Blood Pump Hemocompatible Devices
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-03-17
- Publication Date
- 2026-03-26
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 321,437, filed March 18, 2022, the entire contents of which are incorporated herein by reference.
[0002] Technical Field FIELD OF THE DISCLOSURE
[0002] Embodiments disclosed herein relate to medical devices, such as intravascular blood pumps, as well as devices and methods for monitoring and / or controlling blood clotting. [Background technology]
[0003] background
[0003] When medical devices, such as intravascular blood pumps, are used, it is beneficial to try to monitor and control blood clotting. For example, human blood naturally clots due to contact pathway activation when blood-contacting medical devices are introduced, so it may be beneficial to monitor and control blood clotting. In general, control of blood clotting is achieved by providing a controlled dose of anticoagulant. Too much anticoagulant may lead to bleeding events, which may be an unacceptable outcome when using blood pumps, while too little anticoagulant may risk blood clotting and clot formation, which may also be unacceptable.
[0004]
[0004] An intravascular blood pump may be introduced into a patient's body, either surgically or percutaneously, and used to pump blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the left heart, an intravascular blood pump may pump blood from the left ventricle into the aorta. Similarly, when deployed in the right heart, an intravascular blood pump may pump blood from the inferior vena cava into the pulmonary artery. Examples of such blood pumps include the IMPELLA® family of devices (Abiomed, Inc., Danvers, MA). Summary of the Invention [Problem to be solved by the invention]
[0005] overview
[0005] New systems and techniques are disclosed to provide informative and rapid testing. [Means for solving the problem]
[0006] A first aspect relates to a system that may include a patient console having a first housing with a first display screen, a pump control module at least partially disposed within the first housing, and a blood monitoring module. The pump control module may be configured to control an intravascular blood pump and display information about the blood pump on the display screen. The blood monitoring module may be configured to derive a value of a blood parameter from information received from a blood monitoring sensor regarding the blood sample and display the value of the blood parameter on the first display screen and / or the second display screen.
[0007] In some embodiments, the system may include a processor. In some embodiments, the pump control module and the blood monitoring module are operably coupled to the processor. In some embodiments, the processor may include multiple processors including a first processor and a second processor. In some embodiments, the first processor may be located in or on the pump control module and the second processor may be located in or on the blood monitoring module. In some embodiments, the processor is located only in the first housing.
[0008] In some embodiments, the blood monitoring module may be in a first housing. In some embodiments, the system may include a blood monitoring console. The blood monitoring module may have a second housing. The second housing may have a second display screen. In some embodiments, the blood monitoring module may be disposed in the second housing. In some embodiments, the blood monitoring console may be coupled to the patient console. In some embodiments, the blood monitoring console may be removably coupled to the first housing. In some embodiments, the blood monitoring module may be at least partially disposed in the first housing.
[0009]
[0009] In some embodiments, the system may include a first port configured to receive a blood sample. The blood sample may be received in a variety of ways. In some embodiments, the first port may be configured to removably receive a cartridge containing a blood sample. In some embodiments, the first port may be configured to be operably coupled to a catheter or tube. In some embodiments, the catheter or tube may be configured to include an electrical connection to a blood pump and / or an access delivery device (e.g., a delivery sheath) in addition to allowing blood to be moved. In some embodiments, the catheter or tube may be operably connected to a patient at a location different from an insertion point of an intravascular blood pump, where the catheter is configured to transfer a blood sample from the patient to the first port. In some embodiments, the catheter or tube may be operably connected to an intravascular blood pump, where the catheter is configured to transfer a blood sample from the patient to the first port.
[0010] In some embodiments, the blood monitoring sensor can be configured to sense a blood parameter of a blood sample received at the first port. In some embodiments, the first port can be located in a blood monitoring console coupled to the patient console or can be located in the patient console.
[0011] In some embodiments, the system can include a second port configured to allow blood to exit the housing. In some embodiments, the second port can be connected to a waste stream.
[0012] In some embodiments, the blood monitoring sensor is remotely located from the blood monitoring module. In some embodiments, the blood monitoring sensor is located on the intravascular blood pump. In some embodiments, the blood monitoring sensor may be located on a removable patch on the patient's skin.
[0013] In some embodiments, the blood parameters may include or be related to blood clotting. In some embodiments, the blood parameters may include prothrombin time (PT), activated clotting time (ACT), clot propagation velocity, clot strength, clot disintegration rate, platelet mapping, functional fibrinogen, and / or fibrin polymerization. In some embodiments, the blood parameters may include the International Normalized Ratio (INR).
[0014]
[0014] A second aspect relates to a system that may include a pump control module configured to control an intravascular blood pump and one or more processors. The one or more processors may be in operative communication with the pump control module. The one or more processors may be in a patient console and / or a blood monitoring console.
[0015] The one or more processors are configured with instructions that, when executed by the one or more processors, cause the system to perform certain tasks. Such tasks may include receiving information about the blood sample from the sensor, determining a value of a blood parameter based on the information about the blood sample, and displaying the value of the blood parameter on the first display screen and / or the second display screen.
[0016] In some embodiments, one or more processors may be configured with instructions that, when executed, cause the system to accept a blood sample. In some embodiments, the processor may include multiple processors, including a first processor and a second processor. In some embodiments, the first processor may be located in or on the pump control module, and the second processor may be located in or on the blood monitoring module. In some embodiments, the processors are located only in the first housing.
[0017]
[0017] In some embodiments, the pump control module may be at least partially disposed within the first housing. In some embodiments, the blood monitoring module may be at least partially disposed within the first housing. In some embodiments, the blood monitoring module may be in the first housing. In some embodiments, the blood monitoring module may be disposed in a second housing comprising a second display screen. In some embodiments, the second housing may be coupled to the first housing. In some embodiments, the second housing may be removably coupled to the first housing.
[0018] In some embodiments, the one or more processors may be configured to move the blood sample to the blood monitoring console. In some embodiments, the blood sample may be collected by an intravascular blood pump. In some embodiments, the blood sample may be moved to the housing via a catheter.
[0019]
[0019] In some embodiments, one or more processors may be configured with instructions that, when executed, cause the system to adjust one or more valves to control the flow of a blood sample through the system.
[0020] In some embodiments, the blood parameters may include or be related to blood clotting. In some embodiments, the blood parameters may include prothrombin time (PT), activated clotting time (ACT), clot propagation velocity, clot strength, clot disintegration rate, platelet mapping, functional fibrinogen, and / or fibrin polymerization. In some embodiments, the blood parameters may include the International Normalized Ratio (INR).
[0021]
[0021] A third aspect relates to a method. The method may include receiving information about a blood sample from a blood monitoring sensor, which may be disposed in a blood monitoring console. The method may include determining a value of a blood parameter based on the received blood sample information, where the blood parameter is or is related to blood clotting. The method may include displaying the value of the blood parameter on a display screen of the patient console and / or the blood monitoring console. The method may include operating a blood pump via a module disposed at least partially in the patient console.
[0022]
[0022] In some embodiments, the method may include controlling a blood pump based on the determined value of the blood parameter.
[0023] In some embodiments, the method may include using a value of the blood parameter to predict at least one other parameter, and may also include using a value of a sensor coupled to the blood pump to predict at least one other parameter. For example, in some embodiments, the other parameter may include future (e.g., predictive) bleeding events and / or bleeding complications. In some embodiments, a trained machine learning algorithm is used to predict the at least one other parameter. In some embodiments, the trained machine learning algorithm further uses a value from the thromboelastogram to predict the at least one other parameter. In some embodiments, the at least one other parameter may include a prediction of heart failure, such as a prediction of right heart failure. In some embodiments, the prediction of heart failure is performed while the blood pump is at least partially positioned in the left ventricle. In some embodiments, the at least one other parameter may include a prediction of a bleeding condition.
[0024] In some embodiments, the method may include determining an anticoagulant countermeasure based on the predicted at least one other parameter. In some embodiments, the method may include displaying the anticoagulant countermeasure (e.g., on the first or second display screen). In some embodiments, the method may include automatically enacting the anticoagulant countermeasure. In some embodiments, the anticoagulant countermeasure may include determining or using a dose of an anticoagulant drug, such as heparin or protamine.
[0025]
[0025] In some embodiments, the method may include accepting a blood sample. In some embodiments, accepting the blood sample may include accepting the blood sample into a first port disposed on a patient console or a blood monitoring console. In some embodiments, the blood sample may be in a cartridge or a vial. In some embodiments, the first port may be configured to be operably coupled to a catheter or a tube. In some embodiments, the catheter may be configured to transfer the blood sample from the patient to the first port. In some embodiments, the method may include obtaining the blood sample via an intravascular blood pump.
[0026] In some embodiments, the blood parameters may include prothrombin time (PT), activated clotting time (ACT), clot propagation velocity, clot strength, clot disintegration rate, platelet mapping, functional fibrinogen, and / or fibrin polymerization. In some embodiments, the blood parameters may include the International Normalized Ratio (INR).
[0027] A fourth aspect relates to a method that may include receiving a value of a blood parameter from a blood monitoring sensor of a monitoring patch configured to be placed on a patient's body, displaying the value of the blood parameter on a display screen of a patient console, and operating an intravascular blood pump via a module at least partially disposed within the patient console.
[0028]
[0028] In some embodiments, the method may include controlling a blood pump based on the value of the blood parameter.
[0029] In some embodiments, the method may include using a value of the blood parameter to predict at least one other parameter, and may also include using a value of a sensor coupled to the blood pump to predict at least one other parameter. For example, in some embodiments, the other parameter may include future (e.g., predictive) bleeding events and / or bleeding complications. In some embodiments, a trained machine learning algorithm is used to predict the at least one other parameter. In some embodiments, the trained machine learning algorithm further uses a value from the thromboelastogram to predict the at least one other parameter. In some embodiments, the at least one other parameter may include a prediction of heart failure, such as a prediction of right heart failure. In some embodiments, the prediction of heart failure is performed while the blood pump is at least partially positioned in the left ventricle. In some embodiments, the at least one other parameter may include a prediction of a bleeding condition.
[0030] In some embodiments, the method may include determining an anticoagulant countermeasure based on the predicted at least one other parameter.
[0031] In some embodiments, the blood parameter may include or be related to blood clotting. In some embodiments, the blood parameter may include prothrombin time (PT). In some embodiments, the blood parameter may include international normalized ratio (INR). [Brief description of the drawings]
[0032] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 is a schematic diagram of one embodiment of the system. [Figure 2A] FIG. 1 is a diagram of a system in which a blood monitoring console is physically coupled to a patient console, where the blood monitoring console has a display. [Figure 2B]
[0032] This is a diagram of a system in which the blood monitoring console is physically coupled to the patient console and does not have a display. [Figure 2C]
[0033] FIG. 1 is a diagram of a system in which the blood monitoring console is integrated with the patient console. [Figure 2D]
[0034] FIG. 2D is a diagram of the system coupled to an intravascular heart pump introduced into a patient's body at a first insertion point, where a blood sample can be taken through the first insertion point (2D). [Figure 2E]
[0034] A diagram of the system coupled to an intravascular heart pump introduced into a patient's body at a first entry point, where a blood sample can be taken through a second entry point (2E). [Figure 2F]
[0035] FIG. 1 is a diagram of a system in which blood samples are manually taken and passed to a console. [Diagram 3]
[0036] FIG. 1 is a diagram of a system in which the blood monitoring sensor is located remotely from the console. [Figure 4]
[0037] FIG. 13 is a diagram of a system in which at least a portion of the blood monitoring console may be coupled to the patient rather than to the patient console. [Diagram 5]
[0038] 1 is a flow chart of one embodiment of a method. [Figure 6]
[0039] FIG. 2 is a schematic diagram of another embodiment of the system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0033] Detailed Description
[0040] The embodiments of the present disclosure will be described in detail with reference to the drawings, in which like reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be provided in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely as a basis for the claims and as a representative basis for teaching various aspects to those skilled in the art.
[0034]
[0041] When medical devices, such as intravascular blood pumps, are used, it may be beneficial to monitor and try to control blood clotting. For example, human blood naturally clots due to contact pathway activation when a blood-contacting medical device is introduced. To manage blood clotting, patients are generally provided with a controlled dose of an anticoagulant. As will be appreciated, too much anticoagulant may lead to bleeding events, which may be an unacceptable outcome when using a blood pump, while too little anticoagulant may risk blood clotting and clot formation, which may also be unacceptable.
[0035]
[0042] Unfortunately, current approaches to monitoring coagulation, including activated partially thromboplastic clotting time (aPTT), anti-Xa assays, and thromboelastography (TEG), can be too time consuming, rendering them useless in light of the rapidly changing coagulation conditions of critically ill patients. Also, these conventional techniques can be poorly correlated with bleeding events, leading to anticoagulation protocols that are often inaccurate. In view of the above, the inventors have recognized the benefit of a new approach to measuring and managing a patient's anticoagulation status.
[0036]
[0043] Turning now to the drawings, as shown in FIG. 1, in some embodiments, a system 100 may be provided that may include a patient console 110. The patient console may include a housing 120 (e.g., a first housing) with a display screen 130 (e.g., a first display screen). In some embodiments, the system 100 may also include a blood monitoring console 220. In such embodiments, the blood monitoring console may include a housing 280 (e.g., a second housing). In some embodiments, a display 230 (e.g., a second display) may be disposed in the second housing 280. In some embodiments, the patient console 110 and / or the blood monitoring console 220 may include one or more knobs, buttons, or controls 170, 270 with which a user may interact.
[0037]
[0044] The system 100 may also include a pump control module 140, which may be at least partially disposed within the first housing 120. The pump control module may be configured to control the intravascular blood pump 150, as described herein.
[0038]
[0045] Different types of blood pumps are known, such as axial, centrifugal, or mixed blood pumps, where blood flow is induced by both axial and radial forces. One such example of a blood pump is the Impella® line of blood pumps (e.g., Impella 2.5®, Impella CP®, Impella 5.5®, etc.) manufactured by Abiomed (Danvers). Intravascular blood pumps can be inserted into a patient's blood vessels by a catheter, for example via the aorta.
[0039]
[0046] Such blood pumps may include the use of numerous medical devices, fluid lines, etc. These fluid lines may provide necessary fluids to the patient, remove or recirculate fluids (e.g., blood) from the patient, or provide fluids required by the medical devices, such as purge fluids. For example, in some blood pumps, purge fluids may be deployed to keep blood from entering the pump mechanism and to mitigate the effects of blood and / or biodeposit accumulation on the pump mechanism.
[0040]
[0047] The pump control module may include all of the circuitry and components necessary to control the intravascular blood pump and receive information from any sensors in or on the blood pump. For example, the module may include circuitry for controlling the power to run the blood pump and receiving information from one or more pressure sensors. The pump control module may also be configured to display information about the blood pump on the display screen 150.
[0041]
[0048] In some embodiments, system 100 may also include a blood monitoring module 200 configured to derive a value for a blood parameter from information received from blood monitoring sensor 210 regarding blood sample 300. In some embodiments, the blood parameter includes or is related to blood clotting (e.g., the blood parameter may be a value representing the degree or amount of blood clotting, the concentration of a chemical or protein associated with blood clotting, etc.).
[0042]
[0049] In some embodiments, the blood parameters may include prothrombin time (PT). As is known in the art, PT generally relates to the time it takes for plasma to clot after a mixture containing tissue factor and phospholipids (e.g., thromboplastin) is added to a patient's plasma sample.
[0043]
[0050] Because the same plasma may provide different results based on the composition of thromboplastin, in some embodiments, the blood parameters may include the International Normalized Ratio (INR). As is known in the art, the INR generally relates to the ratio of the measured PT divided by a control PT value, where the control PT value is obtained using a reference thromboplastin reagent.
[0044]
[0051] In some embodiments, blood parameters may also include activated clotting time (ACT), clot propagation velocity, clot strength, clot disintegration rate, platelet mapping, functional fibrinogen, and / or fibrin polymerization.
[0045]
[0052] In some embodiments, the blood monitoring module 200 can also be configured to display the values of the blood parameters on the first display screen 130 and / or the second display screen 230.
[0046]
[0053] In various embodiments and scenarios, there may be different levels of integration between the patient console and the blood monitoring console and / or blood monitoring module.
[0047]
[0054] In some embodiments, the blood monitoring console 220 may be operably coupled to, but physically separate from, the patient console 110. In some embodiments, the blood monitoring console may be electrically coupled to the patient console. In some embodiments, the blood monitoring console may communicate wirelessly with the patient console.
[0048]
[0055] As can be seen in FIG. 2A, in some embodiments, the blood monitoring console 221 may be physically coupled to the patient console 111. In some embodiments, the second housing 281 may be configured to attach to the first housing 121. In some embodiments, the blood monitoring console 221 may be removably coupled to the patient console 111. In some non-limiting examples, the side portion 191 of the first housing 121 includes a slot and locking mechanism such that a portion of the second housing 281 may be removably slid into the slot until it is in the correct position (e.g., a position that allows electrical contact from each console to connect) and temporarily locked in place until a user presses a button or lever to release the locking mechanism. As will be appreciated, in other embodiments, other suitable fasteners may be used to connect the patient console and the monitoring console.
[0049]
[0056] In some embodiments, each console may include at least one processor. In some embodiments, blood monitoring console 221 may include blood monitoring module 201, but blood monitoring console 221 may not include one or more processors 160, 260. That is, in some embodiments, the processor may be located only in the first housing.
[0050]
[0057] As can be seen in FIGURE 2A, in some embodiments, both the patient console and the blood monitoring console may include a display. As can be seen in FIGURE 2B, in other embodiments, the system 102 may be configured such that the first housing 122 for the patient console 112 has a display 130, but the second housing 282 for the blood monitoring console 222 does not include a display. In some embodiments, the second housing may also be free of buttons, knobs, or controls 270. In some embodiments, the blood monitoring console 222 may include the blood monitoring module 202, but the blood monitoring console 222 may be free of one or more processors 160, 260.
[0051]
[0058] 2C, in some embodiments, the system may be fully integrated, i.e., in some embodiments, the system 103 may be configured such that the blood monitoring module 203 is at least partially within the first housing 123 that defines the patient console 113.
[0052]
[0059] 1, in some embodiments, the system 100 may include a first port 240 configured to receive a blood sample 300. In some embodiments, the first port may be located on a blood monitoring console 220 coupled to a patient console (see, e.g., FIGS. 2A and 2B). In some embodiments, the first port 240 may be configured to removably receive a cartridge 310 (e.g., including a vial) containing the blood sample 300. In some embodiments, with reference to FIG. 2C, the first port 243 may be located on the patient console 113.
[0053]
[0060] 2D , in some embodiments, the first port 243 may be configured to be operably coupled to a catheter or tube 400. For example, in some embodiments, an intravascular heart pump 150 may be positioned within the heart 510 of the patient 500. In some embodiments, a blood sample may be taken, for example, by the blood pump 150 and moved through the catheter 400 to the patient console 113. That is, in some embodiments, the catheter or tube 400 may be operably connected to the intravascular blood pump 150, where the catheter or tube 400 is configured to transfer the blood sample from the patient to the first port 243. In an illustrative example, an inlet port on the blood pump may draw blood from the patient into the blood pump, which is then available for transfer to the patient console 113.
[0054]
[0061] In some embodiments, the catheter or tube 400 can be configured such that at least a portion 410 of the catheter or tube includes an electrical connection 152 to the blood pump 150 .
[0055]
[0062] As another illustrative example, a tube or catheter may be connected to an access delivery device (e.g., an access sheath) and a blood sample is drawn from another part of the body (e.g., an artery near the delivery site of the intravascular blood pump). In such an embodiment, the catheter or tube 400 may be operably connected to the patient 500 at the insertion point 420 of the intravascular blood pump 150.
[0056]
[0063] 2E, in some embodiments, the catheter or tube 400 may also be operably connected to the patient 500 at a location 430 different than the insertion point 420 of the intravascular blood pump 150, where the catheter or tube 400 is configured to transfer a blood sample from the patient to the first port 243. For example, the intravascular blood pump may be inserted through the jugular vein, while the catheter or tube 400 may be operably connected to an access site at the femoral artery.
[0057]
[0064] 2F, in some embodiments, the blood sample may be collected separately and manually transferred to the system (e.g., via port 243). In some embodiments, the blood sample may be collected using a syringe 600. In some embodiments, the blood sample may then be provided directly to the patient console 111 and / or blood monitoring console 221 and / or injected into tube 400 for delivery to system 101.
[0058]
[0065] 1, in some embodiments, the system 100 may also include a second port 250 configured to allow blood to exit the housing. In some embodiments, the second port 250 may be connected to a waste stream 330. In some embodiments, the second port 250 may be operably coupled to a container 335 for disposal of biohazardous materials.
[0059]
[0066] In some embodiments, the blood monitoring sensor 210 can be configured to sense a blood parameter of the blood sample 300 received in the first port 243.
[0060]
[0067] 3, in some embodiments, blood monitoring sensor 212 may be located in or on intravascular blood pump 150. In some embodiments, patient console 114 and / or blood monitoring console may not have a first port. The system may still include blood monitoring module 204 in patient console 114 and / or blood monitoring console, but blood monitoring sensor 212 may be located remotely (here, in or on the blood pump).
[0061]
[0068] 3, in some embodiments, information from blood monitoring sensor 212 may be communicated to a patient console and / or blood monitoring console via a catheter or tube 400 (e.g., one or more wires). In some embodiments, catheter or tube 400 may be the same catheter or tube that is operably coupled to intravascular blood pump 150.
[0062]
[0069] Referring to FIG. 4, in some embodiments, some or all of the blood monitoring console and sensors may be operably coupled to a patient. In some embodiments, one or more patches 600 may be attached to an arm 530 or other suitable portion of a patient 500. In some embodiments, the patch 600 may include a substrate 620 that may have a surface that adheres to the patient's skin. Each patch 600 may independently include circuitry 610 that may include some or all of the blood monitoring console and / or sensors (see, e.g., 200 and 210, respectively, from FIG. 1). For example, in some embodiments, the patch 600 may include a blood monitoring sensor that senses a blood parameter and communicates the parameter to the patient console and / or blood monitoring console.
[0063]
[0070] In some embodiments, each patch can be operably coupled to the patient console 114 and / or the blood monitoring console 630. This can be done wired or wirelessly.
[0064]
[0071] 1, in some embodiments, the system 100 may include one or more processors 160, 260. In some embodiments, the pump control module 140 and the blood monitoring module 200 are operatively coupled 145 to at least one of the one or more processors 160, 260.
[0065]
[0072] In some embodiments, the system includes a single processor (e.g., processor 160). In some embodiments, the system includes multiple processors, including a first processor 160 and a second processor 260. In some embodiments, pump control module 140 may include first processor 160. In some embodiments, blood monitoring module 200 may include second processor 260.
[0066]
[0073] In some embodiments, the system 100 may include a non-transitory computer-readable storage medium 180. In some embodiments, the computer-readable storage medium may include instructions that, when executed by one or more processors, cause the system to first receive information about the blood sample from a sensor. The system may then determine a value of the blood parameter based on the information about the blood sample. Finally, the system may display the value of the blood parameter on the first display screen and / or the second display screen.
[0067]
[0074] In some embodiments, the sensed blood parameters may be stored in the patient console and / or blood monitoring console. As will be appreciated, in some embodiments, the system may also be operatively connected (e.g., via one or more wires or wirelessly) to a cloud-based system to communicate the sensed data from the system. As will be further appreciated, in some embodiments, information about the blood sample may be transmitted to the cloud-based system, where the information may be converted into blood parameters. The blood parameters may then be transmitted back to the patient console and / or blood monitoring console, where they may be placed on one of the screens.
[0068]
[0075] In some embodiments, the one or more processors are further configured with instructions that, when executed, cause the system to accept a blood sample. For example, if a cartridge or vial containing a blood sample is inserted into the first slot, the system may be configured to recognize the vial or cartridge as inserted and / or to detect whether the cartridge or vial contains a blood sample. In some embodiments, the system may be configured to contact at least a portion of the blood sample with a blood monitoring sensor. In some embodiments, the processor may be configured to cause the blood sample to be withdrawn by an intravascular blood pump. In some embodiments, the processor may be configured to move the blood sample via a catheter or tube into a housing (either the first or second housing, depending on the configuration of the system).
[0069]
[0076] In some embodiments, the one or more processors may be further configured with instructions that, when executed, cause the system to adjust one or more valves to control the flow of the blood sample through the system. In some embodiments, this may include opening or closing a valve in or on the blood pump itself. In some embodiments, this may include opening or closing a valve to a vacuum source to pull blood up a tube toward the housing.
[0070]
[0077] A flow chart of one embodiment of the method may be shown in FIG. 5, where the method 700 includes operating 710 a blood pump, for example an intravascular blood pump. The blood pump may be operated by a module that is at least partially disposed in a patient console. This step is shown in FIG. 5 as occurring recursively. However, it will be understood that it may occur at any time or all the time, and the blood pump may be operated continuously while the remainder of the method is being performed. As will be appreciated, although shown with use of the blood pump, it will be understood that the method may not include this step (e.g., if such monitoring occurs before or after use of the blood pump).
[0071]
[0078] As also shown in FIG. 5, method 700 may include receiving 720 information regarding the blood sample from a blood monitoring sensor. As will be appreciated, this may include receiving an analog signal from the sensor, or a digital signal including the sensor information. In some embodiments, this information may be received from a blood monitoring sensor in a blood monitoring console or patient console (e.g., via port 243 from a vial inserted through one or more tubes or catheters). In some embodiments, this information may be received from a blood monitoring sensor in or on a blood pump. In some embodiments, this information may be received from a blood monitoring sensor in a monitoring patch configured to be placed on the patient's body.
[0072]
[0079] The method may include determining 730 a value of a blood parameter based on the received blood sample information. The blood parameter may be or may be related to blood clotting. In some embodiments, the blood parameter may include prothrombin time (PT). In some embodiments, the blood parameter may include international normalized ratio (INR).
[0073]
[0080] The method may also include displaying 740 the value of the blood parameter on a display screen of the patient console and / or blood monitoring console. In some embodiments, this may include displaying the numerical value of the blood parameter on the display screen. The method may also include displaying a visual indicia 600 of the sensed blood parameter. For example, as can be seen in some embodiments from FIG. 6, the display may be configured to display a colored indicia (e.g., red 602, yellow 604, green 606) depending on whether the blood parameter falls within (or outside) a set threshold. In some embodiments, a threshold line may be displayed. As will be appreciated, such visual indicia may also serve as a warning to the physician, depending on the colored indicia shown. As will be appreciated, in some embodiments, the visual indicia may include a slider or other suitable indicia.
[0074]
[0081] The method may also include accepting 750 the blood sample at one of the patient console and the blood monitoring console. Upon acceptance, a blood monitoring sensor, which may be part of the blood monitoring module, may be used to detect or sense information about the blood sample. In some embodiments, accepting the blood sample may include accepting the blood sample at a first port located at the patient console or the blood monitoring console. In some embodiments, the sample may be in a cartridge or a vial. In some embodiments, the sample may be provided via a catheter or a tube. In some embodiments, the first port may be configured to be operably coupled to the catheter or the tube. In some embodiments, the catheter may be configured to transfer the blood sample from the patient to the first port. In some embodiments, the method may include acquiring 751 the blood sample. In some embodiments, this may be done using an intravascular blood pump. In some embodiments, this may be done manually (e.g., drawing blood from the patient using a needle / syringe).
[0075]
[0082] The method may also include predicting 770 at least one other parameter using the value of the blood parameter. In some embodiments, values of a sensor coupled to the blood pump may also be used to predict the at least one other parameter. In some embodiments, a trained machine learning algorithm may be used to predict the at least one other parameter. In some embodiments, the trained machine learning algorithm may further use values from the thromboelastogram to predict the at least one other parameter. In some embodiments, the other parameter may include a prediction of heart failure made while the blood pump is positioned at least partially within the left ventricle. In some embodiments, the at least one other parameter may include a prediction of a bleeding condition.
[0076]
[0083] The method may also include controlling 760 the provision of an alert to a clinician based on the value of the blood parameter or a parameter predicted using the value of the blood parameter. For example, if the value is outside a desired threshold, the clinician is alerted (e.g., to provide more anticoagulant). In other embodiments, the alert may suggest that the clinician modify the operation of the blood pump. For example, the blood parameter may be an increase in the rate of blood clotting, and it may be beneficial to try to reduce the risk of clot formation by adjusting the speed of the pump, thereby adjusting the flow characteristics of the blood through the blood pump. As will be appreciated, in some embodiments, the method may include controlling the blood pump (e.g., by adjusting the speed of the pump) in response to the blood parameter.
[0077]
[0084] The method may also include determining 780 an anticoagulant strategy based on the predicted at least one other parameter. The method may also include displaying 781 the anticoagulant strategy and / or automatically executing 782 the anticoagulant strategy. In some embodiments, the anticoagulant strategy includes a dose of an anticoagulant drug. In some embodiments, the anticoagulant strategy includes a dose of heparin or protamine. For example, the method may include determining an appropriate dose of heparin.
[0078]
[0085] Similar to the blood parameters, in some embodiments, the method may include displaying the anticoagulant countermeasure on the display. In some embodiments, this may include displaying a numerical value on the display. As can be seen from FIG. 6, this may include displaying a visual indicia 600 (e.g., a colored indicia--red 602, yellow 604, green 606) depending on whether the anticoagulant countermeasure is within (or outside) a set threshold. As will be appreciated, such visual indicia may also serve as a warning to the physician depending on the indicia shown. For example, in some embodiments, this may alert the clinician that more (or less) anticoagulant may be needed for the patient depending on the sensed blood parameters (and the displayed anticoagulant countermeasure). As will be appreciated, in some embodiments, the visual indicia may include a slider or other suitable indicia.
[0079]
[0086] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein which equivalents are intended to be encompassed by the following claims.
Claims
1. A patient console having a first housing equipped with a first display screen, A pump control module, at least partially disposed within the first housing, is configured to control an intravascular blood pump and to display information relating to the intravascular blood pump on a first display screen, A blood monitoring module is configured to extract blood parameter values from information received from a blood monitoring sensor regarding a blood sample, and to display the values of the blood parameters on the first display screen and / or the second display screen. A system that includes this.
2. The system according to claim 1, further comprising a processor.
3. The system according to claim 2, wherein the pump control module and the blood monitoring module are operably coupled to the processor.
4. The system according to claim 2, wherein the processor comprises a plurality of processors including a first processor and a second processor, the pump control module further comprises the first processor, and the blood monitoring module further comprises the second processor.
5. The system according to claim 1, wherein the blood monitoring module is located within the first housing.
6. The system according to claim 1, further comprising a blood monitoring console having a second housing comprising the second display screen, wherein the blood monitoring module is located within the second housing.
7. The system according to claim 6, wherein the blood monitoring console is coupled to the patient console.
8. The system according to claim 7, wherein the blood monitoring console is detachably coupled to the first housing.
9. The system according to claim 7, wherein the blood monitoring module is at least partially located within the first housing.
10. The system further includes a processor, The system according to claim 7, wherein the processor is located only within the first housing.
11. The system according to claim 1, further comprising a first port configured to receive the blood sample.
12. The system according to claim 11, wherein the blood monitoring sensor is configured to sense the blood parameters of the blood sample received into the first port.
13. The system according to claim 11, wherein the first port is configured to removably receive a cartridge containing the blood sample.
14. The system according to claim 11, wherein a catheter is operably connected to the patient at a location different from the insertion point of the intravascular blood pump, and the catheter is configured to transfer the blood sample from the patient to the first port.
15. The system according to claim 14, wherein the catheter is operably connected to the intravascular blood pump, and the catheter is configured to transfer the blood sample from the patient to the first port.
16. The system according to claim 11, further comprising a second port configured to allow blood to exit the first housing.
17. The system according to claim 1, wherein the blood monitoring sensor is located in the intravascular blood pump.
18. The aforementioned blood parameters include or relate to blood coagulation, and / or The blood parameters include prothrombin time (PT), activated clotting time (ACT), clot propagation velocity, clot strength, clot degradation rate, platelet mapping, functional fibrinogen, and / or fibrin polymerization, and / or The system according to claim 1, wherein the values related to the blood parameters include the International Normalized Ratio (INR).
19. It is a system, A pump control module configured to control an intravascular blood pump, One or more processors that are operable to communicate with the pump control module, the one or more processors being located in the patient console and / or blood monitoring console, and the one or more processors, when executed by the one or more processors, the system The sensor receives information about the blood sample. Based on the information relating to the blood sample, the values of the blood parameters are determined. The values of the blood parameters are displayed on the first display screen and / or the second display screen. One or more processors configured with instructions A system that includes this.
20. Receiving information about blood samples from a blood monitoring sensor, Determining the value of a blood parameter based on the information relating to the received blood sample, wherein the blood parameter is related to or is associated with blood coagulation. Displaying the values of the blood parameters on the display screen of the patient console and / or blood monitoring console, The blood pump is operated via a pump control module that is at least partially located within the patient console. Methods that include...