Chemical apparatus and process disinfecting – deodorizing – preser – Blood treating device for transfusible blood
Reexamination Certificate
1998-07-17
2001-01-30
Sykes, Angela D. (Department: 3762)
Chemical apparatus and process disinfecting, deodorizing, preser
Blood treating device for transfusible blood
C422S045000, C604S004010, C604S005010, C604S005010, C604S006150
Reexamination Certificate
active
06180058
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a blood treatment system, such as a venous and cardioplegia blood reservoir, with a high degree of visibility.
BACKGROUND OF THE INVENTION
Various surgical procedures require interrupting the normal functioning of the heart and lungs of the patient. Some of the functions of these organs are temporarily replaced by an extracorporeal blood handling system. The main volume of the patient's blood, known as the venous return stream, is typically withdrawn from the patient through a venous cannula inserted into the right atrium. The blood handling system collects the volume of blood in a venous reservoir. The blood handling system serves to pump the blood, regulate the carbon dioxide and oxygen content, regulate the temperature, defoam and remove emboli and particulate matter using one or more filters. The blood is then returned to the patient through an aortic cannula inserted into the aorta distal to the heart.
Blood from the surgical field, known as cardiotomy blood, is typically drawn into a cardiotomy reservoir. The cardiotomy blood typically contains gas bubbles, fragments of tissue, bone chips, blood clots, surgical debris and other dangerous and undesirable contaminants. The cardiotomy reservoir defoams, filters and collects the cardiotomy blood prior to combining it with blood in the venous reservoir. The level of filtration required for cardiotomy blood is typically greater than that required for the relatively clean venous return stream.
The high level of filtration necessary for cardiotomy blood may cause damage to blood constituents, such as due to sheer stress. Consequently, cardiotomy blood filtration is preferably performed separately from filtration of the relatively clean venous return stream. Integrated cardiotomy reservoirs (ICR) combine the treatment of both cardiotomy and venous blood streams.
Turbulent flow may develop at various locations within the blood handling system. Turbulent flow can cause bubbles to form in the blood and can increase the blood-to-air contact. Blood to air contact causes hemolysis of red blood cells. Hemolysis refers to the lysis or destruction of erythrocytes with the release of hemoglobin, resulting in a reduction in the ability of the blood to carry oxygen.
Blood handling systems can also have locations of blood stasis that can cause blood clotting or separation of blood components. Medical care providers are increasingly interested in viewing the condition of the blood throughout the entire blood circuit. Current blood treatment systems typically have internal regions that are not visible to the medical staff, such as the interior of cylindrically shaped filter media. Areas within the blood handling system that cannot be viewed by the medical staff may result in undetected blood stasis or clots.
Typical blood handling systems have a large number of discrete parts, requiring manual assembly, increasing the risk of assembly errors and increasing manufacturing costs. Manufacturing a variety of distinct extracorporeal blood handling systems with different blood treatment elements increases manufacturing and inventory costs. Variability between products also raises the risk of errors in assembly or marketing of finished products, resulting in a potentially detrimental medical impact on the patient.
SUMMARY OF THE INVENTION
The present invention relates to a modular blood treatment cartridge and a method of assembling the same.
The present modular blood treatment system utilizes a blood treatment cartridge with a two-dimensional assembly process that facilitates automated assembly and substitution of a variety of blood treatment media.
The present invention is also directed to a modular blood treatment cartridge with a high degree of biocompatibility and visibility.
The modular blood treatment system defines a blood flow path for facilitating automated assembly along a single build axis. A blood treatment cartridge has a blood treatment media receiving opening that defines an entrance to a first chamber. The first chamber includes a first interior space and a second interior space. At least one cardiotomy blood sucker port is in fluid communication with the first interior space via a cardiotomy manifold. A venous blood inlet is in fluid communication with the second interior space. A first blood treatment media is interengaged with the blood treatment cartridge along the build axis. The first blood treatment media is preferably interposed between the first interior space and the second interior space. A second blood treatment media is interengaged with the blood treatment cartridge along the build axis. The second blood treatment media is preferably interposed between the second interior space and the blood treatment media receiving opening. A blood storage section is interengaged with the blood treatment cartridge along the build axis and extends substantially across the blood treatment media receiving opening. The blood storage section includes an outlet port.
The modular blood treatment system is preferably a transparent plastic material configured so that substantially the entire blood flow path is visible.
The blood treatment cartridge has a first ledge for receiving the first blood treatment media and a second ledge for receiving the second blood treatment media. The first ledge preferably defines a perimeter larger than the second ledge.
The first blood treatment media is a cardiotomy blood treatment media. The second blood treatment media is a venous blood treatment media. In one embodiment, the cardiotomy blood treatment media includes both a defoamer mesh and a filter media. The cardiotomy blood treatment media is a filter media with an average pore size of about 20 to 40 microns. The venous blood treatment media is preferably a defoamer media. A first frame preferably extends around a perimeter of the first blood treatment media. A second frame preferably extends around a perimeter of the second blood treatment media.
The blood storage section includes a blood diverter forming a pair of funnel-shaped blood flow channel extending between the blood treatment media opening and the outlet port. The funnel-shaped blood flow channels define a first downward flow axis at an angle of about 20 to 24 degrees with respect to horizontal. The funnel-shaped blood flow channel also defines a second flow axis perpendicular from the first flow axis extending downward from the blood diverter at an angle of about 3 to 7 degrees.
The cardiotomy manifold defines a downward curving surface extending from the at least one cardiotomy blood sucker port to the first interior space having a radius of about 2.54 to 7.62 cm. The opening in a blood sucker port is tangent to the downward curving surface of the cardiotomy manifold. The venous blood inlet includes a directionalized, low-velocity prime bowl for directing a portion of the blood flow path toward edges of the first chamber. The venous blood inlet has a cross-section at least four times greater than a cross-section of the venous blood inlet.
In an alternate embodiment, the blood storage section is a flexible blood reservoir in fluid communication with the outlet port.
In an alternate embodiment, the modular blood treatment system includes a blood treatment cartridge having a blood treatment media receiving opening defining an entrance of a first chamber. The first chamber includes a first interior space and a second interior space. At least one cardiotomy blood sucker port is in fluid communication with the first interior space via a cardiotomy manifold. A venous blood inlet is in fluid communication with a second interior space within the interior space. At least one cardiotomy blood treatment media is interposed between the first interior space and the second interior space. At least one venous blood treatment media is interposed between the second interior space and the blood treatment media receiving opening. A blood storage section extends substantially across the blood treatment media receiving opening. The blood storage section includes
Bianco Patricia
Burns Doane , Swecker, Mathis LLP
Sykes Angela D.
Terumo Cardiovascular Systems Corporation
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