Patent Publication Number: US-11648390-B2

Title: Intravascular blood pump

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/375,477, filed Dec. 12, 2016 (now U.S. Pat. No. 10,610,626) which is a continuation of U.S. patent application Ser. No. 14/377,704, filed on Aug. 8, 2014 (now U.S. Pat. No. 9,550,017), which is a U.S. National Stage Application Under 35 U.S.C. § 371 of International Patent Application No. PCT/EP2013/053001, filed on Feb. 14, 2013 (now expired), which claims priority to German Patent Application No. 102012202411.5, filed Feb. 16, 2012. The specifications of each of the foregoing applications are incorporated herein by reference in their entirety. 
    
    
     This invention relates to an intravascular blood pump for supporting blood circulation in human or optionally also animal bodies. It is inserted percutaneously for example into the femoral artery and guided through the body&#39;s vascular system in order, for example, to support or replace the pumping action in the heart. The invention likewise relates to a system comprising such an intravascular blood pump, and to a method for supporting blood circulation while employing such an intravascular blood pump. 
     The requirements to be met by such blood pumps with regard to duration of service and small size are continually increasing. The smallest pumps of this kind have an outer diameter of about 4 mm. A further reduction of the outer diameter is limited, inter alia, by the machine elements employed within the pump, which are not available in arbitrarily small sizes. Furthermore, the machine elements are subjected to enormous loads, since these pumps work at high rotational speeds of several 10,000 turns per minute on account of the small package size and the substantial volume flows to be conveyed in human blood circulation. While blood pumps of this kind were originally intended only for short-term heart support, they are increasingly also being used for long-term treatment over several days up to weeks. 
     From EP 0 961 621 B1 there is known an intravascular blood pump that possesses a drive section, a catheter attached at the proximal end of the drive section and having lines extending therethrough for the power supply to the drive section, and a pump section fastened at the distal end of the drive section. The drive section comprises a motor housing having an electric motor disposed therein, with the motor shaft of the electric motor distally protruding out of the drive section and into the pump section. The pump section in turn comprises a tubular pump housing having an impeller rotating therein which is seated on the end of the motor shaft protruding out of the motor housing. The motor shaft is mounted in the motor housing in exactly two bearings which are maximally removed from each other in order to guarantee a true, exactly centered guidance of the impeller within the pump housing. While a radial ball bearing is used in practice for the bearing at the proximal end of the motor housing, the impeller-side bearing is moreover configured as a shaft seal, in order to prevent blood from entering the motor housing. In practice, the entry of blood into the motor housing is furthermore counteracted by a purge fluid being passed through the motor housing and the impeller-side bearing configured as a shaft seal. This is done at a purge-fluid pressure that is higher than the blood pressure present. 
     The intravascular blood pump normally conveys the blood through the pump housing and past the motor housing from distal to proximal. A reverse conveying direction is also possible. In both cases the impeller, when conveying the blood, produces axial forces that are transferred to the bearings via the motor shaft and taken up by the radial ball bearing. 
     Starting out from this prior art, it is the object of the present invention to propose measures for how to further reduce the package size of such intravascular blood pumps and increase their service life. 
     This object is achieved by an intravascular blood pump having the features of claim  1 . Claims dependent thereon state advantageous developments and embodiments of the invention. 
     The blood pump according to the invention is characterized in that it is mounted in the motor housing axially by means of an axial bearing, the axial bearing being an axial sliding bearing or combined radial-axial sliding bearing. The axial forces of the motor shaft thus no longer need to be taken up by the radial ball bearing disposed at the proximal end of the motor housing. The radial ball bearing can hence be constructed accordingly smaller or be replaced by another compact radial bearing, in particular a radial sliding bearing. This in turn makes it possible to develop blood pumps having a further reduced outer diameter. 
     At the same time, this measure prolongs the service life of the blood pump, because the radial bearing is relieved on account of the reduced axial forces, which a radial bearing is not primarily intended to take up anyway, so that it is subject to less wear. 
     Alternatively, the invention can be integrated into existing package sizes in order to increase service life and reduce the degree of complexity. 
     The axial forces acting on the motor shaft are contrary to the conveying direction. When the blood pump is arranged for conveying alternatively in the proximal direction and in the distal direction, axial forces act on the motor shaft in the distal direction in one case and in the proximal direction in the other case. In such a blood pump, two axial sliding bearings or axial-radial sliding bearings are accordingly to be provided in the motor housing for axially mounting the motor shaft. The axial sliding bearing can be formed in a simple manner by a disk disposed on the motor shaft and supported against a circumferential shoulder of the motor housing. In the case of an axial-radial sliding bearing, the disk possesses a convex or concave, in particular spherical, bearing surface. Hereinafter the term “axial sliding bearing” will be employed synonymously for both variants, the axial sliding bearing and the radial-axial sliding bearing. 
     The motor housing itself is filled with a suitable fluid which forms a lubricating film in the bearing gap of the axial sliding bearing. Alternatively, purge fluid fed through a purge-fluid feed line and flowing through the radial bearing located at the distal end of the motor housing can also flow through the bearing gap of the axial sliding bearing and in this manner be used for forming the lubricating film in the bearing gap. To ensure in this case that the purge fluid reaches the distal radial bearing at a pressure higher than the blood pressure present, there can be provided, in at least one of the surfaces forming the bearing gap of the axial sliding bearing, a channel which penetrates the bearing gap from radially outward to radially inward, so that the purge fluid can flow through this channel to the distal radial bearing. This channel need not necessarily lie in a bearing-gap surface, but can also be realized as a separate channel or as a bore. However, providing the channel in one of the hearing-gap surfaces has the advantage that the lubricating film in the bearing gap heats up less, because a part of the lubricating film is continually being replaced by purge fluid flowing in later. Preferably, the channel is located in the stationary bearing-gap surface in order to minimize the radial conveying capacity. 
     Preferably, the axial sliding bearing is configured as a hydrodynamic sliding bearing. In contrast to a simple sliding bearing, in a hydrodynamic sliding bearing a pressure is built up in the lubricating film through the pumping action of the two surfaces moved relative to each other. For this purpose, according to a preferred variant, the bearing gap can be configured as a converging gap in some regions in the circumferential direction of the axial sliding bearing. In this connection the moved surface is preferably even, that is, the opposing stationary surface of the hearing gap has ramps which converge toward the moved surface in the rotation direction of the moved surface. Thus there is formed in the bearing gap a wedge into which the lubricating fluid is transported, thereby building up a pressure causing the moved surface to move away from the static surface. In this state, sliding friction prevails on a fluid film, said friction being virtually wear-free. Since the blood pump normally conveys continuously at high rotational speed, the blood pump has especially low wear and is accordingly suitable for long-term applications. 
     In the simplest embodiment, the moved disk can be configured as a wobble disk and form the convergent gap or wedge simply through the slant. 
     Instead of the bearing gap having converging surface zones, one of the surfaces forming the bearing gap can have one or more spirally disposed grooves. In this case, the lubricating fluid is pumped along the grooves toward the center of the bearing through the relative motion of the two surfaces, and builds up a pressure there which in turn leads to the two surfaces moving away from each other. In the spiral-groove bearing variant, it is preferred to provide the spirally disposed grooves in the moved surface, because this makes the conveying of lubricating fluid into the grooves more effective. 
     Should the axial thrust (F axMotor ) of the pumping apparatus be greater than the load-carrying capacity of the axial sliding bearing for design reasons, the axial thrust of the pumping apparatus can be compensated partly through a suitable axial arrangement of the rotating magnet in the motor. According to the invention, the rotating magnet behaves like a solenoid which strives magnetically to be situated in the center of the static motor section. When it is now pulled out of this rest position, a magnetic force arises in the reverse direction (F axMagnet ). This force can be used in the direction of the axial thrust (F axMotor ) for further axial stabilization or in the opposite direction and relieve the axial sliding bearing. Further, the resultant force on the axial bearing can be adjusted by varying the pressure of the purge fluid (cf.  FIG.  2   ). 
     It is further preferred when the surfaces forming the bearing gap of the axial sliding bearing are made of ceramic, preferably zirconium oxide. Surfaces made of ceramic have high strength and low wear. In particular, the total distal end of the motor housing, including the surface for the axial sliding hearing, can be manufactured from a one-piece ceramic part in a simple manner, so that the total manufacturing costs of the blood pump are low. 
     The lead wires of the electric motor received in the motor housing are normally guided around the proximally situated radial bearing on the outside and electroconductively connected, in particular soldered, to the power supply lines extending within the catheter. According to a preferred embodiment of the invention, the lead wires of the electric motor are now guided through the outer ring of the radial bearing or advantageously within one or more radially outer slots of the outer ring. This saves overall space in the radial direction, which is in turn positive for the development of blood pumps having a small outer diameter. It is thus for example possible to obtain space for a pressure measurement and its implementation at the proximal motor end. 
     The lead wires can advantageously be soldered to the power supply lines on a surface of the motor housing proximally of the proximally situated radial bearing. This is advantageous because electrically connecting the lead wires of the electric motor to the power supply tines directly can cause difficulties on account of the small thickness of the lead wires and the relatively great thickness of the power supply lines. When the relevant surface of the electric motor is made of a plastic or of ceramic, as to be explained hereinafter, the soldering-point region can be coated conductively, for example with copper, before soldering, and the soldering of the lead wires and of the supply lines is respectively effected separately in this region. 
     Preferably, the relevant part of the motor housing is subsequently embedded into plastic, with the soldering points and preferably also the motor windings being embedded as well, so that the soldering points are electrically isolated, on the one hand, and mechanically protected, on the other hand. 
     According to a preferred development of the invention, the radial bearings for the motor shaft are also respectively configured as sliding bearings at the proximal end and at the distal end of the motor housing. Since these radial bearings serve substantially only for guiding the shaft in an exactly centered manner and accordingly only low radial forces are to be taken up, they can be configured as simple sliding bearings. A radial sliding bearing requires considerably less overall space in the radial direction than a rolling-element bearing with its inner and outer rings. This again has a positive effect on the possibilities of manufacturing blood pumps having a small outer diameter. 
     In particular, it is preferred to make the radial sliding bearing located at the proximal end of the motor housing of ceramic, with the ceramic bearing lying directly against the circumferential surface of the motor shaft. The radial bearing located at the distal end of the motor housing can also be configured in a corresponding manner. The surface of the motor shaft opposing the ceramic surface, which together with the ceramic surface forms the bearing gap of the radial sliding bearing, is preferably coated with an amorphous carbon coating (DLC=diamond-like carbon or diamond-like coating). DLC layers are especially wear-resistant and low-friction. They are only a few micrometers thick and can be produced for example by chemical vapor deposition (CVD) or physical vapor deposition (PVD). Alternatively, the shaft can be made of a breakproof ceramic. 
     During operation, the blood pump is attached to a purge-fluid source, and fluid passed into the motor housing through the purge-fluid line. The purge fluid then flows through the axial sliding bearing and further through the distal radial bearing. In the axial sliding bearing it forms the lubricating film in the bearing gap. The pressure at which the purge fluid flows through the motor housing has an adverse effect, however, on the width of the bearing gap. For the higher the purge-fluid pressure is, the smaller the bearing-gap width becomes and the thinner the lubricating film between the sliding surfaces is. The thinner the lubrication film is, the greater in turn the motor current for driving the electric motor is that is necessary for overcoming the frictional forces. This is unfavorable for the control of the blood pump, because the current conveying volume is normally established by stored characteristic curves solely on the basis of the motor current and the rotational speed (both known quantities). When the purge-fluid pressure additionally affects the motor current, a further influence quantity would have to be taken into consideration. In view of the fact that the same blood-pump type can be operated for a great variety of applications with different purge-fluid pressures between 300 and 1400 mmHg, it is important to avoid a dependence of motor current on purge-fluid pressure. 
     This can actually be obtained when there is chosen as a purge fluid a fluid having a viscosity that is considerably higher than the viscosity of water (η=0.75 mPa·s at 37° C.). For with a highly viscous purge fluid, the fluid film is maintained even at high pressures and the friction of the axial sliding bearing is accordingly independent of the purge-fluid pressure. It has turned out that the axial sliding bearing can be configured as a simple sliding bearing, and does not have to be configured as a hydrodynamic sliding bearing, with a purge fluid whose viscosity at 37° C. amounts to approx. 1.2 mPa·s or higher. Good results were achieved for example with a ≥20% glucose solution between ceramic surfaces made of zirconium oxide. 
    
    
     
       Hereinafter the invention will be explained by way of example with reference to the accompanying drawings. Therein are shown: 
         FIG.  1    a schematic representation of the insertion of a blood pump before the left ventricle, with positioning of its inflow cannula within the left ventricle, 
         FIG.  2    a schematic longitudinal section of an exemplary embodiment of the blood pump, 
         FIG.  3    an enlarged representation of the detail III from  FIG.  2   , 
         FIG.  4    a variant of the detail III from  FIG.  3   , 
         FIG.  5    an enlarged representation of the detail IV from  FIG.  2   , 
         FIGS.  6 A and  6 B  an axial sliding bearing surface in plan view and as a development according to a first exemplary embodiment, 
         FIG.  7    an axial sliding bearing surface in cross section according to a second exemplary embodiment, and 
         FIG.  8    an axial sliding bearing surface in plan view according to a third exemplary embodiment. 
     
    
    
       FIG.  1    represents the employment of a blood pump  10  for supporting the left ventricle. The blood pump has a motor section  11  and a pump section  12  which are disposed coaxially one behind the other and result in a rod-shaped construction form. The pump section is extended by a flexible suction hose  13  which has, at its end and/or in its side wall, openings for the entry of blood to the pump. The end of the blood pump  10  facing away from the suction hose  13  is connected to a catheter  14 , which has been inserted through the aortic arch  15   a  and the aorta  16 . The blood pump  10  is so placed that it lies primarily in the ascending aorta  15   b , whereas the pump section  12  with the suction hose  13  lies substantially in the left ventricle  17 . The aortic valve  18  comes to lie, in the closed state, against the outer side of the pump housing or of the suction hose  13 . The blood pump  10  with the suction hose  13  in front is advanced into the represented position by advancing the catheter  14 , optionally employing a guide wire. In so doing, the suction hose  13  passes the aortic valve  18  retrograde, so that blood is sucked in through the suction hose  13  and pumped into the aorta  16 . Thus far, the blood pump corresponds to the blood pump known from EP 0 961 621 B1. 
     The use of the blood pump is not restricted to the application represented in  FIG.  1   , which merely involves a typical example of application. Thus, the pump can also be inserted through other peripheral vessels, such as the subclavian artery, or also be placed in the right heart. 
       FIG.  2    shows a preferred exemplary embodiment of the blood pump with the motor section  11  and the pump section  12  firmly connected thereto. The motor section  11  has an elongate housing  20  in which the electric motor  21  is housed. The stator  24  of the electric motor  21  has, in the usual way, numerous circumferentially distributed windings as well as a magnetic return path  28  in the longitudinal direction. It is firmly connected to the motor housing. The stator  24  surrounds the rotor  26  connected to the motor shaft  25  and consisting of permanent magnets magnetized in the active direction. The motor shaft  25  extends over the total length of the motor housing  20  and protrudes distally out of the latter. There, it carries an impeller  34  with vanes  36  projecting therefrom or pump vanes which rotate within a tubular pump housing  32  which is in turn firmly connected to the motor housing  20 . 
     The proximal end of the motor housing  20  has the flexible catheter  14  sealingly attached thereto. Through the catheter  14  there extend electrical cables  23  for power supply to and control of the electric motor  21 . There additionally extends through the catheter  14  a purge-fluid line  29  which penetrates the proximal end wall  22  of the motor housing  20 . Purge fluid is fed through the purge-fluid line  29  into the interior of the motor housing  20  and exits through the end face  30  at the distal end of the motor housing. The purging pressure is so chosen that it is higher than the blood pressure present, in order to thereby prevent blood from penetrating into the motor housing, being between 300 and 1400 mmHg depending on the case of application. 
     Upon a rotation of the impeller  34 , blood is sucked n through the end-face suction opening  37  of the pump housing  32  and conveyed backward within the pump housing  32  in the axial direction. Through outlet openings  38  in the pump housing  32  the blood flows out of the pump section  12  and further along the motor housing  20 . This ensures that the heat produced in the drive is carried off. It is also possible to operate the pump section with the reverse conveying direction, with blood being sucked in along the motor housing  20  and exiting from the opening  37 . 
     The motor shaft  25  is mounted in radial bearings  27  and  31  at the proximal end of the motor housing, on the one hand, and at the distal end of the motor housing, on the other hand. The radial bearings are in this exemplary embodiment respectively configured as simple sliding bearings. Furthermore, the motor shaft  25  is also mounted axially in the motor housing  20 . The axial bearing  40  is likewise configured as a sliding bearing. The axial sliding bearing  40  will be explained more precisely hereinafter with reference to  FIG.  3   . It serves for taking up axial forces of the motor shaft  25  which act in the distal direction when the impeller  34  conveys from distal to proximal. Should the blood pump be used for conveying blood also or only in the reverse direction, a corresponding axial sliding bearing  40  is (also/only) to be provided at the proximal end of the motor housing  20  in a corresponding manner. 
     The blood pump according to  FIG.  2    can alternatively be employed without purge fluid for short-term use over a few hours. In this case the sliding bearings are lubricated once, and the distal sliding bearing  31  is moreover furnished with a radial lip seal in order to prevent the entry of blood. A purge-fluid line can then advantageously be omitted altogether. 
       FIG.  3    shows the detail HI from  FIG.  2    in greater detail. There can be seen in particular the radial sliding bearing  31  and the axial sliding bearing  40 . The bearing gap of the radial sliding bearing  31  is formed, on the one hand, by the circumferential surface of the motor shaft  25 , which is DLC-coated, and, on the other hand, by the surface of the through bore in the distal end wall  30  of the motor housing  20 , which is manufactured as a ceramic part, for example of zirconium oxide. 
     The bearing gap of the axial sliding bearing  40  is formed, on the one hand, by the axially interior surface  41  of the end wall  30  and a surface  42  opposing it. This opposing surface  42  is part of a ceramic disk  44  which is seated on the motor shaft  25  distally of the rotor  26  and rotates with the rotor  26 . A channel  43  in the bearing-gap surface  41  of the end wall  30  ensures that purge fluid can flow through between the bearing-gap surfaces  41  and  42  of the axial sliding bearing  40  to the radial sliding hearing  31  and exit from the motor housing  20  distally. The purge fluid is chosen to have a viscosity of at least 1.2 mPa·s at 37° C. A suitable fluid has turned out to be 20% glucose solution, for example. The axial sliding bearing  40  represented in  FIG.  3    is a normal sliding bearing. Hydrostatic sliding-bearing variants will be described hereinafter with reference to  FIGS.  6 A /B,  7  and  8 . Unlike the representation, the axial gap of the axial sliding bearing  40  is very small, being a few μm. 
     Instead of the axial sliding bearing  40  and radial sliding bearing  31 , there can also be realized a combined radial-axial sliding bearing  46  having a concave bearing shell in which a convex bearing surface runs. Such a variant is represented in  FIG.  4    by a spherical sliding bearing  46 . The bearing-gap surface  41  is of spherically concave design, and the opposing bearing-gap surface  42  is of corresponding spherically convex design. The channel  43  again lies in the stationary bearing-gap surface  41  of the end wall  30 . Alternatively, the stationary hearing-gap surface  41  of the end wall  30  can be of convex configuration and the opposing bearing-gap surface  42  of concave configuration. The surfaces  42 ,  43  can also be conical instead of spherical. Preferably, a corresponding radial-axial sliding bearing is provided on both sides of the motor housing  20  in order not to permit any radial offset upon axial travel of the shaft  25 . The advantage of a combined axial-radial sliding bearing lies in the higher loading capacity. However, a disadvantage is the greater frictional diameter. 
       FIG.  5    shows the radial bearing  27  at the distal end of the motor housing  20 . Here, too, the motor shaft  25  is furnished with a DLC coating and runs in a bearing bush which forms an integral part of the proximal end wall  22 , again made of ceramic, of the motor housing  20 . Thus far, the radial sliding bearing  27  corresponds to the radial sliding bearing  31 . 
     Distributed over the circumference of the end wall  22  there are provided three axially extending slots  50  spaced at 120°, of which only one is to be seen in  FIG.  2   . Through these slots  50 , thin lead wires  51  lead to the windings of the stator  24 . The lead wires  51  are soldered on the proximal side of the end wall  20 , the soldering point  52  having been previously made conductive with a local copper coating. At the same soldering point  52  the end of the power supply line  23  is also soldered. The connection of the wires of the stator windings with the power supply lines can be effected with all conventional joining methods (soldering, welding, clamping, laser welding, gap welding, contact bonding, etc.). Subsequently the end wall  22  including the lead wires  51  and the soldering points  52  is encased in a plastic material, with the motor windings of the stator also being encased at the same time. This can be effected by vacuum casting by way of example. 
     The previously described blood pump does without radial ball bearings for mounting the motor shaft  25 , which are hard to mount and possess a minimum size of 3 min. This makes it possible to manufacture pumps having even smaller outer diameters of for example only 3 mm. Moreover, the service life of this blood pump is considerably increased compared with those having radial ball bearings on account of lower wear. Run times &gt;30 days can thus be realized with low wear. The latter is extremely significant, since the mounting and the true running of the impeller are vital for low blood damage. 
       FIG.  6 A  shows in plan view the surface  41  of the distal end wall  30  of the motor housing  20  according to an alternative exemplary embodiment.  FIG.  6 B  shows a development of the surface  41  from  FIG.  6 A . The surface  41  itself is stationary. The direction indicated by the arrow indicates in which direction the opposing surface  42  of the sliding bearing  40  moves. This then also corresponds to the direction in which the lubricating film moves within the bearing gap relative to the stationary surface  41 . Accordingly, the surface  41  possesses ramps disposed one behind the other which form converging gaps together with the opposing moved surface  42 , which is even. This causes a hydrodynamic pressure to build up in the lubricating film, which ensures that the surfaces forming the bearing gap remain at a distance. 
     A configuration of the rotating surface with the ramp-like structures according to  FIGS.  6 A and  69    is advantageous for the efficiency of the axial sliding bearing, but leads to an elevated radial conveying effect in the bearing gap which is opposed to the conveying direction of the purge fluid.  FIG.  7    represents the simplest form of a ramp-like realization of the convergent gap in the form of a wobble disk. Here, the disk  44  is simply installed on a slant or minimally beveled. The slant typically amounts to 1 to 5 μm. 
       FIG.  8    shows another variant for a hydrodynamically acting surface of the axial sliding bearing  40 . This involves a so-called spiral groove bearing, which is preferably formed on the moving surface of the bearing gap, i.e. accordingly on the surface  42  of the ceramic disk  44 . In this case, several grooves  45  are spirally disposed in the surface  42 . The grooves  45  are indicated only schematically in  FIG.  8   . When the ceramic disk  44  rotates in the direction indicated by the arrow in  FIG.  8   , the lubricating film is conveyed radially inward along the grooves  45  and builds up a pressure there which in turn ensures that the surfaces forming the bearing gap are kept at a distance apart.