Abstract:
The invention is directed to a multi-disk centrifugal pump suitable for pumping fluids, including biocompatible fluids, such as blood. The design of the pump components is optimized to reduce or eliminate the probability of clotting and hemolysis when pumping blood, and to be energy efficient and resistant to physical shock for portable applications.

Description:
PRIORITY INFORMATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/074,053, filed on Jun. 19, 2008. 
     
    
     GOVERNMENT RIGHTS 
       [0002]    This invention was made with United States Government support under Grant No. W81XWH-07-1-0496, awarded by the United States Army. The United States Government has certain rights in the invention. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The invention is directed to a multi-disk centrifugal pump suitable for pumping fluids, including biocompatible fluids, such as blood. The design of the pump components is optimized to reduce or eliminate the probability of clotting and hemolysis when pumping blood, and to be energy efficient and resistant to physical shock for portable applications. 
       BACKGROUND OF THE INVENTION 
       [0004]    Existing centrifugal blood pumps are large and waste electrical energy. Accordingly, they are not well suited for portable use. Existing ventricular assist devices (“VADs”) do not scale down in size so that they can not be used in the pediatric application. These pumps have elaborate configurations of the inlet and outlet geometries to reduce turbulence, in order to provide high flow at acceptable rates of hemolysis. These complex features, when scaled down in size, no longer act to reduce turbulence but instead act to increase shear forces. The inlet and outlet of this pump design have a wide, continuous (uninterrupted) cross section without complex surface features, allowing the pump to be scaled down in size while still retaining acceptable performance 
     
    
     
       DETAILED DESCRIPTION OF THE DRAWINGS 
         [0005]      FIG. 1   a  is a top view of the bottom housing of a preferred embodiment of the invention. 
           [0006]      FIG. 1   b  is a side view of the bottom housing of a preferred embodiment of the invention. 
           [0007]      FIG. 1   c  is a bottom view of the bottom housing of a preferred embodiment of the invention. 
           [0008]      FIG. 1   d  is an isometric view of the bottom housing of a preferred embodiment of the invention. 
           [0009]      FIG. 2   a  is a top view of the top housing of a preferred embodiment of the invention. 
           [0010]      FIG. 2   b  is a side view of the top housing of a preferred embodiment of the invention. 
           [0011]      FIG. 2   c  is a bottom view of the top housing of a preferred embodiment of the invention. 
           [0012]      FIG. 2   d  is an isometric view of the top housing of a preferred embodiment of the invention. 
           [0013]      FIG. 3  is a cross sectional view of a preferred embodiment of the invention. 
           [0014]      FIG. 4   a  is a top view of the rotor of a preferred embodiment of the invention. 
           [0015]      FIG. 4   b  is a side view of the rotor of a preferred embodiment of the invention. 
           [0016]      FIG. 4   c  is a bottom view of the rotor of a preferred embodiment of the invention. 
           [0017]      FIG. 4   d  is an isometric view of the rotor of a preferred embodiment of the invention. 
           [0018]      FIG. 5  is an exploded side view of a preferred embodiment of the invention. 
           [0019]      FIG. 6  is a side view of a preferred embodiment of the invention. 
           [0020]      FIG. 7   a  is a side view of a single piece rotor suitable for use with the present invention. 
           [0021]      FIG. 7   b  is a bottom view of the single piece rotor shown in  FIG. 7   a.    
           [0022]      FIG. 7   c  is an isometric view of the single piece rotor shown in  FIG. 7   a.    
           [0023]      FIG. 8  is a side cross sectional view of the embodiment of the invention shown in  FIG. 8   a.    
           [0024]      FIG. 9   a  is a bottom view of another embodiment of a rotor suitable for use with the present invention. 
           [0025]      FIG. 9   b  is an isometric view of the rotor shown in  FIG. 9   a.    
           [0026]      FIG. 9   c  is an exploded side view of the rotor shown in  FIG. 9   a.    
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]    A preferred embodiment of the invention is directed to a Tesla centrifugal pump for pumping biocompatible fluids, such a blood. In one preferred embodiment, the pump is made from biocompatible materials, thereby making it suitable for implantation in a patient, including in a human patient. In another preferred embodiment, the pump is made from non-biocompatible materials and coated with a biocompatible material coating. The Tesla design was chosen because it creates less turbulence and is less susceptible to cavitation than traditional bladed centrifugal pumps. Therefore, the Tesla design should produce less hemolysis. Additionally, the bladeless geometry of the Tesla impeller allows the design to be scaled down in size while less susceptible to performance variability from the dominance of viscous forces at a small scale. 
         [0028]    A preferred embodiment of the invention comprises a pump housing bottom  10 , as shown in  FIGS. 1   a - 1   d,    7   b  and  9   a.  In a preferred embodiment, the pump housing bottom is circular. A preferred embodiment of the invention comprises a post  12  located in the center of the top surface of the pump housing bottom and protruding outward. The post defines a longitudinal axis. In a preferred embodiment, the post is integrally formed with the pump housing bottom. In a preferred embodiment, the pump housing bottom is made from a biocompatible material. 
         [0029]    A preferred embodiment of the invention further comprises a first sheath  14  mounted over the post  12 , as shown in  FIGS. 3 and 5 . In a preferred embodiment, the first sheath is made from a flurocarbon polymer, such as polytetrafluoroethylene (“PTFE”). In a preferred embodiment, the invention further comprises a second sheath  16  mounted over the first sheath, as shown in  FIG. 3 . In a preferred embodiment, the second sheath is made from stainless steel. In a preferred embodiment, the first sheath comprises a thrust bearing. 
         [0030]    A preferred embodiment of the invention further comprises a pump housing top  20 , as shown in  FIGS. 2   a - 2   d.  The pump housing top and bottom collectively form the pump housing, In a preferred embodiment, the pump housing top is circular. In another preferred embodiment, as shown in  FIG. 8 , the pump housing top comprises a conically shaped interior  59 . This conically shaped interior reduces the rapid acceleration of fluid as it enters this pump. 
         [0031]    The pump housing top comprises an inlet conduit  22  centrally located in the pump housing. As shown in  FIG. 5 , the pump housing top is mounted on the pump housing bottom to form the pump housing. In a preferred embodiment, the inlet conduit is oriented in substantial alignment with the longitudinal axis. In another preferred embodiment, the inlet conduit is centered over the post. In a preferred embodiment, no vanes or diffusers are present inside the inlet conduit. In a preferred embodiment, the inlet conduit permits fluid to enter the housing along an axis that is substantially parallel to the longitudinal axis. In a preferred embodiment, the inlet conduit  22  is circular. 
         [0032]    The pump housing top further comprises an outlet conduit  24  located in an outer radial region of the pump housing. In a preferred embodiment, the outlet can be integrally formed as part of the pump housing bottom. In a preferred embodiment, the outlet conduit  24  is circular. In another preferred embodiment, the orientation of the inlet conduit is substantially perpendicular to the orientation of the outlet conduit. In another preferred embodiment, the outlet conduit extends beyond the outer radial edge of the pump housing top. In a preferred embodiment, the pump housing top is made from a biocompatible material. In a preferred embodiment, the inlet conduit and the outlet conduit are integrally formed in the pump housing top. 
         [0033]    A preferred embodiment of the invention further comprises a rotatably mounted pump rotor,  18 , as shown in  FIGS. 3 and 4   a - 4   d.  The rotor design used in a preferred embodiment of the invention is commonly known in the centrifugal pump arts as a “Tesla” design. In a preferred embodiment, the rotor comprises multiple disks  15  stacked in a longitudinally aligned configuration as shown in  FIGS. 3 and 4   d.  In a preferred embodiment, the rotor comprises four disks. In a preferred embodiment, the rotor is made from a polycarbonate material. In a preferred embodiment, the rotor comprises a central channel  21 , as shown in  FIG. 4   d.  As shown in  FIG. 3 , the rotor is positioned such that the second sheath  16  protrudes through the central channel. 
         [0034]    In a preferred embodiment, a cap  13  is mounted on the top central region of the rotor, as shown in  FIG. 8 . The cap holds the rotor in a fixed axial position, thereby preventing lift and subsequent decoupling. 
         [0035]    In one preferred embodiment, the rotor disk diameters are substantially equivalent to each other, as shown in  FIG. 4   b.  In another preferred embodiment, the top rotor disk has a smaller diameter than all rotor disks below it and the second rotor disk from the top has a smaller diameter than all rotor disks below it, as shown in  FIG. 7   a.  In this embodiment, the outer edges of the top three rotor discs are beveled, as shown in  FIG. 7   a.  The embodiment of the invention shown in  FIGS. 7   a  and  7   c  provides a more gradual acceleration of the fluid in the pump, than does the embodiment shown in  FIG. 4   b.  This more gradual acceleration reduces the shear forces caused by elevated velocity gradients. 
         [0036]    The term “third of said disk” is used herein to refer to a one third slice of a disk extending from the radial center to the disk to the outer periphery of the disk and comprising a 120 degree arc length of the disk. In another preferred embodiment, the top disk has at least two diametrically opposed studs  46  protruding downward and each remaining disk comprises at least one hole aligned with and positioned to receive each stud, thereby aligning all of the disks, as shown in  FIG. 9   c.  In another preferred embodiment, each disk comprises at least three spacers  47 , each positioned in a separate third of said disk, as shown in  FIG. 9   c.    
         [0037]    In a preferred embodiment, the spacing between each disk is greater than or equal to 0.02″. In a preferred embodiment, it is desirable to make the disks as thin as possible, while maintaining the desired structural integrity for pumping biocompatible fluids. In a preferred embodiment, the disk thickness is greater than or equal to 0.03″. Thinner disks allow for greater total surface area of the rotor at the cost of reducing the strength of the disks and increasing the risk of vibration or breakage. A larger moment of inertia would require more energy to turn, hence reducing motor battery life. For pumps of constant overall volute volume, thicker disks reduce overall priming volume of the pump. 
         [0038]    In one preferred embodiment, the disks are integrally formed as one piece of the pump, as shown in  FIG. 7   a.  This one piece or “monolithic” construction provides increased strength to the rotor. This monolithic construction also avoids the vibration or jitter problems associated with multipiece stacked rotor designs of prior art Tesla centrifugal pumps. Such mechanical vibration is particularly undesirable in a pump intended to pump biocompatible fluids, such as blood, because higher rates of hemolysis are produced and energy consumption is increased. Additionally, the monolithic construction is more resistant to external forces, including random vibrations and shocks, than a multipiece rotor design. This attribute further reduces the probability of hemolysis when pumping blood with this pump. 
         [0039]    In a preferred embodiment, the rotor has an outer diameter that is less than 1.75″, and an inner diameter that is less than 1.25″. In another preferred embodiment, the inner diameter is at least 0.7″ and the outer diameter is at least 1.3″. 
         [0040]    In order to eliminate the need to create a shaft seal for power transfer, a preferred embodiment of the invention comprises a magnetic coupling system. In a preferred embodiment, this coupling comprises a first set of magnets, comprising an even number of magnets  17  embedded in the bottom of the rotor in a circular fashion or arrangement. In another preferred embodiment, the first set of magnets comprises two magnets embedded in the bottom of the rotor, as shown in  FIG. 3 . In a preferred embodiment, each of the magnets in a set is substantially equal in mass to each of the other magnets in the set. In another preferred embodiment, the first set of magnets contains eight magnets, and the rotor bottom is configured to hold eight magnets, as shown in  FIGS. 7   b  and  9   a.  In another preferred embodiment, the magnets are sealed with a cap  50  in the bottom of the rotor, as shown in  FIG. 9   c.    
         [0041]    In a preferred embodiment, a second set of magnets  29  identical in number and geometry to the first set is operatively coupled to a motor  30  located outside the pump housing, as shown in  FIG. 8 . In a preferred embodiment, the motor is located in a motor housing  40 , as shown in  FIG. 8 . In a preferred embodiment, the motor housing is connected to the bottom housing by a coupler  42 , as shown in  FIG. 8 . In a preferred embodiment, the motor comprises a shaft  31  that is coupled to the second set of magnets, such that rotation of the shaft causes rotation of the second set of magnets, as shown in  FIG. 8 . In a preferred embodiment, the shaft comprises at least two fins. 
         [0042]    In a preferred embodiment, the second set of magnets are mounted in a magnet housing  35 , as shown in  FIG. 8 . The magnets of opposite polarity are attracted to each other, and one set of magnets tries to maintain its position relative to the other set, creating a magnetic coupling through the housing. This coupling provides effective torque transfer to the rotor. This design eliminates the need for a shaft seal. In a preferred embodiment, the motor is battery powered. In another preferred embodiment, the motor is a DC flat motor. 
         [0043]    In a preferred embodiment, this pump is not designed to replace the cardiac output capacity of an adult&#39;s heart. Such high flow requirements would demand power levels that are neither suitable nor necessary for mobile use. In one embodiment, a target flow rate for this pump is approximately 1 L/min at a pressure head of 120 mm Hg. 
         [0044]    In a preferred embodiment, the rotor further comprises at least two washout fins  19  on the bottom of the rotor, as shown in  FIG. 4   c.  These washout fins keep pumped fluid moving in an area where it could otherwise become stagnant and begin to clot. 
         [0045]    In a preferred embodiment, the central bearing is quite wide by comparison to other pump designs. This allows external perturbing forces to be distributed across a much larger area than with other pumps, giving greater resistance to external shock/vibration. The cross section of the overall central spindle is a segment of a cone (frustum) with the smaller diameter pointed into the inlet stream. This allows both a more gradual acceleration of the fluid and less resistance to flow through the inlet, reducing the overall pressure drop across the pump and reducing hemolysis. 
         [0046]    Those skilled in the art of pumping blood will appreciate that a tradeoff occurs in the design of a blood pump between keeping the fluid moving to reduce the chances of clot (thrombus) formation within the pump. It is important to avoid introducing areas of excessive shear rate that can cause the destruction of red blood cells (hemolysis). This tradeoff manifests itself in the design process through selecting proper clearances between the rotor and the housing. 
         [0047]    The differences in centrifugal pump disk support structure design lie in the location and shape of the support. The tradeoff between hemolysis and thrombosis is important. Disk supports that are too close to the center of the rotor could produce eddies where stagnation could occur, causing thrombi formation. Alternatively a set of disk supports on the outermost edge may create an unacceptably high level of trauma to blood cells due to the increased velocity present at the outer radii of the disks. A teardrop shaped disk support structure that is narrow near the center and widens as it moves radially outward acts as an effective shape that eliminates areas of stagnation while allowing smooth movement around it, limiting both hemolysis and thrombosis. 
         [0048]    An important design criterion for a pediatric ventricular assist device (“VAD”) is the priming volume of the device, which cannot use a significant percentage of the infant&#39;s overall blood volume simply to fill up the pump. In a preferred embodiment, this pump minimizes priming volumes in two ways: first, the inter-disc spacing is reduced to just above the point where hemolysis begins to increase (−1 mm, a function of blood viscosity and surface roughness of the rotor). In a preferred embodiment, the overall rotor is elevated off the bottom of the housing in order to prevent excessive hemolysis. In another preferred embodiment, the fluid encounters disks of successively increasing diameter, as it flows from inlet to outlet, as shown in  FIG. 7 . 
         [0049]    The foregoing disclosure and description of the inventions are illustrative and explanatory. Various changes in the size, shape, and materials, as well as in the details of the illustrative construction and/or an illustrative method may be made without departing from the spirit of the invention.