PATHOGEN CONTAINMENT DEVICE

Abstract

The present invention provides a safer way to intubate 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, such as bacterial, myco-bacterial, viral, or fungal infections, originating from the patient and keeps them from 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.

Claims

1. A pathogen containment device which is particularly useful for intubating human patients, said device being comprised of a pathogen 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.

2. The pathogen containment device as specified in claim 1 wherein the containment chamber is comprised of folding sides which are affixed together through living hinges.

3. The pathogen containment device as specified in claim 1 wherein the pathogen containment chamber is comprised of a wall assembly and a top, wherein the wall assembly includes a back, a left side, and a right side, wherein the left side and the right side are capable of being folded onto the back, and wherein the left side and the right side are capable of being extended to be perpendicular to the back, and wherein the top is configured to fit over the left side, the back, and the right side in an essentially air tight manner when the left side and the right side are in a configuration where they are extended to be perpendicular to the back.

4. The pathogen containment device as specified in claim 3 wherein the right side wall and the left side wall are connected to the back wall through living hinges.

5. The pathogen containment device as specified in claim 4 wherein the top includes lips which are adapted to fit firmly over the left side, the back, and the right side when the left side and the right side are in a configuration where they are extended to be perpendicular to the back.

6. The pathogen containment device as specified in claim 3 wherein the pathogen containment chamber includes an air exhaust coupling.

7. The pathogen containment device as specified in claim 1 which is further comprised of a flexible sheet which is attached to the containment chamber and which is adapted to cover at least part of the patient in a manner that impedes pathogens from escaping from the containment chamber.

8. The pathogen containment device as specified in claim 7 wherein the flexible sheet is adapted to cover the entire body of the patient.

9. The pathogen containment device as specified in claim 7 wherein the flexible sheet seals the patient within the interior of the pathogen containment device.

10. The pathogen containment device as specified in claim 3 wherein the pathogen containment chamber is comprised of a plastic.

11. The pathogen containment device as specified in claim 10 wherein the plastic is a polyester.

12. The pathogen containment device as specified in claim 11 wherein the polyester is polyethylene terephthalate.

13. The pathogen containment device as specified in claim 12 wherein the polyethylene terephthalate has 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.

14. The pathogen containment device as specified in claim 4 wherein the left side wall, the right side wall, the back wall, and the top of the pathogen containment chamber have a wall thickness which is within the range of 14 mils to 100 mils and wherein the living hinges are within the range of 4 mils to 12 mils thick.

15. The pathogen containment device as specified in claim 4 wherein the left side wall, the right side wall of the back wall of the pathogen containment chamber have a wall thickness which is within the range of 20 mils to 40 mils and wherein the living hinges are within the range of 7 mils to 9 mils thick.

16. A pathogen containment kit which is comprised of the pathogen containment device as specified in claim 1 wherein the sides of the containment chamber are folded together and enclosed within a container.

17. The pathogen containment kit as specified in claim 15 wherein the container is a resealable bag.

18. The pathogen containment kit as specified in claim 15 wherein the container is a cardboard box.

19. The pathogen containment kit as specified in claim 16 which is further comprised of a flexible sheet which is adapted for attachment to the pathogen containment chamber in an essentially air tight manner and which is adapted for at least partially covering the body of a patient.

20. A method for intubating a patient which comprises (1) positioning the patient in an essentially horizontal position for performing the intubation; (2) positioning the pathogen containment device as specified in claim 7 over the head and body of the patient; (3) activating the means for exhausting air from the containment chamber; and (4) intubating the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a front side view of the pathogen containment device of this invention with the head of a patient shown within the containment chamber of the device.

[0012] FIG. 2 is a front view of the containment chamber showing the hands of a healthcare professional extending through the access ports on the back wall of the containment chamber as a patient is being intubated.

[0013] FIG. 3 illustrates the hands of a healthcare professional extending into the interior of the pathogen containment chamber of the pathogen containment device of this invention with a laryngoscope.

[0014] FIG. 4 illustrates a patient in the pathogen containment device of this invention wherein the body of the patient is substantially covered with a flexible sheet that extends from the pathogen containment chamber of the device.

[0015] FIG. 5 is a top view of the pathogen containment device showing an optional entry port and a roll of flexible sheet which is attached to the containment chamber and which can be extended partially or totally over a patient in a manner that impedes pathogens from escaping from the containment chamber.

[0016] FIG. 6 is a front perspective view of the pathogen containment device showing an optional entry port and a flexible sheet which is attached to the containment chamber and which substantially covers the patient in a manner that impedes pathogens from escaping from the containment chamber.

[0017] FIG. 7 is a side view of the pathogen containment chamber with an air exhaust line connected to the air exhaust coupling on the side of the chamber.

[0018] FIG. 8 is an exploded view of a pathogen containment kit of this invention.

[0019] FIG. 9 illustrates the wall assembly of the pathogen containment chamber with the left side wall and the right side wall being fully extended from the back wall.

[0020] FIG. 10 is an exploded view showing the left side wall and the right side wall extending from the back wall at 90° angles which allows the top to be lowered firmly onto the wall assembly so as to make an essentially air tight seal between the left side wall, the right side wall, and the back wall of the pathogen containment chamber.

[0021] FIG. 11 is an exploded lower left side perspective view of the pathogen containment chamber.

[0022] FIG. 13 is an exploded view of an entry port cover attachment.

[0023] FIG. 14 is a perspective view which further illustrates the access port cover attachment.

[0024] FIG. 15 is a perspective view which illustrates a removable adhesive cover being removed from the access port cover attachment to expose a layer of adhesive.

[0025] FIG. 16 is an exploded view of the pathogen containment chamber including the entry port cover attachments.

[0026] FIG. 17 illustrates the fully assembled pathogen containment chamber including the access port cover attachments.

[0027] 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:

[0028] 1—pathogen containment device

[0029] 2—pathogen containment chamber

[0030] 3—left side wall (of the pathogen containment chamber)

[0031] 4—right side wall (of the pathogen containment chamber)

[0032] 5—back wall (of the pathogen containment chamber)

[0033] 6—top (of the pathogen containment chamber)

[0034] 7—patient

[0035] 8—head of the patient

[0036] 9—healthcare professional

[0037] 10—hands (of healthcare professional)

[0038] 12—access port(s)

[0039] 13—flexible sheet

[0040] 14—laryngoscope

[0041] 15—optional entry port(s)

[0042] 16—roll of flexible sheet

[0043] 17—air tight removable covering

[0044] 18.—pathogen containment kit

[0045] 19—roll of flexible sheet

[0046] 20—air exhaust coupling

[0047] 21—air exhaust line

[0048] 22—air pump

[0049] 23—disinfecting zone

[0050] 24—packaging container

[0051] 25—wall assembly

[0052] 26—access port cover(s)

[0053] 27—equipment access port(s)

[0054] 28—flexible strips

[0055] 29—lip

[0056] 30—adhesive surface

[0057] 31—access port cover attachment

[0058] 32—access port cover support

[0059] 33—adhesive tape

[0060] 34—removable adhesive cover strip

DETAILED DESCRIPTION OF THE INVENTION

[0061] FIG. 1 and FIG. 2 are a perspective view taken from the back side of the pathogen containment device 1 of this invention. As can be seen, the pathogen containment chamber 2 is comprised of a left side wall 3, and right side wall 4, a back wall 5, and a top 6 with two access ports 12 which are adapted for allowing the hands 10 of a health care professional 9 access into the pathogen containment chamber 2. As can be seen, these access ports 12 are sufficient in size to allow the hands 10 of a healthcare professional 9 access therethrough and also are of sufficient size to permit the degree of movement necessary to carry out the required medical procedure with needed equipment, such as a laryngoscope 14. Typically, the access ports 12 are essentially circular and have a diameter which is within the range of about 4 inches to about 6 inches and normally have a diameter which is within the range of about 4.5 inches to about 5.5 inches.

[0062] FIG. 3 illustrates the hands 10 of a health care professional 9 extending into the pathogen containment chamber 2 in a manner whereby the health care professional 9 is capable of carrying out needed procedures on the head 8 of a patient 7. As can been seen, the access ports 12 on the back wall 5 of the pathogen containment chamber 2 allow sufficient access for the health care professional 9 to manipulate medical instruments, such as a laryngoscope 15, within the pathogen containment chamber 2 as need to carry out needed medical procedures

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] FIG. 4 illustrates the pathogen containment device 1 of this invention with a patient 7 being positioned with a flexible sheet 13 which is attached to the containment chamber 2 partially covering the patient 7 in a manner that impedes pathogens from escaping from the pathogen containment chamber 2. In this embodiment of the invention a flexible sheet 13 extends from the left side 3, the right side 4, and the top 6 of the pathogen containment chamber 2 in a manner which inhibits the flow of contaminated air from the inside to the outside of the pathogen containment device 1. In any case, the flexible sheet 13 impedes pathogens from escaping from the pathogen containment device 1 and entering into the surrounding environment. The flexible sheet 13 can be permanently attached to the pathogen containment chamber 2 or it can be attached and detached as needed with adhesive tape, a hook and loop fastener, such as Velcro, or some other means. The flexible sheet 13 can be comprised of plastic, a non-woven fabric, or a woven fabric, such as a woven cotton sheet. However, it is preferable for the material to have a low degree of air permeability.

[0068] FIG. 5 is a top view of the pathogen containment device 1 showing an optional entry port 15 on the top 6 of the containment chamber 2 and a roll of flexible sheet 16 which is attached to the containment chamber 2 and which can be unrolled so as to be extended partially or totally over a patient 7 in a manner that inhibits pathogens for escaping to the environment on the outside of the pathogen containment device 1. Optional entry ports 15, such as the one illustrated in FIG. 5, which are positioned on the top side 6 of the containment chamber 2 can preferably be sealed and resealed as needed to treat a patient. This can be done by simply positioning an essentially air tight removable covering 17, such as a plastic film, over the optional access port 15 which is not being used at the time.

[0069] FIG. 6 illustrates the pathogen containment device 1 of this invention with a patient 7 being positioned within the device. FIG. 6 shows the patient 7 being covered with a flexible roll of sheet 16 so as to reduce the level of pathogen laden air that can escape from the device into the environment surrounding the patient 7. The flexible sheet

[0070] FIG. 7 is a side perspective view of the containment chamber 1 showing an air exhaust coupling 20 which extends through right side wall 4 of the pathogen containment chamber 2. As can be seen an exhaust line 21 is connected to the air exhaust coupling 20 through which contaminated air is pumped from the containment chamber 2 with an air pump 22 and then passed through a disinfecting zone 23 which is capable of destroying pathogens in the contaminated air. This can be accomplished by sparged (bubbling) the contaminated air through a container, such as a bottle of disinfecting solution. For example, the disinfecting solution can be an aqueous sodium hypochlorite solution or an alcohol solution. The contaminated air can also be passed through a zone of which exposes it to a sufficient level of ionizing radiation to destroy or eradicate any pathogens that may be present. For instance, the air can be passed through an area that exposes it to a high level of ultra-violet light or an electron beam. The contaminated air can also be passed through a high efficiency filter which is capable of trapping bacteria and virus. For example the filter can be a one-gallon ULPA filter which is comprised of 56 pleat media including one cellulose layer and two glass layers which have a 99.999% efficient of trapping 0.12 micron particles including virus.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] FIG. 8 is an exploded view of a pathogen containment kit 18 of this invention. The pathogen containment kit 18 is comprised of a packaging container 24, a wall assembly 25 (which is comprised of the left side wall 3, the right side wall 4, and the back wall 5), a top 6, optionally a flexible sheet 13 which is adapted for attachment to the assembled pathogen containment chamber 2, and optionally a plurality of access port covers 26. The packaging container 24 can be a box, a bag, such as a zip lock bag, or another container that is capable of conveniently holding the components of the pathogen containment device 1.

[0075] FIG. 9 illustrates the wall assembly 25 with the left side wall 3 and the right side wall 4 being fully extended from the back wall 5. As can be seen, the back wall 5 includes two access ports 12 are positional apart horizontally to conveniently allow both hands of a health care professional to extend into the fully assembled pathogen containment chamber 2. The left side wall 3 and the right side wall 4 both include optional access ports 15 in this embodiment of the invention. In this embodiment of the invention the left side wall 3 and the right side wall 4 both include optional equipment access ports 27 through which equipment and/or intubation tubes can pass into the pathogen containment chamber 2. In any case the optional access ports 15 and optional equipment access ports 27 can be covered with air tight coverings to inhibit the escape of pathogens from the pathogen containment device 1.

[0076] FIG. 10 is an exploded view showing the left side wall 3 and the right side wall 4 extending from the back wall 5 at 90° angles which allows the top 6 to be lowered firmly onto the wall assembly 25 so as to make an essentially air tight seal between the left side wall 3, the right side wall 4, and the back wall 5 of the pathogen containment chamber 2. The left side wall 3 and the right side wall 4 are flexibly attached to the back wall 5 with flexible strips 28. The flexible strips 28 can be comprised of a flexible adhesive tape or preferably a thin layer of plastic. For instance, the wall assembly 25 of the pathogen containment chamber 2 can be made in a single molding wherein the left side wall 3 and the right side wall 4 are separated from the back wall 5 by flexible strips 28 with the flexible strips 28 being thinner than the walls to facilitate the ease with which the sides can be folded and unfolded from the back wall 5. These flexible strips act as living hinges through which the left side wall 3 and right side wall 4 are connected to the back side wall 5. It should be noted that such a living hinge is thin and flexible enough to allow movement between two otherwise rigid sections of the same part (the left side wall 3, the right side wall 4 and back wall 5 of the pathogen containment chamber). This wall assembly 25 is designed in such a fashion that all three sections (the left side wall 3, the right side wall 4, back wall 5, and the living hinges) are fabricated in one single form. The living hinge strip is designed to allow rotational movement of at least 90° and preferably at least 180° . These flexible strips will typically have a thickness which is within the range of 4 mils to 12 mils, will more typically have a thickness which is within the range of 6 mils to 10 mils, and will preferably have a thickness which is within the range of 7 mils to 9 mils. The sides and top of the pathogen containment chamber will typically have a thickness which is within the range of 14 mils to 100 mils, will more typically have a thickness which is within the range of 16 mils to 50 mils, and will preferably have a thickness which is within the range of 20 mils to 40 mils.

[0077] 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.

[0078] FIG. 11 is an exploded lower left side perspective view of the pathogen containment chamber 2. As can be seen the top 6 includes lips 29 that extend downwardly so that an essentially air tight seal is made when the top 6 is lowered onto the wall assembly 25. The top 6 can optionally be taped onto the wall assembly 25 to make an even tighter seal and to further stabilize the structural integrity of the assembled pathogen containment chamber 2. FIG. 12 is an expanded view of area 12 of the top 6 which more clearly shows the lip 29 and optional adhesive tape 33 that can be used to further secure the top 6 to the left side wall 3, the right side wall 4, and the back wall 5 of the pathogen containment chamber 2.

[0079] FIG. 13 is an exploded view of an entry port cover attachment 31 that can optionally be used to conveniently affix a cover over access ports. The entry port cover attachment 31 is comprised of an access port cover support 32 which is adapted to firmly fit into the access port. The access port cover support 32 will preferably have an adhesive surface 30 covering the top surface thereof and a removable protective cover 34 which covers the adhesive surface 30 until such time that it is desired to cover the access port by affixing a film or fabric to the exposed adhesive on the entry port cover attachment 31. FIG. 14 and FIG. 15 further illustrate the access port cover attachment. FIG. 16 is an exploded view of the pathogen containment chamber 2 including the entry port cover attachments 31 and FIG. 17 illustrates the fully assembled pathogen containment chamber 2 including the access port cover attachments 31.

[0080] 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.