Patent Description:
Hemostasis is the human body's response to blood vessel injury and bleeding. Hemostasis involves a coordinated effort between platelets and numerous blood clotting proteins (or clotting factors), resulting in the formation of a blood clot and the subsequent to stoppage of bleeding.

One group of tests to assess the potential of blood to form an adequate clot are known as "viscoelastic methods. " In at least some viscoelastic methods, the blood clot firmness (or other parameters dependent thereon) is determined over a period of time, for example, from the formation of the first fibrin fibers until the dissolution of the blood clot by fibrinolysis. Blood clot firmness is a functional parameter which contributes to hemostasis in vivo, as a clot must resist blood pressure and shear stress at the site of vascular injury or incision. In many cases, clot firmness may result from, multiple interlinked processes including coagulation activation, thrombin formation, fibrin formation and polymerization, platelet activation, and fibrin-platelet interaction.

Viscoelastic method test result data and the result data from other types of analytical blood tests are sometimes used by medical practitioners for determining patient diagnoses, or for identifying potential health conditions for further investigation. In some scenarios, the medical practitioner may be required to assess two or more types of blood test result data (e.g., data from two or more different blood testing machines), which can be complex and time-consuming in medical emergency situations. Moreover, different hospitals or other medical care facilities may impose different standards or responses to the same blood test result data, thereby further increasing the complexity imposed upon the medical practitioner attempting to assess the blood test result data from two or more different blood testing machines.

<CIT> discloses a clinical decision support system which makes use of a numerical model which dynamically describes a blood dilution of a blood circulation.

The publication "<NPL> describes the CLOT knowledge base, whose primary objective is to identify the presence and type of bleeding defect in a patient.

A method in accordance with the claimed invention is defined by appended claim <NUM>. A system in accordance with the claimed invention is defined by appended claim <NUM>. A computer memory device storing computer-readable instructions in accordance with the claimed invention is defined by appended claim <NUM>.

Embodiments described herein provide a system configured to receive blood test result data (from one or more blood analyzer machines) and, based on the blood test result data, to provide a result interpretation output via a user interface to assist the user in identifying a relevant diagnosis or potential health conditions for further investigation. As used herein, the term "result interpretation output" means a communication output via a user interface that, based upon the blood test result data received from one or more blood analyzer machines that analyzed a blood sample, identifies a suggested diagnosis or potential health condition for a patient from which the blood sample was obtained. The "result interpretation output" is different from the actual blood test result data received from a blood analyzer machine, and instead provides a computer-driven interpretation of the blood test result data. Accordingly, a blood analyzer machine is configured not only to perform test operations on a blood sample and provide blood test result data, but also to provide a result interpreter interface that compares the various data points from the blood test result data to previously stored threshold values and thereby outputs to the user one or more meaningful messages to the user that identify a relevant diagnosis of the patient or potential health conditions for further investigation. In addition, the previously stored threshold values are user-customizable in that a machine operator can modify the default threshold values in accordance with the standards of a particular hospital or other medical care facility.

Particular embodiments of a system described herein include a computer-implemented algorithm (optionally, implement by a control console of a blood analyzer machine) that is configured to generate a result interpretation output based at least in part on the blood test result data received from one or more blood analyzer machines that analyzed a particular blood sample. Such a system may optionally include any of the features described in the text below.

Embodiments described herein include a method that includes the following steps. The method includes the step of receiving, at a blood analyzer machine, user input indicative of a clinical setting of a patient that provided a blood sample. The method also includes the step of receiving, at the blood analyzer machine, the blood sample of the patient. The method also includes the step of performing, by the blood analyzer machine, one or more blood characteristic tests on the blood sample for providing blood test result data. The method includes the step of interpreting, by the blood analyzer machine and using an algorithm from a plurality of algorithms accessible to the blood analyzer machine, the blood test result data provided from the one or more blood characteristic tests. The method includes the step of displaying, using a user interface of the blood analyzer machine, one or more messages indicative of a potential diagnosis or health condition based on said interpreting the blood test result data provided from the one or more blood characteristic tests.

Such a method may optionally include one or more of the following features. In some embodiments, the one or more messages determined and displayed by the blood analyzer machine are a result interpretation output that is different from blood test result data output from the blood analyzer machine. The blood analyzer machine may comprise a thromboelastometry system including a movable probe to interact with at least a portion of the blood sample for measuring blood coagulation characteristics. In particular embodiments, the method may further include the step of receiving, at the blood analyzer machine, external test result data from one or more external blood analyzer devices that are different from and remote from said blood analyzer machine. The external test result data from the one or more external blood analyzer devices may result from additional blood characteristic tests on the blood sample by the one or more external blood analyzer devices.

In some embodiments, the interpreting by the blood analyzer machine may include analyzing, using the algorithm, the blood test result data from the blood analyzer machine and the external test result data from the one or more external blood analyzer devices. The one or more messages displayed by the blood analyzer machine may be based on the interpreting of the blood test result data from the blood analyzer machine and the external test result data from the one or more external blood analyzer devices. In some embodiments, the one or more external blood analyzer devices comprises a blood gas analyzer configured to perform a blood characteristic test on the blood sample. In particular embodiments, the one or more external blood analyzer devices are connected to the blood analyzer machine via one or more data cables or a wireless network connection for transferring data to the blood analyzer machine. The method may optionally include, after displaying the one or more messages, receiving, at the blood analyzer machine, a user selection of a selectable element for changing a display mode of the user interface. Some such methods may include, in response to receiving the user selection, changing from displaying the one or more messages to displaying graphical or numeric information corresponding to at least some of the blood test result data.

In embodiments of the method, the interpreting by the blood analyzer machine comprises analyzing the blood test result data in comparison to one or more preset threshold values using the algorithm so as to determine said one or more messages. In some embodiments of the method, the one or more present threshold values are customizable by an operator of the machine so as to modify one or more default threshold values to one or more customized threshold values. Additionally, the blood analyzer machine comprises a control console including a user interface display device, one or more computer processors, and a computer-readable memory device. The plurality of algorithms accessible to the blood analyzer machine and the one or more present threshold values may be stored by the computer-readable memory device in some embodiments.

Embodiments described herein include a blood analyzer system. The blood analyzer system may include a thromboelastometry testing device including a movable probe to interact with at least a portion of a blood sample for measuring blood coagulation characteristics of the blood sample. In embodiments, the blood analyzer system also includes a user interface comprising a display device configured to display blood test result data which may be indicative of the blood coagulation characteristics of the blood sample. The blood analyzer system also includes one or more processors and a computer memory device storing computer-readable instructions for one or more algorithms for interpreting the blood test result data. In embodiments, the computer-readable instructions, when executed by the one or more processors, are configured to cause the system to carry out the method as defined by any one of appended claims <NUM> - <NUM>.

In embodiments, the blood analyzer is defined by the subject-matter of appended claims <NUM> - <NUM>.

Particular embodiments described herein include a method for providing a result interpretation output using blood test result data of blood analyzer machine. The method may include one or more of the following steps. Some embodiments include the step of receiving blood test result data generated from one or more blood characteristic tests performed on a blood sample by a blood test device. Particular embodiments include the step of outputting, via a user interface, a result interpretation output based upon the blood test result data from the one or more blood characteristic tests. The result interpretation output is different from the blood test result data, in some embodiments. In some embodiments, the blood test device may comprise a thromboelastometry testing device including a movable probe to interact with at least a portion of a blood sample for measuring blood coagulation characteristics of the blood sample. In particular embodiments, the user interface may comprise a display device of a control console that houses at least a portion of the thromboelastometry testing device.

Some or all of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the blood analyzer system provided herein can be used in the clinical setting to reduce clinical decision-making errors, for example, by a clinician attempting to assess blood test result data (possibly from two or more different blood testing machines) in a medical emergency situation. The performance of clinical tests on a patient's blood sample, for example, can result in an overwhelming amount of information (e.g., data and test results from multiple tests). In such a case, a clinician may find it challenging to contemporaneously evaluate and interpret the extensive information so as to arrive at a proper diagnosis or conclusion. That can be especially true in the context of less experienced clinicians. Particular embodiments of the system described herein can assist the clinician by running computerized algorithms that may result in the determination of messages that may include recommendations for patient treatment or further testing. Such messages are displayed to the user on a user interface of the system. However, decision-making is done by the attending physician and recommendations are provided merely as information to assist the attending physician with the decision-making.

Second, some embodiments of the blood analyzer system described herein can advantageously facilitate standardization within a medical care facility (e.g., a hospital, a clinic, or the like) that controls the blood analyzer system. That is, each owner/operator or the blood analyzer system can create a customized protocol for analysis of blood test result data, customized test parameter threshold values, and customized messages that may include recommendations for patient treatment or further testing. Thus, although the blood analyzer system may be equipped with default protocols, threshold values, and recommendation outputs, each hospital can modify the default values so as to create a hospital-specific (e.g., specific to the hospital or other medical care facility) standard, thereby removing user-to-user variability and enhancing systemic process controls within the hospital or other medical care facility.

Third, use of the blood analyzer system described herein can, in particular embodiments, advantageously save time in a clinical setting, especially during a medical emergency situation in which a patient is bleeding. The time savings can be realized, for example, by automation of the analysis of multiple test results to arrive at a computer-generated message that may include a recommendation or suggested diagnosis to be considered by a clinician (as compared to a manual analysis). Such a time savings can be especially important in an urgent clinical setting (e.g., when timely action is needed because a patient's health or life is at risk). In some cases, a time savings from the automation of the analysis of multiple test results can also result in a reduction of patient care costs.

Fourth, use of the blood analyzer system described herein can, in various embodiments, advantageously improve the quality of care. Such quality of care improvements can result from, for example, implementation of clinical best practices into computer-automated algorithms that are embodied integrally with the blood analyzer system when implementing the result interpretation interface, as well as from standardization and error reduction as described above.

Further advantages associated with the blood analyzer systems described herein are also envisioned, as will be evident from the following disclosure.

Referring to <FIG>, some embodiments of a blood testing system <NUM> include a first blood analyzer machine <NUM> (e.g., a thromboelastometry analyzer console in this depicted embodiment) that includes a results interpretation interface configured to receive blood test result data (generated from the blood test performed by the console) and, based on the blood test result data, to identify a relevant diagnosis or potential health conditions for further investigation. Optionally, the thromboelastometry analyzer console <NUM> may be connected, via a data connection <NUM> (e.g., a data communication network in this embodiment, or a direct data cable connection or a wireless communication network in other embodiments), with one or more other blood analyzer devices. In the depicted blood testing system <NUM>, the thromboelastometry analyzer console <NUM> is connected with a second thromboelastometry analyzer console <NUM>, a blood gas analyzer <NUM>, and a platelet aggregation analyzer <NUM>, but other blood analyzer devices are also contemplated herein.

While in the depicted example blood testing system <NUM> the thromboelastometry analyzer console <NUM> is connected in the data communication network <NUM> with three additional analytical testing devices, in some implementations zero, one, two, four, five, six, seven, or more than seven other analytical testing devices are networked with the thromboelastometry analyzer console <NUM>. Any and all such implementations are within the scope of this disclosure. It should also be understood that, while the example blood testing system <NUM> is depicted as including particular types of analytical testing devices, the blood testing system <NUM> is provided as an illustrative example that is representative of all potential combinations of different analytical testing devices of any and all kinds. For example, in some embodiments additional types of analytical testing devices such as, but not limited to, a system for measuring activated coagulation time (ACT) and/or hemodynamic monitors can be included as part of the blood testing system <NUM>.

In the depicted embodiment, the thromboelastometry analyzer console <NUM>, the second thromboelastometry analyzer console <NUM>, the blood gas analyzer <NUM>, and the platelet aggregation analyzer <NUM> can communicate with each other via the data communication network <NUM>. For example, in some embodiments test results from the second thromboelastometry analyzer console <NUM>, the blood gas analyzer <NUM>, and/or the platelet aggregation analyzer <NUM> can be communicated to the first thromboelastometry analyzer console <NUM> via the data communication network <NUM>.

The data communication network <NUM> can be implemented using any type of networking technology that is capable of facilitating communications between the analytical testing devices of blood testing system <NUM>. In some embodiments the data communication network <NUM> is a computer data network such as, but not limited to an intranet, the internet, a LAN, and the like, and combinations thereof. In some embodiments, portions or all of the data communication network <NUM> is a hard-wired network. In some embodiments, portions or all of the data communication network <NUM> is a wireless network (e.g., Wi-Fi, Bluetooth, NFC, RF, IR, and the like). In particular embodiments, the data communication network <NUM> comprises a combination of hard-wired and wireless network connections.

In some embodiments, the thromboelastometry analyzer console <NUM> performs a coordination and overall analysis role within the blood testing system <NUM>. For example, in some embodiments one or more analytical testing devices within the blood testing system <NUM> communicates one or more test results to the thromboelastometry analyzer console <NUM>. Thereafter, the thromboelastometry analyzer console <NUM> performs a results interpretation analysis using the test results received from the other analytical testing devices within the blood testing system <NUM>, in conjunction with the test results generated from the thromboelastometry analyzer console <NUM> itself. In that fashion, the blood testing system <NUM> facilitates performance of a range of analytical tests, in some cases by multiple testing devices, and the test results can potentially be compared and contrasted to each other using a computerized algorithm to thereby enhance the analytical capabilities of the blood testing system <NUM>. In such a case, blood samples from the same patient are run in the various analytical testing devices within the blood testing system <NUM>. The test results from the patient's sample(s) are then communicated to the thromboelastometry analyzer console <NUM> for performance of the computerized algorithm.

In some scenarios, as described further below, the performance of the computerized algorithm may yield a recommended action for treating the patient, and/or for further testing, and the like. Such a recommendation(s) may be displayed on the user interface display <NUM> of the thromboelastometry analyzer console <NUM>. However, decision-making is done by the attending physician and such recommendations are provided merely to assist the attending physician. In some embodiments, the user interface display <NUM> is a touchscreen display that can receive user inputs (as described further below).

In some implementations, the blood testing system <NUM> includes just the first blood analyzer machine <NUM> itself. Or, while the blood testing system <NUM> may include other test devices in addition to the first blood analyzer machine <NUM>, in some situations no relevant test results from the other test devices are available to the console <NUM>. Nevertheless, as described further below, because the first blood analyzer machine <NUM> can perform multiple tests, the blood test result data generated from the multiple tests performed by the first blood analyzer machine <NUM> can be compared/contrasted with each other in a results interpretation analysis performed by first blood analyzer machine <NUM>. Hence, it should be understood that while in some embodiments the results interpretation analysis performed by first blood analyzer machine <NUM> is performed using test results from other test devices in addition to results from the analyzer console <NUM>, in some embodiments the results interpretation analysis is performed using test results from the analyzer console <NUM> exclusive of test results from other test devices.

In some implementations, the first blood analyzer machine <NUM> (of any type) performs an results interpretation analysis using the blood test result data from one or more of the analytical testing devices within the blood testing system <NUM>. Alternatively, in some implementations an additional computer that is external to the first blood analyzer machine <NUM> performs the results interpretation analysis. That is, in some implementations an additional computer (not shown) is included within the blood testing system <NUM>, and the additional computer performs the results interpretation analysis described herein.

Still referring to <FIG>, in this embodiment, the thromboelastometry analyzer console <NUM> is configured to determine a number of blood coagulation characteristics of a blood sample that is input into a cartridge <NUM>. However, such a cartridge <NUM> is not required in some embodiments of thromboelastometry analyzers that can be used to perform the results interpretation analysis described herein. In some embodiments, the cartridge <NUM> is configured as a single-use cartridge that includes a blood sample receiver for mating with a blood sample reservoir <NUM> (e.g., a vacutainer sample tube supplied by Becton, Dickinson & Company of Franklin Lakes, NJ, or another blood reservoir structure). In some cases, an adapter may be used to couple other types of blood sample reservoirs <NUM> with the cartridge <NUM> (e.g., tubing may be used through which blood can be injected into the cartridge <NUM>, and the like). The thromboelastometry analyzer console <NUM> can be used as a whole blood coagulation analysis system that is particularly advantageous at a point-of-care site (e.g., in a surgical theater while a patient is undergoing or preparing for surgery, or the like). Additionally, thromboelastometry analyzer console <NUM> can be used as a whole blood coagulation analysis system in a laboratory setting.

In some embodiments, the thromboelastometry analyzer console <NUM> includes a probe or pin that can be removably positioned within a cup of the cartridge <NUM> (or another type of blood sample container). The cup may contain a blood/reagent mixture. A clearance space exists between the probe and cup. In some embodiments, the probe is oscillated rotationally, back and forth, by about +/- <NUM>°. The oscillations are measured, and as the blood/reagent begins to become firmer because of thrombolysis, the oscillations are reduced. The measurements, by the thromboelastometry analyzer console <NUM>, of such oscillations over a period of time thereby generates thromboelastometry results.

The example thromboelastometry analyzer console <NUM> includes the user interface <NUM> (with touchscreen display in this embodiment) and a main chassis <NUM>. The user interface display <NUM> can be configured to output one or more graphical results from the blood testing assays performed via the cartridge <NUM> (e.g., one or more plots, such as those sometimes refer to as a TEMogram, numeric data or measurements, or a combination thereof). In some embodiments, the user interface display <NUM> is rigidly attached to the analyzer console <NUM>. In particular embodiments, the user interface display <NUM> is pivotable and/or is otherwise positionally adjustable in relation to the main chassis <NUM>.

The main chassis <NUM> of the thromboelastometry analyzer console <NUM> houses the hardware devices and sub-systems that control the operations of the analyzer console <NUM> and that facilitate communications with other blood analyzer devices over a network (e.g., data communication network <NUM>). For example, the analyzer console <NUM> houses one or more processors <NUM> (refer to <FIG>). In addition, the analyzer console <NUM> houses memory devices that can store an operating system and other executable instructions. For example, the analyzer console houses memory devices <NUM> that can store computer-readable instructions for one or more algorithms for interpreting the blood test result data of the blood testing system <NUM>.

In some embodiments, the computer-readable instructions, when executed by the one or more processors <NUM>, are configured to cause the system to perform operations such as analyzing of the blood test result data indicative of the blood coagulation characteristics, and outputting via the user interface <NUM> one or more messages indicative of a potential diagnosis or health condition based on the analysis of the blood test result data. Further, in some embodiments the computer-readable instructions stored in the memory devices <NUM>, when executed by the one or more processors <NUM>, are configured to cause the analyzer console <NUM> to prompt a user for input indicative of a clinical setting of patient from which the blood sample is drawn.

As described further below, in some embodiments the computer-readable instructions stored in the memory devices <NUM>, when executed by the one or more processors <NUM>, are configured to cause the thromboelastometry analyzer console <NUM> to select a particular algorithm of a plurality of the algorithms for interpreting the blood test result data in response to the user input indicative of the clinical setting of the patient. In addition, in some embodiments the computer-readable instructions stored in the memory devices <NUM>, when executed by the one or more processors <NUM>, are configured to cause the thromboelastometry analyzer console <NUM> to receive external test result data from one or more external blood analyzer devices (e.g., the second thromboelastometry analyzer console <NUM>, the blood gas analyzer <NUM>, and the platelet aggregation analyzer <NUM>) that are different from and remote from thromboelastometry analyzer console <NUM>.

Referring now to <FIG>, in some implementations the blood testing system <NUM> can be operated in accordance with an example process <NUM>. In particular, the first blood analyzer machine <NUM> (e.g., a thromboelastometry analyzer console in this embodiment, but a different type of blood analyzer machine in other embodiments), in its coordination and overall analysis role within the blood testing system <NUM>, can perform the process <NUM>. For example, as previously described, the thromboelastometry analyzer console <NUM> can implement the process <NUM> using the one or more processors <NUM> to execute computer-readable instructions stored on the memory device <NUM> (housed in the main chassis <NUM>; refer to <FIG>) for the algorithms for interpreting the blood test result data. As such, the blood testing system <NUM> can be configured to receive blood test result data (generating using one or more blood testing devices) and, based on the blood test result data, to provide a result interpretation output via a user interface to assist the user in identifying a relevant diagnosis or potential health conditions for further investigation.

At step <NUM>, patient identification and clinical information can be entered into the thromboelastometry analyzer console <NUM>. In the depicted embodiment, such information can be entered by a clinician using, for example, the user interface display <NUM>. That is, the touchscreen display <NUM> is configured to receive user input and to display output information to the user. For example, the user can enter information to the thromboelastometry analyzer console <NUM> by making selections of various soft-buttons that may be displayed on the touchscreen display <NUM> at times during the beginning, middle, and end of the process <NUM>. In some embodiments, other selections such as, but not limited to, soft keyboard entries can be provided via touchscreen display <NUM>.

One example implementation of step <NUM> is illustrated in a screen shot <NUM> shown in <FIG>. The screen shot <NUM> can be implemented, for example, on the touchscreen display <NUM>, or on another user interface that is part of the blood testing system <NUM>.

The patient information can be entered in a field <NUM> entitled "Patient Data / Identification:". The patient information entered can include, for example, patient name, patient birth date, patient ID number (e.g., numeric or alpha-numeric), blood sample ID number, and the like. Data may be entered using a keyboard, soft keyboard, barcode scanner, and the like.

In some embodiments, the clinical information can be entered, for example, by making selections from a clinical setting selection menu <NUM>, a clot firmness parameter selection menu <NUM>, a clinical situation / timing selection menu <NUM>, and a severity of bleeding selection menu <NUM>. In the depicted implementation, the clinical information is entered via touchscreen selections.

The clinical information entered during step <NUM> can include, for example, the clinical setting (e.g., cardiovascular surgery, trauma, liver surgery or GI bleeding, postpartum hemorrhage (PPH), and the like) as displayed in the clinical setting selection menu <NUM>. In the depicted example, "Severe Bleeding (non-cardiac)" has been selected (as identified by the reverse highlighting). A clot firmness parameter can be selected from the clot firmness parameter selection menu <NUM>. In the depicted example, "A5" has been selected (as identified by the reverse highlighting). Additionally, in some embodiments the clinical information entered during step <NUM> can include the clinical situation (e.g., emergency, at hospital admission, pre-operative, intra-operative, before heparin, on bypass, after heparin-reversal, pre-anhepatic, anhepatic, after reperfusion, at ICU admission, post-operative, and the like) as displayed in the clinical situation / timing selection menu <NUM>. In the depicted example, "Emergency" has been selected (as identified by the reverse highlighting). Still further, in some embodiments the clinical information entered during step <NUM> can include the severity of bleeding (e.g., no bleeding, insignificant, mild, moderate, severe, massive, and the like) as displayed in the severity of bleeding selection menu <NUM>. In the depicted example, "Massive" has been selected (as identified by the reverse highlighting). In some embodiments, other types of clinical information may additionally, or alternatively, be entered during step <NUM>.

In some embodiments, the data entry at step <NUM> can be performed additionally or alternatively by user voice entry. In other embodiments, the user interface of thromboelastometry analyzer console <NUM> may include other peripheral devices (e.g., a mouse, a keyboard, an additional display device, and the like) that can be used to input patient and clinical information. In some embodiments, the data communication network <NUM> may be used to allow for remote devices to input information to the thromboelastometry analyzer console <NUM>. For example, in some embodiments one or more remote displays can be utilized via network connections. In some embodiments, the thromboelastometry analyzer console <NUM> also includes an external barcode reader <NUM>. The external barcode reader <NUM> can facilitate convenient one-dimensional or two-dimensional barcode entry of data such as, but not limited to, patient identification data, clinical information, blood sample data, user identification, normal values, and the like. Alternatively or additionally, the thromboelastometry analyzer console <NUM> can be equipped with a reader configured to read near-field communication tags, RFID tags, or the like, to provide for convenient input of data into analyzer console <NUM>.

Still referring to <FIG>, at step <NUM> the thromboelastometry tests are run by the thromboelastometry analyzer console <NUM>, and corresponding results from the thromboelastometry tests are determined. In some implementations, the thromboelastometry tests are run by the performance of two or more test process cycles of the same thromboelastometry analyzer console <NUM>. In some implementations, the thromboelastometry tests are run by the performance of a single test process cycle of the thromboelastometry analyzer console <NUM>. Additionally or alternatively, blood test result data from one or more test cycles performed by one or more other blood analyzer machines (which are performed contemporaneously with, or sequentially before or after, the test cycles performed by the thromboelastometry analyzer console <NUM>) can be communicated to the thromboelastometry analyzer console <NUM>.

Thromboelastometry and thromboelastography are based on the measurement of the elasticity of blood by continuous graphic logging of the firmness of a blood clot during clot formation (e.g., pertaining to coagulation factors and inhibitors, platelets and fibrin) and subsequent fibrinolysis. An example of such a continuous graphic logging <NUM> of the firmness of a blood clot during clot formation, as calculated and optionally displayed by the thromboelastometry analyzer console <NUM>, is shown in <FIG>. <FIG> illustrates the thromboelastometry analyzer console <NUM> displaying multiple such graphic loggings of the firmness of a blood clot during clot formation.

In some embodiments, the thromboelastometry analyzer console <NUM> facilitates determination of various thromboelastometry parameters such as, but not limited to, clotting time, clot formation time, alpha angle, amplitude, maximum clot firmness, lysis onset time, lysis time, lysis index (%), and maximum lysis (%). Those example parameters are described in TABLE <NUM> below:.

In addition to the parameters above, the thromboelastometry analyzer console <NUM> may perform certain assays to monitor and analyze different aspects of the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. For example, in some embodiments the ROTEM® thromboelastometry system can perform at least four of five different assays: INTEM, HEPTEM, EXTEM, FIBTEM, and APTEM. Particular reagents are mixed with a blood sample to facilitate performance of each of the assays. Each assay is generally described in the next paragraphs.

The INTEM assay is the typical screening test for coagulation disorders. The clotting time (CT) gives information on the clotting factor activity(s) of the intrinsic and common pathway or on presence of heparin in the sample. The clot formation time (CFT) gives information on the speed of clot formation which is mainly influenced by the thrombin generation, platelets and fibrinogen levels. Similar information to CFT is also given by the alpha angle. The clot firmness parameters (e.g., A5, A10, MCF) give information on the overall clot firmness, which is a function for platelet activity, fibrinogen concentration and F XIII (factor XIII) availability. Deviations of the parameters from the established reference ranges indicate a potential coagulation disturbance.

The HEPTEM assay provides information that is similar to the INTEM assay but eliminates a potential heparin effect. HEPTEM is useful for cardiac surgery where patients are highly heparinized and coagulation tests may become less meaningful because of the heparin effect in the sample. In the HEPTEM assay, the heparin is digested rapidly and the resulting ROTEM® result reflects the coagulation status of the patient in the absence of heparin. HEPTEM helps to rationally treat a heparinized patient under transient high dose heparin therapy and to identify a heparin effect in combination with the INTEM assay.

The EXTEM assay is a screening test for coagulation disorders. The CT gives information on the clotting factor activity(s) of the extrinsic or common pathways or on the presence of oral anticoagulants, e.g. vitamin K antagonists or direct thrombin inhibitors. The CFT gives information on the speed of clot formation which is substantially influenced by the thrombin generation, platelets and fibrinogen levels. Similar information to CFT is also given by the alpha angle. The clot firmness parameters (e.g., A5, A10, MCF) give information on the overall clot firmness, which is related to platelet activity, fibrinogen concentration and F XIII availability. Deviations of the parameters from the established reference ranges indicate a potential coagulation disturbance.

Using the FIBTEM assay, the quality of fibrin polymerization or the fibrinogen level can be estimated quickly. The clot firmness parameters give information on the overall clot firmness.

The APTEM assay provides information regarding coagulation without fibrinolysis effects. Fibrinolytic processes are detected by a loss of the clot firmness during the clot formation analysis with the ROTEM® in the EXTEM assay.

In some embodiments, the thromboelastometry analyzer console <NUM> may be used to perform some or all of the assays described above. Alternatively, or additionally, in some embodiments the second thromboelastometry analyzer console <NUM> may be used to perform some or all of the assays described above, and the results from the second thromboelastometry analyzer console <NUM> may be communicated via the data communication network <NUM> to the thromboelastometry analyzer console <NUM> for additional analysis.

In step <NUM>, the thromboelastometry analyzer console <NUM> optionally receives data from one or more external analytical testing devices. For example, in the context of blood testing system <NUM> the thromboelastometry analyzer console <NUM> may optionally receive data via the data communication network <NUM> from one or more of the second thromboelastometry analyzer console <NUM>, the blood gas analyzer <NUM>, and/or the platelet aggregation analyzer <NUM>. The thromboelastometry analyzer console <NUM> can thereby beneficially receive data pertaining to the patient that is not directly attainable using the analyzer console <NUM> alone. For example, the blood gas analyzer <NUM> may provide to the thromboelastometry analyzer console <NUM> information about the patient such as, but not limited to, hemoglobin concentration (Hb), base excess (BE), pH of the blood, lactate, Cai<NUM>+, partial pressures of carbon dioxide and oxygen, bicarbonate level, and the like. In addition, in some embodiments the platelet aggregation analyzer <NUM> can provide measurements pertaining to platelet aggregation of the patient's blood. In one nonlimiting example, a ROTEM® platelet system (available from Tem International GmbH) performs at least two of three different assays for assessing platelet function: ARATEM, ADPTEM, and TRAPTEM. The ARATEM assay can be used, for example, for the detection of cyclooxygenase inhibitors. The ADPTEM assay can be used, for example for the detection of adenosine diphosphate (ADP) receptor blockage. The TRAPTEM assay can be used, for example, for the detection of glycoprotein (GP) IIb/IIIa or PAR-<NUM> (protease-activated receptor-<NUM>) receptor antagonists.

In step <NUM>, algorithm-specific threshold values are accessed by the thromboelastometry analyzer console <NUM>. In some embodiments, the algorithm-specific threshold values are stored in memory of the thromboelastometry analyzer console <NUM>. Alternately, or additionally, in some embodiments the algorithm-specific threshold values are stored in another database that is accessible by the thromboelastometry analyzer console <NUM>, such as using the data communication network <NUM>.

An example of algorithm-specific threshold values is shown in risk matrix <NUM> of <FIG>. These threshold values are referred to herein as "algorithm-specific" because, as described further below, different algorithms are available (e.g., trauma, cardiovascular surgery, liver surgery or GI bleeding, PPH, and the like) and each algorithm can have a unique set of threshold values established. The risk matrix <NUM> illustrates some algorithm-specific threshold values that may be appropriate for a trauma algorithm, for example. As described further below, the algorithm-specific threshold values (from risk matrix <NUM> for example) are usable within an algorithm that can result in recommendations for patient treatment, further testing, and the like. Alternatively, the threshold values can be organized in any other suitable format other than a table.

In the example of risk matrix <NUM>, threshold values for particular parameters (e.g., "MLFIB," "MLEX," "A5EX," etc.) are established. For example, as described above, MLFIB quantifies the maximum lysis as measured using a FIBTEM assay; MLEX quantifies the maximum lysis as measured using an EXTEM assay; and A5EX quantifies the amplitude (clot firmness) <NUM> minutes after CT in the EXTEM assay. As depicted in example risk matrix <NUM>, a MLFIB value of ≥ <NUM>% can be established such that it is associated with a high risk of bleeding. Likewise, an A5EX value in the range of <NUM>-<NUM> can be associated with a moderate risk of bleeding.

In some implementations, color coding of information such as the threshold values and the algorithm results and/or recommendations presented by the thromboelastometry analyzer console <NUM> is beneficially used. For example, a clinician user of the thromboelastometry analyzer console <NUM> may be readily able to ascertain a high risk situation when information is presented in a red color, in contrast, for example to an orange or yellow color which may be defined to represent lower risks. Such color coding is described further below.

Risk matrix <NUM> also illustrates how particular messages with recommendations can be established for additional testing when certain criteria are met. For example, as depicted in risk matrix <NUM> a FIBTEM assay and an APTEM assay will be recommended in response to a MLEX value that is ≥ <NUM>% (which represents a high risk of bleeding in this example).

The threshold values and recommendations for additional testing (as defined in the risk matrix <NUM>, for example) can be established and customized by a particular local institution (or by a particular doctor, if so desired) in keeping with the preferences of the particular local institution (or particular doctor). This customization allows each local institution to establish threshold values and recommendations for additional testing that are based on and/or consistent with the institution's specific approach to clinical analysis and patient care. In addition, the establishment of such threshold values and recommendations for additional testing facilitates standardization of clinical analysis and patient care within a local institution, or potentially across multiple institutions if the multiple institutions desire to so coordinate.

Still referring to <FIG>, in step <NUM> the thromboelastometry analyzer console <NUM> applies a user-selected algorithm to processes thromboelastometry data, data received from one or more external analytical testing devices (optionally), and the algorithm-specific threshold values. The outcome of running the algorithm is the potential determination of recommendations for patient treatment and/or further testing. As a threshold matter, before using any data received from the one or more external analytical testing devices in the algorithm, the thromboelastometry analyzer console <NUM> will verify that the data pertains to the appropriate patient and is current (e.g., measure within <NUM> minutes of the thromboelastometry measurements).

Examples of algorithms are provided and described below in reference to <FIG>. In some embodiments, the thromboelastometry analyzer console <NUM> informs the user if parameters or assays are missing for adequate data interpretation according to the diagnostic algorithm being run.

In step <NUM>, results are displayed by the thromboelastometry analyzer console <NUM>. For example, in some embodiments the results are displayed on the touchscreen display <NUM> of the thromboelastometry analyzer console <NUM>. At least two different types of results presentations are envisioned: thromboelastometry results <NUM> and messages that may include recommendations (based on algorithm results) <NUM>. In some embodiments, the user can selectively switch ("toggle") between the displays of different modes of results presentations, (e.g., from displaying the one or more messages based on algorithm results to displaying graphical or numeric information corresponding to at least some of the blood test result data).

An example of displaying thromboelastometry results <NUM> is depicted in <FIG>. Such thromboelastometry results <NUM> include one or more graphics that are continuous plots of the firmness of a blood clot during the performance of an assay, as depicted in <FIG>, for example.

An example of displaying recommendations (based on algorithm results) <NUM> is depicted in the screen shot <NUM> of <FIG>. In this example, the displayed message includes a recommendation for the attending physician to consider: "Consider: <NUM>. Fibrinogen deficiency or fibrin polymerization disorder.

Referring to <FIG> and <FIG>, an example performance of a cardiovascular algorithm is depicted. <FIG> illustrates a user interface <NUM> of a display device, such as the user interface display <NUM> of the thromboelastometry analyzer console <NUM> (refer to <FIG>). <FIG> illustrates an example cardiovascular algorithm <NUM> that can be run by the thromboelastometry analyzer console <NUM> (e.g., as in step <NUM> of process <NUM> depicted in <FIG>). The cardiovascular algorithm <NUM> includes parameter threshold values that can be established by a user (e.g., refer to risk matrix <NUM> of <FIG>).

In this illustrative example, the following information is assumed: a clinical setting of "Cardiovascular" is selected, a clot firmness parameter of "A5" is selected, a clinical situation/timing of "After Heparin-Reversal" is selected, and a severity of bleeding of "Moderate" is selected. In addition, the following example test parameter results are assumed (solely for the purpose of illustrating how the algorithm <NUM> can be applied-because such test parameter results can vary): the CTEX is <NUM> seconds, the CTIN is <NUM> seconds, the CTHEP is <NUM> seconds, the A5EX is <NUM>, the A5FIB is <NUM>, the MLEX is <NUM>%, and the ACT is <NUM> seconds (as determined by system for measuring activated coagulation time).

Applying the information and test parameters to the example cardiovascular algorithm <NUM>, the resulting recommendation is to consider "Fibrinogen deficiency or fibrin polymerization disorder" as shown in the results <NUM> of user interface <NUM>. In this example, the recommendation is color coded in orange to indicate that the recommendation is important (e.g., a moderate risk of bleeding may exist), but not as critical as if the recommendation were to be color coded in red. Such a color coding determination can be made as a result from the application of threshold values from a risk matrix (e.g., refer to risk matrix <NUM> of <FIG>).

The aforementioned resulting recommendation is determined by applying the example cardiovascular algorithm <NUM> as follows. Because ML is less than <NUM>%, the first action step is answered in the negative. Next, because ACT is normal and CTIN is similar to CTHEP, the second action step is also answered in the negative. Then, because A5EX (which is given as <NUM>) is less than <NUM>, and A5FIB (which is given as <NUM>) is less than <NUM>, the third action step is answered in the positive. Therefore, the resulting recommendation is to consider "Fibrinogen deficiency or fibrin polymerization disorder.

As described above, the threshold values and recommendations for further testing, as defined in a risk matrix, can be customized by a local institution. In addition, the algorithms can be customized by a local institution. For example, some steps from the example cardiovascular algorithm <NUM> can be omitted, and/or other steps can be added. In one such example, the step to identify hyperfibrinolysis may be chosen to be omitted in a hospital where anti-fibrinolytic drugs are administered routinely (prophylactically).

Other user input options can also be provided, as illustrated in the example user interface <NUM>. For example, selection of a "Back" button <NUM> can allow the user to step the user interface <NUM> backward to re-enter data, for example. Selection of a "Toggle Results" button <NUM> can allow the user to switch between displaying the user interface <NUM> and a screen that shows one or more graphics that are continuous plots of the firmness of a blood clot during the performance of an assay (e.g., as depicted in <FIG>). Selection of a "Save/Exit" button <NUM> can allow the user to save the results and exit the session that is running the cardiovascular algorithm <NUM>.

Referring to <FIG> and <FIG>, an example performance of a trauma algorithm is depicted. <FIG> illustrates a user interface <NUM> of a display device, such as the user interface display <NUM> of the thromboelastometry analyzer console <NUM> (refer to <FIG>). <FIG> illustrates an example cardiovascular algorithm <NUM> that can be run by the thromboelastometry analyzer console <NUM> (e.g., as in step <NUM> of process <NUM> depicted in <FIG>).

In this example, the following information is assumed: a clinical setting of "Trauma" is selected, a clot firmness parameter of "A5" is selected, a clinical situation/timing of "At Hospital Admission" is selected, and a severity of bleeding of "Severe" is selected. In addition, the following test parameter results are assumed: the CTEX is <NUM> seconds, the CTIN is <NUM> seconds, the CTHEP is <NUM> seconds, the A5EX is <NUM>, the A5FIB is <NUM>, the MLEX is <NUM>%, the Hb is <NUM>/dL (as determined by a BGA), the pH is <NUM> (as determined by a BGA), and the BE is -<NUM> mmol/L (as determined by a BGA).

Applying the information and test parameters to the example cardiovascular algorithm <NUM>, the resulting recommendations are to consider "High risk of (hyper)fibrinolysis" and "Fibrinogen deficiency or fibrin polymerization disorder" as shown in the results <NUM> of user interface <NUM>. In this example, the "High risk of (hyper)fibrinolysis" and the "Fibrinogen deficiency or fibrin polymerization disorder" are both color coded in red to indicate a high risk. Such a color coding determination can be made as a result from the application of threshold values from a risk matrix (e.g., refer to risk matrix <NUM> of <FIG>).

Referring to <FIG> and <FIG>, an example performance of a liver surgery/gastrointestinal (GI) bleeding algorithm is depicted. <FIG> illustrates a user interface <NUM> of a display device, such as the user interface display <NUM> of the thromboelastometry analyzer console <NUM> (refer to <FIG>). <FIG> illustrates an example liver surgery/gastrointestinal (GI) bleeding algorithm <NUM> that can be run by the thromboelastometry analyzer console <NUM> (e.g., as in step <NUM> of process <NUM> depicted in <FIG>).

In this example, the following information is assumed: a clinical setting of "Liver/GI" is selected, a clot firmness parameter of "A5" is selected, a clinical situation/timing of "After Reperfusion" is selected, and a severity of bleeding of "Mild" is selected. In addition, the following test parameter results are assumed: the CTEX is <NUM> seconds, the CTIN is <NUM> seconds, the A5EX is <NUM>, the A5FIB is <NUM>, the MLEX is <NUM>%, the Hb is <NUM>/dL (as determined by a BGA), the pH is <NUM> (as determined by a BGA), the BE is -<NUM> mmol/L (as determined by a BGA), and the Cai<NUM>+ is <NUM> mmol/L (as determined by a BGA).

Applying the information and test parameters to the example cardiovascular algorithm <NUM>, the resulting recommendations are to consider "Calcium Substitution," "Deficiency of Coagulation Factors (Extrinsic or Common Pathway)," and "Check HEPTEM" as shown in the results <NUM> of user interface <NUM>. In this example, the "Calcium Substitution" is color coded in red, the "Deficiency of Coagulation Factors (Extrinsic or Common Pathway)" is color coded in orange, and the "Check HEPTEM" is color coded in black. The color coding represents the risk or urgency of the issues leading to the recommendations. Such color coding determinations can be made as a result from the application of threshold values from a risk matrix (e.g., refer to risk matrix <NUM> of <FIG>).

Referring to <FIG>, an example severe bleeding (non-cardiac) algorithm <NUM> is provided. As with the examples provided above, the severe bleeding (non-cardiac) algorithm <NUM> can be applied in the context of particular clinical information and test parameter results to arrive at recommendations that are presented to the user. The severe bleeding (non-cardiac) algorithm <NUM> includes parameter threshold values that can be established by a user (e.g., refer to risk matrix <NUM> of <FIG>). In addition, the severe bleeding (non-cardiac) algorithm <NUM> can be customized by a local institution. For example, some steps from the example severe bleeding (non-cardiac) algorithm <NUM> can be omitted, revised, and/or added.

Claim 1:
Method, comprising:
receiving, at a blood analyzer machine (<NUM>) of a system (<NUM>), a blood sample of a patient;
performing, by the blood analyzer machine (<NUM>), one or more blood characteristic tests on the blood sample for providing blood test result data;
the system (<NUM>) comprising one or more processors, a computer memory device storing computer-readable instructions for a plurality of algorithms for interpreting the blood test result data, wherein the computer-readable instructions, when executed by the one or more processors, are configured to cause the system (<NUM>) to perform at least the following operations:
receiving user input indicative of a clinical setting of the patient that provided the blood sample;
selecting, a particular algorithm from the plurality of algorithms accessible to the blood analyzer machine in response to the user input indicative of the clinical setting of the patient;
interpreting, using the particular algorithm, the blood test result data provided from the one or more blood characteristic tests;
displaying, using a user interface (<NUM>), one or more messages indicative of a potential diagnosis or health condition based on said interpreting the blood test result data provided from the one or more blood characteristic tests; and
accessing algorithm-specific threshold values,
characterized in that
said interpreting the blood test result data provided from the one or more blood characteristic tests comprises analyzing the blood test result data in comparison to the algorithm-specific threshold values, wherein the algorithm-specific threshold values are customizable by a local institution.