CN116350934B

CN116350934B - Device for assisting heart in the event of failure

Info

Publication number: CN116350934B
Application number: CN202310412353.1A
Authority: CN
Inventors: 付建新; 托马斯·乔治·罗根
Original assignee: Xinqing Medical Suzhou Co ltd
Current assignee: Xinqing Medical Suzhou Co ltd
Priority date: 2022-01-26
Filing date: 2022-01-26
Publication date: 2024-05-17
Anticipated expiration: 2042-01-26
Also published as: CN116585609A; CN114452527B; CN116350933A; CN116350934A; CN114452527A; WO2023143155A1; CN116603163A

Abstract

The invention discloses a device for assisting the heart in the event of failure, comprising: a drive assembly, a work assembly; wherein: the drive assembly includes: a motor, a driving member driven by the motor; the work assembly includes: a driven member coupled to the driving member to be driven to rotate, a driving shaft driven by the driven member, a pump driven by the driving shaft; one of the driving member and the driven member is a magnetic force providing element, the other is a conductor, and a gap is formed between the driving member and the driven member; the pump includes: a pump housing connected to the distal end of the catheter and having an inlet end and an outlet end, an impeller received within the pump housing, the impeller being driven in rotation by the drive shaft to draw blood into the pump housing from the inlet end and to discharge blood from the outlet end; the device further comprises a guide channel extending through the working assembly, the guide channel comprising an end side outlet located on the proximal side for passage of a guidewire; a seal with resealable is disposed in the end-side outlet.

Description

Device for assisting heart in the event of failure

The application is a divisional application with the application number of 202210093108.4, the application date of 2022, 1 month and 26 days, and the name of the device for assisting the heart in the case of functional failure.

Technical Field

The invention relates to a device for assisting a heart in the occurrence of functional failure, and belongs to the technical field of medical appliances.

Background

Heart failure is a health problem with high mortality. Taking cardiogenic shock as an example, the ejection performance of the left ventricle of a patient is significantly reduced, and the reduced coronary blood supply may lead to irreversible heart failure. Thus, for this case, temporary interventional support (ventricular assist) would replace the pumping function of the left ventricle, either locally or mostly, and increase coronary blood supply.

In the existing ventricular assist device, the power of the motor is transmitted to the driving shaft in a magnetic coupling mode due to the requirement of liquid sealing (preventing perfusate from entering the motor), so that the ventricular assist device is a common means. The method comprises the following steps: when the motor drives the active magnet to rotate, the driving shaft is driven to rotate under the action of magnetic coupling of the active magnet and the passive magnet, so that the impeller is driven to rotate, and blood pumping is realized.

As described in CN103120810B, the magnetic coupling has a clutch function. When the torque transmissible by the magnetic coupling exceeds the set torque, for example, the rotation of the impeller at the front end is blocked, the two magnets are separated. At this time, even if the motor rotates normally, the drive shaft and the impeller are in a state of being or substantially in a stopped state, and the pump fails to continue pumping blood.

Notably, the magnetic coupling has the property of blocking rotation and interrupting the power transmission, with the aim of protecting the ventricular tissue from damage. At the same time, however, this can have a number of adverse consequences, including:

1. In the event that the pump loses pumping, the insufficient pumping capacity of the heart of the subject (e.g., a human) in which the ventricular assist device is interposed, necessarily results in poor or even no flow of blood, and the portion of the ventricular assist device interposed in the subject, including the catheter and the pump assembly, is susceptible to thrombus formation. While the hazard of thrombus is apparent, including but not limited to: thrombus enters the brain after flowing in the whole body, so that stroke is caused, thrombus does not flow, and the thrombus stays in a certain position of a blood vessel, so that poor oxygen supply of nearby nerve tissues is caused, and nerve injury occurs.

2. Based on the principle of magnetic coupling, after the impeller is greatly decelerated due to the blocked rotation, the impeller is difficult to realize complete re-rotation even after the resistance disappears. In practice, in the high-rotation-speed scenario of ventricular assist, the impeller is intended to be re-rotated after the impeller is decelerated, and the impeller can only be realized by stopping the machine. This is clearly disadvantageous in that it provides a sustained ventricular assist to the subject in clinical need.

Further, without the aid of other automated detection means, feedback of the decrease in blood flow due to substantial impeller deceleration can generally only be determined by human observation and experience. And, even after the resistance disappears, human intervention is required to realize the re-rotation. This is also impractical for the intense medical resources and complex clinical environments that are typically faced by ventricular assist in this high-risk deployment scenario.

Disclosure of Invention

The object of the present invention is to provide a device for assisting the heart in the event of failure, which solves at least one of the above-mentioned problems.

The invention aims at realizing the following technical scheme:

An apparatus for assisting a heart in the occurrence of functional failure, comprising: the device comprises a motor, a coupler detachably engaged with the motor, a driving rotor, a driven rotor arranged in the coupler, a catheter with a proximal end connected to the coupler, a driving shaft penetrating the catheter and driven by a rotor shaft, and a pump driven by the driving shaft to pump blood. Wherein the pump comprises: a pump housing connected to the distal end of the conduit and having an inlet end and an outlet end, an impeller received within the pump housing. The impeller is driven in rotation by the drive shaft to draw blood into the pump housing from the inlet end and expel blood from the outlet end. The driving rotor includes: a first bracket connected to the output shaft of the motor, and a driving piece arranged on the first bracket. The driven rotor includes: the rotor shaft, set up on the rotor shaft and the follower coupled with driving piece. One of the driving member and the driven member is a magnetic force providing element, and the other is a conductor, with a gap formed therebetween.

Compared with the prior art, the invention has the following beneficial effects:

1. The magnetic force providing element is coupled with the conductor to form a power transmission structure similar to an Eddy Current coupling (Eddy Current). Based on the working principle of the vortex coupling, the rotation speed of the working side (the driving shaft or the impeller) is not obviously reduced in the process of transmitting rotary power by adopting the structure, such as the rotation of the impeller is blocked compared with the power transmission mode of magnetic coupling. Therefore, the device has a certain clutch function, and does not cause significant reduction of the pump blood flow under the condition of protecting the ventricular tissue, thereby greatly reducing the risk of thrombus generation caused by blood flow reduction and device intervention.

2. Based on the working principle of the eddy current coupling, the difference of the rotation speeds of the driving piece and the driven piece is also the reason why the eddy current coupling can be coupled. Therefore, after the resistance which hinders the rotation of the impeller disappears, as long as the motor is still operating normally, the driven member automatically realizes the re-rotation without restarting the motor after stopping. Thus, the persistence of providing ventricular assist to the subject is better, and this persistence is independent of complex monitoring and control means, with greater clinical stability.

Drawings

FIGS. 1 and 2 are schematic perspective views of a device according to an embodiment of the present invention at different angles;

FIG. 3 is a schematic perspective view of the drive assembly of FIG. 1 separated from the work assembly;

FIG. 4 is a schematic structural view of a part of a transmission mechanism according to a first embodiment of the present invention;

FIG. 5 is a schematic structural view of a part of a transmission mechanism according to a second embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a part of a transmission mechanism according to a third embodiment of the present invention;

FIG. 7 is a schematic structural view of a part of a transmission mechanism according to a fourth embodiment of the present invention;

FIG. 8 is a schematic structural view of a part of a transmission mechanism according to a fifth embodiment of the present invention;

FIGS. 9 a-9 e are schematic illustrations of different seals used in a fifth embodiment of the present invention;

FIG. 10 is a schematic view of a portion of a transmission mechanism according to a sixth embodiment of the present invention;

fig. 11 is a schematic perspective view of a part of the structure shown in fig. 10.

FIG. 12 is a schematic view of a portion of a transmission mechanism according to a seventh embodiment of the present invention;

fig. 13 is a schematic structural view of a part of a transmission mechanism according to an eighth embodiment of the present invention.

Detailed Description

The present invention will be described in detail below with reference to embodiments shown in the drawings. The embodiments are not intended to limit the invention and structural, methodological, or functional modifications of the invention based on the embodiments are within the scope of the invention.

The terms "proximal", "posterior" and "distal", "anterior" are used herein with respect to a clinician manipulating the device. The terms "proximal", "posterior" and "anterior" refer to portions relatively closer to the clinician, and the terms "distal" and "anterior" refer to portions relatively farther from the clinician. For example, the drive assembly is at the proximal and rear ends and the working assembly is at the distal and front ends; for another example, the proximal end of a member/assembly represents an end relatively close to the drive assembly, and the distal end represents an end relatively close to the working assembly.

The device of the invention defines an "axial" or "axial direction of extension" in terms of the direction of extension of the motor shaft or rotor shaft, the drive shaft. The terms "inner" and "outer" as used herein are relative to an axially extending centerline, with the direction being "inner" relative to the centerline and the direction being "outer" relative to the centerline.

It is to be understood that the terms "proximal," "distal," "rear," "front," "inner," "outer," and these orientations are defined for convenience in description. However, the device may be used in many orientations and positions, and therefore these terms expressing relative positional relationships are not limiting and absolute.

For example, the above definition of each direction is only for the convenience of illustrating the technical solution of the present invention, and does not limit the direction of the auxiliary device of the present invention in other scenarios including, but not limited to, product testing, transportation and manufacturing, etc. that may cause the auxiliary device to be inverted or change its position. In the present invention, the above definitions should follow the above-mentioned explicit definitions and definitions, if they are defined otherwise.

In the present invention, the terms "connected," "connected," and the like should be construed broadly unless otherwise specifically indicated and defined. For example, the device can be fixedly connected, detachably connected, movably connected or integrated; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

Referring to fig. 1-3, an apparatus 100 according to an embodiment of the present invention may at least partially assist in the pumping function of the heart to achieve an effect of at least partially reducing the burden on the heart. In an exemplary scenario, the device 100 may be used as a left ventricular assist, the working portion of which (hereinafter referred to as a pump) may be interposed in the left ventricle, and the pump may be operated to pump blood in the left ventricle into the ascending aorta.

It should be noted that the above example is used as left ventricular assist, and is only one possible applicable scenario for the present device 100. In other possible and not explicitly excluded scenarios, the device 100 may also be used as a right ventricular assist, where a pump may be interposed, which pumps blood in a vein into the right ventricle when the pump is running.

Alternatively, the device 100 may be adapted for pumping blood from the vena cava and/or the right atrium into the right ventricle, from the vena cava and/or the right atrium into the pulmonary artery and/or from the renal vein into the vena cava, and may be configured for placement in the subclavian vein or jugular vein at the junction of the vein and lymphatic vessel, and for increasing the flow of lymphatic fluid from the lymphatic vessel to the vein.

The scenario described below is primarily described with respect to the use of the present device 100 as left ventricular assist. It will be appreciated from the foregoing that the scope of embodiments of the invention is not limited thereby.

Referring to fig. 3 and 4, the apparatus 100 includes a drive assembly 10 and a work assembly 30. The drive assembly 10 provides power to the working assembly 30 to drive the working assembly 30 to perform a pumping function. The drive assembly 10 includes a motor housing 12 and a motor 14 housed within the motor housing 12. The drive assembly further includes a drive rotor comprising: a first bracket 511 connected to an output shaft of the motor 14, a driving member 994 provided on the first bracket 511. The output shaft of the motor 14 may be the motor shaft 16 directly or may be an output shaft driven indirectly through a motor shaft.

The apparatus 100 also includes a control module that is electrically or communicatively coupled to the motor 14, as will be described in greater detail below.

The working assembly 30 includes a coupler 39 that removably engages the motor 14 in a manner that includes a socket, a snap-fit connection, a nut lock connection, etc. The working assembly further includes a driven rotor disposed in the coupler 39, the driven rotor comprising: rotor shaft 44, follower 896 provided on rotor shaft 44, follower 896 coupled to driver 994 to be driven for rotation about the axis of rotation.

The working assembly 30 further includes a catheter 32, a drive shaft (not shown) disposed through the catheter 32, and a pump 36 driven by the drive shaft. The proximal end of catheter 32 is connected to the distal end of coupler 39. A drive shaft is disposed through the conduit 32 and is driven by a rotor shaft 44.

The pump 36 may be delivered to a desired location of the heart (e.g., the left ventricle) via the catheter 32 and includes a pump housing 363 coupled to the distal end of the catheter 32 and having an inlet end 361 and an outlet end 362, an impeller (not shown) received within the pump housing, the impeller being driven in rotation by the drive shaft to draw blood into the pump housing 363 from the inlet end 361 and out of the outlet end 362.

The pump housing 363 includes a bracket 3631 made of nickel, titanium alloy in a metallic lattice and an elastic coating 3632 covering the bracket 3631. The metal lattice of the stent 3631 has a mesh design, the coating 3632 covers a portion of the stent 3631, and the mesh of the portion of the front end of the stent 3631 not covered by the coating 3632 forms the inlet end 361. The rear end of the coating 3632 is wrapped over the distal end of the catheter 32, and the outlet end 362 is an opening formed in the rear end of the coating 3632.

The impeller comprises a hub connected to the distal end of the drive shaft and blades supported on the outer wall of the hub, wherein the blades are spiral, and the number of the blades can be one or a plurality of blades, such as two.

A proximal bearing housing (not shown) is connected between the distal end of catheter 32 and the proximal end of bracket 3631. That is, the bracket 3631 is connected to the catheter 32 through a proximal bearing chamber. The drive shaft is threaded through a proximal bearing located in a proximal bearing chamber. A distal bearing chamber 37 is provided between the distal end of the bracket 3631 and a protective head 38 (described in more detail below). That is, the protective head 38 is connected to the bracket 3631 through a distal bearing chamber. The distal end of the drive shaft is threaded through a distal bearing located in a distal bearing chamber 37. The limit of the impeller is formed by the proximal and distal bearings, so that the impeller can be preferably held in the pump casing 363, and the pump clearance between the impeller and the pump casing 363 can be stably maintained.

The pump 36 is a collapsible pump having a compressed state and an expanded state. In the corresponding access configuration of the pump 36, the pump housing 363 and impeller are in a compressed state, and the pump 36 can be accessed or delivered within the vasculature of a human body at a first, smaller outer diameter dimension. In the corresponding operating configuration of the pump 36, the pump housing 363 and impeller are in a deployed state, and the pump 36 is capable of pumping blood within the left ventricle at a second radial dimension that is greater than the first radial dimension.

The size and hydrodynamic properties of pump 363 are two conflicting parameters in the art. In short, the pump 363 is desired to be small in size from the viewpoints of relief of pain of the subject and ease of intervention. While a large flow rate of pump 363 is desirable to provide a strong auxiliary function to the subject, a large flow rate generally requires a large size of pump 363.

By providing a collapsible pump 363, the pump 363 has a smaller collapsed size and a larger expanded size, which allows for both ease of intervention and ease of intervention in the intervention/delivery procedure, as well as providing a large flow rate.

By the design of the multi-mesh, especially diamond-shaped mesh, of the pump housing 3631, the folding can be realized well, and the unfolding can be realized by the memory property of the nickel-titanium alloy.

The blades wrap around the hub outer wall and at least partially contact the pump housing inner wall when the pump 36 is in the corresponding access configuration. The vanes extend radially outwardly from the hub and are spaced from the inner wall of the pump 36 when the pump 36 is in its corresponding operating configuration. The blades are made of flexible elastic materials, store energy when being folded, and release the energy storage of the blades after the external constraint is removed, so that the blades are unfolded. The pump 36 is folded by external restraint, and after the restraint is removed, the pump 36 is self-expanding.

In the present embodiment, the "compressed state" refers to a state in which the pump 36 is radially constrained. That is, the pump 36 is compressed radially to collapse to a minimum radial dimension under external pressure. "deployed state" refers to a state in which the pump 36 is not radially constrained. That is, the bracket 3631 and the impeller are deployed radially outward to a maximum radial dimension.

The application of the external restraint described above is accomplished by a folding sheath (not shown) that is slidably disposed over the catheter 32. When the folding sheath is moved forward outside the catheter 32, the pump 36 can be housed entirely within it, effecting forced collapsing of the pump 36. When the folded sheath is moved back, the radial constraint imposed by the pump 36 is removed and the pump 36 self-expands.

From the above, collapsing of the pump 36 is achieved by the radial restraining force exerted by the folded sheath, with the impeller contained by the pump 36 being housed within the pump housing 363. Thus, essentially, the collapsing process of the pump 36 is: the folded sheath applies a radial restraining force to the pump housing 363, which applies a radial restraining force to the impeller when the pump housing 363 is radially compressed.

That is, the pump casing 363 is folded directly by the folded sheath, and the impeller is folded directly by the pump casing 363. And as mentioned above, the impeller has elasticity. Therefore, although in the folded state, the impeller is folded and stored so as to have a tendency to be unfolded radially all the time, and the impeller is brought into contact with the inner wall of the pump casing 363 and applies a reaction force to the pump casing 363.

After the constraint of the folding sheath is removed, the pump casing 363 supports the elastic covering film 3632 to be unfolded under the action of the self memory property, and the impeller is self-unfolded under the action of released energy storage. In the deployed state, the outer diameter of the impeller is smaller than the inner diameter of the pump casing 363. In this way, a separation, which is the pump clearance, is maintained between the radially outer end of the impeller (i.e., the tips of the blades) and the inner wall of the pump casing 363 (specifically the inner wall of the cradle 3631). The presence of the pump gap allows for unimpeded rotation of the impeller without wall slamming.

In addition, from a hydrodynamic point of view, it is desirable that the pump gap size be small and maintained.

In this embodiment, the outer diameter of the impeller is slightly smaller than the inner diameter of the support 3631 so that the pump clearance is as small as possible while satisfying the impeller rotation without hitting the wall.

The main means for maintaining the pump gap is the supporting strength provided by the bracket 3631, which resists the back pressure of the fluid (blood) without deformation, and thus the shape of the pump housing 363 is maintained stable, and the pump gap is also maintained stably.

The following description of the collapsing and expanding process of pump 36 follows:

During intervention of the pump 36 into the left ventricle, the pump 36 is in a radially constrained state (compressed state) due to an externally applied radially constraining force. Or the pump 36 may be collapsible only during intervention in the subject's vasculature. After intervention into the left ventricle (forward delivery in the vasculature in collapsed configuration) or into the subject's vasculature (forward delivery in the vasculature in expanded configuration), the radial restraining force is removed and the stent 3631 self expands utilizing its memory properties and the impeller's blades by energy storage release so the pump 36 automatically assumes its unconstrained shape (expanded configuration).

Conversely, when the device 100 is to be withdrawn from the subject as is necessary, the pump 36 is collapsed using the collapsed sheath, and after the pump 36 is completely withdrawn from the subject, the restraint of the pump 36 by the collapsed sheath is removed, allowing the pump 36 to return to its natural, minimally stressed state, i.e., the expanded state.

The protective head 38 is flexible and may be made of any material that macroscopically exhibits flexibility without harming the subject's tissue. Specifically, the protecting head 38 is a flexible protrusion with an arc-shaped or winding-shaped end, and the flexible end is supported on the inner wall of the ventricle in a non-invasive or non-invasive manner, so that the suction inlet 361 of the pump 36 is separated from the inner wall of the ventricle, and the suction inlet 361 of the pump 36 is prevented from being attached to the inner wall of the ventricle due to the reaction force of blood in the working process of the pump 36, so that the effective pumping area is ensured.

The drive assembly 10 is detachably connected to the work assembly 30 by a coupler 39 and the motor housing 12. Thus, in preparation for delivering the distal end portions of the pump 36 and catheter 32 into the subject, the drive assembly 10 can be removed from the working assembly 30, avoiding the larger, heavier drive assembly 10 from affecting the operation of the pump 36 and the distal end portion of the catheter 32 being delivered into the subject, which is more portable.

Referring to fig. 3 and 4 with particular emphasis, the drive assembly 10 includes a drive member 99 driven by the motor shaft 16 of the motor 14. The working assembly 30 includes a follower 89 coupled to a drive member 99 to be driven in rotation about an axis of rotation, the follower 89 driving a drive shaft. A rotor shaft 44 is provided between the follower 89 and the drive shaft, the follower 89 driving the rotor shaft 44, the drive shaft being connected to the rotor shaft 44, so that the follower 89 drives the rotor shaft 44, the drive shaft and the pump 36 in sequence.

One of the driving member 99 and the driven member 89 is a magnetic force providing element, and the other is a conductor, with a gap 79 formed therebetween. The magnetic force providing element is a magnet with magnetism, such as a permanent magnet or a hard magnet. Alternatively, the magnetic force providing element may be an electromagnetic element, such as a coil, capable of generating magnetism when energized. The conductor may be made of metal, such as copper, aluminum or alloy containing copper and aluminum with good conductivity.

After the motor shaft 16 rotates to drive the driving member 99 to rotate, the conductor cuts magnetic lines of force in the magnetic field generated by the magnetic force providing element, so that eddy current is generated in the conductor. This eddy current in turn generates a counter-induction magnetic field on the conductor that magnetically couples with the magnetic field generated by the magnetic force providing element, thereby effecting coupling of the follower 89 with the driver 99 and being driven in rotation about the axis of rotation. The rotation of follower 89 drives rotor shaft 44, the rotation of the drive shaft, and ultimately pump 36.

It is particularly notable that the coupling of the magnetic force providing element with the conductor constitutes a power transmission structure resembling an eddy current coupling (Edd yCurrent). Based on the working principle of the vortex coupling, if the impeller is blocked from rotating in the process of transmitting rotary power by adopting the structure, the rotating speed of the working side (the driving shaft or the impeller) is not obviously reduced compared with the power transmission mode of magnetic coupling. Therefore, the device has a certain clutch function, and does not cause significant reduction of the pump blood flow under the condition of protecting the ventricular tissue, thereby greatly reducing the risk of thrombus generation caused by blood flow reduction and device intervention.

The rotational speed difference between the driving piece and the driven piece is also the reason why the driving piece and the driven piece can be coupled based on the working principle of the vortex coupling. Therefore, after the resistance which hinders the rotation of the impeller disappears, as long as the motor is still operating normally, the driven member automatically realizes the re-rotation without restarting the motor after stopping. Thus, the persistence of providing ventricular assist to the subject is better, and this persistence is independent of complex monitoring and control means, with greater clinical stability.

The gap 79 between the driving member 99 and the driven member 89 allows the magnetic coupling of the driving member 99 and the driven member 89 to achieve a non-contact power transfer, facilitating a fluid tight seal that prevents liquids from entering the motor 14.

The fluid is Purge to be infused into the body during operation of the device 100, and the Purge is a physiological fluid required to partially maintain the function of the body, such as saline, dextrose solution, anticoagulant, or any combination thereof. To smoothly infuse Purge fluid into the human body, the device 100 includes an infusion system including a housing, an infusion pump in communication with the coupler 39 through tubing. A control unit (a second control unit described below) provided in the housing controls the operation of the infusion pump, which injects Purge liquid into the coupler 39 through a pipeline, and injects Purge liquid into the human body through a pipeline system in the working assembly 30.

The proximal end of the catheter 32 is connected to and in fluid communication with a coupler 39, the coupler 39 being provided with an interface adapted for connection to a pipeline through which an infusion pump injects Purge fluid into the coupler 39 into the catheter 32 for onward flow in the catheter 32. In this process, the drive shaft is lubricated and the proximal bearing is flushed to effect lubrication.

The gap 79 is configured to provide a distance between the magnetizing surface of the magnetic force providing element and the surface of the conductor facing the magnetizing surface. A gap 79 is required between the driving member 99 and the driven member 89, but too large a gap 79 can affect the efficiency of the transmission. Therefore, in the present embodiment, the width of the gap 79 is 5mm or less. The width of the gap 79 is further less than 4mm, still further less than 3mm, still further less than 2mm, and especially further less than 1mm.

It is to be noted that the above-mentioned numerical values include all values of the lower value and the upper value that are incremented by one unit from the lower value to the upper value, and that there is at least two units of interval between any lower value and any higher value.

For example, the illustrated gap 79 has a width of 5mm or less, preferably 0.5 to 4.5mm, more preferably 1 to 4mm, still more preferably 1.5 to 3.5 mm, for the purpose of illustrating values such as 2mm, 2.5 mm, 3mm, which are not explicitly recited above.

As mentioned above, the exemplary ranges of integers do not preclude the growth in intervals of appropriate units such as numerical units of 0.1, 0.2, 0.3, 0.5, etc. These are merely examples that are intended to be explicitly recited in this description, and all possible combinations of values recited between the lowest value and the highest value are believed to be explicitly stated in the description in a similar manner.

Unless otherwise indicated, all ranges include endpoints and all numbers between endpoints. "about" or "approximately" as used with a range is applicable to both endpoints of the range.

Other numerical range limitations that may appear herein are referred to the above description and are not repeated.

To constrain the magnetic field lines of the driving member 99 in a direction towards the driven member 89, a side of the driving member 99 facing away from the driven member 89 is provided with a first magnetic constraint member 71. The first magnetic confinement member 71 is made of a magnetically conductive material, and may include, for example, a solid back iron, a parallel flux silicon steel sheet back iron, a perpendicular flux silicon steel sheet back iron, or the like. The first magnetic restraint 71 moves in synchronism with the drive 99.

Likewise, to constrain the magnetic field lines of the follower 89 in the direction of the driver 99, a second magnetic force constraint 72 is provided on the side of the follower 89 facing away from the driver 99. The second magnetic restraint 72 is made of a magnetically conductive material, and reference is made to the above description, and details thereof will be omitted. The second magnetic restraint 72 moves in synchronism with the follower 89.

The first and second magnetic force restraints 71, 72 cooperate to restrain the magnetic force lines between the driving member 99 and the driven member 89, so that the magnetic force therebetween is maximally enhanced, thereby improving the transmission efficiency.

Having described the eddy current drive principle between the driving member 99 and the driven member 89 of the embodiment of the present invention, a specific drive structure is described below by way of different embodiments. The principle of these transmission structures is the same and will not be described again.

Referring to fig. 4, a portion of a transmission mechanism according to a first embodiment of the present invention is shown.

In this embodiment, the distal end face of the driving member 99 and the proximal end face of the driven member 89 are opposed, configured for end-face coupling. The driver 99 includes a main body 993, a connection 995 connected to a side of the main body 993 remote from the follower 89. The main body 993 is disc-shaped, the connecting portion 995 is tubular or hollow cylindrical, and the motor shaft 16 is inserted into the connecting portion 995 to drive the driving member 99 by the motor shaft 16.

Follower 89 is annular, and rotor shaft 44 is inserted into the central bore of annular follower 89 and connected to follower 89, with the proximal end face of rotor shaft 44 being flush with the proximal end face of follower 89. The gap 79 between the distal end face of the driving member 99 and the proximal end face of the driven member 89 is 5mm or less.

The first magnetic force limiter 71 limits the magnetic force lines of the driving member 99 to the distal side of the first magnetic force limiter 71, avoiding the magnetic force lines of the driving member 99 from spreading in a direction away from the driven member 89. The first magnetic force restraint member 71 is annular and sleeved on the connecting portion 995 of the driving member 99, and the first magnetic force restraint member 71 abuts against the proximal end face of the main body 993 of the driving member 99, so that the structure is compact.

The first magnetic restraint 71 moves in synchronism with the drive 99. One way is that the first magnetic restraint 71 is in close fit with the outer surface of the connection portion 995 of the driving member 99 to achieve synchronous movement of the first magnetic restraint 71 and the driving member 99. Alternatively, the proximal end surfaces of the first magnetic restraint 71 and the driving member 99 may be coupled to each other by some means, such as adhesion, to allow for synchronous movement of the first magnetic restraint 71 and the driving member 99.

Of course, other ways of implementing the synchronous movement of the first magnetic force restraining member 71 and the driving member 99 are also possible, and all the solutions similar to or the same as the present embodiment are included in the protection scope of the present invention.

Likewise, the second magnetic force limiter 72 limits the magnetic force lines of the follower 89 to the proximal side of the second magnetic force limiter 72, avoiding the magnetic force lines of the follower 89 from spreading away from the driver 99. The second magnetic force restraint 72 moves synchronously with the follower 89, and the implementation is described above and will not be repeated.

The driven member 89 and the driving member 99 are magnetically coupled by eddy current transmission and sequentially drive the rotor shaft 44, the drive shaft and the impeller of the pump 36, and the first and second magnetic force restricting members 71, 72 cooperate to restrict magnetic force lines therebetween, making transmission efficient.

Referring to fig. 5, a portion of a transmission mechanism of a second embodiment of the present invention is shown.

The known embodiment, represented by US 7393181B 2, provides a solution meeting the above-mentioned needs and essentially opens the way for a collapsible ventricular assist device (abbreviated as blood pump). The blood pump is foldable, and the pump head (comprising a pump shell and an impeller) is folded in the intervention process and unfolded after the intervention in place. The advantages are that the intervention size can be reduced, the infection and complications can be reduced, the pain of the patient can be reduced, and the best hydraulic performance can be obtained when the pump head works.

The pump head (in particular the impeller) of a collapsible blood pump is typically driven in operation by a motor located outside the body by means of a long flexible shaft. In the driving process, the rotating flexible shaft is inevitably rubbed with the inner wall of the catheter accommodating the rotating flexible shaft, and then the heat is generated. This heating can exacerbate wear of the flexible shaft and the catheter, resulting in reduced life of the components. The same problem is also present for other rotating parts, such as bearings, in the whole transmission chain.

The known embodiment, represented by US8591393B2, therefore provides a solution for cooling and/or lubricating the above-mentioned long transmission link when the collapsible blood pump is in operation. The general process is as follows: the external fluid supply source fills the catheter with fluid which lubricates the rotating flexible shaft and the bearing, reduces the friction heat generation amount, and timely cools the heat generation amount.

However, the introduction of a fluid acting as a cooling/lubricating function, with the consequent further problem of sealing, has to be of interest. Essentially, it is undesirable for the priming fluid to enter the motor to avoid damage to the motor.

Therefore, how to transmit the rotation power of the motor to the impeller of the pump head by the flexible shaft and avoid the perfusion liquid from entering the motor in the process is a urgent problem in the field.

This embodiment differs from the first embodiment shown in fig. 4 in that a liquid barrier 75 is provided in the gap 79 between the driving member 99 and the driven member 89, thereby facilitating the sealing of the fluid against liquid entering the motor 14.

The device 100 is operated by pouring Purge fluid into the body. As described above, purge fluid, if flowing into the interior of the motor 14, may cause damage to the motor 14 and cause malfunction of the device. Thus, providing the liquid barrier 75 in the gap 79 between the driving member 99 and the driven member 89 effectively avoids liquid from being injected into the motor 14.

In addition, heat is generated during a series of transmissions of the work assembly 30, exacerbating wear of the components. Therefore, thermal management of the work module 30 is required. The liquid separation wall 75 defines the direction of flow of the liquid so that the liquid can only flow toward the front end, i.e., the working assembly 30, thereby cooling the working assembly 30.

The liquid separation wall 75 encloses at least a portion of the end surface and at least a portion of the side surface of the follower 89 to better prevent the liquid from flowing into the motor 14 to damage the motor 14, and to more uniformly and efficiently thermally manage the working assembly 30.

A liquid barrier (not shown) is provided outside the follower 89 to isolate liquid from contact with the follower 89. The liquid is Purge liquid mentioned above. The liquid isolation wall isolates the liquid from contact with the follower 89, so that the liquid can be prevented from corroding the follower 89, and the performance of the follower 89 can be maintained to the greatest extent.

In particular, in embodiments where the follower 89 is used as a magnetic force providing element, the fluid isolation may prevent the magnet or coil from being eroded by the fluid, resulting in a weakening of the magnetic force, as long as possible, as the life of the follower 89 providing the magnetic force. In the embodiment in which the driven member 89 is used as a conductor, the liquid isolation can prevent the conductor from being corroded to reduce the conductivity, so as to ensure the stable performance of the driven member 89 in generating eddy current and thus an induced magnetic field.

In one embodiment, the liquid barrier layer may be a water-resistant coating, such as a titanium coating. The water-resistant coating may be lightweight and effectively insulates the liquid from contact with the follower 89. The liquid isolation layer constructed of the water-resistant coating has the advantages of thin thickness, light weight, easy formation, high bonding strength, etc., which will provide beneficial improvements in coupling efficiency, assembly, manufacturing cost, and service life.

In another embodiment, the liquid barrier may be a mechanical structure, such as a resin encapsulation, that encases or encases the follower 89, forming a receiving cavity within which the follower 89 is received. As with the waterproof coating embodiment described above, the receiving cavity can reliably protect the follower 89 and reliably isolate the liquid from eroding the follower 89.

Referring to fig. 6, a portion of a transmission mechanism of a third embodiment of the present invention is shown.

Unlike the first embodiment, in the present embodiment, the inner and outer peripheral surfaces of the driving member 993 and the driven member 893 are relatively vortex-driven, configured to be radially coupled.

Whether the end faces are opposite or the inner peripheral face and the outer peripheral face are opposite, the principle is consistent, and the description is omitted. The "circumferential surface" may be a "circumferential surface" or may be a circumferential surface of another shape.

Specifically, the driving member 993 and the driven member 893 are at least partially overlapped with each other in the circumferential direction of the rotation axis, and are spaced apart from each other in the radial direction of the rotation axis with a gap 79. Alternatively, the driver 993 includes a channel 73 and the follower 893 is disposed in the channel 73.

More specifically, the driver 993 and the follower 893 are circumferentially continuous rings or the driver 993 and the follower 893 include a plurality of circumferentially spaced ring segments. It should be noted that the driving member 993 and the driven member 893 are at least partially overlapped in the circumferential direction, and it is not strictly required that the driving member 993 and the driven member 893 be annular or annular in section, and annular shapes of other shapes may be used.

To mount the driver 993, the motor shaft 16 is connected to a first bracket 51, the first bracket 51 includes a first hollow portion 52, the driver 993 is provided on an outer wall of the first hollow portion 52, and the first magnetic force restraining member 713 is provided radially outside the driver 993.

The function of the first magnetic force restriction 713 is the same as that of the previous embodiment and will not be described again.

The first bracket 51 includes a mounting portion 53 connected to the first hollow portion 52, the mounting portion 53 being provided with a mounting hole for mounting the motor shaft 16, and the first bracket 51 is rotated by the motor shaft 16 to rotate the driver 993. The first bracket 51 further includes a stopper 54 connected to the first hollow portion 52, the stopper 54 extending radially outward from a distal end of the first hollow portion 52, the stopper 54 extending in a direction perpendicular to the extending direction of the first hollow portion 52. The driver 993 is abutted against both the first hollow portion 52 and the stopper portion 54. Preferably, the first hollow portion 52, the mounting portion 53, and the stopper portion 54 of the first bracket 51 are integrally formed. The limiting portion 54 is flush with the outer peripheral surface of the driver 993, and the first magnetic force restraining member 713 and the driver 993 are attached to the outer peripheral surface of the limiting portion 54, so that magnetic force lines of the driver 993 are restrained inside the first magnetic force restraining member 713.

Of course, it is understood that the first magnetic force restraining member 713 is only attached to the outer peripheral surface of the driving member 993, and all the embodiments with the same or similar design are also included in the scope of the present invention.

Follower 893 has a through hole, and rotor shaft 44 is inserted into the through hole and connected to follower 893, so that rotation of follower 893 drives rotation of rotor shaft 44. The proximal face of rotor shaft 44 is flush with the proximal face of follower 893.

Work assembly 30 also includes a second magnetic restraint 723, second magnetic restraint 723 being disposed between rotor shaft 44 and follower 893, second magnetic restraint 723 connecting follower 893 and rotor shaft 44. The second magnetic force restraining member 723 is fitted around the outer peripheral surface of the rotor shaft 44, and the follower 893 is fitted around the outer peripheral surface of the second magnetic force restraining member 723. The second magnetic force restraining member 723 restrains magnetic force lines of the follower 893 outside the second magnetic force restraining member 723. The second magnetic restraint 723 has the same axial length as the follower 893 and the second magnetic restraint 723 is disposed in axial alignment with the follower 893, i.e., with both proximal and distal faces flush.

Thus, the rotation of the motor shaft 16 rotates the first bracket 51, the rotation of the first bracket 51 rotates the driver 993, the rotation of the driver 993 rotates the follower 893 through the eddy current transmission, and the rotation of the follower 893 rotates the rotor shaft 44, thereby driving the pump 36 to operate through the drive shaft. The first magnetic force restrainer 713 and the second magnetic force restrainer 723 cooperate to restrain magnetic force lines therebetween.

In an alternative embodiment, second magnetic restraint 723 is integrally provided with rotor shaft 44. Alternatively, the rotor shaft 44 itself is made of a magnetically conductive material, and the rotor shaft 44 itself is configured as the second magnetic force restraining member 723, so that the provision of a separate second magnetic force restraining member 723 can be eliminated, and the structure is simpler.

In this embodiment, the driver 993 defines a channel into which the follower 893 extends at least partially. In other alternative embodiments, the follower 893 includes a channel and the driver 993 is disposed in the channel.

In the present embodiment, the motor shaft 16 is connected to the first bracket 51, the driving member 993 is connected to the first bracket 51, or the first bracket 51 itself is configured as the driving member 993. In other alternative embodiments, rotor shaft 44 is coupled to a second bracket that includes a second hollow portion, follower 893 disposed on an outer wall of the second hollow portion, the second hollow portion configured as a second magnetic restraint; or the follower 893 is provided on an inner wall of the second hollow portion, and the second magnetic restraint is provided radially inward of the follower 893.

In this embodiment, the liquid separation wall 75 is also disposed in the gap 79 in the same manner as in the second embodiment, and will not be described again.

When the device 100 is in operation, the motor shaft 16 drives the driving member 993 to rotate, the driven member 893 is coupled with the driving member 993, the driven member 893 is driven to rotate by the driving member 993, the driven member 893 sequentially drives the rotor shaft 44 and the driving shaft to rotate, and the driving shaft rotates to drive the pump 36 to realize the blood pumping function.

Referring to fig. 7, a portion of a transmission mechanism of a fourth embodiment of the present invention is shown.

As described above, the rotational speeds of the driving member 993 and the driven member 893 are not synchronized based on the transmission principle of the eddy current coupling. It is because of this lack of synchronization of the rotational speeds that the coupling of the driver 993 and the follower 893 is achieved by eddy currents and reverse induced magnetic fields generated in the conductors. In short, there must be a rotational speed difference between the motor shaft 16 and the drive shaft or impeller.

If there is no rotation speed difference between the motor shaft 16 and the driving shaft, the control module can indirectly control the rotation speed of the driving shaft or the impeller by directly detecting and controlling the rotation speed of the motor shaft 16, so that the rotation speed of the impeller is in a reasonable range, and the pump can meet the working requirement.

In the present invention, however, the manner in which the driver 993 and the follower 893 are coupled determines that there must be a speed differential between the motor shaft 16 and the drive shaft (typically, the drive shaft has a lower rotational speed than the motor shaft 16). The control module then knows the rotational speed of the drive shaft in time, which is necessary for the control of the drive shaft and the proper functioning of the pump. To this end, the apparatus 100 includes a rotational speed detection assembly in communication with the control module for detecting the rotational speed of the drive shaft.

When the control module determines that the rotation speed of the driving shaft is lower than the target rotation speed based on the signal provided by the rotation speed detection component, the control module controls the motor 14 to increase the rotation speed, so that the rotation speed of the driving shaft is increased, and the rotation speed of the driving shaft is adjusted to be close to the target rotation speed. When the rotational speed of the drive shaft is within 10%, preferably 5%, and more preferably 1% of the target rotational speed, the control module determines that the rotational speed of the drive shaft is near the target rotational speed.

When the control module determines that the rotational speed of the drive shaft is near the target rotational speed based on the signal provided by the rotational speed detection component, the control module controls the motor 14 to maintain the current rotational speed so that the rotational speed of the drive shaft is maintained near the target rotational speed.

Preferably, the apparatus 100 further includes an alarm unit electrically or communicatively connected to the control module, and the control module controls the alarm unit to operate when the rotational speed of the drive shaft is determined to be lower than the target rotational speed based on the signal provided by the rotational speed detection assembly, but the rotational speed of the motor 14 is higher than the set value. That is, when the rotational speed of the motor 14 is higher than the set value, theoretically, the rotational speed of the drive shaft is not lower than the target rotational speed, in which case, if the rotational speed of the drive shaft is detected to be lower than the target rotational speed, it is indicated that a problem occurs in the transmission link of the motor 14 to the drive shaft, such as that there is rotational resistance of the impeller or the drive shaft, resulting in a stall problem of the impeller or the drive shaft compared to the motor shaft 16. At this time, the alarm unit sends out an alarm signal, so that an operator (for example, a doctor) can timely learn the situation, and accordingly, corresponding measures can be timely taken, and safety is improved. The alarm unit may be, for example, an audible alarm, a flashing alarm, a combination of both, or the like.

The control module comprises a first control unit integrated in the motor 14, a second control unit provided in the housing of the perfusion system. The first control unit may provide the converted level signal to the motor 14 and may also provide reverse electrical isolation to the motor 14. The second control unit is electrically or communicatively connected to the rotational speed detection assembly and controls the operation of the motor 14 and the infusion pump.

The first control unit is a first PCB unit, and the functions include: first, a suitable voltage is provided to the motor 14 to effect a voltage transition, such as a transition from a high level to a low level, or a transition from a low level to a high level, which is then provided to the motor 14. Second, electrical isolation, such that the electronic and electrical related regulations are based on safety requirements. For example, when there are other high voltage scenarios on the interventional side, such as the defibrillator transmitting back to the motor 14 through a conductive flexible shaft, it may cause the device 100 to fail and fail, thus requiring electrical isolation.

The second control unit is a second PCB unit, and the functions include: controlling the operation of the motor 14. The rotational speed of the motor 14 is controlled, for example, based on the received signal. Wherein the signals at least include: and the second PCB unit converts the rotating speed electric signal (voltage) into rotating speed information, judges the rotating speed information and further performs rotating speed control. The function of the second PCB unit also includes controlling the motor (syringe pump motor) in the priming system, thereby controlling the priming of Purge liquids.

Since the control module includes the first PCB unit and the second PCB unit which are separately provided, the first PCB unit and the second PCB unit can be provided at different positions and each performs its own function, without being provided entirely in the motor 14, so that the size of the motor 14 can be reduced.

Differences between the present embodiment and the third embodiment are described with emphasis.

To detect the rotational speed of the drive shaft, the rotational speed detection assembly includes a synchronizer 202 that rotates in synchronization with the drive shaft, and a sensor 204 that detects the rotational speed of the synchronizer 202, the sensor 204 being in electrical communication or communicative connection with the control module.

The sensor 204 may detect the rotational speed of the drive shaft and transmit the rotational speed information of the drive shaft to the control module, which may determine whether the rotational speed of the drive shaft meets the requirements, and determine whether the rotational speed of the driver 994 needs to be adjusted by adjusting the rotational speed of the motor 14, and finally control the rotational speed of the drive shaft within a desired range, thereby meeting the operational requirements of the pump driven by the drive shaft.

For example, in one scenario, if the control module determines that the rotational speed of the drive shaft is below the minimum requirement, the rotational speed of the drive shaft may be increased by increasing the rotational speed of the motor 14, thereby increasing the rotational speed of the drive shaft via the coupling of the driver 994 and the follower 894, and thus meeting the operational requirements of the pump. Of course, the reverse control is also possible, and will not be described again.

In one embodiment, synchronizer 202 is a magnetic force providing element and sensor 204 is a coil. According to the electromagnetic induction principle, current can be generated in the coil in the synchronous rotation process of the magnetic force providing element along with the driving shaft, when the magnetic force providing element rotates at different speeds, the current in the coil can be changed, the coil is electrically or communicatively connected with the control module, the control module can determine the rotation speed of the magnetic force providing element through the change of the current of the coil through certain calculation, so that the rotation speed of the driving shaft is determined, whether the rotation speed of the motor 14 needs to be adjusted or not is judged according to the requirement, and the rotation speed of the driving shaft is adjusted.

In other embodiments of the present invention, the rotation speed detecting component may be implemented by using grating, light reflection, stroboscope, etc., and all the schemes similar to or the same as the present embodiment are included in the protection scope of the present invention.

In another embodiment, synchronizer 202 is a magnetic force providing element and sensor 204 is a hall sensor. When the magnetic force providing element rotates at different speeds, the Hall sensor can send out different pulse signals, and the control module can obtain the rotating speed of the driving shaft through detecting the change of the pulse signals sent out by the Hall sensor and through certain calculation, and judges whether the rotating speed of the motor needs to be adjusted according to the requirement, so that the rotating speed of the driving shaft is adjusted.

Since the hall sensor is a sensor 204 with relatively mature technology, only a proper sensor is required to be purchased, and the design and the manufacture of the device are simpler.

As described above, the rotor shaft 44 is provided between the driven member 894 and the driving shaft, and the driven member 894 is mounted to the rotor shaft 44 and drives the rotor shaft 44, and the driving shaft is connected to the rotor shaft 44, so that the driven member 894 sequentially drives the rotor shaft 44, the driving shaft, and the pump.

In operation of the device, the distal portion of the drive shaft is delivered into the subject with the catheter, the drive shaft including a flexible shaft that is flexible and which is capable of macroscopic deformation. Rotor shaft 44 mounts follower 894, and rotor shaft 44 is a stiff shaft, which may provide for a more stable and reliable mounting of follower 894.

Synchronizer 202 is provided on rotor shaft 44. That is, the positions of the synchronizer 202 and the sensor 204 do not change during the rotation of the synchronizer 202 along with the rotor shaft 44, and the sensor 204 detects the rotation speed of the synchronizer 202 more accurately.

As previously described, synchronizer 202 provides a magnetic force providing element, and synchronizer 202 is provided on rotor shaft 44. Preferably, rotor shaft 44 is made of a magnetically non-conductive material. The non-magnetic material may be, for example, stainless steel, ceramic, polymer material, or a combination of these materials. Thus, rotor shaft 44 itself does not affect the magnetic field of synchronizer 202, which allows sensor 204 to detect the rotational speed of synchronizer 202 more accurately.

The device 100 is in a liquid environment during use that is not sufficiently friendly to the operation of the synchronizer 202, for example, when the synchronizer 202 is a magnetic force providing element, if the magnetic force providing element contacts a liquid, the liquid can attack the magnetic force providing element, thereby causing the magnetic force to be weakened. To prevent erosion of synchronizer 202 by the liquid, synchronizer 202 is externally covered with a housing 206, housing 206 being circumferentially fixed to rotor shaft 44.

The housing 206 isolates the synchronizer 202 from the liquid environment, allowing the synchronizer 202 to operate well. The housing 206 encloses the synchronizer 202 therein, i.e., the housing 206 forms a receiving space, and the shape of the synchronizer 202 matches that of the receiving space, so that the synchronizer 202 moves synchronously with the housing 206. Housing 206 is circumferentially fixed to rotor shaft 44, i.e., housing 206 rotates in synchronization with rotor shaft 44, ensuring that synchronizer 202 rotates in synchronization with rotor shaft 44, thereby accurately measuring the rotational speed of rotor shaft 44 and the drive shaft, and thus providing reliable support for whether motor 14 is rotating speed-adjusting.

The manner in which housing 206 and rotor shaft 44 move synchronously may be, for example, a close fit of housing 206 and rotor shaft 44 or a flat fit of housing 206 and rotor shaft 44. Housing 206 mates with rotor shaft 44 flat, i.e., rotor shaft 44 is non-circular in cross-section. Specifically, the peripheral surface of the rotor shaft 44 includes a first surface and a second surface, and the first surface or an outer tangential plane of the first surface is disposed at an angle to the second surface or an outer tangential plane of the second surface. Housing 206 has a central passage for insertion of rotor shaft 44, the surface of which matches the shape of the peripheral surface of rotor shaft 44, thereby achieving a flat square fit of housing 206 with rotor shaft 44, and synchronizing rotation of housing 206 and synchronizer 202 with rotor shaft 44.

The housing 206 is made of an insulating material to avoid interaction of the synchronizer 202 with possible currents.

In one embodiment, the housing 206 includes a first portion 208 and a second portion 210, the first portion 208 and the second portion 210 being manufactured separately and mated to form a space for receiving the synchronizer 202. Thus, upon installation, after the synchronizer 202 is installed in the first portion 208, the synchronizer 202 may be packaged in the housing 206 after the second portion 210 is mated with the first portion 208.

In another embodiment, the synchronizer 202 may be integrally injection molded with the housing 206, thereby allowing the housing 206 to better encase the synchronizer 202.

The synchronizer 202 is provided radially inward of the liquid partition wall 75, and the sensor 204 is provided radially outward of the liquid partition wall 75. Thus, the liquid separation wall 75 enables the synchronizer 202 and the sensor 204 to be arranged at intervals, and normal operation of the synchronizer 202 and the sensor 204 is ensured. And, the space on both sides of the liquid partition wall 75 is reasonably utilized, which is advantageous for miniaturization of the device.

It can be seen from this: synchronizer 202 is enclosed in a housing 206, and housing 206 is circumferentially fixed to rotor shaft 44 such that synchronizer 202 is circumferentially fixed to rotor shaft 44 substantially without relative rotation therebetween. Synchronizer 202 rotates in synchronization with rotor shaft 44 when rotor shaft 44 rotates at a certain rotational speed. When the synchronizer 202 rotates at different rotation speeds, a signal change is generated in the sensor 204, and the sensor 204 is electrically or communicatively connected with a control module of the device, and after the control module detects the signal change, the rotation speed of the synchronizer 202 can be determined through a certain calculation, so as to determine the rotation speeds of the rotor shaft 44 and the driving shaft (the driving shaft rotates synchronously with the rotor shaft 44), and determine whether the rotation speed of the driving shaft is within a reasonable range. If the rotational speed of the drive shaft is not within a reasonable range, the control module may adjust the rotational speed of the rotor shaft 44, the drive shaft by adjusting the rotational speed of the motor to ensure proper pump operation.

During operation of the device, the synchronizer 202, the sensor 204, and the control module are in the process of dynamic adjustment. That is, after the control module adjusts the rotational speed of the rotor shaft 44 as described above, the synchronizer 202 and the sensor 204 again feed back the rotational speed of the rotor shaft 44 to the control module, and the control module determines whether further adjustment is required according to the requirement. And repeatedly, the pump is always ensured to work in a relatively stable state.

Referring to fig. 8 and 9 a-9 e, a part of a transmission mechanism of a fifth embodiment of the present invention is shown.

In this embodiment, the driven member 895 is a magnetic force providing member, specifically a magnetic ring, and a second magnetic force limiter 725 is disposed between the magnetic ring and the rotor shaft 44. The second magnetic force restraining member 725 is a ring-shaped back iron, and is sleeved on the rotor shaft 44, the driven member 895 is sleeved on the second magnetic force restraining member 725, and the second magnetic force restraining member 725 is flush with both end portions of the driven member 895.

To prevent liquid from eroding follower 895, rotor shaft 44 is provided at both ends with first and second end caps 231, 232 on both end sides of follower 895, respectively, first and second end caps 231, 232 providing seals for follower 895 in the axial direction. The first and second end caps 231, 232 have a disc shape with a certain thickness. Is in close fit with rotor shaft 44 to provide axial seal protection for follower 895.

The outer diameters of the first and second end caps 231, 232 are greater than the outer diameter of the follower 895. Alternatively, the first and second end caps 231, 232 extend radially beyond the follower 895. Radially outward of the follower 895 is provided with a protective layer 234. The protective layer 234 is coupled to the first and second end caps 231, 232 to encase the follower 895 therein, the protective layer 234 providing a seal for the follower 895 in a radial direction.

The protective layer 234 has a hollow cylindrical shape and is coupled to portions of the first and second end caps 231, 232 that radially protrude beyond the follower 895, so that the protective layer 234 cooperates with the first and second end caps 231, 232 to form a receiving cavity that receives the follower 895. Preferably, the first and second caps 231, 232 are provided with stepped surfaces, and the protective layer 234 is fitted with the stepped surfaces, and the outer side surface of the protective layer 234 does not protrude beyond the radially outer surfaces of the first and second caps 231, 232. More preferably, the outer side of the protective layer 234 is flush with the radially outer surfaces of the first and second endcaps 231, 232. Thus, first and second end caps 231, 232, protective layer 234, rotor shaft 44 cooperate to completely encase follower 895 therein, thereby preventing liquids from eroding follower 895. It will be appreciated that the second magnetic restraint 725 is disposed between the follower 895 and the rotor shaft 44, and that the first and second end caps 231, 232, the protective layer 234, and the rotor shaft 44 cooperate to also completely encase the second magnetic restraint 725 therein, preventing liquid from eroding the second magnetic restraint 725.

For reasons of machining, assembly, material uniformity, etc., it is possible and highly probable that the center of mass of rotor shaft 44 is offset from the axis, vibrations may be induced during high rotational speeds of rotor shaft 44, and additional vibrations may cause problems such as being detrimental to the stable maintenance of gap 79 where liquid barrier 75 is disposed.

To reduce vibration, the first end cap 231 and/or the second end cap 232 include a body and trim portion (not shown) that are connected. Balancing the rotor shaft 44 with the first end cap 231 and/or the second end cap 232 may be accomplished by the balancing portion, thereby reducing vibration.

In one embodiment, the trim portion is an aperture extending from one end face of the body to the other end face, the aperture extending a length less than the thickness of the end cap. That is, the balancing portion performs weight reduction on the main body, thereby achieving balancing and reducing vibration. For better balancing, the first end cap 231 and/or the second end cap 232 are preferably made of a relatively dense metallic or ceramic material, with a more pronounced weight loss effect. The thickness of the first end cap 231 and/or the second end cap 232 is greater than the minimum thickness that the metallic material can be processed, preferably greater than 10% of the minimum thickness that the metallic material can be processed, further greater than 30%, still further greater than 50%, but no greater than 20 times the minimum thickness that the metallic material can be processed.

For example, the minimum thickness that the material of which the first end cap 231 and/or the second end cap 232 can be made is 0.3mm, the actual design thickness of the first end cap 231 and/or the second end cap 232 is 0.3mm or more and 10mm or less. Preferably, the thickness of the body is greater than 1mm and less than or equal to 8mm.

The main purpose of the design is to achieve the desired dynamic balance by means of weight-reducing balancing of the metal or ceramic end cover, and simultaneously, the thickness of the end cover is reduced as soon as possible, so as to meet the requirements of vibration optimization and structure miniaturization.

In another embodiment, the body and trim portion overlap, and the trim portion includes an aperture or weight. That is, the trim portion may weight the body, and the trim portion itself may be weight-reduced or weight-weighted, thereby enabling the first end cap 231 and/or the second end cap 232 to trim the rotor shaft 44 to a greater extent.

The second end cap 232 is provided on the side of the rotor shaft 44 where the drive shaft is mounted, the second end cap 232 being closer to the drive shaft than the first end cap 231, and the second end cap 232 being more likely to vibrate than the first end cap 231 during operation of the pump. To reduce vibration to a greater extent, the thickness of the second end cap 232 is greater than the thickness of the first end cap 231. That is, there may be more room on second end cap 232 to provide a trim portion to second end cap 232, thereby providing a greater degree of trim design to second end cap 232, and thus providing a greater degree of relief to second end cap 232 from rotor shaft 44 vibrations.

The rotor shaft 44 is provided with a first bearing 235 on a side of the first end cap 231 remote from the second end cap 232, and a second bearing 236 on a side of the second end cap 232 remote from the first end cap 231, the first bearing 235 and the second bearing 236 being capable of supporting the rotor shaft 44. Consistent with the principle that the thickness of the second end cap 232 is greater than that of the first end cap 231, the size of the second bearing 236 is greater than that of the first bearing 235. Specifically, the thickness of the second bearing 236 is greater than the thickness of the first bearing 235, and the radial dimension of the second bearing 236 is greater than the radial dimension of the first bearing 235. So configured, the second bearing 236 cooperates with the first bearing 235 to more stably support the rotor shaft 44 and further mitigate vibration.

For ease of description, the portion that can be delivered into the subject is referred to as the access assembly.

To facilitate delivery of the access assembly into the subject, the device further includes a guide channel 237 extending through the working assembly.

In use, a guiding guidewire (not shown) is first introduced into the subject via the vasculature. The user (typically a healthcare worker) then holds the access assembly by hand, threading the proximal end of the guidewire into the distal end of the guide channel 237 until the guidewire passes through the entire working assembly, with its proximal end threaded out of the proximal end of the working assembly. The pump is then delivered to the left ventricle along the guide path created by the guidewire in the subject's vasculature, and after delivery to the left ventricle at the proximal end of the pump, the guidewire is withdrawn, the working assembly is connected to the drive assembly, and the motor 14 is activated to work.

The guide passage 237 includes an end-side outlet 238 on the proximal end side, and as shown in fig. 8, the liquid partition wall 75 includes a cylindrical portion that is located in the gap 79 and encloses the driven rotor therein, and a burring portion that is located at an end of the cylindrical portion, the burring portion being compressed between the coupler 39 and the motor case 12 when the coupler 39 is engaged with the motor 14. This allows the liquid partition wall 75 to be compressed, thereby ensuring the liquid sealing effect.

The fluid barrier 75 includes a proximal portion, and an end-side outlet 238 is provided at the proximal portion of the fluid barrier 75 for passage of a guidewire. The end side outlet 238 is provided at the proximal end portion of the liquid partition wall 75. The end side outlet 238 forms part of the irrigation channel. Thus, the end side outlet 238 needs to be designed to be re-openable or sealable.

Specifically, a seal 240 having a resealable seal is disposed in the end side outlet 238. The seal 240 has two states: a sealed state and an open state. When the seal 240 is in the first state, the seal 240 closes the end side outlet 238, preventing Purge of the fluid from exiting the end side outlet 238 and eroding the motor. When the seal 240 is in the second state, the end side outlet 238 is open for passage of a guidewire, delivering the access assembly into the subject.

When threading of the guidewire is desired, the seal 240 is opened, allowing the guidewire to pass through the end side opening, ensuring that the pump enters the subject. After the pump intervention is completed, the guide wire is pulled away, the sealing element 240 is sealed, and the pump is prevented from leaking Purge liquid in the working process.

In one embodiment, the seal 240 includes a flexible sealing plug 241 axially movable in the end side outlet 238, with the outer wall of the flexible sealing plug 241 and/or the inner wall of the end side outlet 238 being angled so that the flexible sealing plug 241 is compressed to switch to a first state when moved axially in a first direction and expands radially to switch to a second state when moved in a second direction opposite the first direction.

The sealing member 240 further includes a hard operating portion 242 connected to the flexible sealing plug 241, the operating portion having a hardness greater than that of the flexible sealing plug 241, the operating portion being remote from the end side outlet 238 with respect to the flexible sealing plug 241.

Fig. 9 a-9 e illustrate perspective and front views of a different specific exemplary seal 240.

It can be seen that: the operation portion 242 and the flexible sealing plug 241 may be connected by a connection portion 243; the operation portion 242 and the flexible sealing plug 241 may be directly connected. The maximum outer diameter of the operation portion 242 may be larger than the maximum outer diameter of the flexible sealing plug 241; the maximum outer diameter of the operation portion 242 may be equal to the maximum outer diameter of the flexible sealing plug 241. The thickness of the operation portion 242 may be greater than or less than the thickness of the flexible sealing plug 241, and the thickness of the operation portion 242 may be equal to the thickness of the flexible sealing plug 241. The operation portion 242 forms a gradual truncated cone shape together with the flexible sealing plug 241; or the operation portion 242 has a pull-ring shape, and the size of the operation portion 242 in the pull-ring shape is significantly larger than that of the flexible sealing plug 241 to provide better operability. The operation portion 242 and the flexible sealing plug 241 can be completely plugged into the end side outlet 238 when the end side outlet 238 is sealed; or only the flexible sealing plug 241 or the part of the flexible sealing plug 241 is plugged into the end side outlet 238 … …, and the description is omitted, and all the solutions which are the same or similar to the present embodiment are covered in the protection scope of the present invention.

In another embodiment, the seal 240 is a bladder structure, the first state corresponding to when the bladder structure is filled with a fluid medium or an elastic material, and the second state corresponding to when the fluid medium in the bladder structure is at least partially released.

Referring to fig. 10 and 11, a portion of a transmission mechanism of a sixth embodiment of the present invention is shown.

In the third embodiment, the driver 993 is provided at the outer wall of the first hollow portion 52 of the first bracket 51. In the present embodiment, the driving member 996 is provided on the inner wall of the first hollow portion 522 of the first bracket 511, and the first hollow portion 522 is made of a magnetically conductive material, and the first hollow portion 522 itself is configured as the first magnetic force restricting member, which is simpler in structure. And the gap between the driving member 996 and the driven member 896 is relatively smaller, resulting in a more efficient transmission.

The front end of the housing of the motor 14 is connected to a cylindrical fixing bracket 250, and a cylindrical first bracket 511 is fixedly connected to the output shaft of the motor 14 and is positioned in the fixing bracket 250. A bearing (not shown) is provided between the rear end of the outer wall of the first bracket 511 and the inner wall of the fixed bracket 250, and the rear end of the inner wall of the first bracket 511 is provided with another bearing for inserting the liquid partition wall 75.

In this embodiment, the driving member 996 is a conductor formed in a ring shape, the conductor forming a channel, and the magnetic force providing member as the driven member 896 extends at least partially into the channel. Specifically, the conductor is a copper ring, and the copper ring is disposed in the first bracket 511.

The conductor heats up seriously during high-speed rotation. After the device is finished, the driving assembly and the working assembly are required to be detached, and the operator may be scalded by the heated conductor. In order to avoid scalding, the heat insulation sleeve 252 is arranged on the inner side of the conductor, and the heat insulation sleeve 252 is made of heat insulation materials, so that operators can be prevented from being scalded by the conductor during disassembly.

The sleeve 252 includes an end cap 254, and the sleeve 252 can be inserted into the holder 250 to prevent the copper ring from being scalded by a person operating the sleeve by mistake. Preferably, an air flow path is formed between the sleeve 252 and the conductor. Therefore, heat generated by the conductor in the operation process can be radiated through the airflow channel, so that the heat cannot penetrate through the heat insulation sleeve 252 and reach the magnetic force providing element, the driving shaft and other parts in the heat insulation sleeve 252, and the influence of the heat generated by the conductor on a patient, such as adverse influence of pruge liquid temperature rise caused by the heat generated by the conductor on the patient, is avoided. Therefore, the heat insulating jacket 252 has a simple structure, but is not simply heat-insulating, but can radiate heat in a predetermined direction.

Preferably, the sleeve 252 is of equal length to the conductor on the side facing the magnetic force providing element, or the sleeve 252 is slightly longer than the conductor. Thereby ensuring the heat insulation and heat dissipation guiding effects. The applicant has shown in practice that the heating value of a conductor is inversely related to its length, i.e. the longer the conductor is, the lower the heating. Therefore, from the standpoint of heat dissipation, the longer the length of the conductor, the better. However, too long a conductor length results in an increase in the size and weight of the device, and decreases the portability of the operation. The applicant repeatedly confirmed that the length of the conductor was 15mm or more and 85mm or less. The length of the insulating sleeve 252 is 20mm or more and 80mm or less.

In this embodiment, the follower 896 is a magnetic force providing element, which in one embodiment is a circumferentially continuous ring, which is easier to install and more stable. In another embodiment, the magnetic force providing element includes at least two arcuately extending magnet pieces disposed circumferentially on an outer wall of the rotor shaft 44. The adjacent magnetic sheets can be contacted with each other or arranged at intervals. When the magnetic sheets are arranged at intervals, the distance between the adjacent magnetic sheets is less than or equal to 2mm. The design can simplify the processing difficulty of the magnetic force providing element.

Referring to fig. 12, a portion of a transmission mechanism of a seventh embodiment of the present invention is shown.

Differences between the present embodiment and the sixth embodiment are described with emphasis.

In the present embodiment, a substantially cylindrical holder 1 is provided outside the motor 14, the driving rotor is positioned in the holder 1, and a bearing 2 is provided between the first bracket 511 and the holder 1. The bearing 2 is provided between the inner wall of the holder 1 and the outer wall of the first hollow 522 of the first bracket 511.

When the device 100 works, the motor 14 runs at a high speed, the driving rotor needs to be supported more stably and balanced better, and the bearing 22 arranged between the first bracket 511 and the retainer 1 can provide stable support and balanced better for the driving rotor, so that the working output of the device is more stable, and the user experience can be improved.

In the present embodiment, the number of the bearings 2 is two, and the center of gravity of the driving rotor is located between the two bearings 2, so that the bearings 2 perform their functions better. In other variations of this embodiment, the number of bearings 2 may be more than two, with the center of gravity of the drive rotor located between any two bearings 2.

Referring to fig. 13, a portion of a transmission mechanism of an eighth embodiment of the present invention is shown.

Differences between the present embodiment and the seventh embodiment are described with emphasis.

In the present embodiment, the number of bearings 2 is one, and the bearings 2 are located near the center of gravity of the drive rotor. I.e. the distance between the centre of gravity of the bearing 2 and the centre of gravity of the driving rotor is less than or equal to 5mm. The number of bearings 2 is only one, and the weight and cost of the device can be reduced.

The above list of detailed descriptions is only specific to practical embodiments of the present invention, and they are not intended to limit the scope of the present invention, and all equivalent embodiments or modifications that do not depart from the spirit of the present invention should be included in the scope of the present invention.

Claims

1. An apparatus for assisting a heart in the occurrence of functional failure, comprising: a drive assembly, a work assembly; wherein:

the drive assembly includes: a motor, a drive rotor, the drive rotor comprising: a first bracket connected to an output shaft of the motor, a driving member provided on the first bracket;

The working assembly includes: a coupler detachably engaged with the motor, a driven rotor provided in the coupler, the driven rotor comprising: a rotor shaft, a driven member provided on the rotor shaft, a drive shaft driven by the rotor shaft, the driven member coupled with the drive member to be driven to rotate about a rotational axis;

One of the driving piece and the driven piece is a magnetic force providing element, the other is a conductor, and a gap is formed between the driving piece and the driven piece; the conductor cuts magnetic force lines in the magnetic field generated by the magnetic force providing element, so that eddy current is generated in the conductor, the eddy current generates a reverse induction magnetic field on the conductor, and the reverse induction magnetic field and the magnetic field generated by the magnetic force providing element are magnetically coupled;

The work assembly further includes a pump, the pump including: a pump housing connected to the distal end of the catheter and having an inlet end and an outlet end, an impeller received within the pump housing, the impeller being driven in rotation by the drive shaft to draw blood into the pump housing from the inlet end and to discharge blood from the outlet end;

the device further includes a guide channel extending through the working assembly, the guide channel including an end side outlet on a proximal side for passage of a guidewire;

A seal having a resealable seal is disposed in the end-side outlet, the seal having two states; when in the first state, the end side outlet is closed by the seal; when in the second state, the end side outlet is open;

The two ends of the rotor shaft are respectively provided with a first end cover and a second end cover which are positioned at two end sides of the driven piece, and the first end cover and the second end cover provide sealing for the driven piece in the axial direction;

The driven piece is a magnetic force providing element, a protective layer is arranged on the radial outer side of the magnetic force providing element, the protective layer is connected with the first end cover and the second end cover to cover the magnetic force providing element inside, and the protective layer provides sealing for the magnetic force providing element in the radial direction;

The first end cap and/or the second end cap includes a body and a trim portion connected, the trim portion being an aperture extending from one end face of the body to the other end face.

2. The device of claim 1, the seal comprising a flexible sealing plug axially movable in the end outlet, the flexible sealing plug outer wall and/or the end outlet inner wall being of a ramped design such that the flexible sealing plug is compressed to switch to the first state when moved axially in a first direction and expands radially to switch to a second state when moved in a second direction opposite the first direction.

3. The device of claim 2, the seal further comprising a rigid handle portion connected to the flexible sealing plug, the handle portion having a hardness greater than the hardness of the flexible sealing plug, the handle portion being remote from the end-side outlet relative to the flexible sealing plug.

4. The device of claim 1, wherein the seal is a bladder structure, the first state corresponds to a state when the bladder structure is filled with a fluid medium or an elastic material, and the second state corresponds to a state after the fluid medium in the bladder structure is at least partially released.

5. The device of claim 1, further comprising a liquid barrier wall comprising a proximal portion, the end-side outlet being provided at the proximal portion;

the work assembly further includes: the driven rotor includes: a rotor shaft driving the drive shaft;

The liquid partition wall includes: a cylinder portion located in the gap and housing the driven rotor therein, and a burring portion located at an end of the cylinder portion; the cuff portion is compressed between the coupler and the motor when the coupler is engaged with the motor.

6. The device of claim 1, wherein the opening has an extension that is less than the thickness of the end cap.

7. The device of claim 1, wherein the first and second end caps are made of a metallic or ceramic material having a thickness greater than a minimum thickness at which the material can be processed.