WO2018022722A1

WO2018022722A1 - Methods and systems for blood donor assessment

Info

Publication number: WO2018022722A1
Application number: PCT/US2017/043894
Authority: WO
Inventors: Linda Barnes; Meghan DELANEY
Original assignee: Bloodworks
Priority date: 2016-07-27
Filing date: 2017-07-26
Publication date: 2018-02-01

Abstract

Methods and systems for blood donor assessment are provided herein. In some versions, the methods are computer implemented methods for identifying a blood donor, and/or methods of transfusing blood without a temperature controlled blood storage step.

Description

METHODS AND SYSTEMS FOR BLOOD DONOR ASSESSMENT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.

62/367,620, filed July 27, 2016, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.

INTRODUCTION

[0002] Hemorrhage is a major cause of potentially preventable deaths. Postpartum hemorrhage is one type of such hemorrhage. Reduction of maternal mortality has long been a global health priority and is a target in the United Nations Millennium Development Goals (MDG) framework and the Global Strategy for Women's, Children's and Adolescents' Health. Despite established interventions to prevent and treat postpartum hemorrhage (PPH) (e.g., active management of the third stage of labor, skilled birth attendants, and facility based births); PPH remains the leading individual cause of maternal death, accounting for 27.1% of maternal mortality globally. In 26% of hemorrhagic deaths, blood product availability is cited as a causative factor. Hemorrhage is also the leading cause of morbidity and mortality in those that have suffered traumatic accidents and severe anemia from malaria increases the likelihood of death in children < 5 years old. Such circumstances impact 23 - 56 million people annually. Death and morbidity is preventable with timely blood transfusion.

SUMMARY

[0003] Methods and systems for blood donor assessment are provided herein. In some versions, the methods are computer implemented methods for identifying a blood donor, and/or methods of transfusing blood with or without a temperature controlled, e.g., refrigerated, blood storage step.

[0004] Computer implemented methods for blood donor assessment are provided herein. In various instances, the methods include applying a client device or aspects thereof. A client device is provided which is configured to provide a first set of instructions to a user to perform a check of the demographic information of the donor and to obtain consent from a potential blood donor. In various instances, the client device receives the demographic information of the donor and the obtained consent data and provides, to the user, a second set of instructions including blood type images to check for the blood type of the blood donor. In some versions, the image yields an interpretation, e.g., a computer-generated interpretation, of an image. Wherever the subject description refers to an image, a computer-generated interpretation of an image can be applied instead. In such versions, the interpretation of the image, not the images themselves are compared. Also, in various aspects, the device is configured to collect information about potential blood donors and/or store the information on a database of the device or a remote database for later access by, for example, a remote database user, such as a doctor or other healthcare authority, and/or by a user of a subject device.

[0005] The client device also can receive a second input that includes an image of blood from the donor and a selection of the provided blood type images. The client device compares the image of blood from the donor with the selected blood type images and provides a warning to the user if the image of the donor blood corresponds to a different blood type than the blood type images selected by the user. Additionally, the client device also provides a third set of instructions to perform an infectious disease test on the obtained donor blood. The client device also can receive the results of the infectious disease test and/or provide or transmit an interpretation of the results.

[0006] In some aspects, the client device provides a donor assessment result to the user based on the received first input of the demographic information of the donor and the obtained consent data, the received second input of the image of blood from the donor and the selected blood type images, and the received third input including the infectious disease test data. Additionally, the client device can wirelessly communicate the donor assessment result to a blood transfusion device or to a remote server. In some embodiments, the blood transfusion device is a portable transfusion device for use in the field (e.g., to obtain blood from a donor at his home or workplace) or at a medical facility. This portable device can be or include a custom-designed backpack or other compact carryable or handheld system including all of the transfusion components needed to perform the transfusion on the field and the computing capability to allow it to receive data from or send data to an application on a client device used to determine donor/patient blood compatibility.

[0007] In various embodiments, the client device additionally provides wireless instructions to other point of care devices to perform an anemia test and vital signs test on the donor and/or patient and subsequently receives data associated with the anemia test, thevital signs test, and/or other quantitative or qualitative tests or measures, e.g., weight, infectious disease tests. The vital signs test may be performed while the blood transfusion procedure occurs to monitor for any adverse events during the blood transfusion process. [0008] In some aspects, the device maintains a registry of potential donors and/or accesses such a registry in a remote database, such as on the cloud. Also, in some embodiments, the device captures information about individuals screening positive for infectious diseases and/or transmits such information to appropriate authorities, such as by transmitting the information to a database accessible by such authorities, for consequent follow-up by the authorities.

[0009] During the blood transfusion procedure, the client device can provide

informational instructions for preparing and transfusing blood from the donor to the patient. Additionally, the client device sends systems notifications and location information to one or more third party systems regarding the blood transfusion procedure. Upon completion of the blood transfusion procedure, the client device can provide study summary information to the user and a third party system for further analysis.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] These and other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures, wherein:

[0011] FIG. 1 depicts a system environment of the blood transfusion device and corresponding software application, in accordance with one embodiment.

[0012] FIG. 2 displays a flow diagram to the steps of patient assessment, mobilization, and screening, in accordance with one embodiment.

[0013] FIG. 3 displays a flow diagram depicting the steps of collecting, testing, and administering blood, in accordance with one embodiment.

[0014] FIG. 4 displays a first interface depicting patient demographics and consent and a second interface depicting patient blood, in accordance with one embodiment.

[0015] FIG. 5 displays a third interface depicting donor demographics and consent and a fourth interface depicting donor blood typing, in accordance with one embodiment.

[0016] FIG. 6 displays a fifth interface detailing the testing of infectious diseases in the donor and a sixth interface specifying the blood transfusion suitability, in accordance with one embodiment.

[0017] FIG. 7 displays a seventh, eight, and ninth interface, each describing instructions for transfusing blood received from a donor to a patient, in accordance with one embodiment. [0018] FIG. 8 displays a tenth, eleventh, and twelfth interface, each displaying summary information regarding the blood transfusion, in accordance with one embodiment.

[0019] FIG. 9 provides an interaction diagram of a process between a client device, a user of the client device, and a blood transfusion device, in accordance with one embodiment.

DETAILED DESCRIPTION

[0020] Methods and systems for blood donor assessment are provided herein. In some versions, the methods are computer implemented methods for identifying a blood donor, and/or methods of transfusing blood with or without a temperature controlled, e.g., refrigerated, blood storage step.

[0021] Before the present invention is described in greater detail, it is to be understood that this invention is not limited to particular embodiments described, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0022] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges can independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0023] Certain ranges can be presented herein with numerical values being preceded by the term "about." The term "about" is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number can be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[0024] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described.

[0025] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided can be different from the actual publication dates which can need to be independently confirmed.

[0026] It is noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation.

[0027] Additionally, certain embodiments of the disclosed devices and/or associated methods can be represented by drawings which can be included in this application.

Embodiments of the devices and their specific spatial characteristics and/or abilities include those shown or substantially shown in the drawings or which are reasonably inferable from the drawings. Such characteristics include, for example, one or more (e.g., one, two, three, four, five, six, seven, eight, nine, or ten, etc.) of: symmetries about a plane (e.g., a cross- sectional plane) or axis (e.g., an axis of symmetry), edges, peripheries, surfaces, specific orientations (e.g., proximal; distal), and/or numbers (e.g., three surfaces; four surfaces), or any combinations thereof. Such spatial characteristics also include, for example, the lack (e.g., specific absence of) one or more (e.g., one, two, three, four, five, six, seven, eight, nine, or ten, etc.) of: symmetries about a plane (e.g., a cross-sectional plane) or axis (e.g., an axis of symmetry), edges, peripheries, surfaces, specific orientations (e.g., proximal), and/or numbers (e.g., three surfaces), or any combinations thereof.

[0028] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which can be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[0029] Computer implemented methods for blood donor assessment are provided herein. Such methods include determining whether a potential blood donor's blood is suitable for transfusion into one or more recipients of transfused blood. Such methods can also, in some aspects include evaluating blood donor compatibility, for example, compatibility with a particular potential recipient. The methods also include evaluating the appropriateness and/or safety of one or more potential blood donors with a particular potential recipient. As such, the methods can also include identifying a safe and appropriate blood donor for a particular recipient, for example, a safer and more appropriate blood donor for a particular recipient as compared to other evaluated blood donors. The subject embodiments also include evaluating a plurality of potential donors according to the subject methods and selecting one of the donors form the plurality who is an appropriate donor for a particular recipient. According to the subject embodiments, many aspects of the subject methods can be non-computer implemented and instead be manually performed.

[0030] In some versions of the subject embodiments, the methods, systems and/or devices are used on or in association with a subject. A subject can include a patient, e.g., a blood recipient or a potential blood recipient, and/or a blood donor or potential blood donor. In certain embodiments, a subject is a "mammal" or a "mammalian" subject, where these terms are used broadly to describe organisms which are within the class mammalia, including the orders carnivore (e.g., dogs and cats), rodentia (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys). In some embodiments, the subject is a human. The term "humans" can include human subjects of both genders and at any stage of development (e.g., fetal, neonates, infant, juvenile, adolescent, and adult), where in certain embodiments the human subject is a juvenile, adolescent or adult. While the devices and methods described herein can be applied in association with a human subject, it is to be understood that the subject devices and methods can also be applied in association with other subjects, that is, on "non-human subjects."

[0031] The subject embodiments include providing to a user on a client device, e.g., a cell phone, a first set of instructions for the user to perform a check of donor demographics, consent of a blood donor, and/or other identifying features such as fingerprint, iris and/or retina patterns. The first set of instructions can include any one or combination of the prompts provided in FIG. 5, screen 3. A check of donor demographics can include a performing and/or checking one or more donor demographic screenings including one or more donor demographic screening questions. Such question scan include, for example, any of the queries presented, for example, in FIG. 5, screen 3.

[0032] The subject aspects can also include receiving, at the client device, a first input from the user including donor demographics and/or consent data. The data can include any one or combination of the No/Yes responses provided, for example, in FIG. 5, screen 3.

[0033] In various embodiments, the methods include providing, on the client device, a second set of instructions for the user to perform a check of donor blood type for the blood donor or any qualifying blood donors. The second set of instructions can include, for example, any one or combination of the prompts provided in FIG. 5, screen 4. For example, the second set of instructions can include two or more blood type images. Blood type images can be distinguishable from one another based on the blood type they each are associated with.

[0034] The embodiments also can include receiving, at the client device, a second input including an image of donor blood, such as an image of donor blood taken with a client device, e.g., a cell phone including a camera. The second input can also include a selection of a suitable blood type or determination regarding blood type data including a selection, e.g., a manual selection, of one or more of the two or more blood type images.

[0035] In various aspects, the methods include comparing, by the client device, the image of donor blood with the selected one or more images and/or a stored database of blood type images. In various instances, the methods include identifying the image of donor blood to be the same and/or different than one or a combination of blood type images in the database. The methods can include providing a donor assessment result at the client device based on the first input and the second input. Such a result can be based upon, the identification of the image of donor blood as same and/or different than one or a combination of blood type images in the database.

[0036] As noted above, the methods include comparing the image of donor blood with the selected one or more images and/or a stored database of blood type images. Such comparing step can be performed automatically by the client device or can be performed by a user based upon a display of the images provided to the user by the client device. When a comparison is performed by the user, the comparison can include a selection of one or more of the images based on the comparison. Comparing the image of donor blood with the selected one or more images and/or a stored database of blood type images can also be performed by a server, e.g., a server remote from the client device, such as a server located at a healthcare facility treating a potential recipient. Comparing the image of donor blood with the selected one or more images and/or a stored database of blood type images can also be performed by a professional, such as a healthcare provider, at a location remote from the client device. As such, the various embodiments can include communicating one or more of the images to a remote server or professional and/or receiving at the client device a selection based on the comparison.

[0037] In various embodiments, the methods include providing a third set of instructions to perform a third test, e.g., an infectious disease test. Performing such a test can include helping to ensure the safety of the donor and/or the recipient. The third set of instructions can include, for example, any one or combination of the prompts provided in FIG. 6, screen 5. The subject aspects also can include receiving a third input including infectious disease test data. The data can include any one or combination of the responses provided, for example, in FIG. 6, screen 5. Also, in some versions, the donor assessment result is based on the first input, the second input, and/or the third input. Providing a donor assessment result at the client device can include performing, e.g., automatically performing, any one or combination of the assessment steps provided in FIG. 6, screen 6. Providing a donor assessment result can also include determining, e.g., automatically determining, based on the first input, and/or the second input, and/or an additional, e.g., third, input, whether a potential donor's blood can be transfused without a significant negative health result, e.g., extreme sickness and/or death, to a potential recipient. The donor assessment result can be an indication that a potential donor's blood can be transfused with or without a significant negative health result, e.g., extreme sickness and/or death, to a potential recipient.

[0038] The subject methods also include providing a recipient assessment result by performing any method step or characteristic of a method step of providing a donor assessment result in association with a recipient rather than a donor. The aspects also include comparing, by the client device, the donor assessment result with a recipient assessment result or one or more aspects thereof. Aspects of a recipient assessment result can include, for example, recipient blood type, recipient infectious disease test results, and/or demographics, or data, e.g., stored data, associated therewith. Aspects of a recipient assessment result can also include any of the additional aspects described herein. Such a comparison can occur automatically, such as without further user input, by confirming the donor as an appropriate blood donor or an inappropriate blood donor for the recipient. An appropriate blood donor is a donor whose blood is suitable for a successful blood transfusion to the recipient. A successful blood transfusion can leave the recipient healthy as a result of the transfusion. [0039] The subject aspects also include comparing, by the client device, a recipient assessment result or an aspect thereof with the first input, the second input and/or a third or additional input. Such a comparison can occur automatically, such as without further user input, after each input is entered or after the first second and/or third and/or all, the inputs are entered. Each individual comparison can include confirming the donor as an appropriate blood donor or an inappropriate blood donor for the recipient. If the donor is an inappropriate blood donor, the methods include providing, with the client device, a warning to the user indicating the same and/or preventing further assessment steps to be performed in association with that donor. In various instances, the client device only provides a supplementary, e.g., second, third, etc. set of instructions if the preceding, e.g., first, second, etc., input indicates that the donor is an acceptable donor.

[0040] The aspects also include comparing, by the client device, the donor assessment result with a one or more pre-selected blood criteria, such as blood type and/or infectious disease test result. The methods also include selecting such blood criteria based on a projected need for blood of a particular type for use in transfusion, e.g., for use in transfusion to one or more particular recipient.

[0041] Aspects of the methods also include communicating, e.g., wirelessly

communicating, the donor assessment result to a remote server. The remote server can be or can be communicatively linked to a computer, for example, at a healthcare facility treating the potential blood recipient. The computer can include a display and the method can include displaying the donor assessment result at a remote location, e.g., a location remote from where the result was produced, e.g., at a healthcare facility. Aspects of the methods also include communicating, e.g., wirelessly communicating, the first input, second input and/or third input, or any combination thereof, to a remote server. Such communications can be separate and made periodically as each input is entered or can be communicated together with one another and/or with a donor assessment result.

[0042] Also, any of the method steps described herein in association with one or more donors can also be performed with respect to a potential blood recipient or recipient. The results of each assessment can then be compared, e.g., compared automatically by a client device, to make a determination of whether the donor's blood is suitable for transfusion to the particular potential recipient.

[0043] The method steps performed in association with the recipient can be performed on the same client device as that used for the donor or a second client device, e.g., a second cell phone. For example, in some embodiments, the methods include providing to a user on the client device or a second client device a third set of instructions for the user to perform a check of recipient demographics and consent of a blood recipient and/or receiving, at the client device or the second client device, a third input from the user including recipient demographics and/or consent data.

[0044] The subject methods also include providing, on the client device or the second client device, a fourth set of instructions for the user to perform a check of recipient blood type for the blood recipient, the fourth set of instructions including two or more blood type images. In some aspects, the methods can include receiving, at the client device or the second client device, a fourth input including an image of donor blood and a selection of blood type data including a selection of one or more of the two or more blood type images. Additionally, the methods can include comparing, by the client device or the second client device, the image of donor blood with the selected one or more images, and/or providing a recipient assessment result at the client device or the second client device based on the third input and the fourth input.

[0045] Furthermore, in some aspects, the methods include providing a fifth set of instructions to perform an infectious disease test, and receiving a fifth input including infectious disease test data. In some versions, the donor assessment result is based on the first input, the second input, the third input, the fourth input, and the fifth input. Also, in some embodiments, the methods include comparing, by the client device or the second client device, the recipient assessment result and the donor assessment result and providing an indication of whether blood of the donor is suitable for transfusion to the recipient based on the comparison.

[0046] Any of such inputs and/or results can also be wirelessly communicated (e.g. BLUETOOTH™ or Near Field Communication (NFC)) to a blood transfusion device, as described herein. The transfusion device can, in turn, process the received communications and provide an indication of suggested transfusion parameters to a user. In various aspects, the transfusion device can process the received communications and perform, e.g., automatically without further user input, a blood collection from a donor and/or a blood delivery to a recipient using parameters associated with one or more of the received inputs.

[0047] In various aspects, a client device can be operatively connectable to a blood transfusion device. As such, in some embodiments, the methods include communicating, e.g., wirelessly communicating, the donor assessment result to a point of care device such as a portable, e.g., hand-held, blood transfusion device. The portable blood transfusion device can be designed as a backpack, suitcase, saddlebag, purse, side pouch, or other easy-to-carry or wearable design that the user can carry around on the field or at a medical facility to determine donor/patient compatability and perform a transfusion. In one example, the blood transfusion device is a backpack that the user carries on the field, such as to a donor's home or other location outside of a medical facility, to perform the transfusion once the client device has been used to confirm compatibility with the patient. A blood transfusion device can include one or more electronic components, e.g., a controller, a user interface for receiving an input, a pump, a power source, and or a transceiver, which can communicate wirelessly with a client device to control one or more aspects of how the blood transfusion device operates, e.g., whether the blood transfusion device collects blood from a donor and/or how much blood the device collects. In various aspects, a blood transfusion device can include one or more containers for containing blood collected from a donor therein. The blood transfusion device can also include one or more receptacles for receiving the blood therein and/or outlets for outputting the blood therefrom. The blood transfusion device can also include one or more biasing elements, e.g., pumps, which can create a positive and/or negative pressure inside the device to facilitate blood input into the device or output out of the device. All of these components can be completely contained in the portable blood transfusion device bag or container, such as in pouches or compartments in the container that can be customized to hold each component. The compartments can be designed to be removable or openable to allow removal of components for washing or discard. The compartments can be sized to fit each component securely in the bag to avoid damage to components as the bag is carried. The blood transfusion device can define dimensions including a length, width and height, which each can range from 5 cm to 1 m, such as from 10 cm to 90 cm, such as from 10 cm to 80 cm, such as from 10 to 50 cm. In various embodiments, the height is less than the length and/or width. The blood transfusion device can also include a container defining any of the same dimensions. The blood transfusion device can also define a volume such as 10 cm³ or less, such as 25 cm³ or less, such as 50 cm³ or less, such as 75, cm³ or less, such as 100 cm³ or less, such as 250 cm³ or less. The blood transfusion device can also include one or more straps, such as two straps, which a user can attach to or place around the user's body to carry and transport the blood transfusion device.

[0048] In various embodiments, aspects of the subject systems and devices can be operatively coupled according to the subject embodiments. For example, a client device such as a cell phone can be operatively coupled or operatively coupleable to a blood transfusion device. By "operatively coupled," "operatively connected" and "operatively attached" as used herein, is meant connected in a specific way that allows the disclosed devices to operate and/or methods to be carried out effectively in the manner described herein. For example, operatively coupling can include removably coupling or fixedly coupling two or more aspects. Operatively coupling can also include fluidically and/or electrically and/or mateably and/or adhesively coupling two or more components. Operatively coupling can also include providing wireless communication between two components which are remote from one another. Also, by "removably coupled," as used herein, is meant coupled, e.g., physically and/or fluidically and/or electrically coupled, in a manner wherein the two or more coupled components can be un-coupled and then re-coupled repeatedly.

[0049] In various aspects, the subject devices, e.g., client devices and/or blood transfusion devices, and components thereof, e.g., housings, are portable and/or hand-held devices or components. As used herein, the term "hand-held" refers to the characteristic ability of an aspect to be held (e.g., retained, or easily or comfortably held) in a hand, such as the hand of a mammal, such as the hand of a human, such as the hand of an adult male or female human of an average size and/or strength. As such, a hand-held aspect is an aspect that is sized and/or shaped to be retained (e.g., easily or comfortably retained) in the hand of a human. Also, a portable aspect can be an aspect that can be moved (e.g., easily moved, such as easily moved in a vertical and/or horizontal direction) manually by a human (e.g., one or two hands of a human).

[0050] According to some versions, the methods include providing a third set of instructions to perform an anemia test on the blood donor, and receiving a third input including anemia test data. Such anemia test data can include a confirmation of the presence or absence of anemia of tested blood. In some aspects, the methods include wirelessly receiving anemia test data from an anemia testing device used to perform an anemia test on the blood donor. Any characteristics of performing in infectious disease test described herein can also be applied to performing an anemia test or one or more additional tests, e.g., a vital signs test.

[0051] In some versions, the methods include providing a third set of instructions to perform a vital signs test on the blood donor, and receiving a third input including vital signs test data. Such vital signs test data can include measurements of any one or combination of pulse rate, respiration rate, temperature, and/or blood pressure. In some aspects, the methods include wirelessly receiving vital signs test data from a vital signs testing device used to perform a vital signs test on the blood donor. A vital signs test can include measuring any one or combination of pulse rate, respiration rate, temperature, and/or blood pressure. [0052] In some aspects, the device maintains a registry of potential donors and/or can access such a registry in a remote database, such as on the cloud. The subject methods can include compiling the registry by obtaining donor information and putting it into the registry. The registry can include information, such as any of the types of information listed herein, on particular potential donors, such as donors identified in a particular geographic region. By accessing the registry, the device user can effectively match an appropriate potential donor with a donee or a specific transfusion need. The registry can also provide an indication of an inappropriate potential donor/donee or transfusion need match.

[0053] Also, in some embodiments, the device captures information about individuals screening positive for infectious diseases and/or transmits, such as automatically transmits, such information to appropriate authorities. Such information can be transmitted to a database accessible by such authorities, such as healthcare providers, for consequent follow- up or analysis by the authorities.

[0054] In various aspects, the methods include methods of compiling a registry of potential donors. Such methods can include providing to a user on a client device a first set of instructions for the user to perform a check of donor demographics and/or consent of a potential blood donor. The methods can include receiving, at the client device, a first input from the user including potential donor demographics and/or consent data. The methods can include providing, on the client device, a second set of instructions for the user to perform a check of donor blood type for the potential blood donor, the second set of instructions potentially including two or more blood type images. The methods can also include receiving, at the client device, a second input including an image of potential donor blood and a selection of blood type data including a selection of one or more of the two or more blood type images. The methods can further include providing a potential blood donor assessment result at the client device based, for example, on the first input and the second input, or any other input described herein. The methods can include storing the potential blood donor assessment result in a database on the device or communicating the result to a remote database where the result is saved with other such results.

[0055] The result can later be accessed, for example, remotely or directly by using the device and compared, e.g., compared automatically by the client device, with a particular blood donation need input to identify suitable potential donors. In some versions, the methods include comparing, by the client device, the potential donor assessment result with one or more aspects of a recipient assessment result and thereby automatically confirming a particular potential donor as an appropriate blood donor or an inappropriate blood donor for the recipient.

[0056] The methods can include, for example, providing, e.g., wirelessly communicating, the donor assessment result to a donor registry module or a database thereof and/or storing the donor assessment result with the module. The methods also can include accessing the donor assessment result in the module and providing, e.g., wirelessly communicating, the donor assessment result at the client device. In such embodiments, the donor assessment result can be based on first, second, third, fourth, and/or additional inputs as described herein. Also, in various instances, aspects of the subject method steps include storing the study summary information as described herein in a donor registry module and accessing the information at a later time.

[0057] Some versions the subject aspects also include providing a warning at the client device in response to an image of donor blood being of a different type than the selected one or more images. Such a difference can represent a difference in blood type between the sources of blood respectively associated with each image. A warning can be provided on a display of a client device such as a cell phone and can include an indication that an initial blood type assessment is incorrect. Furthermore, in some versions the subject aspects include providing a warning at the client device in response to the image of donor blood being of a different type than one or more blood images stored in a database. Such stored images can each include an association with one or more conditions, such as blood type, which can in turn be provided with the warning as appropriate. A warning or a confirmation as described below can be provided on a display of a client device such as a cell phone and can include an indication that an initial blood type assessment is incorrect.

[0058] Instead of or as an alternative to a warning, a confirmation can instead be provided at the client device in response to an image of donor blood being of a same type as compared to the selected one or more images. Also, in some versions the subject aspects include providing a confirmation at the client device in response to the image of donor blood being of a same type as compared to one or more blood images stored in a database. Such stored images can each include an association with one or more conditions, such as blood type, which can in turn be provided with the confirmation as appropriate.

[0059] As noted above, FIG. 9 depicts an interaction diagram of a process between a client device, a user of the client device, and a blood transfusion device, in accordance with one embodiment. FIG. 9 is presented for purposes of illustration as other embodiments may have different process steps that are executed by other parties (e.g. a server). In various embodiments, the client device provides 905 a first set of instructions to check donor demographics and obtain consent from the blood donor. The client device receives 910 information about the demographics of the donor as well as the obtained consent. The client device provides 915 a second set of instructions to check the blood type of the donor. In some embodiments, the provided second set of instructions includes two or more blood type images that may be selected by a user to identify the blood type of the donor. The client device receives 920 an image of the collected donor blood and additionally receives 925 a selection of the blood type images from the user.

[0060] Also, in various aspects, and as is shown in FIG. 9, the client device receives donor registry information 950 from, for example, a user and/or a blood transfusion device. Such donor registry information can include information on one or more potential donors and can specify them as a suitable or unsuitable donor for a particular transfusion or transfusion need. Such donor registry information can also include information on where the one or more potential donors might be found at a time of a donation need, such as an address. In various embodiments, the client device can in turn communicate the donor registry information to designated healthcare providers or other authorities (not shown in FIG. 9). The information can be transmitted and added to a database maintained by the healthcare providers or other authorities providing a list of suitable and unsuitable donors in association with related information. The database or information therein can be later communicated to the client device or other devices at a time of a donation need so that the device can determine, e.g., automatically determine, whether a particular donor is or is not a suitable donor for a particular transfusion.

[0061] In various embodiments, the client device compares 930 the image of the collected donor blood and the received selection of the blood type images. In some embodiments, the comparison may be conducted by the user or a server distinct from the client device. The client device may also provide 935 a third set of instructions to perform an infectious disease test. The infectious disease test may be performed by the blood transfusion device, after which the client device receives 940 the infectious disease test data. The client device provides 945 the donor assessment result to the user. In other embodiments, the donor assessment result is provided to the blood transfusion device. If the donor assessment result indicates that the donor is suitable as a blood donor, the blood transfusion device is used to conduct a transfusion procedure.

[0062] In some aspects, the methods include providing an identifier, e.g., a wristband, in association with, such as worn by, the potential blood recipient. The identifier can include a bar-code or QR-code. The identifier can be associated, e.g., associated in a database, with data specific to the recipient including, consent information, demographics information, blood type information, and/or infectious disease information. The subject methods also include obtaining such information, for example by the methods described herein, and/or storing the information in the database.

[0063] The methods can include providing to a user of a client device a set of instructions for the user to perform a check of the identifier. The methods can also include receiving at the client device an input including an image of the identifier. The client device can compare, e.g., automatically compare, the image of the identifier to a database of images or other information and associate the image with data associated with the identifier, such as the recipient-specific information. The client device can then provide an indication that blood collected from a donor can be transfused safely or cannot be transfused safely to the potential recipient associated with the identifier, e.g., wearing the wristband, based on the comparison.

[0064] In various embodiments, each of the aspects, such as the steps, of the computer implemented methods for blood donor assessment as provided herein can be performed automatically, e.g., without user interaction, by a computer processor of a client device.

[0065] Methods of transfusing blood are also provided. Such methods can include transfusing blood without a blood storage step, such as a temperature controlled, e.g., refrigerated, blood storage step. A blood storage step refers to storing blood for an extended period of time, e.g., one hour to 60 days, such as 6 hours to 45 days, such as such as 1 day to 40 days, each range inclusive. By "inclusive", as used herein in association with a range is meant that the values defining the endpoints of the range provided are also included in the range. Even if the term "inclusive" is not specifically recited in association with a range, all the ranges provided herein, including open-ended ranges, are inclusive. A blood storage step also can include storing the blood in a container, such as a non-portable, such as a non-handheld, container which can be a room. A blood storage step also can include storing the blood in a refrigerated container, e.g., a residential, commercial or industrial refrigerator and/or a refrigerated room. In various embodiments, a blood storage step includes actively lowering the temperature of collected blood to thereby lengthen its shelf life.

[0066] The subject embodiments include transfusing blood by transferring the blood from a donor into to a recipient in a limited period of time, such as 1 day or less, such as 12 hours or less, such as 6 hours or less, such as 3 hours or less, such as 2 hours or less, such as 1 hour or less, such as 30 minutes or less. The subject embodiments include transferring blood from a donor to a portable blood transfusion device, transporting the blood transfusion device to a recipient, and transferring the blood from the transfusion device to the recipient. Various embodiments include transferring a collected blood unit into a stored inventory of blood for a future transfusion. Such blood can be stored for, example, for 1 day or more, such as 30 days or more, such as 40 days or more, such as 45 days or more, such as 50 days or more. Such blood can be stored for, example, for 1 day or less, 30 days or less, 40 days or less, 45 days or less, or 50 days or less. Various aspects include not storing, such as storing for 1 hour or more, 2 hours or more, 3 hours or more, 6 hours or more, or 12 hours or more, the blood transfusion device when it has transfused blood in it. The subject embodiments also can include treating hemorrhage, e.g., obstetrical hemorrhage, by providing collected blood to a recipient who is a mother hemorrhaging after giving birth to a child.

[0067] The subject methods also can include performing a computer implemented method for blood donor assessment including any of the methods described herein or aspects therein. Such methods include, for example, providing a donor assessment result indicating that the potential donor's blood is acceptable or not acceptable for transfusion into the potential recipient. A result indicating that the potential donor's blood is acceptable for transfusion into the potential recipient is a positive result. A result indicating that the blood is not acceptable for transfusion is a negative result.

[0068] The subject methods include collecting blood with a portable blood transfusion device from the donor in response to the donor assessment result being positive. The donor assessment result can, in some versions, be wirelessly communicated from a client device, such as a cell phone, to the blood transfusion device. The methods also include transfusing the collected blood to a recipient without a blood storage step, e.g., a refrigerated blood storage step.

[0069] The subject embodiments also include computer program products including a non-transitory computer-readable medium having instructions encoded thereon that, when executed, cause a processor to perform any of the methods or aspects thereof described herein. All the steps described in association with computer program products can also be steps of computer implemented methods as provided herein.

[0070] Additionally, in some versions the embodiments include a computer program product including a non-transitory computer-readable medium having instructions encoded thereon that, when executed, cause a processor to perform steps including: receiving a first input including, for example, a first image of blood obtained from the patient, e.g., recipient, the first image including blood agglutination patterns and/or other photonic characteristics, e.g., size, shape, color, shade, contrast, etc., indicative of one or more characteristics of the blood, and/or identifying a blood type of the patient based on the input, such as the image. The photonic characteristics can be specific automatically or manually identifiable characteristics. The steps can also include receiving a second input including, for example, a second image of blood obtained from the donor, the second image including blood agglutination patterns and/or photonic characteristics and/or identifying a blood type of the donor based on the input, such as the image.

[0071] The steps can also include receiving a third input specifying a presence or lack of detected infectious disease from blood obtained from the donor. The steps can also include receiving a fourth input specifying a blood transfusion suitability between the donor and patient. In some versions, the steps also include providing for display in a user interface study summary information. The study summary information can include results from each of the conducted blood evaluations.

[0072] In various embodiments, the steps include an input specifying consent from a patient to a blood transfusion procedure and/or from a donor to the blood transfusion procedure. Steps according to the aspects provided herein also can include sending to one or more third party, e.g., a remote server and/or a cloud, systems notification and/or location information. In some versions, the embodiments also include providing in a user interface informational instructions for preparing and transfusing blood from the donor to the patient. The subject aspects also include providing the study summary information to a third party system and/or remote server for further analysis.

[0073] Client devices for use according to the subject methods can be a cell phone and/or can include one or more power source and/or housing. In some versions, client devices include for example, a control unit such as a central processing unit, a display for displaying data and/or an interface for receiving an input. Client devices can be, for example, laptop computer or a mobile electronic device, such as a mobile media player, such as an ipad and/or cellular telephone. A client device also can be configured for delivering a signal, e.g., a wireless signal, an audio signal, and/or an electric potential, voltage and/or current to a speaker device or wireless transmitter components thereof.

[0074] The disclosed client devices can also include a wireless signal transmitter and/or a wireless signal receiver. A wireless signal transmitter can be operably coupled to a signal generation unit and can be configured to transmit a signal, such as a wireless and/or an audio signal, from the signal generation unit to, for example, a wireless receiver on a remote device, such as a cell phone or computer located at a healthcare facility treating the potential blood recipient. Additionally, the disclosed client devices can also include a global positioning system (GPS) that tracks the geographical location of the client device. The client device may provide the geographical location to a third party (e.g. healthcare facility, national blood store).

[0075] Embodiments of the disclosed client devices include one or more power sources. By "power source", as used herein, is meant a device that supplies electric power to an electrical load. As such, in some aspects, power sources can include, for example, one or more battery, direct current (DC) power supply, alternating current (AC) power supply, linear regulated power supply, switched-mode power supply, programmable power supply, uninterruptible power supply, high-voltage power supply and/or a voltage multiplier. The amount of power, current and/or voltage capable of being provided by a power supply can, for example, be equivalent to that of an electronic media player, e.g., a computer, or one or more components thereof, a television, and/or a cellular telephone.

[0076] Embodiments of power sources include power sources configured to turn on to provide electrical power to another component and/or turn off to stop providing electrical power to another component. Such power sources can be configured to be turned on and/or off, for example, by operation of a switch, button, timer or other component operably connected to or included in the power source.

[0077] The disclosed client devices can also include one or more housings, such as portable and/or hand-held housings. A housing can also include one or more openings for a display and/or an interface for receiving an input.

[0078] An embodiment of the disclosed subject matter includes a blood transfusion device that accesses blood from a potential donor individual to be transfused to a patient individual. The blood transfusion device enables a streamlined process to facilitate blood collection and transfusion in situations where a trained user lacks access to stored blood and/or a patient is at risk of hemorrhagic and/or anemic death. In one embodiment, the blood transfusion device checks a donor and patient for blood transfusion suitability. Additionally, the blood transfusion device checks the donor blood for infectious diseases to prevent the spread of possible diseases to a patient.

[0079] The blood transfusion device can also be configured to communicate with a software application executed on a smartphone with a decision-support logic that outlines blood collection steps and guides transfusion, performs quality control checks, and/or automatically records critical information while simultaneously alerting local providers to ready for the patient's imminent transfer. The software application provides an interface that a user of the blood transfusion device and software application can interact with. The application may provide informational instructions and summary information for the blood transfusion procedure. Additionally, the application can be designed to receive input from the user in regards to the blood transfusion suitability and/or infectious disease screens. In various embodiments, the software application provides notifications (e.g. text message, GPS geographical location) to third parties (e.g. hospital, national blood supplier) to provide information in regards to the blood transfusion procedure.

[0080] FIG. 1 illustrates a system environment 100 of the blood transfusion device 130 and software application 110, in accordance with an embodiment. The system environment 100 can include a client device 105 that is configured to run the software application 1 10, the blood transfusion device 130, a clinician 135, one or more donors 140, a patient 145 to receive a blood transfusion, one or more point of care devices, a network 160, third party systems 170, and the server 180.

[0081] The blood transfusion device 130 is operated by the clinician 135 to receive blood from the donor 140 and provide blood through the blood transfusion to the patient 145. In various embodiments, the blood transfusion device 130 can have multiple compartments and chambers for conducting the various tests (tests for blood type and infectious diseases). The blood transfusion device 130 communicates with the client device 105 through various aspects such as BLUETOOTH™ or Near Field Communication (NFC) connections.

[0082] The blood transfusion device 130 can be further configured to communicate with additional point of care devices 150. For example, additional point of care devices 150 can measure anemia levels, blood pressure, heart rate, and other vital signs during the transfusion process for the patient. The blood transfusion device 130 can perform quality control checks using the information from the additional point of care devices 150 prior to starting the blood transfusion. Based on the readings of the point of care devices 150 prior to the blood transfusion and any additional clinical and laboratory presentations (e.g. clinical symptoms of PPH), the clinician can be notified to start the transfusion at a certain time (e.g. notified with a "start now"). The notification can be provided by the software application on the client device. Any adverse reactions detected by the point of care devices 150 can be stored or recognized by the blood transfusion device 130 and presented on the client device 105 to notify the clinician.

[0083] The client device 105 is operated by the clinician 135 and/or a trained healthcare workher (HCW). In one embodiment, the client device 105 used a can be a personal computer (PC), a desktop computer, a laptop computer, a notebook, a tablet PC executing an operating system, for example, a Microsoft Windows-compatible operating system (OS), Apple OS X, and/or a Linux distribution. In another embodiment, the client device 105 can be any device having computer functionality, such as a personal digital assistant (PDA), mobile telephone, smart phone, etc. In some embodiments, the client device 105 can use a web browser, such as MICROSOFT INTERNET EXPLORER™, MOZILLA FIREFOX™, GOOGLE CHROME™, APPLE SAFARI™ and/or OPERA™, as an interface to run the software application 1 10. In other embodiments, specialized application software that runs native on a mobile device is used to run the software application 1 10. In some aspects, the client device is, includes or is operably connectable to, e.g., wirelessly connectable to, a room sensing device such as HOMEPOD™, ELGATO EVE™, or ALEXA™.

[0084] The software application 1 10 can further include a consent module 1 15, a blood typing module 120, an infectious disease module 125, and a donor registry module (DRM) 165. The consent module 1 15 is responsible for storing consent questions for the patient and the donor. The consent module 1 15 can store the answers to the consent query provided by either the patient or the donor.

[0085] The blood typing module 120 is responsible for determining the blood type of the patient and the donor. For example, the blood typing module 120 receives images taken by the blood transfusion device 130 of the donor blood and patient blood when conducting the ELDON testing or a testing equivalent. The blood typing module 120 can store standard images associated with certain blood types and conduct standard image processing algorithms or other patters, e.g., photonic patterns, to identify the blood type of the donor or patient. The infectious disease module 125 is responsible for determining whether the infectious disease testing, e.g., the iCARE testing or an equivalent, conducted by the blood transfusion device 130 results in a positive or negative result for infectious diseases. The infectious disease module 125 can run standard image processing algorithms to analyze the image results obtained by the blood transfusion device 130.

[0086] The donor registry module 165 provides identification, locator information and/or advance screening of potential donors. The donor registry module module 165 is responsible for determining, e.g., automatically determining, whether a particular potential donor is a suitable donor or a non-suitable donor. It may include a database storing a list of potential donors and specifically associated information, such as any of the types of information described herein, such as identification and/or geographic position/locator information, which can be accessed by a user, for example, at a time when a potential blood donation will be taken and/or at a time when a donation of a particular type is needed. The database can also be automatically accessed by the device when a potential donor is located and screened. Information in the database can include the location as to where a potential donor might be found, such as an address and/or a phone number for the donor.

[0087] Information in the donor registry module 165 can be added to, deleted, or otherwise modified via a device as described herein and can be stored on the device or on a remote database accessible by the device, such as on the cloud. Potential donors can be added to a stored list in the database as a pre-screening is performed of the potential donor. The pre-screening, and associated information compiling, can take place at a time before there is a specific need for donated blood. Furthermore, the donor registry module 165 can, based on information input into or obtained by the device, provide, such as automatically provide, a recommendation as to whether a potential donor is a suitable donor. Such a recommendation can be provided at a time when a specific blood donation is needed or before that time, such as when a pre-screening is performed.

[0088] The client device 105 communicates with third party systems 170 such as hospitals or national blood organizations through a network 160. The client device 105 sends summary information of the transfusion. For example, information can include how many units of blood were transferred in the transfusion. The summary information can also include logged key strokes and post even responses to enable further improvements to the blood transfusion device 130 and the software application 110.

[0089] In various embodiments, the client device 105 communicates with the server 180 that stores information regarding blood transfusion procedures. For example, the server 180 can hold the blood type and infectious disease test results of prior donors so that if a new patient appears, the server 180 can rapidly provide previous donors that are matches for the new patient. The client device 105 can send notification alerts to these previous donors. The server 180 can also store information of past blood transfusions including the number of adverse effects. The server 180 can use this information to improve on the software application 110.

[0090] FIG. 2 displays a flow diagram to the steps of patient assessment, mobilization, and screening using the blood transfusion device and the software application, in accordance with one embodiment. Patients are checked for symptoms of post-partum hemorrhage (PPH). If clinically indicated, the clinician takes the patient demographic information. [0091] The clinician determines the blood type of the patient. In some embodiments, the blood transfusion device can intake the blood from the patient and accurately identify the blood type of the patient. The blood transfusion device can achieve this by using a standard blood test such as the ELDON™ testing or photonic chip testing. The clinician tags the patient with an identifier indicating the patient blood type. The patient is asked for his/her consent to undergo the blood transfusion. In various embodiments, the patient consent is obtained via the software application. If the patient refuses to provide consent, the standard of care is provided as an alternative treatment.

[0092] In the mobilization phase, blood donors are identified and located. In one embodiment, the software application sends notification alerts to prior donors that have a blood type that is compatible with the patient blood type and are lacking infectious diseases. Once a blood donor is identified and located, the clinician records information of the blood donor (e.g. name, demographics). In various embodiments, the recording of information of the blood donor can occur using the software application. The software application provides a donor questionnaire to identify possible indications that can rule out the individual as an ineligible blood donor. The application can also be configured to receive donor consent to provide blood through a blood transfusion procedure.

[0093] The blood transfusion device retrieves blood from the donor and tests for the donor blood type and any presence of infectious diseases. The blood transfusion device can have separate chambers to conduct the blood type and infectious disease tests. In various embodiments, the blood type test is conducted using the ELDON testing or an equivalent and the infectious disease test is conducted using iCARE testing or an equivalent. The blood transfusion device provides to the software application the test results for display to the user (e.g. clinician). The software application can wait to receive input from the user to proceed. In other embodiments, the software application can provide the user with an indication of the infectious disease and blood type test results. In some aspects, the application can provide an interpretation of the results, such as information considered relevant and specifically pertaining to the specific results. Also, in some aspects, the application can transmit the results to an interpreting authority who can in turn transmit a results interpretation back to the user via the app. If the results are appropriate, the application can automatically proceed to provide further transfusion instructions.

[0094] FIG. 3 displays a flow diagram detailing the steps of collecting, testing, and administering blood. In one embodiment, this process occurs after the software application has deemed the donor as an appropriate donor (e.g. no infectious diseases, donor blood type is suitable for patient). The clinician prepares the donor for blood transfusion (e.g. vein selection, arm preparation, phlebotomy) and ensures that enough donor blood is obtained. In one embodiment, the obtaining of donor blood occurs in a blood bag located in the blood transfusion device. In another embodiment, venous access is conducted with support through other devices, e.g., electronic radiographic vascular access devices.

[0095] The clinician also prepares the patient for the blood transfusion procedure (e.g. administration set-up, vein selection, arm preparation, phlebotomy). In various

embodiments, the clinician can prepare the donor and patient simultaneously (e.g. donor and patient are in the same location). In some embodiments clinician must obtain the donor blood from the donor first in the blood transfusion device and geographically displace to the location of the patient in order to provide the blood transfusion.

[0096] The clinician checks the intravenous line for patency and provides saline or another solution to keep open (TKO) the vein of the patient. The patient and donor blood can perform a safety check prior to beginning the transfusion. For example, the blood transfusion device reconfirms the donor and patient's blood for transfusion suitability with one another. In one embodiment, the blood transfusion device can conduct this reconfirmation by mixing a small amount of blood from the donor and the patient in a separate chamber to test for agglutination. The results are provided to the software application. The clinician can view the results of the assessment to ensure the patient and donor blood are suitable for transfusion.

[0097] If the blood transfusion suitability is reconfirmed, the clinician connects the donor blood from the blood transfusion device and begins the transfusion to the patient. The clinician provides transfusion and post-transfusion care.

[0098] FIG. 4 displays a first interface depicting patient demographics and consent and a second interface depicting patient blood, in accordance with one embodiment. In various embodiments, the interfaces of the software application are provided to the user (e.g.

clinician) on a client device (e.g. cell phone). On the first interface, the software application can provide the user a location to "Enter patient demographics" information including the patient's name and demographic origin. In various embodiments, the interface can also provide selectable input mechanisms, each tied to a corresponding action. For example, a first input mechanism, if selected by the user, is configured to text a national blood supplier the received patient information. A second input mechanism enables the client device to capture the current location of the user using the GPS located on the client device. A third input mechanism sends patient information to the closest hospital. The closest hospital is determined based on the coordinates determined by the GPS on the client device. A fourth input mechanism allows the client device to capture or receive biometric data, such as any of the data described herein. In various embodiments, the client device can automatically execute the first, second, third, and/or fourth aforementioned actions without a need for a user input. For example, after the clinician enters the patient demographic information and/or biometric data, the application automatically communicates, e.g., texts, the national blood supplier, captures the GPS location of the client device, and texts the closest hospital.

[0099] In various embodiments, the software application can provide a variety of other notifications in response to receiving the patient information. For example, the client device can transmit notification alerts to previous donors that were previously determined to be appropriate donors. The previous donors have been previously screened to be lacking of any infectious diseases and have a blood type that is acceptable to the patient.

[00100] In some embodiments, the client device receives a recommendation for the most expedient mechanism to provide blood to a patient. The recommendation can be provided by a third party system (e.g. national blood supplier). For example, a recommendation can suggest that identifying potential donors and transfusing blood to the patient through the blood transfusion device is the optimal method. Other recommendations can include air delivery (e.g. airplane, drone) or ground delivery of transfusion-suitable blood from another source to the current location of the clinician (as determined by GPS). Accordingly, the recommendation can have a corresponding estimated time of arrival (ETA) for the blood supply. Thus, the clinician can make a decision based on the recommendation and corresponding ETA.

[00101] The first interface provides consent questions for the clinician to review with the patient. FIG. 4 depicts six consent questions; however there can be more or less questions in different embodiments. The first interface can also provide a selection choice to either proceed (if the patient consents) or to stop (if the patient refuses to consent).

[00102] A second interface can be provided by the software application for testing the blood type of the patient. The blood testing can be conducted within the blood transfusion device. In one embodiment, the instructions for the blood test are for the ELDON testing or an equivalent method. For example, a small amount of the patient's blood is obtained and the blood is transferred into separate test wells and allowed to interact with substrate (e.g.

antibody) in each well. The blood transfusion device can take images of each well and provide it to the software application. The clinician can observe the image and identify the corresponding blood type of the patient. [00103] In some embodiments, the software application can analyze each image. For example, the client device processes the image of each well received from the blood transfusion device using standard image processing algorithms to detect the agglutination level (e.g. strong agglutinate, typical agglutinate, weak agglutinate, and no agglutinate) in each well. Standard image processing algorithms include edge detection, Blob extraction, histogram analysis, pixel intensity filtering, gradient filtering, or scale -invariant feature transform to extract visual features of each well image. After identifying the agglutination level in each well, the software application guides the clinician in identifying the blood type of the patient. For example, if a clinician interprets an image of a well to have "no agglutination" but the software application analyzes the image to have "weak agglutinate," the software application can query the clinician in response to his/her selection. The query can be a "Are you sure?" question that prompts the clinician to check and ensure that his/her analysis was not mistaken.

[00104] In various embodiments, the software application on the client device can automatically recognize and output the blood type of the patient without the need for a clinician to analyze the images. The client device can store images of standard combinations of the wells. Each image is associated with a certain blood type or interpretation thereof. For example, if the image demonstrates no agglutinate in all 4 test wells, the software application is configured to compare the image to a stored standard combination and identify or interpret that the patient's blood type is type O and RhD negative.

[00105] In various embodiments, the software application on the client device sends the received images from the blood transfusion device to the server. The server can analyze the images and provide, back to the client device, the analysis of the agglutination level in each image.

[00106] FIG. 5 displays a third interface depicting donor demographics and consent and a fourth interface depicting donor blood typing, in accordance with one embodiment. The software application provides a third interface to receive information and obtain consent for a potential donor. In some embodiments, the third interface is similar to the first interface for receiving information and consent for the patient.

[00107] The third interface can pose queries in regards to possible infectious diseases of the donor (e.g. malaria, HIV, hepatitis, syphilis) as well as any other questions that can deem the donor as ineligible to provide blood for the blood transfusion. The third interface can also provide a selection choice to either proceed (if the donor consents) or to stop (if the donor refuses to consent). [00108] The fourth interface is provided by the software application to determine the blood type of the donor. In various embodiments, the software application uses the same techniques in identifying the blood type of the donor as was also done in identifying the blood type of the patient. For example, the software application can present the clinician with the images and enable the clinician to identify the blood type of the donor. In another embodiment, the software application analyzes the received images using standard image processing algorithms and guides the clinician in identifying the blood type of the donor. In another embodiment, the software application on the client device identifies the blood type of the donor based on image processing algorithms without input from the clinician. In other embodiments, the client device sends the images through the network to the server to be analyzed and processed. The server sends the results back to the client device to be presented to the clinician through the software application.

[00109] FIG. 6 displays a fifth interface detailing the testing of infectious diseases in the donor and a sixth interface specifying the blood transfusion suitability, in accordance with one embodiment. In addition to conducting the blood type test for the donor, the blood transfusion device can also use a portion of the obtained donor blood to conduct an infectious disease test. In various embodiments, the blood transfusion device employs standard testing hardware and techniques (e.g. iCARE testing) for the infectious disease test. The blood transfusion device can be designed with individual compartments to test for each infectious disease. As depicted in FIG. 6, tests for hepatitis B antigen (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and syphilis (Treponema Pallidum (TP)) can be conducted.

[00110] In some embodiments, the software application of the client device is designed to recognize positive and negative results for each test. The blood transfusion device takes an image of the results of each test and provides the image to the software application for image analysis. For example, the software application can employ standard edge detection algorithms to determine whether one band (negative) or two bands (positive) appear for each test. Upon identifying any positive result for an infectious disease test, the software application deems the donor as ineligible and stops the donor from proceeding any further in the blood transfusion process. If all infectious disease tests are negative, the application can automatically proceed to a sixth interface.

[00111] In various embodiments, the client device can send the images of each infectious disease test to the server for analysis. The server can conduct the image analysis and determines whether each test is negative or positive for the respective infectious disease. Following the analysis, the server sends the results back to the client device to be presented to the clinician.

[00112] The sixth interface depicts the blood type comparison between the patient and the potential donor. In one embodiment, the sixth interface depicts possible combinations of blood type transfusion suitability matches and non-matches. The clinician can view the possible combinations and select the appropriate combination to either proceed to the next screen, or stop the process. In various embodiments, the software application highlights (e.g. different color boxes, bolded text) the combination of the donor and patient blood and presents it in the interface to notify the clinician of the assessment results.

[00113] FIG. 7 displays a seventh, eight, and ninth interface, each describing instructions for transfusing blood received from a donor to a patient, in accordance with one embodiment. The seventh interface provides instructions to the clinician for preparing the donor and accessing the donor's vein to obtain the donor blood. Additionally, the seventh interface can provide pictorial instructions for accessing the donor vein or attaching the blood collection bag.

[00114] In one embodiment, the eighth interface depicts instructions for preparing the patient for the transfusion. The ninth interface depicts instructions for transfusing the blood to the patient. Additionally, the ninth interface provides instructions to the clinician regarding patient adverse reactions to the transfusion. For example, the interface can state that the clinician is to "administer antihistamine or epinephrine" if an adverse reaction to the blood transfusion occurs.

[00115] FIG. 8 displays a tenth, eleventh, and twelfth interface, each displaying summary information regarding the blood transfusion, in accordance with one embodiment. The tenth interface provides the patient demographics and results of the blood transfusion. For example, the tenth interface depicts the patient name, age, description of the location of the blood transfusion, and the blood type of the patient. In some embodiments, the tenth interface allows the clinician to select information to be included in the summary. For example, the clinician can input the total number of blood units that were transfused into the patient and specify any adverse reactions, if any, that occurred during the transfusion.

[00116] The eleventh interface depicts demographic information of one or more donors such as the donor name, gender, age, and description of location. Additionally, the clinician can specify in the interface certain information such if a unit of blood was collected from the donor. [00117] The twelfth interface depicts final disposition information regarding the patient and the newborn. As shown in FIG. 8, the clinician can select the outcome of the delivery and the outcome of the patient to be included in the summary information. Furthermore, in various embodiments, the twelfth interface, as provided for example on Screen 12, includes an indication of a disposition, e.g, a final disposition, of collected blood being transferred to storage for future use.

[00118] In various embodiments, the summary information depicted in tenth, eleventh, and twelfth interfaces in FIG. 8 is stored by the client device. Additionally, the client device can transmit the information to a third party 170 (e.g. hospital) or to the server 180 for recordkeeping.

[00119] FIGS. 4-8 depict twelve different interfaces. One skilled in the art will readily recognize that the implementation need not be limited to the described twelve interfaces. UTILITY

[00120] Timely and safe blood transfusion (BT) is important to treat various instances of hemorrhage including the coagulopathy that is induced during PPH. As bleeding continues, hypoxia to critical organs is treated by oxygen carrying red blood cells. Without access to BT to support vital organs, PPH (defined by WHO as bleeding >500 mL), leads to death.

[00121] "Low-resource" environments such as sub-Saharan Africa (SSA) nations struggle with immense blood shortages. There is an estimated 40 million blood unit shortfall in sub- Saharan Africa alone. The poor access is due to the expense and complexity of managing a centralized infrastructure to collect, test and distribute blood stocks to health centers. For example, in some aspects, the infrastructure fails to provide storage, e.g., refrigerated storage, of blood for extending the shelf-life of stored blood.

[00122] Despite efforts to strengthen blood systems world-wide, developing countries struggle to build and maintain the infrastructure to operate blood services; blood is often not available when it is most desperately needed. While infrastructure system strengthening should continue, innovative delivery solutions such as that provided in the subject disclosure are important to provide a rapid, safe, and/or accessible source of blood to save a bleeding subject, such as a mother and/or her newborn.

[00123] The subject devices and methods can also be applied in "high-index"

environments. Such environments are remote and have access to limited resources, such as blood storage facilities. Such environments can include, for example, oil rigs and ships, or field locations where access to blood transfusion may require transfer or take, for example, 4 hours or more. [00124] Provided herein is a "just-in-time" solution for blood transfusion to prevent mortality, such as maternal mortality from obstetrical hemorrhage, in low-resource settings.

The blood transfusion methods and systems include an on-demand blood donation and transfusion system, composed of rapid point-of-care tests to, for example, identify safe volunteer blood donors. Also provided is a computer-implemented clinical guide, e.g., a guide on a smart phone application, to provide decision support during the intervention, and/or supplies required to supply fresh whole blood when stored blood is not available. The subject systems and methods modify the conventional approach to blood procurement by drastically changing the delivery model such as, for example, by avoiding a blood storage step, such as a step of storing transfused blood in a refrigerated environment, for a period of time, such as 1 hour or longer, such as 1 day or longer, such as 1 week or longer.

* * *

[00125] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications can be made thereto without departing from the spirit or scope of the appended claims. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[00126] Accordingly, the preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and

embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims.

Claims

CLAIMS What is claimed is:

1. A computer implemented method for blood donor assessment, the method

comprising:

a. providing to a user on a client device a first set of instructions for the user to perform a check of donor demographics and consent of a blood donor; b. receiving, at the client device, a first input from the user comprising donor

demographics and consent data;

c. providing, on the client device, a second set of instructions for the user to perform a check of donor blood type for the blood donor, the second set of instructions comprising two or more blood type images;

d. receiving, at the client device, a second input comprising an image of donor blood and a selection of blood type data comprising a selection of one or more of the two or more blood type images;

e. providing a donor assessment result at the client device based on the first input and the second input; and

f. comparing, by the client device, the donor assessment result with one or more aspects of a recipient assessment result and thereby automatically confirming the donor as an appropriate blood donor or an inappropriate blood donor for the recipient.

2. The method according to Claim 1, further comprising providing a third set of

instructions to perform an infectious disease test, and receiving a third input comprising infectious disease test data.

3. The method according to Claim 2, wherein the donor assessment result is based on the first input, the second input, and the third input.

4. The method according to Claim 1, further comprising wirelessly communicating the donor assessment result to a remote server.

5. The method according to Claim 1, further comprising wirelessly communicating the donor assessment result to a hand-held blood transfusion device.

6. The method according to Claim 1, further comprising providing a third set of instructions to perform an anemia test on the blood donor, and receiving a third input comprising anemia test data.

7. The method according to Claim 6, wherein the method further comprises wirelessly receiving anemia test data from an anemia testing device used to perform an anemia test on the blood donor.

8. The method according to Claim 1, further comprising providing a third set of

instructions to perform a vital signs test on the blood donor, and receiving a third input comprising vital signs test data.

9. The method according to Claim 8, wherein the method further comprises wirelessly receiving vital signs test data from a vital signs testing device used to perform a vital signs test on the blood donor.

10. The method according to Claim 1, further comprising providing a warning at the client device in response to the image of donor blood being of a different type than the selected one or more images.

1 1. The method according to Claim 1, further comprising comparing, by the client device, the image of donor blood with the selected one or more images.

12. The method according to Claim 1, further comprising:

a. providing to a user on the client device or a second client device a third set of instructions for the user to perform a check of recipient demographics and consent of a blood recipient;

b. receiving, at the client device or the second client device, a third input from the user comprising recipient demographics and consent data;

c. providing, on the client device or the second client device, a fourth set of

instructions for the user to perform a check of recipient blood type for the blood recipient, the fourth set of instructions comprising two or more blood type images; d. receiving, at the client device or the second client device, a fourth input

comprising an image of donor blood and a selection of blood type data comprising a selection of one or more of the two or more blood type images;

e. comparing, by the client device or the second client device, the image of donor blood with the selected one or more images; and f. providing a recipient assessment result at the client device or the second client device based on the third input and the fourth input.

13. The method according to Claim 12, further comprising providing a fifth set of

instructions to perform an infectious disease test, and receiving a fifth input comprising infectious disease test data.

14. The method according to Claim 13, wherein the donor assessment result is based on the first input, the second input, the third input, the fourth input, and the fifth input.

15. The method according to Claim 12, further comprising comparing, by the client

device or the second client device, the recipient assessment result and the donor assessment result and providing an indication of whether blood of the donor is suitable for transfusion to the recipient based on the comparison.

16. A method of transfusing blood without a temperature controlled blood storage step, the method comprising:

performing a computer implemented method for conducting a blood donor assessment comprising:

a. providing a first set of instructions to perform a check of donor demographics and consent;

b. receiving a first input comprising donor demographics and consent data; c. providing a second set of instructions to perform a check of donor blood type; d. receiving a second input comprising a selection of blood type data; and e. providing a donor assessment result based on the first input and the second input;

collecting blood with a portable blood transfusion device from the donor in response to the donor assessment result being positive; and

transfusing the collected blood to a recipient without a temperature controlled blood storage step.

17. The method according to Claim 16, wherein the donor assessment result is wirelessly communicated to the blood transfusion device.

18. A computer program product comprising a non-transitory computer-readable medium having instructions encoded thereon that, when executed, cause a processor to perform steps comprising: receiving a first input comprising a first image of blood obtained from the patient, the first image comprising blood agglutination patterns;

identifying a blood type of the patient based on the image comprising blood

agglutination patterns;

receiving a second input comprising a second image of blood obtained from the donor, the second image comprising blood agglutination patterns; identifying a blood type of the donor based on the image comprising blood

agglutination patterns;

receiving a third input specifying a lack of detected infectious disease from blood obtained from the donor;

receiving a fourth input specifying a blood transfusion acceptability between the donor and patient; and

providing for display in a user interface study summary information.

19. The computer program product according to Claim 18, that cause a processor to perform steps further comprising receiving an input specifying consent from a patient to a blood transfusion procedure.

20. The computer program product according to Claim 18, that cause a processor to perform steps further comprising receiving an input specifying consent from a donor to the blood transfusion procedure.

21. The computer program product according to Claim 18, that cause a processor to perform steps further comprising sending to one or more third party systems notification and location information.

22. The computer program product according to Claim 18, that cause a processor to perform steps further comprising providing in the user interface informational instructions for preparing and transfusing blood from the donor to the patient.

23. The computer program product according to Claim 18, that cause a processor to perform steps further comprising providing the study summary information to a third party system for further analysis.

24. The method according to Claim 1, further comprising providing the donor assessment result to a donor registry module and storing the donor assessment result with the module.

25. The method according to Claim 16, further comprising providing the donor assessment result to a donor registry module and storing the donor assessment result with the module.

26. The computer program product according to Claim 18, wherein the steps further comprise storing the study summary information in a donor registry module.