WO2021195515A1

WO2021195515A1 - Device and method for automated blood draw and testing

Info

Publication number: WO2021195515A1
Application number: PCT/US2021/024386
Authority: WO
Inventors: Joseph R. SCALEA; Kevin Barnes
Original assignee: University Of Maryland, Baltimore
Priority date: 2020-03-27
Filing date: 2021-03-26
Publication date: 2021-09-30

Abstract

Devices and methods are disclosed for automated blood draw and testing that employ a modular, automated blood draw and testing apparatus that includes a blood draw portion configured to draw blood from a patient, a sampling portion configured to control the flow of blood and optionally other fluids through the apparatus, and a testing portion configured to test blood that has been drawn from the patient, all without interaction with the patient by a human operator. The device employs a modular assembly in which pump and valve components are contained in a removable and replaceable module that may deliver blood samples to a plurality of test chambers each holding a disposable test component, such as a blood contact card.

Description

DEVICE AND METHOD FOR AUTOMATED BLOOD DRAW AND TESTING

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 63/000,829 titled “Device and Method for Automated Blood Draw and Testing,” filed March 27, 2020, and to U.S. Provisional Application No. 63/090,450 titled “Device and Method for Automated Blood Draw and Testing,” filed October 12, 2020, which applications are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods for point-of-care blood drawing and analysis, and more particularly to systems and methods enabling the drawing and testing of a patient’s blood and reporting of testing results while limiting potentially hazardous exposure of health care personnel.

BACKGROUND Quarantined intensive care unit (ICU) patients represent infectious exposure to healthcare workers. Despite this, there are numerous unnecessary automatable patient cares which are performed (sometimes hourly) by nurses, technicians, phlebotomists, and doctors. Blood draws are required for nearly every patient in the ICU, multiple times per day. Blood draws require that a provider walk into the patient’s room and interact with and contact the patient and/or contaminated equipment. Automating blood draws and combining this process with point-of- care (POC) testing would limit exposure to health care workers, provide for more rapid testing, and decrease the volume of blood drawn from seriously ill patients. There are many bedside ICU monitors, and there are a growing number of point-of-care tools to assay blood samples. However, most previously known systems and methods require that healthcare workers interact with or work closely with potentially infected patients. Further, while some prior art systems do provide for remote operation (e.g., U.S. Patent No. 8,523,797 of Lowery et ah, the specification of which is incorporated herein by reference), such prior art efforts have met with limited success as they comprise complex assemblies that increase difficulty in use.

Thus, there remains an unmet need for protecting healthcare workers tasked with blood collection and analysis from the risk of infectious exposure, while providing a remote, automated blood drawing and analysis device that is easy to setup, use, and maintain.

SUMMARY OF THE INVENTION

Disclosed herein are devices and methods for automated blood draw and testing that avoid one or more disadvantages of prior art systems and methods. With regard to certain aspects of an exemplary embodiment of the invention, a modular, automated blood draw and testing apparatus is provided that includes a blood draw portion configured to draw blood from a patient, a sampling portion configured to control the flow of blood and optionally other fluids through the apparatus, and a testing portion configured to test blood that has been drawn from the patient, all without interaction with the patient by a human operator. In a particularly preferred configuration, systems and methods configured in accordance with certain aspects of the invention may include a replaceable, modular cartridge that includes two or more of a pump for pumping a measured portion of blood from a patient, tubing for carrying blood from the patient that is to be tested, valves for controlling the flow of blood in the tubing, and a dispensing assembly for dispensing the minimally necessary amount of blood onto a testing platform. As a replaceable, modular cartridge, such assembly may be inserted into a housing when ready for use, initiated via remote activation, and after use removed from the housing for cleaning, service, sterilization, and reuse with the same or even a different patient. The testing platform may be positioned in the housing with respect to the replaceable, modular cartridge so as to receive the minimally necessary amount of blood from the dispensing assembly and perform a test on the sample to measure the desired blood characteristic, such as (by way of non-limiting example) hemoglobin, blood cell counts, platelet counts, blood chemistry, etc. In an exemplary configuration, the testing platform may include a plurality of testing mediums, such as by way of non-limiting example blood contact cards, that may test for differing blood characteristics. A controller is also provided to control the operation of the pump, valves, dispensing assembly, and testing platform, and to report test results to a remote device, such as a computer maintaining the patient’s electronic medical record, a nursing or doctor alert computer, or other devices. In accordance with an aspect of an embodiment of the invention, a modular, automated blood draw and testing device is provided, comprising a housing, a blood draw portion configured for connection to an intravenous line from a patient, a blood sampling portion positioned in the housing downstream from the blood draw portion, a blood testing portion positioned in the housing downstream from the blood sampling portion and comprising a testing array having multiple disposable blood test components and a dispensing component configured to dispense a measured volume of blood from the blood sampling portion onto one of the blood test components, and a controller configured to operate the blood draw and testing device without interaction between medical personnel and a patient to whom the blood draw and testing device is connected, wherein the blood draw portion, the blood sampling portion, and the dispensing component of the blood testing portion are contained within a module that is removably attachable and replaceable into the housing.

In accordance with another aspect of an embodiment of the invention, a method for remote, automated blood drawing and testing is provided, comprising the steps of providing a modular, automated blood draw and testing device comprising a housing, a blood draw portion configured for connection to an intravenous line from a patient, a blood sampling portion positioned in the housing downstream from the blood draw portion, a blood testing portion positioned in the housing downstream from the blood sampling portion and comprising a testing array having multiple disposable blood test components and a dispensing component configured to dispense a measured volume of blood from the blood sampling portion onto one of the blood test components, and a controller configured to operate the blood draw and testing device without interaction between medical personnel and a patient to whom the blood draw and testing device is connected, wherein the blood draw portion, the blood sampling portion, and the dispensing component of the blood testing portion are contained within a module that is removably attachable and replaceable into the housing; positioning the module in the housing; inputting an instruction at a remote computing device to conduct a blood test at the device, and transmitting the instruction from the remote computing device to the controller; in response to receiving the instruction, causing the controller to draw a predetermined amount of blood from a patient and direct a blood sample to a selected one of the blood test components to determine a characteristic of the blood sample; and causing the controller to transmit to the remote computing device data indicative of the characteristic.

Still other aspects, features and advantages of the invention are readily apparent from the following detailed description, simply by illustrating a number of particular embodiments and implementations, including the best mode contemplated for carrying out the invention. The invention is also capable of other and different embodiments, and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized. The present invention is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements, and in which: FIG. 1 is a schematic view of a modular, automated blood draw and testing system in accordance with certain aspects of an embodiment of the invention.

FIG. 2 is a close-up view of an optional dispensing and testing apparatus for use in the system of FIG. 1.

FIG. 3 is a top view of a formable blood container for use with the optional dispensing and testing apparatus of FIG. 2.

FIG. 4 is a schematic view of a modular, automated blood draw and testing device in accordance with certain aspects of an embodiment of the invention.

FIG. 5 is a system component view of the modular, automated blood draw and testing device of FIG. 4.

FIG. 6 is a component view of a testing array for use in the modular, automated blood draw and testing device of FIG. 5.

FIG. 7 is a top view of an embodiment of the testing array of FIG. 6. FIGs. 8(a) and 8(b) are perspective views of a modular, automated blood draw and testing device in closed and open configurations, respectively, according to further aspects of an embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following detailed description is provided to gain a comprehensive understanding of the methods, apparatuses and/or systems described herein. Various changes, modifications, and equivalents of the systems, apparatuses and/or methods described herein will suggest themselves to those of ordinary skill in the art.

Descriptions of well-known functions and structures are omitted to enhance clarity and conciseness. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, the use of the terms a, an, etc. does not denote a limitation of quantity, but rather denotes the presence of at least one of the referenced items. The use of the terms “first”, “second”, and the like does not imply any particular order, but they are included to identify individual elements. Moreover, the use of the terms first, second, etc. does not denote any order of importance, but rather the terms first, second, etc. are used to distinguish one element from another. It will be further understood that the terms “comprises” and/or “comprising”, or “includes” and/or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof. Although some features may be described with respect to individual exemplary embodiments, aspects need not be limited thereto such that features from one or more exemplary embodiments may be combinable with other features from one or more exemplary embodiments.

FIG. 1 is a schematic view of a modular, automated blood draw and testing system 10 in accordance with certain aspects of an embodiment of the invention. In the exemplary configuration of FIG. 1, automated blood draw and testing system 10 includes a modular, automated blood draw and testing device 100 contained within a portable housing 110, which modular, automated blood draw and testing device may be positioned bedside to a patient 20 from whom blood is to be tested. A computing device having a user interface 200 may be provided for, as discussed in greater detail below, communicating with a controller 160 of blood draw and testing device 100 for purposes of selecting, initiating, and collecting data from blood tests that are performed by blood draw and testing device 100. In order that medical personnel may engage such blood draw and testing device 100 without engaging the patient 20, user interface 200 may communicate remotely with controller 160, such as via a network 300 (such as a wired or wireless local area network, a wired or wireless wide area network, or such other remote network configuration as may readily occur to those skilled in the art). Blood draw and testing device 100 is configured to automatically draw blood samples from patient 20, test the blood samples for certain targeted characteristics or interest, and report test results. Blood draw and testing device 100 may in certain configurations be deployed bedside in an intensive care unit or the like, and may generate and report blood test results to healthcare workers while reducing the necessity for interaction with the patient, compared to typical devices and methods.

With continuing reference to FIG. 1, blood draw and testing device 100 includes a drawing and sampling portion 120, a testing portion 140, and a controller 160. The draw portion of drawing and sampling portion 120 is configured to automatically draw blood from patient 20, and in certain configurations is further configured to return blood to the patient. For this purpose, a first fluid line 21 may extend from the patient 20 for connection to a first end 121 of drawing and sampling portion 120, and a second fluid line 22 (only partially shown in FIG. 1) may extend from a second end 122 of drawing and sampling portion 120 and ultimately return to the patient’s circulatory system. For example, a central venous catheter (“CVC”) port (not shown) may be provided to access the patient’s circulatory system, with both first fluid line 21 and second fluid line 22 being connectable to the CVC port. Alternatively and as discussed in greater detail below, blood may be returned to the patient in certain configurations from first end 121 of drawing and sampling portion 120 through first fluid line 21. Likewise, the sampling portion of drawing and sampling portion 120 is configured to automatically distribute fluid, such as blood drawn from patient 20 or a flushing or infusion fluid 30, to other components of blood draw and testing device 100. Further and as discussed in greater detail below, testing portion 140 is configured to automatically test blood drawn from patient 20 for desired characteristics. Finally, controller 160 is configured to automate at least one other portion of blood draw and testing device 100, including the draw portion, sampling portion, and testing portion.

In accordance with certain aspects of an embodiment, the draw portion of drawing and sampling portion 120 is configured to automatically draw blood from patient 20. In certain configurations, the draw portion includes a catheter, while in other configurations the draw portion may be configured to couple to an external catheter, such as at first end 121. In any case, the catheter may be a venous or arterial connection to patient 20. Furthermore, the catheter may be a peripheral or a central line. For example, in certain configurations and as referenced above, the draw portion is configured to couple to a central venous catheter, such as those typically used for manually drawing blood for testing. The catheter may include tubing and routing portions, as typically used for drawing blood, and may be fluidly coupled via tube 21 to other components of the device at first end 121, and further fluidly coupling other components of the device. More particularly, the tubing can be ultimately coupled to pump 122 configured to force blood through the tubing. In certain configurations, pump 122 may comprise a peristaltic pump. In other configurations, pump 122 may comprise a roller pump. In still further configurations, pump 122 may comprise a piston pump, a tube and valve compression pump, or such other low volume precision pumps configured for metered sampling required by tests as may occur to those of ordinary skill in the art.

With continuing reference to FIG. 1 and in accordance with certain aspects of an embodiment, the sampling portion of drawing and sampling portion 120 is configured to automatically distribute fluid, such as blood drawn from patient 20 or a flushing fluid 30, to other components of the blood draw and testing device 100. The sampling portion is fluidly coupled to the draw portion via tubing 21 and 124 (such as described above) such that it is adapted to transport blood from patient 20 for testing. In certain configurations and as mentioned above, blood may be returned to the patient using tubing 122 that may be attached to second end 122 of blood draw and testing device 100. In other configurations, blood may be returned to patient 20 using the same tube 21 from which it was drawn. Furthermore, the sampling portion may be configured to measure and divide portions of blood into at least one sample. In an exemplary configuration, the size or volume of each sample may be based on requirements for testing different blood characteristics or the number of desired tests. For example, in some tests a blood sample may be less than 20 pL, however, other blood samples may be approximately 20 pL, while in still other tests the blood samples may be greater than 20 pL. In certain configurations, the size of a sample may be determined by a sensor, either directly or indirectly. For example, indirectly measuring the size of a sample may include determining the volume flowing through pump 122 over time, such as can be done using known methods implemented at control portion 160. As a further example, directly measuring the size of the sample may include using a flow sensor or a volume sensor (not shown). Furthermore, fluid coupling and flow of the blood and fluid in the sampling portion and device may be regulated by valves 126(a) - 126(d). In certain configurations, valves 126(a) - 126(d) are part of the sampling portion, while in other configurations valves 126(a) - 126(d) may form a part of other portions of the blood draw and testing device 100, yet still are configured to regulate flow of the blood and fluid. As an example, one or more of valves 126(a) - 126(d) may be pinchers or the like, although other types of valves configured to regulate blood flow may be used.

As mentioned above and in accordance with further aspects of an embodiment, the sampling portion of drawing and sampling portion 120 may further be configured to receive fluids, such as saline or other flushing fluid, from flush / infusion source container 30 which may be connected to blood draw and testing device 100 at flush connector 128. The sampling portion may be configured to use such flushing fluids 30 to flush tubing and other portions of blood draw and testing device 100. As a further example, fluids 30 may include an infusion providing intravenous therapeutic compounds and the like. As mentioned above, flow of flush fluid 30 may be regulated by valves 126(a) - 126(d) of the sampling portion, and also by pump 130, which may also comprise a peristaltic pump or the like (e.g., roller, centrifugal, etc.). Still further, the sampling portion of drawing and sampling portion 120 may include typical risk mitigation components (not shown) configured to reduce the likelihood of causing low blood pressure to the patient, air bubbles reaching the patient, or the like. For example, the risk mitigation components may include pressure sensors, bubble detectors, or the like.

In accordance with further aspects of an embodiment, the sampling portion of drawing and sampling portion 120 may further include a dispensing component 132 configured to automatically transfer blood from the sampling portion of drawing and sampling portion 120 to testing portion 140. For example, dispensing component 132 may comprise a pipette or the like that dispenses fluid pumped via the first pump 122 of the drawing and sampling portion 120 to the dispensing component 132 when valve 126(a) from the patient and valve 126(d) to the dispensing component are open, and valve 126(b) from the flush / infusion source 30 and valve 126(c) to the patient (if provided) are closed. The valves 126(a) - 126(d), dispensing component 132, and first pump 122 are configured to operate automatically as controlled by controller 160 (as further described below) according to the desired tests, patient condition, manual control by a healthcare worker, or program or schedule of the controller portion. According to certain aspects of an exemplary embodiment, the drawing and sampling portion 120 may also include in-line sensors 134 configured to test blood samples before reaching the testing portion 140. For example, in-line sensors 134 may include optical sensors, such as disposable oxygen sensors, configured to determine blood oxygenation levels, cell types, cell counts, and other typical blood characterization tests whose configuration and operation are known to those of ordinary skill in the art.

With continued reference to FIG. 1 and in accordance with further aspects of an embodiment, testing portion 140 of blood draw and testing device 100 is configured to automatically test blood drawn from the patient for desired characteristics in conjunction with the drawing and sampling portion 120 and the controller 160. In certain exemplary configurations, testing portion 140 includes a sample receiver 142 having at least one sampling bay 143. However, in other configurations, sample receiver 142 may have a plurality of sampling bays 143. Each sampling bay 143 may be configured to receive one or many types of blood test components, such as strips, vials, tubing, blood contact cards or the like (the configurations and operation of which are known to those skilled in the art), which blood test components may be filled with a blood sample. Each sampling bay 143 is configured in sample receiver 142 such that, when in operation, one of sampling bays 143 is positioned to automatically receive blood samples from dispensing component 132 of the drawing and sampling portion 120. For example, a sampling bay 143 may be positioned vertically underneath dispensing component 132, but other configurations are possible, such as adjacent positions. Furthermore, in certain exemplary configurations, sampling bays 143 do not contact dispensing component 132. However, in other configurations at least one of the sampling bays 143 may be configured to contact dispensing component 132 when receiving blood samples and without contaminating samples. For example, the sample receiver 142 may include sterilizing or cleaning components (not shown).

In configurations of testing portion 140 in which sample receiver 142 includes multiple sampling bays 143, sample receiver 142 may be configured to automatically align any sampling bay 143 with the dispensing component 132. For example, the sample receiver may be operated by a motor (or linear actuator or the like, not shown) of standard configuration that is controlled by controller 160. In certain exemplary configurations, sample receiver 142 may be of a generally elliptical or circular shape, such that sampling bays 143 are configured around the sample receiver 142 and the sample receiver is configured to rotate to orient sampling bays 143 with respect to dispensing component 132. In other exemplary configurations, sampling bays

143 may be oriented linearly on sample receiver 142, in which at least one of sample receiver 142 or dispensing component 132 can be configured to move laterally or longitudinally to align sampling bays 143 to the dispensing component 132.

With continued reference to FIG. 1 and in accordance with still further aspects of an embodiment, testing portion 140 may be configured to move blood test components (which, as mentioned above, may comprise strips, vials, tubing, blood contact cards and the like) to a testing component or analyzer 144. For example, in certain exemplary configurations, the blood test components may be automatically moved from sample receiver 142 to analyzer 144 using a robotic assembly 146, such as a robotic arm (e.g., each blood test component can be placed in a different analysis slot 144(a) of analyzer 144 by robotic assembly 146). As a further example, the sample receiver may release the blood test components and an arm of robotic assembly 1146 (or the like) may receive the blood test components (e.g., via gravity or grabbing the blood test components). The analyzer 144 is configured to receive at least one blood test component, or in other embodiments a plurality of blood test components, with each analyzer slot 144(a) receiving a single blood test component that is to be analyzed. In other exemplary configurations, analyzer

144 may be integrated with sample receiver 142 in a single assembly such that the containers need not be transferred between separate elements of a sample receiver 142 and analyzer 144. In any case, the testing component automatically analyzes the characteristics of the blood as controlled by controller 160, or by manual control of a healthcare work in some embodiments.

In an exemplary configurations, certain analyzer slots 144(a) may be configured to test for certain blood characteristics, while other analyzer slots 144(a) may be configured to test for other blood characteristics. In still further exemplary configurations, some analyzer slots 144(a) may be configured to test for multiple types of blood characteristics. The analyzer 144 automatically produces results that can be received by controller 160, and the blood test component can be automatically removed to waste 145. In certain exemplary configurations, robotic assembly 146 may include a second robotic arm to move blood test components between the sample receiver 142 and other devices, such as other point of care testing devices. Thus, the testing portion 140 is configured to automatically test blood samples. In certain configurations, a supply of unused blood test components 147 may also be provided for replacement in sample receiver 142 when a blood test component 147 has been used and moved to or processed by analyzer 144.

Those of ordinary skill in the art will recognize that analyzer 144 may employ a wide number of tests on blood test components using known methods and analysis platforms. By way of non-limiting example, known testing methods and analysis platforms may be readily adapted by those of ordinary skill in the art for use in testing portion 140, including CBC whole blood tests (e.g., hemoglobin, hematocrit, white blood cell count, platelet count, and red cell width), CMP serum tests (e.g., sodium, potassium, chloride, bicarbonate, blood sugar (serum glucose), blood urea nitrogen, creatinine, AST, ALT, bilirubin, and alkaline phosphatase), coagulation parameter whole blood tests (e.g., INR, prottime, and prothrombin time), shock tests (e.g., myoglobin, lactate dehydrogenase, and lactate), and cardiac tests (e.g., cardiac troponin I and cardiac troponin T).

In accordance with further aspects of an embodiment and as mentioned above, controller 160 portion is configured to control the draw and sampling portion 120 and testing portion 140. More particularly and in an exemplary configuration, controller 160 is in electrical communication with at least pumps 122 and 130, valves 126(a) - 126(d), and dispensing component 132 of draw and sampling portion 120, and with sample receiver 142 and analyzer 144 (and if provided robotic assembly 146) of testing portion 140. Controller 160 may include a processor or the like, such as a computer or system of computers, including servers and the like. For example, controller 160 may cause the draw portion of drawing and sampling portion 120 to draw blood from patient 20 according to a control scheme, such as at specified times, frequency of operation, on-demand, in response to a patient condition, or the like. Furthermore, controller 160 may receive signals from sensors that indicate the operating states of the drawing and sampling portion 120 and the testing portion 140. For example, controller 160 may receive a signal that indicates the operating speed of pump 122, from which controller 160 may change the control scheme or operating states of each portion. Still further, controller 160 may receive signals from sensors that indicate the state of fluids in the blood draw and testing device 100 and patient 20. For example, controller 160 may receive signals from in-line oximetry and hemometry sensors 134 that indicate characteristics of the blood, including hemoglobin levels, oxygen saturation, arterial oxygenation, and the like. Thus, controller 160 may change the control scheme or operating states of the portions of blood draw and testing device 100 based on states of the blood or fluids.

In certain exemplary configurations, controller 160 controls the draw portion of drawing and sampling portion 120 by signaling pump 122 and valves 126(a) - 126(d) to operate according to the control scheme, including time of operation, frequency of operation, fluid flow volumes, fluid flow rates, etc. Likewise in certain exemplary configurations, controller 160 may cause the sampling portion of drawing and sampling portion 120 to automatically distribute fluid, such as blood drawn from patient 20 or a flushing fluid from flush / infusion source 30, to other components of the blood draw and testing device 100. For example, controller 160 may cause the sampling portion to distribute a certain volume of blood, as determined by the control scheme (e.g., to conduct certain tests on a blood sample) to the testing portion 140. Still further, controller 160 may communicate test results to external devices or sources.

For example, controller 160 may communicate test results to a display (e.g., bedside monitor), electronic medical record systems, servers, personal electronic devices of healthcare workers, and the like. In an exemplary configuration, the control scheme (including test types, test frequency, etc.) can be changed by healthcare workers via bedside monitor, electronic medical record systems, servers, personal electronic devices (e.g., including via wired and wireless internet protocols or Bluetooth) and the like, all of which may be provided with user interface 200 enabling interaction with blood draw and testing device 100 while avoiding direct or even near contact between medical personnel and patient 20. Such external devices may thus be adjacent to the patient or separated from the patient, such as opposite a quarantine barrier. Thus, blood draw and testing device 100 is configured to reduce the risk of exposure of healthcare workers to infectious diseases while conducting blood testing and providing test results to healthcare workers faster than in typical devices.

In operating the system for remote, automated blood draw and testing 10 of FIG. 1, medical personnel may engage user interface 200, for example on a wall-mounted touch screen terminal of a remote computing device or the like. At this stage, preferably all pincher valves 126(a) - 126(d) are closed. Appropriate lab tests for the particular patient 20 are selected via user interface 200, and intravenous infusion rates may be programmed (e.g., normal saline, blood, etc.). The medical personnel may then initiate a blood draw by, for example, tapping a “draw blood” function button presented by user interface 200, which in turn communicates an instruction to controller 160 to start the blood draw process. The controller may also receive other data including the blood volume that is needed from patient 20 and the test types that are to be performed so as to ultimately instruct how much blood is to be drawn. Blood volume may, in certain exemplary configurations, be converted to “seconds of blood draw” such that blood draw and testing device 100 will only draw the prescribed blood volume over a specified period of time. Test type (e.g., “CBC”, “CMP”, etc.) may also be selected and communicated to controller 160 at this time.

Following receipt of the instruction at controller 160 to initiate the blood draw process, pump 122 is activated and pulls blood from a central line in patient 20, wasting blood only until hemoglobin (“Hgb”) and oxygen saturation (“Sp02”) levels in tubing 124 are stable. This wasted blood may be ultimately reinfused into the patient after the blood draw process is carried out. Blood oximetry Sp02 and Hgb may be measured directly through the intravenous tubing using 575-1 lOOnm light sources and analyzed by in-line sensors 134. Sp02 and Hgb levels may be sent from sensors 134 to controller 160. Once the Sp02 and Hgb levels are stable, the dispensing operation may begin by closing valve 126(c) so as to divert blood towards sample receiver 142 only fast enough to let a single drop (e.g., 25ml) per 0.5-1 seconds. Drops of blood fall through dispensing component 132 into blood test components in sample receiver 142, such as by way of non-limiting example point-of-care test strips, blood contact cards, or the like that have been preloaded into the rotating sample receiver 142 based on the selected test type. After the designated number of drops of blood have been dispensed to sample receiver 142, sample receiver 142 may be rotated by controller 160 to the next position for preparing another test.

Once the designated blood draw volume is reached (e.g., after a predetermined time has elapsed at a particular flow rate), the testing sequence is completed and pincher valve 126(d) to dispensing component 132 is closed by controller 160. At this point and while keeping pincher valve 126(d) closed, controller 160 may close pincher valve 126(a) from the patient, open the pincher valve 126(b) from the flush / infusion fluid source 30 and 126(c) for the patient return (if provided), and via pump 130 flush saline or other fluid through the blood draw and testing device 100 to avoid clotting and to reinfuse wasted blood to the patient. After such reinfusion process, pincher valve 126(c) may be closed, pincher valve 126(a) from patient 20 may be opened, and with pincher valve 126(b) from the flush / infusion source 30 remaining open and pincher valve 126(d) to dispensing component 132 remaining closed, pump 130 may flush saline or other fluid through the line from patient 20 to prevent clotting.

With regard to the testing process carried out by testing portion 140, following the collection of drops of blood from dispensing component 132 into one or more blood test components in sample receiver 142, the blood test component may be analyzed by analyzer 144, the spent blood test component may be expelled to waste 145, and optionally a replacement blood test component may be placed in the now-empty sampling bay 143 of sample receiver 142 to enable further testing from that sampling bay 143. Likewise, the sample receiver 142 may be rotated to bring the next available sampling bay 143 (and an unused blood test component stored therein) into position to receive blood drops from dispensing component 132.

Likewise, after analyzer 144 has analyzed the blood test component containing patient’s 20 blood sample, data indicative of measured characteristics of that blood sample may be transferred via controller 160 to remote user interface 200 for review by medical personnel for monitoring the patient’s condition and to alert if abnormal values of any such measured characteristics are detected. Next, with reference to FIGs. 2 and 3 and in accordance with further aspects of an embodiment, the sampling portion of drawing and sampling portion 120 may optionally be configured to form blood samples in pellet-like sample containers. For example, the dispensing component 132 may optionally include a formable container as shown in FIG. 3 (such as a container formed of a soft, sterile, pliable plastic container or bag-like material) configured to be formed into many sample containers. Thus, in accordance with certain aspects of an embodiment, the dispensing component 132 can distribute blood, for example from the sampling portion of drawing and sampling portion 120 to the testing portion 140, without using a pipette. This may increase the sterility of the blood testing compared to typical devices and methods. In certain configurations and as particularly shown in FIG. 3, the formable container 170 is configured to receive blood from the sampling portion of drawing and sampling portion 120. A stamping device 171, such as a thermal stamp having heated edges, may press against the blood- filled formable container 170 to form at least one pellet-like sample container 172 filled with blood and having a shape and size that is formed by the stamping device 171. For example, the stamping device 171 can have a ring-like shape (e.g., circular-like internal area) such that sample containers 172 have a circular-like shape. In an exemplary configuration, the stamping device 171 may be heated to form, seal, and separate each sample container 172 from the formable container 170. In an exemplary configuration, the sample containers 172 may be formed in batches, while in other configurations the sample containers 172 may be formed in response to desired tests (e.g., on-demand for scheduled or requested blood tests, such as individual blood tests). In other exemplary configurations, sampling containers 172 can be formed by sealing and separating in-line tubing containing blood samples that can be tested using optical or laser test components (e.g., within the device or using external devices). In still further configurations, sample containers 172 may include commercially-available sampling containers (e.g., contact cards). In certain configurations, a plurality of sample containers may be configured on a replaceable component (e.g., a disk or module) to increase replaceability, use, and ease of testing. For example, a plurality of sample containers 172 may be configured on a module for a patient that is likely to require a number of tests of a particular type within a given period. Thus, the module would include a sufficient number of sample containers 172 (e.g., contact cards) to perform that number of tests within the given period automatically (i.e. without physician or operator involvement) and provide reporting as necessary (as further described herein).

Thus, the stamping device 171 is configured to form sample containers of blood, and further forms a blood sample matrix of the formable container 170 from a plurality of sample containers 172. The size of the matrix can depend on many factors, such as a size (e.g., diameter of the stamping device), relative positioning of each sample container 172 on the formable container 170 (e.g., wherein the relative positioning can determine a packing factor of sample containers 172), a size (e.g., length, width, circumference, or outer outline of the formable container), and the number of desired tests, among other factors. In an exemplary configuration, the size (e.g., dimensions or volume) of the formable container 170 can depend on many factors, and is generally limited to no larger than necessary for given circumstances to avoid clotting or over-drawing blood from the patient. For example, the size of the formable container 170 can be determined by health conditions of the patient (i.e., an amount of blood that can be drawn from the patient without compromising the patient’s health), the likelihood of blood clotting in the formable container 170, and the number and type of desired blood tests in a given period, among other factors. Thus, the blood matrix of the formable container 170 can form many sample containers 172, such as twelve sample containers, 24 sample containers, or other numbers as may be customized by persons of ordinary skill in the art to accommodate particular testing environments and objectives.

With continued reference to FIG. 2, after a sample container 172 has been formed and before engaging sample receiver 142, further measures may be provided to allow for testing blood within each sample container for blood characteristics. Specifically, testing portion 140 may receive sample containers 172 in a bin 148 (e.g., hammer bin) through which a test sample can be taken by an automated syringe 149 or the like. Specifically, a formed sample container 172 may be dropped into hammer bin 148 and automated syringe 149 may be inserted into hammer bin 148 and the pellet-like sample container 172 through an opening in the side of hammer bin 148, allowing syringe 149 to withdraw blood from inside of the sample container 172. A hammer 150 may be positioned adjacent hammer bin 148 and may compress hammer bin 148 to hold sample container 172 in place therein as the blood drawing process is carried out by syringe 149. After the blood has been withdrawn from the sample container, hammer 150 may be withdrawn and the now-empty sample container 172 may be released from hammer bin 148 to waste. The automated syringe 149 can be further configured to transfer blood to the sample receiver 142 for further processing by testing portion 140, such as described above. In an exemplary configuration, the automated syringe 149 may draw various amounts of blood from each sample container 172, depending on the desired test, such as 0.1 mL -0.25 mL of blood for some tests, although more or less blood may be required for some tests. Thus, provided herein are devices and methods configured to automatically draw blood samples from patients, test the blood samples for characteristics, and report test results. Devices and methods configured in accordance with at least certain aspects of the invention may be configured to operate in an intensive care unit or the like. Likewise, devices and methods configured as discussed herein may generate and report blood test results to healthcare workers while reducing the necessity for interaction with the patient, compared to typical devices and methods.

In accordance with certain aspects of a particularly preferred embodiment of the invention, FIG. 4 is a schematic view and FIG. 5 is a system component view of a modular, automated blood draw and testing device 400 contained within portable housing 410, which modular, automated blood draw and testing device 400 is positioned bedside to a patient 401 from whom blood is to be tested. As in the configurations described above, blood draw and testing device 400 is configured to automatically draw blood samples from patients, test the blood samples for characteristics, and report test results, such as to a remote device having a user interface 200 as discussed above. In certain configurations, blood draw and testing device 400 and the methods it implements may be configured to operate in an intensive care unit or the like. Thus, the blood draw and testing device 400 and its related methods may generate and report blood test results to healthcare workers while reducing the necessity for interaction with patient 401, compared to typical devices and methods.

Blood drawing and testing device 400 includes a draw portion 420, a sampling portion 430, a testing portion 440, and a controller 460. The draw portion 420 is configured to automatically draw blood from a patient 401 and/or return blood to the patient 401. The sampling portion 430 is configured to automatically distribute fluid, such as blood drawn from the patient 401 or a flushing fluid 402, to other components of the device 400. The testing portion 440 is configured to automatically test blood drawn from the patient 401 for desired characteristics. In the exemplary configuration of FIGs. 4 and 5, a replaceable card or cartridge 412 is configured for releasable attachment in portable housing 410, and may be configured to include the draw portion 420, the sampling portion 430, and an optional in-line sensor 443 and a dispensing mechanism 440 of the test portion 440. Further, the test portion 440 also includes a plurality of disposable sample containers, such as blood contact cards, in an openable and closeable tray 450 (FIG. 8(b), discussed below) in housing 410 and positioned downstream from sampling portion 430. Replaceable card or cartridge 412 may be configured to be removed to be cleaned, sterilized, or to replace components. The controller 460 is configured to automate at least one other portion of the blood draw and testing device 400, including draw portion 420, sampling portion 430, and testing portion 440.

In an exemplary configuration, draw portion 420 is configured to automatically draw blood from patient 401 using a pinch valve 422 fluidly coupled to intravenous tubing 402.

Intravenous tubing 402 may connect to a standard intravenous lines extending from patient 401 at intravenous line connector 421. Pinch valve 422 is configured to automatically open and close as controlled by controller 460, such as discussed below. Sampling portion 430 is configured to automatically distribute fluid, such as blood drawn from patient 401 or a flushing fluid 403, to other components of the blood draw and testing device 400. For example, sampling portion 430 preferably includes a plurality of one-way valves 432 and 434 to control blood flow within the device 400 and to external components or the patient 401. Sampling portion 430 may include one one-way valve 432 downstream of the draw portion and a saline flush. Thus, at least one of the one-way valves 432 and 434 is configured to restrict blood flow to the draw portion 430 and saline flush provided by flush source 403, pump 433 and one-way valve 434. Furthermore, blood draw and testing device 400 may configure the sampling portion 430 such that the saline flush is configured to flush and clean the fluid lines to prepare for the next test sample. Still further, the saline flush may include one-way valve 434 configured to allow saline flow from the saline source 403 (which may optionally be positioned either within or outside of the device 400) into the sampling portion 430 and testing portion 440 to flush the device 400, but restricts blood flow into the saline source 403.

In an exemplary configuration, sampling portion 430 includes both first pump 431 and second pump 433. First pump 431 is configured to pump blood from the patient to the testing portion 440. Likewise, second pump 433 is configured to pump saline flush fluid through the blood draw and testing device 400 (e.g., through the sampling portion 430 and testing portion 440). In the exemplary configuration of FIGs. 4-8(b), first pump 431 is downstream of one-way valve 432 such that first pump 431 cannot pump fluid upstream of that one-way valve 432 (i.e. to the patient), but can pump blood fluid or saline flush (downstream) to the testing portion 440 as controlled by controller 460. Still further, first pump 431 may comprise a hybrid fast prime pump, although other pumps configured for pumping blood may be used, such as piston pumps, peristaltic pumps, and the like.

In an exemplary configuration, testing portion 440 of the device 400 includes dispensing mechanism 441, a testing array 442, and optionally an in-line sensor 443. For example, the dispensing mechanism 441 may comprise a precision microliter volume dispense mechanism. The in-line sensor 443 may comprise a typical fluid flow sensor (e.g., optical, rotary, laser, etc.) configured to determine properties of the fluid flow, such as flow speed, velocity, pressure, and the like. Optionally, in-line sensor 443 may comprise a cell counter or sorter. Sensor 443 transmits the properties of the fluid flow to controller 460 to control device 400. For example, in-line fluid sensor 443 may be configured to determine that a desired volume of blood is present in the dispensing mechanism 441 and/or is ready to perform a test. Furthermore, the dispensing mechanism 441 may include an injection device having a pump (not shown), such as a piston pump, peristaltic pump, or combination of pumps, configured to force a blood sample through a needle operated by an actuator, such as a stepper motor. Dispensing mechanism 441 may be configured to dispense a small volume (e.g., approximately between 5 microliters to 25 microliters) of blood by forcing fluid through the pump and needle, redrawing the small volume into the needle, and reinjecting (e.g., purging) the blood into sampling bays 445 of testing array 442.

Next and with reference to FIGs. 5-7, testing array 442 is configured to perform testing of the patient’s blood that is received from the dispensing mechanism without intervention by medical personnel. For example, testing array 442 may comprise a disk (or other holder) that includes a set of test cartridges (or chambers) configured to test blood samples as required by a physician or operator. In an exemplary configuration, the set of test cartridges (or chambers) includes a septum (e.g., configured to seal the chamber) inside of an openable and closeable tray (450 of FIG. 8(b)) that provides an array of preferably sealed testing chambers in each sample bay testing chamber 445. In an exemplary embodiment, those testing chambers 445 may each hold a sterile disposable fluid contact card configured to receive a blood sample for automatically testing the blood sample. In certain exemplary configurations, the testing array 442 may include a test pack configured to automatically perform tests of the blood samples, for example, as programmed and controlled by controller 460. The disk may be configured to perform common or likely required tests for a patient over a period of time as discussed above. For example, the disk can include chambers 445 for a patient that will need several tests of one type and fewer tests of another type. Thus, physicians and operators may select how many chambers 445 are required for specific tests depending on the patient and the patient’s condition during a given period to automatically generate and report blood test results to healthcare workers while reducing the necessity for interaction with the patient, compared to typical devices and methods.

Still further, testing array 442 may be configured to dispose of a blood sample, such as a blood sample on a contact card or overflow from the dispensing mechanism 441, into a waste chamber 444 (e.g., due to error, waste, or after testing is completed). The device 400 may be configured to dispose of a blood sample and/or contact card automatically (e.g., as controlled by controller 460) or manually by an operator. Furthermore, the waste chamber 444 can be a chamber in the disk or positioned around the disk, as best shown in FIG. 7.

In accordance with further aspects of an embodiment, one or more of the test chambers 445 of the test array 442 may include a filter 445(b) configured to retain components of a patient’s blood. For example, a filter 445(b) may be provided in test chambers 445 that are configured to perform tests that require cells, such as red blood cells, to be removed. For example, such tests may include antibody tests. The test chambers 445 may be configured to perform various tests, for example, using light-based or laser test sensors 461. Furthermore, sensors 461 can be positioned on the replaceable card 412 or as a part of testing array 442. In an exemplary configuration, test chambers 445 may be configured to perform cell sorting and identification, glucose measurement, and oxygenation measurement. In certain configurations, test sensors 461 may be disposable. For example, one test sensor may comprise a blood oxygenation level test sensor configured to determine that a new blood sample has been primed and is ready to dispense into a test chamber 445 of test array 442. As a further example, test sensors 461 may comprise proprietary or platform tests that are integrated into the chamber 445 and sensor 461.

According to certain aspects of an embodiment, sampling portion 430 and testing portion 440 of device 400 may be configured to draw a defined volume of a patient’s blood (e.g., as determined by controller 460 to perform a particular test) to test array 442. For example, controller 460 may control blood flow from sampling portion 430 to testing portion 440 using signals from the pinch valve 422, one-way valve 432, first pump 431, and sensor 443 to control blood flow from patient 401 to test array 442. Likewise, controller 460 may be configured to control flow of saline flush through the sampling portion 430 and testing portion 440 to prepare the device 400 for another test (e.g., a different type of test or future test).

According to certain aspects of an embodiment, device 400 may be configured to administer fluid and medication to patients at controlled rates and volumes. For example, flush / infusion source 403 may include a medication source to provide medication to patient 401 through device 400. In an exemplary configuration, second pump 433 of the saline flush may serve as an infusion pump. More particularly, second pump 433 may be coupled to a saline flush and medication source 403 where such fluids are held separately, in which controller 460 may be configured to independently control fluid flow of the saline flush and medication source. Sampling portion 430 of the device 400 may optionally include a third pump (not shown) coupled to a medication source that is controlled by the controller to administer medication fluid independently of the saline flush at particular rates. In some configurations, the saline flush and/or medication may be flushed into the patient, for example, through the pinch valve 422.

Furthermore, blood draw and testing device 400 is preferably configured to prevent the device from causing severe negative effects to the patient. For example, device 400 may include various safety devices or equipment in sampling portion 430. These safety devices may include pressure sensors, bubble avoidance drip tubes and detectors, flow rate validation, and the like, the configuration and operation of which are well known to those of ordinary skill in the art. As noted above, all fluid contact lines (not shown) can be placed on replaceable card or module 412 that can be aligned and snapped into place on the device 400. As particularly shown in FIGs. 8(a) and 8(b), an integrated closing and locking lid 411 may be provided in conjunction with typical clamping systems (not shown) for the pumps and valves in replaceable card or module 412, thus increasing the likelihood of providing a reliable test environment and reducing the likelihood of testing noise and ambient interference (e.g., ambient light, airflow, vibration, etc.).

Devices and methods configured in accordance with the foregoing may be configured to automate testing and sampling of blood in a more safe and reliable manner compared to typical devices and techniques. Using a modular system employing a replaceable card 412 increases the likelihood of proper installation, which in turn increases the reliability of automatic sampling and testing. Furthermore, a blood draw and testing device configured in accordance with the foregoing may include safety sensors and equipment configured to increase patient safety and reliable test performance compared to typical devices and techniques. Still further, a blood draw and testing device configured in accordance with the foregoing may be further configured to be programmable via the controller (e.g., internal or external) to provide results to a physician or operator for examination on the device and/or remotely, for example, on a mobile device (e.g., smartphone or tablet application) or computer system connected to a server.

Thus, provided herein is an exemplary configuration of devices and methods configured to automatically draw blood samples from patients, test the blood samples for characteristics, and report test results. The devices and methods set forth herein may be configured to operate in an intensive care unit or the like. Devices and methods configured in accordance with the above disclosure may generate and report blood test results to healthcare workers while reducing the necessity for interaction with the patient compared to typical devices and methods.

Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. Thus, it should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein.

Claims

CLAIMS What is claimed is:

1. A modular, automated blood draw and testing device, comprising: a housing; a blood draw portion configured for connection to an intravenous line from a patient; a blood sampling portion positioned in said housing downstream from said blood draw portion; a blood testing portion positioned in said housing downstream from said blood sampling portion and comprising a testing array having multiple disposable blood test components and a dispensing component configured to dispense a measured volume of blood from said blood sampling portion onto one of said blood test components; and a controller configured to operate said blood draw and testing device without interaction between medical personnel and a patient to whom said blood draw and testing device is connected; wherein said blood draw portion, said blood sampling portion, and said dispensing component of said blood testing portion are contained within a module that is removably attachable and replaceable into said housing.

2. The modular, automated blood draw and testing device of claim 1, said blood draw portion further comprising a pinch valve positioned to regulate fluid flow between said sampling portion and a patient.

3. The modular, automated blood draw and testing device of claim 1, said blood sampling portion further comprising a first pump and a first valve positioned to regulate flow of fluid to said testing portion.

4. The modular, automated blood draw and testing device of claim 3, wherein said first valve further comprises a one-way valve.

5. The modular, automated blood draw and testing device of claim 4, said blood sampling portion further comprising a second pump and a second valve configured to regulate flow of a flushing fluid from an external flushing fluid source in at least said blood draw portion and said sampling portion.

6. The modular, automated blood draw and testing device of claim 5, wherein said first valve and said first pump are downstream from said second valve and said second pump.

7. The modular, automated blood draw and testing device of claim 1, wherein said testing array further comprises a rotatable disc positioned to sequentially align said disposable blood test components with said dispensing component.

8. The modular, automated blood draw and testing device of claim 7, wherein said blood test components further comprise blood contact cards.

9. The modular, automated blood draw and testing device of claim 1, wherein said testing array is removably positioned within an openable and closeable drawer in said housing.

10. The modular, automated blood draw and testing device of claim 9, further comprising a waste container in said housing and positioned to receive one or more of said disposable blood test components after administration of a blood test by said device.

11. A method of remote, automated blood drawing and testing, comprising the steps of: providing a modular, automated blood draw and testing device comprising: a housing; a blood draw portion configured for connection to an intravenous line from a patient; a blood sampling portion positioned in said housing downstream from said blood draw portion; a blood testing portion positioned in said housing downstream from said blood sampling portion and comprising a testing array having multiple disposable blood test components and a dispensing component configured to dispense a measured volume of blood from said blood sampling portion onto one of said blood test components; and a controller configured to operate said blood draw and testing device without interaction between medical personnel and a patient to whom said blood draw and testing device is connected; wherein said blood draw portion, said blood sampling portion, and said dispensing component of said blood testing portion are contained within a module that is removably attachable and replaceable into said housing; positioning said module in said housing; inputting an instruction at a remote computing device to conduct a blood test at said device, and transmitting said instruction from said remote computing device to said controller; in response to receiving said instruction, causing said controller to draw a predetermined amount of blood from a patient and direct a blood sample to a selected one of said blood test components to determine a characteristic of said blood sample; and causing said controller to transmit to said remote computing device data indicative of said characteristic.

12. The method of remote, automated blood drawing and testing of claim 11, wherein said blood draw portion further comprises a pinch valve positioned to regulate fluid flow between said sampling portion and a patient.

13. The method of remote, automated blood drawing and testing of claim 11, wherein said blood sampling portion further comprises a first pump and a first valve positioned to regulate flow of fluid to said testing portion.

14. The method of remote, automated blood drawing and testing of claim 13, wherein said first valve further comprises a one-way valve.

15. The method of remote, automated blood drawing and testing of claim 14, wherein said blood sampling portion further comprises a second pump and a second valve configured to regulate flow of a flushing fluid from an external flushing fluid source in at least said blood draw portion and said sampling portion.

16. The method of remote, automated blood drawing and testing of claim 15, wherein said first valve and said first pump are downstream from said second valve and said second pump.

17. The method of remote, automated blood drawing and testing of claim 11, wherein said testing array further comprises a rotatable disc positioned to sequentially align said disposable blood test components with said dispensing component.

18. The method of remote, automated blood drawing and testing of claim 17, wherein said blood test components further comprise blood contact cards.

19. The method of remote, automated blood drawing and testing of claim 11, wherein said testing array is removably positioned within an openable and closeable drawer in said housing.

20. The method of remote, automated blood drawing and testing of claim 19, wherein said modular, automated blood draw and testing device further comprises a waste container in said housing and positioned to receive one or more of said disposable blood test components after administration of a blood test by said device.