Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Biological or biochemical
Reexamination Certificate
1999-07-26
2001-05-15
Wachsman, Hal (Department: 2857)
Data processing: measuring, calibrating, or testing
Measurement system in a specific environment
Biological or biochemical
C702S019000, C702S045000, C702S050000, C700S266000, C700S281000, C700S282000
Reexamination Certificate
active
06233525
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to the field of blood component collection systems and, more particularly, to providing management capabilities by incorporating optimization principles into such systems.
BACKGROUND OF THE INVENTION
The utilization of blood taken from donors and infused into recipients is well known for purposes of treating medical emergencies and other conditions. More recently, selected blood components have been separated and collected from blood for subsequent infusion into recipients requiring blood component therapy. The primary blood components include platelets, red blood cells, white blood cells, and plasma.
In order to collect blood components, blood is removed from a donor by a needle assembly or other blood access device and is thereafter processed utilizing centrifugation or other appropriate separation techniques to isolate and collect the desired components. This procedure is carried out most effectively in an on-line process wherein blood is removed from a donor, processed through a disposable extracorporeal circuit to obtain the desired components, and thereafter returned to the donor. One blood component collection system which provides for this type of blood component collection procedure is the COBE SpectraÔ which is commercially available from the assignee of the present application.
The yield of a particular collection of blood components is an important factor. For instance, presently in the United States a yield must be associated with a collection of blood components in order to be a useful blood component product. COBE SpectraÔ presently accommodates for this requirement by processing certain donor biological data such as height, weight, sex, and hematocrit, preconfigured/operator-input data such as the total procedure time, and system-related data such as the type of collection procedure (e.g., single or double needle) and collection efficiency to generate certain process parameters such as the inlet flow to COBE SpectraÔ (a combined flow of whole blood from the donor plus typically a flow of anticoagulant) and a predicted blood component yield as well.
An additional consideration presently in the United States relating to blood component yield is that it is determinative of the product classification. With regard to platelets, presently a single platelet product is considered to be a collection of 3×10
11
platelets and a double platelet product is considered to be a collection of 6×10
11
platelets. If the collection is between 3×10
11
and 6×10
11
platelets it is still considered to be a single platelet product. This classification as a single or double platelet product is relevant to blood component collection facilities (e.g., blood banks/centers) since a double platelet product has a higher selling price associated therewith than a single platelet product and also typically benefits more patients. The yield of a particular collection of blood components may also be a relevant consideration for certain therapeutic treatments.
Other important considerations relating to blood component collection systems relate to the donor. For instance, blood component collection facilities are not only experiencing an increase in the overall demand for blood components, but the demand now typically varies between the blood component types as well. Moreover, not only is the supply of donors unfortunately in many cases inadequate, but donor time constraints are becoming more prevalent. Furthermore, obtainable yields from a given donor may vary from one blood component to another (i.e., one donor may be a better platelet source than a red blood cell source).
Based upon the foregoing, the management of the various aspects of blood component collection systems is becoming increasingly important.
SUMMARY OF THE INVENTION
The present invention relates in one application to a blood component collection system which provides management capabilities by incorporating optimization principles. Generally and in this case, the present invention utilizes principles of optimization in terms of the donor, blood component collection system, and/or desired blood component product. For instance, the present invention may be adapted to provide for the collection of a predetermined quantity of at least one predetermined blood component (or more typically the collection of such blood components within a particular range) in a “iminimum” amount of time and/or for the collection of a “maximum” quantity of at least one predetermined blood component in a fixed amount of time, all based upon certain process conditions. Moreover, the present invention may be adapted to provide for blood component inventory control by basing donor selection and/or collection procedure selection in terms of the type of blood component to be collected on blood component demand and/or existing inventory. In addition, the present invention may be adapted to provide for further donor management by collecting that blood component type(s) from the donor which provides a maximum yield.
In one aspect, the present invention may be characterized as a blood component collection system having blood component product-based optimization-like capabilities. One embodiment comprises a method for collecting at least one predetermined blood component (e.g., a collection of platelets, red blood cells) from a source of whole blood using a blood component collection system which includes a blood component collection device and which utilizes a collection procedure. More particularly, a desired yield of the predetermined blood component(s) is identified (such yield including a single yield or range of yields) and biological data relating to the source is provided to the blood component collection system. Moreover, a value or magnitude is associated with each of the various process parameters used in the collection procedure. A magnitude of at least one of these process parameters is derived from the biological data and the desired yield. These magnitudes, including all magnitudes of process parameters derived from the desired yield, are input to the blood component collection system. Thereafter, the collection procedure is performed with the blood component collection device and with the input process parameters to collect the desired yield of at least one predetermined blood component(s) from the whole blood source.
In another aspect, the present invention may be characterized as a blood component collection system having time-based optimization-like capabilities. One embodiment of such is a method for collecting at least one predetermined blood component from a source of whole blood using a blood component collection system which includes a blood component collection device and which utilizes a collection procedure. A flow of the whole blood from the source, as well as a flow of anticoagulant, is provided to the blood component collection system and collectively constitutes an inlet flow. In the method, a total procedure time for the collection procedure is identified (e.g., based upon donor time availability). One potential inlet flow to the system is derived from at least this identified total procedure time. Another potential inlet flow to the system is derived which provides an “optimum” collection efficiency and is effectively the apex of a bell-shaped yield/inlet flow curve (i.e., the inlet flow which provides the maximum blood component yield). Consequently, if the total procedure time-based inlet flow is greater than the maximum yield-based inlet flow, and thus is an inlet flow on the decreasing slope portion of the yield/inlet flow curve, the maximum yield-based inlet flow magnitude is used in the performance of the collection procedure. However, if the total procedure time-based inlet flow is less than the maximum yield-based inlet flow, and thus is an inlet flow on the increasing slope portion of the yield/inlet flow curve, the total procedure time-based inlet flow magnitude is used in the performance of the collection procedure.
The subject inven
Keller John J.
Langley Robert W.
Urdahl Steven Gage
Gambro Inc
O'Connor Edna M.
Scull Peter B.
Wachsman Hal
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