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WO2025019833A1 - Désinfection par longueur d'onde antimicrobienne sûre en champ proche par l'intermédiaire de fibres optiques, de guides de lumière ou de tubes de lumière pour la désinfection ambulatoire percutanée ou à demeure de cathéters, de lignes d'accès vasculaire, de drains, de tubes endo-trachéaux et de dispositifs médicaux similaires - Google Patents

Désinfection par longueur d'onde antimicrobienne sûre en champ proche par l'intermédiaire de fibres optiques, de guides de lumière ou de tubes de lumière pour la désinfection ambulatoire percutanée ou à demeure de cathéters, de lignes d'accès vasculaire, de drains, de tubes endo-trachéaux et de dispositifs médicaux similaires Download PDF

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Publication number
WO2025019833A1
WO2025019833A1 PCT/US2024/038884 US2024038884W WO2025019833A1 WO 2025019833 A1 WO2025019833 A1 WO 2025019833A1 US 2024038884 W US2024038884 W US 2024038884W WO 2025019833 A1 WO2025019833 A1 WO 2025019833A1
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WO
WIPO (PCT)
Prior art keywords
light
antimicrobial
wavelengths
percutaneous
tube
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Pending
Application number
PCT/US2024/038884
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English (en)
Inventor
Sharon A. Keene
Erik Shahoian
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Individual
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Individual
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Filing date
Publication date
Priority claimed from US18/224,511 external-priority patent/US20240016246A1/en
Application filed by Individual filed Critical Individual
Publication of WO2025019833A1 publication Critical patent/WO2025019833A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation

Definitions

  • the present disclosure relates generally to near field application of safe antimicrobial wavelengths for disinfection of percutaneous or indwelling medical devices while they are in use to curb nosocomial infections.
  • the disclosure has particular utility with respect to either immediate or long term maintenance of disinfection or sterilization of percutaneous or indwelling medical devices and adjacent potentially contaminated tissues, such devices include catheters, drains, vascular access devices, trocars and endotracheal or tracheostomy tubes, and will be described in connection with the use of near field application of safe antimicrobial wavelengths such as far UVC (200-230 nm) to maintain disinfection of such medical devices while simultaneously disinfecting or sterilizing surrounding animate and inanimate areas that serve as a source of contamination or infection.
  • far UVC 200-230 nm
  • Nosocomial (hospital-acquired) infections are a leading cause of extended hospital stays, increased hospitalization costs, and unnecessary morbidity and mortality in the United States.
  • pandemic pathogens such as COVID
  • a primary source of nosocomial infection involves ambient bacteria, fungi, virus and other pathogens which invade areas of a patient’s body via medical devices such as percutaneous or indwelling catheters accessing various body cavities or spaces, vascular access lines, endotracheal or tracheostomy tubes, trocars and surgical drains to cause infection.
  • drains may be placed for drainage of suspected contaminated fluids, in these cases antimicrobial light can be used to disinfect already contaminated tissues as well as the drains being used to reduce the pathogen burden.
  • broadband UV light and in particular broadband UVC wavelengths have been used as part of an effective antimicrobial disinfection strategy in hospitals and clinics, both for air and surface disinfection. Such disinfection has been established as superior to many topical disinfectants.
  • broadband UVC light has limitations for use in the presence of people or animals because longer wavelengths within this group, the most popular being 254 nm, are genotoxic and damaging to a patient’s skin and eyes and therefore pose health risks to humans or animals with direct exposure.
  • a narrow band of UVC light termed far UV-C light termed far UV-C light (200-230 nm) maintains the antimicrobial properties of broadband UVC, but exhibits the distinct advantage of being safe for exposure in humans or animals because its wavelengths are too short to be absorbed by the epidermis or even the tears of the eye, making it safe for exposure of skin and eyes of patients and healthcare workers that care for them.
  • the near field application of such disinfecting wavelengths is maximized in this invention based on the property of light known as the inverse square law where antimicrobial radiance is stronger and more effective when applied in a near field distance (0-100 cm) from the photon source to a target which is advantageously achieved with devices described in this invention.
  • Far UV-C light as well as certain other antimicrobial wavelengths of visible light can be delivered into small devices and tiny spaces such as IV catheters via optical fibers, or light pipes, or light guides to advantageously disinfect percutaneous areas and indwelling medical devices such as catheters, vascular access lines, endotracheal or tracheostomy tubes, surgical drains and trocars and surrounding skin or adjacent potentially contaminated tissues or to decontaminate them after an inadvertent contaminated manipulation of such a device, safely without damaging the skin or other tissues.
  • the ability to deliver antimicrobial wavelengths in a near field location is advantageous for efficacy, as well as to limit the dose of light (power density (mW/cm2) x time x frequency of application) needed to deactivate a target pathogen and maintain disinfection at the intended target site.
  • Reducing the need for greater time or frequency of antimicrobial wavelengths is advantageous for sparing the antimicrobial impact on non-targeted human or environmental surfaces in order to preserve critically important and healthy human or environmental microbiomes.
  • Microbiomes refers to the plethora of useful bacteria, virus, and fungi or similar microbiota and their genomes that maintain health and wellness and also mediate various antibiotic resistance mechanisms.
  • nosocomial infections especially caused by pandemic respiratory pathogens such as SARS CoV 2 or COVID can significantly be relieved with effective control of infectious respiratory aerosols using near field antimicrobial light disinfection of a face mask/face shield designed to deactivate such pathogens on or in a mask or face shield as well as on a patients own skin additionally such safe antimicrobial wavelengths such as far UV-C (200-230 nm) are effective for simultaneous disinfection of frequently contaminated animate and inanimate fomite surfaces in the healthcare setting using near field application (within 100 cm, preferentially within 10 cm, and more preferentially ⁇ 1 cm) in an ambulatory setting, simultaneously deactivating both animate and inanimate sources of contamination while surfaces are being touched or used, to deactivate pathogens before they cause infection.
  • near field application within
  • urinary, spinal, or peritoneal catheters or tubes indwelling vascular access lines such as intravenous or arterial lines, dialysis catheters (vascular or peritoneal), endotracheal or tracheostomy or chest tubes, feeding tubes, trocars and surgical drains into body cavities or subcutaneous spaces each of which represent access points for pathogens to enter a patient’s body or have been placed in a potentially already contaminated cavity and where pathogen entry or multiplication of nonresident organisms can create infection.
  • Reducing nosocomial infections with applicant’s invention can substantially reduce patient’s morbidity and mortality while saving billions of dollars in health care costs to hospitals and healthcare systems.
  • ascending infection into the urinary bladder from the outer wall of the urinary catheter as it enters the urethra reportedly is the number one source for nosocomial urinary tract infection.
  • the percutaneous skin entrance where a catheter traverses the skin and enters a blood vessel for vascular access lines is a location where natural microbial inhabitants or pathogenic contaminants can migrate along the exposed wall of the vascular catheter into the body which can result in serious systemic infection. Similar pathogen migration also can occur along exposed surfaces of a spinal or epidural catheter, or surgical drain entering or exiting the body especially those drains with a man-made entry point (percutaneous) that are draining a potentially contaminated space (ex. surgery drain post ruptured appendix).
  • Efforts to render such percutaneous or indwelling medical devices microbially resistant have involved various dressings and protective antimicrobial coverings such as silver tipped catheters to protect from contamination during catheter placement, which has reduced but not eliminated infection.
  • Antibiotics cannot sterilize an infected drain since it has no blood supply to deliver the medication.
  • Use of antimicrobial light to disinfect such devices while they are in use provides a novel method of reducing the risk of nosocomial infections, but requires judicious stewardship of both human and environmental microbiomes, recalling that the latter refers to the combination of useful bacteria, virus and fungi collectively called microbiota, and their genomic contributions that mediate immunity, as well as antibiotic resistance where a well balanced microbiota is important for general health and wellness.
  • US Patent 10,245,424 discloses providing broadband UV sterilization of a fluid as it flows through a catheter or catheter connector.
  • a light reflector is disposed between the outer wall and inner wall of the connector body to reflect UV light into the interior of the connecting body, and no attempt is made to disinfect the external surface of a catheter or adjacent skin or tissues which is the primary route of pathogen access. That is not unexpected, since employing broadband UVC light (100-280 nm) as disclosed in the ’424 Patent could only be used on inanimate, unexposed surfaces to avoid exposing the patient or any healthcare worker to the toxicities of broad band UVC irradiance on eyes, skin or any adjacent tissue as this would result in potential damage to a patient or healthcare provider.
  • safe antimicrobial wavelengths such as far UV-C wavelengths (200-230 nm) or safe visible antimicrobial light wavelengths are used to simultaneously disinfect indwelling medical devices such as catheters, vascular access lines, surgical drains, endotracheal or tracheostomy tubes, chest tubes, dialysis access catheters, feeding tubes and trocars while simultaneously disinfecting the patient’s adjacent skin and tissues which can act as contamination or infection sources, or alternatively to disinfect such devices from inadvertent healthcare worker contamination during manipulation to curtail nosocomial infection.
  • indwelling medical devices such as catheters, vascular access lines, surgical drains, endotracheal or tracheostomy tubes, chest tubes, dialysis access catheters, feeding tubes and trocars while simultaneously disinfecting the patient’s adjacent skin and tissues which can act as contamination or infection sources, or alternatively to disinfect such devices from inadvertent healthcare worker contamination during manipulation to curtail nosocomial infection.
  • Optical fibers, light guides and light pipes employ a property known as total internal reflection (TIR) to efficiently transmit light from a photon source to a target site with minimal loss of radiance.
  • TIR total internal reflection
  • the core of the cable which may be made up of multiple fibers or liquid constantly bouncing photons from the cladding (i.e., the mirror lined walls of the cable), by a principle called total internal reflection, and primarily exits the fiber optic cable or light guide only at the end of the cable.
  • planned leakage of light can occur along the length of the cable or fiber in a fashion known as diffusion.
  • Tn accordance with one embodiment of this disclosure we provide percutaneous and indwelling medical devices such as urinary catheters, vascular catheters, spinal or epidural catheters or various surgical drains whether in body cavities or subcutaneous spaces, or endotracheal tubes, tracheostomy or chest tubes or trocars with longitudinal or helically shaped circumferential optical fibers or light pipes, or light guides with optical features to direct, refract, focus, select or diffuse safe antimicrobial light toward a defined target surface to deactivate target pathogens.
  • the optical fibers, light pipes or light guides in turn are attached to a light source of safe antimicrobial light such as far UV-C light, or a safe antimicrobial visible light source.
  • the percutaneous or indwelling medical device itself can also function as an optical fiber, i.e., as a light pipe or light guide.
  • the light source may be either stationary such as a wall mounted unit in an ICU or hospital room or ambulance, or configured to be a mobile photon source attachable to a percutaneous or indwelling medical device to disinfect both internal and external surfaces of the indwelling medical devices as well as to deliver disinfecting irradiance to adjacent areas of the skin or tissues of the patient, and in particular at the catheter entry interface into the patient but also into tissues adjacent to the area for the full length of the device.
  • the safe antimicrobial light can be continuous, intermittent, pulsed, automated, or manually activated to optimize deactivation of pathogens, while minimizing the dose of light to non-targeted skin or tissues, thereby minimizing irradiance of ambient environmental non target surfaces or health care workers in order to minimize the impact of such wavelengths on a patient’s or health care workers individual or environmental microbiomes.
  • the indwelling medical device comprises a urinary catheter formed of Teflon® coated latex, or silicon or hydrogel coated latex, or PVC (polyvinyl chloride) wrapped with, embedded with or co molded with optical fibers, or light pipes or light guides to transmit safe antimicrobial wavelengths in a near field location to both external and internal walls of the catheter for specific targets or intervals.
  • a urinary catheter formed of Teflon® coated latex, or silicon or hydrogel coated latex, or PVC (polyvinyl chloride) wrapped with, embedded with or co molded with optical fibers, or light pipes or light guides to transmit safe antimicrobial wavelengths in a near field location to both external and internal walls of the catheter for specific targets or intervals.
  • the indwelling medical device comprises a vascular access catheter such as central or peripheral IV catheter, a PICC line, a dialysis access line, an arterial line, or a non-vascular access catheter such as Tenckoff peritoneal dialysis catheter or a spinal or epidural anesthesia catheter.
  • a vascular access catheter such as central or peripheral IV catheter, a PICC line, a dialysis access line, an arterial line, or a non-vascular access catheter such as Tenckoff peritoneal dialysis catheter or a spinal or epidural anesthesia catheter.
  • the medical device in these examples contains a linearly or helically disposed optical fiber, light pipe or light guide configured to carry safe antimicrobial wavelengths to disinfect the skin/tissue-medical device interface and optionally may be used to disinfect a portion or the entire length of a device as well as adjacent tissues when desired.
  • the optical fiber cable, light pipe, or light guide may be configured to release antimicrobial wavelengths at intervals for specific targets, in near field locations, at specified intervals to minimize dosing requirements to achieve and maintain disinfection at the skin catheter interface or other target areas both animate and inanimate along the medical device while limiting antimicrobial irradiance to non-targeted animate or inanimate surfaces, thus protecting the natural microbiome.
  • the indwelling medical device itself can also function as a light guide or light pipe with similar features.
  • the indwelling medical device comprises a surgical drain such as a Jackson Pratt drain, a Hemovac drain or a negative pressure dressing or any other type of surgical drain, which is provided with a linear or circumferential helically configured optical fiber, light pipes or light guides to deliver antimicrobial wavelengths to disinfect the drain, on both interior and exterior surfaces thereof where the drain enters the patient’s body and optionally along the entirety of or at intervals along the length of the drain, in particular targeting the tubing/skin interface where pathogens might migrate into the body to create infection — thereby eliminating the risk of ascending infection, but also allowing antimicrobial treatment of tissues adjacent to the drainage device when needed.
  • a surgical drain such as a Jackson Pratt drain, a Hemovac drain or a negative pressure dressing or any other type of surgical drain, which is provided with a linear or circumferential helically configured optical fiber, light pipes or light guides to deliver antimicrobial wavelengths to disinfect the drain, on both interior and exterior surfaces thereof where the drain enters the patient’
  • optical fibers, light pipes or light guides are configured to carry and deliver antimicrobial wavelengths which are safe for skin, tissue or ocular exposure, from a photon source to identified targets such as the tubing/skin interface and adjacent skin areas as well as along the length of the device inside the body.
  • the indwelling medical device itself can also function as a light guide or light pipe.
  • the percutaneous or indwelling medical device comprises an endotracheal or tracheostomy tube embedded with optical fibers, lightpipes or light guides, either linearly configured or helically configured to radiate the circumference of such tubes both internally and externally with safe wavelengths of light to deactivate pathogens and prevent the transmission of pathogens along the length of such devices or at various intervals to targeted locations on the surfaces of such endotracheal tubes and surrounding skin or oral or nasal interface surfaces of the patient.
  • the indwelling medical device itself can also function as a light guide or light pipe.
  • the central wavelength photon source such as a far UV-C excimer lamp, works in similar fashion to an electrical harness, wherein the central photon source of antimicrobial wavelengths serves as a manifold to connect to a plurality or network of multiple optical connectors which then connect to a plurality or network of optical fibers, light pipes or light guide such fibers, pipes or guides acting as conduits for distribution of disinfecting wavelengths in a near field location for efficient and targeted disinfection of various tubes, catheters, or drains for a single patient ensuring each potential source of nosocomial infection is routinely and actively disinfected while in use.
  • the central photon source of antimicrobial wavelengths serves as a manifold to connect to a plurality or network of multiple optical connectors which then connect to a plurality or network of optical fibers, light pipes or light guide such fibers, pipes or guides acting as conduits for distribution of disinfecting wavelengths in a near field location for efficient and targeted disinfection of various tubes, catheters, or drains for a single patient ensuring
  • the light source may be an excimer lamp, or an LED source of safe antimicrobial wavelengths such as far UV-C wavelengths (200-230 nm), that is stationary within a hospital room, or mobile and configured for use in an ambulatory capacity as in an ambulance, or on a patient who is mobile.
  • safe antimicrobial wavelengths such as far UV-C wavelengths (200-230 nm)
  • percutaneous or indwelling medical devices such as catheters, drainage tubes, endotracheal or tracheostomy tubes and those similarly functioning apparatus are fitted with optical fibers, light pipes, or light guides to transmit safe antimicrobial wavelengths from a light source, and deliver it in a near field location using optical filters within such optical fibers, pipes or guides features configured to focus the light on specific targets at specific dosing taking care to limit dosing to only what is necessary to achieve safe disinfection of specific pathogen targets such as a patient’s skin/tubing or skin/catheter interface as well as specific targets within the device itself in order to limit ambient or environmental antimicrobial irradiance to avoid microbial disruption of human or environmental microbiomes.
  • the indwelling medical device itself can also function as a light guide or light pipe with diffusion capabilities for specific targets.
  • indwelling medical devices such as catheters, drainage tubes, or endotracheal or tracheostomy tubes feeding tubes and the like are fitted with optical fibers, light pipes, or light guides configured to transmit safe antimicrobial wavelengths such as far UV-C or visible light to focus near field irradiance on specific pathogen targets such as skin/tubing or skin/tissuc/cathctcr interface in order to limit the time and dose to achieve disinfection as well as to focus radiance on specific decontamination targets for individual human exposure, or to limit the wavelength exposure for healthcare workers working in the vicinity of treated patients, or limit exposure of other people or environments as a means to limit microbial disruption of a patient’s or nearby individual’s human microbiome or environmental microbiomes while at the same time preventing nosocomial infections.
  • safe antimicrobial wavelengths such as far UV-C or visible light to focus near field irradiance on specific pathogen targets such as skin/tubing or skin/tissuc/cathctcr interface
  • an apparatus maintaining disinfection or sterilization of percutaneous or indwelling medical devices configured for insertion into a patient’s body comprising a tube or similarly functioning form of medical grade material having a proximal end at the percutaneous entry and a distal end within the patient’s body, wherein the drainage or delivery tube incorporates one or more fiber optic cables, optical fibers, light pipes or light guides extending from adjacent a proximal end of the tube towards a distal end of the tube configured to direct and deliver safe antimicrobial wavelengths near field ( ⁇ 10 cm and preferably ⁇ 1 cm) from source to both animate and inanimate targets, such wavelengths preferably include far UV-C (200-230 nm) to safely and efficiently disinfect the medical device and adjacent patient tissue at targeted locations while in use with a optimally efficient dosing to reduce nosocomial infections while protecting the human and environmental microbiome.
  • a tube or similarly functioning form of medical grade material having a proximal end at the percutaneous entry and a distal end within the patient’s body
  • the optical fibers, light pipe or light guide may be configured with optical features selected from variable cladding and reflective materials to mediate refraction, filters or micro prisms to mediate direction, or spiral or various shaped grooves lasered into the fibers to create diffusion, buffering modalities include fiber delay lines, each added onto, or manufactured as part of the optical fibers, light tubes or light guides which are then molded onto or into such devices to refract, diffuse, reflect, focus or direct antimicrobial light on either or both external and internal surfaces of a device or along its length as well as into adjacent targeted patient tissues to aid in preventing or reducing pathogen burden in the case of an already contaminated device.
  • the optical features may be configured to directionally reverse antimicrobial light direction inside an optical fiber, light tube, or light guide such that light within an IV or other catheters and drains can radiate the skin puncture both from outside and inside a percutaneous wound site in order to disinfect the puncture site and prevent ascending infection further along the device.
  • the optical fiber, light pipe or light guide may be configured to confine, direct, diffuse, reflect, refract, or diffusely emit or focus antimicrobial wavelengths of light at selected positions along its length.
  • the fiber optic cable, optical fiber, light pipe or light guide may have surface features configured with optical features that intentionally diffuse, refract, reflect, or focus antimicrobial wavelengths of light inwardly and/or outwardly and/or at a focused target backwardly from the sides or distal end of the optical fibers, light pipe or light guide to direct antimicrobial light to specific targets to reduce the risk of infection or reduce pathogen burden when contaminants are already present.
  • the apparatus may further include an antimicrobial light source safe for patient and health care worker exposure, wherein the light is far UV-C and has a wavelength of 200-230 nm, or a blue visible light source having a wavelength of 400-470 nm or any antimicrobial visible wavelengths as may be identified safe and effective for human or animal exposure and provides ongoing disinfection of the device and adjacent tissues while the device is in use.
  • an antimicrobial light source safe for patient and health care worker exposure wherein the light is far UV-C and has a wavelength of 200-230 nm, or a blue visible light source having a wavelength of 400-470 nm or any antimicrobial visible wavelengths as may be identified safe and effective for human or animal exposure and provides ongoing disinfection of the device and adjacent tissues while the device is in use.
  • the percutaneous or indwelling medical device may be selected from the group consisting of a urinary system catheters (nephrostomy, suprapubic, urethral, bladder), a vascular access line (intravenous or arterial), spinal or epidural anesthesia catheters, a peritoneal or vascular dialysis catheter an endotracheal or tracheostomy tube, chest tubes, feeding tubes, a trocar or any percutaneous surgical drains which enter any body cavity spaces, orthopedic spaces or subcutaneous spaces.
  • a urinary system catheters nephrostomy, suprapubic, urethral, bladder
  • a vascular access line intravenous or arterial
  • spinal or epidural anesthesia catheters a peritoneal or vascular dialysis catheter an endotracheal or tracheostomy tube
  • chest tubes feeding tubes
  • a trocar any percutaneous surgical drains which enter any body cavity spaces, orthopedic spaces or subcutaneous spaces.
  • the optical features may be selected from variable cladding and reflective materials to mediate refraction, filters or micro prisms to mediate direction, or spiral or various shaped grooves lasered into the fibers to create diffusion, buffering modalities include fiber delay lines, each added onto, or manufactured as part of the optical fibers, light tubes or light guides which are then molded onto or into such devices to refract, diffuse, reflect, focus or direct antimicrobial light on either or both external and internal surfaces of a device or along its length as well as into adjacent targeted patient tissues to aid in preventing or reducing pathogen burden in the case of an already contaminated device.
  • the catheter may comprise a urethral catheter, a PICC line or a vascular dialysis line.
  • the apparatus may comprise multiple fiber optic cables, optical fibers, light tubes, or light guides for delivery of antimicrobial wavelengths in a near field location (preferably ⁇ 10 cm, more preferably ⁇ 1 cm) to a specified target for optimally effective dosing allowing for shorter periods of irradiance to provide effective disinfection of target pathogens while protecting the human and environmental microbiome from dysbiosis.
  • a near field location preferably ⁇ 10 cm, more preferably ⁇ 1 cm
  • the apparatus may comprise single or multiple fiber optic cables, optical fibers, light tubes, or light guides which may be an ‘add on’ or wrap around to an existing medical device or the medical device and optical fibers, light tubes or light guides are manufactured to be co-molded or embedded into as part of the device.
  • the fiber optic cable, optical fibers, light tube or light guide may be helically wound onto the medical device or manufactured to be co molded in a helical configuration within the medical device.
  • the fiber optic cable or single or multiple optical fiber, light tube or light guide may comprise a side-emitting device or may provide openings configured for diffusion and dispersion of a particular dose of light along its length as well as its distal end.
  • the catheter tube or drain itself may further include a polarizing layer along its entirety or a part thereof, wherein the polarizing layer preferably comprises a linear, elliptical or a circular polarizing configuration.
  • the light source may include a central safe antimicrobial photon source attached to an optical harness which acts as a manifold emitting safe antimicrobial light wavelengths, preferably UVC wavelengths, (200-230 nm) configured to deliver the light via a plurality of optical connectors attached by a single connector to each of one or more fiber optic cables, optical fibers, light tubes or light guides attached to or within percutaneous or indwelling medical devices to simultaneously or consecutively provide antimicrobial disinfecting wavelengths for multiple different percutaneous or indwelling medical devices used in care of a patient such as urinary catheters, spinal or epidural catheters, various types of vascular access catheters, dialysis vascular or peritoneal access catheters, surgical drains into body cavity spaces, orthopedic spaces or joints or subcutaneous spaces, trocars, endotracheal or tracheostomy tubes, chest tubes, intracranial pressure monitors, each device having been manufactured or co molded or attached with one or more fiber optic cables, optical fibers, light tubes or light guides to connect to the
  • the apparatus may include an optical fiber, light tube or light guide emanating from the photon source where the source is fitted with an optical twist connector which then connects to a length of fiber optic cable or optical fibers from 1-5 m in length that offers a plurality of connectors at its distal end to connect to other individual optical fiber connectors that then deliver antimicrobial wavelengths to different devices again using a twist connector from the source to an extension fiber optic cable, optical fiber, light tube or light guide which then attaches via a connector such as a twist or other types of optical connectors to the optical fiber, light tube or light guide which is embedded in or attached to the various percutaneous or indwelling catheters, drains, endotracheal or other tubes, or trocar assembly, so that two connections and connectors are required to deliver the desired wavelengths at a specified dose to the medical devices — the harness extension being a re-useable connector.
  • each device would require its own 1-5 m fiber optic, light tube or light guide extension to connect to the central photon
  • the central antimicrobial light source may be configured for an automatic, or manual or electronic or mechanical controller, or is programmable for continuous, intermittent, or pulsed or for variable intensity dosing in a near field location to specific targets to achieve optimal antimicrobial efficacy with a lowest targeted dose of effective irradiance in order to minimize the impact on human and environmental microbiomes.
  • the light source may include a linear or circular light polarizer to achieve optimal desired wavelengths and control the flow of light.
  • an indwelling or percutaneous medical device configured for insertion into a patient’s body, comprising a tube or similarly functioning configuration for fluid delivery, physiologic monitoring, or physiologic drainage is formed of medical grade material having a proximal end and a distal end, wherein an internal surface of the tube is covered at least in part with a light reflecting material, whereupon the device is configured to carry both a fluid and antimicrobial light delivery source such as optical fiber, light pipe or light guide along its length, or at least in part.
  • a fluid and antimicrobial light delivery source such as optical fiber, light pipe or light guide along its length, or at least in part.
  • the light reflective material may be at least partially reflective to far UV- C light having a wavelength of 200-230 nm, or blue light having a wavelength of 400-470 nm.
  • the tube or device may act an optical fiber, light tube or light guide to include optical features selected from variable cladding and reflective materials to mediate refraction, filters or micro prisms to mediate direction, or spiral or various shaped grooves lasered into the fibers to create diffusion, buffering modalities include fiber delay lines, each added onto, or manufactured as part of the optical fibers, light tubes or light guides which are then molded onto or into such devices to refract, diffuse, reflect, focus or direct antimicrobial light on either or both external and internal surfaces of a device or along its length as well as into adjacent targeted patient tissues to aid in preventing or reducing pathogen burden in the case of an already contaminated device on its outer and or inner surface.
  • optical features selected from variable cladding and reflective materials to mediate refraction, filters or micro prisms to mediate direction, or spiral or various shaped grooves lasered into the fibers to create diffusion, buffering modalities include fiber delay lines, each added onto, or manufactured as part of the optical fibers, light tubes or
  • the medical device may be selected from the group consisting of various percutaneous urinary drainage, spinal or epidural monitoring or delivery catheters, an indwelling vascular access or monitoring line, an endotracheal, tracheostomy, chest tube, feeding tubes a trocar and any surgical drain that enters a body cavity or space, orthopedic spaces, or subcutaneous spaces.
  • the device may further comprise a central disinfecting light source configured to generate safe antimicrobial light which acts as a manifold to deliver antimicrobial wavelengths near field to such devices as well as to adjacent animate and inanimate targets using optical fibers, light pipes or light guides to prevent nosocomial infections or reduce contaminant burdens in various physiologic spaces.
  • a central disinfecting light source configured to generate safe antimicrobial light which acts as a manifold to deliver antimicrobial wavelengths near field to such devices as well as to adjacent animate and inanimate targets using optical fibers, light pipes or light guides to prevent nosocomial infections or reduce contaminant burdens in various physiologic spaces.
  • the light source may be configured to generate antimicrobial far UV-C light having a wavelength of 200-230 nm, or blue light having a wavelength of 400-470 nm.
  • Fig. 1 schematically illustrates an IV catheter and tuhing embedded with optical fibers configured for delivering antimicrobial light in accordance with a first embodiment of the disclosure
  • Fig. 2 schematically shows the catheter of Fig. 1 affixed to the skin of a patient
  • Fig. 2 A is a side view of the catheter of Fig. 1;
  • Fig. 3 schematically illustrates a drain with embedded optical fibers transmitting far UV-C light (200-230 nm) or any visible antimicrobial wavelengths in accordance with another embodiment of the present disclosure
  • Fig. 4 schematically illustrates a urinary catheter having optical fibers or light guides configured to emit antimicrobial wavelengths in accordance with the present disclosure
  • Fig. 5 schematically illustrates a urethral catheter of Fig. 4, in a bladder
  • Figs. 6-8A illustrate various arrangements of tubular medical devices carrying optical fibers, light pipes, or light guides for distribution of safe antimicrobial wavelengths in accordance with present disclosure.
  • fiber optic cable or cables As used herein the terms “fiber optic cable or cables”, “light pipe”, “light guide”, and “optical fibers” are used interchangeably.
  • indwelling medical device is intended to include any type of medical device with hollow or tubular characteristics configured for insertion into the body, including but not limited to catheters, drains, endotracheal or tracheostomy tubes, vascular access devices and trocars.
  • catheters are manufactured for various applications such as cardiovascular, urological, gastrointestinal, neurologic, and ophthalmic procedures.
  • Catheters can comprise thin hollow tubes typically configured for insertion into a body cavity, orifice, duct or vessel, skin, or adipose tissue.
  • Catheters are designed to be left inside the body either temporarily, or permanently and functionally may allow for drainage, administration of fluids or gases, access by surgical instruments, or to provide a wide variety of medical tasks depending on the type of catheter or tube. Special types of catheters, sometimes called “probes”, may be used in preclinical or clinical sampling of fluids or tissues.
  • Fig. 1 illustrates a catheter 10 typically used for intravenous therapy, e.g., for administration of fluids or medications and nutrients directly into a patient’s vein.
  • Catheter 10 includes an elongated hollow tube 12 formed of a medical grade flexible polymeric material.
  • Catheter 10 includes a housing 16 configured to hold a needle 18 at its distal end.
  • a coaxial fiber optic cable 20 is provided running the length of tube 12 from the proximal to distal end of the catheter.
  • Fiber optic cable 20 may comprise a light guide or light pipe inside clear tubing that radiates the light filtered to emit filtered UVC light (200-230nm), or other antimicrobial light back onto tubing or onto skin or surrounding tissue catheter interface, which limits ambient radiance to limit effect on microbiome.
  • a fiber optic connector 22 is affixed to one end of the fiber optic cable 20 at the proximal end 14 and configured to be attached to a safe antimicrobial light source 24.
  • Light source 24 may comprise a far UV-C (200-230 nm) light source, or a visible antimicrobial light source that is safe for human skin and tissue exposure such as blue light of 400-470 nm wavelength.
  • a concave lens 26 is provided at the distal end of fiber optic cable 20 and configured to direct wavelength irradiation onto needle 18 and also to diffuse light in a targeted fashion out of housing 16.
  • Housing 16 is made of a clear polymeric material such as polycarbonate with integrated lens which produces a light source coaxial with needle and high intensity illumination at puncture site and omnidirectional diffuse emission out of entire housing in all directions, and is transmissive to wavelengths in at least the 200-230 nm (far UV-C) and/or the 400-470 nm wavelengths.
  • the optical fibers, light pipes, or light guides direct light waves back into the catheter tubing and skin/catheter interface as indicated by arrows 28.
  • Fiber optical cable 20 may also be designed to leak, diffuse, or emit light wavelengths along selected and targeted locations as will be described below. Controller 29 controls the light source emission on intervals and/or varies intensity over time.
  • Figs. 2 and 2A illustrate the catheter of Fig. 1 with the needle 18 inserted into the skin 30 and a cone of UVC light illuminates the needle and IV entry into the skin/vein of a patient.
  • the fiber optic cable 20 shown in Fig. 1 is configured to emit antimicrobial wavelengths back onto the catheter tubing and the skin catheter interface, but due to its internal reflective coating avoids radiating the ambient environment to protect the microbiome.
  • the needle housing 16 shown in Fig.
  • the needle housing 16 also functions as an antimicrobial wavelengths light pipe and carries light from the fiber optic cable 20 through housing and coaxially omnidirectionally diffusing along the needle 18 (shown in Fig. 2) into the patient tissue in targeted directions, using filters and openings.
  • the light source 24 may comprise a light source of safe antimicrobial light, more particularly, a far UV-C light source (200-230 nm), or visible antimicrobial blue light source (400-470 nm), such as an excimer light or LED light.
  • a far UV-C light source 200-230 nm
  • visible antimicrobial blue light source 400-470 nm
  • Green light primarily exhibits antimicrobial activity by directly damaging the genetic material of a pathogen but is considered safe for skin and tissue exposure as well as ocular exposure because it is not absorbed by these structures.
  • Blue light primarily exhibits antimicrobial activity through activation of androgenous photo synthesizers, which leads to formation of reactive oxygen species that attack components of bacterial cells. Blue light is considered innocuous to the skin, but potentially may inflict photo damage to the eyes.
  • the light source is a blue light source
  • measures should be taken to prevent the light from shining outwardly or from ocular exposure, i.e.. away from the skin of the patient. This can be accomplished by exterior shielding of the proximal end of the catheter, i.e., so that antimicrobial light may radiate surfaces internal to the patient but is prevented from shining outwardly from the skin of the patient.
  • Fig. 3 illustrates a surgical drain configured with an optical fiber system for delivering antimicrobial light in accordance with the present disclosure.
  • Drain 50 comprises an elongated hollow tube 52 formed of a medical grade flexible polymeric material. Drain 50 includes a connector 54 at its proximal end.
  • An optical fiber 56 is provided within tube 52 running the length of tube 52.
  • Optical fiber 56 is connected at its proximal end 58 to an antimicrobial light source 60.
  • antimicrobial light source 60 may comprise a far UV-C wavelength (200-230 nm) source or a visible antimicrobial light source such as a blue light source.
  • optical fiber 56 internal coating should be continuous at visibly exposed surfaces to minimize blue light from escaping along its length of the cable up to the point where the drain is introduced into the patient tissue/skin 62.
  • Fig. 4 illustrates a urethral catheter 70 in accordance with the present disclosure.
  • Urethral catheter 70 comprises an elongate optically clear flexible tube 72 formed of a medical grade material having a balloon 74 adjacent its distal end 76.
  • a connector 78 at the proximal end of catheter 70 includes a luer fitting 80 and an optical fiber connector 82 which in turn is connected to a remote antimicrobial light source 84 which travels down the catheter circumferentially and leaves fiber at specified locations at the entrance to urethra, and emits far UVC (200-230 nm), or other antimicrobial light reflects back on itself to catheter, or focused on surrounding tissue that touches the catheter, such as a urethral opening.
  • far UVC 200-230 nm
  • a flexible side-emitting optical fiber 86 is provided inside or embedded into tube 72 running from optical fiber connector 82 to balloon 74.
  • antimicrobial light source 84 may comprise a far UV-C light source, or a blue light source or any visible safe and effective antimicrobial wavelength source. If the light source comprises a blue light source, optical fiber 86 internal coating should be continuous along its length designed to be outside the body to minimize blue light from escaping up to the point where the catheter is introduced into the urethra. In use, antimicrobial light travels down catheter circumferentially and may leave optical fiber at specific locations 88, and at the entrance to the urethra 90.
  • a cannula 100 may be coated on its inside walls 102 with reflective material so that the catheter itself also function as an optical fiber, light pipe or light guide when connected to a far UV-C light source or other antimicrobial light source (not shown) to radiate safe antimicrobial light in accordance with the present disclosure.
  • a catheter tube 120 may be provided with multiple co-molded optical fibers and serves as an optical guide, light pipes or light guides 122, 124, 126.
  • the optical fiber 130 may comprise a spiral shape running the length of a hollow medical device such as a catheter or a trocar 132.
  • a hollow medical device such as a catheter 150 is provided with a light reflective coating 152 on its inner wall so as to also function as an optical fiber, and has a plurality of optical features such as facets 154 formed, e.g., by molding or machining on its outer wall 156 whereby to permit light rays 158 to reflect, refract, diffuse or focus light off the walls of the facets 154, and reflect light back out as light rays 160.
  • Catheter 150 may also be provided with a light blocking coating such as a polarizing layer 162 along selected portions of its length to prevent light emission for microbiome protection and/or ocular protection in the case of a blue light source.
  • Polarizing layers 162 may be chemical or plated and comprise a linear or circular polarization function that blocks most of the light emission into the room but allows the light to shine on the patient’s skin.
  • the proximal end of the optical fiber may be coterminous with the proximal end of the catheter and permanently fixed to the proximal end of the catheter, for direct connection to a light source on the wall or on the patient’s bed or for an ambulatory light source if the patient is ambulatory. Still other changes are possible.

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Abstract

Les longueurs d'onde UV-C lointaines constituent des désinfectants antimicrobiens sûrs et efficaces sans toxicités génotoxiques ou oculaires associées à une désinfection par UV-C à large bande. Les longueurs d'onde antimicrobiennes doivent être appliquées judicieusement pour éviter une dysbiose des microbiomes humains et environnementaux. Est divulguée l'application d'UV-C lointain ou d'autres longueurs d'onde antimicrobiennes sûres par l'intermédiaire d'une administration par fibres optiques pour désinfecter des dispositifs médicaux percutanés ou à demeure tels que divers cathéters de qualité médicale (urinaire, IV), des tubes ou des drains qui constituent une source primaire d'infection nosocomiale. Une source de photons centrale est configurée pour délivrer des longueurs d'onde antimicrobiennes désinfectantes dans une ou plusieurs fibres optiques, un ou plusieurs tubes de lumière ou guides de lumière intégrés ou moulés dans de tels dispositifs pour distribuer des longueurs d'onde désinfectantes en champ proche sur des cibles animées et inanimées spécifiques pour une efficacité optimale avec un dosage rayonnant limité réduisant au minimum l'exposition antimicrobienne de surfaces non ciblées afin de réduire ou d'éliminer des pathogènes infectieux, de réduire une infection nosocomiale tout en réduisant au minimum l'impact sur les microbiomes humains et environnementaux.
PCT/US2024/038884 2023-07-20 2024-07-19 Désinfection par longueur d'onde antimicrobienne sûre en champ proche par l'intermédiaire de fibres optiques, de guides de lumière ou de tubes de lumière pour la désinfection ambulatoire percutanée ou à demeure de cathéters, de lignes d'accès vasculaire, de drains, de tubes endo-trachéaux et de dispositifs médicaux similaires Pending WO2025019833A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18/224,511 US20240016246A1 (en) 2020-03-25 2023-07-20 Near field safe antimicrobial wavelength disinfection via optical fibers, light guides, or light pipes for percutaneous or indwelling ambulatory disinfection of catheters, vascular access lines, drains, endo-tracheal tubes and similar medical devices
US18/224,511 2023-07-20

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WO2025019833A1 true WO2025019833A1 (fr) 2025-01-23

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120321509A1 (en) * 2010-03-03 2012-12-20 U-VIVO ApS Assembly and method for disinfecting lumens of devices
US20170119915A1 (en) * 2013-10-29 2017-05-04 Ultraviolet Interventions, Inc. Systems and methods for sterilization using uv light
US20200360548A1 (en) * 2018-01-16 2020-11-19 Corning Incorporated Illumination of light diffusing optical fibers, illumination of blue-violet light delivery systems, blue-violet light delivery systems, and methods for blue-violet light induced disinfection
US20220184370A1 (en) * 2017-06-21 2022-06-16 Uv Light Care, Inc. System and method for sterilization using ultraviolet radiation
WO2022246075A1 (fr) * 2021-05-19 2022-11-24 University Of Georgia Research Foundation, Inc. Insert de désinfection à libération d'oxyde nitrique
WO2022248691A1 (fr) * 2021-05-28 2022-12-01 Aseptuva Gmbh Système de désinfection de tissu cutané autour de cathéters

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120321509A1 (en) * 2010-03-03 2012-12-20 U-VIVO ApS Assembly and method for disinfecting lumens of devices
US20170119915A1 (en) * 2013-10-29 2017-05-04 Ultraviolet Interventions, Inc. Systems and methods for sterilization using uv light
US20220184370A1 (en) * 2017-06-21 2022-06-16 Uv Light Care, Inc. System and method for sterilization using ultraviolet radiation
US20200360548A1 (en) * 2018-01-16 2020-11-19 Corning Incorporated Illumination of light diffusing optical fibers, illumination of blue-violet light delivery systems, blue-violet light delivery systems, and methods for blue-violet light induced disinfection
WO2022246075A1 (fr) * 2021-05-19 2022-11-24 University Of Georgia Research Foundation, Inc. Insert de désinfection à libération d'oxyde nitrique
WO2022248691A1 (fr) * 2021-05-28 2022-12-01 Aseptuva Gmbh Système de désinfection de tissu cutané autour de cathéters

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