Surgery – Container for blood or body treating material – or means used... – Filter or series thereof for liquid entering or leaving...
Reexamination Certificate
2001-02-28
2004-08-10
Bianco, Patricia (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
Filter or series thereof for liquid entering or leaving...
C604S006150, C604S320000, C128SDIG003, C422S044000
Reexamination Certificate
active
06773426
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention is a blood reservoir with at least one pliable wall having at least three innovative features. First, the compliant reservoir is sealed within a rigid housing allowing control of the “atmospheric” pressure surrounding the bag, and therefore the pressure at which the bag would collapse. This first invention enables vacuum augmented venous drainage (VAVD) with a collapsible soft-shell reservoir (i.e. venous bag) and is particularly useful for cardiopulmonary bypass. Second, the invention incorporates means that improve gas bubble removal from blood transiting the collapsible reservoir. Third, a reservoir with all ports extending from its top is disclosed, an innovation that provides easy loading/unloading of the reservoir in/out of its holder and simplifies sealing the reservoir in a chamber thereby allowing the aforementioned VAVD.
2. Description of the Prior Art
Blood is routinely pumped outside the body during dialysis, cardiopulmonary bypass, and long-term cardiac and/or respiratory support (e.g. extracorporeal membrane oxygenation, ECMO). In general, blood flows from the venous side of the patient to a venous reservoir that is usually maintained at atmospheric pressure. Blood flow from the patient to the reservoir is a function of the resistance of the fluid conduit between patient and reservoir, and the pressure difference between patient and reservoir. When the reservoir is maintained at atmospheric pressure, that pressure difference is the height difference between patient and reservoir; the resulting flow is referred to as gravity drainage. Venous drainage by gravity alone provides inadequate return during procedures such as minimally invasive cardiac surgery and bypass via femoral cannulation. Usually it is the resistance of the venous cannula that limits the flow rate. Vacuum augmented venous drainage (VAVD) is a technique that overcomes flow limitations by applying suction to the hard shell reservoir thereby increasing the pressure difference between the venous cannulation site and venous reservoir. VAVD allows for a decrease in the inner diameter of the venous line, thereby reducing prime volume and enabling the
1
o use of a smaller cannula, which translates to an easier insertion, a better surgical view and a smaller surgical incision. This method precludes the use of the safer soft-shell closed venous reservoir (venous bag) unless a more expensive and complicated two-pump system is used (see McKusker K, Hoffman D, Maldarelli W, Toplitz S, and Sisto D. High-flow femoro-femoral bypass utilizing small cannulae and a centrifugal pump on the venous side, see Perfusion 1992; 7:295-300.
Clinically, a venus bag is used because it provides significant safety features. If the ba emptiels, it collapses, thereby preventing gross air from being pumped to the patient. It usually has no air-blood interface, and it requires no antifoam agents that can embolize into the blood. A recent study by Schonberger et al (Schonberger JPAM, Everts PAM, and Hoffmann J J. “Systemic blood activation with open and closed venous reservoirs. Annals of Thoracic Surgery, 1995; Vol. 59, pages 1549-55) comparing the hard shell to the bag reservoir found significantly lower blood activation, shed blood loss, crystalloid infusion, and hemolysis, and less donor blood infusion with the bag reservoir. Schonberger's group recommended against routine use of an open (hard shell) venous reservoir system. Currently, a slight negative pressure applied to the venous line (to facilitate blood drainage) using a single pump is possible with less desirable hard shell venous reservoirs. It is impossible to apply negative pressure to current soft-shell reservoirs, but it is possible with the present invention.
In an open, hard shell reservoir, air escapes by floating to the top of the reservoir. In a bag reservoir, air floats to the top but must be actively eliminated. This can be done manually with a syringe, or more frequently with a roller pump operating slowly so as to continuously pump fluid to the cardiotomy reservoir. With either method, a sudden large volume of air can overwhelm the air removal system and cause disastrous consequences, especially without a vigilant perfusionist. With one preferred embodiment of the present invention, air would be eliminated automatically without a roller pump or intervention by the perfusionist, and priming of the extracorporeal circuit would be facilitated through faster air removal utilizing either a floating ball valve or a hydrophobic membrane. Currently there are devices used in the CPB circuit that incorporate hydrophobic membranes that remove air yet do not allow blood to cross (e.g. Model # AutoVent-SV, Pall Corp Glen Cove N.Y.). Studies with filters used in these applications have shown that the membranes clear air from water almost indefinitely (many days), even if high suction is applied, without reducing gas transfer rate over time. However, when the membrane is exposed to blood, especially when high suction is applied, a film forms on the membrane over time, causing a significant increase in resistance to gas flow. The present invention incorporates designs and means to reduce this problem and extend the life of the membrane when used with blood. Likewise, U.S. Pat. No. 3,849,071 shows a floating ball within a blood filter that supposed to open a purge port when air enters and close when the blood level rises. However, as described, it is a physical impossibility for the ball to “fall” and open the purge port because, as shown, the weight of the floating ball is insufficient to overcome the force holding the ball against the purge port. With the present invention, the relative weight of the ball, the internal diameter of the purge port, and the suction applied to the purge port are designed to assure that the ball will drop to open the purge port in response to air level in the venous reservoir.
With prior art soft-shell reservoirs (SSR) air may be trapped at the top of the liquid by the collapsed walls of the reservoir, see
FIGS. 1
a
and
1
aa
. U.S. Pat. No. 4,622,032 illustrates a soft shell reservoir having an inlet tube extending from the bottom half way into the reservoir. This arrangement helps bubbles move up to the top of the extended tubes but the bubbles can still be trapped above said tubes. U.S. Pat. No. 5,573,526 illustrates the prior art soft-shell reservoir having its gas removal tubes (i.e.
18
and
20
of
FIG. 1
) extending from the top less 40% of the height of its blood chamber into the reservoir. All other prior art SSR have air removal tubes that are shorter with many having vent tubes that do not extend into the SSR at all (e.g. U.S. Pat. No. 5,580,349). As
FIGS. 1
b
and
1
bb
illustrate, a tube extending from the top and into the SSR prevents complete collapse of the pliable walls of the bag thereby forming a pathway for air to move upward. The prior SSR air removal tubes extend less than 40% of the height of the blood chamber and therefore air still may be trapped below said tubes.
A soft shell venous reservoir sold by [Johnson and Johnson (and now by]Medtronic, Model # Maxima 1386[see Reference
13
)]shows a soft shell reservoir with an inline tube extending, along one side of, along one side of the bag, to the gas purge port at a 45° incline. This design has a rigid fluid path between blood inlet and gas purge port. However, this design is not as conducive to air removal as a vertical fluid path would be. In addition, the tube extending between inlet tube and purge port had an ID of ⅝″, or only 25% greater diameter than the inlet tube. Thus, the velocity of the liquid in the column slows to only 64% of the inlet velocity. In another aspect of the present invention, a vertical path is provided from the blood inlet at the bottom of the bag to the gas purge port at the top of the bag, such path limiting the aforementioned problem of trapped air. The vertical path also has a large enough diameter that slows the velocity
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