CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No.

62/778,997, filed December 13, 2018, the entire disclosure of which is incorporated herein by reference for all purposes.

BACKGROUND

[0002] 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.

[0003] The global health system is entering a new age where deadly strains of pathogens are emerging and evolving that are not addressable with existing drugs and infection control technologies. Many are calling this the post-antibiotic age of infection risk, as pathogens emerge and evolve that are not responsive to current antibiotics, creating complex, new infection prevention and control circumstances where new innovations are critically needed. Experts, including the U.S. Center for Disease Control, state that this rapidly growing problem could be a greater source of early mortality than current cancer cases unless new innovations are created to address this rapidly escalating problem.

[0004] This new, evolving and increasingly dangerous situation is made even more complex due to the fact that the points of potential infection occur across a broad array of contact points with patients. Thus, treatment by patient identification, isolation and quarantine approaches (i.e., traditional isolation protocols) is not a realistic a way to remove or eliminate the risk of deadly outbreaks, even if these steps may have some mitigating impact in certain instances.

[0005] The breadth and unpredictable nature of where these pathogens emerge, exist and evolve support the need for new technologies. Drug- resistant superbugs and other deadly, hard to kill pathogens are arising in long-term care hospitals, nursing homes, acute care hospitals and a variety of other locations, including sports clinics and gym locker rooms, synthetic athletic fields, public bathrooms and other widespread areas. As a result, many patients present for otherwise routine examinations and treatments at a wide variety of healthcare institutions as carriers of these pathogens, often without symptoms and therefore with no awareness for the patient or the healthcare institution that the patient they are treating is a potentially significant vector for an outbreak involving a deadly pathogen. Almost none of the current healthcare treatment points possess established, consistently applied ways to pre-screen patients to determine if they are carriers of these deadly pathogens before they enter their facility and receive treatment. To deal with these circumstances, patients should be managed the same way healthcare institutions have responded to HIV infection risks. Precautions and technologies are in place so that each patient is managed as if they are a potential carrier of HIV as a way to offset the lack of pre-screening capabilities and to maintain and respect patient privacy. The same approach is needed with potential carriers of drug-resistant infections.

[0006] An additional factor with this complex problem is that there are many well- established, important and successful medical treatment approaches to correct and remedy patient conditions that rely on well-adopted medical technologies. These technologies involve reusable devices or well-adopted disposable medical technologies that must reside in the body for a period of time. These proven devices often are the central, enabling technology for these important, beneficial procedures. At the same time, the use of these devices can promote infection risk unless properly cleaned, disinfected or sterilized.

[0007] This circumstance is exacerbated further by the fact that many of these technologies have long, very involved learning curves that physicians must complete to become skilled at using these technologies to perform these important, beneficial, well-established procedures. Changing physician technique to learn on a new technology introduces another measure of risk to patients because of the need for physicians to repeat a long, involved learning curve on a new, replacement technology. Effectively addressing these new infection concerns, while preserving the significant benefits tied to the installed-based of technology and related established physician technique, becomes a critical point to preserve while introducing new infection prevention technologies. Otherwise, changing physician and/or healthcare worker techniques introduce a new, additional risk point for patients.

[0008] Problems with the Current Approach

[0009] The current standard of care for reprocessing reusable devices after each patient use involves manually cleaning the devices to attempt to remove all biomatter and then performing a multi-step process using cleaning chemicals to achieve high level disinfection. These processes, which have over 100 steps, are highly prone to human error and, even when performed precisely, do not address the full range of potential levels of contamination of an endoscope from each use.

[0010] Further, the necessary mechanical and optical aspects of these devices create additional issues. These devices, by necessity, have extremely small crevasses as part of certain mechanical and optical functionality. Some of these crevasses are no wider than the thickness of a piece of paper, resulting in areas on the device that are nearly impossible to effectively clean. Thus, biomatter can remain on the scope after cleaning and reprocessing, which means pathogens from previous patients are transferred to the next patient. If the previous patient is a carrier of a drug resistant pathogen, then the next patient can be infected and this cycle can continue until the device is fully cleaned of all pathogens. It also means that biomatter that is in the patient and not initially drug resistant, if left on the device and not cleaned and disinfected, can colonize, grow a biofilm protective cover and become drug resistant before the device is returned to use, infecting the next patient with a dangerous pathogen. Failure to properly and completely remove biomatter and any potential pathogens means these otherwise safe procedures and otherwise well-conceived and well-performing medical technologies now become potentially deadly carriers of life-threatening infection risk.

[0011] Issues with Attempting to Sterilize Reusable Scopes

[0012] To address these growing infection dangers, some experts have taken the position that endoscopes and other reusable medical devices should be sterilized after every use. While this is a worthwhile objective, there are numerous issues associated with attempting to sterilize complex medical technology. Taking the endoscope as a case in point, nearly all of the well-established approaches for achieving sterilization are not compatible with reusable endoscopes. As potentially beneficial as a sterilization step may seem, there are multiple problems and issues with achieving sterilization of reusable scopes. Current sterilization methods all have significant issues when attempts are made to apply these methods to current scopes. The scope’s optical elements plus the other functional, mechanical elements, including seals and other attributes, are not able to hold-up to the demands of the various current sterilization approaches over time.

[0013] For example, 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, however, is not currently feasible because the radiation permanently damages the critical optical sensor that creates the visualization that is the hallmark of the endoscope. Additionally, 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.

[0014] The use of autoclaves to sterilize reusable instruments is common in hospitals, although this method relies on the use of heat generated by steam (essentially a sophisticated pressure cooker). The use of heat to sterilize through autoclaves also damages the endoscope’s key functional attributes. Sensitive endoscopes are not able to withstand this heat and again experience damage to the optical elements of the scopes, as well as degradation of epoxy joints and seals.

[0015] A few hospitals are sterilizing certain high-infection-risk endoscopes, called duodenoscopes, using ethylene oxide (ETO) sterilization. ETO sterilization involves a poisonous gas. Thus, 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. In addition, 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.

[0016] Attempts have been made to sterilize flexible endoscopes using a mixture of water and peracetic acid, which requires careful flushing and management of the fluid mixture to avoid cross contamination and other issues. Peracetic acid has the benefit of being an effective biocide against many bacteria without subjecting the scope to elevated temperatures. That said, notable questions exist as to its overall benefit due to its poor efficacy dealing with blood-borne pathogens, safety issues for healthcare workers, the need to access sterile water to avoid cross contamination, and recent concerns related to links between residual elements of the peracetic acid and outbreaks of colitis with patients who are treated by scopes that were disinfected or subject to attempted sterilization using peracetic acid. In addition, 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. At most healthcare facilities, the source of this water is not sterile and therefore pathogens are potentially introduced into the scope from this step.

[0017] It is important to note that with all attempts at disinfection or sterilization, it is well-established that unless all biomatter contamination on a scope or other reusable device is removed, the device cannot be successfully disinfected or sterilized. This is because biomatter acts to shield pathogens from the disinfection or sterilization activity, allowing the organisms to survive the disinfection or sterilization process rather than be killed. Preventing the intrusion of biomatter into hard, if not impossible, to clean places is a critical first step to address for disinfection or sterilization to have even a remote chance of success. 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.

[0018] Other Infection Issues

[0019] A related infection issue exists with single-use disposable devices that must be placed in patients for a limited duration. These devices are exposed to external and internal bacteria, as well as varying temperature changes and other risk elements. Over time, these devices begin to support the colonization of bacteria and eventually biofilm growth, leading to the promotion of infection because of these indwelling devices. In addition, the devices can carry external pathogens into the body as they are placed in the patient. These devices include, by way of example but not limitation, Foley catheters, central venous catheters, arterial lines, drainage catheters, peripherally inserted central catheters, drug delivery ports, endotracheal tubes, and other devices that in-dwell, penetrate and/or navigate in the body. These devices are also significant sources of infection risk that can be effectively addressed by the present disclosure.

[0020] Accordingly, it would be desirable to provide improved systems and methods for cleaning, sterilizing and disinfecting endoscopic instruments. SUMMARY OF THE INVENTION

[0021] 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. 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.

[0022] In one aspect of the invention, 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.

[0023] In certain embodiments, 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. Preferably, the plasma is a non-equilibrium or non-thermal plasma comprising an ionized gas generated at or around atmospheric pressures (i.e., “cold plasma”). In preferred embodiments, 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.

[0024] 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.

[0025] 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. In some embodiments, the working gas is air, or an inert gas, such as helium, argon, nitrogen or the like. In other embodiments, the plasma is created from the ambient air already surrounding the electrodes(s) in which case a gas delivery system is not required.

[0026] In certain embodiments, 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.

[0027] In another aspect of the invention, 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. In one such embodiment, 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. In another embodiment, 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. In both of these embodiments, 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.

[0028] 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. In certain embodiments, 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.

[0029] In certain embodiments with a light source, the light source may comprise an LED, a flexible light fiber or other suitable light source. In a preferred embodiment, 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. In exemplary embodiments, 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.

[0030] In certain embodiments, 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.

[0031] As an example of an application of this innovation, in embodiments, 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. In a related embodiment, 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. In embodiments, more than one energy medium can be delivered in this manner. [0032] In another embodiment, 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.

[0033] In another embodiment, 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. In one such embodiment, 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. In an exemplary embodiment, the annular cap comprises an absorbent material, such as polymer, foam or the like, configured to absorb fluid within the lumen of the instrument.

[0034] In another aspect of the invention, 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. In this embodiment, 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.

[0035] In another aspect of the invention, 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.

[0036] In embodiments, 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. For example, 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.

[0037] In one embodiment, 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. In some embodiments, the gas is an inert gas, such as helium, argon, nitrogen or the like. In other embodiments, the gas is air (i.e. , cold atmospheric plasma (CAP) technology). In certain embodiments, the plasma is created from the air already surrounding the electrodes(s) in which case a gas delivery system is not required.

[0038] In certain embodiments, 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.

[0039] In another embodiment, 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.

[0040] In certain embodiments, 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.

[0041] In another aspect of the invention, 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. In one embodiment, 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

[0042] In another embodiment, 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. In certain embodiments, 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.

[0043] The performance of these steps could occur before or after other cleaning and disinfection steps. In addition, 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.

[0044] 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. [0045] In embodiments, 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.

[0046] In embodiments, the energy delivery could also occur through a detachable element. For example, 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.

[0047] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure. Additional features of the disclosure will be set forth in part in the description which follows or may be learned by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure.

[0049] FIG. 1 illustrates a representative endoscope for use with the disinfection systems and methods of the present disclosure;

[0050] FIG. 2 illustrates a disinfection system according to the present disclosure;

[0051] FIG. 3 illustrates an alternative embodiment of the disinfection system of

FIG. 2;

[0052] FIG. 4 illustrates another alternative embodiment of the disinfection system of FIG. 2;

[0053] FIG. 5 illustrates another cleaning system according to the present disclosure;

[0054] FIG. 6 illustrates an alternative embodiment of the disinfection system of

FIG. 5;

[0055] FIG. 7 is a cross-sectional view of a distal portion of a representative endoscope incorporated a disinfection system according to the present invention;

[0056] FIGS. 8A and 8B illustrate a representative endoscopic instrument incorporating a disinfection system according to the present disclosure;

[0057] FIG. 9 illustrates a representative drug delivery implant incorporating a disinfection system according to the present disclosure; and

[0058] FIG. 10 illustrates a representative stent incorporating the disinfection system according to the present disclosure. DESCRIPTION OF THE EMBODIMENTS

[0059] This description and the accompanying drawings illustrate exemplary embodiments and should not be taken as limiting, with the claims defining the scope of the present disclosure, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

[0060] It is noted that, as used in this specification and the appended claims, the singular forms“a,”“an,” and“the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term“include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0061] While the following disclosure is primarily directed to an endoscope and a catheter-based system for cleaning and disinfecting the endoscope, it should be understood that the features of the presently described disinfection system may be readily adapted for use with a variety of reusable or disposable endoscopic instruments and devices, such as 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. [0062] The term“endoscope” in the present disclosure 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.

[0063] 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. Many of these 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.

[0064] Smaller and less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity, are also used in medical applications. For example, 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. When a surgeon is repairing a meniscal tear in the knee using arthroscopic surgery, 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

[0065] Other 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). In addition, robotic medical devices rely on scopes for remote visualization of the areas the robotic device is assessing and treating.

[0066] These and other 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. Examples of the 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).

[0067] Referring now to Fig. 1 , 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. In the representative embodiment, 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. Similarly, 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.

[0068] 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. [0069] 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. The term“image capture device” as used herein also need not refer to devices that only have lenses or other light directing structure. Instead, for example, 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. Generally, the image capture device can be any device that can view objects, capture images and/or capture video.

[0070] In some embodiments, 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. In other embodiments, 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.

[0071] Referring now to FIG. 2, a disinfection system 600 according to the present invention 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.

[0072] 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.

[0073] Although the overall temperature of the gas remains relatively cool, 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. In addition, they collide with the gas molecules to produce large quantities of short-lived chemically reactive species, such as atomic H, N and O species, OH and ON radicals, ozone, nitrous and nitric acids and other molecules. These 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. In addition, this process allows the disinfection or sterilization of thermosensitive materials and allow in vivo applications.

[0074] 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. In preferred embodiments, 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.

[0075] In certain embodiments, 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. Of course, it will be recognized that catheter 602 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e. , no motor). In addition, power source 604 may be integrated within catheter 602. [0076] 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. In the exemplary embodiment, shaft 608 will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm. In certain embodiments, catheter 602 includes an opening, such as a nozzle 610 or other suitable opening, disposed on shaft 608. In the exemplary embodiment, 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

610 for advancement through the internal lumen of endoscope 10 and then rotated relative to shaft 610 to point laterally outward towards an internal lumen surface of the endoscope 10, as shown in FIG. 2.

[0077] Nozzle 610 is designed to emit a working gas and/or plasma 611 onto a surface adjacent to or near nozzle 610. Of course, it will be recognized that a variety of suitable nozzles known by those skilled in the art may be used with the present invention. Alternatively, shaft 608 may include one or more openings (see, for example, Figs. 3 and 4) for emitting the plasma. In some embodiments, the ambient air is the working gas. In these embodiments, an electric arc discharge is created in the ambient air surrounding the openings in shaft 608.

[0078] Catheter 602 further includes one or more metallic surfaces or electrodes

(not shown) located near the entrance of nozzle 610. Power source 604 is configured to create high voltage discharges from the electrodes in the presence of a working gas to create a plasma

611 within nozzle 610. 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.

[0079] In certain embodiments, 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). In certain embodiments, the working gas may comprise an inert gas, such as helium, argon, nitrogen or the like. In other embodiments, the working gas may comprise air. [0080] In an alternative embodiment, 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.

[0081] In certain embodiments, 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.

[0082] 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.

[0083] Piezoelectric transformers convert electric energy in the form of low voltage

AC into mechanical oscillations. Consequently, these mechanical oscillations produce high voltage AC at the other end of the transformer. The highest amplitude is achieved at mechanical resonances, which occur at the frequencies typically between 10 kHz and 500 kHz. The dimensions of the piezoelectric crystal define the resonance frequency, while its dielectric environment can cause small shifts of the resonance. The low voltage electronics continuously adjusts the frequency to keep the transformer operating within the resonance. At the resonance, such transformers offer very high voltage conversion factors up to 1000 with voltages of 5 - 15 kV.

[0084] In other embodiments, 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. [0085] In one embodiment, 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. In an exemplary embodiment, 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. Alternatively, or in addition, 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.

[0086] 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.

[0087] In certain embodiments, 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.

[0088] FIG. 3 illustrates another embodiment of disinfection system 600 that does not include a nozzle. In this embodiment, catheter shaft 608 includes one or more openings 620 at its distal end for discharging the plasma towards the internal lumen of endoscope 10. In certain embodiments, 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. In other embodiments, 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. [0089] 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. In this embodiment, the plasma may be applied simultaneously at multiple axial locations along shaft 608. Alternatively, the plasma may be sequentially applied to each of the axially-spaced openings 630.

[0090] Referring now to Fig. 5, a disinfection system 100 according to another embodiment of the present invention includes a catheter 102 coupled to a power source 104 by a connector 106. In certain embodiments, 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. Of course, it will be recognized that catheter 102 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e., no motor). In addition, power source 104 may be integrated within catheter 102.

[0091] 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. In the exemplary embodiment, shaft 108 will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm. In certain embodiments, catheter 102 includes a plurality of light sources 110 preferably spaced from each other along shaft 108 and suitably coupled to power source 104. Alternatively, 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.

[0092] In an alternative embodiment, catheter 102 includes a single light source

110. In this embodiment, 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.

[0093] 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. In an exemplary embodiment, each of the light sources 110 will emit light at a different UV spectrum. For example, in one such embodiment, 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 and a third light source emits light having a wavelength of about 270 nm. Of course, it will be recognized that other configurations will be envisioned by those skilled in the art. In embodiments, 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.

[0095] In another embodiment, power source 104 is configured to emit different energies (i.e. , other than light) to energy transmission elements 1 10 on catheter 102. For example, 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. In some embodiments, 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). In still other embodiments, 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.

[0096] The light delivered from each light source 110 may be varied in its delivery length. In addition, 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. Of course, other configurations are possible. For example, catheter 102 may include only two light sources that emit light having wavelengths between about 250 nm to about 270 nm. Alternatively, 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.

[0097] In some embodiments, light sources 1 10 comprises light emitting diodes

(LEDs) that comprise semiconductor light sources that emit light when current passes through them. In other embodiments, 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.

[0098] In certain embodiments, 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. Alternatively, 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.

[0099] In one embodiment, 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. In an alternative embodiment, 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. For example, 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. Alternatively, 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.

[00100] In certain embodiments, disinfection system 100 may comprise multiple pull cables configured to allow the operator to clean multiple lumens within scope 10. For example, 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.

[00101] 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.

[00102] 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.

[00103] According to another aspect of the present disclosure, 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.

[00104] Referring now to Fig. 3, another embodiment of disinfection system 100 will now be described. As shown, 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. As in the previous embodiment, 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. In certain embodiments, 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. In other embodiments, 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. [00105] In one aspect of the invention, 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.

[00106] 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. In some embodiments, 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.

[00107] The disinfection system of the present disclosure is not limited to a catheter. For example, 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.

[00108] In this embodiment, 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. In this embodiment, the energy can be delivered to disinfect and sterilize the external surfaces of the endoscopic instrument.

[00109] Referring now to Fig. 4, a distal end portion of a representative endoscope 200 that incorporates a disinfection system according to the present disclosure will now be described. As shown, 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).

[00110] 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.

[0011 1] In certain embodiments, 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. Alternatively, 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. In use, pathogen-killing energy may be delivered throughout the internal lumens 204 of endoscope 206 during, of after, use within a patient.

[00112] Referring now to Figs. 5A and 5B, 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. However, it will be recognized that 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.

[00113] As shown, 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).

[00114] As in previous embodiments, energy transmission element 308 is configured to emit energy into internal lumen 304 to sterilize or disinfect a portion of internal lumen 304. In certain embodiments, 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. Alternatively, 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.

[00115] Referring now to Fig. 6, a representative implantable drug delivery device 400 incorporating a disinfection system according to the present invention will now be described. Of course, it should be recognized that the present invention can be incorporated into a variety of implantable devices, such as electrical nerve stimulators, defibrillators, stents, pacemakers, joint implants, internal fixation devices, spinal implants and other devices that are implanted within a patient’s body. As shown, 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. Of course, device 400 is merely representative and may comprise a number of conventional drug delivery devices known in the art.

[00116] According to the present disclosure, 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). As in previous embodiments, 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.

[00117] In certain embodiments, 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. Alternatively, 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.

[00118] Referring now to FIG. 7, a 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. Of course, 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. In one such embodiment, the implantable device comprises a tubular support device for maintaining patency of a body lumen.

[00119] In the exemplary embodiment, 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. nitinol), bioabsorbable materials or the like. [00120] As shown, 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). As in previous embodiments, 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.

[00121] In another aspect of the invention, systems and methods for treating wound tissue, such as chronic wound tissue, are now described. 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.

[00122] In one embodiment, 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. In a preferred embodiment, 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, however, 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.

[00123] 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.

[00124] 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. In one embodiment, 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.

[00125] 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. In certain embodiments, the working gas may comprise an inert gas, such as helium, argon, nitrogen or the like. In other embodiments, the working gas may comprise air. In an alternative embodiment, 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.

[00126] 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. Alternatively, the shaft may include one or more openings for emitting the plasma.

[00127] 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. For purposes of the present disclosure, 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. These and other 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.

[00128] Alternatively, 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.

[00129] In certain embodiments, a device for generating a plasma at a surgical site, such as wound tissue, 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. In some embodiments, 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, for example, 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.

[00130] In certain embodiments, an optical coupler device, such as one described above, includes one or more electrodes suitably coupled to a power source. As described above, 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. [00131] 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.

[00132] 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.

[00133] Hereby, all issued patents, published patent applications, and non-patent publications that are mentioned in this specification are herein incorporated by reference in their entirety for all purposes, to the same extent as if each individual issued patent, published patent application, or non-patent publication were specifically and individually indicated to be incorporated by reference.

[00134] While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.