• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    fixing device for the identification of components within a fluid. fixation device aimed at identifying one or more components present within a fluid including a first end configured to selectively attach to an opening of a fluid holding container, with a sensor being coupled to the fixing copra. the sensor further includes one or more sensor elements positioned for the detection and analysis of the fluid present in the container. the sensor is further configured to perform one or more tests useful in the identification of one or more components present in the fluid.
    公开号:BR112013022655B1
    申请号:R112013022655-2
    申请日:2012-03-02
    公开日:2020-12-08
    发明作者:Elizabeth Nelson；Karthik Ranganathan；Bart D. Peterson；William R. Marshall；David Feygin；Weston F. Harding
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    Fundamentals of the Invention
    [001] Each year, dangerous errors involving medications via injecting drugs lead to many events with adverse effects from drugs that could be avoided. These medication errors include errors arising from the incorrect preparation of liquid medications, such as intravenous (IV) medications and oral liquid medications (referred to in this document simply as "fluid" or "fluid IV"). For example, fluids can be prepared incorrectly when produced with the wrong drug, when prepared with an incorrect drug dose, or when prepared with contaminated drugs or with expiry dates. Such errors can be complex, costly, or impossible for pharmacists, nurses, or for aid facilities to detect.
    [002] After being prepared, a fluid is placed in a container, such as a type IV bag or syringe. The container can be labeled with the identification of the fluid and drugs inside the fluid. When the fluid is provided for nurses to administer to a patient, the nurse checks the label for correct fluid identification. If the label indicates the correct fluid, the nurse administers the fluid. However, the nurse in general does not find a way to verify that the label is correctly identifying the fluid.
    [003] In view of the high number of errors in drug preparation that occurs despite current practices, it should be beneficial if it develops systems and methods aimed at reducing the occurrence of events of misuse of drugs due to incorrect preparation of drugs. same. Brief Summary of the Invention
    [004] The present invention came to be developed in response to problems and needs in the technical part not fully developed by systems and methods currently available. Thus, these systems and methods were developed to enable the identification and verification of a fluid containing one or more drugs after the preparation. The systems and methods of the present invention are further developed to enable the identification and verification of fluids that do not contain drugs, but whose identification of them will still be beneficial. Such systems and methods can identify one or more contents and / or the characteristics of a fluid (also referred to in this document simply as "fluid identification") ensuring that it has been properly prepared or labeled correctly. The use of these systems and methods, provide pharmacists and nurses with a higher probability of detecting errors in drug preparation before it is administered to a patient.
    [005] Consequently, current systems may include a fixture that attaches to an opening in the fluid container by testing the fluid inside the container. The fixture includes a sensor having one or more sensor elements positioned so that they come in contact with a fluid flowing through the fixture when the fixture comes to be connected to a container containing a fluid. In some implementations, a sensor is available in the vicinity of a fluid, with the sensor being able to detect and / or analyze the fluid without contacting that fluid. For example, the sensor may include an optical sensor, such as a photodiode, an image sensor, a thermographic camera, or a fiber optic connection. The sensor is configured to perform one or more tests with the fluid, these tests being one or more useful in identifying the fluid and / or a component of the fluid.
    [006] As used in this document, the term “fluid identification” refers to the process or method by which the identification, content or properties of a fluid are identified and are made available to a user. The identification of a fluid can further include the identification of one or more of the contents and / or characteristics of the fluid, such as concentration, a flow measurement, a dosage, and / or a degradation (for example, expiration or contamination) of one or more of the fluid components.
    [007] A fixing device according to the present invention can include several configurations. For example, in some implementations, a fixture includes a clip for fixing a type IV pouch. In other implementations, a fixation device comprises a cap, a stopper, a glass bottle, a luer connector, or some other type of device capable of being connected to a container. In some implementations, a fixture is provided by being configured to be attached to a type IV pouch, a syringe, an ampoule, and a glass bottle. In some configurations, the fastening body has a first end incorporating a fastening factor that attaches to an opening or another surface of a container. The fixing device can also be opened to a first or second end and contain a sensor element arranged thereon to contact and test the fluid present inside the inner chamber. In some implementations, a fixation device may also include an expansion chamber that facilitates the entry of the fluid, and does not allow the fluid to come into contact with an external environment.
    [008] The sensor can also incorporate one or more contact surfaces that are accessible externally from the fixing device. In some implementations, a ventilation membrane is positioned between the inner chamber and an external environment to facilitate the entry of fluid inside the inner chamber, and the ventilation membrane allows air to pass through, but is impermeable to liquids, such as blood. In some implementations, the fixing body may also include a clamp that extends from its first end and forms a fluid path in the inner chamber. In some circumstances, a separate adapter unit is provided to allow compatibility of coupling of the fixture with one or more different types of containers.
    [009] The systems of the present invention may also include a display unit that is connected with a processing unit for viewing information by the processing unit. The systems of the present invention can also be configured to access and update an electronic medical record (EMR) system containing the information provided by the processing unit. For example, in some implementations, the processing unit accesses information from a medical order registered in the EMR system, then comparing it with the identification of the requested fluid with the identification of the fluid present in the container, as determined by the present system. invention. The processing unit can then provide an alert if the processing unit has detected a discrepancy between the two identifications. The system can also be connected electronically to a printer or an RFID programmer.
    [010] These and other factors and advantages of the present invention can be incorporated into certain embodiments of the invention and will become more fully evident from the description and claims only below, or can be understood through the practice of the invention as to be established ahead. Brief Description of the Different Views of the Drawings
    [011] One can readily understand the way in which the characteristics and advantages and other factors mentioned above can be obtained, from a more specific description of the invention succinctly detailed above with reference to its specific modalities illustrated in the drawings in attached. These drawings describe only the typical modalities of the invention and should not be considered as coming, therefore, to restrict the scope of the invention
    [012] Figure 1 consists of a perspective view of a system aimed at identifying one or more components present in the fluid, according to a representative embodiment of the present invention.
    [013] Figure 2 consists of a perspective view of a type IV pouch and a fixation device coming in accordance with a representative embodiment of the present invention.
    [014] Figure 3 consists of a perspective view of a fixation device coming in accordance with a representative embodiment of the present invention.
    [015] Figure 4 consists of a cross-sectional view of the fixture in Figure 3.
    [016] Figure 5 comprises a cross-sectional view of the fixing device of Figure 3 before fixing it to a container according to a representative embodiment of the present invention.
    [017] Figure 6 consists of a cross-sectional view of the fixation device of Figure 3 in sequence the fixation next to a container according to a representative embodiment of the present invention.
    [018] Figure 7 consists of a perspective, diagrammatic view of a system aimed at identifying one or more components present in the fluid coming according to a representative embodiment of the present invention.
    [019] Figure 8 consists of a perspective, diagrammatic view of the system of Figure 7 according to a representative embodiment of the present invention.
    [020] Figure 9 consists of a perspective view of a fixture and an adapter unit according to a representative embodiment of the present invention.
    [021] Figure 10 consists of a cross-sectional view of the fixing device and the adapter unit of Figure 9 where the adapter unit is to be inserted into the fixing device according to a representative embodiment of the present invention.
    [022] Figure 11 comprises a perspective, diagrammatic view of a fluid identification system operatively connected to a computer network and to an EMR system according to a representative embodiment of the present invention.
    [023] Figure 12 consists of a diagrammatic view of a fluid identification system according to a representative embodiment of the present invention.
    [024] Figure 13 consists of a diagrammatic view of a fluid identification system according to a representative embodiment of the present invention. Detailed Description of the Invention
    [025] The currently preferred embodiments of the present invention can be understood by reference to the drawings, where the reference numerals indicate functionally similar or identical elements. It should be readily understood that the components of the present invention, described and illustrated generically in the relevant figures, can be positioned and designed from a wide variety of different configurations. Thus, the following more detailed description, represented according to the figures, is not intended to restrict the scope of the invention as claimed, being merely for illustrative purposes of the presently preferred embodiments of the invention.
    [026] The figures indicate some of the various representative modalities of systems and methods for identifying a fluid inside a container. The system can identify a fluid, and then communicate its identification with a computer system, a pharmacist, and / or a nurse, in order to detect and reduce the occurrence of errors in the preparation of drugs. The system and method can also be used in pharmacies and other types of facilities where liquids containing drugs (substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease) are being prepared or administered. The use of the system can enable pharmacists and nurses to identify a fluid without sending the fluid to a laboratory for testing and identification. The system can also provide with real-time identification of fluids, which can facilitate a nurse in identifying errors in preparation. The system can also register the identification of the fluid with a registration system, which can be used to prepare a precise label that can be placed on the container.
    [027] Referring now to Figure 1, illustrating a fixture 20 configured to identify a fluid 24 contained within a container 22. In some embodiments, the fixture 20 consists of a sensor 26 configured to perform tests on the fluid 24 for the identification of one or more parameters, components, or fluid characteristics 24. In some embodiments, the fixture 20 comprises a surface for facilitating the fixation of the fixture 20 next to a container 22. The The fixing device 20 further comprises a second surface for facilitating the fixing of the fixing device 20 next to a receiving unit 36. The specific structures related to the fixing device 20 and the receiving unit 36 will be discussed below.
    [028] The fixation device 20, according to the description given in this report, is used to identify a fluid. According to the use given in this report, the term “fluid identification” refers to the process or method of identifying at least one or more of the components, properties, characteristics or parameters of a fluid 24. For example, the process identification of a fluid 24 may include the identification of at least one or more drugs present within a fluid 24. identification of the fluid 24 may further include the identification of at least one or more of the other components and / or characteristics of fluid 24, such as the concentration, dosage, or degradation (eg, expiration or contamination) of one or more of the components of fluid 24. The process of identifying a fluid 24 may further include the identification of a fluid that does not contain drugs, through which accurate identification is beneficial (for example, such as the identification of a saline solution). The fixture 20 can be configured to selectively attach to an opening 40 in a container 22 of fluid 24. The fixture 20 can be in the form of a cap, a stopper, a glass bottle, or a luer connector ( such as a Q-SyteTM connector from Becton, Dickinson and Company).
    [029] As mentioned, the fixture 20 comprises a sensor 26 configured to perform one or more tests against the fluid 24. The fixture 20 is further coupled to a processing unit 32 configured to receive and analyze the measurements of the sensor or data from sensor 26. The processing unit 32 may also comprise of instructions executable by computer aimed at receiving and analyzing sensor measurements or data from sensor 26. Once identification or other information has been determined characteristics of the fluid 24, the processing unit 32 displays said information on a display device 34.
    [030] The sensor 26 in combination with the processing unit 32 can be referred to as a fluid identification system 30. The fluid identification system 30 can include several configurations, which will be described in detail below. The various examples of sensors suitable for the implementation of the present invention are described in International Application No. WO 2009/114115, published on September 17, 2009, included in this report as a reference, in its entirety.
    [031] Taking Figure 1 as a reference, a sensor 26 can include one or more sensor elements 28. The sensor element 28 is configured to detect or, on the other hand, to test various characteristics of the fluid 24. In In some embodiments, the sensor element 28 comprises a sensing surface adapted for interaction and responding to the fluid 24 inside the container 22. In some circumstances, one or more elements of the sensor 28 incorporate one or more electrodes. Sensor elements 28 and / or sensor 26 can incorporate a semiconductor device that can be installed on a printed circuit board or some other substrate.
    [032] The sensor 26 can be configured to monitor one or more parameters or characteristics of the fluid 24 inside the container 22 by performing one or more tests on the fluid 2.4 The parameters of the fluid 24 can include any set of physical properties whose values determine a fluid characteristic or behavior (for example, temperature, density, impedance, pressure, viscosity, etc.). The data resulting from the tests performed by the sensor 26 can be referred to as measurements of the sensor or data that can be transmitted to a processing unit 32 configured for the identification of one or more characteristics, perimeters or components present inside the fluid based on these measurements. of the sensor.
    [033] For example, in some modalities, sensor 26 can be configured to monitor the impedance of fluid 24. To do so, an electrical signal can be transmitted through one or more elements of sensor 28 to fluid 24 in a range of frequencies. The elements of the sensor 28 can be checked, later, on the current generated in the fluid by the electrical signal. The electrical signal is then sent to the processing unit 32, in the form of sensor measurements. The sensor measurements can be conditioned and / or processed by the processing unit 32. The sensor measurements, which can include the measured current and the transmitted voltages, are then used for mapping, the frequency being dependent on the impedance of fluid 24. Maps, or signatures, can be unique for each fluid 24 containing the drug, from a given concentration, purity, and state of degradation. The signatures can then be compared to a library of pre-loaded signatures, with comparison being used for fluid identification 24. In some configurations, sensor 26 makes use of one or more additional sensing methods or alternatives for monitoring one or more fluid parameters 24.
    [034] The fluid identification system 30 can also use a multi-parametric approach for the identification of drugs present in the fluid 24. In such an approach, multiple parameters can be monitored (for example, the refractive index). electrochemical potential, impedance, admittance, and conductivity). This multi-parametric approach is referred to as a multiplexing. Therefore, a fluid 24 can be monitored with multiple sensors 26, or with a sensor 26 showing multiple sensor elements 28. Fluid 24 can be monitored with a single element of sensor 28 using multiplexing to obtain independent sensor measurements. In this way, sensor measurements can generate a multi-parametric profile for the fluid 24.
    [035] A more specific reference will be made next to the processing unit 32 in Figure 1. As mentioned, the processing unit 32 can be configured to receive the sensor measurements from the sensor 26 and make use of the sensor measurements for the identification of fluid 24. Consequently, the processing unit 32 communicates with the sensor 26 via a communication link 38. In some embodiments, the processing unit 32 also activates the sensor 26. For example, in in some embodiments, processing unit 32 is electronically coupled to sensor 26, with this processing unit 32 energizing sensor 26 to enable it to perform tests on fluid 24. During the testing procedure or upon completion of these tests , the processing unit 32 can receive the sensor measurements from the sensor 26.
    [036] The processing unit 32 can also include a computer system, where part or all of the processing logistics can be implemented for the identification of a fluid using the sensor measurements. The computer system can include a processing subsystem for special purposes or general purposes. For example, the computer system may consist of a personalized computer, a portable computer, a tablet, a work center, a minicomputer, a large structure, a supposed computer, a multi-processing system, a portable electronic device ( for example, a mobile cell phone), a processor-based electronic device, or the like, which can be attached to any of the other components of processing unit 32. Additionally, processing unit 32 can be incorporated into a computer system used in medical equipment installations, such as an intelligent pump, an automated dosing unit (ADC), a computer-administered bed system, a personalized computer, a weakened customer, or some other suitable computer system .
    [037] In some modalities, instructions executable by computer are provided containing instructions leading the processor of the computer system to perform the functions for the implementation of logistical operations. Computer executable instructions can be permanently stored in the computer system's memory, or they can be temporarily loaded and stored in the computer system's instruction memory from computer readable media. Computer executable instructions can include data structures, objects, programs, routines, or other program modules that can be accessed by the processor.
    [038] In some modalities, a computational system of the processing unit 32 comes to be used for the implementation of a process for the identification of the fluid 24 based on the measurements of the sensor. In some modalities, one or more software modules are provided containing instructions to make the processor implement these modules. The processing unit 32 can also be used to implement a process aimed at processing, storing, displaying or transmitting data regarding the identification of the fluid 24.
    [039] The processing unit 32 can further be electronically coupled to a display device 34 configured to display the fluid identification 24 and / or other desired information. The display device 34 thus provides real-time delivery to the individual performing the test on fluid 24, providing immediate assistance in determining whether fluid 24 has been properly prepared. This provision of information can provide pharmacists and nurses with a check on appropriate preparation or a warning of inadequate preparation. As shown, the display device 34 can be integrated within the same body as in the case of the processing unit 32. The display device 34 can be further separated from the processing unit 32. For example, in some embodiments, the display device 32 represents part of a bed system separate from the processing unit 32. The display device 34 can include any compatible display technology. For example, in some embodiments, the display device 34 comprises at least a liquid crystal display (LCD) device, a cathode ray tube (CRT) display device, and a plasma display panel ( PDP), a light emitting diode (LED) viewer, or any other suitable viewer.
    [040] As shown, in some modalities, the display device 34 comes to be configured to display a graphical user interface (GUI) to display the identification of fluid 24 and / or other relevant information. In some modes, a GUI is configured to provide or display the name of a patient with a view to being attended to, incorporating a touch screen display device 34, this display device 34 can function as an input device and the GUI may include entry regions where the user can enter data, such as the volume of the fluid, and the identification of the nurse. The GUI can also include the impulse key, such as a scan key, where the user can initiate a scan of the fluid 24 in a container via an electronically coupled sensor 26.
    [041] The sensor 26 and the processing unit 32 are operationally interconnected via a communication link 38. In some embodiments, the communication link 38 comprises a link without wiring (for example, WiFi, Blutooth®, WiMAx, IR, RF, or other known wireless communication approaches). In other embodiments, the communication link 38 comprises a direct connection with wires (for example, electrical or optical cables). In addition, in some modalities the communication link 38 comprises a direct connection through one or more direct main contacts. The communication link 38 may further include a cable coupled to an input interface of the processing unit 32. Such input interface may include a USB port or some other suitable type of port. In some embodiments, sensor 26 is electronically energized via one or more power lines coupled to direct connection with wires.
    [042] When processing unit 32 is electronically coupled to sensor 26 via a direct wired connection or a main direct connection, sensor 26 can be electronically coupled to a connector member 36. The connector member 36 can include one or more main contacts that can establish an electrical connection with the sensor 26. In some embodiments, the connector member 36 extends externally from the container 22 so that it can be physically accessed from the outside of the container 22. In these circumstances, a user can connect an electrical cable to connector member 36 by establishing a communication link 38 between them. In some embodiments, the spun connection includes a cable that is coupled to an input interface of processing unit 32. Such an input interface may include a USB port or other types of suitable inputs. In some embodiments, sensor 26 is energized electronically via one or more power lines of a direct spun connection.
    [043] In other modalities, the sensor 26 is energized electronically via a separate power supply coupled to the container 22 or powered without wires. In some embodiments, one or more power supplies, such as one or more batteries, are attached to the container 22 and electronically attached to the sensor 26 to energize the sensor 26. In other embodiments, the sensor 26 is energized without the use of wires, such as through the use of wireless RFID technology. Examples of sensors 26 incorporating RFID technology are described in United States Patent Application No. 2008/0129475, published on June 5, 2008, incorporated in this report as a full reference.
    [044] In some embodiments, the clamping device 20 comprises a first end 21 facilitating the coupling of the clamping device 20 near the opening 40 of the container 22, and further comprising a second end 23 facilitating the coupling of the clamping device 20 next to receptacle 37 of the receiving unit 36. The receiving unit 36 is, in general, provided as a mechanism for receiving and transmitting the sensor measurements from the sensor 26 of the fixture 20. The receiving unit 36 further comprises a mechanism for transferring the sensor measurements from the receiving unit 36 to the processing unit 32. In some embodiments, the receiving unit 36 is still configured to supply the sensor 26 with electrical energy. example, in some embodiments, the receiving unit 36 consists of an internal power supply and main contacts, where a portion of the internal power supply is transferred to the fixture 20 via the main contacts (not shown). In other embodiments, the receiving unit 36 is energized via an external power source. The sensor 26 can be further powered by an internal or external power supply of the fixture 20.
    [045] In some aspects of the present invention, the fluid 24 coming from the container 22 is introduced into the fixture 20 with the fluid being directly exposed to the sensor elements 28. The sensor 26 and the sensor elements 28 are then able to detect the various parameters or characteristics of the fluid 24 and communicate this information to the processing unit 32 via the receiving unit 36 and the communication link 38.
    [046] Referring now to Figure 2, the fixture 20 is shown as attached to a type IV pouch 22. According to the previous discussion, the fixture 20 can be configured in such a way as to selectively secure the various types of fluid containers 22. Consequently, the fixing device 20 can be employed to test fluids 24 stored in the container. For example, the fixation device 20 can be configured to attach to a syringe, IV pouch, ampoule, glass vial, self-injection container, or any other suitable container used to treat a patient. In this way, the first end 21 of the fixing device 20 can be configured and outlined to attach to several containers 22.
    [047] The fixing device 20 can also be made available in the form of a single-use or multiple-use device. In addition, it should be noted that the fixing device 20 can be used repeatedly next to a simple container 22. For example, after a fluid container 24 has been prepared and tested, the fixing device 20 may remain in the container 22 acting as a lid. One or more containers of the container 22 can leave the fixture 20 in its position and retest the fluid present inside the container 22 by coupling the fixture 22 to a processing unit 32. The new test can be particularly useful and beneficial just before drug administration to verify that the patient is prescribing the correct medication. Consequently, the clamping device 20 provides with varied and repeated benefits.
    [048] Referring now to Figures 3 and 4, an isolated fixing device 20 is shown. In some embodiments, the first end 21 of the clamping device 20 is dimensioned and designed to selectively attach to an opening 40 of the container 22. The second end 22 is configured in the same way to selectively connect to a processing unit 32 , connecting directly or alternatively with the receiving unit 36, which then leads to a direct coupling with the processing unit 32 via the communication link 38. The fixing device 20 further comprises an inner chamber 56 coming from be defined as a hollow portion of the fixture 20 positioned between the first and second ends 21 and 23. The fixture 20 further comprises a sensor 26 incorporating one or more sensing elements 29 disposed within the inner chamber 56. The sensing elements 28 are positioned inside the inner chamber 56 so that they come into direct contact with a fluid (not shown) present in inner chamber 56.
    [049] In some configurations, the first end 21 of the fixing device 20 also includes an opening 50 that opens towards an internal cavity 52 bounded by one or more walls 54. These one or more walls can be configured and delineated to selectively attach to an opening 40 of a container 22. For example, the inner surface 70 of one or more walls 54 can be delineated and configured to form a snap fit, a locking fixture, a tongue fixture, a screw fastening, or some other type of fastening with the opening 40 of a container 22. For example, in some embodiments, these one or more walls 54 include a fastening template comprising one or more internal grooves, one or more prominences, one or more tongues, one or more male or female threads, and / or other types of suitable fasteners. In some embodiments, the panels 54 consist of a simple wall circumscribing a clamp IV 58, where this clamp IV 58 extends into the cavity 52 at the first end 21 of the fixing device 20. The walls 54 can extend beyond the clamp IV 58 shielding the clamp IV 58, preventing the occurrence of needle locking accidents. In some configurations, the walls 54 are configured to at least partially surround a portion of the container 22, such as an opening 40 or receptacle of the container 22. The walls 54 may also comprise templates for selective fixation next to a opening 40 or container receptacle 22.
    [050] In some configurations, the second end 21 of the fixture 20 includes an electrical connector 66 configured to operationally connect sensor 26 to processing unit 32. In some embodiments, electrical connector 66 is directly coupled to an input receptacle (not shown) in the processing unit 32. In other embodiments, the electrical connector 66 is indirectly coupled to the processing unit 32 via a communication link 38 and / or the receiving unit 36. The electrical connector 66 may include one or more contact surfaces 68 configured to form a direct main connection with another device, such as a receiving unit 36. When connected to electrical connector 66, processing unit 32 can establish and effect electronic communication with sensor 26. In some embodiments , the electrical connector 66 is positioned in another portion of the fastening body 21 in addition to the second end 23. For example, and In some embodiments, the electrical connector 66 is positioned on a side or intermediate portion of the fixing device 20.
    [051] In some embodiments, the inner chamber 56 of the fixture 20 is configured to retain a liquid 24 therein when the first end 21 of the fixture 20 is fixed to the container 22. In addition, in some modalities, the inner chamber 56 is configured to retain the liquid 24 after the release of the fixing device 20 from the container 22. Therefore, the inner chamber 56 can be completely enclosed when the fixing device 20 is attached to the container 22. In some configurations, the inner chamber 56 forms part of the cavity 52 that opens at the first end 21 of the fixture 20. In other configurations, the inner chamber 56 is separated from the cavity 52 via an inner wall 72. As shown, the inner wall 72 can support clip IV 58, the fluid path 60 of clip IV 58 providing with a mechanism in which fluid 24 can flow between inner chamber 56 and c avity 53. In other types of configurations a fixing device 20 is provided without including the presence of clip IV 58.
    [052] The fixture 20 can further include a membrane 62. The membrane 62 can be positioned inside the fixture 20 between the inner chamber 56 and the external environment. In some embodiments, membrane 62 is air-permeable and fluid-impermeable. For this purpose, when a fluid 24 flows into the inner chamber 56, the air is allowed to leave the inner chamber 56 via a membrane 62, however, fluid 24 is prevented from leaving the inner chamber 56 to the external environment via the membrane 62. In this way, the fluid 24 is retained within the fixing device 20.
    [053] The membrane 62 can include various materials and components providing these properties. For example, in some embodiments, membrane 62 is hydrophobic. In other embodiments, the membrane 62 comprises glass, polyethylene terephthalate (PET), a microfiber material, and / or another type of synthetic material made from high density polyethylene fibers, such as a TYVEK type material. ® from DuPont. In addition, in some embodiments, the membrane 62 consists of a plurality of small orifices repositioned between the inner chamber 56 and the cavity 64, with the small orifices covering sufficient surface areas to allow the passage of air, however preventing the passage of fluid 24.
    [054] Referring now to Figures 5 and 6, a fixation device 20 is shown during its use. Figure 5 shows the first end 21 of the fixing device 20 approaching the opening 40 of the container 22. The opening 40 can include a valve portion 80 of an IV bag intended to be pierced by the clip IV 58. As already discussed, the portion 80 of the container 22 can incorporate any size as desired for selective attachment of the container 22 to the fixing device 20. As indicated, the portion 80 is configured and sized to fit under pressure within the cavity 52 at the first end 21 of the fixing device 20.
    [055] Figure 6 illustrates the fixation device 20 in sequence to the coupling of the container 22. The opening 40 is admitted by the cavity 52 causing the clamp IV 58 to make the drilling and provide a path through the opening 40. After having once the container 22 has been punctured by clip IV 58, a path for the fluid 60 is opened between the container 22 and the inner chamber 56. As the fluid 24 continues to flow into the inner chamber 56, air is expelled from the inner chamber 56 via membrane 62. The fluid inside the inner chamber 56 is in direct contact with the elements of sensor 28 of sensor 26, thus allowing sensor 26 to perform one or more tests on fluid 24. The fixing device 20 it is further coupled to the processing unit 32, while preserving the connection between the fixing device 20 and the container 22. In some embodiments, the fluid 24 is retained inside the inner chamber 56 following the removal of the fixing device o 20 of the container 22. For this purpose, the fluid 24 can be analyzed by the sensor 26 and with the processing unit 32 by proceeding to release the container 22 from the fixture 20.
    [056] In some embodiments, sensor 26 is provided in the vicinity of fluid 24, with sensor 26 being able to detect and / or analyze fluid 24 without contacting fluid 24. For example, sensor 26 may include a optical sensor, such as a photo diode, an image sensor, a thermal camera, or a fiber optic connection. Consequently, the identification or other desirable characteristics of the fluid 24, can be determined by the sensor 26 without the need for contact between the fluid 24 and the sensor 26.
    [057] Referring now to Figures 7 and 8, a holding device 20 and a receiving unit 36 are presented according to a representative embodiment of the present invention. Some embodiments of the present invention comprise of a receiving unit 36 having a start button 92. When pressed, the start key 92 causes the receiving unit 36 to energize sensor 36 inside the fixture 20. Once energized , sensor 26 initiates the performance of one or more tests on fluid 24. In some embodiments, the fixing device 20 can be coupled to a container, while being coupled to the receiving unit 36. Alternatively, the device fixing device 20 can be separated from a container 22, as shown, with a portion of the fluid 24 coming from the container 22 remaining inside the inner chamber 56 of the fixing device 20.
    [058] The receiving unit 36 may include several mechanisms for electronic coupling or otherwise operational coupling with the fixture 20. For example, in some embodiments, the receiving unit 36 consists of a prominent connector member 90 outlined and configured to enter into the cavity 64 of the second end 23 of the fixture 20. The prominent connector member 90 may have one or more contact surfaces 68 of the fixture 20 forming an electrical connection.
    [059] In some configurations, the receiving unit 36, the processing unit 32, and the display device 34 consist of individual components of a fluid identification system 30. In other configurations, the processing unit 32 and the unit receiver 36 form an integral unit operatively coupled to a separate display device 34. In still other configurations, the processing unit 32, the receiving unit 36 and the display unit 34 form an integrated unit. Consequently, it should be understood that a processing unit 32 can have different configurations.
    [060] Referring now to Figures 9 and 10, there is the presentation of an attachment adapter 100 and an incompatible container 22. In some embodiments, the size or configuration of the first end 21 of the attachment device 20 can be incompatible for fixing a desired container 22. Consequently, a fixing adapter 100 can be provided incorporating a first and second ends 102 and 104 for coupling compatibility with the container 22 and the adapter device 20, respectively. The use of a fixture 20 with or without a fixture adapter 100 can provide a relatively inexpensive and / or disposable device for testing a fluid from a variety of containers 22 and types of containers. By providing one or more clamping adapters 100, the clamping device 20 can be attached to many types of IV containers 22.
    [061] For example, in some embodiments, the fixation device 20 is configured to attach to an IV pouch. For this purpose, the fixation device 20 consists of an IV clip 58. To enable a coupling between the fixation device 20 and a syringe 120 incorporating a blunt tip 122, a fixation adapter 100 can be provided.
    [062] Fixing adapter 100 may include a first adapter end 102 that attaches to container 22 and a second adapter end 100 that attaches to fixture 20. In some configurations, second adapter end 104 is dimensioned and configured within a cavity 52 of the first end 456 of the fixture 20. The second adapter end 104 further includes an internal passage 116 admitting the clip IV 58 to form a fluid path within the clip IV 58. The outer surface 112 of the second end of the adapter 104 can be dimensioned and configured to fit inside the cavity 52 of the first end 46 of the fixture 20. This external surface 112 can also include the ribs 114 or other structural aspects that form a fixation between the clamping adapter 100 and clamping device 20, such as a snap-fit or locking fixture nto. In addition, it is also understood that the first adapter end 102 may include an inner surface 106 and / or an outer surface 108 being outlined, dimensioned or otherwise configured for attachment to the container 22.
    [063] In some embodiments, the first end of adapter 102 is configured to attach to a syringe 120 incorporating a blunt tip 122. In other embodiments, the first end of adapter 102 consists of one or more threads (not shown) for the threaded coupling 124 of a container 22. In some configurations, an annular ring 110 extends out of the adapter unit 100, separating the first adapter end 102 from the second adapter end 104, further forming a barrier that at least partially seals cavity 52 from an external environment.
    [064] Referring now to Figure 11, a fluid identification system 30 of the present invention is presented operating electronically or on the other hand operationally coupled to a computational network 130, and the computational network 130 comes to be operationally coupled, or on the other hand, it includes an EMR 132 system. In some configurations, computer network 130 comprises a computer network 130 of a hospital or some other hospital institution. It is understood that the computational network 130 can be presented in any format along a network covering a wide area (WAN), for example, the Internet, or any form of local area network (LAN).
    [065] Computational network 130 and processing unit 32 are operationally connected, so that processing unit 32 is able to receive and record information from the EMR 132 system. An EMR consists of a computerized medical record of a patient. EMRs are generally provided to record information about the patient's treatment, the patient's medical history, the patient's contact information, the patient's hospital insurance and information about charges, and the like. The EMR 132 systems of the present invention refer to computer systems operating on one or more sets of EMRs. For example, a hospital facility may include one or more EMR 132 systems operating alongside a plurality of computing devices and / or computing systems. Some of the EMR 132 systems store hospital test results, hospital images or scans, and other types of records, documents, and assessments. An EMR 132 system can also be specific to a hospital facility, such as a doctor's office or a hospital.
    [066] For example, when fluid 24 is initially prescribed to a patient, the medical prescription is recorded in the EMR 132 system through a prescription from the professional or some other nurse. When operationally connected to the computer network 130, the processing unit 32 is able to access the medical prescription stored in the EMR 132 system. When using this information, the processing unit 32 compares the identification of the prescribed fluid with the identification of the fluid prepared 24, identified accordingly by the fluid identification system 30. In addition, the processing unit 32 can record the identified content and characteristics of the fluid 24 in the EMR 132 system. This information can be used for record preservation purposes, for monitoring the life cycle of container 22 and / or fluid 24, for charges to a patient for the use of fluid 24, and / or for the monitoring history performed.
    [067] An EMR can also include a subset of records, generally referred to as hospital administration electronic records (EMARs). An EMAR can include any type of medical care record that will be generated and stored in electronic format. An EMAR can record drug prescriptions by providing specific instructions for fluid identification 24. These drug prescriptions can provide processing unit 32 with the data by which to compare the identification of fluid 24 present inside the container 22 For example, processing unit 32 can access a medical prescription registered with EMAR and compare the identification of the prescribed fluid with the identification of the current fluid 24 present inside the container 22, as identified by the fluid identification system 30. Case the identification of the fluid does not match the medical prescription, the system 30 can provide an alert to the nurse. The nurse can then prepare or prescribe a fluid replacement 24. The processing unit 32 may also require the pharmacist or nurse to respond to the alert before they can finalize any further operations on the system.
    [068] The processing unit 32 can be further configured to record the information for the patient's EMR for the time when fluid 24 is to be used. For example, the processing unit 32 can record the identification of one or more drugs present in the fluid 24, the dosage of such drugs, the temperature of the drugs, a diluent, and / or other types of information. The processing unit 32 can further comprise of the automatic registration factors that can be employed for the reduction of manual registration services, improvement of the procedures regarding subsequent charges, and the reduction of the possibility of erroneous data entry.
    [069] Referring now to Figures 12 and 13, there is the presentation of a fluid identification system 200 configured to prepare a label 136. In sequence the identification of the fluid 24 by the processing unit 32, this information is displayed to a user via a display device. For example, when system 200 is used in a pharmacy, the identification of the fluid can be communicated to the pharmacist or technician through a computer screen. The pharmacist can then verify that the compound fluid has the same levels and characteristics as those prescribed by the professional involved in the medical prescription.
    [070] Referring to Figure 12, after the identification of the fluid 24 has been verified, the system 100 provides with a label 136 that can be affixed to a portion 134 of the container 22. The label 136 contains information indicating the correct identification and checked the fluid 24. This automated or semi-automated labeling process avoids problems involving incorrect labels. In some embodiments, the label 136 contains a bar code 132 or some other type of code that can be identified by the computer communicating the information to an appropriate reader (not shown), such as those used in some hospitals or other types of facilities hospitals. Label 136 can also include simple texts that can be read by the nurse. Consequently, in some embodiments, a printer 130 is electronically coupled to processing unit 32 and configured to print a label 136 containing a bar code 132 or some other type of desired format that includes information related to fluid identification 24.
    [071] Referring to Figure 13, the processing unit 32 can alternatively or additionally be coupled to an RFID 140 programmer. The RFID 140 programmer can program an RFID 142 chip that can be attached to a portion 134 of the container 22, in the form of a label. In some examples, an RFID 142 chip is embedded in a lid or some other container wrap 22. The RFID 142 chip can perform the transmission of information with a computer system incorporating an RFID reader (not shown), such as those included in a treatment facility, such as a hospital or some other type of hospital facility. The RFID chip 142 can be programmed with information communicating the identification of the fluid 24. Consequently, in some modalities, an RFID programmer 140 is electronically coupled to the processing unit 32 and configured to program an RFID chip 142 with the information related to fluid identification 24.
    [072] In some modalities, a label may also include information related to the patient, such as the patient's name, age, weight, sex, marital status, ethnicity, and / or allergies. This information can be obtained from the patient's EMR, as contained in the EMR 132 system. Other data can be included on the 132 tag, or on the RFID microcircuit 142, including the specific contents and characteristics of the fluid 24, a batch number of the drug, and the drug manufacturer of the drug contained in fluid 24. The labels can also identify the clinician who came to prepare fluid 24, the date and time when fluid 24 came to be prepared, and / or the temperature , history, and / or history of exposure to fluid light 24. Once applied to container 22, the tag can be used for later verification by clinicians and nurses,
    [073] When drug preparation and drug identification are carried out at a pharmacy outside the circuit, a label can be scanned to verify the identification of the fluid 24. Alternatively, the pharmacy outside the circuit can check the contents of the container using a fluid identification system 30 or 200, according to the description given by this report.
    [074] In some hospital facilities, fluids 24 are delivered using an automatic dosing enclosure (ADC). When supplied by means of the ADCs, the processing unit 32 can be incorporated in the ADC for the identification of the fluid 24 present inside the container 22, with the visualization of this information in the display device 34 of the ADC. Alternatively, if there is a RID tag or microcircuit attached after a scan by the pharmacy, the fluid identification can be obtained directly from the tag without re-scanning the contents of the container 22 using the fluid identification system 30 or 200.
    [075] If the fluid 24 is stored in a hospital environment, the processing unit 32 can be located next to an area facing the identification of the fluid. Alternatively, if a label is affixed to the container 22 by a pharmacy, the nurse can avoid identifying the fluid by the fluid identification system 30 or 200, and simply scan the label to obtain the desired information. In case the system communicates with the patient's EMR, the system 200 can automatically compare the contents of the container 22 against the drug prescription for the patient.
    [076] In some embodiments, a fluid identification system 30 or 200 is used by the nurse prior to the administration of fluid 24 verifying the identification of fluid 24 by the medical prescription of the fluid. In case the label is affixed to the container 22 after the scan has been carried out by the pharmacy, the nurse simply obtains the desired information from the label. When the system is used next to the patient's bed, information about the patient can be communicated to clinicians through the visualization device 34 located or close to the patient's bed. The visualization devices, according to the present invention, can also be used to access the electronic records of the patient from an EMR 132 system. Consequently, the system can also be used to print a record for the nurse, checking whether the drug identified matches the prescribed medication. When the sensor of the system 30 or 200 is configured to communicate with the patient's EMR, it can automatically perform a verification of the contents of the container 22 according to the medicine outlined for the patient.
    [077] The approaches to identification described in this report may also include certain noted aspects (for example, alarms) providing information to the pharmacist, nurse, clinician, or some other professional that fluid 24 does not comply with the given drug prescription . Such information can alert the pharmacist or nurse of the error, so that it can be corrected. In this way, the devices, systems, and methods present may reduce the possibility of harmful drug events involving dangerous medical errors.
    [078] The systems presently described provide a number of utilitarian factors. For example, the systems of the present invention accurately identify the identification of fluid 24 allowing conditions for clinicians and nurses to verify that fluid 24 has been correctly prepared in the various stages prior to administering the fluid to a patient. Additionally, in some configurations, there is the identification by the present systems of a drug dosage and its concentration, the identification of a diluent, the temperature of the fluid 24, a measurement of the flow of a fluid 24, and / or the degradation of a drug in the heart of fluid 24. The system can also automatically synchronize information from the contents of container 22 with a patient's EMR and / or EMAR to verify the identification of fluid 24 according to the medical prescription, and subsequently automatically record the fluid identification in the patient's EMR and / or EMAR. The system can also automatically prepare a tag 136 or an RFID microcircuit 142 that can be attached to the container 22.
    [079] The present invention can be embodied in other types of specific formats without deviating from its structures, methods, or other essential characteristics as widely described and claimed later in this report. The described modalities should be considered in all aspects as being only illustrative, and not restrictive. Therefore, the scope of the invention is indicated by the attached claims table, instead of the previous description. Any changes that fall within the scope and equivalent scope of the claims must be included within its scope.
    权利要求:
    Claims (15)
    [0001]
    1. Fixation device (20) aimed at identifying one or more parameters of a fluid (24), comprising: a first end (21) configured to selectively attach to an opening (40) of a container (22); a sensor (26) having a sensor element (28), the sensor element being positioned inside an internal chamber (56) of the fixture, the sensor being configured to perform at least one test for the identification of one or more more fluid parameters inside the inner chamber; FEATURED by the fact that the fixing device including a clamp (58) extending into a cavity (52) at the first end (21) of the fixing device (20), where the opening (40) is received by the cavity (52), causing the clamp (58) to perforate and provide a path through the opening (40) when the container is attached to the first end, causing fluid to flow from the container into the internal chamber of the fixture.
    [0002]
    2. Fixation device according to claim 1, CHARACTERIZED by the fact that it also comprises a second end (23), in which the inner chamber is positioned between the first end and the second end.
    [0003]
    Clamping device according to claim 2, CHARACTERIZED by the fact that the sensor comprises a contact surface (68) externally accessible via the second end of the clamping device.
    [0004]
    4. Fixation device, according to claim 2, CHARACTERIZED by the fact that it also comprises a gas permeable membrane (62) positioned between the internal chamber and an external environment, the gas permeable membrane allowing the gas to escape through the second end while preventing fluid from flowing through the second end.
    [0005]
    5. Fixation device according to claim 1, CHARACTERIZED by the fact that it also comprises an inner wall (72) that separates the inner chamber from a cavity (52) formed by the first end, the clamp extending through the inner wall to create a fluidic path (60) from cavity to the inner chamber.
    [0006]
    6. Fixation device according to claim 1, CHARACTERIZED in that it also comprises a fixing adapter (100) containing a first adapter end (102) configured to secure the first end (21) of the fixing device ( 20) and a second adapter end (104) configured to secure the opening (40) of the container (20).
    [0007]
    7. Clamping device according to claim 6, CHARACTERIZED by the fact that the second end of the adapter is configured to be inserted in the first end of the clamping device.
    [0008]
    8. Fixation device according to claim 7, CHARACTERIZED by the fact that the second end of the adapter includes an internal passage (116) that admits the clamp.
    [0009]
    9. Fixation device according to claim 6, CHARACTERIZED by the fact that the container is a syringe (120) that is attached to the first end of the adapter.
    [0010]
    Attachment device according to claim 6, CHARACTERIZED by the fact that the annular ring (110) extends out of the adapter unit (100) separating the first adapter end (102) from the second adapter end ( 104), forming a barrier that at least partially seals the cavity (52) from an external environment.
    [0011]
    11. Fixation device according to claim 1, CHARACTERIZED in that it further comprises a processing unit (32), the fixation device having a second end (23) configured to couple to the processing unit to allow the sensor data is transmitted from the sensor to the processing unit.
    [0012]
    12. Fixing device according to claim 11, CHARACTERIZED by the fact that the fixing device is configured to retain liquid inside the inner chamber after the fixing device is disconnected from the container and before the fixing device be coupled to the processing unit to thereby enable the performance of at least one test when the fixture is not attached to the container.
    [0013]
    13. Fixation device according to claim 11, CHARACTERIZED by the fact that the processing unit is configured to access a medical prescription that specifies a prescribed fluid and to compare the prescribed fluid with one or more parameters of the identified fluid using at least a test.
    [0014]
    14. Fixation device according to claim 11, CHARACTERIZED by the fact that a printer (130) is electronically coupled to the processing unit (32) and configured to print a label (136).
    [0015]
    15. Fixation device, according to claim 11, CHARACTERIZED by the fact that an RFID programmer (140) is electronically coupled to the processing unit (32) and configured to program an RFID microcircuit (142).
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    同族专利:
    公开号 | 公开日
    EP2680902B1|2021-07-28|
    ES2890479T3|2022-01-20|
    US9067014B2|2015-06-30|
    BR112013022655A2|2016-12-06|
    US20120222468A1|2012-09-06|
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    EP2680901B1|2020-05-13|
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    BR112013022370B1|2021-03-30|
    BR112013022370A2|2016-12-06|
    EP2680903A1|2014-01-08|
    CN202870823U|2013-04-10|
    BR112013022518A2|2016-12-06|
    US20120226446A1|2012-09-06|
    WO2012121991A1|2012-09-13|
    WO2012121989A1|2012-09-13|
    CN202854125U|2013-04-03|
    EP2680902A1|2014-01-08|
    US9155833B2|2015-10-13|
    EP2680901A1|2014-01-08|
    ES2807540T3|2021-02-23|
    BR112013022518B1|2020-11-17|
    WO2012121990A1|2012-09-13|
    US9283321B2|2016-03-15|
    EP2680903B1|2016-11-02|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-12-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161449314P| true| 2011-03-04|2011-03-04|
    US201161449263P| true| 2011-03-04|2011-03-04|
    US61/449,263|2011-03-04|
    US61/449,314|2011-03-04|
    US201161450204P| true| 2011-03-08|2011-03-08|
    US201161450198P| true| 2011-03-08|2011-03-08|
    US61/450,204|2011-03-08|
    US61/450.198|2011-03-08|
    US13/410.077|2012-03-01|
    US13/410,077|US9067014B2|2011-03-04|2012-03-01|Attachment device for identifying constituents within a fluid|
    PCT/US2012/027373|WO2012121990A1|2011-03-04|2012-03-02|An attachment device for identifying constituents within a fluid|
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