METHODS AND DEVICES FOR PORTABLE STERILIZATION AND CONTAINMENT OF MEDICAL DEVICES

• US 20190328915A1
• Filed: 04/30/2019
• Published: 10/31/2019
• Est. Priority Date: 04/30/2018
• Status: Active Grant

• Current Assignee: CathBuddy, Inc.
• Original Assignee: CathBuddy, Inc.
• Inventors: Paul, Souvik, Wollin, Daniel
• Granted Patent: US 10,639,389 B2
• Time in Patent Office: Days
• 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 electromagnetic 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;

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

an internal control circuit for controlling a sterilization cycle, the internal control circuit includes an RFID scanner for use with 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, and prevent radiation emission into the external environment, and wherein the plurality of sensors includes a radiation sensor located in a hardest to sterilize location within the housing, wherein the sterilization cycle continues until the radiation sensor has received a radiation dose greater than a minimum radiation dose set within the internal control circuit,

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, further comprising one or more individualized trays that correspond to the one or more medical devices, wherein each individualized tray can independently pivot out of the sterilizer for ease of loading by a user.

3. The sterilizer of claim 2, wherein each individualized tray is registered to accept a placement of the one or more medical devices in a specific orientation.

4. The sterilizer of claim 1, wherein the RFID scanner validates an authenticity of the one or more medical devices placed within the sterilizer and writes data to an RFID chip embedded in each of the one or more medical devices.

5. The sterilizer of claim 1, wherein the plurality of sensors includes one or more of the following:

a Hall Effect sensor, a temperature sensor, an ultraviolet light sensor, or a pressure sensor.

6. The sterilizer of claim 1, wherein the electromagnetic radiation source is a plurality of mercury-based UV-C bulbs.

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

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

10. The sterilizer of claim 1, wherein the electromagnetic 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 plurality of 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 plurality of 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 internal control circuit includes sterilizer software.

16. The sterilizer of claim 15, 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 uses remaining in the one or more medical devices used with the sterilizer.

17. The sterilizer of claim 15, wherein the sterilizer software pairs with a digital application for a mobile device to provide detailed status updates and diagnostics of the one or more medical devices to the user.

18. 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 electromagnetic 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 correspond to the one or more medical devices, wherein each individualized tray can independently pivot out of the sterilizer for ease of loading by a user;

at least one electromagnetic UV-C radiation source comprising a plurality of mercury-based UV-C 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 electromagnetic UV-C 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 that validates an authenticity of the one or more medical devices placed within the sterilizer and writes data to an 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, and prevent radiation emission into the external environment, and wherein the plurality of sensors includes a UV-C sensor located in a hardest to sterilize location within the housing, wherein the sterilization cycle continues until the UV-C sensor has received a UV-C radiation dose greater than a minimum UV-C radiation dose set within the internal control circuit,

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

19. The sterilizer of claim 18, wherein the plurality of sensors include one or more of the following:

a Hall Effect sensor, a temperature sensor, an ultraviolet light sensor, or a pressure sensor.

20. The sterilizer of claim 18, wherein the liner is made of one of either:

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

21. The sterilizer of claim 18, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.

22. The sterilizer of claim 18, 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 uses remaining in the one or more medical devices used with the sterilizer.

23. The sterilizer of claim 18, wherein the sterilizer software pairs with a digital application for a mobile device to provide detailed status updates and diagnostics of the one or more medical devices to the user.

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

enclosing one or more medical devices in a sterilizer, the sterilizer including a housing with one or more walls defining a sterilization chamber for containing electromagnetic 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, and prevent radiation emission into the external environment, and wherein the plurality of sensors includes a UV-C sensor located in a hardest to sterilize location within the housing, wherein the sterilization cycle continues until the UV-C sensor has received a UV-C radiation dose greater than a minimum UV-C radiation dose set within the internal control circuit; and

irradiating surfaces of the one or more medical devices with electromagnetic radiation from at least one electromagnetic UV-C radiation source comprising a plurality of mercury-based UV-C 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 electromagnetic UV-C radiation within the sterilization chamber thereby destroying biological contaminants on the surfaces of the one or more medical devices.

25. The method of claim 24, wherein the plurality of sensors include one or more of the following:

a Hall Effect sensor, a temperature sensor, an ultraviolet light sensor, or a pressure sensor.

26. The method of claim 24, wherein the liner is made of one of either:

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

27. The method of claim 24, wherein the one or more medical devices includes up to six catheters and catheter insertion aids.

28. A sterilization system comprising:

one or more urinary intermittent catheters made from UVC-transparent 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 electromagnetic 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 correspond to the one or more catheters and the one or more insertion aids, wherein each individualized tray can independently pivot out of the sterilizer for ease of loading by a user;

at least one electromagnetic UV-C radiation source comprising a plurality of mercury-based UV-C 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 electromagnetic UV-C 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 that validates an authenticity of the one or more catheters and the one or more insertion aids placed within the sterilizer 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, and prevent radiation emission into the external environment, and wherein the plurality of sensors includes a UV-C sensor located in a hardest to sterilize location within the housing, wherein the sterilization cycle continues until the UV-C sensor has received a UV-C radiation dose greater than a minimum UV-C radiation dose set within the internal control circuit,

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

29. The sterilizer system of claim 28, wherein the plurality of sensors includes one or more of the following:

a Hall Effect sensor, a temperature sensor, an ultraviolet light sensor, or a pressure sensor.

30. The sterilizer system of claim 28, wherein the liner is made of one of either:

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