Background of the Invention
This invention is directed toward a buoyant blood stop valve which stops blood flow as blood is exhausted. The valve may also be used for cutting off other types of liquid flow when the liquid approaches exhaustion from the reservoir.
During open-heart surgery, both the heart and lungs are bypassed with an extra-corporeal circuit which includes a pump and an oxygenator. In a hard-shell oxygenator, oxygen is bubbled through the blood, and the displaced carbon dioxide escapes from the blood. The oxygenated arterial blood is filtered and returned to the body. Air can be inadvertently introduced into the arterial line when the reservoir contents of the hardshell oxygenator is accidentaly emptied, such as when no more venous blood is being fed to the oxygenator, but the blood in the reservoir is being returned to the patient. The introduction of air into the arterial line can cause massive air embolism and usually death of the patient.
Thus, there is need for a valve to be positioned in the arterial line, which presents as little resistance to flow as is possible, which minimizes blood turbulence and trauma that may cause hemolysis and which closes automatically when massive air or other gas reaches the valve so that the valve shuts off before air passes into the arterial line beyond the blood stop valve. Such a valve should not have a tendency to inadvertently close during normal flow and should not require external manipulation or separate sensors or signals to actuate the valve. Such a valve should be pre-sterilizable and inexpensively producible.
Summary of the Invention
In order to aid in the understanding of this invention, it can be stated in essentially summary form that it is directed to a buoyant blood-stop valve having a body with a top blood inlet and a bottom blood outlet. A ball, buoyant in blood, is free within the body. Next to the inlet is a downwardly open cup, sized to receive the ball and structured to guide the ball up into the cup when the ball is floating. An upwardly directed valve seat connected to the outlet receives the ball if blood level decreases, to cut off outlet flow. The valve can be used with other liquids.
It is a purpose and object of this invention to provide an automatic blood stop valve which shuts off blood flow when gross air enters the body of the stop valve in order to prevent the air from passing into a line connected to the outlet of the stop valve to automatically cut off blood flow when the blood source is depleted.
It is another purpose and object of this invention to provide a buoyant blood stop valve which presents as little resistance to flow as possible when the valve is flowing full of blood and to minimize turbulence and blood trauma that may cause hemolysis to the blood as consequence of employment of the blood stop valve.
It is a further object and advantage of the buoyant blood stop valve of this invention to automatically operate to close the stop valve upon the depletion of the blood supply without external manipulation to actuate the valve and without the requirement for other sensors or power supply.
It is another object of this invention to provide a blood stop valve which is inexpensively mass producible, compatible with blood, reliable and presterilizable so that it can be supplied to the place of use without need for further treatment.
It is another object of this invention to provide a buoyant stop valve which is useful to cut off the flow of other liquids, beside blood, upon their depletion.
Other objects and advantages of this invention will become apparent from a study of the following portion of the specification, the claims and the attached drawings.
Brief Description of the Drawings
FIG. 1 is an isometric view of the buoyant blood stop valve of this invention.
FIG. 2 is an enlarged section taken generally along the line 2--2 of FIG. 1, with parts broken away.
FIG. 3 is an upward-looking sectional view as seen generally along the line 3--3 of FIG. 2.
Description of the Preferred Embodiment
The buoyant blood stop valve of this invention is generally indicated at 10 in FIGS. 1, 2 and 3. The valve 10 has a body 12 which is formed of upper body portion 14 and lower body portion 16. The upper and lower body portions are respectively fitted with flanges 18 and 20 and interfitting guide and recess 22 so that the portions may be fit together and secured, as by adhesive or ultrasonic weld bond 24.
The valve body may be defined as having an upright axis, for convenience of description, and this axis is a generally central axis which is perpendicular to the plane of the flanges and passes generally through the center line of the lower body portion and outlet tube 26. Inlet tube 28 is offset with respect to this axis in order to make room for hemispheric cup 30 which is positioned on the other side of the axis. Inlet tube 28 is the inlet fitting to which the flexible arterial blood line is attached by slipping over the inlet tube.
In order to provide retention, inlet tube 28 can be provided with the conventional barbs, or more preferably has one or more annular beads 32. These beads may be rounded, as shown in FIG. 2, or may be more sharply defined as, for example, a 90.degree. to 120.degree. total included angle annular serration. These beads are sufficiently large to retain the arterial blood line thereon without the need for a clamp, but have a sufficiently large angle away from the end of the tube so that the tube can be pulled from the mold after the core pin which forms the inlet passage 34 is pulled. Some injection molding materials are sufficiently elastic when warm, at the point the molding is pulled from the mold, to permit withdrawal of the bead 32. A similar bead 36 is formed on outlet tube 26.
As is seen in FIGS. 1 and 2, inlet tube 28 and dome 38 which contains hemispherical cup 30, are positioned side-by-side on the upper body portion. Both are downwardly directed. They are connected by passage 40, see FIGS. 2 and 3, which is a slot within web 42 seen in FIGS. 1 and 2. Passage 40 eliminates trapping of air within cup 30 so that the liquid level in cup 30 is the same as the liquid level within inlet passage 34. Valve ball 44 is shown in the lower, no-liquid position in FIG. 2 and is shown as being a hollow ball. Valve ball 44 is made of such material as to be buoyant in the liquid in question. A hollow aluminum ball or a solid polypropylene ball is suitable when the liquid is blood. The ball is spherical and is sized to be effective as a valve. The downwardly directed hemispherical cup 30 is sized to receive the ball with a small amount of clearance. In addition, the upper interior of the hemispherical cup 30 contains tips 46 which hold the ball slightly away from the cup surface. This is to ensure that when the valve empties, there will be no suction developed between the ball and its cup which would tend to hold the ball in the upper position. Only a small clearance is necessary, and a much larger cup might allow too much ball movement so the ball rattles during flow.
The lower body 16 is also hemispherically shaped, but with a diameter which embraces both the cup and inlet passage. The hemispherical shaped surface 48 is interrupted on the axis by circular cylinder walls 50 which define an O-ring recess which contains O-ring 52. O-ring 52 is constrained between cylindrical wall 50 and end wall 54 of the recess. Outlet tube 26 and its passage 56 extend through end wall 54. O-ring 52 is sized with respect to valve ball 44 to act as a valve seat for the valve ball. When the ball is in position on its seat, as indicated in FIG. 2, downward flow through valve 10 is prevented.
When the system is being charged with blood, the ball 44 floats thereon and rises. In order to ensure that the ball rises into its cup, four vanes or posts 58, 60, 62 and 64 are formed on flange 18 to extend downwardly therefrom into the lower body. These vanes are on opposite sides of the inlet passage 34 and have surfaces which direct the rising ball away from the inlet passage and away from the underside of flange 18 toward its cup 30. In this way, ball 44 is quickly guided into its rest position for blood flow. During emptying of the valve body, ball 44 descends toward its seat on O-ring 52. Since the surface 48 is curved, ball 44 readily goes into its seat. However, to more directly guide the ball to its seat, six ball guides 66, 68, 70 and 72 are formed on the interior of the lower body portion. These ball guides have angular interior guide surfaces which direct the ball away from the hemispherical surface of the lower body toward the center where it can be more directly acted upon by downward flowing blood, so that ball 44 with more assurance quickly seats on the outlet O-ring seat even if valve axis is off vertical. These guides also improve reliability of valve closing when the valve is installed in a not quite vertical position. between cylindrical wall 50 and end wall 54 of the recess. Outlet tube 26 and its passage 56 extend through end wall 54. O-ring 52 is sized with respect to valve ball 44 to act as a valve seat for the valve ball. When the ball is in position on its seat, as indicated in FIG. 2, downward flow through valve 10 is prevented.
When the system is being charged with blood, the ball 44 floats thereon and rises. In order to ensure that the ball rises into its cup, four vanes or posts 58, 60, 62 and 64 are formed on flange 18 to extend downwardly therefrom into the lower body. These vanes are on opposite sides of the inlet passage 34 and have surfaces which direct the rising ball away from the inlet passage and away from the underside of flange 18 toward its cup 30. In this way, ball 44 is quickly guided into its rest position for blood flow. During emptying of the valve body, ball 44 descends toward its seat on O-ring 52. Since the surface 48 is curved, ball 44 readily goes into its seat. However, to more directly guide the ball to its seat, six ball guides 66, 68, 70 and 72 are formed on the interior of the lower body portion. These ball guides have angular interior guide surfaces which direct the ball away from the hemispherical surface of the lower body toward the center where it can be more directly acted upon by downward flowing blood, so that ball 44 with more assurance quickly seats on the outlet O-ring seat even if valve axis is off vertical. These guides also improve reliability of valve closing when the valve is installed in a not quite vertical position.
The upper and lower valve body portions are preferably separately injection-molded and ultrasonically welded together. Transparent polycarbonate is a suitable material therefor. Silicone rubber is a suitable material for the O-ring, and the ball is preferably polypropylene. These materials are suitable for use with blood in an extra-corporeal blood circuit. In such a circuit, the valve 10 can be configured as shown in FIG. 2 with a ball of 3/4 inch diameter to form a valve suitable for such extra-corporeal blood circuits. Configured in that way, the valve has a priming volume of only 30 milliliters and is easily primed. As seen in FIG. 2, inlet flow down through inlet passage 34 tangentially engages the hemispherical surface 48 in the lower body. This causes a clockwise circulation of blood through the lower body in addition to the downward flow from inlet to outlet. The clockwise circulation is in a direction to hold the ball 44 upward in its cup 30. This circulation prevents rattling or vibration of the ball in its cup. When the liquid-air interface comes down inlet tube 28, the air spreads out through slot 40 to fill the top of the cup as the liquid level falls. Once the ball is lowered to a point where it is out of its cup, it is engaged by the mainstream liquid flow from inlet to outlet and is swept onto the valve seat and closes the valve. Thus, the valve closes the line when there is still about 10 milliliters of liquid in the chamber in the lower body. These results are the accumulative effect of the combination of geometric shapes and sizes thus described. A smooth flow path to prevent blood trauma and minimum priming volume are achieved.
This invention has been described in its presently contemplated best mode, and it is clear that it is susceptible to numerous modifications, modes and embodiments within the ability of those skilled in the art and without the exercise of the inventive faculty. Accordingly, the scope of this invention is defined by the scope of the following claims.