[go: up one dir, main page]

WO2025198940A1 - Systèmes à ultrasons et procédés de désinfection et d'imagerie simultanées - Google Patents

Systèmes à ultrasons et procédés de désinfection et d'imagerie simultanées

Info

Publication number
WO2025198940A1
WO2025198940A1 PCT/US2025/019838 US2025019838W WO2025198940A1 WO 2025198940 A1 WO2025198940 A1 WO 2025198940A1 US 2025019838 W US2025019838 W US 2025019838W WO 2025198940 A1 WO2025198940 A1 WO 2025198940A1
Authority
WO
WIPO (PCT)
Prior art keywords
ultrasound
light
antimicrobial
skin
probe
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/019838
Other languages
English (en)
Inventor
Shayne Messerly
James L. Freasier
Christopher QUACH
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bard Access Systems Inc
Original Assignee
Bard Access Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bard Access Systems Inc filed Critical Bard Access Systems Inc
Publication of WO2025198940A1 publication Critical patent/WO2025198940A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4422—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to hygiene or sterilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • 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
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances

Definitions

  • Infection control is an integral part of the safe and effective use of ultrasound in medicine.” (American Institute of Ultrasound in Medicine. Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Probes Between Patients, Safe Handling, and Use of Ultrasound Coupling Gel, 2018.) Such infection control is particularly important when ultrasound transducers are used on non-intact skin or during percutaneous procedures including vascular access, thoracentesis, paracentesis, arthrocentesis, pericardiocentesis, lumbar puncture, regional anesthesia, or other such procedures.
  • ultrasound systems including a stimuloresponsive antimicrobial ultrasound gel that addresses the foregoing.
  • the ultrasound system includes, in some embodiments, a console, an ultrasound probe operably connected to the console, and a stimuloresponsive antimicrobial ultrasound gel.
  • the console includes electronic circuitry having memory and one or more processors.
  • the memory includes executable instructions configured to cause the console to instantiate one or more processes for the disinfecting and the ultrasound imaging.
  • the ultrasound probe includes an ultrasound sensor array disposed in a probe head of the ultrasound probe. The ultrasound sensor array is configured to emit ultrasound signals into the patient and receive echoed ultrasound signals from the patient when sliding the probe head over the patient’s skin.
  • the stimuloresponsive antimicrobial ultrasound gel includes one or more stimulosensitizers configured to produce reactive oxygen species that disinfect the patient’s skin when the stimuloresponsive antimicrobial ultrasound gel is stimulated by one or more stimuli emitted by the ultrasound probe.
  • the stimuloresponsive antimicrobial ultrasound gel is a sonoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more sonosensitizers configured to produce the reactive oxygen species that disinfect the patient’s skin when the sonoresponsive antimicrobial ultrasound gel is insonifed by the ultrasound sensor array while sliding the probe head over the patient’s skin.
  • the one-or-more sonosensitizers are selected from chlorin e6, optionally, conjugated to polyvinyl pyrrolidone; sonoflora 1; and sonnelux-1.
  • the ultrasound probe further includes one or more light emitters disposed in the probe head or a probe body of the ultrasound probe configured to emit light toward the patient’s skin.
  • the stimuloresponsive antimicrobial ultrasound gel is a photoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more photosensitizers configured to produce the reactive oxygen species that disinfect the patient’s skin when the photoresponsive antimicrobial ultrasound gel is irradiated by the one- or-more light emitters while sliding the probe head over the patient’s skin.
  • the one-or-more photosensitizers are selected from organic photosensitizers and organometallic photosensitizers.
  • the light emitted by the one-or-more light emitters is selected from broad spectrum ultraviolet (“UV”)-visible light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, cyan light, green light, yellow light, orange light, red light, near infrared (“NIR”) light, infrared (“IR” light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof.
  • UV broad spectrum ultraviolet
  • UVA light UVA light
  • UVB light UVC light
  • broad spectrum visible light violet light
  • blue light blue light
  • cyan light green light
  • yellow light yellow light
  • orange light red light
  • NIR near infrared
  • IR infrared
  • the one-or-more light emitters are disposed in the probe head.
  • a plurality of light emitters are disposed about a perimeter of the probe head.
  • the plurality of light emitters are disposed about the perimeter of the probe head proximal of the ultrasound sensor array. [0013] In some embodiments, the plurality of light emitters are disposed about the perimeter of the probe head substantially in plane with the ultrasound sensor array but outboard of the ultrasound sensor array.
  • the one-or-more light emitters are disposed in a face of the probe body.
  • the one-or-more light emitters are one or more light sources selected from light-emitting diodes (“LEDs”), superluminescentLEDs (“SLEDs”), and laser diodes.
  • LEDs light-emitting diodes
  • SLEDs superluminescentLEDs
  • laser diodes laser diodes
  • the one-or-more light emitters are one or more optical- fiber termini corresponding to one or more optical fibers operably connected to one or more light sources selected from LEDs, SLEDs, laser diodes, and light bulbs.
  • the ultrasound system further includes a display integrated into the console or a monitor operably connected to the console.
  • the one-or-more processes instantiated by the console are further for sending display signals to the display for displaying selectable options in a graphical user interface (“GUI”) for disinfecting the patient’s skin.
  • GUI graphical user interface
  • the selectable options correspond to at least different types of photoresponsive antimicrobial ultrasound gels for corresponding disinfection profiles.
  • the stimuloresponsive antimicrobial ultrasound gel includes one or more stimulosensitizers disposed in water, glycerin, propylene glycol, or some combination thereof.
  • the one-or-more stimulosensitizers are configured to produce reactive oxygen species that disinfect the patient’s skin when the stimuloresponsive antimicrobial ultrasound gel is stimulated by one or more stimuli emitted by an ultrasound probe.
  • the stimuloresponsive antimicrobial ultrasound gel is a sonoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more sonosensitizers configured to produce the reactive oxygen species that disinfect the patient’s skin when the sonoresponsive antimicrobial ultrasound gel is insonifed by an ultrasound sensor array of the ultrasound probe while sliding a probe head of the ultrasound probe over the patient’s skin.
  • the one-or-more sonosensitizers are selected from chlorin e6, optionally, conjugated to polyvinyl pyrrolidone; sonoflora 1; and sonnelux-1.
  • the stimuloresponsive antimicrobial ultrasound gel is a photoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more photosensitizers configured to produce the reactive oxygen species that disinfect the patient’s skin when the photoresponsive antimicrobial ultrasound gel is irradiated by one or more light emitters of the ultrasound probe while sliding a probe head of the ultrasound probe over the patient’s skin.
  • the one-or-more photosensitizers are selected from organic photosensitizers and organometallic photosensitizers.
  • the one-or-more photosensitizers are configured to produce one or more reactive oxygen species when the photoresponsive antimicrobial ultrasound gel is irradiated by the light emitted by the one-or-more light emitters.
  • the light is selected from broad spectrum ultraviolet UV- visible light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, cyan light, green light, yellow light, orange light, red light, NIR light, IR light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof.
  • a method of simultaneously disinfecting a patient’s skin while ultrasound imaging thereunder includes, in some embodiments, enabling electronic circuitry including memory and one or more processors in a console of an ultrasound system to instantiate one or more processes from instructions stored in the memory for the disinfecting and the ultrasound imaging; applying a stimuloresponsive antimicrobial ultrasound gel to the patient’s skin; and sliding a probe head of an ultrasound probe operably connected to the console over the patient’s skin. Sliding the probe head of the ultrasound probe over the patient’s skin emits ultrasound signals into the patient with an ultrasound sensor array disposed in the probe head of the ultrasound probe and receives echoed ultrasound signals from the patient by the ultrasound sensor array for the ultrasound imaging.
  • the stimuloresponsive antimicrobial ultrasound gel includes one or more stimulosensitizers that produce reactive oxygen species when stimulated for the disinfecting of the patient’s skin.
  • the stimuloresponsive antimicrobial ultrasound gel is a sonoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more sonosensitizers configured to produce the reactive oxygen species for disinfecting the patient’s skin when the sonoresponsive antimicrobial ultrasound gel is insonifed by the ultrasound sensor array while sliding the probe head over the patient’s skin.
  • the one-or-more sonosensitizers are selected from chlorin e6, optionally, conjugated to polyvinyl pyrrolidone; sonoflora 1; and sonnelux-1.
  • the ultrasound probe includes one or more light emitters disposed in the probe head or a probe body of the ultrasound probe configured to emit light toward the patient’s skin.
  • the stimuloresponsive antimicrobial ultrasound gel is a photoresponsive antimicrobial ultrasound gel.
  • the one-or-more stimulosensitizers are one or more photosensitizers configured to produce the reactive oxygen species for disinfecting the patient’s skin when the photoresponsive antimicrobial ultrasound gel is irradiated by the one- or-more light emitters while sliding the probe head over the patient’s skin.
  • the one-or-more photosensitizers are selected from organic photosensitizers and organometallic photosensitizers.
  • the light emitted by the one-or-more light emitters is selected from broad spectrum UV-visible light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, cyan light, green light, yellow light, orange light, red light, NIR light, IR light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof.
  • the one-or-more light emitters are disposed about a perimeter of the probe head.
  • the one-or-more light emitters are disposed in a face of the probe body.
  • the one-or-more light emitters are one or more light sources selected from LEDs, SLEDs, and laser diodes.
  • the one-or-more light emitters are one or more optical-fiber termini corresponding to one or more optical fibers operably connected to the foregoing one-or-more light sources.
  • the method further includes selecting an option for disinfecting the patient’s skin from selectable options displayed in a GUI on a display integrated into the console or a monitor operably connected to the console.
  • the selectable options correspond to at least different types of photoresponsive antimicrobial ultrasound gels for corresponding disinfection profiles.
  • FIG. 1 illustrates an ultrasound system in accordance with some embodiments.
  • FIG. 2 illustrates an ultrasound probe of the ultrasound system having a light emitter disposed in a probe body of the ultrasound probe in accordance with some embodiments.
  • FIG. 3 illustrates the ultrasound probe having a plurality of light emitters disposed in a probe head of the ultrasound probe in accordance with some embodiments.
  • FIG. 4 illustrates the ultrasound probe having the plurality of light emitters disposed in the probe head of the ultrasound probe in accordance with some other embodiments.
  • FIG. 5 illustrates a block diagram of the ultrasound probe operably coupled to a console of the ultrasound system in accordance with some embodiments.
  • FIG. 6 illustrates a mechanism for producing reactive oxygen species for disinfection of a patient’s skin when a photoresponsive antimicrobial ultrasound gel of the ultrasound system is irradiated by light from one or more light emitters of the ultrasound probe in accordance with some embodiments.
  • Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
  • Proximal is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient.
  • a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient.
  • a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient.
  • a “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient.
  • the proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device.
  • proximal portion includes the proximal end of the medical device, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.
  • distal is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient.
  • a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient.
  • a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient.
  • a “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient.
  • the distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medical device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device.
  • distal portion includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.
  • “Stimuloresponsive” is used to indicate a compound, substance, material, composition, mixture, formulation, or the like such as the stimuloresponsive antimicrobial ultrasound gel set forth below that can be stimulated by one or more stimuli to produce reactive oxygen species.
  • the stimuloresponsive antimicrobial ultrasound gel can be a sonoresponsive antimicrobial ultrasound gel including one or more sonosensitizers configured to produce reactive oxygen species when insonified with ultrasound.
  • the stimuloresponsive antimicrobial ultrasound gel can be a photoresponsive antimicrobial ultrasound gel including one or more photosensitizers configured to produce reactive oxygen species when irradiated with light.
  • Stimuvantsitizer is used to indicate a compound, substance, material, or the like having a relatively constant chemical composition that can be stimulated by one or more stimuli to produce reactive oxygen species.
  • the stimulosensitizer can be a sonosensitizer configured to produce reactive oxygen species when insonified with ultrasound.
  • the stimulosensitizer can be a photosensitizer configured to produce reactive oxygen species when irradiated with light.
  • infection control is an integral part of the safe and effective use of ultrasound in medicine. Such infection control is particularly important when ultrasound transducers are used on non-intact skin or during percutaneous procedures including vascular access, thoracentesis, paracentesis, arthrocentesis, pericardiocentesis, lumbar puncture, regional anesthesia, or other such procedures.
  • ultrasound systems including a stimuloresponsive antimicrobial ultrasound gel that addresses the foregoing.
  • FIG. 1 illustrates an ultrasound system 100 for simultaneously disinfecting a patient’s skin S while ultrasound imaging thereunder in accordance with some embodiments.
  • the ultrasound system 100 can include a console 102, an ultrasound probe 104 operably connected to the console 102, and a stimuloresponsive antimicrobial ultrasound gel 106 such as a sonoresponsive antimicrobial ultrasound gel or a photoresponsive antimicrobial ultrasound gel.
  • the ultrasound system 100 can further include the display 108 integrated into the console 102, as set forth below, or the ultrasound system 100 can include an external monitor operably connected to the console 102.
  • FIG. 5 illustrates a block diagram of the console 102 in accordance with some embodiments.
  • the console 102 can include electronic circuitry including memory 110, one or more processors 112, and logic 114 for use in any one or more processes of those set forth below.
  • the one-or-more processors 112 and the memory 110 e.g., primary memory such as non-volatile memory including electrically erasable, programmable, read-only memory [“EEPROM”] and volatile memory including static or dynamic random-access memory [“SRAM”] or [“DRAM”]
  • the memory 110 can include executable instructions 116 configured to cause the console 102 to instantiate one or more processes for at least disinfecting the patient’s skin S while ultrasound imaging thereunder when the instructions 116 are executed by the one-or-more processors 112.
  • the one-or-more processes performed by the console 102 can also include, as set forth above, a process for ultrasound imaging.
  • a process for ultrasound imaging can include emitting ultrasound signals into the patient with the ultrasound probe 104 and transforming echoed ultrasound signals received from the patient to produce ultrasound images.
  • the one-or-more processes performed by the console 102 can include, as set forth above, a process for disinfecting the patient’s skin S.
  • the process for disinfecting the patient’s skin S can include operating the ultrasound sensor array 142 of the ultrasound probe 104 or some selection of transducers of the ultrasound sensor array 142.
  • Operating the ultrasound sensor array 142 or the selection of transducers thereof can include using the logic 114 to modulate ultrasound emitted by the ultrasound sensor array 142 with respect to frequency, power, duration, or a combination thereof in accordance with inputted conditions, selected disinfection profiles, system-determined conditions, or the like.
  • the process for disinfecting the patient’s skin S can include operating the one-or-more light sources corresponding to the one-or-more light emitters 136 of the ultrasound probe 104.
  • operating the one-or-more light sources can include using the logic 114 to modulate light emitted by the one- or-more light emitters 136 with respect to frequency, power, duration, or a combination thereof in accordance with the inputted conditions, selected disinfection profiles, system-determined conditions, or the like.
  • the one-or-more processes performed by the console 102 can also include a process for sending display signals to the display 108 for displaying information in a GUI. Such a process can include sending display signals to the display 108 for displaying ultrasound images as well as any disinfection-related information, options, or the like.
  • the console 102 can also include a digital controller or analog interface 118, which can be in communication with the one-or-more processors 112 and any of the additional components set forth below to govern interfacing between the console 102 and the ultrasound probe 104, as well as any other components of the additional components set forth below.
  • a digital controller or analog interface 118 can be in communication with the one-or-more processors 112 and any of the additional components set forth below to govern interfacing between the console 102 and the ultrasound probe 104, as well as any other components of the additional components set forth below.
  • the console 102 can also include a display 108 having a display screen such as a liquid crystal display (“LCD”) screen integrated into the console 102 for displaying information to a clinician before, during, or after an ultrasound procedure in which the patient’ s skin S is disinfected while ultrasound imaging.
  • the ultrasound system 100 can include an external monitor that can be operably connected to the console 102.
  • the display 108 can be configured to display 108 ultrasound images as well as any disinfection-related information, options, or the like.
  • the disinfection-related options can include selectable options as buttons in the GUI for disinfecting the patient’s skin S.
  • Such selectable options can correspond to at least different types of stimuloresponsive antimicrobial ultrasound gels for corresponding disinfection profiles, which could require certain types of stimulus.
  • the sonoresponsive antimicrobial ultrasound gel could require a certain type of ultrasound including a certain range of frequencies, a peak frequency, exposure time, power, or some combination thereof.
  • the photoresponsive antimicrobial ultrasound gel could require a certain type of light including a certain range of wavelengths, a peak wavelength, exposure time, power, or some combination thereof.
  • the console 102 can also include a console button interface 120.
  • the console button interface 120 can be used by a clinician to immediately call up a desired mode (e.g., ultrasound mode, disinfection mode incorporating a certain disinfection profile, etc.) of the ultrasound system 100 on the display 108 for use by the clinician.
  • a desired mode e.g., ultrasound mode, disinfection mode incorporating a certain disinfection profile, etc.
  • the console 102 can also include ports 124 for connecting any additional components of the ultrasound system 100, if not integrated into the console 102, the ultrasound probe 104, or other optional components 126 such as a printer, a storage device, a keyboard, a mouse, etc.
  • the ports 124 can be universal serial bus (“USB”) ports, though other ports or a combination of various ports can be used.
  • the console 102 can also include a power connection 128 for connecting an external power supply 130.
  • An internal power supply 132 e.g., a disposable or rechargeable battery
  • the console 102 can also include power management circuitry 134 such as part of the digital controller or analog interface 118 of the console 102 to regulate power use and distribution.
  • FIGS. 2-4 illustrates the ultrasound probe 104 of the ultrasound system 100 having one or more light emitters 136 disposed in the ultrasound probe 104 in accordance with some embodiments.
  • FIG. 5 illustrates a block diagram of the ultrasound probe 104 in accordance with some embodiments.
  • the ultrasound probe 104 can include a probe head 138 in a distal portion of the ultrasound probe 104, wherein the probe head 138 extends from a probe body 140 in a proximal portion of the ultrasound probe 104.
  • the ultrasound probe 104 can include an ultrasound sensor array 142 disposed in the probe head 138 of the ultrasound probe 104.
  • the one-or-more light emitters 136 can be disposed in the probe head 138 of the ultrasound probe 104, the probe body 140 of the ultrasound probe 104, or some combination thereof.
  • the ultrasound sensor array 142 can include a plurality of transducers such as piezoelectric transducers or capacitive micromachined ultrasonic transducers (“CMUTs”). Configured as such, the ultrasound probe 104 can emit the ultrasound signals into the patient and receive the echoed ultrasound signals from the patient when sliding the probe head 138 over the patient’s skin S. In addition, the ultrasound probe 104 can be configured with a continuous wave or a pulsed-wave imaging mode. For example, the ultrasound probe 104 can be configured with a pulsed-wave Doppler imaging mode for emitting the ultrasound signals into the patient and receiving the echoed ultrasound signals from the patient. Such an imaging mode is useful for estimating blood flow through one or more blood vessels.
  • CMUTs capacitive micromachined ultrasonic transducers
  • some selection of transducers of the plurality of transducers of the ultrasound sensor array 142 inclusive of an entirety of the ultrasound sensor array 142 can be configured to emit ultrasound toward the patient’s skin S when sliding the probe head 138 thereover for the purpose of disinfecting the patient’s skin S.
  • the foregoing selection of transducers of the ultrasound sensor array 142 can be a permanent selection of transducers such as a plurality of dedicated transducers of the ultrasound sensor array 142 for disinfecting the patient’s skin S while ultrasound imaging with a remainder of the plurality of transducers of the ultrasound sensor array 142.
  • the foregoing selection of transducers of the ultrasound sensor array 142 can alternatively be a temporal selection of transducers such as a plurality of activated transducers of the ultrasound sensor array 142 specifically activated for disinfecting the patient’s skin S while ultrasound imaging with a remainder of the plurality of transducers of the ultrasound sensor array 142.
  • a plurality of activated transducers of the ultrasound sensor array 142 can be activated by the process for disinfecting the patient’s skin S and modulated by the logic 114 with respect to frequency, power, duration, or a combination thereof, as needed, for disinfecting the patient’s skin S.
  • the sonoresponsive antimicrobial ultrasound gel can include one or more sonosensitizers configured to produce reactive oxygen species when insonified with ultrasound used for routine ultrasound imaging, thereby employing the entirety of the ultrasound sensor array 142 for both ultrasound imaging and disinfecting the patient’s skin S.
  • the one-or-more light emitters 136 can be disposed in the probe head 138 of the ultrasound probe 104, the probe body 140 of the ultrasound probe 104, or some combination thereof such that the one-or-more light emitters 136 are configured to emit light toward the patient’s skin S when sliding the probe head 138 thereover for the purpose of disinfecting the patient’s skin S while ultrasound imaging with the plurality of transducers of the ultrasound sensor array 142.
  • FIGS. 2-4 illustrate the one-or-more light emitters 136 in accordance with different embodiments.
  • FIG. 2 illustrates a single light emitter 136 disposed in the probe body 140 of the ultrasound probe 104 in accordance with some embodiments.
  • the one-or-more light emitters 136 can be disposed in one or more faces of the probe body 140 as shown in FIG. 2 by the single light emitter 136 in an anterior face of the probe body 140. Locating the one-or-more light emitters 136 in the anterior face of the probe body 140 can be advantageous in that a posterior face of the probe body 140 is often occupied by the bulk of a clinician’s hand while ultrasound imaging, thereby leaving the anterior face of the ultrasound probe 104 unobstructed for emitting light from the one-or-more light emitters 136 toward the patient’s skin S. That said, the one-or-more light emitters 136 can be located in the one-or-more faces of the probe body 140 distal of that shown FIG.
  • the one- or-more faces of the probe body 140 remain largely unobstructed closer to the probe head 138 of the ultrasound probe 104, thereby allowing the one-or-more light emitters 136 to emit light toward the patient’s skin S while ultrasound imaging.
  • FIGS. 3 and 4 illustrate a plurality of light emitters 136 disposed in the probe head 138 of the ultrasound probe 104 in accordance with some embodiments.
  • the one-or-more light emitters 136 can be disposed in one or more faces of the probe head 138 as shown in FIGS. 3 and 4 by the plurality of light emitters 136 disposed about a perimeter of the probe head 138. Like that set forth above, locating the one-or-more light emitters 136 in the one-or-more faces of the probe head 138 such that the plurality of light emitters 136 are disposed about the perimeter of the probe head 138 can be advantageous in that the probe body 140, not the probe head 138, is often occupied by the bulk of the clinician’s hand while ultrasound imaging.
  • the one-or-more emitters can be disposed in the probe head 138 proximal of the ultrasound sensor array 142.
  • Such a configuration particularly when it is the plurality of light emitters 136 disposed about the perimeter of the probe head 138, advantageously provides a relatively larger illumination area over the patient’s skin S.
  • the one-or-more light emitters 136 can be disposed about the probe head 138 substantially in plane with the ultrasound sensor array 142 but outboard of the ultrasound sensor array 142.
  • the one-or-more light emitters 136 can be one or more light sources selected from LEDs, SLEDs, laser diodes, or the like. Alternatively, the one-or-more light emitters 136 can be one or more optical-fiber termini corresponding to one or more optical fibers operably connected to the one-or-more light sources. While not shown in the block diagram illustrated in FIG. 5, the one-or-more light sources in such embodiments of the ultrasound system 100 can be disposed in the console 102, and each of the console 102 and the ultrasound probe 104 can include their corresponding portions of the one-or-more optical fibers for operable connection of the one-or-more light emitters 136 to the one-or-more light sources.
  • the light emitted by the one-or-more light emitters 136 can be selected from broad spectrum UV-visible light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, cyan light, green light, yellow light, orange light, red light, NIR light, IR light, and modulated light thereof, the modulated light being modulated with respect to frequency, power, duration, or a combination thereof.
  • the photoresponsive antimicrobial ultrasound gel and the UV light can synergistically disinfect the patient’s skin S while ultrasound imaging thereunder.
  • the ultrasound probe 104 can include a button-and- memory controller 144 for governing operation of the ultrasound probe 104 and control buttons 145 thereof.
  • the button-and-memory controller 144 can include non-volatile memory such as EEPROM.
  • the button-and-memory controller 144 can be in operable communication with the control buttons 145 of the ultrasound probe 104 and an ultrasound probe interface 146 of the console 102, which ultrasound probe interface 146 include a sensor input-output (“VO”) component 148 for interfacing with the ultrasound sensor array 142 of the ultrasound probe 104 and a button-and-memory VO component 150 for interfacing with the button-and-memory controller 144 of the ultrasound probe 104.
  • VO sensor input-output
  • FIG. 1 illustrates the stimuloresponsive antimicrobial ultrasound gel 106 in two different packaging formats in accordance with some embodiments.
  • the stimuloresponsive antimicrobial ultrasound gel 106 is configured for simultaneously disinfecting the patient’s skin S while ultrasound imaging thereunder.
  • a stimuloresponsive antimicrobial ultrasound gel 106 can include one or more stimulosensitizers 152 configured to produce the reactive oxygen species that disinfect the patient’s skin S when the stimuloresponsive antimicrobial ultrasound gel 106 is stimulated by one or more stimuli emitted by the ultrasound probe 104.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be the sonoresponsive antimicrobial ultrasound gel including the one-or-more sonosensitizers for the one-or-more stimulosensitizers 152, which sonoresponsive antimicrobial ultrasound gel is configured to produce the reactive oxygen species that disinfect the patient’s skin S when insonified with ultrasound by the ultrasound sensor array 142 of the ultrasound probe 104.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be the photoresponsive antimicrobial ultrasound gel including the one-or-more photosensitizers for the one-or-more stimulosensitizers 152, which photoresponsive antimicrobial ultrasound gel is configured to produce the reactive oxygen species that disinfect the patient’s skin S when irradiated with light by the one-o-more light emitters 136 of the ultrasound probe 104. That said, the stimuloresponsive antimicrobial ultrasound gel 106 can be characterized as sonoresponsive, photoresponsive, or both sonoresponsive and photoresponsive if the stimuloresponsive antimicrobial ultrasound gel 106 includes some combination of at least one sonosensitizer and at least one photosensitizer.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be characterized as sonoresponsive, photoresponsive, or both sonoresponsive and photoresponsive if the stimuloresponsive antimicrobial ultrasound gel 106 includes a stimulosensitizer configured to produce the reactive oxygen species when either insonified with ultrasound or irradiated with light.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can include the one-or- more stimulosensitizers 152 disposed in liquid- or gel -like medium.
  • a liquid- or gel-like medium of the stimuloresponsive antimicrobial ultrasound gel 106 can be, but is not limited to, water, glycerin, propylene glycol, or some combination thereof.
  • the one-or-more sonosensitizers are, again, configured to produce the reactive oxygen species that disinfect the patient’s skin S when the sonoresponsive antimicrobial ultrasound gel is insonifed with ultrasound by the ultrasound sensor array 142 while sliding the probe head 138 over the patient’s skin S.
  • the one-or-more sonosensitizers can be selected from at least organic sonosensitizers and organometallic sonosensitizers. Indeed, the one-or-more sonosensitizers can be selected from those set forth below for the one-or-more photosensitizers as various sonosensitizers follow the same mechanism as that illustrated in FIG.
  • the one-or-more sonosensitizers are soluble in the liquid- or gel-like medium, thereby allowing the one-or-more sonosensitizers to diffuse therethrough.
  • the sonoresponsive antimicrobial ultrasound gel includes an efflux pump inhibitor (EPI) or an electron acceptor with the one-or-more sonosensitizers.
  • the ultrasound for producing the reactive oxygen species can include, but is not limited to, 1.0-2.0 MHz ultrasound at an intensity of 0.5-3.0 W/cm 2 and modulated ultrasound thereof. Indeed, such ultrasound can form cavitation bubbles in the sonoresponsive antimicrobial ultrasound gel when the sonoresponsive antimicrobial ultrasound gel is insonified by the ultrasound from the ultrasound sensor array 142 of the ultrasound probe 104. As set forth in the mechanism below, the cavitation bubbles formed in the sonoresponsive antimicrobial ultrasound gel subsequently implode to produce sonoluminescent light, which produces the reactive oxygen species as shown in FIG. 6. Additionally or alternatively, the one- or-more sonosensitizers can be sensitized to such ultrasound to form antimicrobial sonolysis products.
  • the one-or-more photosensitizers are, again, configured to produce the reactive oxygen species that disinfect the patient’s skin S when the photoresponsive antimicrobial ultrasound gel is irradiated with light by the one-or-more light emitters 136 while sliding the probe head 138 over the patient’s skin S.
  • the one-or-more photosensitizers can be selected from at least organic photosensitizers and organometallic photosensitizers.
  • the one-or-more photosensitizers can be selected from a phenothiazine such as a phenothiazinium dye, a benzophenothiazine such as a benzophenothiazinium dye, a naphthoxazine such as a naphthoxazinium dye, a fluorescein or fluorescein-related compound, a chlorin, a porphyrin, a porphyrazin, a phthalocyanine, and a fullerene.
  • a phenothiazine such as a phenothiazinium dye
  • a benzophenothiazine such as a benzophenothiazinium dye
  • a naphthoxazine such as a naphthoxazinium dye
  • fluorescein or fluorescein-related compound a chlorin, a porphyrin, a porphyrazin, a phthalocyanine, and a full
  • the one-or-more photosensitizers can be a phenothiazine such as methylene blue, dimethylmethylene blue, new methylene blue, methylene green, toluidine blue, azure A, or azure B.
  • the one-or-more photosensitizers can be a benzophenothiazine such as 5-ethylamino-9-diethylaminobenzo(a)phenothiazinium, which is also known as EtNBS, or an analog of EtNBS such as EtNBS-OH, EtNBS-COOH, EtNBS-2C- COOH, or EtNBS-NH2.
  • the one-or-more photosensitizers can be a naphthoxazine such as nile blue.
  • the one-or-more photosensitizers can be a fluorescein or fluorescein-related compound such as rose bengal.
  • the one-or-more photosensitizers can be a porphyrin such as 5,10,15,20-tetrakis(l- methylpyridinium-4-yl)porphyrin tetra-iodide; 5,10,15-tris(l-methylpyridinium-4-yl)-20- (pentafluorophenyl)porphyrin tri-iodide; hematoporphyrin monomethyl ether; chlorin e6, optionally, conjugated to polyvinyl pyrrolidone; sonoflora 1, or sonnelux-1.
  • a porphyrin such as 5,10,15,20-tetrakis(l- methylpyridinium-4-yl)porphyrin tetra-iodide; 5,10,15-tris(l-methylpyridinium-4-yl)-20- (pentafluorophenyl)porphyrin tri-iodide; hema
  • the one-or-more photosensitizers are soluble in the liquid- or gel-like medium, thereby allowing the one-or-more photosensitizers to diffuse therethrough.
  • the photoresponsive antimicrobial ultrasound gel includes an efflux pump inhibitor (EPI) or an electron acceptor with the one-or-more photosensitizers.
  • the light for producing the reactive oxygen species can be selected from broad spectrum UV-visible light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, cyan light, green light, yellow light, orange light, red light, NIR light, IR light, and modulated light thereof.
  • the one-or-more photosensitizers can be sensitized to such light, the one-or-more photosensitizers producing the reactive oxygen species when the photoresponsive antimicrobial ultrasound gel is irradiated by the light from the one-or-more light emitters 136 of the ultrasound probe 104.
  • FIG. 6 illustrates a mechanism for producing the reactive oxygen species for disinfection of the patient’s skin S when the photoresponsive antimicrobial ultrasound gel is irradiated by light from the one-or-more light emitters 136 in accordance with some embodiments.
  • the light from the one-or-more light emitters 136 can produce the reactive oxygen species by way of the one-or-more photosensitizers (see photosensitizer “PS” in FIG. 6) when the photoresponsive antimicrobial ultrasound gel is irradiated by the light from one-or-more light emitters 136. Indeed, upon irradiation with the light from the one-or-more light emitters 136, some population of photosensitizers of the one-or-more photosensitizers can enter an excited singlet state (see photosensitizer “ J PS” in FIG. 6).
  • Such photosensitizers can lose energy by way of fluorescence, but some population of the one-or-more photosensitizers in the excited single state can alternatively enter an excited triplet state (see photosensitizer “ 3 PS” in FIG. 6) through intersystem crossing. And, depending upon whether such photosensitizers are type-I photosensitizers or type-II photosensitizers, the population of photosensitizers in their excited triplet state can react with oxygen by way of electron transfer or energy transfer to produce the reactive oxygen species for disinfecting the surface of the patient’s skin S while ultrasound imaging.
  • any type-I photosensitizer in its excited triplet state can react with oxygen by way of electron transfer to produce superoxide (’Ch ) by reduction of oxygen, hydrogen peroxide (H2O2) by disproportionation of the superoxide, and hydroxyl radical (*OH) by reduction of the hydrogen peroxide.
  • Any type-II photosensitizer in its excited triplet state can react with oxygen by way of energy transfer to produce singlet oxygen ( 1 02).
  • the reactive oxygen species in turn, lead to microbial death and inactivation of microbial endotoxins by various reaction mechanisms involving the reactive oxygen species.
  • the mechanism for producing the reactive oxygen species from the sonoresponsive antimicrobial ultrasound gel can, in some embodiments, incorporate the mechanism shown in FIG. 6 for producing the reactive oxygen species when the photoresponsive antimicrobial ultrasound gel is irradiated by light from the one-or-more light emitters 136. Indeed, when the sonoresponsive antimicrobial ultrasound gel is insonified by ultrasound from the ultrasound sensor array 142 of the ultrasound probe 104, cavitation bubbles can form and, subsequently, implode, thereby producing sonoluminescent light.
  • the sonoluminescent light can excite some population of sonosensitizers of the one-or-more sonosensitizers into the excited singlet state shown in FIG. 6 for ultimately producing the reactive oxygen species by the illustrated mechanism.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be packaged in at least two different packaging formats.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be packaged in a multi-use container such as a squeeze bottle.
  • the stimuloresponsive antimicrobial ultrasound gel 106 can be packaged in a single-use package such as pouches or packets, which are generally recommended when ultrasound transducers are used on non-intact skin or during percutaneous procedures.
  • the stimuloresponsive antimicrobial ultrasound gel 106 need not be sterile as packaged because the stimuloresponsive antimicrobial ultrasound gel 106 is self-disinfecting or self-sterilizing upon stimulation by the one-or-more stimuli emitted by the ultrasound probe 104.
  • Methods include methods of disinfecting the patient’s skin S while ultrasound imaging thereunder.
  • a method of disinfecting the patient’s skin S while ultrasound imaging thereunder can include the following steps or operations.
  • the method can include enabling the electronic circuitry including the memory 110 and the one-or-more processors 112 in the console 102 of the ultrasound system 100 to instantiate the one-or-more processes from the instructions 116 stored in the memory 110 for the disinfecting of the patient’s skin S and the ultrasound imaging thereunder.
  • the method can also include applying the stimuloresponsive antimicrobial ultrasound gel 106 to the patient’s skin S.
  • the method can also include sliding the probe head 138 of the ultrasound probe 104 operably connected to the console 102 over the patient’s skin S. Sliding the probe head 138 of the ultrasound probe 104 over the patient’s skin S emits ultrasound signals into the patient with the ultrasound sensor array 142 disposed in the probe head 138 of the ultrasound probe 104. Also, sliding the probe head 138 of the ultrasound probe 104 over the patient’s skin S receives echoed ultrasound signals from the patient by the ultrasound sensor array 142 for the ultrasound imaging. In addition, sliding the probe head 138 of the ultrasound probe 104 over the patient’s skin S stimulates the stimuloresponsive antimicrobial ultrasound gel 106 with the one-or-more stimuli emitted toward the patient’ s skin S by the ultrasound probe 104. Again, the stimuloresponsive antimicrobial ultrasound gel 106 includes the one-or-more stimulosensitizers 152 that produce the reactive oxygen species when stimulated for the disinfecting of the patient’s skin S.
  • the method can also include selecting an option for disinfecting the patient’s skin S from selectable options displayed in the GUI on the display 108 integrated into the console 102 or the monitor operably connected to the console 102.
  • the selectable options can correspond to at least different types of stimuloresponsive antimicrobial ultrasound gels for corresponding disinfection profiles.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Acoustics & Sound (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un système à ultrasons qui peut désinfecter simultanément la peau d'un patient pendant qu'un examen par imagerie ultrasonore est en cours. Le système à ultrasons peut comprendre une console, une sonde à ultrasons reliée fonctionnellement à la console, et un gel à ultrasons antimicrobien stimulateur choisi parmi au moins un gel à ultrasons antimicrobien sonosensible et un gel à ultrasons antimicrobien photosensible. La sonde à ultrasons peut comprendre un réseau de capteurs à ultrasons pour l'imagerie ultrasonore et la désinfection de la peau s'effectue avec le gel à ultrasons antimicrobien sonosensible par l'intermédiaire d'un ou de plusieurs sonosensibilisateurs de celui-ci. La sonde à ultrasons peut également comprendre un ou plusieurs émetteurs de lumière conçus pour émettre de la lumière vers la peau pour désinfecter la peau avec le gel à ultrasons antimicrobien photosensible par l'intermédiaire d'un ou de plusieurs photosensibilisateurs de celui-ci.
PCT/US2025/019838 2024-03-21 2025-03-13 Systèmes à ultrasons et procédés de désinfection et d'imagerie simultanées Pending WO2025198940A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463568393P 2024-03-21 2024-03-21
US63/568,393 2024-03-21

Publications (1)

Publication Number Publication Date
WO2025198940A1 true WO2025198940A1 (fr) 2025-09-25

Family

ID=95364926

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/019838 Pending WO2025198940A1 (fr) 2024-03-21 2025-03-13 Systèmes à ultrasons et procédés de désinfection et d'imagerie simultanées

Country Status (1)

Country Link
WO (1) WO2025198940A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120150033A1 (en) * 2010-12-13 2012-06-14 Loren Curtis Rauch Antimicrobial ultrasound transmission gel
US20130251590A1 (en) * 2005-01-11 2013-09-26 BioMed Protect ,LLC Peracid/Peroxide Composition, Process for Accurately Making the Same, and Method for Use as an Evaporating Film Anti-Microbial Solution and as a Photosensitizer
US20180055481A1 (en) * 2015-05-20 2018-03-01 Fujifilm Corporation Coating-type contact medium for ultrasound diagnosis
US20210361821A1 (en) * 2020-05-20 2021-11-25 Becton, Dickinson And Company Medical device having a photosensitizer and related methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130251590A1 (en) * 2005-01-11 2013-09-26 BioMed Protect ,LLC Peracid/Peroxide Composition, Process for Accurately Making the Same, and Method for Use as an Evaporating Film Anti-Microbial Solution and as a Photosensitizer
US20120150033A1 (en) * 2010-12-13 2012-06-14 Loren Curtis Rauch Antimicrobial ultrasound transmission gel
US20180055481A1 (en) * 2015-05-20 2018-03-01 Fujifilm Corporation Coating-type contact medium for ultrasound diagnosis
US20210361821A1 (en) * 2020-05-20 2021-11-25 Becton, Dickinson And Company Medical device having a photosensitizer and related methods

Similar Documents

Publication Publication Date Title
US20040259053A1 (en) Method and apparatus for laser-assisted dental scaling
USRE47491E1 (en) Light transmission system for photoreactive therapy
AU2007317707B2 (en) Apparatus and method for application of a pharmaceutical to the tympanic membrane for photodynamic laser myringotomy
US20130274833A1 (en) Micro-organism reducing device
US9555111B2 (en) Ocular cross-linking system and method for sealing corneal wounds
US7435252B2 (en) Control of microorganisms in the sino-nasal tract
JP2005523088A (ja) バイオセラピーに可視光を用いる化学発光光源
RU112631U1 (ru) Устройство фотодинамического воздействия на ткани живого организма
KR20120101020A (ko) 광선요법의 개인 사용을 위한 장치
JP2005527493A (ja) 光線力学療法のためのシステムおよび方法
US20090297455A1 (en) Device for and a method of activating a physiologically effective substance by ultrasonic waves, and a capsule
WO2025198940A1 (fr) Systèmes à ultrasons et procédés de désinfection et d'imagerie simultanées
Astuti et al. Effectiveness of bacterial biofilms photodynamic inactivation mediated by curcumin extract, nanodoxycycline and laser diode
US20120172408A1 (en) Active ingredient comprising indocyanine green and/or infracyanine green
CN210138330U (zh) 一种超声生物显微镜换能器的紫外线消毒装置
US11291855B2 (en) Device for feeding a line through the skin of a patient
CN115666660A (zh) 具有光敏剂的医疗装置以及相关方法
US20090156656A1 (en) Use of light-active indocyanine green for treating inflammatory disorders in the oral cavity
George et al. Laser-assisted endodontics
Model et al. Photobiomodulation Therapy in Clinical Dentistry
KR20250060778A (ko) 다기능 피부 미용장치
Bhar Laser Applications in Medicine and Photodynamic Therapy
DE102022118867A1 (de) Gerät und Zusammensetzung zur Behandlung einer Wunde, Kartusche für das Gerät, Verfahren zur Herstellung der Zusammensetzung
CN106491643A (zh) 一种等离子体活化双氧水溶液的制备装置和制备方法
KR20140142886A (ko) 광원을 이용한 치아 미백용 조성물

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 25718169

Country of ref document: EP

Kind code of ref document: A1