Apparatus and method for irradiating with therapeutic light to reduce the risk of healthcare providers contracting infectious diseases.

Abstract

To reduce the risk of healthcare providers contracting infectious diseases, the present invention provides apparatus and methods for irradiating or otherwise using therapeutic light. [Solution] A therapeutic lighting assembly used to reduce a patient's viral load, comprising a housing that houses at least one therapeutic light source configured to emit light using air coming out of the patient's airway, a power supply coupled to the at least one therapeutic light source, and a tube attachment coupled to the housing configured to secure the housing to the patient's tube.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit and priority of U.S. Non - Provisional Patent Application No. 17 / 323,155, filed on May 18, 2021, and U.S. Provisional Patent Application No. 63 / 026,319, filed on May 18, 2020, the disclosures of which are hereby incorporated by reference in their entirety.

[0002] The subject invention relates to surgical instruments, and more particularly, to devices and methods for delivering therapeutic illumination or otherwise being used by a healthcare provider to reduce the risk of contracting an infectious disease.

Background Art

[0003] Viruses are small, infectious agents with a simple composition that can only replicate in living cells of animals, plants, or bacteria. Specifically, viruses are microscopic parasites and are generally much smaller than bacteria. They cannot grow and reproduce outside a host. There are many types of viruses, including rhinoviruses that frequently cause colds, viruses that are the cause of contagious diseases such as the Ebola pandemic in West Africa in 2014, the H1N1 / swine influenza pandemic in 2009, and more recently, the novel coronavirus (COVID - 19) in 2019, which is better known as SARS - CoV - 2. Many of these viruses are primarily transmitted by direct contact with mucous membranes.

[0004] Direct contact can be more specifically described as transmission through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouth or nose of people nearby, or, in some cases, be inhaled into their lungs. For example, both seasonal influenza viruses and novel coronaviruses are thought to be transmitted primarily through close contact with aerosolized droplets released from the nose and mouth of infected individuals. Infection can occur not only through direct contact such as kissing, but also by talking at close range to infected people.

[0005] Seasonal influenza viruses or novel coronaviruses can be transmitted within hours or even days if not disinfected, by touching a table, telephone, or other surface that has been coughed on, and then touching the eyes, nose, or mouth. Data reveal that the R0 metric, which represents how many people are infected by an individual carrying the virus, is between 2 and 2.5 for novel coronaviruses. This number is significantly higher than that of seasonal influenza, where the R0 value is approximately 1.3. With appropriate precautions, the R0 value can decrease, and it is said that a decrease in the R0 value to below 1 would mark the end of a pandemic.

[0006] Healthcare professionals (HCPs) are at high risk because they are in very close contact with infected patients on a daily basis. In our HCPs, there was a high infection rate during each of these contact-transmitted diseases while treating patients. It has been reported that up to 25% of confirmed cases in recent pandemics were HCPs. Additional exposure and the risk of infection to other vulnerable patients increase the potential social impact. Furthermore, sick healthcare providers must be away from the healthcare system during recovery, preventing them from treating patients and further exacerbating the demand and shortages during outbreaks. Intubation is a medical procedure that typically involves inserting a flexible plastic tube into the patient's mouth and then into the airway. It is a common procedure performed in operating rooms, emergency departments, and intensive care units (ICUs) worldwide. Intubation may be necessary for several reasons, such as mechanical ventilation for anesthetized patients undergoing surgical procedures, or to improve oxygen saturation for patients with lung damage or respiratory illnesses.

[0007] Ventilation has been used to treat patients with many different viruses, including COVID-19. Once intubated, air is delivered to the lungs via a machine or manually using a bag or other mechanism.

[0008] There are several different types of intubation, classified based on the location of the tube and what it aims to achieve. Endotracheal tube (ETT) intubation involves passing a tube through the nose or mouth into the trachea to assist a person breathing while under anesthesia or with poor airway function. Nasogastric intubation involves passing a tube through the nose into the stomach to remove air or to supply or deliver medication to a patient. Fiber optic intubation involves a physician inserting a camera-equipped tube into the throat to examine the throat or assist in endotracheal intubation when a person is unable to properly extend or bend their head or when the anatomical structure is found to be abnormal or difficult. A laridial mask (LMA) is a type of supraglottic airway device that is a less invasive alternative to endotracheal tube intubation in certain clinical scenarios. Tracheostomy or tracheostomy tube is inserted through a surgically created opening or small hole through the trachea via the anterior skin of the neck.

[0009] The primary purposes of intubation include opening the airway to administer oxygen, anesthesia, or medication; clearing obstructions; assisting a person to breathe in cases of lung injury, heart failure, or trauma; allowing a physician to monitor the airway; and helping to prevent a person from inhaling fluids. All of these intubation methods require close contact between the patient and the healthcare professional (HCP).

[0010] Intubation procedures vary depending on their purpose and whether they occur in an operating room or in an emergency. Typically, intubation is performed before placing a patient on a ventilator to assist breathing under anesthesia or during a critical illness.

[0011] In an operating room or other controlled setting, the doctor typically first sedates the person. Then, the doctor inserts a laryngoscope into the person's mouth to assist in inserting a flexible tube. The doctor uses the laryngoscope to locate sensitive tissues such as the vocal cords and to avoid damaging them. If the doctor has difficulty seeing, they may insert a small fiber optic camera to help guide them. In an operating room, the doctor typically uses intubation to help the person breathe under anesthesia.

[0012] HCPs, including physicians, nurses, anesthesiologists, anesthetic technicians, and respiratory therapists, intubate and provide regular care to intubated patients. In addition to inserting intubation / ventilator tubes and connecting ventilators, they may also need to reposition, clean, remove, or replace intubation tubes, as well as aspirate mucus or other fluids that have accumulated in the patient's mouth. Being very close to the patient's respiratory system significantly increases the risk of exposure to droplet and aerosolized transmissible viral infections.

[0013] Smoke generated during surgical procedures utilizing electrosurgery can also pose an additional risk to HCP due to its association with the transmission of aerosolized viruses. Electrosurgery utilizes a heating electrical device with a metal "blade" to cauterize or vaporize tissue to aid in tissue removal or excision, while simultaneously cauterizing or sealing blood vessels to minimize bleeding. There is a wealth of literature studying the potential transmission of bio-derived materials via surgical smoke generated from electrosurgical devices, lasers, and ultrasonic scalpels.

[0014] The researchers identified HIV DNA2 and complete HPV DNA strands in laser smoke.

[0015] Researchers have further studied the transmission of infections via surgical smoke. In one study, for example, researchers demonstrated that transmission of HIV DNA recovered from surgical plumes to cultured cells is indeed possible. One case of a surgeon who developed laryngeal papillomatosis after treating a patient with anogenital condyloma with laser tissue vaporization strongly suggests transmission via surgical smoke. The HPV strain the surgeon contracted matched the HPV strain of the treated patient, and no other method of exposure other than inhalation of the surgical plume was identified as a risk factor. Cases of verrucae (highly contagious viral warts treated by laser cauterization) in laser operators at abnormal sites such as the anterior nostrils of the nasal cavity have also been recorded, suggesting transmission via surgical smoke.

[0016] A study of surgeons treating warts at the Mayo Clinic found that while the prevalence was not elevated in the surgeon group compared to the general population, 13% of surgeons developed nasopharyngeal warts, a rare infection site in the general population, which could best be explained by smoke plume inhalation. Surgeons, physician assistants, surgical residents, nurses, scrub technicians, and other HCPs who come into contact with surgical plumes are at increased risk of contracting the virus from infected patients.

[0017] HCPs typically utilize personal protective equipment (PPE) when treating patients with known viruses. In the absence of recognition of a highly contagious virus, a simple face mask and, if possible, gloves are used as standard PPE. To limit the spread of disease during epidemics with greater contagiousness than the common cold and seasonal influenza, HCPs take additional measures to protect themselves while caring for infected patients, including the use of isolation gowns, face masks, face shields, N95 masks, goggles or other types of eye protection, and sterile gloves. While this raises the PPE threshold during known epidemics and improves HCP protection, it still leaves many scenarios in which HCPs can become ill.

[0018] PPE is effective for single use only, and in the early stages of an outbreak before HCPs recognize a new virus, regular masks and gloves may be insufficient to prevent transmission of a highly transmissible disease. Other reasons why PPE may not protect HCPs include improper use, failure of PPE material or equipment, self-contamination, shortages, and reuse. While there are clinical trials on PPE treated with antimicrobial agents that have proven ineffective, other studies suggest that each HCP should enter a UV chamber before removing PPE after treating an infected patient.

[0019] Unfortunately, the latter is not a practical solution in many countries or most facilities, even in developed countries like the United States. Traces of viral RNA have been found on hospital and operating room walls, even when PPE protocols are properly used. Furthermore, studies show that greater exposure to the virus can potentially lead to more severe cases and higher transmission rates. Hospitals and other healthcare facilities that treat infected patients are centers of viral activity, so simply protecting them from the virus is not enough.

[0020] The most effective way to protect HCPs from contact-borne diseases is to physically remove or eliminate the hazard itself. Following elimination, the hazard is replaced, and another hazard is substituted. Following substitution, controls are developed and designed to isolate people from the hazard, and management controls are implemented to change how people work. The likelihood or number of transmissions can be reduced by reducing or limiting the amount of hazard or exposure. Finally, PPE is one of the least effective ways to protect HCPs from contact-borne diseases. Therefore, the use of PPE alone does not eliminate the risk to HCPs treating patients with contact-borne diseases. A reduction in viral load in hospitals has the combined effect of increasing the effectiveness of all subsequent policies and procedures implemented to reduce viral transmission to HCPs.

[0021] Currently, procedures involving UV-C photomedicine include lamps, room disinfection, and cumbersome commercially available handheld UV floodlights. Devices like Biomation's TheraBand are used for wound care but are not sterilized and are brought into the surgical field.

[0022] One of the most significant obstacles to its use to date has been the need to interrupt surgery to position particularly cumbersome UV-C devices in close proximity to the tissue at risk. Another obstacle is the need to manufacture sterilization equipment that can be used within the sterile surgical field during therapeutic procedures such as surgery.

[0023] Other types of therapeutic illumination, including but not limited to UV light, UV-C light, far UV-C light, infrared light, near-infrared light, low-level laser light, and white light, have shown effectiveness in controlling viral and bacterial loads.

[0024] Past methods for protecting HCPs and other healthcare workers from viral load spread have failed to provide acceptable results, and together with the aforementioned limitations, indicate a clear need for alternative approaches to treating the surgical area of ​​patients. This disclosure provides a solution to this need by incorporating therapeutic lighting into devices such as intubation tubes and masks, as well as suction tubes, which are commonly used during surgery. [Overview of the project]

[0025] Disclosed is a set of devices and methods for protecting healthcare providers (HCPs) by reducing viral counts, bacterial counts, or other potentially infectious or infection-causing factors. Therapeutic illumination is directly shone onto a light source (typically the mouth and nasal area of ​​an infectious or potentially infectious patient) to denature, inactivate, kill, or otherwise render harmless some of these infectious factors. Other locations for irradiating with therapeutic illumination include near surgical sites on infectious or potentially infectious patients, or along pathways leading to healthcare providers, including the patient's respiratory equipment and personal protective equipment (PPE). The effect of these devices and methods is to reduce the risk to HCPs by partially (reducing) or completely (eliminating) infectious factors, thereby reducing or eliminating exposure to HCPs. Devices are intended to be sterile single-use, partially sterile single-use, non-sterile single-use, or reusable.

[0026] When incorporated into a stationary device specifically intended to directly irradiate therapeutic lighting to a potential source of infectious agents, the device can be designed to irradiate the therapeutic lighting at an optimal distance for effectiveness. To improve the effectiveness of therapeutic lighting treatments or to ensure that the lighting is only irradiated when desired, an optical lens can be used to directly focus or redirect the therapeutic lighting.

[0027] The device can be used in any type of patient care facility, including emergency treatment rooms, operating rooms, intensive care units (ICUs), respiratory therapy treatment centers, and other locations where healthcare providers can benefit from reducing the risk of exposure to harmful infectious agents. The device can be used continuously throughout a procedure such as surgery or over the entire duration of intubation, periodically during care (i.e., once an hour during intubation), or at specified times during care (i.e., only when the tube is inserted or removed, when a healthcare provider is present, etc.).

[0028] The disclosed concept shows different embodiments of medical devices incorporating therapeutic lighting. This lighting can use lighting of wavelengths effective in reducing the number of viruses, bacteria or other potential contaminants / infectious agents, such as molds or fungi and other pathogens, such as protozoa and helminths. The therapeutic lighting can be selected from a group of light sources including UV light, UV-C light, far UV-C light, infrared light, near infrared light, low level laser light, and white light. The power source can be housed within an internal cavity of the body or can be housed externally or remotely from the body. The internal power source can be selected from a group of power sources including, but not limited to, thin-film batteries, coin batteries, rechargeable batteries, and other types of batteries. The external power source can include a wall outlet, an external battery pack, or a wired wall outlet from another power source.

[0029] The light source includes at least one light source associated with a printed circuit board supported within the device, and the light source is preferably an LED. The light source can also comprise at least one laser diode or other therapeutic light source. The control circuit is operably associated with the printed circuit board such that it can activate and deactivate the power supply and / or the light source via a button, switch, or some other mechanism. The control circuit may include a further function of measuring the treatment period or indicating that a predetermined treatment period has been completed. By continuously operating the therapeutic illumination, the HCP can be active without the need to interrupt the operation. By using more targeted intermittent treatment, the HCP can more accurately target potential sources of infection and avoid overexposure to patient tissue.

[0030] Furthermore, the additional usefulness of the device can be visible light that is used in combination with the therapeutic illumination within the same device to improve the illuminance. This can be achieved by connecting visible light LEDs alternately with the light treatment (e.g., UV) LEDs or having separate illumination areas on the same device. The device may have a switch for activating the visible light separately from the therapeutic illumination, or both may be controlled via the same switch.

[0031] A therapeutic illumination assembly for reducing the viral load of a patient includes a housing containing at least one therapeutic light source configured to directly illuminate the airway or the exhaled gas path of the patient, a power supply coupled to the at least one therapeutic light source, and a tube attachment coupled to the housing configured to secure the housing to the patient's tube.

[0032] The patient's tube can include an endotracheal tube or a nasal cannula. The housing can be coupled to a headset for attachment to the patient's head, and the headset can be secured to the patient's head via a strap, a plurality of face pads coupled to an arch-shaped headset base, or other means. The headset can be configured to be positioned under the patient's nose.

[0033] The housing may include a first panel and a second panel, the first panel including a plurality of inward-facing ribs for positioning therapeutic light sources within the housing. At least one therapeutic light source may be positioned via a directional assembly having an opening in the housing, adhesive or other fastening method, or other means. A tube attachment may be coupled to the housing by a pair of spacing ribs. The spacing ribs may be configured at specific distances to optimize the effectiveness of the therapeutic illumination. The housing may include an opening through which therapeutic illumination can be directed towards and illuminate the tube attachment. The device may include an optical lens for guiding the therapeutic illumination.

[0034] The tube attachment may be rotatable around an axis. The tube attachment may be rotatable in a plane parallel to the plane defined by the housing. Rotation can improve patient comfort and improve the directivity of the therapeutic light. The energy source may be a battery housed in the first cover. The therapeutic light source may include multiple LEDs or other light sources controlled by a printed circuit board in the housing, and can be selected from a group including UV light, UV-C light, far UV-C light, infrared light, near-infrared light, low-level laser light, and white light. The therapeutic light source may include multiple light sources arranged circumferentially around the housing. The housing may be placed inside the patient's tube. The tube attachment may be securely mounted to the housing, or the tube attachment may be placed coplanar with the plane defined by the housing. The therapeutic light source may be incorporated into a face mask.

[0035] These and other features of the apparatus and system of the present invention will be readily apparent to those skilled in the art from the drawings and the following brief description of the drawings themselves. [Brief explanation of the drawing]

[0036] Preferred embodiments of the apparatus and system of the present invention will be described in detail below with reference to the drawings, so that those skilled in the art can easily understand how to manufacture and use them without excessive experimentation. [Figure 1] This shows an isometric view of a therapeutic lighting arc configured to produce a regional lighting effect. [Figure 2] Figure 1 shows a front view of the illumination arc. [Figure 3] Figure 1 shows a front view of the illumination arc. [Figure 4] Figure 1 shows an exploded isometric view of the illumination arc. [Figure 5] Figure 1 shows a bottom view of the illumination arc. [Figure 6] Figure 1 shows a top view of the illumination arc with the upper housing removed. [Figure 7] Figure 1 shows a side view of the illumination arc with the upper housing removed. [Figure 8] Figure 2 shows a cross-sectional view obtained along AA. [Figure 9] An enlarged view C obtained from Figure 8 is shown. [Figure 10] An enlarged view B, obtained from Figure 6, is shown. [Figure 11] Figure 1 shows an isometric view of the bottom housing of the illumination arc. [Figure 12] Figure 1 shows a top view of the bottom housing of the illumination arc. [Figure 13] An enlarged view D obtained from Figure 12 is shown. [Figure 14] This shows an isometric view of a PCB with a UV LED. [Figure 15] This shows a bottom view of the PCB. [Figure 16] A side view of the PCB is shown. [Figure 16A] Figure 1 shows the therapeutic lighting arc mounted on a hospital bed with the patient lying on the floor. [Figure 16B] Figure 1 shows the therapeutic lighting arc mounted on a hospital bed with the patient lying on the floor. [Figure 16C] This diagram shows a therapeutic lighting arc (Figure 1) mounted on a hospital bed, along with an intubated patient using a ventilator with their head down. [Figure 16D] This figure shows the therapeutic lighting arc (Figure 1) attached to the operating table while the patient is undergoing surgery. [Figure 17] This shows a therapeutic lighting arc with a smoke emission function. [Figure 18] Figure 17 shows a front view of the therapeutic illumination arc. [Figure 19] Figure 17 shows a side view of the therapeutic illumination arc. [Figure 20] Figure 17 shows an exploded isometric view of the illumination arc assembly. [Figure 21] Figure 17 shows a bottom view of the illumination arc. [Figure 22] Figure 17 shows a top view of the illumination arc. [Figure 23] The EE cross-section obtained from Figure 18 is shown. [Figure 24] An enlarged view G, obtained from Figure 23, is shown. [Figure 25] Figure 17 shows an isometric view of the bottom housing of the illumination arc. [Figure 25A] This figure shows the illumination arc attached to the operating table while the patient is undergoing surgery. [Figure 26] This shows a therapeutic illumination ring for surgical sites with smoke emission. [Figure 27] Figure 26 shows a front view of the surgical ring. [Figure 28] Figure 26 shows a side view of the surgical ring. [Figure 29] Figure 26 shows an exploded view of the surgical ring. [Figure 30] Figure 26 shows a top view of the surgical ring. [Figure 31] Figure 30 shows the cross-section HH. [Figure 32] An enlarged view J of Figure 31 is shown. [Figure 33] Figure 26 is an isometric view of the surgical site ring with the cover plate and filter removed. [Figure 34] Figure 26 shows an isometric view of the inside of the surgical site ring. [Figure 35] Figure 26 shows an isometric view of the outside of the housing of the surgical site ring. [Figure 36] Figure 26 shows an isometric view of the cover plate of the surgical site ring. [Figure 37] Figure 26 shows an isometric view of the filter enclosed within the chamber of the surgical site ring. [Figure 38] This shows an isometric view of a PCB with a UV LED. [Figure 39] Figure 26 shows isometric fracture diagrams of the electrical wires and connectors of the surgical site ring. [Figure 39A] Figure 26 shows a top view of the light ring around the surgical wound of a patient undergoing surgery. [Figure 39B] Figure 26 shows an isometric view of the light ring around the laparoscopic trocar / access port in a patient undergoing surgery. [Figure 40] An embodiment is shown having therapeutic lighting incorporated into the nasal cannula assembly to provide supplemental oxygen. [Figure 41] Another perspective view of the therapeutic lighting shown in Figure 40 is presented. [Figure 42] Another perspective view of the therapeutic lighting shown in Figure 40 is presented. [Figure 43] Figure 40 shows a bottom view of the therapeutic lighting. [Figure 44] Figure 40 is a front view of the therapeutic lighting with the front plate removed. [Figure 45] Figure 40 shows a rear view of the therapeutic lighting. [Figure 46] Figure 40 shows an exploded isometric view of the therapeutic lighting system. [Figure 47] Figure 40 shows a top view of the therapeutic lighting. [Figure 48] Figure 43 shows a cross-sectional view of the therapeutic lighting along the KK line. [Figure 49] An enlarged view N obtained from Figure 47 is shown. [Figure 50] Figure 45 shows a cross-sectional view obtained along MM. [Figure 51] An enlarged view L obtained from Figure 44 is shown. [Figure 52] Figure 40 shows an isometric view of the nasal insert and posterior light plate components of the therapeutic illumination incorporated into the nasal cannula assembly. [Figure 53] Figure 40 shows a bottom view of the nasal insert and posterior light plate components of the therapeutic illumination. [Figure 54] Figure 40 shows bottom, side, and top views of the nasal insert and posterior light plate components of the therapeutic illumination. [Figure 53] Figure 40 shows bottom, side, and top views of the nasal insert and posterior light plate components of the therapeutic illumination. [Figure 56] Figure 40 shows an isometric view of the wire holder components of the therapeutic lighting. [Figure 57] Figure 40 shows an isometric view of the PCB of the therapeutic lighting. [Figure 57A] Figure 40 shows a diagram of therapeutic lighting integrated into a nasal cannula assembly fitted to a patient lying in a hospital bed. [Figure 57B] Figure 40 shows a diagram of therapeutic lighting integrated into a nasal cannula assembly fitted to a patient lying in a hospital bed. [Figure 58] This shows a surgical site illumination ring for open surgery. [Figure 58] This shows an isometric view of a surgical site illumination ring for open surgery. [Figure 59] Figure 58 shows a front view of the therapeutic illumination surgical site ring. [Figure 60] Figure 58 shows a side view of the therapeutic illumination surgical site ring. [Figure 61] Figure 58 shows an isometric exploded view of the therapeutic illumination surgical site ring. [Figure 62] Figure 63 shows a cross-sectional view of the therapeutic illumination surgical site ring from Figure 58, along the line RR obtained from Figure 63. [Figure 63] Figure 58 shows a top view of the therapeutic illumination surgical site ring. [Figure 64]Figure 58 shows an isometric view of the therapeutic illumination surgical site ring with the outer housing and cover plate removed. [Figure 65] An enlarged view P obtained from Figure 62 is shown. [Figure 66] Figure 58 shows an isometric view of the therapeutic illumination surgical site ring inside the body. [Figure 67] Figure 58 shows an isometric view of the PCB of a therapeutic illumination surgical site ring equipped with UV LEDs. [Figure 67A] Figure 58 shows a light ring for open and laparoscopic surgery, fitted around the surgical incision of a patient undergoing surgery. [Figure 67A] Figure 58 shows a light ring for open and laparoscopic surgery, fitted around the surgical incision of a patient undergoing surgery. [Figure 67C] This is an isometric view of a light ring for open and laparoscopic surgery, fitted around the laparoscopic trocar / access port of a patient undergoing surgery. [Figure 68] This shows therapeutic lighting integrated into a ventilator mouthpiece or head strap for intubated patients. [Figure 69] Figure 68 shows an isometric view of the therapeutic lighting. [Figure 70] Figure 68 shows an exploded view of the therapeutic lighting system. [Figure 71] Figure 68 shows a top view of the therapeutic lighting. [Figure 72] Figure 68 shows a side view of the therapeutic lighting. [Figure 73] Figure 68 shows a rear view of the therapeutic lighting. [Figure 74] Figure 68 shows a front view of the therapeutic lighting assembly with the front cover removed. [Figure 75] An enlarged view S obtained from Figure 74 is shown. [Figure 76] Figure 68 shows an isometric view of the therapeutic lighting assembly with the front cover and PCB removed. [Figure 77] Figure 68 shows a front view of the therapeutic lighting assembly with the front cover and PCB removed. [Figure 78] Figure 68 shows an isometric view of the PCB of the therapeutic lighting. [Figure 79] Figure 68 shows a rear view of the face pad of the therapeutic light. [Figure 80] Figure 68 shows a side view of the ventilator tube. [Figure 81] Figure 68 shows an isometric view of the ventilator tube. [Figure 82] Figure 68 shows an isometric view of a ventilator tube with a therapeutic lighting assembly attached. [Figure 83] Figure 68 shows a side view of a ventilator tube with a therapeutic lighting assembly attached. [Figure 83A] Figure 68 shows the therapeutic illumination incorporated into a ventilator mouthpiece for intubated patients, fitted to the patient without a ventilator tube. [Figure 83B] Figure 68 shows therapeutic lighting integrated into a head strap for intubated patients, fitted to the patient without a ventilator tube. [Figure 83C] Figure 68 shows therapeutic lighting integrated into a ventilator mouthpiece or head strap for intubated patients, fitted to an intubated patient with a ventilator tube. [Figure 84] This shows a front view of a retaining structure assembly with therapeutic lighting integrated into a ventilator tube for an intubated patient. [Figure 85] Figure 84 shows a side view of a retaining structure assembly with therapeutic lighting integrated into a ventilator tube for an intubated patient. [Figure 86] Figure 84 shows a top view of a retaining structure assembly with therapeutic lighting integrated into a ventilator tube for intubated patients. [Figure 87] Figure 84 shows an isometric view of the therapeutic lighting integrated into the ventilator tube. [Figure 88] Figure 84 shows an exploded view of the therapeutic lighting integrated into the ventilator tube. [Figure 89] Figure 84 shows a diagram of the intubation tube. [Figure 90]Figure 84 shows a bottom view of the PCB with a UV LED. [Figure 91] Figure 84 shows a side view of the PCB. [Figure 92] Figure 84 shows a side view of the ventilator tube, indicating the area for attaching the PCB. [Figure 93] Figure 84 shows an isometric view of the tube having a therapeutic lighting and retaining structure assembly. [Figure 94] Figure 84 shows a top view of the PCB of the therapeutic lighting system with UV LEDs. [Figure 95] Figure 84 shows an isometric view of the battery components of the therapeutic lighting system. [Figure 96] Figure 84 shows an isometric view of the assembly with therapeutic lighting incorporated into the ventilator tube and retention structure assembly. [Figure 96A] Figure 84 shows therapeutic lighting incorporated into a ventilator tube and retention structure assembly attached to an intubated patient in a hospital bed connected to a ventilator. [Figure 96B] Figure 84 shows therapeutic lighting incorporated into a ventilator tube and retention structure assembly attached to an intubated patient in a hospital bed connected to a ventilator. [Figure 97] A rear view of an attachable therapeutic light with a ventilator tube for an intubated patient is shown. [Figure 98] Figure 84 shows an exploded view of the therapeutic lighting. [Figure 99] Figure 84 shows a front view of the main components of the therapeutic lighting system. [Figure 100] Figure 84 shows an isometric view of the lens cover components of the therapeutic lighting. [Figure 101] Figure 84 shows a side view of the battery components of the therapeutic lighting. [Figure 102] Figure 84 shows a front view of the battery and PCB assembly for the therapeutic lighting. [Figure 103] Figure 84 shows a side view of the PCB of the therapeutic light. [Figure 104] Figure 84 shows a rear view of the PCB of the therapeutic lighting device. [Figure 105] Figure 84 shows the ventilator tube before attachment of the attachable therapeutic light. [Figure 106] Figure 84 shows the ventilator tube after the attachment of the attachable therapeutic light. [Figure 106A] Figure 84 shows a mountable therapeutic light for attachment to a ventilator tube. [Figure 106B] Figure 84 shows a mountable therapeutic light for attachment to a ventilator tube. [Figure 107] This shows a therapeutic light integrated into a tracheostomy tube. [Figure 108] Figure 107 shows a front view of the optical PCB. [Figure 109] Figure 107 shows a side view of the intermediate tube. [Figure 110] Figure 107 shows an isometric view of the tracheostomy tube. [Figure 111] Figure 107 shows a side view of the PCB. [Figure 112] Figure 107 shows an isometric view of the battery components. [Figure 113] Figure 107 shows the rear view of the PCB. [Figure 114] This shows a side view of a therapeutic light integrated into a tracheostomy tube. [Figure 115] Figure 107 shows an exploded view of the therapeutic lighting integrated into the tracheostomy tube. [Figure 115A] Figure 107 shows the therapeutic lighting incorporated into a tracheostomy tube used in patients undergoing tracheostomy in a hospital bed. [Figure 115B] Figure 107 shows the therapeutic lighting incorporated into a tracheostomy tube used in patients undergoing tracheostomy in a hospital bed. [Figure 116] This shows a front view of a bag-mask ventilation system for therapeutic lighting. [Figure 117] Figure 116 shows a side view of a bag-mask ventilation system for therapeutic lighting. [Figure 118]Figure 116 shows a front view of the PCB components of the optical bag mask ventilation system. [Figure 119] Figure 116 shows a front view of the PCB components of the optical bag mask ventilation device with the battery installed. [Figure 120] Figure 116 shows a side view of the PCB of the optical bag mask ventilation system. [Figure 121] Figure 116 shows a rear view of the PCB of the optical bag mask ventilation system. [Figure 122] Figure 116 shows a side view of the battery of the optical bag-mask ventilation system. [Figure 123] Figure 116 shows a rear view of the mask components of the optical bag-mask ventilation system. [Figure 124] Figure 116 shows the bag of the optical bag mask ventilation device. [Figure 125] Figure 116 shows a front view of the mask bag ventilation assembly for therapeutic lighting. [Figure 125A] Figure 116 shows a mask bag ventilation system for therapeutic lighting used for patients in hospital beds. [Figure 125B] Figure 116 shows a mask bag ventilation system for therapeutic lighting used for patients in hospital beds. [Figure 126] This shows a front view of the mask component of a bag ventilation system for therapeutic lighting. [Figure 127] Figure 126 shows an isometric view of the mask components of a bag ventilation system for therapeutic lighting. [Figure 128] Figure 126 shows a front view of the lighting bag ventilation assembly for therapeutic lighting. [Figure 129] An enlarged view T obtained from Figure 127 is shown. [Figure 130] The cross-sectional UU obtained from Figure 128 is shown. [Figure 131] This shows a front view of the mask components of a therapeutic illumination mask for a ventilator. [Figure 132] Figure 131 shows a top view of a therapeutic illumination mask for a ventilator assembly. [Figure 133]Figure 131 shows a front view of a therapeutic illumination mask for a ventilator assembly. [Figure 134] Figure 131 shows a rear view of a therapeutic illumination mask for a ventilator assembly. [Figure 135] This shows a personal protective mask for therapeutic lighting used by healthcare providers. [Figure 136] Figure 135 shows a front view of the PCB of a personal protective mask for therapeutic lighting. [Figure 137] Figure 135 shows a side view of the PCB of a personal protective mask for therapeutic lighting. [Figure 138] Figure 135 shows a top view of a therapeutic illumination mask with a built-in face shield assembly. [Figure 139] Figure 135 shows a front view of the mask components of a therapeutic illumination mask with a built-in face shield assembly. [Figure 140] Figure 135 shows a rear view of the mask components of a therapeutic illumination mask with a built-in face shield. [Figure 140A] This shows a healthcare provider wearing a mask device for therapeutic lighting. [Figure 140B] This shows a healthcare provider wearing a mask device for therapeutic lighting. [Modes for carrying out the invention]

[0037] The following describes a set of devices and methods for protecting healthcare providers (HCPs) by irradiating a source of infection (typically the oral and nasal areas of an infectious or potentially infectious patient) with therapeutic illumination to reduce viral counts, bacterial counts, or other potentially infectious or infection-causing factors, thereby denaturing, inactivating, killing, or otherwise rendering some of these infectious factors harmless. Therapeutic illumination is harmless to humans and can be used to penetrate and kill airborne viruses. Integrating such therapeutic illumination into devices such as intubation tubes and masks, as well as suction tubes commonly used during surgery, as described in detail below, can be used to reduce or eliminate the associated viral load, thereby reducing the risk of transmission and infection to HCPs who come into close contact with affected respiratory droplets while performing intubation, surgery, and other similar airway-related procedures, and to others.

[0038] Specifically, therapeutic lighting includes UV light (ultraviolet light), UV-C light (deep ultraviolet light), and Far UV-C light (far ultraviolet), infrared light, near-infrared light, low-level laser light, white light, and other short-wavelength ultraviolet light for germicidal irradiation (UVGI) that damages microbial DNA may be included. Specifically, UV-C therapy has been noted for also promoting wound healing. Furthermore, UV-C light is beginning to prove more useful in preventing surgical site infections (SSIs), with one study revealing a reduction in infection rates from 10% to 0.24% with UV therapy.

[0039] This is the most commonly known commercially available UV sterilizer for consumer disinfection of mobile phones.

[0040] Herein, referring to drawings where similar reference numerals identify similar structural elements and features of the present invention, Figure 1-16D shows a therapeutic illumination arc 10 designed to generate “area” style therapeutic illumination from a therapeutic light source 6 around a treatment area critical to reducing the number of infectious agents. In one illustrated embodiment, it is possible for a patient to be in bed with the arc 10 localized over their head for treatment of the mouth and nose area, whether or not they are intubated (Figure 16C).

[0041] The arc 10 comprises an inner panel 2 and an outer panel 4, which constitute the arc 10 body and are powered via an electrical cord 8 and lead wires 16. The inner panel 2 may include multiple openings of holes 18 for illuminating the therapeutic light source 6. The therapeutic light source 6 is packaged between the inner panel 2 and the outer panel 4 by multiple strips 12. Each of the strips 12 is held in place by ribs 14 extending from the edge of the inner panel 2. Exhaled breath and droplets within it are treated with the therapeutic illumination. The arc 10, shown here as a three-sided arc, can be stationary on a bed, but in alternative embodiments, the user can hook the arc around the patient's head or around the back of a hospital sofa bed / upright bed. The patient may wear UV protective eyewear as needed. Further versions utilize the arc around an open surgical site where the illumination acts to combat any infectious agents aerosolized during surgery via electrocautery, blood jet, smoke, or airflow. The illustrated concept involves wired power, but the device may be battery-powered. This embodiment may also have the effect of reducing the infection rate in patients by treating bacteria, viruses, and other harmful factors that may be present in surgical cavities.

[0042] Referring to Figures 17–25A, a therapeutic illumination arc 20 is shown, made up of an inner panel 22 and an outer panel 24 having smoke exhaust capability through an exhauster 26. A filter element 34 is embedded within the exhauster 26 for filtering particulate matter and harmful substances from cauterization smoke, and a conduit 32 for exhausting smoke. This arc 20, shown here as a three-sided arc, acts to actively remove air or smoke from around an infected patient and can be used to aspirate and kill infectious agents from a breathing patient or from smoke generated at the surgical site. The inner panel 22 includes multiple openings of holes 18 for illuminating a therapeutic light source 6. The therapeutic light source 6 is packaged between the inner panel 22 and the outer panel 24 by multiple strips 12. Each of the strips 12 is held in place by ribs 14 extending from the edge of the inner panel 2. A power supply 8 is shown, but it may be battery-powered. The inner panel 24 also includes a slit 28 that allows the exhauster 26 to draw smoke through the illumination arc 20. This embodiment shows a conduit 32 connected to an external suction source, but an internal fan or pump is also conceivable to draw untreated air into a therapeutic illumination area (and / or filter) and treat it at the surgical site.

[0043] Referring here to Figures 26 to 39B, a therapeutic illumination surgical site ring 30 is shown, connecting panels 44 and 42 with smoke evacuation capabilities, forming a closed space defined by an inner panel 44 and an outer panel 42 and a brace 46. The outer panel 42 includes guides 74 for aligning the brace and corresponding ribs 82. The ring device 30 surrounding the surgical site or endoscopic or laparoscopic surgical port site includes a slit 56 for smoke to pass through, a filter element 68, and a conduit 58 attached to a suction device such as a smoke evacuation device or wall suction. The suction removes surgical smoke and gases generated from the surgical area by an electrocautery device or other source. Infectious agents carried by the smoke or gases can be aligned on the sheet 62, held in place by the ribs 72, and treated by a bright therapeutic light source 54 illuminating through the port 66. The filter element may consist of a paper filter, a carbon or activated carbon filter, or other types of filters. The illustrated embodiment connects to an external power source via wires 52 and leads 64, but integrated battery power can be utilized. While positioning ribs 82 are shown in this embodiment and other embodiments, other positioning mechanisms can be used to align the therapeutic light source with the enclosure or housing, which is within the scope of this disclosure.

[0044] Referring to Figures 40 to 57B, therapeutic illumination incorporated into a nasal cannula assembly 40 is shown. Patients with some respiratory distress can be treated with supplemental oxygen via a nasal cannula. This delivers additional oxygen to the patient's nose to improve oxygen saturation and alleviate respiratory distress. Therapeutic illumination is incorporated into, assembled with, or mounted on a nasal cannula to illuminate the nasal and oral areas of potentially infected patients. Assembly 40 includes a housing for containing an LED 106. The LED 106 is associated with a circuit board 118 between an inner plate 102 and an outer plate 104. The inner plate 101 includes an opening 122 for illuminating the therapeutic light source 106 and a number of ribs 124 for securing the therapeutic light source board 118. The inner plate 101 is attached to a pair of spacing ribs 128, which include a mounting mechanism for coupling with the nasal cannula 102. The nasal cannula 102, having a tube 108 and a wire support ring 114, also includes a pair of ports 116. Spacing ribs 128 are positioned adjacent to the ports 116 to position the therapeutic light source 106 at a specific distance from the patient's nose and mouth. While other shapes and connection points are included within the scope of this disclosure, one embodiment of therapeutic lighting connected to the nasal cannula using wired power 112 is shown as an item. The device may also be battery-powered.

[0045] Referring here to Figures 58–67C, a therapeutic illumination surgical site ring is shown. This device is an assembly constructed to surround an open surgical site and irradiate therapeutic illumination radially inward to reduce the amount of virus from infectious agents escaping the surgical site. Particularly for surgeons and nurses who need to be close to the open surgical site to see what is happening, this is an important safety device that can work to reduce the risk of breathing in any infectious agent that is aerosolized during surgery, whether through electrocautery, bleeding, smoke, or airflow. One rectangular embodiment is shown by item 50. The therapeutic illumination surgical site rectangle 50 forms a closed space defined by an inner panel 152 and an outer panel 154 and a brace 156 connecting the panels 152 and 154. The outer panel 154 includes a guide 155 for aligning the brace 156 and the corresponding rib 157. Any infectious agent can be treated with therapeutic illumination emanating from a therapeutic light source 54, which is aligned on the sheet 62, held in place by ribs 72, and illuminated through port 162. The illustrated embodiment connects to an external power source via wires 158 and leads 164, but integrated battery power can be utilized.

[0046] To protect the device from accidental movement, it can be attached to the patient's skin or drape via adhesive tape, or weighted to hold it in place. Alternative embodiments with smaller shapes and dimensions can be used in laparoscopic surgery by positioning them around laparoscopic ports. This may be particularly useful in pneumoperitoneal surgical cavities where pressurized pneumoperitoneal gas may leak from the port or port site while carrying infectious agents, as shown in Figure 67C. Multiple rings can be used so that each laparoscopic port site has a therapeutic illumination ring during surgery.

[0047] Referring here to Figures 68–83C, a therapeutic lighting assembly 60 is shown integrated into a ventilator mouthpiece / head strap 202. The lighting assembly 60 includes a plate 204 and a second plate 218 having a PCB 222 containing multiple therapeutic light sources 212. The therapeutic light sources 212 illuminate through ports 232. Intubated patients often wear a mouthpiece or head strap to secure the ventilator tube, thereby preventing the ventilator tube from pulling down or pulling out the patient's mouth or jaw, thus preventing discomfort or injury. The head strap 220 here includes multiple spaced pads 208, and here therapeutic lighting attached to or integrated into the mouthpiece / head strap is shown to illuminate the patient's nose and mouth, where the most infectious viruses are localized and aerosolized. The head strap 202 is coupled to the lighting assembly 60 by a pair of spaced ribs 216.

[0048] Activating this therapeutic illumination can also reduce the number of viruses at insertion of the ventilator tube, a process that requires the HCP to be in close contact with the sick patient's mouth. The ventilator tube 70 can be attached to the assembly 60 by a tube attachment structure 214 located on one side of the rib 216. The tube attachment structure 214 can be swiveled as needed to attach to the tube 70. The attachment swivels in the same plane as the illumination assembly 60. The design of the ventilator mouthpiece / head strap can vary but typically includes a strap for tightening around the head, a portion that contacts the front of the patient's head, usually between the nose and mouth, and a portion for attaching the ventilator tube via adhesive, clips, or some other mechanism. It may include at least one adhesive patch for securing the mouthpiece / head strap to the patient's head. The ventilator tube can be single or branched, flexible, extendable, etc. The device may include an optical lens. A complete device showing the mouthpiece / head strap and ventilator tube is shown as item 80. The illustrated embodiment connects to an external power source via wires 206 and lead 224, but integrated battery power can be used.

[0049] Referring to Figures 84 to 96B, a therapeutic lighting assembly 314 is shown, which is incorporated into the ventilator tube between the corrugated ventilator tube 316 and the intubation tube 312, and is part of assembly 100. The lighting assembly 314 includes a therapeutic light source 328. The lighting assembly 314 is activated by a push button 318. An intubated patient has a tube that goes through the throat and into the lungs to assist breathing when the lungs are damaged. In infectious respiratory diseases, insertion, washing, removal, and other actions associated with the ventilator tube put the HCP at risk of contracting airborne viruses and other contact-borne diseases from the infectious patient. By incorporating therapeutic lighting into the tube, the light shines into the patient's mouth, is inside the tube, travels to the ventilator, and escapes into the air surrounding the patient, reducing the number of viruses in the patient. The ventilator tube may be single or branched, flexible, stretchable, etc.

[0050] Therapeutic illumination may be directly integrated into the tube or assembled into the tube assembly. The device may include an optical lens, or the tube may be manufactured from a material that transmits therapeutic illumination. The ventilator tube may be connected to or attached to a mouthpiece / head strap, as shown in assembly 110. The head strap can be attached to the tube by attachment structure 404. Embodiments showing an endotracheal intubation device are included, which can be readily adapted to a nasogastric intubation device or an optical fiber intubation device.

[0051] Referring to Figures 97–106B, a mountable therapeutic lighting assembly 120 intended for mounting to a ventilator tube is shown. The assembly 120 includes a mountable lighting body 332 that is mounted on a non-rotating tube mounting clamp and is coplanar. A printed circuit board (PCB) assembly 338 fits into a PCB assembly cavity 336 and is covered by a lens cover 342 and a lens 348. The lighting is activated by a push button 344. Here, the therapeutic lighting assembly 120 is a separate component (not built integrally with the ventilator tube) and is mounted to the ventilator tube to illuminate the patient's mouth / nose and reduce the number of viruses. A clip mechanism is shown, but it can be mounted via adhesive, strap, clamp, or any other mechanism. This allows the assembly 120 to be mounted independently to any tube, with or without a head strap, and makes it more versatile for various ventilator tube shapes from different manufacturers. Embodiments showing an endotracheal intubation device are included, which can be easily adapted to a transnasogastric or fiber optic intubation device. The mouthpiece is shown as item 300, and a fully assembled embodiment is shown as item 130.

[0052] Referring here to Figures 107–115B, a therapeutic lighting assembly 414 is shown, integrated into the tracheostomy tube between the intermediate tube 412 and the corrugated ventilator tube 416. The lighting 428 is circumferentially arranged around the PCB 422 and powered by a battery 426 operated by a push button 418. A tracheostomy or tracheostomy tube is a ventilator tube inserted directly into the lungs through an incision in the neck into the trachea. Tracheostomy tubes can typically be connected and disconnected on the surface of the neck and include ports that seal the incisions in the neck and trachea. Nevertheless, having therapeutic lighting that illuminates inside and around the tube can act to reduce the number of viruses from anywhere inside and around the tube site. Instead of an integrated battery power supply, wired or external power supplies may also be present.

[0053] Referring to Figures 116–134, therapeutic illumination bag-mask ventilators, which are bag-mask type ventilators 502, are shown. These devices typically include some kind of face mask 528 that seals to cover the nose and mouth, and a bag 516 attached via a bag-mask manifold 532, the bag 516 of which can be manually compressed to deliver air to the lungs of a patient with respiratory distress. Illumination 548 can be inserted into a structure that houses the illumination component 506. Some ventilator-assisted patients who cannot be intubated may also have modified ventilation via a mask connected to the ventilator. One embodiment shows therapeutic illumination positioned within a mask to directly illuminate the nose and mouth of an infected patient. This embodiment is shown as item 150.

[0054] An alternative embodiment involves placing therapeutic lighting within the mask's airway to reduce the amount of virus entering the bag and help protect the HCP, particularly the person treating the patient, by compressing the bag. This embodiment is shown as item 160. The mask may also include a filter material through which air is expelled to capture particulate matter exhaled by the patient. Another embodiment shows mask ventilation attached to a tube connected to a ventilator rather than a bag. This embodiment is shown as item 170.

[0055] Referring here to Figures 135-140B, therapeutic illumination personal protective masks are shown. This concept 602 is not about reducing the viral load at the site of viral shedding (the infected patient and their mouth, nose, or surgical site), but rather about treating the infectious agent as it enters the body of the HCP. Applying therapeutic illumination to surgical masks, face shields, goggles, or other devices reduces the amount of virus that passes through to other PPE and HCP.

[0056] One embodiment, shown as item 180, includes a surgical mask, shield, or face shield for protecting the eyes and a head strap for securing the device to 602. This embodiment includes therapeutic illumination 638 within the mask for treating infectious agents before they are inhaled, and therapeutic illumination mounted on the shield to reduce the amount of virus that could come into contact with the eyes. A second embodiment, shown as item 190, simply includes therapeutic illumination within a surgical mask. Both embodiments show battery-powered illumination, but an external power source may also be used. Both embodiments show LEDs, but other types of therapeutic light sources, such as laser diodes, may also be used.

[0057] While this disclosure is shown and described with reference to preferred embodiments, those skilled in the art will readily understand that changes and / or modifications can be made without departing from the spirit or scope of this disclosure.

Claims

1. A therapeutic lighting assembly for reducing the viral load in a patient, A housing for at least one therapeutic light source configured to emit light using air coming out of the patient's airway, A power supply coupled to at least the therapeutic light source, The housing comprises a tube attachment coupled to the housing, configured to secure the housing to the patient's tube, The therapeutic lighting assembly for reducing the viral load in a patient.

2. The tubes of the aforementioned patient include an endotracheal tube or a nasal cannula. The lighting assembly according to claim 1.

3. The housing is coupled to a headset for attachment to the patient's head. The lighting assembly according to claim 1.

4. The headset includes a plurality of adhesive pads attached to an arched headset base. The lighting assembly according to claim 3.

5. The headset is configured to be positioned below the patient's nose. The lighting assembly according to claim 3.

6. The housing includes a first panel and a second panel, the first panel including a plurality of inward-facing ribs for positioning the therapeutic light source within the housing. The lighting assembly according to claim 1.

7. The tube attachment is coupled to the housing by a pair of spaced ribs. The lighting assembly according to claim 1.

8. The lighting assembly according to claim 1, wherein the housing includes an opening that allows the therapeutic light to illuminate toward and through the tube attachment.

9. The aforementioned tube attachment is rotatable around its axis. The lighting assembly according to claim 1.

10. The tube attachment is rotatable in a plane parallel to the plane defined by the housing. The lighting assembly according to claim 1.

11. The energy source is a battery housed within the housing. The lighting assembly according to claim 1.

12. The therapeutic light source includes a plurality of UV LEDs associated with a circuit board within the housing. The lighting assembly according to claim 1.

13. The therapeutic light source is selected from the group consisting of UV light, UV-C light, far UV-C light, infrared light, near-infrared light, low-level laser light, and white light. The lighting assembly according to claim 1.

14. The housing is placed inside the patient's tube. The lighting assembly according to claim 1.

15. The therapeutic light source comprises a plurality of light sources arranged circumferentially around the housing. The lighting assembly according to claim 1.

16. The tube attachment is securely attached to the housing. The lighting assembly according to claim 1.

17. The tube attachment is positioned on the same plane as the plane defined by the housing. The lighting assembly according to claim 16.

18. The aforementioned therapeutic light source is incorporated into the face mask. The lighting assembly according to claim 1.

19. The aforementioned therapeutic illumination is guided by an optical lens component, The lighting assembly according to claim 1.

20. A method for reducing the number of viruses released by a patient, Attaching a therapeutic light to the tube coming out of the patient's airway, When the tube is attached, the therapeutic light is activated, The method includes guiding the therapeutic light into the airway in order to reduce the amount of virus coming out of the airway. The method for reducing the number of viruses released by a patient.

21. The aforementioned airway is the patient's nose. The method according to claim 20.

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