| Extracorporeal blood processing information management system -> Monitor Keywords |
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Extracorporeal blood processing information management systemRelated Patent Categories: Data Processing: Measuring, Calibrating, Or Testing, Measurement System In A Specific Environment, Biological Or Biochemical, Cell Count Or Shape Or Size Analysis (e.g., Blood Cell)Extracorporeal blood processing information management system description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060052949, Extracorporeal blood processing information management system. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This case is a divisional of U.S. patent application Ser. No. 09/797,325, filed Mar. 1, 2001, which claims the benefit of priority of U.S. provisional patent application Ser. No. 60/186,123, filed on Mar. 1, 2000. BACKGROUND OF THE INVENTION [0002] The present invention generally relates to the field of extracorporeal blood processing systems and, more particularly, to providing information management and/or data manipulation and/or optimization capabilities to, in and/or with such systems. [0003] The utilization of blood taken from donors and transfused into recipients is well known for purposes of treating medical conditions. More recently, selected blood components have been separated and collected from donated blood for subsequent transfusion into recipients for the more specific therapeutic benefits of those particular blood components. The primary blood components of current interest in many separation and collection technologies include platelets, red blood cells, white blood cells, stem cells and plasma. [0004] In the harvesting of blood components, blood is removed from a donor through a needle assembly or other blood access device and may thereafter be processed by centrifugation or other appropriate separation techniques to isolate and collect the desired components. This procedure is often carried out very effectively in an on-line procedure wherein blood is removed from a donor, processed in and through a disposable extracorporeal fluid circuit to obtain the desired components, and the uncollected components thereafter returned to the donor. Two illustrative blood component collection systems that provide for this type of on-line blood component collection procedure are the COBE Spectra (Registered Trademark) and Trima (Registered Trademark) apheresis systems, which are commercially available from the assignee of the present application. [0005] The yield of a particular collection of blood components from such a process is an important factor in the ultimate usefulness of those particular components. For instance, in the United States a minimum yield is associated with a collected blood component product in order for that product to meet certain criteria and qualify for use as a transfusable blood component product. The COBE Spectra and Trima apheresis systems presently accommodate for this requirement by processing certain donor biological data such as height, weight, gender, and platelet pre-count or hematocrit, together with pre-configured and/or 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 the apheresis centrifugation device (including, for example, the combined flow of whole blood from the donor plus typically a flow of anticoagulant). These apheresis machines then generate a predicted blood component yield from these data as well. [0006] An additional consideration presently in the United States, for example, relating to blood component yield is that the yield is determinative of the product classification. With regard to platelets, a single platelet product is presently considered to be a collection of 3.times.1 011 platelets and a double platelet product is considered to be a collection of 6.times.1 011 platelets. If a collection is between 3.times.1 011 and 6.times.1 011 platelets, it is still considered to be a single platelet product. This classification as a single or double platelet product is important to blood component collection facilities (e.g., blood banks/centers) since a double platelet product may have a higher selling price than a single platelet product and may also have a greater benefit for the recipient/patient. The yield of a particular collection of blood components may also be a relevant consideration for certain therapeutic treatments (e.g., red blood cell or plasma exchanges). [0007] Furthermore, advances in blood component collection technologies offer the possibility of collecting multiple combinations of products from a single donor. These products can be defined within a large range of volumes and contents. Add to this multitude of collection choices, a multitude of donors with differing physiologies, each being subject to potential variations in collection procedures to yield a potential very large plurality of choices of products to be collected, as may be desired. [0008] Still other important considerations relating to blood component collection systems relate to the donor and product demand. 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, the supply of donors is unfortunately inadequate in many cases, and 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. [0009] The result is a large number of variables which must preferably be simultaneously managed in order to meet the blood bank collection goals which will thus also satisfy the needs of the ultimate hospital or like customer. Computerized information systems are tools, which are beginning to prove useful in assisting in controlling parts of blood collection processes. This will likely further impact, if not transform, how blood banking will be managed in the future. Computer information systems may prove important in aiding the provision of just-in-time supply of products to meet customized demand for blood products and better satisfying the individual needs of patients and providers. Automated component collection systems will also allow for flexibility in producing customized blood products in a just-in-time fashion from potentially fewer donors to help meet the demands of patients and providers. [0010] In view of the foregoing, it should be readily understood that better management of the various aspects of blood component collection processes and systems is increasingly desirable in providing preferred product collection and customer supply options. SUMMARY OF THE INVENTION [0011] The present invention relates in one application to a blood component collection system and the provision of management capabilities, which may include the incorporation of data manipulation and/or optimization principles. Generally, the present invention preferably utilizes an information management system, which provides simplified donor data storage and control as well as communications with actual blood component collection machines to both ease and optimize the set-up and operation thereof. The principles of data manipulation and/or optimization are further improved also, particularly in terms of the individual donor, a given pool of donors, the particular blood component collection system, and/or the blood component product or products to be collected. 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 "minimum" 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 donor and/or blood center defined 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 or types from the donor, which provides a maximum yield. [0012] A preferred central computational, data storage, manipulation and communication system serving as the primary basis of the present invention is preferably a software-type of application run in tandem with one or more hardware devices including, for example, a data input device, a data storage device, a data manipulation device and one or more communications devices which connect in data communication relationship one or more of such input, storage and/or manipulation devices to at least one blood component separation and/or collection machine. The software application may be and in preferred form is operable in/on a Microsoft (Registered Trademark) Windows (Registered Trademark) software platform (or a similar such system) that allows blood donation center operators to prepare apheresis machines and donors for apheresis donations in an automated manner. The present system may preferably have two primary components, a computation-manipulation application with associated software and devices, and a server system also including associated software and devices. The computation-manipulation application is used by the blood center staff to perform data management and/or manipulation functions. The server system is used preferably to store data and to provide communications with the apheresis machines and/or other information systems. In a typical setting, one or more operators from different locations within a single blood center and/or remotely from various disparate blood centers (and/or other sites) can communicate with a centralized server system to perform specific functions such as donor check-in, preparing a donor for a particular donation, or finalizing and/or preparing reports on collection activities, inter alia. [0013] An important purpose of the present system is to address various challenges in the area of blood donation management including increasing productivity, better donor qualification/utilization and improved product quality control and disposition. [0014] Increased productivity may be accomplished through centralized management of apheresis machine configurations. Operators and/or system administrators may easily create and store several configurations using the present system on a centralized server/computer or a like environment. These configurations are preferably kept in a centralized database and can be downloaded to each apheresis machine on a permanent or a temporary/one-time donation basis. This reduces the inherent contemporary difficulty of editing apheresis machine configurations by allowing the operator to update a centralized configuration and not be required to repeatedly make the same change on several stand-alone apheresis machines. [0015] Donor qualification/utilization may be improved through procedure customization and/or optimization. Each donation may be customized by this system to account for the current needs of a blood center and/or optimized by what each particular donor is eligible/qualified for or capable of donating. This allows the operator to determine what product or combination of products will best be collected even before the donor is connected to the machine. It also allows the blood center operators to see what tubing set is required for the donation. With this information the customer can avoid wasting tubing sets and reduce incomplete procedures. Decision support for donor eligibility is a preferred beneficial feature of the system. At a minimum, eligibility may be determined by the interval between donations, the number of donations previously given, the blood component loss over a period of time, and other donor screening issues. [0016] Another important, yet optional feature of donor qualification/utilization and management in using a system of the present invention involves donor recruitment. The present invention provides a tool that may analyze and predict donation outcomes prior to running a donor on an apheresis machine. Such a tool can use donor and procedure information from the central database or optionally from an imported text file containing the required minimum information. Thus, such predictions can be used independently of actual runs on donors, even those actual runs involving the system of the present invention. These predictions may also be independent of procedures not currently entered into the central database, but rather from data generated by the blood center or data obtained from the blood center information system. Donor data may refer to a particular donor or to a statistical distribution of donor population. At a minimum, the system of the present invention may preferably analyze the outcomes of the following three scenarios: a) a single donor relative to many possible procedures; b) many donors relative to a single type of procedure; and c) many donors relative to many possible procedures. [0017] Improved product disposition may be enhanced through the provision of alterable prioritizations of the product needs of a blood center. The present system presents the capability of providing a prioritization of which products are preferred to be collected. This allows the blood center to begin to incorporate the concept of demand drive where donors are used to fill existing and/or imminent product needs. This also reduces waste from the over collection of certain products. The system also presents the capability to tailor a blood center's priorities by blood type, CMV status, and/or HLA type matching. [0018] The present system also provides for quality control (QC) in the entry of laboratory data for products collected by blood separation devices operated in accordance with the present invention. Data may include (but is not limited to) measured yields, volumes, concentrations, product contaminants, and pH levels. The present system provides the capability to associate anomalous QC lab data to donation events and to generate exception reports where the device prediction and QC lab results may differ. The present system can also utilize this data to automatically calculate and adjust a separation device's yield calibration value, i.e., a yield scaling factor, depending on the particular device type. [0019] Overall procedure and apheresis machine management may also be improved by recording procedure history information for each apheresis donation and storing it in a central database. Thus, the system may contain a detailed log of each donation. These logs can include procedure comments, tubing sets used, alarms experienced, adjustments made, and machine run summary information. Operators may additionally annotate this procedure history information and/or obtain reports using such logged information. [0020] To implement the above and other features of the present invention, it is preferred that a central computational/data storage system be established according to the present invention so that it communicates with each of one or more blood collection machines, preferably apheresis machines, in both directions (even though one-way communications may be desirable in certain situations). Two way communications provide for directing to each machine configuration information of both temporary and permanent natures, procedural lists and priority information, donor vital information, including height, weight, gender, blood component pre-counts and total blood volume (TBV), as well as donor identification which may include a donor picture with the donor's name and perhaps the date of birth. The centralized system may then also communicate in the reverse direction with each machine to retrieve from each apheresis machine immediate information regarding conditions such as alarms, procedure adjustments, and run progress (product collection information) for monitoring purposes. It also provides for retrieving end of run summary information and run logs after each procedure is complete. The centralized system can also use data from the apheresis devices to detect and isolate potential maintenance problems before they manifest themselves to the blood center. These can then be reported so that preventive maintenance may be performed. [0021] The present system preferably uses prediction algorithms like those used in the COBE Spectra and/or Trima apheresis machines. Moreover, the prediction algorithms can also be applied to individual donors, a reference donor list, and/or ranges of donors within the database. This capability is helpful to predetermine donor eligibility for specific product collections, and what products would be available given specific apheresis machine configuration settings. [0022] The present system has been developed with an open architecture to provide integration capabilities and collaborative capabilities with other computing environments (such as Mak and/or Wyndgate donor database information systems) and/or with other component separation machines (such as the Haemonetics and/or the Baxter series, e.g., the MCS+ (Trademark) and/or the Amicus (Trademark) and/or CS-3000 (Trademark) apheresis machines, inter alia). This ultimately will allow ancillary applications to be used. For example, this allows for the manipulation and formatting of donor identification data and/or images obtained from other information or software systems. Bar code capability is another preferable alternative, which may be incorporated into the present system. Any field entry point which could/would require keyboard data entry could be filled using a bar code reader. In addition, special entry fields such as unit or batch number, manufacturer and expiry dates of disposable tubing sets may be fully decoded utilizing administratively editable decoding information; an example is manufacturer identification of a disposable tubing set. Continue reading about Extracorporeal blood processing information management system... 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