# Patent

## Title
UV-C catheter hub sterilization and data acquisition system

## Abstract

A hand held hub sterilization and data acquisition device includes a housing having an opening for receiving a medical device, a sterilization chamber formed in the housing, a source of UV radiation disposed within the sterilization chamber for uniform emission of UV-C radiation into the sterilization chamber, and an RFID scanner configured into the housing. A patient care system includes a hand held hub sterilization and data acquisition device and an RFID enabled medical device.

## Background
CROSS REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application No. 61/783,768, filed on Mar. 14, 2013, the disclosure of which is hereby incorporated by reference in its entirety.


FIELD OF THE INVENTION
The invention generally relates to ultraviolet irradiation systems, and, more particularly, to methods and systems for catheter hub sterilization and combined data acquisition.
BACKGROUND OF THE INVENTION
Intravascular catheters are an indispensable modern medical device used commonly in many situations and especially in intensive care units (ICUs). The use of these catheters is essential to providing critical therapies and diagnostic services for patients but also places the patient at significant risk for a variety of catheter related bloodstream infections (CRBSI). Any time a catheter is accessed for introduction of therapeutic materials it is possible that foreign pathogenic organisms may also be introduced to the catheter lumen and eventually the bloodstream. Commonly, access sites are required to be scrubbed with solutions containing isopropyl alcohol (IPA) or other antimicrobial agent. These prophylactic measures are often time consuming, minimally effective and poorly complied with.
A need exists for methods and systems of insuring a sterile access site prior to access that minimizes the possibility of the introduction of pathogenic organisms to the catheter lumen.
SUMMARY OF THE INVENTION
The foregoing needs are met by the present invention, wherein according to certain aspects, a hand held hub sterilization and data acquisition device includes a housing having an opening for receiving a medical device, a sterilization chamber formed in the housing, a source of UV radiation disposed within the sterilization chamber for uniform emission of UV-C radiation into the sterilization chamber, and an RFID scanner configured into the housing.
In accordance with other aspects of the present invention, the source of UV radiation for the hand held hub sterilization and data acquisition device is a high voltage tube lamp that produces two ultraviolet wavelengths. In accordance with yet other aspects of the invention, the source of UV radiation for the hand held hub sterilization and data acquisition device is two UV-C lamps comprising a silica quartz envelope to prevent 190 nm wavelength production and provide minimal attenuation to a 254 nm principal wavelength.
In accordance with other aspects of the present invention, the sterilization chamber is a silica quartz tube and an aluminum cylinder may enclose the sterilization chamber to provide high reflection efficiency of outward directed UV-C energy.
In accordance with other aspects of the present invention, the housing may include an access door for receiving the medical device into the sterilization chamber.
In accordance with yet other aspects of the present invention, the hand held hub sterilization and data acquisition device may include a safety interlock mechanism. The safety interlock mechanism may comprise a Hall sensor and a rare earth magnet, and wherein the Hall sensor senses the magnetic field of the magnet when the access door is closed and sends a signal to the user interface indicating a ready state for excitation of the radiation source.
In accordance with other aspects of the present invention, the hand held hub sterilization and data acquisition device may include a barcode module. The barcode module may utilize a CMOS 2D imager capable of omnidirectional decoding with regard to code orientation.
In accordance with other aspects of the present invention, the hand held hub sterilization and data acquisition device may receive a catheter extension line with a hub and valve assembly for sterilization.
In accordance with other aspects of the present invention, a patient care system may include a hand held hub sterilization and data acquisition device comprising a housing having an opening for receiving a medical device, a sterilization chamber formed in the housing, a source of UV radiation disposed within the sterilization chamber for uniform emission of UV-C radiation into the sterilization chamber, a user interface, and an RFID scanner configured into the housing, and an RFID enabled medical device.
In accordance with yet other aspects of the present invention, the RFID enabled medical device may be a port.
In accordance with yet other aspects of the present invention, the patient care system may include a device charging and download/upload station and/or an electronic medical record data interface.
There has thus been outlined, rather broadly, certain aspects of the present disclosure in order that the detailed description herein may be better understood, and in order that the present contribution to the art may be better appreciated.
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of the construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a UV-C catheter hub sterilization and data acquisition system, in accordance with aspects of the present disclosure;
FIG. 2 illustrates an exploded view showing component parts of the system illustrated in FIG. 1, in accordance with aspects of the present disclosure;
FIG. 3 illustrates another UV-C catheter hub sterilization and data acquisition system, in accordance with aspects of the present disclosure;
FIG. 4 is a functional diagram of features provided in the system shown in FIG. 3, in accordance with aspects of the present disclosure; and
FIG. 5 illustrates the system of FIG. 3 in a state of use, in accordance with aspects of the present disclosure.



DETAILED DESCRIPTION
FIG. 1 illustrates a hand held hub sterilization and data acquisition device 10 in accordance with aspects of the present invention. The sterilization device 10 may include a housing 11 configured to form a handle portion 12 and a sterilization chamber portion 14. The sterilization portion 14 may include a hinged door 16 for providing access to a UV-C sterilization chamber 18. The chamber 18 may be configured to receive a distal end portion of a catheter extension line including a luer hub and valve assembly, for example.
As shown in FIG. 2, the housing 11 may be an elongated, essentially hollow structure comprised of a thermoplastic material. The housing 11 may include an upper frame component 20 and a lower frame component 22 that mates with and/or is fastened to the upper frame component 20. The handle portion 12 of the housing 11 may form a substantially hollow area for mounting, securing and protection of critical components, including, for example, a battery 24, various electronic components 26, including a battery charger circuit, a micro controller power regulation circuit, a micro controller, a high voltage lamp ballast and modulation circuit, an output power sensor, and/or various user interface components, such as an LED display or membrane switch assembly). The sterilization chamber portion 14 may be configured to house a UV-C lamp 30 in the sterilization chamber. A spring 32 may cooperate with a rocker arm 34 to bias the hinged door 16 into a closed position. Pressing on a proximal end of the rocker arm 34 to overcome the spring force applied by the spring 32 allows a user to open the hinged door 16 in a clamshell manner, for example. A chamber closure detector 36 may be provided to indicate when the hinged door 16 is closed and the sterilization chamber 18 is sealed and safe for application of a sterilization dose of UV-C radiation. In accordance with other aspects of the present invention, light seals may be provided at or about the interface of the hinged door 16 with the housing 11 to form a substantially light-tight seal of the sterilization chamber 18.
The sterilization device 10 relies on ultraviolet C photonic energy to provide the antimicrobial impact needed to insure a sterile access site. Ultraviolet C photonic energy includes the optical spectrum in the invisible range from  ̃140 nm to 280 nm wavelength. As shown in FIG. 2, the sterilization device 10 includes a high voltage tube lamp 30 that may produce two ultraviolet wavelengths, 190 nm and 254 nm. In accordance with other aspects of the present invention, the lamp 30 may produce a single wavelength or be configured to produce a broad spectrum source of light. The device 10 provides a sealable irradiating and oxidizing volume adequate to accommodate a catheter extension line including luer hub and valve assembly.
The dual wavelength action may provide two distinct antimicrobial mechanisms to minimize or prevent CRBSI occurrence. The 254 nm wavelength acts directly on the genetic material of the pathogenic organism, cleaving critical molecular bonds and rendering the pathogen incapable of reproduction or normal cellular activity. The second wavelength (190 nm) breaks diatomic oxygen (O2) and fosters the generation of Ozone (O3) from the resulting monatomic oxygen. Ozone rapidly oxidizes any organic material it comes into contact with. In an embodiment using two wavelength radiation, any pathogenic organism not adequately denatured by the 254 nm mechanism may be consumed in oxidation by Ozone.
In addition to providing a superior mechanism of antimicrobial action, the issue of clinician compliance may also be improved. The estimated duration of UV-C/Ozone exposure to insure sterilization is less than 10 seconds. This represents a significant reduction from treatment with isopropyl alcohol, for example, including both application and drying time. The UV-C device 10 may also include an audio and visual progress and process completion indication. This feedback mechanism to the clinician in conjunction with reduced process time may be used to improve procedural compliance by the clinician.
FIG. 3 illustrates another embodiment of a hand held hub sterilization device 100 in accordance with aspects of the present invention. The sterilization device 100 may include a body 111 configured to form a handle portion 112 and a sterilization chamber portion 114. The sterilization chamber portion 114 may include a hinged door 116 at a distal end for providing access to a UV-C sterilization chamber 118. The chamber 118 may be configured to receive a distal end portion of a catheter extension line including a luer hub and valve assembly, for example.
In accordance with aspects of the present invention, the device 100 may be configured with two UV-C lamps comprising a silica quartz envelope to prevent 190 nm wavelength/Ozone production and provide minimal attenuation (<5%) to the 254 nm principal wavelength. The sterilization chamber 118 may comprise a silica quartz tube and the UV-C lamps may be mounted into the sterilization chamber 118 in a fashion that evenly distributes the radiation throughout the sterilization chamber 118. The lamps and sterilization chamber 118 may be enclosed by an aluminum cylinder processed to provide high reflection efficiency of outward directed UV-C energy, creating an integration effect.
The UV-C sterilization chamber 118 of device 100 may include a safety interlock mechanism for ensuring the user and patient are protected from possible UV-C exposure during the sterilization process. A rare earth magnet may be mounted on the hinged door 116 and a Hall sensor provided at an appropriate location in the sterilization chamber 118 near where the rare earth magnet will be positioned with the hinged door 116 in the closed and sealed position. In this manner, the Hall sensor may sense the magnetic field of the magnet when the hinged door 116 is closed and send a voltage signal to the control electronics indicating when it is safe to proceed with UV-C lamp excitation. The UV-C fluence value (uw/cm2) shall be monitored via a Silicon Carbide photo detector permanently mounted within the sterilization chamber 118.
Input buttons 120, for example, and other user interface features, such as a graphic display 122, may be provided to allow users to interact and control the various functions provided in the hub sterilization device 100 as well as receive or transmit data from the device 100.
FIG. 4 is a functional diagram illustrating various features that may be provided in the hub sterilization device 100. For example, the device 100 may include the sterilization chamber 118, a user interface consisting of the graphic display 122 and input buttons 120, a radio frequency identification (RFID) and barcode decoding engine 130, a control, data storage and charging circuit 140, a lithium polymer battery 150, a UV-C integration space assembly 160, and high voltage inverter electronics 170 for UV-C lamp excitation.
The device 100 may be capable of decoding all 1D and 2D barcodes associated with user or patient identification parameters. In addition, the barcode engine shall utilize a CMOS 2D imager capable of decoding omni directionally with regard to the code orientation.
In accordance with other aspects of the present invention, the RFID engine shall operate on a 2.4 GHz standard and have read and write capability with all enabled medical devices. RFID chips are robust, passive and small in size. These chips can be programmed with various data and be interrogated or reprogrammed. As shown in FIG. 5, an RFID chip 200 may be added to medical devices like an implantable subcutaneous port 210. The user may use the RFID function of the device 100 to interrogate the RFID chip 200 on the port 210 below the skin 212 to identify the device's indicated capabilities, for example, pressure injectability. Additional data may be added to the RFID for clinical use. These data could include, but are not limited to, for example, manufacturer's name, product number, lot number, implant date, device capability, patient data, injection history, etc. These data would be saved and/or modified by scanning the device 100 in close proximity to the RFID chip 200, and the data may then be synced with the hospital's Electronic Medical Records (EMR) database.
Data attributed to the RFID enabled device shall include but is not limited to the following: GS1 manufacturer information, Patient ID, Last user ID, Last Use Time and Date, Implant Date, Implant facility ID, Incrementing number of accesses, and Sterilization statistics. Data stored within the device 100 for electronic medical record upload shall include but is not limited to the following: User ID Log with Time and Date stamp, Device ID Log with implant date, Usage log with patient data and Time and Date stamp, Fault condition log, and Sterilization statistics.
The user interface of the device 100 may, for example, provide the following information to a user: battery charge level, fault conditions, including unsafe condition due to possible user/patient UV-C exposure, insufficient UV-C fluence value for adequate sterilization, a barcode read error, an RFID read error, a power failure, and/or a user input error, the sequence state, which may be Ready, Scan User, Scan Patient, Sterilize, UV-C in process (time to complete), Sterilization Complete, Fault.
The sterilization device 100 may be incorporated into a patient care system that includes multiple device charging and download/upload stations, a single device bedside charging and download/upload station, RFID enabled medical devices, such as catheters, ports, or suitable disposable medical devices, for example, device control and data acquisition software, charging station control and electronic medical record data interface software.
It is to be understood that any feature described in relation to any one aspect may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the disclosed aspects, or any combination of any other of the disclosed aspects.
It is to be understood that any feature described in relation to any one aspect may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the disclosed aspects, or any combination of any other of the disclosed aspects.
The many features and advantages of the invention are apparent from the detailed specification, and, thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and, accordingly, all suitable modifications and equivalents may be resorted to that fall within the scope of the invention.

## Claims

1. A hand held hub sterilization and data acquisition device comprising:
a housing having an opening for receiving a medical device;
a sterilization chamber formed in the housing;
a source of UV radiation disposed within the sterilization chamber for uniform emission of UV-C radiation into the sterilization chamber;
a user interface; and
an RFID scanner configured into the housing.

2. The device of claim 1, wherein the source of UV radiation is a high voltage tube lamp that produces two ultraviolet wavelengths.

3. The device of claim 1, wherein the source of UV radiation is two UV-C lamps comprising a silica quartz envelope to prevent 190 nm wavelength production and provide minimal attenuation to a 254 nm principal wavelength.

4. The device of claim 3, wherein the sterilization chamber is a silica quartz tube.

5. The device of claim 4, further comprising an aluminum cylinder enclosing the sterilization chamber and providing high reflection efficiency of outward directed UV-C energy.

6. The device of claim 1, wherein the sterilization chamber is a silica quartz tube.

7. The device of claim 1, further comprising an aluminum cylinder enclosing the sterilization chamber and providing high reflection efficiency of outward directed UV-C energy.

8. The device according to claim 1, wherein the housing includes an access door for receiving the medical device into the sterilization chamber.

9. The device according to claim 1, further comprising a safety interlock mechanism.

10. The device of claim 9, wherein the safety interlock mechanism comprises a Hall sensor and a rare earth magnet, and wherein the Hall sensor senses the magnetic field of the magnet when the access door is closed and sends a signal to the user interface indicating a ready state for excitation of the radiation source.

11. The device according to claim 1, further comprising a barcode module.

12. The device according to claim 11, wherein the barcode module utilizes a CMOS 2D imager capable of omnidirectional decoding with regard to code orientation.

13. The device according to claim 1, wherein the medical device is a catheter extension line with a hub and valve assembly.

14. A patient care system comprising:
a hand held hub sterilization and data acquisition device comprising:
a housing having an opening for receiving a medical device;
a sterilization chamber formed in the housing;
a source of UV radiation disposed within the sterilization chamber for uniform emission of UV-C radiation into the sterilization chamber;
a user interface; and
an RFID scanner configured into the housing; and

an RFID enabled medical device.

15. The system according to claim 14, wherein the RFID enabled medical device is a port.

16. The system according to claim 14, further comprising a device charging and download/upload station.

17. The system according to claim 14, further comprising an electronic medical record data interface.