Chemical apparatus and process disinfecting – deodorizing – preser – Blood treating device for transfusible blood – Oxygenator
Reexamination Certificate
1999-12-20
2002-10-22
Sykes, Angela D. (Department: 3762)
Chemical apparatus and process disinfecting, deodorizing, preser
Blood treating device for transfusible blood
Oxygenator
C604S004010, C604S006140, C604S006150, C261SDIG002
Reexamination Certificate
active
06468473
ABSTRACT:
TECHNICAL FIELD
The present invention relates to extracorporeal blood circuits for oxygenation and circulation of a patient's blood during cardiac bypass surgery or similar procedures, and in particular to a self-contained pack assembly that includes the tubing and other disposable components of an extracorporeal blood circuit.
BACKGROUND OF THE INVENTION
During cardiac bypass surgery a patient's heart is slowed or stopped for surgical repair, and his or her blood must be artificially oxygenated and pumped through the body using an extracorporeal support circuit. Using this system, venous blood is diverted from entering the right chambers of the heart and is instead directed through a series of tubes, pumps and filters, which provide fresh oxygen to the blood and return it to the body's systemic circulation at the aorta. The oxygenated blood is then circulated throughout the body. The circuit thus ensures that the patient continues to be nourished by oxygenated blood flow while the heart is unable to function.
In performing such a procedure, a complicated multi-component system is required. One or two blood reservoirs, an oxygenator (possibly combined with a heat exchanger), a blood pump, and multiple tubes to connect the various components are needed and must be assembled and arranged before surgery may begin. Typically a significant amount of time must be spent just prior to surgery to accomplish the set-up, and great attention must be paid to the details of this complicated task.
In a conventional extracorporeal support circuit, a venous line drains blood from the right side of the patient's heart and delivers it to a blood reservoir. The blood is then pumped by a specially designed pump from the outlet of the blood reservoir into a blood oxygenator for oxygenation and cooling. The oxygenated blood is artificially pumped via an arterial line to the venous line, and the circuit is continued in this fashion until the surgical repair is complete.
The support circuit normally includes a blood scavenging sub-circuit for recovering and recycling blood from the surgical field. The sub-circuit includes one or more suckers (typically two to four) for sucking blood from the surgical field. Vacuum is applied to the suckers by a peristaltic positive displacement pump (also known as a roller pump) or wall vacuum to deliver the scavenged blood to a cardiotomy reservoir. The cardiotomy reservoir includes a defoaming section to remove entrained air and a filter. The outlet for the cardiotomy reservoir delivers the de-foamed, filtered blood to the venous blood reservoir of the main circuit. Various cardiotomy reservoirs are described in U.S. Pat. Nos. 3,891,416, 3,993,461, 4,208,193 and 4,243,531. The cardiotomy reservoir may alternatively be an integral portion of the venous blood reservoir in which the scavenged blood flows through a filter section and the venous blood does not.
A schematic diagram of a conventional “open” extracorporeal support system is shown in
FIG. 1. A
hardshell reservoir
20
is provided for cleaning, debubbling, and collecting the blood. This type of system is called an “open” system because the hardshell reservoir
20
is vented, and thus open to the atmosphere. A tubing assembly called a pump loop
22
includes a pump inlet line
24
and a pump outlet line
26
. These two lines are connected to an arterial pump
28
, which for the purposes of this invention will most conveniently be of the type which has a pump header
30
which is separable from the motor portion. The pump outlet
26
leads to the inlet of the oxygenator
32
, which may include a heat exchanger
34
.
The elements so far described are connected to the body of the patient by a tubing assembly called an A-V loop
36
. The A-V loop
36
includes a venous line
38
to carry the patient's low-pressure, oxygen depleted venous blood to the reservoir, and an arterial line
40
carrying high-pressure, oxygen rich arterial blood from the oxygenator
32
back to the patient. It may be convenient to monitor the condition of the blood in these two lines, so a blood parameter monitor
42
may be provided having sensors
44
and
46
, which are kept in chemical equilibrium with the blood flowing in the venous line
38
and the arterial line
40
, respectively. A hematocrit monitor
48
may also be provided, having its own sensor
50
, conveniently monitoring the blood in the venous line
38
.
It may be convenient to perfuse the patient's heart directly with a different solution than is provided to the rest of the patient's body. Cardioplegia solution is typically used in this fashion to slow or stop the patient's heart during surgery. A cardioplegia pump
52
may be used to deliver cardioplegia solution supplied by solution line
56
from a solution supply
58
. The cardioplegia pump outlet line
60
passes through a cardioplegia heat exchanger
62
and a bubble trap
64
before delivering cardioplegia solution to the heart at the cardioplegia catheter
66
.
Two suction lines are typically provided to recapture blood from the site of the surgical incision that has escaped the closed system. The first is called the vent line
68
, and runs from a vent catheter
70
through a vent pump
72
to the reservoir
20
. The second is called the suction line
74
, and runs from a suction device
76
through a suction pump
78
and once again to the reservoir
20
.
A further embodiment of the prior art system utilizes a flexible venous reservoir. A system having a flexible venous reservoir utilizes gravity to drain the cardiotomy blood to the venous reservoir, since the flexible venous reservoir is not vented. Such a system is called a “closed” system because there is minimal blood-air contact.
To prepare the above-described systems for use, each of the tubing connections must be individually made by a skilled person in the operating room. Many of these connections are between disposable system components, such as tubes and filters, which could advantageously be pre-connected and assembled in an assembly pack for quick attachment to the nondisposable elements of the system, thus enhancing operating room efficiency. Furthermore, because the operating room protocol differs between hospitals, the assembly pack should be capable of accommodating either a closed system or an open system, as described above, depending upon the particular procedures followed by a hospital. However, no such assembly packs have heretofore been developed in the art.
SUMMARY OF THE INVENTION
The present invention provides an assembly pack that contains the major disposable components of an extracorporeal support circuit, conveniently packaged in ready-to-use condition. All the tubing needed to connect the patient for bypass surgery is included in the pack, with all or some of the necessary attachments between the various elements in the pack being optionally pre-made in a sterilized condition. In preparation for surgery, when the attachments are pre-made, only a few connections must be made between the assembly pack and the nondisposable elements of the circuit compared to the numerous connections that were previously required. The assembly pack allows one to carry and mount all of the disposable paraphernalia needed for perfusion with a single hand.
The pack assembly is built around a backbone called the carrier, which serves as a support and handle for the other components. Preferably, a reservoir and an oxygenator are both physically but releasably attached to this carrier. Disposed around these central components, and attached to them in some way, will preferably be at least one tray. In preferred embodiments, two trays will be present, and it is considered particularly convenient that each of these trays be releasably attached to both the carrier and the reservoir. The carrier preferably has a handle so that the pack assembly can be easily moved and manipulated after being removed from its shipping container.
In preferred embodiments, various tubing assemblies will be pre-attached to the reservoir and
Bianco P. M.
Sykes Angela D.
Terumo Cardiovascular Systems Corporation
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