Patent Application
20230147927
This invention relates generally to an isolation chamber that allows medical personnel to safely and efficiently perform necessary airway and aerodigestive procedures on a patient suffering from an easily transmittable and infectious disease during treatment of the patient. More particularly, to an isolation chamber and methods for protecting medical personnel against exposure from infectious agents transmitted from patients, while performing such medical procedures.
COVID-19 is a virulent species of coronaviridae that often causes severe pulmonary damage to patients and is easily transmitted to healthcare workers. COVID-19 is typically caused by the spread of the virus in respiratory droplets and/or particles from an infected patient and the virus has been shown to persist in the environment for significant periods with up to 3 hours of viability in aerosols and up to 3 days on surfaces. Hospitalized patients with this infectious disease often require significant respiratory care and medical procedures associated with such care, such as nebulization and intubation. Case reports in China documented a severely increased risk for healthcare professionals managing the airways and upper aerodigestive tracts of these patients. In fact, current critical care algorithms advocate for early intubation which increases the demand for ventilators. Exposed healthcare providers often become infected more frequently as compared to their non-medical counterparts likely due to increased viral load from higher exposure.
It is desirable to isolate a patient having a highly contagious infectious disease to ensure that the infectious disease is not spread to the medical personnel providing treatment. Conventional isolation devices and structures exist in the art for isolating a patient to protect medical personnel against prolonged exposure to the infectious disease. Unfortunately, prior art isolation apparatuses currently available for treating the patient in the field provide only physical barriers. These physical barriers do not effectively prevent transmission of the infectious disease to the medical personnel performing medical procedures during treatment to the infected patient. Other isolation chambers, such as disclosed in U.S. Pat. No. 7,503,890, are isolation systems that are cumbersome and difficult for medical personnel to perform medical procedures such as nebulization or intubation to the patient during treatment.
One solution to this problem, as disclosed in the present invention, is to provide an isolation chamber that is placed over an infected/contagious patient's head to contain disease and prevent contamination of the environment and mitigate exposure to medical personnel and healthcare workers. In addition to a barrier, vacuum suction can be used to decrease the concentration of disease within the chamber, which is particularly helpful during nebulizer, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) therapy and could prevent patients from needing a highly coveted respiratory ventilator.
The present invention is directed to an airway management isolation enclosure that allows medical personnel to safely manage the airway and upper aerodigestive tract of a patient having a transmittable infectious disease, while isolating the infected patient to an area about a bed, wherein the infected patient is supine or sitting upright on the bed.
The invented airway management isolation enclosure for protecting medical personnel from infectious agents when performing airway management or other medical procedures on a patient having an infectious disease, comprises: (a) a frame that is positioned over the head and anterior thoracic region of the patient; (b) a transparent barrier supported by the frame, which covers and forms a seal around the head and anterior thoracic region of the patient and which allows the medical personnel to create sealable entry ports; and (c) an air flow entry and a vacuum exit connection to direct the infectious agents in the form of respiratory droplets and particles produced by the patient to flow away from the head of the patient and out of the transparent barrier while the medical personnel manages the airway and upper aerodigestive tract of the patient. The term “air flow” as used herein includes the use of other breathable gases, such as medical oxygen.
In one embodiment, the airway management isolation enclosure comprises a frame that is hollow and further comprises a plurality holes and further comprises one or more air flow entry connections and one or more vacuum exit connections to direct air flow away from the head of the patient and out of the transparent covering. In a separate embodiment, the airway management isolation enclosure comprises an additional frame that is hollow and further comprises a plurality holes, wherein the additional frame is proportionally and progressively smaller, each frame further comprising one or more air flow entry connections and one or more vacuum exit connections,
In a separate embodiment, the air flow entry and a vacuum exit connection are a separate unit that is supported on the frame of the airway management isolation enclosure. The air flow entry and vacuum exit are connected by flexible tubing. The frame supports tubing comprising a plurality of holes, an air flow entry connection and a vacuum exit connection, to direct air flow away from the head of the patient and out of the isolation enclosure.
In a separate embodiment, the transparent barrier comprises a disposable plastic material. In another embodiment, the transparent barrier comprises a reusable and sterilizable material, including metals and ceramics.
In a separate embodiment, the airway management isolation enclosure comprises a modular frame, wherein the frame comprises polyvinylchloride (PVC) and is sterilizable.
In a separate embodiment, the airway management isolation enclosure comprises a modular frame, wherein the frame comprises a stainless steel that is autoclavable.
In a separate embodiment, the airway management isolation enclosure protects medical personnel while performing airway management from infectious agents selected from viruses possess positive-sense single-stranded RNA genomes, including the picornaviruses (which is a family of viruses that includes well-known viruses like Hepatitis A virus, enteroviruses, rhinoviruses, poliovirus, and foot-and-mouth virus), SARS virus, hepatitis C virus, yellow fever virus, and rubella virus, viruses possess negative-sense single-stranded RNA genomes, including Ebola and Marburg viruses, influenza virus, measles, mumps, rabies, Virion-Type of naked/Capsid nucleic Virus Family Virus Genera enveloped Symmetry acid, Reoviridae Reovirus, Rotavirus Naked Icosahedral, Picornaviridae Enterovirus, Rhino virus, Naked Icosahedral Hepatovirus, Cardiovirus, Aphthovirus, Parechovirus, Erbovirus, Kobuvirus, Teschovirus Caliciviridae, Norwalk virus, Hepatitis E virus Naked Icosahedral, Togaviridae Rubella virus Enveloped Icosahedral, Arenaviridae Lymphocytic choriomeningitis Enveloped Complex virus, Retroviridae HIV-1, HIV-2, HTLV-I Enveloped Complex, Flaviviridae Dengue virus, Hepatitis C virus, Enveloped Complex Yellow fever virus, Orthomyxoviridae Influenzavirus A, Influenzavirus B, Enveloped Helical ss Influenzavirus C, Isavirus, Thogotovirus, Paramyxoviridae Measles virus, Mumps virus, Enveloped Helical Respiratory syncytial virus, Bunyaviridae California encephalitis virus, Enveloped Helical Hantavirus, Rhabdoviridae Rabies virus Enveloped Helical, Filoviridae Ebola virus, Marburg virus Enveloped Helical, Coronaviridae Corona virus Enveloped Complex, SARS-CoV-2, COVID-19, Astroviridae Astrovirus Naked Icosahedral, Bornaviridae Borna disease virus Enveloped Helical, and bacterial pathogens.
In one embodiment, there is provided a method for protecting medical personnel from infectious agents when performing airway management on a patient having an infectious disease by assembling an isolation enclosure that comprises the steps of: (a) positioning a frame over the head and anterior thoracic region of the patient laying in a supine position or a sitting position; (b) placing a transparent barrier supported by frame, which covers and forms a seal around the head and anterior thoracic region of the patient; (c) creating sealable entry ports in the transparent barrier; and (d) using a vacuum from an exit connection to direct the infectious agents in the form of respiratory droplets and particles produced by the patient to flow away from the head of the patient and out of the transparent barrier while the medical personnel manages the airway and upper aerodigestive tract of the patient.
The following drawings form part of the present specification and are included to further demonstrate certain embodiments of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein.
The present invention overcomes problems known in the art and associated with conventional enclosures for protecting patients from infecting medical personnel while performing medical procedures such as airway management. The advantages, and other features of the system disclosed herein, will become more readily apparent to those having ordinary skill in the art from the following detailed description of certain preferred embodiments taken in conjunction with the drawings which set forth representative embodiments of the present invention.
A major problem in hospitals, and particularly in emergency wards, is the risk of the medical personnel contracting contagious diseases from an infectious agents transmitted by a patient while performing medical procedures such as airway management on the patient. SARS-CoV-2 is an example of such an infectious agent that causes the disease COVID-19. COVID-19 is typically caused by spread of the virus in respiratory droplets and/or particles from an infected patient and the virus has been shown to persist in the environment for significant periods with up to 3 hours of viability in aerosols and up to 3 days on surfaces.
Conventional physical barriers disclosed in the relevant art (
The invented airway management enclosure provides a solution for protecting medical personnel or healthcare workers while performing airway management procedures, such as high flow nasal cannula (when cannulization reaches a limit, such as 6 L/min and patient is still hypoxic, then patient is intubated in a controlled manner), nebulizer therapy, bilevel positive airway pressure (BiPAP), continuous positive airway pressure (CPAP) therapy. Prior to the inventors' discovery, COVID-19 therapy resulted in more intubations and significantly increasing mechanical ventilator usage. In fact, current COVID-19 therapeutic guidance significantly elevates airway management to minimize airborne and droplet production via early intubation.
The invented airway management isolation enclosure for protecting medical personnel from infectious agents when performing airway management or other medical procedures on a patient having an infectious disease, comprises: (a) a frame that is positioned over the head and anterior thoracic region of the patient; (b) a transparent barrier supported by the frame, which covers and forms a seal around the head and anterior thoracic region of the patient and which allows the medical personnel to create sealable entry ports; and (c) an air flow entry and a vacuum exit connection to direct the infectious agents in the form of respiratory droplets and particles produced by the patient to flow away from the head and out of the transparent barrier while the medical personnel manages the airway and upper aerodigestive tract of the patient.
One embodiment of the invented airway management isolation enclosure using a plastic frame is summarized in
In one embodiment, the frame of the airway management isolation enclosure is hollow and comprises an air flow inlet connection port, a vacuum exit connection port which is connected to a vacuum source to create a negative pressure and a plurality of holes in the frame. The material of the frame can be fabricated from medical grade thermoplastics and polymers, as disclosed in U.S. Pat. No. 6,635,324 B1. In some embodiments, the frame can be manufactured from a reusable plastic, metal, ceramic, a composite or a combination of materials that can be decontaminated or sterilized. In some embodiments the isolation enclosure frame includes one or more air flow entry connections and one or more vacuum exit connections. In other embodiments, the frame is manufactured from a disposable plastic or composite material. In one embodiment the frame is a plastic material selected from medical grade polyvinylchloride (PVC), Teflon tubing, 3D printed carbon fiber and nylon12. In some embodiments, the frame can be manufactured from a reusable medical grade metal (e.g. stainless steel, aluminum, titanium) that can be decontaminated or sterilized. In some embodiments, other types of medical grade metals or ceramics can be used as frame materials. In some embodiments, the frame can be rigid or collapsible. In some embodiments, the frame can be modular or monolithic. In a separate embodiment, the airway management isolation enclosure comprises two or more frames, an outer frame and an inner frames one progressively and proportionally smaller than the outer frame or sequential smaller frames. The two or more frames accommodate two or more barriers, increasing the effectiveness of infectious agent removal while medical personnel perform air management on a patient.
In one embodiment, the airway management isolation enclosure is referred to as a COVID-19 Airway Management Isolation Chamber, or CAMIC. When used with other PPE, CAMIC protects health care personnel by providing a physical barrier to aerosolized droplets from patients with COVID-19 by capturing and removing viral particles emitted by the patient. The self-contained device centers around the head, neck, and torso of the patient, providing a barrier between patient and provider. The air/vacuum circulation ports are purposely positioned, tested and integrated directly into the CAMIC's support frame.
In one embodiment, the metal frame of the airway management isolation enclosure (CAMIC) is foldable (
In a separate embodiment, the air flow entry and a vacuum exit connection are a separate unit that is supported on the frame of the airway management isolation enclosure. The frame supports tubing comprising a plurality of holes, an air flow entry connection and a vacuum exit connection, to direct air flow away from the head of the patient and out of the isolation enclosure. The air flow entry and vacuum exit are connected by flexible tubing (
A transparent barrier of the airway management isolation enclosure is supported by the frame, which covers and forms a seal around the head and anterior thoracic region of the patient and which allows the medical personnel to create sealable entry ports. The barrier can be manufactured from a suitable medical grade thermoplastic or polymers, such as polyethylene, that is transparent and allows the medical personnel to create sealable entry ports. The barrier covering of the isolation can be disposable clear/translucent plastic (e.g., materials used for bags/trash bags or even such consumer products in an emergency) or a longer-lasting translucent vinyl or a similar thermoplastic material that is reusable and can be sterilized. In one embodiment, the medical personnel to create sealable entry ports in the barrier. In some embodiments, working ports (e.g., slits, magnetic slits, or sleeves) can be incorporated in the barrier on the chamber to facilitate procedures (such as intubation/extubation, surgery, and nursing/respiratory therapy care). In some embodiments, the barrier of the isolation enclosure frame includes one or more air flow entry connections and one or more vacuum exit connections.
Infectious agents are removed from the airway management isolation enclosure by flowing air or oxygen (O2) away from the head of the patient and out of the isolation chamber, while medical personnel perform airway management on a patient. In some embodiments, air flow direction with the isolation enclosure is effected by flowing air or O2 though one or more entry connections and applying vacuum to one or more vacuum exit connections. In one embodiment, an entry port is provided within the frame connected to air or oxygen. A corresponding exit port is also provided in the frame which connects to a vacuum source. The relative negative pressure effect by vacuum moves infectious agents out of the isolation enclosure, as shown in
Ventilation smoke tests using a testing device outside the isolation chamber (
Vacuum and Air Testing
Vacuum Only Testing
CAMIC Spacing Testing (Vacuum and Air)
Infectious agents removed by the invented airway management isolation enclosure are pathogenic viruses and bacterial that can form aerosols or droplets, having a particle size from 0.002 to 2.00 microns.
In some embodiments, the infectious agents are viruses including:
In some embodiments, the infectious agents are bacterial pathogens that have been implicated in airborne transmission in health care facilities include, but are not limited to, group A streptococci, S. aureus, Neisseria meningitidis, and Bordetella pertussis. An outbreak of methicillin-resistant S. aureus in an intensive therapy unit was linked to the exhaust ducting of the adjacent isolation room ventilation system. Legionnaires' disease has occurred from exposure to aerosols generated from contaminated cooling towers. Additionally, the causative agent, Legionella pneumophila, has been isolated from aerosols produced by water faucets and shower heads, by humidifiers and nebulizers, and by squeezing manual ventilation bags.
The invented airway management isolation enclosure has a number of advantages, namely reducing the need for immediate intubation and mechanical ventilator use. By decreasing the risk of exposure of medical personnel to infectious agents, the isolation enclosure allows for the use of aerosolizing procedures (such as nebulizers and positive airway pressure (BiPAP/CPAP) to be used for patients in respiratory distress, potentially removing or delaying their need for a ventilator. This is crucial during the COVID-19 pandemic. The device also allows clinicians to perform procedures through access ports while maximizing their protection as they work near the infected airway. The device can be manufactured with these access ports pre-established in the device or without. The latter option allows the healthcare worker using the device to cut access ports/slots in the desired location and length for their particular suitability and ease of performing a given medical procedure.
There are significant advantages of the invented airway management isolation enclosure: the elements of the isolation enclosure can be easily modified for situations where airway management are required (emergency room versus examination room) or by the requirements of the airway management equipment (e.g. laryngoscope, intubating equipment. The isolation enclosure allows airway specialist to make holes where needed to allow normal technique in management of airway. The isolation enclosure provides protection of medical personnel with the respect to intubation and extubation. The isolation enclosure provides airway management by mitigating the risk and enabling other procedures before intubation, such as nebulizer delivery of medicines, BiPAP and CPAP therapy, while protecting medical personnel associated with airway management of the patient. The mitigation avoids unnecessary or early intubations, reduces mechanical ventilator demand and may render ventilator use unnecessary for certain patients.
Other advantageous features on the invented isolation enclosure include: an optional disposable or easily decontaminated barrier; single or double barriers depending on the nature of the infectious agent; suction within the chamber to reduce the concentration of virus particles; optional second layer of suction between double barrier layers; flexibility to introduce air/oxygen into the chamber either through the frame itself or via a separate disposable component inserted into the chamber(s); the option to have working ports (e.g., slits, magnetic slits, sleeves) to facilitate treatments (by surgeons, doctors, nurses, respiratory therapists) or to allow the user to make such ports; various model designs specific for the working environment (i.e., larger width to facilitate intubation/extubation in the operating room/ICU) and smaller cubic chamber to allow for more air turnovers for better use in the Intensive Care Unit/Floor/Emergency Room where aerosol-generating procedures are more likely to be performed. Also, a smaller design could be used for patient transport or for use by Emergency Medical Services/Paramedics/Combat Medics to mitigate exposure in the field.
While specific aspects of the subject disclosure have been discussed, the above specification is illustrative and not restrictive. Many variations of the disclosure will become apparent to those skilled in the art upon review of this specification and the claims below. The full scope of the disclosure should be determined by reference to the claims, along with their full scope of equivalents, and the specification, along with such variations.
This application claims priority to U.S. provisional patent application Ser. Nos. 63/008,033 filed Apr. 10, 2020 and 63/009,885 filed Apr. 14, 2020.
The invention was made with government support from organizations within the Defense Health Agency and the United States Army Medical Research and Development Command. The United States Government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/26591 | 4/9/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63008033 | Apr 2020 | US | |
| 63009885 | Apr 2020 | US |
