Methods and devices for portable sterilization and containment of medical devices

• US 10,639,389 B2
• Filed: 04/30/2019
• Issued: 05/05/2020
• Est. Priority Date: 04/30/2018
• Status: Active Grant

• Current Assignee: CathBuddy, Inc.
• Original Assignee: CathBuddy, Inc.
• Inventors: Paul, Souvik, Wollin, Daniel
• Primary Examiner(s): Chorbaji, Monzer R
• Application Number:
  US16/399,658
• Publication Number:
  US 20190328915A1
• Time in Patent Office: 371 Days
• Field of Search: 422 22, 422 24, 422300, 25045311, 25045411, 25045511, 2504921
• CPC Class Codes: A61L 2/085 Infrared radiation
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2/12 Microwaves
• CPC Class Codes: A61L 2202/11 Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30

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.

Claims

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 radiation 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 radiation source comprising a plurality of radiation emitters arranged in an at least one array, wherein the emitters are positioned to emit radiation within the sterilization chamber;

one or more individualized trays that each correspond to a single medical device, wherein each individualized tray is substantially transmissive to the radiation emitted 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, the internal control circuit includes an RFID scanner to scan an RFID chip embedded in each one of 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 RFID chip on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the radiation 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 individualized tray is registered to accept a placement of the single medical device in a specific orientation to enable each device to be independently scanned by one or more RFID sensors located in the sterilizer to scan each medical device placed into the sterilizer,

wherein the internal control circuit includes sterilizer software that 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 RFID-validated uses remaining in the one or more medical devices used with the sterilizer,

the sterilization chamber further including a liner with sterilizing radiation reflecting material adapted to reflect and distribute the radiation.

2. The sterilizer of claim 1, wherein the internal control circuit and the RFID 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 the RFID chip embedded 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 RFID tag of each medical device when it is placed in the sterilizer.

4. The sterilizer of claim 2, wherein the digital application indicates the remaining longevity of the RFID-tagged medical device after the medical device has been scanned.

5. The sterilizer of claim 1, wherein the plurality of sensors includes 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.

6. The sterilizer of claim 1, wherein the radiation source is a plurality of thermal elements.

7. The sterilizer of claim 1, wherein the radiation 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 radiation comprises ultraviolet wavelengths of radiation.

9. The sterilizer of claim 1, wherein the radiation comprises infrared wavelengths of radiation.

10. The sterilizer of claim 1, wherein the radiation comprises microwave wavelengths of radiation.

11. The sterilizer of claim 1, wherein the liner is made of one of either:

mirrored aluminum or poly-tetra-fluoro-ethylene (PTFE).

12. The sterilizer of claim 1, wherein the at least one of the radiation sources are contained within the one or more walls of the sterilization chamber and distributed such that each individualized tray is located between two radiation sources when the sterilizer is closed.

13. The sterilizer of claim 1, wherein the at least one of the radiation sources are distributed throughout an inner surface of the sterilization chamber.

14. The sterilizer of claim 1, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.

15. 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.

16. The sterilizer of claim 15, 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.

17. 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 radiation 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 hinges open 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;

one or more individualized trays that each correspond to a single medical device, wherein each individualized tray is substantially transmissive to the radiation emitted 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 thermal radiation source comprising a plurality of thermal emitting bulbs arranged in an at least one array and embedded within the one or more walls of the sterilization chamber, wherein the bulbs are positioned to emit thermal radiation within the sterilization chamber; and

an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes an RFID scanner to scan an RFID chip embedded in each one or the one or more medical devices that 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 the RFID chip embedded in each of the one or more medical devices, 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 RFID chip on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the radiation 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 individualized tray is registered to accept a placement of the single medical device in a specific orientation to enable each device to be independently scanned by one or more RFID sensors located in the sterilizer to scan each medical device placed into the sterilizer,

the sterilization chamber further including a liner with sterilizing radiation reflecting material adapted to reflect and distribute the thermal radiation.

18. The sterilizer of claim 17, wherein the plurality of sensors include 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.

19. The sterilizer of claim 17, wherein the liner is made of one of either:

mirrored aluminum or poly-tetra-fluoro-ethylene (PTFE).

20. The sterilizer of claim 17, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.

21. The sterilizer of claim 17, wherein the sterilizer software includes an automatic replenishment mode that automatically initiates a medical device reorder with a user'"'"'s medical device distributor for the one or more medical devices based on a number of RFID-validated uses remaining in the one or more medical devices used with the sterilizer.

22. The sterilizer of claim 17, 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 an ability to initiate sterilization cycles, stop sterilization cycles, receive push notifications, examine aggregated sterilizer usage data, and receive sterilizer troubleshooting instructions.

23. A method for sterilizing one or more medical devices using radiation comprising:

removing and inserting one or more individualized trays from a sterilizer that each tray corresponds to a single medical device from one or more medical devices, wherein each individualized tray is substantially transmissive to the radiation emitted in the sterilizer and is independently inserted into and removed out of a sterilizer for ease of loading by a user;

enclosing one or more medical devices via the individualized trays in the sterilizer, the sterilizer including a housing with one or more walls defining a sterilization chamber for containing radiation, the sterilization chamber further including a liner with sterilizing radiation reflecting material adapted to reflect and distribute the radiation;

scanning, by an RFID scanner within the sterilizer, the one or more medical devices placed within the sterilizer to validate the one or more medical devices;

write, by the RFID scanner, data to an RFID chip embedded in each of the one or more medical devices;

sealing the sterilization chamber with a door that hinges open 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 RFID chip on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the radiation 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

irradiating surfaces of the one or more medical devices with radiation from at least one radiation source arranged in an at least one array and embedded within the one or more walls of the sterilization chamber, wherein the radiation source is positioned to emit radiation within the sterilization chamber thereby destroying biological contaminants on the surfaces of the one or more medical devices.

24. The method of claim 23, wherein the plurality of sensors include 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.

25. The method of claim 23, wherein the liner is made of one of either:

mirrored aluminum or poly-tetra-fluoro-ethylene (PTFE).

26. The method of claim 23, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.

27. 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 an RFID chip 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 matches a French size of the catheter, the one or more insertion aids further including an RFID chip that contains authentication information and usage information; and

a sterilizer including;

a housing including one or more walls defining a sterilization chamber for containing radiation 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 hinges open 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 individualized trays that each correspond to a single catheter of the one or more catheters and a single insertion aid of the one or more insertion aids, wherein each individualized tray is substantially transmissive to the radiation emitted 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 radiation source comprising a plurality of mercury-based radiation emitting bulbs arranged in an at least one array and embedded within the one or more walls of the sterilization chamber, wherein the bulbs are positioned to emit radiation within the sterilization chamber; and

an internal control circuit for controlling a sterilization cycle with sterilizer software, the internal control circuit includes an RFID scanner to scan an RFID chip embedded in each one of the one or more catheters and 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 RFID chips 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 RFID chip on the non-system components and preventing activation of the sterilization cycle, and prevent emission of the radiation 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 individualized tray is registered to accept a placement of the single medical device in a specific orientation to enable each device to be independently scanned by one or more RFID sensors located in the sterilizer to scan each medical device placed into the sterilizer,

the sterilization chamber further including a liner with sterilizing radiation reflecting material adapted to reflect and distribute the radiation.

28. The sterilizer system of claim 27, wherein the plurality of sensors include 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.

29. The sterilizer system of claim 27, wherein the liner is made of one of either:

mirrored aluminum or poly-tetra-fluoro-ethylene (PTFE).

30. The sterilization system of claim 27, 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 RFID-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.