Endotracheal intubation involves passing a tube through the mouth/nose, between the vocal cords, and ultimately into the trachea of a patient. Intubation is typically carried out for the purpose of helping a patient to breathe during surgical procedures, after an injury, and to facilitate breathing which is compromised by virtue of complications resulting from heart failure, collapsed lungs, cancer, bacterial infections (such as pneumonia, chronic obstructive pulmonary disease, or severe asthma), and viral infections. For example, thousands of patients are currently being intubated for the purpose of being mechanically ventilated as a result of severe cases of coronavirus (COVID-19). Thousands of other patients having a wide variety of other infectious diseases are also being intubated for one purpose or another.
In any case, coronavirus is a highly infectious disease which poses a great risk to healthcare workers that are caring for patients that are infected with this dangerous virus. Intubation of such patients is particularly dangerous because during the intubation procedure patients exhale virus laden breath and also frequently cough, gag, vomit, sneeze, and otherwise project bodily fluids and pathogen containing aerosols into the atmosphere in close proximity to or even onto the health care workers that are intubating the patient. The incidence of being infected with coronavirus among such health care workers is alarmingly high even though such health care workers wear masks, shields, goggles, gowns, and other protective gear. Accordingly, there is a critical need for such health care professionals to be further protected from pathogens, such as COVID-19, while intubating patients.
Aerosol boxes which are designed to cover the head of a patient during an intubation procedure are used in some cases. Such aerosol boxes are comprised of a clear plastic which allow the healthcare professional with an unobstructed view of the patient to facilitate carrying out the intubation procedure. Such prior art devices typically include two openings situated on the back wall of the aerosol box to allow for the healthcare professional administering the intubation to have access of his or her hands to the head and mouth of the patient. Such prior art device will inherently block bodily fluids from being directly projected onto healthcare workers that are administering the intubation. However, it does not prevent airborne suspensions or aerosols containing pathogens from escaping from the box and entering into the air in close proximity to the healthcare professionals. Another problem with conventional aerosol boxes of the prior art is that they required a great deal of storage space. This can lead to difficulties in the case health care facilities which have only a limited amount of storage space in supply rooms and storage areas. Ridged aerosol boxes are also costly and difficult to transport in large numbers by virtue of being bulky and in some cases susceptible to being damaged. In the case of reusable aerosol boxes cleaning and sterilization between patients is also difficult and time consuming. Rigid aerosol boxes also present a solid waste disposal problem by virtue of being bulky and potentially contaminated with dangerous pathogens.
Better pathogen containment systems are needed to better protect doctors, nurses, and other healthcare professionals from airborne pathogens, such as bacterial and virus, during the intubation of patients and in carrying out other procedures. There is also a continuing need for a pathogen containment system than can be transported and stored in a compacted state and which can be easily a quickly assembled for use. Preferably such a pathogen containment system is low enough in cost to make it commercially viable to be used as a single use disposable product. After being used it should also be capable of being compacted again for easy of disposal as solid waste.
The present invention provides a safer way to intubate and to carry out other procedures on patients having communicable diseases, such as bacterial and viral infections. It protects health care professionals performing the intubation from bodily fluids of the patients that might otherwise be projected directly onto them by coughing, gagging, vomiting, or sneezing. Additionally, it traps airborne suspensions or aerosols containing pathogens originating from the patient and keeps them entering into the air in close proximity to the healthcare professionals. The contaminated air can then be vented to a location which is away from personnel, such as an outdoor containment area. In one embodiment of this invention the contaminated air is passed through a disinfecting solution which destroys the pathogens before the air is recycled into the environment, such as the room where the intubation is carried out. In still another embodiment of the invention the contaminated air from the device is filtered to remove pathogens. Passing the exhaust gas from the device of this invention through a disinfecting solution and/or filtering it is of particular value in cases where it is not possible or practical to vent the contaminated air to a safe location.
In one highly preferred embodiment of this invention the pathogen containments device is provided in a configuration that allows it to be shipped in stored in a highly compact form. In this embodiment of the invention the side walls and back wall of the pathogen containment chamber are designed so that they can be folded together into a compact form which can nest into the top of the containment chamber. This allows for easy shipment and storage in packaging of minimal volume. Additionally, the pathogen containment chamber can be easily and quickly assembled by simply unfolding the sides from the back (the sides will be extended at an angel of approximately 90° from the back). Then, the assembly of the pathogen containment chamber is completed by simply placing the top on the extended sides and back of the chamber. The pathogen containment system of this invention is preferably made of a low cost polyester, such as polyethylene terephthalate, with will provide it with adequate strength, durability, and clarity for its intended used at a low enough in cost to make it commercially viable to be used as a single use disposable product. In this embodiment of the invention after being used the pathogen containment chamber can also be again folded into a compacted form to allow for easy disposal which occupies minimal volume as solid waste.
The subject invention more specifically discloses a pathogen containment device which is particularly useful for intubating human patients, said device being comprised of a containment chamber which is adapted for being positioned over and covering the head of the patient, said containment chamber having two access ports which are adapted for allowing the hands of a health care worker access into the containment chamber, and said containment chamber having an air exhaust coupling, wherein the containment chamber is at least partially comprised of an essentially transparent material which allows for the health care worker to have a sufficient view of the head of the patient to perform intubation of the patient.
The present invention further reveals a pathogen containment kit which is comprised of a pathogen containment device which is particularly useful for intubating human patients, said device being comprised of a containment chamber which is adapted for being positioned over and covering the head of the patient, said containment chamber having two access ports which are adapted for allowing the hands of a health care worker access into the containment chamber, and said containment chamber having an air exhaust coupling, wherein the containment chamber is at least partially comprised of an essentially transparent material which allows for the health care worker to have a sufficient view of the head of the patient to perform intubation of the patient, and wherein the sides of the containment chamber are folded together and enclosed within a sealed bag.
The present invention also discloses a method for intubating a patient which comprises (1) positioning the patient in an essentially horizontal position for performing the intubation; (2) positioning a pathogen containment device over the head of the patient, wherein the pathogen containment device is comprised of a containment chamber which is adapted for being positioned over and covering the head of the patient, said containment chamber having two access ports which are adapted for allowing the hands of a health care worker access into the containment chamber, and said containment chamber having an air exhaust coupling and a means for exhausting air from the containment chamber through the air exhaust coupling, wherein the containment chamber is at least partially comprised of an essentially transparent material which allows for the health care worker to have a sufficient view of the head of the patient to perform intubation of the patient; (3) activating the means for exhausting air from the containment chamber; and (4) intubating the patient. In most cases it is desirable to keep the pathogen containment device positioned over the head of the patient after completion of the intubation procedure and throughout the entire period during which the patient is contagious. In such cases, it is advantageous to seal all access ports to reduce the risk of pathogens escaping and to minimize the required level of exhaust air flow. For instance, during the intubation procedure it may be desirable to exhaust air from the pathogen containment chamber at a flow rate of 1500 to 3000 liters per minute. However, after completing the procedure and plugging the access ports an air flow art of only 30 to 50 liters per minute may be required. In such procedures the access ports can easily be plugged by simply affixing a plastic film over them by use of tape or any other suitable means.
The reference numerals used in the drawings used to identify the elements of the aerosol box of the prior art and the pathogen containment device of this invention are as follows:
1—pathogen containment device
2—pathogen containment chamber
3—left side wall (of the pathogen containment chamber)
4—right side wall (of the pathogen containment chamber)
5—back wall (of the pathogen containment chamber)
6—top (of the pathogen containment chamber)
7—patient
8—head of the patient
9—healthcare professional
10—hands (of healthcare professional)
12—access port(s)
13—flexible sheet
14—laryngoscope
15—optional entry port(s)
16—roll of flexible sheet
17—air tight removable covering
18.—pathogen containment kit
19—roll of flexible sheet
20—air exhaust coupling
21—air exhaust line
22—air pump
23—disinfecting zone
24—packaging container
25—wall assembly
26—access port cover(s)
27—equipment access port(s)
28—flexible strips
29—lip
30—adhesive surface
31—access port cover attachment
32—access port cover support
33—adhesive tape
34—removable adhesive cover strip
In various embodiments of this invention the pathogen containment chamber 2 can be a clear square, rectangular, trapezoid, or circular box with open areas for the hands 10 of a practitioner and/or assistants to access and serve the needs of a patient 7. These access ports 12 can be customized as required to perform desired tasks. The pathogen containment chamber 2 is typically made of light clear plastic that can optionally be colored or darkened as needed to facilitate the conduction of needed medical procedures. It can also include optional internal and/or external lightening sources, access points for suction of air, or for the delivery of aerosolized treatments. The pathogen containment device 1 can also optionally include flexible extension sheets 13 which are attached to the front, sides and/or back of the pathogen containment chamber 2 and which can be adapted to fully or partly cover the body of the patient 7 to better contain pathogens with the pathogen containment device 1. In any case, the pathogen containment device can be designed to (1) protect healthcare workers, (2) protect the patient, and/or (3) provide the patient with a beneficial controlled environment.
The pathogen containment device 1 of this invention can be used to protect doctors, dentists, nurses, dental hygienists, health care workers, beauticians, facial cosmetologists, tattoo artists, makeup artists, and others from any harmful elements and pathogens that the patient may emit into the environment (air) around them. It can be of particular value in carrying out medical procedures, such as the introduction or withdrawal of intubation including, but not limited to, endo-tracheal tubes, naso tracheal tubes, LMA tubes, nasogastric tubes, tracheostomy tubes, gastric tubes, tracheostomy care, bronchoscopy, endoscopy, tracheal suction or irrigation, central line, EGD, and the like. The pathogen containment device 1 of this invention is of particular value in conducting such procedures on contagious patients having bacterial, myco-bacterial, viral, or fungal infections. Continued use of the pathogen containment device 1 of this invention after such procedures have been completed through the end of the period during which the patient 7 is contagious can be high desirable in limiting the spread of disease to health care professionals 9 caring for the patient 7. For example, the pathogen containment device 1 of this invention can be kept on the patient 7 for a period on many days of even longer than a week. In another scenario, the pathogen containment device 1 can be placed over the head 8 of any patient showing signs of infection, such as elevated temperature, labored breathing, gaging, coughing, sneezing, vomiting, or belching, without the need to carry out any type of intubation procedure or other specific procedure.
In some cases the pathogen containment device 1 of this invention is useful for the purpose of isolating a patient 7 from airborne pathogens originating from health care workers or visitors, and/or unhealthy environment conditions, including dust, harmful airborne particles, allergens, perfumes, toxic gases, or light. The use of the device of this invention for reverse isolation of a patient can be particularly beneficial in the case of immune compromised patients, such as those having neutropenia. It can also be useful as a barrier for burn patients and to prevent drying or insensible fluid loss.
In another scenario the pathogen containment device 1 of this invention can be used to provide a patient 7 with a clean filtered air or a beneficial controlled environment, such as temperature control, humidity control, pH control, and oxygen content control. It can also be used in therapy, including light therapy or the application of mist, oxygen fortified air, and/or aerosolized medications under conditions of an engineered and controlled environment.
In one embodiment of this invention, contaminated air from the pathogen containment chamber 2 is drawn through the exhaust line 21 and into the vacuum system of a building, such as a hospital, clinic, or other health care facility, in which the pathogen containment device 1 is being used. In this particular embodiment of the invention the air exhaust line 21 is connected to a standard hospital suction (vacuum) coupling. The air exhaust line 21 is connected to the pathogen containment chamber 2 through the air exhaust coupling 20 to create a negative pressure within the pathogen containment chamber 2 thereby helping to prevent pathogens from escaping into the atmosphere surrounding the pathogen containment device 1. The level of suction applied will normally be sufficient to provide a gas flow rate which is within the range of 20 liters per minute to 4000 liters per minute and will typically be within the range of 30 liters per minute to 3000 liters per minute. It is, of course, important for the contaminated art being exhausting to be released into an area where it does not pose a health risk. In cases where the contaminated air is reintroduced into the room where the patient is being treated or where other people may be present it should be passed through a disinfecting zone, such as a disinfecting solution, ionizing radiation, or a ULPA filter, as previously explained.
In a preferred embodiment of this invention the pathogen containment chamber is supplied in a compact form wherein the sides of the chamber have been folded together into a relatively thin square or rectangular shaped piece. In one embodiment of this invention the pathogen containment device 1 is provided in a pathogen containment kit 18. By virtue of their compacted size and shape these compacted pathogen containment chambers can be sealed in plastic bags to keep them clean for subsequent use after shipment and storage. It is preferable for them to be sealed in resealable plastic bags, such as zip-lock bags, so that they can be again deposited into such bags for safe disposal (for instance in hospital waste) in their folded state. In this embodiment of the invention the top side 6 of the compacted pathogen containment chamber is be folded over the back section 5 with the left side 3 being folded under the back section 5 and the right side 4 being folded under the lift side 3. It is, of course, possible for the various sides of the pathogen containment chamber to be folded over or under the back section 5 in other orders. For instance, the top side 6 could be folded over the back section 5 with the left side 3 being folded under the back section 5 and the right side 4 being folded under the lift side 3. In still another scenario, the top side 6, the left side 3, and the right side 4 could all be folded under the back section 5 in any desired order.
After being unfolded the assembled pathogen containment chamber 2 can be used in the intubation of patients for any number of other procedures that are being performed on infectious patients. The walls will preferably include a means for holding them together in the assembled position such as snap locks, ties, or adhesive tape. In a preferred embodiment of this invention the assembled pathogen containment chamber 2 includes two patient access ports 12 on its back wall 5, an optional access port 15 on its right side wall 4, and one or more optional air exhaust line ports or air exhaust couplings 20 on either its right side wall 4 or its left side wall 3. In one embodiment of the invention the pathogen containment chamber 2 is about 20 inches wide, about 16 inches deep, and has a height of about 19 inches. However, the width, depth, and height of the assembled pathogen containment chamber can vary with the width typically being within the range of 18 inches to 24 inches, the depth typically being within the range of 15 inches to 22 inches, and the height being within the range of 18 inches to 22 inches.
The plastic used in manufacturing the pathogen containment chamber should be clear for healthcare workers to have an excellent view of the patient. It should also be tough and durable. In cases where a one piece pathogen containment chamber is being made by molding the plastic it should also have enough flexibility to allow for the walls to be folded, such as through living hinges. It has been determined that polyethylene bottle resin having an intrinsic viscosity which is within the range of about 0.72 dl/g to about 0.82 dl/g as measured in a 60:40 phenol:tetrachloroethane solvent system at a temperature of 30° C. and at a concentration of 0.4 g/dl has excellent characteristics for this purpose. Polyethylene terephthalate having these characteristics is commercially available from DKA Americas as Cleartuf® 8600 polyester resin having an IV of 0.80 dl/g.
While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention.
This application claims benefit of U.S. Provisional Patent Application Ser. No. 63/019,244, filed on May 1, 2020 and additionally claims the benefit of U.S. Design Pat. Application Serial No. 29/768,754, filed on Feb. 1, 2021. The teachings of U.S. Patent Application Ser. No. 63/019,244 and U.S. Design Pat. Application Serial No. 29/768,754 are incorporated herein by reference in their entirety.
Number | Date | Country | |
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63019244 | May 2020 | US |
Number | Date | Country | |
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Parent | 29768754 | Feb 2021 | US |
Child | 17241278 | US |