WO2010044801A1 - Systems and methods for preventing mistransfusion - Google Patents

Systems and methods for preventing mistransfusion Download PDF

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Publication number
WO2010044801A1
WO2010044801A1 PCT/US2008/080293 US2008080293W WO2010044801A1 WO 2010044801 A1 WO2010044801 A1 WO 2010044801A1 US 2008080293 W US2008080293 W US 2008080293W WO 2010044801 A1 WO2010044801 A1 WO 2010044801A1
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WO
WIPO (PCT)
Prior art keywords
blood
patient
mixing chamber
supply
mistransfusion
Prior art date
Application number
PCT/US2008/080293
Other languages
French (fr)
Inventor
Christopher D. Hilllyer
John D. Roback
James C. Zimring
Original Assignee
Emory University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Emory University filed Critical Emory University
Priority to PCT/US2008/080293 priority Critical patent/WO2010044801A1/en
Publication of WO2010044801A1 publication Critical patent/WO2010044801A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • A61M5/16827Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood

Definitions

  • red blood cell (RBC) units are transfused annually, representing approximately 40% of the world's RBC usage.
  • the complexity of blood cells and plasma necessitate that transfused RBCs be compatible with the blood of the recipient. That is, the blood type of the unit and the recipient must match each other very closely in order to prevent serious clinical consequences, which could include death.
  • Mistransfusion is a term generally used to describe administration of the wrong type of blood to a patient. Mistransfusion occurs for a variety of reasons, including improper identification of the intended recipient during initial sample collection for blood typing, improper typing or pretransfusion testing of the blood component or recipient in the blood bank, or misidentification of the recipient and/or the blood supply at the time of initiation of the blood transfusion.
  • Mistransfusion is considered by most authorities to be the leading cause of transfusion-related mortality and has a reported estimated incidence approaching 1 in 14,000 units in the United States.
  • RFID radio frequency identification
  • combination-locked pouches that require a special bedside code
  • bedside ABO tests that enable an operator to "retype" the patient and match the patient blood type with the RBC unit label.
  • Unfortunately none of those methods has enjoyed even moderate implementation to date, and each relies on human action, interpretation, or decision, thereby providing many opportunities for human error. It is such human error that leads to the number one cause of transfusion-associated death.
  • Fig. 1 is a perspective view of a system for preventing mistransfusion.
  • Fig. 2 is a block diagram of an embodiment of a mistransfusion prevention device and a mixing chamber cartridge used with the device.
  • Figs. 3A and 3B are side views of example mixing chambers illustrating absence and presence of agglutination, respectively.
  • Fig. 4 is a schematic view of an embodiment of a portion of the mistransfusion prevention device and an embodiment of the mixing chamber cartridge shown in Fig. 2.
  • Figs. 5A and 5B illustrate a first example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
  • Figs. 6A and 6B illustrate a second example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
  • Fig. 7 illustrates a third example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
  • Figs. 8A and 8B illustrate a fourth example method for detecting incompatibility between a patient plasma sample and blood supply sample.
  • Figs. 9A and 9B are schematic views of an embodiment of a stop element shown in use in preventing and enabling infusion of blood, respectively.
  • mistransfusion is a potentially life-threatening phenomenon that is typically the result of human error. It can therefore be appreciated that it would be of great benefit to have a system and method that automatically determines whether blood that is about to be administered to a patient is compatible with that patient's blood and, more particularly, that patient's blood plasma.
  • Fig. 1 illustrates an example system 100 that can be used to prevent mistransfusion.
  • the system 100 generally comprises a mobile IV pole 102 that includes a shaft 104 on which is mounted a mistransfusion prevention device 106.
  • the mistransfusion prevention device 106 comprises an outer housing 108 that includes a front cover 110 that can be opened to access an interior space (not shown) in which a removable cartridge (not shown) may be placed.
  • a user interface 112 Integrated with the cover 110 is a user interface 112 that, in the example of Fig. 1 , includes a display 114 and multiple keys or buttons 116.
  • a hanging element 118 from which is suspended a blood supply 120, such as a red blood cell (RBC) unit.
  • a blood supply 120 such as a red blood cell (RBC) unit.
  • a tube 122 Extending from the blood supply 120 to the mistransfusion prevention device 106 is a tube 122 that is used to deliver blood contained in the blood supply to the mistransfusion prevention device and, potentially, to a patient.
  • Extending from the mistransfusion prevention device 106 is a catheter 124 that is intended for insertion into a patient vessel, such as a vein.
  • the catheter 124 is a two-lumen catheter having first and second lumens 126 and 128 that are respectively used to collect blood from the patient and administer blood to the patient.
  • the first lumen 126 is used to collect a sample of patient blood for use in making a blood compatibility determination and the second lumen 128 is used to administer blood from the blood supply 120 if that blood is determined to be compatible with the patient.
  • the mistransfusion prevention device 106 is placed between the patient and the blood supply 120. Specifically, the terms of delivery of blood from the blood supply to the patient, the mistransfusion prevention device 106 is downstream of the blood supply and upstream of the patent.
  • Fig. 2 is a block diagram illustrating an example architecture for the mistransfusion prevention device 106. As indicated in Fig. 2, the device 106 includes a central controller 200 that controls operation of the device.
  • the central controller 200 can comprise one or more components and can include, for example, a central processing unit (CPU), microprocessor, and/or one or more application specific integrated circuits (ASICs).
  • the central controller 200 may further comprise memory, for example volatile and/or non-volatile memory (i.e., computer-readable media) that contains the various logic, for example in the form of software and/or firmware, used to
  • the mistransfusion prevention device 106 further includes the user interface 112 described above as well as a compatibility sensor 202 and a stop device 204, each of which is controlled by the central controller 200. As described in greater detail below,
  • the compatibility sensor 202 is configured to, in conjunction with logic of the device 106, detect compatibility or incompatibility between patient and blood supply blood, and the stop device 204 is configured to prevent administration of the blood supply blood when incompatibility is detected.
  • mistransfusion prevention device 106 also serves as a mistransfusion prevention device 106 .
  • [5 comprises first and second pumps 206 and 208.
  • the pumps comprise syringe-type pumps or roller pumps.
  • the first pump 206 is adapted to draw a blood sample from a patient along the first lumen 126 and a first pump supply tube 209 connected to the first lumen with a coupler 211 and, at least in some embodiments, pump that blood through a first cartridge supply tube 210 to a removable mixing
  • the second pump 208 is adapted to pump blood received from the blood supply 120 (Fig. 1) via the blood supply tube 122 and a second pump supply tube 213 coupled to the blood supply tube with a coupler 215 along a second cartridge supply tube 212 to the mixing chamber cartridge 216.
  • the second pump 208 is adapted to pump blood from the blood supply 120 along a patient supply tube 214 to the second lumen 128 of the catheter 124 (Fig. 1) to which the patient supply tube 214 is connected with a further coupler 217.
  • the second pump 208 is adapted to, in at least some embodiments, alternately pump blood into and draw blood out of the mixing chamber cartridge 216 in order to promote mixing of the patient sample and the blood supply sample.
  • mixing chamber cartridge 216 comprises a removable, one-time use, disposable cartridge that includes an RBC filter 218 and a mixing chamber 220.
  • the RBC filter is adapted to separate RBCs from patient blood that is received with filter supply tube 222, which is connected to the first cartridge supply tube 210 with a coupler 224. Due to the filtration of the RBCs, substantially only the plasma from the patient's blood is provided to the mixing chamber 220 along a first chamber supply tube 226.
  • the mixing chamber 220 receives the patient plasma and mixes it with a sample of blood from the blood supply obtained from a second chamber supply tube 228, which connects to the second cartridge supply tube 212 with a coupler 230.
  • the mistransfusion prevention device 106 optionally includes a mixing device 232 that is used to cause or increase mixing of the patient sample and the blood supply sample in the mixing chamber 220.
  • the mixing device 232 can comprise a device that is used to rock or vibrate the mixing chamber 220.
  • a medical practitioner such as a nurse, selects a blood supply 120 that is believed to contain the correct blood type for the patient and obtains an available mistransfusion prevention device 106.
  • the mistransfusion prevention device 106 may be mounted to an IV pole 102 and the blood supply 120 may be hung from a hanging element 118 of the IV pole.
  • the practitioner then connects the blood supply tube 122 to the mistransfusion prevention device 106, connects a new catheter 124 to the device, inserts a new mixing chamber cartridge 216 into the device, and connects the cartridge to the device in the manner illustrated in Fig. 2 and described above.
  • the mistransfusion prevention device 106 is prepared for use with the patient.
  • the practitioner can therefore insert the catheter 124 into a vein of a patient into which blood is to be infused, assuming the catheter has not already been inserted.
  • the practitioner can power the mistransfusion prevention device 106 using the user interface 112 and, optionally, input the desired quantity of blood that is to be administered and/or the rate at which the blood is to be administered.
  • the first pump 206 then operates to draw blood from the patient's vein along the first lumen 126 of the catheter 124. If the first pump 206 is to be used to provide the patient's blood to the mixing chamber 220, the first pump 206 further pumps the blood along the first cartridge supply tube 210, along the filter supply tube 222 of the mixing chamber cartridge 216, and through the RBC filter 218. As the patient's blood passes through the RBC filter 220, the RBCs contained in the blood are trapped by the filter such that substantially only the plasma from the patient's blood exits the filter and therefore can travel through the first chamber supply tube 226 and into the mixing chamber 220.
  • a sample of blood from the blood supply 120 is likewise provided to the mixing chamber. Specifically, blood supplied to the second pump 208 via the blood supply tube 122 is pumped through the second cartridge supply tube 212, through the second chamber supply tube 228, and into the mixing chamber 220.
  • appropriate pressure relief means can be provided so as to enable the free passage of the patient plasma sample and the blood supply sample into the mixing chamber 220.
  • a relief valve (not shown) can be provided on or in association with the mixing chamber 220 such that air contained in the chamber may escape as plasma and/or blood is pumped into the chamber.
  • the first pump 206 can in some embodiments be used to deliver the patient's blood to the mixing chamber 220, in other embodiments the patient's blood can be drawn into the mixing chamber using the second pump 208. In such embodiments, the first pump 206 may be omitted.
  • the patient plasma and the blood from the blood supply 120 are both contained within the mixing chamber 220.
  • One or more steps may then be taken to mix those components to cause a reaction in cases in which the blood from the unit 120 is not compatible with the patient's blood.
  • mixing can be achieved using a pipetting technique in which the two samples are caused to flow back and forth within the mixing chamber 220, through reciprocal pump actuation, rocking of the mixing chamber, or through vibration of the mixing chamber.
  • the latter two forms of mixing can be performed by the mixing device 232 shown in Fig. 2, when provided.
  • a mixture results that can be evaluated for purposes of determining whether or not the blood from the blood supply 120 is or is not compatible with the patient's blood.
  • a substantially homogeneous mixture results.
  • Such a mixture 302 is depicted in Fig. 3A, in which the mixing chamber is illustrated as an elongated cylindrical tube 300.
  • Fig. 3B depicts the RBCs from the blood supply clump together in discrete groups 304 separated by the patient's plasma 306. Therefore, a heterogeneous agglutinated mixture results.
  • the compatibility sensor 202 can, for example, comprise an optical sensor, a sonic sensor, an electrical impedance sensor, or a rheologic resistance sensor. Regardless of its specific configuration, the compatibility sensor 202 provides data to the device 106 that can be used to make a determination as to whether the blood is or is not compatible with the patient's blood.
  • the central controller 200 controls the stop device 204 to enable blood to flow through the patient supply tube 214, through the second lumen 128, and into the patient's vein. Such a flow can be facilitated using the second pump 208.
  • stop device 204 is an electronically-controlled device, such as an electronically controlled- value, that is in a normally-closed default position such that blood cannot flow through the tube 214. In such a case, the central controller 200 actuates the stop device 204 to open the stop device and enable blood flow through the tube 214.
  • the central controller 200 prevents blood flow to the patient.
  • the central controller 200 leaves the stop device 204 in its normally-closed default position and the second pump 208 is not operated so that blood cannot flow along patient supply tube 214 and into the catheter 124. Therefore, the incompatible blood is not and cannot be administered to the patient.
  • an alarm comprising an audible and/or visual indication, is triggered to alert the practitioner to the incompatibility and provide an opportunity for the practitioner to replace the incompatible blood supply 120 with a compatible blood supply.
  • the mistransfusion prevention device 106 automatically operates to prevent administration of incompatible blood to the patient without the need for human intervention. Indeed, after the device is initiated, no further human action is undertaken, thereby virtually eliminating the opportunity for human error.
  • Fig. 4 is a schematic view of an embodiment of a portion of the mistransfusion prevention device 106 and an embodiment of the mixing chamber cartridge 216 shown in Fig. 2.
  • the mistransfusion prevention device 106 includes a first pump in the form of a first syringe 400 that is associated with a first valve 402.
  • the first syringe 400 is adapted to draw patient blood through the first pump supply tube 209 when the first valve 402 is controlled, for example by the central controller 200 (Fig. 2), to enable fluid communication between the first pump supply tube and the first syringe.
  • the first syringe 400 is adapted to pump the drawn patient blood through the first valve 402 and into the first cartridge supply tube 210 when the first valve is controlled to enable fluid communication between the first syringe and the first cartridge supply tube.
  • the first valve 402 comprises an electronically-controlled two- position valve.
  • the mistransfusion prevention device 106 includes a second pump in the form of a second syringe 404 that is associated with a second valve 406.
  • the second syringe 404 is adapted to draw blood from the blood supply 120 (Fig. 1) through the second pump supply tube 213 when the second valve 406 is controlled to enable fluid communication between the second pump supply tube and the second syringe.
  • the second syringe 404 is adapted to pump the drawn blood supply blood through the second valve 406 and into the second cartridge supply tube 212 when the second valve is controlled to enable fluid communication between the second syringe and the second cartridge supply tube.
  • the second syringe 404 is adapted to pump blood supplied by the blood supply through the second valve 406 and into the patient supply tube 214 when the second valve is controlled to enable fluid communication between the second syringe and the patient supply tube.
  • the second valve comprises an electronically-controlled three-position valve.
  • the mixing chamber cartridge 216 comprises an RBC filter 407.
  • the RBC filter 407 includes both a glass filter element and a polycarbonate filter element (not shown).
  • the glass filter element comprises a 25-75 millimeter (mm) Whatman Glass Microfibre Filter (GF/D) and the polycarbonate filter element comprises a 25-75 mm x 0.6 ⁇ m Osmonics Foretics Polycarbonate Membrane Filter.
  • the RBC filter 407 may isolate an approximately 12% volume of liquid plasma from whole blood, for example, 12 microliters ( ⁇ L) from a 100 ⁇ L blood sample.
  • the mixing chamber comprises an elongated, cylindrical glass or plastic capillary tube 408.
  • the tube 408 has an inner diameter ranging from approximately 0.5 mm to 3 mm and a length of approximately
  • the inner surfaces of the tube 408 are coated with potentiating agents that expose RBC antigens.
  • the compatibility sensor 202 in the illustrated embodiment comprises a light source 410 and a light sensor 412.
  • the light source 410 is adapted to shine light through the capillary tube 408 and onto the light sensor 412.
  • the light source 410 emits a focused beam and the light sensor 412 comprises a light intensity detector.
  • the light sensor 412 comprises a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) sensor that is capable of capturing light data over an area to form a two- dimensional digital image.
  • CCD charge-coupled device
  • CMOS complementary metal-oxide-semiconductor
  • the data collected by the light sensor 412 can be evaluated by the device 106, for example using an appropriate algorithm stored in memory of the controller 200, to determine whether the mixture is substantially homogeneous or heterogeneous.
  • the mixture is homogeneous.the amount of light that passes through the mixing chamber 220, and which can be detected by the light sensor 412, will generally be the same or relatively similar across the length of the mixing chamber 220.
  • the mixture is heterogeneous, however, the light that passes through the mixing chamber 220, and which can be detected by the light sensor 412, will fluctuate along the length of the mixing chamber.
  • a single image can be captured and evaluated.
  • evaluation can be performed relative to multiple images (e.g., when the mixing chamber 220 is linearly scanned).
  • a determination of compatibility or incompatibility may be made relative to the absolute magnitude of the detected light intensities.
  • syringes 400, 404 are shown in Fig. 4 and are described above, it is to be understood that various other types of pumps could be used. Therefore, the syringes 400, 404 are shown by way of example to facilitate the discussion of operation of the mistransfusion prevention device 106. Furthermore, it is noted that although the syringe 404 (or other pump) has been described as pumping blood from the blood supply 120 into and through the patient supply tube 214, the blood from the blood supply can, alternatively, flow into and through the patient supply tube under the force of gravity.
  • Figs. 5A and 5B illustrate an example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility using the apparatus shown in Fig. 4.
  • the second valve 406 is controlled to enable fluid communication between the second syringe 404 and the capillary tube 408. Mixing can then be performed by alternate reciprocal actuation of the second syringe 404 such that the mixture 500 within the capillary tube 408 flows back and forth within the tube.
  • Such reciprocal action is illustrated in Fig. 5B, in which a plunger of the second syringe 404 has been moved in the direction of arrow 502 so as to cause the mixture 500 to move downward (in the orientation of Figs.
  • the reciprocal action is further useful in making the compatibility determination. Specifically, the reciprocal action can be used to cause the mixture, and any agglutinated clumps, to pass back and forth before the compatibility sensor 202.
  • Figs. 6A and 6B illustrate another example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
  • the mixing chamber 220 for example a capillary tube, is mounted to a turntable 600 with retainer clips 602.
  • the compatibility sensor 202 comprises a light sensor 410 and associated light detector 412, which are also mounted to the turntable 600.
  • the mixing chamber 220 can be rotated, using an electric motor (not shown), to rock the mixing chamber back and forth.
  • the mixing chamber can be rotated through approximately 180 degrees to alternately invert the mixing chamber and return it back to its initial position.
  • Such rotation can, for example, be enabled by providing the first and second chamber supply tubes 226 and 228 with a relatively large amount of slack.
  • the rocking also provides a mechanism for the mixture to flow back and forth relative to the compatibility sensor 202.
  • any agglutinated clumps will pass before the compatibility sensor 202 under the force of gravity.
  • Fig. 7 illustrates a further example method of mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
  • the mixing chamber 220 for example a capillary tube, is secured by retainer clips 700 that are connected to a vibration table 702 that is vibrated by a suitable vibration mechanism
  • the compatibility sensor 202 is decoupled from the vibration table 702 to avoid interference with the sensor's operation.
  • Figs. 8A and 8B illustrate yet another example method for detecting incompatibility between patient plasma and blood supply blood.
  • Figs. 8A and 8B illustrate yet another example method for detecting incompatibility between patient plasma and blood supply blood.
  • the compatibility sensor 202 comprises a light source 410 and a light sensor 412 that are mounted to a common carriage 800.
  • the carriage 800 can linearly translate along the length of the mixing chamber 220 so as to scan a length of the chamber 202 and determine its contents.
  • the carriage 800 is translated using a stepper motor (not shown). During such scanning,
  • multiple images may be captured by the light sensor 412, which can then be evaluated by the device 106 to make the compatibility determination.
  • Figs. 9A and 9B illustrate an embodiment for the stop device 204 identified in Fig. 2.
  • the stop device 204 comprises an electronically-controlled stop member 900 that can linearly translate in a direction
  • the patient delivery tube 214 is positioned between the stop member 900 and the stop plate 902.
  • the stop member 900 In the default position shown in Fig. 9A, the stop member 900 is in an extended position in which its tip 904 is placed adjacent the stop plate 902.
  • the stop member 900 pinches the flexible patient delivery tube 214 when the stop member is in the extended position.
  • the stop member 900 In the actuated positioned shown in Fig. 9B, the stop member 900 is in a retracted position in which its tip 904 is placed relatively distant from the stop plate 902. When the stop member 900 is in the retracted position, the patient delivery tube 214 is unimpeded and blood can flow through the tube toward the patient.

Abstract

In some embodiments, a system and a method for preventing mistransfusion of a patient pertain to obtaining a sample of the patient's blood, obtaining a sample of blood that is about to be infused into the patient, mixing the samples together, determining whether the samples are compatible, and if the samples are not compatible, automatically preventing infusion of the blood into the patient.

Description

SYSTEMS AND METHODS FOR PREVENTING MISTRANSFUSION
BACKGROUND
In the United States, more than 13 million red blood cell (RBC) units are transfused annually, representing approximately 40% of the world's RBC usage. The complexity of blood cells and plasma necessitate that transfused RBCs be compatible with the blood of the recipient. That is, the blood type of the unit and the recipient must match each other very closely in order to prevent serious clinical consequences, which could include death.
"Mistransfusion" is a term generally used to describe administration of the wrong type of blood to a patient. Mistransfusion occurs for a variety of reasons, including improper identification of the intended recipient during initial sample collection for blood typing, improper typing or pretransfusion testing of the blood component or recipient in the blood bank, or misidentification of the recipient and/or the blood supply at the time of initiation of the blood transfusion.
Mistransfusion is considered by most authorities to be the leading cause of transfusion-related mortality and has a reported estimated incidence approaching 1 in 14,000 units in the United States. A number of technologies exist that are thought to be able to reduce mistransfusion, including bar coding of patient and blood supply identifiers, radio frequency identification (RFID), combination-locked pouches that require a special bedside code, and bedside ABO tests that enable an operator to "retype" the patient and match the patient blood type with the RBC unit label. Unfortunately, none of those methods has enjoyed even moderate implementation to date, and each relies on human action, interpretation, or decision, thereby providing many opportunities for human error. It is such human error that leads to the number one cause of transfusion-associated death.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosed systems and methods can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale.
Fig. 1 is a perspective view of a system for preventing mistransfusion. Fig. 2 is a block diagram of an embodiment of a mistransfusion prevention device and a mixing chamber cartridge used with the device.
Figs. 3A and 3B are side views of example mixing chambers illustrating absence and presence of agglutination, respectively.
Fig. 4 is a schematic view of an embodiment of a portion of the mistransfusion prevention device and an embodiment of the mixing chamber cartridge shown in Fig. 2.
Figs. 5A and 5B illustrate a first example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
Figs. 6A and 6B illustrate a second example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility. Fig. 7 illustrates a third example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility.
Figs. 8A and 8B illustrate a fourth example method for detecting incompatibility between a patient plasma sample and blood supply sample.
Figs. 9A and 9B are schematic views of an embodiment of a stop element shown in use in preventing and enabling infusion of blood, respectively. DETAILED DESCRIPTION
As described above, mistransfusion is a potentially life-threatening phenomenon that is typically the result of human error. It can therefore be appreciated that it would be of great benefit to have a system and method that automatically determines whether blood that is about to be administered to a patient is compatible with that patient's blood and, more particularly, that patient's blood plasma.
As described in the following, disclosed are automated systems and methods for preventing mistransfusion. Using the disclosed systems and methods, compatibility or incompatibility of blood that is about to be administered to a patient can be automatically determined. In addition, when it is determined that the blood is not compatible, the systems and methods can automatically prevent administration of the blood to the patient, thereby preventing potential harm to, or even death of, the patient. Given that the systems and methods are used at the point and time immediately prior to blood infusion, the opportunities for human error that could cause mistransfusion are reduced or eliminated.
Referring now to the drawings, in which like numerals identify corresponding parts throughout the several views, Fig. 1 illustrates an example system 100 that can be used to prevent mistransfusion. As indicated in that figure, the system 100 generally comprises a mobile IV pole 102 that includes a shaft 104 on which is mounted a mistransfusion prevention device 106. The mistransfusion prevention device 106 comprises an outer housing 108 that includes a front cover 110 that can be opened to access an interior space (not shown) in which a removable cartridge (not shown) may be placed. Integrated with the cover 110 is a user interface 112 that, in the example of Fig. 1 , includes a display 114 and multiple keys or buttons 116.
With further reference to Fig. 1 , positioned at the top end of the IV pole shaft 104 is a hanging element 118 from which is suspended a blood supply 120, such as a red blood cell (RBC) unit. Extending from the blood supply 120 to the mistransfusion prevention device 106 is a tube 122 that is used to deliver blood contained in the blood supply to the mistransfusion prevention device and, potentially, to a patient.
Extending from the mistransfusion prevention device 106 is a catheter 124 that is intended for insertion into a patient vessel, such as a vein. In the example of Fig. 1 , the catheter 124 is a two-lumen catheter having first and second lumens 126 and 128 that are respectively used to collect blood from the patient and administer blood to the patient.
More particularly, the first lumen 126 is used to collect a sample of patient blood for use in making a blood compatibility determination and the second lumen 128 is used to administer blood from the blood supply 120 if that blood is determined to be compatible with the patient. As can be appreciated from the above discussion, the mistransfusion prevention device 106 is placed between the patient and the blood supply 120. Specifically, the terms of delivery of blood from the blood supply to the patient, the mistransfusion prevention device 106 is downstream of the blood supply and upstream of the patent. Fig. 2 is a block diagram illustrating an example architecture for the mistransfusion prevention device 106. As indicated in Fig. 2, the device 106 includes a central controller 200 that controls operation of the device. The central controller 200 can comprise one or more components and can include, for example, a central processing unit (CPU), microprocessor, and/or one or more application specific integrated circuits (ASICs). The central controller 200 may further comprise memory, for example volatile and/or non-volatile memory (i.e., computer-readable media) that contains the various logic, for example in the form of software and/or firmware, used to
5 execute its control functionality, including making determinations as to blood compatibility and enabling or preventing infusion.
The mistransfusion prevention device 106 further includes the user interface 112 described above as well as a compatibility sensor 202 and a stop device 204, each of which is controlled by the central controller 200. As described in greater detail below,
IO the compatibility sensor 202 is configured to, in conjunction with logic of the device 106, detect compatibility or incompatibility between patient and blood supply blood, and the stop device 204 is configured to prevent administration of the blood supply blood when incompatibility is detected.
With further reference to Fig. 2, the mistransfusion prevention device 106 also
[5 comprises first and second pumps 206 and 208. By way of example, the pumps comprise syringe-type pumps or roller pumps. The first pump 206 is adapted to draw a blood sample from a patient along the first lumen 126 and a first pump supply tube 209 connected to the first lumen with a coupler 211 and, at least in some embodiments, pump that blood through a first cartridge supply tube 210 to a removable mixing
!0 chamber cartridge 216 described below. The second pump 208 is adapted to pump blood received from the blood supply 120 (Fig. 1) via the blood supply tube 122 and a second pump supply tube 213 coupled to the blood supply tube with a coupler 215 along a second cartridge supply tube 212 to the mixing chamber cartridge 216. In addition, if compatibility is determined, the second pump 208 is adapted to pump blood from the blood supply 120 along a patient supply tube 214 to the second lumen 128 of the catheter 124 (Fig. 1) to which the patient supply tube 214 is connected with a further coupler 217. Furthermore, the second pump 208 is adapted to, in at least some embodiments, alternately pump blood into and draw blood out of the mixing chamber cartridge 216 in order to promote mixing of the patient sample and the blood supply sample.
In some embodiments, mixing chamber cartridge 216 comprises a removable, one-time use, disposable cartridge that includes an RBC filter 218 and a mixing chamber 220. The RBC filter is adapted to separate RBCs from patient blood that is received with filter supply tube 222, which is connected to the first cartridge supply tube 210 with a coupler 224. Due to the filtration of the RBCs, substantially only the plasma from the patient's blood is provided to the mixing chamber 220 along a first chamber supply tube 226. The mixing chamber 220 receives the patient plasma and mixes it with a sample of blood from the blood supply obtained from a second chamber supply tube 228, which connects to the second cartridge supply tube 212 with a coupler 230.
As is further illustrated in Fig. 2, the mistransfusion prevention device 106 optionally includes a mixing device 232 that is used to cause or increase mixing of the patient sample and the blood supply sample in the mixing chamber 220. As is described below in relation to Figs. 6 and 7, the mixing device 232 can comprise a device that is used to rock or vibrate the mixing chamber 220.
Having described various components of the example system 100 shown in Figs. 1 and 2, operation of the system will now be described. When transfusion of blood is advised, a medical practitioner, such as a nurse, selects a blood supply 120 that is believed to contain the correct blood type for the patient and obtains an available mistransfusion prevention device 106. As indicated in Fig. 1, the mistransfusion prevention device 106 may be mounted to an IV pole 102 and the blood supply 120 may be hung from a hanging element 118 of the IV pole. The practitioner then connects the blood supply tube 122 to the mistransfusion prevention device 106, connects a new catheter 124 to the device, inserts a new mixing chamber cartridge 216 into the device, and connects the cartridge to the device in the manner illustrated in Fig. 2 and described above. At this point, the mistransfusion prevention device 106 is prepared for use with the patient. The practitioner can therefore insert the catheter 124 into a vein of a patient into which blood is to be infused, assuming the catheter has not already been inserted. Once the catheter 124 has been inserted, the practitioner can power the mistransfusion prevention device 106 using the user interface 112 and, optionally, input the desired quantity of blood that is to be administered and/or the rate at which the blood is to be administered.
With particular reference to Fig. 2, the first pump 206 then operates to draw blood from the patient's vein along the first lumen 126 of the catheter 124. If the first pump 206 is to be used to provide the patient's blood to the mixing chamber 220, the first pump 206 further pumps the blood along the first cartridge supply tube 210, along the filter supply tube 222 of the mixing chamber cartridge 216, and through the RBC filter 218. As the patient's blood passes through the RBC filter 220, the RBCs contained in the blood are trapped by the filter such that substantially only the plasma from the patient's blood exits the filter and therefore can travel through the first chamber supply tube 226 and into the mixing chamber 220.
Prior to, simultaneous to, or after provision of the plasma to the mixing chamber 220, a sample of blood from the blood supply 120 is likewise provided to the mixing chamber. Specifically, blood supplied to the second pump 208 via the blood supply tube 122 is pumped through the second cartridge supply tube 212, through the second chamber supply tube 228, and into the mixing chamber 220.
Notably, appropriate pressure relief means can be provided so as to enable the free passage of the patient plasma sample and the blood supply sample into the mixing chamber 220. For example, a relief valve (not shown) can be provided on or in association with the mixing chamber 220 such that air contained in the chamber may escape as plasma and/or blood is pumped into the chamber. Furthermore, it is noted that although the first pump 206 can in some embodiments be used to deliver the patient's blood to the mixing chamber 220, in other embodiments the patient's blood can be drawn into the mixing chamber using the second pump 208. In such embodiments, the first pump 206 may be omitted.
At this point, the patient plasma and the blood from the blood supply 120 are both contained within the mixing chamber 220. One or more steps may then be taken to mix those components to cause a reaction in cases in which the blood from the unit 120 is not compatible with the patient's blood. As described in greater detail below, such mixing can be achieved using a pipetting technique in which the two samples are caused to flow back and forth within the mixing chamber 220, through reciprocal pump actuation, rocking of the mixing chamber, or through vibration of the mixing chamber. The latter two forms of mixing can be performed by the mixing device 232 shown in Fig. 2, when provided.
Once the patient plasma and unit blood have been adequately mixed, a mixture results that can be evaluated for purposes of determining whether or not the blood from the blood supply 120 is or is not compatible with the patient's blood. When the blood from the blood supply 120 is compatible, a substantially homogeneous mixture results. Such a mixture 302 is depicted in Fig. 3A, in which the mixing chamber is illustrated as an elongated cylindrical tube 300. When the blood from the blood supply is incompatible, however, agglutination occurs, as depicted in Fig. 3B, in which the RBCs from the blood supply clump together in discrete groups 304 separated by the patient's plasma 306. Therefore, a heterogeneous agglutinated mixture results.
As can be appreciated from Figs. 3A and 3B, the difference between compatibility and incompatibility is clear, thereby facilitating ready differentiation between the two conditions and, therefore, the compatibility determination. That determination is made through use of the compatibility sensor 202. The compatibility sensor 202 can, for example, comprise an optical sensor, a sonic sensor, an electrical impedance sensor, or a rheologic resistance sensor. Regardless of its specific configuration, the compatibility sensor 202 provides data to the device 106 that can be used to make a determination as to whether the blood is or is not compatible with the patient's blood.
Assuming first that the blood from the blood supply 120 is compatible, in which case a substantially homogenous mixture such as that depicted in Fig. 3A results, the central controller 200 controls the stop device 204 to enable blood to flow through the patient supply tube 214, through the second lumen 128, and into the patient's vein. Such a flow can be facilitated using the second pump 208. By way of example, stop device 204 is an electronically-controlled device, such as an electronically controlled- value, that is in a normally-closed default position such that blood cannot flow through the tube 214. In such a case, the central controller 200 actuates the stop device 204 to open the stop device and enable blood flow through the tube 214.
Next, assuming that the blood from the blood supply 120 is incompatible, in which case a heterogeneous mixture such as that depicted in Fig. 3B results, the central controller 200 prevents blood flow to the patient. By way of example, the central controller 200 leaves the stop device 204 in its normally-closed default position and the second pump 208 is not operated so that blood cannot flow along patient supply tube 214 and into the catheter 124. Therefore, the incompatible blood is not and cannot be administered to the patient. Optionally, an alarm, comprising an audible and/or visual indication, is triggered to alert the practitioner to the incompatibility and provide an opportunity for the practitioner to replace the incompatible blood supply 120 with a compatible blood supply.
As can be appreciated from the above, the mistransfusion prevention device 106 automatically operates to prevent administration of incompatible blood to the patient without the need for human intervention. Indeed, after the device is initiated, no further human action is undertaken, thereby virtually eliminating the opportunity for human error.
Fig. 4 is a schematic view of an embodiment of a portion of the mistransfusion prevention device 106 and an embodiment of the mixing chamber cartridge 216 shown in Fig. 2. In the embodiment of Fig. 4, the mistransfusion prevention device 106 includes a first pump in the form of a first syringe 400 that is associated with a first valve 402. The first syringe 400 is adapted to draw patient blood through the first pump supply tube 209 when the first valve 402 is controlled, for example by the central controller 200 (Fig. 2), to enable fluid communication between the first pump supply tube and the first syringe. In addition, the first syringe 400 is adapted to pump the drawn patient blood through the first valve 402 and into the first cartridge supply tube 210 when the first valve is controlled to enable fluid communication between the first syringe and the first cartridge supply tube. In such an embodiment, the first valve 402 comprises an electronically-controlled two- position valve.
In addition, the mistransfusion prevention device 106 includes a second pump in the form of a second syringe 404 that is associated with a second valve 406. The second syringe 404 is adapted to draw blood from the blood supply 120 (Fig. 1) through the second pump supply tube 213 when the second valve 406 is controlled to enable fluid communication between the second pump supply tube and the second syringe. In addition, the second syringe 404 is adapted to pump the drawn blood supply blood through the second valve 406 and into the second cartridge supply tube 212 when the second valve is controlled to enable fluid communication between the second syringe and the second cartridge supply tube. Furthermore, the second syringe 404 is adapted to pump blood supplied by the blood supply through the second valve 406 and into the patient supply tube 214 when the second valve is controlled to enable fluid communication between the second syringe and the patient supply tube. In such an embodiment, the second valve comprises an electronically-controlled three-position valve. With further reference to Fig. 4, the mixing chamber cartridge 216 comprises an RBC filter 407. In some embodiments, the RBC filter 407 includes both a glass filter element and a polycarbonate filter element (not shown). By way of example, the glass filter element comprises a 25-75 millimeter (mm) Whatman Glass Microfibre Filter (GF/D) and the polycarbonate filter element comprises a 25-75 mm x 0.6 μm Osmonics Foretics Polycarbonate Membrane Filter. In such a case, the RBC filter 407 may isolate an approximately 12% volume of liquid plasma from whole blood, for example, 12 microliters (μ L) from a 100 μ L blood sample.
In the embodiment of Fig. 4, the mixing chamber comprises an elongated, cylindrical glass or plastic capillary tube 408. By way of example, the tube 408 has an inner diameter ranging from approximately 0.5 mm to 3 mm and a length of approximately
75 mm. Optionally, the inner surfaces of the tube 408 are coated with potentiating agents that expose RBC antigens.
With continued reference to Fig. 4, the compatibility sensor 202 in the illustrated embodiment comprises a light source 410 and a light sensor 412. The light source 410 is adapted to shine light through the capillary tube 408 and onto the light sensor 412. By way of example, the light source 410 emits a focused beam and the light sensor 412 comprises a light intensity detector. In some embodiments the light sensor 412 comprises a charge-coupled device (CCD) or complementary metal-oxide-semiconductor (CMOS) sensor that is capable of capturing light data over an area to form a two- dimensional digital image. The data collected by the light sensor 412 can be evaluated by the device 106, for example using an appropriate algorithm stored in memory of the controller 200, to determine whether the mixture is substantially homogeneous or heterogeneous. When the mixture is homogeneous.the amount of light that passes through the mixing chamber 220, and which can be detected by the light sensor 412, will generally be the same or relatively similar across the length of the mixing chamber 220. When the mixture is heterogeneous, however, the light that passes through the mixing chamber 220, and which can be detected by the light sensor 412, will fluctuate along the length of the mixing chamber. In some embodiments, a single image can be captured and evaluated. In other embodiments, evaluation can be performed relative to multiple images (e.g., when the mixing chamber 220 is linearly scanned). Optionally, a determination of compatibility or incompatibility may be made relative to the absolute magnitude of the detected light intensities.
Although syringes 400, 404 are shown in Fig. 4 and are described above, it is to be understood that various other types of pumps could be used. Therefore, the syringes 400, 404 are shown by way of example to facilitate the discussion of operation of the mistransfusion prevention device 106. Furthermore, it is noted that although the syringe 404 (or other pump) has been described as pumping blood from the blood supply 120 into and through the patient supply tube 214, the blood from the blood supply can, alternatively, flow into and through the patient supply tube under the force of gravity.
Figs. 5A and 5B illustrate an example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility using the apparatus shown in Fig. 4. Beginning with Fig. 5A, the second valve 406 is controlled to enable fluid communication between the second syringe 404 and the capillary tube 408. Mixing can then be performed by alternate reciprocal actuation of the second syringe 404 such that the mixture 500 within the capillary tube 408 flows back and forth within the tube. Such reciprocal action is illustrated in Fig. 5B, in which a plunger of the second syringe 404 has been moved in the direction of arrow 502 so as to cause the mixture 500 to move downward (in the orientation of Figs. 5A and 5B) along the capillary tube 408. Through such reciprocal motion, significant mixing is achieved and, if the unit blood is incompatible with the patient's blood, agglutination will occur. The reciprocal action is further useful in making the compatibility determination. Specifically, the reciprocal action can be used to cause the mixture, and any agglutinated clumps, to pass back and forth before the compatibility sensor 202.
Figs. 6A and 6B illustrate another example method for mixing a patient plasma sample with a blood supply sample and detecting incompatibility. In the embodiment of Figs. 6A and 6B, the mixing chamber 220, for example a capillary tube, is mounted to a turntable 600 with retainer clips 602. The compatibility sensor 202 comprises a light sensor 410 and associated light detector 412, which are also mounted to the turntable 600. With such an arrangement, the mixing chamber 220 can be rotated, using an electric motor (not shown), to rock the mixing chamber back and forth. By way of example, the mixing chamber can be rotated through approximately 180 degrees to alternately invert the mixing chamber and return it back to its initial position. Such rotation can, for example, be enabled by providing the first and second chamber supply tubes 226 and 228 with a relatively large amount of slack. In addition to providing for mixing of the samples, the rocking also provides a mechanism for the mixture to flow back and forth relative to the compatibility sensor 202. In particular, any agglutinated clumps will pass before the compatibility sensor 202 under the force of gravity. Fig. 7 illustrates a further example method of mixing a patient plasma sample with a blood supply sample and detecting incompatibility. In the embodiment of Fig. 7, the mixing chamber 220, for example a capillary tube, is secured by retainer clips 700 that are connected to a vibration table 702 that is vibrated by a suitable vibration mechanism
5 (not shown). Through such vibration, mixing and clump detection can be achieved. In some embodiments, the compatibility sensor 202 is decoupled from the vibration table 702 to avoid interference with the sensor's operation.
Figs. 8A and 8B illustrate yet another example method for detecting incompatibility between patient plasma and blood supply blood. In the embodiment of Figs. 8A and 8B,
0 the compatibility sensor 202 comprises a light source 410 and a light sensor 412 that are mounted to a common carriage 800. As is depicted in Fig. 8B relative to Fig. 8A, the carriage 800 can linearly translate along the length of the mixing chamber 220 so as to scan a length of the chamber 202 and determine its contents. By way of example, the carriage 800 is translated using a stepper motor (not shown). During such scanning,
5 multiple images may be captured by the light sensor 412, which can then be evaluated by the device 106 to make the compatibility determination.
Figs. 9A and 9B illustrate an embodiment for the stop device 204 identified in Fig. 2. In the embodiment of Figs. 9A and 9B, the stop device 204 comprises an electronically-controlled stop member 900 that can linearly translate in a direction
:0 perpendicular to a stop plate 902. As shown in the figures, the patient delivery tube 214 is positioned between the stop member 900 and the stop plate 902. In the default position shown in Fig. 9A, the stop member 900 is in an extended position in which its tip 904 is placed adjacent the stop plate 902. As can be appreciated from Fig. 9A, the stop member 900 pinches the flexible patient delivery tube 214 when the stop member is in the extended position. In the actuated positioned shown in Fig. 9B, the stop member 900 is in a retracted position in which its tip 904 is placed relatively distant from the stop plate 902. When the stop member 900 is in the retracted position, the patient delivery tube 214 is unimpeded and blood can flow through the tube toward the patient.

Claims

CLAIMSClaimed are:
1. A method for preventing mistransfusion of a patient, the method comprising: obtaining a sample of the patient's blood; obtaining a sample of blood that is about to be infused into the patient; mixing the samples together; determining whether the samples are compatible; and if the samples are not compatible, automatically preventing infusion of the blood into the patient.
2. The method of claim 1 , wherein obtaining a sample of the patient's blood comprises drawing a blood sample from the patient using a catheter that will be used to infuse the patient.
3. The method of claim 2, wherein drawing a blood sample from the patient comprises drawing the blood sample using a first lumen of the catheter, a second lumen of the catheter intended for use in infusing the patient.
4. The method of claim 1 , wherein mixing the samples together comprises mixing the samples together in a mixing chamber of a mistransfusion prevention device placed between the patient and a blood supply that contains the blood to be infused into the patient.
5. The method of claim 4, wherein mixing the samples together in a mixing chamber comprises moving the mixture back and forth within the mixing chamber, rocking the mixing chamber, or vibrating the mixing chamber.
6. The method of claim 1 , wherein determining whether the samples are compatible comprises determining whether the mixture is homogeneous, which is indicative of compatibility, or heterogeneous, which is indicative of incompatibility.
7. The method of claim 6, wherein determining whether the mixture is homogeneous or heterogeneous comprises collecting image data associated with the mixture.
8. The method of claim 7, wherein collecting image data comprises capturing at least one image of the mixture and wherein determining whether the mixture is homogeneous or heterogeneous further comprises analyzing intensity data of the at least one image.
9. The method of claim 1 , wherein automatically preventing infusion of the blood into the patient comprises automatically controlling a stop device adapted to prevent flow of blood to the patient.
10. The method of claim 9, wherein automatically controlling a stop device comprises leaving an electronically-controlled valve in a normally-closed default position.
11. A method for preventing mistransfusion of a patient, the method comprising: connecting a blood supply to a mistransfusion prevention device such that blood can flow from blood supply to the mistransfusion prevention device; connecting a catheter to the mistransfusion prevention device such that blood received by the mistransfusion device from the blood supply can be delivered to the catheter; inserting the catheter into a vein of the patient; drawing blood from the patient's vein along a first lumen of the catheter and delivering the blood into a mixing chamber of the mistransfusion prevention device; delivering blood from the blood supply into the mixing chamber such that the blood from the blood supply and the blood drawn from the patient mix within the mixing chamber to form a mixture; collecting data about the mixture using a sensor of the mistransfusion prevention device; analyzing the collected data to determine whether the blood from the blood supply and the blood from the patient are compatible; if it is determined that the blood from the blood supply and the blood from the patient are compatible, enabling blood from the blood supply to flow through into a second lumen of the catheter and into the patient's vein; and if it is determined that the blood from the blood supply and the blood from the patient are not compatible, preventing the flow of blood into the second lumen and the patient's vein.
12. The method of claim 11 , further comprising mixing the blood from the blood supply and the blood drawn from the patient by moving the mixture back and forth within the mixing chamber, rocking the mixing chamber, or vibrating the mixing chamber.
13. The method of claim 11 , wherein collecting data comprises collecting image data about the mixture using a light detector.
14. The method of claim 13, wherein collecting image data comprises capturing an image of the mixture.
15. The method of claim 14, wherein analyzing the collected data comprises analyzing the image to determine whether the mixture is homogeneous, indicating compatibility, or heterogeneous, indicating incompatibility.
16. The method of claim 11 , wherein enabling blood from the blood supply to flow into a second lumen of the catheter comprises opening an electronically-controlled valve of the mistransfusion prevention device.
17. The method of claim 11 , wherein preventing the flow of blood into the second lumen and the patient's vein comprises not opening an electronically-controlled valve of the mistransfusion prevention device.
18. A mistransfusion prevention system comprising: a mixing chamber; a tube adapted to deliver blood from a blood supply to the mixing chamber; a tube adapted to deliver blood from a patient to the mixing chamber; a sensor configured to collect data regarding a blood mixture that results within the mixing chamber; logic configured to evaluate the collected data and make a determination as to compatibility or incompatibility of the blood from the blood supply and the blood from the patient; and a stop device configured to enable or prevent the flow of blood from the blood supply to the patient depending upon whether compatibility or incompatibility is determined.
19. The system of claim 18, wherein the mixing chamber comprises an elongated tube.
20. The system of claim 18, wherein the sensor comprises a light sensor.
21. The system of claim 20, wherein the light sensor comprises a charge- coupled device (CCD) or a complementary metal-oxide-semiconductor (CMOS) sensor.
22. The system of claim 18, wherein the logic configured to evaluate is configured to determine whether the mixture is homogeneous, which indicates compatibility, or heterogeneous, which indicates incompatibility.
23. The system of claim 18, wherein the stop device comprises an electronically-controlled valve.
24. The system of claim 18, wherein the mixing chamber is part of a disposable cartridge that can be removed from the mistransfusion prevention device and replaced.
25. The system of claim 18, further comprising a catheter, the catheter comprising a first lumen adapted to deliver blood from the patient to the mixing chamber and a second lumen adapted to deliver blood from the blood supply to the patient.
26. The system of claim 18, further comprising a pump that draws blood.
27. The system of claim 18, further comprising a mixing device that promotes mixing of the blood from the blood supply and the blood from the patient in the mixing chamber.
28. The system of claim 18, further comprising a filter adapted to filter red blood cells from the patient's blood before the blood reaches the mixing chamber.
29. A mistransfusion prevention device adapted to be connected to both a blood supply and a patient, the device comprising: a patient supply tube adapted to deliver blood from the blood supply to the patient; a mixing chamber; a first chamber supply tube connected to the mixing chamber, the first chamber supply tube being adapted to deliver blood from the blood supply to the mixing chamber; a second chamber supply tube connected to the mixing chamber, the second chamber supply tube being adapted to deliver blood from the patient to the mixing chamber; a sensor associated with the mixing chamber, the sensor being configured to collect data regarding a blood mixture that results within the mixing chamber; a central controller configured to evaluate the collected data from the sensor and make a determination as to compatibility or incompatibility of the blood from the blood supply and the blood from the patient; and a stop device associated with the patient supply tube and automatically controlled by the central controller, the stop device being adapted to enable or prevent blood flow through the patient supply tube and to the patient depending upon whether the central controller determines compatibility or incompatibility.
30. The device of claim 29, wherein the mixing chamber comprises an elongated tube.
31. The device of claim 29, wherein the sensor comprises a light sensor.
32. The device of claim 31 , wherein the light sensor comprises a charge- coupled device (CCD) or a complementary metal-oxide-semiconductor (CMOS) sensor.
33. The device of claim 29, wherein the logic configured to evaluate is configured to determine whether the mixture is homogeneous, which indicates compatibility, or heterogeneous, which indicates incompatibility.
34. The device of claim 29, wherein the stop device comprises an electronically-controlled valve.
35. The device of claim 29, wherein the mixing chamber is part of a disposable cartridge that can be removed from the mistransfusion prevention device and replaced.
36. The device of claim 29, further comprising a pump that draws blood.
37. The device of claim 29, further comprising a mixing device that promotes mixing of the blood from the blood supply and the blood from the patient in the mixing chamber.
38. The device of claim 29, further comprising a filter adapted to filter red blood cells from the patient's blood before the blood reaches the mixing chamber.
PCT/US2008/080293 2008-10-17 2008-10-17 Systems and methods for preventing mistransfusion WO2010044801A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5116312A (en) * 1989-11-03 1992-05-26 The Uab Research Foundation Method and apparatus for automatic autotransfusion
US5984893A (en) * 1997-03-27 1999-11-16 Ward; Roger T. Blood infusion control system
US6139748A (en) * 1997-09-22 2000-10-31 Gambro Ab Method and device for monitoring an infusion pump
US6572576B2 (en) * 2001-07-07 2003-06-03 Nxstage Medical, Inc. Method and apparatus for leak detection in a fluid line
US20060229531A1 (en) * 2005-02-01 2006-10-12 Daniel Goldberger Blood monitoring system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5116312A (en) * 1989-11-03 1992-05-26 The Uab Research Foundation Method and apparatus for automatic autotransfusion
US5984893A (en) * 1997-03-27 1999-11-16 Ward; Roger T. Blood infusion control system
US6139748A (en) * 1997-09-22 2000-10-31 Gambro Ab Method and device for monitoring an infusion pump
US6572576B2 (en) * 2001-07-07 2003-06-03 Nxstage Medical, Inc. Method and apparatus for leak detection in a fluid line
US20060229531A1 (en) * 2005-02-01 2006-10-12 Daniel Goldberger Blood monitoring system

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