Device for the automatic drawing of blood from a vascular line for subsequent testing

Abstract

A system and method for automated blood sampling and coagulation analysis are disclosed. In one embodiment, the system includes a test module having a test cartridge with at least one test chamber and a rotor configured to rotate through a blood sample. A torque detector monitors resistance applied to the rotor as the blood coagulates, and a processor calculates coagulation time based on torque data. The system further includes a flush module for cleansing fluid pathways and a flow controller with a motorized selector valve for directing fluid between the patient, the test module, and the flush module. In another embodiment, a wearable coagulation monitoring device includes a base attachable to the patient's skin, a test cartridge with multiple chambers containing rotors and lancets, and a camera for image-based analysis of blood flow. Both embodiments enable automated coagulation testing without manual blood draws, improving patient safety and clinical efficiency.

Description

P2970PC01 (OU 2025-048) Filed December 15, 2025DEVICE FOR THE AUTOMATIC DRAWING OF BLOOD FROM A VASCULAR LINE FOR SUBSEQUENT TESTINGCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of United States Provisional Patent Application Serial No. 63 / 734,025 filed December 13, 2024 entitled, ‘"Apparatus and Method for Periodic Blood Sampling and Coagulation Analysis” and United States Provisional Patent Application Serial No. 63 / 762,612 filed February' 24, 2025 entitled, “Device for the Automatic Drawing of Blood from a Vascular Line and Subsequent Testing for Coagulation,” the disclosures of which are herein incorporated as if fully set forth herein.BACKGROUND

[0002] Pulmonary' embolisms are one of the most prevalent causes of preventable death in hospitals. Patients often are kept on extended bedrest, which can lead to blood stagnation in their inactive limbs. Under these conditions, clots can form and grow in the static veins in a process called Deep Vein Thrombosis (DVT). These clots can grow to dangerous sizes, eventually detaching from their growth site and traveling through the circulatory system to the lungs. Clots then block blood flow in the narrower blood vessels of the lungs in a condition known as Pulmonary' Embolism (PE). With this blockage, patients can suffer from decreased blood flow, damage to vasculature, or in severe cases, suffocation. PE results in tens of thousands of deaths every’ year in hospitals, often without any warning.

[0003] The current standards of care to prevent dangerous blood clots have been largely ineffective. Current methods include low er limb massaging devices, which can reduce stagnation of blood in deep veins that cause DVT. However, this is not enough to negate the rates of death by PE. Blood thinners are effective at decreasing a patient’s clotting tendencies, but administration of such drugs requires up-to-date knowledge of a patient’s coagulation time to avoid overdosing. Without proper knowledge of coagulation time, too much blood thinner can be administered, thus increasing the chance of bleeding disorders. Coagulation time is a measure of how long an individual’s blood takes to clot: a time that is too high or low' indicates an increased chance of over-bleeding and clot formation, respectively. While coagulation time is a valuable tool to decide how' to manage a patient’s blood thinning regime, current methods to measure coagulation times are highly manual, necessitating a burden on patients and healthcare staff. An automated system for determining a patient’s clotting potential would be beneficial. It is to such a system that the present disclosure is directed.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more implementations described herein and, together with the description, explain these implementations. The drawings are not intended to be drawn to scale, and certain features and certain views of the figures may be shown exaggerated, to scale or in schematic in the interest of clarity and conciseness. Not every component may be labeled in every drawing. Like reference numerals in the figures may represent and refer to the same or similar element or function.

[0005] FIG. 1 is a first diagrammatic depiction of the blood sampling system of exemplary embodiments connected to a patient in a hospital bed.

[0006] FIG. 2 is a functional diagram of the connection of the blood sampling system connected to the patient.

[0007] FIG. 3 is a perspective view of an embodiment of the flow controller of the blood sampling system.

[0008] FIG. 4 is a top view of the flow controller of FIG. 3 with the harness removed.

[0009] FIG. 5 is a bottom perspective view of the flow controller of FIG. 3 with the harness removed.

[0010] FIG. 6 is a bottom plan view of the flow controller of FIG. 3 with the harness removed.

[0011] FIG. 7 is a top view of a portion of the test module and test cartridge of the blood sampling system of FIG. 1.

[0012] FIG. 8 is a top perspective view of a portion of the test module and test cartridge of the blood sampling system of FIG. 1.

[0013] FIG. 9 is a functional diagram of the connections to the test module of the blood sampling system.

[0014] FIG. 10 is a functional diagram of the connections to the test cartridge of the blood sampling system.

[0015] FIG. 11 is a bottom view of the test cartridge of the blood sampling system.

[0016] FIG. 12 is a top view of the test cartridge of the blood sampling system.

[0017] FIG. 13 is a perspective view of the cartridge drive engagement assembly of the test module.

[0018] FIG. 14 is a side view of the cartridge drive engagement assembly of the test module.

[0019] FIG. 15 is a side, partial cross-sectional view of the test module.

[0020] FIG. 16 is a top view of the test cartridge of the blood sampling system in a first state.

[0021] FIG. 17 is a close-up view of an active test chamber and test chamber diverter valve of the test cartridge of FIG. 14.

[0022] FIG. 18 is a top view of the test cartridge of the blood sampling system in a second state.

[0023] FIG. 19 is a close-up view of an active test chamber and test chamber diverter valve of the test cartridge of FIG. 18.

[0024] FIG. 20 is a top view of the test cartridge of the blood sampling system in a third state.

[0025] FIG. 21 is a close-up view of an active test chamber and test chamber diverter valve of the test cartridge of FIG. 20.

[0026] FIG. 22 is a depiction of an alternate embodiment of the blood sampling system connected to a patient.

[0027] FIG. 23 is a close up view of a two-piece rotor from a test cartridge of the blood sampling system of FIG. 22.

[0028] FIG. 24 is a perspective view of a test cartridge from the embodiment of the blood sampling system depicted in FIG. 22.

[0029] FIG. 25 is a perspective view of a test module from the embodiment of the blood sampling system depicted in FIG. 22.

[0030] FIG. 26 is a front of the test module from FIG. 25.

[0031] FIG. 27 is a bottom perspective view of the flexible rotor shaft used to drive the rotor within the test cartridge of FIG. 24.

[0032] FIG. 28 is a top view of the test cartridge of FIG. 24 during a sampling operation.

[0033] FIG. 29 depicts a third embodiment of a coagulation monitor connected directly to the patient.

[0034] FIG. 30 depicts the third embodiment of the coagulation monitor connected directly to the patient.

[0035] FIG. 31 is a perspective exploded view of the coagulation monitor of FIG. 28.

[0036] FIG. 32 is a perspective view of the coagulation monitor of FIG. 28.

[0037] FIG. 33 is a side view of the test cartridge and nested cartridge actuation assembly of the coagulation monitor of FIG. 28.

[0038] FIG. 34 is a side cross-sectional view of the test cartridge and nested cartridge actuation assembly of the coagulation monitor of FIG. 28.

[0039] FIG. 35 is a bottom view of the cartridge actuation assembly of the coagulation monitor of FIG. 28.DETAILED DESCRIPTION

[0040] The present disclosure, in at least certain embodiments, is directed to systems and methods for automated blood sampling and coagulation analysis. In one embodiment, a blood sampling system is configured to automatically draw blood from a vascular line connected to a patient, transfer the blood sample to a test module, and determine coagulation time without manualintervention. The system includes a test module having a test cartridge with one or more test chambers, each equipped with a rotor for circulating blood during testing. A torque detector monitors resistance applied to the rotor as blood coagulates, and a processor calculates coagulation time based on torque data. The system further includes a flush module for cleansing the fluid pathways and a flow controller with one or more motorized selector valves for directing fluid between the patient, the test module, and the flush module.

[0041] In another embodiment, the invention provides a wearable coagulation monitoring device configured for continuous, minimally invasive testing. The device includes a base attachable to the patient’s skin, a test cartridge with multiple chambers containing rotors and lancets, and a cartridge actuation assembly for automated blood collection and testing. A camera monitors blood movement within the test chamber, and coagulation time is determined through image analysis of blood flow characteristics.

[0042] Both embodiments enable automated, periodic testing without requiring repeated manual blood draws or constant staff involvement.

[0043] The present disclosure describes a blood sampling system 100 and method for automatically collecting blood from a vascular port and directing it to a testing module. The system 100 generally includes a test module 102, a flow controller 104, and flush module 106. The system 100 is generally configured to automatically obtain a blood sample from an intravenous line connected to a mammalian subject using the flow controller 104, direct the blood sample to the test module 102 for testing, and then cleanse the blood sampling system 100 with saline or another rinse fluid with the flush module 106. The flush module 106 can be configured to transport blood other products to a waste container 108. In exemplary embodiments, the test module 102 includes a test cartridge 164 with one or more test chambers 188. Although the system 100 is particularly well suited for evaluating blood coagulation properties, in other embodiments the system 100 can be used to test blood sugar, liver function, or other diagnostic studies based on blood samples.

[0044] In exemplar}' embodiments, the blood sampling system 100 is programmed for automatic operation based on inputs from healthcare staff. The flow controller 104 is connected to a vascular port, such as but not limited to a peripheral intravenous line (IV line), Arterial line (A- line), or Central Venous Catheters (CVCs). The blood sampling system 100 uses a series of lines and tubing connectors, such as stopcocks, valves, and clamps, to direct blood or other test fluids to the test module 102, the w aste container 108, or back to the patient. Fluids are pushed to points of interest via pumps or gravitational force. In some embodiments, the blood sampling system 100 is configured to test for blood coagulation properties on a periodic basis withoutrequiring multiple blood draws from the subject. The blood sampling system 100 can be used to automatically conduct a plurality of tests over a schedule or testing period prescribed by a care provider, as 24 hours. As used herein, the term “testing session” refers to the plurality of tests performed over a defined period of time. The term “testing run” refers to the acquisition and testing of a single blood sample during the testing session. The blood sampling system 100 automatically provides results to healthcare staff and can be configured to issue alarms or warnings if the test results indicate a prioritized need for intervention.

[0045] With regard to the many non-limiting embodiments of the apparatuses and methods of use disclosed herein, it will be appreciated that the use of the blood sampling system 100 will help reduce the clotting conditions caused by low coagulation time, such as PE and DVT, but may also be used to reduce incidence of bleeding disorders caused by high coagulation times, which can result from a high dosage of blood thinners like warfarin. For the purposes of this disclosure, clotting will be described as the target condition, but testing for bleeding is understood to be identical and thus fall under the bounds of this disclosure.

[0046] At the discretion of a qualified physician or healthcare provider, and / or informed by standards set by recognized medical organizations, patients may be identified whose medical tendencies may put them at high risk to develop a clotting or bleeding disorder. These patients may be prescribed the disclosed apparatus to monitor coagulation time. Certain standards of care, informed consent, and risk / reward analysis may be needed to ensure proper / safe use like any other medical device. The system 100 would not be reasonable for use in all patients, and physicians need to carefully consider which individuals would benefit from its use. Additional factors, such as age, body mass, or others may be identified in future studies to affect results, and as such the device ought to be used cautiously regarding study results.

[0047] The blood sampling system 100 regularly tests blood throughout a given time period. The blood sampling system 100 automatically draws and tests blood without staff or patient involvement and without any noticeable sensation to the patient. Doing so, the blood sampling system 100 can continuously monitor coagulation time, even while the patient is asleep. By doing so, hospital staff will have a constant, up-to-date reading on a patient’s risk for a clotting disorder and can preventatively treat patients, thus averting blood clot formation. Blood can be accessed from any vasculature in the body under the assumption that coagulation time is a system-wide property. Therefore, when a patient is prescribed use of the blood sampling system 100, a healthcare professional first inserts a suitable vascular port or identifies a suitable existing port. Blood may be collected from a vascular catheter port of any kind, so long as it can safely provide an adequate testing volume. In most cases, the blood sampling system 100 would beapplied to a catheter already connected to the patient. The flow controller 104 can be added if the catheter is attached to another system, such as an IV drip bag or an A-line pressure monitor. In cases with other systems, the system 100 would normally have the flow controller 104 connect the other system to the vascular port while the system 100 is blocked, and when it is time for a coagulation time test, the junction would instead block the other testing device and allow the test module 102 to connect to the patient. This feature would be optional depending on the circumstances, but an ordinary person trained in the art would understand the device would still function in this configuration, and as such this feature is not pictured / mentioned in figures or following descriptions. Although the system 100 is disclosed in connection with conducting a test for coagulation time, the blood sampling system 100 can also be adapted to carry out other diagnostic tests.

[0048] Before further describing various embodiments of the apparatus, component parts, and methods of the present disclosure in more detail by way of exemplary description, examples, and results, it is to be understood that the embodiments of the present disclosure are not limited in application to the details of apparatus, component parts, and methods as set forth in the following descnption. The embodiments of the apparatus, component parts, and methods of the present disclosure are capable of being practiced or carried out in various ways not explicitly described herein. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments are meant to be exemplary, not exhaustive. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting unless otherwise indicated as so. Moreover, in the following detailed description, numerous specific details are set forth in order to provide a more thorough understanding of the disclosure. However, it will be apparent to a person having ordinary skill in the art that the embodiments of the present disclosure may be practiced without these specific details. In other instances, features which are well known to persons of ordinary skill in the art have not been described in detail to avoid unnecessary complication of the description. While the apparatus, component parts, and methods of the present disclosure have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the apparatus, component parts, and / or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit, and scope of the inventive concepts as described herein. All such similar substitutes and modifications apparent to those having ordinary skill in the art are deemed to be within the spirit and scope of the inventive concepts as disclosed herein.

[0049] All patents, published patent applications, and non-patent publications referenced or mentioned in any portion of the present specification are indicative of the level of skill of those skilled in the art to which the present disclosure pertains, and are hereby expressly incorporated by reference in their entirety to the same extent as if the contents of each individual patent or publication was specifically and individually incorporated herein. Unless otherwise defined herein, scientific and technical terms used in connection with the present disclosure shall have the meanings that are commonly understood by those having ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0050] As utilized in accordance with the methods and compositions of the present disclosure, the following terms and phrases, unless otherwise indicated, shall be understood to have the following meanings: The use of the word '‘a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” The use of the term “or” in the claims is used to mean “and / or” unless explicitly indicated to refer to alternatives only or when the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or.” The use of the term “at least one” will be understood to include one as well as any quantity7more than one, including but not limited to, 2, 3. 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 100. or any integer inclusive therein. The phrase “at least one” may7extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100 / 1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term “at least one of X, Y and Z” will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y and Z.

[0051] As used in this specification and claims, the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any7form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0052] The term “or combinations thereof’ as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof’ is intended to include at least one of: A, B. C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB. CBA, BCA, ACB, BAC. or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term,such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CAB ABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.

[0053] Throughout this application, the terms “about” or “approximately” are used to indicate that a value includes the inherent variation of error for the composition, the method used to administer the composition, or the variation that exists among the study subjects. As used herein the qualifiers “about” or “approximately” are intended to include not only the exact value, amount, degree, orientation, or other qualified characteristic or value, but are intended to include some slight variations due to measuring error, manufacturing tolerances, observer error, and combinations thereof, for example. The term “about” or “approximately”, where used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass, for example, variations of ± 20% or ± 10%, or ± 5%, or ± 1%, or ± 0.1% from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary7skill in the art. As used herein, the term “substantially” means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree. For example, the term “substantially” means that the subsequently described event or circumstance occurs at least 80% of the time, at least 90% of the time, at least 91% of the time, at least 92% of the time, at least 93% of the time, at least 94% of the time, at least 95% of the time, at least 96% of the time, at least 97% of the time, at least 98% of the time, or at least 99% of the time.

[0054] As used herein any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

[0055] As used herein, all numerical values or ranges include fractions of the values and integers within such ranges and fractions of the integers within such ranges unless the context clearly indicates otherwise. Thus, to illustrate, reference to a numerical range, such as 1-10 includes 1, 2, 3, 4, 5, 6, 7, 8, 9. 10. as well as 1.1, 1.2, 1.3, 1.4, 1.5, etc., and so forth. Reference to a range of 1-50 therefore includes 1, 2, 3. 4, 5, 6. 7, 8, 9. 10. 1 1. 12. 13. 14. 15. 16. 17. 18. 19. 20, etc., up to and including 50, as well as 1.1, 1.2, 1.3, 1.4, 1.5, etc., 2.1, 2.2, 2.3, 2.4, 2.5, etc., and so forth. Reference to a series of ranges includes ranges which combine the values of the boundaries of different ranges within the series. Thus, to illustrate reference to a series of ranges, for example, a range of 1-1,000 includes, for example, 1-10, 10-20, 20-30. 30-40, 40- 50, 50-60, 60-75, 75-100, 100-150, 150-200, 200-250, 250-300, 300-400, 400-500, 500-750,750-1,000, and includes ranges of 1-20, 10-50, 50-100, 100-500, and 500-1,000. The range 100 units to 2000 units therefore refers to and includes all values or ranges of values of the units, and fractions of the values of the units and integers within said range, including for example, but not limited to 100 units to 1000 units, 100 units to 500 units, 200 units to 1000 units, 300 units to 1500 units, 400 units to 2000 units, 500 units to 2000 units, 500 units to 1000 units, 250 units to 1750 units, 250 units to 1200 units, 750 units to 2000 units, 150 units to 1500 units, 100 units to 1250 units, and 800 units to 1200 units. Any two values within the range of about 100 units to about 2000 units therefore can be used to set the lower and upper boundaries of a range in accordance with the embodiments of the present disclosure. More particularly, a range of 10-12 units includes, for example, 10, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, and 12.0, and all values or ranges of values of the units, and fractions of the values of the units and integers within said range, and ranges which combine the values of the boundaries of different ranges within the series, e.g., 10.1 to 11.5. The use of ordinal number terminology (i.e., "first", "second", "third", "fourth", etc.) is solely for the purpose of differentiating between two or more items and, unless explicitly stated otherwise, is not meant to imply any sequence or order or importance to one item over another or any order of addition.

[0056] Turning to FIG. 1, shown therein is a depiction of an embodiment of the blood sampling system 100 connected to a human patient 10 in a hospital bed 12. In this embodiment, the blood sampling system 100 includes an intravenous (IV) fluid bag 110. a bag line 112 connected between the flow controller 104 and the fluid bag 110, a vascular port 1 14 connected to the patient 10, and a vascular line 116 connected between the vascular port and the flow controller 104. The bag line 112 delivers fluids from the fluid bag 110 to the flow controller 104 or can be connected to other instruments for other purposes, such as blood pressure monitoring. The fluid bag 110 can contain a saline solution or an IV-deliverable medicine. The vascular line 116 conveys fluids betw een the flow controller 104 and the patient 10. The vascular port 114 can be located on the arm of the patient 10, or anywhere else on the patient 10 where vascular ports can be installed.

[0057] The blood sampling system 100 includes a sample line 1 18 and a flush line 120, which are both connected between the test module 102 and the flow controller 104. The flush line 120 generally carries fluid from the test module 102 to the How controller 104, while the sample line 118 carries fluids from the flow controller 104 to the test module 102. In the embodiment depicted in FIG. 1. the test module 102 is located below the patient 10, but in other embodiments the test module 102 is located at approximately the same level as the vascularport 114 or above the vascular port 114. The basic connections for this embodiment of the blood sampling system 100 are similarly depicted in FIG. 2.

[0058] Turning to FIGS. 3-6, shown therein are various depicts of the flow controller 104 constructed in accordance with an exemplary embodiment. The flow controller 104 has a flow controller body 122, a bag line connector 124, a vascular line connector 126, a flush line connector 128, and a sample line connector 130. Each of the connectors can include a threaded, press fit or other mechanism for capturing a corresponding line within the flow controller body 122. It will be appreciated that the labels used to identify the bag line connector 124, the vascular line connector 126, the flush line connector 128, and the sample line connector 130 are provided to identify one of several ways in which the various lines are connected to the flow controller 104 and that in other embodiments the flow lines within the blood sampling system 100 are connected to the flow controller 104 in different configurations.

[0059] In this embodiment, the flow controller 104 includes a first diverter valve 132, a second diverter valve 134 and a central passage 136. The first diverter valve 132 includes a first diverter valve passage 138 and the second diverter valve 134 includes a second diverter valve passage 140. When the first diverter valve 132 is in a first position, the first diverter valve passage 138 connects the bag line connector 124 to the vascular line connector 126. In this position, fluid from the fluid bag 110 will pass through the bag line 112 through the flow controller 104 to the patient 10 through the vascular line 116. When the first diverter valve 132 is rotated to a second position, the first diverter valve passage 138 aligns with the bag line connector 124 and the central passage 136 to place the bag line 112 in fluid communication with the central passage 136. When the first diverter valve 132 is rotated to a third position, the first diverter valve passage 138 aligns with the central passage 136 and the vascular line connector 126 to place the vascular line 116 in fluid communication with the central passage 136.

[0060] Similarly, in a first position, the second diverter valve passage 140 connects the flush line connector 128 to the sample line connector 130, to place the flush line 120 in fluid communication with the sample line 118. When the second diverter valve 134 is rotated to a second position, the second diverter valve passage 140 aligns with the sample line connector 130 and the central passage 136. When the second diverter valve 134 is rotated to a third position, the second diverter valve passage 140 is aligned between the central passage 136 and the flush line connector 128.

[0061] As depicted in FIGS. 5-6, the flow controller 104 includes a first drive motor 142, a first drive shaft 144, a first transmission 146, and a first diverter valve drive gear 148. The flow controller 104 also includes a second drive motor 150, a second drive shaft 152, a second transmission154, and a second diverter valve drive gear 156. In response to a signal communicated to the flow controller 104, the first and second drive motors 142, 150 are energized to rotate the first and second drive shafts 144, 152, respectively, in a selected direction. The rotary motion of the first and second drive shafts 144, 152 is transferred to the first and second diverter valve drive gears 148, 156 through the first and second transmission 146, 154, respectively. In the depicted embodiments, the first and second transmissions 146, 154 incorporate intermeshed gears. In other embodiments, belts or bands can be used to transfer torque from the first and second drive motors 142, 150 to the first and second diverter valve drive gears 148, 156. In some embodiments, the first and second drive motors 142, 150 are connected directly to the first and second diverter valve drive gears 148, 156 without an intervening transmission. The rotation of the first and second diverter valve drive gears 148, 156 causes the first and second valves 132, 134 to rotate.

[0062] In some embodiments, the flow controller 104 includes a harness 158 that is configured to attach the flow controller 104 to an appendage of the patient 10, as depicted in FIGS. 1 and 3. In other embodiments, the flow controller 104 is integrated with, or connected to, the test module 102. In each case, the flow controller 104 and test module 102 communicate through a wired or wireless data connection.

[0063] Turning to FIGS. 7-15, shown therein are various depictions of an embodiment of the test module 102. In the depicted embodiment, the test module 102 includes a test module body 160, a cartridge carrier 162. a replaceable test cartridge 164, a cartridge drive 166. a cartridge drive engagement assembly 168, a sample chamber drive 170, and a cartridge manifold drive 172. The test module 102 further includes an inlet connector 174, an outlet connector 176, an inlet line 178, and a waste line 180. In the depicted embodiment, the flush module 106 is integrated into the test module 102, which also includes a flush fluid container 182 and a flush pump 184. The waste container 108 can also be incorporated into the test module 102 in the depicted embodiment. The flush pump 184 can be a peristaltic pump that moves the flush fluid from the flush fluid container 182 through the outlet connector 176.

[0064] In some embodiments, the test module 102 includes an onboard computer and interface controls that allow an operator to set test parameters and cany’ out other functions of the blood sampling system 100. In other embodiments, the test module 102 is connected to a remote computer that controls the operation of the test module 102. In some embodiments, the test module 102 includes a computer display screen for graphically displaying device settings, test progress, test results, alarm codes, operational error codes, flush fluid volumes and waste container fill levels.

[0065] As illustrated in the functional diagram of FIG. 9, the sample line 118 is connected to the inlet connector 174. which in turn is connected to the inlet line 178. A one-way or check valve can be used to prevent backflow away from the test module 102 through the sample line 118. The inlet line 178 extends from the inlet connector 174 to the test cartridge 164. In the depicted embodiment, the inlet line 178 and outlet line 180 are coiled so that they remain connected to the test cartridge 164 as the test cartridge 164 is rotated. Fluids are removed from the test cartridge 164 through the waste line 180 to the waste container 108. Fluids from the fluid container 182 are pushed by the flush pump 184 to the flush line 120 through the outlet connector 176.

[0066] The test cartridge 164 includes a test cartridge body 186, a plurality of test chambers 188 within the test cartridge body 186, a cartridge inlet connector 190, a cartridge outlet connector 192 and a manifold assembly 194 connected between the cartridge inlet connector 190 and the cartridge outlet connector 192. The test cartridge body 186 is configured to engage with the cartridge drive 166. In the depicted embodiment, the test cartridge 164 includes peripheral cartridge teeth 196 that engage with a drive gear 198 on the cartridge drive 166. The cartridge drive 166 rotates the drive gear 198 to selectively rotate the test cartridge 164 such that a selected test chamber 188 can be positioned for engagement with the sample chamber drive 170. Selected test reagents can be included in each test chamber 188 during manufacture or prior to use. For example, clotting agents can be incorporated into the test chambers 188 if the test cartridge 164 is intended for blood clotting tests.

[0067] The manifold assembly 194 includes a flow loop 200 and a plurality of test chamber diverter valves 202. The flow loop 200 extends from the cartridge inlet connector 190 to the cartridge outlet connector 192 around the test cartridge body 186. Each of the plurality of test chamber diverter valves 202 connects the flow loop 200 to a corresponding one of the test chambers 188. As best depicted in FIGS. 16-21, each test chamber diverter valve 202 includes first and second test chamber diverter valve passages 204, 206. In a first position, the first test chamber diverter valve passage 204 provides a continuous path along the flow loop 200 while the second test chamber diverter valve passage 206 is in fluid communication with the interior of the test chamber 188, as depicted in FIG. 17. When the test chamber diverter valve 202 is rotated to a second position, the first and second test chamber diverter valve passages direct fluid from the flow loop 200 through the test chamber 188, as depicted in FIGS. 18-21. Each test chamber diverter valve 202 includes a test chamber diverter valve drive receiver 208 that engages with the cartridge manifold drive 172.

[0068] The cartridge drive engagement assembly 168 is depicted in FIGS. 13-15. The cartridge drive engagement assembly 168 includes a test chamber diverter valve drive motor 210 that selectively rotates the cartridge manifold drive 172. The cartridge drive engagement assembly 168 further includes a lift assembly 212 that selectively raises and lowers the cartridge manifold drive 172. When the cartridge drive 166 rotates the test cartridge 164 into a test-ready position, the intended test chamber diverter valve 202 is positioned above the cartridge manifold drive 172. The lift assembly 212 is then activated to lift the cartridge manifold drive 172 into engagement with the test chamber diverter valve receiver 208. The test chamber diverter valve drive motor 210 then rotates the cartridge manifold drive 172, which in turn selectively rotates the test chamber diverter valve 202 to an intended position to either isolate the active test chamber 188 from the flow loop 200, or align the first and second test chamber diverter valve passages 204, 206 so that fluid moves from the flow loop 200 through the active test chamber 188. Once the test chamber diverter valve 202 has been rotated between positions by the cartridge manifold drive 172, the lift assembly 212 lowers the cartridge manifold drive 172 to disengage the cartridge manifold drive 172 from the active test chamber diverter valve 202. In exemplary embodiments, the lift assembly 212 includes a threaded rod 214 that engages a threaded platen 216 that supports the sample chamber drive 170 and cartridge manifold drive 172. Rotating the threaded rod 214 in a first direction raises the threaded platen 216 while rotating the threaded rod 214 in a second direction lowers the threaded platen 216.

[0069] In embodiments in which the test module 102 is used for evaluating blood clotting, each test chamber 188 includes a rotor 218 that is configured to rotate back and forth within the test chamber 188. The rotor 218 is essentially a paddle that pushes fluid back and forth within the test chamber 188. The test chamber 188 includes an internal barrier 234 that provides a sealing interface with the test chamber diverter valve 202. As illustrated, the second test chamber diverter valve passage 206 forms a flow path within the active test chamber 188 so that fluid pushed by the movement of the rotor 218 can pass through the second test chamber diverter valve passage 206 from one side of the internal barrier 234 to the other side of the internal barrier 234. In other embodiments, the rotor 218 includes a small hole that allows the blood to pass through the rotor 218 as the rotor 218 rotates back and forth within the test chamber 188.

[0070] The rotor 218 includes a rotor receiver 220 that is configured for engagement with the sample chamber drive 170. The sample chamber drive 170 includes a shaft coupled to the rotor 218 that is rotated by a sample chamber drive motor 222. The amount of torque applied by the sample chamber drive motor 222 is measured with a torque detector 224 that is operably coupled to the sample chamber drive motor 222. The lift assembly 212 is configured to raisethe sample chamber drive 170 into engagement with the rotor receiver 220 of the rotor 218 in the active test chamber 188. Once the test has been completed, the lift assembly 212 lowers the sample chamber drive 170 out of engagement with the rotor 218.

[0071] An exemplary method of using the blood sampling system 100 begins with loading a full saline bag into the flush fluid container 182. In some embodiments, the flush fluid container 182 is the saline bag. A new test cartridge 164 is loaded into the test module 102. The inlet line 178 is connected to the inlet connector 174 and the waste line 180 is connected the waste container 108. The fluid container 182 is connected to outlet connector 176 via the flush pump 184. The flow controller 104 is connected to the test module 102 through the sample line 118 and the flush line 120. The flow controller 104 is set such that the flush line 120 and sample line 118 are connected through the second diverter valve 134.

[0072] The flush pump 184 is then activated to push the saline or other flush fluid through the flush line 120 to the flow controller 104 and back to the test module 102 through the sample line 118. The flush fluid flows through the inlet line 178 into the flow loop 200 of the test cartridge 164. In the initial configuration, each of the plurality of test chamber diverter valves 202 is positioned such that the flush fluid passes through each test chamber diverter valve 202 without entering a test chamber 188. The flush fluid passes through the flow loop 200 and is discharged from the test cartridge 164 through the cartridge outlet connector 192, which directs the flush fluid through waste line 180 to the waste container 108. This process purges air from the test cartridge 164 and the lines connecting the test module 102 to the flow controller 104.

[0073] The vascular line 1 16 from the patient 10 is then connected to the vascular line connector 126 on the flow controller 104. If a fluid bag 110 is present, then the bag line 112 can be connected from the fluid bag 110 to the bag line connector 124 of the flow controller. It may be desirable to discharge a small volume of flush fluid through the vascular line connector 126 and bag line connector 124 to expel any air from the flow controller 104 before connecting the vascular line 116 and bag line 112.

[0074] Once the blood sampling system 100 has been connected to the patient 10 and air has been removed from the system, the healthcare provider accesses the on-board computer of the test module 102 to set up control settings and manage testing results. To begin a testing session, the healthcare professional specifies patient identifying information (e.g., Name and Date of Birth), testing parameters such as testing run frequency and alert thresholds, and / or prior data pertinent to the device’s ability to adequately detect risk (although the coagulation time alone can be interpreted by a qualified healthcare professional as well). The test settings may include, for example, the test frequency, test period, and thresholds for alerts and alarms. Testingparameters, test results, and patient information can be seamlessly connected to a patient’s online medical records for ease of use. Once testing parameters are set, the healthcare provider initiates the test module 102 to begin a testing session, and until the session is complete, no staff is needed to operate the system 100.

[0075] The test begins by rotating the first diverter valve 132 and second diverter valve 134 on the flow controller 104 so that the vascular line 116 is connected to the flush line 120 through the central passage 136. The flush pump 184 is activated to pull a small amount of blood (a "test sample”) out of the vascular line 116 into the flush line 120. The second diverter valve 134 is then rotated to a second position in which the flush line 120 is connected to the sample line 118, as depicted in FIG. 4.

[0076] Once the test sample has been pulled into the flush line 120, the flush pump 184 can be reversed to push flush fluid through second diverter valve 134 to push the test sample into the sample line 118 to the test module 102. The test sample is captured within the sample line 118 between adjacent volumes of flush fluid. The test sample passes from the sample line 118 into the inlet line 178 through the inlet connector 174. The test sample enters the flow loop 200 and travels to the first unused test chamber 188, which becomes the active test chamber 188. If the test is the first test to be conducted using the test cartridge 164, the first test chamber 188 downstream from the cartridge inlet connector 190 is the active test chamber 188. The test chamber diverter valve 202 associated with the active test chamber 118 is rotated such that the first test chamber diverter valve passage 204 and second test chamber diverter valve passage 206 are connected to the interior of the test chamber 188, as depicted in FIGS. 18-21 .

[0077] Once the test sample fills the active test chamber 188, the associated test chamber diverter valve 202 is rotated back to the bypass position to isolate the active test chamber 188 from the flow loop 200, as depicted in FIGS. 16-17. The flush pump 184 then continues pushing flush fluid through the blood sampling system 100 until the remaining test sample has been discharged from the flow loop 200 into the waste container 108 through the waste line 180. In some modes of operation, the flow controller 104 is then reactivated to connect the flush line 120 to the vascular line 116 to push any blood in the vascular line 116 back into the patient 10. This prevents blood from clotting in the vascular line 116. The first diverter valve 132 can then be rotated back into the initial position in which the bag line 112 is connected to the vascular line 116 through the first diverter valve 132. In this way, the flow controller 104 only briefly interrupts the flow of fluid from the bag line 112 to the vascular line 116 to pull the test sample through the flow controller 104.

[0078] At the same time, the test module 102 begins to test the test sample in the active test chamber 188. For blood coagulation tests, the sample chamber drive 170 is activated to rotate the rotor 218 back and forth, thereby circulating the test sample blood within the test chamber 188, including through the second test chamber diverter valve passage 206. In exemplary embodiments, the test sample blood reacts with the clotting reagent and is pushed by the rotor 218 through the second test chamber diverter valve passage 206 from one side of the internal barrier 234 to the other side of the internal barrier 234 to encourage clotting. A computer processor within the blood sampling system 100 or in a connected computer automatically determines the coagulation time by measuring the amount of torque applied to the rotor 218 by the sample chamber drive 170, which is determined by the torque detector 224. Once the amount of torque applied to the rotor 218 exceeds a threshold level associated with blood clotting, the blood sampling system 100 calculates the amount of time that was required to reach clotting. The coagulation time is then recorded, displayed and reported to the operator.

[0079] The testing process repeats when the method outlined above when the test schedule input into the blood sampling system 100 calls for another test run. Multiple tests can be performed until all of the test chambers 188 in the test cartridge 164 have been used. Once the test cartridge 164 has been exhausted, the used test cartridge 164, flush fluid container 182 and waste container 108 are discarded. A new set of sterile disposable items, including the test cartridge 164, flush fluid container 182, waste container 108, flush line 120 and sample line 118 are then installed so that additional testing can be performed.

[0080] Thus, the blood sampling system 100 is capable of automatically taking a scheduled series of blood samples from the patient 10 using minimally invasive procedures. Although the blood sampling system 100 can be used for any number of blood tests, the blood sampling system 100 is particularly well suited for determining blood coagulation time of hospital patients. The system 100 regularly tests blood throughout a given time period. The blood sampling system 100 automatically draws and tests blood without staff or patient involvement and without any noticeable sensation to the patient. By doing so, the blood sampling system 100 can continuously monitor coagulation time, even while the patient is 10 asleep, so the hospital staff will have a constant, up-to-date reading on a patient's risk for a clotting disorder and can preventatively treat patients, thus averting blood clot formation.

[0081] Turning to FIG. 22, depicted therein is another embodiment of the blood sampling system 100. In this embodiment, the flow controller 104 includes a single diverter valve 226 that selectively connects the vascular line 116 to the sample line 118, or the vascular line 116 to the bag line 112, or the bag line 1 12 to the sample line 118. An IV controller 228 can be used to control theflow of fluid from the fluid bag 110. in this embodiment, the motorized single diverter valve 226 is a 3-way stopcock that can be automatically rotated to connect two of the three connections at the flow controller 104. In this way, when the flow controller 104 is in a first position, blood can be drawn directed from the vascular line 116 into the test module 102, and when the flow controller 104 is in a second position, the flush module 106 delivers saline (or other flush fluids) to flush blood from the tubing when the test module 102 is between tests.

[0082] Turning to FIGS. 23-24, depicted therein is an alternate embodiment of the test cartridge 164. In this embodiment, the test cartridge 164 includes a two-piece rotor 230. The two-piece rotor 230 includes two halves 232a, 232b, as best depicted in FIGS. 23-24. One of the rotor halves 232a is driven by the motorized sample chamber drive 170, while the second rotor half 232b is passive. When the rotor half 232a is rotated by the motorized sample chamber drive 170, the two rotor halves 232a, 232b approximate and lock together to form a locked rotor 230. Locking mechanisms on the two rotor halves 232a, 232b secure the two halves 232a, 232b together. Suitable locking mechanisms include interference-fit or intermeshed fingers that lock when approximated together. As the first rotor half 232a is rotated into contact with the second rotor half 232b, the first rotor half 232a draws a small vacuum in the space within the test chamber 188 previously occupied by the first rotor half 232a, which encourages the movement of the test sample into the active test chamber 188 from the flow loop 200. The locked, combined rotor 230 can be rotated back and forth within the test chamber 188 by the motorized sample chamber drive 170. The test chamber 188 includes an internal barrier 234 with a port 236 that permits the passage of fluid through the port 236 as the rotor 230 rotates back and forth within the test chamber 188. In the embodiment depicted in FIG. 24, the test chamber diverter valve 202 has been replaced with a two-position diverter or stopcock 238 that can be rotated by the cartridge manifold drive 172 between a first position that directs fluid into the active test chamber 188 and a second position in which fluid is directed through the flow loop 200.

[0083] FIGS. 25-28 depict an alternate embodiment of the test module 102. In the embodiment depicted in FIGS. 25-28, the test module 102 includes an alternate mechanism for determining coagulation time. The test module 102 includes a camera 240 that is placed above the test cartridge 164. The cartridge drive engagement assembly 168 includes a flexible rotor drive shaft 242 that connects between the sample chamber drive motor 222 and the rotor receiver 220. As the blood in the active test chamber 188 coagulates and becomes more viscous, the increased resistance applied to the rotor 230 causes a twisting deflection in the flexible rotor drive shaft 242. The camera 240 is programmed to monitor the movement of the rotor 230, which can be compared against the known rotational movement and position of the samplechamber drive motor 222. The offset in rotational position caused by the deflection of the flexible rotor drive shaft 242 can be used to determine the extent of coagulation and coagulation time. In particular, equations and charts have been developed and loaded into the blood sampling system 100 to correlate coagulation time based on changes to the viscosity of the blood in the test chamber as a function of torque and angular deflection. FIG. 28 shows how this angle of deflection as captured by the camera can be used to calculate the viscosity of the blood at any given time based on the calculated torque induced on the blood to cause the deformation of the rotor shaft.

[0084] Turning to FIGS. 39-35, shown therein is another embodiment of a self-contained, wearable coagulation monitor 300. The coagulation monitor 300 is secured to the skin of a patient and includes one or more puncturing devices such as lancets or capillaries used to puncture the skin. The coagulation monitor 300 can be secured to the patient's skin with an attaching device, such as but not limited to a strap, a belt, a band, an elastic bandage, a cord, a tape, or an adhesive. The coagulation monitor 300 includes a puncturing device that obtains a plurality' of blood samples over a predetermined duration of time, such as 24 hours. Each blood sample is drawn into a test chamber in the coagulation monitor 300 where it is tested for its rate of coagulation by any suitable means, (e.g., electrical, mechanical, or chemical). The results obtained during the testing period are used to determine further treatment by a healthcare worker, such as a physician, physician's assistant, or a nurse.

[0085] As illustrated in FIGS. 31-35, the coagulation monitor 300 includes a base 302. a test cartridge 304, a cartridge cover 306, a cartridge actuation assembly 308, a first drive assembly 310, a second drive assembly 312, and a camera 314. As illustrated in FIG. 31, the base 302 includes a cartridge aperture 316 that permits the test cartridge 304 to directly contact the skin of the patient 10.

[0086] The first drive assembly 310 is attached to the base 302 and configured to rotate the test cartridge 304 within the base 302 over the position to be tested. The first drive assembly 310 includes a stepper motor and a drive gear (not separately numbered) that engage with a ring gear 318 on the test cartridge 304. The second drive assembly 312 is also attached to the base 302 and configured rotate the cartridge actuation assembly 308. The second drive assembly 312 includes a stepper motor and a drive gear (not separately numbered) that engage with a ring gear 320 on the cartridge actuation assembly 308. In this way, the test cartridge 304 and cartridge actuation assembly 308 are independently rotatable.

[0087] The test cartridge 304 includes a plurality of test chambers 322. Each test chamber 322 is sealed in a sterile state with a penetrable membrane prior to use to prevent contamination. Each testchamber 322 includes a rotor 324 and a lancet 326. In the depicted embodiment, each test cartridge 304 is configured as a hollow cylinder that includes 8 vertically oriented test chambers 322 within the body of the test cartridge 304. The cartridge actuation assembly 308 is configured to fit into the interior of the test cartridge 304 to selectively manipulate the rotor 324 and lancet 326. Each test chamber 322 may include a divider 328 with a port 330 that permits blood or other fluids to pass through the divider 328.

[0088] The rotor 324 is a mobile part within each test chamber 322 that may be rotated on an axis by interfacing with a rotor drive assembly 332 within the cartridge actuation assembly 308. The test chamber 322 is a cylindrical space with a stationary wall of the test cartridge 304 normal to the circular faces along a radial line. The flat face nearer to the center of the test cartridge 304 is flat plastic while the exterior face is clear plastic to allow viewing of the contents of the test chamber 322 by the camera 314. The rotor 324 is an arcuate member that extends roughly 250 degrees, with the gap creating chambers on either side of the divider 328. By rotating the rotor 324, these chambers may be expanded or contracted, while the sum of the volumes will remain constant. This expansion and contraction functions as the mode at which the rotor 324 interacts with the blood for safe and effectual testing.

[0089] The rotor 324 serves three main purposes. First, the rotor 324 is responsible for drawing blood into the test chamber 322. This blood draw is accomplished by expanding the left sealed chamber with the only available inlet being a hole in contact with newly pricked skin where blood actively pools. An outlet is formed that connects the left and right chambers formed by puncturing a membrane that covers the outlet. Second, the rotor 324 pushes the collected blood through the outlet repeatedly in view of the camera 314. The behavior of the blood is tracked, and the diminishing of flow will be used to calculate coagulation time. Thirdly, the rotor 324 houses the lancet 326. Thus, it starts in a position to allow the lancet 326 to be driven into the skin and may end at an angle that angles the lancet 326 away from exit holes to allow for safe inactivation.

[0090] In addition to the rotor drive assembly 332, the cartridge actuation assembly 308 also includes a puncture drive assembly 334 and an engagement assembly 336. The puncture drive assembly 334 includes a puncture drive motor 338 that drives a rack and pinion set 340 to raise or lower a slide arm 342 that selectively engages with the lancet 326 when the slide arm 342 is approximated into contact with the lancet 326. When the puncture drive motor 338 is rotated in a first direction, the rack and pinion set 340 lowers the slide arm 342, which in turn deploys the lancet 326 into the skin of the patient 10. When the puncture drive motor 338 is rotated in a second direction, the rack and pinion set 340 raises the slide arm 342 to withdraw the lancet326 from the patient’s skin. Similarly, the rotor drive assembly 332 includes a rotor drive motor 344 and a rotor drive shaft 346 that is configured to selectively engage with the rotor 324 in an active test chamber 322. When the rotor drive motor 344 is energized, the rotor drive shaft 326 causes the rotor 324 to rotate back and forth within the test chamber 322.

[0091] The engagement assembly 336 includes a stationary engagement motor 348, a threaded engagement shaft 350 driven for rotation by the engagement motor 348. a plurality of threaded nuts 352 and a movable carrier 354. The rotor drive assembly 332 and puncture drive assembly 334 are both connected to the carrier 354. When the engagement motor 348 rotates the threaded engagement shaft 350 in a first direction, the threaded nuts 352 push the movable carrier 354 laterally in a first direction within the cartridge actuation assembly 308. When the engagement motor 348 rotates the threaded engagement shaft 350 in a second direction, the movable carrier 354 shifts laterally in a second direction within the cartridge actuation assembly 308. In this way, the engagement assembly 336 is used to selectively push the puncture drive assembly 334 into engagement with the lancet 326 of a first test chamber 322. When the engagement assembly 336 is reversed, the engagement assembly 336 disengages the puncture drive assembly 334 from the lancet 326 while pushing the rotor drive assembly 332 into engagement with the rotor 324 of a second test chamber 322. By rotating the cartridge actuation assembly 308 within the test cartridge 304, the engagement assembly 336 can selectively engage and disengage the puncture drive assembly 334 and rotor drive assembly 332 from test chambers 322.

[0092] A suitable location for placement of the sampling device on the body is identified in FIGS. 29- 30. Deep Vein Thrombosis (DVT), the primary origin of dangerous blood clots for patients in hospital care, tend to form in stationary limbs (arms and legs) with poor blood movement. The coagulation monitor 300 is most reliable when affixed to areas with high rates of DVT formation. The patients' anterior and lateral thighs are perhaps best suited to this application, as this tends to be the areas of greatest surface area. Other locations may be viable depending on the patient, such as the upper arm. Certain locations should be avoided due to important structures in underlying tissue. For example, the great saphenous vein runs along the inner thigh and is relatively close to the surface, and so the medial thigh ought to be avoided as a testing location.

[0093] Prior to securing the coagulation monitor 300 to the patient, the skin at the placement location may be shaved with an electric razor and wiped clean with alcohol. Generally, the human body excels at handling small, shallow, and clean puncture wounds. So. while the cleanliness of a patient's skin at a sample site may not have much bearing on the infection risk of the sampling,further precaution will not harm patient outcomes. The location of the coagulation monitor 300 placement should be shaved to prevent catching on moving components and wiped with an alcohol wipe just before the device is placed on the skin. Once the device is placed on the tissue, the skin will be kept isolated from outside environment, and risk of unsafe puncture will be minimal.

[0094] The coagulation monitor 300 is secured via the attaching device to the sterile site (FIGS. 39- 30) such that it is secure to the skin surface of the patient without impeding blood flow. A sterile test cartridge 304 is removed from its packaging and placed into the coagulation monitor 300, and the sampling device lid is secured. The cartridge component contains the lancet and all parts that will interact with the patient's blood. These will be packaged in a sealed bag, which will be opened just before use. Additionally, the chambers are sealed by membranes, which keep the lancet contained in the air-tight chamber until activated. In this combination, all lancets will be sealed in a sterile environment until they are actively puncturing the membrane and patient skin. This should keep parts in a sterile environment for a sufficient amount of time. The sampling device is powered on and ready for connection to a local network such a local network of a hospital or other medical facility.

[0095] An exemplary method of using the coagulation monitor 300 begins with the healthcare provider uses a computer system of the hospital or medical facility , or a tablet, laptop, smartphone, or other computing device to connect to the coagulation monitor 300 via WiFi, or other secure system developed in compliance with local regulations. An interface is loaded and the healthcare provider selects enters patient information and test information. At this point, device information will be loaded into the window along with a real-time monitoring diagram of the coagulation monitor 300. Once all necessary' information is in the window, the healthcare provider may press "Start Measurement" to commence monitoring for the specified period. While coagulation monitor 300 is in operation, components will be highlighted green while active and blood-occupied chambers will be filled with red. Sample data will fill the table to the right of the diagram as samples are collected, including Sample number, sample time, and notable results. The coagulation monitor 300 may automatically calibrate its motors before beginning the testing session.

[0096] In exemplary embodiments, samples are taken from the patient 10 at positions that are approximately 135 rotational degrees offset from the previous sampling location. This ensures adequate spacing between lancet pricks to minimize trauma to the patient 10 by preventing a test from being conducted on a site that is adjacent to the site that was just tested. The test cartridge 304 rotates so that an empty test chamber 322 is positioned over the testing location.Next, the cartridge actuation assembly 308 is rotated inside the test cartridge 304 so that the puncture drive assembly 334 is aligned with the lancet 326 of the active test chamber 322. The engagement assembly 336 is then activated to push the slide arm 342 of the puncture drive assembly 334 into engagement with the lancet 326.

[0097] Using the rack and pinion set 340, the puncture drive motor 338 is activated to push the slide arm 342 and lancet 326 downward, puncturing the sterile film membrane and into the skin to a depth of around 2.5 mm. The range of motion of the lancet 326 is limited by a stop to prevent the lancet 326 from extending too deeply into the patient 10. The selected depth is slightly higher than established standards of blood draws from fingers and heels as the vasculature will be less sensitive in the patient's leg. This aims to reach mid dermis to increase access to blood while avoiding sensitive structures. The puncture drive assembly 334 retracts the lancet 326 back into the test cartridge 304, leaving a droplet of blood to pool on the skin.

[0098] The engagement assembly 336 then disengages the slide arm 342 from the lancet 326 by shifting the carrier 354 away from the active test chamber 322. The engagement assembly 336 is then rotated by 180 degrees and the engagement assembly 336 is activated to push the rotor drive shaft 346 into engagement with the rotor 324. The rotor drive motor 344 then activates to rotate the rotor 324 in a clockwise direction to draw the blood into the left portion of the test chamber 322 using negative pressure.

[0099] At full rotation of the rotor 324, a membrane blocking the small port 330 between the left and right chambers is broken, allowing for the blood to move freely between chambers. At this point, the test cartridge 304 is rotated to 0 degrees to orient the active rotor 324 and contained blood to face the camera 314. Once the test cartridge 304 is aligned, the coagulation monitor 300 turns on an internal LED that illuminates the test chamber 322 and the blood within and begins recording the movement of the blood within the test chamber 322. To test the blood, the rotor 324 rotates back and forth, forcing blood through the small port 330. This process is continued until the rotor 324 is not able to rotate any longer due to the increasing viscosity of the blood in the test chamber 322. At that point, the rotor 324 disengages and the camera 314 stops recording, and the rotor drive motor 344 deactivates to preserve power during the wait period between samples. The collected video file is sent to the network computer to run image processing. In the meantime, the coagulation monitor 300 keeps the test cartridge 304 stationary to allow the collected blood to fully solidify to prevent dangerous exposure to fluidstate blood. Blood drawn into the test cartridge 304 is kept with the intention of allowing blood to coagulate / solidify prior to future handling by hospital staff. With this, all blood will be either within the test cartridge 304 as a solid or formed as a crust at puncture sites. Thus, withrelatively standard personal protective equipment, hospital staff can remove the coagulation monitor 300 from the patient, take out the test cartridge 304, and prepare the base 302 for reuse.

[0100] The video file is received by the main computer and passed through an image processing algorithm. In brief, the individual pixels of the video file are analyzed by color, and red pixels are isolated and quantified on either side of the test chamber 322. The ability7of the blood to flow through the small port 330, associated with its viscosity7, is linked to the coagulation of the blood. The amount of blood that freely moves through the port 330 with each trial is normalized against total blood and plotted against time. Using this plot, blood coagulation time can be estimated. When a blood coagulation time that is out of the ordinary7is measured, the patient's healthcare team is alerted to administer a preventative treatment.

[0101] Once the testing of a particular sample is completed, the coagulation monitor 300 waits for the designated time period between samples and repeats sample collection at anew location on the patient 300. This cycle continues for the predetermined number of blood samples to be collected (e.g., 8 samples). At the end of the testing period, the coagulation monitor 300 can be removed from the patient 10, and if testing is desired to continue, the coagulation monitor 300 can be repositioned to another are of the skin surface to avoid over-stressing one area of tissue. The coagulation monitor 300 is meant to be a reusable device. All components with substantial cost are in the base 302 of the coagulation monitor 300, while the inexpensive but necessary7parts are contained within the test cartridge 304.

[0102] The embodiments disclosed herein overcome a number of deficiencies in the prior art, including by eliminating the need for manual blood draws and testing, which reduces staff workload and minimizes human error. Additionally, the systems and methods disclosed herein provide continuous monitoring and real-time, scheduled coagulation measurements, thereby enabling proactive intervention to prevent clotting or bleeding complications. The systems and methods disclosed herein also improve patient safety by reducing the risk of pulmonary embolism and deep vein thrombosis by maintaining up-to-date coagulation data for timely administration of anticoagulants. The disclosed systems are configured for simplified integration with existing clinical systems and are capable of transmitting test results to electronic medical records, ensuring seamless data management and compliance with hospital protocols.

[0103] It will be appreciated that certain features from one embodiment can be used with another embodiment. For example, in some embodiments, the camera 314 is replaced with the torque detector 224. In other embodiments, the torque detector 224 is replaced with the camera 240. Although the disclosed embodiments have been focused on coagulation tests, the systemsdisclosed herein are easily adaptable for multiple diagnostic tests beyond coagulation analysis, including blood sugar and liver function testing. The systems are minimally invasive and, in certain embodiments, utilize existing vascular access or small lancet punctures, minimizing patient discomfort and infection risk.

[0104] Thus, in some embodiments, the present disclosure is directed to a blood sampling system for measuring coagulation time from blood drawn through a vascular line connected to a patient, where the system includes a test module including a test cartridge having at least one test chamber and a rotor disposed within the test chamber, a torque detector configured to determine torque applied to the rotor during rotation, a processor configured to calculate coagulation time based on torque data, a flush module configured to deliver a rinse fluid, and a flow controller including a motorized selector valve configured to control fluid flow between the vascular line, the test module, and the flush module.

[0105] In some of the blood sampling system embodiments, the test cartridge can include a plurality of test chambers arranged circumferentially.

[0106] In some of the blood sampling system embodiments, the chamber includes a port configured to permit blood flow during rotation.

[0107] In some of the blood sampling system embodiments, the torque measurement assembly comprises a torque sensor operably coupled to a rotor drive motor.

[0108] In some of the blood sampling system embodiments, the torque detector is replaced by a camera system.

[0109] In some of the blood sampling system embodiments, the processor is configured to generate an alert when coagulation time exceeds a threshold.

[0110] In some of the blood sampling system embodiments, the flow controller comprises a first diverter valve and a second diverter valve.

[0111] In some of the blood sampling system embodiments, the flush module includes a peristaltic pump for delivering saline solution.

[0112] In some of the blood sampling system embodiments, the processor can be configured to generate an alert when coagulation time exceeds a threshold.

[0113] In any of the blood sampling system embodiments outlined above, the flush module can include a peristaltic pump for delivering saline solution.

[0114] In any of the blood sampling system embodiments outlined above, the flow controller can include a first diverter valve and a second diverter valve.

[0115] In any of the blood sampling system embodiments outlined above, the present disclosure is directed to a method for automatically determining blood coagulation time of a patient thatincludes the steps of drawing a blood sample from a vascular line using a motorized flow controller, transferring the blood sample to a test chamber of a test cartridge, rotating a rotor within the test chamber and measuring torque applied to the rotor over time, calculating coagulation time based on torque measurements, and flushing the vascular line and test module with a rinse fluid after testing.

[0116] In some of the method embodiments, the method includes the step of rotating a diverter valve to connect the vascular line to the flush module after testing.

[0117] In some of the method embodiments, the method includes the step of rotating the rotor back and forth to circulate blood within the test chamber.

[0118] In some of the method embodiments, the method includes the step of isolating the test chamber from a flow loop after filling with blood.

[0119] In some of the method embodiments, the method includes the step of determining coagulation time as the point at which torque exceeds a predetermined threshold.

[0120] In some of the method embodiments, the method includes the step of transmitting test results to a remote computer system.

[0121] In some of the method embodiments, the method includes the step of capturing the blood sample between volumes of flush fluid during transfer.

[0122] In any of the method embodiments outlined above, the method further comprising the step of isolating the test chamber from a flow loop after filling with blood.

[0123] In any of the method embodiments outlined above, the method further comprising the step of determining coagulation time as the point at which torque exceeds a predetermined threshold.

[0124] In any of the method embodiments outlined above, the method further comprising the step of transmitting test results to a remote computer system.

[0125] In yet other embodiments, the present disclosure is directed at a wearable coagulation monitoring device that includes a base configured to attach to a patient's skin, a test cartridge including a plurality of test chambers, each test chamber having a rotor and a lancet, a cartridge actuation assembly configured to selectively engage the rotor and lancet, a camera configured to monitor blood movement within the test chamber, and a processor configured to determine coagulation time based on image analysis of blood flow through a port in the test chamber.

[0126] In some of the wearable device embodiments, the test cartridge comprises eight test chambers arranged in a cylindrical configuration.

[0127] In some of the wearable device embodiments, each lancet is sealed by a penetrable membrane prior to activation.

[0128] In some of the wearable device embodiments, the cartridge actuation assembly includes a rotor drive assembly and a puncture drive assembly.

[0129] In some of the wearable device embodiments, the processor is configured to analyze pixel movement in recorded video to determine coagulation time.

[0130] In some of the wearable device embodiments, the camera is positioned to capture blood flow through a port between two chambers of the test chamber.

[0131] In any of the wearable device embodiments outlined above, the cartridge actuation assembly includes a rotor drive assembly and a puncture drive assembly.

[0132] In any of the wearable device embodiments outlined above, the processor is configured to analyze pixel movement in recorded video to determine coagulation time.

[0133] In any of the wearable device embodiments outlined above, the camera is positioned to capture blood flow through a port between two chambers of the test chamber.

[0134] In any of the wearable device embodiments outlined above, the camera is replaced by a torque detector.

[0135] It is to be understood that even though numerous characteristics and advantages of various embodiments of the present invention have been set forth in the foregoing description, together with details of the structure and functions of various embodiments of the invention, this disclosure is illustrative only, and changes may be made in detail, especially in matters of structure and arrangement of parts within the principles of the present invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.

Claims

It is Claimed:

1. A blood sampling system for measuring coagulation time from blood drawn through a vascular line connected to a patient, the system comprising: a test module including a test cartridge having at least one test chamber and a rotor disposed within the test chamber; a torque detector configured to determine torque applied to the rotor during rotation; a processor configured to calculate coagulation time based on torque data; a flush module configured to deliver a rinse fluid; and a flow controller including a motorized selector valve configured to control fluid flow between the vascular line, the test module, and the flush module.

2. The system of claim 1, wherein the test cartridge comprises a plurality of test chambers arranged circumferentially.

3. The system of claim 1, wherein the chamber includes a port configured to permit blood flow during rotation.

4. The system of claim 1, wherein the torque measurement assembly comprises a torque sensor operably coupled to a rotor drive motor.

5. The system of claim 1, wherein the processor is configured to generate an alert when coagulation time exceeds a threshold.

6. The system of claim 1, wherein the flow controller comprises a first diverter valve and a second diverter valve.

7. The system of claim 1, wherein the flush module includes a peristaltic pump for delivering saline solution.

8. A method for automatically determining blood coagulation time of a patient, comprising: drawing a blood sample from a vascular line using a motorized flow controller; transferring the blood sample to a test chamber of a test cartridge; rotating a rotor within the test chamber and measuring torque applied to the rotor over time; calculating coagulation time based on torque measurements; and flushing the vascular line and test module with a rinse fluid after testing.

9. The method of claim 8, further comprising rotating a diverter valve to connect the vascular line to the flush module after testing.

10. The method of claim 8, wherein the rotor is rotated back and forth to circulate blood within the test chamber.

11. The method of claim 8, further comprising isolating the test chamber from a flow loop after filling with blood.

12. The method of claim 8, wherein coagulation time is determined when torque exceeds a predetermined threshold.

13. The method of claim 8, further comprising transmitting test results to a remote computer system.

14. The method of claim 8. wherein the blood sample is captured between volumes of flush fluid during transfer.

15. A wearable coagulation monitoring device comprising: a base configured to attach to a patient’s skin;a test cartridge including a plurality' of test chambers, each test chamber having a rotor and a lancet; a cartridge actuation assembly configured to selectively engage the rotor and lancet; a camera configured to monitor blood movement within the test chamber; and a processor configured to determine coagulation time based on image analysis of blood flow through a port in the test chamber.

16. The device of claim 15, wherein the test cartridge comprises eight test chambers arranged in a cylindrical configuration.

17. The device of claim 15. wherein each lancet is sealed by a penetrable membrane prior to activation.

18. The device of claim 15, wherein the cartridge actuation assembly includes a rotor drive assembly and a puncture drive assembly.

19. The device of claim 15, wherein the processor is configured to analyze pixel movement in recorded video to determine coagulation time.

20. The device of claim 15, wherein the camera is positioned to capture blood flow through a port between two chambers of the test chamber.

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