Systems and methods for sterilization using UV light

• US 9,550,005 B2
• Filed: 04/28/2015
• Issued: 01/24/2017
• Est. Priority Date: 10/29/2013
• Status: Active Grant

• Current Assignee: Roger C. Lin
• Original Assignee: Ultraviolet Interventions, Inc.
• Inventors: Lin, Roger C, Sandell, Laurence M
• Primary Examiner(s): THOMSON, WILLIAM D
• Assistant Examiner(s): Lipitz, Jeffrey
• Application Number:
  US14/698,778
• Publication Number:
  US 20150231287A1
• Time in Patent Office: 637 Days
• Field of Search: 422/22, 422/24
• US Class Current: 1/1
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2209/10 Equipment for cleaning
• 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
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

Embodiments of this disclosure include systems, methods, and kits for sterilizing in vivo catheters using an optical fiber to deliver UV light. In an embodiment, a method for sterilizing a catheter with at least a first lumen, includes inserting a distal end of a fiber optic cable into a fiber insertion port of a catheter connector attached to a hub of the first lumen, flushing the first lumen with fluid from a fluid source, inserting the fiber optic cable into the first lumen until a stopper of the fiber optic cable is adjacent to the fiber insertion port, providing light to the fiber optic cable from a light source after the fiber optic cable is inserted into the first lumen, withdrawing the fiber optic cable from the first lumen while the light is provided, and ceasing to provide light to the fiber optic cable after the fiber optic cable is withdrawn from the first lumen. The disclosure is also applicable to catheters with multiple lumens and to catheters accessed through subcutaneous ports.

Claims

1. A method for sterilizing a catheter with at least a first lumen, comprising:

attaching a hub of the first lumen to a hub adapter of a catheter connector and attaching a fluid source to a fluid port of the catheter connector, prior to flushing the first lumen;

unlocking the first lumen by disengaging a tubing clamp configured to block fluid flow through the first lumen, prior to flushing the first lumen;

inserting a distal end of a fiber optic cable into a fiber insertion port of the catheter connector attached to the hub of the first lumen;

flushing the first lumen with fluid from the fluid source;

inserting the fiber optic cable into the first lumen until a stopper of the fiber optic cable is adjacent to the fiber insertion port after flushing the first lumen;

providing light to the fiber optic cable from a light source after the fiber optic cable is inserted into the first lumen;

withdrawing the fiber optic cable from the first lumen while the light is provided;

ceasing to provide light to the fiber optic cable after the fiber optic cable is withdrawn from the first lumen;

locking the first lumen by engaging the tubing clamp, after withdrawing the fiber optic cable from the catheter; and

disengaging the hub from the hub adapter, after locking the first lumen.

2. The method of claim 1, wherein the step of inserting the fiber optic cable into a fiber insertion port occurs prior to the step of flushing the first lumen.

3. The method of claim 1, wherein, when the stopper is adjacent to the fiber insertion port, the distal end of the fiber optic cable is within 6 cm from a distal end of the first lumen and does not extend beyond a distal end of the first lumen.

4. The method of claim 3, wherein, during the step of inserting the fiber optic cable into the first lumen, when the stopper is adjacent to fiber insertion port, the distal end of the fiber optic cable is within 3 cm from the distal end of the first lumen.

5. The method of claim 1, wherein:

the step of withdrawing the fiber optic cable from the catheter ends when the distal end of a fiber optic cable is positioned within the catheter connector, and

the step of ceasing to provide light to the fiber optic cable occurs while the distal end of a fiber optic cable is positioned within the catheter connector.

6. The method of claim 1, wherein the stopper is at least one of at torque device, a hinged device, a clamping apparatus, and a bead comprising at least one of silica, plastic, resin, or epoxy.

7. The method of claim 1, further comprising:

providing, as the catheter connector and fiber insertion port, respectively, a hemostasis valve with a one-way valve.

8. The method of claim 1, further comprising:

aligning the stopper on a first stopper marker of the fiber optic cable; and

securing the stopper to the fiber optic cable.

9. The method of claim 8, further comprising:

selecting the first stopper marker from a plurality of stopper markings, such that first stopper marker corresponds to a combined length of the first lumen and the catheter connector.

10. The method of claim 1, further comprising:

treating a second lumen of the catheter with light from the light source.

11. The method of claim 1, further comprising:

confirming a match in color between at least one of the hub and at least a portion of the catheter connector, and at least one of a fiber optic connector, the stopper, and a marking on the fiber optic cable.

12. The method of claim 1, further comprising:

providing, as the light source, a laser that provides light in the UVC band.

13. The method of claim 1, wherein the step of withdrawing the fiber optic cable is performed by hand using a time-keeping device to maintain a steady withdrawal rate.

14. The method of claim 1, further comprising:

withdrawing fluid from the first lumen through the catheter connector using suction,

wherein the step of withdrawing fluid from the first lumen occurs prior to the step of flushing the first lumen.

15. The method of claim 1, further comprising:

providing, as the fluid source, a syringe containing a saline solution.

16. The method of claim 1, further comprising:

providing, as the light source, a laser that provides light at a power of between 1 mW and 50 mW.

17. The method of claim 1, further comprising:

providing, as the light source, a laser that provides light with a peak wavelength of approximately 266 nm.

18. The method of claim 1, further comprising:

providing, as the light source, a laser that provides pulsed light.

19. The method of claim 1, further comprising:

providing, as the fiber optic cable, a sheathed fiber comprising a cable sheath; and

at least partially withdrawing the cable sheath from the first lumen to expose a tip of the sheathed fiber, prior to providing light to the fiber optic.

20. The method of claim 1, wherein:

the step of withdrawing the fiber optic cable from the first lumen occurs at a rate approximately equal to the light source power divided by the product of a desired light dose times the diameter of the first lumen times π

.

21. A method for sterilizing a catheter with at least a first lumen, comprising:

inserting a distal end of a fiber optic cable into a fiber insertion port of a catheter connector attached to a hub of the first lumen;

flushing the first lumen with fluid from a fluid source;

inserting the fiber optic cable into the first lumen until a stopper of the fiber optic cable is adjacent to the fiber insertion port;

providing light to the fiber optic cable from a light source after the fiber optic cable is inserted into the first lumen;

ceasing to provide light to the fiber optic cable;

withdrawing the fiber optic cable from the first lumen; and

locking the first lumen by engaging the tubing clamp, after withdrawing the fiber optic cable from the catheter.

22. The method of claim 21, wherein:

the step of proceeds for a predetermined duration of time approximately equal to a desired light dose times the length of the first lumen the diameter of the first lumen times π

divided by the light source power.

23. The method of claim 21, further comprising:

withdrawing fluid from the first lumen through the catheter connector using suction,

wherein the step of withdrawing fluid from the first lumen occurs prior to the step of flushing the first lumen.

24. The method of claim 21, further comprising:

providing, as the fluid source, a syringe containing a saline solution.

25. The method of claim 21, further comprising:

providing, as the light source, a laser that provides light at a power of between 1 mW and 50 mW and a peak wavelength of approximately 266 nm.

26. The method of claim 21, further comprising:

providing, as the light source, a laser that provides pulsed light.

27. A method for sterilizing a catheter with at least a first lumen, comprising:

confirming a match in color between at least one of a hub of the first lumen and at least a portion of a catheter connector, and at least one of a fiber optic connector, the stopper, and a marking on the fiber optic cable;

inserting a distal end of a fiber optic cable into a fiber insertion port of the catheter connector attached to the hub of the first lumen;

flushing the first lumen with fluid from a fluid source;

inserting the fiber optic cable into the first lumen until a stopper of the fiber optic cable is adjacent to the fiber insertion port;

providing light to the fiber optic cable from a light source after the fiber optic cable is inserted into the first lumen;

ceasing to provide light to the fiber optic cable;

withdrawing the fiber optic cable from the first lumen.

28. The method of claim 27, wherein:

the step of proceeds for a predetermined duration of time approximately equal to a desired light dose times the length of the first lumen the diameter of the first lumen times π

divided by the light source power.

29. The method of claim 27, further comprising:

withdrawing fluid from the first lumen through the catheter connector using suction,

wherein the step of withdrawing fluid from the first lumen occurs prior to the step of flushing the first lumen.

30. The method of claim 27, further comprising:

providing, as the light source, a laser that provides light at a power of between 1 mW and 50 mW and a peak wavelength of approximately 266 nm.