along the insertion direction. When the clearance groove 193U is opposite to the receiving groove 191 (as shown in Figure c), since the distance between the bottom of the clearance groove 193U and the bottom of the receiving groove 191 is greater than or equal to the width of the long axis of the spring coil 195, the spring coil 195 returns to its deformation and no longer applies a locking force to the insert bushing 199 and receiving bushing 197. At this time, the insert bushing 199 can be pulled out relative to the receiving bushing 197, as shown in Figure d. During the pulling process, the pulling direction of the insert bushing 199 is the same as the deformation direction of the spring coil 195. Even if the spring coil 195 gets stuck when passing the locking groove 193L, the insert bushing 199 can still be completely pulled out of the receiving bushing 197 to achieve unlocking.

[0267] Please participate Figures 12 to 13In another embodiment of the invention, a third locking mechanism is provided to achieve locking and unlocking between the insert bushing and the receiving bushing. Specifically, a locking groove 185 is recessed outward from the inner surface of the receiving bushing 187, and a locking member is configured as a protrusion 183 formed on the outer wall of the insert bushing 189. The locking groove 185 includes a first groove 181 extending along the insertion direction of the receiving bushing 187 and a second groove 179 connecting the first groove 181. The extending direction of the second groove 179 forms an angle of non-zero with the extending direction of the first groove 181. The inner wall of the second groove 179 forms a stop surface 177 for the protrusion 183 to engage.

[0268] When locking is required, the protrusion 183 aligns with the opening of the first groove 181 and slides within the first groove 181, causing the insertion bushing 189 and the receiving bushing 187 to approach each other axially. Subsequently, the protrusion 183 slides from the first groove 181 into the second groove 179, and slides within the second groove 179 until it abuts against the stop surface 177, at which point the insertion bushing 189 and the receiving bushing 187 are relatively fixed. When unlocking is required, the receiving bushing 187 or the insertion bushing 189 is rotated in the opposite direction, causing the protrusion 183 to slide from the second groove 179 into the first groove 181. Then, the receiving bushing 187 and / or the insertion bushing 189 are pulled axially to cause the protrusion 183 to slide out of the opening of the first groove 181, thus unlocking the insertion bushing 189 and the receiving bushing 187.

[0269] Preferably, the angle between the first groove 181 and the second groove 179 is 90° to prevent the protrusion 183 from sliding into the first groove 181 in the locked state, ensuring reliable locking. Furthermore, this locking scheme requires relative rotation of the two bushings. The 90° angle design between the two grooves accommodates the rotation of the two bushings. Therefore, during locking, the two bushings only need to rotate, without any further axial movement, making the locking operation convenient.

[0270] Please pay close attention. Figure 14 In another embodiment of the invention, a fourth locking mechanism is provided to lock and unlock between the insert bushing and the receiving bushing. Specifically, the motor end bushing and the intervention end bushing are plugged into each other, one of which is configured as a plug, and the other of which includes a slot for receiving the plug. The bushing configured as a plug is defined as the insert bushing, and the bushing defining the slot is defined as the receiving bushing. The device also includes a locking mechanism for engaging and fixing the insert bushing and the receiving bushing, the locking mechanism being configured to achieve axial fixation of the insert bushing and the receiving bushing by increasing friction.

[0271] The locking mechanism includes a clamp 169 fitted over the receiving bushing and a locking actuating element 167 operable to lock or release the clamp. The clamp includes a circumferentially extending body 165 with a circumferential extension angle of less than 360 degrees. The clamp also includes a first end 161 and a second end 162 connected to both ends of the body 165 and extending radially.

[0272] The locking mechanism is a cam with a radially varying cam surface 157 that abuts against the surface of the first end 161 that is away from the second end 162. The locking mechanism also includes a mating member 159 connected to the cam, one end of which is connected to the cam, and the other end which passes through the first end 161 and the second end 162 and abuts against the surface of the second end 162 that is away from the first end 161.

[0273] The rotation of the cam causes the cam surfaces 157 with different radial dimensions to abut against the first end 161. The rotation of the cam pulls the mating part 159 to move, thereby changing the distance between the first end 161 and the second end 162 of the clamp, causing the clamp to clamp or loosen the receiving bushing, thereby causing the receiving bushing to clamp or loosen the insertion bushing, thus achieving locking and unlocking.

[0274] In another embodiment of the invention, a fifth locking mechanism is provided to achieve locking and unlocking between the insert bushing and the receiving bushing. Specifically, the engagement portion is an opening penetrating the side wall of the receiving bushing or a groove penetrating only the inner wall of the receiving bushing; the outer surface of the insert bushing is recessed inward to form a receiving groove, and the locking member is configured as a pin or ball that is at least partially housed in the receiving groove and is radially movable; the radially outer end of the pin or ball has an unlocked state that does not exceed the outer surface of the insert bushing to unlock the insert bushing and the receiving bushing, and a locked state that extends radially outward from the outer surface of the insert bushing to engage with the engagement portion to fix the insert bushing and the receiving bushing together.

[0275] A resilient reset element is biased between the pin or ball and the receiving groove. The reset force applied by the resilient reset element to the pin or ball causes it to always move radially outward to maintain the locked state or move toward the locked state. After the insert bushing and the receiving bushing are axially inserted into place, the resilient reset element causes the pin or ball to automatically engage with the opening or groove of the receiving bushing, thus achieving locking. When unlocking is required, the insert bushing and / or receiving bushing are axially pulled to overcome the force of the resilient reset element, causing the pin or ball to disengage from the opening or groove, thereby achieving unlocking.

[0276] In another embodiment of the invention, a sixth locking mechanism is provided to achieve locking and unlocking between the insert bushing and the receiving bushing. Specifically, the locking mechanism is configured to achieve axial fixation of the insert bushing and the receiving bushing by increasing friction. Specifically, the locking mechanism includes a threaded hole penetrating the sidewall of the receiving bushing and a bolt screwed into the threaded hole; the bolt is operably rotated to press its inner end against or disengage from the outer surface of the insert bushing, thereby achieving locking and unlocking between the insert bushing and the receiving bushing.

[0277] It should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This way of describing the specification is only for clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

[0278] The detailed descriptions listed above are merely specific descriptions 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: A drive assembly and a working assembly detachably connected to the drive assembly; The drive assembly includes a motor and an active magnet driven by the motor; The working components include: Connecting shaft; A passive magnet is located at the proximal end of the connecting shaft and is coupled to the active magnet; catheter; A drive shaft, which passes through a conduit and is connected to the distal end of the connecting shaft; A pump for pumping blood to a desired location in the heart includes: a pump housing having an inlet end and an outlet end, and an impeller housed within the pump housing; the impeller is connected to the distal end of a drive shaft and is driven to rotate to draw blood from the inlet end into the pump housing and discharge it from the outlet end. in: The active magnet and the passive magnet have two engagement states: in the first engagement state, the passive magnet and the active magnet rotate synchronously; in the second engagement state, the rotational speed of the passive magnet is lower than that of the active magnet. Furthermore, before the motor speed decreases to a specific threshold, the active magnet and the passive magnet can only switch from the first engagement state to the second engagement state.

2. In the device as described in claim 1, during the process of the motor starting and its rotational speed increasing from zero to the set rotational speed in the first cooperative state, the rotational speed of the passive magnet increases synchronously with the rotational speed of the motor.

3. In the device as described in claim 2, after the motor reaches the set speed, the rotational speed of the passive magnet is basically maintained at the set speed.

4. The apparatus of claim 1, wherein when the resistance encountered by the working component is greater than the rated torque between the active magnet and the passive magnet, the active magnet and the passive magnet switch from the first engagement state to the second engagement state.

5. In the device as described in claim 4, after the active magnet and the passive magnet switch from the first engagement state to the second engagement state, the rotational speed of the passive magnet does not increase as the resistance decreases or disappears.

6. In the apparatus of claim 1, after the active magnet and the passive magnet switch from the first engagement state to the second engagement state, the rotational speed of the passive magnet decreases to a specific value and then remains substantially at that specific value.

7. The apparatus of claim 6, wherein the specific value is at least 50% lower than the rated rotational speed at which the active magnet is driven to rotate by the motor.

8. The apparatus of claim 1, wherein when the active magnet and the passive magnet are in the second engagement state, when the rotational speed of the motor decreases to less than the specific threshold, the active magnet and the passive magnet switch to the first engagement state.

9. In the device of claim 1, when the rotational speed of the motor is reduced to approximately equal to the rotational speed of the passive magnet, the active magnet and the passive magnet can switch from the second engagement state to the first engagement state.

10. A device for assisting the heart in the event of cardiac failure, comprising: A drive assembly and a working assembly detachably engaged with the drive assembly; The drive assembly includes a motor and an active magnet driven by the motor; The working components include: Connecting shaft; A passive magnet is located near the end of the connecting shaft and is coupled to the active magnet. catheter; A drive shaft, which passes through a conduit and is connected to the distal end of the connecting shaft; A pump for pumping blood to a desired location in the heart includes: a pump housing having an inlet end and an outlet end, and an impeller housed within the pump housing; the impeller is connected to the distal end of a drive shaft and is driven to rotate to draw blood from the inlet end into the pump housing and discharge it from the outlet end. in: When the resistance of the working component is less than or equal to the rated torque between the active magnet and the passive magnet, the passive magnet and the active magnet are in a first engagement state of synchronous rotation; when the resistance of the working component is greater than the rated torque between the active magnet and the passive magnet, the passive magnet is in a second engagement state with a rotational speed lower than that of the active magnet.

11. The apparatus of claim 10, wherein the active magnet and the passive magnet can only switch from the first engagement state to the second engagement state before the rotational speed of the motor decreases to a specific threshold.

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