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    • 专利摘要:
    summary “uv disinfection system for needleless connector” a device is presented to disinfect needleless connectors. the device has a housing (102) which contains a uv light source (140). the uv light source is operably connected to a power source. the housing (102) has a receptacle (146) configured to selectively receive a shield (110). the shield (110) has an inner reflective chamber (116) with an inner surface (118) that reflects uv light. in use, the uv light source can illuminate a needleless connector (120) inserted into the shield.
    公开号:BR112014029374B1
    申请号:R112014029374-0
    申请日:2013-05-30
    公开日:2019-11-12
    发明作者:Ma Yiping
    申请人:Becton Dickinson Co；
    IPC主号:
    专利说明:

    "UV DISINFECTION SYSTEM FOR NEEDLE-FREE CONNECTOR" BACKGROUND OF THE INVENTION [001] The present invention relates to systems and methods for disinfecting needle-free connectors. In particular, the present invention relates to a disinfection device that disinfects using an ultraviolet light source.
    [002] One of the biggest challenges of modern medical treatment is infection control and the spread of microbial organisms. One area where this challenge is constantly presented is that of infusion therapy procedures. Infusion therapy is one of the most common health care procedures. Hospitalized patients, with home care and others receive fluids, pharmaceuticals and blood products through a vascular access device inserted in the vascular system. Infusion therapy can be used to treat an infection, provide anesthesia or analgesia, provide nutritional support, treat cancerous growths, and maintain blood pressure and heart rate, or many other clinically significant uses.
    [003] Infusion therapy is promoted through a set of intravenous (IV) administration. The IV administration set can access a peripheral or central vasculature of the patient. The IV administration set can be implemented for short term (days), medium term (weeks) or long term (months to years). The IV administration set can be used for continuous infusion therapy or for intermittent therapy.
    [004] A common component of an IV administration set is a plastic catheter that is inserted into a patient's vein. The IV administration set may additionally include several connectors and fittings that additionally facilitate intravenous access and communication. For example, an IV administration set can include a needle-free Luer adapter to which other medical devices can be attached. Commonly, a set of
    2/25 IV administration comprises one or more vascular access devices that can be attached to another vascular access device, close the vascular access device, and allow intermittent infusion or injection of fluids and pharmaceuticals. An IV administration set can additionally include a connector (including a Luer connector) with a septum to close the system. The septum can be opened with a needle-free connector, such as a blunt cannula or a male Luer from a medical device.
    [005] An IV administration set can serve as an infection nest, resulting in a widespread BSI (bloodstream infection). In some instances, this can be caused by insufficient disinfection of the various connectors and other access components of the IV administration set. In general, disinfection of connectors without needles and other access components of the IV administration set is carried out by means of manual washing using a disinfection pad or pad. However, this process varies greatly from clinician to clinician in terms of both duration and contact forces. These variations result in inconsistent disinfection that can stimulate bacterial growth and infection.
    [006] So, although there are currently techniques for disinfecting needleless connectors and components of an IV administration set, challenges still exist. In this way, it would be an improvement in the technique to expand or even replace current techniques with other techniques.
    SUMMARY OF THE INVENTION [007] The present invention relates to systems and methods for disinfecting needleless connectors. In particular, the present invention relates to a disinfection device that disinfects using an ultraviolet light source. In some aspects of the invention, a disinfection device includes a housing that contains a source of ultraviolet (UV) light. The UV light source is connected
    3/25 operationally to a power source. The housing has a receptacle configured to selectively receive a bulkhead. The bulkhead has an internal reflective chamber with an internal surface that reflects UV light. In use, the UV light source can illuminate a needle-free connector inserted in the bulkhead, thereby resulting in disinfection of the needle-free connector.
    BRIEF DESCRIPTION OF THE DIVERSE VIEWS OF THE DRAWINGS [008] In order that the way in which the previously reported and other features and advantages of the invention are obtained is readily understood, a more particular description of the invention set out above in a brief manner will be rendered by reference to specific modalities of it that are illustrated in the attached drawings. These drawings represent only typical embodiments of the invention and for this reason are not to be considered as limiting the scope of the invention.
    [009] Figure 1 shows a flow chart of a representative system that provides a suitable operating environment in which various modalities of the present invention can be implemented.
    [010] Figure 2 shows a flow chart of a representative network system that provides a suitable environment in which various embodiments of the present invention can be implemented.
    [011] Figure 3 is a perspective view of a portable disinfection device according to a representative embodiment of the present invention.
    [012] Figure 4 is a cross-sectional view of a disinfectant device according to a representative embodiment of the present invention.
    [013] Figure 5 is a cross-sectional view of a bulkhead and a needleless connector according to a representative embodiment of the present invention.
    [014] Figure 6 is a perspective view of a disinfection device
    4/25 portable additionally comprising input and output features according to a representative embodiment of the present invention.
    [015] Figure 7 is a diagrammatic view of a portable disinfection device operationally connected to an electronic medical record through a network according to a representative embodiment of the present invention.
    [016] Figure 8 is a diagrammatic view of a portable disinfection device operationally connected to an electronic medical record by means of a computing device and a network according to a representative embodiment of the present invention.
    [017] Figure 9 is a diagrammatic view of a portable disinfection device showing various input and output features according to a representative embodiment of the present invention.
    DETAILED DESCRIPTION OF THE INVENTION [018] The currently preferred embodiments of the present invention will be better understood by reference to the drawings, in which equal reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures in this document, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of currently preferred embodiments of the invention.
    [019] The present invention relates to systems and methods for disinfecting needleless connectors. In particular, the present invention relates to a disinfection device having a UV source and a cavity configured to receive a needle-free connector, in which a disposable shield is placed between the needle-free connector and the UV source, and in which the connector without needle is disinfected
    5/25 upon exposure to the UV source.
    [020] As used in this document, the term "disinfection" is used to denote a level of sanitation that is free of infection or free of microorganisms that are capable of promoting infection in the patient.
    [021] As used in this document, the term "disinfectant" is used to denote an agent that destroys vegetative forms of harmful microorganisms such as bacteria, fungi, foams, viruses and other harmful pathogens.
    [022] As used in this document, the term “needle-free connector” is used to denote a medical coupler that is used as part of an intravenous assembly. In some instances, a needleless connector comprises a Luer adapter or a male Luer. In other instances, a needleless connector comprises a PRN connector. An example of a needleless connector is the Luer Q-Syte ™ access port from Becton, Dickinson. In addition, in some instances a needleless connector comprises a port or valve of an intravenous tube section or a connector thereof. Those skilled in the art will understand that the systems and methods of the present invention can be adapted for use with various other types of connectors and other devices for which automated disinfection is desirable.
    [023] As used in this document, the term “UV light source” is used to denote a lamp, light emitting diode (LED), laser or other similar technology that is capable of emitting wavelengths in the range 290 nm - 100 nm, and / or that are capable of killing pathogens present in a needleless connector. In some instances, a UV light source denotes an LED lamp configured to emit UV-C wavelengths.
    [024] Figures 1 and 2, and the corresponding discussion, provide a general description of a suitable operating environment in which modalities of the invention can be implemented. Those skilled in the art will realize that
    6/25 modalities of the invention can be practiced by means of one or more computing devices and in a variety of system configurations, including in a networked configuration. However, while the methods and processes of the present invention have been proven to be particularly useful in association with a system comprising a general purpose computer, embodiments of the present invention include use of the methods and processes in a variety of environments, including systems incorporated in units general purpose processing, digital / media signal processors (DSP / MSP), application specific integrated circuits (ASIC), standalone electronic devices and other such electronic environments.
    [025] Modalities of the present invention encompass one or more computer-readable media, in which each media can be configured to include or include computer executable data or instructions to manipulate data. Computer executable instructions include data structures, objects, programs, routines or other program modules that can be accessed by a processing system, such as one associated with a general purpose computer capable of performing several different functions or one associated with a special-purpose computer capable of performing a limited number of functions. Computer executable instructions induce the processing system to perform a particular function or group of functions and are examples of program code resources for implementing steps for methods revealed in this document. In addition, a particular sequence of executable instructions provides an example of corresponding procedures that can be used to implement such steps. Examples of computer-readable media include random access memory (“RAM”), read-only memory (“ROM”), programmable read-only memory (“PROM”), programmable and erasable read-only memory (“EPROM”) , read-only memory
    7/25 programmable and electrically erasable (“EEPROM”), read-only memory for compact disc (“CD-ROM”), or any other device or component that is capable of providing executable data or instructions that can be accessed by a system processing.
    [026] With reference to figure 1, a representative system for implementing modalities of the invention includes computing device 10, which can be a general purpose or special purpose computer. For example, computing device 10 can be a personal computer, notebook, personal digital assistant (“PDA”) or other handheld device, a workstation, a minicomputer, a large computer, a supercomputer, a multi-processor system, a network computer, a processor-based consumer electronic device, a smart phone, a position identifier, a sphere collector or the like.
    [027] The computing device 10 can include a system bus 12, which can be configured to connect several components of the same and enable data to be exchanged between two or more components. System bus 12 can include one of a variety of bus structures including a memory bus or memory controller, a peripheral bus, or a local bus that uses any of a variety of bus architectures. Typical components connected by system bus 12 include processing system 14 and memory 16. Other components can include one or more mass storage device interfaces 18, input interfaces 20, output interfaces 22 and / or network interfaces 24, each of which will be discussed below.
    [028] Processing system 14 includes one or more processors, such as a central processor and optionally one or more other processors designed to perform a particular function or task. Typically it is the system
    8/25 processing 14 that executes the instructions provided on computer-readable media, such as memory 16, a magnetic hard disk, a removable magnetic disk, a magnetic cassette, an optical disk, pendrives, solid state memory, a bus universal serial or from a communication connection, which can also be seen as a computer-readable medium.
    [029] Memory 16 includes one or more computer-readable media that can be configured to include or include data or instructions therein to manipulate data, and can be accessed by processing system 14 via system bus 12. Memory 16 may include, for example, ROM 28 used to store information permanently, and / or RAM 30 used to store information temporarily. ROM 28 may include a basic input / output system (“BIOS”) having one or more routines that are used to establish communication, such as during the initialization of the computing device 10. RAM 30 may include one or more program modules , such as one or more operating systems, application programs and / or program data.
    [030] One or more mass storage device interfaces 18 can be used to connect one or more mass storage devices 26 to the system bus 12. Mass storage devices 26 can be incorporated into computing device 10 or they can be peripheral to it and allow computing device 10 to retain large amounts of data. Optionally, one or more of the mass storage devices 26 can be removable from the computing device 10. Examples of mass storage devices include hard disk drives, magnetic disk drives, pendrive drives and optical disk drives. A mass storage device 26 can read and / or write
    9/25 on a magnetic hard disk, a removable magnetic disk, a magnetic cassette, an optical disk, or other computer-readable media. Mass storage devices 26 and their corresponding computer-readable media provide non-volatile storage of data and / or executable instructions that may include one or more program modules such as an operating system, one or more application programs, other information modules. program, or program data. Such executable instructions are examples of program code resources for implementing steps for methods revealed in this document.
    [031] One or more input interfaces 20 can be employed to enable a user to input data and / or instructions to the computing device 10 via one or more corresponding input devices 32. Examples of such input devices include a keyboard and alternative input devices, such as a mouse, stationary mouse, light pen, pointer, or other pointing device, a microphone, a joystick, a computer game controller, a satellite dish , a scanner, a portable camcorder, a digital camera and more. Similarly, examples of input interfaces 20 that can be used to connect input devices 32 to system bus 12 include a serial port, a parallel port, a game port, a universal serial bus (“USB”), an integrated circuit, a FireWire (IEEE 1394), or another interface. For example, in some embodiments the input interface 20 includes an application specific integrated circuit (ASIC) that is designed for a particular application. In an additional modality, the ASIC is incorporated and connects building blocks of existing circuits.
    [032] One or more output interfaces 22 can be employed to connect one or more output devices 34 corresponding to system bus 12. Examples of output devices include a monitor or display screen.
    10/25 display, a speaker, a printer, a multifunctional peripheral and more. A particular output device 34 can be integrated with the computing device 10 or be a peripheral thereof. Examples of output interfaces include a video adapter, an audio adapter, a parallel port and more.
    [033] One or more network interfaces 24 enable computing device 10 to exchange information with one or more other local or remote computing devices, illustrated as computing devices 36, over a network 38 that can include connected links physically and / or wirelessly. Examples of network interfaces include a network adapter for connecting to a local area network (“LAN”) or a modem, wireless link, or other adapter for connecting to an extended area network (“WAN”), such as the Internet. The network interface 24 can be incorporated into the computing device 10 or be peripheral to it. In a networked system, accessible program modules or parts of them can be stored on a remote memory storage device. In addition, in a networked system the computing device 10 can participate in a distributed computing environment, where functions or tasks are performed by a plurality of networked computing devices.
    [034] Thus, those skilled in the art will understand that, although modalities of the present invention can be practiced in a variety of different environments with many types of system configurations, Figure 2 provides a representative network system configuration that can be used in association with the modalities of the present invention. The representative system of Figure 2 includes a computing device, illustrated as client 40, which is connected to one or more other computing devices (illustrated as client 42 and client 44) and one or more peripheral devices (illustrated as multifunctional peripheral (MFP) MFP 46) over network 38. Although figure 2
    11/25 illustrate a modality that includes a client 40, two additional clients, client 42 and client 44, an MFP 46 peripheral device and optionally a server 48, connected to network 38, alternative modalities include more or less clients, more than a peripheral device, no peripheral device, no server 48 and / or more than one server 48 connected to network 38. Other embodiments of the present invention include local, networked or non-hierarchical environments where one or more computing devices can be connected to a or more local or remote peripheral devices. In addition, embodiments in accordance with the present invention also encompass a single consumer electronic device, wireless network environments and / or extended area network environments, such as the Internet.
    [035] Referring now to figure 3, an implementation of a disinfection device 100 is shown. In some embodiments, a disinfection device 100 is provided as a portable unit, wherein the disinfection device comprises a housing 102 which is sized and configured to be held in the user's hand during disinfection of a needle-free connector 120. Housing 102 of the disinfection device 100 can be of any size, shape and / or configuration as may be desirable. For example, in some embodiments, the disinfection device 100 comprises a stationary table top unit.
    [036] In some embodiments, the housing 102 of the disinfection device 100 additionally comprises one or more status indicators 104 which indicate a disinfection level of the needle-free connector 120. For example, in some instances, the status indicators 104 include a or more lights 106 that are configured to provide information to a user. In some instances, lights 106 may flash to indicate a disinfection stage or level for the needleless connector 120. Lights 106 may comprise
    12/25 additionally two or more colors, where one color indicates a disinfection stage or level for the needle-less connector 120. For example, in some embodiments a red light indicates incomplete or unsatisfactory disinfection of the needle-free connector 120. Additionally, a yellow light can indicate an intermediate or active disinfection process for the needleless connector 120. In addition, a green light can indicate a satisfactory or complete disinfection for the needleless connector 120.
    [037] Lights 106 can be additionally programmed to flash or otherwise demonstrate an illuminated pattern to further communicate a condition of the disinfection device 100. For example, in some embodiments lights 106 can be programmed to demonstrate an illuminated pattern to indicate a low battery. The lights 106 can be additionally programmed to demonstrate error or mechanical malfunction. In some instances, the lights 106 can be programmed to indicate that the disinfection device 100 is ready to receive the needleless connector 120.
    [038] In place of lights 106, status indication 104 may alternatively include a display screen (not shown), such as an LCD screen, which displays operating times, disinfection status, battery levels or other such notifications. conditions. In addition, a variety of other alternative status indicators 104 can be used with the disinfection device 100.
    [039] In some embodiments, the disinfection device 100 includes a disposable shield 110 that is selectively connected to housing 102 in a location that facilitates access to the needle-free connector 120. In some instances, the shield 110 is positioned opposite the safety indicators. status 104, thereby allowing the user to access the bulkhead 110 with the needle-free connector 120 while maintaining view of the status indicators 104. The bulkhead 110 can be accessed while a user retains the
    13/25 disinfection 100 in one hand while aligning and placing the needleless connector 120 in contact with the bulkhead 110 using the other hand.
    [040] Referring now to figures 3 and 4, the disposable shield 110 comprises a first end that is configured to be coupled to the cavity or receptacle 146 of the housing 102. In some embodiments, the cavity 146 comprises an opening 132 that is sized and configured to receive and retain the screen 110. The first end of the disposable screen 110 additionally comprises a proximal opening 112 which is sized and configured to receive a UV light source 140. The screen 110 additionally comprises a second end having a distal opening 126 which is sized and configured to receive a part of a needleless connector 120 in a compatible manner. In some instances, the interface connections between the bulkhead 110, the cavity 146, the UV light source 140, the proximal opening 126 and the needleless connector 120 provide a closed system that prevents light scattering from the UV 140 light source to the outside environment.
    [041] An activation key 124 initiates a disinfection operation in which UV light is emitted by the UV light source 140 into the bulkhead 110. Pressing the activation key 124 can initiate continuous disinfection operation until the activation key 124 be pressed again. Alternatively, the activation key 124 can initiate the temporary disinfection operation. A temporary disinfection operation can take approximately 1, 2, 3, 4, 5, 10, 15, 20, 30 or more than 30 seconds. During disinfection, the screen 110 reflects the UV light from the UV light source 140 to each of the outer surfaces of the needleless connector 120 to disinfect the connector. After exposure for a predetermined time, the needleless connector 120 is disinfected and ready for use. The user can then remove the needleless connector 120 from inside the bulkhead 110, thereby completing the disinfection process.
    14/25 [042] In some embodiments, an eject button 122 in housing 102 can activate an ejector, or disengagement mechanism (not shown), which ejects the bulkhead 110 from inside the disinfection device 100. The ejected bulkhead 110 can remain attached to the needle-free connector 120 as a physical barrier against contamination or it can be removed from the needle-free connector 120 and released to waste.
    [043] Continuing with reference to figure 4, a top cross-sectional view of the disinfection device 100 is shown. In some embodiments, housing 102 comprises an interior 130 in which various components of the device are housed. For example, interior 130 houses a UV light source 140 that is positioned and configured to illuminate the interior of a bulkhead 110 removably coupled to a distal end of housing 102. UV light source 140 can project out of an end surface of the housing 102, as shown, or alternatively may be leveled or recessed within a surface such as this. Alternatively, the UV 140 light source can be protected against accidental damage by staying inside a protective window. The protective window would be transparent to UV light. The UV 140 light source can comprise any device or technology capable of emitting light waves capable of killing pathogens. In some instances, the UV 140 light source comprises a lamp capable of emitting wavelengths in the range of 290 nm - 100 nm. In other instances, the UV 140 light source comprises a fluorescent lamp, a light-emitting diode (LED) or a laser. For example, a UV-C LED can provide disinfection lighting while having a low energy consumption and robust structure. Although a UV 140 light source can be effectively used, some modalities can incorporate multiple UV 140 light sources into the disinfection device 100.
    [044] In some embodiments, housing 102 includes a distal opening
    15/25
    132 forming a cavity or receptacle 146 that is accessible to the user. The receptacle 146 is dimensioned and configured to receive and retain at least a proximal part of the bulkhead 110. In some embodiments, the bulkhead 110 is removable and disposable. In other embodiments, the screen 110 is reusable. The screen 110 can be modeled and sized to form an internal reflection chamber 116 having a length and diameter configured to receive the needleless connector 120 in a compatible manner. The reflection chamber 116 may include a proximal opening 112 in which the UV light source 140 it can be inserted or UV light can be transmitted in another way through it. In addition, the reflection chamber 116 may include a distal opening 126 configured to receive the needleless connector 120 without allowing substantial amounts of UV illumination to escape.
    [045] The bulkhead 110 can be manufactured using various materials. Material used to produce a disposable bulkhead 110 can be selected for its low cost, ability to be recycled and / or environmental impact. Non-limiting examples of materials used to make the screen 110 include polymers (e.g., plastics), compounds and / or metals. In some embodiments, the selected materials provide sufficient rigidity for the bulkhead 110 to substantially maintain the shape of the reflection chamber 116 against pressure from the housing 102, the needle-free connector 120 and other external forces (for example, force used to insert the bulkhead 110 in receptacle 146). In addition, in some embodiments the selected material provides sufficient flexibility to withstand these forces and / or in such a way that the opening 126 can substantially mold around the needle-free connector 120.
    [046] In some embodiments, the screen 110 additionally includes an internal reflective surface 118 that reflects light 114 within the reflection chamber 116 in such a way that each surface of the needle-free connector 120 is exposed to the
    16/25 UV light 114. In this way, the inner surface of the screen 110 can include various shapes, sizes and geometries, including a spherical or other suitable geometry configured to achieve optimal light scattering or distribution within the screen 110. In some instances , the screen 110 is manufactured using a reflective material or includes a reflective coating or layer that forms the internal reflective surface 118. In some configurations, reflective surfaces 118 are diffusive to ensure substantially complete UV coverage. The screen 110 can thus limit or eliminate UV exposure for a clinical operator and patients in the vicinity of the disinfection device 100.
    [047] The UV light source 140 is generally provided as a device to provide UV illumination to disinfect the needleless connector 120. In some instances, the disinfection device 100 includes a power control (not shown) by which the energy supplied to the UV 140 source is regulated. Increasing the energy of a UV 140 light source can increase the intensity of illumination and thereby speed up a disinfection process. In this way, some implementations of the disinfection device 100 include an energy control that regulates or modifies energy supplied to the UV light source from a battery 150 or other energy source. Energy supplied can be continuous, pulsed or varied in another way.
    [048] Disinfection device 100 may additionally comprise a printed circuit board 160 comprising several sets of monitoring and feedback circuits to control proper disinfection of the needle-free connector 120. Printed circuit board 160 can be electronically coupled to the battery 150 and / or UV light source 140. For example, in some embodiments the printed circuit board 160 comprises a power sensor 162 which is configured to monitor and measure the energy supplied to the UV source 140. The printed circuit board 160 can additionally comprise a
    17/25 status indicator controller 170. The status indicator controller 170 can control condition indicator 104, including lights 106.
    [049] The printed circuit board 160 may additionally comprise a timer 170 used to measure or count a lapse or time interval during which UV illumination is provided for the bulkhead 110. In some instances, sufficient disinfection is an energy factor and lighting time. For example, in some embodiments, complete disinfection requires that the minimum energy threshold be maintained for a minimum period of time, such as from about 1 second to about 15 seconds. In some embodiments, complete disinfection requires that the minimum energy threshold be maintained from a minimum interval of about 5 seconds or less. Thus, timer 170 can be used to control the time interval during which the engine operates.
    [050] Reference will now be made to figure 5, which illustrates a modality of a shield 210 disposed within receptacle 146. The shield 210 includes a reflection chamber 116 that fits at least a part of the needleless connector 120. Some modalities of the bulkhead 210 include a diffuser, spreader, light tube or light tube 220 used to disperse, direct and / or guide UV light within the reflection chamber 116. For example, the light tube 220 may include a stem part 224 adjacent or contiguous to UV light source 140. UV light can be directed along stem part 224 and then along two or more branch parts 222. Branch parts 222 can direct beams of UV light 114 to multiple sides needle-free connector 120 to directly or indirectly illuminate substantially all external surfaces, including threaded surfaces, of needle-free connector 120. Thus, a light tube or other optical device can and help to completely illuminate the needle-free connector 120.
    [051] As additionally shown in figure 5, the bulkhead 210 can
    18/25 include one or more securing features 232 that can be used to selectively couple the bulkhead 210 within the recess 146 of housing 102. As shown, securing features 232 may include a protrusion, lock, hook, or the like protruding structure that can be secured or otherwise secured within receptacle 142. Conversely, in other embodiments, the securing features 232 comprise a notch, annular or partial groove or groove, or another structure that can be hooked or secured otherwise within the recess 146. In some embodiments, the recess 146 includes a corresponding securing feature 230 configured to match and securing the securing features 232 of the bulkhead 208.
    [052] In some embodiments, one or more ejectors 240 are disposed within a proximal end of receptacle 146. Ejectors 240 may be one or more pistons or another movable structure that can selectively press distally against bulkhead 210 until it be pushed out of receptacle 146. The distal force of ejector 240 can cause the clamping features 230, 232 to disengage, releasing bulkhead 210 from receptacle 146. As mentioned earlier, ejection can be initiated when a user presses a eject button (122 in figure 3). The ejected bulkhead 110 can remain attached to the needle-free connector 120 as a physical barrier against contamination or it can be removed from the needle-free connector 120 and released to waste.
    [053] In some embodiments, the disinfection device 600 additionally comprises an input interface 610 and an output interface 620 to facilitate collection and reporting of information related to a cleaning event of the disinfection device 600, as shown in figure 6 For example, in some embodiments the input interface 610 comprises a barcode scanner that is capable of reading a barcode readable by
    19/25 computer that is placed in a needle-free connector, and / or in a patient identification tag or card and / or in the bulkhead identification. In other embodiments, the input interface 610 further comprises a magnetic card reader, or an optical camera that is capable of retrieving information stored on a magnetic tape or a computer-readable code, respectively. For example, a patient may have an identification card with a magnetic strip that contains the patient's identity and other related medical information. The patient, the shield and / or the needle-free connector can additionally include a QR code that is capable of being detected and deciphered using an optical camera and computer executable software configured to retrieve information from the QR code. In another embodiment, the patient, the shield and / or the needle-free connector can additionally include an RFID tag that can be read by an RFID reader on the disinfection device.
    [054] Some embodiments of the present invention further comprise a device or component of a device that includes a material, a coating or a label containing a material or coating that is configured to change color in response to prolonged exposure to air and / or to a liquid. A color-changing material can be useful in communicating to a user for a period of time during which the bulkhead and / or needle-free connector were exposed to a non-sterile environment. A color-changing material can also be useful in communicating to a user that the device or component has been used previously. In some instances, a device or component of the present invention is packaged in an air-tight package, thereby preserving an initial color of the material which changes color. When opening the air-tight package, the color-changing material is exposed to air, thereby changing the color of the device or component. This feature can prevent a device or component from being reused. This feature can also prevent a
    20/25 non-sterile device or component is used.
    [055] In some modalities, information relating to the patient's identity and the needle-free adapter's identity is retrieved and stored through the 610 input interface before a disinfection event. In some instances, additional information relating to the disinfection event is collected and additionally stored in the disinfection device's memory. For example, the disinfection device 600 can collect and store additional information such as the date and time of the disinfection event, the identity of the clinician and a final disinfection status of the needle-free connector. Following the disinfection event, the information collected and stored is transferred to a remote computing device via the 620 exit interface.
    [056] Output interface 620 may include any type or configuration of output that is capable of transferring stored information from the disinfecting device 600 to a remote computing device. For example, in some embodiments the output interface 620 comprises a wireless antenna. In other embodiments, the output interface 620 comprises an electrical connector, such as a universal serial bus. Output interface 620 may additionally comprise an RFID transmitter. The 620 output interface may additionally include a wireless link (for example, WiFi, Bluetooth®, IR, RF or other known wireless communication approaches), a direct wired connection (for example, electrical wire or optical cable), or a direct connection via one or more direct conductor contacts. Thus, the output interface 620 facilitates communication between the disinfection device 600 and a remote computing device, whereby information obtained by the disinfection device 600 and stored in its memory can be transferred to a remote computing device for long-term storage. .
    21/25 [057] The input and output interfaces 610 and 620 can be located in any position in the housing of the disinfection device 600. In some modalities, the input and output interfaces are positioned in such a way that a user can retain disinfection device 600 in your hand and still have access to the interfaces. The input and output interfaces 610 and 620 can additionally comprise a separate device that is operationally connected to the disinfection device 600 by means of a tied or wired connection, or a wireless connection. For example, the 610 input interface may comprise a wireless antenna that receives a barcode scanner signal that is wirelessly connected to the 610 input interface.
    [058] In some instances, information retrieved by the disinfection device 600 is temporarily stored in the memory of the disinfection device 600. The information subsequently stored can be transferred to a remote computing device via the 620 output interface. In some embodiments, information retrieved is transferred to a remote computing device in real time via the output interface 620. The input and output interfaces 610 and 620 can be used additionally to retrieve, record and report information regarding a patient's identity, in which the information of patient is contained in a computer-readable format. In some instances, the processes of recording and reporting the retrieved information are automatic, thereby eliminating user error.
    [059] In some embodiments, information regarding the identity of the patient and / or the needle-free connector is entered manually into the disinfection device 600 or a remote computing device. For example, the disinfection device 600 may include a keyboard. The disinfection device 600 can additionally include a microphone and transcription software, whereby a clinician can audibly input information into the disinfection device
    22/25
    600. The disinfection device 600 can additionally be operatively connected to a separate input device, so the clinician is able to input information into the disinfection device 600 via a separate input device.
    [060] In some embodiments, the process of detecting a disinfection status, tracking a disinfection event, recording the disinfection event and reporting the disinfection event can ensure compliance with appropriate cleaning procedures, thereby helping with clinical outcomes for patients and treatment providers. This information can be additionally stored in a patient's electronic medical record (EMR). As such, the disinfection event becomes part of the patient's medical history that can be accessible to other doctors and clinicians to assist in the patient's treatment. The information can be accessed additionally as part of an audit procedure, such as a security compliance audit. This information can be accessed additionally to assess areas, methods and techniques that may need revision to increase the quality and / or consistency of patient treatment.
    [061] Referring now to figure 7, in some modalities the disinfection device 600 is operationally connected to a network 38 by means of a physically and / or wirelessly connected link 750. In some modalities, the link 750 comprises a part output interface 620. When information is obtained by the disinfection device 600, the information is transmitted to network 38 where the information is made accessible to several remote computing devices also operationally connected to network 38. In addition, in some modalities, information obtained it is stored in a database, such as an EMR 760.
    [062] The EMR 760 generally comprises a medical record
    23/25 computerized for a patient, as known in the art. In some modalities, the EMR 760 is configured to receive and store information related to the disinfection event. For example, the EMR 760 can receive information such as the date of the disinfection event, a final status of the disinfection event, the identity of the clinician who performed the disinfection event, the identity of the needle-free connector, as well as a time and / or duration of the disinfection event.
    [063] Network 38 may include a server on which a computer executable program is loaded with instructions for receiving, analyzing and storing information received from disinfection device 600. Network 38 may additionally include network security software or other precautionary software as may be required to comply with Patient Health Information Privacy Procedure requirements. In some embodiments, network 38 comprises a local area network. In other embodiments, network 38 is a global area network.
    [064] In some configurations, the disinfection device 600 is operationally connected to network 38 via an 870 processor unit or another computer system, as shown in figure 8. The 870 processor unit receives and processes information retrieved from the interface output 620 before storing the information in the EMR 760. The processing unit 870 can include any type or form of computing device that is compatible with the precepts of the present invention. In some embodiments, the processing unit 870 comprises a tablet. In other embodiments, the processing unit 870 comprises a desktop computer. The processing unit 870 may additionally comprise a large computer. In addition, in some embodiments, the 870 processor unit comprises a mobile smart device, such as a smart phone,
    24/25 laptop or personal digital assistant device.
    [065] Referring now to figure 9, the disinfection device 600 can include various systems and / or methods by which information relating to the needle-free connector 120 can be collected and reported. For example, in some embodiments, the disinfection device 600 comprises input and output interfaces 610 and 620 which are capable of scanning a barcode 122 from the needle-free connector 120. Input and output interfaces 610 and 620 can scan additionally a barcode 128 of an IV fluid pouch 121 coupled to the needle-free connector 120. In some instances, the needle-free connector 120 comprises an RFID chip 126. In this way, the disinfection device 600 may include an RFID reader. The disinfection device 600 may additionally include an RFID transmitter by which it can report retrieved information to a computing device comprising an RFID receiver.
    [066] Input interface 610 can additionally comprise a microphone 630 through which information is inputted when speaking information into microphone 630. The information can subsequently be reported or transferred to a remote computing device via any of the various interface interfaces. output 620 with which the disinfection device 600 is equipped. In this way, various embodiments of the present invention provide a disinfection device having one or more input interfaces 610 and one or more output interfaces 620, whereby information is retrieved by one or more of the input interfaces 610 and subsequently transferred to a device remote computing via one or more of the 620 output interfaces.
    [067] From the foregoing it is seen that the present disinfection device can disinfect a needleless connector. When a needle-free connector is inserted at least partially into a disinfection device bulkhead it is exposed to UV light that can disinfect the external surfaces of the
    25/25 connector.
    [068] The present invention can be incorporated in other specific forms without deviating from its structures, methods or other essential characteristics as widely described in this document and claimed below. Thus, the modalities described are to be considered in all respects only as illustrative and not as restrictive. The scope of the invention, therefore, is indicated by the appended claims, rather than by the previous description. All changes that occur within the meaning and equivalence range of the claims are within its scope.
    权利要求:
    Claims (20)
    [1]
    1. Device for disinfecting a needle-free connector, the device FEATURED by the fact that it comprises a housing containing a UV light source, the UV light source being operationally connected to a power source, the housing additionally comprising a receptacle for receiving a needle-free connector, where the needle-free connector is exposed to the light emitted by the UV light source when the needle-free connector is received by the receptacle.
    [2]
    2. Device according to claim 1, CHARACTERIZED by the fact that it additionally comprises a bulkhead configured to be selectively inserted into the receptacle and retained within it, the bulkhead having an internal reflection chamber having an internal surface configured to receive the connector without needle, the inner surface additionally comprising a reflective surface to reflect UV light emitted by the UV light source.
    [3]
    3. Device, according to claim 2, CHARACTERIZED by the fact that the screen is disposable.
    [4]
    4. Device according to claim 2, CHARACTERIZED by the fact that it additionally comprises one or more fixing features configured to selectively fix the bulkhead inside the receptacle.
    [5]
    5. Device according to claim 1, CHARACTERIZED by the fact that the UV light source includes a UV-C LED lamp.
    [6]
    6. Device according to claim 1, CHARACTERIZED by the fact that it additionally comprises a timer electronically coupled to the UV light source to turn off the UV light source after a predetermined period of time.
    [7]
    7. Device according to claim 6, CHARACTERIZED by the fact that the time period is approximately 5 seconds.
    2/4
    [8]
    8. Device according to claim 1, CHARACTERIZED by the fact that it additionally comprises a disinfection status indicator configured to communicate a disinfection status of the needle-free connector.
    [9]
    9. Device, according to claim 6, CHARACTERIZED by the fact that the disinfection status indicator comprises one or more lights configured to indicate a disinfection status.
    [10]
    10. Device according to claim 1, CHARACTERIZED by the fact that it additionally comprises an input device for receiving an identification from at least one of the needleless connector, the shield and the patient.
    [11]
    11. Device according to claim 10, CHARACTERIZED by the fact that it additionally comprises an output to communicate the identification of at least one of the needle-free connector, the shield and the patient.
    [12]
    12. Method for disinfecting a needle-free connector, the method CHARACTERIZED by the fact that it comprises:
    inserting a shield in the receptacle of the device according to claim 1;
    insert a needle-free connector into the bulkhead; and exposing the needle-free connector to the light emitted by the device's UV light source according to claim 1 for a predetermined period of time.
    [13]
    13. Method according to claim 12, CHARACTERIZED by the fact that the UV light source emits light having a wavelength of approximately 290 nm to approximately 100 nm.
    [14]
    14. Method according to claim 12, CHARACTERIZED by the fact that the predetermined period of time is approximately 5 seconds or less.
    [15]
    15. Method, according to claim 12, CHARACTERIZED by the fact
    3/4 of which additionally comprises a step to send a disinfection status from the needle-free connector to a remote computer system.
    [16]
    16. Method, according to claim 12, CHARACTERIZED by the fact that it additionally comprises:
    identify the needle-free connector;
    identify a needle-free connector disinfection status;
    send the disinfection status and needle-free connector identification to a remote computer system; and store the disinfection status and needle-free connector identification in an electronic medical record.
    [17]
    17. Method, according to claim 16, CHARACTERIZED by the fact that it additionally comprises a step to identify a patient identification associated with the needleless connector.
    [18]
    18. Method, according to claim 17, CHARACTERIZED by the fact that the electronic medical record is the patient's electronic medical record.
    [19]
    19. Method, according to claim 16, CHARACTERIZED by the fact that the step of sending the disinfection status and the identification of the needle-free connector to a remote computer system is performed using at least one of a wireless antenna, one electrical connection, an RFID transmitter, a Bluetooth transmitter, an audio speaker and a manual input device.
    [20]
    20. Device for disinfecting a needle-free connector, the device CHARACTERIZED by the fact that it comprises:
    a housing comprising a UV light source operatively connected to a power source, the housing further comprising a receptacle configured to receive a shield having an interior configured to receive a needleless connector;
    an entry for receiving a needle-free connector ID; and
    4/4 an output to communicate the identification and disinfection status of the needleless connector.
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    同族专利:
    公开号 | 公开日
    JP2015528709A|2015-10-01|
    JP6306574B2|2018-04-04|
    CA2872962C|2019-09-10|
    BR112014029374A2|2017-06-27|
    US10279057B2|2019-05-07|
    EP2854873A1|2015-04-08|
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    WO2013181393A1|2013-12-05|
    US20130323120A1|2013-12-05|
    CN104363928B|2017-08-15|
    EP3943123A2|2022-01-26|
    US20160339127A1|2016-11-24|
    CN203329075U|2013-12-11|
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    CA2872962A1|2013-12-05|
    CN107349443B|2020-02-07|
    EP2854873B1|2021-11-03|
    US20150265735A1|2015-09-24|
    CN104363928A|2015-02-18|
    AU2013267399B2|2016-07-14|
    US9056147B2|2015-06-16|
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    法律状态:
    2018-03-06| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2018-03-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2018-03-20| B06I| Publication of requirement cancelled [chapter 6.9 patent gazette]|Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA. |
    2019-05-21| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2019-08-20| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2019-10-22| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2019-11-12| 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 30/05/2013, OBSERVADAS AS CONDICOES LEGAIS. (CO) 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/05/2013, OBSERVADAS AS CONDICOES LEGAIS |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261653932P| true| 2012-05-31|2012-05-31|
    US13/904,295|US9056147B2|2012-05-31|2013-05-29|UV disinfection system for needleless connector|
    PCT/US2013/043366|WO2013181393A1|2012-05-31|2013-05-30|Uv disinfection system for needleless connector|
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