METHOD AND APPARATUS FOR DISINFECTING A TUBE

Abstract

An applicator in the form of a container or cannister that is arranged to apply one or more photosensitizers to surfaces. The applicator includes at least one light source and the one or more photosensitizers. Light combined with the photosensitizers creates singlet oxygen and other radical species which are toxic to viruses and other pathogens. The photosensitizers may be combined in a powder form, or in an aqueous solution. Any light source can be used that emits the proper wavebands or wavelengths of light that are effectively absorbed by the photosensitizers leading to singlet oxygen generation.

Claims

1. A device, comprising: a photosensitizer formulation; and an elongated structure with a lumen that is configured for medical use, wherein illumination of the photosensitizer formulation causes production of singlet oxygen inside the lumen, and wherein the singlet oxygen causes antimicrobial activity to decontaminate the lumen to prevent microbial infection of a patient.

2. The device of claim 1, wherein the elongated structure, further comprises: one or more of a tube or a channel that is formed by one or more of an intravenous tube, a medical instrument, an endoscope, a catheter, or a biopsy device.

3. The device of claim 1, further comprising: one or more light sources that are configured to illuminate the photosensitizer formulation to cause the production of singlet oxygen, wherein the one or more light sources include one or more a light emitting diode, xenon lamp, fluorescent bulb or tube, incandescent light bulb, electroluminescent device, lasers, or natural sunlight.

4. The device of claim 1, further comprising: one or more light sources that are configured to illuminate the photosensitizer formulation, wherein a light intensity of the illumination ranges from 1 to 50,000 lux, and wherein one or more portions of the light sources are arranged remotely to the elongated structure, proximate to an orifice of the lumen or integrated within the elongated structure to provide illumination of the photosensitizer formulation inside the lumen.

5. The device of claim 1, wherein the decontamination further comprises: employing the antimicrobial activity caused by the singlet oxygen to decontaminate the lumen for a period of time that ranges from one minute to 5 hours.

6. The device of claim 1, wherein the elongated structure, further comprises: one or more portions of the elongated structure that are optically transparent or translucent, wherein one or more light sources are configured to emit light proximate to one or more of an orifice of the lumen or through the one or more portions to illuminate the photosensitizer formulation.

7. The device of claim 1, wherein the photosensitizer formulation, further comprises: a fluid that is dissolved with the photosensitizer formulation to form an aqueous solution, wherein the aqueous solution is atomized into a mist of droplets that flows along a length of the lumen of the elongated structure, wherein the droplets provide one or more of refraction, reflection or diffusion of light transmitted within the length of the lumen.

8. The device of claim 1, further comprising: a container for a fluid that is dissolved with the photosensitizer formulation to form an aqueous solution; and a connector that is configured to couple an outlet of the container to the lumen of the elongated structure, wherein the aqueous solution flows from the outlet of the container along a length of the lumen.

9. The device of claim 1, wherein the photosensitizer formulation, further comprising: one or more of methylene blue or riboflavin at a concentration having a range from 10 to 1000 micromolar.

10. The device of claim 1, further comprising: an applicator that is configured for providing the photosensitizer formulation into an orifice of the lumen within the elongated structure.

11. The device of claim 1, further comprises: a pump that is coupled to a container for a fluid that is dissolved with the photosensitizer formulation to form an aqueous solution, wherein the pump is configured to pressurize the aqueous solution into an orifice of the lumen to create a flow along a length of the lumen.

12. The device of claim 11, wherein the pump further comprises: a nozzle to convert the aqueous solution into a mist of droplets directed into the orifice of the lumen to spread the mist of droplets along the length of the lumen.

13. The device of claim 1, wherein the photosensitizer formulation further comprises: a mixture of photosensitizer formulation particles that provide a powder form for the photosensitizer formulation.

14. A method, comprising: providing a photosensitizer formulation; and employing an elongated structure with a lumen that is configured for medical use to illuminate the photosensitizer formulation to cause production of singlet oxygen inside the lumen, wherein the singlet oxygen causes antimicrobial activity to decontaminate the lumen to prevent microbial infection of a patient.

15. The method of claim 14, wherein the elongated structure, further comprises: providing one or more of a tube or a channel that is formed by one or more of an intravenous tube, a medical instrument, an endoscope, a catheter, or a biopsy device.

16. The method of claim 14, further comprising: providing one or more light sources that are configured to illuminate the photosensitizer formulation to cause the production of singlet oxygen, wherein the one or more light sources include one or more a light emitting diode, xenon lamp, fluorescent bulb or tube, incandescent light bulb, electroluminescent device, lasers, or natural sunlight.

17. The method of claim 14, further comprising: providing one or more light sources that are configured to illuminate the photosensitizer formulation, wherein a light intensity of the illumination ranges from 1 to 50,000 lux, and wherein one or more portions of the light sources are arranged remotely to the elongated structure, proximate to an orifice of the lumen or integrated within the elongated structure to provide illumination of the photosensitizer formulation inside the lumen.

18. The method of claim 14, wherein the decontamination further comprises: employing the antimicrobial activity caused by the singlet oxygen to decontaminate the lumen for a period of time that ranges from one minute to 5 hours.

19. The method of claim 14, wherein the elongated structure, further comprises: providing one or more portions of the elongated structure that are optically transparent or translucent, wherein one or more light sources are configured to emit light proximate to one or more of an orifice of the lumen or through the one or more portions to illuminate the photosensitizer formulation.

20. The method of claim 14, wherein the photosensitizer formulation, further comprises: providing a fluid that is dissolved with the photosensitizer formulation to form an aqueous solution, wherein the aqueous solution is atomized into a mist of droplets that flows along a length of the lumen of the elongated structure, wherein the droplets provide one or more of refraction, reflection or diffusion of light transmitted within the length of the lumen.

Description

DESCRIPTION OF FIGURES FOR VARIOUS EMBODIMENTS

[0028] FIG. 1A depicts an overview 100 of pressurized container 102 filled with one or more photosensitizer aqueous solution 104, with pressurized container 102 connected to flexible or rigid tube 106 which incorporates nozzle 108. Photosensitizer aqueous solution 104 is delivered to medical or equipment catheter, channel, or tube 110 via nozzle 108 which is positioned with an air gap, or directly juxtaposed to medical or equipment catheter, channel, or tube 110. Photosensitizer aqueous solution 104 is injected into tube 110 under pressure sufficient to fill tube 110 with photosensitizer aqueous solution 104. The orifice of nozzle 108 may fit within or be aligned with the mouth of tube 110, or be a 1.0 mm diameter or larger, up to 30.0 mm than the mouth of tube 110 which allows for simultaneous deposition of photosensitizer aqueous solution 104 within the lumen of tube 110 and extraluminal deposition of photosensitizer aqueous solution 104 on the external surface of tube 110. Photoactivation of photosensitizer aqueous solution 104 is accomplished by light source 112 emitting light waves (hr) that illuminate the external surface of tube 110 after surface deposition of photosensitizer aqueous solution 104.

[0029] FIG. 1B illustrates an overview 120 of an arrangement of light source 122 that incorporates optical fiber 124 which guides light waves 126 into the mouth of tube 128.

[0030] FIG. 1C shows an overview 130 of an arrangement of vapor mist generator 132 to generate cool aqueous steam 136 which is transmitted by hollow connector 134 and injected onto the lumen of tube 138, the cool steam or vapor serving to transmit light waves down the lumen of tube 138, which photoactivates photosensitizer aqueous solution 139 within the lumen of tube 138.

[0031] FIG. 1D shows an overview 140 of an arrangement of non-imaging lens 144 that is incorporated into an end of optical fiber 142 which focuses light waves 146 into an orifice of tube 146.

[0032] FIG. 2A depicts an overview 200 of an arrangement of chamber or cabinet or box 201 which incorporates elements described in FIGS. 1A-1D, enabling high level disinfection or decontamination of medical or other equipment J contained within chamber 201.

[0033] FIG. 2B shows an arrangement of intravenous bag 210 containing a medicinal fluid 212 connected to intravenous tubing 214.

[0034] FIG. 2C depicts an arrangement of intravenous tubing 214 that contains photosensitizer aqueous solution 216 which is photoactivated by light source 218, which illuminates photosensitizer solution 216 through optically transparent intravenous tubing 214. In all cases of illumination of photosensitizer aqueous solutions, the photoactivation process is such that pathogens are inactivated or killed.

[0035] Also, FIG. 2C depicts an arrangement of urinary catheter 222 connected to urine drainage collection bag 224. Urinary catheter 222 is shown exiting urethral orifice 220. External light source 226 emits light waves (hr) that illuminate photosensitizer aqueous solution 228 contained in the lumen of urinary catheter 222 and bag 224, killing or inactivating pathogens within the optically transparent urinary catheter 222 and/or within optically transparent urine collection bag 224.

[0036] FIG. 3 shows an overview 300 of an arrangement of mirror system 302 that employs mirrors 306A, 306B and 306C to direct photoactivating light waves (hr) emitted from light source 304 into the orifice of tube 308.

[0037] FIG. 4A illustrates an arrangement of pump 400 which pumps steam, vapor, or liquid optionally containing at least one photosensitizer formulation into the orifice 404 of rigid or flexible polymeric or metallic hose 402. Also shown is reservoir 406 which holds and supplies at least one photosensitizer formulation in an aqueous solution form or a powder form which is delivered into the orifice 404.

[0038] FIG. 4B shows an arrangement of adjustable clamp 412 which surrounds hose 410 which is positioned around the mouth orifice 416 of tube or channel 414 which may optionally represent the distal or proximal end of an endoscope or a pipe.

[0039] FIG. 4C illustrates an arrangement of tub or container 420 which is shown containing or incorporating pump assembly 422 which also contains a vapor, steam, or liquid with or without at least one photosensitizer formulation. Pump 422 is connected to tube or hose 424 which is connected reversibly to tube or pipe 426.

[0040] FIG. 4D shows an arrangement of light emitting diode (LED) array 430 surrounding the inlet 432 of tube, pipe, or channel 434. LED array 430 emits light waves towards the origin of tube, pipe or channel 434, causing illumination throughout the length of tube or pipe or channel 434. In FIGS. 4A, 4B, 4C and 4D, the arrangements enable at least one photosensitizer formulation to be delivered and transmitted along the length of tubes and/or channels, which may represent endoscopes, catheters, vascular grafts, stents, hoses, pipes, and the like, which are in need of decontamination.

[0041] Furthermore, in one or more embodiments, a photosensitizer formulation may be activated via vapor, steam, or an optically transparent liquid capable of transmitting light in a similar fashion to a light pipe, or cool steam fireplace, wherein the emitted light waves are of sufficient intensity and spectral overlap to enable useful and effective photoactivation of a photosensitizer formulation.

DESCRIPTION OF EXAMPLES FOR VARIOUS EMBODIMENTS

Example 1

[0042] A series of laboratory experiments may be carried out using tubes of various diameters and lengths containing vapor microdroplets of varying diameters, through which light is delivered at the orifices of the tubes. Maximum light transmission is measured at the ends of the tubes opposite the orifice, in order to determine the optimum range of vapor microdroplet sizes and microdroplet density that transmits an effective total light dose, which activates at least one photosensitizer. In addition, various combinations and concentrations of photosensitizers are tested for pathogen and toxin inactivation and degradation at various light transmission parameters. Speed and degree of pathogen and toxin inactivation and degradation are determined to select the optimal the photosensitizer and light conditions, which includes a determination of optimal vapor microdroplet speed and flow in the various tube diameters, lengths, and configurations. Configurations may include linear straight disposition of the tubes, with or without coiling and bending configurations. Test pathogens and toxins are inoculated into the tubes at various distances, and in various amounts for inactivation and killing tests. In these experiments, the microdroplets may contain at least one photosensitizer formulation in an aqueous solution, with the microdroplets serving a dual purpose of light transmission and photoactivation for decontamination purposes.

Example 2

[0043] Another experiment may include a balloon tipped urinary catheter that is decontaminated using a system comprising an oral riboflavin formulation and a methylene blue formulation which is contained within the positioning balloon which is part of the urinary catheter, as in the well-known Foley urinary catheter. The methylene blue formulation is injected through the balloon fluid filling port into the reservoir balloon, which incorporates a membrane interface with the drainage catheter which allows for passage of a metered amount of methylene blue solution into the urine drainage part of the urinary catheter. Photoactivating light, which in the case of methylene blue and riboflavin are centered on the red and blue absorption bands respectively, is supplied by a light source, which may be a light emitting diode array located external to the distal urethral orifice. The light source transmits light from a distal to proximal direction, causing a pathogen inactivation and killing effect within the drainage catheter. An option is bidirectional light delivery, simultaneously into the urinary drainage channel and the drainage collection bag. The oral riboflavin will be excreted into the urinary tract, eventually into the bladder. With blue light directed into the bladder, pathogens in the bladder can be inactivated and killed. In addition, if the positioning balloon is temporarily partially deflated or positioned deeper into the bladder, which allows for leakage of riboflavin containing urine around the exterior of the catheter, pathogens external to the catheter wall can be inactivated and killed by light transmitted through the wall of the catheter, which in this case is comprised of an optically transparent polymer.

Example 3

[0044] Another experiment may be performed during the precleaning and/manual cleaning stage of a high level endoscope disinfection, an aqueous solution containing at least one photosensitizer such as methylene blue and/or riboflavin, at concentrations ranging from 10 to 1000 micromolar are injected from a polymeric catheter into the proximal mouths of one or more endoscope channels. The injection process occurs till the aqueous fluid is visualized at the distal end. Light is then delivered, red light for methylene blue and blue light for riboflavin into the distal and/or proximal ends of the endoscope channels, photoactivating the photosensitizer(s) for antimicrobial effect, which includes biofilm eradication.