CN218871068U - Device for assisting the heart in the occurrence of functional failure - Google Patents

Abstract

The utility model provides a device for being directed at heart is supplementary when taking place functional failure, including motor, pipe, wear to establish in the pipe and the near-end is passed through connecting axle by motor drive's drive shaft, pump. The pump includes a pump housing having an inlet end and an outlet end, an impeller housed within the pump housing. An impeller is connected to the distal end of the drive shaft and is driven in rotation to draw blood into the pump housing from the inlet end and expel it from the outlet end. The drive shaft comprises a main body and a connecting part which are adjacent in the axial direction, the cross section of the connecting part is non-circular, a matching channel matched with the connecting part is formed at the far end of the connecting shaft, and the connecting part can be inserted into the matching channel in an axially sliding manner.

Description

Device for assisting the heart in the occurrence of functional failure

[ technical field ] A

The utility model relates to a device for assisting the heart when functional failure occurs, which belongs to the technical field of medical instruments.

[ background ] A method for producing a semiconductor device

Heart failure is a life-threatening disease with an annual mortality rate of about 75% once worsening to an advanced stage. Given the limited number of heart donors in advanced heart failure, ventricular assist device technology has become a viable treatment or replacement therapy option between the setting up of the subject and the transplant procedure. Adverse events resulting from current techniques still limit the use of ventricular assist devices for the treatment of critically ill subjects.

The existing ventricular assist device has the problems of complex structure and the like.

[ Utility model ] content

An object of the utility model is to provide a device for being directed at heart is supplementary when taking place the functional failure, can obviously improve the performance of device.

The utility model aims at realizing through the following technical scheme:

an apparatus for assisting a heart in the occurrence of failure, comprising: the device comprises a motor, a catheter, a driving shaft and a pump, wherein the driving shaft penetrates through the catheter, and the near end of the driving shaft is driven by the motor through a connecting shaft. The pump includes a pump housing having an inlet end and an outlet end, an impeller housed within the pump housing. An impeller is connected to the distal end of the drive shaft and is driven in rotation to draw blood into the pump housing from the inlet end and expel it from the outlet end. The drive shaft includes the main part and the connecting portion that face in the axial, and the cross section of connecting portion is non-circular, and the distal end of connecting axle is formed with the connection of connecting portion adaptation and is joined in marriage the passageway, and connecting portion axial slidable inserts and joins in marriage the passageway.

Preferably, the body and the connecting portion do not overlap in the axial direction.

Preferably, the circumferential surface of the connecting part comprises a first surface and a second surface, and an outer tangent plane of the first surface or the first surface and an outer tangent plane of the second surface or the second surface are arranged at an angle.

Preferably, the body is integrally formed with the connecting portion.

Preferably, the main body and the connecting part are independent parts, and the proximal end of the main body and the distal end of the connecting part are fixed through welding.

Preferably, the length of the connecting portion is smaller than the length of the main body.

Preferably, the diameter of the circumscribed circle of the connecting portion is equal to or smaller than the diameter of the circumscribed circle of the main body.

Preferably, the friction coefficient between the outer wall of the connecting part and the inner wall of the matching channel is between 0.05 and 0.2.

Preferably, the length of the connecting part is between 10 and 50 mm.

Preferably, the axial relative position between the conduit and the connecting shaft is fixed.

Preferably, the proximal end of the catheter is fixedly connected to the coupler, and the connecting shaft is axially fixedly arranged in the coupler.

Preferably, the axial relative position between the distal end of the drive shaft and the catheter is fixed.

Preferably, the outer wall of the far end of the driving shaft is provided with an intermediate piece; the distal end of the drive shaft is sleeved with a first proximal end bearing, and the first proximal end bearing is positioned at the near side of the intermediate piece.

Preferably, the distal end of the drive shaft is further externally sleeved with a second proximal bearing located distal to the intermediate member.

Preferably, the connecting portion is axially slidable relative to the mating passage and is configured to accommodate changes in the length of the conduit.

Preferably, the change in length of the catheter is due at least in part to bending occurring during the intervention; or, at least in part, due to liquid immersion; or at least in part due to forces exerted during collapsing of the pump.

[ description of the drawings ]

Fig. 1 and fig. 2 are schematic perspective views of the device of the present invention from different angles;

FIG. 3 is a perspective view of the drive assembly of FIG. 1 shown separated from the working assembly;

FIG. 4 is a cross-sectional view of the device of the present invention taken along the axial direction;

FIG. 5 is a partially exploded perspective view of FIG. 1;

FIG. 6 is a partial cross-sectional view of a proximal portion of the pump of FIG. 1;

FIG. 7 is a perspective view of a proximal portion of the drive shaft of FIG. 1;

FIG. 8 is a sectional view in one plane in the axial direction of the partial structure of the drive assembly of FIG. 1;

FIG. 9 is a cross-sectional view of another plane in the axial direction of a portion of the construction of the working assembly of FIG. 1;

FIGS. 10 and 11 are proximal, partial cross-sectional views of the working assembly of FIG. 1, with the seal closing the proximal end face opening in FIG. 10; in fig. 11, the first guide passage is communicated with the outside at the sealing member.

[ detailed description ] embodiments

The present invention will be described in detail below with reference to specific embodiments shown in the drawings. However, these embodiments are not intended to limit the present invention, and structural, methodical, or functional changes that may be made by one of ordinary skill in the art based on these embodiments are all included in the scope of the present invention.

The terms "proximal", "posterior" and "distal", "anterior" are used herein with respect to a clinician administering a device for assisting the heart in experiencing failure (hereinafter referred to as a device). The terms "proximal" and "posterior" refer to portions that are relatively close to the clinician, and the terms "distal" and "anterior" refer to portions that are relatively far from the clinician. For example, the drive assembly is at the proximal and rear ends, the working assembly is at the distal and front ends; for another example, the proximal end of a component/assembly may represent the end relatively close to the drive assembly, while the distal end may represent the end relatively close to the working assembly.

The device of the utility model defines the axial direction or the axial extending direction by the extending direction of the motor shaft or the connecting shaft and the driving shaft. The axial direction of the drive shaft means an axial direction when the drive shaft is adjusted to extend straight. The terms "inner" and "outer" used in the present invention refer to the axially extending centerline, the direction relatively close to the centerline is "inner" and the direction relatively far from the centerline is "outer".

It is to be understood that "proximal," "distal," "rear," "front," "inner," "outer," and these orientations are defined for convenience of description. However, devices may be used in many orientations and positions, and thus these terms are not intended to be limiting and absolute. For example, the above definitions of the directions are only for convenience of illustrating the technical solution of the present invention, and do not limit the directions of the auxiliary device of the present invention in other scenarios that may cause the auxiliary device to be inverted or the position of the auxiliary device to be changed, including but not limited to product testing, transportation, manufacturing, and the like. In the present invention, the above definitions shall, if there are other explicit provisions and limitations, comply with the explicit provisions and limitations.

In the present invention, the terms "connected" and "connected" are to be interpreted broadly unless otherwise explicitly defined or limited. For example, the connection can be fixed connection, detachable connection, movable connection or integration; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.

Referring to fig. 1-3, the device 100 of the present invention can partially replace the blood pumping function of the heart, thereby at least partially reducing the burden on the heart. The "substitution" may indicate that the heart is in a certain degree of failure or decline, but still has a certain blood pumping function, but the blood pumping function is weak and the cardiac output required for normal survival of the body is difficult to maintain.

In an exemplary scenario, the present device 100 may be used as a left ventricular assist device, the working portion of which (hereinafter pump 36) may be inserted into the left ventricle, which when operated may pump blood from the left ventricle into the ascending aorta.

It should be noted that the above example is only one possible application scenario of the present apparatus 100. In other possible and not explicitly excluded scenarios, the present device 100 may also be used as a right ventricular assist, with the pump operating to pump blood in the vein into the right left ventricle.

Alternatively, the present device 100 may also be adapted for pumping 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 may also be configured for placement within the subclavian or jugular vein at the junction of the vein and lymphatic catheter, and for increasing the flow of lymphatic fluid from the lymphatic vessel into the vein.

The following will be described primarily in the context of the use of the present device 100 as a left ventricular assist. However, as can be seen from the above description, the scope of the embodiments of the present invention is not limited thereto.

The apparatus 100 includes a drive assembly 10 and a working assembly 30. The drive assembly 10 includes a motor housing 12 and a motor 14 received within the motor housing 12 and having a motor shaft 16. Working assembly 30 includes a conduit 32, a drive shaft 34 disposed within conduit 32, and a pump 36 driven by drive shaft 34. Drive assembly 10 provides power to working assembly 30 to drive working assembly 30 to perform a blood pumping function.

In use of the device 100, the pump 36 and the forward portion of the catheter 32 are advanced into and maintained within the subject. Thus, the smaller size of the pump 36 and catheter 32 may be introduced into the body through the smaller interventional size, reducing the pain and complications to the subject from the interventional procedure.

Other portions of working assembly 30 may have relatively large dimensions to meet structural design requirements. The relatively large size of the drive assembly 10 may be sufficient to meet the design requirements and provide sufficient power to the drive shaft 34 and the pump 36 to meet the power requirements of the drive shaft 34 and the pump 36.

Drive assembly 10 is removably coupled to working assembly 30. Thus, when pump 36 and the forward end portion of catheter 32 are ready to be delivered into the subject, drive assembly 10 can be removed from working assembly 30, avoiding the larger and heavier drive assembly 10 from interfering with the delivery of the forward end portion of pump 36 and catheter 32 into the subject, and making the procedure lighter.

Referring to fig. 4 and 5, the driving assembly 10 drives the working assembly 30 through magnetic coupling, specifically:

the drive assembly 10 includes a hub and the working assembly 30 includes a coupler. The hub includes a motor end bushing 20 connected to the motor housing 12 and an active magnet 22 received inside the motor end bushing 20 and connected to the motor shaft 16. The coupler includes an access end bushing 40 disposed at the proximal end of the working assembly 30 and a passive magnet 42 received within the access end bushing 40 and coupled to the proximal end of the drive shaft 34.

The drive link of the drive assembly 10 includes a motor shaft 16 and a drive magnet 22 coupled to the motor shaft 16. The drive link of working assembly 30 includes a passive magnet 42, a connecting shaft 44 mounting passive magnet 42, a drive shaft 34 connected to a distal end of connecting shaft 44, and a pump 36 connected to a distal end of drive shaft 34.

The distal end of the pump 36 is provided with a protective head 38, and the protective head 38 is configured to be soft and may be made of any material that macroscopically exhibits flexibility so as not to damage the tissue of the subject. Specifically, the protective head 38 is a flexible projection having an arc-shaped or winding end, and the flexible end is supported on the inner wall of the heart chamber in a non-invasive or non-invasive manner to separate the suction port of the pump 36 from the inner wall of the heart chamber, so that the suction port of the pump 36 is prevented from being attached to the inner wall of the heart chamber by the reaction force of the fluid (blood) during the operation of the pump 36, and the effective pumping area is ensured.

In operation of the device 100, the distal portion of the drive shaft 34 is advanced with the catheter 32 into the subject, and the drive shaft 34 is formed as a flexible shaft. The connecting shaft 44 is provided with the passive magnet 42, and the connecting shaft 44 is a hard shaft, so that the active magnet 22 can be more stably arranged.

When the device 100 is operated, the motor shaft 16 drives the driving magnet 22 to rotate, the driven magnet 42 is magnetically coupled with the driving magnet 22, the driven magnet 42 is driven to rotate by the driving magnet 22, the driven magnet 42 rotates to sequentially drive the connecting shaft 44 and the driving shaft 34 to rotate, and the driving shaft 34 rotates to drive the pump 36 to pump blood.

For convenience of description, the combination of the socket and the coupler is referred to as a connection assembly. The connection component is configured to: when the corresponding plug is not connected to the coupler, the motor end bushing 20 is separated from the medium end bushing 40; and, when the corresponding plug is connected to the coupler, the motor end bushing 20 is connected to the insertion end bushing 40, the driving magnet 22 and the driven magnet 42 are at least partially overlapped in axial projection of the driving shaft 34, and the driving magnet 22 and the driven magnet 42 are axially spaced.

Since the driving magnet 22 and the driven magnet 42 are at least partially overlapped along the axial projection of the driving shaft 34, the driving magnet 22 can drive the driven magnet 42 more efficiently, and the transmission efficiency is improved. The axial spacing between the active magnet 22 and the passive magnet 42 can realize non-contact power transmission by magnetic coupling between the two magnets, which is beneficial to sealing the fluid and preventing the liquid from entering the motor.

The above-mentioned liquid is a Purge liquid to be infused into the human body during the operation of the device 100, and the Purge liquid is a physiological liquid partially required for maintaining the function of the human body, such as a physiological saline, a glucose solution, an anticoagulant, or any combination thereof.

As previously described, drive assembly 10 is removably coupled to working assembly 30. Specifically, the motor end bushing 20 is detachably connected to the medium end bushing 40, so that the driving assembly 10 is detachably connected to the working assembly 30.

In order to achieve a detachable connection of the motor end bushing 20 with the inlet bushing 40, the motor end bushing 20 is plug-fitted with the inlet bushing 40, one of the two being configured as a plug, and the other of the two comprising a socket for receiving the plug. A sleeve configured as a plug is defined as an insertion sleeve and a sleeve defining a socket is defined as a receiving sleeve. The device 100 also includes a locking mechanism for engaging the fixed insertion sleeve with the receiving sleeve.

The locking mechanism includes an engagement portion formed in one of the outer wall of the insertion sleeve and the inner wall of the receiving sleeve, and a locking member operatively inserted into the engagement portion. The locking member is fitted into the engaging portion to effect locking, and the insertion bush is relatively fixed to the receiving bush. The locking member is disengaged from the engagement portion and the insertion bush is disengaged from the receiving bush.

Referring to fig. 9 and 10, the end-fitting bushing 40 is provided with a first axial passage 101, and the connecting shaft 44 is rotatably provided in the first axial passage 101. At least one bearing 90 is arranged outside the connecting shaft 44, and a damping piece 92 is arranged between the outer ring of the bearing 90 and the inner wall of the first axial channel 101. The damping member 92 not only reduces vibration, but also provides a certain movement buffering space, so that the passive magnet 42 and the active magnet 22 are aligned as much as possible, thereby improving transmission efficiency.

Specifically, as described above, there is a situation of incomplete axial alignment between the active and passive magnets 22, 42. When the two magnets are axially offset by more than a predetermined amount, then there is vibration in the radial direction of the passive magnet 42.

By providing the damper member 92 between the bearing 90 and the first axial passage 101 and configuring the damper member 92 to be flexible, the flexible damper member 92 can be compressively deformed by the connecting shaft 44, thereby providing a radial deformation space for the vibration of the passive magnet 42. The compression deformation of the damping member 92 will simultaneously accumulate energy to provide an axially centered restoring action to the coupling shaft 44 to restore alignment of the two magnets.

The damper 92 is substantially annular and is fitted around the outer peripheral surface of the bearing 90. The damping member 92 may be circumferentially continuous or circumferentially discontinuous, i.e., comprises a plurality of arc-shaped damping units. Due to the annular structural design of the damper 92, the damper 92 can reset the vibration of the passive magnet 42 along 360 ° of the circumferential direction.

As described above, the pump 30 and the leading end portion of the catheter 36 are accessed anteriorly from the vasculature of the subject. It is known that the vascular system is tortuous, in particular with overbending segments that may have an angle of less than 30 °.

At the proximal end of the catheter 32, the axial relative position between the catheter 32 and the coupling shaft 44 is fixed. Specifically, the guide tube 32 and the connecting shaft 44 are fixed in relative position by a coupler. More specifically, the proximal end of the catheter 32 is fixedly connected to a coupler, specifically to the insertion end bushing 40. The connecting shaft 44 is axially fixed in the coupler, specifically, in the end-of-line bushing 40, and the connecting shaft 44 is axially fixed by two bearings.

Referring to fig. 6, at the distal end of catheter 32, the axial position between the distal end of drive shaft 34 and catheter 32 is fixed. Specifically, the driving shaft 34 includes a main body 35 and a supporting portion 39 connected to each other, and the main body 35 is a flexible shaft and is located at a proximal end. The support 39 is a hard shaft that supports the impeller of the pump 36 and maintains the position of the impeller in the pump casing stable. The support portion 39 is relatively located at the distal end, i.e., the support portion 39, of the drive shaft 34.

The support 39 and the guide tube 32 are fixed relative to each other in axial position by a bearing chamber 41. More specifically, a bearing is disposed within the bearing chamber 41, and a proximal end of the bearing chamber 41 is fixedly coupled to the distal end of the catheter 32, for example, by bonding. The bearing is sleeved on the supporting portion 39, and the axial positions of the bearing and the supporting portion 39 are relatively fixed. Thereby, the catheter 32 is fixed relative to the distal end of the drive shaft 34, i.e. the axial position between the catheter 32 and the support 39.

The bearings comprise a first proximal bearing 45 located relatively proximally and a second proximal bearing 47 located relatively distally, the outer wall of the distal end of the drive shaft 34, i.e. the outer wall of the support portion 39, being provided with an intermediate member 49 located between the first proximal bearing 45 and the second proximal bearing 47, providing a stop between the impeller of the pump 36, the drive shaft 34 and the catheter 32.

Thus, the proximal end of the catheter 32 is fixed relative to the shaft 44 in axial position; the axial position between the distal end of the catheter 32 and the distal end of the drive shaft 34, i.e. the abutment 39, is fixed relative thereto.

That is, both ends of the catheter 32 are relatively fixed, but the length of the catheter 32 may change during use of the device. The change in length of tube 32 is due, at least in part, to bending during the intervention, i.e., deformation from bending changes the length of tube 32; alternatively, the change in length of catheter 32 is due at least in part to a fluid infusion, where the fluid is primarily blood, including a portion of Purge fluid; still alternatively, the change in length of the catheter 32 may be due, at least in part, to forces exerted during collapsing of the pump 36, i.e., the pump 36 may stretch the catheter 32 during collapsing thereby changing the length of the catheter 32.

When the length of the catheter 32 changes, the catheter 32 will cause the drive shaft 34 to move axially because the distal end of the catheter 32 is fixed relative to the distal end of the drive shaft 34. Thus, to accommodate axial movement of the drive shaft 34, the drive shaft 34 is axially slidably engaged with the connecting shaft 44. Further, since the connecting shaft 44 is required to transmit rotation to the drive shaft 34, the drive shaft 34 is circumferentially fixed to the connecting shaft 44. I.e. the drive shaft 34 is circumferentially fixed and axially slidably engaged with the connecting shaft 44.

Specifically, the method comprises the following steps: referring now more particularly to fig. 7 and 10, drive shaft 34 includes a body 35 and a coupling portion 94 connected together, with body 35 and coupling portion 94 disposed axially adjacent one another. The two are arranged adjacently in the axial direction, namely the two are not overlapped in the axial direction, the structure is simpler, the cost is lower, and the reliability and the stability of the driving shaft can be improved. As previously described, the drive shaft 34 includes the main body 35 and the support portion 39 connected, and thus it can be seen that, from the proximal end to the distal end, the drive shaft 34 includes the connecting portion 94, the main body 35 and the support portion 39 connected in series, which are disposed adjacent to (not overlapping) in the axial direction and each function.

The body 35 is constructed as a multi-layer braided structure with sidewalls that are fluid permeable so that the body 35 can be cooled using Purge fluid. Specifically, the main body 35 is in a solenoid shape, and the main body 35 has an axially extending hollow axial cavity through which fluid can flow; the "solenoids" of the body 35 are woven to allow fluid to permeate therethrough, thereby maximizing the cooling of the body 35.

The connecting portion 94 is used for axially slidably and circumferentially fixedly coupling the drive shaft 34 with the connecting shaft 44. Specifically, the distal end of the connecting shaft 44 is formed with a mating passage into which the connecting portion 94 is fitted, and the connecting portion 94 is axially slidably inserted into the mating passage. Thereby effecting an axially slidable engagement of the drive shaft 34 with the connecting shaft 44. The connecting portion 94 is axially slidable relative to the mating passage configured to accommodate an increase in length of the conduit 32. That is, when the length of the guide tube 32 changes, the guide tube 32 pulls the drive shaft 34 to move axially, and the connecting portion 94 of the drive shaft 34 axially slidably engages with the engagement channel to provide a margin for the axial movement of the drive shaft 34, thereby ensuring the proper operation of the drive shaft 34.

The friction coefficient between the outer wall of the connecting part 94 and the inner wall of the adapting channel is between 0.05 and 0.2, so that the resistance is small during sliding, and smooth sliding is realized.

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

For example, the range of the friction coefficient is set forth as 0.05 to 0.2, preferably 0.07 to 0.18, more preferably 0.09 to 0.16, further preferably 0.11 to 0.14, for the purpose of explaining values such as 0.12, 0.13 which are not explicitly enumerated above.

As described above, the example range of 0.02 as the interval unit cannot exclude the increase of the interval in an appropriate unit, for example, a numerical unit such as 0.01, 0.03, 0.04, 0.05, etc. These are only examples of what is intended to be explicitly recited, and all possible combinations of numerical values between the lowest value and the highest value that are explicitly recited in the specification in a similar manner are to be considered.

Unless otherwise indicated, all ranges include the endpoints and all numbers between the endpoints. The use of "about" or "approximately" with a range applies to both endpoints of the range. Thus, "about 20 to about 30" is intended to cover "about 20 to about 30", including at least the endpoints specified.

Other definitions of numerical ranges appearing herein may be found in reference to the above description and will not be repeated.

The above range of the friction coefficient can be achieved by an appropriate means. For example, the outer wall of the connecting portion 94 and/or the inner wall of the mating passage may be ground or polished to a low roughness. Alternatively, the outer wall of the connecting portion 94 and/or the inner wall of the mating passage may be coated with a lubricious coating, such as a graphite coating. Alternatively, the connecting portion 94 and/or the connecting shaft 34 may be made of a material with good lubricity, such as a material made of a metal matrix of a solid self-lubricating composite material, such as copper, aluminum, nickel, silver, iron, and the like.

The length of the connecting portion 94 is between 10-50mm, preventing the connecting portion 94 from being removed from the mating passage, thereby allowing the drive shaft 34 to operate reliably.

The cross section of the connecting portion 94 is an arbitrary shape other than a circle. For example, the circumferential surface of the connecting portion 94 includes a first surface 941 and a second surface 942, and an outer tangent plane of the first surface 941 or the first surface 941 is disposed at an angle to an outer tangent plane of the second surface 942 or the second surface 942, so that the cross section of the connecting portion 94 is non-circular. The cross section of the connecting portion 94 is not circular, but may be square or oval, so that the connecting portion 94 is configured as a flat shaft, and can circumferentially stop rotation, thereby achieving circumferential fixation of the driving shaft 34 and the connecting shaft 44, and enabling the driving shaft 34 to synchronously rotate along with the connecting shaft 44.

A connecting portion 94 is provided or formed at the proximal end of the body 35. That is, the connecting portion 94 and the main body 35 may be separate parts, and they are separately formed and fixed to each other by a specific process, for example, welding. The connecting portion 94 may be integrally formed with the main body 35, and specifically, the connecting portion 94 may be obtained by subjecting the rear (proximal) end of the main body 35 to a non-circular process, for example, by extruding the proximal end of the main body 35.

The connecting portion 94 is configured to be axially slidably and circumferentially fixedly coupled to the drive shaft 34, the main body 35 is configured to enter the subject, and the length of the connecting portion 94 is less than the length of the main body 35, such that the main body 35 has a sufficient length to enter the subject. The diameter of the circumscribed circle of the connecting part 94 is smaller than or equal to that of the main body 35, the structure is regular, the stress is uniform, and the transmission is reliable.

As mentioned above, the main body 35 has a hollow cavity extending axially, preferably, the connecting portion 94 also has a hollow cavity 37 extending axially, and the hollow cavities of the main body 35 and the connecting portion 94 are communicated, so that the entire driving shaft 34 has a hollow cavity (hereinafter, the second axial passage 102) extending axially, and therefore, the Purge liquid can flow in the entire length direction of the driving shaft 34, and the temperature of the driving shaft 34 is reduced to the maximum extent.

As mentioned above, the driving shaft 34 is a flexible shaft, which means that the main body 35 of the driving shaft 34 is a flexible shaft.

It should be noted that although the driving shaft 34 and the connecting shaft 44 are axially slidable, there is no fear that the driving shaft 34 and the connecting shaft 44 may be disengaged because the distal end of the driving shaft 34 is connected to the pump 36, and thus the distal end of the driving shaft 34 is defined by the pump 36 at the axial distal position, that is, the mating passage and the pump 36 respectively define the proximal position and the distal position of the driving shaft 34 in the axial direction, so that the driving shaft 34 is not separated by the sliding mating with the connecting shaft 44.

The drive shaft 34 is arranged in the guide pipe 32 in a penetrating mode, the guide pipe 32 prevents the drive shaft 34 from contacting with the outside, on one hand, the normal work of the drive shaft 34 is guaranteed, and on the other hand, the contact of the tissue of a subject in the working process of the drive shaft 34 is avoided.

The pump 36, which may be delivered to a desired location of the heart through the conduit 32, pumps blood, and includes a pump housing 363 connected to a distal end of the conduit 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 34 to draw blood into the pump housing 363 from the inlet end 361 and out the outlet end 362.

As shown in fig. 1 to 3, the pump housing 363 includes a support 3631 made of nickel or titanium alloy and having a metal lattice structure, and an elastic coating 3632 covering the support 3631. The metallic lattice of the stent 3631 has a mesh design, the covering membrane 3632 covers the portion of the stent 3631, and the mesh of the portion of the front end of the stent 3631 not covered by the covering membrane 3632 forms the inlet end 361. The rear end of the membrane 3632 covers the distal end of the catheter 32, and the outlet end 362 is an opening formed in the rear end of the membrane 3632.

The distal end of drive shaft 34 is connected to the hub and bracket 3631 is connected to catheter 32 through bearing housing 41. The drive shaft 34 is threaded through proximal bearings 45, 47 located in the bearing chamber 41.

In the present embodiment, the pump 36 is a collapsible pump having a compressed state and an expanded state. In the intervention configuration of the pump 36, the pump housing 363 and impeller are in a compressed state, in which the pump 36 can be introduced into or delivered within the subject's vasculature at the first, smaller outer diameter dimension. In a corresponding operating configuration of the pump 36, the pump housing 363 and impeller are in an expanded state in which the pump 36 can pump blood at a desired location of the heart, such as the left ventricle, with a second radial dimension that is greater than the first radial dimension.

In the art, the size and hydrodynamic performance of the pump 363 are two contradictory parameters. In short, the pump 363 is desirably small in size from the viewpoint of alleviating pain of the subject and ease of intervention. While a large flow rate is desirable for the pump 363 to provide a strong assisting function for the subject, a large flow rate generally requires a large size of the pump 363. By providing a collapsible pump 363, the pump 363 has a smaller collapsed size and a larger expanded size, which is both convenient for alleviating pain of the subject during the intervention/delivery process and easy for the intervention, and provides a large flow rate.

As described above, the multiple mesh, especially the diamond mesh, of the pump housing 3631 can be folded and unfolded with the memory of nitinol.

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 impeller blades wrap around the hub outer wall and at least partially contact the pump casing inner wall when the pump 36 corresponds to the intervening configuration. The impeller blades extend radially outward from the hub and are spaced from the inner wall of the pump 36 when the pump 36 is in the corresponding operating configuration. The blades are made of flexible elastic materials, the blades can store energy when being folded, and the stored energy of the blades is released after the external constraint is removed, so that the blades can be unfolded.

The pump 36 is collapsible by external restraint and the pump 36 self-expands after the restraint is removed. In the present embodiment, the "compressed state" refers to a state in which the pump 36 is radially constrained, that is, a state in which the pump 36 is radially compressed to be folded into a minimum radial dimension by the external pressure. The "deployed state" refers to a state in which the pump 36 is not radially constrained, that is, a state in which the bracket 3631 and the radially outer side of the impeller are deployed to the maximum radial dimension.

The collapsing and expanding process of the pump 36 is as follows: during intervention of pump 36 in the left ventricle, pump 36 is in a radially constrained state (compressed state) due to an externally applied radially constraining force. Alternatively, the pump 36 may be collapsible only during the intervention in the vasculature of the subject. After intervention into the left ventricle (delivered anteriorly in the vasculature in the collapsed configuration), or into the subject's vasculature (delivered anteriorly in the vasculature in the expanded configuration), the radially constraining force is removed, and stent 3631 self-expands using its memory characteristics and the vanes of the impeller via stored energy release, so pump 36 automatically assumes its unconstrained shape (expanded state).

Conversely, when the device 100 is removed from the subject, the pump 36 is folded by the folding sheath, and when the pump 36 is completely removed from the subject, the constraint of the folding sheath on the pump 36 is removed, so that the pump 36 returns to the natural state with the least stress, i.e., the unfolded state.

During operation of the apparatus 100, heat is generated between relatively rotating components, such as the connection shaft 44 and the end-of-life bushing 40, the drive shaft 34, and the conduit 32, and the build-up of heat can increase the wear and tear on these components and reduce the useful life thereof. Therefore, measures are necessary for thermal management.

In view of this, apparatus 100 also includes an irrigation channel extending substantially throughout working assembly 30. Specifically, the irrigation channel extends through the passive magnet 42 to the drive link of the pump 36. During operation of the device 100, the filling channel may be filled with a fluid, which is the Purge liquid described above, and which acts to lubricate and cool the transmission link.

Specifically, referring with emphasis to fig. 10 and 11, the proximal inlet 96 of the irrigation channel is a cavity provided at the proximal end of the insertion end bushing 40 and receiving the passive magnet 42 therein. Preferably, the cavity not only houses the passive magnet 42, but also houses the passive magnet protection assembly 46 therein.

The passive magnet 42 is the starting point of the drive train in the working assembly 30, and the proximal inlet 96 of the irrigation passage is provided as a cavity that receives the passive magnet 42 therein, which may be filled with a fluid that lubricates and cools the passive magnet 42. Therefore, the filling channel starts to lubricate and cool the transmission link from the starting point of the transmission link of the working assembly 30, and the effective work of the working assembly 30 is ensured.

As noted above, the irrigation channel extends from the proximal end of the coupler to the distal end of the pump 36. It should be noted that the structure design can achieve the beneficial effect of convenient exhaust operation. The concrete description is as follows:

conventionally, when infusing a liquid (Purge) into a subject, it is desirable to avoid the introduction of gases into the subject in advance or during the process that could cause fatal harm to the subject. Therefore, before the working component of the device 100 is inserted into the subject, the working component is filled with the perfusion fluid by evacuating the air from the working component with the perfusion fluid.

In known irrigation implementations, the irrigation fluid interface is located between the ends of the working assembly, typically located closer to the proximal end of the working assembly, i.e., the proximal end of the coupler. Thus, bounded by the perfusate interface, the working assembly is divided into a proximal section and a distal section on either side of the perfusate interface. Thus, the proximal and distal sections are separately vented.

That is, in the prior known embodiment, the air discharging operation is performed twice. The method comprises the following specific steps:

firstly, a perfusion fluid source is connected to a perfusion fluid interface (arranged on the coupler shell), and the perfusion fluid source can adopt a syringe. The injector is filled with perfusion liquid and pushed to be injected into the working assembly through the perfusion liquid interface.

Because the perfusate interface is disposed near the proximal end of the coupler, the length of the distal segment is much greater than the length of the proximal segment; the distal section is primarily configured as a catheter 32, drive shaft 34, and pump 36. Thus, the flow resistance of the liquid in the distal section is much greater than in the proximal section.

Thus, the perfusion fluid first enters the proximal segment, evacuating the air in the proximal segment. Wherein the evacuation of air in the proximal section is verified by the perfusate flowing out of the proximal section end face, i.e. the first guide channel of the sealing member 118 described below.

The proximal section is then sealed, i.e. the first guide channel of the sealing member 118 is sealed (in a manner described below). And then the syringe is used for filling liquid into the working assembly. Because the proximal section is sealed, the perfusion fluid can only flow to the distal section, evacuating the air in the distal section. Wherein the evacuation of air in the distal section is verified by the perfusate flowing out of the distal end of the distal section, i.e. the front end of the catheter 32 and/or the hub distal end of the impeller.

Thus, in the prior known embodiments, the proximal gas is expelled from the perfusate and subsequently the distal gas is expelled.

In contrast, the starting point of the perfusion channel of the present embodiment is the cavity that receives the passive magnet 42, which is located at the proximal end of the entire working assembly. Thus, the perfusion fluid enters from the proximal end of the entire perfusion channel, and the flow path of the perfusion fluid can only be towards the distal end of the working assembly. Therefore, the emptying of the working assembly can be realized only by performing one operation, and the emptying operation is greatly simplified.

The inlet end bushing 40 is provided with an irrigation inlet passage 98 in communication with the lumen, the outer end of the irrigation inlet passage 98 passing through the connection assembly and being adapted to communicate with an irrigation fluid source. The outer end penetrates out of the connecting component to be conveniently communicated with a perfusion liquid source, and fluid is provided for the perfusion channel.

The extending direction of the perfusion input channel 98 is arranged at an angle with the axial direction, so that the outer end of the perfusion input channel 98 is far away from the near end of the working component 30, the influence on the installation of the working component 30 and the driving component 10 is avoided, the perfusion is more convenient, and the structural design is very reasonable.

As mentioned above, the connecting shaft 44 is connected to the passive magnet 42, and the passive magnet 42 is sleeved on the mounting portion of the proximal end of the connecting shaft 44. The connecting shaft 44 is mounted to the coupler, and in particular, the connecting shaft 44 is mounted to the intervening end bushing 40, the intervening end bushing 40 is provided with a first axial passage 101, and the connecting shaft 44 is rotatably disposed in the first axial passage 101. The connecting shaft 44 has an axially extending hollow cavity, which may also be referred to as a second axial passage 102.

The portion of the pouring channel at the coupler comprises a second axial channel 102 formed in the connection shaft 44, a first gap formed between the connection shaft 44 and the first axial channel 101; the second axial passage 102, the first gap and the cavity communicate. Thus, fluid entering through the fill inlet passage 98 flows through the chamber housing the passive magnet 42, and then through the bearing and first gap in sequence.

As previously described, the connecting portion 94 of the drive shaft 34 is inserted into the mating passage of the connecting shaft 44, the connecting portion 94 is hollow, and the connecting shaft 44 is in communication with the internal axial passage of the drive shaft 34. The mating passageway is part of the second axial passageway 102. Specifically, the mating channel is a distal portion of the second axial channel 102, the mating channel communicates with a proximal portion of the second axial channel 102, and the radial widths of the mating channel and the proximal portion of the second axial channel 102 are different to form a step, which facilitates proximal axial retention of the connection portion 94.

Therefore, at the distal end of the connecting shaft 44, the fluid flows through the matching passage to cool and lubricate the inside of the distal end of the connecting shaft 44 and the connecting portion 94 at the proximal end of the driving shaft 34, the mounting structures of the connecting shaft 44 and the driving shaft 34 are reasonably utilized to cool and lubricate the connecting shaft 44 and the driving shaft 34, the flow passage is guaranteed to be smooth, and the structural design is very reasonable.

As previously described, working assembly 30 includes a catheter 32 with a drive shaft 34 extending through catheter 32. The perfusion channel further comprises: a second gap is formed between the drive shaft 34 and the lumen of the catheter 32. Therefore, after flowing through the passive magnet 42 and the connecting shaft 44, the fluid flows through the second gap, and cools and lubricates the outer surface of the driving shaft 34.

As shown in fig. 9, in some embodiments, the coupler further includes a locating sleeve 108 connected to the distal end of the insertion liner 40; the proximal end of the catheter 32 is received within the locating sleeve 108, and the proximal end of the drive shaft 34 is exposed out of the locating sleeve 108 for connection to the coupling shaft 44. Specifically, the positioning sleeve 108 includes a proximal portion and a distal portion connected to each other, an end of the proximal portion is connected to the insertion end bushing 40, the proximal portion is recessed from the proximal end surface in a direction toward the distal end to form an accommodating space 110, the distal portion forms a catheter receiving cavity for receiving the catheter 32, a proximal end of the catheter 32 is received in the catheter receiving cavity, and a proximal end of the driving shaft 34 extends out of the catheter receiving cavity and is connected to the connecting shaft 44 through the accommodating space 110.

The radial width of the receiving space 110 is greater than the width of the catheter receiving cavity. Therefore, relatively more fluid can be transferred and retained in the accommodating space 110, so that the liquid flows out from the axial channel of the first gap and the connecting shaft 44, is transferred and buffered in the accommodating space 110 with a larger volume, and then enters the conduit 32 and the second gap, thereby avoiding the pressure build-up of the liquid.

In addition, a larger diameter and volume receiving space 110 is formed in a proximal portion of positioning sleeve 108 to facilitate assembly of positioning sleeve 108 with interventional tip liner 40 and housing 112 (described below). Specifically, the proximal end of the positioning sleeve 108 is formed with a radial lug structure 1081, and the proximal inner wall of the housing 112 is provided with a radial intermediate member 1121. When housing 112 is engaged with access port bushing 40, lug structure 1081 of positioning sleeve 108 is clamped between the distal end of access port bushing 40 and intermediate member 1121 to effect securement of positioning sleeve 108.

The locating sleeve 108 is generally centrally disposed within the housing 112 and serves to center the catheter 32 relative to the coupling shaft 44 to prevent buckling of the drive shaft 34 extending from the proximal opening of the catheter 32.

As described above, the position of the positioning sleeve 108 is fixed by the cooperation of the lug structure 1081 and the intermediate member 1121. The positioning sleeve 108 is centered within the housing 112 by the abutment of the ledge structure 1081 against 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. Specifically, the lug structure 1081 is made of a flexible and elastic material, and is circular, and the outer diameter thereof is slightly larger than or equal to the inner diameter of the body 112. Thereby, the proximal end of the drive shaft 34 is ensured to be engaged with the connecting shaft 44 in an incompletely or slightly bent posture.

The second gap communicates with the first gap through a locating sleeve 108. Specifically, the second gap is communicated with the first gap through the accommodating space 110 of the positioning sleeve 108. More specifically, the outlet end (distal end) of the first gap communicates with the accommodating space 110, and the inlet end (proximal end) of the second gap communicates with the accommodating space 110. Therefore, after flowing out of the first gap, the fluid flows into the second gap through the accommodating space 110 of the positioning sleeve 108, so as to cool and lubricate the outer surface of the driving shaft 34.

The coupler further includes a housing 112 connected to the distal end of the insertion end sleeve 40 and receiving the positioning sleeve 108 therein, the housing 112 being configured such that the outer surface of the coupler is flush with the outer surface of the hub when the coupler is in a connected state with the hub. Not only avoids the scratch possibly caused by the uneven outer surface, but also has regular and beautiful appearance.

Further, 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 being opposite or contiguous to the distal end of the positioning sleeve 108 with the central passages aligned for the same purpose as described above. The distal end of the retaining sleeve 114 extends a length and has a strength greater than the strength of the catheter 32, which provides support and bending resistance for the catheter 32, further providing a fixation function, and providing a transition in strength support for the catheter 32 at the exit of the housing 112, thereby preventing the catheter 32 from breaking due to strong and/or frequent bending.

The drive shaft 34 is axially through, i.e., the entire drive shaft 34, including the coupling portion 94 at the proximal end of the drive shaft 34 that mates with the coupling shaft 44, has an axially extending axially hollow cavity that forms a third axial passage 103, the third axial passage 103 communicating with the second axial passage 102. The perfusion channel also includes, in the portion of the catheter 32 and drive shaft 34: a third axial passage 103 formed in the drive shaft 34. Fluid flowing through the second axial passage 102 of the connecting shaft 44 enters the third axial passage 103 of the drive shaft 34 via the hollow connecting portion 94 and eventually exits at the distal end of the drive shaft 34 into the subject to provide physiological support to the subject.

The body 35 of the drive shaft 34 is constructed in a multi-layer braided structure so that its side walls are liquid permeable. That is, the fluid flowing through the second gap and the third axial passage 103 can not only be balanced by the side wall penetration of the driving shaft 34, but also be used for cooling and lubricating the entire driving shaft 34.

In essence, in the prior known irrigation schemes described above, since the Purge fluid enters the irrigation channel in the middle section, in some cases, the location of the irrigation fluid port may be distal to the proximal end of the drive shaft. In this case, it is difficult for the Purge fluid to enter the drive shaft from its proximal opening. Thus, if it is desired to have Purge fluid enter the interior of the drive shaft, the drive shaft can only be constructed so that the side walls are liquid permeable.

In contrast, the proximal end of the filling channel of the embodiment of the present invention is a cavity for accommodating the passive magnet 42, and the entering Purge liquid will enter the driving shaft 34 through the cavity and the connecting shaft 44 in sequence.

That is, even though the drive shaft 34 in the present embodiment is not constructed to be permeable to the side wall, the Purge liquid may also enter the interior of the drive shaft 34. This provides a more flexible choice space for the driving shaft 34 of the present invention, which is beneficial to the manufacturing process of the driving shaft 34.

Further, the perfusion channel includes, in part of the pump 36: a fourth axial passage formed in the hub and communicating with the third axial passage 103. Thus, fluid flowing through the third axial passage 103 may flow into the fourth axial passage and out through the fourth axial passage.

In this implementation, the distal outlet of the perfusion channel comprises the distal opening of the catheter 32, further comprising the distal opening of the hub. That is, fluid flowing through the second gap flows out through the distal opening of the catheter 32; fluid flowing through the fourth axial passage exits through the distal opening of the hub.

Thus, it can be seen that the priming channel of working assembly 30 extends through the drive link from passive magnet 42 to pump 36, and that the priming channel first flows through the cavity that receives passive magnet 42, cooling and lubricating passive magnet 42. Then, the perfusion channel is divided into two paths, one path sequentially flows through the second axial channel 102 inside the connecting shaft 44, the third axial channel 103 inside the driving shaft 34, and the fourth axial channel inside the hub of the pump 36, and flows out from the distal end opening of the hub; the other path of the Purge fluid flows through the first gap between the end-inserted bushing 40 and the outer wall of the connecting shaft 44, the bearing 92, the accommodating space 110 of the positioning sleeve 108, and the second gap between the guide tube 32 and the outer wall of the driving shaft 34 in sequence, and flows out from the distal opening of the guide tube 32, and the Purge fluid divided by the path can lubricate and cool various components such as the bearing 92, the connecting shaft 44, the driving shaft 34, and the like.

The whole perfusion channel is reasonable in design and smooth in fluid flow, and the multi-branch distributable design is adopted, so that the perfusion amount of the Purge fluid can be increased. In addition, when the Purge liquid flows through each relative rotating component, the Purge liquid can naturally have lubricating and cooling effects, and heat accumulation on the rotating components, particularly the driving shaft 34, is avoided.

Furthermore, by virtue of the particular design of the drive shaft 34 as being fluid permeable and/or the proximal beginning of the irrigation passage, the Purge fluid can enter the interior of the drive shaft 34, thereby providing an overall cooling and lubrication of the entire drive shaft 34.

As previously discussed, the distal portions of the pump 36, catheter 32 and drive shaft 34 of the device 100 need to be delivered to the subject prior to operation of the device 100. 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 100 also includes a guide channel that extends through the pump 36, drive shaft 34, and coupler. When in use, the guide wire with the guiding function is firstly sent into the body of a subject through the vascular system. The user (typically a medical professional) then holds the distal end of the access assembly of the device 100 and passes the proximal end of the guidewire into the distal end of the guide channel until the guidewire passes through the entire working assembly 30, with its proximal end exiting the proximal end of the coupler (specifically the first guide channel of seal 118, or bypass exit 120 of the end insert 40, described below). Subsequently, the pump 36 is delivered in a compressed state to a desired location (e.g., the left ventricle) along a guide path established by the guidewire in the vasculature of the subject. Until the proximal end of pump 36 is advanced to the desired location, the guidewire is withdrawn, the pump 36 is released from its restraint and allowed to resume deployment, the working assembly 30 is connected to the drive assembly 10, and the motor is activated.

As previously described, 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, and the fourth axial passage, the third axial passage 103, and the second axial passage 102 are connected in series to form a first guide passage.

In fact, the protection head 38 is of hollow construction, in abutting communication with the fourth axial passage of the hub. Thus, the inner channel of the protection head 38 constitutes a part of the first guide channel.

Referring now more particularly to fig. 4, 10 and 11, the guide channels further include end face outlets 116 located on the proximal end face of the end insert 40, the hub distal outlet communicating with the end face outlets 116 through the first guide channel. That is, working assembly 30 has an axially extending first guide channel that guides the guidewire out of end face exit 116 to deliver the entry assembly into the subject.

As described above, since the present device 100 needs to be filled with Purge liquid during operation, the end face outlet 116 formed on the proximal end face of the insertion end liner 40 constitutes a proximal starting point cavity of the filling channel. Thus, the face outlet 116 requires a re-openable or sealable design.

Specifically, a seal 118 having a resealable first guide channel is disposed in the face outlet 116. The seal 118 has two states-a closed sealing state and an open state.

When the seal 118 is in the first state, the first guide passage is sealed, and the first guide passage is in a closed, sealed state. When the working assembly 30 is in operation, the sealing member 118 closes the end face opening, and prevents fluid in the filling passage from flowing out of the end face outlet 116, and prevents the motor 14 from being eroded by the Purge fluid.

When the seal 118 is in the second state, the first guide channel is open and the first guide channel is in communication for passage of a guidewire therethrough to deliver the access assembly into a subject.

Thus, when it is desired to pass a guidewire, the seal 118 may be opened to pass the guidewire through the first guide channel to secure the pump 36 within the subject. After the intervention of the pump 36 is completed, the guide wire is withdrawn, and the sealing member 118 can be sealed, so that the pump 36 is prevented from leaking the Purge liquid during the operation.

In one embodiment of the present invention, the sealing member 118 is a flexible sealing plug that is axially movable in the end face outlet 116. The outer wall of the flexible plug and/or the inner wall of the face outlet 116 are angled so that the flexible plug is squeezed to switch to the first state when moving in a first direction in the axial direction and expands radially to switch to the second state when moving in a second direction opposite to the first direction.

As illustrated in fig. 10 and 11, the first direction may be a direction toward an inside of the end liner 40, and the second direction may be a direction away from or toward an outside of the end liner 40. More specifically, the first direction may be a rightward direction as illustrated in fig. 10 and 11, and the second direction may be a leftward direction as illustrated in fig. 10 and 11.

As described above, the passive magnet 42 received in the cavity is fitted over the mounting portion 441 having a larger diameter. To avoid obstructing the inward travel of the flexible sealing plug, the proximal end of the mounting portion 441 is recessed inwardly to form an escape slot 4411 for receiving the inner end of the flexible sealing plug.

The proximal end of the central passage 102 of the connecting shaft 44 communicates with the escape groove 4411. The inner end of the flexible plug is substantially conical and the inner wall of the end outlet 116 is configured to be substantially conical. Thus, the tapered flexible sealing plug and the end face outlet 116 have a flow guiding function, and the Purge liquid is smoothly guided from the cavity to the central channel 102.

Preferably, the guide channel includes a bypass outlet 120 located on the side of the inlet bushing 40. As previously described, the proximal end of the working element 30 is provided with the passive magnet 42 and the cavity for receiving the passive magnet 42, after the bypass exit 120 is provided, the guide wire can pass out from the bypass exit 120 without having to pass out from the end face exit 116, and the end face exit 116 can be eliminated without the sealing member 118, thereby shortening the distance between the passive magnet 42 and the active magnet 22 and improving the transmission efficiency.

Specifically, the inlet bushing 40 is provided with a first bypass passage 121, and the first bypass passage 121 connects the bypass outlet 120 and an axial passage that receives the connecting shaft 44 inside the inlet bushing 40, that is, the first bypass passage 121 extends from the bypass outlet 120 to the first axial passage 101 that receives the inlet bushing 40.

The side wall of the connecting shaft 44 is provided with a second bypass passage 122 communicating with the internal passage of the connecting shaft 44, i.e., the second bypass passage 122 extends from the side wall opening of the connecting shaft 44 to the second axial passage 102 of the connecting shaft 44. The second bypass passage 122 is selectively communicated with the first bypass passage 121. Specifically, the second bypass passage 122 is disposed in the connecting shaft 44, and the connecting shaft 44 is rotatably coupled to the insertion end bushing 40. Therefore, two interfaces of the second bypass passage 122 and the first bypass passage 121 which are close to each other have two states of being opposed and being staggered.

When the two interfaces are opposite, the guide wire can conveniently pass through; when the two ports are misaligned, the guidewire cannot exit the bypass exit port 120. When it is desired to exit the guide wire from the bypass, the pump 36, and in particular the rotatable impeller, can be rotated by manual adjustment if the two ports are staggered, thereby causing the drive shaft 34, and, in turn, the connecting shaft 44 to rotate. Until the two ports are opposite, the guide wire can exit via the second bypass passage 122, the first bypass passage 121, the bypass exit 120.

Preferably, working assembly 30 further includes a guidewire bypass cannula 124. When the second bypass passage 122 is in communication with the first bypass passage 121, the guide wire bypass cannula 124 is operable to be inserted sequentially through the two bypass passages, with the inner end of the guide wire bypass cannula 124 in abutting communication with the second axial passage 102 of the drive shaft 34. Guidewire bypass cannula 124 may facilitate insertion of the guidewire.

Since the bypass outlet 120 communicates with the first axial passage 101 constituting the priming passage via the first bypass passage 121, in order to prevent the discharge of the Purge liquid flowing through the first axial passage 101 in the priming passage during the operation of the pump 36, a sealing plug (not shown) may optionally be provided in the bypass outlet 120 to seal the priming passage and prevent the discharge of the Purge liquid through the bypass outlet 120.

An alternative arrangement of the sealing plug is that the sealing plug is configured to be removed from the bypass exit 120 when the device 100 is in a threading condition in which the guide wire needs to be threaded out through the bypass exit 120, which removal may be manually unplugged. Thus, the bypass guide channel of the guide wire is opened, and the bypass passing-out operation of the guide wire can be performed.

Accordingly, the sealing plug is inserted into the bypass outlet 120 in any operating state other than the threading state. The other arbitrary operating states mainly include: the state in which the pump 36 is operated after the threading operation of the guide wire is completed (at this time, the Purge liquid needs to be pumped into the perfusion channel), the state in which the guide wire is threaded from the end face, and the like.

As previously described, the working assembly 30 is provided with an end face exit 116 and also with a bypass exit 120, the guide channel being configured to operably guide the guidewire out of one of the end face exit 116 and the bypass exit 120. The guide is smoother after passing through the end face outlet 116; and out of the bypass outlet 120 to avoid the influence of the seal 118 on the passive magnet 42 and the perfusion channel.

Alternatively, the bypass exit 120 is in a sealed state as the guidewire exits through the end face exit 116. The end face exit 116 is in a sealed condition as the guidewire exits through the bypass exit 120. The purpose of the design is mainly to keep the smoothness of a target threading path of the guide wire, avoid the guide wire from penetrating into a non-target guide path and ensure the efficient completion of guide wire threading.

As described above, when the guidewire needs to exit through the end face exit 116, the guidewire's path of traversal is relatively straight. At this point, it is not necessary nor possible to insert the guidewire bypass cannula 124 into the first and second bypass channels 121, 122. Conversely, based on the above description, when it is desired to thread a guidewire through the bypass exit port 120, the guidewire is forcibly redirected by the guidewire bypass cannula 124 from an original straight orientation to a proximally kinked orientation. Thus, when the guidewire bypass cannula 124 is inserted, the path of the guidewire exiting through the end face exit 116 is blocked to force the guidewire to exit through the bypass.

As shown in fig. 10, the inner end surface of the guide wire bypass cannula 124 is formed as a wedge surface having the same angle with the axial direction of the guide wire bypass cannula 124 as the inclination of the first or second bypass channel 121, 122, for example, 45 °. Thus, after insertion of the guide wire bypass cannula 124, its inner end face is generally vertical for a face-to-face fit with the proximal end face of the drive shaft 32.

In this way, the occurrence of a gap at the junction of the guidewire bypass cannula 124 and the end face of the drive shaft 32, which could lead to an undesired event of the guidewire passing from the gap to a space other than the guidewire bypass cannula 124, is avoided, ensuring that the guidewire can only pass out of the bypass exit port 120.

The path of the guidewire out of the bypass exit 120 is referred to as the second guide path. In the embodiment, 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 choices, and flexible guide wire threading configuration is provided for users.

It will be appreciated that the first guide channel and the second guide channel have coinciding portions. Specifically, the distal ends of the first and second guide channels coincide, while the proximal ends diverge and communicate with the end face outlet 116 and the bypass outlet 120, respectively.

Of course, the device 100 may be provided with only the face outlet 116 or the bypass outlet 120, which will not be described in detail. All the schemes similar to or the same as the present embodiment are covered by the protection scope of the present invention.

The following describes the use of the apparatus 100 of the present embodiment.

The drive assembly 10 and the working assembly 30 are detachably connected by a locking mechanism interposed between the bushing and the receiving bushing. When it is desired to use the device 100, the locking mechanism is operated to disengage the drive assembly 10 from the working assembly 30 prior to insertion into the subject; a guide wire is inserted into the body of the subject, and the entering component (the pump 36 is in a folding state) is sent to a required position in the body of the subject through the matching of the guide wire and the first guide channel or the second guide channel; removing the guide wire, sealing the first guide channel or the second guide channel (i.e., the end face opening and the bypass outlet); priming fluid into working assembly 30 through the priming channel; subsequently, drive assembly 10 is coupled to working assembly 30 via a locking mechanism, which removes the radial constraint of pump 36 and allows it to deploy. Activation of the motor 14 of the drive assembly 10 causes the drive assembly 10 to drive the pump 36 of the working assembly 30 to an operative configuration to effect a blood pumping function of the heart assist.

It should be understood that although the present description refers to embodiments, not every embodiment contains only a single technical solution, and such description is for clarity only, and those skilled in the art should make the description as a whole, and the technical solutions in the embodiments can also be combined appropriately to form other embodiments understood by those skilled in the art.

The above list of details is only for the practical implementation of the present invention, and they are not intended to limit the scope of the present invention, and all equivalent implementations or modifications that do not depart from the technical spirit of the present invention should be included in the scope of the present invention.

Claims (12)

1. An apparatus for assisting a heart in the occurrence of failure, comprising:

a motor;

a conduit;

the drive shaft is arranged in the catheter in a penetrating mode, and the proximal end of the drive shaft is driven by the motor through a connecting shaft;

a pump including a pump housing having an inlet end and an outlet end, an impeller housed within the pump housing; the impeller is connected to the distal end of the drive shaft and is driven to rotate to draw blood into the pump housing from the inlet end and discharge the blood from the outlet end;

the drive shaft comprises a main body and a connecting part, wherein the main body and the connecting part are in axial abutment, the cross section of the connecting part is non-circular, the distal end of the connecting shaft is provided with a matching passage matched with the connecting part, and the connecting part is axially and slidably inserted into the matching passage.

2. The device of claim 1, wherein the body and the connecting portion do not overlap in an axial direction.

3. The device of claim 1, wherein the circumferential surface of the connecting portion comprises a first surface and a second surface, and wherein an outer tangent of the first surface or the first surface is disposed at an angle to an outer tangent of the second surface or the second surface.

4. The device of claim 1, wherein the body is integrally formed with the connecting portion; or the main body and the connecting part are independent parts, and the near end of the main body and the far end of the connecting part are fixed through welding.

5. The device of claim 1, wherein the length of the connecting portion is less than the length of the body; or the diameter of the circumscribed circle of the connecting part is smaller than or equal to the diameter of the circumscribed circle of the main body.

6. The apparatus of claim 1, wherein the coefficient of friction between the outer wall of the connecting portion and the inner wall of the mating passage is between 0.05 and 0.2; alternatively, the length of the connecting part is between 10 and 50 mm.

7. The device of claim 1, wherein the axial relative position between the conduit and the connecting shaft is fixed.

8. The device of claim 1 or 7, wherein the catheter proximal end is fixedly connected to a coupler, the connection shaft being axially fixedly disposed within the coupler.

9. The device of claim 1, wherein an axial relative position between the distal end of the drive shaft and the catheter is fixed.

10. The device of claim 1 or 9, wherein the distal outer wall of the drive shaft is provided with an intermediate member; a first proximal end bearing is sleeved outside the far end of the driving shaft and is positioned at the near side of the intermediate piece; the distal end of the drive shaft is further sleeved with a second proximal bearing located distally of the intermediate member.

11. The apparatus of claim 1, wherein the connecting portion is axially slidable relative to the mating channel configured to accommodate changes in length of the conduit.

12. The apparatus of claim 11, wherein the change in length of the catheter is due, at least in part, to bending during an intervention; or, at least in part, due to liquid immersion; or at least in part due to forces exerted during collapsing of the pump.

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