WO2023284339A1 - 用于对心脏在发生功能衰竭时进行辅助的装置 - Google Patents
用于对心脏在发生功能衰竭时进行辅助的装置 Download PDFInfo
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- WO2023284339A1 WO2023284339A1 PCT/CN2022/086472 CN2022086472W WO2023284339A1 WO 2023284339 A1 WO2023284339 A1 WO 2023284339A1 CN 2022086472 W CN2022086472 W CN 2022086472W WO 2023284339 A1 WO2023284339 A1 WO 2023284339A1
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- magnet
- passive
- active
- passive magnet
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
Definitions
- the invention relates to a device for assisting the heart when its function fails, and belongs to the technical field of medical devices.
- Heart failure is a life-threatening disease, and once it progresses to an advanced stage, the one-year mortality rate is about 75%.
- ventricular assist device technology Given the limited number of heart donors in advanced heart failure, ventricular assist device technology has emerged as a viable therapeutic or alternative treatment option between erected subjects and transplant surgery.
- adverse events caused by current technology still limit the use of ventricular assist devices in the treatment of critically ill subjects.
- the existing ventricular assist devices have problems such as low transmission efficiency, and the continuous improvement of the safety of ventricular assist devices has always been a technical problem that those skilled in the art are committed to improving.
- the purpose of the present invention is to provide a device for assisting the heart in failure, which can significantly improve the performance of the device.
- a device for assisting the heart when its function fails comprising: a driving assembly and a working assembly detachably connected with the driving assembly.
- the drive assembly includes a motor, an active magnet driven by the motor.
- the working assembly includes: 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 far end of the connecting shaft, and a pump.
- the pump includes: a pump casing having an inlet port and an outlet port, and an impeller accommodated in the pump casing. An impeller is connected to the distal end of the drive shaft to be driven in rotation to draw blood into the pump housing from the inlet end and out from the outlet end.
- the active magnet and the passive magnet have synchronous rotation in a first mating state and a second mating state in which the rotational speed of the passive magnet is lower than that of the active magnet. Before the rotational speed of the motor decreases to a certain threshold, the active magnet and the passive magnet can only switch from the first mating state to the second mating state.
- the passive magnet and the active magnet are in the first mating state.
- the resistance of the working assembly is greater than the rated torque between the active magnet and the passive magnet, the passive magnet is in the second mating state.
- the present invention has the following beneficial effects: the device of the present invention can obviously improve the performance of the device, and can enhance the safety of the device.
- Fig. 1 and Fig. 2 are three-dimensional schematic diagrams of different angles of the device provided by the present invention.
- Fig. 3 is a three-dimensional schematic diagram of the separation of the drive assembly and the working assembly of the device shown in Fig. 1;
- Fig. 4 is an axial sectional view of the device shown in Fig. 1;
- Fig. 5 is a partial three-dimensional exploded schematic diagram of the device shown in Fig. 1;
- Fig. 6 is a sectional view of the device shown in Fig. 1 along a plane perpendicular to the axial direction;
- Fig. 7 is the partial structure of the drive assembly of the device shown in Fig. 1 along the sectional view of a plane of axial aspect;
- Fig. 8 is the sectional view of another plane along the axial aspect of the partial structure of the working assembly of the device shown in Fig. 1;
- FIG. 9 and 10 are partial cross-sectional views of the proximal end of the working assembly of the device shown in FIG. 1.
- the sealing member closes the end face opening at the proximal end; in FIG. Connected to the outside world.
- Fig. 11 shows a schematic structural view of a locking mechanism provided by another embodiment of the present invention.
- Fig. 14 shows a schematic structural diagram of a locking mechanism provided by another embodiment of the present invention.
- proximity refers to the clinician who manipulates the device (hereinafter referred to as the device) for assisting the heart when its function fails.
- proximal and posterior refer to the part relatively close to the clinician
- distal refers to the part relatively far away from the clinician.
- the driving component is at the proximal end and the rear end
- the working component is at the distal end and the front end; for another example, the proximal end of a certain part/component means the end relatively close to the driving component, and the far end means the end relatively close to the working component.
- the device of the present invention defines "axial direction” or “axial extension direction” by the extension direction of the motor shaft, connecting shaft, and drive shaft.
- the driving shaft is a flexible shaft, and the axial direction of the driving shaft refers to the axial direction when the driving shaft is adjusted to extend in a straight line.
- the terms “inner” and “outer” used in the present invention are relative to the axially extending centerline, the direction relatively close to the centerline is “inner”, and the direction relatively far away from the centerline is “outer”.
- orientations of “near”, “far”, “rear”, “front”, “inner”, and “outer” are definitions for convenience of description.
- the device can be used in many orientations and positions, and thus these terms expressing relative positional relationships are not intended to be limiting and absolute.
- the above definition of each direction is only for the convenience of explaining the technical solution of the present invention, and does not limit the auxiliary device of the present invention when it includes but is not limited to product testing, transportation and manufacturing, etc., which may lead to its inversion or position
- the orientation in the scene where the transformation occurs In the present invention, if the above definitions are otherwise clearly defined and limited, they shall follow the above clearly specified and limited.
- connection and “connected” should be interpreted in a broad sense unless otherwise specified and limited. For example, it can be a fixed connection, a detachable connection, a movable connection, or an integral body; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components or two components. interaction relationship. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
- the device 100 of the embodiment of the present invention can partially replace the pumping function of the heart, and at least partially reduce the burden on the heart.
- the above-mentioned "replacement” can indicate that the heart has failed or declined to a certain extent, but still has a certain blood pumping function, but the blood pumping function is weak and it is difficult to maintain the cardiac output required for normal survival of the body.
- the device 100 can be used as a left ventricular assist, and its working part (specifically referred to as the pump below) can be inserted into the left ventricle, and the pump can pump the blood in the left ventricle when it is running into the ascending aorta.
- the pump can pump the blood in the left ventricle when it is running into the ascending aorta.
- the device 100 is used as left ventricular assistance, which is only a possible application scenario of the device 100 .
- the device 100 can also be used as a right ventricular assist, the working part can be inserted into the right ventricle, and the pump pumps the blood in the vein to the right and left ventricle during operation.
- the device 100 can also be adapted 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 as Placed within the subclavian or jugular vein at the junction of the vein with the lymphatic duct and used to increase the flow of lymphatic fluid from the lymphatic vessel to the vein.
- the following will mainly use the device 100 as left ventricular assistance as the main scenario for illustration. However, based on the above description, it can be seen that the protection scope of the embodiments of the present invention is not limited thereby.
- the device 100 includes a driving assembly 10 and a working assembly 30 .
- the drive assembly 10 includes a motor housing 12 and a motor 14 accommodated in 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 driving assembly 10 provides power for the working assembly 30 to drive the working assembly 30 to realize the function of pumping blood.
- the pump 36 and part of the catheter 32 (specifically, the front end of the catheter 32 ) are sent into and kept in the body of the subject, and it is desirable that the size of the pump 36 and the catheter 32 be as small as possible. Therefore, the axially projected areas of the pump 36 and the conduit 32 are smaller than the axially projected areas of other components of the working assembly 30 and also smaller than the axially projected area of the driving assembly 10 .
- the pump 36 and the catheter 32 with a smaller size can enter the human body through a smaller intervention size, which reduces the pain caused to the subject during the intervention process and reduces complications caused by an oversized intervention size.
- Other parts of the working assembly 30 may have relatively large dimensions, so as to meet the requirements of structural design.
- the relatively large size of the drive assembly 10 can meet the needs of structural design and provide sufficient power for the drive shaft 34 and the pump 36 to meet the power requirements of the drive shaft 34 and the pump 36 .
- the driving assembly 10 is detachably connected with the working assembly 30 .
- the driving assembly 10 and the working assembly 30 can be disassembled to prevent the larger and heavier driving assembly 10 from affecting the pump 36 and the front end of the catheter 32
- the operation in which part is sent into the subject's body is easier to operate.
- the driving assembly 10 drives the working assembly 30 through magnetic coupling, specifically:
- the driving assembly 10 includes a socket, and the working assembly 30 includes a coupler.
- the socket 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 intervening end bushing 40 disposed at the proximal end of the working component 30 and a passive magnet 42 accommodated inside the intervening end bushing 40 and connected to the proximal end of the driving shaft 34 .
- the transmission chain of the driving assembly 10 includes a motor shaft 16 and an active magnet 22 connected to the motor shaft 16 .
- the transmission link of the working assembly 30 includes a passive magnet 42 , a connecting shaft 44 on which the passive magnet 42 is installed, a driving shaft 34 connected to the distal end of the connecting shaft 44 , and a pump 36 connected to the distal end of the driving shaft 34 .
- a protective head 38 is provided at the distal end of the pump 36, which is configured to be soft so as not to damage the tissue of the subject, and the protective head 38 can exhibit flexibility from any macro material.
- the protective head 38 is a flexible protrusion (Pigtail or Tip member) with an arc-shaped or coiled end, and the flexible end is supported on the inner wall of the ventricle in a non-invasive or non-damaging manner, and the pump 36
- the suction port of the pump is separated from the inner wall of the ventricle, so as to prevent the suction port of the pump 36 from adhering to the inner wall of the ventricle due to the reaction force of the fluid (blood) during the working process, so as to ensure the effective area of pumping.
- the driving shaft 34 is a flexible shaft that can be deformed visible to the naked eye.
- the proximal end of the connecting shaft 44 is equipped with a passive magnet 42, the connecting shaft 44 is a hard shaft, and the hard shaft cannot undergo visible deformation, which can make the installation of the driving magnet more stable.
- the motor shaft 16 drives the active magnet 22 to rotate
- the passive magnet 42 is magnetically coupled with the active magnet 22
- the passive magnet 42 is driven to rotate by the active magnet 22
- the passive magnet 42 rotates to drive the connecting shaft 44 and the drive shaft 34 to rotate in turn.
- the drive shaft 34 rotates to drive the pump 36 to pump blood.
- the active magnet 22 and the passive magnet 42 have a first mating state in which they rotate synchronously, and a second mating state in which the rotational speed of the passive magnet 42 is lower than that of the active magnet 22 .
- the rotation speed of the passive magnet 42 increases synchronously with the rotation speed of the motor 14 .
- the speed of the passive magnet 42 basically maintains the set speed. That is to say, in the first mating state, the passive magnet 42 begins to increase dynamically with the rotational speed of the motor 14 . After reaching a specific value, the specific value is basically maintained.
- the rotational speed of the passive magnet 42 is basically the same as that of the active magnet 22, thereby maximizing the efficiency of transmission.
- the first mating state is a state in which the device 100 is in normal use.
- resistance may be encountered.
- the resistance encountered by working assembly 30 arises from contact between the components it contains and adjacent components.
- the above-mentioned resistance also includes contact between the working component 30 and human tissue.
- the contact between the impeller and the inner wall of the ventricle, and between the drive shaft 34 and the inner wall of the blood vessel is caused by damage to the membrane 3632 and the catheter 32 .
- the passive magnet 42 still maintains a high rotational speed
- the impeller driven by the passive magnet 42 rotates at a high speed, which may aggravate wear between parts or cause damage to human tissue.
- the active magnet 22 and the passive magnet 42 will automatically switch to the second mating state.
- the rotational speed of the passive magnet 42 is lower than that of the active magnet 22 , which can slow down or even avoid wear caused by high-speed friction between components, and/or prevent the device 100 from causing damage to human tissues.
- the passive magnet 42 and the active magnet 22 are in The first mating state for synchronous rotation. That is to say, when the resistance encountered is small, the resistance is most likely due to the normal friction of related parts, such as the friction between the drive shaft 43 and the inner wall of the conduit 32, the bearing supporting the connecting shaft 44, the bearing supporting the impeller Rotational friction, etc., is unlikely to be due to contact between rotating parts such as the drive shaft 43 and/or impeller and human tissue due to exposure. At this time, the active magnet 22 and the passive magnet 42 are in the first mating state, and can maintain normal blood pumping work.
- the active magnet 22 and the passive magnet 42 switch from the first mating state to the second mating state and remain in the second mating state. That is to say, when a large resistance is encountered, there is a high probability that at least one of events such as jamming between the drive shaft 43 and the inner wall of the conduit 32, the bearing supporting the connecting shaft 44, and the bearing supporting the impeller occurs, and/or, the driving Rotating parts such as the shaft 43 and/or the impeller come into contact with human tissue.
- the rotating speed of the passive magnet 42 is reduced, and the rotating speed of the impeller can be quickly reduced, thereby preventing component wear from increasing and the driving shaft 43 and/or the impeller from hurting human tissue.
- the rotating speed of the passive magnet 42 does not increase with the reduction or disappearance of the resistance, but decreases to a specific value and then basically maintains at the specific value.
- the specified value is at least 50% lower than the rated rotational speed at which the active magnet 22 is driven by the motor 14 to rotate.
- the rated rotational speed of the active magnet 22 is the rotational rotational speed driven by the motor 14 under the rated power.
- the above numerical values include all values from the lower value to the upper value in increments of any one unit between the lower value and the upper value, and there is a difference of at least two units between any lower value and any higher value.
- the interval is fine.
- the specific value is at least 50% lower than the rated rotational speed at which the active magnet 22 is driven by the motor 14, preferably 5%-45°, more preferably 10%-40%, and even more preferably 15%-35% , more preferably 20% ⁇ 30%, the purpose is to illustrate the above-mentioned not explicitly listed such as 6%, 8%, 12%, 16%, 18%, 22%, 24%, 28%, 32%, 36% , 39%, 41%, 43%, 46%, 49%, etc.
- the passive magnet 42 is maintained at a specific value, and the impeller rotates at the lower specific value, and the speed of this rotation will not cause the aggravation of component wear and disturb the human body
- the impeller also maintains a certain rotation and blood pumping function, which can prevent the impeller from stopping to cause the blood flow to slow down, thereby avoiding the part where the working component 30 intervenes in the human body, such as the pump and the outer wall of the catheter 32, to the greatest extent.
- the risk of thrombus formation can be minimized to the greatest extent to avoid the damage to the human body caused by stopping the pump, and the safety of the device 100 can be improved.
- the active magnet 22 and the passive magnet 42 can only switch from the first mating state to the second mating state. That is, the rotational speed of the passive magnet 42 cannot be increased until the rotational speed of the motor 14 decreases to a certain threshold, which can prevent accidents.
- the active magnet 22 and the passive magnet 42 can switch to the first mating state only when the rotation speed of the motor 14 is lower than a certain threshold.
- the passive magnet 42 rotates synchronously with the active magnet 22 again, and the original normal working state can be restored.
- the specified threshold is less than the rotational speed of the motor 14 required by the device 100 to achieve a specified pumped blood flow.
- the actual or expected pump blood flow provided by the device 100 is 5 L/min, and the rotation speed supporting this flow is 20000-30000 rpm.
- the specific threshold may be 5000 rpm, or any value below 5000 rpm, including zero.
- the active magnet 22 and the passive magnet 42 can switch from the second mating state to the first mating state.
- the rotational speeds of the motor 14 and the passive magnet 42 are equivalent, the active magnet 22 and the passive magnet 42 can be coupled again, and the active magnet 22 drives the passive magnet 42 to rotate synchronously and gradually increase the rotational speed to the rated working state.
- the rerotation of the passive magnet 42 (impeller) can be realized without waiting for the motor 14 to be shut down and restarted.
- the rotational speed of the motor 14 decreases to zero, and the rotational speed of the passive magnet 42 decreases to zero accordingly.
- the passive magnet 42 is coupled with the active magnet 22 again, and the motor 14 is restarted again.
- the active magnet 22 can drive the passive magnet 42 to rotate synchronously, and the two switch to the first mating state.
- the motor 14 has a process of restarting, which can remind the user of the device 100 to rule out accidents, and the safety is higher.
- the active magnet 22 and the passive magnet 42 are in the first mating state again.
- the passive magnet 42 (impeller) gradually speeds up, if the working assembly 30 encounters greater resistance again, the active magnet 22 and the passive magnet 42 will switch from the first mating state to the second mating state again.
- the active magnet 22 and the passive magnet 42 can only switch from the first mating state to the second mating state, which will not be repeated here.
- the driving assembly 10 is detachably connected to the working assembly 3 , the driving assembly 10 includes a socket, and the working assembly 30 includes a coupler.
- the connection assembly is configured as follows: when the corresponding socket is not connected to the coupler, the motor end bush 20 is separated from the intervening end bush 40; The bushing 40 is connected, the active magnet 22 and the passive magnet 42 are at least partially coincident 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.
- the active magnet 22 can drive the passive magnet 42 more efficiently, improving transmission efficiency.
- the active magnet 22 and the passive magnet 42 are spaced apart in the axial direction, and the non-contact power transmission can be realized through the magnetic coupling between the two magnets, which is beneficial to realize the sealing of the fluid and prevent the fluid from entering the motor.
- the liquid referred to above is the purge liquid that needs to be poured into the human body during the operation of the device 100.
- the purge liquid is a physiological fluid that can partially maintain the functions of the human body, such as physiological saline, glucose solution, anticoagulant, or any combination of the above .
- connection assembly is further configured such that: the magnetic coupling force between the active magnet 22 and the passive magnet 42 when the corresponding socket and the coupler are in an unconnected state is smaller than that between the active magnet 22 and the passive magnet 42 when the corresponding socket and the coupler are in a connected state. Magnetic coupling force between magnets 42 .
- the driving assembly 10 and the working assembly 30 are in an unconnected state, the magnetic coupling force between the active magnet 22 and the passive magnet 42 is small, and the driving assembly 10 is not enough to drive the working assembly. 30. Avoid misuse.
- the driving assembly 10 and the working assembly 30 are in the connected state, the magnetic coupling force between the active magnet 22 and the passive magnet 42 is strong enough, and the driving assembly 10 can drive the working assembly 30 smoothly.
- 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 rotation resistance of the drive shaft 34; or, the magnetic coupling force is zero. Therefore, when the socket and the coupler are not connected, the driving assembly 10 cannot drive the working assembly 30, so as to avoid misoperation.
- the active magnet 22 and the passive magnet 42 have at least a state in which the axial projection coincidence degree is 0. That is to say, when the connector and the coupler are not connected, the active magnet 22 and the passive magnet 42 are completely staggered, the drive assembly 10 is far away from the working assembly 30, and the catheter 32 and the pump 36 of the working assembly 30 can be easily sent into the subject. In the body; and the active magnet 22 cannot drive the passive magnet 42, and the driving assembly 10 cannot drive the working assembly 30, so as to avoid misoperation.
- the cross-sectional shapes of the active magnet 22 and the passive magnet 42 along a direction perpendicular to the axial direction are substantially the same.
- the active magnet 22 and the passive magnet 42 may be cylindrical or conical. In this way, the cross-sectional shapes of the active magnet 22 and the passive magnet 42 are both circular.
- the surfaces of the two magnets facing each other have the same shape, which is beneficial to achieve better magnetic coupling. Therefore, in some embodiments, the overall shape of the active magnet 22 and the passive magnet 42 may be different, but the magnetization surfaces of the two are the same, which is also feasible. For example, one of the magnets is cylindrical and the other is conical.
- the axial alignment of the two magnets will affect the two coupling efficiencies, and will also affect the positional stability of the magnets in the axial direction and possible vibrations during the transmission process after coupling. Therefore, it is desirable that the two magnets be fully aligned in the axial direction.
- the two magnets After considering factors such as magnet manufacturing precision and assembly tolerance, it is acceptable for the two magnets to appear 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 projection coincidence degree 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 is completely aligned with the passive magnet 42 along the axial direction.
- the center of mass of the magnet can be its center of circle.
- the offset value of the centers of mass of the two magnets may be a radial offset value based on the axis center of the connecting shaft.
- the offset between the two can be the ratio of the difference between the offset between the two and the offset of any one magnet.
- the offset between the two is less than 20%, which can realize magnetic coupling and power transmission. Further, the offset between the two is less than 15%, 10%, 5% or even 1%. When the offset of the two is 0, the two magnets are fully aligned along the axial direction.
- the overlapping degree of the axial projections of the two magnets may be the ratio of the overlapping area of the axial projections of the two magnets to the axial projection area of any one magnet. Likewise, the coincidence degree is greater than or equal to 80%, further, greater than 85%, 90%, 95% or even 100%.
- the active magnet 22 can drive the passive magnet 42 more efficiently, the transmission efficiency is higher, and the driving assembly 10 can drive the working assembly 30 more efficiently, so that the working assembly 30 can be better realized as The subject's heart provides assistance in pumping blood.
- the active magnet 22 and the passive magnet 42 are circular magnets continuous in the circumferential direction, or the active magnet 22 and the passive magnet 42 include a plurality of magnets arranged at intervals in the circumferential direction.
- 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 a plurality of magnets arranged at intervals along the circumferential direction.
- the magnet 22 and the passive magnet 42 are still ring-shaped during the rotation process, thus, the rotational power of the motor 14 can be transmitted to the working assembly 30 continuously and stably, and the working assembly 30 can realize the blood pumping function stably and reliably.
- Passive magnet 42 is provided with passive magnet protection assembly 46 outside, and this protection assembly 46 can protect passive magnet 42 from mechanical or chemical damage on the one hand, on the other hand, can provide orientation to the magnetic force of passive magnet 42, restrict its magnetic field range, avoid An undesired spread of magnetic force occurs, allowing the passive magnet 42 to work reliably.
- the passive magnet protection assembly 46 includes a first protection layer at least partially covering the outer surface of the passive magnet 42 , and the first protection layer is configured to at least isolate liquid from contacting the passive magnet 42 . This liquid is the purge liquid mentioned above.
- the first protective layer isolates the liquid from being in contact with the passive magnet 42, which can prevent the liquid from corroding the passive magnet 42, prevent the magnet 42 from being corroded by the liquid and cause the magnetic force to weaken, and prolong the life of the magnet 42 providing magnetic force as much as possible.
- the first protective layer may be a waterproof coating.
- the waterproof coating can be light and thin but effectively isolate the contact between the liquid and the passive magnet 42 .
- the first protective layer formed by the waterproof coating has the advantages of thin thickness, light weight, easy forming and high bonding strength, and these advantages will provide beneficial promotion for coupling efficiency, assembly, production cost and service life.
- the advantage of thin thickness can reduce the setting space for the rear end face of the passive magnet 42, and then shorten the axial distance between the passive magnet 42 and the active magnet, which can improve the coupling efficiency between the two magnets and ensure the transmission effect of rotational power. , is extremely beneficial.
- the advantages of thin thickness and light weight can also reduce the size and gravity of the magnet, which is conducive to reducing the gravity of the working components and has high adaptability to the assembly space.
- the waterproof coating can be realized by using existing mature solutions such as spraying, evaporation, and PVD, which have lower requirements on the manufacturing process and the corresponding manufacturing costs can also be reduced.
- the high bonding strength can significantly improve the anti-peeling performance of the waterproof coating, continuously provide waterproof protection for the magnet 42, and prolong the life of the magnet 42.
- the first protective layer may be a mechanical structure that wraps or wraps the passive magnet 42 to form a first storage cavity for storing the passive magnet 42 therein. Similar to the above embodiment of the waterproof coating, the first storage chamber can reliably protect the passive magnet 42 and reliably isolate the passive magnet 42 from being corroded by liquid.
- the passive magnet 42 is arranged at the proximal end of the connecting shaft 44 .
- the connecting shaft 44 is of variable diameter structure, and its proximal end has a larger diameter, forming a mounting portion 441 , and the passive magnet 42 is sheathed outside the mounting portion 441 .
- the first protective layer includes a first proximal protection member 451 covering the proximal end surface of the passive magnet 42, a first distal protection member 452 sleeved outside the connecting shaft 44 and covering the distal end surface of the passive magnet 42, and a first distal protection member 452 connected to the first
- the first peripheral protection member 453 between the proximal protection member 451 and the first distal protection member 452 and covers the peripheral surface of the passive magnet 42 .
- the first proximal protection part 451 , the first distal protection part 452 , the first peripheral surface protection part 453 and the connecting shaft 44 jointly define the first receiving cavity.
- the first proximal protection member 451 is in the shape of a thin plate or sheet, and fits on the proximal end surface of the passive magnet 41 , and is connected to the proximal end of the connecting shaft 44 , and the connection is preferably a fixed connection.
- the first proximal protection member 451 is integrated with the connecting shaft 44 . That is, the first proximal protection member 451 is formed by extending radially outward from the proximal end of the connecting shaft 44 .
- the first proximal protection member 451 of this structure can fix and limit the passive magnet 42 .
- the two magnets have a tendency to move towards each other under the action of magnetic force. Therefore, adopt the mode that the first proximal protection part 451 is fixedly connected with the proximal end of the connecting shaft 44, the first proximal protection part 451 acts as a stopper for the passive magnet 42 or restricts its movement toward the proximal end, and maintains the passive magnet 42. The position is fixed.
- the first distal protection member 452 is in the shape of a circular thin plate or sheet, and is sleeved on the outside of the connecting shaft 44 . In this way, the proximal and distal protection pieces 451 , 452 can clamp the passive magnet 42 in the axial direction, keeping the position of the passive magnet 42 fixed.
- a step is formed at the distal end of the mounting portion 441 .
- the first distal protection member 452 can lean against the step, and the step can form a limit on the first distal protection member 452 to ensure that its axial position is fixed.
- the shape of the first peripheral surface protector 453 is adapted to the trend of the outer peripheral surface of the passive magnet 42, such as a hollow cylinder, a conical thin plate or a sheet, and is attached to the outer peripheral surface of the passive magnet 42.
- the front and rear ends are respectively connected to the near and far ends.
- the protection pieces 451, 452 are connected.
- the first protective layer configured as a waterproof coating or the first protective layer configured as the first storage cavity
- the first protective layer is non-magnetic and configured to rotate with the passive magnet 42 . That is, the first protective layer and the passive magnet 42 are fixedly arranged, and the two remain relatively stationary.
- the non-magnetic first protective layer can prevent the passive magnet 42 from magnetically absorbing some impurities and affect the normal operation of the passive magnet 42; in addition, it can also constrain the orientation of the magnetic force of the passive magnet 42 to avoid the undesired diffusion of the magnetic force of the passive magnet 42 Furthermore, on the one hand, the magnetic coupling force and coupling efficiency are improved, and on the other hand, other parts of the working assembly 30 can be avoided from being magnetized by the passive magnet 42, causing unnecessary troubles. For example, other components of the working assembly 30 are prevented from being magnetized to magnetically attract some impurities to affect the normal operation of the working assembly 30 .
- Passive magnet protection assembly 46 also includes a second protection layer disposed within intervening end bushing 40 and physically spaced from passive magnet 42 ; the second protection layer is configured not to rotate with passive magnet 42 .
- the second protection layer is arranged radially on the periphery of the passive magnet 42 and fixed in the inner cavity of the intervening bush 40 , and the second protection layer is arranged at a distance from the passive magnet 42 . Since the passive magnet 42 is rotatable, the second protective layer is fixed. Therefore, during the rotation process of the magnetic passive magnet 42 , the second protective layer moves relative to it due to the fixation. If the second protective layer is made of conductive material, eddy current may be generated in the second protective layer.
- the non-conductive configuration of the second protective layer can avoid the generation of eddy current in the second protective layer, ensure that the equipment shell is not charged, and avoid the risk of electric shock.
- the second protective layer is further configured with non-magnetic conduction, which can restrict the direction of the magnetic force. For details, please refer to the above description, and will not repeat them here.
- a first magnetic force constraining member is provided inside the inserting end bush 40 .
- the first magnetic constraining member is roughly disc-shaped, installed on the connecting shaft 44 , and located at the distal end of the passive magnet 42 .
- the first magnetic constraining component is disposed at the distal end of the connecting shaft 44, and the passive magnet 42 is fixed on the proximal end surface of the first magnetic constraining component.
- the first magnetic constraint is magnetically permeable. The first magnetic constraint can constrain the magnetic field lines of the passive magnet 42 on the proximal surface of the first magnetic constraint, preventing the magnetic force of the passive magnet 42 from spreading forward, that is, away from the active magnet 22 .
- the active magnet 22 is also provided with an active magnet protection assembly 24, which can protect the active magnet 22 from mechanical or chemical damage on the one hand, and on the other hand, can provide orientation to the magnetic force of the active magnet 22, and constrain it.
- the range of the magnetic field avoids the undesired diffusion of the magnetic force, so that the active magnet 22 can work reliably.
- the active magnet protection assembly 24 includes a third protection layer at least partially covering the outer surface of the active magnet 22 .
- the third protective layer can be a mechanical structure that wraps or wraps the active magnet 22 to form a second storage cavity for storing the active magnet 22 therein.
- the second storage cavity can reliably protect the active magnet 22 .
- the active magnet 22 is disposed at the distal end of the motor shaft 16 .
- a magnet fixing block 26 is formed or installed on the motor shaft 16 , and the active magnet 22 is sheathed outside the magnet fixing block 26 .
- the third protective layer includes the second distal protection member 251 covering the distal end face of the active magnet 22, the second proximal protection member 252 sleeved outside the magnet fixing block 26 and covering the proximal end face of the active magnet 22, and connected to the second proximal end face of the active magnet 22.
- the second peripheral protection part 253 is between the two distal protection parts 251 and the second proximal protection part 252 and covers the peripheral surface of the active magnet 22 .
- the second distal protection part 251 , the second proximal protection part 252 , the second peripheral surface protection part 253 and the magnet fixing block 26 jointly define the second storage cavity.
- the second distal protection member 251 is in the shape of a thin plate or sheet, and fits on the distal end surface of the active magnet 22, and is connected to the distal end of the magnet fixing block 26, and the connection is preferably a fixed connection.
- the second distal end protection member 251 and the magnet fixing block 26 are integrally constructed. That is, the second distal end protection member 251 is formed by extending radially outward from the distal end of the magnet fixing block 26 .
- the second distal protection member 251 of this structure can fix and limit the active magnet 22 .
- two magnets have a tendency to move towards each other under the action of magnetic force. Therefore, the second distal protection member 251 is fixedly connected to the distal end of the connecting shaft 44, the second distal protection member 251 stops the active magnet 22 or restricts its tendency to move distally, and maintains the active magnet 22. The position is fixed.
- the second proximal protection member 252 is in the shape of a circular thin plate or sheet, and is sheathed outside the magnet fixing block 26 . In this way, the distal and proximal protectors 251 and 252 can respectively clamp the active magnet 22 in the axial direction, keeping the position of the active magnet 22 fixed.
- the shape of the second peripheral surface protector 253 is adapted to the trend of the outer peripheral surface of the active magnet 22, for example, it is in the shape of a hollow cylinder, a conical thin plate or a sheet, and is attached to the outer peripheral surface of the active magnet 22.
- the front and rear ends are respectively connected to the far and near ends.
- the protection pieces 251, 252 are connected.
- the third protection layer is non-magnetic and configured to rotate with the active magnet 22 . That is, the third protection layer and the active magnet 22 are fixedly arranged, and the two keep relatively stationary.
- the non-magnetic third protective layer can prevent the active magnet 22 from magnetically absorbing some impurities and affect the normal operation of the active magnet 22; in addition, it can also constrain the orientation of the magnetic force of the active magnet 22 to avoid undesired diffusion of the magnetic force of the active magnet 22 Furthermore, on the one hand, the magnetic coupling force and coupling efficiency are improved, and on the other hand, it is possible to prevent the active magnet 22 from magnetizing other components of the drive assembly 10, causing unnecessary troubles. For example, other components of the drive assembly 10 are prevented from being magnetized and some impurities are magnetically attracted to affect the normal operation of the drive assembly 10 .
- 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 .
- the fourth protective layer is arranged radially on the periphery of the active magnet 22 and fixed in the inner cavity of the intervening bush 40 , and the fourth protective layer is arranged at a distance from the active magnet 22 . Since the active magnet 22 is rotatable, the fourth protective layer is fixed. Therefore, during the rotation of the magnetically charged active magnet 22 , the fourth protection layer moves relative to it due to the fixation. If the fourth protection layer is made of conductive material, eddy current may be generated in the fourth protection layer.
- the non-conductive configuration of the fourth protective layer can avoid the generation of eddy current in the fourth protective layer, ensure that the equipment shell is not charged, and avoid the risk of electric shock.
- the fourth protective layer is further configured with non-magnetic conduction, which can restrict the direction of the magnetic force. For details, please refer to the above description, and will not repeat them here.
- a second magnetic force constraining member is provided inside the motor end bushing 20 .
- the second magnetic constraining member is generally disc-shaped, installed on the motor shaft 16 or the magnet fixing member 26 , and located at the proximal end of the active magnet 22 .
- the second magnetic constraining component is disposed at the proximal end of the motor shaft 16 or the magnet fixing component 26 , and the active magnet 22 is fixed at the distal end surface of the second magnetic constraining component.
- the second magnetic constraint is magnetically permeable.
- the second magnetic restraint can constrain the magnetic field lines of the active magnet 22 on the distal end surface of the second magnetic restraint, preventing the magnetic force of the active magnet 22 from spreading backward, that is, away from the active magnet 22 .
- the front end of the active magnet 22 is exposed.
- the second distal end protection member 251 can be eliminated, and the distal end of the motor end bushing 20 faces the part of the outer surface of the active magnet 22 in the radial direction to limit the position; or the active magnet 22 is directly fixed to the magnet holder 26 or The pair of motor shafts 16 prevents the active magnet 22 from moving axially upwards.
- the active magnet 22 is located on the drive assembly 10, and the drive assembly 10 is located outside the subject's body when the device 100 is working, the front end of the active magnet 22 is exposed without additional components, which can make the structure of the drive assembly 10 more compact; and The distance between the active magnet 22 and the passive magnet 42 can be made closer to improve transmission efficiency.
- the driving assembly 10 is detachably connected to the working assembly 30 .
- the bushing 20 at the motor end is detachably connected to the bushing 40 at the intervention end, so as to realize the detachable connection between the driving assembly 10 and the working assembly 30 .
- the motor end bushing 20 is mated with the intervening end bushing 40, one of the two is configured as a plug, and the other of the two includes a A socket configured to receive a plug; a bushing configured as a plug is defined as an inserting bushing, and a bushing defining a slot is defined as a receiving bushing; the device 100 also includes a lock for engaging and securing the inserting bush and the receiving bushing mechanism.
- the locking mechanism includes an engaging portion formed in one of the outer wall of the inserting bush and the inner wall of the receiving bushing, and a locking member operatively embedded in the engaging portion.
- the locking part is embedded in the joint part to realize locking, and the inserting bush and the receiving bush are relatively fixed; the locking part is disengaged from the joint part, and the inserting bush and the receiving bush can be disengaged.
- FIG. 6 shows the first locking mechanism provided by the specific embodiment of the present invention.
- the engaging portion is a lock groove 48 formed inwardly recessed from the outer surface of the inserting bush, and the side wall of the receiving bush is provided with an opening, and the locking member is configured as a radially movable pin 50; the pin 50 is operable to be inserted through the opening Or move out of the lock groove 48, thereby realizing locking or unlocking.
- the pin 50 is arranged in the supporting sleeve 52, and the supporting sleeve 52 is sleeved outside the receiving bush and fixedly arranged relative to the receiving bush.
- the support sleeve 52 is provided with a radially extending guide groove 54
- the guide groove 54 is formed by indenting outward from the inner wall of the support sleeve 52 , and the pin 50 slides in the guide groove 54 to realize locking or unlocking.
- the pin 50 has a locked state in which it is inserted into the lock slot 48 to securely engage the motor end bush 20 with the access end bush 40 , and an unlocked state in which it is removed from the lock slot 48 to release the fixed engagement of the motor end bush 20 with the access end bush 40
- the first elastic member 56 is biased between the pin 50 and the support sleeve 52, and the reset force exerted by the first elastic member 56 on the pin 50 makes the pin 50 have a tendency to maintain the locked state or move toward the locked state.
- a compressed first elastic member 56 is provided between the side of the pin 50 away from the lock groove 48 and the closed end of the guide groove 54, and the first elastic member 56 exerts a radially inward force on the pin 50,
- the pin 50 has a tendency to maintain the locked state or move towards the locked state.
- the side of the pin 50 facing away from the locking groove 48 is provided with an elastic member receiving groove 58 recessed inward, and the first elastic member 56 is partially accommodated in the elastic member receiving groove 58 .
- the first elastic member 56 can return to deformation more stably, so that the pin 50 has a tendency to maintain the locked state or move toward the locked state.
- the pin 50 includes a connected outer section 60 and an inner section 62, the width (diameter) of the outer section 60 is greater than the width of the inner section 62, and the elastic member receiving groove 58 is arranged on the wider outer section 60, The elastic member receiving groove 58 is formed inwardly from the end surface of the outer section 60 facing away from the locking groove 48 .
- the locking mechanism further includes an unlocking actuator rotatably arranged outside the receiving bush, and the unlocking actuator includes an annular main body portion 64, which is rotatably sleeved on the receiving bush.
- the unlocking actuator includes a profiling part 66 cooperating with the pin 50 , the profiling part 66 is connected with the annular main body part 64 , and the profiling part 66 protrudes radially outward from the annular main part 64 .
- the profiling part 66 is configured to exert a force on the pin 50 opposite to the reset direction of the first elastic member 56 when the annular body portion 64 of the unlocking actuator rotates along the first direction, Rotation in a second, opposite direction removes the force on pin 50 .
- the pin 50 includes an inner section 62 and an outer section 60 having unequal widths, and on the outer surface of the pin 50 , the junction of the inner section 62 and the outer section 60 forms a corner.
- the annular body portion 64 of the unlocking actuator is rotated in a first direction (clockwise as shown in FIG. 6 )
- the contoured member 66 abuts against the corner, exerting a radially outward force on the pin 50, By urging the pin 50 out of the lock slot 48, the insert and receiver bushings can be disengaged.
- the annular body portion 64 of the unlocking actuator rotates in the second direction (counterclockwise as shown in FIG. 6 )
- the profiling part 66 is away from the pin 50, and the pin 50 is inserted into the locking groove under the action of the first elastic member 56. 48.
- the inserting bush and the receiving bush are relatively fixed.
- the pin 50 is in the unlocked state when the unlocking actuator rotates to the first dead point along the first direction, and the pin 50 is in the locked state when the unlocking actuator rotates to the second dead point along the second direction. That is to say, during the rotation of the unlocking actuator in the first direction, the pin 50 moves radially outward and gradually unlocks. When the unlocking actuator rotates to the first dead point along the first direction, the pin 50 is completely disengaged from the locking groove 48, and the unlocking is successful.
- the pin 50 moves radially inward under the action of the first elastic member 56 and gradually locks.
- the profiling part 66 completely moves the overhead 50, and the pin 50 is inserted into the locking groove 48 to a certain depth to realize locking.
- a second elastic member 70 is provided between the unlocking actuator and the support sleeve 52, and the reset force exerted by the second elastic member 70 on the unlocking actuator makes it maintain the position at the second dead point or move toward the second dead point. trend.
- the reset force exerted by the first elastic member 56 on the pin 50 makes the pin 50 have a tendency to maintain the locked state or move toward the locked state, while the reset force exerted by the second elastic member 70 on the unlocking actuator makes it maintain the locking state.
- the profiling component 66 lets the state of the overhead 50 or tends to move toward the state of the overhead 50 .
- the first elastic member 56 and the second elastic member 70 have a synergistic effect. Only when the effects of the second elastic member 70 and the first elastic member 56 are overcome can the inserting bush be separated from the receiving bushing, and the pin 50 can be kept. The reliable locking of the inserting bush and the receiving bush prevents accidents during the working process of the device 100 .
- the support sleeve 52 is provided with a track opening 72 that is generally arc-shaped along the circumference.
- the unlocking actuator includes a locking protrusion 74 extending into the track opening 72.
- the locking protrusion 74 is connected with the ring-shaped main body 64 and along the Radially protrudes from the annular body portion 64 .
- the locking protrusion 74 has a first stop surface 76 pointing to the first direction and a second stop surface 78 pointing to the second direction, and the second elastic member 70 is arranged on the first stop surface 76 and the track opening 72 along the first between the inner walls of the direction.
- the second elastic member 70 is compressed so that the locking projection 74 has a state of keeping the second stop surface 78 abutting against the inner wall of the track opening 72 along the second direction, or has a tendency to move toward the second direction and abut against the inner wall, thereby
- the contoured part 66 of the unlocking actuator allows the overhead 50 to maintain the locked state.
- the unlocked state of the unlocking actuator corresponds to the state in which the locking protrusion 74 pushes the second elastic member 70 to be further compressed, so that the first stop surface 76 rotates in the inner wall direction toward the first direction in the track opening 72 .
- the profiling component 66 in the locked state, under the action of the second elastic member 70 , the profiling component 66 is away from the pin 50 , and the profiling component 66 cannot push the pin 50 .
- the pin 50 maintains the state of being inserted into the lock slot 48 under the action of the first elastic member 56 .
- overcome the active force of the second elastic member 70 overcome the active force of the second elastic member 70, and rotate the locking projection 74 along the first direction to drive the ring-shaped main body 64 to rotate.
- the pushing pin 50 moves radially outward against the force of the first elastic member 56 to unlock the inserting bush and the receiving bush.
- the unlocking actuator is connected with an operating member 80 located outside the support sleeve 52, and the operating member 80 is configured to receive an external force to drive the unlocking actuator to rotate in a first direction.
- the operating part 80 is fixedly connected with the locking protrusion 74, and the operating part 80 drives the locking protrusion 74 to rotate, and then drives the ring-shaped main part 64 and the profiling part 66 to rotate to realize unlocking.
- the operating member 80 includes an annular portion 82 sleeved on the support sleeve 52 .
- a part of the inner wall of the annular portion 82 is connected to the locking protrusion 74 ; another part of the inner wall of the annular portion 82 at least covers the part where the second elastic member 70 is installed in the track opening 72 of the supporting sleeve 52 . That is to say, the annular portion 82 , the locking protrusion 74 , and the supporting sleeve 52 are arranged to form a relatively closed space for accommodating the second elastic member 70 , which can ensure the reliable operation of the second elastic member 70 .
- the profiling part 66 extends radially outward relative to the annular body part 64 , to allow space for the movement of the profiling part 66 , the inner wall of the support sleeve 52 is recessed outwardly to form a clearance groove 84 .
- the circumferential extension length of the slot 84 be approximately equal to the length of the circumferential movement track of the unlocking actuator from locking to unlocking.
- the number of pins 50 is two, and the number of locking grooves 48 is also two.
- the pins 50 and the locking grooves 48 correspond one-to-one, that is, one pin 50 corresponds to one locking groove 48, and the two pins 50 are in a circumferential direction. Set at intervals of 180 degrees, the insertion bush and the receiving bush can be locked relatively evenly.
- the number of first elastic members 56 and the number of profiling parts 66 are also two, corresponding to the pins 50 one by one.
- the number of pins 50 is two, the number of the locking projection 74 and the operating member 80 is only one, that is, one operating member 80 and one locking projection 74 can operate two pins 50 at the same time, not only locking is reliable, but also Easy to operate.
- the number of the pin 50, the lock groove 48, the first elastic member 56, and the profiling member 66 can be more than two, and will not be repeated here.
- the first direction is referred to as a clockwise direction
- the second direction is referred to as a counterclockwise direction. But this is only for convenience of description, and does not constitute a limitation to the present invention.
- the reset force of the first elastic member 56 pushes the pin 50 to move radially inwards and inserts into the lock groove 48
- the reset force of the second elastic member 70 pushes the locking protrusion 74 to rotate counterclockwise until the second stop
- the blocking surface 78 abuts against the counterclockwise inner wall of the track opening 72 .
- the locking protrusion 74 rotates counterclockwise to drive the ring-shaped main part 64 and the profiling part 66 away from the pin 50 , and the pin 50 is inserted into the locking groove 48 under the action of the first elastic member 56 and remains locked.
- first elastic member 56 and the second elastic member 70 are compressed to store energy and have a tendency to reset. Therefore, the restoring action of the first elastic member 56 and the second elastic member 70 can be performed simultaneously.
- the operator pushes the operating member 80 to rotate clockwise, and the clockwise rotation of the operating member 80 drives the locking protrusion 74 to overcome the force of the second elastic member 70 to rotate clockwise, and the locking protrusion 74 rotates clockwise Drive the ring-shaped main part 64 and the profiling part 66 to rotate clockwise.
- the profiling component 66 rotates clockwise to abut against the corner of the pin 50 , the profiling component 66 pushes the pin 50 to move radially outward against the force of the first elastic member 56 , thereby realizing unlocking.
- the intervening end bushing 40 is configured to insert the bushing
- the motor end bushing 20 is configured to receive the bushing
- the front end of the motor housing 12 is configured to support Sleeve 52.
- the configuration of the inserting bush and the receiving bush can be substantially opposite to the above example. That is, the insertion end bush 40 is configured to receive the bush, the motor end bush 20 is configured to be inserted into the bush, and the support sleeve 52 is an additional component that complies with the description of the above embodiments.
- the device 100 of the present invention needs to be sufficiently compact in structure, and the size of each component needs to be sufficiently precise and small enough. Insertion fit between the insert bush and the receiving bush, because the size of the insert bush and the receiving bush is sufficiently precise, when the two are plugged and fitted, the space between the insert bush and the receiving bush is small, and the assembly resistance is relatively small Large, the assembly operation is not easy.
- a drag reducing structure is provided between the inserting bush and the receiving bush.
- the drag reducing structure is configured to reduce the insertion resistance to the inserting bush formed by compressed gas during the insertion of the inserting bush into the receiving bush.
- a gap is formed between the support sleeve 52 and the receiving bush;
- the drag reducing structure includes a pressure relief hole 86 penetrating through the side wall of the receiving bush. It communicates with the external space through the gap between the support sleeve 52 and the receiving bush. Therefore, when the inserting bush is inserted into the receiving bush, the gas between the inserting bush and the receiving bush can be discharged to the external space through the pressure relief hole 86, reducing or even avoiding the resistance of the compressed gas to the inserting bush.
- the drag reducing structure includes a pressure relief groove formed on the inner wall of the receiving bush and/or the outer wall of the insertion bush, and the pressure relief groove communicates with the external space.
- the pressure relief groove can store a part of air to reduce the resistance of the air; on the other hand, the pressure relief groove communicates with the external space, and the air can be discharged to the external space through the pressure relief groove, reducing or even avoiding the compression of the gas on the insert bushing formed resistance.
- the pressure relief groove extends along the insertion direction of the insert bush, and the extension may be a straight line or a curved line, such as a helical extension.
- the distal end of the pressure relief groove is connected to the proximal end of the inner wall of the receiving bushing and/or the distal end of the outer wall of the inserting bushing to realize communication with the external space.
- the pressure relief groove is only formed on the inner wall of the receiving bush.
- the pressure relief groove and the outer wall of the inserting liner define a passage leading to the external space to realize pressure relief.
- the pressure relief groove can also be formed only on the outer wall of the insert bush.
- the pressure relief grooves are simultaneously formed on the inner wall of the receiving bush and the outer wall of the inserting bush.
- the drag reducing structure includes a space formed between the insert bush and the receive bush when the insert bush and the receive bush are in an engaged state. This space is used to temporarily store the compressed air during the insertion of the inserting bush into the receiving bushing to indirectly achieve the purpose of pressure relief, thereby reducing the resistance of the compressed gas to the inserting bush.
- the space includes a groove formed in the insertion bush that is open toward the end.
- the groove makes there is a space between the inserting bush and the receiving bush, and at the same time, the gap between the outer wall of the inserting bush and the inner wall of the receiving bush can still be small enough, and the small enough gap not only makes the structure compact, but also makes the inserting bush and the receiving bush
- the receiving bush can be slidably fitted but not relatively shaken, which ensures the normal operation of the device 100 .
- the transmission link of the working assembly 30 includes a passive magnet 42, a connecting shaft 44 on which the passive magnet 42 is installed, a drive shaft 34 connected to the far end of the connecting shaft 44, and a pump 36 connected to the far end of the drive shaft 34 .
- the motor shaft 16 drives the active magnet 22 to rotate
- the passive magnet 42 is magnetically coupled with the active magnet 22
- the passive magnet 42 is driven to rotate by the active magnet 22
- the passive magnet 42 rotates to drive the connecting shaft 44 and the drive shaft 34 to rotate in turn.
- the drive shaft 34 rotates to drive the pump 36 to pump blood.
- the inserting end bush 40 is provided with a first axial channel 101 , and the connecting shaft 44 is rotatably provided in the first axial channel 101 .
- At least one bearing 90 is arranged on the outside of the connecting shaft 44 , and a damping member 92 is arranged between the outer ring of the bearing 90 and the inner wall of the first axial passage 101 .
- the damping member 92 can not only reduce vibration, but also provide a certain movement buffer space, so that the passive magnet 42 and the active magnet 22 can be aligned as much as possible, and the transmission efficiency can be improved.
- the flexible damping member 92 By setting the damping member 92 between the bearing 90 and the first axial channel 101, and configuring the damping member 92 to be flexible, the flexible damping member 92 can be squeezed and deformed by the connecting shaft 44, thereby reducing the vibration of the passive magnet 42. Provide radial deformation space. The extruded deformation of the damping member 92 will store energy at the same time, thereby providing a restoring effect on the connecting shaft 44 to make it axially centered, so that the alignment of the two magnets can be restored.
- the damping element 92 is substantially circular and sleeved on the outer peripheral surface of the bearing 90 . It should be noted that the damping element 92 may be continuous in the circumferential direction, or discontinuous in the circumferential direction, that is, it may comprise a plurality of arc-shaped damping elements. Due to the ring-shaped structural design of the damping member 92 , the damping member 92 can reset the vibration of the passive magnet 42 along a 360° circumferential direction.
- the forward portion of the pump and catheter is advanced by the subject's vasculature. While it is known that the vasculature is tortuous, in particular there are bends where the angle may be less than 30°.
- the driving shaft 34 Since the driving shaft 34 is passed through the catheter 32, the catheter 32 and the driving shaft 34 will bend to conform to the vasculature when being transported in such a tortuous vasculature. However, since the softness of the driving shaft 34 and the catheter 32 are different, and the driving shaft 34 is located inside the catheter 32 . Therefore, the drive shaft 34 will move axially in the conduit 32 during the delivery curve.
- the driving shaft 34 and the connecting shaft 44 are slidably fitted in the axial direction. Further, since the connecting shaft 44 needs to transmit the rotation to the driving shaft 34 , the driving shaft 34 and the connecting shaft 44 are circumferentially fixed.
- the proximal end of the drive shaft 34 is provided with or formed with a connecting portion 94, and the cross section of the connecting portion 94 is in any shape other than a circle;
- the distal end of the connecting shaft 44 is formed with a matching channel adapted to the connecting portion 94 , the connecting portion 94 is slidably inserted into the mating channel in the axial direction.
- the cross-section of the connecting portion 94 is any shape other than a circle, such as a square or an ellipse, configured as a flat shaft, which can prevent rotation in the circumferential direction, and ensure that the drive shaft 34 and the connecting shaft 44 are fixed in the circumferential direction, so that the drive shaft 34 and the connecting shaft 44 are fixed in the circumferential direction.
- the shaft 34 rotates synchronously with the connecting shaft 44 .
- the connecting portion 94 can be integrally constructed with the drive shaft 34 and can be configured as a part of the structure of the drive shaft 34 , specifically, the rear end of the drive shaft 34 can be obtained by a non-circular process.
- the connecting portion 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 above description.
- the pump 36 defines the distal position in the axial direction, that is to say, the mating channel and the pump 36 respectively define the proximal position and the distal position of the drive shaft 34 in the axial direction, so the drive shaft 34 will not be connected to the connecting shaft 44 slip fit and come off.
- 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 shaft 34 is penetrated in the catheter 32, and the catheter 32 prevents the drive shaft 34 from contacting with the outside world. On the one hand, it 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 the working process. cause harm.
- the pump 36 which can be delivered to the desired location of the heart through the conduit 32 to pump blood, includes a pump casing 363 connected to the distal end of the conduit 32 and having an inlet end 361 and an outlet end 362, an impeller (not shown) housed in the pump casing ), the impeller is rotated by the drive shaft 34 to draw blood into the pump housing 363 from the inlet port 361 and discharge it from the outlet port 362 .
- the pump casing 363 includes a metal lattice bracket 3631 made of nickel or titanium alloy and an elastic film 3632 covering the bracket 3631 .
- the metal lattice of the bracket 3631 has a mesh design
- the coating 3632 covers the part of the bracket 3631
- the mesh of the front end of the bracket 3631 not covered by the coating 3632 forms the inlet end 361 .
- the rear end of the membrane 3632 covers the outside of the distal end of the catheter 32
- the outlet end 362 is an opening formed at the rear end of the membrane 3632 .
- 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 may be in a helical shape, and the number of the blades may be one, or multiple such as two.
- the distal end of the drive shaft 34 is connected to the hub, and a proximal bearing chamber (not shown) is connected between the distal end of the catheter 32 and the proximal end of the bracket 3631 . That is, the bracket 3631 is connected with the catheter 32 through the proximal bearing chamber.
- the drive shaft 34 passes through the proximal bearing located in the proximal bearing chamber.
- a distal bearing chamber 37 is provided between the distal end of the bracket 3631 and the protection head 38 . That is, the protective head 38 is connected with the bracket 3631 through the distal bearing chamber.
- the distal end of the hub 12 is inserted into a distal bearing located in the distal bearing chamber 37 .
- the limit of the impeller 9 is formed by the proximal and distal bearings, so that the impeller can be preferably held in the pump casing 363, and the pump gap between the impeller and the pump casing 363 is stably maintained.
- the pump 36 is a collapsible pump with a compressed state and an expanded state.
- the pump housing 363 and the impeller are configured to: be in a compressed state in the corresponding interventional configuration of the pump 36, so that the pump 36 delivers in the subject's vasculature with a smaller first outer diameter dimension, and, when the pump 36 36 is in a deployed state corresponding to the operative configuration such that pump 36 pumps blood at a desired location with a second radial dimension that is greater than the first radial dimension.
- the size and hydrodynamic performance of the pump 363 are two conflicting parameters. In short, it is desirable that the size of the pump 363 be small from the standpoint of relieving the subject's pain and ease of intervention. In order to provide a strong auxiliary function for the subject, it is desirable that the flow rate of the pump 363 be large, which generally requires a large size of the pump 363 .
- the pump 363 has a smaller collapsed size and a larger expanded size, so as to reduce the pain of the subject during the intervention/transportation process, facilitate the intervention, and provide a large flow rate demand.
- the multi-mesh design of the pump casing 3631 can achieve better folding, and at the same time, it can be unfolded by virtue of the memory characteristics of nickel-titanium alloy.
- 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 a corresponding intervention configuration, and
- the pump 36 extends radially outward from the hub and is spaced from the inner wall of the pump 36 in the corresponding operative configuration.
- the blades are made of soft and elastic materials, which store energy when they are folded, and release the energy storage of the blades to unfold them after the external constraints are removed.
- the pump 36 is folded by means of external constraints, and after the constraints are removed, the pump 36 realizes self-deployment.
- the "compressed state” refers to the state in which the pump 36 is radially constrained, that is, the state in which the pump 36 is radially compressed and folded into a minimum radial dimension under external pressure.
- the “deployed state” refers to the state in which the pump 36 is not radially constrained, that is, the state in which the bracket 3631 and the radially outer side of the impeller are deployed to the maximum radial size.
- the aforementioned external constraints are applied by sliding a folded sheath (not shown) over the catheter 32 .
- the pump 36 When the folded sheath moves forward outside the catheter 32, the pump 36 can be accommodated in it as a whole, so that the pump 36 can be forcibly folded. When the folded sheath is moved rearwardly, the radial constraint on the pump 36 is lost and the pump 36 self-deploys.
- the retraction of the pump 36 is realized by means of the radial restraint force exerted by the folded sheath.
- the impeller contained in the pump 36 is accommodated in the pump casing 363. Therefore, in essence, the folding process of the pump 36 is: the folded sheath exerts a radial constraint force on the pump casing 363, and when the pump casing 363 radially compresses, it exerts a force on the impeller. radial restraint.
- the pump casing 363 is folded directly under the action of the folding sheath, while the impeller is directly folded under the action of the pump casing 363 .
- the impeller has elasticity. Therefore, although the impeller is in the collapsed state, the energy storage of the impeller always has a tendency to expand radially, and then the impeller will contact the inner wall of the pump casing 363 and exert a reaction force on the pump casing 363 .
- the pump housing 363 supports the expansion of the elastic membrane under the action of its own memory characteristic, and the impeller self-expands under the action of the released energy storage.
- the outer diameter of the impeller is smaller than the inner diameter of the pump casing 363 .
- the pump clearance size be kept at a small value.
- the outer diameter of the impeller is slightly smaller than the inner diameter of the bracket 3631, so that the pump clearance is as small as possible under the condition that the impeller rotates without bumping against the wall.
- the main means of maintaining the pump clearance is the supporting strength provided by the bracket 3631, which can resist the back pressure of the fluid (blood) without deformation, thereby keeping the shape of the pump casing 363 stable, and the pump clearance is also maintained. Hold steady.
- the pump 36 is radially constrained (compressed) due to an externally applied radial constraining force.
- the stent 3631 uses its own memory characteristics and the blades of the impeller expand autonomously with the release of energy storage, so the pump 36 automatically assumes its unconstrained shape (deployed state).
- the device 100 completes its work and needs to be withdrawn from the subject, use the foldable sheath to fold the pump 36. After the pump 36 is completely withdrawn from the subject, remove the restraint of the foldable sheath on the pump 36 to make the pump 36 returns to the natural state with the least stress, that is, the unfolded state.
- the device 100 also includes a perfusion channel that basically runs through the entire working assembly 30 . Specifically, the perfusion channel runs through the transmission link from the passive magnet 42 to the pump 36 .
- fluid can be injected into the perfusion channel, and the fluid is the Purge liquid described above, which can lubricate and cool down the transmission link.
- the proximal inlet 96 of the perfusion channel is a cavity provided at the proximal end of the intervention-end bushing 40 and containing the passive magnet 42 therein.
- the cavity not only accommodates the passive magnet 42, but also accommodates the passive magnet protection component 46 therein.
- the passive magnet 42 is the starting point of the transmission chain in the working assembly 30, and the proximal entrance 96 of the perfusion channel is set as a cavity in which the passive magnet 42 is accommodated, and fluid can be perfused in the cavity, and the fluid lubricates and cools the passive magnet 42 . Therefore, the perfusion channel lubricates and cools the transmission link from the starting point of the transmission link of the working component 30 to ensure the effective work of the working component 30 .
- the perfusion channel runs from the proximal end of the coupler to the distal end of the pump 36 . It should be particularly noted that this structural design can achieve the beneficial effect of convenient exhaust operation.
- the specific instructions are as follows:
- the perfusion fluid interface is located between the two ends of the working component, and is generally located closer to the proximal end of the working component, that is, the proximal end of the coupler.
- the working assembly is divided into a proximal section and a distal section located on both sides of the perfusion fluid interface. In this way, the exhaust operation needs to be performed on the proximal section and the distal section respectively.
- the exhaust operation needs to be performed twice. Specifically:
- a perfusion fluid source is connected to the perfusion fluid interface (set on the coupler shell), and the perfusion fluid source can be a syringe.
- Perfusate is accommodated in the syringe, and the perfusate is injected into the working component through the perfusate interface by pushing the syringe.
- the length of the distal section is much longer than that of the proximal section; in addition, the distal section is mainly composed of a catheter 32 , a drive shaft 34 and a pump 36 . Therefore, the flow resistance of the liquid in the distal section is much greater than the flow resistance in the proximal section.
- the perfusate enters the proximal section first, evacuating the proximal section of air.
- the fact that the air in the proximal section is evacuated can be verified by the perfusate flowing out from the end surface of the proximal section, that is, the first guide channel of the sealing member 118 described below.
- the proximal section is sealed, that is, the first guiding channel of the sealing member 118 is sealed (the specific sealing method is described below). Then use the syringe to pour liquid into the working components. Since the proximal section is sealed, perfusate can only flow toward the distal section, evacuating the distal section of air. Wherein, the air in the distal section is evacuated can be verified by perfusate flowing out from the end of the distal section, that is, the front end of the catheter 32 and/or the distal end of the hub of the impeller.
- the starting point of the perfusion channel in the embodiment of the present invention is the cavity for accommodating the passive magnet 42 , and the cavity is located at the proximal end of the entire working assembly.
- the perfusate enters from the proximal end of the entire perfusion channel, and the flow path of the perfusate can only go toward the far end of the working component.
- only one operation is required to realize the emptying of the working components, which greatly simplifies the emptying operation.
- the access end hub 40 is provided with a perfusion input channel 98 in communication with the lumen, the outer end of the perfusion input channel 98 passes out of the connection assembly and is intended to communicate with a source of perfusate.
- the outer end passes through the connecting component to facilitate communication with the perfusion fluid source, so as to provide fluid for the perfusion channel.
- the extension direction of the perfusion input channel 98 is set at an angle to the axial direction, so that the outer end of the perfusion input channel 98 is away from the proximal end of the working component 30, so as to avoid affecting the installation of the working component 30 and the driving component 10, and the perfusion is also more convenient.
- the design is very reasonable.
- the connecting shaft 44 is connected to the passive magnet 42 , specifically as mentioned above, the passive magnet 42 is sheathed on the installation part at the proximal end of the connecting shaft 44 .
- the connecting shaft 44 is installed on the coupler, specifically, the connecting shaft 44 is installed on the inserting end bushing 40, the inserting end bushing 40 is provided with a first axial channel 101, and the connecting shaft 44 is rotatably arranged in the first axial channel 101 middle.
- the connecting shaft 44 has an axially extending axial hollow cavity, which can also be referred to as a second axial channel 102 .
- the perfusion channel includes in the coupling part: the second axial channel 102 formed in the connecting shaft 44, the first gap formed between the connecting shaft 44 and the first axial channel 101; the second axial channel 102, the first axial channel 101 A gap communicates with the cavity.
- the fluid after the fluid is input from the perfusion input channel 98 , it first flows through the cavity for accommodating the passive magnet 42 , and then passes through the bearing and the first gap in sequence.
- the connecting portion 94 of the drive shaft 34 is plug-fitted with the matching passage of the connecting shaft 44 , the connecting portion 94 is hollow, and the connecting shaft 44 communicates with the inner axial passage of the driving shaft 34 .
- the mating channel is part of the second axial channel 102 .
- the matching channel is the distal part of the second axial channel 102, and the matching channel communicates with the proximal part of the second axial channel 102, and the radial width of the two is different to form a step, which is convenient for connection.
- the portion 94 is used to limit the axial direction of the proximal end.
- the fluid flows through the matching channel to cool down and lubricate the inside of the far end of the connecting shaft 44 and the connecting portion 94 at the proximal end of the drive shaft 34, and rationally utilize the installation of the connecting shaft 44 and the drive shaft 34.
- the structure cools and lubricates the two, and ensures the smoothness of the flow channel, and the structural design is very reasonable.
- the working assembly 30 includes a guide tube 32 , and the drive shaft 34 passes through the guide tube 32 .
- the perfusion channel also includes a second gap formed between the drive shaft 34 and the shaft lumen of the catheter 32 .
- the coupler also includes a positioning sleeve 108 connected to the distal end of the intervention end bushing 40; the proximal end of the catheter 32 is accommodated in the positioning sleeve 108, and the proximal end of the drive shaft 34 is exposed
- the positioning sleeve 108 is connected with the connecting shaft 44 .
- the positioning sleeve 108 includes a connected proximal part and a distal part, the end of the proximal part is connected to the inserting end bushing 40, and the proximal part is recessed from the proximal end surface along the direction toward the distal end to form an accommodating space 110 , the distal part forms a catheter storage cavity for receiving the catheter 32, the proximal end of the catheter 32 is stored in the catheter storage cavity, and the proximal end of the drive shaft 34 extends out of the catheter storage cavity and passes through the accommodation space 110 to connect with the connecting shaft 44.
- the radial width of the accommodating space 110 is greater than the width of the catheter receiving cavity. Therefore, a relatively large amount of fluid can be stored in the accommodating space 110, so that the liquid flows out from the first gap and the axial channel connecting the shaft 44, and then enters the fluid after being transferred and buffered in the larger accommodating space 110.
- the conduit 32 and the second gap prevent the liquid from holding pressure.
- the accommodating space 110 with larger diameter and larger volume is formed at the proximal part of the positioning sleeve 108 , which facilitates the assembly of the positioning sleeve 108 with the inserting end sleeve 40 and the housing 112 (described below).
- a radial lug structure 1081 is formed on the proximal end of the positioning sleeve 108
- a radial stopper 1121 is formed on the proximal inner wall of the housing 112 .
- the lug structure 1081 of the positioning sleeve 108 is clamped between the distal end of the inserting end bushing 40 and the stopper 1121 , thereby realizing the fixing of the positioning sleeve 108 .
- the positioning sleeve 108 is centrally arranged in the housing 112 and is used to straighten the axial position of the catheter 32 so that the center of the catheter 32 is aligned with the connecting shaft 44 and prevent the drive shaft 34 protruding from the proximal opening of the catheter 32 from bending.
- the position of the positioning sleeve 108 is fixed through the cooperation between the lug structure 1081 and the stopper 1121 .
- the positioning sleeve 108 is located in the center of the housing 112 by the abutting effect of the lug structure 1081 and the inner wall of the housing 112 , and the central passage of the positioning sleeve 108 is aligned with the axial passage of the connecting shaft 44 .
- the lug structure 1081 is made of soft and elastic material, in the shape of a ring, and its outer diameter is slightly greater than or equal to the inner diameter of the body 112 . In this way, it is ensured that the proximal end of the driving shaft 34 cooperates with the connecting shaft 44 in an incomplete or slightly bent posture.
- the second gap communicates with the first gap through the positioning sleeve 108 .
- the second gap communicates with the first gap through the accommodating space 110 of the positioning sleeve 108 .
- the outlet end (distal end) of the first gap communicates with the accommodating space 110
- the inlet end (proximal end) of the second gap communicates with 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 driving shaft 34 .
- the coupler also includes a housing 112 that is connected to the distal end of the inserting end bushing 40 and accommodates the positioning sleeve 108 therein.
- the housing 112 is configured when the coupler and the socket are in a connected state.
- the outer surface is even. It not only avoids scratches that may be caused by uneven outer surfaces, but also has a regular and beautiful appearance.
- the distal opening of the housing 112 is provided with a retaining sleeve 114 for the catheter 32 to pass through.
- the proximal end of the retaining sleeve 114 is opposite or connected to the distal end of the positioning sleeve 108. or center channel alignment.
- the distal end of the retaining sleeve 114 extends for a certain length and has a strength greater than that of the catheter 32, which can support and prevent the catheter 32 from bending, and further play a role of fixing, providing a strength support transition for the catheter 32 at the outlet of the housing 112 , to avoid the phenomenon that the lead-out part of the catheter 32 is broken due to strong and/or frequent bending.
- the drive shaft 34 is axially penetrated, that is, the entire drive shaft 34, including the connecting portion 94 located at the proximal end of the drive shaft 34 and mated with the connecting shaft 44, has an axially extending axial hollow cavity, and the axial hollow The cavity forms a third axial channel 103 which communicates with the second axial channel 102 .
- the perfusion channel also includes a third axial channel 103 formed in the drive shaft 34 at the portion of the catheter 32 and the drive shaft 34 .
- the fluid flowing through the second axial channel 102 of the connecting shaft 44 enters the third axial channel 103 of the drive shaft 34 through the hollow connection part 94, and finally flows out into the body of the subject at the distal end of the drive shaft 34, as Subjects were provided with physical support.
- the drive shaft 34 is constructed as a multi-layer braided structure, the sidewalls of which are liquid permeable. That is, the fluid flowing through the second gap and the third axial channel 103 can not only permeate through the side wall of the drive shaft 34 to achieve balance, but also can completely cool down and lubricate the entire drive shaft 34 .
- the position of the perfusate interface may be located far from the proximal end of the drive shaft . In this case, it is difficult for Purge fluid to enter the drive shaft from the proximal opening thereof.
- the drive shaft can only be constructed so that the side walls are liquid permeable.
- the proximal end of the perfusion channel in the embodiment of the present invention is a cavity for accommodating the passive magnet 42 , and the entering Purge liquid will enter the drive shaft 34 through the cavity and the connecting shaft 44 in sequence.
- the Purge liquid can also enter the interior of the drive shaft 34 .
- This provides a more flexible selection space for the drive shaft 34 of the present invention, which is of great benefit to the manufacturing process of the drive shaft 34 .
- the priming channel includes, at the part of the pump 36 , a fourth axial channel formed in the hub and communicating with the third axial channel 103 .
- the fluid flowing through the third axial channel 103 can flow into the fourth axial channel and flow out through the fourth axial channel.
- the distal outlet of the perfusion channel includes the distal opening of the catheter 32, further comprising the distal opening of the hub. That is, the fluid flowing through the second gap flows out through the distal opening of the conduit 32; the fluid flowing through the fourth axial channel flows out through the distal opening of the hub.
- the perfusion channel of the working component 30 runs through the transmission link from the passive magnet 42 to the pump 36 , and the perfusion channel first flows through the cavity containing the passive magnet 42 to cool down and lubricate the passive magnet 42 .
- the perfusion passage is divided into two paths, one path flows through the second axial passage 102 inside the connecting shaft 44, the third axial passage 103 inside the drive shaft 34, the fourth axial passage inside the hub of the pump 36, And flow out from the distal opening of the hub; the other path flows through the first gap between the intervening end bush 40 and the outer wall of the connecting shaft 44, the bearing 92, the accommodating space 110 of the positioning sleeve 108, the gap between the conduit 32 and the outer wall of the drive shaft 34
- the second gap flows out from the distal opening of the catheter 32 , and the Purge liquid that is shunted in this way can lubricate and cool down various components such as the bearing 92 , the connecting shaft 44 , the driving shaft 34 , and the
- the entire perfusion channel is designed reasonably, the fluid flow is smooth, and the multi-branch diversion design is adopted, which can increase the perfusion volume of Purge solution.
- the Purge fluid flows through the relative rotating parts, it can naturally have lubricating and cooling effects, so as to avoid heat accumulation on the rotating parts, especially the driving shaft 34 .
- the Purge liquid can enter the drive shaft 34 to cool down and lubricate the entire drive shaft 34 comprehensively.
- the pump 36, catheter 32, and the distal portion of the drive shaft 34 need to be delivered to the subject before the device 100 can function.
- the part that can be delivered into the body of the subject is called the access component.
- the device 100 also includes a guide channel through the pump 36, the drive shaft 34 and the coupler.
- a guiding wire is sent into the body of the subject through the vasculature.
- the user generally a medical staff
- the proximal end of the coupler specifically the first guide channel of the seal 118 described below, or the bypass outlet 120 of the intervening end bushing 40 ) passes out.
- the pump 36 is then delivered in the compressed state to the desired location (eg, the left ventricle) along the guided path established by the guidewire in the subject's vasculature. Until, after the proximal end of the pump 36 is sent to the desired position, the guide wire is pulled out, the constraint on the pump 36 is removed to resume deployment, the working component 30 is connected to the driving component 10, and the motor is activated to start working.
- the desired location eg, the left ventricle
- the hub of the pump 36 has a fourth axial passage
- the drive shaft 34 has a third axial passage 103
- the connecting shaft 44 has a second axial passage 102
- the fourth axial passage the third axial passage 103
- the second axial channels 102 are connected in sequence to form the first guiding channel.
- the protection head 38 is a hollow structure, which is in butt communication with the fourth axial channel of the hub.
- the inner channel of the protective head 38 forms part of the first guide channel.
- the guide channel also includes an end face outlet 116 located on the proximal end face of the intervening end bushing 40 , and the distal end outlet of the hub communicates with the end face outlet 116 through the first guide channel. That is to say, the working component 30 has a first guiding channel extending axially, and the first guiding channel can guide the guide wire to pass through the end face outlet 116, so as to send the access component into the body of the subject.
- the end surface outlet 116 formed on the proximal end surface of the interventional end bush 40 constitutes the proximal starting cavity of the perfusion channel. Therefore, the end face outlet 116 needs to be designed to be re-openable or sealed.
- a seal 118 having a resealable first guide channel is disposed in the end face outlet 116 .
- the seal 118 has two states - a closed seal state and an open state.
- the sealing member 118 When the sealing member 118 is in the first state, the first guiding passage is sealed, and the first guiding passage is in a closed sealing state.
- the sealing member 118 closes the opening on the end face, preventing the fluid in the perfusion channel from flowing out from the end face outlet 116 and preventing the Purge liquid from corroding the motor 14 .
- the sealing member 118 is in the second state, the first guiding channel is opened, and the first guiding channel is in a communicating state for the guide wire to pass through, so as to send the access assembly into the body of the subject.
- the sealing member 118 can be opened to allow the guide wire to pass through the first guiding channel, ensuring that the pump 36 enters the body of the subject. After the intervention of the pump 36 is completed, the guide wire is withdrawn to seal the seal 118 to avoid leakage of the Purge fluid during the operation of the pump 36 .
- the seal 118 is a flexible sealing plug that can move axially in the 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 switched to the first state when it moves axially toward the first direction, and when it moves in the second direction opposite to the first direction radially expands to switch to the second state.
- the first direction may be a direction toward the inner side of the inserting end bush 40
- the second direction may be a direction away from or toward the outer side of the inserting end bushing 40
- the first direction may be a rightward direction as shown in FIGS. 9 and 10
- the second direction may be a leftward direction as shown in FIGS. 9 and 10 .
- the passive magnet 42 accommodated in the cavity is sheathed on the mounting portion 441 with a larger diameter.
- the proximal end of the mounting portion 441 is recessed inwardly to form an escape groove 4411 for receiving the inner end of the flexible sealing plug.
- the proximal end of the central passage 102 of the connecting shaft 44 is connected to the escape groove 4411 .
- the inner end of the flexible sealing plug is generally conical, and the inner wall of the outlet 116 on the end surface is generally configured to match the conical shape. In this way, the tapered flexible sealing plug and the end face outlet 116 have a flow guiding effect, leading the Purge liquid from the cavity to the central channel 102 smoothly.
- the sealing member 118 may be a balloon structure similar to a hemostatic valve, which is made of elastic material and has an inner cavity and a channel similar to the above-mentioned first guiding channel.
- the bladder structure communicates with a fluid source of filling medium or elastic material, and has a bulging state and a collapsed state.
- the first state is the above-mentioned swollen state, which corresponds to the state when the bladder structure is filled with fluid medium or elastic material, and the channel is occupied by the swollen side wall of the bladder structure to achieve sealing.
- the second state is the above-mentioned collapsed state, which corresponds to the state after the fluid medium in the capsule structure is at least partially released, and the channel is exposed to realize opening.
- the guide channel includes a bypass outlet 120 located on the side of the bushing 40 at the intervention end.
- the proximal end of the working assembly 30 is provided with a passive magnet 42 and a cavity for accommodating the passive magnet 42.
- the guide wire can pass through the bypass outlet 120 without having to pass through the end face outlet 116.
- the end surface outlet 116 can be omitted and the seal 118 can be omitted, thereby shortening the distance between the passive magnet 42 and the active magnet 22 and improving transmission efficiency.
- the inserting end bushing 40 is provided with a first bypass passage 121, and the first bypass passage 121 connects the bypass outlet 120 and the axial passage for receiving the connecting shaft 44 inside the inserting end bushing 40, that is, the first bypass passage. 121 extends from the bypass outlet 120 to the first axial channel 101 that receives the intervening bushing 40 .
- the side wall of the connecting shaft 44 is provided with a second bypass passage 122, and the second bypass passage 122 communicates with the inner passage of the connecting shaft 44, that is, the second bypass passage 122 extends from the opening of the side wall of the connecting shaft 44 to the connecting shaft 44
- the second axial channel 102 The second bypass channel 122 is selectively communicated with the first bypass channel 121 .
- the second bypass channel 122 is disposed on the connecting shaft 44 , and the connecting shaft 44 is rotatable and mated with the bushing 40 at the intervention end. Therefore, the two interfaces where the second bypass channel 122 and the first bypass channel 121 are close to each other have two states of facing and staggering.
- the guide wire When the two interfaces are facing each other, it is convenient for the guide wire to pass through; when the two interfaces are staggered, the guide wire cannot pass through the bypass outlet 120 .
- the rotating pump 36 specifically the rotatable impeller, can be manually adjusted to drive the drive shaft 34 and the connecting shaft 44 to rotate in sequence.
- the guide wire can pass through the second bypass channel 122 , the first bypass channel 121 , and the bypass outlet 120 .
- the working assembly 30 further includes a guidewire bypass cannula 124 .
- the guide wire bypass cannula 124 is operable to be inserted through the two bypass channels in sequence, and the inner end of the guide wire bypass cannula 124 is connected to the drive shaft.
- the second axial channel 102 of 34 is butt connected.
- the guide wire bypass cannula 124 can make the insertion of the guide wire more convenient.
- bypass outlet 120 communicates with the first axial passage 101 constituting the perfusion passage through the first bypass passage 121, in order to avoid the Purge liquid flowing through the first axial passage 101 in the perfusion passage from spraying during the operation of the pump 36
- a sealing plug (not shown) is optionally provided in the bypass outlet 120 to seal the perfusion channel and prevent the purge liquid from being sprayed out through the bypass outlet 120 .
- the optional setting of the sealing plug is embodied in that when the device 100 is in the state of passing the guide wire when the guide wire needs to pass through the bypass outlet 120, the sealing plug is configured to be removed from the bypass outlet 120, and the removal can be human To be pulled out manually. In this way, the bypass guiding channel of the guide wire is opened, and the bypass passing operation of the guide wire can be performed.
- the sealing plug is inserted into the bypass outlet 120 when it is in any other working state except the state of passing through the guide wire.
- the other arbitrary working states mainly include: the state where the pump 36 is turned on after the threading operation of the guide wire is completed (at this time, Purge fluid needs to be pumped into the perfusion channel), the state of threading the guide wire from the end surface, and so on.
- the working assembly 30 is provided with the end face outlet 116 and also provided with the bypass outlet 120 , and the guide channel is configured to guide the guide wire through one of the end face outlet 116 and the bypass outlet 120 . Passing through the end face outlet 116 provides smoother guidance; while passing through the bypass outlet 120 can avoid the influence of the sealing member 118 on the passive magnet 42 and the perfusion channel.
- the bypass outlet 120 is in a sealed state.
- the end surface outlet 116 is in a sealed state.
- the purpose of this design is mainly to keep the target threading path of the guide wire unobstructed, avoid the guide wire from passing into the non-target guiding path, and ensure the efficient completion of the guide wire threading.
- the passing path of the guide wire is relatively straight. At this time, it is unnecessary and impossible to insert the guidewire bypass cannula 124 into the first and second bypass channels 121 , 122 .
- the guide wire bypass cannula 124 is used to force the guide wire to change direction from the original straight direction to the bent direction at the proximal end.
- the guidewire bypass cannula 124 is inserted, the passage of the guidewire through the end face outlet 116 is blocked to force the guidewire to pass through the bypass.
- the inner end surface of the guide wire bypass cannula 124 is a wedge-shaped surface, and the angle between the wedge-shaped surface and the axial direction of the guide wire bypass cannula 124 is different from that of the first or second bypass channel.
- the inclinations of 121 and 122 are the same, for example, both are 45°. In this way, after the guidewire bypass cannula 124 is inserted, its inner end surface is substantially vertical, so as to achieve surface-to-surface fit with the proximal end surface of the drive shaft 32 .
- the channel through which the guide wire passes through the bypass outlet 120 is called the second guiding channel.
- the guide wire can alternatively pass through the first guide channel or the second guide channel, so that the guide wire threading operation has more options, and provides users with flexible guide wire configurations.
- first guiding channel and the second guiding channel have overlapping parts. Specifically, the distal ends of the first guiding channel and the second guiding channel overlap, and the proximal ends are separated, communicating with the end surface outlet 116 and the bypass outlet 120 respectively.
- the device 100 can also only be provided with the end face outlet 116 or the bypass outlet 120 , which will not be described in detail here, and any solution that is the same as or similar to this embodiment is within the protection scope of the present invention.
- the driving assembly 10 and the working assembly 30 of the device 100 in this embodiment are detachably connected through a locking mechanism between the insertion bush and the receiving bush.
- the locking mechanism is operated to separate the driving component 10 from the working component 30;
- the cooperation of the guide channel sends the access assembly (pump 36 in the collapsed state) into the desired position in the subject; the guide wire is removed, and the first guide channel or the second guide channel (i.e., the end face opening and bypass outlet); pour fluid into the working assembly 30 through the perfusion channel; then, connect the drive assembly 10 with the working assembly 30 through the locking mechanism, remove the radial constraint of the pump on the pump 36, and make it unfold.
- the driving assembly 10 can drive the pump 36 of the working assembly 30 to be in a working configuration, thereby realizing the blood pumping function of assisting the heart.
- a second locking mechanism is provided to realize the locking and unlocking between the inserting bush and the receiving bush, specifically: the outer surface of the inserting bush 199 faces inward The recess forms a locking groove 193L; the inner wall of the receiving bush 197 is formed with a substantially annular receiving groove 191, and the locking member is configured as a substantially annular spring ring 195 formed on the inner wall of the receiving bush 197, and the spring ring 195 is limited at In the receiving groove 191.
- the depth of the receiving groove 191 is smaller than the diameter of the spring ring 195 .
- the spring coil 195 is a canted coil spring, and the projection of the spring coil 195 on a radial plane is an ellipse.
- the depth of the receiving groove 191 is smaller than the major axis width of the spring ring 195 .
- the spring ring 195 protrudes from the inner surface of the receiving bushing 197, and the spring ring 195 has a recoverable deformation in the radial direction.
- the spring ring 195 can be snapped into the locking groove 193L and the receiving groove 191 at the same time.
- the receiving groove 191 realizes locking.
- the depth of the spring coil 195 sinking into the receiving groove 191 when the inserting bush 199 is engaged with the receiving bush 197 is greater than the depth of sinking into the receiving groove 191 when the inserting bush 199 is not engaged with the receiving bush 197 . That is to say, when the inserting bush 199 engages with the receiving bush 197 , the reaction force of the inserting bush 199 to the spring ring 195 makes the spring ring 195 sink into the receiving groove 191 further, so as to ensure reliable locking.
- the recoverable deformation of the spring coil 195 is not more than 20%, further not more than 15%, and further not more than 10%. This makes the locking and unlocking operations more reliable.
- the inserting bush 199 is also provided with an escape groove 193U spaced apart from the lock groove 193L.
- the depth of the escape groove 193U is greater than the depth of the lock groove 193L, and the width of the avoidance groove 193U is greater than the width of the lock groove 193L.
- the escape groove 193U is farther away from the receiving bush 197 relative to the lock groove 193L.
- the distance between the bottom of the locking groove 193L and the bottom of the receiving groove 191 is smaller than the width of the major axis of the spring ring 195 .
- the distance between the groove bottom of the escape groove 193U and the groove bottom of the receiving groove 191 is greater than or equal to the major axis width of the spring ring 195 .
- FIG. 11 An avoidance groove 193U is set on the insert bushing 199, which can make the unlocking operation easier.
- Figures a to d in Figure 11 show the process from locking to unlocking.
- the inserting bush 199 is inserted into the receiving bush 197.
- the spring ring 195 located in the receiving groove 191 is snapped into the locking groove 193L, and the inserting bushing 199 is connected to the receiving groove 191.
- the receiving bushing 197 is relatively locked.
- the inclination direction of the spring coil 195 is the same as the insertion direction of the insertion bush 199 .
- the spring ring 195 is pushed by the inserting bush 199 to be deformed toward the insertion direction and snapped into the locking groove 193L to realize locking.
- the deformation direction of the spring ring 195 is the same as the insertion direction
- the pulling-out direction of the insertion bush 199 is opposite to the deformation direction of the spring ring 195, and a self-locking is formed between the spring ring 195 and the lock groove 193L, which cannot be pulled out directly Insert bushing 199 .
- a third locking mechanism is provided to realize the locking and unlocking between the inserting bush and the receiving bushing, specifically: the locking groove 185 self-receiving
- the inner surface of the bushing 187 is recessed outwards, and the locking member is configured as a protrusion 183 formed on the outer wall of the inserting bushing 189;
- the locking groove 185 includes a first groove 181 extending along the insertion direction of the receiving bushing 187 and a connection
- the second groove 179 of the first groove 181 , the extending direction of the second groove 179 and the extending direction of the first groove 181 form an angle not equal to 0°.
- the inner wall of the second groove 179 forms a stop surface 177 for the protrusion 183 to be hooked on.
- the protrusion 183 When locking is required, the protrusion 183 is aligned with the opening of the first groove 181 and slides in the first groove 181, and the inserting bush 189 and the receiving bush 187 are axially close; subsequently, the protrusion 183 slides from the first groove 181 Insert the second groove 179, and when sliding in the second groove 179 to abut against the stop surface 177, the inserting bush 189 and the receiving bush 187 are relatively fixed.
- the angle between the first groove 181 and the second groove 179 is 90°, so as to prevent the protrusion 183 from sliding into the first groove 181 in the locked state, and the locking is reliable.
- the locking scheme of the structure requires relative rotation of the two bushings. Through the 90° angle design of the two slots, it can comply with the rotation of the two bushings. Then, when locking, the two bushes only need to be rotated without axial movement, and the locking operation is convenient.
- a fourth locking mechanism is provided to realize the locking and unlocking between the inserting bush and the receiving bush, specifically: the motor end bush and the intervening end bush socket fit, one of which is constructed as a plug, the other of which contains a socket for receiving the plug; a bush constructed as a plug is defined as an inserting bushing, and a bushing defining a socket is defined as For receiving the bushing; the device also includes a locking mechanism for engaging and fixing the inserting bush and the receiving bushing, the locking mechanism is configured to achieve axial fixation of the inserting bush and the receiving bushing by increasing friction.
- the locking mechanism includes a hoop 169 sheathed outside the receiving bush and a locking operating member 167 operable to lock or release the hoop.
- the hoop includes a circumferentially extending body 165 that extends circumferentially through an angle of less than 360 degrees.
- the hoop further includes a first end portion 161 and a second end portion 162 connected to two ends of the main body 165 and extending radially.
- the locking operation member is a cam
- the cam has a cam surface 157 with a gradually changing radial dimension, and the cam surface 157 abuts against a surface of the first end portion 161 away from the second end portion 162 .
- the locking mechanism also includes a fitting 159 connected to the cam. One end of the fitting 159 is connected to the cam, and the other end passes through the first end 161 and the second end 162 and is away from the second end 162 from the end of the first end 161. surface abutment.
- the cam rotates so that the cam surface 157 with different radial dimensions abuts against the first end 161, and the cam rotates and pulls the fitting 159 to move to change the distance between the first end 161 and the second end 162 of the hoop, so that the hoop
- the hoop clamps or loosens the receiving bushing, so that the receiving bushing clamps or loosens the inserting bushing to realize locking and unlocking.
- a fifth locking mechanism is provided to realize the locking and unlocking between the inserting bush and the receiving bush, specifically: the joint part is an opening through the side wall of the receiving bush or only through Receiving the groove of the inner wall of the bushing; the outer surface of the inserting bushing is recessed inwardly to form a receiving groove, and the locking member is configured as a pin or ball that is at least partially accommodated in the receiving groove and movable in the radial direction; the pin or The radially outer end of the ball has an unlocked state that does not exceed the outer surface of the inserting bush to unlock the inserting bush and the receiving bush, and radially extends outwards from the outer surface of the inserting bush to embed the joint to connect the inserting bush and the receiving bush.
- the receiving bushing combines a fixed locked state.
- An elastic reset member is biased between the pin or the ball and the accommodating groove, and the reset force applied by the elastic reset member to the pin or the ball makes it always move radially outward to maintain the locked state or move toward the locked state. trend.
- the elastic reset member makes the pin or ball automatically snap into the opening or groove of the receiving bush to realize locking; when unlocking is required, the inserting bush and the receiving bush are axially pulled /or receive the bushing, overcome the force of the elastic reset member, so that the ball or ball breaks away from the opening or groove, and then the unlocking can be realized.
- a sixth locking mechanism is provided to realize the locking and unlocking between the inserting bush and the receiving bushing, specifically: the locking mechanism is configured to realize the insertion of the bushing by increasing the friction Axial fixation with receiving bushing.
- the locking mechanism includes a threaded hole penetrating through the side wall of the receiving bush, and a bolt screwed into the threaded hole; the bolt is operable to rotate its inner end to compress or break away from the outer surface of the inserting bushing, thereby realizing insertion Locking and unlocking between bushing and receiving bushing.
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Abstract
一种用于对心脏在发生功能衰竭时进行辅助的装置(100),包括驱动组件(10),与驱动组件(10)可拆卸地连接的工作组件(30)。驱动组件(10)包括马达(14),由马达(14)驱动的主动磁体(22)。工作组件(30)包括连接轴(44),设在连接轴(44)近端并与主动磁体(22)耦合的被动磁体(42),连接至连接轴(44)远端的驱动轴(34),泵(36)。泵(36)包括具有进口端(361)和出口端(362)的泵壳(363),收纳在泵壳(363)内的叶轮。叶轮连接至驱动轴(34)的远端,以被驱动旋转以将血液从进口端(361)吸入泵壳(363)并从出口端(362)排出。主动磁体(22)与被动磁体(42)具有同步转动的在第一配合状态和被动磁体(42)转速低于主动磁体(22)转速的第二配合状态。在马达(14)的转速降低至特定阈值之前,主动磁体(22)与被动磁体(42)仅可从第一配合状态切换至第二配合状态。
Description
本发明涉及一种用于对心脏在发生功能衰竭时进行辅助的装置,属于医疗器械技术领域。
心脏衰竭是一种威胁生命的疾病,一旦恶化至晚期,一年死亡率约为75%。鉴于晚期心脏衰竭的心脏供体有限,心室辅助设备技术已成为搭起受试者和移植手术之间的可行治疗或替代治疗选择。但是当前技术导致的不良事件仍然限制了心室辅助设备用于重症受试者的治疗。
现有的心室辅助设备存在传动效率不高等问题,而且不断提升心室辅助设备的安全性一直是本领域技术人员致力改进的技术问题。
本发明的目的在于提供一种用于对心脏在发生功能衰竭时进行辅助的装置,可以明显改善装置的性能。
本发明的目的是通过以下技术方案实现:
一种用于对心脏在发生功能衰竭时进行辅助的装置,包括:驱动组件、与驱动组件可拆卸地连接的工作组件。驱动组件包括马达、由马达驱动的主动磁体。工作组件包括:连接轴、设在连接轴近端并与驱动磁体耦合的被动磁体、连接至连接轴远端的驱动轴、泵。泵包括:具有进口端和出口端的泵壳、收纳在泵壳内的叶轮。叶轮连接至驱动轴的远端,以被驱动旋转以将血液从进口端吸入泵壳并从出口端排出。
主动磁体与被动磁体具有同步转动的在第一配合状态和被动磁体转速低于主动磁体转速的第二配合状态。在马达的转速降低至特定阈值之前,主动磁体与被动磁体仅可从第一配合状态切换至所述第二配合状态。
在工作组件的阻力小于或等于主动磁体与被动磁体之间的额定扭力时,被动磁体与主动磁体处于第一配合状态。在工作组件的阻力大于主动磁体与被动磁体之间的额定扭力时,被动磁体处于第二配合状态。
与现有技术相比,本发明具有如下有益效果:本发明的装置,可以明显改善装置的性能,而且能提升装置的安全性。
图1和图2是本发明提供的装置的不同角度的立体示意图;
图3是图1所示的装置的驱动组件与工作组件分开的立体示意图;
图4是图1所示的装置沿轴向的剖面图;
图5是图1所示的装置的局部立体分解示意图;
图6是图1所示的装置沿垂直于轴向一个平面上的剖面图;
图7是图1所示的装置的驱动组件的部分结构的沿轴向方面的一个平面的剖面图;
图8是图1所示的装置的工作组件的部分结构的沿轴向方面的另一个平面的剖面图;
图9和图10是图1所示的装置的工作组件的近端局部剖视图,在图9中,密封件封闭近端的端面开口;在图10中,密封件处使第一导引通道与外界连通。
图11示出了本发明另一实施方式提供的锁定机构的结构示意图;
图12和13示出了本发明再一实施方式提供的锁定机构的结构示意图;
图14示出了本发明又一实施方式提供的锁定机构的结构示意图。
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限制本发明,本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变换均包含在本发明的保护范围内。
本发明所用术语“近”、“后”和“远”、“前”是相对于操纵用于对心脏在发生功能衰竭时进行辅助的装置(以下简称装置)的临床医生而言的。术语“近”、“后”是指相对靠近临床医生的部分,术语“远”、“前”则是指相对远离临床医生的部分。例如,驱动组件在近端及后端,工作组件在远端及前端;再例如,某个部件/组件的近端表示相对靠近驱动组件的一端,远端则表示相对靠近工作组件的一端。
本发明的装置以马达轴或连接轴、驱动轴的延伸方向定义“轴向”或“轴向延伸方向”。驱动轴为软轴,驱动轴的轴向是指驱动轴调整为直线延伸时的轴向。本发明所用术语“内”“外”是相对轴向延伸的中心线而言的,相对靠近中心线的方向为“内”,相对远离中心线的方向为“外”。
需要理解的是,“近”、“远”、“后”、“前”、“内”、“外”、这些方位是为了方便描述而进行的定义。然而,装置可以在许多方向和位置使用,因此这些表达相对位置关系的术语并不是受限和绝对的。举例为,上述对各方向的定义,只是为了说明本发明技术方案的方便,并不限定本发明的辅助装置在包括但不限定于产品测试、运输和制造等等其他可能导致其发生颠倒或者位置发生变换的场景中的方向。在本发明中,上述定义如果另有明确的规定和限定,它们应遵循上述明确的规定和限定。
在本发明中,除非另有明确的规定和限定,“相连”“连接”等术语应做广义理解。例如,可以是固定连接,也可以是可拆卸连接,还可以是可活动连接,或成一体;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
请参见图1至图3,本发明实施例的装置100可部分地替代心脏的泵血功能,实现至少部分地减轻心脏负担的作用。上述“替代”可以表明心脏在一定程度上出现功能衰竭或衰退,但仍具有一定的泵血功能,只是该泵血功能较弱而难以维持机体正常存活所需的心输出量。
在一种示意性的场景中,本装置100可以为用作为左心室辅助,其工作部分(具体指下文的泵)可被介入至左心室中,泵运转时可以将左心室中的血液泵送至升主动脉中。
值得注意的是,上述举例中本装置100被用作为左心室辅助,仅是本装置100一种可行的适用场景。在其他可行且不可被明确排除的场景中,本装置100也可以用作为右心室辅助,工作部分可被介入至右心室中,泵运转时将静脉中的血液泵送至右左心室中。
或者,本装置100也可以适用于将血液从腔静脉和/或右心房泵入右心室、从腔静脉和/或右心房泵入肺动脉和/或从肾静脉泵入腔静脉,还可以配置为在静脉与淋巴导管的接合部处放置在锁骨下静脉或颈静脉内,并用于增加淋巴流体从***到静脉的流动。
下文将主要以本装置100用作为左心室辅助作为主述场景来阐述的。但基于上文描述可知,本发明实施例的保护范围并不因此而受到限定。
装置100包括驱动组件10和工作组件30。驱动组件10包括马达壳12以及收纳在马达壳12内并具有马达轴16的马达14。工作组件30包括导管32、穿设在导管32中的驱动轴34、由驱动轴34驱动的泵36。驱动组件10为工作组件30提供动力,以驱动工作组件30实现泵血功能。
装置100使用时,泵36和部分导管32(具体为导管32前端部分)被送入并保持在受试者体内,泵36和导管32的尺寸尽可能的小是期望的。因此,泵36和导管32的轴向投影面积小于工作组件30其它部件的轴向投影面积,也小于驱动组件10的轴向投影面积。
由此,较小尺寸的泵36和导管32可以经由较小的介入尺寸进入人体,减少介入过程给受试者带来的痛苦,并可以减小因介入尺寸过大而导致的并发症。
工作组件30的其它部分可以具有相对较大的尺寸,从而满足结构设计的需要。相对较大尺寸的驱动组件10,可以满足结构设计的需要,并为驱动轴34及泵36提供足够的动力,以满足驱动轴34及泵36的功率需求。
驱动组件10与工作组件30可拆卸地连接。由此,在准备将泵36和导管32的前端部分送入受试者体内时,可将驱动组件10与工作组件30拆卸,避免较大较重的驱动组件10影响泵36和导管32的前端部分被送入受试者体内的操作,操作更轻便。
请重点参见图4和图5,驱动组件10通过磁耦合驱动工作组件30,具体的:
驱动组件10包括插接器,工作组件30包括耦合器。插接器包括连接至马达壳12的马达端衬套20以及收纳在马达端衬套20内部并与马达轴16连接的主动磁体22。耦合器包括设于工作组件30近端的介入端衬套40以及收纳在介入端衬套40内部并与驱动轴34近端连接的被动磁体42。
驱动组件10的传动链路包括马达轴16及与马达轴16连接的主动磁体22。工作组件30的传动链路包括被动磁体42、安装被动磁体42的连接轴44、与连接轴44的远端连接的驱动轴34、与驱动轴34的远端连接的泵36。
如图1至图3所示,在泵36的远端设有保护头38,其被配置为是柔软的,从而不伤害受试者的组织,保护头38可以由任意的宏观表现出柔性的材料制成。具体而言,保护头38为端部呈圆弧状或卷绕状的柔性凸起(Pigtail或Tip member),该柔性的端部以无创或无损伤的方式支撑在心室内壁上,将泵36的吸入口与心室内壁隔开,避免泵36在工作过程中由于流体(血液)的反作用力而使泵36的吸入口贴合在心室内壁上,保证泵吸的有效面积。
装置100工作时,驱动轴34的远端部分随导管32被送入受试者体内,驱动轴34为可弯曲的软轴,软轴可发生肉眼可见的变形。连接轴44的近端安装被动磁体42,连接轴44为硬轴,硬轴不可发生肉眼可见的变形,可以使驱动磁体的安装更稳定。
装置100工作时,马达轴16驱动主动磁体22旋转,被动磁体42与主动磁体22磁耦合,被动磁体42被主动磁体22驱动旋转,被动磁体42旋转顺次驱动连接轴44、驱动轴34旋转,驱动轴34旋转而驱动泵36实现泵血功能。
主动磁体22与被动磁体42具有同步转动的第一配合状态,和被动磁体42转速低于主动磁体22转速的第二配合状态。在第一配合状态,马达14启动后转速从零达到设定转速过程中,被动磁体42的转速随马达14的转速同步增大。马达14达到设定转速后,被动磁体42的转速基本保持设定转速。也就是说,在第一配合状态,被动磁体42刚开始随马达14的转速动态增大。在到达特定值后,基本保持该特定值。但无论被动磁体42的转速是动态增大,还是保持在特定的静态值,被动磁体42的转速基本与主动磁体22相同,从而最大化的提升传动的效率。
第一配合状态是装置100正常使用的状态。但装置100在使用过程中,特别是工作组件30介入人体及工作过程中,可能会遇到阻力。通常情况下,工作组件30遇到的阻力来源于其所包含的部件与相邻部件之间的接触。例如,驱动轴34与导管32之间的接触、叶轮与泵壳363(尤其是支架3631)之间的接触,等等。在某些特别不期望发生的场景中,上述阻力还包括工作组件30与人体组织的接触。例如,由于覆膜3632、导管32发生破损而导致叶轮与心室内壁、驱动轴34与血管内壁的接触。此时,如果被动磁体42仍保持高转速,由被动磁体42驱动的叶轮高速转动,可能会加剧部件间的磨损,或者对人体组织造成伤害的事件发生。
因此,在发生上述事件时,主动磁体22与被动磁体42将自动切换至第二配合状态。在第二配合状态,被动磁体42的转速低于主动磁体22的转速,可以减缓甚至避免由于部件之间的高速摩擦而引起的磨损,和/或防止装置100对人体组织造成损伤。
如果工作组件30遇到的阻力小于主动磁体22与被动磁体42之间的额定扭力(也就是主动磁体22与被动磁体42由于磁耦合而能传递的最大扭力),被动磁体42与主动磁体22处于同步转动的第一配合状态。也就是说,遇到的阻力较小时,则该阻力大概率是由于相关部件的正常摩擦引起的,例如驱动轴43与导管32内壁之间的摩擦、支撑连接轴44的轴承、支撑叶轮的轴承的转动摩擦,等等,而不太可能是由于驱动轴43和/或叶轮等转动部件由于发生裸露而与人体组织之间发生接触引起的。此时,主动磁体22与被动磁体42处于第一配合状态,可保持正常的泵血工作。
在工作组件30的阻力大于主动磁体22与被动磁体42之间的额定扭力时,主动磁体22与被动磁体42从第一配合状态切换至第二配合状态并保持于第二配合状态。也就是说,遇到较大的阻力时,大概率是驱动轴43与导管32内壁之间、支撑连接轴44的轴承、支撑叶轮的轴承卡堵等事件发生至少之一,和/或,驱动轴43和/或叶轮等转动部件与人体组织发生接触。此时,切换至第二配合状态,被动磁体42的转速降低,可快速降低叶轮的转动速度,从而防止部件磨损加剧和驱动轴43和/或叶轮搅伤人体组织。
主动磁体22与被动磁体42从第一配合状态切换至第二配合状态后,被动磁体42的转速不随阻力的降低或消失而增大,而是降低至特定值后基本保持于该特定值。优选的,特定值至少比主动磁体22由于被马达14驱动而旋转的额定转速低50%。其中,主动磁体22的额定转速为马达14在额定功率下带动其旋转的转速。
值得注意的是,上述数值包括从下限值到上限值之间以任意一个单位递增的下值和上值的所有值,在任何下值和任何更高值之间存在至少两个单位的间隔即可。
举例来说,特定值至少比主动磁体22由于被马达14驱动而旋转的额定转速低50%,优选为5%~45°,更优选为10%~40%,进一步优选为15%~35%,更进一步优选为20%~30%,目的是为说明上述未明确列举的诸如6%、8%、12%、16%、18%、22%、24%、28%、32%、36%、39%、41%、43%、46%、49%等值。
如上述,以5%为间隔单位的示例范围,并不能排除以适当的单位例如1%、2%、3%、4%、6%、7%、8%、9%、10%等数值单位为间隔的增长。这些仅仅是想要明确表达的示例,可以认为在最低值和最高值之间列举的数值的所有可能组合都是以类似方式在该说明书明确地阐述了的。
除非另有说明,所有范围都包括端点以及端点之间的所有数字。与范围一起使用的“大约”或“近似”适合于该范围的两个端点。因而,“大约20到30”旨在覆盖“大约20到大约30”,至少包括指明的端点。
本文中出现的其他关于数值范围的限定说明,可参照上述描述,不再赘述。
在主动磁体22与被动磁体42切换至第二配合状态后,被动磁体42保持于特定值,叶轮以该较低的特定值进行转动,该转动的速度不会引起部件磨损的加剧和搅伤人体组织,同时叶轮还保持一定的转动和泵血功能,可防止叶轮停止工作而导致血液流动降速,进而最大限度的避免因此而在工作组件30介入至人体内的部分例如泵、导管32外壁上形成血栓的风险,最大程度的避免由于停泵而对人体产生的伤害,提升装置100的安全性。
本实施例特别的,在马达14的转速降低至特定阈值之前,主动磁体22与被动磁体42仅可从第一配合状态切换至第二配合状态。也就是说,在马达14的转速降低至特定阈值之前,被动磁体42的转速不可能升高,可防止意外。
进一步的,在主动磁体22与被动磁体42处于第二配合状态时,只有当马达14的转速降低至小于特定阈值,主动磁体22与被动磁体42才能切换至第一配合状态。当马达14的转速降低至小于特定阈值,被动磁体42再次与主动磁体22同步转动,可恢复原来的正常工作状态。
特定阈值小于本装置100为达到特定泵血流量所需的马达14转速。例如,本装置100实际或期望提供的泵血流量为5L/min,支撑该流量的转速为20000~30000rpm。特定阈值可以为5000rpm,或者低于5000rpm的任意值,包括0。
在一种场景下,马达14的转速降低至与被动磁体42的转速基本相当(两者的转速差在20%范围内浮动)时,主动磁体22与被动磁体42即可从第二配合状态切换至第一配合状态。此时,马达14和被动磁体42的转速相当,主动磁体22与被动磁体42可再次耦合,主动磁体22驱动被动磁体42随之同步转动并逐步提升转速至额定工作状态。这种情况下,无需等待马达14关机重启,即可实现被动磁体42(叶轮)的复转。
在另一种场景下,马达14的转速降低至零,被动磁体42的转速随之降低至零。此时,被动磁体42重新与主动磁体22耦合,再次重启马达14,主动磁体22可带动被动磁体42同步转动,两者切换至第一配合状态。这种情况下,马达14有重启的过程,可以提醒装置100的使用者排除意外情况,安全性更高。
需要说明的是,马达14重启后,主动磁体22与被动磁体42重新处于第一配合状态。在被动磁体42(叶轮)逐渐升速的过程中,如工作组件30再遇到较大阻力时,则主动磁体22与被动磁体42将再次从第一配合状态切换至第二配合状态。并且同样的,在马达14的转速降低至特定阈值之前,主动磁体22与被动磁体42仅可从第一配合状态切换至第二配合状态,不再赘述。
如前所述,驱动组件10与工作组件3可拆卸地连接,驱动组件10包括插接器,工作组件30包括耦合器。为方便描述,将插接器与耦合器的组合称为连接组件。连接组件被配置为:对应插接器与耦合器未连接时,马达端衬套20与介入端衬套40分离;以及,对应插接器与耦合器连接时,马达端衬套20与介入端衬套40连接,主动磁体22与被动磁体42沿驱动轴34的轴向投影至少部分地重合,且主动磁体22与被动磁体42沿轴向间隔。
由于主动磁体22与被动磁体42沿驱动轴34的轴向投影至少部分地重合,主动磁体22可以更高效的驱动被动磁体42,提高传动效率。而主动磁体22与被动磁体42沿轴向间隔,则可籍由两个磁体间的磁力耦合实现非接触式动力传递,有利于实现对流体的密封,防止液体进入马达。
上述所指液体为装置100运行过程中需灌注至人体内的purge液,该purge液为可部分维持人体机能所需的生理液,例如生理盐水、葡萄糖溶液、抗凝剂,或者上述任意的组合。
连接组件进一步被配置为:对应插接器与耦合器处于未连接状态下主动磁体22与被动磁体42之间的磁耦合力,小于对应插接器与耦合器处于连接状态下主动磁体22与被动磁体42之间的磁耦合力。
因此,插接器与耦合器处于未连接状态时,驱动组件10与工作组件30处于未连接状态,主动磁体22与被动磁体42之间的磁耦合力较小,驱动组件10不足以驱动工作组件30,避免误操作。插接器与耦合器处于连接状态时,驱动组件10与工作组件30处于连接状态,主动磁体22与被动磁体42之间的磁耦合力足够大,驱动组件10可以顺利的驱动工作组件30。
优选的,插接器与耦合器未连接时,主动磁体22与被动磁体42之间磁耦合力被配置为不足以将马达14的旋转动力传递至驱动轴34;或者,磁耦合力不足以克服驱动轴34的旋转阻力;亦或者,磁耦合力为0。由此,插接器与耦合器未连接时,驱动组件10无法驱动工作组件30,避免误操作。
优选的,插接器与耦合器未连接时,主动磁体22与被动磁体42至少存在沿轴向投影重合度为0的状态。也就是说,插接器与耦合器未连接时,主动磁体22与被动磁体42完全错开,驱动组件10远离工作组件30,可以轻便的将工作组件30的导管32及泵36送入受试者体内;且主动磁体22无法驱动被动磁体42,驱动组件10无法驱动工作组件30,避免误操作。
在某些实施例中,主动磁体22与被动磁体42沿垂直于轴向的截面形状大致相同。例如,主动磁体22与被动磁体42可以呈圆柱状,或者圆锥状。这样,主动磁体22与被动磁体42的截面形状均呈现圆形。
实质上,两个磁体彼此面对对方的表面(也就是充磁面)的形状相同,对实现较佳的磁耦合是有利的。因此,在某些实施例中,主动磁体22与被动磁体42的整体形状可以不同,但两者的充磁面相同,也是可行的。例如,其中一个磁体是圆柱状,另一个磁体是圆锥状。
此外,两个磁体的轴向对准度会影响两个耦合效率,还会影响耦合后传动过程中磁体在轴向上位置稳定性及可能引发的振动。因此,期望的是,两个磁体在轴向上能够完全对准。
在考虑到磁体制造精度、装配公差等因素后,两个磁体在轴向上出现预定范围内是接受的。例如,沿轴向,被动磁体42的质量中心的投影相对于主动磁体22的质量中心的偏移量不超过20%,或者,主动磁体22与被动磁体42沿轴向的投影重合度大于等于80%;更优选地,主动磁体22与被动磁体42沿轴向完全对准。
以圆柱状或圆锥状的磁体为例,磁体的质量中心可以为其圆心。两个磁体的质量中心的偏移值,可以为以连接轴的轴心为基准的径向偏移值。则两者的偏移量可以为两者的偏移值差与任意一个磁体的偏移值的比。如上,两者的偏移量小于20%可实现磁耦合及动力传递。进一步,两者的偏移量小于15%、10%、5%甚至是1%。当两者的偏移量为0,则两个磁体沿轴向完全对准。
两个磁体轴向投影重合度可以为两个磁体轴向投影重合的面积与任意一个磁体的轴向投影面积的比值。同样的,该重合度大于等于80%,进一步,大于85%、90%、95%甚至100%。
由此,插接器与耦合器连接时,主动磁体22可以更高效的驱动被动磁体42,传动效率更高,驱动组件10可以更高效地驱动工作组件30,使得工作组件30更好地实现为受试者心脏提供辅助泵血的功能。
优选的,主动磁体22和被动磁体42为沿周向连续的环状磁体,或者,主动磁体22和被动磁体42包括多个沿圆周方向间隔设置的磁体。
装置100工作时,马达轴16旋转驱动主动磁体22旋转,主动磁体22旋转驱动被动磁体42旋转,主动磁体22和被动磁体42为环状磁体,或者包括多个沿周向间隔设置的磁体,主动磁体22和被动磁体42在旋转过程中仍然为环状,由此,马达14的旋转动力可以连续稳定的传递至工作组件30,工作组件30可以稳定可靠地实现泵血功能。
被动磁体42外设有被动磁体保护组件46,该保护组件46一方面可保护被动磁体42不受机械或化学损伤,另一方面,可以对被动磁体42的磁力提供定向,约束其磁场范围,避免磁力发生非期望的扩散,使被动磁体42可靠地工作。具体的,被动磁体保护组件46包括至少部分地覆盖被动磁体42的外表面的第一保护层,第一保护层被配置为至少用于隔离液体与被动磁体42的接触。该液体即为上文提及的purge液。第一保护层隔离液体与被动磁体42接触,可避免液体腐蚀被动磁体42,避免磁体42被液体侵蚀而导致磁力衰弱,尽可能延长磁体42提供磁力的寿命。
在本发明的一实施方式中,第一保护层可以为防水涂层。防水涂层可以轻薄而有效的隔绝液体与被动磁体42的接触。防水涂层构造成的第一保护层具有厚度薄、质轻、易成形和结合强度高等优势,而这些优势将对耦合效率、装配、制作成本和使用寿命等方面提供有益的促进。
例如,厚度薄的优势可减小对被动磁体42后端端面的设置空间,进而可使被动磁体42与主动磁体轴向距离缩短,这对两个磁体间的耦合效率、保证旋转动力的传递效果,是极其有利的。
而厚度薄和质轻的优势还可减小磁体的尺寸和重力,有利于工作组件的重力减轻,并对装配空间的适应性高。同时,防水涂层可采用现有成熟的方案例如喷涂、蒸镀、PVD来实现,对制作工艺要求较低,相应的制造成本也可以降低。而结合强度高可显著的提升防水涂层的防剥离性能,可持续的对磁体42提供防水保持,延长磁体42的寿命。
在本发明的另一实施方式中,第一保护层可为包裹或包覆被动磁体42的机械结构,形成将被动磁体42收纳在其内的第一收纳腔。同上述防水涂层的实施例,第一收纳腔可以可靠地保护被动磁体42,可靠地隔离液体侵蚀被动磁体42。
参见图4和图5所示,被动磁体42设在连接轴44的近端。具体的,连接轴44为变径构造,其近端直径较大,形成安装部441,被动磁体42套设在安装部441外。
第一保护层包括覆盖被动磁体42近端端面的第一近端保护件451、套设在连接轴44外并覆盖被动磁体42远端端面的第一远端保护件452,以及连接在第一近端保护件451与第一远端保护件452之间并覆盖被动磁体42周面的第一周面保护件453。第一近端保护件451、第一远端保护件452、第一周面保护件453与连接轴44共同限定所述第一收纳腔。
第一近端保护件451呈薄板状或薄片状,与被动磁体41近端端面贴合,并与连接轴44的近端连接,该连接优选为固定连接。可选的,第一近端保护件451与连接轴44一体构造。也就是,第一近端保护件451由连接轴44的近端沿径向向外延伸形成。
该构造的第一近端保护件451可对被动磁体42起固定和限位作用。具体而言,基于主被动磁体22、42的耦合原理,两个磁体在磁力作用下具有朝向对方运动的趋势。因此,采用第一近端保护件451与连接轴44的近端固定连接的方式,第一近端保护件451对被动磁体42起止挡或限制其向近端移动的作用,维持被动磁体42的位置固定。
同上,第一远端保护件452呈圆环薄板状或薄片状,套设在连接轴44外。这样,近、远端保护件451、452可在前后将被动磁体42沿轴向夹持,保持被动磁体42的位置固定。
如上文,连接轴44采用变径结构,则在安装部441的远端形成台阶。第一远端保护件452可抵靠在台阶上,该台阶可对第一远端保护件452形成限位,保证其轴向位置固定。
第一周面保护件453形状与被动磁体42的外周面走势适配,例如呈空心圆柱、圆锥形薄板状或薄片状,并贴合在被动磁体42外周面,前后端分别与近、远端保护件451、452连接。
在第一周面保护件453与近、远端保护件451、452的连接处,以及近、远端保护件451、452与连接轴44的连接处存在密封处理,以避免在接缝处发生液体渗漏。
无论是构造成为防水涂层的第一保护层,还是构造为第一收纳腔的第一保护层,优选的,第一保护层是不导磁的,并被配置为可随被动磁体42一起旋转。也就是,第一保护层与被动磁体42固定设置,两者保持相对静止。
不导磁的第一保护层可以避免被动磁体42磁吸一些杂质而影响被动磁体42的正常工作;此外,还可以将被动磁体42的磁力定向约束,避免被动磁体42的磁力发生非期望的扩散,进而,一方面提高磁耦合力和耦合效率,另一方面可避免被动磁体42磁化工作组件30的其它部件,造成不必要的麻烦。例如,避免工作组件30的其它部件被磁化而磁吸一些杂质影响工作组件30的正常工作。
被动磁体保护组件46还包括设在介入端衬套40内且与被动磁体42物理间隔的第二保护层;第二保护层被配置为不随被动磁体42一起旋转。
具体而言,第二保护层沿径向设置于被动磁体42的***,并固定于介入衬套40的内腔,第二保护层与被动磁体42间隔设置。由于被动磁体42可旋转,而第二保护层固定。因此,在带磁的被动磁体42在旋转过程,第二保护层由于固定与之相对发生相对运动,如若第二保护层为导电材质,则可能会在第二保护层中产生涡电流。
有鉴于此,将第二保护层不导电配置,可避免在第二保护层中产生涡电流,确保设备外壳不带电,保避免触电风险。而第二保护层进一步被不导磁配置,可将磁力进行定向约束,具体参见上文描述,不在赘述。
为进一步将被动磁体42的磁力朝主动磁体22约束,介入端衬套40内设有第一磁力约束件。第一磁力约束件大致呈盘状,安装于连接轴44,并位于被动磁体42远端。换句话说,第一磁力约束件设在连接轴44的远端,被动磁体42固定在第一磁力约束件的近端端面。第一磁力约束件是导磁的。第一磁力约束件可将被动磁体42的磁力线约束在第一磁力约束件的近端面,避免被动磁体42的磁力向前方也就是背离主动磁体22的方向扩散。
同样的,主动磁体22外也设有主动磁体保护组件24,该保护组件24一方面可保护主动磁体22不受机械或化学损伤,另一方面,可以对主动磁体22的磁力提供定向,约束其磁场范围,避免磁力发生非期望的扩散,使主动磁体22可靠地工作。
具体的,主动磁体保护组件24包括至少部分地覆盖主动磁体22的外表面的第三保护层。第三保护层可为包裹或包覆主动磁体22的机械结构,形成将主动磁体22收纳在其内的第二收纳腔。第二收纳腔可以可靠地保护主动磁体22。
参见图4和图5所示,主动磁体22设在马达轴16的远端。具体的,马达轴16上形成或安装有磁体固定块26,主动磁体22套设在磁体固定块26外。
第三保护层包括覆盖主动磁体22远端端面的第二远端保护件251、套设在磁体固定块26外并覆盖主动磁体22近端端面的第二近端保护件252,以及连接在第二远端保护件251与第二近端保护件252之间并覆盖主动磁体22周面的第二周面保护件253。第二远端保护件251、第二近端保护件252、第二周面保护件253与磁体固定块26共同限定所述第二收纳腔。
第二远端保护件251呈薄板状或薄片状,与主动磁体22远端端面贴合,并与磁体固定块26的远端连接,该连接优选为固定连接。可选的,第二远端保护件251与磁体固定块26一体构造。也就是,第二远端保护件251由磁体固定块26的远端沿径向向外延伸形成。
该构造的第二远端保护件251可对主动磁体22起固定和限位作用。具体而言,基于主被动磁体的耦合原理,两个磁体在磁力作用下具有朝向对方运动的趋势。因此,采用第二远端保护件251与连接轴44的远端固定连接的方式,第二远端保护件251对主动磁体22起止挡或限制其向远端移动的趋势,维持主动磁体22的位置固定。
同上,第二近端保护件252呈圆环薄板状或薄片状,套设在磁体固定块26外。这样,远、近端保护件251、252可分别在前后将主动磁体22沿轴向夹持,保持主动磁体22的位置固定。
第二周面保护件253形状与主动磁体22的外周面走势适配,例如呈空心圆柱、圆锥形薄板状或薄片状,并贴合在主动磁体22外周面,前后端分别与远、近端保护件251、252连接。
在第二周面保护件253与远、近端保护件251、252的连接处,以及远、近端保护件251、252与磁体固定块26的连接处存在密封处理,以避免在接缝处发生液体渗漏。
第三保护层是不导磁的,并被配置为可随主动磁体22一起旋转。也就是,第三保护层与主动磁体22固定设置,两者保持相对静止。
不导磁的第三保护层可以避免主动磁体22磁吸一些杂质而影响主动磁体22的正常工作;此外,还可以将主动磁体22的磁力定向约束,避免主动磁体22的磁力发生非期望的扩散,进而,一方面提高磁耦合力和耦合效率,另一方面可避免主动磁体22磁化驱动组件10的其它部件,造成不必要的麻烦。例如,避免驱动组件10的其它部件被磁化而磁吸一些杂质影响驱动组件10的正常工作。
主动磁体保护组件24还包括设在马达端衬套20内且与主动磁体22物理间隔的第四保护层;第四保护层被配置为不随主动磁体22一起旋转。
具体而言,第四保护层沿径向设置于主动磁体22的***,并固定于介入衬套40的内腔,第四保护层与主动磁体22间隔设置。由于主动磁体22可旋转,而第四保护层固定。因此,在带磁的主动磁体22在旋转过程中,第四保护层由于固定与之相对发生相对运动,如若第四保护层为导电材质,则可能会在第四保护层中产生涡电流。
有鉴于此,将第四保护层不导电配置,可避免在第四保护层中产生涡电流,确保设备外壳不带电,保避免触电风险。而第四保护层进一步被不导磁配置,可将磁力进行定向约束,具体参见上文描述,不在赘述。
为进一步将主动磁体22的磁力朝被动磁体42约束,马达端衬套20内设有第二磁力约束件。第二磁力约束件大致呈盘状,安装于马达轴16或磁体固定件26,并位于主动磁体22近端。换句话说,第二磁力约束件设在马达轴16或磁体固定件26的近端,主动磁体22固定在第二磁力约束件的远端端面。第二磁力约束件是导磁的。第二磁力约束件可将主动磁体22的磁力线约束在第二磁力约束件的远端面,避免主动磁体22的磁力向后方也就是背离主动磁体22的方向扩散。
在本发明的另一实施方式中,主动磁体22的前端面裸露。例如,可以取消第二远端保护件251,通过马达端衬套20的远端面对主动磁体22在径向上的部分外表面进行限位;或者直接通过主动磁体22固定于磁体固定件26或马达轴16对防止主动磁体22沿轴向上移动。
由于主动磁体22位于驱动组件10上,而驱动组件10在装置100工作时位于受试者体外,因此,主动磁体22的前端面裸露无额外的部件,可以使得驱动组件10的结构更加紧凑;而且可以使主动磁体22与被动磁体42之间的距离更近,提升传动效率。
如前所述,驱动组件10与工作组件30可拆卸地连接。具体的,马达端衬套20与介入端衬套40可拆卸地连接,实现驱动组件10与工作组件30可拆卸地连接。
为了实现马达端衬套20与介入端衬套40可拆卸地连接,马达端衬套20与介入端衬套40插接配合,两者中之一构造为插头,两者中之另一包含用于接纳插头的插槽;将构造为插头的衬套定义为***衬套,将限定插槽的衬套定义为接收衬套;装置100还包括用于接合固定***衬套与接收衬套的锁定机构。
锁定机构包括形成在***衬套外壁和接收衬套内壁中之一的接合部,以及可操作的嵌入接合部中的锁定件。锁定件嵌入接合部,实现锁定,***衬套与接收衬套相对固定;锁定件脱离接合部,***衬套与接收衬套可脱离。
请重点参见图6,图6示出了本发明具体实施方式提供的第一种锁定机构。
接合部为自***衬套外表面向内凹陷形成的锁槽48,接收衬套的侧壁贯穿设有开口,锁定件被构造成沿径向可移动的销50;销50可操作的通过开口***或移出锁槽48,从而实现锁定或解锁。
销50设在支撑套筒52内,支撑套筒52套设在接收衬套外并与接收衬套相对固定设置。具体的,支撑套筒52内设有径向延伸的导向槽54,导向槽54自支撑套筒52的内壁向外凹陷形成,销50在导向槽54内滑动实现锁定或解锁。
销50具有***锁槽48以使马达端衬套20与介入端衬套40固定接合的锁定状态,以及移出锁槽48以使马达端衬套20与介入端衬套40解除固定接合的解锁状态;销50与支撑套筒52之间偏压设置第一弹性件56,第一弹性件56对销50施加的复位力使得销50具有维持锁定状态或朝向锁定状态运动的趋势。
具体的,销50背离锁槽48的一侧与导向槽54的封闭端之间设有被压缩的第一弹性件56,第一弹性件56对销50施以径向向内的作用力,从而使得销50具有维持锁定状态或朝向锁定状态运动的趋势。
为了更可靠的安装第一弹性件56,销50背离锁槽48的一侧设有向内凹陷形成的弹性件收容槽58,第一弹性件56部分收容于弹性件收容槽58内。在弹性件收容槽58的限定下,第一弹性件56可以更稳定的恢复形变,使销50具有维持锁定状态或朝向锁定状态运动的趋势。
为保证销50的强度,销50包括相连的外段60和内段62,外段60的宽度(直径)大于内段62的宽度,弹性件收容槽58设于宽度较大的外段60,弹性件收容槽58自外段60背离锁槽48的端面向内凹陷形成。
锁定机构还包括可转动的设在接收衬套外的解锁执行件,解锁执行件包括环形主体部64,环形主体部64可转动的套设于接收衬套。解锁执行件包含与销50配合的仿形部件66,仿形部件66与环形主体部64相连,仿形部件66径向向外凸出于环形主体部64。仿形部件66被配置为在解锁执行件的环形主体部64沿第一方向旋转时对销50施加与第一弹性件56复位方向相反的力,在解锁执行件的环形主体部64沿与第一方向相反的第二方向旋转时撤除对销50施加的力。
如前所述,销50包括宽度不等的内段62和外段60,在销50的外表面,内段62与外段60的连接处形成拐角部。当解锁执行件的环形主体部64沿第一方向(如图6中所示意的顺时针方向)转动时,仿形部件66抵接拐角部,对销50施以径向向外的作用力,促使销50脱离锁槽48,***衬套与接收衬套可脱离。当解锁执行件的环形主体部64沿第二方向(如图6中所示意的逆时针方向)转动时,仿形部件66远离销50,销50在第一弹性件56的作用下***锁槽48,***衬套与接收衬套相对固定。
解锁执行件沿第一方向旋转至第一死点位置时销50处于解锁状态,解锁执行件沿第二方向旋转至第二死点位置时销50处于锁定状态。也就是说,解锁执行件沿第一方向旋转过程中,销50径向向外移动逐渐解锁。解锁执行件沿第一方向旋转至第一死点位置时,销50完全脱离锁槽48,解锁成功。
解锁执行件沿第二方向旋转过程中,销50在第一弹性件56的作用下径向向内移动逐渐锁定。当解锁执行件沿第二方向旋转至第二死点位置时,仿形部件66完全让开销50,销50***锁槽48一定的深度,实现锁定。
解锁执行件与支撑套筒52之间设有第二弹性件70,第二弹性件70对解锁执行件施加的复位力使其具有维持在第二死点位置或者朝向第二死点位置运动的趋势。
如前所述,第一弹性件56对销50施加的复位力使得销50具有维持锁定状态或朝向锁定状态运动的趋势,而第二弹性件70对解锁执行件施加的复位力使其具有维持仿形部件66让开销50的状态或朝向让开销50的状态运动的趋势。第一弹性件56和第二弹性件70具有协同的作用,只有克服第二弹性件70和第一弹性件56两弹性件的作用时才能使***衬套与接收衬套分离,可保持销50对***衬套和接收衬套的可靠锁定,避免装置100在工作过程中出意外。
同时,在撤除外力作用后,在两个弹性件的共同作用下,实现锁定。
支撑套筒52上设有沿周向大致呈弧形构造的轨迹开口72,解锁执行件包含延伸至轨迹开口72中的卡擎凸起74,卡擎凸起74与环形主体部64相连并沿径向凸出于环形主体部64。
卡擎凸起74具有指向第一方向的第一止挡面76和指向第二方向的第二止挡面78,第二弹性件70设在第一止挡面76与轨迹开口72沿第一方向的内壁之间。第二弹性件70被压缩使得卡擎凸起74具有保持第二止挡面78与轨迹开口72沿第二方向的内壁抵接的状态,或朝向第二方向运动与内壁抵接的趋势,从而使得解锁执行件的仿形部件66让开销50而维持锁定状态。解锁执行件的解锁状态对应为卡擎凸起74推动第二弹性件70被进一步压缩,使第一止挡面76在轨迹开口72内沿朝向第一方向的内壁方向转动的状态。
由此,在锁定状态,在第二弹性件70的作用下,仿形部件66远离销50,仿形部件66不可推动销50。而销50在第一弹性件56的作用,维持***锁槽48的状态。需要解锁时,克服第二弹性件70的作用力,操作卡擎凸起74沿第一方向转动可带动环形主体部64转动,环形主体部64转动带动仿形部件66转动,仿形部件66转动推动销50克服第一弹性件56的作用力径向向外移动,实现***衬套与接收衬套的解锁。
解锁执行件连接有位于支撑套筒52外的操作件80,操作件80被配置为接收外力以驱动解锁执行件沿第一方向转动。具体的,操作件80与卡擎凸起74固定连接,操作件80带动卡擎凸起74转动,进而带动环形主体部64、仿形部件66转动实现解锁。
操作件80包括环形部82,环形部82套设于支撑套筒52外。环形部82的部分内壁与卡擎凸起74连接;环形部82的另一部分内壁至少遮盖设于支撑套筒52的轨迹开口72中安装第二弹性件70的部分。也就是说,环形部82、卡擎凸起74、支撑套筒52围设成收容第二弹性件70的相对封闭的空间,可保证第二弹性件70可靠的工作。
如前所述,仿形部件66相对于环形主体部64径向向外延伸,为给仿形部件66的运动让出空间,支撑套筒52内壁向外凹陷形成的让开槽84。让开槽84的周向延伸长度与解锁执行件从锁定至解锁过程中的周向运动轨迹长度大致相等。
本实施方式中,销50的数量为两个,锁槽48的数量亦为两个,销50和锁槽48一一对应,即一个销50对应一个锁槽48,两个销50在周向上间隔180度设置,可以相对均衡的锁定***衬套和接收衬套。与销50的数量相对应,第一弹性件56的数量、仿形部件66的数量亦为两个,与销50一一对应。
虽然销50的数量为两个,但卡擎凸起74、操作件80的数量仅为一个,即一个操作件80、一个卡擎凸起74可以同时操作两个销50,不仅锁定可靠,而且操作方便。
本领域技术人员可以想到,销50、锁槽48、第一弹性件56、仿形部件66的数量还可以是两个以上,不再赘述,凡采用与本实施方式相同或类似的方案均涵盖在本发明的保护范围内。
下面描述本锁定机构的操作方式。为方便描述,将第一方向称为顺时针方向,将第二方向称为逆时针方向。但这仅仅是为了方便描述,并不对本发明构成限定。
从解锁状态至锁定状态,第一弹性件56的复位力推动销50径向向内移动***锁槽48,第二弹性件70的复位力推动卡擎凸起74逆时针转动,直至第二止挡面78与轨迹开口72逆时针方向的内壁抵接。卡擎凸起74逆时针转动带动环形主体部64、仿形部件66远离销50,销50在第一弹性件56作用下***锁槽48并保持锁定状态。
需要说明的是,第一弹性件56和第二弹性件70被压缩而蓄能,同时具有复位的趋势。所以,第一弹性件56和第二弹性件70的复位作用可以同时进行。
从锁定状态至解锁状态,操作者推动操作件80顺时针转动,操作件80顺时针转动带动卡擎凸起74克服第二弹性件70的作用力顺时针转动,卡擎凸起74顺时针转动带动环形主体部64、仿形部件66顺时针转动。当仿形部件66顺时针转动至与销50的拐角部抵接时,仿形部件66推动销50克服第一弹性件56的作用力径向向外移动,从而实现解锁。
值得注意的是,在如图6所示意的实施例中,由介入端衬套40构造成***衬套,马达端衬套20构造成接收衬套,马达壳12的前部端头构造成支撑套筒52。
不过,基于上文的描述可以得知,***衬套和接收衬套的构成实质上可与上述示例相反。即:介入端衬套40构造成接收衬套,马达端衬套20构造成***衬套,支撑套筒52为一个额外设置并符合上述实施例描述的部件。
本发明的装置100作为外科器械,结构需要足够紧凑、各部件的尺寸需要足够精密、足够小。***衬套与接收衬套之间插接配合,由于***衬套和接收衬套的尺寸足够精密,两者插接配合时,***衬套与接收衬套之间的空间较小,装配阻力较大,装配操作不容易。
为了让***衬套与接收衬套在保证尺寸精密的前提下,装配操作更方便,***衬套与接收衬套之间设有减阻结构。减阻结构被配置在***衬套***接收衬套的过程中减小气体被压缩形成对***衬套的***阻力。
请重点参见图7,在本发明的一实施方式中,支撑套筒52与接收衬套之间形成有间隙;减阻结构包括贯穿接收衬套的侧壁的泄压孔86,泄压孔86通过支撑套筒52与接收衬套之间的间隙与外部空间连通。从而***衬套***接收衬套过程中,***衬套与接收衬套之间的气体可通过泄压孔86排出至外部空间,减少甚至避免气体被压缩对***衬套形成的阻力。
在本发明的另一实施方式中,减阻结构包括形成在接收衬套内壁和/或***衬套外壁的泄压沟槽,泄压沟槽与外部空间连通。泄压沟槽一方面可以存储一部分空气,减少空气的阻力;另一方面泄压沟槽与外部空间连通,空气可通过泄压沟槽排出至外部空间,减少甚至避免气体被压缩对***衬套形成的阻力。
在本实施例中,泄压沟槽沿***衬套的***方向延伸,该延伸可以是直线延伸,也可以是曲线延伸,例如螺旋延伸。泄压沟槽的远端接通至接收衬套内壁的近端和/或***衬套外壁远端,实现与外部空间的连通。
在一个具体的实施例中,泄压沟槽仅形成在接收衬套内壁。***衬套在***过程中,泄压沟槽与***衬套外壁限定连通至外部空间的通道,实现泄压。同样的,在另一个具体实施例中,泄压沟槽也可仅形成在***衬套外壁。或者,泄压沟槽同时形成在接收衬套内壁和***衬套外壁。
在本发明的再一实施方式中,减阻结构包括在***衬套与接收衬套处于接合到位的状态时形成在***衬套与接收衬套之间的空间。该空间用于在***衬套***接收衬套过程中,暂存被压缩的空气,间接实现泄压的目的,从而减少气体被压缩对***衬套形成的阻力。
优选的,空间包括形成在***衬套中朝向端部开口的凹槽。凹槽使得***衬套与接收衬套之间存在空间,同时,***衬套外壁与接收衬套内壁之间的间隙仍然可以足够小,足够小的间隙不仅使得结构紧凑,而且使得***衬套与接收衬套可以滑动配接但不至于相对晃动,保证装置100的正常工作。
以上描述了申请人设计的不同的减阻结构,当然,本领域技术人员可以想到,减阻结构可以是以上两种以上减阻结构的结合。凡采用与本实施方式相同或类似的方案均涵盖在本发明的保护范围内。
如前所述,工作组件30的传动链路包括被动磁体42、安装被动磁体42的连接轴44、与连接轴44的远端连接的驱动轴34、与驱动轴34的远端连接的泵36。装置100工作时,马达轴16驱动主动磁体22旋转,被动磁体42与主动磁体22磁耦合,被动磁体42被主动磁体22驱动旋转,被动磁体42旋转顺次驱动连接轴44、驱动轴34旋转,驱动轴34旋转而驱动泵36实现泵血功能。
请重点参见图8和图9,本实施方式中,介入端衬套40设有第一轴向通道101,连接轴44可转动地设在第一轴向通道101中。连接轴44外设有至少一个轴承90,轴承90外圈与第一轴向通道101内壁之间设有阻尼件92。阻尼件92不仅可以减少振动,还可以提供一定的移动缓冲空间,使被动磁体42与主动磁体22尽可能的对中,提高传动效率。
具体而言,如上文描述,主被动磁体22、42之间存在轴向不完全对准的情形。当两个磁体轴向错开大于预定程度时,则被动磁体42会在径向上存在振动。
通过在轴承90与第一轴向通道101之间设置阻尼件92,并将阻尼件92配置为柔性的,则柔性的阻尼件92可被连接轴44挤压变形,从而为被动磁体42的振动提供径向的形变空间。而阻尼件92的被挤压变形会同时蓄能,从而对连接轴44提供使其轴向居中的复位作用,使两个磁体恢复对准。
此外,阻尼件92大致呈圆环状,套接在轴承90外周面。值得注意的使,阻尼件92可以是周向连续的,也可以是周向不连续的,即包含多个呈弧形的阻尼单体。借由阻尼件92呈圆环状的结构设计,阻尼件92可沿周向的360°对被动磁体42的振动进行复位。
如上文描述,泵和导管的前端部分由受试者的脉管***向前介入。而已知的,脉管***是曲折的,尤其是存在角度可能小于30°的过弯段。
由于驱动轴34穿设在导管32中,因此,在如此曲折的脉管***中输送时,导管32及驱动轴34会发生顺应脉管***的弯曲。不过,由于驱动轴34与导管32的柔软度不同,加之驱动轴34位于导管32内侧。因此,在输送过弯过程中,驱动轴34会在导管32中发生轴向的移动。
因此,为了适应驱动轴34的轴向移动,驱动轴34与连接轴44沿轴向可滑动配合。进一步地,由于连接轴44需要将旋转传递给驱动轴34,因此,驱动轴34与连接轴44周向固定。
具体的:驱动轴34的近端设置或形成有连接部94,连接部94的横截面呈不为圆形的任意形状;连接轴44的远端形成有与连接部94适配的配接通道,连接部94轴向可滑动的***配接通道。
连接部94的横截面呈不为圆形的任意形状,例如可以为方形、椭圆形,构造成扁轴,可周向止转,保证驱动轴34与连接轴44的周向固定,从而使驱动轴34随连接轴44同步转动。
连接部94可与驱动轴34一体构造,构造成驱动轴34结构的一部分,具体可以为驱动轴34的后端端部经非圆形化工艺处理得到。
或者,连接部94可为额外设置在驱动轴34后端的部件,并具有符合上文描述的截面形状。
需要说明的是,虽然驱动轴34与连接轴44之间轴向可滑动,但不用担心两者会脱离,因为驱动轴34的远端与泵36连接,由此,驱动轴34的远端由泵36限定轴向上的远端位置,也就是说,配接通道与泵36分别限定了驱动轴34在轴向的近端位置和远端位置,因此驱动轴34不会因为与连接轴44滑动配接而脱落。
如前所述,工作组件30包括导管32、穿设在导管32中的驱动轴34、由驱动轴34驱动的泵36。
驱动轴34穿设在导管32中,导管32避免驱动轴34与外界接触,一方面保障驱动轴34的正常工作,另一方面,避免驱动轴34工作过程中直接接触受试者,对受试者造成伤害。
泵36,可通过导管32被输送至心脏的期望位置泵送血液,包括连接至导管32远端并具有进口端361和出口端362的泵壳363、收纳在泵壳内的叶轮(未示出),叶轮被驱动轴34驱动旋转以将血液从进口端361吸入泵壳363并从出口端362排出。
如图1至图3所示,在本实施例中,泵壳363包括由镍、钛合金制作的呈金属格构的支架3631和覆盖在支架3631上的弹性的覆膜3632。支架3631的金属格构具有网孔设计,覆膜3632覆盖支架3631的部分,支架3631前端未被覆膜3632覆盖的部分的网孔形成所述进口端361。覆膜3632的后端包覆在导管32远端外部,出口端362为形成在覆膜3632后端的开口。
进一步地,叶轮包括连接至驱动轴34远端的轮毂以及支撑在轮毂外壁的叶片,叶片可以呈螺旋状,其数量可以是一个,也可以是多个例如两个。
驱动轴34的远端连接至轮毂,导管32远端与支架3631近端之间连接有近端轴承室(未示出)。也就是,支架3631通过近端轴承室与导管32连接。驱动轴34穿设在位于近端轴承室中的近端轴承。
支架3631的远端与保护头38之间设有远端轴承室37。也就是,保护头38通过远端轴承室与支架3631连接。轮毂12的远端插设在位于远端轴承室37中的远端轴承。通过近远端轴承形成对叶轮9的限位,使叶轮能较佳的被保持在泵壳363中,并使叶轮与泵壳363之间的泵间隙被稳定的保持。
在本实施例中,泵36为可收折式泵,具有压缩状态和展开状态。具体的,泵壳363和叶轮被配置为:在泵36对应介入构型下处于压缩状态,以便泵36以较小的第一外径尺寸在受试者脉管***中输送,以及,在泵36对应工作构型下处于展开状态以便泵36以大于第一径向尺寸的第二径向尺寸在期望位置泵送血液。
在本领域中,泵363的尺寸与流体力学性能是两个相互矛盾的参数。简言之,出于减轻受试者痛苦和介入容易的角度,希望泵363的尺寸小。而出于为受试者提供较强的辅助功能,希望泵363的流量大,流量大一般要求泵363的尺寸大。
通过设置可收折的泵363,使得泵363具有较小的收折尺寸和较大的展开尺寸,以兼顾在介入/输送过程中减轻受试者痛苦且介入容易,以及提供大流量这两方面的需求。
由上述,泵壳3631的多网孔尤其是菱形网孔的设计可实现较佳的实现收折,同时借助镍钛合金的记忆特性实现展开。
叶轮包括连接至驱动轴34远端的轮毂以及支撑在轮毂外壁的叶片,叶片被配置为:在泵36对应介入构型时包裹在轮毂外壁上并至少部分地与泵壳内壁接触,以及,在泵36对应工作构型时自轮毂径向向外延伸并与泵36的内壁间隔。
叶片由柔弹性材料制成,在被收折时蓄能,在外界的约束撤除后,叶片的蓄能释放,使叶片展开。
泵36是借助外界的约束实现收折,在约束撤除后,泵36实现自展开。在本实施例中,“压缩状态”是指泵36被径向约束的状态,也就是说,泵36受到外界压力被径向压缩折叠成最小径向尺寸的状态。“展开状态”是指泵36未被径向约束的状态,也就是说,支架3631和叶轮径向外侧展开成最大径向尺寸的状态。上述的外界约束的施加,通过滑动套设在导管32外的折叠鞘管(未示出)完成。当折叠鞘管在导管32外向前移动时,可将泵36整体收纳在其内,实现泵36的强制收折。当折叠鞘管向后移动时,泵36受到的径向约束消失,泵36自展开。
由上述,泵36的收折,是借助折叠鞘管施加的径向约束力实现的。而泵36包含的叶轮收纳在泵壳363内,因此,实质上,泵36的收折过程是:折叠鞘管对泵壳363施加径向约束力,泵壳363径向压缩时,对叶轮施加径向约束力。
也就是,泵壳363是直接在折叠鞘管的作用下被收折,而叶轮却是直接在泵壳363的作用下被收折。而如上述,叶轮具有弹性。因此,尽管处于收折状态,但叶轮收折蓄能使其始终具有径向展开的趋势,进而叶轮会与泵壳363内壁接触,并对泵壳363施加反作用力。
在折叠鞘管的约束撤除后,泵壳363在自身的记忆特性作用下,支撑弹性的覆膜展开,叶轮在释放的蓄能作用下自展开。在展开状态下,叶轮的外径小于泵壳363的内径。
这样,叶轮的径向外端(也就是叶片的叶尖)与泵壳363的内壁(具体为支架3631内壁)之间保持间隔,该间隔为泵间隙。泵间隙的存在,使得叶轮能无阻碍的旋转,而不发生碰壁。
此外,出于流体力学方面的考虑,泵间隙尺寸为较小的数值且被维持,是期望的。在本实施例中,叶轮的外径略小于支架3631内径,使得在满足叶轮旋转不碰壁的情况下,泵间隙尽可能的小。而泵间隙保持的主要实现手段是通过支架3631提供的支撑强度,该支撑强度可抵抗流体(血液)的背压的作用而不发生变形,进而保持泵壳363的形状稳定,则泵间隙也被稳定的保持。
下面对本装置100以用作左心室辅助装置为例时泵36的收折和展开过程介绍如下:
在将泵36介入左心室的过程中,泵36由于外部施加的径向约束力而处于径向约束状态(压缩状态)。在介入至左心室中并撤去径向约束力后,支架3631利用自身的记忆特性以及叶轮的叶片借助蓄能释放而自主扩张,所以泵36自动地呈现其非约束形状(展开状态)。
反之,在本装置100完成工作需要从受试者体内撤出时,利用折叠鞘将泵36收折,待泵36完全撤出受试者体内,再撤除折叠鞘对泵36的约束,使泵36恢复至应力最小的自然状态,也就是展开状态。
装置100在工作时,相对旋转的部件之间,例如连接轴44与介入端衬套40、驱动轴34与导管32之间会产生热量,热量的聚集会加剧这些部件的磨损,降低使用寿命。因此,有必要措施进行热管理。
有鉴于此,装置100还包括基本贯穿整个工作组件30的灌注通道。具体的,灌注通道贯穿被动磁体42至泵36的传动链路。在装置100工作时,灌注通道内可注入流体,该流体为上文描述的Purge液体,对传动链路起到润滑和降温的作用。
具体的,请重点参见图9和图10,灌注通道的近端入口96为设在介入端衬套40的近端且将被动磁体42收纳在其内的腔。优选的,腔不仅收容被动磁体42,还将被动磁体保护组件46亦收纳在其内。
被动磁体42是工作组件30中传动链路的起点,而灌注通道的近端入口96设为将被动磁体42收纳在其内的腔,腔内可灌注流体,流体对被动磁体42进行润滑及降温。因此,灌注通道从工作组件30传动链路的起点开始对传动链路进行润滑及降温,保证工作组件30的有效工作。
从上述可知,灌注通道从耦合器的近端开始贯穿至泵36的远端。需要特别予以说明的是,该结构设计可取得排气操作方便的有益效果。具体说明如下:
习知的,向受试者体内灌注液体(Purge)时,应避免有会对受试者产生致命伤害的气体在事先或过程中进入受试者体内。因此,在本装置100的工作组件介入受试者体内之前,需用灌注液排出工作组件内的空气,使工作组件内被事先充满灌注液。
已知的灌注实施中,灌注液接口位于工作组件的两端之间,一般更靠近工作组件近端也就是耦合器的近端设置。这样,以灌注液接口为界,工作组件被分为位于灌注液接口两侧的近端段和远端段。这样,需分别对近端段和远端段进行排气操作。
也就是,现有已知实施例中,排气操作需执行两次。具体为:
首先,在灌注液接口(设在耦合器外壳上)上连接灌注液源,灌注液源可采用注射器。注射器中容置有灌注液,通过推送注射器,通过灌注液接口将灌注液注入工作组件。
由于灌注液接口靠近耦合器近端设置,远端段的长度远大于近端段的长度;加之远端段主要为导管32、驱动轴34和泵36等结构。因此,液体在远端段中的流动阻力远大于在近端段中的流动阻力。
所以,灌注液首先进入近端段,将近端段中的空气排空。其中,近端段中的空气被排空可由灌注液从近端段端面,也就是下文所述的密封件118的第一导引通道中流出验证。
随后,将近端段密封,也就是使密封件118的第一导引通道密封(具体密封方式如下文描述)。再利用注射器向工作组件中灌注液体。由于近端段被密封,灌注液只能向远端段流动,将远端段中的空气排空。其中,远端段中的空气被排空可由灌注液从远端段的末端也就是导管32前端和/或叶轮的轮毂远端流出验证。
因此,现有已知实施例,先由灌注液排出近端的气体,随后再排出远端的气体。
而与之相对的,本发明实施例的灌注通道的起点为收纳被动磁体42的腔,而该腔位于整个工作组件的近端端部。这样,灌注液从整个灌注通道的近端进入,灌注液的流动路径只能朝向工作组件的远端。因此,只需执行一次操作即可实现工作组件的排空,排空操作大大简化。
介入端衬套40设有与腔连通的灌注输入通道98,灌注输入通道98的外端穿出连接组件并用于与灌注液源连通。外端穿出连接组件方便与灌注液源连通,为灌注通道提供流体。
灌注输入通道98的延伸方向与轴向方向呈角度设置,使得灌注输入通道98的外端远离工作组件30的近端,避免影响工作组件30与驱动组件10的安装,而且灌注也更加方便,结构设计十分合理。
如前所述,连接轴44与被动磁体42连接,具体的如上文所述,被动磁体42套设在连接轴44的近端的安装部上。连接轴44安装于耦合器,具体的,连接轴44安装于介入端衬套40,介入端衬套40设有第一轴向通道101,连接轴44可转动地设在第一轴向通道101中。连接轴44具有轴向延伸的轴向中空腔,该轴向中空腔还可称为第二轴向通道102。
灌注通道在耦合器的部分包括:形成在连接轴44中的第二轴向通道102、形成在连接轴44与第一轴向通道101之间的第一间隙;第二轴向通道102、第一间隙与腔连通。
由此,流体从灌注输入通道98输入后,先流经收容被动磁体42的腔,再依次经过轴承和第一间隙。
如前所述,驱动轴34的连接部94与连接轴44的配接通道插接配合,连接部94为中空构造,进而连接轴44与驱动轴34的内部轴向通道连通。配接通道为第二轴向通道102的一部分。具体的,配接通道为第二轴向通道102的远端部分,配接通道与第二轴向通道102的近端部分连通,且两者的径向宽度有差别而形成台阶,方便对连接部94进行近端的轴向限位。
因此,在连接轴44的远端,流体流经配接通道对连接轴44远端的内部、驱动轴34近端的连接部94进行降温及润滑,合理利用连接轴44与驱动轴34的安装结构对两者进行降温及润滑,而且保障流道的通畅,结构设计十分合理。
如前所述,工作组件30包括导管32,驱动轴34穿设在导管32中。灌注通道还包括:形成在驱动轴34与导管32的轴腔之间的第二间隙。由此,流体流经被动磁体42、连接轴44后,流经第二间隙,对驱动轴34的外表面进行降温及润滑。
如图8所示,在某些实施例中,耦合器还包括连接至介入端衬套40远端的定位套108;导管32的近端收纳在定位套108内,驱动轴34的近端露出定位套108与连接轴44连接。具体的,定位套108包括相连的近端部分和远端部分,近端部分的端部与介入端衬套40连接,近端部分自近端端面沿朝向远端的方向凹陷形成容置空间110,远端部分形成收纳导管32的导管收纳腔,导管32的近端收纳在导管收纳腔中,驱动轴34的近端伸出导管收纳腔、并穿过容置空间110与连接轴44连接。
容置空间110的径向宽度大于导管收纳腔的宽度。因此,容置空间110中可中转存留相对较多的流体,使液体从第一间隙和连接轴44的轴向通道流出后,经由体积较大的容置空间110的中转和缓存后,再进入导管32和第二间隙,避免液体憋压。
此外,直径和体积较大的容置空间110形成在定位套108的近端部分,有利于定位套108与介入端衬套40和壳体112(下文介绍)的装配。具体而言,定位套108的近端端部形成有径向的凸耳结构1081,壳体112的近端内壁设有径向的止挡1121。壳体112与介入端衬套40接合时,定位套108的凸耳结构1081被夹紧在介入端衬套40远端与止挡1121之间,实现定位套108的固定。
定位套108整体居中设置在壳体112中,用于扶正导管32的轴向位置,使导管32与连接轴44中心对准,避免从导管32近端开口伸出的驱动轴34发生弯曲。
如上述,借助凸耳结构1081与止挡1121的配合作用,实现定位套108的位置固定。而借助凸耳结构1081与是壳体112内壁的顶抵作用,使得定位套108居中位于壳体112中,定位套108的中心通道与连接轴44的轴向通道对准。具体为,凸耳结构1081为柔弹性材质,呈圆环状,外径略大于或等于体112内径。籍此,保证驱动轴34近端以不完全或小幅度弯曲的姿态与连接轴44配合。
第二间隙通过定位套108与第一间隙连通。具体的,第二间隙通过定位套108的容置空间110与第一间隙连通。更具体的,第一间隙的出口端(远端)与容置空间110连通,第二间隙的进口端(近端)与容置空间110连通。因此,流体流出第一间隙后,通过定位套108的容置空间110流进第二间隙,进而可对驱动轴34外表面进行降温及润滑。
耦合器还包括连接至介入端衬套40远端并将定位套108收纳在其内的外壳112,外壳112被配置在耦合器与插接器处于连接状态时,耦合器外表面与插接器的外表面平齐。不仅避免不平齐的外表面可能造成的刮伤,而且外观规整美观。
进一步地,外壳112的远端开口设有供导管32穿过的保持套114,出于与上文所述相同的目的,该保持套114近端与定位套108远端相对或相接,两者中心通道对齐。保持套114的远端延伸一定长度,并具有大于导管32强度的强度,可对导管32起支撑和防弯作用,进一步起到固定的作用,为导管32在壳体112引出处提供强度支撑过渡,避免导管32该引出处发生因强烈和/或频繁的弯曲而断裂的现象。
驱动轴34是沿轴向贯通的,即,整个驱动轴34,包括位于驱动轴34近端的与连接轴44配接的连接部94,具有轴向延伸的轴向中空腔,该轴向中空腔形成第三轴向通道103,第三轴向通道103与第二轴向通道102连通。灌注通道在导管32和驱动轴34的部分还包括:形成在驱动轴34中的第三轴向通道103。流经连接轴44的第二轴向通道102的流体,经由中空的连接部94进入驱动轴34的第三轴向通道103,并最终在驱动轴34的远端流出进入受试者体内,为受试者提供生理支持。
驱动轴34构造成多层编织结构,其侧壁是液体可渗透的。即,流经第二间隙、第三轴向通道103的流体不仅可通过驱动轴34的侧壁渗透而达到平衡,而且可以对整个驱动轴34进行全面的降温及润滑。
实质上,在上文介绍的现有已知的灌注方案中,由于Purge液是在灌注通道的中段进入,则在某些情形下,灌注液接口的位置有可能位于驱动轴近端的远侧。在该情形下,Purge液难以从驱动轴的近端开口进入其中。从而,如果欲想Purge液进入驱动轴的内部,则驱动轴只能构造成侧壁是液体可渗透的。
而与之相对的,本发明实施例的灌注通道的近端为收纳被动磁体42的腔,进入的Purge液将依次经由腔和连接轴44进入驱动轴34内。
也就是,即便是本发明实施例中的驱动轴34不是构造成侧壁可渗透的,Purge液同样可进入驱动轴34的内部。这就为本发明的驱动轴34提供了更灵活的选择空间,对驱动轴34的制作工艺大有裨益。
进一步地,灌注通道在泵36的部分包括:形成在轮毂中且与第三轴向通道103连通的第四轴向通道。由此,流经第三轴向通道103的流体可流入第四轴向通道,并经由第四轴向通道流出。
灌注通道的远端出口包括导管32的远端开口,进一步包括轮毂的远端开口。也就是说,流经第二间隙的流体通过导管32的远端开口流出;流经第四轴向通道的流体通过轮毂的远端开口流出。
由此,可以看出,工作组件30的灌注通道贯穿被动磁体42至泵36的传动链路,灌注通道首先流经收纳被动磁体42的腔,对被动磁体42进行降温及润滑。随后,灌注通道分为两路,一路顺次流经连接轴44内部的第二轴向通道102、驱动轴34内部的第三轴向通道103、泵36的轮毂内部的第四轴向通道,并从轮毂的远端开口流出;另一路顺次流经介入端衬套40与连接轴44外壁的第一间隙、轴承92、定位套108的容置空间110、导管32与驱动轴34外壁的第二间隙,并从导管32的远端开口流出,该路分流的Purge液可对各部件例如轴承92、连接轴44、驱动轴34等进行润滑及降温。
整个灌注通道设计合理、流体流动顺畅,且采用多分支可分流设计,可增大Purge液灌注量。此外,Purge液在流经各相对旋转部件时,可天然的具有润滑及降温效果,避免旋转部件尤其是驱动轴34上出现热量聚集。此外,借助驱动轴34是流体可渗透的和/或灌注通道近端起点的特殊结构设计,Purge液可进入驱动轴34内部,从而对整个驱动轴34进行全面的降温及润滑。
如前所述,泵36、导管32及驱动轴34的远端部分,在装置100工作前需要送入受试者体内。为方便描述,将能送入受试者体内的部分称为进入组件。
为了将进入组件顺利送入受试者体内,装置100还包括贯穿泵36、驱动轴34和耦合器的导引通道。使用时,先将起引导作用的导丝经脉管***送入受试者体内。随后,用户(一般为医护人员)手持本装置100的进入组件的远端,将导丝的近端穿入导引通道的远端,直至导丝穿过整个工作组件30,使其近端从耦合器的近端(具体为下文所述的密封件118的第一导引通道,或者介入端衬套40的旁路出口120)穿出。随后,泵36以压缩状态沿着导丝在受试者的脉管***中建立的引导路径被被向期望位置(例如,左心室)输送。直至,泵36的近端被送入所述期望位置后,抽出导丝,撤除对泵36的约束使其恢复展开,工作组件30连接上驱动组件10,激活马达,即可工作。
如前所述,泵36的轮毂具有第四轴向通道、驱动轴34具有第三轴向通道103、连接轴44具有第二轴向通道102,第四轴向通道、第三轴向通道103、第二轴向通道102顺次连接形成第一导引通道。
事实上,保护头38是中空构造,其与轮毂的第四轴向通道对接连通。因此,保护头38的内部通道构成第一导引通道的一部分。
请重点参见图4、图9和图10,导引通道还包含位于介入端衬套40的近端端面的端面出口116,轮毂的远端出口与端面出口116通过第一导引通道连通。也就是说,工作组件30具有轴向延伸的第一导引通道,第一导引通道可引导导丝从端面出口116穿出,从而将进入组件送入受试者体内。
如上文描述,由于本装置100在工作过程中,需要灌注Purge液,而形成在介入端衬套40近端端面的端面出口116构成灌注通道的近端起点腔。因此,端面出口116需要做可重复打开或密封的设计。
具体而言,端面出口116中设置具有可重复密封第一导引通道的密封件118。密封件118具有两种状态-关闭密封状态和打开状态。当密封件118处于第一状态时,第一导引通道密封,第一导引通道处于被关闭的密封状态。在工作组件30工作时,密封件118封闭端面开口,避免灌注通道内的流体从端面出口116流出,避免Purge液侵蚀马达14。当密封件118处于第二状态时,第一导引通道打开,第一导引通道处于连通状态,以供导丝穿过,从而将进入组件送入受试者体内。
这样,当需要穿导丝时,可以将密封件118打开,使导丝穿过第一导引通道,确保泵36进入受试者体内。在完成泵36的介入后,抽离导丝,可以将密封件118密封,避免泵36在工作过程中Purge液渗漏。
在本发明的一实施方式中,密封件118为可在端面出口116中沿轴向移动的柔性密封塞。柔性密封塞外壁和/或端面出口116内壁倾斜设计,以使柔性密封塞沿轴向朝第一方向移动时被挤压而切换至第一状态,沿与第一方向相反的第二方向移动时径向膨胀而切换至第二状态。
如图9和图10所示意,在本实施例中,所述第一方向可以为朝向介入端衬套40内侧的方向,第二方向为远离或朝向介入端衬套40外侧的方向。更具体的,第一方向可以为如图9和图10中所示意的向右的方向,第二方向为如图9和图10中所示意的向左的方向。
如上文描述,腔内收纳的被动磁体42套设在直径较大的安装部441上。为避免对柔性密封塞的向内行程形成阻碍,安装部441的近端向内凹陷形成避让槽4411,用以收纳柔性密封塞的内端。
连接轴44的中心通道102的近端接通至避让槽4411。进一步地,柔性密封塞的内端端头大致呈锥状,端面出口116内壁大致构造成与之匹配的锥状。这样,锥状的柔性密封塞进和端面出口116具有导流作用,将Purge液顺滑的由腔导至中心通道102内。
在本发明的另一实施方式中,密封件118可以为类似止血阀的囊结构,该囊结构由弹性材料制成,具有内腔和一个类似于上述第一导引通道的通道。囊结构与流体质的填充介质源或弹性材料连通,具有涨鼓状态和坍缩状态。
第一状态即为上述涨鼓状态,对应为囊结构被充满流体介质或弹性材料时的状态,通道被涨鼓的囊结构侧壁占据,实现密封。第二状态为上述的坍缩状态,对应为囊结构中的流体介质被至少部分的释放后的状态,通道露出,实现打开。
本实施方式优选的,导引通道包含位于介入端衬套40的侧面的旁路出口120。如前所述,工作组件30的近端设置被动磁体42及收容被动磁体42的腔,设置旁路出口120后,导丝可从旁路出口120穿出而不用必须从端面出口116穿出,可不设置端面出口116而取消密封件118,从而缩短被动磁体42与主动磁体22之间的距离,提升传动效率。
具体的,介入端衬套40设置第一旁路通道121,第一旁路通道121接通旁路出口120与介入端衬套40内部收纳连接轴44的轴向通道,即第一旁路通道121从旁路出口120延伸至收纳介入端衬套40的第一轴向通道101。
连接轴44的侧壁设有第二旁路通道122,第二旁路通道122与连接轴44的内部通道连通,即第二旁路通道122从连接轴44的侧壁开口延伸至连接轴44的第二轴向通道102。第二旁路通道122可选择地与第一旁路通道121连通。
具体的,第二旁路通道122设于连接轴44,而连接轴44可转动与介入端衬套40配接。因此,第二旁路通道122与第一旁路通道121相互靠近的两个接口具有相对和错开两种状态。
当两个接口相对时,可方便导丝穿过;当两个接口错开时,导丝不能从旁路出口120穿出。当需要从该旁路穿出导丝时,如果两个接口错开,可通过手动调节转动泵36,具体为可转动叶轮,从而顺次带动驱动轴34、连接轴44旋转。直至两个接口相对,导丝可经由第二旁路通道122、第一旁路通道121、旁路出口120穿出。
优选的,工作组件30还包括导丝旁路插管124。在第二旁路通道122与第一旁路通道121处于连通状态时,导丝旁路插管124可操作依次经由两个旁路通道***,导丝旁路插管124的内端与驱动轴34的第二轴向通道102对接连通。导丝旁路插管124可以使导丝的穿插更加方便。
由于旁路出口120通过第一旁路通道121与构成灌注通道的第一轴向通道101连通,因此,为避免在泵36操作过程中,灌注通道中流经第一轴向通道101的Purge液喷出,旁路出口120中可选择地设置密封塞(未示出),以密封灌注通道,避免Purge液经由旁路出口120喷出。
密封塞的可选择设置体现为,在装置100处于导丝需要经由旁路出口120穿出时的穿导丝状态时,密封塞被配置被从旁路出口120中移除,该移除可以为人为手动拔出。这样,导丝的旁路导引通道被打开,可执行导丝的旁路穿出操作。
相应的,在处于除去穿导丝状态以外的其他任意工作状态时,密封塞被塞入旁路出口120中。该其他任意工作状态主要包括:完成导丝的穿引操作后泵36开启工作的状态(此时,需向灌注通道中打Purge液)、从端面穿引导丝的状态,等等。
如前所述,工作组件30设置有端面出口116,也设置有旁路出口120,导引通道被配置为可操作的引导导丝从端面出口116和旁路出口120中的一个穿出。从端面出口116穿出,引导更顺畅;而从旁路出口120穿出,可避免密封件118对被动磁体42及灌注通道的影响。
作为可选地,当导丝经由端面出口116穿出时,旁路出口120处于密封状态。当导丝经由旁路出口120穿出时,端面出口116处于密封状态。该设计的目的,主要在于保持导丝的目标穿引路径的通畅,而避免导丝穿入非目标导引路径中,保证导丝穿引的高效完成。
如上文描述,当导丝需要经由端面出口116穿出时,导丝的穿引路径相对笔直。此时,不必也不能将导丝旁路插管124***第一和第二旁路通道121、122中。
相反,基于上述描述,当需要经由旁路出口120穿引导丝时,需借助导丝旁路插管124来强制导丝改向,由原来的笔直走向修改为近端弯折的走向。由此,当导丝旁路插管124***时,导丝经由端面出口116穿出的路径被阻断,以强制导丝经由旁路穿出。
如图9所示,导丝旁路插管124的内端端面呈楔形面,该楔形面与导丝旁路插管124的轴向之间的夹角,与第一或第二旁路通道121、122的倾斜度相同,例如均为45°。这样,在导丝旁路插管124***后,其内端端面大致呈竖直状态,以与驱动轴32的近端端面实现面-面配合。
以此,避免在导丝旁路插管124与驱动轴32的端面接合处出现缝隙,而导致导丝出现从该缝隙穿引至除导丝旁路插管124以外的其他空间的非期望事件的发生,确保导丝仅能从旁路出口120穿出。
将导丝从旁路出口120穿出的通道称为第二导引通道。本实施方式中,导丝可以择一地通过第一导引通道或第二导引通道,使得导丝穿引操作具有更多的选择,为用户提供灵活的穿导丝配置。
可以理解,第一导引通道和第二导引通道具有重合的部分。具体的,第一导引通道和第二导引通道的远端重合,而近端分开,分别与端面出口116及旁路出口120连通。
当然,装置100也可仅设置端面出口116或旁路出口120,不再赘述,凡采用与本实施方式相同或类似的方案均涵盖在本发明的保护范围内。
下面描述本实施方式的装置100的使用过程。
本实施方式的装置100的驱动组件10与工作组件30通过***衬套与接收衬套之间的锁定机构可拆卸地连接。需要使用装置100时,在介入受试者体内之前,先操作锁定机构使驱动组件10与工作组件30分离;在受试者体内***导丝,再通过导丝与第一导引通道或第二导引通道的配合将进入组件(泵36以收折状态)送入受试者体内需要的位置;取出导丝,密封第一导引通道或第二导引通道(即,端面开口和旁路出口);通过灌注通道向工作组件30内灌注流体;随后,通过锁定机构将驱动组件10与工作组件30连接,撤除泵对泵36的径向约束,使其展开。启动驱动组件10的马达14,即可使驱动组件10驱动工作组件30的泵36处于工作构型,实现辅助心脏的泵血功能。
请参加图11,在本发明的再一实施方式中,提供了第二种锁定机构,以实现***衬套与接收衬套之间的锁定与解锁,具体的:***衬套199的外表面向内凹陷形成锁槽193L;接收衬套197内壁形成有大致呈环形的收纳槽191,锁定件被构造成形成在接收衬套197内壁并大致呈环状的弹簧圈195,弹簧圈195被限位在收纳槽191中。收纳槽191的深度小于弹簧圈195的直径。优选的,弹簧圈195为斜圈弹簧,弹簧圈195在径向平面的投影为椭圆形。收纳槽191的深度小于弹簧圈195的长轴宽度。
由此,弹簧圈195凸出于接收衬套197内表面,弹簧圈195具有沿径向可恢复的变形,当锁槽193L与收纳槽191相对时,弹簧圈195可同时卡入锁槽193L和收纳槽191,实现锁定。
弹簧圈195在***衬套199与接收衬套197接合时陷入收纳槽191中的深度,大于***衬套199未与接收衬套197接合时陷入收纳槽191中的深度。也就是说,***衬套199与接收衬套197接合时,***衬套199对弹簧圈195的反作用力使弹簧圈195进一步陷入收纳槽191中,保证锁定的可靠。弹簧圈195可恢复的变形不超过20%,进一步不超过15%,更进一步不超过10%。使得锁定及解锁操作的可靠性更高。
***衬套199上还设有与锁槽193L间隔设置的避让槽193U。避让槽193U的深度大于锁槽193L的深度,避让槽193U的宽度大于锁槽193L的宽度。避让槽193U相对锁槽193L远离接收衬套197。锁槽193L的槽底与收纳槽191的槽底之间的距离小于弹簧圈195的长轴宽度。避让槽193U的槽底与收纳槽191的槽底之间的距离大于等于弹簧圈195的长轴宽度。
***衬套199上设置避让槽193U,可以让解锁操作更轻松。从图11中的图a至图d示出了从锁定至解锁的过程。在图a中,***衬套199***接收衬套197,***过程中,当锁槽193L与收纳槽191相对时,位于收纳槽191中的弹簧圈195卡入锁槽193L,***衬套199与接收衬套197相对锁定。此时,弹簧圈195的倾斜方向与***衬套199的***方向相同。也就是说,在***衬套199***的过程中,弹簧圈195被***衬套199推动产生朝向***方向的变形而卡入锁槽193L中,实现锁定。锁定后,由于弹簧圈195产生的形变方向与***方向相同,***衬套199的拉出方向与弹簧圈195的形变方向相反,弹簧圈195与锁槽193L之间形成自锁,无法直接拉出***衬套199。
需要解锁时,将***衬套199进一步沿***方向***接收衬套197,当避让槽193U与收纳槽191相对(如图c所示)时,由于避让槽193U的槽底与收纳槽191的槽底距离大于等于弹簧圈195的长轴宽度,弹簧圈195恢复形变不再对***衬套199和接收衬套197施以锁紧的作用力,此时,可相对接收衬套197拉出***衬套199,如图d所示,拉出过程中,***衬套199的拉出方向与弹簧圈195的变形方向相同,即使弹簧圈195经过锁槽193L时会有卡顿,仍可将***衬套199完全拉出接收衬套197实现解锁。
请参加图12至图13,在本发明的再一实施方式中,提供了第三种锁定机构,以实现***衬套与接收衬套之间的锁定与解锁,具体的:锁槽185自接收衬套187内表面向外凹陷形成,锁定件被构造成形成在***衬套189外壁上的凸起183;锁槽185包含沿接收衬套187的插接方向延伸的第一槽181以及接通第一槽181的第二槽179,第二槽179的延伸方向与第一槽181的延伸方向呈不为0°的夹角。第二槽179的内壁形成供凸起183挂接的止挡面177。
需要锁定时,凸起183对准第一槽181的开口并在第一槽181内滑动,***衬套189与接收衬套187在轴向上靠近;随后,凸起183从第一槽181滑入第二槽179,并在第二槽179内滑动至与止挡面177抵接时,***衬套189与接收衬套187相对固定。需要解锁时,操作接收衬套187或***衬套189反向转动,使凸起183从第二槽179滑入第一槽181,随后轴向拉动接收衬套187和/或***衬套189使凸起183从第一槽181的开口滑出,即可实现***衬套189与接收衬套187的解锁。
优选的,第一槽181与第二槽179的夹角为90°,避免凸起183在锁定状态滑入第一槽181,锁定可靠。此外,该结构的锁定方案,需对两个衬套执行相对旋转操作。通过两个槽位90°夹角设计,可顺应两个衬套的旋转。则锁紧时,两个衬套仅需旋转即可,而不必再发生轴向的运动,锁紧操作方便。
请重点参见图14,在本发明的再一实施方式中,提供了第四种锁定机构以实现***衬套与接收衬套之间的锁定与解锁,具体的:马达端衬套与介入端衬套插接配合,两者中之一构造为插头,两者中之另一包含用于接纳插头的插槽;将构造为插头的衬套定义为***衬套,将限定插槽的衬套定义为接收衬套;装置还包括用于接合固定***衬套与接收衬套的锁定机构,锁定机构被构成为通过增大摩擦而实现***衬套与接收衬套的轴向固定。
锁定机构包括套设在接收衬套外的抱箍169以及可操作地锁紧或释放抱箍的锁紧操作件167。抱箍包括周向延伸的主体165,主体165的周向延伸角度小于360度。抱箍还包括与主体165的两端相连并沿径向延伸的第一端部161和第二端部162。
锁紧操作件为凸轮,凸轮具有径向尺寸渐变的凸轮面157,凸轮面157与第一端部161的远离第二端部162的表面抵接。锁定机构还包括与凸轮相连的配合件159,配合件159的一端与凸轮相连,另一端穿过第一端部161和第二端部162并与第二端部162远离第一端部161的表面抵接。
凸轮旋转使得其径向尺寸不同的凸轮面157抵接第一端部161,凸轮转动拉动配合件159移动而改变抱箍的第一端部161和第二端部162之间的距离,使得抱箍夹紧或松开接收衬套,从而使得接收衬套夹紧或松开***衬套,实现锁定及解锁 。
在本发明的再一实施方式中,提供了第五种锁定机构以实现***衬套与接收衬套之间的锁定与解锁,具体的:接合部为贯穿接收衬套侧壁的开口或仅贯穿接收衬套内壁的凹槽;***衬套的外表面向内凹陷形成有容置槽,锁定件被构造成至少部分地收纳在容置槽中并沿径向可移动的销或圆球;销或圆球的径向外端具有不超过***衬套外表面以使***衬套与接收衬套解锁的解锁状态,及径向向外伸出***衬套外表面以嵌入接合部将***衬套与接收衬套结合固定的锁定状态。
销或圆球与容置槽之间偏压设置有弹性复位件,弹性复位件向销或圆球施加的复位力使其具有始终沿径向向外移动以维持锁定状态或朝向锁定状态运动的趋势。在***衬套与接收衬套在轴向上***到位后,弹性复位件使得销或圆球自动卡入接收衬套的开口或凹槽,实现锁定;需要解锁时,轴向拉动***衬套和/或接收衬套,克服弹性复位件的作用力,使得稍或圆球脱离开口或凹槽,即可实现解锁。
在本发明的再一实施方式中,提供了第六种锁定机构以实现***衬套与接收衬套之间的锁定与解锁,具体的:锁定机构被构造成通过增大摩擦而实现***衬套与接收衬套的轴向固定。具体的,锁定机构包括贯穿接收衬套的侧壁的螺纹孔、旋合在螺纹孔中的螺栓;螺栓可操作的通过旋转而使其内端压紧或脱离***衬套外表面,从而实现***衬套与接收衬套之间的锁定及解锁。
应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施方式中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明,它们并非用以限制本发明的保护范围,凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。
Claims (11)
- 一种用于对心脏在发生功能衰竭时进行辅助的装置,包括:驱动组件、与所述驱动组件可拆卸地连接的工作组件;所述驱动组件包括马达、由所述马达驱动的主动磁体;所述工作组件包括:连接轴;被动磁体,设在所述连接轴的近端,与所述驱动磁体耦合;驱动轴,连接至所述连接轴的远端;泵,包括:具有进口端和出口端的泵壳、收纳在所述泵壳内的叶轮;所述叶轮连接至所述驱动轴的远端,以被驱动旋转以将血液从所述进口端吸入所述泵壳并从所述出口端排出;其中:所述主动磁体与被动磁体具有两种配合状态:在第一配合状态,所述被动磁体与主动磁体同步转动;在第二配合状态,所述被动磁体的转速低于所述主动磁体的转速;并且,在所述马达的转速降低至特定阈值之前,所述主动磁体与被动磁体仅可从所述第一配合状态切换至所述第二配合状态。
- 如权利要求1所述的装置,在所述第一配合状态,所述马达启动后转速从零达到设定转速过程中,所述被动磁体的转速随所述马达的转速同步增大。
- 如权利要求2所述的装置,所述马达达到设定转速后,被动磁体的转速基本保持所述设定转速。
- 如权利要求1所述的装置,当所述工作组件遇到的阻力大于所述主动磁体与被动磁体之间的额定扭力时,所述主动磁体与被动磁体从第一配合状态切换至第二配合状态。
- 如权利要求4所述的装置,所述主动磁体与被动磁体从第一配合状态切换至第二配合状态后,所述被动磁体的转速不随阻力的降低或消失而增大。
- 如权利要求1所述的装置,所述主动磁体与被动磁体从第一配合状态切换至第二配合状态后,所述被动磁体的转速降低至特定值后基本保持于该特定值。
- 如权利要求6所述的装置,所述特定值至少比所述主动磁体被马达驱动旋转的额定转速低50%。
- 如权利要求1所述的装置,在所述主动磁体与被动磁体处于第二配合状态时,当所述马达的转速降低至小于所述特定阈值,所述主动磁体与被动磁体切换至所述第一配合状态。
- 如权利要求1所述的装置,当所马达的转速降低至与所述被动磁体的转速基本相当时,所述主动磁体与所述被动磁体可从所述第二配合状态切换至所述第一配合状态。
- 一种用于对心脏在发生功能衰竭时进行辅助的装置,包括:驱动组件、与所述驱动组件可拆卸地接合的工作组件;所述驱动组件包括马达、由所述马达驱动的主动磁体;所述工作组件包括:连接轴;被动磁体,设在所述连接轴近端,与所述主动磁体耦合;驱动轴,连接至所述连接轴远端;泵,包括:具有进口端和出口端的泵壳、收纳在所述泵壳内的叶轮;所述叶轮连接至所述驱动轴的远端,以被驱动旋转以将血液从所述进口端吸入所述泵壳并从所述出口端排出;其中:在所述工作组件的阻力小于或等于所述主动磁体与被动磁体之间的额定扭力时,所述被动磁体与主动磁体处于同步转动的第一配合状态;在所述工作组件的阻力大于所述主动磁体与被动磁体之间的额定扭力时,所述被动磁体处于转速低于所述主动磁体转速的第二配合状态。
- 如权利要求10所述的装置,在所述马达的转速降低至特定阈值之前,所述主动磁体与被动磁体仅可从所述第一配合状态切换至所述第二配合状态。
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PCT/CN2021/105656 WO2023283751A1 (zh) | 2021-07-12 | 2021-07-12 | 用于对心脏在发生功能衰竭时进行辅助的装置 |
CN202210331831.1 | 2022-03-30 | ||
CN202210331831 | 2022-03-30 |
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Citations (4)
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US6351048B1 (en) * | 1999-06-22 | 2002-02-26 | Levitronix Llc | Electrical rotary drive |
US6398506B1 (en) * | 1999-07-23 | 2002-06-04 | Terumo Kabushiki Kaisha | Centrifugal fluid pump and control device for operating the same |
CN101820933A (zh) * | 2007-10-08 | 2010-09-01 | 亚琛创意解决方案Ais有限责任公司 | 导管装置 |
WO2018088939A1 (ru) * | 2016-11-09 | 2018-05-17 | Алексей Васильевич КОРОТЕЕВ | Микроаксиальный насос поддержки кровообращения (варианты) |
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2022
- 2022-04-13 WO PCT/CN2022/086472 patent/WO2023284339A1/zh active Application Filing
- 2022-07-06 CN CN202210795839.3A patent/CN115382093A/zh active Pending
Patent Citations (5)
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US6351048B1 (en) * | 1999-06-22 | 2002-02-26 | Levitronix Llc | Electrical rotary drive |
US6398506B1 (en) * | 1999-07-23 | 2002-06-04 | Terumo Kabushiki Kaisha | Centrifugal fluid pump and control device for operating the same |
CN101820933A (zh) * | 2007-10-08 | 2010-09-01 | 亚琛创意解决方案Ais有限责任公司 | 导管装置 |
WO2018088939A1 (ru) * | 2016-11-09 | 2018-05-17 | Алексей Васильевич КОРОТЕЕВ | Микроаксиальный насос поддержки кровообращения (варианты) |
EP3539584A1 (en) * | 2016-11-09 | 2019-09-18 | Koroteev, Alexey Vasilievich | Microaxial pump for assisting blood circulation (variants) |
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