The present invention relates to pulsatile fluid pumps, and more particularly to pulsatile fluid pumps suitable for pumping blood.
A pulsatile fluid pump is taught in U.S. Pat. No. 7,850,593 (“our prior patent”) for an invention of Douglas Vincent and Matthew Murphy, who are co-inventors of the present invention. Our prior patent discloses a pump actuated by a linear motor configured to cause reciprocation of a flexible membrane, serving as a wall of a fluid housing, that is in turn coupled to a pair of ball valves, in a manner as to implement pulsatile fluid flow.
In accordance with one embodiment of the invention, a pump-valving assembly for a pulsatile fluid pump includes a generally cylindrical pumping chamber, an inlet port having an entrance and coupled to the pumping chamber, and an outlet port having an exit and coupled to the pumping chamber. The pump-valving assembly further includes a spherically shaped inlet ball check-valve assembly coupled to the inlet port, first and second tapered tracts coupled to the inlet ball check-valve assembly and disposed between the inlet port and the pumping chamber respectively, a spherically shaped outlet ball check-valve assembly coupled to the outlet port, and third and fourth tapered tracts coupled to the outlet ball check-valve assembly and disposed between the pumping chamber and outlet port respectively. The first tapered tract expands in cross sectional area from the entrance to the inlet port to the inlet ball check valve assembly, and the second tapered tract decreases in cross sectional area from the inlet ball check valve assembly to the chamber, and the inlet ball check valve assembly gates flow between the pumping chamber and the inlet port. Further, the third tapered tract expands in cross sectional area from the chamber to the outlet ball check valve assembly and the fourth tapered tract decreases in cross sectional area from the outlet ball check valve assembly to the exit from the outlet port and the outlet ball check valve assembly gates flow between the pumping chamber and the outlet port.
Alternatively, or in addition, a taper of at least one of the tapered tracts is conical. Also, alternatively or in addition, the pump-valving assembly further includes an inflow transition region, coupled between the second tapered tract and the chamber, configured to conduct fluid along a path that is roughly tangential to an internal circumference of the chamber, so as to smoothly establish fluid flow in the chamber.
Alternatively, or in addition, the pump-valving assembly further includes an outflow transition region, coupled between the chamber and the third tapered tract, providing a channel, beginning in the chamber, of gradually increasing width, the outflow transition region configured to allow fluid to smoothly exit from fluid rotation in the chamber to linear flow in the third tapered tract.
The foregoing features of embodiments will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which:
Definitions. As used in this description and the accompanying claims, the following terms shall have the meanings indicated, unless the context otherwise requires:
“Normal flow” is flow from the entrance to the inlet port 111 through the chamber 102 to the exit of the outlet port 121.
A “slight reversal of flow” past a ball in a ball check valve is a small, controlled amount of desired reverse flow past the ball before the ball is seated in a closed position.
“Diastole mode” is a phase of operation of a pulsatile pump, according to embodiments of the present invention, during which the diaphragm (not shown) of the pump-valving assembly 101 is pulled away from the chamber 102 so as to create negative pressure within the chamber 102, inlet ball check valve assembly 110, and third tapered tract 126, but not the fourth tapered tract 122.
“Systole mode” is a phase of operation of a pulsatile pump, according to embodiments of the present invention, during which the diaphragm (not shown) is pushed towards the chamber 102, so as to create positive pressure within the chamber 102, outlet ball check valve assembly 120, and the second tapered tract 116, but not the first tapered tract 112.
Fluid flow in the tapered tracts 112, 116, 122, and 126 provides a gradual change in velocity as a function of cross-sectional area to maintain continuity of flow leading up to and past each of the balls 114 and 124. For either ball 114 or 124, the ball 114 or 124 geometry, the physical properties of the ball 114 or 124, and the ball check-valve assembly 110 or 120 as a whole are configured to stabilize the ball 114 or 124 in successive positions and transitions to these positions, as well as the velocity of the ball 114 or 124, as these things are modulated in the course of pulsatile flow of fluid through the pump—over the ranges of viscosity for blood or other fluids being pumped. In the course of pumping, the pulsatile nature of the pump causes a change in direction of flow over the balls 114 and 124; the pump is configured to achieve this change in direction in a manner that minimizes the total pressure loss across the ball check valve assembly 110 and 120. Additionally, when a given one of the balls 114 or 124 has moved to an open position (against the ribs 115 or 125, as the case may be) enabling flow past the given ball 114 or 124, the pump is configured to maintain sufficient flow velocity (and differential pressure across the given ball 114 or 124) to cause it to be retained against the ribs 115 or 125. Similarly, the check valve assembly 110 and 120 is configured to create symmetry of other fluid velocity forces on the given ball 114 or 124 to prevent unwanted lateral motion of the given ball 114 or 124.
The ribs 115 and 125 occupy a portion of the volume of the ball check valve assembly 110 or 120 in which they are located. That volume displaced by these ribs 115 or 125 therefore reduces the cross-sectional area of the ball check valve assembly 110 or 120 in the vicinity of the ribs 115 or 125 and thus causes an increase in velocity of fluid flow in the region. We utilize this increased velocity, as described in the previous paragraph, to cause the given ball 114 or 124 to be retained against the ribs 115 or 125.
Although operation of the pump-valving assembly 101 is pulsatile in nature, the flow in the chamber 102 is always in a uniform direction (in this figure, clockwise). Fluid enters the chamber 102 ultimately from the inlet port 111 and leaves the chamber 102 ultimately through the outlet port 121. This flow produces clockwise motion of the fluid in the chamber 102. The clockwise motion is triggered at least in part by configuring the geometry of the pump-valving assembly 101 to introduce tangential flow of fluid from the inlet port 111 into the chamber 102. Additionally, the large change in volume of the chamber 102, caused by the diaphragm (not shown), in the course of pumping causes fluid to undergo multiple revolutions in the chamber 102 over each stroke of the diaphragm 202. The fluid motion produces what we call a “fluidic flywheel” 103, wherein the inertia of the fluid rotating in the chamber 102 engages with fluid entering from the inlet port 111 and thus continues the fluidic flywheel. Without the fluidic flywheel 103, in-flowing fluid would encounter static resistance of fluid already in the chamber 102. The fluidic flywheel 103 produces a relatively smooth flow of fluid through the pump from end to end.
The pump-valving assembly 101 includes a fluid inflow transition region 117 protruding into the chamber 102, and a fluid outflow transition region 127 protruding from the chamber 102. These transition regions 117 or 127 mediate between the circular flow in the chamber 102 and the linear flow in the tapered tracts 116 or 126, respectively. The transition region 117 has the principal function of smoothly establishing circular flow in the chamber 102 and does so by conducting the fluid along a path that is roughly tangential to an internal circumference of the chamber 102. In contrast, the transition area 127 has the somewhat more complex function of allowing fluid to smoothly exit from the fluidic flywheel in the chamber 102 and achieve a transition to linear flow in the third tapered tract 126 to enable flow through the outlet port 121, and does so by providing a channel, beginning in the chamber 102, of gradually increasing width.
The structure of a pulsatile pump in accordance with various embodiments of the present invention can usefully reflect attributes of the human heart. The human heart is preload sensitive—the heart cannot “pull” blood into the left ventricle; it can only allow the blood available to flow naturally into the ventricle. The human heart is also afterload sensitive in that it is responsive to the compliance and resistance in the downstream vasculature and doesn't exert excess force on the blood, which could damage the vasculature. Lastly, the left ventricle cannot deliver blood that isn't in the ventricle when it contracts; there is a limited bolus of blood that it can deliver.
The pump-valving assembly 101 has similar attributes of inherent safety: it is preload and afterload sensitive, and it is limited in both the volume of blood it can deliver and the force at which it can deliver that bolus of blood. When filling, the pump-valving assembly 101 allows gravity filling from the venous reservoir, exerting minimal negative pressure. When the chamber in the pump-valving assembly 101 is emptying, the linear motor that powers the pump valving assembly is limited by design. In consequence the pump valving assembly cannot overpressure the downstream tubing or vasculature, instead delivering less than the volume of blood in the pump chamber 102, thereby only delivering as much volume as the vasculature can receive.
The pump-valving assembly 101 is analogous to a left ventricle of the human heart; the inlet ball check valve assembly 110 used in various embodiments hereof is analogous to a mitral valve; and the outlet ball check valve assemblyl20 used in various embodiments hereto is analogous to an aortic valve. Like the human heart, the inlet 110 and outlet 120 ball check valve assemblies are passive and require a slight reversal of flow to close. This slight reversal of flow mimics the slight reversal that occurs when the aortic valve of the human heart closes.
The embodiments of the invention described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in any appended claims.
The present application is one of four applications being filed on the same day and bearing attorney docket numbers 4747/1001, 4747/1002, 4747/1003, and 4747/1004. Each of these related applications, other than the present application, is hereby incorporated herein by reference in its entirety.