WO2020123679A1 - Instrument endoscopique et système de désinfection - Google Patents

Instrument endoscopique et système de désinfection Download PDF

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Publication number
WO2020123679A1
WO2020123679A1 PCT/US2019/065761 US2019065761W WO2020123679A1 WO 2020123679 A1 WO2020123679 A1 WO 2020123679A1 US 2019065761 W US2019065761 W US 2019065761W WO 2020123679 A1 WO2020123679 A1 WO 2020123679A1
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Prior art keywords
energy
light
instrument
transmission element
energy transmission
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PCT/US2019/065761
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English (en)
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Scott Miller
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GI Scientific LLC
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GI Scientific LLC
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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet [UV] radiation
    • 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/14—Plasma, i.e. ionised gases
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/15—Laboratory, medical or dentistry appliances, e.g. catheters or sharps

Definitions

  • the field of the present disclosure generally relates to endoscopic instruments and systems and methods for disinfection of these instruments, and more particularly, to energy-based disinfection systems and methods for use with endoscopic instruments.
  • gamma radiation is a frequently used method for sterilizing medical products, with the ability to achieve very high pathogen kill ratios.
  • Applying this technique to a reusable endoscope is not currently feasible because the radiation permanently damages the critical optical sensor that creates the visualization that is the hallmark of the endoscope.
  • many of the seals, glue joints and outer surface material of an endoscope are harmed by exposure to certain levels of radiation, resulting in damaged critical seals and joints, which allows more bacteria to congregate, resulting in greater infection risk than if sterilization using gamma radiation had not been attempted.
  • ETO sterilization involves a poisonous gas.
  • the scope must be handled carefully and out-gassed after sterilization to avoid injury to healthcare workers handling the scope.
  • the turn-around time to perform ETO sterilization and to out-gas the scope is notable. Therefore, hospitals using ETO sterilization typically must increase their scope inventory to have enough scopes to manage the downtime with ETO sterilization and still be responsive to their clinical case load.
  • experience using ETO for sterilization indicates that these scopes suffer from greater leaks, more cracks in joints, epoxy issues and other elevated maintenance issues tied to the increased heat and other demands on the scope from the ETO sterilization process.
  • peracetic acid and any other liquid chemical attempts at sterilization require the use of water at the healthcare facility to flush the internal channels of the endoscope.
  • the source of this water is not sterile and therefore pathogens are potentially introduced into the scope from this step.
  • biomatter If biomatter is not fully removed, then the biomatter shields microbes from the disinfection and sterilization chemicals, allowing the microbes to survive these steps and remain alive and able to infect a patient even after taking these comprehensive steps.
  • This central microbiology fact is of particular import with reusable endoscopes, as on many endoscopes, there are crevasses and joints that are as thin as a piece of paper, yet become contaminated with thousands of bacteria and biomatter during a given case.
  • the present disclosure is directed to endoscopic instruments and systems and methods for disinfection of these instruments.
  • the systems and methods disclosed herein involve the delivery of energy to one or more surfaces within, or on, the endoscopic instruments.
  • This delivery of energy may involve the generation of plasma, such as non-thermal, non equilibrium or atmospheric-pressure plasmas (e.g.,“cold plasmas”), one or more spectrums of light, electrical energy, electromagnetic energy, ultrasound energy, laser energy, microwave energy or other energy forms at levels sufficient to disrupt the formation and proliferation of pathogens on these devices.
  • plasma such as non-thermal, non equilibrium or atmospheric-pressure plasmas (e.g.,“cold plasmas”), one or more spectrums of light, electrical energy, electromagnetic energy, ultrasound energy, laser energy, microwave energy or other energy forms at levels sufficient to disrupt the formation and proliferation of pathogens on these devices.
  • the energy delivery methods and devices of the present disclosure may be used with, or may be incorporated into, a variety of different reusable or disposable endoscopic instruments and devices, such as endoscopes, trocars, cannulas, dilatation devices, biopsy brushes, needles or forceps, Foley catheters, guidewires, stone retrieval devices, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, snares, endoscopic staplers and other clamping or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, drug delivery ports, endotracheal tubes, implantable devices, such as electrical nerve stimulators, defibrillators, stents, pacemakers, joint implants, internal fixation devices, spinal implants and other devices that in-dwell, penetrate and/or navigate in the body.
  • endoscopes such as endoscopes, trocars, cannulas, dilatation devices, biopsy brushes, needles or forceps, Foley catheters, guidewires, stone retrieval devices,
  • a cleaning or disinfection system for use with an endoscopic instrument includes a catheter having an elongate shaft with a distal end configured for advancement through an internal lumen within the endoscopic instrument and at least one energy transmission element disposed on the elongate shaft.
  • the disinfection system also includes a power source coupled to the energy transmission element and configured to transmit energy to the energy transmission element sufficient to at least sanitize, and preferably to disinfect, at least a portion of the lumen of the endoscopic instrument.
  • the energy transmission element and the power source are configured to generate a plasma at one or more locations at or around the catheter.
  • the plasma has sufficient energy to destroy biofilm, toxins, bacteria, prions, fungi, viruses or other pathogens within, or on, the endoscopic instrument.
  • the plasma is a non-equilibrium or non-thermal plasma comprising an ionized gas generated at or around atmospheric pressures (i.e., “cold plasma”).
  • the plasma generates sufficient energy to disinfect the surfaces of the endoscopic instrument.
  • Disinfect as used in the present disclosure means that the plasma generates sufficient energy to meet at least a 4 kill log, preferably at least a 6 kill log standard for sterilization of medical instruments.
  • One of the advantages of the plasma of the present disclosure is that it can achieve a 6 kill log standard for sterilization in a relatively short period of time, relative to other methods of sterilization (e.g., less than 2 minutes, preferably between about 30-60 seconds). This reduces the damage that may otherwise occur to sensitive surfaces, such as PTFE and the like.
  • the disinfection system may further comprise one or more electrodes disposed on the catheter and configured for ionizing a working gas around the catheter to create the plasma.
  • the power source may comprise an AC, DC or other suitable power supply configured to create electric arc discharges, corona discharges and/or dielectric barrier discharges within the working gas, thereby creating sufficient energy within the plasma to sterilize the endoscopic instrument.
  • the disinfection system may further include a gas delivery system coupled to the catheter or the endoscopic instrument and configured to deliver a working gas at or around the electrode(s) for generation of the plasma.
  • the working gas is air, or an inert gas, such as helium, argon, nitrogen or the like.
  • the plasma is created from the ambient air already surrounding the electrodes(s) in which case a gas delivery system is not required.
  • the power source comprises a piezoelectric transformer configured to generate AC high voltage at or around the electrode(s).
  • the piezoelectric transformer acts as an electrode, generating electric discharges in the air or other working gases, thereby producing an atmospheric-pressure plasma within the endoscopic instrument sufficient to kill pathogens and disinfect the instrument.
  • the energy transmission element comprises a light source and the power source is configured to generate sufficient energy to cause the light source to emit light within the lumen of the endoscopic instrument.
  • a plurality of light sources are coupled to the power source and spaced from each other along the elongate shaft of the catheter. Each of the light sources is configured to emit light at a different spectrum.
  • the catheter includes a single light source and the power source is configured to generate light energy at the light source at a plurality of different spectrums.
  • the light spectrum may be varied in its delivery length and in the spectrum delivered in order to match the energy delivery with a range of targeted pathogens and to carefully deliver the energy in a manner that does not adversely alter the materials used in the manufacturing of the device.
  • the energy delivery may be one or more energy forms which could be delivered in a continuous fashion, in a pulsatile form, in a series of energy delivery periods, in concert with one or more other energy forms, in an alternative form, or in response to a sensor.
  • the energy is delivered according to one of more algorithms that correspond to certain anti-infective objectives, including killing a broad array of existing pathogens, preventing the proliferation of pathogens, or preventing the formation of pathogens.
  • the light source may comprise an LED, a flexible light fiber or other suitable light source.
  • the light source(s) are configured to deliver light in and around the UV spectrum, preferably having a wavelength between about 10 and 400 nanometers, more preferably within the UV-C range of about 200 to 280 nanometers and even more preferably between about 250 to 280 nanometers.
  • the light source(s) are each configured to emit light within a more narrow range within this spectrum, for example, between about 250-260 nanometers, 260-270 nanometers and/or about 270-280 nanometers.
  • the disinfection system includes a programmable motor coupled to the catheter and configured to translate the elongate shaft through the lumen of the endoscopic instrument.
  • the programmable motor is preferably configured to withdraw the catheter through the lumen a specified distance for a specified duration of time. For example, energy within certain light spectrums might be delivered for a specific targeted time before shifting the light delivery to another spectrum by withdrawing the catheter a certain distance to avoid damaging a surface and/or to kill or otherwise disrupt the replication of other pathogens at a different point in the spectrum of light.
  • the energy could be delivered through one or more fiber optic cables that are fed down the multiple channels of an endoscope and then connected to a light source that delivers multiple forms of light through the fiber optic cable to use light to kill pathogens.
  • an electromagnetic probe or an ultrasound probe could also be advanced through the internal channels of the scope to delivery energy for the same effect.
  • more than one energy medium can be delivered in this manner.
  • the catheter includes a centering device coupled to the elongate shaft and configured to center at least a portion of the elongate shaft within the lumen. This ensures that the energy emitted from the catheter is substantially uniform around the internal surfaces of the instrument.
  • the centering device may comprise one or more protrusions extending from the outer surface of the catheter shaft sized to contact the inner surface of an internal lumen of the endoscopic instrument and to maintain the catheter substantially within the center of the lumen.
  • the catheter further comprises a mechanism for removing any fluid, tissue, biomatter or other debris within the internal lumen before or during the cleaning process. Removing biomatter eliminates one potential area for pathogens to survive and grow within the instrument.
  • this debris removal mechanism comprises one or more annular caps at a proximal end of the elongate shaft.
  • the annular cap(s) preferably has an outer diameter greater than a diameter of the elongate shaft and is sized to contact the inner surface of the lumen so as to catch and remove debris as the catheter is retracted from the internal lumen.
  • the annular cap comprises an absorbent material, such as polymer, foam or the like, configured to absorb fluid within the lumen of the instrument.
  • a disinfection system for use with an endoscopic instrument comprises a housing having an interior configured for housing or otherwise enclosing the endoscopic instrument, at least one energy transmission element disposed within the interior of the housing and a power source coupled to the energy transmission element.
  • the power source is configured to generate energy at the energy transmission energy sufficient to disinfect at least a portion of the endoscopic instrument.
  • the energy can be delivered to disinfect and sterilize the external surfaces of the endoscopic instrument.
  • the housing may comprise a tube or cabinet that delivers one or more forms of energy to the surface of the reusable device to disinfect and/or sterilize the surface of the device. This tube or cabinet could be open or sealed to limit air-borne contaminates and could be filtered, including using a Hepa or other filtration system.
  • an endoscopic device comprises an elongate shaft having an internal lumen and one or more energy transmission element(s) disposed within the elongate shaft adjacent to the internal lumen.
  • the endoscopic device may comprise a single-use disposable instrument, such as a Foley catheter, central venous catheter, arterial lines, drainage catheter, peripherally inserted central catheter, drug delivery port, endotracheal tubes or a reusable instrument, such as an endoscope or the like.
  • the energy transmission element is configured to emit energy at a level sufficient to at least sanitize, and preferably disinfect or sterilize, at least a portion of the internal lumen.
  • the energy transmission element(s) can be attached to or incorporated into single-use devices that in-dwell, penetrate and/or navigate in the body.
  • a central venous catheter may include an imbedded energy element that is used to inhibit the attachment and growth of bacteria and other pathogens on the surfaces of the central venous catheter.
  • the energy element could be delivering energy constantly or intermittently based on determined parameters that result in anti-infection benefits while avoiding complications to the patient, including avoiding adverse impacts on blood flow, surrounding tissue, as well as medications being delivered through the catheter.
  • the energy transmission element comprises one or more electrodes and the power source is configured to generate a plasma at or around the electrode(s).
  • the endoscopic device may further comprise a gas delivery system configured to deliver a gas at or around the electrode(s) for generation of the plasma.
  • the gas is an inert gas, such as helium, argon, nitrogen or the like.
  • the gas is air (i.e. , cold atmospheric plasma (CAP) technology).
  • CAP cold atmospheric plasma
  • the plasma is created from the air already surrounding the electrodes(s) in which case a gas delivery system is not required.
  • the power source comprises a piezoelectric transformer configured to generate AC high voltage at or around the electrode(s).
  • the piezoelectric transformer acts as an electrode, generating electric discharges in the air or other working gases, thereby producing an atmospheric-pressure plasma within the endoscopic instrument sufficient to kill pathogens and disinfect the instrument.
  • the energy transmission element is a light source and the endoscopic instrument includes a power source, either integrated into the instrument shaft, a proximal handle or other suitable location, or the power source may be a separate component disposed external to the instrument, and suitably coupled to the light source.
  • the light source is preferably configured to emit light having wavelengths within the UV spectrum, or about 10 to 400 nanometers, preferably in the range of about 200 to about 280 nanometers.
  • the light source may comprise a UV-C LED, a flexible UV-C light fiber or other suitable device.
  • the light source may emit a constant light or a pulsed light.
  • the endoscopic instrument comprises a plurality of light sources spaced from each other within the instrument and adjacent to selected areas within the internal lumen(s) of the instrument.
  • the lights sources may be configured to emit light at different spectrums.
  • a method for disinfecting an endoscopic instrument comprises translating a catheter through an internal lumen of the instrument transmitting energy from an energy transmission element on the catheter at a level sufficient to disinfect at least a portion of the internal lumen.
  • the method includes generating a plasma at or around the energy transmission element sufficient to disinfect at least a portion of the internal lumen.
  • the plasma may be an atmospheric-pressure, non-thermal or cold plasma.
  • the method may further include delivering a gas to the energy transmission element to provide molecules for the plasma
  • the method comprises emitting light from a light source on the catheter at an energy level sufficient to disinfect at least a portion of the internal lumen.
  • the method further includes emitting light at different spectrums from a plurality of light sources on the catheter.
  • the light is preferably in the UV spectrum, i.e. , having wavelengths around 10 to 400 nanometers, and more preferably between about 200 to about 280 nanometers.
  • the performance of these steps could occur before or after other cleaning and disinfection steps.
  • the device to be cleaned could have one or more shielding or sheath elements, including an endoscopic shield, to inhibit the intrusion of biomatter into hard to access areas of the device and therefore the invention includes the use of the energy-based infection capability with protective elements such as endoscopic shields, lenses, optical couplers, sheaths, gloves and any other protective elements.
  • the invention may also include one or more special swabs, including kite tailed swabs and cleaning instruments and brushes that can be attached to the infection control energy delivery elements to enhance the cleaning and disinfection approach as they are passed over and through the device in connection with the energy-based infection control element.
  • the energy delivery could be one or more energy forms which could be delivered in a continuous fashion, in a pulsatile form, in a series of energy delivery periods, in concert with one or more other energy forms, in an alternative form, or in response to a sensor or according to one of more algorithms that correspond to certain anti-infective objectives, including killing a broad array of pathogens, or preventing the proliferation of pathogens, or preventing the formation of pathogens.
  • the energy delivery could also occur through a detachable element.
  • an implanted port for delivering drugs could include energy-delivery elements that are able to receive and transmit energy on the surface of the port to inhibit microbial growth and biofilm development.
  • An external energy source such as a battery or a controller attached to a battery or other energy source could deliver one or more forms of energy to the port to provide in-dwelling and ongoing infection prevention capability to the port to prevent infection due to the in-dwelling nature of the port. This is valuable with a wide-variety of patients, including those who are immune-compromised. More than one form of energy may be delivered.
  • FIG. 1 illustrates a representative endoscope for use with the disinfection systems and methods of the present disclosure
  • FIG. 2 illustrates a disinfection system according to the present disclosure
  • FIG. 3 illustrates an alternative embodiment of the disinfection system of
  • FIG. 2
  • FIG. 4 illustrates another alternative embodiment of the disinfection system of FIG. 2;
  • FIG. 5 illustrates another cleaning system according to the present disclosure
  • FIG. 6 illustrates an alternative embodiment of the disinfection system of
  • FIG. 5 A first figure.
  • FIG. 7 is a cross-sectional view of a distal portion of a representative endoscope incorporated a disinfection system according to the present invention.
  • FIGS. 8A and 8B illustrate a representative endoscopic instrument incorporating a disinfection system according to the present disclosure
  • FIG. 9 illustrates a representative drug delivery implant incorporating a disinfection system according to the present disclosure.
  • FIG. 10 illustrates a representative stent incorporating the disinfection system according to the present disclosure. DESCRIPTION OF THE EMBODIMENTS
  • endoscope refers generally to any scope used on or in a medical application, which includes a body (human or otherwise) and includes, for example, a laparoscope, arthroscope, colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvester with a scope, whether robotic or non-robotic.
  • a laparoscope arthroscope, colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvester with a scope, whether robotic or non-robotic.
  • scopes When engaged in remote visualization inside the patient’s body, a variety of scopes are used. The scope used depends on the degree to which the physician needs to navigate into the body, the type of surgical instruments used in the procedure and the level of invasiveness that is appropriate for the type of procedure. For example, visualization inside the gastrointestinal tract may involve the use of endoscopy in the form of flexible gastroscopes and colonoscopes and specialty duodenum scopes with lengths that can run many feet and diameters that can exceed 1 centimeter. These scopes can be turned and articulated or steered by the physician as the scope is navigated through the patient.
  • scopes include one or more working channels for passing and supporting instruments, fluid channels and washing channels for irrigating the tissue and washing the scope, insufflation channels for insufflating to improve navigation and visualization and one or more light guides for illuminating the field of view of the scope.
  • Smaller and less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity are also used in medical applications.
  • a smaller, narrower and much shorter scope is used when inspecting a joint and performing arthroscopic surgery, such as surgery on the shoulder or knee.
  • a shorter, more rigid scope is usually inserted through a small incision on one side of the knee to visualize the injury, while instruments are passed through incisions on the opposite side of the knee. The instruments can irrigate the scope inside the knee to maintain visualization and to manipulate the tissue to complete the repair
  • scopes may be used for diagnosis and treatment using less invasive endoscopic procedures, including, by way of example, but not limitation, the use of scopes to inspect and treat conditions in the lung (bronchoscopes), mouth (enteroscope), urethra (cystoscope), abdomen and peritoneal cavity (laparoscope), nose and sinus (laryngoscope), anus (sigmoidoscope) and other aspects of the gastrointestinal tract (gastroscope, duodenoscope, colonoscope), chest and thoracic cavity (thoracoscope), and the heart (cardioscope).
  • bronchoscopes to inspect and treat conditions in the lung
  • enteroscope to inspect and treat conditions in the mouth
  • cystoscope to inspect and treat conditions in the abdomen and peritoneal cavity
  • laparoscope laparoscope
  • laparoscope to inspect and treat conditions in the abdomen and peritoneal cavity
  • laparoscope to inspect and treat conditions in the abdomen and peritoneal cavity
  • laparoscope to inspect and treat conditions in the abdomen
  • scopes may be inserted through natural orifices (such as the mouth, sinus, ear, urethra, anus and vagina) and through incisions and port-based openings in the patient’s skin, cavity, skull, joint, or other medically indicated points of entry.
  • diagnostic use of endoscopy with visualization using these medical scopes includes investigating the symptoms of disease, such as maladies of the digestive system (for example, nausea, vomiting, abdominal pain, gastrointestinal bleeding), or confirming a diagnosis, (for example by performing a biopsy for anemia, bleeding, inflammation, and cancer) or surgical treatment of the disease (such as removal of a ruptured appendix or cautery of an endogastric bleed).
  • a representative endoscope 10 for use with the present disclosure includes a proximal handle 12 adapted for manipulation by the surgeon or clinician coupled to an elongate shaft 14 adapted for insertion through an endoscopic or percutaneous penetration into a body cavity of a patient.
  • Endoscope 10 further includes a fluid delivery system 16 coupled to handle 12 via a universal cord 15.
  • Fluid delivery system 16 may include a number of different tubes coupled to internal lumens within shaft 14 for delivery of fluid(s), such as water and air, suction, and other features that may be desired by the clinician to displace fluid, blood, debris and particulate matter from the field of view. This provides a better view of the underlying tissue or matter for assessment and therapy.
  • fluid delivery system 16 includes a water-jet connector 18, water bottle connector 20, a suction connector 22 and an air pipe 24.
  • Water-jet connector 18 is coupled to an internal water-jet lumen 26 that extends through handle 12 and elongate shaft 14 to the distal end of endoscope 10.
  • water jet connector 18, water bottle connector 20, suction connector 22 and air pipe 24 are each connected to internal lumens 28, 30, 32, 34 respectively, that pass through shaft 14 to the distal end of endoscope 10.
  • Endoscope 10 may further include a working/biopsy channel (not shown) for passing instruments therethrough.
  • the working channel permits passage of instruments down the shaft 14 of endoscope 10 for assessment and treatment of tissue and other matter.
  • Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including mini-scopes, baskets, snares and other devices for use with a scope in a lumen.
  • Proximal handle 12 may include a variety of controls for the surgeon or clinician to operate fluid delivery system 16. In the representative embodiment, handle 12 include a suction valve 35, and air/water valve 36 and a biopsy valve 38 for extracting tissue samples from the patient.
  • Handle 12 will also include an eyepiece (not shown) coupled to an image capture device (not shown), such as a lens and light transmitting system.
  • image capture device as used herein also need not refer to devices that only have lenses or other light directing structure.
  • the image capture device could be any device that can capture and relay an image, including (i) relay lenses between the objective lens at the distal end of the scope and an eyepiece, (ii) fiber optics, (iii) charge coupled devices (CCD), (iv) complementary metal oxide semiconductor (CMOS) sensors.
  • An image capture device may also be merely a chip for sensing light and generating electrical signals for communication corresponding to the sensed light or other technology for transmitting an image.
  • the image capture device may have a viewing end - where the light is captured.
  • the image capture device can be any device that can view objects, capture images and/or capture video.
  • endoscope 10 includes some form of positioning assembly (e.g., hand controls) attached to a proximal end of the shaft to allow the operator to steer the scope.
  • the scope is part of a robotic element that provides for steerability and positioning of the scope relative to the desired point to investigate and focus the scope.
  • a disinfection system 600 includes a catheter 602 coupled to a power source 604 by a connector 606.
  • Disinfection system 600 is configured to generate a plasma at certain locations along catheter 602 to destroy or kill biofilm, toxins, bacteria, prions, fungi, viruses or other pathogens within, or on, the endoscopic instrument.
  • Plasma is a partially ionized gas. Electric arcs, dielectric barriers, coronas and piezoelectric direct discharges ionize gases at atmospheric pressures to create plasmas. The charged particles (i.e. , electrons and ions) within the plasma accelerate within the discharged electric fields to high energies. In certain types of plasma, termed non-equilibrium or non-thermal plasmas (i.e.,“cold plasmas”), the constituent electrons, ions and the neutral gas particles have different kinetic energy distributions. Only a small fraction of the gas molecules, which are the main carriers of heat, collide with electrically generated highly energetic electrons. This results in excitation and ionization of certain particles, while the rest of the plasma gas remains neutral and relatively cold. Thus, the overall temperature of the gas remains within about 30-50 degrees C, which minimizes damage to sensitive surfaces and reduces collateral damage to surrounding tissue.
  • the energetic electrons and ions reach energies of 1-10 eV, which is 300-3000 times higher than the average energy of the neutral gas particles.
  • chemically active molecules and species, along with the energetic ions and electrons, bombard and decompose organic molecules of living organisms. These processes produce lighter and volatile organic molecules, which evaporate from the surface, killing any pathogens on the surface.
  • this process allows the disinfection or sterilization of thermosensitive materials and allow in vivo applications.
  • Plasmas according to the present disclosure are sufficient to at least sanitize the surfaces of endoscopic instruments.
  • Sanitize as used in the present disclosure means that 99.99% of bacteria, viruses and other pathogens are destroyed.
  • the plasma generates sufficient energy to disinfect or sterilize the surface of the internal lumen.
  • Disinfect as used in the present disclosure means that the plasma generates sufficient energy to meet at least a 4 kill log, preferably at least a 6 kill log standard for sterilization of medical instruments.
  • One of the advantages of the plasma is that it can achieve a 6 kill log standard for sterilization in a relatively short period of time, relative to other methods of sterilization (e.g., less than 2 minutes, preferably between about 30-60 seconds). This reduces the damage that may otherwise occur to sensitive surfaces, such as PTFE and the like.
  • connector 606 is a pull cable configured to withdraw or advance catheter 602 within an internal lumen in endoscope 10.
  • Power source 104 preferably includes an energy source configured to generate a plasma within the internal lumen(s) of endoscope 10 and a motor for advancing and/or withdrawing catheter 602 with pull cable 606.
  • catheter 602 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e. , no motor).
  • power source 604 may be integrated within catheter 602.
  • Catheter 602 preferably includes an elongate shaft 608 having an outer diameter sized to fit within, and translate through, the internal lumens in endoscope 10.
  • shaft 608 will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm.
  • catheter 602 includes an opening, such as a nozzle 610 or other suitable opening, disposed on shaft 608.
  • nozzle 610 is pivotally coupled to the distal end of shaft 608 such that nozzle 610 can be rotated to face the internal lumen of an endoscope 10 surrounding shaft 608. In use, nozzle 610 may be pivoted such that it is substantially aligned with the longitudinal axis of shaft
  • Nozzle 610 is designed to emit a working gas and/or plasma 611 onto a surface adjacent to or near nozzle 610.
  • shaft 608 may include one or more openings (see, for example, Figs. 3 and 4) for emitting the plasma.
  • the ambient air is the working gas.
  • an electric arc discharge is created in the ambient air surrounding the openings in shaft 608.
  • Catheter 602 further includes one or more metallic surfaces or electrodes
  • Power source 604 is configured to create high voltage discharges from the electrodes in the presence of a working gas to create a plasma
  • Power source 604 may comprise any suitable source of AC or DC power configured to generate sufficient voltage at the electrodes to ignite the plasma within the working gas and create a discharge at the electrode.
  • the discharge may be an electric arc discharge, a corona discharge or a dielectric barrier discharge.
  • disinfection system 600 further comprises a gas delivery system (not shown) for delivering a working gas through an internal lumen in catheter 602 coupled to nozzle 610.
  • the gas delivery system may include a pump coupled to a source of working gas and a fluid channel or conduit for pumping the working gas through catheter 602 to nozzle 610 or other openings in the fluid conduit.
  • the working gas exits nozzle 610 and carries the plasma 611 to the surface to be cleaned (as shown in Fig. 2).
  • the working gas may comprise an inert gas, such as helium, argon, nitrogen or the like.
  • the working gas may comprise air.
  • disinfection system 600 is designed to operate with the ambient air surrounding the electrode(s). In this embodiment, the electric discharges are transmitting to the ambient air to generate the plasma on the surfaces to be cleaned.
  • disinfection system 600 comprises a piezoelectric transformer configured to generate AC high voltage at or around the electrode(s).
  • the piezoelectric transformer acts as an electrode, generating electric discharges in the air or other working gases, thereby producing an atmospheric-pressure plasma within the endoscopic instrument sufficient to kill pathogens and disinfect the instrument.
  • Piezoelectric direct discharge uses a piezoelectric transformer as a generator of AC high voltage.
  • the high voltage side of this transformer acts as an electrode generating electric discharges in the air or other working gases producing atmospheric-pressure plasmas.
  • the piezoelectric transformer is very compact and requires only a source of a low power low voltage AC.
  • the transformer may be located on the catheter 608 or it may be external to the catheter and suitably coupled thereto.
  • Piezoelectric transformers convert electric energy in the form of low voltage
  • disinfection system 600 includes a cold atmospheric plasma (CAP) technology, such as surface microdischarge or the like. With this technology, a non-thermal or cold plasma is created in ambient air around catheter 608.
  • the electrode(s) typically comprise two metal surfaces separated by a dielectric material. The plasma is ignited between the electrodes and a weakly ionized plasma discharge is generated that creates excited species (e.g., reactive oxygen species, reactive nitrogen species and the like), chemical reactions and photon emissions that provide sufficient energy to kill pathogens.
  • catheter 608 further includes an annular cap(s) 120 extending around its proximal end.
  • Cap 120 preferably comprises a flexible material that is designed to fit within the internal lumens of scope and provide resistance against the inner surface of the lumens to remove any debris or biomatter that resides within the lumens.
  • cap 120 comprises a superabsorbent polymer, foam or other suitable material for absorbing liquid and debris from the internal lumens of scope 10.
  • Annular cap 120 may also perform the function of centering catheter 608 within the internal lumen(s) of scope 10.
  • catheter 102 may further include a centering device (not shown) at its distal end to keep the energy elements optimally positioned and to ensure that plasma or light coverage is substantially uniform throughout the lumen of scope 10.
  • the invention may also include one or more special swabs (not shown), including kite-tailed swabs and cleaning instruments and brushes that can be attached to the infection control energy delivery elements to enhance the cleaning and disinfection approach as they are passed over and through the device in connection with the energy-based infection control element.
  • the swabs or cleaning instruments are configured to remove biomatter and/or fluid from endoscope 10 prior to, or during, the energy delivery phase.
  • disinfection system 100 further includes a disposable kink-resistant tube (not shown) designed to replace the glue-in suction tube 34 of scope 10.
  • the disposable kink-resistant tube may include one or more magnetic and/or mechanical connectors for coupled the tube to suction valve 35 and the internal surfaces of scope 10. This allows the disposable tube to simply be removed after a procedure to facilitate the cleaning and disinfection process.
  • FIG. 3 illustrates another embodiment of disinfection system 600 that does not include a nozzle.
  • catheter shaft 608 includes one or more openings 620 at its distal end for discharging the plasma towards the internal lumen of endoscope 10.
  • shaft 608 includes a single opening extending laterally outward from shaft 608 and shaft 608 may be rotated around its longitudinal axis to apply the plasma to the entire circumference of the internal lumen of scope 10.
  • shaft 608 comprises a plurality of openings or nozzles 620 spaced around its circumference such that the plasma may be applied to the entire circumference of the internal lumen simultaneously or sequentially through the plurality of openings.
  • FIG. 4 illustrates yet another embodiment of disinfection system 600 that comprises a plurality of openings or nozzles 630 spaced axially from each other along shaft 608 of catheter 602.
  • the plasma may be applied simultaneously at multiple axial locations along shaft 608.
  • the plasma may be sequentially applied to each of the axially-spaced openings 630.
  • a disinfection system 100 includes a catheter 102 coupled to a power source 104 by a connector 106.
  • connector 106 is a pull cable configured to withdraw or advance catheter 102 within an internal lumen in endoscope 10.
  • Power source 104 preferably includes an energy source for delivering light energy to catheter 102 and a motor for advancing and/or withdrawing catheter 102 with pull cable 106.
  • catheter 102 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e., no motor).
  • power source 104 may be integrated within catheter 102.
  • Catheter 102 preferably includes an elongate shaft 108 having an outer diameter sized to fit within, and translate through, the internal lumens in endoscope 10.
  • shaft 108 will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm.
  • catheter 102 includes a plurality of light sources 110 preferably spaced from each other along shaft 108 and suitably coupled to power source 104.
  • light sources 110 may be disposed adjacent to each other on shaft 108.
  • Catheter 102 may include any number of light sources, preferably between about 1- 10 light sources, and more preferably between about 2-5 light sources.
  • catheter 102 includes a single light source
  • power source 104 may be configured to deliver a variety of different energies to light source 110 such that light source emits light at different spectrums.
  • Light sources 110 are configured to emit light at a sufficient energy to as least sanitize the surface of an internal lumen within endoscope 10. Sanitize as used in the present disclosure means that 99.99% of bacteria, viruses and other pathogens are destroyed. In preferred embodiments, light sources 1 10 emits sufficient energy to disinfect the surface of the internal lumen. Disinfect as used in the present disclosure means that the light sources emits sufficient energy to meet at least a 4 kill log, preferably at least a 6 kill log standard for sterilization of medical instruments. [0094] Light sources 1 10 preferably emit light in a UV spectrum or having wavelengths of about 10 nm to about 400 nm, more preferably between about 200 nm to about 280 nm.
  • each of the light sources 110 will emit light at a different UV spectrum.
  • one of the light sources emits a UV-C spectrum having a wavelength of about 254 nm
  • a second light source emits light having a wavelength of about 265 nm
  • a third light source emits light having a wavelength of about 270 nm.
  • the energy delivery could be one or more energy forms which could be delivered in a continuous fashion, in a pulsatile form, in a series of energy delivery periods, in concert with one or more other energy forms.
  • power source 104 is configured to emit different energies (i.e. , other than light) to energy transmission elements 1 10 on catheter 102.
  • power source 104 may emit electrical energy, electromagnetic energy, ultrasound energy, laser energy, microwave energy or other energy forms at levels sufficient to disrupt the formation and proliferation of pathogens on the endoscopic device.
  • power source 104 may delivery different types of energy to catheter (e.g., light energy to one or more of the energy transmission elements 110 and microwave energy to others).
  • power source 104 may be configured to alternative between different types of energy: delivering light energy for a predetermined period of time and then switching to another suitable energy source.
  • each light source 110 may be varied in its delivery length.
  • having light delivered in different spectrums within the UV range allows the operator to match the energy delivery with a range of targeted pathogens and to carefully deliver the energy in a manner that does not adversely alter the materials used in the manufacturing of the device.
  • catheter 102 may include only two light sources that emit light having wavelengths between about 250 nm to about 270 nm.
  • catheter 102 may include four or more light sources emitting light over a broader range, e.g., from about 200 nm to about 280 nm.
  • light sources 1 10 comprises light emitting diodes
  • light sources 1 10 may comprise optical fibers that pass light from an energy source external to catheter 102 through the elongate shaft to a designated position along catheter 102.
  • Other suitable light sources may be used, such as liquid crystals, nanofiber- based, organic light emitting diodes (OLEDs) and the like.
  • disinfection system 100 further includes a programmable motor (not shown) that may be part of, or separate from, power source 104.
  • the programmable motor is coupled to pull cable 106 and designed to withdraw catheter 102 from the internal lumen of endoscope 10 at a fixed or variable velocity.
  • motor may be programmed with a particular algorithm that corresponds to certain anti- infective objectives, including killing a broad array of pathogens, preventing the proliferation of pathogens, or preventing the formation of pathogens.
  • the motor is programmed to withdraw catheter at a fixed velocity based on established sterilization times required to completely disinfect the internal lumen with the plasma or UV light.
  • the motor is programmed to withdraw the catheter in a series of discrete steps, i.e. , holding the catheter in place for a specified period of time and then withdrawing it a specified distance and repeating this step until it has been withdrawn and the disinfection procedure is complete. This ensures a sufficient duration of exposure to the plasma or UV light and optimizes the full kill power of disinfection system 100.
  • the motor may be programmed to ensure that one of the nozzles 610, openings 630 or light sources 1 10 remains within a specific target area of the internal lumen of endoscope 10 for a sufficient period of time to disinfect that target area.
  • energy within a certain ultraviolet-C light spectrum from one of the light sources 110 might be delivered for a specific targeted time before shifting the light delivery to another spectrum from a second light source 1 10 (i.e., by withdrawing the catheter such that the second light source is disposed within the targeted area) to avoid damaging a surface and to kill or otherwise disrupt the replication of other pathogens at a different point in the spectrum of light.
  • disinfection system 100 may comprise multiple pull cables configured to allow the operator to clean multiple lumens within scope 10.
  • the cables may be designed to allow catheter to be pulled through one internal lumen of the scope, retracted from that lumen, and then pulled through a second internal lumen of scope 10.
  • Catheter 102 may include one or more sensors (not shown) along shaft 108 for detecting pathogens, liquids or other particulate matter within the endoscope 10. Suitable sensors for use with the present invention may include PCT and microarray based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric, potentiometric, amperometric, conductometric, nanosensors or the like. Catheter 102 may further include an indicator, such as a display on the outer surface of power source 104, coupled to the sensor(s) and configured to indicator the presence of pathogens, liquids or other particulars detected by the sensor. The indicator may be any suitable chemical indicator validated for sterilization procedures that undergoes a physical or chemical change visible to the human eye after exposure to certain parameters. The indicator and sensor may be part of the same device, or separate from each other.
  • Some embodiments can include a printout from the power source or a connection to a printer that allows the hospital to print out a record showing the UV wavelengths, and/or duration of energy exposure, to put in the cleaning record.
  • some embodiments may include the ability to infuse a disinfectant, cleaning chemical or other fluid in advance of the UV-C lighting, plasma generation or other energy delivery or in connection with the energy delivery to additional germicidal effect.
  • the fluid may also serve to lubricate the lumen so it is easier to pull the catheter through or for other reasons, including to leave behind a chemistry with a longer half-life for acting as a germicide or for other benefits.
  • disinfection system 100 comprises a catheter 130 that include a light fiber 132 extending along all or a portion of its length.
  • Light fiber 132 is preferably coupled to an energy source 134 by a suitable connector 136.
  • power source 134 is configured to deliver energy through light fiber 132 such that light fiber 132 transmits light at specified, programmable wavelengths for specified durations, including across all germicidal light wave lengths.
  • power source 134 will deliver energy throughout the entire or a substantial portion of light fiber 132 such that light is emitted through a larger portion of the internal lumen of scope 10 at any given time.
  • power source 134 is programmed to deliver energy such that the light fiber transmits light at different spectrums along its length. In another alternative embodiment, power source 134 is programmed to sequentially deliver energy to light fiber 134 such that light fiber 134 sequentially emits light in different spectrums along its length.
  • catheter 130 is specifically designed to advance through working/biopsy channel 38 of endoscope 10. In other embodiments, catheter 130 may be designed to fit through some or all of the other lumens of scope 10.
  • Catheter 130 may include a superabsorbent polymer or foam 138 coupled to its proximal end for removing any fluid or debris from internal lumen(s) of scope 10.
  • a centering device 140 is preferably coupled to distal end of catheter 130 to keep light coverage uniform by centering the light source in the lumen of the scope or catheter.
  • a printout from the power source or a connection to a printer can be provided that allows the hospital to print out a record showing the UV wavelengths and duration of exposure to put in the cleaning record. It is contemplated that the light source may be a constant or a pulsed light source.
  • the disinfection system of the present disclosure is not limited to a catheter.
  • the disinfection system may comprise a housing having an interior configured for housing or otherwise enclosing the endoscopic instrument.
  • the housing may comprise a tube or cabinet that delivers one or more forms of energy to the surface of the reusable device to disinfect and/or sterilize the surface of the device.
  • This tube or cabinet could be open or sealed to limit air-borne contaminates and could be filtered, including using a Hepa or other filtration system.
  • At least one energy transmission element is disposed within the interior of the housing and a power source is coupled to the energy transmission element.
  • the power source is configured to generate energy at the energy transmission energy sufficient to disinfect at least a portion of the endoscopic instrument.
  • the energy can be delivered to disinfect and sterilize the external surfaces of the endoscopic instrument.
  • endoscope 200 includes a distal end portion 202 and one or more internal lumens 204 therein for performing various functions, such as viewing the surgical site, disinfection the camera lens, suction, irrigation, advancing instruments through a working channel in the scope and the like.
  • Endoscope 200 includes one or more energy transmission element(s) 206, such as a light source or a plasma generation element, embedded within one of the walls of the scope on the inner or outer surface of one or more of the internal lumen(s) 204.
  • Energy transmission element 206 is coupled to a power source (not shown), which may be disposed in the proximal handle of scope 200 or it may be external to scope (i.e., a separate component).
  • Energy transmission element 206 is configured to emit energy into internal lumen 204 to sterilize or disinfect a portion of internal lumen 204. Alternatively, or in addition, energy transmission element 206 may be configured to transmit energy to the exterior surfaces of internal lumen 204. In certain embodiments, energy transmission element 206 may comprise a light source configured to emit light in the UV C spectrum as discussed above. In other embodiments, energy transmission element 206 may comprise one or more electrodes configured to generate a plasma, as discussed above.
  • endoscope 206 includes a plurality of energy transmission elements 206 spaced throughout the walls of scope 206 adjacent to the inner surfaces of lumen(s) 204.
  • the energy transmission elements may be designed to emit light within the same UV C spectrum, or they may each emit light in a different spectrum within the UV C range.
  • the power source may be configured to transmit different levels of energy to energy transmission elements 206 such that they each emit light at different spectrums at different times.
  • pathogen-killing energy may be delivered throughout the internal lumens 204 of endoscope 206 during, of after, use within a patient.
  • a representative disposable (i.e., single use) endoscopic instrument that incorporates a disinfection system according to the present disclosure is shown.
  • the representative instrument is a guidewire system 300 for use in medical procedures to guide catheters, sheath or other devices from a remote site to a surgical site in the patient’s body.
  • Guidewire may be advanced through the vasculature system to a target site where, for example, an angiogram, balloon, stent, catheter or other vascular device is to be positioned.
  • the present invention may be used with a variety of endoscopic instruments, such trocars, cannulas, dilatation devices, biopsy brushes, needles or forceps, Foley catheters, guidewires, stone retrieval devices, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, snares, endoscopic staplers and other clamping or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes and the like.
  • endoscopic instruments such trocars, cannulas, dilatation devices, biopsy brushes, needles or forceps, Foley catheters, guidewires, stone retrieval devices, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, snares, endoscopic staplers and other clamping or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes and the like.
  • a guidewire system 300 includes an elongate shaft 302 with one or more internal lumen(s) 304 for receiving various inner devices, such as stiffeners, guidewires, instruments and the like.
  • Guidewire shaft 302 further includes an energy transmission element 308, such as a light source, embedded within one of the walls of shaft 302 on the inner surface of internal lumen 304.
  • Energy transmission element 308 is coupled to a power source (not shown), which may be disposed along shaft 302, in a proximal handle (not shown) of guidewire system 300, or it may be external to guidewire system 300 (i.e. , a separate component).
  • energy transmission element 308 is configured to emit energy into internal lumen 304 to sterilize or disinfect a portion of internal lumen 304.
  • energy transmission element 308 may comprise a light source configured to emit light in the UV C spectrum, as discussed above.
  • Instrument 300 may include a plurality of energy transmission elements 308 spaced throughout the walls of shaft 302 adjacent to the inner surfaces of lumen(s) 304.
  • the energy transmission elements may be designed to emit light within the same UV C spectrum, or they may each emit light in a different spectrum within the UV C range.
  • the power source may be configured to transmit different levels of energy to elements 308 such that they emit light at different spectrums at different times.
  • drug delivery device 400 includes a housing 402 with one or more openings 404 and a drug reservoir 406 within the interior of housing 402 for delivering drugs to a patient.
  • Housing 402 may further include a piston 408 or other mechanical means for advancing the drugs from reservoir 406 through opening(s) 404 into the patient.
  • device 400 is merely representative and may comprise a number of conventional drug delivery devices known in the art.
  • device 400 further includes one or more energy transmission elements 410 disposed on the exterior or interior surfaces of housing 402.
  • Energy transmission element(s) 408 are coupled to a power source (not shown), which may be disposed within housing 402 or it may be external to the patient (i.e., a separate component).
  • energy transmission element(s) 408 are configured to receive and transmit energy on the surface of device 400 to inhibit microbial growth and biofilm development.
  • An external energy source such as a battery or a controller attached to a battery or other energy source could deliver one or more forms of energy to the port to provide in-dwelling and ongoing infection prevention capability to the port to prevent infection due to the in-dwelling nature of the port.
  • energy transmission element 408 may comprise a light source configured to emit light in the UV spectrum as discussed above.
  • Drug delivery device 400 may include a plurality of energy transmission elements 408 spaced along the exterior surfaces of housing 402.
  • the energy transmission elements may be designed to emit light within the same UV C spectrum, or they may each emit light in a different spectrum within the UV C range.
  • the power source may be configured to transmit different levels of energy to element(s) 408 such that they emit light at different spectrums at different times.
  • Tubular support device 500 for maintaining patency of a body lumen is illustrated.
  • Tubular support device 500 may be, for example, a stent or similar device placed temporarily inside a blood vessel, canal, or duct to aid healing or relieve an obstruction, such as a plastic stent, self-expanding metallic stent (e.g., via temperature change in the patient’s body), bioabsorbable stent, ultrasound-guided stent or the like.
  • the tubular support device is preferably configured to advance through the working channel of the endoscope and the working channel extension of the coupler device.
  • tubular support device 500 may be any implantable device configured to reside or in-dwell within the patient’s body for a temporary or permanent period of time.
  • the implantable device may include, for example, electrical nerve stimulators, defibrillators, drug delivery ports, endotracheal tubes, stents, pacemakers, joint implants, internal fixation devices, spinal implants and the like.
  • the implantable device comprises a tubular support device for maintaining patency of a body lumen.
  • tubular support device 500 is a biliary stent comprising a flexible metallic tube 532 configured to hold open a bile duct during or after an endoscopic procedure.
  • Stent 500 may be placed within the bile duct and expanded therein to maintain patency of the bile duct such that fluids, such as bile (bilirubin) are able to flow into the duodenum to aid in digestion.
  • Stent 500 may be expanded through any suitable means knows in the art, such as body temperature (e.g., nitinol material) or actuating mechanisms.
  • Stent 500 may comprise any suitable material, such as plastic, temperature-based self-expanding materials (e.g.
  • stent 500 includes one or more energy transmission elements 534 disposed on the exterior surfaces of 532.
  • Energy transmission element(s) 534 are coupled to a power source (not shown), which may be disposed within stent 500 or it may be external to the patient (i.e. , a separate component).
  • energy transmission element(s) 534 are configured to receive and transmit energy on the surface of stent 500 to inhibit microbial growth and biofilm development due to the in-dwelling nature of the stent.
  • Chronic wound tissue may include diabetic ulcers, venous ulcers, pressure ulcers, surgical wounds, trauma wounds, burns, amputation wounds, radiated tissue, tissue affected by chemotherapy treatment, infected tissue compromised by a weakened immune system or any other tissue that does not heal on its own.
  • T reating wound tissue may include perforating tissue on and in the vicinity of the wound, debriding tissue to induce blood flow, debriding necrotic tissue, killing and removing biofilm and bacteria or other pathogens from the wound bed and/or applying plasma energy to the wound to stimulate or induce a metabolic, biochemical and/or physiological change in the wound tissue to induce the body’s natural healing response.
  • a system for treating wound tissue includes an instrument or probe with a distal end portion having one or more electrodes, and a power source coupled to the electrodes and configured to create a plasma at the electrodes for treating the wound.
  • the plasma created is a non-equilibrium or non-thermal plasma that has sufficient energy to destroy or kill pathogens, such as bacteria, viruses and the like and to cause molecular dissociation of biofilm that may have grown over the wound.
  • the plasma may also be an atmospheric-pressure plasma that operates at or around atmospheric pressure.
  • the cold plasma of the present invention has a sufficiently low temperature to minimize collateral damage to tissue underlying and surrounding the wound.
  • the plasma may be created by any number of methods known in the art, but generally is created by heating a gas and ionizing the gas by driving an electric current through it or by shining radio waves into the gas.
  • the system of the present invention is designed to remove unhealthy or necrotic tissue and debris, biofilm, bacteria and other pathogens, both on the periphery of the wound and within the wound bed itself.
  • the plasma may also stimulate and/or modulate an expression of healing mediators, such as growth factors, heat shock proteins, and cytokines to promote a stabilized wound healing response.
  • the power source may comprise any other suitable source of AC or DC power configured to generate sufficient voltage at the electrodes on the distal end of the instrument to ignite the plasma within the working gas and create a discharge at the electrode.
  • the discharge may be an electric arc discharge, corona discharge or a dielectric barrier discharge.
  • the power source comprises a high voltage piezoelectric transformer configured to generate AC voltage and to convert the AC voltage into mechanical oscillations. These mechanical oscillations produce high voltage AC at the electrode(s) to create electric discharges within the working gas.
  • the system for treating wound tissue may further comprise a gas delivery system for delivering a working gas through the instrument and onto the wound tissue.
  • the working gas exits the distal end of the instrument and carries the plasma to the surface of the wound tissue.
  • the working gas may comprise an inert gas, such as helium, argon, nitrogen or the like.
  • the working gas may comprise air.
  • the system is designed to operate with the ambient air surrounding the electrode(s). In this embodiment, the electric discharges are transmitting to the ambient air to generate the plasma on the wound tissue.
  • the system for treating wounds may further include one or more nozzles at the distal end of the instrument shaft configured emit the working gas and plasma onto the wound tissue.
  • the shaft may include one or more openings for emitting the plasma.
  • the system and methods for treating wounds may further include devices for viewing the surgical site during the procedure in order to visualize the removal of biofilm, bacteria, viruses or other pathogens from the wound tissue.
  • These systems may include endoscopes and their accessories.
  • the instrument may be, for example, passed through a working channel of an endoscope, or it may be part of the actual endoscope.
  • an endoscope is any scope used on or in a medical application, which includes a body (human or otherwise) and includes, for example, a laparoscope, duodenoscope, arthroscope, colonoscope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, whether robotic or non-robotic.
  • a laparoscope duodenoscope
  • arthroscope colonoscope
  • bronchoscopes enteroscope
  • cystoscope laparoscope
  • laryngoscope sigmoidoscope
  • thoracoscope thoracoscope
  • cardioscope whether robotic or non-robotic.
  • the systems of the present invention may be incorporated into endoscope companion devices or components that are used in conjunction with
  • endoscopes such as optical couplers.
  • Some of these endoscopic companion devices or components can be placed over, or onto, the endoscope, such as for example, endoscopic caps, endoscopic shields, sheaths, optical couplers, lenses, variceal banding devices, and endoscopic submucosal resection devices, to name a few. These devices further enhance the functionality of the endoscope and/or provide protection from contamination.
  • a device for generating a plasma at a surgical site is incorporated into an optical coupler device attached to the distal end portion of an endoscope.
  • the coupler device may be provided as a single-use disposable accessory to an endoscope that protects the distal end of the scope from bacteria, debris, fluid and particulate matter.
  • the device attaches to the end of the endoscope and covers the working channel of the endoscope with a working channel extension in the coupler device, allowing an instrument to be passed down the working channel of the endoscope and into the working channel extension of the coupler device.
  • the working channel extension can provide a seal against the scope working channel, so instruments can be passed back and forth through the scope working channel and out the working channel extension of the coupler device without fluid and bacteria entering areas outside of the scope working channel.
  • Optical coupling devices suitable for use by the systems and methods of the present invention are described in International Application Nos: PCT/US2016/043371 , filed July 21 , 2016, PCT/US2016/035566, filed June 2, 2016 and U.S. Patent No. 8,905,921 , the entire disclosures of which are incorporated herein by reference for all purposes.
  • an optical coupler device such as one described above, includes one or more electrodes suitably coupled to a power source.
  • the power source may comprise any suitable source of AC or DC power configured to generate sufficient voltage at the electrodes on the distal end of the instrument to ignite the plasma within a working gas or the ambient air and create a discharge at the electrode.
  • the discharge may be an electric arc discharge, corona discharge or a dielectric barrier discharge.
  • the optical coupler or the endoscope may further include a gas delivery system for delivering a working gas through the instrument and onto the wound tissue. The working gas exits the distal end of the instrument and carries the plasma to the surface of the wound tissue.
  • the coupler device may include one or more nozzles configured to emit the working gas and plasma onto the wound tissue. Alternatively, the coupler device may include one or more openings for emitting the plasma.
  • the wound treatment system may include one or more sensors (not shown) within the optical coupler or the endoscope for detecting biofilm or pathogens within the wound tissue.
  • Suitable sensors for use with the present invention may include PCT and microarray based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric, potentiometric, amperometric, conductometric, nanosensors or the like.
  • the system may further include an indicator, such as a display on the outer surface of the power source or handle of the endoscope, coupled to the sensor(s) and configured to indicator the presence of biofilm and/or pathogens detected by the sensor.
  • the indicator may be any suitable chemical indicator validated for sterilization procedures that undergoes a physical or chemical change visible to the human eye after exposure to certain parameters.
  • the indicator and sensor may be part of the same device, or separate from each other.

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Abstract

La présente invention concerne des instruments endoscopiques et des systèmes de désinfection à base d'énergie et des procédés d'utilisation avec ces instruments. Un système de désinfection pour l'utilisation avec un instrument endoscopique comprend un cathéter ayant une tige allongée avec une extrémité distale configurée pour avancer à travers une lumière à l'intérieur de l'instrument endoscopique, au moins un élément de transmission d'énergie disposé sur la tige allongée et une source d'énergie couplée à l'élément de transmission d'énergie. La source d'énergie est configurée pour générer de l'énergie au niveau de l'élément de transmission d'énergie suffisamment pour désinfecter au moins une partie de la lumière de l'instrument endoscopique. La source d'énergie et l'élément de transmission d'énergie peuvent être configurés pour générer un plasma non thermique avec suffisamment d'énergie pour détruire le biofilm, les bactéries ou d'autres agents pathogènes sur l'instrument endoscopique.
PCT/US2019/065761 2018-12-13 2019-12-11 Instrument endoscopique et système de désinfection Ceased WO2020123679A1 (fr)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021239909A1 (fr) 2020-05-29 2021-12-02 University Of Southampton Stérilisation d'endoscopes
CN114041842A (zh) * 2021-11-17 2022-02-15 吉林大学 一种整形外科用吻合器
US20220080469A1 (en) * 2020-09-11 2022-03-17 Clarus Medical, Llc Medical device cleaning devices and methods
GB2601160A (en) * 2020-11-20 2022-05-25 Creo Medical Ltd Apparatus for sterilising a channel of a surgical scoping device
US11559597B2 (en) 2018-01-23 2023-01-24 Clarus Medical, Llc Medical device inspection system
WO2023219884A1 (fr) * 2022-05-08 2023-11-16 GI Scientific, LLC Systèmes et procédés de séchage de dispositifs endoscopiques
US12109081B2 (en) 2018-03-16 2024-10-08 Clarus Medical, Llc Medical device inspection scope
DE102023112628A1 (de) * 2023-05-12 2024-11-14 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung eingetragener Verein Vorrichtung und Verfahren zur Desinfektion eines Lumens mittels UV-Strahlung
US12357164B2 (en) 2018-01-23 2025-07-15 Clarus Medical, Llc Medical device inspection scope

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5637877A (en) * 1995-06-06 1997-06-10 Rare Earth Medical, Inc. Ultraviolet sterilization of instrument lumens
US20030213501A1 (en) * 2002-04-06 2003-11-20 Timothy Thomson Apparatus and method for cleaning an endoscope
US20170136136A1 (en) * 2015-11-16 2017-05-18 Rayvio Corporation On-demand medical device sterilization device and methods
US20170182194A1 (en) * 2015-12-29 2017-06-29 Webb Medical LLC Apparatus and method of sterilizing lumens in medical instruments
KR101784213B1 (ko) * 2017-08-07 2017-10-12 부경대학교 산학협력단 내시경 내부 채널 표면 소독 장치 및 그 방법
US20180318459A1 (en) * 2017-05-05 2018-11-08 Creo Medical Limited Apparatus for sterilizing an instrument channel of a surgical scoping device

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5637877A (en) * 1995-06-06 1997-06-10 Rare Earth Medical, Inc. Ultraviolet sterilization of instrument lumens
US20030213501A1 (en) * 2002-04-06 2003-11-20 Timothy Thomson Apparatus and method for cleaning an endoscope
US20170136136A1 (en) * 2015-11-16 2017-05-18 Rayvio Corporation On-demand medical device sterilization device and methods
US20170182194A1 (en) * 2015-12-29 2017-06-29 Webb Medical LLC Apparatus and method of sterilizing lumens in medical instruments
US20180318459A1 (en) * 2017-05-05 2018-11-08 Creo Medical Limited Apparatus for sterilizing an instrument channel of a surgical scoping device
KR101784213B1 (ko) * 2017-08-07 2017-10-12 부경대학교 산학협력단 내시경 내부 채널 표면 소독 장치 및 그 방법

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11559597B2 (en) 2018-01-23 2023-01-24 Clarus Medical, Llc Medical device inspection system
US12357164B2 (en) 2018-01-23 2025-07-15 Clarus Medical, Llc Medical device inspection scope
US12109081B2 (en) 2018-03-16 2024-10-08 Clarus Medical, Llc Medical device inspection scope
GB2595651A (en) * 2020-05-29 2021-12-08 Univ Southampton Sterlisation of endoscopes
WO2021239909A1 (fr) 2020-05-29 2021-12-02 University Of Southampton Stérilisation d'endoscopes
US20220080469A1 (en) * 2020-09-11 2022-03-17 Clarus Medical, Llc Medical device cleaning devices and methods
WO2022106215A1 (fr) * 2020-11-20 2022-05-27 Creo Medical Ltd Appareil de stérilisation d'un canal d'un dispositif d'endoscopie chirurgicale
CN116367868A (zh) * 2020-11-20 2023-06-30 科瑞欧医疗有限公司 用于对外科窥视装置的通道进行灭菌的设备
GB2601160A (en) * 2020-11-20 2022-05-25 Creo Medical Ltd Apparatus for sterilising a channel of a surgical scoping device
CN114041842B (zh) * 2021-11-17 2023-08-22 吉林大学 一种整形外科用吻合器
CN114041842A (zh) * 2021-11-17 2022-02-15 吉林大学 一种整形外科用吻合器
WO2023219884A1 (fr) * 2022-05-08 2023-11-16 GI Scientific, LLC Systèmes et procédés de séchage de dispositifs endoscopiques
DE102023112628A1 (de) * 2023-05-12 2024-11-14 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung eingetragener Verein Vorrichtung und Verfahren zur Desinfektion eines Lumens mittels UV-Strahlung
WO2024235698A1 (fr) * 2023-05-12 2024-11-21 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e. V. Dispositif et procédé pour désinfecter une lumière au moyen d'un rayonnement uv

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