WO2009055733A1

WO2009055733A1 - Fluid transfer port information system

Info

Publication number: WO2009055733A1
Application number: PCT/US2008/081207
Authority: WO
Inventors: Yashar Behzadi
Original assignee: Proteus Biomedical, Inc.
Priority date: 2007-10-25
Filing date: 2008-10-24
Publication date: 2009-04-30
Also published as: JP5845206B2; JP2013128850A; US9125979B2; EP2211974A4; JP5243548B2; EP2211974A1; US20090112178A1; JP2011500290A

Abstract

Methods are provided for associating a specific one of two or more distinct fluid transfer ports of a patient with a given fluid transfer event of fluid from a parenteral fluid delivery device. Aspects of the methods include establishing a fluid transfer connection between the parenteral fluid delivery device and the patient via one of the two or more distinct fluid transfer ports and transmitting a fluid transfer signal between the parenteral fluid delivery device and a patient associated identifier using the patient's body as a signal conduction medium. Association may result in identification of the fluid transfer port that will be, is being or has been employed for the given fluid transfer event. Also provided are systems for practicing methods of the invention.

Description

FLUID TRANSFER PORT INFORMATION SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS Pursuant to 35 U. S. C. § 1 19 (e), this application claims priority to the filing date of: United States Provisional Patent Application Serial No. 60/982,661 filed October 25, 2007; the disclosure of which applications is herein incorporated by reference.

INTRODUCTION

The parenteral administration (i.e., administration in a manner other than through the digestive tract, such as by intravenous or intramuscular injection or inhalation) of beneficial agents and fluids is an established clinical practice. Parenteral administration of beneficial agents are effective remedies for many patients when administered properly, e.g., according to instructions. However, studies have shown that, on average, about 10% of patients receive an incorrect injectable medication. For example, a significant percentage of serious errors are associated with the administration of intravenous (IV) medication.

In the clinical setting, misconnections of tubing used to link patients to medical devices have the potential to result in serious injury or death. Medical devices used in hospitals must have the ability to connect to related tubing and accessories. Connection is generally achieved through the standard "luer" connector. However, because the luer connector is a standard size and is used on such a broad range of medical devices and products with totally different functions, the risk for tubing misconnections is great.

A patient, for example, may be connected to several devices used to administer fluids through a vein; deliver feedings via a tube to the stomach; monitor blood pressure; and administer oxygen via mask or cannula. This collection of devices, all of which may include luer connectors, poses a risk of tubing misconnection especially in a busy clinical environment where stress, fatigue and distractions are common. Misconnections, which have been made between numerous types of medical devices in diverse clinical settings, include but are not limited to the following: enteral feeding tubes mistakenly connected to IV lines; IV tubing connected to the tracheal- cuff pilot balloon port; noninvasive blood pressure (BP) cuffs connected to IV lines; and drugs intended for IV administration given intrathecally.

SUMMARY Aspects of the invention include systems and methods for associating a specific one of multiple distinct fluid transfer ports in a patient with a given fluid transfer even of a fluid from a parenteral fluid delivery device to that patient. Aspects of the methods include establishing a fluid connection between the parenteral fluid delivery device and the patient via one of the two or more distinct fluid transfer ports. Next, a fluid transfer signal is transmitted between the parenteral fluid delivery device and a patient associated identifier using the patient's body as a signal conduction medium, e.g., from the fluid delivery device to the patient associated identifier or from the patient associated identifier to the fluid delivery device. A parameter of the fluid transfer signal, such as the strength of the fluid transfer signal, is then employed to a specific one of the two or more distinct fluid transfer ports of the patient with the given fluid transfer even. The association may include identification of the specific fluid transfer port that has been, is being or will be employed for the fluid delivery of fluid from the parenteral fluid delivery device to the patient. Where desired, the methods may include production of an error signal upon identification of an error concerning a specific fluid transfer port and a given fluid transfer event.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an IV bag delivery system according to a first embodiment of the invention.

FIG. 2 illustrates an IV bag delivery system according to a second embodiment of the invention.

DETAILED DESCRIPTION Methods are provided for associating a specific one of two or more distinct fluid transfer ports of a patient with a given fluid transfer event of fluid from a parenteral fluid delivery device. Aspects of the methods include establishing a fluid transfer connection between the parenteral fluid delivery device and the patient via one of the two or more distinct fluid transfer ports and transmitting a fluid transfer signal between the parenteral fluid delivery device and a patient associated identifier using the patient's body as a signal conduction medium. Association may result in identification of the fluid transfer port that wiii be, is being or has been employed for the given fluid transfer event. Also provided are systems for practicing methods of the invention.

Systems of the invention may include a parenteral fiuid delivery device and one or more patient associated identifiers. The parenteral fluid delivery device and the one or more patient associated identifiers are configured so that a fiuid transfer signal can be transmitted between the two components using the body of the patient as a communication medium. To employ the body as a conduction medium for the fluid transfer signal, a fiuid communication between the fiuid delivery device and the patient is first established. As the body of the patient is used as a communication medium, the signal that is transferred between the parenteral fluid delivery device and the patient travels through the body, (e.g., in a direction from the patient associated identifier to the delivery device and/or from the delivery device to the patient associated identifier), and requires the body as the conduction medium. The fiuid transfer signal may be conductiveiy transmitted between the fiuid delivery device and the patient associated identifiers) using the patient as a conductive medium.

As the body is required as a conduction medium and requires the establishment of fiuid transfer connection between the fluid delivery device and the patient, receipt of the signal (either at the patient associated identifier, the parenteral fiuid delivery device or another component of the system, e.g., as reviewed in greater detail below) provides accurate knowledge about a fiuid transfer event and a particular fluid transfer port associated with the fiuid transfer event, e.g., that will be, is being or has been employed for the fluid transfer event. This accurate knowledge can then be further employed in a variety of different ways, depending on the application, where such applications include prospective, reai-time and historic applications. Examples of prospective applications are those applications in which the fluid transfer signal is employed to determine beforehand which of two or more fluid transfer ports associated with a patient is going to be employed for a contemplated (i.e., future) fluid delivery event between the fiuid delivery device and the patient. Such applications may further include a determination of whether the particular fluid transfer port is the correct fluid transfer port for the contemplated fluid delivery event. Examples of historic or retrospective applications of the methods and systems of the invention include applications where the fluid transfer signal is employed to obtain an accurate history of a fluid(s) that have been delivered to a patient via a parenteral fluid deliver device, and specifically which of two or more fluid transfer ports have been employed for delivery of the fluid.

As reviewed above, the components of the systems of the invention include a fluid delivery device, one or more patient associated identifiers and two or more fluid transfer ports. The various components are configured such thai, during use, a fluid transfer signal is transmitted between them and a parameter of the signal, such as a measure of signal strength, is then employed to identify a particular fluid transfer port via which a fiuid delivery event is contemplated or wiii occur. in further describing embodiments of the invention, aspects of the systems are further reviewed in greater detail, followed by more detailed discussion of how the systems are employed in methods of fiuid transfer port identification.

SYSTEMS

Systems of the invention may include a fluid delivery device, one or more patient associated identifiers, and two or more fiuid transfer ports, where the systems may further include additional components, e.g., additional communication components, etc.

Parenteral Fluid Delivery Device

The parenteral fluid delivery device of systems of the invention is a device that delivers a quantity of a fiuid (e.g., liquid) to a patient by a route other than the digestive tract, e.g., via intravenous delivery, etc. Of particular interest are fiuid delivery devices that are configured to interact with a patient associated fiuid transfer port via connection element, e.g., by a luer lock fitting, in certain embodiments, the delivery device includes a fiuid transfer signal generator, e.g., in the form of an integrated circuit device or other suitable structure, that generates and transmits a signal to a receiver, e.g., which may be part of a patient associated identifier uoon tsansfer of fluid to the patient in certain situations the oarentesal fluid delivery device is one that orovides for one way transfer of fluid from the device to the patient For oarenteral delivery of a liquid, the dehveiy device may vaiy One type of device of interest is an intravenous administration device which may include a liquid storage element, e g a fluid containment or IV bag a fluid metering unit or pump, a drip oag, etc The liquid delivered to the patient may vary greatly in comoosition, and may include one Oi more distinct Doneficiai agents in a liquid oharmaceutically aceoptaDlo vehicle, e g , one or more pharmaceutical agents, or may oe a oeneficia! agent in its own right, e g such as where the liquid is a olasma volume expandei Also of interest ase delivery devices that provide foi transfes of fluid both to and fiom the patient Such devices include those where the fluid e g , blood dialysate, etc , is Uansferred from a patient to an externa! device and then transferred oack from the device to the patient, typically after some type of psocessing in the device An example of a oarentesa! fluid delivery device that finds use in these Situations is a dialysis machine, where such devices may oe parenteral dialysis devices or hemodialysis devices, etc

A given fluid delivery device may include a single component or two or more disparate components, e.g , syringes and vials, fluid containment oags and !V pumps, etc ) which are opeiatively connected to one another during use and collectively have the ability to transfer a fluid tsansfer signal oetween the device and a patient associated identifies, as reviewed above As such, the vaπous comoonents of the systems may further include communication elements, e g bioadcasteis and, or receivers as may be sequπed or desired for a given emoodiment of the system Such components may further include power sources, as may be desired, where any convenient power source may be present including those mentioned in connection with the oatient associated identifier, below

Embodiments of the fluid delivery devices may include what are viewed as pharma-informatics enaoled components such as phai ma-informatics enabled fluid containers By pharma-informatics enabled fluid container is meant a fluid container which includes an identifier that orovides identifying information aoout the fluid in the container The container may vary, where the container may be a, bag vial, etc which includes a volume of fluid that is to be transferred to a patient. The nature of the identifying information may vary greatly from the simple, e.g., the name of the fluid, the name of the pharmaceutical agent present therein, to the more complex, e.g., the dosage present in the container, the history of the fluid in the container, the quality of the fluid in the container (e.g., whether it is compromised or spoiled), etc. The nature of the identifier may aiso vary, e.g., from being a passive interrogatable element, such as a barcode or other machine readable identifier, to a more active component, such as a component that can broadcast information and may include a power source. Sensors, as described below, may also be associated with the medical containers.

Where a given system includes two or more different fiuid containers, the system may be configured as a multiplex system. Multiplex systems of interest are configured to sufficiently reduce or eliminate cross-taik and confusion between various broadcast signals of multiple components of the multiplex system such that a given fiuid transfer signal about a given fiuid and a patient may be properly matched up or associated with each other. For example, a signal generated about a first IV bag may be distinguishable from a signal generated about a second bag, where distinguishable signals may be provided in a number of different ways, e.g., by using an appropriate time based communication protocol, by having signals of different frequencies, etc. Of interest are the signal protocols described in PCT/US2006/016370 filed on April 28, 2008, the disclosure of which is herein incorporated by reference, in certain embodiments where multiple different fiuid containers are present in a given fluid delivery system, the different fluids may be color coded to provide an additional distinguishing feature, where this color coding may be detected and transmitted to the patient associated identifier (e.g., as part of a fluid transfer signal) for further confirmation that the right medicine, e.g., composition, dosage, quality, etc., is being delivered to the right patient.

Parenteral fluid delivery devices of interest, including examples of circuitry that may be used therein for the broadcaster and/or receiver elements thereof, are further described in PCT application serial no. PCT/US2007/015547 titled "Smart Parenteral Administration System" and filed on July 6, 2007; the disclosure of which is herein incorporated Dy reference. Patient Associated Identifier

As summarized above, a component of the systems of the invention is one or more patient associated identifiers, The patient associate identifier is a device that is configured to be associated with the patient, e.g., either topicaiiy or by implantation, and includes a communications element that performs at ieast one of broadcasting and receiving functions. The patient associated identifier is one that at least provides for broadcast and/or receipt of a fluid transfer signal, where the signal may comprise a variety of different types of information, such as identifying information about the patient. The identifier can be configured in a variety of different ways, including formats that are configured to simply broadcast a signal to more complex formats where the identifier receives information about a fluid transfer event (e.g., where the patient associated identifier includes a receiver element) and internally processes that information to evaluate the fluid transfer event in some manner. For example, the identifier may have a memory containing pre-existing knowledge of which medications are to be delivered to the patient. The identifier may compare the identifying information in the signal to the information in the memory to confirm that the medication associated with the fluid transfer event is correct, if it is not correct, the patient associate identifier may generate an error signal, e.g., as described in greater detail below. The identifiers may be configured to simply broadcast a signal, which may include identifying information about the patient, to the fluid delivery device. Alternatively, the identifiers may be configured to receive a signal from the fluid delivery device. In these cases, the identifiers are signal receivers that are configured to receive a signal from a parenteral fluid delivery device enabled to transmit a fluid transfer signal.

Where desired, the patient associated identifier may be one that is sized to be stably associated with a living subject in a manner that does not substantially impact movement of said living subject. In these instances, the patient associated identifier has dimensions that, when employed with a subject, such as a human subject, will not cause the subject to experience any difference in its ability to move. As such, the patient associated identifier is dimensioned such that its size does not hinder the ability of the subject to physically move. In certain embodiments, the patient associated identifier has a small size, where in certain embodiments the signal receiver has occupies a volume of space of about 5 cm³ or less, such as about 3 cm³ or less, including about 1 cm³ or less.

The patient associated identifiers of interest include both external and implantable devices. In external embodiments, the patient associated identifier is ex vivo, by which is meant that the receiver is present outside of the body during use. Where the identifiers are external, they may be configured in any convenient manner, where in certain embodiments they are configured to be associated with a desirable skin location. As such, in certain embodiments the external signal receivers are configured to be contacted with a topical skin location of a subject. Configurations of interest include, but are not limited to: patches, wrist bands, belts, etc. For instance, a watch or belt worn externally and equipped with suitable receiving electrodes can be used as signal receivers in accordance with one embodiment of the present invention. By further example, it could be positioned by a harness that is worn outside the body and has one or more electrodes that attach to the skin at different locations. In these external embodiments, a portion of the patient associate identifier, e.g., electrode, contacts the skin in a manner such that a communication line that includes the patient's body, e.g., a conductive communication line, may be established between the identifier and a fluid delivery device during use of the system. Patient associated identifiers of interest also include implantable components. By implantable is meant that the identifier is designed, i.e., configured, for implantation into a patient, e.g., on a semi-permanent or permanent basis. In these instances, the signal receiver is in vivo during use. By implantable is meant that the patient associated identifiers are configured to maintain functionality when present in a physiological environment, including a high salt, high humidity environment found inside of a body, for 2 or more days, such as about 1 week or longer, about 4 weeks or longer, about 6 months or longer, about 1 year or longer, e.g., about 5 years or longer. In certain embodiments, the implantable circuits are configured to maintain functionality when implanted at a physiological site for a period ranging from about 1 to about 80 years or longer, such as from about 5 to about 70 years or longer, and including for a period ranging from about 10 to about 50 years or longer.

Where the patient associated identifiers are implantable, the identifiers may have any convenient shape, including but not limited to: capsule-shaped, disc-shaped, etc. The patient associated identifiers may have any convenient power source, which could either be a primary cell or rechargeable battery, or one that is powered by broadcast inductively to a coil, or even a photoelectric or other power source, as may be appropriate for the identifier given its site of association with the patient (e.g., topical or internal) and expected operating conditions. Implantable patient associated identifiers of interest include a rechargeable battery, e.g., one that recharges automatically from a power transmitter, e.g., coils, present in the patient's environment, e.g., associated with the patient's bed. The patient associated identifier may be configured to be placed in a number of different locations, e.g., the abdomen, small of the back, shoulder (e.g., where implantable pulse generators are placed), etc.

In addition to being configured to participate in transmission of a signal between the identifier and a fluid delivery device using the patient's body as a conduction medium, the patient associated identifier may further include one or more distinct physiological parameter sensing abilities. By physiological parameter sensing ability is meant a capability of sensing a physiological parameter or biomarker, such as, but not limited to: heart rate, respiration rate, temperature, pressure, chemical composition of fluid, e.g., analyte detection in blood, fluid state, blood flow rate, accelerometer motion data, IEGM (intra cardiac electrogram) data, etc.

Patient associated identifiers of the invention may be configured to provide a further communication path via which collected data can be extracted by a patient or health care practitioner. For instance, an implanted collector may include conventional RF circuitry (operating, e.g., in the 405-MHz medical device band) with which a practitioner can communicate, e.g., using a data retrieval device, such as a wand or analogous device. Where the patient associated identifier includes an external component, that component may have output devices for providing, e.g., audio and/or visual feedback; examples include audible alarms, light emitting diodes, display screens, or the like. The external component may also include an interface port via which the component can be connected to a computer for reading out data stored therein. In these instances, the circuitry of the patient associated identifier may be configured to receive signals from devices inside of the subject, e.g., from an identifier of a pharma- informatics enabled pharmaceutical composition, and then relay this information to an external processing device, e.g., a PDA, smartphone, etc.

Of interest in certain situations are parenteral fluid delivery devices that are configured to transmit the fluid transfer signal only when fluid is delivered from the device to the patient and in a manner such that transmission of the signal can only occur when the device actually contacts patient and fluid is transferred to the patient. As such, the system is distinguished from other systems which provide for generation of a signal when a package is opened, or other proxy-type signals for actual administration of the fluid. Instead, the system of the invention provides a signal which provides information that delivery of the fluid to the patient actually occurred, e.g., by only transmitting the signal when the device touches the patient and fluid enters the patient from the device. While the fluid transfer signal may be transmitted between the parenteral fluid delivery device and the patient associated identifier using any convenient protocol, in certain embodiments protocols that ensure transmission only occurs upon contact of the device with the patient are employed. One such protocol of interest is conductive transmission, e.g., where the body is employed as a conductive medium between the fluid delivery device and the patient associated identifier to provide for transmission of the signal. Patient associated identifiers of interest, including examples of circuitry for the broadcaster and/or receiver elements thereof, include, but are not limited to, those described in: PCT/US2006/16370 titled "Pharma-lnformatics System" and filed on April 28, 2006; PCT/US2007/015547 titled "Smart Parenteral Administration System" and filed on July 6, 2007; and PCT/US2008/52845 titled "Ingestible Event Marker Systems" and filed on February 1 , 2008; the disclosures of which are herein incorporated by reference.

Fluid Transfer Ports

Fluid transfer ports that are part of systems of the invention may vary widely. In certain embodiments, the ports are partially implanted, while in other embodiments the ports are fully implanted, as is known in the art. The ports may vary from simple to complex, and where desired may include a connector element, e.g., luer lock, for mating with a fluid conveyer, e.g., IV catheter, IV line, etc., of the fluid delivery device. A patient may include two or more fluid transfer ports, such as three or more, four or more, five or more, etc., where the distinct fluid transfer ports are positioned as different locations of the body, e.g., in the neck/collarbone region, on the arms, on the legs, etc.

Additional System Components

As detailed below, certain embodiments are characterized in that the patient associated identifier and/or the fluid delivery device further transmits a signal to and/or receives a signal from an additional external component. The external component is. in certain embodiments, an external processing component, such that it is designed to accept data, perform prescribed mathematical and/or logical operations, and output the results of these operations. Examples of external components of interest include, but are not limited to: a healthcare provider network (e.g., a hospital information system (HiS); a home healthcare information system, etc). Accordingly, systems of the invention may further include an external processor component, such as a hospital information system (HIS) or analogous system that includes various aspects of a patient specific data, such as a prescriptions, treatment regimens, health history, dosage guidelines, etc. This data may include information obtained from an electronic medication storage unit. e.g.. a Pyxis system, etc. The systems may further include various sensors. Physiological sensors may be associated with the patient, and may or may not be part of the patient associated identifier. Physiological sensors of interest include, but are not limited to: heart rate sensors, breathing sensors, temperature sensors, etc., as described more fully above in connection with the patient associated identifier. Sensors may aiso be associated with various components of the fluid delivery system. Sensors may be associated with fluid containers, e.g., to detect a color-coded liquid therein, to detect clarity of a fluid, to detect the presence of one or more analytes in the fluid, etc. Sensors may aiso be present in tubing components of the system, e.g., to detect proxies of bacterial infection, such as turbidity, etc.

Fluid Transfer Signal

As reviewed above, systems of the invention are configured to transfer a fluid transfer signal between the patient associated identifier and the fiuid delivery device, where the signal is transferred between these two components using the patient^'s body as a signai conduction medium. The physicai nature of the signal may vary, e.g., where physicai types of signals of interest include electric, magnetic, optical thermal, acoustic, etc. Because the fluid transfer signai Is transferred between the two components using the patient's body as a conduction medium, fluid communication is established between the parenteral fluid deiivery device and the patient prior Io transmission of the fluid transfer signal

The content of the fiuid transfer signal may vary depending on the particular application in which the methods and systems are employed, where the content may range from simple to complex, depending on the particular type of application, e.g., prospective, real-time or historical, the direction, e.g., to and/or from the patient associated identifier, etc. A given fiuid transfer signai provides prospective information about a fiuid transfer event if the fiuid transfer event is a future fluid transfer event, i.e., the fiuid transfer event has not yet occurred. A given fiuid transfer signai provides real-time information about a fiuid transfer- event if the fiuid transfer event is a currently occurring fiuid transfer event, i.e., the fiuid transfer currently happening. A given fiuid transfer signal provides retrospective information about a fiuid transfer event if the fiuid transfer event is a past fluid transfer event, i.e., the fluid transfer event has already occurred.

In certain embodiments, the content of the fluid transfer signai is that a fiuid connection has been established between the fiuid delivery device (including disparate components thereof) and the patient. In certain embodiments, the content of the fluid transfer signai is that of a previously established fiuid connection between the fiuid deiivery device (including disparate components thereof) and the patient has Peen interrupted. In addition to an indication that a fluid connection has been established, the fiuid transfer signai may include additional content, e.g.. where additional content of interest includes, but is not limited to: patient specific content, fiuid specific content, deiivery device specific content, etc.

Patient specific content of interest includes, but is not limited to: identity of patient (e.g.. name, unique identifier), general information about the patient, e.g., gender, age, race, etc., health history of patient, health status of patient, including one or more sensed physiological parameters, which may or may not be combined into a health indicative marker, e.g., a wellness marker or index, and the like.

Fluid specific content of interest includes, but is not limited to: identity of the fluid, the contents of the fluid, the identity of one or more pharmacological agents in the fluid, the concentrations of such agents in the fluid, the history of the fluid, e.g., where manufactured, how stored, the quality of the fluid, e.g., whether compromised or not, etc. Also of interest is fiuid container specific content, which content includes, but is not limited to: the source/history of the container, the identity of the container, e.g., general (e.g.. type such as bag) or specific (e.g., serial no,), etc.

The fiuid transfer signal may include information that an actual fiuid transfer event has occurred, e.g., a transfer between a parenteral fiuid delivery device and a patient. In such embodiments, the fluid transfer signal provides information about whether fluid has been transferred between the parenteral delivery device and the patient. The fluid transfer signal is one that provides for actual knowledge that fluid has been parenterally transferred from the device to the patient.

Accordingly, a given fiuid transfer signal may include qualitative or quantitative information. Qualitative information is information that is not tied to specific numerical values or units, and includes but is not limited to: identifying information, quality control information about a fluid (e.g., age, storage conditions, etc.), information about a patient, e.g., how patient is responding, etc.. whether something is or is not present, etc. Quantitative information is information that includes numerical values or units, and includes but is not limited to dosage information, etc.

Communication Between System Components

As reviewed above, communication of the fluid transfer signal between the patient associated identifier and the fiuid delivery device employs the patient's body as a conductive medium. One or more additional and separate communication lines may be established between various components of the system, such as between the patient associated identifier and an external component, such as a hospital information system, between components of a fluid delivery device, such as an infusion pump and a fluid container, between the fluid delivery device and the hospital information system, etc. These additional communication lines may be wired or wireless communication lines, as desired, employing traditional physical connections, such as wires, optical fibers, etc., or wireless communication protocols, e.g., RFiD, etc. These additional communication iines may be employed to transfer information and/or power between the different device components, For example, disparate components of a fluid deliver system may Include communications components that are powered via wireless transmission of power from one element to another. These additional communication lines are, in certain embodiments, non-conductive communication lines.

FLUID TRANSFER PORT IDENTIFICATION

As summarized above, the systems as described above are employed in a manner that allows for association of a given fluid transfer event with a specific fluid transfer port. The association may include identification of the specific fluid transfer port that has been, is being or will be employed for a fiuid transfer event from a possibility of two or more distinct fiuid transfer ports that are associated with a given patient. Accordingly, for those patients that include two or more distinct fluid transfer ports, such as three or more, four or more, etc, the methods and systems of the invention provide for identification of the particular fiuid transfer port that has been, is being or will be employed for a given fluid transfer event. in practicing methods of invention, a parameter of the fiuid transfer signal is employed to identify the fiuid transfer port that has been, is being or will be used for a given fiuid transfer event. The parameter of the fiuid transfer signal that is employed is, in certain instances, a non-informational parameter, such as a parameter that does not provide specific information about the patient, nature of the fluid delivery device, nature of the delivered fiuid. etc. instead, the parameter that is employed is a parameter that is independent of any specific content of the signal.

Signal parameters of interest include those parameters that change as a function of distance traveled by the signal between the origin of the signal, e.g., the fiuid delivery device or the patient associated identifier, and the destination and/or receiver of the signal, e.g., the patient associated identifier or the fluid delivery device. The parameter may change as a function of distance in either a linear or non-linear manner, depending on the particular nature of the parameter.

One type of parameter that may be employed is a measure of strength of the fluid transfer signal. The fiuid transfer signal may consist of a binary signal pattern encoding the information of interest communicated using ampiitude modulation, phase key shifting, frequency modulation, or wide-band communication techniques. The parameter that may be employed is the amplitude of the signal, such that the ampiitude of the signal at the receiver is employed in determining which of two or more distinct fluid transfer ports will be or has been employed for a given fiuid transfer event, in certain embodiments, of interest is an evaluation, e.g., measurement, quantification or other appropriate analysis that provides for comparison to a suitable control, of amplitude of a decoded signal, the envelope strength of a demodulated signal, or statistics related to the time-series or frequency domain characterization of the transmitted signal (i.e., power at specified transmission frequency, standard deviation of time- series transmission packet). Characteristics of the decoded transmission packet, such as signal-to-noise, relative phase, or time-of-detection may also be employed. In practicing the methods, the parameter of the fluid transfer signal as detected at the receiver component of the system being employed, e.g., the patient associated identifier or the fluid delivery device, is evaluated to determine the identity of the particular fluid transfer port with which the fluid delivery device has established a fluid connection. Evaluation of the signal parameter may include a comparison of the signal parameter to a suitable reference or control value, e.g., an predetermined expected signal parameter value associated with a given fluid transfer port, a comparison to the parameter of the original signal at the fluid transfer port, etc. For example, a patient may have two separate IV ports for use with an IV bag delivery system, where one is located on the left arm and one is located on the right arm. The patient may also have a patient associated identifier located on the right wrist, which acts as a receiver for the fluid transfer signal generated by the IV bag delivery system upon establishment of fluid contact with the patient via one of the two IV ports. The receiver is configured to measure the amplitude of the decoded fluid transfer signal. The signal-to-noise ratio of the signal broadcast by the intelligent IV bag when used to deliver fluid via the IV port on the on the same arm as the patient associated identifier will have a larger amplitude at the patient associated identifier than the signal-to-noise ratio of the signal broadcast by the bag when used to delivery fluid via the IV port on the opposite arm of the receiver. By comparing this measure signal strength at the patient associated identifier on the right wrist to either the signal strength originally broadcast from the fluid delivery device or a predetermined value associated with each of the IV ports, the particular IV port via which fluid communication was established between the fluid delivery device and the patient is identified.

Where the patient has two or more patient associated identifiers associated with different physical locations, e.g., present on each wrist and/or at a torso location, such as the chest, abdomen, etc., one can evaluate the parameter of the signal received at each of the distinct patient associated identifiers and employ derivative and/ or triangulation methods to identify the port with which fluid communication was established.

The receiver/evaluation functions performed in practicing the methods may be located at the patient associated identifier or the fluid deliver device, as desired. For example, the signal whose parameter is evaluated in practicing the methods may be one broadcast by the fluid delivery device and received at the patient identifier. Alternatively, the signal whose parameter is evaluated may be one that is broadcast by the patient associated identifier and received at the fluid delivery device. In the latter embodiment, the signal may be one that is continually broadcast, such that it will be broadcast and detected when fluid communication is established by the fluid delivery device via a fluid transfer port. In the former case, the signal may be one that is only broadcast by the fluid delivery device upon establishment of fluid communication.

Where desired, the methods include generating an error signal when the identified fluid transfer port is an incorrect fluid transfer port. For example, the system may be configured to have knowledge regarding which IY ports are to be employed for a given fluid delivery device. When the wrong IV port is employed by a fluid delivery device, the system is configured in these embodiments to produce an error signal. The nature of the error signal may vary, may cause an alarm, e.g., visual and/or sound, to be produced: a message to be sent to a health care manager, e.g., via a hospital information system, etc. Such embodiments are desirable where intervention because of the error is desired, e.g., to counteract any probiems caused by the error. In such appiications, a processor is conveniently employed to match a port and fluid transfer event specific information, e.g., to determine whether or not to allow the fluid transfer event to occur, to produce an error signal, etc. The location of this processor may vary within the components of the system, as desired. As such, in certain embodiments, the processor may be located in the patient associated identifier. In certain other embodiments, the processor may be located in the fluid delivery device, in yet other embodiments, the processor may be located in the hospital information system.

Where desired, the system may be configured to produce a fluid administration log comprising information about fluid delivery via the two or more distinct fluid transfer ports. The log (i.e., history) that is produced may vary in format, including a recorded fiie on a suitable computer readable medium which can be output to a user via a user interface of a monitor, a paper printout, etc.

Systems of the invention may be configured to associate a signal fluid transfer port at a time with a given fiuid transfer event, or the systems may be configured to associate two or more fluid transfer ports with two or more simultaneous fluid transfer events. For example, the systems may be configured to evaluate fluid transfer events that are simultaneously occurring at each of two or more distinct fluid transfer ports, e.g., where each distinct fiuid transfer event has a unique fiuid transfer signal that can be distinguished by the receiver component, e.g., present in the patient associate identifier(s).

APPLICATIONS

The methods of the invention find use in a variety of different appiications, including those where one wishes to identify which port of a plurality of two or more distinct fluid transfer ports will be, is being or has been employed for a given fiuid transfer event. Certain applications of the systems are prospective applications, in that the system is employed prospectiveiy to evaluate a fiuid transfer event (e.g., delivery of a fluid dosage to a patient), where the fiuid transfer event has yet to actually occur. Specificaliy, the prospective appiications enable identification of which fluid transfer port will be employed for a fluid transfer event before the event occurs. Such applications include situations where the system is employed as a check to ensure that a given dosage of a fluid is going to be administered Io the patient via the correct fluid transfer port. If a proper match is detected between the fluid transfer port and the fluid transfer event of interest, the system can be configured to automatically enable the fluid transfer event to occur, e.g., by activating the fluid delivery device, such as the pump. Alternatively, where a proper match between a fluid transfer port and a given fluid transfer event is not detected, the system can be configured to disable the fluid transfer event, e.g., by inactivating the fluid delivery device, etc.

Where desired, the systems of the invention are configured to provide an error signal upon detection of an error in a parenteral administration event. As such, the systems may be configured to generate an error signal when the wrong port is identified for a given fluid transfer event. The signal may also vary greatly, including an audible alarm, an alarm signal sent to a physician, etc. Such embodiments include methods where the system is monitored for the occurrence of the error signal.

Applications of interest also include real-time applications, where the system is employed to evaluate a fluid transfer event (e.g., which port is employed for delivery of a fluid dosage to a patient), while the fluid transfer event is actually occurring, i.e., is in progress. For example, the system can be used to monitor the patient for an adverse reaction during delivery of the fluid, e.g., by monitoring physiological parameters of the patient. If monitored physiological parameters vary from acceptable predetermined ranges, the system can be configured to produce an error signal, e.g., as described above, and or take action, e.g., investigate the specific port to ensure that the specific port is operating correctly. One example of such an application is where, during a given fluid transfer event, the transfer of fluid is compromised in some manner, e.g., interrupted. The system may be configured to generate a signal indicative of such an interruption, which could be manifested as an alarm, etc., causing the particular functionality of the identified port to be investigated, in response to the error signal, the particular fluid transfer port that may be evaluated, fixed as necessary and/or replaced, e.g., in order to avoid further complications.

Also of interest are uses of the systems and methods for historical applications, such that the systems are employed to obtain a true and correct record of fluid transfer events that have actually occurred between a patient and a fluid delivery device, and specifically which ports have Deen employed for which specific fluid transfer events. Historical applications are any applications that use information which includes knowledge that a fluid transfer event has actually occurred and which fiuid transfer port was employed. True and accurate records of fiuid transfer events find use in providing health care practitioners or other individuals of accurate treatment records for a given patient. As such, historical applications include employing the fiuid transfer event data in further treatment of an individual, e.g., developing future treatment regimens and/or modifying existent treatment regimens. Additional historical applications of interest include employing the fiuid transfer event data for invoicing purposes, e.g., so that patients are accurately billed for medications and/or services that they actually receive, etc. (for example, where compensation is tied to which port is employed, accurate records of port employment are obtained for such invoicing purposes).

SPECIFIC ILLUSTRATIVE EMBODIMENTS OF THE METHODS AND SYSTEMS

Aspects of the invention having been described in general terms above, additional details in the context of specific embodiments are now provided. One embodiment of an IV fluid delivery system according to the invention is shown in FIG. 1. As shown in FIG. 1 , a transmitter 52 is attached to the IV bag 56 or the IV set, which is anything connected to the IV bag, and a receiver 53 is implanted in the patient. When the IV bag is not connected to the patient, the receiver 53 cannot detect the transmitter 52 transmitting from the IV bag 54. But when the IV bag is infusing fluid, or there is a fluid connection between the IV bag 54 and the receiver 53 via the patient 50 acting as a conducting bridge, or at least attached to the arm in anticipation of delivery of fluid from the IV bag to the patient, then a signal is transmitted by the IV bag 54 and received by the receiver 53. During operation, the transmitter capacitively couples a signal to the fluid.

That signal transmits through the fluid and to the patient, through the patient's body, and to the receiver, e.g., one electrode of the receiver (thereby making up one side of the conductive loop). The other side of the conductive loop is that on the other side of the transmitter, which capacitively couples a signal to ground, which is everything surrounding a patient which is not attached to the patient. The ground could be chairs, tables, the floor, etc. The signal goes through the ground and then is capacitively coupled to the other side of the patch receiver, thereby completing the loop. This capacitive coupling on either side to ground is illustrated in the FIG. 1 by capacitors and dashed arrows 55 and 57, respectively.

Referring to 1 , starting at transmitter 52, the fluid signal goes through the bag 54, which is the container or IV bag, and is capacitively coupled through the

IV bag. Then the signal progresses to the fluid in the IV bag 56 through the IV tube 58, through the patient's arm, or a vein somewhere in the body, e.g., arm, leg or elsewhere in the body. The signal continues to go through the body to the receiver 53. On the other side of the receiver, a capacitive coupling 57 between the receiver housing and the ground is provided to give a differential signal. The loop is completed through the ground and back up through the capacitive coupling 55 from the ground to the broadcaster, which is attached to the IV bag. The fluid transfer signal may be a high frequency signal, e.g., between 1 and 10 MHz, and may be higher, e.g., 100 MHz or more, e.g., 1 GHz or more. The frequency is in a range such that the receiver only picks up the signal when the IV bag is connected to the body, and not just by the electromagnetic waves that are emitted by the broadcaster. In certain embodiments, the frequency is chosen based on the considerations that the higher the frequency, the easier it is to couple it directly to the IV bag, but the more likely it is that the signal will be picked up by the receiver regardless of whether the IV bag is connected to the body.

In certain embodiments, the fluid transfer signal also encodes a number, either through phase shift keying, or through frequency shift keying, or one of any other telecommunication convenient technique.

Also shown in FIG. 1 are fluid transfer ports 59A and 59B. By evaluating a parameter of the fluid transfer signal at receiver 53, identification that port 59A is being employed for the fluid transfer event with bag 56 is made. A variation of this system is where there are two separate links. One of the links goes from an IV bag via a fluid processing unit, e.g., a pump. A second of the links is established between the processing unit and the patient. Such an embodiment is illustrated in FIG. 2. A transconduction link 61 goes from the IV bag 54 into the IV pump 66. A second transconduction link 63 goes from the IV pump 66 to the patient 50, e.g., via one of multiple fluid transfer ports (not shown). If, for example, there are any processing or filtering, or additional chemicals at the IV pump, a different signal may be transmitted to the body which is distinct from the signal transmitted from the IV bags. For example, if there are two different IV bags that are being mixed by the pump, and delivered immediately after being mixed, each of them would be broadcasting identifying information about one of the solutions to the IV pump, and a different signal reflecting that combination being administered to the patient would be broadcast from the pump 66 to the patient associated identifier 53. Still referring to FIG. 2, the entire system is depicted, where the patient associated identifier 53 broadcasts via an RF link to one or more external devices, e.g., a network of relay stations 65, handheld devices, personal digital assistants, e.g., smart phones, etc. The transmitted data may be data that have been gathered over time, or obtained immediately following reception of delivery data, or even instantaneous data. The data may be further communicated, e.g., via an RF link to a relay station, which then may be further communicated, e.g., through either an RF link or a conductive path link such as a cable or any other type of telecommunication link to an external processing component 68, such as a Health Information System or Service or Server (Hospital Information System (HIS)) within the hospital or care facility. Then this information is processed an output, e.g., recorded to a physical recordable medium, displayed to a user, etc., such as displayed to a nurse or other medical practitioner.

Where desired, the external processor 68 can provide various alerts. For example, an IV bag could have bar codes on it for shipping and receiving purposes, and also before for providing information to be transferred before the contents of the bag are administered to the patient. For example, a given medical fluid container with fluid may be bar coded and entered into the health information system (hospital information system). The prescription for a given patient with respect to that medical fluid container may also be entered into the health information system, and that prescription may be downloaded into the patient's patient associated identifier, e.g., through an RF link. In addition, the same information may be downloaded, for example to the IV pump that is being used to deliver the fluid inside the container to the patient. The IV pump, for example, may only permit delivery after two confirmations occur. In addition, the system may be configured to confirm that the correct IV port will be employed for delivery of the fluid.

In certain embodiments, the port identification information obtained with methods and systems of the invention can also be linked to an internet system. For example, by using a wireless communication protocol, the port identification information can be broadcasted to a hospital bedside monitor. The bedside monitor may then be configured to relay the information to the internet and subsequently to the data base management system. As such, the patient's medical record and IV port usage information is immediately updated and could be verified against the patient's health record so that if the administered medicine was incorrectly administered via the wrong port, an alert to an appropriate individual, e.g., a nursing staff member may be made.

KITS Also provided are kits for practicing the subject methods. Kits may include one or more receivers of the invention, as described above. In addition, the kits may include one or more parenteral fluid deliver devices, e.g., IV bags, etc.

The subject kits may also include instructions for how to practice the subject methods using the components of the kit. The instructions may be recorded on a suitable recording medium or substrate. For example, the instructions may be printed on a substrate, such as paper or plastic, etc. As such, the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e., associated with the packaging or sub-packaging) etc. In other embodiments, the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g. CD-ROM, diskette, etc. In yet other embodiments, the actual instructions are not present in the kit, but means for obtaining the instructions from a remote source, e.g. via the internet, are provided. An example of this embodiment is a kit that includes a web address where the instructions can be viewed and/or from which the instructions can be downloaded. As with the instructions, this means for obtaining the instructions is recorded on a suitable substrate.

Some or all components of the subject kits may be packaged in suitable packaging to maintain sterility. In many embodiments of the subject kits, the components of the kit are packaged in a kit containment element to make a single, easily handled unit, where the kit containment element, e.g., box or analogous structure, may or may not be an airtight container, e.g., to further preserve the sterility of some or all of the components of the kit. It is to be understood that this invention is not limited to particular embodiments described, as such may 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. 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 may 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.

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. 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 may be different from the actual publication dates which may need to be independently confirmed. 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 may 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.

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 may 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.

Claims

WHAT IS CLAIMED IS:

1 . A method of associating a specific fluid transfer port with a given fiuid transfer event of fluid to a patient from a parenteral fiuid delivery device, the method comprising; estabiishing a fiuid transfer connection between the parenteral fiuid delivery device and the patient via one of two or more distinct fiuid transfer ports of the patient; transmitting a fluid transfer signal between the parenteral fiuid delivery device and a patient associated identifier using the patient's body as a signal conduction medium; from a parameter of the fiuid transfer signai associating a specific fluid transfer port of the two or more distinct fluid transfer ports of the patient with the fluid transfer event.

2. The method according to Claim 1 , wherein the associating comprises identifying which of the fiuid transfer ports has been, is being or wil! be used for delivery of the fiuid from the parenteral fluid delivery device to the patient.

3, The method according to Claim 1 . wherein the parameter is a parameter that varies with respect to distance traveled by the signal.

4. The method according to Claim 3, wherein the parameter is a measure of signai strength.

5. The method according to Giaim 1 . wherein the fluid transfer signai is transmitted from the patient associated identifier to said parenteral fiuid delivery device.

8. The method according to Claim 1 , wherein the fluid transfer signal is transmitted to the patient associated identifier from the parenteral fiuid delivery device.

7. The method according to Ciaim 6, wherein the fiuid transfer signai is transmitted to a first and second patient associated identifier and a signal parameter of the signal received at each of the first and second patient associated identifiers is employed to associate a specific fiuid transfer port with a given fiuid transfer event

8. The method according to Claim 1 , wherein the fluid transfer signal is conductiveiy transmitted between the parenteral fiuid delivery device and the patient associated identifier using the patient as a conductive medium.

9. The method according to Claim 8, wherein the method further comprises norvcondiictiveiy communicating between the patient associated identifier and the parenteral fiuid delivery device.

10. The method according to Claim 1 , wherein the method further comprises transmitting a signal from at least one of the patient associated identifier and the parenteral fluid delivery device to an external processing system.

1 1 . The method according to Claim 10, wherein the external processing system is a hospital information system.

12. The method according to Claim 1 , wherein the method further comprises generating an error signal when the associated fluid transfer port is an incorrect fluid transfer port.

13. The method according to Claim 1 . wherein the method further comprises producing a fiuid administration log comprising information apout fluid delivery via the two or more distinct fluid transfer ports.

14. A system comprising: (a) a parenteral fluid delivery device;

(b) a patient associated identifier configured to be associated with a patient; and

(c) two or more distinct fiuid transfer ports wherein the system is configured to: transmit a fluid transfer signal between the parenteral fluid delivery device and the patient associated identifier using a patient's body as a signai conduction medium following establishment of a fluid transfer connection between the parenteral fluid delivery device and the patient; and from a parameter of the fiuid transfer signai associate a specific one of the two or more distinct fluid transfer ports of the patient with a given fluid transfer event from the parenteral fluid delivery device to the patient.

15. The system according to Claim 14, wherein the parenteral fluid delivery device comprises a broadcasting element for transmitting a fiuid transfer signal to the patient associated identifier and the patient associated identifier comprises a receiver eiement for receiving a fiuid transfer signai from the parenteral fiuid delivery device.

16. The system according to Claim 15, wherein the system comprises two or more patient associated identifiers each comprising a receiver element for receiving a fiuid transfer signal from the parenteral tiuid delivery device.

17. The system according to Claim 15, wherein the patient associated identifier comprises a broadcasting element for transmitting a fluid transfer signal to the parenteral fluid delivery device and the parenteral fiuid delivery device comprises a receiver element for receiving a fluid transfer signal from the patient associated identifier.

18. The system according to Claim 14, wherein the system is configured to conductiveiy transmit the fiuid transfer signal between the parenteral fluid delivery device and the patient associated identifier using said patient as a conductive medium.

19. The system according to Claim 14, wherein said system further comprises an external processing system.

20. The system according to Claim 19, wherein said external processing system is a hospital information system.

21 , The system according to Claim 14. wherein the system is configured to produce an error signal when the associated specific fluid transfer port is an incorrect fluid transfer port.

22. The method according to Claim 14, wherein the system is configured to produce a fluid administration log comprising information about fluid delivery via the two or more distinct fluid transfer ports.