Methods and Devices for Portable Sterilization and Containment of Medical Devices

Abstract

An at-home sterilization and data acquisition and deposition device including a housing having an opening or series of openings for receiving up to six medical devices, a sterilization chamber formed within the housing that is lined with sterilizing radiation reflecting material, and several sources of sterilizing radiation disposed within the sterilization chamber for sufficient emission of radiation to achieve a significant log reduction of any pathogens present on the medical devices, and an RFID scanner and sensor suite configured into the housing that prevents sterilization of non-system components, radiation emission into the environment, and that can pair with a user's mobile device. An individual catheterization system includes an at-home sterilization and data acquisition device, a software-enabled analysis of data acquired through the system, a set of accessories to enable proper lubrication, cleaning, and radiation-based sterilization of medical devices, and a set of RFID-enabled medical devices designed to facilitate sterile emptying of the bladder by providing a tactile interface that prevents direct contact between the individual and the parts of the medical devices that enter the individual's body.

We claim: 
     
         1 . A sterilizer for sterilizing one or more medical devices, the sterilizer comprising:
 a housing including one or more walls defining a sterilization chamber for containing a sterilant and for enclosing the one or more medical devices, the housing having one or more openings for receiving the one or more medical devices and a door that opens to allow individual access to the one or more medical devices, the door providing a seal between the sterilization chamber and an external environment when closed;   at least one sterilant source comprising a plurality of sterilant generators arranged in an at least one array, wherein the plurality of sterilant generators are positioned to generate the sterilant within the sterilization chamber;   one or more trays, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and can independently be inserted into and removed out of the sterilizer for ease of loading by a user; and   an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes an scanner to scan the one or more medical devices and a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of the non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit,   wherein each tray is registered to accept a placement of the one or more medical devices in a specific orientation to enable each device to be scanned by one or more scanners located in the sterilizer to scan each medical device placed into the sterilizer.   
     
     
         2 . The sterilizer of  claim 1 , wherein the internal control circuit and the scanner validates an authenticity and a remaining longevity of each one of the one or more medical devices placed within the sterilizer in order to begin the sterilization cycle and writes data to a data-storage tag in each of the one or more medical devices following a successful completion of the sterilization cycle. 
     
     
         3 . The sterilizer of  claim 2 , further comprising a user interface that indicates to the user the remaining longevity of each medical device placed in the sterilizer, based on a successful reading and authentication of the data-storage tag of each medical device when it is placed in the sterilizer. 
     
     
         4 . The sterilizer of  claim 1 , wherein the plurality of sensors includes one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met. 
     
     
         5 . The sterilizer of  claim 1 , wherein the sterilant source is a plurality of thermal elements. 
     
     
         6 . The sterilizer of  claim 5 , wherein the plurality of thermal elements causes a water supply to vibrate and heat up to generate the sterilant source comprising steam. 
     
     
         7 . The sterilizer of  claim 1 , wherein the sterilant source is one or more of the following: a plurality of UV-C LEDs, a plurality of infrared emitters, or a plurality of microwave emitters. 
     
     
         8 . The sterilizer of  claim 1 , wherein the sterilant comprises ultraviolet wavelengths of radiation. 
     
     
         9 . The sterilizer of  claim 1 , wherein the sterilant comprises infrared wavelengths of radiation that generates heat. 
     
     
         10 . The sterilizer of  claim 1 , wherein the sterilant comprises microwave wavelengths of radiation. 
     
     
         11 . The sterilizer of  claim 1 , wherein the sterilization chamber maintains a pressurized environment. 
     
     
         12 . The sterilizer of  claim 1 , wherein the at least one of the sterilant sources are contained within the one or more walls of the sterilization chamber and distributed such that each tray is located proximal to at least one sterilant source when the sterilizer is closed. 
     
     
         13 . The sterilizer of  claim 1 , wherein the at least one of the sterilant sources are distributed throughout an inner surface of the sterilization chamber. 
     
     
         14 . The sterilizer of  claim 1 , wherein the sterilizer software pairs with a digital application for a mobile device to provide a user with detailed sterilizer status updates and diagnostics of the one or more medical devices to the user, as well as the ability to initiate sterilization cycles, stop sterilization cycles, receive push notifications, examine aggregated sterilizer usage data, and receive sterilizer troubleshooting instructions. 
     
     
         15 . The sterilizer of  claim 14 , wherein the digital application indicates the remaining longevity of the medical device after the medical device has been scanned. 
     
     
         16 . The sterilizer of  claim 14 , wherein collected data is stored on-board the sterilizer or transmitted to the digital application in a HIPAA-compliant fashion. 
     
     
         17 . The sterilizer of  claim 1 , wherein the trays are mounted such that when the sterilizer is opened, the trays are pushed towards the sterilizer opening, enabling easy access to the trays by the user. 
     
     
         18 . A method for sterilizing one or more medical devices using a sterilant comprising:
 removing and inserting one or more trays from a sterilizer that each tray corresponds to one or more medical devices, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and is independently inserted into and removed out of a sterilizer for ease of loading by a user;   cleaning one or more medical devices with a silicone brush capable of dispersing chemical sterilizing agents while abrading pathogenic residue from the surfaces of the medical devices; enclosing one or more medical devices via the trays in the sterilizer, the sterilizer including a housing with one or more walls defining a sterilization chamber for containing the sterilant;   scanning, by a scanner within the sterilizer, the one or more medical devices placed within the sterilizer to validate the one or more medical devices;   writing, by the scanner, data to a data storage device in each of the one or more medical devices;   sealing the sterilization chamber with a door opens to allow individual access to the one or more medical devices, the door providing a seal between the sterilization chamber and an external environment when closed;   starting a sterilization cycle with an internal control circuit for controlling the sterilization cycle with sterilizer software, the internal control circuit further including a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit; and   exposing surfaces of the one or more medical devices with the sterilant from at least one sterilant source arranged in an at least one array and embedded within the one or more walls of the sterilization chamber, wherein the sterilant source is positioned to provide the sterilant within the sterilization chamber thereby destroying biological contaminants on the surfaces of the one or more medical devices.   
     
     
         19 . The method of  claim 18 , wherein the plurality of sensors include one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor, and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met. 
     
     
         20 . The method of  claim 18 , wherein the one or more medical devices includes up to six catheters and catheter insertion aids. 
     
     
         21 . A sterilization system comprising:
 one or more urinary intermittent catheters made from sterilization-resilient and flexible material, the one or more catheters including a curved funnel and a first data-storage tag that contains authentication information and usage information;   one or more catheter insertion aids that mate with the one or more catheters and provide support and lubrication to the one or more catheters, the one or more insertion aids including a flexible insertion tip that is similar to a French size of the catheter, the one or more insertion aids further including a second data-storage tag that contains authentication information and usage information; and   a sterilizer including:
 a housing including one or more walls defining a sterilization chamber for containing a sterilant and for enclosing the one or more catheters and the one or more insertion aids, the housing having one or more openings for receiving the one or more catheters and the one or more insertion aids and a door that opens to allow individual access to the one or more catheters and the one or more insertion aids, the door providing a seal between the sterilization chamber and an external environment when closed; 
 one or more trays that each correspond to the one or more catheters and the one or more insertion aids, wherein each tray is substantially transmissive to the sterilant generated in the sterilizer and can independently be inserted into and removed out of the sterilizer for ease of loading by a user; 
 at least one sterilant source comprising a plurality of sterilant generators arranged in an at least one array, wherein the generators are positioned to generate the sterilant within the sterilization chamber; and 
 an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes a scanner to scan the first data-storage tag embedded in each one of the one or more catheters and the second data-storage tag embedded in each one of the one or more insertion aids that validates an authenticity and a remaining longevity of each one of the one or more catheters and the one or more insertion aids placed within the sterilizer in order to begin the sterilization cycle and writes data to the first and second data-storage tags in each of the one or more catheters and the one or more insertion aids, the internal control circuit further including a plurality of sensors that validate the sterilizer is completely closed during the sterilization cycle, prevent sterilization of non-system components by recognizing a placement of non-system components within the sterilizer and an absence of a valid scan on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the sterilant into the external environment, and wherein the plurality of sensors located within the housing and the sterilization cycle continues until the plurality of sensors has received a sterilization dose greater than or equal to a minimum sterilization dose set within the internal control circuit, 
   wherein each tray is registered to accept a placement of the one or more urinary intermittent catheters and the one or more catheter insertion aids in a specific orientation to enable each device to be scanned by one or more scanners located in the sterilizer to scan each medical device placed into the sterilizer.   
     
     
         22 . The sterilizer system of  claim 21 , wherein the plurality of sensors include one or more of the following: a Hall Effect sensor, a temperature sensor, a humidity sensor, and a pressure sensor, wherein the plurality of sensors collect a set of data that is continuously transferred into the internal control circuit to increase a duration of the sterilization cycle so long as a set of pre-defined parameters are not met. 
     
     
         23 . The sterilization system of  claim 21 , wherein the sterilizer software pairs with a digital application for a mobile device to provide a user with detailed sterilizer status updates and diagnostics of the one or more medical devices to the user. 
     
     
         24 . The sterilization system of  claim 23 , wherein the sterilizer software includes an automatic replenishment mode to automatically initiate a medical device reorder with a user's medical device distributor for the one or more medical devices based on a number of scan-validated uses remaining in the one or more medical devices used with the sterilizer, and further wherein the automatic replenishment mode utilizes a pre-populated shopping cart in the digital application that requires user consent before the digital application transmits the shopping cart to a user's medical device distributor.